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CPAP and oxygen have different cardiac effects in OSA
BALTIMORE – Continuous positive airway pressure (CPAP) may supersede supplemental oxygen and patient education for improving one key marker of cardiac electrophysiological autonomic function during sleep, but supplemental oxygen may have the upper hand in improving a second key electrophysiological biomarker, according to results of a multicenter, randomized clinical trial presented at the annual meeting of the Associated Professional Sleep Societies.
“Based on these findings, it appears that there are opposing alterations in both frequency and time domain in heart rate variability indices in the CPAP versus oxygen groups,” said Jenie George, MD, of the Cleveland Clinic.
The study evaluated 3-month outcomes of frequency-based heart rate variability (HRV) indices obtained with ECG from sleep studies in 203 patients with obstructive sleep apnea and increased cardiovascular risk in the Heart Biomarker Elevation in Apnea Treatment (HeartBEAT) trial. The interventions were either CPAP, supplemental oxygen, or healthy lifestyle education. Dr. George noted that HRV is a noninvasive tool to evaluate autonomic function by quantifying changes in intervals between sinus beats during sleep.
On the high-frequency power index, patients on CPAP had a 9% reduction versus a 19% increase for those on supplemental oxygen, Dr. George said. However for the low frequency to high frequency ratio, the CPAP group had a 4% increase, whereas the oxygen group had a 34% reduction.
The increase of low frequency to high frequency ratio in the CPAP group is a reflection of sympathovagal balance – the ratio between low-frequency and high-frequency powers – while the changes in high-frequency power in the CPAP patients reflect changes in sinoatrial node electrophysiological function, Dr. George said.
Strengths of the study were its use of data from a large clinical trial, careful preprocessing of ECG data, and consideration of the influence of oxygen in sleep apnea and of confounding influences, such as medications. Limitations of the study, Dr. George noted, include the absence of sleep-wake data and acknowledgment that HRV measures are accepted surrogates of autonomic imbalance but that they are not direct measures.
The next steps for the current research, Dr. George said, include an analysis of how respiratory events influence HRV indices in CPAP and supplemental oxygen. Future trials should be designed to examine how the two interventions affect direct measures of autonomic function and consider a longer follow-up duration, she said.
Dr. George had no financial relationships to disclose. The trial received support from the National Heart, Lung, and Blood Institute and the National Center for Research Resources.
SOURCE: George J et al. Sleep 2018, Abstract 0444.
BALTIMORE – Continuous positive airway pressure (CPAP) may supersede supplemental oxygen and patient education for improving one key marker of cardiac electrophysiological autonomic function during sleep, but supplemental oxygen may have the upper hand in improving a second key electrophysiological biomarker, according to results of a multicenter, randomized clinical trial presented at the annual meeting of the Associated Professional Sleep Societies.
“Based on these findings, it appears that there are opposing alterations in both frequency and time domain in heart rate variability indices in the CPAP versus oxygen groups,” said Jenie George, MD, of the Cleveland Clinic.
The study evaluated 3-month outcomes of frequency-based heart rate variability (HRV) indices obtained with ECG from sleep studies in 203 patients with obstructive sleep apnea and increased cardiovascular risk in the Heart Biomarker Elevation in Apnea Treatment (HeartBEAT) trial. The interventions were either CPAP, supplemental oxygen, or healthy lifestyle education. Dr. George noted that HRV is a noninvasive tool to evaluate autonomic function by quantifying changes in intervals between sinus beats during sleep.
On the high-frequency power index, patients on CPAP had a 9% reduction versus a 19% increase for those on supplemental oxygen, Dr. George said. However for the low frequency to high frequency ratio, the CPAP group had a 4% increase, whereas the oxygen group had a 34% reduction.
The increase of low frequency to high frequency ratio in the CPAP group is a reflection of sympathovagal balance – the ratio between low-frequency and high-frequency powers – while the changes in high-frequency power in the CPAP patients reflect changes in sinoatrial node electrophysiological function, Dr. George said.
Strengths of the study were its use of data from a large clinical trial, careful preprocessing of ECG data, and consideration of the influence of oxygen in sleep apnea and of confounding influences, such as medications. Limitations of the study, Dr. George noted, include the absence of sleep-wake data and acknowledgment that HRV measures are accepted surrogates of autonomic imbalance but that they are not direct measures.
The next steps for the current research, Dr. George said, include an analysis of how respiratory events influence HRV indices in CPAP and supplemental oxygen. Future trials should be designed to examine how the two interventions affect direct measures of autonomic function and consider a longer follow-up duration, she said.
Dr. George had no financial relationships to disclose. The trial received support from the National Heart, Lung, and Blood Institute and the National Center for Research Resources.
SOURCE: George J et al. Sleep 2018, Abstract 0444.
BALTIMORE – Continuous positive airway pressure (CPAP) may supersede supplemental oxygen and patient education for improving one key marker of cardiac electrophysiological autonomic function during sleep, but supplemental oxygen may have the upper hand in improving a second key electrophysiological biomarker, according to results of a multicenter, randomized clinical trial presented at the annual meeting of the Associated Professional Sleep Societies.
“Based on these findings, it appears that there are opposing alterations in both frequency and time domain in heart rate variability indices in the CPAP versus oxygen groups,” said Jenie George, MD, of the Cleveland Clinic.
The study evaluated 3-month outcomes of frequency-based heart rate variability (HRV) indices obtained with ECG from sleep studies in 203 patients with obstructive sleep apnea and increased cardiovascular risk in the Heart Biomarker Elevation in Apnea Treatment (HeartBEAT) trial. The interventions were either CPAP, supplemental oxygen, or healthy lifestyle education. Dr. George noted that HRV is a noninvasive tool to evaluate autonomic function by quantifying changes in intervals between sinus beats during sleep.
On the high-frequency power index, patients on CPAP had a 9% reduction versus a 19% increase for those on supplemental oxygen, Dr. George said. However for the low frequency to high frequency ratio, the CPAP group had a 4% increase, whereas the oxygen group had a 34% reduction.
The increase of low frequency to high frequency ratio in the CPAP group is a reflection of sympathovagal balance – the ratio between low-frequency and high-frequency powers – while the changes in high-frequency power in the CPAP patients reflect changes in sinoatrial node electrophysiological function, Dr. George said.
Strengths of the study were its use of data from a large clinical trial, careful preprocessing of ECG data, and consideration of the influence of oxygen in sleep apnea and of confounding influences, such as medications. Limitations of the study, Dr. George noted, include the absence of sleep-wake data and acknowledgment that HRV measures are accepted surrogates of autonomic imbalance but that they are not direct measures.
The next steps for the current research, Dr. George said, include an analysis of how respiratory events influence HRV indices in CPAP and supplemental oxygen. Future trials should be designed to examine how the two interventions affect direct measures of autonomic function and consider a longer follow-up duration, she said.
Dr. George had no financial relationships to disclose. The trial received support from the National Heart, Lung, and Blood Institute and the National Center for Research Resources.
SOURCE: George J et al. Sleep 2018, Abstract 0444.
REPORTING FROM SLEEP 2018
Key clinical point: CPAP and oxygen in sleep apnea have countering effects on ECG.
Major finding: CPAP conferred a 9% reduction in high-frequency power but a 4% increase in low-frequency power.
Study details: Evaluation of 203 participants in the multicenter, randomized controlled Heart Biomarker Elevation in Apnea Treatment (HeartBEAT) trial.
Disclosures: Dr. George reported no financial relationships. The trial received support from the National Heart, Lung, and Blood Institute and the National Center for Research Resources.
Source: George J et al. Sleep 2018, Abstract 0444.
OSA with worsening hypoxemia raises metabolic syndrome risk
BALTIMORE – An 8-year cohort study has found that patients with who are prone to worsening of hypoxemia at night have a heightened risk of developing metabolic syndrome, an investigator reported at the annual meeting of the Associated Professional Sleep Societies
“Considering that we have a very high prevalence of moderate to severe obstructive sleep apnea (OSA) in the general population, this is a very important finding because it indicates that we need some clinical options of treating OSA in those that have metabolic syndrome to decrease the risk of morbidity and mortality and cardiac events in these patients,” said Camila Hirotsu, PhD, of the Federal University of São Paulo (Brazil).
Dr. Hirotsu presented 8-year follow-up results of the EPISONO cohort, an observational prospective study conducted in Brazil, the goal of which was to evaluate the how OSA can impact the risk of developing metabolic syndrome (MetS) the general population. MetS is defined as a cluster of three or more cardiovascular metabolic components: low HDL levels, high glucose and triglycerides, hypertension and abdominal obesity. Dr. Hirotsu said that 50%-60% of MetS patients have OSA (PLoS One 2010;5:e12065).
The study enrolled 1,074 patients at baseline, closing enrollment in 2008, and obtained follow-up on 712, evaluated from July 2015 to April 2016. After exclusions, the study evaluated 476 patients who were free of MetS at baseline. Of those 476, 44% went on to develop MetS.
Median age of patients who developed MetS was 40.8 years vs. 36.1 for those who did not. Patients who developed MetS also had a higher body mass index, but were not obese: 26.9 kg/m2 vs. 23.8 kg/m2. Patients were evaluated by completing questionnaires, undergoing full polysomnography, and having clinical assessments.
Patients with moderate to severe OSA were found to have an odds ratio of 2.47 (P = .016) of developing incident MetS, Dr. Hirotsu said. Rates of moderate to severe OSA were 21.3% for the group that developed MetS vs. 9% for the non-MetS group, said Dr. Hirotsu.
The study determined that the following sleep changes were associated with incident MetS: apnea-hypopnea index (AHI) (OR 1.16); 3% oxygen desaturation index (ODI) (OR 1.24); and time with oxygen saturation by pulse oximeter (SpO2) less than 90% (OR 1.42).
“Moderate to severe OSA at baseline and worsening of nocturnal hyperemia from baseline to follow-up are really independent risk factors to increase the incidence of MetS in the general population,” Dr. Hirotsu said.
A secondary aim of the study was to evaluate the impact of MetS on the risk of developing OSA in the general population. “It seems that MetS is not really an independent risk factor for OSA.”
Dr. Hirotsu reported having no conflicts of interest.
BALTIMORE – An 8-year cohort study has found that patients with who are prone to worsening of hypoxemia at night have a heightened risk of developing metabolic syndrome, an investigator reported at the annual meeting of the Associated Professional Sleep Societies
“Considering that we have a very high prevalence of moderate to severe obstructive sleep apnea (OSA) in the general population, this is a very important finding because it indicates that we need some clinical options of treating OSA in those that have metabolic syndrome to decrease the risk of morbidity and mortality and cardiac events in these patients,” said Camila Hirotsu, PhD, of the Federal University of São Paulo (Brazil).
Dr. Hirotsu presented 8-year follow-up results of the EPISONO cohort, an observational prospective study conducted in Brazil, the goal of which was to evaluate the how OSA can impact the risk of developing metabolic syndrome (MetS) the general population. MetS is defined as a cluster of three or more cardiovascular metabolic components: low HDL levels, high glucose and triglycerides, hypertension and abdominal obesity. Dr. Hirotsu said that 50%-60% of MetS patients have OSA (PLoS One 2010;5:e12065).
The study enrolled 1,074 patients at baseline, closing enrollment in 2008, and obtained follow-up on 712, evaluated from July 2015 to April 2016. After exclusions, the study evaluated 476 patients who were free of MetS at baseline. Of those 476, 44% went on to develop MetS.
Median age of patients who developed MetS was 40.8 years vs. 36.1 for those who did not. Patients who developed MetS also had a higher body mass index, but were not obese: 26.9 kg/m2 vs. 23.8 kg/m2. Patients were evaluated by completing questionnaires, undergoing full polysomnography, and having clinical assessments.
Patients with moderate to severe OSA were found to have an odds ratio of 2.47 (P = .016) of developing incident MetS, Dr. Hirotsu said. Rates of moderate to severe OSA were 21.3% for the group that developed MetS vs. 9% for the non-MetS group, said Dr. Hirotsu.
The study determined that the following sleep changes were associated with incident MetS: apnea-hypopnea index (AHI) (OR 1.16); 3% oxygen desaturation index (ODI) (OR 1.24); and time with oxygen saturation by pulse oximeter (SpO2) less than 90% (OR 1.42).
“Moderate to severe OSA at baseline and worsening of nocturnal hyperemia from baseline to follow-up are really independent risk factors to increase the incidence of MetS in the general population,” Dr. Hirotsu said.
A secondary aim of the study was to evaluate the impact of MetS on the risk of developing OSA in the general population. “It seems that MetS is not really an independent risk factor for OSA.”
Dr. Hirotsu reported having no conflicts of interest.
BALTIMORE – An 8-year cohort study has found that patients with who are prone to worsening of hypoxemia at night have a heightened risk of developing metabolic syndrome, an investigator reported at the annual meeting of the Associated Professional Sleep Societies
“Considering that we have a very high prevalence of moderate to severe obstructive sleep apnea (OSA) in the general population, this is a very important finding because it indicates that we need some clinical options of treating OSA in those that have metabolic syndrome to decrease the risk of morbidity and mortality and cardiac events in these patients,” said Camila Hirotsu, PhD, of the Federal University of São Paulo (Brazil).
Dr. Hirotsu presented 8-year follow-up results of the EPISONO cohort, an observational prospective study conducted in Brazil, the goal of which was to evaluate the how OSA can impact the risk of developing metabolic syndrome (MetS) the general population. MetS is defined as a cluster of three or more cardiovascular metabolic components: low HDL levels, high glucose and triglycerides, hypertension and abdominal obesity. Dr. Hirotsu said that 50%-60% of MetS patients have OSA (PLoS One 2010;5:e12065).
The study enrolled 1,074 patients at baseline, closing enrollment in 2008, and obtained follow-up on 712, evaluated from July 2015 to April 2016. After exclusions, the study evaluated 476 patients who were free of MetS at baseline. Of those 476, 44% went on to develop MetS.
Median age of patients who developed MetS was 40.8 years vs. 36.1 for those who did not. Patients who developed MetS also had a higher body mass index, but were not obese: 26.9 kg/m2 vs. 23.8 kg/m2. Patients were evaluated by completing questionnaires, undergoing full polysomnography, and having clinical assessments.
Patients with moderate to severe OSA were found to have an odds ratio of 2.47 (P = .016) of developing incident MetS, Dr. Hirotsu said. Rates of moderate to severe OSA were 21.3% for the group that developed MetS vs. 9% for the non-MetS group, said Dr. Hirotsu.
The study determined that the following sleep changes were associated with incident MetS: apnea-hypopnea index (AHI) (OR 1.16); 3% oxygen desaturation index (ODI) (OR 1.24); and time with oxygen saturation by pulse oximeter (SpO2) less than 90% (OR 1.42).
“Moderate to severe OSA at baseline and worsening of nocturnal hyperemia from baseline to follow-up are really independent risk factors to increase the incidence of MetS in the general population,” Dr. Hirotsu said.
A secondary aim of the study was to evaluate the impact of MetS on the risk of developing OSA in the general population. “It seems that MetS is not really an independent risk factor for OSA.”
Dr. Hirotsu reported having no conflicts of interest.
REPORTING FROM SLEEP 2018
Key clinical point: Obstructive sleep apnea may raise the risk of metabolic syndrome.
Major finding: Rates of moderate to severe OSA were 21.3% in the MetS group vs. 9% in the non-MetS group.
Study details: Observational, prospective cohort study of 476 patients with OSA who were free of MetS at enrollment in 2008.
Disclosures: Dr. Hirotsu and coauthors reported no financial relationships. The São Paulo Research Foundation, Association Research Incentive Fund and Brazilian National Council for Scientific and Technological Development funded the study.
Sleep problems may point to health disparity for black women
BALTIMORE – Analysis of data from a national multicenter study of women’s health has found that according to a presentation at the annual meeting of the Associated Sleep Societies.
“Race is emerging as a significant moderator in the relationship between sleep and health outcomes,” said Marissa Bowman, a doctoral student at the University of Pittsburgh. The study was based on 10- to 15-year follow-up data from the SWAN (Study of Women’s Health Across the Nation) sleep research. The researchers evaluated sleep in 265 midlife women, 45% of whom were black.
At baseline, the study assessed sleep health using both actigraphy and a daily diary, along with body mass index (BMI), waist circumference (WC), and waist-to-hip ratio (WHpR), then collected data on the anthropometric factors 10-15 years later.
Cross-sectional and prospective analyses found that sleep health was correlated with lower BMI but was not significantly associated with WC or WHpR. A prospective analysis found no overall significant correlation between sleep health and any of the three factors. But in a separate the analysis of the study group by race, all three anthropometric factors had a stronger link to sleep health in black women than in those of European descent, respectively, with beta coefficients of –0.14 vs. 0.1 for BMI, –0.17 and 0.1 for WC and –0.17 and 0.07 for WHpR.
“We need to explain this association and conceptualize how sleep health might be more strongly related with weight in African Americans,” Ms. Bowman said. “One possibility might be that sleep health reflects a health disparity. We can see how race is related to other health disparities, and this might be one of them.”
During questions, Ms. Bowman acknowledged that SWAN did not have data on what kind of access to health care the black women in the study had. “That might be a possible reason they’re not getting their sleep treated; they’re not getting other health factors treated,” she said.
Ms. Bowman and her coauthors reported no financial relationships. The study was funded by the National Institute on Aging, National Institutes of Health, and the National Institutes of Health Office of Research on Women’s Health.
BALTIMORE – Analysis of data from a national multicenter study of women’s health has found that according to a presentation at the annual meeting of the Associated Sleep Societies.
“Race is emerging as a significant moderator in the relationship between sleep and health outcomes,” said Marissa Bowman, a doctoral student at the University of Pittsburgh. The study was based on 10- to 15-year follow-up data from the SWAN (Study of Women’s Health Across the Nation) sleep research. The researchers evaluated sleep in 265 midlife women, 45% of whom were black.
At baseline, the study assessed sleep health using both actigraphy and a daily diary, along with body mass index (BMI), waist circumference (WC), and waist-to-hip ratio (WHpR), then collected data on the anthropometric factors 10-15 years later.
Cross-sectional and prospective analyses found that sleep health was correlated with lower BMI but was not significantly associated with WC or WHpR. A prospective analysis found no overall significant correlation between sleep health and any of the three factors. But in a separate the analysis of the study group by race, all three anthropometric factors had a stronger link to sleep health in black women than in those of European descent, respectively, with beta coefficients of –0.14 vs. 0.1 for BMI, –0.17 and 0.1 for WC and –0.17 and 0.07 for WHpR.
“We need to explain this association and conceptualize how sleep health might be more strongly related with weight in African Americans,” Ms. Bowman said. “One possibility might be that sleep health reflects a health disparity. We can see how race is related to other health disparities, and this might be one of them.”
During questions, Ms. Bowman acknowledged that SWAN did not have data on what kind of access to health care the black women in the study had. “That might be a possible reason they’re not getting their sleep treated; they’re not getting other health factors treated,” she said.
Ms. Bowman and her coauthors reported no financial relationships. The study was funded by the National Institute on Aging, National Institutes of Health, and the National Institutes of Health Office of Research on Women’s Health.
BALTIMORE – Analysis of data from a national multicenter study of women’s health has found that according to a presentation at the annual meeting of the Associated Sleep Societies.
“Race is emerging as a significant moderator in the relationship between sleep and health outcomes,” said Marissa Bowman, a doctoral student at the University of Pittsburgh. The study was based on 10- to 15-year follow-up data from the SWAN (Study of Women’s Health Across the Nation) sleep research. The researchers evaluated sleep in 265 midlife women, 45% of whom were black.
At baseline, the study assessed sleep health using both actigraphy and a daily diary, along with body mass index (BMI), waist circumference (WC), and waist-to-hip ratio (WHpR), then collected data on the anthropometric factors 10-15 years later.
Cross-sectional and prospective analyses found that sleep health was correlated with lower BMI but was not significantly associated with WC or WHpR. A prospective analysis found no overall significant correlation between sleep health and any of the three factors. But in a separate the analysis of the study group by race, all three anthropometric factors had a stronger link to sleep health in black women than in those of European descent, respectively, with beta coefficients of –0.14 vs. 0.1 for BMI, –0.17 and 0.1 for WC and –0.17 and 0.07 for WHpR.
“We need to explain this association and conceptualize how sleep health might be more strongly related with weight in African Americans,” Ms. Bowman said. “One possibility might be that sleep health reflects a health disparity. We can see how race is related to other health disparities, and this might be one of them.”
During questions, Ms. Bowman acknowledged that SWAN did not have data on what kind of access to health care the black women in the study had. “That might be a possible reason they’re not getting their sleep treated; they’re not getting other health factors treated,” she said.
Ms. Bowman and her coauthors reported no financial relationships. The study was funded by the National Institute on Aging, National Institutes of Health, and the National Institutes of Health Office of Research on Women’s Health.
REPORTING FROM SLEEP 2018
Key clinical point: Black women are at greater risk for poor sleep help than white women.
Major finding: Beta coefficient for BMI and sleep health was –0.14 for black women and 0.1 for white women.
Study details: The SWAN sleep study, a multicenter, longitudinal, epidemiologic study of 265 midlife women.
Disclosures: Ms. Bowman and her coauthors reported no financial relationships. The study was funded by the National Institute on Aging, National Institutes of Health, and the National Institutes of Health Office of Research on Women’s Health.
Impact of marijuana on sleep not well understood
BALTIMORE – Although the national trend of legalization of marijuana for medical and recreational uses has accelerated, physicians should be cautious about prescribing , a sleep specialist told attendees at the annual meeting of the Associated Professional Sleep Societies.
“Increased legalization of medical marijuana may cause reduction in perception of the risk of potential harm” said Ashima Sahni, MD, of Northwestern University, Chicago.
“Overall the consensus is that the short-term use of medical marijuana causes an increase in slow-wave sleep (SWS), a decrease in sleep onset latency, a decrease in wake after sleep onset (WASO) and a decrease in REM sleep,” Dr. Sahni said. But chronic use decreases SWS and results in inconsistencies in REM sleep patterns and sleep fragmentation. These changes lead to a self-perpetuating negative cycle that causes chronic users to progressively increase their intake, furthering sleep disruption, she noted.
Marijuana withdrawal also can cause significant disturbances in sleep patterns, including reduced total sleep time and SWS, increased WASO, increased REM sleep associated with strange dreams, and increased limb movements during sleep, Dr. Sahni said. “The effects can be seen as early as 24 hours after discontinuation and can last as long as 6 weeks,” she said. In addition, poor sleep quality prior to a withdrawal attempt has been linked to relapse (Am J Psychiatry. 2004;161:1967-77).
The use of medical marijuana in the management of sleep disorders is fraught with controversy, Dr. Sahni said. She reviewed studies investigating the use of dronabinol for obstructive sleep apnea (OSA). “This is not medical marijuana,” Dr. Sahni said. “It’s a synthetic tetrahydrocannabinol (THC) cannabinoid, which acts on the nonselective CB1 and CB2 agonists,” she said. THC is the euphoria-inducing compound in marijuana. While the mechanism of action of dronabinol is similar to marijuana, the pharmacokinetics may differ. Dronabinol has been approved by the Food and Drug Administration for cancer-related nausea and appetite stimulation in AIDS patients. She referred to a proof-of-concept study of 17 patients with OSA in which dronabinol reduced the apnea-hypopnea index (AHI) with no degradation of sleep architecture or serious adverse events (Front Psychiatry. 2013 Jan 22;4:1-5). Dr. Sahni also noted a randomized, placebo-controlled trial of 73 patients that reported an average reduction in AHI of 12.9 (Sleep. 2018 Jan 1;41[1]; doi: 10.1093/sleep/zsx184). But she pointed out that the American Academy of Sleep Medicine does not recommend medical cannabis or its synthetic extracts for treatment of OSA (J Clin Sleep Med. 2018 Apr 15;14:679-81).
Insomnia, on the other hand, represents the most common use of medical marijuana for sleep. “Studies have shown mixed results because of differences in the ratios of THC to CBD [corticobasal degeneration] in the forms of marijuana examined,” she said. “In the short term, subjective sleepiness is reported to be better, but then the self-perpetuating negative cycle initiates with chronic long-term use.”
In treatment of nightmares and posttraumatic stress syndrome, Dr. Sahni cited studies that found “good effects” of medical marijuana use (CNS Neurosci Ther. 2009;15:84-8; J Clin Psychopharmacol. 2014 Oct;34:559-64). For REM behavior disorder, medical marijuana was found to be beneficial in four patients with Parkinson disease (J Clin Pharm Ther. 2014 Oct;39:564-6). In poorly treated restless leg syndrome, medical marijuana was reported to be beneficial (Sleep Med. 2017 Aug;36:182-3).
“It should be noted that these were very small studies and therefore more research is needed before we change our medical practices toward various sleep disorders,” Dr. Sahni said.
Dr. Sahni and her coauthors reported having no financial relationships to disclose.
BALTIMORE – Although the national trend of legalization of marijuana for medical and recreational uses has accelerated, physicians should be cautious about prescribing , a sleep specialist told attendees at the annual meeting of the Associated Professional Sleep Societies.
“Increased legalization of medical marijuana may cause reduction in perception of the risk of potential harm” said Ashima Sahni, MD, of Northwestern University, Chicago.
“Overall the consensus is that the short-term use of medical marijuana causes an increase in slow-wave sleep (SWS), a decrease in sleep onset latency, a decrease in wake after sleep onset (WASO) and a decrease in REM sleep,” Dr. Sahni said. But chronic use decreases SWS and results in inconsistencies in REM sleep patterns and sleep fragmentation. These changes lead to a self-perpetuating negative cycle that causes chronic users to progressively increase their intake, furthering sleep disruption, she noted.
Marijuana withdrawal also can cause significant disturbances in sleep patterns, including reduced total sleep time and SWS, increased WASO, increased REM sleep associated with strange dreams, and increased limb movements during sleep, Dr. Sahni said. “The effects can be seen as early as 24 hours after discontinuation and can last as long as 6 weeks,” she said. In addition, poor sleep quality prior to a withdrawal attempt has been linked to relapse (Am J Psychiatry. 2004;161:1967-77).
The use of medical marijuana in the management of sleep disorders is fraught with controversy, Dr. Sahni said. She reviewed studies investigating the use of dronabinol for obstructive sleep apnea (OSA). “This is not medical marijuana,” Dr. Sahni said. “It’s a synthetic tetrahydrocannabinol (THC) cannabinoid, which acts on the nonselective CB1 and CB2 agonists,” she said. THC is the euphoria-inducing compound in marijuana. While the mechanism of action of dronabinol is similar to marijuana, the pharmacokinetics may differ. Dronabinol has been approved by the Food and Drug Administration for cancer-related nausea and appetite stimulation in AIDS patients. She referred to a proof-of-concept study of 17 patients with OSA in which dronabinol reduced the apnea-hypopnea index (AHI) with no degradation of sleep architecture or serious adverse events (Front Psychiatry. 2013 Jan 22;4:1-5). Dr. Sahni also noted a randomized, placebo-controlled trial of 73 patients that reported an average reduction in AHI of 12.9 (Sleep. 2018 Jan 1;41[1]; doi: 10.1093/sleep/zsx184). But she pointed out that the American Academy of Sleep Medicine does not recommend medical cannabis or its synthetic extracts for treatment of OSA (J Clin Sleep Med. 2018 Apr 15;14:679-81).
Insomnia, on the other hand, represents the most common use of medical marijuana for sleep. “Studies have shown mixed results because of differences in the ratios of THC to CBD [corticobasal degeneration] in the forms of marijuana examined,” she said. “In the short term, subjective sleepiness is reported to be better, but then the self-perpetuating negative cycle initiates with chronic long-term use.”
In treatment of nightmares and posttraumatic stress syndrome, Dr. Sahni cited studies that found “good effects” of medical marijuana use (CNS Neurosci Ther. 2009;15:84-8; J Clin Psychopharmacol. 2014 Oct;34:559-64). For REM behavior disorder, medical marijuana was found to be beneficial in four patients with Parkinson disease (J Clin Pharm Ther. 2014 Oct;39:564-6). In poorly treated restless leg syndrome, medical marijuana was reported to be beneficial (Sleep Med. 2017 Aug;36:182-3).
“It should be noted that these were very small studies and therefore more research is needed before we change our medical practices toward various sleep disorders,” Dr. Sahni said.
Dr. Sahni and her coauthors reported having no financial relationships to disclose.
BALTIMORE – Although the national trend of legalization of marijuana for medical and recreational uses has accelerated, physicians should be cautious about prescribing , a sleep specialist told attendees at the annual meeting of the Associated Professional Sleep Societies.
“Increased legalization of medical marijuana may cause reduction in perception of the risk of potential harm” said Ashima Sahni, MD, of Northwestern University, Chicago.
“Overall the consensus is that the short-term use of medical marijuana causes an increase in slow-wave sleep (SWS), a decrease in sleep onset latency, a decrease in wake after sleep onset (WASO) and a decrease in REM sleep,” Dr. Sahni said. But chronic use decreases SWS and results in inconsistencies in REM sleep patterns and sleep fragmentation. These changes lead to a self-perpetuating negative cycle that causes chronic users to progressively increase their intake, furthering sleep disruption, she noted.
Marijuana withdrawal also can cause significant disturbances in sleep patterns, including reduced total sleep time and SWS, increased WASO, increased REM sleep associated with strange dreams, and increased limb movements during sleep, Dr. Sahni said. “The effects can be seen as early as 24 hours after discontinuation and can last as long as 6 weeks,” she said. In addition, poor sleep quality prior to a withdrawal attempt has been linked to relapse (Am J Psychiatry. 2004;161:1967-77).
The use of medical marijuana in the management of sleep disorders is fraught with controversy, Dr. Sahni said. She reviewed studies investigating the use of dronabinol for obstructive sleep apnea (OSA). “This is not medical marijuana,” Dr. Sahni said. “It’s a synthetic tetrahydrocannabinol (THC) cannabinoid, which acts on the nonselective CB1 and CB2 agonists,” she said. THC is the euphoria-inducing compound in marijuana. While the mechanism of action of dronabinol is similar to marijuana, the pharmacokinetics may differ. Dronabinol has been approved by the Food and Drug Administration for cancer-related nausea and appetite stimulation in AIDS patients. She referred to a proof-of-concept study of 17 patients with OSA in which dronabinol reduced the apnea-hypopnea index (AHI) with no degradation of sleep architecture or serious adverse events (Front Psychiatry. 2013 Jan 22;4:1-5). Dr. Sahni also noted a randomized, placebo-controlled trial of 73 patients that reported an average reduction in AHI of 12.9 (Sleep. 2018 Jan 1;41[1]; doi: 10.1093/sleep/zsx184). But she pointed out that the American Academy of Sleep Medicine does not recommend medical cannabis or its synthetic extracts for treatment of OSA (J Clin Sleep Med. 2018 Apr 15;14:679-81).
Insomnia, on the other hand, represents the most common use of medical marijuana for sleep. “Studies have shown mixed results because of differences in the ratios of THC to CBD [corticobasal degeneration] in the forms of marijuana examined,” she said. “In the short term, subjective sleepiness is reported to be better, but then the self-perpetuating negative cycle initiates with chronic long-term use.”
In treatment of nightmares and posttraumatic stress syndrome, Dr. Sahni cited studies that found “good effects” of medical marijuana use (CNS Neurosci Ther. 2009;15:84-8; J Clin Psychopharmacol. 2014 Oct;34:559-64). For REM behavior disorder, medical marijuana was found to be beneficial in four patients with Parkinson disease (J Clin Pharm Ther. 2014 Oct;39:564-6). In poorly treated restless leg syndrome, medical marijuana was reported to be beneficial (Sleep Med. 2017 Aug;36:182-3).
“It should be noted that these were very small studies and therefore more research is needed before we change our medical practices toward various sleep disorders,” Dr. Sahni said.
Dr. Sahni and her coauthors reported having no financial relationships to disclose.
EXPERT ANALYSIS FROM SLEEP 2018
Upping the game of surgical researchers
Many are submitted, but few are chosen.
Concerned about the quality of submitted research papers based on large surgical databases that are not accepted for publication, the editorial board of JAMA Surgery has taken the initiative by giving some pointers to would-be authors. The journal editors have published a 10-point checklist of dos and don’ts to address commonly seen problems with submitted manuscripts. In addition, JAMA Surgery collaborated with the Surgical Outcomes Club to commission a series of practical guides on the most widely used data sets in an effort to improve the quality of surgical database research. The Surgical Outcomes Club is a consortium of surgeons and scientists who work to advance health services and outcomes research in surgery that was launched in 2005 at the American College of Surgeons Clinical Congress.
The authors noted that, although JAMA Surgery receives hundreds of submissions of retrospective studies of large surgical databases each year, most of these studies have flaws in the data analysis or use a hypothesis that the data sets cannot address. Hence, the editors do not send most of them out for peer review. “Of those that are sent out for peer review, many are recommended to be rejected by expert peer reviewers as they find major methodological flaws in the use of these otherwise powerful data sets,” the team wrote.
“Research using data sets can be very powerful as the research can address questions and hypotheses using large populations of people. However, the research can have many weaknesses. First, the research is only as good as the data collection for each data set. Second, the investigator needs to be familiar with the types of research questions and hypotheses that can be addressed with each data set. Third, the statistical methodology used to analyze the data is also imperative,” said Dr. Kibbe in an interview.
The checklist begins with a recommendation that the researchers develop a clear, concise hypothesis using established criteria – either FINER (for feasible, interesting, novel, ethical, relevant) or PICO (patient, population, or problem; intervention, prognostic factor, or exposure; comparison or intervention; outcome); the checklist then goes on to include compliance with institutional review board and data use agreements and to emphasize the importance of a clear take-home message that addresses policy or clinical implications.
The series comprises 11 two-page articles that aim to serve as practical guides for using each of the most widely used surgical data sets, starting with the National Inpatient Sample and ending with the Society of Thoracic Surgeons data set. Each article includes a bulleted list of the data set’s attributes, an explanation of its limitations, a history of the data set, an explanation of how the data is collected and what is unique about the set’s features, and statistical considerations researchers should take into account when analyzing the data.
The series concludes with tips from the statistical editors of JAMA Surgery – Amy H. Kaji, MD, PhD, of Harbor–University of California Los Angeles Medical Center in Torrance; Alfred W. Rademaker, PhD, of Northwestern University, Chicago; and Terry Hyslop, PhD, of Duke University, Durham, N.C. – for performing statistical analysis of large data sets: “With bigger data, random signals may denote statistical significance, and precision may be incorrectly inferred because of narrow confidence intervals,” the statistical editors noted. “While many principles apply to all studies, the importance of these methodological issues is amplified in large, complex data sets.”
However, they noted that large data sets are prone to bias and measurement errors. “It is important to respect and acknowledge the limitations of the data,” the statistical team wrote. They also reprise the introductory editorial’s call for a clear hypothesis and take-home message. “The challenge with Big Data is that it requires a carefully thought-out research question and a transparent analytic strategy,” the statistical editors said.
And there are pitfalls. Dr. Bilimoria noted, “We shouldn’t let the database define our research. We should instead be asking interesting questions and then seeking out a database that fits best to answer the question.” He said one particular problem that comes up often for reviewers is trying to discern how researchers arrived at the population of interest in a study. “A lot of inclusion and exclusions criteria are applied, and unless [the reviewer] can see the decisions that were made in the process, some fairly important biases can be introduced unintentionally. We as reviewers would like to be able to follow that exclusion pathway.”
He said, “A problem we frequently see is that these databases change the variable definitions over time – in fact, change the variables over time. So if researchers aren’t checking to see if that variable was reported the same every year of the study and in the same way, they will get spurious results. Similarly, the number of hospitals reporting is important as well since hospitals come in and out of these data sets.”
In their introductory editorial, the JAMA Surgery team noted that the checklist, practical guides, and statistical tips are a three-pronged approach that authors should consult before submitting their manuscripts. “We hope that by following these simple guides, authors can benefit from the collective wisdom of so many colleagues who have successfully completed similar analyses in the past,” they wrote.
Dr. Bilimoria sees great strengths in database research, such as giving researchers a population-level view of how care is being delivered, insights into the outcomes of care, indications of the effects of policy decisions, and data on rare diseases and operations.
Big Data of all kinds will be increasingly available for researchers. Dr. Kibbe commented that, “In the future, having a comprehensive (not sampling) country- or worldwide electronic medical record that will allow for robust inclusion of all medical data at the individual as well as cohort level will greatly contribute to the era of personalized medicine. In my opinion, this would be a real-time inclusive medical database that would allow for individual as well as population-based prospective studies.”
Dr. Haider receives support from the Henry M. Jackson Foundation of the Department of Defense, the Orthopaedic Research and Education Foundation, and the National Institutes of Health, and nonfinancial research support the Centers for Medicare and Medicaid Services Office of Minority Health. Dr. Bilimoria was the president of the Surgical Outcomes Club from 2016 to 2017.
Many are submitted, but few are chosen.
Concerned about the quality of submitted research papers based on large surgical databases that are not accepted for publication, the editorial board of JAMA Surgery has taken the initiative by giving some pointers to would-be authors. The journal editors have published a 10-point checklist of dos and don’ts to address commonly seen problems with submitted manuscripts. In addition, JAMA Surgery collaborated with the Surgical Outcomes Club to commission a series of practical guides on the most widely used data sets in an effort to improve the quality of surgical database research. The Surgical Outcomes Club is a consortium of surgeons and scientists who work to advance health services and outcomes research in surgery that was launched in 2005 at the American College of Surgeons Clinical Congress.
The authors noted that, although JAMA Surgery receives hundreds of submissions of retrospective studies of large surgical databases each year, most of these studies have flaws in the data analysis or use a hypothesis that the data sets cannot address. Hence, the editors do not send most of them out for peer review. “Of those that are sent out for peer review, many are recommended to be rejected by expert peer reviewers as they find major methodological flaws in the use of these otherwise powerful data sets,” the team wrote.
“Research using data sets can be very powerful as the research can address questions and hypotheses using large populations of people. However, the research can have many weaknesses. First, the research is only as good as the data collection for each data set. Second, the investigator needs to be familiar with the types of research questions and hypotheses that can be addressed with each data set. Third, the statistical methodology used to analyze the data is also imperative,” said Dr. Kibbe in an interview.
The checklist begins with a recommendation that the researchers develop a clear, concise hypothesis using established criteria – either FINER (for feasible, interesting, novel, ethical, relevant) or PICO (patient, population, or problem; intervention, prognostic factor, or exposure; comparison or intervention; outcome); the checklist then goes on to include compliance with institutional review board and data use agreements and to emphasize the importance of a clear take-home message that addresses policy or clinical implications.
The series comprises 11 two-page articles that aim to serve as practical guides for using each of the most widely used surgical data sets, starting with the National Inpatient Sample and ending with the Society of Thoracic Surgeons data set. Each article includes a bulleted list of the data set’s attributes, an explanation of its limitations, a history of the data set, an explanation of how the data is collected and what is unique about the set’s features, and statistical considerations researchers should take into account when analyzing the data.
The series concludes with tips from the statistical editors of JAMA Surgery – Amy H. Kaji, MD, PhD, of Harbor–University of California Los Angeles Medical Center in Torrance; Alfred W. Rademaker, PhD, of Northwestern University, Chicago; and Terry Hyslop, PhD, of Duke University, Durham, N.C. – for performing statistical analysis of large data sets: “With bigger data, random signals may denote statistical significance, and precision may be incorrectly inferred because of narrow confidence intervals,” the statistical editors noted. “While many principles apply to all studies, the importance of these methodological issues is amplified in large, complex data sets.”
However, they noted that large data sets are prone to bias and measurement errors. “It is important to respect and acknowledge the limitations of the data,” the statistical team wrote. They also reprise the introductory editorial’s call for a clear hypothesis and take-home message. “The challenge with Big Data is that it requires a carefully thought-out research question and a transparent analytic strategy,” the statistical editors said.
And there are pitfalls. Dr. Bilimoria noted, “We shouldn’t let the database define our research. We should instead be asking interesting questions and then seeking out a database that fits best to answer the question.” He said one particular problem that comes up often for reviewers is trying to discern how researchers arrived at the population of interest in a study. “A lot of inclusion and exclusions criteria are applied, and unless [the reviewer] can see the decisions that were made in the process, some fairly important biases can be introduced unintentionally. We as reviewers would like to be able to follow that exclusion pathway.”
He said, “A problem we frequently see is that these databases change the variable definitions over time – in fact, change the variables over time. So if researchers aren’t checking to see if that variable was reported the same every year of the study and in the same way, they will get spurious results. Similarly, the number of hospitals reporting is important as well since hospitals come in and out of these data sets.”
In their introductory editorial, the JAMA Surgery team noted that the checklist, practical guides, and statistical tips are a three-pronged approach that authors should consult before submitting their manuscripts. “We hope that by following these simple guides, authors can benefit from the collective wisdom of so many colleagues who have successfully completed similar analyses in the past,” they wrote.
Dr. Bilimoria sees great strengths in database research, such as giving researchers a population-level view of how care is being delivered, insights into the outcomes of care, indications of the effects of policy decisions, and data on rare diseases and operations.
Big Data of all kinds will be increasingly available for researchers. Dr. Kibbe commented that, “In the future, having a comprehensive (not sampling) country- or worldwide electronic medical record that will allow for robust inclusion of all medical data at the individual as well as cohort level will greatly contribute to the era of personalized medicine. In my opinion, this would be a real-time inclusive medical database that would allow for individual as well as population-based prospective studies.”
Dr. Haider receives support from the Henry M. Jackson Foundation of the Department of Defense, the Orthopaedic Research and Education Foundation, and the National Institutes of Health, and nonfinancial research support the Centers for Medicare and Medicaid Services Office of Minority Health. Dr. Bilimoria was the president of the Surgical Outcomes Club from 2016 to 2017.
Many are submitted, but few are chosen.
Concerned about the quality of submitted research papers based on large surgical databases that are not accepted for publication, the editorial board of JAMA Surgery has taken the initiative by giving some pointers to would-be authors. The journal editors have published a 10-point checklist of dos and don’ts to address commonly seen problems with submitted manuscripts. In addition, JAMA Surgery collaborated with the Surgical Outcomes Club to commission a series of practical guides on the most widely used data sets in an effort to improve the quality of surgical database research. The Surgical Outcomes Club is a consortium of surgeons and scientists who work to advance health services and outcomes research in surgery that was launched in 2005 at the American College of Surgeons Clinical Congress.
The authors noted that, although JAMA Surgery receives hundreds of submissions of retrospective studies of large surgical databases each year, most of these studies have flaws in the data analysis or use a hypothesis that the data sets cannot address. Hence, the editors do not send most of them out for peer review. “Of those that are sent out for peer review, many are recommended to be rejected by expert peer reviewers as they find major methodological flaws in the use of these otherwise powerful data sets,” the team wrote.
“Research using data sets can be very powerful as the research can address questions and hypotheses using large populations of people. However, the research can have many weaknesses. First, the research is only as good as the data collection for each data set. Second, the investigator needs to be familiar with the types of research questions and hypotheses that can be addressed with each data set. Third, the statistical methodology used to analyze the data is also imperative,” said Dr. Kibbe in an interview.
The checklist begins with a recommendation that the researchers develop a clear, concise hypothesis using established criteria – either FINER (for feasible, interesting, novel, ethical, relevant) or PICO (patient, population, or problem; intervention, prognostic factor, or exposure; comparison or intervention; outcome); the checklist then goes on to include compliance with institutional review board and data use agreements and to emphasize the importance of a clear take-home message that addresses policy or clinical implications.
The series comprises 11 two-page articles that aim to serve as practical guides for using each of the most widely used surgical data sets, starting with the National Inpatient Sample and ending with the Society of Thoracic Surgeons data set. Each article includes a bulleted list of the data set’s attributes, an explanation of its limitations, a history of the data set, an explanation of how the data is collected and what is unique about the set’s features, and statistical considerations researchers should take into account when analyzing the data.
The series concludes with tips from the statistical editors of JAMA Surgery – Amy H. Kaji, MD, PhD, of Harbor–University of California Los Angeles Medical Center in Torrance; Alfred W. Rademaker, PhD, of Northwestern University, Chicago; and Terry Hyslop, PhD, of Duke University, Durham, N.C. – for performing statistical analysis of large data sets: “With bigger data, random signals may denote statistical significance, and precision may be incorrectly inferred because of narrow confidence intervals,” the statistical editors noted. “While many principles apply to all studies, the importance of these methodological issues is amplified in large, complex data sets.”
However, they noted that large data sets are prone to bias and measurement errors. “It is important to respect and acknowledge the limitations of the data,” the statistical team wrote. They also reprise the introductory editorial’s call for a clear hypothesis and take-home message. “The challenge with Big Data is that it requires a carefully thought-out research question and a transparent analytic strategy,” the statistical editors said.
And there are pitfalls. Dr. Bilimoria noted, “We shouldn’t let the database define our research. We should instead be asking interesting questions and then seeking out a database that fits best to answer the question.” He said one particular problem that comes up often for reviewers is trying to discern how researchers arrived at the population of interest in a study. “A lot of inclusion and exclusions criteria are applied, and unless [the reviewer] can see the decisions that were made in the process, some fairly important biases can be introduced unintentionally. We as reviewers would like to be able to follow that exclusion pathway.”
He said, “A problem we frequently see is that these databases change the variable definitions over time – in fact, change the variables over time. So if researchers aren’t checking to see if that variable was reported the same every year of the study and in the same way, they will get spurious results. Similarly, the number of hospitals reporting is important as well since hospitals come in and out of these data sets.”
In their introductory editorial, the JAMA Surgery team noted that the checklist, practical guides, and statistical tips are a three-pronged approach that authors should consult before submitting their manuscripts. “We hope that by following these simple guides, authors can benefit from the collective wisdom of so many colleagues who have successfully completed similar analyses in the past,” they wrote.
Dr. Bilimoria sees great strengths in database research, such as giving researchers a population-level view of how care is being delivered, insights into the outcomes of care, indications of the effects of policy decisions, and data on rare diseases and operations.
Big Data of all kinds will be increasingly available for researchers. Dr. Kibbe commented that, “In the future, having a comprehensive (not sampling) country- or worldwide electronic medical record that will allow for robust inclusion of all medical data at the individual as well as cohort level will greatly contribute to the era of personalized medicine. In my opinion, this would be a real-time inclusive medical database that would allow for individual as well as population-based prospective studies.”
Dr. Haider receives support from the Henry M. Jackson Foundation of the Department of Defense, the Orthopaedic Research and Education Foundation, and the National Institutes of Health, and nonfinancial research support the Centers for Medicare and Medicaid Services Office of Minority Health. Dr. Bilimoria was the president of the Surgical Outcomes Club from 2016 to 2017.
Enhanced recovery led to fewer complications for major oncologic procedures
CHICAGO – Use of an enhanced recovery protocol for oncology patients has been shown to improve outcomes in colorectal surgery but has been largely unproven in other types of major oncology operations. That prompted researchers at the University of Texas MD Anderson Cancer Center in Houston to investigate They found that the enhanced recovery protocol led to a reduction in complication rates and a decrease in hospital stay with no increase in readmissions, according to an analysis of more than 3,000 oncologic operations presented at the Society of Surgical Oncology Annual Cancer Symposium here.
“Patients treated with enhanced recovery did better,” Rebecca Marcus, MD, said in reporting the results. “There were decreased rates of perioperative transfusions, decreased rates of surgical site infections, decreased rates of complications, including severe complications such as wound dehiscence, pneumonia, renal failure, and unintended returns to the operating room.” She noted that the shorter hospital stays – 4 days for patients on the enhanced recovery protocol versus 5 days for those on the traditional postoperative protocol – did not result in increased readmissions.
The study reviewed 3,256 operations performed during 2011-2016 in the MD Anderson institutional American College of Surgeons National Surgical Quality Improvement Program database. The operations were colorectal (20.4%), gynecologic (19.5%), hepatobiliary (8.9%), thoracic (41.9%) and urologic (9.3%). Most employed the traditional postoperative protocol (53.4%). Colorectal and thoracic/vascular surgery were early adopters of the enhanced recovery protocol at MD Anderson.
Dr. Marcus noted that the overall complication rates were 21.9% for those treated with enhanced recovery–protocol versus 33.9% for those treated with traditional postoperative protocol (P less than .0001). The group treated with enhanced recovery protocol also had lower rates of severe complications: 8.7% vs. 11.7% (P =.0048). The study also noted a trend toward reduced National Surgical Quality Improvement Program 30-day mortality with the enhanced recover protocol (0.4% vs. 0.86%; P = .097). Readmission rates were similar between the two groups: 8.3% for enhanced recovery protocol versus 8.9% for traditional postoperative protocol.
The researchers performed a subanalysis of high-magnitude cases that had a relative value unit of 30 or more and involved operations of greater complexity, which constituted 38% of the study population. “In this group, we still saw the benefit of having treatment with an enhanced recovery protocol with decreased rates of preoperative transfusions, complications, and shorter length of stay without any recent readmission,” Dr. Marcus said. Complication rates in the high-magnitude group were 19% for the enhanced recovery protocol versus 26% for the traditional postoperative protocol in colorectal cases, 21% vs. 40% in gynecology, and 19% vs. 28% in thoracic/vascular.
“The beneficial impact of enhanced recovery appears to be maintained across all specialties and to be independent of case magnitude,” Dr. Marcus said.
She said future research of enhanced recovery in surgical oncology should focus on more long-term outcomes, “such as oncologic benefits of these protocols, especially given the known detrimental effect of the delayed return to adjuvant therapy for this patient population.”
Dr. Marcus and her coauthors reported having no financial disclosures.
SOURCE: Marcus RK et al. SSO 2018, Abstract 21.
CHICAGO – Use of an enhanced recovery protocol for oncology patients has been shown to improve outcomes in colorectal surgery but has been largely unproven in other types of major oncology operations. That prompted researchers at the University of Texas MD Anderson Cancer Center in Houston to investigate They found that the enhanced recovery protocol led to a reduction in complication rates and a decrease in hospital stay with no increase in readmissions, according to an analysis of more than 3,000 oncologic operations presented at the Society of Surgical Oncology Annual Cancer Symposium here.
“Patients treated with enhanced recovery did better,” Rebecca Marcus, MD, said in reporting the results. “There were decreased rates of perioperative transfusions, decreased rates of surgical site infections, decreased rates of complications, including severe complications such as wound dehiscence, pneumonia, renal failure, and unintended returns to the operating room.” She noted that the shorter hospital stays – 4 days for patients on the enhanced recovery protocol versus 5 days for those on the traditional postoperative protocol – did not result in increased readmissions.
The study reviewed 3,256 operations performed during 2011-2016 in the MD Anderson institutional American College of Surgeons National Surgical Quality Improvement Program database. The operations were colorectal (20.4%), gynecologic (19.5%), hepatobiliary (8.9%), thoracic (41.9%) and urologic (9.3%). Most employed the traditional postoperative protocol (53.4%). Colorectal and thoracic/vascular surgery were early adopters of the enhanced recovery protocol at MD Anderson.
Dr. Marcus noted that the overall complication rates were 21.9% for those treated with enhanced recovery–protocol versus 33.9% for those treated with traditional postoperative protocol (P less than .0001). The group treated with enhanced recovery protocol also had lower rates of severe complications: 8.7% vs. 11.7% (P =.0048). The study also noted a trend toward reduced National Surgical Quality Improvement Program 30-day mortality with the enhanced recover protocol (0.4% vs. 0.86%; P = .097). Readmission rates were similar between the two groups: 8.3% for enhanced recovery protocol versus 8.9% for traditional postoperative protocol.
The researchers performed a subanalysis of high-magnitude cases that had a relative value unit of 30 or more and involved operations of greater complexity, which constituted 38% of the study population. “In this group, we still saw the benefit of having treatment with an enhanced recovery protocol with decreased rates of preoperative transfusions, complications, and shorter length of stay without any recent readmission,” Dr. Marcus said. Complication rates in the high-magnitude group were 19% for the enhanced recovery protocol versus 26% for the traditional postoperative protocol in colorectal cases, 21% vs. 40% in gynecology, and 19% vs. 28% in thoracic/vascular.
“The beneficial impact of enhanced recovery appears to be maintained across all specialties and to be independent of case magnitude,” Dr. Marcus said.
She said future research of enhanced recovery in surgical oncology should focus on more long-term outcomes, “such as oncologic benefits of these protocols, especially given the known detrimental effect of the delayed return to adjuvant therapy for this patient population.”
Dr. Marcus and her coauthors reported having no financial disclosures.
SOURCE: Marcus RK et al. SSO 2018, Abstract 21.
CHICAGO – Use of an enhanced recovery protocol for oncology patients has been shown to improve outcomes in colorectal surgery but has been largely unproven in other types of major oncology operations. That prompted researchers at the University of Texas MD Anderson Cancer Center in Houston to investigate They found that the enhanced recovery protocol led to a reduction in complication rates and a decrease in hospital stay with no increase in readmissions, according to an analysis of more than 3,000 oncologic operations presented at the Society of Surgical Oncology Annual Cancer Symposium here.
“Patients treated with enhanced recovery did better,” Rebecca Marcus, MD, said in reporting the results. “There were decreased rates of perioperative transfusions, decreased rates of surgical site infections, decreased rates of complications, including severe complications such as wound dehiscence, pneumonia, renal failure, and unintended returns to the operating room.” She noted that the shorter hospital stays – 4 days for patients on the enhanced recovery protocol versus 5 days for those on the traditional postoperative protocol – did not result in increased readmissions.
The study reviewed 3,256 operations performed during 2011-2016 in the MD Anderson institutional American College of Surgeons National Surgical Quality Improvement Program database. The operations were colorectal (20.4%), gynecologic (19.5%), hepatobiliary (8.9%), thoracic (41.9%) and urologic (9.3%). Most employed the traditional postoperative protocol (53.4%). Colorectal and thoracic/vascular surgery were early adopters of the enhanced recovery protocol at MD Anderson.
Dr. Marcus noted that the overall complication rates were 21.9% for those treated with enhanced recovery–protocol versus 33.9% for those treated with traditional postoperative protocol (P less than .0001). The group treated with enhanced recovery protocol also had lower rates of severe complications: 8.7% vs. 11.7% (P =.0048). The study also noted a trend toward reduced National Surgical Quality Improvement Program 30-day mortality with the enhanced recover protocol (0.4% vs. 0.86%; P = .097). Readmission rates were similar between the two groups: 8.3% for enhanced recovery protocol versus 8.9% for traditional postoperative protocol.
The researchers performed a subanalysis of high-magnitude cases that had a relative value unit of 30 or more and involved operations of greater complexity, which constituted 38% of the study population. “In this group, we still saw the benefit of having treatment with an enhanced recovery protocol with decreased rates of preoperative transfusions, complications, and shorter length of stay without any recent readmission,” Dr. Marcus said. Complication rates in the high-magnitude group were 19% for the enhanced recovery protocol versus 26% for the traditional postoperative protocol in colorectal cases, 21% vs. 40% in gynecology, and 19% vs. 28% in thoracic/vascular.
“The beneficial impact of enhanced recovery appears to be maintained across all specialties and to be independent of case magnitude,” Dr. Marcus said.
She said future research of enhanced recovery in surgical oncology should focus on more long-term outcomes, “such as oncologic benefits of these protocols, especially given the known detrimental effect of the delayed return to adjuvant therapy for this patient population.”
Dr. Marcus and her coauthors reported having no financial disclosures.
SOURCE: Marcus RK et al. SSO 2018, Abstract 21.
REPORTING FROM SSO 2018
Key clinical point: Enhanced recovery protocol implementation is feasible in major oncologic surgery.
Major finding: Complication rates were 21.9% for enhanced recovery protocol versus 33.9% for traditional postoperative protocol.
Study details: Analysis of 3,256 oncology operations in an institutional ACS NSQIP database performed from 2011 to 2016.
Disclosures: Dr. Marcus and her coauthors reported having no financial disclosures.
Source: Marcus RK et al. SSO 2018, Abstract 21
Gene strong predictor of metastasis in melanoma
CHICAGO – Investigators have identified four genes that are overexpressed in primary melanoma, including one, CXCL1, that holds promise as a strong predictor of future metastatic disease, according to study results presented at the Society of Surgical Oncology Annual Cancer Symposium.
The study implicated four genes strongly expressed in primary melanoma tumors of patients who develop distant metastases – CXCL1, CXCL2, CBL, and CD276 – said Jennifer Erdrich, MD, MPH, of Cedars Sinai Medical Center, Los Angeles. However, CXCL1 stood out. “CXCL1 overexpression is an independent predictor of developing metastatic disease. Patients with CXCL1 overexpression in the primary tumor in our study had decreased overall 5-year survival.” CXCL1 may be a useful predictive marker in primary melanoma and a potential target for immunotherapy, she said.
The rationale for analyzing the 79 genes implicated in cancer only rather than the entire array of 22,000 genes was to reduce the odds of a high false-discovery rate from 5% to 0.007%. “This is what strengthens our findings in a cohort of 37 patients,” Dr. Erdrich said.
The study analyzed pathological characteristics of the metastatic and nonmetastatic groups. Most characteristics were similar between the two groups, including location of the primary tumor in the trunk and extremities of 67% and 71%, respectively, and age of 60 years and older. The analysis noted two deviations: primary tumor size was thicker in the metastatic group (2.1 mm vs. 1.05 mm; P = .6), although Dr. Erdrich noted this was “not significantly different”; and a higher rate of ulceration in the metastatic group (50% vs. 13%; P = .05).
The genes CXCL1 and CXCL2 are both chemokines involved in growth and inflammation. “CXCL1 expression was 2.51 times greater in the metastatic group,” Dr. Erdrich said (P less than .001). Overexpression in the other three genes of interest was: CXCL2, 1.68 times greater (P less than .01); CD276, which is involved in T-cell immunity, 1.16 times greater (P = .04); and C-CBL, which is a photo-oncogene involved in the ubiquitin pathway, 1.15 times greater (P = .01). “The overexpression of all four of these was statistically significant,” she said.
Univariate analysis found ulceration of the primary along with overexpression of
the four genes to be significant predictors of metastasis. “However, in our multivariate model, three of the genes dropped out but CXCL1 remained robust,” she said.
Dr. Erdrich noted that CXCL1 is a cytokine located on chromosome 4, is secreted by macrophages, exerts its signal through CXCR2, and is one of five cytokines upregulated in lesions that respond to immunotherapy (Br J Dermatol. 2016;175:966-78).
CXCL1 compares favorably with S100, the existing blood-based biomarker for predicting recurrence in high-risk melanoma, as a predictor of metastases, Dr. Erdrich said, with an area under the curve of 0.80 versus 0.66; sensitivity of 67% versus 77%; specificity of 97% versus 61%; positive predictive value of 80% versus 40%; and negative predictive value of 94% versus 88% (Anticancer Res. 1999;19:2685-90; Cancer. 2003;97:1737-45).
The study also looked at overall survival in patients with low and high expression of CXCL1. “The patients with high expression had 5-year survival of only 50% compared to those of low expression, whose 5-year survival was 97%,” Dr. Erdrich said.
Dr. Erdrich and her coauthors reported having no financial relationships.
SOURCE: Erdrich J et al. SSO 2018, Abstract 82.
CHICAGO – Investigators have identified four genes that are overexpressed in primary melanoma, including one, CXCL1, that holds promise as a strong predictor of future metastatic disease, according to study results presented at the Society of Surgical Oncology Annual Cancer Symposium.
The study implicated four genes strongly expressed in primary melanoma tumors of patients who develop distant metastases – CXCL1, CXCL2, CBL, and CD276 – said Jennifer Erdrich, MD, MPH, of Cedars Sinai Medical Center, Los Angeles. However, CXCL1 stood out. “CXCL1 overexpression is an independent predictor of developing metastatic disease. Patients with CXCL1 overexpression in the primary tumor in our study had decreased overall 5-year survival.” CXCL1 may be a useful predictive marker in primary melanoma and a potential target for immunotherapy, she said.
The rationale for analyzing the 79 genes implicated in cancer only rather than the entire array of 22,000 genes was to reduce the odds of a high false-discovery rate from 5% to 0.007%. “This is what strengthens our findings in a cohort of 37 patients,” Dr. Erdrich said.
The study analyzed pathological characteristics of the metastatic and nonmetastatic groups. Most characteristics were similar between the two groups, including location of the primary tumor in the trunk and extremities of 67% and 71%, respectively, and age of 60 years and older. The analysis noted two deviations: primary tumor size was thicker in the metastatic group (2.1 mm vs. 1.05 mm; P = .6), although Dr. Erdrich noted this was “not significantly different”; and a higher rate of ulceration in the metastatic group (50% vs. 13%; P = .05).
The genes CXCL1 and CXCL2 are both chemokines involved in growth and inflammation. “CXCL1 expression was 2.51 times greater in the metastatic group,” Dr. Erdrich said (P less than .001). Overexpression in the other three genes of interest was: CXCL2, 1.68 times greater (P less than .01); CD276, which is involved in T-cell immunity, 1.16 times greater (P = .04); and C-CBL, which is a photo-oncogene involved in the ubiquitin pathway, 1.15 times greater (P = .01). “The overexpression of all four of these was statistically significant,” she said.
Univariate analysis found ulceration of the primary along with overexpression of
the four genes to be significant predictors of metastasis. “However, in our multivariate model, three of the genes dropped out but CXCL1 remained robust,” she said.
Dr. Erdrich noted that CXCL1 is a cytokine located on chromosome 4, is secreted by macrophages, exerts its signal through CXCR2, and is one of five cytokines upregulated in lesions that respond to immunotherapy (Br J Dermatol. 2016;175:966-78).
CXCL1 compares favorably with S100, the existing blood-based biomarker for predicting recurrence in high-risk melanoma, as a predictor of metastases, Dr. Erdrich said, with an area under the curve of 0.80 versus 0.66; sensitivity of 67% versus 77%; specificity of 97% versus 61%; positive predictive value of 80% versus 40%; and negative predictive value of 94% versus 88% (Anticancer Res. 1999;19:2685-90; Cancer. 2003;97:1737-45).
The study also looked at overall survival in patients with low and high expression of CXCL1. “The patients with high expression had 5-year survival of only 50% compared to those of low expression, whose 5-year survival was 97%,” Dr. Erdrich said.
Dr. Erdrich and her coauthors reported having no financial relationships.
SOURCE: Erdrich J et al. SSO 2018, Abstract 82.
CHICAGO – Investigators have identified four genes that are overexpressed in primary melanoma, including one, CXCL1, that holds promise as a strong predictor of future metastatic disease, according to study results presented at the Society of Surgical Oncology Annual Cancer Symposium.
The study implicated four genes strongly expressed in primary melanoma tumors of patients who develop distant metastases – CXCL1, CXCL2, CBL, and CD276 – said Jennifer Erdrich, MD, MPH, of Cedars Sinai Medical Center, Los Angeles. However, CXCL1 stood out. “CXCL1 overexpression is an independent predictor of developing metastatic disease. Patients with CXCL1 overexpression in the primary tumor in our study had decreased overall 5-year survival.” CXCL1 may be a useful predictive marker in primary melanoma and a potential target for immunotherapy, she said.
The rationale for analyzing the 79 genes implicated in cancer only rather than the entire array of 22,000 genes was to reduce the odds of a high false-discovery rate from 5% to 0.007%. “This is what strengthens our findings in a cohort of 37 patients,” Dr. Erdrich said.
The study analyzed pathological characteristics of the metastatic and nonmetastatic groups. Most characteristics were similar between the two groups, including location of the primary tumor in the trunk and extremities of 67% and 71%, respectively, and age of 60 years and older. The analysis noted two deviations: primary tumor size was thicker in the metastatic group (2.1 mm vs. 1.05 mm; P = .6), although Dr. Erdrich noted this was “not significantly different”; and a higher rate of ulceration in the metastatic group (50% vs. 13%; P = .05).
The genes CXCL1 and CXCL2 are both chemokines involved in growth and inflammation. “CXCL1 expression was 2.51 times greater in the metastatic group,” Dr. Erdrich said (P less than .001). Overexpression in the other three genes of interest was: CXCL2, 1.68 times greater (P less than .01); CD276, which is involved in T-cell immunity, 1.16 times greater (P = .04); and C-CBL, which is a photo-oncogene involved in the ubiquitin pathway, 1.15 times greater (P = .01). “The overexpression of all four of these was statistically significant,” she said.
Univariate analysis found ulceration of the primary along with overexpression of
the four genes to be significant predictors of metastasis. “However, in our multivariate model, three of the genes dropped out but CXCL1 remained robust,” she said.
Dr. Erdrich noted that CXCL1 is a cytokine located on chromosome 4, is secreted by macrophages, exerts its signal through CXCR2, and is one of five cytokines upregulated in lesions that respond to immunotherapy (Br J Dermatol. 2016;175:966-78).
CXCL1 compares favorably with S100, the existing blood-based biomarker for predicting recurrence in high-risk melanoma, as a predictor of metastases, Dr. Erdrich said, with an area under the curve of 0.80 versus 0.66; sensitivity of 67% versus 77%; specificity of 97% versus 61%; positive predictive value of 80% versus 40%; and negative predictive value of 94% versus 88% (Anticancer Res. 1999;19:2685-90; Cancer. 2003;97:1737-45).
The study also looked at overall survival in patients with low and high expression of CXCL1. “The patients with high expression had 5-year survival of only 50% compared to those of low expression, whose 5-year survival was 97%,” Dr. Erdrich said.
Dr. Erdrich and her coauthors reported having no financial relationships.
SOURCE: Erdrich J et al. SSO 2018, Abstract 82.
REPORTING FROM SSO 2018
Key clinical point: The CXCL1 gene may predict metastatic risk in primary melanoma.
Major findings: CXCL1 overexpression yielded 50% 5-year survival, almost half that of underexpression.
Study details: Gene analysis of samples from 37 patients with nonmetastatic primary melanoma who had surgical removal of primary lesion with median follow-up of 38 months.
Disclosures: Dr. Erdrich and her coauthors reported having no financial disclosures.
Source: Erdrich J et al. SSO 2018, Abstract 82.
Extracapsular spread predicts survival in SLN+ melanoma
CHICAGO – Extracapsular extension, or extracapsular spread (ECS), has been recognized as a risk factor in melanoma patients with macrometastatic (N+) disease, but a study from the United Kingdom has found it may also be an important indicator of progression-free and overall survival in patients who have sentinel node positive (SLN+) micrometastatic disease, a researcher reported at the Society of Surgical Oncology Annual Cancer Symposium.
“There is limited published data on ECS in micrometastatic disease, although there is progression-free survival data published in the literature,” Michelle Lo, MBCHB, MRCS, of Norfolk and Norwich University Hospitals, in Norwich, England, said in presenting the results. “The goal of the study was to determine the incidence of ECS in the micrometastatic group and to determine the prognostic significance of this.”
The study found that the incidence of ECS in the N+ group was significantly higher than the SLN+ group, 52.4% vs. 16.2% (P less than .0001). ECS proved to be a significant prognostic indicator of disease-specific survival and overall survival for both N+ and SLN+ disease. “There was no statistical difference in Breslow thickness between the two groups regardless of ECS,” she said.
Both the N+ and SLN+ groups with ECS had more lymph nodes than the ECS-absent subgroups, Dr. Lo said. However, in the ECS-absent subgroups, N+ patients had twice the number of lymph nodes than SLN+ patients. “This would suggest that ECS is a high-risk phenotype from the outset of metastases rather than something that’s developed over time,” she said. “Our data is in line with international staging data.”
The ECS-absent SLN– disease group had the most favorable survival outcomes, while those with ECS-present N+ disease had the worst outcomes. The prognosis of ECS-present, SLN+ patients was statistically similar to the ECS-absent, N+ group, she said.
In patients with SLN+ disease, Breslow thickness and N-stage were independent prognostic indicators for progression-free survival (hazard ratio 2.4, P less than .0001) and disease-free survival (HR 2.3, P less than .0001), Dr. Lo noted that median progression-free survival in SLN+ and N+ disease was 20 and 10 months, respectively. “Within our cohort of patients with ECS present in the micrometastatic group, their disease progressed within 3 years,” she said.
A multivariate analysis showed the survival data from this study was consistent with American Joint Committee on Cancer staging criteria, Dr. Lo said. “ECS is well recognized in the macrometastatic group, but we demonstrated from our data that the incidence of ECS in the micrometastatic group is one in six. It’s an independent risk factor for disease progression and an independent risk factor for worst disease-specific and overall survival, and it upstages micrometastatic disease.” ECS upstages stage III disease in a fashion similar to that of ulceration in primary melanoma, she said.
“In the absence of data to suggest otherwise, we would still recommend completion lymph node dissection in our micrometastatic group where ECS is present, and we would advocate that ECS should be included as an independent staging variable in the future,” Dr. Lo said.
Dr. Lo and her coauthors reported having no financial disclosures.
SOURCE: Lo M, et al. SSO 2018 Abstract 70.
CHICAGO – Extracapsular extension, or extracapsular spread (ECS), has been recognized as a risk factor in melanoma patients with macrometastatic (N+) disease, but a study from the United Kingdom has found it may also be an important indicator of progression-free and overall survival in patients who have sentinel node positive (SLN+) micrometastatic disease, a researcher reported at the Society of Surgical Oncology Annual Cancer Symposium.
“There is limited published data on ECS in micrometastatic disease, although there is progression-free survival data published in the literature,” Michelle Lo, MBCHB, MRCS, of Norfolk and Norwich University Hospitals, in Norwich, England, said in presenting the results. “The goal of the study was to determine the incidence of ECS in the micrometastatic group and to determine the prognostic significance of this.”
The study found that the incidence of ECS in the N+ group was significantly higher than the SLN+ group, 52.4% vs. 16.2% (P less than .0001). ECS proved to be a significant prognostic indicator of disease-specific survival and overall survival for both N+ and SLN+ disease. “There was no statistical difference in Breslow thickness between the two groups regardless of ECS,” she said.
Both the N+ and SLN+ groups with ECS had more lymph nodes than the ECS-absent subgroups, Dr. Lo said. However, in the ECS-absent subgroups, N+ patients had twice the number of lymph nodes than SLN+ patients. “This would suggest that ECS is a high-risk phenotype from the outset of metastases rather than something that’s developed over time,” she said. “Our data is in line with international staging data.”
The ECS-absent SLN– disease group had the most favorable survival outcomes, while those with ECS-present N+ disease had the worst outcomes. The prognosis of ECS-present, SLN+ patients was statistically similar to the ECS-absent, N+ group, she said.
In patients with SLN+ disease, Breslow thickness and N-stage were independent prognostic indicators for progression-free survival (hazard ratio 2.4, P less than .0001) and disease-free survival (HR 2.3, P less than .0001), Dr. Lo noted that median progression-free survival in SLN+ and N+ disease was 20 and 10 months, respectively. “Within our cohort of patients with ECS present in the micrometastatic group, their disease progressed within 3 years,” she said.
A multivariate analysis showed the survival data from this study was consistent with American Joint Committee on Cancer staging criteria, Dr. Lo said. “ECS is well recognized in the macrometastatic group, but we demonstrated from our data that the incidence of ECS in the micrometastatic group is one in six. It’s an independent risk factor for disease progression and an independent risk factor for worst disease-specific and overall survival, and it upstages micrometastatic disease.” ECS upstages stage III disease in a fashion similar to that of ulceration in primary melanoma, she said.
“In the absence of data to suggest otherwise, we would still recommend completion lymph node dissection in our micrometastatic group where ECS is present, and we would advocate that ECS should be included as an independent staging variable in the future,” Dr. Lo said.
Dr. Lo and her coauthors reported having no financial disclosures.
SOURCE: Lo M, et al. SSO 2018 Abstract 70.
CHICAGO – Extracapsular extension, or extracapsular spread (ECS), has been recognized as a risk factor in melanoma patients with macrometastatic (N+) disease, but a study from the United Kingdom has found it may also be an important indicator of progression-free and overall survival in patients who have sentinel node positive (SLN+) micrometastatic disease, a researcher reported at the Society of Surgical Oncology Annual Cancer Symposium.
“There is limited published data on ECS in micrometastatic disease, although there is progression-free survival data published in the literature,” Michelle Lo, MBCHB, MRCS, of Norfolk and Norwich University Hospitals, in Norwich, England, said in presenting the results. “The goal of the study was to determine the incidence of ECS in the micrometastatic group and to determine the prognostic significance of this.”
The study found that the incidence of ECS in the N+ group was significantly higher than the SLN+ group, 52.4% vs. 16.2% (P less than .0001). ECS proved to be a significant prognostic indicator of disease-specific survival and overall survival for both N+ and SLN+ disease. “There was no statistical difference in Breslow thickness between the two groups regardless of ECS,” she said.
Both the N+ and SLN+ groups with ECS had more lymph nodes than the ECS-absent subgroups, Dr. Lo said. However, in the ECS-absent subgroups, N+ patients had twice the number of lymph nodes than SLN+ patients. “This would suggest that ECS is a high-risk phenotype from the outset of metastases rather than something that’s developed over time,” she said. “Our data is in line with international staging data.”
The ECS-absent SLN– disease group had the most favorable survival outcomes, while those with ECS-present N+ disease had the worst outcomes. The prognosis of ECS-present, SLN+ patients was statistically similar to the ECS-absent, N+ group, she said.
In patients with SLN+ disease, Breslow thickness and N-stage were independent prognostic indicators for progression-free survival (hazard ratio 2.4, P less than .0001) and disease-free survival (HR 2.3, P less than .0001), Dr. Lo noted that median progression-free survival in SLN+ and N+ disease was 20 and 10 months, respectively. “Within our cohort of patients with ECS present in the micrometastatic group, their disease progressed within 3 years,” she said.
A multivariate analysis showed the survival data from this study was consistent with American Joint Committee on Cancer staging criteria, Dr. Lo said. “ECS is well recognized in the macrometastatic group, but we demonstrated from our data that the incidence of ECS in the micrometastatic group is one in six. It’s an independent risk factor for disease progression and an independent risk factor for worst disease-specific and overall survival, and it upstages micrometastatic disease.” ECS upstages stage III disease in a fashion similar to that of ulceration in primary melanoma, she said.
“In the absence of data to suggest otherwise, we would still recommend completion lymph node dissection in our micrometastatic group where ECS is present, and we would advocate that ECS should be included as an independent staging variable in the future,” Dr. Lo said.
Dr. Lo and her coauthors reported having no financial disclosures.
SOURCE: Lo M, et al. SSO 2018 Abstract 70.
REPORTING FROM SSO 2018
Key clinical point: Extracapsular spread (ECS) may be a reliable biomarker of survival in stage III melanoma.
Major finding: ECS status was an indicator of progression-free survival (hazard ratio 2.4; P less than .0001) in micrometastatic disease.
Study details: Retrospective cohort study of 515 patients who had micro- or macrometastatic lymphadenopathy at two U.K. centers from 2000 to 2017.
Disclosures: Dr. Lo and coauthors reported having no financial disclosures.
Source: Lo M et al. SSO 2018 Abstract 70.
How complications drive post-surgery spending upward
JACKSONVILLE, FLA. – Post-hospital care after major surgery is a significant driver of overall surgery-related spending, and hospitals are focused on reducing this spending as payers move away from the fee-for-service model.
with a trend toward utilizing more expensive inpatient post-acute care and less outpatient care, according to an analysis of more than 700,000 Medicare procedures presented at the Association for Academic Surgery/Society of University Surgeons Academic Surgical Congress.
This cross-sectional cohort study involved 707,943 cases in the Medicare database of coronary artery bypass grafting (CABG), colectomy, and total hip replacement (THR) from January 2009 to June 2012. The study found postoperative complication rates of 32% for CABG, 31% for colectomy, and 5% for THR. Postoperative complications resulted in an additional $4,083 spent on post-acute care following a CABG, an additional $4,049 after a colectomy, and an additional $1,742 after a THR.
This spending followed an increasing utilization of inpatient post-acute care and decreasing use of outpatient settings. “Relative to clinically similar patients with an uncomplicated course, patients who experienced a postoperative complication were more likely to utilize inpatient post-acute care than outpatient care,” Dr. Kanters said. For CABG, utilization rates of inpatient post-acute care increased 9.6% versus a decrease of 10.4% for outpatient post-acute care; for colectomy, inpatient post-acute care utilization increased 7.3% versus a drop of 6.2% for outpatient care; and for THR, inpatient post-acute care utilization rose 5.3% versus a drop of 2.4% for outpatient post-acute care. “The greatest impact is seen in the higher-risk procedures,” Dr. Kanters said.
The complications included cardiopulmonary complications, venous thromboembolism, renal failure, surgical site infections, and postoperative hemorrhage.
“Reductions in post-acute care spending will be central to hospitals’ efforts to reduce episode costs around major surgery,” Dr. Kanters said. “It is understood that complications are associated with increased cost, and this study helps quantify to what degree complications drive differences in spending on post-acute care.”
Hospitals’ efforts to reduce post-acute care spending must focus on preventing complications. “Thus, quality improvement efforts that reduce postoperative complications will be a key component of success in emerging payment reform,” Dr. Kanters noted
Session moderator Courtney Balentine, MD, of the University of Alabama at Birmingham, asked Dr. Kanters whether the research considered the incentives hospital systems have for referring patients to their own post-acute care facilities. “Post-acute care association with a single hospital has been documented as a likely incentive for discharge to a non-home destination,” Dr. Kanters replied, which leads to higher utilization of “certain” post-acute care facilities and higher costs. However, she said, this study’s dataset could not parse out that trend. “That’s certainly something that needs to be investigated,” she said.
Dr. Kanters and her coauthors had no financial relationships to disclose.
Source: Kanters AE. Annual Academic Surgical Congress 2018.
JACKSONVILLE, FLA. – Post-hospital care after major surgery is a significant driver of overall surgery-related spending, and hospitals are focused on reducing this spending as payers move away from the fee-for-service model.
with a trend toward utilizing more expensive inpatient post-acute care and less outpatient care, according to an analysis of more than 700,000 Medicare procedures presented at the Association for Academic Surgery/Society of University Surgeons Academic Surgical Congress.
This cross-sectional cohort study involved 707,943 cases in the Medicare database of coronary artery bypass grafting (CABG), colectomy, and total hip replacement (THR) from January 2009 to June 2012. The study found postoperative complication rates of 32% for CABG, 31% for colectomy, and 5% for THR. Postoperative complications resulted in an additional $4,083 spent on post-acute care following a CABG, an additional $4,049 after a colectomy, and an additional $1,742 after a THR.
This spending followed an increasing utilization of inpatient post-acute care and decreasing use of outpatient settings. “Relative to clinically similar patients with an uncomplicated course, patients who experienced a postoperative complication were more likely to utilize inpatient post-acute care than outpatient care,” Dr. Kanters said. For CABG, utilization rates of inpatient post-acute care increased 9.6% versus a decrease of 10.4% for outpatient post-acute care; for colectomy, inpatient post-acute care utilization increased 7.3% versus a drop of 6.2% for outpatient care; and for THR, inpatient post-acute care utilization rose 5.3% versus a drop of 2.4% for outpatient post-acute care. “The greatest impact is seen in the higher-risk procedures,” Dr. Kanters said.
The complications included cardiopulmonary complications, venous thromboembolism, renal failure, surgical site infections, and postoperative hemorrhage.
“Reductions in post-acute care spending will be central to hospitals’ efforts to reduce episode costs around major surgery,” Dr. Kanters said. “It is understood that complications are associated with increased cost, and this study helps quantify to what degree complications drive differences in spending on post-acute care.”
Hospitals’ efforts to reduce post-acute care spending must focus on preventing complications. “Thus, quality improvement efforts that reduce postoperative complications will be a key component of success in emerging payment reform,” Dr. Kanters noted
Session moderator Courtney Balentine, MD, of the University of Alabama at Birmingham, asked Dr. Kanters whether the research considered the incentives hospital systems have for referring patients to their own post-acute care facilities. “Post-acute care association with a single hospital has been documented as a likely incentive for discharge to a non-home destination,” Dr. Kanters replied, which leads to higher utilization of “certain” post-acute care facilities and higher costs. However, she said, this study’s dataset could not parse out that trend. “That’s certainly something that needs to be investigated,” she said.
Dr. Kanters and her coauthors had no financial relationships to disclose.
Source: Kanters AE. Annual Academic Surgical Congress 2018.
JACKSONVILLE, FLA. – Post-hospital care after major surgery is a significant driver of overall surgery-related spending, and hospitals are focused on reducing this spending as payers move away from the fee-for-service model.
with a trend toward utilizing more expensive inpatient post-acute care and less outpatient care, according to an analysis of more than 700,000 Medicare procedures presented at the Association for Academic Surgery/Society of University Surgeons Academic Surgical Congress.
This cross-sectional cohort study involved 707,943 cases in the Medicare database of coronary artery bypass grafting (CABG), colectomy, and total hip replacement (THR) from January 2009 to June 2012. The study found postoperative complication rates of 32% for CABG, 31% for colectomy, and 5% for THR. Postoperative complications resulted in an additional $4,083 spent on post-acute care following a CABG, an additional $4,049 after a colectomy, and an additional $1,742 after a THR.
This spending followed an increasing utilization of inpatient post-acute care and decreasing use of outpatient settings. “Relative to clinically similar patients with an uncomplicated course, patients who experienced a postoperative complication were more likely to utilize inpatient post-acute care than outpatient care,” Dr. Kanters said. For CABG, utilization rates of inpatient post-acute care increased 9.6% versus a decrease of 10.4% for outpatient post-acute care; for colectomy, inpatient post-acute care utilization increased 7.3% versus a drop of 6.2% for outpatient care; and for THR, inpatient post-acute care utilization rose 5.3% versus a drop of 2.4% for outpatient post-acute care. “The greatest impact is seen in the higher-risk procedures,” Dr. Kanters said.
The complications included cardiopulmonary complications, venous thromboembolism, renal failure, surgical site infections, and postoperative hemorrhage.
“Reductions in post-acute care spending will be central to hospitals’ efforts to reduce episode costs around major surgery,” Dr. Kanters said. “It is understood that complications are associated with increased cost, and this study helps quantify to what degree complications drive differences in spending on post-acute care.”
Hospitals’ efforts to reduce post-acute care spending must focus on preventing complications. “Thus, quality improvement efforts that reduce postoperative complications will be a key component of success in emerging payment reform,” Dr. Kanters noted
Session moderator Courtney Balentine, MD, of the University of Alabama at Birmingham, asked Dr. Kanters whether the research considered the incentives hospital systems have for referring patients to their own post-acute care facilities. “Post-acute care association with a single hospital has been documented as a likely incentive for discharge to a non-home destination,” Dr. Kanters replied, which leads to higher utilization of “certain” post-acute care facilities and higher costs. However, she said, this study’s dataset could not parse out that trend. “That’s certainly something that needs to be investigated,” she said.
Dr. Kanters and her coauthors had no financial relationships to disclose.
Source: Kanters AE. Annual Academic Surgical Congress 2018.
AT THE ANNUAL ACADEMIC SURGICAL CONGRESS
Key clinical point: Complications after major surgery are a huge driver of increasing post-acute care spending.
Major finding: Complications after major surgery that led to post-acute care increased costs by $4,083 for coronary artery bypass grafting, $4,049 for colectomy, and $1,742 for total hip replacement.
Data source: Cross-sectional cohort study of all Medicare beneficiaries who had coronary artery bypass graft (n = 281,940), colectomy (n = 189,229) and total hip replacement (n = 231,773) between January 2009 and June 2012.
Disclosures: Dr. Kanters and her coauthors reported having no financial disclosures.
Source: Kanters AE. Annual Academic Surgical Congress 2018.
Study finds gaps in bundled colectomy payments
CHICAGO – As Medicare transitions to a value-based model that uses bundled payments, oncologic surgeons and medical institutions may want to take a close look at enhanced recovery pathways and more minimally invasive surgery for colectomy in both benign and malignant disease to close potential gaps in reimbursement and outcomes, according to a retrospective study of 4-year Medicare data presented at the Society of Surgical Oncology Annual Cancer Symposium here.
The study evaluated reimbursement rates of three Medicare Severity–Diagnosis Related Groups (MS-DRG) assigned to the study cohort of 10,928 cases in the Medicare database from 2011-2015: 331 (benign disease), 330 (colon cancer/no metastases), and 329 (metastatic colon cancer). “There is little data comparing the relative impact of MS-DRG on cost and reimbursement for oncologic versus benign colon resection as it relates to the index admission, post-acute care costs, and Centers for Medicare & Medicaid Services total costs,” Dr. Hughes said.
With descriptive statistics, the study showed that benign resection resulted in higher average total charges than malignant disease ($66,033 vs. $60,581, respectively; P less than .001) and longer hospital stays (7.25 days vs. 6.92; P less than .002), Dr. Hughes said. However, Medicare reimbursements were similar for both pathology groups: $10,358 for benign disease versus $10,483 for oncologic pathology (P = .434). Cancer patients were about 25% more likely to be discharged to a rehabilitation facility than were those in the benign group (16.6% vs. 12.4%, respectively; P less than .001).
“What we know from other data is that, compared to fee-for-service for surgical colectomies, a value-based payment model resulted in lower payments for the index admission,” Dr. Hughes said. “A greater proportion of these patients also contributed to a negative margin for hospitals when compared to the fee-for-service model, as well as a higher risk across acute care services.”
Of patients in the study cohort, 67% had surgery for malignant disease. Both benign and malignant groups had more open colectomies than minimally invasive colectomies: 60% and 36.8%, respectively, of procedures in the benign group and 63% and 40% in the cancer group (P less than .001).
The goal of the study was to identify potential gaps in adopting MS-DRG for the bundled payment model in benign versus malignant colectomy, Dr. Hughes said. The study identified three gaps:
- DRG poorly differentiates between benign and malignant disease. This problem is evidenced by the higher cost for the index admission in benign disease. “Whereas in malignant disease, there is a greater unrecognized cost-shifting to post-acute care services which are not addressed by the DRG system,” he said.
- The dominance of open colectomy where MIS could reduce episode costs. The study cited research that reported the advantages of MIS include lower episode costs in both younger and older patients, by $1,466 and $632, respectively; shorter hospital stays by 1.46 days; 20% lower 30-day readmissions rates; and lower rates of post-acute care services (J Laparoendosc Adv Surg Tech A. 2017 Dec 13. doi: 10.1089/lap.2017.0521)
- Potential for DRG migration from code 331 (benign disease) to 330 (colon cancer but not with metastasis). Dr. Hughes and his coauthors published a study that reported a 14.2% rate of DRG migration in this same Medicare cohort, that is, classified as 331 on admission but migrated to 330. So, compared with other patients, this group ended up with longer LOS (7.6 vs. 4.8 days); higher total charges ($63,149 vs. $46,339); and higher CMS payment ($11,159 vs. $7,210) (Am J Surg. 2018;215:493-6). “We also identified a potential role for enhanced-recovery pathways to mitigate these factors,” he said.
He noted that the different stakeholders – hospitals, surgeons, anesthesiologists, hospitalists, other physicians, nurses, and extenders – will have to resolve how to divide bundled payments. “The biggest thing is communication between these groups, because moving forward CMS is trying to step away from the role of determining who gets paid what,” Dr. Hughes said. He noted this finding is consistent with his own previously published findings, along with those from senior study coauthor Anthony J. Senagore, MD, FACS, on resource consumption in value-based care.
Dr. Hughes and coauthors reported having no financial disclosures. Dr. Hughes is supported by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health.
SOURCE: Huges BD. SSO 2018.
CHICAGO – As Medicare transitions to a value-based model that uses bundled payments, oncologic surgeons and medical institutions may want to take a close look at enhanced recovery pathways and more minimally invasive surgery for colectomy in both benign and malignant disease to close potential gaps in reimbursement and outcomes, according to a retrospective study of 4-year Medicare data presented at the Society of Surgical Oncology Annual Cancer Symposium here.
The study evaluated reimbursement rates of three Medicare Severity–Diagnosis Related Groups (MS-DRG) assigned to the study cohort of 10,928 cases in the Medicare database from 2011-2015: 331 (benign disease), 330 (colon cancer/no metastases), and 329 (metastatic colon cancer). “There is little data comparing the relative impact of MS-DRG on cost and reimbursement for oncologic versus benign colon resection as it relates to the index admission, post-acute care costs, and Centers for Medicare & Medicaid Services total costs,” Dr. Hughes said.
With descriptive statistics, the study showed that benign resection resulted in higher average total charges than malignant disease ($66,033 vs. $60,581, respectively; P less than .001) and longer hospital stays (7.25 days vs. 6.92; P less than .002), Dr. Hughes said. However, Medicare reimbursements were similar for both pathology groups: $10,358 for benign disease versus $10,483 for oncologic pathology (P = .434). Cancer patients were about 25% more likely to be discharged to a rehabilitation facility than were those in the benign group (16.6% vs. 12.4%, respectively; P less than .001).
“What we know from other data is that, compared to fee-for-service for surgical colectomies, a value-based payment model resulted in lower payments for the index admission,” Dr. Hughes said. “A greater proportion of these patients also contributed to a negative margin for hospitals when compared to the fee-for-service model, as well as a higher risk across acute care services.”
Of patients in the study cohort, 67% had surgery for malignant disease. Both benign and malignant groups had more open colectomies than minimally invasive colectomies: 60% and 36.8%, respectively, of procedures in the benign group and 63% and 40% in the cancer group (P less than .001).
The goal of the study was to identify potential gaps in adopting MS-DRG for the bundled payment model in benign versus malignant colectomy, Dr. Hughes said. The study identified three gaps:
- DRG poorly differentiates between benign and malignant disease. This problem is evidenced by the higher cost for the index admission in benign disease. “Whereas in malignant disease, there is a greater unrecognized cost-shifting to post-acute care services which are not addressed by the DRG system,” he said.
- The dominance of open colectomy where MIS could reduce episode costs. The study cited research that reported the advantages of MIS include lower episode costs in both younger and older patients, by $1,466 and $632, respectively; shorter hospital stays by 1.46 days; 20% lower 30-day readmissions rates; and lower rates of post-acute care services (J Laparoendosc Adv Surg Tech A. 2017 Dec 13. doi: 10.1089/lap.2017.0521)
- Potential for DRG migration from code 331 (benign disease) to 330 (colon cancer but not with metastasis). Dr. Hughes and his coauthors published a study that reported a 14.2% rate of DRG migration in this same Medicare cohort, that is, classified as 331 on admission but migrated to 330. So, compared with other patients, this group ended up with longer LOS (7.6 vs. 4.8 days); higher total charges ($63,149 vs. $46,339); and higher CMS payment ($11,159 vs. $7,210) (Am J Surg. 2018;215:493-6). “We also identified a potential role for enhanced-recovery pathways to mitigate these factors,” he said.
He noted that the different stakeholders – hospitals, surgeons, anesthesiologists, hospitalists, other physicians, nurses, and extenders – will have to resolve how to divide bundled payments. “The biggest thing is communication between these groups, because moving forward CMS is trying to step away from the role of determining who gets paid what,” Dr. Hughes said. He noted this finding is consistent with his own previously published findings, along with those from senior study coauthor Anthony J. Senagore, MD, FACS, on resource consumption in value-based care.
Dr. Hughes and coauthors reported having no financial disclosures. Dr. Hughes is supported by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health.
SOURCE: Huges BD. SSO 2018.
CHICAGO – As Medicare transitions to a value-based model that uses bundled payments, oncologic surgeons and medical institutions may want to take a close look at enhanced recovery pathways and more minimally invasive surgery for colectomy in both benign and malignant disease to close potential gaps in reimbursement and outcomes, according to a retrospective study of 4-year Medicare data presented at the Society of Surgical Oncology Annual Cancer Symposium here.
The study evaluated reimbursement rates of three Medicare Severity–Diagnosis Related Groups (MS-DRG) assigned to the study cohort of 10,928 cases in the Medicare database from 2011-2015: 331 (benign disease), 330 (colon cancer/no metastases), and 329 (metastatic colon cancer). “There is little data comparing the relative impact of MS-DRG on cost and reimbursement for oncologic versus benign colon resection as it relates to the index admission, post-acute care costs, and Centers for Medicare & Medicaid Services total costs,” Dr. Hughes said.
With descriptive statistics, the study showed that benign resection resulted in higher average total charges than malignant disease ($66,033 vs. $60,581, respectively; P less than .001) and longer hospital stays (7.25 days vs. 6.92; P less than .002), Dr. Hughes said. However, Medicare reimbursements were similar for both pathology groups: $10,358 for benign disease versus $10,483 for oncologic pathology (P = .434). Cancer patients were about 25% more likely to be discharged to a rehabilitation facility than were those in the benign group (16.6% vs. 12.4%, respectively; P less than .001).
“What we know from other data is that, compared to fee-for-service for surgical colectomies, a value-based payment model resulted in lower payments for the index admission,” Dr. Hughes said. “A greater proportion of these patients also contributed to a negative margin for hospitals when compared to the fee-for-service model, as well as a higher risk across acute care services.”
Of patients in the study cohort, 67% had surgery for malignant disease. Both benign and malignant groups had more open colectomies than minimally invasive colectomies: 60% and 36.8%, respectively, of procedures in the benign group and 63% and 40% in the cancer group (P less than .001).
The goal of the study was to identify potential gaps in adopting MS-DRG for the bundled payment model in benign versus malignant colectomy, Dr. Hughes said. The study identified three gaps:
- DRG poorly differentiates between benign and malignant disease. This problem is evidenced by the higher cost for the index admission in benign disease. “Whereas in malignant disease, there is a greater unrecognized cost-shifting to post-acute care services which are not addressed by the DRG system,” he said.
- The dominance of open colectomy where MIS could reduce episode costs. The study cited research that reported the advantages of MIS include lower episode costs in both younger and older patients, by $1,466 and $632, respectively; shorter hospital stays by 1.46 days; 20% lower 30-day readmissions rates; and lower rates of post-acute care services (J Laparoendosc Adv Surg Tech A. 2017 Dec 13. doi: 10.1089/lap.2017.0521)
- Potential for DRG migration from code 331 (benign disease) to 330 (colon cancer but not with metastasis). Dr. Hughes and his coauthors published a study that reported a 14.2% rate of DRG migration in this same Medicare cohort, that is, classified as 331 on admission but migrated to 330. So, compared with other patients, this group ended up with longer LOS (7.6 vs. 4.8 days); higher total charges ($63,149 vs. $46,339); and higher CMS payment ($11,159 vs. $7,210) (Am J Surg. 2018;215:493-6). “We also identified a potential role for enhanced-recovery pathways to mitigate these factors,” he said.
He noted that the different stakeholders – hospitals, surgeons, anesthesiologists, hospitalists, other physicians, nurses, and extenders – will have to resolve how to divide bundled payments. “The biggest thing is communication between these groups, because moving forward CMS is trying to step away from the role of determining who gets paid what,” Dr. Hughes said. He noted this finding is consistent with his own previously published findings, along with those from senior study coauthor Anthony J. Senagore, MD, FACS, on resource consumption in value-based care.
Dr. Hughes and coauthors reported having no financial disclosures. Dr. Hughes is supported by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health.
SOURCE: Huges BD. SSO 2018.
REPORTING FROM SSO 2018
Key clinical point: Medicare payment methodology does not truly reflect episode costs for colectomy.
Major finding: Colectomy charges were higher for benign disease than for cancer.
Study details: Retrospective cohort study of 10,928 patients in a national Medicare database who had colon surgery during 2011-2014.
Disclosures: The investigators had no financial relationships to disclose. Dr. Hughes is supported by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health.
Source: Huges BD. SSO 2018.
