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Adding ACEI to Chemotherapy Does Not Prevent Cardiotoxicity
a new randomized trial showed.
The results suggested adding an ACE inhibitor doesn’t affect cardiac injury or cardiac function outcomes “and should not be used as a preventative strategy” in these patients, David Austin, MD, consultant cardiologist, Academic Cardiovascular Unit, The James Cook University Hospital, Middlesbrough, England, and chief investigator for the PROACT study, told this news organization.
But while these negative results are disappointing, he said, “we now have a definitive result in a robustly conducted trial that will take the field forward.”
The findings were presented on April 8, 2024, at the American College of Cardiology (ACC) Scientific Session 2024.
Anthracyclines, which are extracted from Streptomyces bacterium, are chemotherapy drugs widely used to treat several types of cancer. Doxorubicin is among the most clinically important anthracyclines.
While extremely effective, anthracyclines can cause irreversible damage to cardiac cells and ultimately impair cardiac function and even cause heart failure, which may only be evident years after exposure. “Cardiac injury is very common in patients treated with high dose anthracyclines,” noted Dr. Austin.
The open-label PROACT study included 111 adult patients, mean age 58 years and predominantly White and women, being treated for breast cancer (62%) or NHL (38%) at National Health Service hospitals in England with high-dose anthracycline-based chemotherapy.
Patients were randomized to standard care (six cycles of high-dose doxorubicin-equivalent anthracycline-based chemotherapy) plus the ACE inhibitor enalapril maleate or standard care alone. The mean chemotherapy dose was 328 mg/m2; any dose greater than 300 is considered high.
The starting dose of enalapril was 2.5 mg twice a day, which was titrated up to a maximum of 10 mg twice a day. The ACE inhibitor was started at least 2 days before chemotherapy began and finished 3 weeks after the last anthracycline dose.
During the study, enalapril was titrated to 20 mg in more than 75% of patients, with the mean dose being 17.7 mg.
Myocardial Injury Outcome
The primary outcome was myocardial injury measured by the presence (≥ 14 ng/L) of high sensitivity cardiac troponin T (cTnT) during anthracycline treatment and 1 month after the last dose of anthracycline.
cTnT is highly expressed in cardiomyocytes and has become a preferred biomarker for detecting acute myocardial infarction and other causes of myocardial injury.
Blood sampling for cTnT and cardiac troponin I (cTnI) was performed at baseline, within 72 hours prior to chemotherapy and at trial completion. All patients had negative troponin results at baseline, indicating no heart damage.
A majority of patients experienced elevations in troponin (78% in the enalapril group and 83% in the standard of care group), but there was no statistically significant difference between groups (adjusted odds ratio [OR], 0.65; 95% CI, 0.23-1.78; P = .405).
There was also no significant difference between groups in terms of cTnI, a secondary endpoint. However, the proportion of patients testing positive for cTnI (47% in the enalapril group and 45% in controls) was substantially lower than that for cTnT.
Large Discrepancy
The “large discrepancy in the rate of injury” with cTnT “has implications for the clinical interpretation of cardiac biomarkers in routine practice, and we should proceed with caution,” Dr. Austin told this news organization.
The finding has implications because guidelines don’t currently differentiate based on the type of troponin, Dr. Austin said in a press release. “I was surprised by the difference, and I think this raises the question of what troponin we should be using.”
Secondary outcomes focused on cardiac function, measured using echocardiography and included left ventricular global longitudinal strain (LVGLS) and left ventricular ejection fraction (LVEF). These were measured at baseline, 4 weeks after the last anthracycline dose and 1 year after the final chemotherapy.
There was no between-group difference in LVGLS cardiac function (21% for enalapril vs 22% for standard of care; adjusted OR, 0.95; 95% CI, 0.33-2.74; P = .921). This was also true for LVEF (4% for enalapril vs 0% for standard of care group; adjusted OR, 4.89; 95% CI, 0.40-674.62; P = .236).
Asked what the research team plans to do next, Dr. Austin said “the immediate first step” is to continue following PROACT patients. “We know heart failure events and cardiac dysfunction can occur later down the line.”
Due to the challenge of enrolling patients into trials like PROACT, “we should come together as a sort of a broader cardiovascular/oncology academic community to try to understand how we can better recruit patients into these studies,” said Dr. Austin.
“We need to solve that problem before we then go on to maybe examine other potential preventative therapies.”
He doesn’t think an alternative ACE inhibitor would prove beneficial. “We need to look elsewhere for effective therapies in this area.”
He noted these new findings are “broadly consistent” with other trials that investigated angiotensin receptor blockers.
Tough Population
Commenting on the study during a media briefing, Anita Deswal, chair, medicine, Department of Cardiology, Division of Internal Medicine, The University of Texas, commended the researchers for managing to enroll patients with cancer as this is “a tough” population to get to agree to being in a clinical trial.
“These patients are often overwhelmed financially, physically, and emotionally with the cancer diagnosis, as well as the cancer therapy and, therefore, to enroll them in something to prevent, maybe, some potential cardiac toxicity down the line, is really hard.”
Past trials investigating neuro-hormonal blockers to prevent cardiotoxicity have been criticized for enrolling patients at “too low risk,” said Dr. Deswal. “But investigators here went that step beyond and enrolled patients who were going to receive higher doses of anthracyclines, so kudos to that.”
And she noted investigators managed to get patients on almost the maximum dose of enalapril. “So, the drug was poised to have an effect — if it was there.”
The negative results may have something to do with endpoints. “Maybe we haven’t quite figured out what are the cutoffs for high sensitivity troponin I that identify patients truly at risk” of developing heart failure in the future.
Commenting on the study for this news organization, Anu Lala, MD, assistant professor of medicine at the Icahn School of Medicine at Mount Sinai, New York City, said the results may come as a surprise to some.
“ACE inhibitors are considered cardioprotective and for this reason are often used prophylactically in patients receiving chemotherapy.”
Dr. Lala agrees troponin may not be the right endpoint. “Another question is whether clinical outcomes should be followed in addition to symptoms or onset of any heart failure symptoms, which may hold greater prognostic significance.”
The study was funded by the National Institute for Health and Care Research.
A version of this article appeared on Medscape.com.
a new randomized trial showed.
The results suggested adding an ACE inhibitor doesn’t affect cardiac injury or cardiac function outcomes “and should not be used as a preventative strategy” in these patients, David Austin, MD, consultant cardiologist, Academic Cardiovascular Unit, The James Cook University Hospital, Middlesbrough, England, and chief investigator for the PROACT study, told this news organization.
But while these negative results are disappointing, he said, “we now have a definitive result in a robustly conducted trial that will take the field forward.”
The findings were presented on April 8, 2024, at the American College of Cardiology (ACC) Scientific Session 2024.
Anthracyclines, which are extracted from Streptomyces bacterium, are chemotherapy drugs widely used to treat several types of cancer. Doxorubicin is among the most clinically important anthracyclines.
While extremely effective, anthracyclines can cause irreversible damage to cardiac cells and ultimately impair cardiac function and even cause heart failure, which may only be evident years after exposure. “Cardiac injury is very common in patients treated with high dose anthracyclines,” noted Dr. Austin.
The open-label PROACT study included 111 adult patients, mean age 58 years and predominantly White and women, being treated for breast cancer (62%) or NHL (38%) at National Health Service hospitals in England with high-dose anthracycline-based chemotherapy.
Patients were randomized to standard care (six cycles of high-dose doxorubicin-equivalent anthracycline-based chemotherapy) plus the ACE inhibitor enalapril maleate or standard care alone. The mean chemotherapy dose was 328 mg/m2; any dose greater than 300 is considered high.
The starting dose of enalapril was 2.5 mg twice a day, which was titrated up to a maximum of 10 mg twice a day. The ACE inhibitor was started at least 2 days before chemotherapy began and finished 3 weeks after the last anthracycline dose.
During the study, enalapril was titrated to 20 mg in more than 75% of patients, with the mean dose being 17.7 mg.
Myocardial Injury Outcome
The primary outcome was myocardial injury measured by the presence (≥ 14 ng/L) of high sensitivity cardiac troponin T (cTnT) during anthracycline treatment and 1 month after the last dose of anthracycline.
cTnT is highly expressed in cardiomyocytes and has become a preferred biomarker for detecting acute myocardial infarction and other causes of myocardial injury.
Blood sampling for cTnT and cardiac troponin I (cTnI) was performed at baseline, within 72 hours prior to chemotherapy and at trial completion. All patients had negative troponin results at baseline, indicating no heart damage.
A majority of patients experienced elevations in troponin (78% in the enalapril group and 83% in the standard of care group), but there was no statistically significant difference between groups (adjusted odds ratio [OR], 0.65; 95% CI, 0.23-1.78; P = .405).
There was also no significant difference between groups in terms of cTnI, a secondary endpoint. However, the proportion of patients testing positive for cTnI (47% in the enalapril group and 45% in controls) was substantially lower than that for cTnT.
Large Discrepancy
The “large discrepancy in the rate of injury” with cTnT “has implications for the clinical interpretation of cardiac biomarkers in routine practice, and we should proceed with caution,” Dr. Austin told this news organization.
The finding has implications because guidelines don’t currently differentiate based on the type of troponin, Dr. Austin said in a press release. “I was surprised by the difference, and I think this raises the question of what troponin we should be using.”
Secondary outcomes focused on cardiac function, measured using echocardiography and included left ventricular global longitudinal strain (LVGLS) and left ventricular ejection fraction (LVEF). These were measured at baseline, 4 weeks after the last anthracycline dose and 1 year after the final chemotherapy.
There was no between-group difference in LVGLS cardiac function (21% for enalapril vs 22% for standard of care; adjusted OR, 0.95; 95% CI, 0.33-2.74; P = .921). This was also true for LVEF (4% for enalapril vs 0% for standard of care group; adjusted OR, 4.89; 95% CI, 0.40-674.62; P = .236).
Asked what the research team plans to do next, Dr. Austin said “the immediate first step” is to continue following PROACT patients. “We know heart failure events and cardiac dysfunction can occur later down the line.”
Due to the challenge of enrolling patients into trials like PROACT, “we should come together as a sort of a broader cardiovascular/oncology academic community to try to understand how we can better recruit patients into these studies,” said Dr. Austin.
“We need to solve that problem before we then go on to maybe examine other potential preventative therapies.”
He doesn’t think an alternative ACE inhibitor would prove beneficial. “We need to look elsewhere for effective therapies in this area.”
He noted these new findings are “broadly consistent” with other trials that investigated angiotensin receptor blockers.
Tough Population
Commenting on the study during a media briefing, Anita Deswal, chair, medicine, Department of Cardiology, Division of Internal Medicine, The University of Texas, commended the researchers for managing to enroll patients with cancer as this is “a tough” population to get to agree to being in a clinical trial.
“These patients are often overwhelmed financially, physically, and emotionally with the cancer diagnosis, as well as the cancer therapy and, therefore, to enroll them in something to prevent, maybe, some potential cardiac toxicity down the line, is really hard.”
Past trials investigating neuro-hormonal blockers to prevent cardiotoxicity have been criticized for enrolling patients at “too low risk,” said Dr. Deswal. “But investigators here went that step beyond and enrolled patients who were going to receive higher doses of anthracyclines, so kudos to that.”
And she noted investigators managed to get patients on almost the maximum dose of enalapril. “So, the drug was poised to have an effect — if it was there.”
The negative results may have something to do with endpoints. “Maybe we haven’t quite figured out what are the cutoffs for high sensitivity troponin I that identify patients truly at risk” of developing heart failure in the future.
Commenting on the study for this news organization, Anu Lala, MD, assistant professor of medicine at the Icahn School of Medicine at Mount Sinai, New York City, said the results may come as a surprise to some.
“ACE inhibitors are considered cardioprotective and for this reason are often used prophylactically in patients receiving chemotherapy.”
Dr. Lala agrees troponin may not be the right endpoint. “Another question is whether clinical outcomes should be followed in addition to symptoms or onset of any heart failure symptoms, which may hold greater prognostic significance.”
The study was funded by the National Institute for Health and Care Research.
A version of this article appeared on Medscape.com.
a new randomized trial showed.
The results suggested adding an ACE inhibitor doesn’t affect cardiac injury or cardiac function outcomes “and should not be used as a preventative strategy” in these patients, David Austin, MD, consultant cardiologist, Academic Cardiovascular Unit, The James Cook University Hospital, Middlesbrough, England, and chief investigator for the PROACT study, told this news organization.
But while these negative results are disappointing, he said, “we now have a definitive result in a robustly conducted trial that will take the field forward.”
The findings were presented on April 8, 2024, at the American College of Cardiology (ACC) Scientific Session 2024.
Anthracyclines, which are extracted from Streptomyces bacterium, are chemotherapy drugs widely used to treat several types of cancer. Doxorubicin is among the most clinically important anthracyclines.
While extremely effective, anthracyclines can cause irreversible damage to cardiac cells and ultimately impair cardiac function and even cause heart failure, which may only be evident years after exposure. “Cardiac injury is very common in patients treated with high dose anthracyclines,” noted Dr. Austin.
The open-label PROACT study included 111 adult patients, mean age 58 years and predominantly White and women, being treated for breast cancer (62%) or NHL (38%) at National Health Service hospitals in England with high-dose anthracycline-based chemotherapy.
Patients were randomized to standard care (six cycles of high-dose doxorubicin-equivalent anthracycline-based chemotherapy) plus the ACE inhibitor enalapril maleate or standard care alone. The mean chemotherapy dose was 328 mg/m2; any dose greater than 300 is considered high.
The starting dose of enalapril was 2.5 mg twice a day, which was titrated up to a maximum of 10 mg twice a day. The ACE inhibitor was started at least 2 days before chemotherapy began and finished 3 weeks after the last anthracycline dose.
During the study, enalapril was titrated to 20 mg in more than 75% of patients, with the mean dose being 17.7 mg.
Myocardial Injury Outcome
The primary outcome was myocardial injury measured by the presence (≥ 14 ng/L) of high sensitivity cardiac troponin T (cTnT) during anthracycline treatment and 1 month after the last dose of anthracycline.
cTnT is highly expressed in cardiomyocytes and has become a preferred biomarker for detecting acute myocardial infarction and other causes of myocardial injury.
Blood sampling for cTnT and cardiac troponin I (cTnI) was performed at baseline, within 72 hours prior to chemotherapy and at trial completion. All patients had negative troponin results at baseline, indicating no heart damage.
A majority of patients experienced elevations in troponin (78% in the enalapril group and 83% in the standard of care group), but there was no statistically significant difference between groups (adjusted odds ratio [OR], 0.65; 95% CI, 0.23-1.78; P = .405).
There was also no significant difference between groups in terms of cTnI, a secondary endpoint. However, the proportion of patients testing positive for cTnI (47% in the enalapril group and 45% in controls) was substantially lower than that for cTnT.
Large Discrepancy
The “large discrepancy in the rate of injury” with cTnT “has implications for the clinical interpretation of cardiac biomarkers in routine practice, and we should proceed with caution,” Dr. Austin told this news organization.
The finding has implications because guidelines don’t currently differentiate based on the type of troponin, Dr. Austin said in a press release. “I was surprised by the difference, and I think this raises the question of what troponin we should be using.”
Secondary outcomes focused on cardiac function, measured using echocardiography and included left ventricular global longitudinal strain (LVGLS) and left ventricular ejection fraction (LVEF). These were measured at baseline, 4 weeks after the last anthracycline dose and 1 year after the final chemotherapy.
There was no between-group difference in LVGLS cardiac function (21% for enalapril vs 22% for standard of care; adjusted OR, 0.95; 95% CI, 0.33-2.74; P = .921). This was also true for LVEF (4% for enalapril vs 0% for standard of care group; adjusted OR, 4.89; 95% CI, 0.40-674.62; P = .236).
Asked what the research team plans to do next, Dr. Austin said “the immediate first step” is to continue following PROACT patients. “We know heart failure events and cardiac dysfunction can occur later down the line.”
Due to the challenge of enrolling patients into trials like PROACT, “we should come together as a sort of a broader cardiovascular/oncology academic community to try to understand how we can better recruit patients into these studies,” said Dr. Austin.
“We need to solve that problem before we then go on to maybe examine other potential preventative therapies.”
He doesn’t think an alternative ACE inhibitor would prove beneficial. “We need to look elsewhere for effective therapies in this area.”
He noted these new findings are “broadly consistent” with other trials that investigated angiotensin receptor blockers.
Tough Population
Commenting on the study during a media briefing, Anita Deswal, chair, medicine, Department of Cardiology, Division of Internal Medicine, The University of Texas, commended the researchers for managing to enroll patients with cancer as this is “a tough” population to get to agree to being in a clinical trial.
“These patients are often overwhelmed financially, physically, and emotionally with the cancer diagnosis, as well as the cancer therapy and, therefore, to enroll them in something to prevent, maybe, some potential cardiac toxicity down the line, is really hard.”
Past trials investigating neuro-hormonal blockers to prevent cardiotoxicity have been criticized for enrolling patients at “too low risk,” said Dr. Deswal. “But investigators here went that step beyond and enrolled patients who were going to receive higher doses of anthracyclines, so kudos to that.”
And she noted investigators managed to get patients on almost the maximum dose of enalapril. “So, the drug was poised to have an effect — if it was there.”
The negative results may have something to do with endpoints. “Maybe we haven’t quite figured out what are the cutoffs for high sensitivity troponin I that identify patients truly at risk” of developing heart failure in the future.
Commenting on the study for this news organization, Anu Lala, MD, assistant professor of medicine at the Icahn School of Medicine at Mount Sinai, New York City, said the results may come as a surprise to some.
“ACE inhibitors are considered cardioprotective and for this reason are often used prophylactically in patients receiving chemotherapy.”
Dr. Lala agrees troponin may not be the right endpoint. “Another question is whether clinical outcomes should be followed in addition to symptoms or onset of any heart failure symptoms, which may hold greater prognostic significance.”
The study was funded by the National Institute for Health and Care Research.
A version of this article appeared on Medscape.com.
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All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>The addition of an angiotensin-converting enzyme (ACE) inhibitor did not decrease risk for chemotherapy-related cardiac damage in patients being treated for bre</metaDescription> <articlePDF/> <teaserImage/> <teaser>“We now have a definitive result in a robustly conducted trial that will take the field forward,” says an author of the new research.</teaser> <title>Adding ACEI to Chemotherapy Does Not Prevent Cardiotoxicity</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>oncr</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>card</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>ob</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>hemn</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">31</term> <term>5</term> <term>23</term> <term>18</term> </publications> <sections> <term>39313</term> <term canonical="true">53</term> </sections> <topics> <term>192</term> <term>242</term> <term canonical="true">270</term> <term>280</term> <term>27442</term> <term>49434</term> <term>48222</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Adding ACEI to Chemotherapy Does Not Prevent Cardiotoxicity</title> <deck/> </itemMeta> <itemContent> <p><span class="tag metaDescription">The addition of an angiotensin-converting enzyme (ACE) inhibitor did not decrease risk for chemotherapy-related cardiac damage in patients being treated for breast cancer and non-Hodgkin lymphoma (NHL),</span> a new randomized trial showed.</p> <p>The results suggested adding an ACE inhibitor doesn’t affect cardiac injury or cardiac function outcomes “and should not be used as a preventative strategy” in these patients, David Austin, MD, consultant cardiologist, Academic Cardiovascular Unit, The James Cook University Hospital, Middlesbrough, England, and chief investigator for the PROACT study, told this news organization.<br/><br/>But while these negative results are disappointing, he said, “we now have a definitive result in a robustly conducted trial that will take the field forward.”<br/><br/>The findings were presented on April 8, 2024, at the <span class="Hyperlink"><a href="https://www.medscape.com/viewcollection/37470">American College of Cardiology (ACC) Scientific Session 2024</a></span>.<br/><br/>Anthracyclines, which are extracted from <em>Streptomyces</em> bacterium, are chemotherapy drugs widely used to treat several types of cancer. Doxorubicin is among the most clinically important anthracyclines.<br/><br/>While extremely effective, anthracyclines can cause irreversible damage to cardiac cells and ultimately impair cardiac function and even cause heart failure, which may only be evident years after exposure. “Cardiac injury is very common in patients treated with high dose anthracyclines,” noted Dr. Austin.<br/><br/>The open-label PROACT study included 111 adult patients, mean age 58 years and predominantly White and women, being treated for breast cancer (62%) or NHL (38%) at National Health Service hospitals in England with high-dose anthracycline-based chemotherapy.<br/><br/>Patients were randomized to standard care (six cycles of high-dose doxorubicin-equivalent anthracycline-based chemotherapy) plus the ACE inhibitor enalapril maleate or standard care alone. The mean chemotherapy dose was 328 mg/m2; any dose greater than 300 is considered high.<br/><br/>The starting dose of enalapril was 2.5 mg twice a day, which was titrated up to a maximum of 10 mg twice a day. The ACE inhibitor was started at least 2 days before chemotherapy began and finished 3 weeks after the last anthracycline dose.<br/><br/>During the study, enalapril was titrated to 20 mg in more than 75% of patients, with the mean dose being 17.7 mg.<br/><br/></p> <h2>Myocardial Injury Outcome</h2> <p>The primary outcome was myocardial injury measured by the presence (≥ 14 ng/L) of high sensitivity cardiac troponin T (cTnT) during anthracycline treatment and 1 month after the last dose of anthracycline.<br/><br/>cTnT is highly expressed in cardiomyocytes and has become a preferred biomarker for detecting acute myocardial infarction and other causes of myocardial injury.<br/><br/>Blood sampling for cTnT and cardiac troponin I (cTnI) was performed at baseline, within 72 hours prior to chemotherapy and at trial completion. All patients had negative troponin results at baseline, indicating no heart damage.<br/><br/>A majority of patients experienced elevations in troponin (78% in the enalapril group and 83% in the standard of care group), but there was no statistically significant difference between groups (adjusted odds ratio [OR], 0.65; 95% CI, 0.23-1.78; <em>P</em> = .405).<br/><br/>There was also no significant difference between groups in terms of cTnI, a secondary endpoint. However, the proportion of patients testing positive for cTnI (47% in the enalapril group and 45% in controls) was substantially lower than that for cTnT.<br/><br/></p> <h2>Large Discrepancy</h2> <p>The “large discrepancy in the rate of injury” with cTnT “has implications for the clinical interpretation of cardiac biomarkers in routine practice, and we should proceed with caution,” Dr. Austin told this news organization.<br/><br/>The finding has implications because guidelines don’t currently differentiate based on the type of troponin, Dr. Austin said in a press release. “I was surprised by the difference, and I think this raises the question of what troponin we should be using.”<br/><br/>Secondary outcomes focused on cardiac function, measured using echocardiography and included left ventricular global longitudinal strain (LVGLS) and left ventricular ejection fraction (LVEF). These were measured at baseline, 4 weeks after the last anthracycline dose and 1 year after the final chemotherapy.<br/><br/>There was no between-group difference in LVGLS cardiac function (21% for enalapril vs 22% for standard of care; adjusted OR, 0.95; 95% CI, 0.33-2.74; <em>P</em> = .921). This was also true for LVEF (4% for enalapril vs 0% for standard of care group; adjusted OR, 4.89; 95% CI, 0.40-674.62; <em>P</em> = .236).<br/><br/>Asked what the research team plans to do next, Dr. Austin said “the immediate first step” is to continue following PROACT patients. “We know heart failure events and cardiac dysfunction can occur later down the line.”<br/><br/>Due to the challenge of enrolling patients into trials like PROACT, “we should come together as a sort of a broader cardiovascular/oncology academic community to try to understand how we can better recruit patients into these studies,” said Dr. Austin.<br/><br/>“We need to solve that problem before we then go on to maybe examine other potential preventative therapies.”<br/><br/>He doesn’t think an alternative ACE inhibitor would prove beneficial. “We need to look elsewhere for effective therapies in this area.”<br/><br/>He noted these new findings are “broadly consistent” with other trials that investigated angiotensin receptor blockers.<br/><br/></p> <h2>Tough Population</h2> <p>Commenting on the study during a media briefing, Anita Deswal, chair, medicine, Department of Cardiology, Division of Internal Medicine, The University of Texas, commended the researchers for managing to enroll patients with cancer as this is “a tough” population to get to agree to being in a clinical trial.<br/><br/>“These patients are often overwhelmed financially, physically, and emotionally with the cancer diagnosis, as well as the cancer therapy and, therefore, to enroll them in something to prevent, maybe, some potential cardiac toxicity down the line, is really hard.”<br/><br/>Past trials investigating neuro-hormonal blockers to prevent cardiotoxicity have been criticized for enrolling patients at “too low risk,” said Dr. Deswal. “But investigators here went that step beyond and enrolled patients who were going to receive higher doses of anthracyclines, so kudos to that.”<br/><br/>And she noted investigators managed to get patients on almost the maximum dose of enalapril. “So, the drug was poised to have an effect — if it was there.”<br/><br/>The negative results may have something to do with endpoints. “Maybe we haven’t quite figured out what are the cutoffs for high sensitivity troponin I that identify patients truly at risk” of developing heart failure in the future.<br/><br/>Commenting on the study for this news organization, Anu Lala, MD, assistant professor of medicine at the Icahn School of Medicine at Mount Sinai, New York City, said the results may come as a surprise to some.<br/><br/>“ACE inhibitors are considered cardioprotective and for this reason are often used prophylactically in patients receiving chemotherapy.”<br/><br/>Dr. Lala agrees troponin may not be the right endpoint. “Another question is whether clinical outcomes should be followed in addition to symptoms or onset of any heart failure symptoms, which may hold greater prognostic significance.”<br/><br/>The study was funded by the National Institute for Health and Care Research.</p> <p> <em>A version of this article appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/adding-acei-chemotherapy-does-not-prevent-cardiotoxicity-2024a10007ht">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
FROM THE ACC 2024
Telemedicine Reduces Rehospitalization, Revascularization in Post-PCI ACS Patients
ATLANTA — Patients with acute coronary syndrome (ACS) who had a myocardial infarction or unstable angina and underwent percutaneous coronary intervention (PCI) had a 76% lower rate of hospital readmission after 6 months if they participated in a remote monitoring protocol compared with similar patients who had standard post-discharge care, results of a new trial suggest.
The TELE-ACS trial showed that at 6 months, telemedicine patients also had statistically significantly lower rates of post-discharge emergency department visits, unplanned coronary revascularizations, and cardiovascular symptoms, such as chest pain, shortness of breath and dizziness. However, the rates of major adverse cardiovascular events (MACE) were similar between the two groups. The protocol included consultation with a cardiologist who reviewed home-monitoring data.
“The team was able to aid in preventing unnecessary presentations and advised the patients to seek emergency care whenever was necessary,” Nasser Alshahrani, MSc, a clinical research fellow at Imperial College London, said while presenting the results at the American College of Cardiology meeting. “The TELE-ACS protocol provided a significant reduction in readmission rates post-ACS and other adverse events.”
The study findings were published online simultaneously in the Journal of the American College of Cardiology.
Telemedicine Protocol
The trial, conducted from January 2022 to April 2023, randomly assigned 337 patients to telemedicine or standard care when they were discharged after PCI and had at least one cardiovascular risk factor. The telemedicine protocol consisted of 12-lead electrocardiogram belt, an automated blood-pressure monitor, and a pulse oximeter.
Patients in the telemedicine arm initiated the remote monitoring protocol if they thought they had cardiac symptoms. The majority (86%) were men with what the study described as “a high preponderance of cardiovascular risk factors.” Average age was 58.1 years.
If a telemedicine patient initiated the protocol, a cardiologist remotely assessed the patient’s symptoms and channeled the patient to the appropriate care pathway, whether reassuring the patient or sending them to a primary care physician or emergency department, or to call emergency services. Patients who didn’t get a call back from the cardiologist within 15 minutes were told to seek care in the standard clinical pathway.
Telemedicine patients were given the telemonitoring package and training in how to use the devices before they were discharged. They also received three follow-up quality control calls in the first two months to ensure they were using the equipment correctly. They kept the telemonitoring equipment for 8 months, but were followed out to 9 months. Six telemedicine patients dropped out while one standard care patient withdrew from the study.
Results showed that at 6 months, telemedicine patients had statistically significantly lower rates of post-discharge emergency department visits (25% vs 37%, P < .001), unplanned coronary revascularizations (3% vs 9%, P < .01) and cardiovascular symptoms, such as chest pain, shortness of breath and dizziness (a 13% to 18% difference for each symptom, P < .01).
MACE rates were similar between the two groups.
At 9 months, 3 months after the protocol ended, 20 telemedicine patients and 50 standard-care patients were readmitted to the hospital, while 52 and 73, respectively, went to the emergency department.
The telemedicine patients also had shorter hospital stays: an average of 0.5 and 1.2 days at 6 and 9 months, respectively, vs 1.5 and 1.8 days in the standard treatment arm (P < .001 for both).
Mr. Alshahrani noted several limitations with the study, namely that 86% of participants were men, and that the intervention was only offered to people who had smartphones. “The high level of support for the telemedicine group, with prompt cardiology responses, may be challenging to replicate outside a trial setting, requiring significant investment and training,” he added.
Human Element Key
In an interview from London after the presentation, lead author Ramzi Khamis, MB ChB, PhD, said, “This was quite a basic study. Really what we did was we integrated a clinical decision-making algorithm that we perfected with some quite novel but basic technology.” Future research should strive to add a home troponin test to the protocol and an artificial intelligence component, he said.
However, Dr. Khamis noted that human interaction was key to the success of the TELE-ACS trial. “The human factor is very important here and I think it would be really interesting to have a head-to-head comparison of human interaction with remote monitoring vs an AI-driven interaction,” he said. “I have my doubts that AI would be able to beat the human factor here.”
Lawrence Phillips, MD, medical director of outpatient cardiology at NYU Langone Heart, told this news organization that the study was appropriately powered to evaluate the telemedicine protocol, and that it could serve as a template for other studies of remote monitoring in cardiology.
“I think that this study is forming the foundation of evolving telemedicine data,” he said. “It shows really interesting results, and I’m sure it’s going to be reproduced in different ways going forward.”
While other studies have shown the utility of telemedicine to decrease unnecessary hospitalizations, this study went one step further, Dr. Phillips said. “What was unique about this study was the package that they put together,” he added. “It was a combination of telehealth and being able to speak with someone when you have concerns with objective data of an electrocardiogram, blood-pressure cuff, and oxygen level assessment, which is an interesting approach having that ejective data with [a] subjective element.”
The trial received funding from the British Heart Foundation; King Khalid University, Abha, Saudi Arabia via The Saudi Arabian Cultural Bureau; Sansour Fund, Imperial Healthcare Charity; and Safwan Sobhan Fund at Imperial College London. Mr. Alshahrani and Dr. Khamis have no relevant relationships to disclose. Dr. Phillips has no relevant disclosures.
A version of this article first appeared on Medscape.com.
ATLANTA — Patients with acute coronary syndrome (ACS) who had a myocardial infarction or unstable angina and underwent percutaneous coronary intervention (PCI) had a 76% lower rate of hospital readmission after 6 months if they participated in a remote monitoring protocol compared with similar patients who had standard post-discharge care, results of a new trial suggest.
The TELE-ACS trial showed that at 6 months, telemedicine patients also had statistically significantly lower rates of post-discharge emergency department visits, unplanned coronary revascularizations, and cardiovascular symptoms, such as chest pain, shortness of breath and dizziness. However, the rates of major adverse cardiovascular events (MACE) were similar between the two groups. The protocol included consultation with a cardiologist who reviewed home-monitoring data.
“The team was able to aid in preventing unnecessary presentations and advised the patients to seek emergency care whenever was necessary,” Nasser Alshahrani, MSc, a clinical research fellow at Imperial College London, said while presenting the results at the American College of Cardiology meeting. “The TELE-ACS protocol provided a significant reduction in readmission rates post-ACS and other adverse events.”
The study findings were published online simultaneously in the Journal of the American College of Cardiology.
Telemedicine Protocol
The trial, conducted from January 2022 to April 2023, randomly assigned 337 patients to telemedicine or standard care when they were discharged after PCI and had at least one cardiovascular risk factor. The telemedicine protocol consisted of 12-lead electrocardiogram belt, an automated blood-pressure monitor, and a pulse oximeter.
Patients in the telemedicine arm initiated the remote monitoring protocol if they thought they had cardiac symptoms. The majority (86%) were men with what the study described as “a high preponderance of cardiovascular risk factors.” Average age was 58.1 years.
If a telemedicine patient initiated the protocol, a cardiologist remotely assessed the patient’s symptoms and channeled the patient to the appropriate care pathway, whether reassuring the patient or sending them to a primary care physician or emergency department, or to call emergency services. Patients who didn’t get a call back from the cardiologist within 15 minutes were told to seek care in the standard clinical pathway.
Telemedicine patients were given the telemonitoring package and training in how to use the devices before they were discharged. They also received three follow-up quality control calls in the first two months to ensure they were using the equipment correctly. They kept the telemonitoring equipment for 8 months, but were followed out to 9 months. Six telemedicine patients dropped out while one standard care patient withdrew from the study.
Results showed that at 6 months, telemedicine patients had statistically significantly lower rates of post-discharge emergency department visits (25% vs 37%, P < .001), unplanned coronary revascularizations (3% vs 9%, P < .01) and cardiovascular symptoms, such as chest pain, shortness of breath and dizziness (a 13% to 18% difference for each symptom, P < .01).
MACE rates were similar between the two groups.
At 9 months, 3 months after the protocol ended, 20 telemedicine patients and 50 standard-care patients were readmitted to the hospital, while 52 and 73, respectively, went to the emergency department.
The telemedicine patients also had shorter hospital stays: an average of 0.5 and 1.2 days at 6 and 9 months, respectively, vs 1.5 and 1.8 days in the standard treatment arm (P < .001 for both).
Mr. Alshahrani noted several limitations with the study, namely that 86% of participants were men, and that the intervention was only offered to people who had smartphones. “The high level of support for the telemedicine group, with prompt cardiology responses, may be challenging to replicate outside a trial setting, requiring significant investment and training,” he added.
Human Element Key
In an interview from London after the presentation, lead author Ramzi Khamis, MB ChB, PhD, said, “This was quite a basic study. Really what we did was we integrated a clinical decision-making algorithm that we perfected with some quite novel but basic technology.” Future research should strive to add a home troponin test to the protocol and an artificial intelligence component, he said.
However, Dr. Khamis noted that human interaction was key to the success of the TELE-ACS trial. “The human factor is very important here and I think it would be really interesting to have a head-to-head comparison of human interaction with remote monitoring vs an AI-driven interaction,” he said. “I have my doubts that AI would be able to beat the human factor here.”
Lawrence Phillips, MD, medical director of outpatient cardiology at NYU Langone Heart, told this news organization that the study was appropriately powered to evaluate the telemedicine protocol, and that it could serve as a template for other studies of remote monitoring in cardiology.
“I think that this study is forming the foundation of evolving telemedicine data,” he said. “It shows really interesting results, and I’m sure it’s going to be reproduced in different ways going forward.”
While other studies have shown the utility of telemedicine to decrease unnecessary hospitalizations, this study went one step further, Dr. Phillips said. “What was unique about this study was the package that they put together,” he added. “It was a combination of telehealth and being able to speak with someone when you have concerns with objective data of an electrocardiogram, blood-pressure cuff, and oxygen level assessment, which is an interesting approach having that ejective data with [a] subjective element.”
The trial received funding from the British Heart Foundation; King Khalid University, Abha, Saudi Arabia via The Saudi Arabian Cultural Bureau; Sansour Fund, Imperial Healthcare Charity; and Safwan Sobhan Fund at Imperial College London. Mr. Alshahrani and Dr. Khamis have no relevant relationships to disclose. Dr. Phillips has no relevant disclosures.
A version of this article first appeared on Medscape.com.
ATLANTA — Patients with acute coronary syndrome (ACS) who had a myocardial infarction or unstable angina and underwent percutaneous coronary intervention (PCI) had a 76% lower rate of hospital readmission after 6 months if they participated in a remote monitoring protocol compared with similar patients who had standard post-discharge care, results of a new trial suggest.
The TELE-ACS trial showed that at 6 months, telemedicine patients also had statistically significantly lower rates of post-discharge emergency department visits, unplanned coronary revascularizations, and cardiovascular symptoms, such as chest pain, shortness of breath and dizziness. However, the rates of major adverse cardiovascular events (MACE) were similar between the two groups. The protocol included consultation with a cardiologist who reviewed home-monitoring data.
“The team was able to aid in preventing unnecessary presentations and advised the patients to seek emergency care whenever was necessary,” Nasser Alshahrani, MSc, a clinical research fellow at Imperial College London, said while presenting the results at the American College of Cardiology meeting. “The TELE-ACS protocol provided a significant reduction in readmission rates post-ACS and other adverse events.”
The study findings were published online simultaneously in the Journal of the American College of Cardiology.
Telemedicine Protocol
The trial, conducted from January 2022 to April 2023, randomly assigned 337 patients to telemedicine or standard care when they were discharged after PCI and had at least one cardiovascular risk factor. The telemedicine protocol consisted of 12-lead electrocardiogram belt, an automated blood-pressure monitor, and a pulse oximeter.
Patients in the telemedicine arm initiated the remote monitoring protocol if they thought they had cardiac symptoms. The majority (86%) were men with what the study described as “a high preponderance of cardiovascular risk factors.” Average age was 58.1 years.
If a telemedicine patient initiated the protocol, a cardiologist remotely assessed the patient’s symptoms and channeled the patient to the appropriate care pathway, whether reassuring the patient or sending them to a primary care physician or emergency department, or to call emergency services. Patients who didn’t get a call back from the cardiologist within 15 minutes were told to seek care in the standard clinical pathway.
Telemedicine patients were given the telemonitoring package and training in how to use the devices before they were discharged. They also received three follow-up quality control calls in the first two months to ensure they were using the equipment correctly. They kept the telemonitoring equipment for 8 months, but were followed out to 9 months. Six telemedicine patients dropped out while one standard care patient withdrew from the study.
Results showed that at 6 months, telemedicine patients had statistically significantly lower rates of post-discharge emergency department visits (25% vs 37%, P < .001), unplanned coronary revascularizations (3% vs 9%, P < .01) and cardiovascular symptoms, such as chest pain, shortness of breath and dizziness (a 13% to 18% difference for each symptom, P < .01).
MACE rates were similar between the two groups.
At 9 months, 3 months after the protocol ended, 20 telemedicine patients and 50 standard-care patients were readmitted to the hospital, while 52 and 73, respectively, went to the emergency department.
The telemedicine patients also had shorter hospital stays: an average of 0.5 and 1.2 days at 6 and 9 months, respectively, vs 1.5 and 1.8 days in the standard treatment arm (P < .001 for both).
Mr. Alshahrani noted several limitations with the study, namely that 86% of participants were men, and that the intervention was only offered to people who had smartphones. “The high level of support for the telemedicine group, with prompt cardiology responses, may be challenging to replicate outside a trial setting, requiring significant investment and training,” he added.
Human Element Key
In an interview from London after the presentation, lead author Ramzi Khamis, MB ChB, PhD, said, “This was quite a basic study. Really what we did was we integrated a clinical decision-making algorithm that we perfected with some quite novel but basic technology.” Future research should strive to add a home troponin test to the protocol and an artificial intelligence component, he said.
However, Dr. Khamis noted that human interaction was key to the success of the TELE-ACS trial. “The human factor is very important here and I think it would be really interesting to have a head-to-head comparison of human interaction with remote monitoring vs an AI-driven interaction,” he said. “I have my doubts that AI would be able to beat the human factor here.”
Lawrence Phillips, MD, medical director of outpatient cardiology at NYU Langone Heart, told this news organization that the study was appropriately powered to evaluate the telemedicine protocol, and that it could serve as a template for other studies of remote monitoring in cardiology.
“I think that this study is forming the foundation of evolving telemedicine data,” he said. “It shows really interesting results, and I’m sure it’s going to be reproduced in different ways going forward.”
While other studies have shown the utility of telemedicine to decrease unnecessary hospitalizations, this study went one step further, Dr. Phillips said. “What was unique about this study was the package that they put together,” he added. “It was a combination of telehealth and being able to speak with someone when you have concerns with objective data of an electrocardiogram, blood-pressure cuff, and oxygen level assessment, which is an interesting approach having that ejective data with [a] subjective element.”
The trial received funding from the British Heart Foundation; King Khalid University, Abha, Saudi Arabia via The Saudi Arabian Cultural Bureau; Sansour Fund, Imperial Healthcare Charity; and Safwan Sobhan Fund at Imperial College London. Mr. Alshahrani and Dr. Khamis have no relevant relationships to disclose. Dr. Phillips has no relevant disclosures.
A version of this article first appeared on Medscape.com.
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All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>ATLANTA — Patients with acute coronary syndrome (ACS) who had a myocardial infarction or unstable angina and underwent percutaneous coronary intervention (PCI) </metaDescription> <articlePDF/> <teaserImage/> <teaser>“The TELE-ACS protocol provided a significant reduction in readmission rates post-ACS and other adverse events.” </teaser> <title>Telemedicine Reduces Rehospitalization, Revascularization in Post-PCI ACS Patients</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>chph</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>card</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>mdsurg</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> <journalTitle/> <journalFullTitle/> <copyrightStatement>2018 Frontline Medical Communications Inc.,</copyrightStatement> </publicationData> </publications_g> <publications> <term>6</term> <term canonical="true">5</term> <term>15</term> <term>21</term> <term>52226</term> </publications> <sections> <term>53</term> <term canonical="true">39313</term> </sections> <topics> <term>48222</term> <term canonical="true">173</term> <term>236</term> <term>194</term> <term>336</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Telemedicine Reduces Rehospitalization, Revascularization in Post-PCI ACS Patients</title> <deck/> </itemMeta> <itemContent> <p>ATLANTA — Patients with acute coronary syndrome (ACS) who had a myocardial infarction or unstable angina and underwent percutaneous coronary intervention (PCI) had a 76% lower rate of hospital readmission after 6 months if they participated in a remote monitoring protocol compared with similar patients who had standard post-discharge care, results of a new trial suggest.</p> <p>The TELE-ACS trial showed that at 6 months, telemedicine patients also had statistically significantly lower rates of post-discharge emergency department visits, unplanned coronary revascularizations, and cardiovascular symptoms, such as chest pain, shortness of breath and dizziness. However, the rates of major adverse cardiovascular events (MACE) were similar between the two groups. The protocol included consultation with a cardiologist who reviewed home-monitoring data.<br/><br/>“The team was able to aid in preventing unnecessary presentations and advised the patients to seek emergency care whenever was necessary,” Nasser Alshahrani, MSc, a clinical research fellow at Imperial College London, said while presenting the results at the American College of Cardiology meeting. “The TELE-ACS protocol provided a significant reduction in readmission rates post-ACS and other adverse events.” <br/><br/>The study findings were <a href="https://doi.org/10.1016/j.jacc.2024.03.398">published online</a> simultaneously in the <em>Journal of the American College of Cardiology</em>.<br/><br/></p> <h2>Telemedicine Protocol</h2> <p>The trial, conducted from January 2022 to April 2023, randomly assigned 337 patients to telemedicine or standard care when they were discharged after PCI and had at least one cardiovascular risk factor. The telemedicine protocol consisted of 12-lead <a href="https://emedicine.medscape.com/article/1894014-overview">electrocardiogram</a> belt, an automated blood-pressure monitor, and a pulse oximeter. </p> <p>Patients in the telemedicine arm initiated the remote monitoring protocol if they thought they had cardiac symptoms. The majority (86%) were men with what the study described as “a high preponderance of <a href="https://emedicine.medscape.com/article/2500031-overview">cardiovascular risk factors</a>.” Average age was 58.1 years. <br/><br/>If a telemedicine patient initiated the protocol, a cardiologist remotely assessed the patient’s symptoms and channeled the patient to the appropriate care pathway, whether reassuring the patient or sending them to a primary care physician or emergency department, or to call emergency services. Patients who didn’t get a call back from the cardiologist within 15 minutes were told to seek care in the standard clinical pathway.<br/><br/>Telemedicine patients were given the telemonitoring package and training in how to use the devices before they were discharged. They also received three follow-up quality control calls in the first two months to ensure they were using the equipment correctly. They kept the telemonitoring equipment for 8 months, but were followed out to 9 months. Six telemedicine patients dropped out while one standard care patient withdrew from the study.<br/><br/>Results showed that at 6 months, telemedicine patients had statistically significantly lower rates of post-discharge emergency department visits (25% vs 37%, <em>P</em> < .001), unplanned coronary revascularizations (3% vs 9%, <em>P</em> < .01) and cardiovascular symptoms, such as chest pain, shortness of breath and dizziness (a 13% to 18% difference for each symptom, <em>P</em> < .01).<br/><br/>MACE rates were similar between the two groups.<br/><br/>At 9 months, 3 months after the protocol ended, 20 telemedicine patients and 50 standard-care patients were readmitted to the hospital, while 52 and 73, respectively, went to the emergency department.<br/><br/>The telemedicine patients also had shorter hospital stays: an average of 0.5 and 1.2 days at 6 and 9 months, respectively, vs 1.5 and 1.8 days in the standard treatment arm (<em>P</em> < .001 for both).<br/><br/>Mr. Alshahrani noted several limitations with the study, namely that 86% of participants were men, and that the intervention was only offered to people who had smartphones. “The high level of support for the telemedicine group, with prompt cardiology responses, may be challenging to replicate outside a trial setting, requiring significant investment and training,” he added.<br/><br/></p> <h2>Human Element Key</h2> <p>In an interview from London after the presentation, lead author Ramzi Khamis, MB ChB, PhD, said, “This was quite a basic study. Really what we did was we integrated a clinical decision-making algorithm that we perfected with some quite novel but basic technology.” Future research should strive to add a home troponin test to the protocol and an artificial intelligence component, he said.</p> <p>However, Dr. Khamis noted that human interaction was key to the success of the TELE-ACS trial. “The human factor is very important here and I think it would be really interesting to have a head-to-head comparison of human interaction with remote monitoring vs an AI-driven interaction,” he said. “I have my doubts that AI would be able to beat the human factor here.”<br/><br/>Lawrence Phillips, MD, medical director of outpatient cardiology at NYU Langone Heart, told this news organization that the study was appropriately powered to evaluate the telemedicine protocol, and that it could serve as a template for other studies of remote monitoring in cardiology. <br/><br/>“I think that this study is forming the foundation of evolving telemedicine data,” he said. “It shows really interesting results, and I’m sure it’s going to be reproduced in different ways going forward.”<br/><br/>While other studies have shown the utility of telemedicine to decrease unnecessary hospitalizations, this study went one step further, Dr. Phillips said. “What was unique about this study was the package that they put together,” he added. “It was a combination of telehealth and being able to speak with someone when you have concerns with objective data of an electrocardiogram, blood-pressure cuff, and oxygen level assessment, which is an interesting approach having that ejective data with [a] subjective element.”<br/><br/>The trial received funding from the British Heart Foundation; King Khalid University, Abha, Saudi Arabia via The Saudi Arabian Cultural Bureau; Sansour Fund, Imperial Healthcare Charity; and Safwan Sobhan Fund at Imperial College London. Mr. Alshahrani and Dr. Khamis have no relevant relationships to disclose. Dr. Phillips has no relevant disclosures.<span class="end"/></p> <p> <em>A version of this article first appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/telemedicine-reduces-rehospitalization-revascularization-2024a10006l4">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Frequent cannabis use tied to coronary artery disease
In the first part, in an observational study, daily cannabis use was associated with 34% higher odds for CAD, compared with never-users, in a large population-based U.S. cohort. Less frequent use was not associated with increased odds for CAD.
In the second part, people with a genetic susceptibility to cannabis use disorder or severe cannabis dependency had an increased risk for CAD, compared with other people.
Ishan Paranjpe, MD, the study’s lead author, reported these results in a press briefing and will present the study at the upcoming joint scientific sessions of the American College of Cardiology and the World Heart Federation 2023.
“A couple of takeaway points are that daily cannabis use, but not less frequent cannabis use, was associated with CAD” in the large population-based cohort, said Dr. Paranjpe, a resident physician at Stanford (Calif.) University, during the press conference.
“This analysis was adjusted for several possible confounders including age, sex at birth, [body mass index (BMI)], race, education, cigarette use, hypertension, high cholesterol, and diabetes,” he noted, and even after accounting for these risk factors, the association with heart disease remained.
“And the next thing, using Mendelian randomization, we sort of implied that there might be a causal relationship between cannabis and heart disease. Importantly this effect is independent of alcohol and cigarette use.
“The notion that cannabis is completely benign is probably wrong, and there might be certain risk of certain cardiovascular effects of cannabis we should be more on the lookout for,” Dr. Paranjpe said in an interview.
“Our main conclusion was that prevalent CAD is associated with cannabis consumption,” he added. “Other mechanistic work published in Cell has also shown that cannabis causes vascular inflammation that may lead to CAD.
“Thus, there is growing evidence from both laboratory and population studies that cannabis consumption may be harmful for cardiovascular health,” he said. “However, we still need more work on whether it affects the risk of incident cardiovascular events (i.e., stroke, heart attack) in patient[s] with existing CAD.”
ASCVD risk
Invited to comment, Robert L. Page II, PharmD, chair of the writing group for the American Heart Association’s scientific statement Medical Marijuana, Recreational Cannabis, and Cardiovascular Health, published in 2020, said, “This adds to our hypothesis that if you are using marijuana over a longer period, greater exposure, you’re going to see an increase in the risk” for atherosclerotic cardiovascular disease (ASCVD).
“We’re seeing this increased risk for ASCVD in young adults between ages 18 to 40 – people who think that they’re invincible,” Dr. Page, a professor at the University of Colorado at Denver, Aurora, who was not involved with this research, told this news organization in an interview.
“The bottom line is that the risk that they are seeing is what has also been documented in other observational studies, and it adds fuel to the fire. We need to be paying close attention to this,” he said.
“Primary care [clinicians], cardiologists, need to address this, particularly in younger adults – because that’s where you’re seeing the highest amount of use.”
‘All of Us’ observational study
In the first part of the study, the researchers analyzed data from the “All of Us” cohort comprising adults age 18 and older from 340 inpatient and outpatient sites across the United States.
They identified 57,958 individuals who replied to a questionnaire asking about cannabis use (medicinal or recreational and whether it was edible or used by smoking or vaping) over the past 3 months.
There were 39,678 never-users, 8,749 who used it once or twice, 2,075 who used it monthly, 2,720 who used it weekly, and 4,736 who used it daily.
Of these, 3,506 individuals had CAD, based on medical records.
Only daily users had a significantly higher risk for CAD, compared with never-users (odds ratio, 1.34; P = .001) after adjusting for age, sex, hypertension, hyperlipidemia, type 2 diabetes, BMI, education, insurance status, and cigarette use.
The median age for daily users was 41, whereas the median age for never-users was 59.
GWAS analyses
The researchers then performed a Mendelian randomization analysis based on genome-wide association studies (GWAS) of cannabis use disorder and of CAD.
“Cannabis use disorder is a psychiatric diagnosis of severe cannabis dependency, equivalent to ‘alcohol use disorder’ for alcohol consumption,” Dr. Paranjpe explained. “The exact definition involves frequent use leading to significant dependence (but does not specify how often it is used).”
The GWAS data for cannabis use disorder came from a recent meta-analysis of three cohorts: the Psychiatric Genomics Consortium Substance Use Disorders working group, iPSYCH, and deCODE.
The GWAS statistics for CAD were obtained from the CARDIoGRAMplusC4D Consortium.
Cannabis use disorder was associated with significantly increased odds for CAD (OR, 1.05; P = .001), which remained after adjusting for both cigarette and alcohol use (OR, 1.04).
A version of this article first appeared on Medscape.com.
In the first part, in an observational study, daily cannabis use was associated with 34% higher odds for CAD, compared with never-users, in a large population-based U.S. cohort. Less frequent use was not associated with increased odds for CAD.
In the second part, people with a genetic susceptibility to cannabis use disorder or severe cannabis dependency had an increased risk for CAD, compared with other people.
Ishan Paranjpe, MD, the study’s lead author, reported these results in a press briefing and will present the study at the upcoming joint scientific sessions of the American College of Cardiology and the World Heart Federation 2023.
“A couple of takeaway points are that daily cannabis use, but not less frequent cannabis use, was associated with CAD” in the large population-based cohort, said Dr. Paranjpe, a resident physician at Stanford (Calif.) University, during the press conference.
“This analysis was adjusted for several possible confounders including age, sex at birth, [body mass index (BMI)], race, education, cigarette use, hypertension, high cholesterol, and diabetes,” he noted, and even after accounting for these risk factors, the association with heart disease remained.
“And the next thing, using Mendelian randomization, we sort of implied that there might be a causal relationship between cannabis and heart disease. Importantly this effect is independent of alcohol and cigarette use.
“The notion that cannabis is completely benign is probably wrong, and there might be certain risk of certain cardiovascular effects of cannabis we should be more on the lookout for,” Dr. Paranjpe said in an interview.
“Our main conclusion was that prevalent CAD is associated with cannabis consumption,” he added. “Other mechanistic work published in Cell has also shown that cannabis causes vascular inflammation that may lead to CAD.
“Thus, there is growing evidence from both laboratory and population studies that cannabis consumption may be harmful for cardiovascular health,” he said. “However, we still need more work on whether it affects the risk of incident cardiovascular events (i.e., stroke, heart attack) in patient[s] with existing CAD.”
ASCVD risk
Invited to comment, Robert L. Page II, PharmD, chair of the writing group for the American Heart Association’s scientific statement Medical Marijuana, Recreational Cannabis, and Cardiovascular Health, published in 2020, said, “This adds to our hypothesis that if you are using marijuana over a longer period, greater exposure, you’re going to see an increase in the risk” for atherosclerotic cardiovascular disease (ASCVD).
“We’re seeing this increased risk for ASCVD in young adults between ages 18 to 40 – people who think that they’re invincible,” Dr. Page, a professor at the University of Colorado at Denver, Aurora, who was not involved with this research, told this news organization in an interview.
“The bottom line is that the risk that they are seeing is what has also been documented in other observational studies, and it adds fuel to the fire. We need to be paying close attention to this,” he said.
“Primary care [clinicians], cardiologists, need to address this, particularly in younger adults – because that’s where you’re seeing the highest amount of use.”
‘All of Us’ observational study
In the first part of the study, the researchers analyzed data from the “All of Us” cohort comprising adults age 18 and older from 340 inpatient and outpatient sites across the United States.
They identified 57,958 individuals who replied to a questionnaire asking about cannabis use (medicinal or recreational and whether it was edible or used by smoking or vaping) over the past 3 months.
There were 39,678 never-users, 8,749 who used it once or twice, 2,075 who used it monthly, 2,720 who used it weekly, and 4,736 who used it daily.
Of these, 3,506 individuals had CAD, based on medical records.
Only daily users had a significantly higher risk for CAD, compared with never-users (odds ratio, 1.34; P = .001) after adjusting for age, sex, hypertension, hyperlipidemia, type 2 diabetes, BMI, education, insurance status, and cigarette use.
The median age for daily users was 41, whereas the median age for never-users was 59.
GWAS analyses
The researchers then performed a Mendelian randomization analysis based on genome-wide association studies (GWAS) of cannabis use disorder and of CAD.
“Cannabis use disorder is a psychiatric diagnosis of severe cannabis dependency, equivalent to ‘alcohol use disorder’ for alcohol consumption,” Dr. Paranjpe explained. “The exact definition involves frequent use leading to significant dependence (but does not specify how often it is used).”
The GWAS data for cannabis use disorder came from a recent meta-analysis of three cohorts: the Psychiatric Genomics Consortium Substance Use Disorders working group, iPSYCH, and deCODE.
The GWAS statistics for CAD were obtained from the CARDIoGRAMplusC4D Consortium.
Cannabis use disorder was associated with significantly increased odds for CAD (OR, 1.05; P = .001), which remained after adjusting for both cigarette and alcohol use (OR, 1.04).
A version of this article first appeared on Medscape.com.
In the first part, in an observational study, daily cannabis use was associated with 34% higher odds for CAD, compared with never-users, in a large population-based U.S. cohort. Less frequent use was not associated with increased odds for CAD.
In the second part, people with a genetic susceptibility to cannabis use disorder or severe cannabis dependency had an increased risk for CAD, compared with other people.
Ishan Paranjpe, MD, the study’s lead author, reported these results in a press briefing and will present the study at the upcoming joint scientific sessions of the American College of Cardiology and the World Heart Federation 2023.
“A couple of takeaway points are that daily cannabis use, but not less frequent cannabis use, was associated with CAD” in the large population-based cohort, said Dr. Paranjpe, a resident physician at Stanford (Calif.) University, during the press conference.
“This analysis was adjusted for several possible confounders including age, sex at birth, [body mass index (BMI)], race, education, cigarette use, hypertension, high cholesterol, and diabetes,” he noted, and even after accounting for these risk factors, the association with heart disease remained.
“And the next thing, using Mendelian randomization, we sort of implied that there might be a causal relationship between cannabis and heart disease. Importantly this effect is independent of alcohol and cigarette use.
“The notion that cannabis is completely benign is probably wrong, and there might be certain risk of certain cardiovascular effects of cannabis we should be more on the lookout for,” Dr. Paranjpe said in an interview.
“Our main conclusion was that prevalent CAD is associated with cannabis consumption,” he added. “Other mechanistic work published in Cell has also shown that cannabis causes vascular inflammation that may lead to CAD.
“Thus, there is growing evidence from both laboratory and population studies that cannabis consumption may be harmful for cardiovascular health,” he said. “However, we still need more work on whether it affects the risk of incident cardiovascular events (i.e., stroke, heart attack) in patient[s] with existing CAD.”
ASCVD risk
Invited to comment, Robert L. Page II, PharmD, chair of the writing group for the American Heart Association’s scientific statement Medical Marijuana, Recreational Cannabis, and Cardiovascular Health, published in 2020, said, “This adds to our hypothesis that if you are using marijuana over a longer period, greater exposure, you’re going to see an increase in the risk” for atherosclerotic cardiovascular disease (ASCVD).
“We’re seeing this increased risk for ASCVD in young adults between ages 18 to 40 – people who think that they’re invincible,” Dr. Page, a professor at the University of Colorado at Denver, Aurora, who was not involved with this research, told this news organization in an interview.
“The bottom line is that the risk that they are seeing is what has also been documented in other observational studies, and it adds fuel to the fire. We need to be paying close attention to this,” he said.
“Primary care [clinicians], cardiologists, need to address this, particularly in younger adults – because that’s where you’re seeing the highest amount of use.”
‘All of Us’ observational study
In the first part of the study, the researchers analyzed data from the “All of Us” cohort comprising adults age 18 and older from 340 inpatient and outpatient sites across the United States.
They identified 57,958 individuals who replied to a questionnaire asking about cannabis use (medicinal or recreational and whether it was edible or used by smoking or vaping) over the past 3 months.
There were 39,678 never-users, 8,749 who used it once or twice, 2,075 who used it monthly, 2,720 who used it weekly, and 4,736 who used it daily.
Of these, 3,506 individuals had CAD, based on medical records.
Only daily users had a significantly higher risk for CAD, compared with never-users (odds ratio, 1.34; P = .001) after adjusting for age, sex, hypertension, hyperlipidemia, type 2 diabetes, BMI, education, insurance status, and cigarette use.
The median age for daily users was 41, whereas the median age for never-users was 59.
GWAS analyses
The researchers then performed a Mendelian randomization analysis based on genome-wide association studies (GWAS) of cannabis use disorder and of CAD.
“Cannabis use disorder is a psychiatric diagnosis of severe cannabis dependency, equivalent to ‘alcohol use disorder’ for alcohol consumption,” Dr. Paranjpe explained. “The exact definition involves frequent use leading to significant dependence (but does not specify how often it is used).”
The GWAS data for cannabis use disorder came from a recent meta-analysis of three cohorts: the Psychiatric Genomics Consortium Substance Use Disorders working group, iPSYCH, and deCODE.
The GWAS statistics for CAD were obtained from the CARDIoGRAMplusC4D Consortium.
Cannabis use disorder was associated with significantly increased odds for CAD (OR, 1.05; P = .001), which remained after adjusting for both cigarette and alcohol use (OR, 1.04).
A version of this article first appeared on Medscape.com.
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<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>162431</fileName> <TBEID>0C048B0D.SIG</TBEID> <TBUniqueIdentifier>MD_0C048B0D</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname/> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20230301T120741</QCDate> <firstPublished>20230301T121800</firstPublished> <LastPublished>20230301T121800</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20230301T121800</CMSDate> <articleSource>FROM ACC 2023</articleSource> <facebookInfo/> <meetingNumber>3377-23</meetingNumber> <byline>Marlene Busko</byline> <bylineText>MARLENE BUSKO</bylineText> <bylineFull>MARLENE BUSKO</bylineFull> <bylineTitleText/> <USOrGlobal/> <wireDocType/> <newsDocType>News</newsDocType> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:imng"> <name>IMNG Medical Media</name> <rightsInfo> <copyrightHolder> <name>Frontline Medical News</name> </copyrightHolder> <copyrightNotice>Copyright (c) 2015 Frontline Medical News, a Frontline Medical Communications Inc. company. All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>A two-part research study suggests that frequent cannabis is a risk factor for coronary artery disease (CAD).</metaDescription> <articlePDF/> <teaserImage/> <teaser>Daily cannabis use, but not less frequent cannabis use, was associated with CAD.</teaser> <title>Frequent cannabis use tied to coronary artery disease</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>card</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">5</term> <term>21</term> <term>15</term> </publications> <sections> <term canonical="true">53</term> <term>39313</term> </sections> <topics> <term canonical="true">193</term> <term>48222</term> <term>194</term> <term>280</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Frequent cannabis use tied to coronary artery disease</title> <deck/> </itemMeta> <itemContent> <p> <span class="tag metaDescription">A two-part research study suggests that frequent cannabis is a risk factor for coronary artery disease (CAD).</span> </p> <p>In the first part, in an observational study, daily cannabis use was associated with 34% higher odds for CAD, compared with never-users, in a large population-based U.S. cohort. Less frequent use was not associated with increased odds for CAD.<br/><br/>In the second part, people with a genetic susceptibility to cannabis use disorder or severe cannabis dependency had an increased risk for CAD, compared with other people.<br/><br/>Ishan Paranjpe, MD, the study’s lead author, reported these results in a press briefing and will present the study at the upcoming joint scientific sessions of the American College of Cardiology and the World Heart Federation 2023.<br/><br/>“A couple of takeaway points are that daily cannabis use, but not less frequent cannabis use, was associated with CAD” in the large population-based cohort, said Dr. Paranjpe, a resident physician at Stanford (Calif.) University, during the press conference. <br/><br/>“This analysis was adjusted for several possible confounders including age, sex at birth, [body mass index (BMI)], race, education, cigarette use, hypertension, high cholesterol, and diabetes,” he noted, and even after accounting for these risk factors, the association with heart disease remained.<br/><br/>“And the next thing, using Mendelian randomization, we sort of implied that there might be a causal relationship between cannabis and heart disease. Importantly this effect is independent of alcohol and cigarette use.<br/><br/>“The notion that cannabis is completely benign is probably wrong, and there might be certain risk of certain cardiovascular effects of cannabis we should be more on the lookout for,” Dr. Paranjpe said in an interview. <br/><br/>“Our main conclusion was that prevalent CAD is associated with cannabis consumption,” he added. “<a href="https://pubmed.ncbi.nlm.nih.gov/35489334/">Other mechanistic work</a> published in Cell has also shown that cannabis causes vascular inflammation that may lead to CAD.<br/><br/>“Thus, there is growing evidence from both laboratory and population studies that cannabis consumption may be harmful for cardiovascular health,” he said. “However, we still need more work on whether it affects the risk of incident cardiovascular events (i.e., stroke, heart attack) in patient[s] with existing CAD.”<br/><br/></p> <h2>ASCVD risk </h2> <p>Invited to comment, Robert L. Page II, PharmD, chair of the writing group for the American Heart Association’s scientific statement Medical Marijuana, Recreational Cannabis, and Cardiovascular Health, <a href="https://www.ahajournals.org/doi/full/10.1161/CIR.0000000000000883">published in 2020</a>, said, “This adds to our hypothesis that if you are using marijuana over a longer period, greater exposure, you’re going to see an increase in the risk” for atherosclerotic cardiovascular disease (ASCVD).</p> <p>“We’re seeing this increased risk for ASCVD in young adults between ages 18 to 40 – people who think that they’re invincible,” Dr. Page, a professor at the University of Colorado at Denver, Aurora, who was not involved with this research, told this news organization in an interview.<br/><br/>“The bottom line is that the risk that they are seeing is what has also been documented in other observational studies, and it adds fuel to the fire. We need to be paying close attention to this,” he said.<br/><br/>“Primary care [clinicians], cardiologists, need to address this, particularly in younger adults – because that’s where you’re seeing the highest amount of use.”<br/><br/></p> <h2>‘All of Us’ observational study </h2> <p>In the first part of the study, the researchers analyzed data from the “All of Us” cohort comprising adults age 18 and older from 340 inpatient and outpatient sites across the United States.</p> <p>They identified 57,958 individuals who replied to a questionnaire asking about cannabis use (medicinal or recreational and whether it was edible or used by smoking or vaping) over the past 3 months.<br/><br/>There were 39,678 never-users, 8,749 who used it once or twice, 2,075 who used it monthly, 2,720 who used it weekly, and 4,736 who used it daily.<br/><br/>Of these, 3,506 individuals had CAD, based on medical records.<br/><br/>Only daily users had a significantly higher risk for CAD, compared with never-users (odds ratio, 1.34; <em>P</em> = .001) after adjusting for age, sex, hypertension, hyperlipidemia, type 2 diabetes, BMI, education, insurance status, and cigarette use.<br/><br/>The median age for daily users was 41, whereas the median age for never-users was 59.<br/><br/></p> <h2>GWAS analyses </h2> <p>The researchers then performed a Mendelian randomization analysis based on genome-wide association studies (GWAS) of cannabis use disorder and of CAD.</p> <p>“Cannabis use disorder is a psychiatric diagnosis of severe cannabis dependency, equivalent to ‘alcohol use disorder’ for alcohol consumption,” Dr. Paranjpe explained. “The exact definition involves frequent use leading to significant dependence (but does not specify how often it is used).”<br/><br/>The GWAS data for cannabis use disorder came from a <a href="https://pubmed.ncbi.nlm.nih.gov/33096046/">recent meta-analysis of three cohorts</a>: the Psychiatric Genomics Consortium Substance Use Disorders working group, iPSYCH, and deCODE.<br/><br/>The GWAS statistics <a href="https://www.nature.com/articles/ng.3396">for CAD</a> were obtained from the CARDIoGRAMplusC4D Consortium.<br/><br/>Cannabis use disorder was associated with significantly increased odds for CAD (OR, 1.05; <em>P</em> = .001), which remained after adjusting for both cigarette and alcohol use (OR, 1.04).</p> <p> <em>A version of this article first appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/988902">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
FROM ACC 2023
Noninvasive FFRCT called ADVANCE in chest pain assessment
NEW ORLEANS – Fractional flow reserve derived noninvasively from coronary CT angiography showed clinical merit as a practical tool for evaluation of chest pain at 1 year of follow-up in the ADVANCE registry, Manesh R. Patel, MD, reported at the annual meeting of the American College of Cardiology.
In ADVANCE, a fractional flow reserve value greater than 0.80 derived from CT angiography, or FFRCT, was associated with a significantly lower rate of cardiovascular death or MI at 1 year than in patients with an FFRCT of 0.80 or lower, according to Dr. Patel, professor of medicine and chief of the division of cardiology at Duke University, Durham, N.C.
“The lower rates of revascularization and clinical events in patients with FFRCT who were managed conservatively provide reassurance regarding this clinical strategy if you were to put it into your practice,” he observed.
ADVANCE is in an international, real-world, prospective registry of more than 5,000 patients in Europe, Japan, and North America. All had clinically suspected ischemic coronary artery disease (CAD). They also had at least 30% atherosclerosis documented on coronary CT angiography as a trigger for noninvasive assessment of FFR calculated from computational fluid dynamics. The idea behind FFRCT is that by combining the anatomic information provided by CT angiography with the physiological, functional data from FFR, the result is a better guide to need for revascularization of true obstructive CAD than with conventional invasive coronary angiography alone. Indeed, FFRCT could eventually prove to be a cost-effective gatekeeper to the cardiac catheterization laboratory by cutting down on high rates of invasive coronary angiography for nonactionable CAD.
[embed:render:related:node:166470]
That point was suggested by the previously reported 90-day outcomes of the ADVANCE registry, the cardiologist explained. Participating physicians first classified patients and made a revascularization/no-revascularization management plan on the basis of the core laboratory CT angiography results alone. But when they received the FFRCT results, they reclassified patients and changed the management plan in 67% of cases. That’s because the prevalence of nonobstructive CAD was 44% in patients with an FFRCT greater than 0.80 in all coronary arteries, compared with just 14% in those with an FFRCT of 0.80 or less. As a result, 72% of patients with an FFRCT of 0.80 or less underwent revascularization, while the vast majority of patients with an FFRCT greater than 0.80 were initially managed conservatively (Eur Heart J. 2018 Nov 1;39[41]:3701-11).
The 1-year outcomes from ADVANCE as presented by Dr. Patel showed low rates of major adverse cardiovascular events overall. Of note, the composite endpoint of cardiovascular death or MI occurred significantly more often in patients with an FFRCT of 0.80 or less, by a margin of 0.8% versus 0.2%, for a 320% increased relative risk. The patients with a FFRCT greater than 0.80 continued to have a much lower revascularization rate from 90 days through 1 year: 5.8% versus 38.4% in the lower-FFRCT group. And 93% of patients placed on medical therapy alone after receiving their FFRCT results remained on medical therapy without revascularization or a major adverse cardiovascular event at 1 year.
Discussant Matthew J. Budoff, MD, commented that it’s time to move beyond observational studies and conduct randomized trials of an FFRCT-based screening strategy in patients with clinical suspicion of obstructive CAD.
“We want to understand the enormous advantages of having FFR-like data before we take patients to the cath lab. And I do think that adding physiology to the anatomy is going to be the approach that we’re going to be predominantly using in the future,” said Dr. Budoff, professor of medicine at the University of California, Los Angeles.
Dr. Patel noted that the ongoing, randomized, 2,100-patient PRECISE study is directed at determining in a more definitive way the clinical and cost-effectiveness of an FFRCT strategy.
The ADVANCE registry is funded by HeartFlow. Dr. Patel reported receiving research grants from that company and several others, as well as the National Institutes of Health. He serves on advisory boards for Bayer, Janssen, and Amgen.
Simultaneous with Dr. Patel’s presentation at ACC 2019, the 1-year ADVANCE registry results were published online (JACC Cardiovasc Imag. 2019 Mar 17. doi: 10.1016/j.jcmg.2019.03.003).
NEW ORLEANS – Fractional flow reserve derived noninvasively from coronary CT angiography showed clinical merit as a practical tool for evaluation of chest pain at 1 year of follow-up in the ADVANCE registry, Manesh R. Patel, MD, reported at the annual meeting of the American College of Cardiology.
In ADVANCE, a fractional flow reserve value greater than 0.80 derived from CT angiography, or FFRCT, was associated with a significantly lower rate of cardiovascular death or MI at 1 year than in patients with an FFRCT of 0.80 or lower, according to Dr. Patel, professor of medicine and chief of the division of cardiology at Duke University, Durham, N.C.
“The lower rates of revascularization and clinical events in patients with FFRCT who were managed conservatively provide reassurance regarding this clinical strategy if you were to put it into your practice,” he observed.
ADVANCE is in an international, real-world, prospective registry of more than 5,000 patients in Europe, Japan, and North America. All had clinically suspected ischemic coronary artery disease (CAD). They also had at least 30% atherosclerosis documented on coronary CT angiography as a trigger for noninvasive assessment of FFR calculated from computational fluid dynamics. The idea behind FFRCT is that by combining the anatomic information provided by CT angiography with the physiological, functional data from FFR, the result is a better guide to need for revascularization of true obstructive CAD than with conventional invasive coronary angiography alone. Indeed, FFRCT could eventually prove to be a cost-effective gatekeeper to the cardiac catheterization laboratory by cutting down on high rates of invasive coronary angiography for nonactionable CAD.
[embed:render:related:node:166470]
That point was suggested by the previously reported 90-day outcomes of the ADVANCE registry, the cardiologist explained. Participating physicians first classified patients and made a revascularization/no-revascularization management plan on the basis of the core laboratory CT angiography results alone. But when they received the FFRCT results, they reclassified patients and changed the management plan in 67% of cases. That’s because the prevalence of nonobstructive CAD was 44% in patients with an FFRCT greater than 0.80 in all coronary arteries, compared with just 14% in those with an FFRCT of 0.80 or less. As a result, 72% of patients with an FFRCT of 0.80 or less underwent revascularization, while the vast majority of patients with an FFRCT greater than 0.80 were initially managed conservatively (Eur Heart J. 2018 Nov 1;39[41]:3701-11).
The 1-year outcomes from ADVANCE as presented by Dr. Patel showed low rates of major adverse cardiovascular events overall. Of note, the composite endpoint of cardiovascular death or MI occurred significantly more often in patients with an FFRCT of 0.80 or less, by a margin of 0.8% versus 0.2%, for a 320% increased relative risk. The patients with a FFRCT greater than 0.80 continued to have a much lower revascularization rate from 90 days through 1 year: 5.8% versus 38.4% in the lower-FFRCT group. And 93% of patients placed on medical therapy alone after receiving their FFRCT results remained on medical therapy without revascularization or a major adverse cardiovascular event at 1 year.
Discussant Matthew J. Budoff, MD, commented that it’s time to move beyond observational studies and conduct randomized trials of an FFRCT-based screening strategy in patients with clinical suspicion of obstructive CAD.
“We want to understand the enormous advantages of having FFR-like data before we take patients to the cath lab. And I do think that adding physiology to the anatomy is going to be the approach that we’re going to be predominantly using in the future,” said Dr. Budoff, professor of medicine at the University of California, Los Angeles.
Dr. Patel noted that the ongoing, randomized, 2,100-patient PRECISE study is directed at determining in a more definitive way the clinical and cost-effectiveness of an FFRCT strategy.
The ADVANCE registry is funded by HeartFlow. Dr. Patel reported receiving research grants from that company and several others, as well as the National Institutes of Health. He serves on advisory boards for Bayer, Janssen, and Amgen.
Simultaneous with Dr. Patel’s presentation at ACC 2019, the 1-year ADVANCE registry results were published online (JACC Cardiovasc Imag. 2019 Mar 17. doi: 10.1016/j.jcmg.2019.03.003).
NEW ORLEANS – Fractional flow reserve derived noninvasively from coronary CT angiography showed clinical merit as a practical tool for evaluation of chest pain at 1 year of follow-up in the ADVANCE registry, Manesh R. Patel, MD, reported at the annual meeting of the American College of Cardiology.
In ADVANCE, a fractional flow reserve value greater than 0.80 derived from CT angiography, or FFRCT, was associated with a significantly lower rate of cardiovascular death or MI at 1 year than in patients with an FFRCT of 0.80 or lower, according to Dr. Patel, professor of medicine and chief of the division of cardiology at Duke University, Durham, N.C.
“The lower rates of revascularization and clinical events in patients with FFRCT who were managed conservatively provide reassurance regarding this clinical strategy if you were to put it into your practice,” he observed.
ADVANCE is in an international, real-world, prospective registry of more than 5,000 patients in Europe, Japan, and North America. All had clinically suspected ischemic coronary artery disease (CAD). They also had at least 30% atherosclerosis documented on coronary CT angiography as a trigger for noninvasive assessment of FFR calculated from computational fluid dynamics. The idea behind FFRCT is that by combining the anatomic information provided by CT angiography with the physiological, functional data from FFR, the result is a better guide to need for revascularization of true obstructive CAD than with conventional invasive coronary angiography alone. Indeed, FFRCT could eventually prove to be a cost-effective gatekeeper to the cardiac catheterization laboratory by cutting down on high rates of invasive coronary angiography for nonactionable CAD.
[embed:render:related:node:166470]
That point was suggested by the previously reported 90-day outcomes of the ADVANCE registry, the cardiologist explained. Participating physicians first classified patients and made a revascularization/no-revascularization management plan on the basis of the core laboratory CT angiography results alone. But when they received the FFRCT results, they reclassified patients and changed the management plan in 67% of cases. That’s because the prevalence of nonobstructive CAD was 44% in patients with an FFRCT greater than 0.80 in all coronary arteries, compared with just 14% in those with an FFRCT of 0.80 or less. As a result, 72% of patients with an FFRCT of 0.80 or less underwent revascularization, while the vast majority of patients with an FFRCT greater than 0.80 were initially managed conservatively (Eur Heart J. 2018 Nov 1;39[41]:3701-11).
The 1-year outcomes from ADVANCE as presented by Dr. Patel showed low rates of major adverse cardiovascular events overall. Of note, the composite endpoint of cardiovascular death or MI occurred significantly more often in patients with an FFRCT of 0.80 or less, by a margin of 0.8% versus 0.2%, for a 320% increased relative risk. The patients with a FFRCT greater than 0.80 continued to have a much lower revascularization rate from 90 days through 1 year: 5.8% versus 38.4% in the lower-FFRCT group. And 93% of patients placed on medical therapy alone after receiving their FFRCT results remained on medical therapy without revascularization or a major adverse cardiovascular event at 1 year.
Discussant Matthew J. Budoff, MD, commented that it’s time to move beyond observational studies and conduct randomized trials of an FFRCT-based screening strategy in patients with clinical suspicion of obstructive CAD.
“We want to understand the enormous advantages of having FFR-like data before we take patients to the cath lab. And I do think that adding physiology to the anatomy is going to be the approach that we’re going to be predominantly using in the future,” said Dr. Budoff, professor of medicine at the University of California, Los Angeles.
Dr. Patel noted that the ongoing, randomized, 2,100-patient PRECISE study is directed at determining in a more definitive way the clinical and cost-effectiveness of an FFRCT strategy.
The ADVANCE registry is funded by HeartFlow. Dr. Patel reported receiving research grants from that company and several others, as well as the National Institutes of Health. He serves on advisory boards for Bayer, Janssen, and Amgen.
Simultaneous with Dr. Patel’s presentation at ACC 2019, the 1-year ADVANCE registry results were published online (JACC Cardiovasc Imag. 2019 Mar 17. doi: 10.1016/j.jcmg.2019.03.003).
REPORTING FROM ACC 19
ACC, AHA release first cardiovascular disease primary prevention guideline
that takes into account each person’s social determinants of health. The guideline substantially dialed down prior recommendations on aspirin for primary prevention by calling for no use in people older than 70 years and infrequent use in those 40-70 years old.
The American College of Cardiology and the American Heart Association released their 2019 guideline on the primary prevention of cardiovascular disease on March 17, during the annual meeting of the American College of Cardiology (J Amer Coll Cardiol. 2019 March 17;doi: 10.1016/j.jacc.2019.03.010.). The guideline is a “one-stop shop” that pulls together existing recommendations from the two organizations and combines it with some new recommendations that address issues such as aspirin prophylaxis, and the social setting of each person, said Donna K. Arnett, Ph.D., professor of epidemiology at the University of Kentucky, dean of the university’s College of Public Health, and co-chair of the guideline writing panel.
“We made the social determinants of health front and center. With many people, clinicians don’t ask whether they have access to healthy foods or a way to get to the pharmacy. Asking about these issues is step one,” toward helping people address their social situation, Dr. Arnett said while introducing the new guideline in a press briefing. The guideline recommends that clinicians assess the social determinants for each person treated for cardiovascular disease prevention using a screening tool developed by the U.S. Centers for Medicare & Medicaid Services and made available by the National Academy of Medicine (NAM Perspectives. 2017; doi:10.31478/201705b).
“No other guideline has highlighted the social determinants of health,” noted Erin D. Michos, MD, associate director of preventive cardiology at Johns Hopkins Medicine in Baltimore, and a member of the guideline-writing panel. Other overarching themes of the guideline are its emphasis on the need for a team of clinicians to deliver all the disparate and time-consuming facets of care needed for comprehensive primary prevention of cardiovascular disease, and its call for a healthy lifestyle throughout life as foundations for prevention, Dr. Michos said in an interview.
With 48 recommendations, the guideline also deals with prevention issues such as a healthy diet and body mass, appropriate control of diabetes, smoking cessation, and control of blood pressure and cholesterol (see chart). The writing committee took the cholesterol and blood pressure recommendations directly from recent guidelines from the ACC and AHA in 2017 (blood pressure:J Amer Coll Cardiol. 2018 May;71[19]:e177-e248) and 2018 (cholesterol:Circulation. 2018 Nov 10;doi: 10.1161/CIR.0000000000000625).
The other major, new recommendations in the guideline deal with aspirin use for primary prevention, which recently underwent a shake up with publication of results from several studies that showed less cardiovascular benefit and more potential bleeding harm from routine aspirin prophylaxis than previously appreciated. Among the most notable of these reports, which led to a class III recommendation – do not use – for aspirin in people more than 70 years old came from the ASPREE (Aspirin in Reducing Events in the Elderly) study (New Engl J Med. 2018 Oct 18;379[16]:1519-28). For those 40-70 years old, the recommendation is class IIb, worded as “might be considered for select adults.”
“Generally no, occasionally yes,” is aspirin appropriate for people in this age group, notably those at high risk for cardiovascular disease and also at low risk for bleeding, explained Amit Khera, MD, a guideline-panel member, and professor of medicine and director of preventive cardiology at the University of Texas Southwestern Medical Center in Dallas.
As a guideline for primary prevention, a prime target audience is primary care physicians, who would need to be instrumental in applying the guideline. But the guideline recommendations released by the ACC and AHA for blood pressure management in 2017 were not accepted by U.S. groups that represent primary care physicians, the American College of Physicians, and the American Academy of Family Physicians.
John J. Warner, MD, an interventional cardiologist, executive vice president for health system affairs at UT Southwestern, and president of the AHA when the blood pressure guideline came out said that the ACC and AHA “learned some lessons” from the blood pressure experience. The societies responded this time around by “trying to view the document through as many lenses as possible” during the peer review process, Dr. Warner said during the press conference.
“I don’t think the new guideline will be seen as anything except positive,” commented Martha Gulati, MD, professor of medicine and chief of cardiology at the University of Arizona in Phoenix. Collecting all the cardiovascular disease recommendations for primary prevention in one document “helps clinicians access the information easily and helps patients see the big picture,” said Dr. Gulati, who was not involved in the guideline’s writing or review.
She especially applauded the recommendations to assess each person’s social determinants of health, the team-care approach, and the recommendations dealing with diet and other aspects of a healthy lifestyle. “This was a perfect time” to bring together the existing blood pressure and cholesterol guidelines, the new guidance on aspirin use, and the other recommendation in a single document, she said in an interview.
Dr. Arnett, Dr. Michos, Dr. Khera, Dr. Warner, and Dr. Gulati had no disclosures.
mzoler@mdedge.com
On Twitter @mitchelzoler
SOURCE: Arnett DK et al. J Amer Coll Cardiol. 2019 March 17;doi: 10.1016/j.jacc.2019.03.010.
that takes into account each person’s social determinants of health. The guideline substantially dialed down prior recommendations on aspirin for primary prevention by calling for no use in people older than 70 years and infrequent use in those 40-70 years old.
The American College of Cardiology and the American Heart Association released their 2019 guideline on the primary prevention of cardiovascular disease on March 17, during the annual meeting of the American College of Cardiology (J Amer Coll Cardiol. 2019 March 17;doi: 10.1016/j.jacc.2019.03.010.). The guideline is a “one-stop shop” that pulls together existing recommendations from the two organizations and combines it with some new recommendations that address issues such as aspirin prophylaxis, and the social setting of each person, said Donna K. Arnett, Ph.D., professor of epidemiology at the University of Kentucky, dean of the university’s College of Public Health, and co-chair of the guideline writing panel.
“We made the social determinants of health front and center. With many people, clinicians don’t ask whether they have access to healthy foods or a way to get to the pharmacy. Asking about these issues is step one,” toward helping people address their social situation, Dr. Arnett said while introducing the new guideline in a press briefing. The guideline recommends that clinicians assess the social determinants for each person treated for cardiovascular disease prevention using a screening tool developed by the U.S. Centers for Medicare & Medicaid Services and made available by the National Academy of Medicine (NAM Perspectives. 2017; doi:10.31478/201705b).
“No other guideline has highlighted the social determinants of health,” noted Erin D. Michos, MD, associate director of preventive cardiology at Johns Hopkins Medicine in Baltimore, and a member of the guideline-writing panel. Other overarching themes of the guideline are its emphasis on the need for a team of clinicians to deliver all the disparate and time-consuming facets of care needed for comprehensive primary prevention of cardiovascular disease, and its call for a healthy lifestyle throughout life as foundations for prevention, Dr. Michos said in an interview.
With 48 recommendations, the guideline also deals with prevention issues such as a healthy diet and body mass, appropriate control of diabetes, smoking cessation, and control of blood pressure and cholesterol (see chart). The writing committee took the cholesterol and blood pressure recommendations directly from recent guidelines from the ACC and AHA in 2017 (blood pressure:J Amer Coll Cardiol. 2018 May;71[19]:e177-e248) and 2018 (cholesterol:Circulation. 2018 Nov 10;doi: 10.1161/CIR.0000000000000625).
The other major, new recommendations in the guideline deal with aspirin use for primary prevention, which recently underwent a shake up with publication of results from several studies that showed less cardiovascular benefit and more potential bleeding harm from routine aspirin prophylaxis than previously appreciated. Among the most notable of these reports, which led to a class III recommendation – do not use – for aspirin in people more than 70 years old came from the ASPREE (Aspirin in Reducing Events in the Elderly) study (New Engl J Med. 2018 Oct 18;379[16]:1519-28). For those 40-70 years old, the recommendation is class IIb, worded as “might be considered for select adults.”
“Generally no, occasionally yes,” is aspirin appropriate for people in this age group, notably those at high risk for cardiovascular disease and also at low risk for bleeding, explained Amit Khera, MD, a guideline-panel member, and professor of medicine and director of preventive cardiology at the University of Texas Southwestern Medical Center in Dallas.
As a guideline for primary prevention, a prime target audience is primary care physicians, who would need to be instrumental in applying the guideline. But the guideline recommendations released by the ACC and AHA for blood pressure management in 2017 were not accepted by U.S. groups that represent primary care physicians, the American College of Physicians, and the American Academy of Family Physicians.
John J. Warner, MD, an interventional cardiologist, executive vice president for health system affairs at UT Southwestern, and president of the AHA when the blood pressure guideline came out said that the ACC and AHA “learned some lessons” from the blood pressure experience. The societies responded this time around by “trying to view the document through as many lenses as possible” during the peer review process, Dr. Warner said during the press conference.
“I don’t think the new guideline will be seen as anything except positive,” commented Martha Gulati, MD, professor of medicine and chief of cardiology at the University of Arizona in Phoenix. Collecting all the cardiovascular disease recommendations for primary prevention in one document “helps clinicians access the information easily and helps patients see the big picture,” said Dr. Gulati, who was not involved in the guideline’s writing or review.
She especially applauded the recommendations to assess each person’s social determinants of health, the team-care approach, and the recommendations dealing with diet and other aspects of a healthy lifestyle. “This was a perfect time” to bring together the existing blood pressure and cholesterol guidelines, the new guidance on aspirin use, and the other recommendation in a single document, she said in an interview.
Dr. Arnett, Dr. Michos, Dr. Khera, Dr. Warner, and Dr. Gulati had no disclosures.
mzoler@mdedge.com
On Twitter @mitchelzoler
SOURCE: Arnett DK et al. J Amer Coll Cardiol. 2019 March 17;doi: 10.1016/j.jacc.2019.03.010.
that takes into account each person’s social determinants of health. The guideline substantially dialed down prior recommendations on aspirin for primary prevention by calling for no use in people older than 70 years and infrequent use in those 40-70 years old.
The American College of Cardiology and the American Heart Association released their 2019 guideline on the primary prevention of cardiovascular disease on March 17, during the annual meeting of the American College of Cardiology (J Amer Coll Cardiol. 2019 March 17;doi: 10.1016/j.jacc.2019.03.010.). The guideline is a “one-stop shop” that pulls together existing recommendations from the two organizations and combines it with some new recommendations that address issues such as aspirin prophylaxis, and the social setting of each person, said Donna K. Arnett, Ph.D., professor of epidemiology at the University of Kentucky, dean of the university’s College of Public Health, and co-chair of the guideline writing panel.
“We made the social determinants of health front and center. With many people, clinicians don’t ask whether they have access to healthy foods or a way to get to the pharmacy. Asking about these issues is step one,” toward helping people address their social situation, Dr. Arnett said while introducing the new guideline in a press briefing. The guideline recommends that clinicians assess the social determinants for each person treated for cardiovascular disease prevention using a screening tool developed by the U.S. Centers for Medicare & Medicaid Services and made available by the National Academy of Medicine (NAM Perspectives. 2017; doi:10.31478/201705b).
“No other guideline has highlighted the social determinants of health,” noted Erin D. Michos, MD, associate director of preventive cardiology at Johns Hopkins Medicine in Baltimore, and a member of the guideline-writing panel. Other overarching themes of the guideline are its emphasis on the need for a team of clinicians to deliver all the disparate and time-consuming facets of care needed for comprehensive primary prevention of cardiovascular disease, and its call for a healthy lifestyle throughout life as foundations for prevention, Dr. Michos said in an interview.
With 48 recommendations, the guideline also deals with prevention issues such as a healthy diet and body mass, appropriate control of diabetes, smoking cessation, and control of blood pressure and cholesterol (see chart). The writing committee took the cholesterol and blood pressure recommendations directly from recent guidelines from the ACC and AHA in 2017 (blood pressure:J Amer Coll Cardiol. 2018 May;71[19]:e177-e248) and 2018 (cholesterol:Circulation. 2018 Nov 10;doi: 10.1161/CIR.0000000000000625).
The other major, new recommendations in the guideline deal with aspirin use for primary prevention, which recently underwent a shake up with publication of results from several studies that showed less cardiovascular benefit and more potential bleeding harm from routine aspirin prophylaxis than previously appreciated. Among the most notable of these reports, which led to a class III recommendation – do not use – for aspirin in people more than 70 years old came from the ASPREE (Aspirin in Reducing Events in the Elderly) study (New Engl J Med. 2018 Oct 18;379[16]:1519-28). For those 40-70 years old, the recommendation is class IIb, worded as “might be considered for select adults.”
“Generally no, occasionally yes,” is aspirin appropriate for people in this age group, notably those at high risk for cardiovascular disease and also at low risk for bleeding, explained Amit Khera, MD, a guideline-panel member, and professor of medicine and director of preventive cardiology at the University of Texas Southwestern Medical Center in Dallas.
As a guideline for primary prevention, a prime target audience is primary care physicians, who would need to be instrumental in applying the guideline. But the guideline recommendations released by the ACC and AHA for blood pressure management in 2017 were not accepted by U.S. groups that represent primary care physicians, the American College of Physicians, and the American Academy of Family Physicians.
John J. Warner, MD, an interventional cardiologist, executive vice president for health system affairs at UT Southwestern, and president of the AHA when the blood pressure guideline came out said that the ACC and AHA “learned some lessons” from the blood pressure experience. The societies responded this time around by “trying to view the document through as many lenses as possible” during the peer review process, Dr. Warner said during the press conference.
“I don’t think the new guideline will be seen as anything except positive,” commented Martha Gulati, MD, professor of medicine and chief of cardiology at the University of Arizona in Phoenix. Collecting all the cardiovascular disease recommendations for primary prevention in one document “helps clinicians access the information easily and helps patients see the big picture,” said Dr. Gulati, who was not involved in the guideline’s writing or review.
She especially applauded the recommendations to assess each person’s social determinants of health, the team-care approach, and the recommendations dealing with diet and other aspects of a healthy lifestyle. “This was a perfect time” to bring together the existing blood pressure and cholesterol guidelines, the new guidance on aspirin use, and the other recommendation in a single document, she said in an interview.
Dr. Arnett, Dr. Michos, Dr. Khera, Dr. Warner, and Dr. Gulati had no disclosures.
mzoler@mdedge.com
On Twitter @mitchelzoler
SOURCE: Arnett DK et al. J Amer Coll Cardiol. 2019 March 17;doi: 10.1016/j.jacc.2019.03.010.
REPORTING FROM ACC 2019
Antibiotic-eluting envelope reduces CIED infections
An absorbable, antibiotic-eluting envelope around cardiac implantable electronic devices could significantly reduce the incidence of infection, according to a presentation at the annual meeting of the American College of Cardiology.
The WRAP-IT trial, which was simultaneously published online March 17 in the New England Journal of Medicine, involved 6,983 patients undergoing cardiac implantable electronic device (CIED) implantation, replacement, revision, or upgrade. Patients were randomized either to receive the TYRX Absorbable Antibacterial Envelope or not.
After a mean follow-up of 20.7 months, there was a significant 40% lower rate of major infections in the envelope group compared to the control group, which met the efficacy objective of the study. Researchers saw 30 major infections in 25 patients in the envelope group; in the control group, there were 45 major infections in 42 patients (P = 0.04). The trial excluded patients at high risk of systemic infection due to other sources and patients with existing infection.
“CIED infection is a rare but serious event, and its management requires prolonged hospitalization, which involves device and lead extraction with adjunctive antibiotic therapy,” wrote Dr. Khaldoun G. Tarakji, from The Cleveland Clinic, and co-authors. “Despite proper management of CIED infection, both short- and long-term mortality remains high.”
One previous randomized study had shown that intravenous administration of antibiotics during CIED procedures can reduce the risk of infection, while a different study failed to find a benefit. The vast majority of patients in this study (98.7%) received periprocedural antibiotics, 74.5% received pocket wash and 29.6% received post-procedural antibiotics. These strategies were not controlled, but there is no clear evidence that any particular strategy influenced the infection rate, the authors wrote.
Patients in the envelope group experienced numerically fewer pocket infections but more endocarditis or bacteremia compared to those in the control group, a finding that the authors could not explain.
The most common pathogen responsible was staphylococcus, but data on antibiotic susceptibility was not collected. The authors stressed that this limited their ability to assess the risk of antibiotic resistance developing.
In this study, the researchers noted that the reduction in the risk of infection was greater among individuals who were implanted with higher-power devices, compared to those implanted with low-power devices or an initial cardiac resynchronization therapy device.
However, they said, the rate of infections was generally lower among those receiving low-power devices.
There was no increase in complications related to use of the envelope. The rate of complications occurring within 12 months of the procedure and relating to the CIED procedure or envelope was 6% in the envelope group and 6.9% in the control group.
When major infections were excluded, the rate of complications in each group was 5.7% and 5/9% respectively. There was also no significant difference in mortality rates between the two groups (17.4% and 17.8% respectively).
The authors wrote that while use of the envelope can require a slightly larger CIED dissection pocket, this was not associated with increased procedural time or complications. The envelope was successfully implanted in 99.7% of procedure attempts.
“There were fewer system revisions in the envelope group than in the control group and no complications due to allergy to the envelope mesh, polymer, or antibiotics,” they wrote.
The study was supported by Medtronic, the maker of the TYRX Absorbable Antibacterial Envelope. Twenty-four authors declared institutional funding or research grants from Medtronic, thirteen declared fees, consultancies and other support from private industry outside the submitted work. Three authors were employees of Medtronic.
SOURCE: Tarakji K et al. NEJM, 2019, March 17. DOI: 10.1056/NEJMoa1901111
An absorbable, antibiotic-eluting envelope around cardiac implantable electronic devices could significantly reduce the incidence of infection, according to a presentation at the annual meeting of the American College of Cardiology.
The WRAP-IT trial, which was simultaneously published online March 17 in the New England Journal of Medicine, involved 6,983 patients undergoing cardiac implantable electronic device (CIED) implantation, replacement, revision, or upgrade. Patients were randomized either to receive the TYRX Absorbable Antibacterial Envelope or not.
After a mean follow-up of 20.7 months, there was a significant 40% lower rate of major infections in the envelope group compared to the control group, which met the efficacy objective of the study. Researchers saw 30 major infections in 25 patients in the envelope group; in the control group, there were 45 major infections in 42 patients (P = 0.04). The trial excluded patients at high risk of systemic infection due to other sources and patients with existing infection.
“CIED infection is a rare but serious event, and its management requires prolonged hospitalization, which involves device and lead extraction with adjunctive antibiotic therapy,” wrote Dr. Khaldoun G. Tarakji, from The Cleveland Clinic, and co-authors. “Despite proper management of CIED infection, both short- and long-term mortality remains high.”
One previous randomized study had shown that intravenous administration of antibiotics during CIED procedures can reduce the risk of infection, while a different study failed to find a benefit. The vast majority of patients in this study (98.7%) received periprocedural antibiotics, 74.5% received pocket wash and 29.6% received post-procedural antibiotics. These strategies were not controlled, but there is no clear evidence that any particular strategy influenced the infection rate, the authors wrote.
Patients in the envelope group experienced numerically fewer pocket infections but more endocarditis or bacteremia compared to those in the control group, a finding that the authors could not explain.
The most common pathogen responsible was staphylococcus, but data on antibiotic susceptibility was not collected. The authors stressed that this limited their ability to assess the risk of antibiotic resistance developing.
In this study, the researchers noted that the reduction in the risk of infection was greater among individuals who were implanted with higher-power devices, compared to those implanted with low-power devices or an initial cardiac resynchronization therapy device.
However, they said, the rate of infections was generally lower among those receiving low-power devices.
There was no increase in complications related to use of the envelope. The rate of complications occurring within 12 months of the procedure and relating to the CIED procedure or envelope was 6% in the envelope group and 6.9% in the control group.
When major infections were excluded, the rate of complications in each group was 5.7% and 5/9% respectively. There was also no significant difference in mortality rates between the two groups (17.4% and 17.8% respectively).
The authors wrote that while use of the envelope can require a slightly larger CIED dissection pocket, this was not associated with increased procedural time or complications. The envelope was successfully implanted in 99.7% of procedure attempts.
“There were fewer system revisions in the envelope group than in the control group and no complications due to allergy to the envelope mesh, polymer, or antibiotics,” they wrote.
The study was supported by Medtronic, the maker of the TYRX Absorbable Antibacterial Envelope. Twenty-four authors declared institutional funding or research grants from Medtronic, thirteen declared fees, consultancies and other support from private industry outside the submitted work. Three authors were employees of Medtronic.
SOURCE: Tarakji K et al. NEJM, 2019, March 17. DOI: 10.1056/NEJMoa1901111
An absorbable, antibiotic-eluting envelope around cardiac implantable electronic devices could significantly reduce the incidence of infection, according to a presentation at the annual meeting of the American College of Cardiology.
The WRAP-IT trial, which was simultaneously published online March 17 in the New England Journal of Medicine, involved 6,983 patients undergoing cardiac implantable electronic device (CIED) implantation, replacement, revision, or upgrade. Patients were randomized either to receive the TYRX Absorbable Antibacterial Envelope or not.
After a mean follow-up of 20.7 months, there was a significant 40% lower rate of major infections in the envelope group compared to the control group, which met the efficacy objective of the study. Researchers saw 30 major infections in 25 patients in the envelope group; in the control group, there were 45 major infections in 42 patients (P = 0.04). The trial excluded patients at high risk of systemic infection due to other sources and patients with existing infection.
“CIED infection is a rare but serious event, and its management requires prolonged hospitalization, which involves device and lead extraction with adjunctive antibiotic therapy,” wrote Dr. Khaldoun G. Tarakji, from The Cleveland Clinic, and co-authors. “Despite proper management of CIED infection, both short- and long-term mortality remains high.”
One previous randomized study had shown that intravenous administration of antibiotics during CIED procedures can reduce the risk of infection, while a different study failed to find a benefit. The vast majority of patients in this study (98.7%) received periprocedural antibiotics, 74.5% received pocket wash and 29.6% received post-procedural antibiotics. These strategies were not controlled, but there is no clear evidence that any particular strategy influenced the infection rate, the authors wrote.
Patients in the envelope group experienced numerically fewer pocket infections but more endocarditis or bacteremia compared to those in the control group, a finding that the authors could not explain.
The most common pathogen responsible was staphylococcus, but data on antibiotic susceptibility was not collected. The authors stressed that this limited their ability to assess the risk of antibiotic resistance developing.
In this study, the researchers noted that the reduction in the risk of infection was greater among individuals who were implanted with higher-power devices, compared to those implanted with low-power devices or an initial cardiac resynchronization therapy device.
However, they said, the rate of infections was generally lower among those receiving low-power devices.
There was no increase in complications related to use of the envelope. The rate of complications occurring within 12 months of the procedure and relating to the CIED procedure or envelope was 6% in the envelope group and 6.9% in the control group.
When major infections were excluded, the rate of complications in each group was 5.7% and 5/9% respectively. There was also no significant difference in mortality rates between the two groups (17.4% and 17.8% respectively).
The authors wrote that while use of the envelope can require a slightly larger CIED dissection pocket, this was not associated with increased procedural time or complications. The envelope was successfully implanted in 99.7% of procedure attempts.
“There were fewer system revisions in the envelope group than in the control group and no complications due to allergy to the envelope mesh, polymer, or antibiotics,” they wrote.
The study was supported by Medtronic, the maker of the TYRX Absorbable Antibacterial Envelope. Twenty-four authors declared institutional funding or research grants from Medtronic, thirteen declared fees, consultancies and other support from private industry outside the submitted work. Three authors were employees of Medtronic.
SOURCE: Tarakji K et al. NEJM, 2019, March 17. DOI: 10.1056/NEJMoa1901111
FROM ACC 19
Apple Watch algorithm showed 84% positive predictive value for Afib
, investigators reported at the annual meeting of the American College of Cardiology.
This was a single-arm, prospective, open-label, observational study of unprecedented size and speediness of completion. It included nearly 420,000 self-enrolled adults living in the U.S., with 8 months of monitoring. But despite the study’s flashy size and trendy digital health theme, the researchers were careful not to oversell the findings.
“This study was just meant to be a very, very first step in trying to learn if this kind of technology can help us to prevent stroke. It was not a randomized trial of a public health intervention for screening. This is the first half of the first inning. Rigorous investigation of this technology and its potential use in clinical settings will need to happen. But we do think from a trial and operational standpoint the Apple Heart Study provides a solid foundation upon which further research in digital health can be conducted,” according to Mintu Turakhia, MD, co-principal investigator and an electrophysiologist as well as executive director of the Center for Digital Health at Stanford (Calif.) University, which conducted the study.
The study was conducted virtually. Screening, consent, and data gathering were performed electronically by smartphone. Participants had to have an Apple Watch Series 1, 2, or 3, and an Apple iPhone 5 or more recent model in order to join. The majority of subjects were under age 40, and just 6% were age 65 or older, when the risks of atrial fibrillation (AFib) and stroke are higher. All participants self-reported having no history of AFib nor currently being on anticoagulation.
The study algorithm utilized the Apple Watch’s built-in light sensor technology to opportunistically sample the time interval between pulses when the wearer was still. An irregular time interval triggered a cascade of more frequent sampling. If 5 of 6 samples were irregular within a 48-hour period, the wearer received an irregular rhythm notification along with a prompt to contact a participating physician via telemedicine. The physician could then arrange for an ECG patch to be mailed to the participant, who wore it for up to 7 days before mailing it back for analysis.
Among the key findings in the Apple Heart Study: the irregular pulse notification rate was low overall, at 0.5%, ranging from 0.16% in the under-40 group to 3.2% in subjects age 65 or older. As a result, the study population of particular interest nosedived from an initial 419,297 to the less than 2,100 who received an irregular pulse notification. Of the 658 participants who were subsequently sent an ECG patch, 450 returned it for analysis.
An average of 13 days went by between an irregular pulse notification and ECG patch receipt and activation, so it wasn’t particularly surprising that only 34% of the patches were positive for AFib, since early-stage paroxysmal AFib comes and goes. However, of the 86 subjects who received a new notification of an irregular rhythm while they were wearing a patch, 72 simultaneously showed AFib on their patch. That translates to an 84% positive predictive value for an irregular rhythm notification as an indicator of AFib.
Of the 153 subjects with evidence of AFib on their ECG patch, 20% proved to be in AFib for the full week they wore it. Of those with AFib, 89% had a longest episode of at least 1 hour in duration.
Several discussants expressed reservations about this approach to finding individuals with previously undetected AFib. Jeanne E. Poole, MD, an electrophysiologist and professor of medicine at the University of Washington in Seattle, observed that the question of whether patients with asymptomatic AFib should receive oral anticoagulation therapy is as-yet unanswered and is the focus of ongoing randomized trials. The Apple Heart Study approach, she said, “might lead a lot of patients into being treated unnecessarily or prematurely, or flooding doctors’ offices with a lot of young people.”
Co-principal investigator Marco Perez, MD, an electrophysiologist at Stanford, replied, “Stroke is important, and we all worry about it. But it’s also important that there are other things atrial fibrillation is associated with, like cardiomyopathy and heart failure. So finding atrial fibrillation in a young population might be important. Maybe they don’t need anticoagulation, but maybe there’s something else going on.”
Patrick T. O’Gara, MD, professor of medicine at Harvard University, Boston, was concerned about what he called “the signal-to-noise ratio – the noise that will come in when there is an irregularity detected on the watch that could range from anything from ventricular premature beats to atrial fibrillation.” He is also leery of what he considers to be at this point the excessive hype surrounding direct-to-consumer wearable digital health technology.
“I applaud your circumspection,” he told Dr. Turakhia and Dr. Perez. “I understand very directly from you that these are limited observations. But it’s a good step forward.”
Dr. Perez reported receiving research funding from and serving as a consultant to Apple. Dr. Turakhia reported serving as a consultant to AliveCor and Cardiva Medical.
Their presentation was immediately followed by a related panel discussion titled, “Digital Disruption at Our Doorstep – Implications for Clinicians and Patients.” Session moderator John Rumsfeld, MD, chief innovation officer at the ACC and professor of medicine at the University of Colorado, Denver, kicked things off by observing, “Digital health technology certainly exists. There’ve been billions of dollars invested in digital health. Outside of health care there’s been successful digital transformation of almost every other sector of the economy except for health care. But we deliver care pretty much the same as we have for the past 50 or more years.”
Paul Stoeffels, MD, chief scientific officer at Johnson & Johnson, said physicians and payers want to see evidence of benefit before adopting change. Towards that end, he announced that Johnson & Johnson and Apple are collaborating on a randomized controlled trial called the HEARTLINE study. The active intervention arm in the study involves utilization of the Apple Watch’s irregular pulse notification algorithm, with confirmation of AFib to be achieved using the ECG app incorporated in the latest version of the watch, coupled with a medication adherence app developed by Johnson & Johnson. Enrollment of 150,000 U.S. adults age 65 and older is planned to begin this summer. The study, conducted on a digital platform akin to the Apple Heart Study, will look at the intervention’s impact on rates of stroke, MI, and death as well as AF detection.
Maulik Majmudar, MD, a cardiologist and chief health officer for health and wellness at Amazon, declared, “There’s no doubt in my mind that digital solutions will become a mainstay in our care delivery going forward. The question is really not if, but when.”
He predicted that just as the past two decades have seen the birth of new medical specialties, including hospitalists and cardiovascular intensivists, the next 10 years or so will see the creation of a new field within cardiovascular medicine, whose skilled practitioners might be called ‘digitalists’ – experts in collecting, moving, and safeguarding massive quantities of digital health data.
Robert Califf, MD, vice chancellor for health data science at Duke Health in Durham, N.C., addressed the issue of how society is going to pay for a shift to digital health: “It’s very simple. I don’t see any way that fee-for-service medicine can deal with this. It’s just not possible. If you think we’re going to add on more cost to the system by doing virtual visits, I just do not see that happening. Our solution to the payment system is to get rid of fee-for-service medicine and go to pay-for-value. The minute you’re in pay-for-value, virtual visits and digital information will become the way to do it – to move the treatment and the interaction more to home and less of having people wait in doctors’ offices and spending time in hospitals.”
SOURCE: Turakhia M, ACC 19 NCT03335800
, investigators reported at the annual meeting of the American College of Cardiology.
This was a single-arm, prospective, open-label, observational study of unprecedented size and speediness of completion. It included nearly 420,000 self-enrolled adults living in the U.S., with 8 months of monitoring. But despite the study’s flashy size and trendy digital health theme, the researchers were careful not to oversell the findings.
“This study was just meant to be a very, very first step in trying to learn if this kind of technology can help us to prevent stroke. It was not a randomized trial of a public health intervention for screening. This is the first half of the first inning. Rigorous investigation of this technology and its potential use in clinical settings will need to happen. But we do think from a trial and operational standpoint the Apple Heart Study provides a solid foundation upon which further research in digital health can be conducted,” according to Mintu Turakhia, MD, co-principal investigator and an electrophysiologist as well as executive director of the Center for Digital Health at Stanford (Calif.) University, which conducted the study.
The study was conducted virtually. Screening, consent, and data gathering were performed electronically by smartphone. Participants had to have an Apple Watch Series 1, 2, or 3, and an Apple iPhone 5 or more recent model in order to join. The majority of subjects were under age 40, and just 6% were age 65 or older, when the risks of atrial fibrillation (AFib) and stroke are higher. All participants self-reported having no history of AFib nor currently being on anticoagulation.
The study algorithm utilized the Apple Watch’s built-in light sensor technology to opportunistically sample the time interval between pulses when the wearer was still. An irregular time interval triggered a cascade of more frequent sampling. If 5 of 6 samples were irregular within a 48-hour period, the wearer received an irregular rhythm notification along with a prompt to contact a participating physician via telemedicine. The physician could then arrange for an ECG patch to be mailed to the participant, who wore it for up to 7 days before mailing it back for analysis.
Among the key findings in the Apple Heart Study: the irregular pulse notification rate was low overall, at 0.5%, ranging from 0.16% in the under-40 group to 3.2% in subjects age 65 or older. As a result, the study population of particular interest nosedived from an initial 419,297 to the less than 2,100 who received an irregular pulse notification. Of the 658 participants who were subsequently sent an ECG patch, 450 returned it for analysis.
An average of 13 days went by between an irregular pulse notification and ECG patch receipt and activation, so it wasn’t particularly surprising that only 34% of the patches were positive for AFib, since early-stage paroxysmal AFib comes and goes. However, of the 86 subjects who received a new notification of an irregular rhythm while they were wearing a patch, 72 simultaneously showed AFib on their patch. That translates to an 84% positive predictive value for an irregular rhythm notification as an indicator of AFib.
Of the 153 subjects with evidence of AFib on their ECG patch, 20% proved to be in AFib for the full week they wore it. Of those with AFib, 89% had a longest episode of at least 1 hour in duration.
Several discussants expressed reservations about this approach to finding individuals with previously undetected AFib. Jeanne E. Poole, MD, an electrophysiologist and professor of medicine at the University of Washington in Seattle, observed that the question of whether patients with asymptomatic AFib should receive oral anticoagulation therapy is as-yet unanswered and is the focus of ongoing randomized trials. The Apple Heart Study approach, she said, “might lead a lot of patients into being treated unnecessarily or prematurely, or flooding doctors’ offices with a lot of young people.”
Co-principal investigator Marco Perez, MD, an electrophysiologist at Stanford, replied, “Stroke is important, and we all worry about it. But it’s also important that there are other things atrial fibrillation is associated with, like cardiomyopathy and heart failure. So finding atrial fibrillation in a young population might be important. Maybe they don’t need anticoagulation, but maybe there’s something else going on.”
Patrick T. O’Gara, MD, professor of medicine at Harvard University, Boston, was concerned about what he called “the signal-to-noise ratio – the noise that will come in when there is an irregularity detected on the watch that could range from anything from ventricular premature beats to atrial fibrillation.” He is also leery of what he considers to be at this point the excessive hype surrounding direct-to-consumer wearable digital health technology.
“I applaud your circumspection,” he told Dr. Turakhia and Dr. Perez. “I understand very directly from you that these are limited observations. But it’s a good step forward.”
Dr. Perez reported receiving research funding from and serving as a consultant to Apple. Dr. Turakhia reported serving as a consultant to AliveCor and Cardiva Medical.
Their presentation was immediately followed by a related panel discussion titled, “Digital Disruption at Our Doorstep – Implications for Clinicians and Patients.” Session moderator John Rumsfeld, MD, chief innovation officer at the ACC and professor of medicine at the University of Colorado, Denver, kicked things off by observing, “Digital health technology certainly exists. There’ve been billions of dollars invested in digital health. Outside of health care there’s been successful digital transformation of almost every other sector of the economy except for health care. But we deliver care pretty much the same as we have for the past 50 or more years.”
Paul Stoeffels, MD, chief scientific officer at Johnson & Johnson, said physicians and payers want to see evidence of benefit before adopting change. Towards that end, he announced that Johnson & Johnson and Apple are collaborating on a randomized controlled trial called the HEARTLINE study. The active intervention arm in the study involves utilization of the Apple Watch’s irregular pulse notification algorithm, with confirmation of AFib to be achieved using the ECG app incorporated in the latest version of the watch, coupled with a medication adherence app developed by Johnson & Johnson. Enrollment of 150,000 U.S. adults age 65 and older is planned to begin this summer. The study, conducted on a digital platform akin to the Apple Heart Study, will look at the intervention’s impact on rates of stroke, MI, and death as well as AF detection.
Maulik Majmudar, MD, a cardiologist and chief health officer for health and wellness at Amazon, declared, “There’s no doubt in my mind that digital solutions will become a mainstay in our care delivery going forward. The question is really not if, but when.”
He predicted that just as the past two decades have seen the birth of new medical specialties, including hospitalists and cardiovascular intensivists, the next 10 years or so will see the creation of a new field within cardiovascular medicine, whose skilled practitioners might be called ‘digitalists’ – experts in collecting, moving, and safeguarding massive quantities of digital health data.
Robert Califf, MD, vice chancellor for health data science at Duke Health in Durham, N.C., addressed the issue of how society is going to pay for a shift to digital health: “It’s very simple. I don’t see any way that fee-for-service medicine can deal with this. It’s just not possible. If you think we’re going to add on more cost to the system by doing virtual visits, I just do not see that happening. Our solution to the payment system is to get rid of fee-for-service medicine and go to pay-for-value. The minute you’re in pay-for-value, virtual visits and digital information will become the way to do it – to move the treatment and the interaction more to home and less of having people wait in doctors’ offices and spending time in hospitals.”
SOURCE: Turakhia M, ACC 19 NCT03335800
, investigators reported at the annual meeting of the American College of Cardiology.
This was a single-arm, prospective, open-label, observational study of unprecedented size and speediness of completion. It included nearly 420,000 self-enrolled adults living in the U.S., with 8 months of monitoring. But despite the study’s flashy size and trendy digital health theme, the researchers were careful not to oversell the findings.
“This study was just meant to be a very, very first step in trying to learn if this kind of technology can help us to prevent stroke. It was not a randomized trial of a public health intervention for screening. This is the first half of the first inning. Rigorous investigation of this technology and its potential use in clinical settings will need to happen. But we do think from a trial and operational standpoint the Apple Heart Study provides a solid foundation upon which further research in digital health can be conducted,” according to Mintu Turakhia, MD, co-principal investigator and an electrophysiologist as well as executive director of the Center for Digital Health at Stanford (Calif.) University, which conducted the study.
The study was conducted virtually. Screening, consent, and data gathering were performed electronically by smartphone. Participants had to have an Apple Watch Series 1, 2, or 3, and an Apple iPhone 5 or more recent model in order to join. The majority of subjects were under age 40, and just 6% were age 65 or older, when the risks of atrial fibrillation (AFib) and stroke are higher. All participants self-reported having no history of AFib nor currently being on anticoagulation.
The study algorithm utilized the Apple Watch’s built-in light sensor technology to opportunistically sample the time interval between pulses when the wearer was still. An irregular time interval triggered a cascade of more frequent sampling. If 5 of 6 samples were irregular within a 48-hour period, the wearer received an irregular rhythm notification along with a prompt to contact a participating physician via telemedicine. The physician could then arrange for an ECG patch to be mailed to the participant, who wore it for up to 7 days before mailing it back for analysis.
Among the key findings in the Apple Heart Study: the irregular pulse notification rate was low overall, at 0.5%, ranging from 0.16% in the under-40 group to 3.2% in subjects age 65 or older. As a result, the study population of particular interest nosedived from an initial 419,297 to the less than 2,100 who received an irregular pulse notification. Of the 658 participants who were subsequently sent an ECG patch, 450 returned it for analysis.
An average of 13 days went by between an irregular pulse notification and ECG patch receipt and activation, so it wasn’t particularly surprising that only 34% of the patches were positive for AFib, since early-stage paroxysmal AFib comes and goes. However, of the 86 subjects who received a new notification of an irregular rhythm while they were wearing a patch, 72 simultaneously showed AFib on their patch. That translates to an 84% positive predictive value for an irregular rhythm notification as an indicator of AFib.
Of the 153 subjects with evidence of AFib on their ECG patch, 20% proved to be in AFib for the full week they wore it. Of those with AFib, 89% had a longest episode of at least 1 hour in duration.
Several discussants expressed reservations about this approach to finding individuals with previously undetected AFib. Jeanne E. Poole, MD, an electrophysiologist and professor of medicine at the University of Washington in Seattle, observed that the question of whether patients with asymptomatic AFib should receive oral anticoagulation therapy is as-yet unanswered and is the focus of ongoing randomized trials. The Apple Heart Study approach, she said, “might lead a lot of patients into being treated unnecessarily or prematurely, or flooding doctors’ offices with a lot of young people.”
Co-principal investigator Marco Perez, MD, an electrophysiologist at Stanford, replied, “Stroke is important, and we all worry about it. But it’s also important that there are other things atrial fibrillation is associated with, like cardiomyopathy and heart failure. So finding atrial fibrillation in a young population might be important. Maybe they don’t need anticoagulation, but maybe there’s something else going on.”
Patrick T. O’Gara, MD, professor of medicine at Harvard University, Boston, was concerned about what he called “the signal-to-noise ratio – the noise that will come in when there is an irregularity detected on the watch that could range from anything from ventricular premature beats to atrial fibrillation.” He is also leery of what he considers to be at this point the excessive hype surrounding direct-to-consumer wearable digital health technology.
“I applaud your circumspection,” he told Dr. Turakhia and Dr. Perez. “I understand very directly from you that these are limited observations. But it’s a good step forward.”
Dr. Perez reported receiving research funding from and serving as a consultant to Apple. Dr. Turakhia reported serving as a consultant to AliveCor and Cardiva Medical.
Their presentation was immediately followed by a related panel discussion titled, “Digital Disruption at Our Doorstep – Implications for Clinicians and Patients.” Session moderator John Rumsfeld, MD, chief innovation officer at the ACC and professor of medicine at the University of Colorado, Denver, kicked things off by observing, “Digital health technology certainly exists. There’ve been billions of dollars invested in digital health. Outside of health care there’s been successful digital transformation of almost every other sector of the economy except for health care. But we deliver care pretty much the same as we have for the past 50 or more years.”
Paul Stoeffels, MD, chief scientific officer at Johnson & Johnson, said physicians and payers want to see evidence of benefit before adopting change. Towards that end, he announced that Johnson & Johnson and Apple are collaborating on a randomized controlled trial called the HEARTLINE study. The active intervention arm in the study involves utilization of the Apple Watch’s irregular pulse notification algorithm, with confirmation of AFib to be achieved using the ECG app incorporated in the latest version of the watch, coupled with a medication adherence app developed by Johnson & Johnson. Enrollment of 150,000 U.S. adults age 65 and older is planned to begin this summer. The study, conducted on a digital platform akin to the Apple Heart Study, will look at the intervention’s impact on rates of stroke, MI, and death as well as AF detection.
Maulik Majmudar, MD, a cardiologist and chief health officer for health and wellness at Amazon, declared, “There’s no doubt in my mind that digital solutions will become a mainstay in our care delivery going forward. The question is really not if, but when.”
He predicted that just as the past two decades have seen the birth of new medical specialties, including hospitalists and cardiovascular intensivists, the next 10 years or so will see the creation of a new field within cardiovascular medicine, whose skilled practitioners might be called ‘digitalists’ – experts in collecting, moving, and safeguarding massive quantities of digital health data.
Robert Califf, MD, vice chancellor for health data science at Duke Health in Durham, N.C., addressed the issue of how society is going to pay for a shift to digital health: “It’s very simple. I don’t see any way that fee-for-service medicine can deal with this. It’s just not possible. If you think we’re going to add on more cost to the system by doing virtual visits, I just do not see that happening. Our solution to the payment system is to get rid of fee-for-service medicine and go to pay-for-value. The minute you’re in pay-for-value, virtual visits and digital information will become the way to do it – to move the treatment and the interaction more to home and less of having people wait in doctors’ offices and spending time in hospitals.”
SOURCE: Turakhia M, ACC 19 NCT03335800
REPORTING FROM ACC 19
Apple Watch algorithm brings wearables closer to clinical practice
NEW ORLEANS – , Matthew W. Martinez, MD, medical director of the Sports Cardiology and Hypertrophic Cardiomyopathy Center at the Lehigh Valley Health Network in Allentown, Pa., said in a video interview.
The Apple Heart Study, presented at the annual meeting of the American College of Cardiology, evaluated a mobile app that uses the watch’s existing light sensor technology to detect subtle changes that might indicate an arrhythmia.
The Apple Watch generates a tachogram, which is a plot of time between heart beats. If an abnormal tachogram occurs five out of six times, they are analyzed by an algorithm and sent to the Apple Watch.
The positive predictive value for the tachogram was 71%, and the positive predictive value for the notification was 84%.
Dr. Martinez, who is lead cardiologist for U.S. Major League Soccer and is also heavily involved with the National Football League, said that the study helps clinicians understand the utility of wearable technology.
His take home from the study is that, when people are notified by their watch, they should notify their health care provider, and the provider should take it seriously.
Dr. Martinez was not involved in the Apple Heart Study, and had no relevant disclosures.
bjancin@mdedge.com
NEW ORLEANS – , Matthew W. Martinez, MD, medical director of the Sports Cardiology and Hypertrophic Cardiomyopathy Center at the Lehigh Valley Health Network in Allentown, Pa., said in a video interview.
The Apple Heart Study, presented at the annual meeting of the American College of Cardiology, evaluated a mobile app that uses the watch’s existing light sensor technology to detect subtle changes that might indicate an arrhythmia.
The Apple Watch generates a tachogram, which is a plot of time between heart beats. If an abnormal tachogram occurs five out of six times, they are analyzed by an algorithm and sent to the Apple Watch.
The positive predictive value for the tachogram was 71%, and the positive predictive value for the notification was 84%.
Dr. Martinez, who is lead cardiologist for U.S. Major League Soccer and is also heavily involved with the National Football League, said that the study helps clinicians understand the utility of wearable technology.
His take home from the study is that, when people are notified by their watch, they should notify their health care provider, and the provider should take it seriously.
Dr. Martinez was not involved in the Apple Heart Study, and had no relevant disclosures.
bjancin@mdedge.com
NEW ORLEANS – , Matthew W. Martinez, MD, medical director of the Sports Cardiology and Hypertrophic Cardiomyopathy Center at the Lehigh Valley Health Network in Allentown, Pa., said in a video interview.
The Apple Heart Study, presented at the annual meeting of the American College of Cardiology, evaluated a mobile app that uses the watch’s existing light sensor technology to detect subtle changes that might indicate an arrhythmia.
The Apple Watch generates a tachogram, which is a plot of time between heart beats. If an abnormal tachogram occurs five out of six times, they are analyzed by an algorithm and sent to the Apple Watch.
The positive predictive value for the tachogram was 71%, and the positive predictive value for the notification was 84%.
Dr. Martinez, who is lead cardiologist for U.S. Major League Soccer and is also heavily involved with the National Football League, said that the study helps clinicians understand the utility of wearable technology.
His take home from the study is that, when people are notified by their watch, they should notify their health care provider, and the provider should take it seriously.
Dr. Martinez was not involved in the Apple Heart Study, and had no relevant disclosures.
bjancin@mdedge.com
REPORTING FROM ACC 19
CAC score over 1,000 carries higher risks
, based on data from a large retrospective study presented by Allison W. Peng at the annual meeting of the American College of Cardiology.
“Our data argues for consideration of CAC 1000 (or more) as a distinct group with CVD mortality greater than that of contemporary secondary prevention trials ... We showed that those with CAC 1000 (or more) have both a higher area and density of calcification, a more dispersed pattern of calcification in their coronary artery tree (the majority with 4-vessel disease), with a markedly more diffuse distribution of extra-coronary calcification compared to the other CAC groups,” Ms. Peng and her colleagues wrote in the study, which was published online in the Journal of the American College of Cardiology.
Future guidelines should address these patients as a distinct risk group that might gain the most benefit from targeted, aggressive preventive therapy, the researchers said.
Current guidelines identify individuals with CAC scores over 400 as the highest risk group. With a mean follow-up time of 12.3 years, the results from 66,636 asymptomatic individuals in the CAC consortium study, which included over 2,800 patients with CAC (Agatston) scores of 1,000 or more, indicate patients with CAC scores of 1000 or more have nearly a 2-fold higher risk of CVD mortality compared to those with CAC scores of 400-999. While the mortality risk levels off slightly in those with scores exceeding 1000, all-cause and cause-specific mortality risk still increases with no apparent upper CAC threshold.
Patients with a CAC score of at least 1000 were 66.3 years old, on average; 86.3% were male, 52.4% had 4-vessel CAC, and they had a larger total CAC area.
Compared to patients with CAC scores of 400-999, those with a CAC score of 1000 or more had a greater risk of cardiovascular disease (HR, 1.71; 95% CI, 1.41-2.08), coronary heart disease (HR, 1.84; 95% CI, 1.43-2.36), cancer (HR, 1.36; 95% CI, 1.07-1.73), and all-cause mortality (HR, 1.51; 95% CI, 1.33-1.70).
Those with CAC scores of 400-999 had a 2.1, 3.6, 2.7, and 9.8 mortality rate per 1000 person-years for CHD, CVD, cancer, and all-cause mortality, respectively. But those with CAC scores of 1000 of more had a 5.1, 8.0, 4.6, and 18.8 mortality rate per 1000 person-years for CHD, CVD, cancer, and all-cause mortality, respectively.
The leading cause of death was CVD; 36.5% in the CAC 400-999 group and 42.6% in the CAC 1000 or more group. CHD mortality, as a subset of CVD mortality, constituted 21.1% of deaths in the CAC 400-999 group and 27.1% of deaths in the CAC 1000 or more group.
“Future randomized controlled trials of aggressive preventative therapies, for example PCSK9-inhibitors and anti-inflammatory drugs, in patients with CAC ≥ 1000, may prove helpful to evaluate the benefits of such treatment in this unique group,” the authors wrote. They also urged updating current guidelines to reflect best practices for these patients.
The study was funded by The National Institutes of Health. The authors have no relevant financial disclosures.
SOURCE: Peng A et al. Journal of the American College of Cardiology.
, based on data from a large retrospective study presented by Allison W. Peng at the annual meeting of the American College of Cardiology.
“Our data argues for consideration of CAC 1000 (or more) as a distinct group with CVD mortality greater than that of contemporary secondary prevention trials ... We showed that those with CAC 1000 (or more) have both a higher area and density of calcification, a more dispersed pattern of calcification in their coronary artery tree (the majority with 4-vessel disease), with a markedly more diffuse distribution of extra-coronary calcification compared to the other CAC groups,” Ms. Peng and her colleagues wrote in the study, which was published online in the Journal of the American College of Cardiology.
Future guidelines should address these patients as a distinct risk group that might gain the most benefit from targeted, aggressive preventive therapy, the researchers said.
Current guidelines identify individuals with CAC scores over 400 as the highest risk group. With a mean follow-up time of 12.3 years, the results from 66,636 asymptomatic individuals in the CAC consortium study, which included over 2,800 patients with CAC (Agatston) scores of 1,000 or more, indicate patients with CAC scores of 1000 or more have nearly a 2-fold higher risk of CVD mortality compared to those with CAC scores of 400-999. While the mortality risk levels off slightly in those with scores exceeding 1000, all-cause and cause-specific mortality risk still increases with no apparent upper CAC threshold.
Patients with a CAC score of at least 1000 were 66.3 years old, on average; 86.3% were male, 52.4% had 4-vessel CAC, and they had a larger total CAC area.
Compared to patients with CAC scores of 400-999, those with a CAC score of 1000 or more had a greater risk of cardiovascular disease (HR, 1.71; 95% CI, 1.41-2.08), coronary heart disease (HR, 1.84; 95% CI, 1.43-2.36), cancer (HR, 1.36; 95% CI, 1.07-1.73), and all-cause mortality (HR, 1.51; 95% CI, 1.33-1.70).
Those with CAC scores of 400-999 had a 2.1, 3.6, 2.7, and 9.8 mortality rate per 1000 person-years for CHD, CVD, cancer, and all-cause mortality, respectively. But those with CAC scores of 1000 of more had a 5.1, 8.0, 4.6, and 18.8 mortality rate per 1000 person-years for CHD, CVD, cancer, and all-cause mortality, respectively.
The leading cause of death was CVD; 36.5% in the CAC 400-999 group and 42.6% in the CAC 1000 or more group. CHD mortality, as a subset of CVD mortality, constituted 21.1% of deaths in the CAC 400-999 group and 27.1% of deaths in the CAC 1000 or more group.
“Future randomized controlled trials of aggressive preventative therapies, for example PCSK9-inhibitors and anti-inflammatory drugs, in patients with CAC ≥ 1000, may prove helpful to evaluate the benefits of such treatment in this unique group,” the authors wrote. They also urged updating current guidelines to reflect best practices for these patients.
The study was funded by The National Institutes of Health. The authors have no relevant financial disclosures.
SOURCE: Peng A et al. Journal of the American College of Cardiology.
, based on data from a large retrospective study presented by Allison W. Peng at the annual meeting of the American College of Cardiology.
“Our data argues for consideration of CAC 1000 (or more) as a distinct group with CVD mortality greater than that of contemporary secondary prevention trials ... We showed that those with CAC 1000 (or more) have both a higher area and density of calcification, a more dispersed pattern of calcification in their coronary artery tree (the majority with 4-vessel disease), with a markedly more diffuse distribution of extra-coronary calcification compared to the other CAC groups,” Ms. Peng and her colleagues wrote in the study, which was published online in the Journal of the American College of Cardiology.
Future guidelines should address these patients as a distinct risk group that might gain the most benefit from targeted, aggressive preventive therapy, the researchers said.
Current guidelines identify individuals with CAC scores over 400 as the highest risk group. With a mean follow-up time of 12.3 years, the results from 66,636 asymptomatic individuals in the CAC consortium study, which included over 2,800 patients with CAC (Agatston) scores of 1,000 or more, indicate patients with CAC scores of 1000 or more have nearly a 2-fold higher risk of CVD mortality compared to those with CAC scores of 400-999. While the mortality risk levels off slightly in those with scores exceeding 1000, all-cause and cause-specific mortality risk still increases with no apparent upper CAC threshold.
Patients with a CAC score of at least 1000 were 66.3 years old, on average; 86.3% were male, 52.4% had 4-vessel CAC, and they had a larger total CAC area.
Compared to patients with CAC scores of 400-999, those with a CAC score of 1000 or more had a greater risk of cardiovascular disease (HR, 1.71; 95% CI, 1.41-2.08), coronary heart disease (HR, 1.84; 95% CI, 1.43-2.36), cancer (HR, 1.36; 95% CI, 1.07-1.73), and all-cause mortality (HR, 1.51; 95% CI, 1.33-1.70).
Those with CAC scores of 400-999 had a 2.1, 3.6, 2.7, and 9.8 mortality rate per 1000 person-years for CHD, CVD, cancer, and all-cause mortality, respectively. But those with CAC scores of 1000 of more had a 5.1, 8.0, 4.6, and 18.8 mortality rate per 1000 person-years for CHD, CVD, cancer, and all-cause mortality, respectively.
The leading cause of death was CVD; 36.5% in the CAC 400-999 group and 42.6% in the CAC 1000 or more group. CHD mortality, as a subset of CVD mortality, constituted 21.1% of deaths in the CAC 400-999 group and 27.1% of deaths in the CAC 1000 or more group.
“Future randomized controlled trials of aggressive preventative therapies, for example PCSK9-inhibitors and anti-inflammatory drugs, in patients with CAC ≥ 1000, may prove helpful to evaluate the benefits of such treatment in this unique group,” the authors wrote. They also urged updating current guidelines to reflect best practices for these patients.
The study was funded by The National Institutes of Health. The authors have no relevant financial disclosures.
SOURCE: Peng A et al. Journal of the American College of Cardiology.
FROM ACC 2019
No benefit of direct stenting in PCI
A patient-level analysis drawn from three randomized, controlled trials finds no evidence that direct stenting improved myocardial reperfusion or clinical outcomes in ST-segment elevation myocardial infarction (STEMI) patients undergoing percutaneous coronary intervention.
Patients who underwent thrombus aspiration were more likely to receive direct stenting than conventional stenting, but there was no interaction between thrombus aspiration and outcomes, Karim D. Mahmoud, MD, reported in the European Heart Journal.
Direct stenting – stent implantation without balloon predilatation – has been widely adopted in an effort to improve PCI outcomes in STEMI patients, though no formal guidelines call for it. Small trials have suggested a benefit, but no large, definitive trials have been conducted.
Three previous trials have looked at thrombus aspiration in STEMI patients: TAPAS (the Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Myocardial Infarction Study) found that routine manual thrombus aspiration led to better myocardial reperfusion and lower 1-year cardiac mortality (N Engl J Med. 2008 Feb 7;358:557-67). Two larger trials – TASTE (Thrombus Aspiration in ST Elevation Myocardial Infarction in Scandinavia; N Engl J Med. 2013 Oct 24;369[17]:1587-97) and TOTAL (Trial of Routine Aspiration Thrombectomy with PCI vs. PCI Alone in Patients with STEMI; N Engl J Med. 2015 Apr 9;372[15]:1389-98) – both failed to show any benefit of routine thrombus aspiration. As a result, international guidelines recommended use of thrombus aspiration only in selected patients.
The TASTE and TOTAL trials suggested that thrombus aspiration may have led to higher rates of direct stenting, but those rates were lower in TAPAS. Some have suggested that a synergistic effect between thrombus aspiration and DS could explain the positive finding in TAPAS, compared with negative findings in TASTE and TOTAL, said Dr. Mahmoud of Erasmus Medical Center, Rotterdam, the Netherlands.
The researchers tested this idea by pooling patient-level data from the more than 17,000 participants in the three studies, 32% of whom underwent direct stenting. Patients who were randomized to undergo thrombus aspiration were nearly twice as likely to undergo direct stenting (41% vs. 22%, P less than .001). When the researchers 1:1 propensity matched direct stenting versus conventional stenting, 30-day cardiovascular death rates were similar between direct (1.7%) and conventional stenting (1.9%), and there was no interaction between direct stenting and thrombus aspiration. The latter result suggested that there is no synergistic effect. Similar results were found at 1-year follow-up, and with respect to 30-day stroke or transient ischemic attack.
One of the study authors received funding and or honoraria from Bayer, Medtronic, Vascular Solutions, Terumo, Boston Scientific, Abbott Vascular, AstraZeneca, and the Medicines Company.
SOURCE: Mahmoud KD et al. Eur Heart J. 2018;39:2472-9.
A patient-level analysis drawn from three randomized, controlled trials finds no evidence that direct stenting improved myocardial reperfusion or clinical outcomes in ST-segment elevation myocardial infarction (STEMI) patients undergoing percutaneous coronary intervention.
Patients who underwent thrombus aspiration were more likely to receive direct stenting than conventional stenting, but there was no interaction between thrombus aspiration and outcomes, Karim D. Mahmoud, MD, reported in the European Heart Journal.
Direct stenting – stent implantation without balloon predilatation – has been widely adopted in an effort to improve PCI outcomes in STEMI patients, though no formal guidelines call for it. Small trials have suggested a benefit, but no large, definitive trials have been conducted.
Three previous trials have looked at thrombus aspiration in STEMI patients: TAPAS (the Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Myocardial Infarction Study) found that routine manual thrombus aspiration led to better myocardial reperfusion and lower 1-year cardiac mortality (N Engl J Med. 2008 Feb 7;358:557-67). Two larger trials – TASTE (Thrombus Aspiration in ST Elevation Myocardial Infarction in Scandinavia; N Engl J Med. 2013 Oct 24;369[17]:1587-97) and TOTAL (Trial of Routine Aspiration Thrombectomy with PCI vs. PCI Alone in Patients with STEMI; N Engl J Med. 2015 Apr 9;372[15]:1389-98) – both failed to show any benefit of routine thrombus aspiration. As a result, international guidelines recommended use of thrombus aspiration only in selected patients.
The TASTE and TOTAL trials suggested that thrombus aspiration may have led to higher rates of direct stenting, but those rates were lower in TAPAS. Some have suggested that a synergistic effect between thrombus aspiration and DS could explain the positive finding in TAPAS, compared with negative findings in TASTE and TOTAL, said Dr. Mahmoud of Erasmus Medical Center, Rotterdam, the Netherlands.
The researchers tested this idea by pooling patient-level data from the more than 17,000 participants in the three studies, 32% of whom underwent direct stenting. Patients who were randomized to undergo thrombus aspiration were nearly twice as likely to undergo direct stenting (41% vs. 22%, P less than .001). When the researchers 1:1 propensity matched direct stenting versus conventional stenting, 30-day cardiovascular death rates were similar between direct (1.7%) and conventional stenting (1.9%), and there was no interaction between direct stenting and thrombus aspiration. The latter result suggested that there is no synergistic effect. Similar results were found at 1-year follow-up, and with respect to 30-day stroke or transient ischemic attack.
One of the study authors received funding and or honoraria from Bayer, Medtronic, Vascular Solutions, Terumo, Boston Scientific, Abbott Vascular, AstraZeneca, and the Medicines Company.
SOURCE: Mahmoud KD et al. Eur Heart J. 2018;39:2472-9.
A patient-level analysis drawn from three randomized, controlled trials finds no evidence that direct stenting improved myocardial reperfusion or clinical outcomes in ST-segment elevation myocardial infarction (STEMI) patients undergoing percutaneous coronary intervention.
Patients who underwent thrombus aspiration were more likely to receive direct stenting than conventional stenting, but there was no interaction between thrombus aspiration and outcomes, Karim D. Mahmoud, MD, reported in the European Heart Journal.
Direct stenting – stent implantation without balloon predilatation – has been widely adopted in an effort to improve PCI outcomes in STEMI patients, though no formal guidelines call for it. Small trials have suggested a benefit, but no large, definitive trials have been conducted.
Three previous trials have looked at thrombus aspiration in STEMI patients: TAPAS (the Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Myocardial Infarction Study) found that routine manual thrombus aspiration led to better myocardial reperfusion and lower 1-year cardiac mortality (N Engl J Med. 2008 Feb 7;358:557-67). Two larger trials – TASTE (Thrombus Aspiration in ST Elevation Myocardial Infarction in Scandinavia; N Engl J Med. 2013 Oct 24;369[17]:1587-97) and TOTAL (Trial of Routine Aspiration Thrombectomy with PCI vs. PCI Alone in Patients with STEMI; N Engl J Med. 2015 Apr 9;372[15]:1389-98) – both failed to show any benefit of routine thrombus aspiration. As a result, international guidelines recommended use of thrombus aspiration only in selected patients.
The TASTE and TOTAL trials suggested that thrombus aspiration may have led to higher rates of direct stenting, but those rates were lower in TAPAS. Some have suggested that a synergistic effect between thrombus aspiration and DS could explain the positive finding in TAPAS, compared with negative findings in TASTE and TOTAL, said Dr. Mahmoud of Erasmus Medical Center, Rotterdam, the Netherlands.
The researchers tested this idea by pooling patient-level data from the more than 17,000 participants in the three studies, 32% of whom underwent direct stenting. Patients who were randomized to undergo thrombus aspiration were nearly twice as likely to undergo direct stenting (41% vs. 22%, P less than .001). When the researchers 1:1 propensity matched direct stenting versus conventional stenting, 30-day cardiovascular death rates were similar between direct (1.7%) and conventional stenting (1.9%), and there was no interaction between direct stenting and thrombus aspiration. The latter result suggested that there is no synergistic effect. Similar results were found at 1-year follow-up, and with respect to 30-day stroke or transient ischemic attack.
One of the study authors received funding and or honoraria from Bayer, Medtronic, Vascular Solutions, Terumo, Boston Scientific, Abbott Vascular, AstraZeneca, and the Medicines Company.
SOURCE: Mahmoud KD et al. Eur Heart J. 2018;39:2472-9.
FROM EUROPEAN HEART JOURNAL
Key clinical point:
Major finding: Thirty-day cardiovascular death rates were similar between direct stenting (1.7%) and conventional stenting (1.9%).
Study details: Propensity-matched analysis of patient data from three previous trials (n = 17,329).
Disclosures: One of the study authors received funding and or honoraria from Bayer, Medtronic, Vascular Solutions, Terumo, Boston Scientific, Abbott Vascular, AstraZeneca, and the Medicines Company.
Source: Mahmoud KD et al. Eur Heart J. 2018;39:2472-9.