Cardiothoracic

ATLANTA — Patients with acute coronary syndrome (ACS) who had a myocardial infarction or unstable angina and underwent percutaneous coronary intervention (PCI) had a 76% lower rate of hospital readmission after 6 months if they participated in a remote monitoring protocol compared with similar patients who had standard post-discharge care, results of a new trial suggest.

The TELE-ACS trial showed that at 6 months, telemedicine patients also had statistically significantly lower rates of post-discharge emergency department visits, unplanned coronary revascularizations, and cardiovascular symptoms, such as chest pain, shortness of breath and dizziness. However, the rates of major adverse cardiovascular events (MACE) were similar between the two groups. The protocol included consultation with a cardiologist who reviewed home-monitoring data.

“The team was able to aid in preventing unnecessary presentations and advised the patients to seek emergency care whenever was necessary,” Nasser Alshahrani, MSc, a clinical research fellow at Imperial College London, said while presenting the results at the American College of Cardiology meeting. “The TELE-ACS protocol provided a significant reduction in readmission rates post-ACS and other adverse events.” 

The study findings were published online simultaneously in the Journal of the American College of Cardiology.
 

Telemedicine Protocol

The trial, conducted from January 2022 to April 2023, randomly assigned 337 patients to telemedicine or standard care when they were discharged after PCI and had at least one cardiovascular risk factor. The telemedicine protocol consisted of 12-lead electrocardiogram belt, an automated blood-pressure monitor, and a pulse oximeter. 

Patients in the telemedicine arm initiated the remote monitoring protocol if they thought they had cardiac symptoms. The majority (86%) were men with what the study described as “a high preponderance of cardiovascular risk factors.” Average age was 58.1 years. 

If a telemedicine patient initiated the protocol, a cardiologist remotely assessed the patient’s symptoms and channeled the patient to the appropriate care pathway, whether reassuring the patient or sending them to a primary care physician or emergency department, or to call emergency services. Patients who didn’t get a call back from the cardiologist within 15 minutes were told to seek care in the standard clinical pathway.

Telemedicine patients were given the telemonitoring package and training in how to use the devices before they were discharged. They also received three follow-up quality control calls in the first two months to ensure they were using the equipment correctly. They kept the telemonitoring equipment for 8 months, but were followed out to 9 months. Six telemedicine patients dropped out while one standard care patient withdrew from the study.

Results showed that at 6 months, telemedicine patients had statistically significantly lower rates of post-discharge emergency department visits (25% vs 37%, P < .001), unplanned coronary revascularizations (3% vs 9%, P < .01) and cardiovascular symptoms, such as chest pain, shortness of breath and dizziness (a 13% to 18% difference for each symptom, P < .01).

MACE rates were similar between the two groups.

At 9 months, 3 months after the protocol ended, 20 telemedicine patients and 50 standard-care patients were readmitted to the hospital, while 52 and 73, respectively, went to the emergency department.

The telemedicine patients also had shorter hospital stays: an average of 0.5 and 1.2 days at 6 and 9 months, respectively, vs 1.5 and 1.8 days in the standard treatment arm (P < .001 for both).

Mr. Alshahrani noted several limitations with the study, namely that 86% of participants were men, and that the intervention was only offered to people who had smartphones. “The high level of support for the telemedicine group, with prompt cardiology responses, may be challenging to replicate outside a trial setting, requiring significant investment and training,” he added.
 

Human Element Key

In an interview from London after the presentation, lead author Ramzi Khamis, MB ChB, PhD, said, “This was quite a basic study. Really what we did was we integrated a clinical decision-making algorithm that we perfected with some quite novel but basic technology.” Future research should strive to add a home troponin test to the protocol and an artificial intelligence component, he said.

However, Dr. Khamis noted that human interaction was key to the success of the TELE-ACS trial. “The human factor is very important here and I think it would be really interesting to have a head-to-head comparison of human interaction with remote monitoring vs an AI-driven interaction,” he said. “I have my doubts that AI would be able to beat the human factor here.”

Lawrence Phillips, MD, medical director of outpatient cardiology at NYU Langone Heart, told this news organization that the study was appropriately powered to evaluate the telemedicine protocol, and that it could serve as a template for other studies of remote monitoring in cardiology. 

“I think that this study is forming the foundation of evolving telemedicine data,” he said. “It shows really interesting results, and I’m sure it’s going to be reproduced in different ways going forward.”

While other studies have shown the utility of telemedicine to decrease unnecessary hospitalizations, this study went one step further, Dr. Phillips said. “What was unique about this study was the package that they put together,” he added. “It was a combination of telehealth and being able to speak with someone when you have concerns with objective data of an electrocardiogram, blood-pressure cuff, and oxygen level assessment, which is an interesting approach having that ejective data with [a] subjective element.”

The trial received funding from the British Heart Foundation; King Khalid University, Abha, Saudi Arabia via The Saudi Arabian Cultural Bureau; Sansour Fund, Imperial Healthcare Charity; and Safwan Sobhan Fund at Imperial College London. Mr. Alshahrani and Dr. Khamis have no relevant relationships to disclose. Dr. Phillips has no relevant disclosures.

A version of this article first appeared on Medscape.com.

ATLANTA — Patients with acute coronary syndrome (ACS) who had a myocardial infarction or unstable angina and underwent percutaneous coronary intervention (PCI) had a 76% lower rate of hospital readmission after 6 months if they participated in a remote monitoring protocol compared with similar patients who had standard post-discharge care, results of a new trial suggest.

The TELE-ACS trial showed that at 6 months, telemedicine patients also had statistically significantly lower rates of post-discharge emergency department visits, unplanned coronary revascularizations, and cardiovascular symptoms, such as chest pain, shortness of breath and dizziness. However, the rates of major adverse cardiovascular events (MACE) were similar between the two groups. The protocol included consultation with a cardiologist who reviewed home-monitoring data.

“The team was able to aid in preventing unnecessary presentations and advised the patients to seek emergency care whenever was necessary,” Nasser Alshahrani, MSc, a clinical research fellow at Imperial College London, said while presenting the results at the American College of Cardiology meeting. “The TELE-ACS protocol provided a significant reduction in readmission rates post-ACS and other adverse events.” 

The study findings were published online simultaneously in the Journal of the American College of Cardiology.
 

Telemedicine Protocol

The trial, conducted from January 2022 to April 2023, randomly assigned 337 patients to telemedicine or standard care when they were discharged after PCI and had at least one cardiovascular risk factor. The telemedicine protocol consisted of 12-lead electrocardiogram belt, an automated blood-pressure monitor, and a pulse oximeter. 

Patients in the telemedicine arm initiated the remote monitoring protocol if they thought they had cardiac symptoms. The majority (86%) were men with what the study described as “a high preponderance of cardiovascular risk factors.” Average age was 58.1 years. 

If a telemedicine patient initiated the protocol, a cardiologist remotely assessed the patient’s symptoms and channeled the patient to the appropriate care pathway, whether reassuring the patient or sending them to a primary care physician or emergency department, or to call emergency services. Patients who didn’t get a call back from the cardiologist within 15 minutes were told to seek care in the standard clinical pathway.

Telemedicine patients were given the telemonitoring package and training in how to use the devices before they were discharged. They also received three follow-up quality control calls in the first two months to ensure they were using the equipment correctly. They kept the telemonitoring equipment for 8 months, but were followed out to 9 months. Six telemedicine patients dropped out while one standard care patient withdrew from the study.

Results showed that at 6 months, telemedicine patients had statistically significantly lower rates of post-discharge emergency department visits (25% vs 37%, P < .001), unplanned coronary revascularizations (3% vs 9%, P < .01) and cardiovascular symptoms, such as chest pain, shortness of breath and dizziness (a 13% to 18% difference for each symptom, P < .01).

MACE rates were similar between the two groups.

At 9 months, 3 months after the protocol ended, 20 telemedicine patients and 50 standard-care patients were readmitted to the hospital, while 52 and 73, respectively, went to the emergency department.

The telemedicine patients also had shorter hospital stays: an average of 0.5 and 1.2 days at 6 and 9 months, respectively, vs 1.5 and 1.8 days in the standard treatment arm (P < .001 for both).

Mr. Alshahrani noted several limitations with the study, namely that 86% of participants were men, and that the intervention was only offered to people who had smartphones. “The high level of support for the telemedicine group, with prompt cardiology responses, may be challenging to replicate outside a trial setting, requiring significant investment and training,” he added.
 

Human Element Key

In an interview from London after the presentation, lead author Ramzi Khamis, MB ChB, PhD, said, “This was quite a basic study. Really what we did was we integrated a clinical decision-making algorithm that we perfected with some quite novel but basic technology.” Future research should strive to add a home troponin test to the protocol and an artificial intelligence component, he said.

However, Dr. Khamis noted that human interaction was key to the success of the TELE-ACS trial. “The human factor is very important here and I think it would be really interesting to have a head-to-head comparison of human interaction with remote monitoring vs an AI-driven interaction,” he said. “I have my doubts that AI would be able to beat the human factor here.”

Lawrence Phillips, MD, medical director of outpatient cardiology at NYU Langone Heart, told this news organization that the study was appropriately powered to evaluate the telemedicine protocol, and that it could serve as a template for other studies of remote monitoring in cardiology. 

“I think that this study is forming the foundation of evolving telemedicine data,” he said. “It shows really interesting results, and I’m sure it’s going to be reproduced in different ways going forward.”

While other studies have shown the utility of telemedicine to decrease unnecessary hospitalizations, this study went one step further, Dr. Phillips said. “What was unique about this study was the package that they put together,” he added. “It was a combination of telehealth and being able to speak with someone when you have concerns with objective data of an electrocardiogram, blood-pressure cuff, and oxygen level assessment, which is an interesting approach having that ejective data with [a] subjective element.”

The trial received funding from the British Heart Foundation; King Khalid University, Abha, Saudi Arabia via The Saudi Arabian Cultural Bureau; Sansour Fund, Imperial Healthcare Charity; and Safwan Sobhan Fund at Imperial College London. Mr. Alshahrani and Dr. Khamis have no relevant relationships to disclose. Dr. Phillips has no relevant disclosures.

A version of this article first appeared on Medscape.com.

ATLANTA — Patients with acute coronary syndrome (ACS) who had a myocardial infarction or unstable angina and underwent percutaneous coronary intervention (PCI) had a 76% lower rate of hospital readmission after 6 months if they participated in a remote monitoring protocol compared with similar patients who had standard post-discharge care, results of a new trial suggest.

The TELE-ACS trial showed that at 6 months, telemedicine patients also had statistically significantly lower rates of post-discharge emergency department visits, unplanned coronary revascularizations, and cardiovascular symptoms, such as chest pain, shortness of breath and dizziness. However, the rates of major adverse cardiovascular events (MACE) were similar between the two groups. The protocol included consultation with a cardiologist who reviewed home-monitoring data.

“The team was able to aid in preventing unnecessary presentations and advised the patients to seek emergency care whenever was necessary,” Nasser Alshahrani, MSc, a clinical research fellow at Imperial College London, said while presenting the results at the American College of Cardiology meeting. “The TELE-ACS protocol provided a significant reduction in readmission rates post-ACS and other adverse events.” 

The study findings were published online simultaneously in the Journal of the American College of Cardiology.
 

Telemedicine Protocol

The trial, conducted from January 2022 to April 2023, randomly assigned 337 patients to telemedicine or standard care when they were discharged after PCI and had at least one cardiovascular risk factor. The telemedicine protocol consisted of 12-lead electrocardiogram belt, an automated blood-pressure monitor, and a pulse oximeter. 

Patients in the telemedicine arm initiated the remote monitoring protocol if they thought they had cardiac symptoms. The majority (86%) were men with what the study described as “a high preponderance of cardiovascular risk factors.” Average age was 58.1 years. 

If a telemedicine patient initiated the protocol, a cardiologist remotely assessed the patient’s symptoms and channeled the patient to the appropriate care pathway, whether reassuring the patient or sending them to a primary care physician or emergency department, or to call emergency services. Patients who didn’t get a call back from the cardiologist within 15 minutes were told to seek care in the standard clinical pathway.

Telemedicine patients were given the telemonitoring package and training in how to use the devices before they were discharged. They also received three follow-up quality control calls in the first two months to ensure they were using the equipment correctly. They kept the telemonitoring equipment for 8 months, but were followed out to 9 months. Six telemedicine patients dropped out while one standard care patient withdrew from the study.

Results showed that at 6 months, telemedicine patients had statistically significantly lower rates of post-discharge emergency department visits (25% vs 37%, P < .001), unplanned coronary revascularizations (3% vs 9%, P < .01) and cardiovascular symptoms, such as chest pain, shortness of breath and dizziness (a 13% to 18% difference for each symptom, P < .01).

MACE rates were similar between the two groups.

At 9 months, 3 months after the protocol ended, 20 telemedicine patients and 50 standard-care patients were readmitted to the hospital, while 52 and 73, respectively, went to the emergency department.

The telemedicine patients also had shorter hospital stays: an average of 0.5 and 1.2 days at 6 and 9 months, respectively, vs 1.5 and 1.8 days in the standard treatment arm (P < .001 for both).

Mr. Alshahrani noted several limitations with the study, namely that 86% of participants were men, and that the intervention was only offered to people who had smartphones. “The high level of support for the telemedicine group, with prompt cardiology responses, may be challenging to replicate outside a trial setting, requiring significant investment and training,” he added.
 

Human Element Key

In an interview from London after the presentation, lead author Ramzi Khamis, MB ChB, PhD, said, “This was quite a basic study. Really what we did was we integrated a clinical decision-making algorithm that we perfected with some quite novel but basic technology.” Future research should strive to add a home troponin test to the protocol and an artificial intelligence component, he said.

However, Dr. Khamis noted that human interaction was key to the success of the TELE-ACS trial. “The human factor is very important here and I think it would be really interesting to have a head-to-head comparison of human interaction with remote monitoring vs an AI-driven interaction,” he said. “I have my doubts that AI would be able to beat the human factor here.”

Lawrence Phillips, MD, medical director of outpatient cardiology at NYU Langone Heart, told this news organization that the study was appropriately powered to evaluate the telemedicine protocol, and that it could serve as a template for other studies of remote monitoring in cardiology. 

“I think that this study is forming the foundation of evolving telemedicine data,” he said. “It shows really interesting results, and I’m sure it’s going to be reproduced in different ways going forward.”

While other studies have shown the utility of telemedicine to decrease unnecessary hospitalizations, this study went one step further, Dr. Phillips said. “What was unique about this study was the package that they put together,” he added. “It was a combination of telehealth and being able to speak with someone when you have concerns with objective data of an electrocardiogram, blood-pressure cuff, and oxygen level assessment, which is an interesting approach having that ejective data with [a] subjective element.”

The trial received funding from the British Heart Foundation; King Khalid University, Abha, Saudi Arabia via The Saudi Arabian Cultural Bureau; Sansour Fund, Imperial Healthcare Charity; and Safwan Sobhan Fund at Imperial College London. Mr. Alshahrani and Dr. Khamis have no relevant relationships to disclose. Dr. Phillips has no relevant disclosures.

A version of this article first appeared on Medscape.com.

An innovative surgical procedure combining breast implants and an artificial lung may help more patients with severe lung disease survive to receive transplants. The case was described in a press conference sponsored by Northwestern University, Evanston, Ill.

In May 2023, a surgical team at Northwestern removed both infected lungs from David “Davey” Bauer, aged 34 years, and temporarily used breast implants to hold his heart in place until new lungs were available.

In April 2023, Mr. Bauer, a longtime smoker and vaper, experienced shortness of breath. His girlfriend, Susan Gore, took him to an urgent care center, and he returned home, but “the next morning he couldn’t walk,” Ms. Gore said in the press conference. A trip to the ED yielded a diagnosis of influenza A, followed rapidly by a bacterial lung infection that proved resistant to antibiotics. Mr. Bauer had no prior medical history of serious illness, but he was soon in an intensive care unit. His condition continued to decline, and a double lung transplant was his only option.

166005_image1_web.jpg

Back from the brink

Mr. Bauer made the transfer to Chicago despite being critically ill. He was in dire need of a lung transplant, and the only way to resolve his infection was to remove the lungs, said Ankit Bharat, MD, chief of thoracic surgery and director of Northwestern Medicine Canning Thoracic Institute, in the press conference.

166005_image2_web.JPG

“Something needed to be done right away,” Dr. Bharat said. Mr. Bauer’s lungs were removed and the chest cavity was extensively debrided to remove the infection.

Then it was time for outside-the-box thinking. “With the lungs taken out, we needed something to support the heart,” he said. Breast implants came to mind, and double Ds were the largest available.

In addition, the surgeons created an artificial lung system of conduits to keep Mr. Bauer’s blood pumping. “We wanted to maintain the natural blood flow in the body that would be present if the lungs were there,” Dr. Bharat explained.

Plastic surgeons at Northwestern gave Mr. Bauer’s surgical team “a crash course” in managing the breast implants, Dr. Bharat said. The team anticipated that their novel surgical solution would need to last for weeks, but Mr. Bauer’s condition improved immediately once the infected lungs were removed. He was placed on a double-lung transplant list, and the team received an offer of new lungs within 24 hours.

The breast implants were removed, the new lungs were implanted, and Bauer spent several months in the ICU before his discharge to rehabilitation therapy at the end of September, according to a Northwestern press release.

This type of procedure could help patients with infections who need transplants but are too sick to undergo them, Dr. Bharat said in the press conference. In Mr. Bauer’s case, “a lot of stars aligned,” including Bauer’s rapid improvement and the quick availability of a perfect lung match, Dr. Bharat said. Many patients don’t survive to the point of transplant.

“We were surprised how quickly he recovered once we removed the infected lungs,” Dr. Bharat noted. The quick recovery may be in part because of Bauer’s youth and relative good health, but “this was uncharted territory.”

Mr. Bauer’s case is the first use of this particular surgical technique, although the team drew on lessons learned in other surgical settings, such as removal of both lungs to prevent cross-contamination in patients with cancer, he added.
 

Causes and effects

As for the factors that contributed to Mr. Bauer’s initial infection, “there is a lot we don’t know, but we can try to put things together,” said Dr. Bharat. Just as many factors lined up to promote Mr. Bauer’s recovery, many factors lined up to cause the problem, including long-standing smoking and vaping. Although some still view vaping as a safer alternative to smoking, patient data and experiences do not support this claim. “We know for a fact that both of them cause harm,” he added.

Mr. Bauer started smoking cigarettes at age 21 and typically smoked a pack of cigarettes each day before switching to vaping in 2014. In addition, Mr. Bauer had not been vaccinated against the flu, and his flu infection was followed by a bacterial infection.

Bacterial infections followed by hospitalizations are not new as an effect of vaping; a series of articles described the ongoing epidemic of e-cigarette or vaping product use–associated lung injury (EVALI). Patients with EVALI often present at urgent care centers, as Bauer did, with symptoms of flu or pneumonia, and they are often given medication and sent home.

Looking ahead: “We expect that Davey will fully recover and live a normal life,” although he will remain in Chicago for another year for monitoring, said Rade Tomic, MD, pulmonologist and medical director of the Northwestern Medicine Canning Thoracic Institute lung transplant program, in the press conference.

Mr. Bauer expressed his thanks to the surgical team, who also presented him with another gift: a T-shirt with his newly chosen nickname, “DD Davey.” “I feel so blessed, I got a second chance at life,” Mr. Bauer said in the press conference. “You should not inhale anything into your lungs except oxygen.”

A version of this article first appeared on Medscape.com.

An innovative surgical procedure combining breast implants and an artificial lung may help more patients with severe lung disease survive to receive transplants. The case was described in a press conference sponsored by Northwestern University, Evanston, Ill.

In May 2023, a surgical team at Northwestern removed both infected lungs from David “Davey” Bauer, aged 34 years, and temporarily used breast implants to hold his heart in place until new lungs were available.

In April 2023, Mr. Bauer, a longtime smoker and vaper, experienced shortness of breath. His girlfriend, Susan Gore, took him to an urgent care center, and he returned home, but “the next morning he couldn’t walk,” Ms. Gore said in the press conference. A trip to the ED yielded a diagnosis of influenza A, followed rapidly by a bacterial lung infection that proved resistant to antibiotics. Mr. Bauer had no prior medical history of serious illness, but he was soon in an intensive care unit. His condition continued to decline, and a double lung transplant was his only option.

166005_image1_web.jpg

Back from the brink

Mr. Bauer made the transfer to Chicago despite being critically ill. He was in dire need of a lung transplant, and the only way to resolve his infection was to remove the lungs, said Ankit Bharat, MD, chief of thoracic surgery and director of Northwestern Medicine Canning Thoracic Institute, in the press conference.

166005_image2_web.JPG

“Something needed to be done right away,” Dr. Bharat said. Mr. Bauer’s lungs were removed and the chest cavity was extensively debrided to remove the infection.

Then it was time for outside-the-box thinking. “With the lungs taken out, we needed something to support the heart,” he said. Breast implants came to mind, and double Ds were the largest available.

In addition, the surgeons created an artificial lung system of conduits to keep Mr. Bauer’s blood pumping. “We wanted to maintain the natural blood flow in the body that would be present if the lungs were there,” Dr. Bharat explained.

Plastic surgeons at Northwestern gave Mr. Bauer’s surgical team “a crash course” in managing the breast implants, Dr. Bharat said. The team anticipated that their novel surgical solution would need to last for weeks, but Mr. Bauer’s condition improved immediately once the infected lungs were removed. He was placed on a double-lung transplant list, and the team received an offer of new lungs within 24 hours.

The breast implants were removed, the new lungs were implanted, and Bauer spent several months in the ICU before his discharge to rehabilitation therapy at the end of September, according to a Northwestern press release.

This type of procedure could help patients with infections who need transplants but are too sick to undergo them, Dr. Bharat said in the press conference. In Mr. Bauer’s case, “a lot of stars aligned,” including Bauer’s rapid improvement and the quick availability of a perfect lung match, Dr. Bharat said. Many patients don’t survive to the point of transplant.

“We were surprised how quickly he recovered once we removed the infected lungs,” Dr. Bharat noted. The quick recovery may be in part because of Bauer’s youth and relative good health, but “this was uncharted territory.”

Mr. Bauer’s case is the first use of this particular surgical technique, although the team drew on lessons learned in other surgical settings, such as removal of both lungs to prevent cross-contamination in patients with cancer, he added.
 

Causes and effects

As for the factors that contributed to Mr. Bauer’s initial infection, “there is a lot we don’t know, but we can try to put things together,” said Dr. Bharat. Just as many factors lined up to promote Mr. Bauer’s recovery, many factors lined up to cause the problem, including long-standing smoking and vaping. Although some still view vaping as a safer alternative to smoking, patient data and experiences do not support this claim. “We know for a fact that both of them cause harm,” he added.

Mr. Bauer started smoking cigarettes at age 21 and typically smoked a pack of cigarettes each day before switching to vaping in 2014. In addition, Mr. Bauer had not been vaccinated against the flu, and his flu infection was followed by a bacterial infection.

Bacterial infections followed by hospitalizations are not new as an effect of vaping; a series of articles described the ongoing epidemic of e-cigarette or vaping product use–associated lung injury (EVALI). Patients with EVALI often present at urgent care centers, as Bauer did, with symptoms of flu or pneumonia, and they are often given medication and sent home.

Looking ahead: “We expect that Davey will fully recover and live a normal life,” although he will remain in Chicago for another year for monitoring, said Rade Tomic, MD, pulmonologist and medical director of the Northwestern Medicine Canning Thoracic Institute lung transplant program, in the press conference.

Mr. Bauer expressed his thanks to the surgical team, who also presented him with another gift: a T-shirt with his newly chosen nickname, “DD Davey.” “I feel so blessed, I got a second chance at life,” Mr. Bauer said in the press conference. “You should not inhale anything into your lungs except oxygen.”

A version of this article first appeared on Medscape.com.

An innovative surgical procedure combining breast implants and an artificial lung may help more patients with severe lung disease survive to receive transplants. The case was described in a press conference sponsored by Northwestern University, Evanston, Ill.

In May 2023, a surgical team at Northwestern removed both infected lungs from David “Davey” Bauer, aged 34 years, and temporarily used breast implants to hold his heart in place until new lungs were available.

In April 2023, Mr. Bauer, a longtime smoker and vaper, experienced shortness of breath. His girlfriend, Susan Gore, took him to an urgent care center, and he returned home, but “the next morning he couldn’t walk,” Ms. Gore said in the press conference. A trip to the ED yielded a diagnosis of influenza A, followed rapidly by a bacterial lung infection that proved resistant to antibiotics. Mr. Bauer had no prior medical history of serious illness, but he was soon in an intensive care unit. His condition continued to decline, and a double lung transplant was his only option.

166005_image1_web.jpg

Back from the brink

Mr. Bauer made the transfer to Chicago despite being critically ill. He was in dire need of a lung transplant, and the only way to resolve his infection was to remove the lungs, said Ankit Bharat, MD, chief of thoracic surgery and director of Northwestern Medicine Canning Thoracic Institute, in the press conference.

166005_image2_web.JPG

“Something needed to be done right away,” Dr. Bharat said. Mr. Bauer’s lungs were removed and the chest cavity was extensively debrided to remove the infection.

Then it was time for outside-the-box thinking. “With the lungs taken out, we needed something to support the heart,” he said. Breast implants came to mind, and double Ds were the largest available.

In addition, the surgeons created an artificial lung system of conduits to keep Mr. Bauer’s blood pumping. “We wanted to maintain the natural blood flow in the body that would be present if the lungs were there,” Dr. Bharat explained.

Plastic surgeons at Northwestern gave Mr. Bauer’s surgical team “a crash course” in managing the breast implants, Dr. Bharat said. The team anticipated that their novel surgical solution would need to last for weeks, but Mr. Bauer’s condition improved immediately once the infected lungs were removed. He was placed on a double-lung transplant list, and the team received an offer of new lungs within 24 hours.

The breast implants were removed, the new lungs were implanted, and Bauer spent several months in the ICU before his discharge to rehabilitation therapy at the end of September, according to a Northwestern press release.

This type of procedure could help patients with infections who need transplants but are too sick to undergo them, Dr. Bharat said in the press conference. In Mr. Bauer’s case, “a lot of stars aligned,” including Bauer’s rapid improvement and the quick availability of a perfect lung match, Dr. Bharat said. Many patients don’t survive to the point of transplant.

“We were surprised how quickly he recovered once we removed the infected lungs,” Dr. Bharat noted. The quick recovery may be in part because of Bauer’s youth and relative good health, but “this was uncharted territory.”

Mr. Bauer’s case is the first use of this particular surgical technique, although the team drew on lessons learned in other surgical settings, such as removal of both lungs to prevent cross-contamination in patients with cancer, he added.
 

Causes and effects

As for the factors that contributed to Mr. Bauer’s initial infection, “there is a lot we don’t know, but we can try to put things together,” said Dr. Bharat. Just as many factors lined up to promote Mr. Bauer’s recovery, many factors lined up to cause the problem, including long-standing smoking and vaping. Although some still view vaping as a safer alternative to smoking, patient data and experiences do not support this claim. “We know for a fact that both of them cause harm,” he added.

Mr. Bauer started smoking cigarettes at age 21 and typically smoked a pack of cigarettes each day before switching to vaping in 2014. In addition, Mr. Bauer had not been vaccinated against the flu, and his flu infection was followed by a bacterial infection.

Bacterial infections followed by hospitalizations are not new as an effect of vaping; a series of articles described the ongoing epidemic of e-cigarette or vaping product use–associated lung injury (EVALI). Patients with EVALI often present at urgent care centers, as Bauer did, with symptoms of flu or pneumonia, and they are often given medication and sent home.

Looking ahead: “We expect that Davey will fully recover and live a normal life,” although he will remain in Chicago for another year for monitoring, said Rade Tomic, MD, pulmonologist and medical director of the Northwestern Medicine Canning Thoracic Institute lung transplant program, in the press conference.

Mr. Bauer expressed his thanks to the surgical team, who also presented him with another gift: a T-shirt with his newly chosen nickname, “DD Davey.” “I feel so blessed, I got a second chance at life,” Mr. Bauer said in the press conference. “You should not inhale anything into your lungs except oxygen.”

A version of this article first appeared on Medscape.com.

Lawrence Faucette, the 58-year-old man with terminal heart disease who received the world’s second genetically modified pig heart transplant, died on Oct. 30, 2023, the University of Maryland Medical Center (UMMC), Baltimore, reported in a statement.

Mr. Faucette, a former lab tech who was turned down repeatedly for a standard allograft transplantation because of his various medical conditions, received the pig heart transplant on Sept. 20, 2023.

He first came to UMMC as a patient on Sept. 14. When he was admitted, he was in end-stage heart failure. Shortly before the surgery, his heart stopped, and he required resuscitation.

On Sept. 15, the Food and Drug Administration granted an emergency authorization for the surgery through its single-patient investigational new drug compassionate use pathway. 

“My only real hope left is to go with the pig heart, the xenotransplant,” Mr. Faucette said in an interview from his hospital room a few days before his surgery. “At least now I have hope, and I have a chance.” He made “significant progress” in the month after the surgery, participating in physical therapy and spending time with family, according to the university. But in the days before his death, the heart showed signs of rejection.

“Mr. Faucette’s last wish was for us to make the most of what we have learned from our experience, so others may be guaranteed a chance for a new heart when a human organ is unavailable,” said Bartley P. Griffith, MD, who transplanted the pig heart into Mr. Faucette at UMMC. “He then told the team of doctors and nurses who gathered around him that he loved us. We will miss him tremendously.”

Muhammad M. Mohiuddin, MD, professor of surgery and scientific/program director of the Cardiac Xenotransplantation Program at the University of Maryland School of Medicine, said that “Mr. Faucette was a scientist who not only read and interpreted his own biopsies, but who understood the important contribution he was making in advancing the field.

“As with the first patient, David Bennett Sr., we intend to conduct an extensive analysis to identify factors that can be prevented in future transplants; this will allow us to continue to move forward and educate our colleagues in the field on our experience,” Dr. Mohiuddin added.

The researchers don’t plan to make further comments until their investigation is complete, a university spokesperson said in an interview.

UMMC performed the first transplant of a genetically modified pig heart in January 2022. Mr. Bennett, the recipient of that heart, survived for 60 days. The researchers published their initial findings in The New England Journal of Medicine, and then the results of their follow-up investigation in The Lancet.
 

A version of this article first appeared on Medscape.com.

Lawrence Faucette, the 58-year-old man with terminal heart disease who received the world’s second genetically modified pig heart transplant, died on Oct. 30, 2023, the University of Maryland Medical Center (UMMC), Baltimore, reported in a statement.

Mr. Faucette, a former lab tech who was turned down repeatedly for a standard allograft transplantation because of his various medical conditions, received the pig heart transplant on Sept. 20, 2023.

He first came to UMMC as a patient on Sept. 14. When he was admitted, he was in end-stage heart failure. Shortly before the surgery, his heart stopped, and he required resuscitation.

On Sept. 15, the Food and Drug Administration granted an emergency authorization for the surgery through its single-patient investigational new drug compassionate use pathway. 

“My only real hope left is to go with the pig heart, the xenotransplant,” Mr. Faucette said in an interview from his hospital room a few days before his surgery. “At least now I have hope, and I have a chance.” He made “significant progress” in the month after the surgery, participating in physical therapy and spending time with family, according to the university. But in the days before his death, the heart showed signs of rejection.

“Mr. Faucette’s last wish was for us to make the most of what we have learned from our experience, so others may be guaranteed a chance for a new heart when a human organ is unavailable,” said Bartley P. Griffith, MD, who transplanted the pig heart into Mr. Faucette at UMMC. “He then told the team of doctors and nurses who gathered around him that he loved us. We will miss him tremendously.”

Muhammad M. Mohiuddin, MD, professor of surgery and scientific/program director of the Cardiac Xenotransplantation Program at the University of Maryland School of Medicine, said that “Mr. Faucette was a scientist who not only read and interpreted his own biopsies, but who understood the important contribution he was making in advancing the field.

“As with the first patient, David Bennett Sr., we intend to conduct an extensive analysis to identify factors that can be prevented in future transplants; this will allow us to continue to move forward and educate our colleagues in the field on our experience,” Dr. Mohiuddin added.

The researchers don’t plan to make further comments until their investigation is complete, a university spokesperson said in an interview.

UMMC performed the first transplant of a genetically modified pig heart in January 2022. Mr. Bennett, the recipient of that heart, survived for 60 days. The researchers published their initial findings in The New England Journal of Medicine, and then the results of their follow-up investigation in The Lancet.
 

A version of this article first appeared on Medscape.com.

Lawrence Faucette, the 58-year-old man with terminal heart disease who received the world’s second genetically modified pig heart transplant, died on Oct. 30, 2023, the University of Maryland Medical Center (UMMC), Baltimore, reported in a statement.

Mr. Faucette, a former lab tech who was turned down repeatedly for a standard allograft transplantation because of his various medical conditions, received the pig heart transplant on Sept. 20, 2023.

He first came to UMMC as a patient on Sept. 14. When he was admitted, he was in end-stage heart failure. Shortly before the surgery, his heart stopped, and he required resuscitation.

On Sept. 15, the Food and Drug Administration granted an emergency authorization for the surgery through its single-patient investigational new drug compassionate use pathway. 

“My only real hope left is to go with the pig heart, the xenotransplant,” Mr. Faucette said in an interview from his hospital room a few days before his surgery. “At least now I have hope, and I have a chance.” He made “significant progress” in the month after the surgery, participating in physical therapy and spending time with family, according to the university. But in the days before his death, the heart showed signs of rejection.

“Mr. Faucette’s last wish was for us to make the most of what we have learned from our experience, so others may be guaranteed a chance for a new heart when a human organ is unavailable,” said Bartley P. Griffith, MD, who transplanted the pig heart into Mr. Faucette at UMMC. “He then told the team of doctors and nurses who gathered around him that he loved us. We will miss him tremendously.”

Muhammad M. Mohiuddin, MD, professor of surgery and scientific/program director of the Cardiac Xenotransplantation Program at the University of Maryland School of Medicine, said that “Mr. Faucette was a scientist who not only read and interpreted his own biopsies, but who understood the important contribution he was making in advancing the field.

“As with the first patient, David Bennett Sr., we intend to conduct an extensive analysis to identify factors that can be prevented in future transplants; this will allow us to continue to move forward and educate our colleagues in the field on our experience,” Dr. Mohiuddin added.

The researchers don’t plan to make further comments until their investigation is complete, a university spokesperson said in an interview.

UMMC performed the first transplant of a genetically modified pig heart in January 2022. Mr. Bennett, the recipient of that heart, survived for 60 days. The researchers published their initial findings in The New England Journal of Medicine, and then the results of their follow-up investigation in The Lancet.
 

A version of this article first appeared on Medscape.com.

TOPLINE:

There are no significant differences in 1-year mortality, survival to hospital discharge, severe primary graft dysfunction (PGD), and other outcomes post heart transplant between patients who receive a heart obtained by donation after circulatory death (DCD) and patients who receive a heart by donation after brain death (DBD), a new study has shown.

METHODOLOGY:

• The retrospective review included 385 patients (median age, 57.4 years; 26% women; 72.5% White) who underwent a heart transplant at Vanderbilt University Medical Center from January 2020 to January 2023. Of these, 263 received DBD hearts, and 122 received DCD hearts.
• In the DCD group, 17% of hearts were recovered by use of ex vivo machine perfusion (EVP), and 83% by use of normothermic regional perfusion followed by static cold storage; 4% of DBD hearts were recovered by use of EVP, and 96% by use of static cold storage.
• The primary outcome was survival at 1 year after transplantation; key secondary outcomes included survival to hospital discharge, survival at 30 days and 6 months after transplantation, and severe PGD.

TAKEAWAY:

• There was no difference in 1-year post-transplant survival between DCD (94.3%) and DBD (92.4%) recipients (hazard ratio, 0.77; 95% confidence interval, 0.32-1.81; P = .54), a finding that was unchanged when adjusted for recipient age.
• There were no significant differences in survival to hospital discharge (93.4% DBD vs. 94.5% DCD; HR, 0.72; 95% CI, 0.26-1.99; P = .53), to 30 days (95.1% DBD vs. 96.7% DCD; HR, 0.67; 95% CI, 0.22-2.05; P = .48), or to 6 months (92.8% DBD vs. 94.3% DCD; HR, 0.68; 95% CI, 0.25-1.85; P = .45) after transplantation.
• The incidence of severe PGD was similar between groups (5.7% DCD vs. 5.7% DBD; HR, 1.00; 95% CI, 0.41-2.4; P = .99).
• There were no significant between-group differences in other outcomes, including incidence of treated rejection and cases of cardiac allograft vasculopathy of grade 1 or greater on the International Society for scale at 1 year.

IN PRACTICE:

“Our findings add to the growing body of evidence in support of DCD heart transplantation,” the authors write, potentially expanding the heart donor pool. They note that outcomes remained similar between groups despite higher-risk patients being overrepresented in the DCD cohort.

In an accompanying editorial, Sean P. Pinney, MD, Center for Cardiovascular Health, Icahn School of Medicine at Mount Sinai, New York, and a colleague called the results “impressive” and “encouraging,” although there are still “important unknowns,” including longer-term outcomes, the financial impact of DCD, and whether results can be replicated in other centers.

“These results provide confidence that DCD can be safely and effectively performed without compromising outcomes, at least in a large-volume center of excellence,” and help provide evidence “to support the spreading acceptance of DCD among heart transplant programs.”

SOURCE:

The study was conducted by Hasan K. Siddiqi, MD, department of medicine, Vanderbilt University Medical Center, Nashville, Tenn., and colleagues. It was published online in the Journal of the American College of Cardiology.

LIMITATIONS:

The study was conducted at a single center and had a retrospective design and a modest sample size that prevented adjustment for all potentially confounding variables. Meaningful differences among DCD recipients could not be explored with regard to organ recovery technique, and small but statistically meaningful differences in outcomes could not be detected, the authors note. Follow-up was limited to 1 year after transplantation.

DISCLOSURES:

The authors report no relevant conflicts of interest. Dr. Pinney has received consulting fees from Abbott, ADI, Ancora, CareDx, ImpulseDynamics, Medtronic, Nuwellis, Procyrion, Restore Medical, Transmedics, and Valgen Medtech.

A version of this article first appeared on Medscape.com.

TOPLINE:

There are no significant differences in 1-year mortality, survival to hospital discharge, severe primary graft dysfunction (PGD), and other outcomes post heart transplant between patients who receive a heart obtained by donation after circulatory death (DCD) and patients who receive a heart by donation after brain death (DBD), a new study has shown.

METHODOLOGY:

• The retrospective review included 385 patients (median age, 57.4 years; 26% women; 72.5% White) who underwent a heart transplant at Vanderbilt University Medical Center from January 2020 to January 2023. Of these, 263 received DBD hearts, and 122 received DCD hearts.
• In the DCD group, 17% of hearts were recovered by use of ex vivo machine perfusion (EVP), and 83% by use of normothermic regional perfusion followed by static cold storage; 4% of DBD hearts were recovered by use of EVP, and 96% by use of static cold storage.
• The primary outcome was survival at 1 year after transplantation; key secondary outcomes included survival to hospital discharge, survival at 30 days and 6 months after transplantation, and severe PGD.

TAKEAWAY:

• There was no difference in 1-year post-transplant survival between DCD (94.3%) and DBD (92.4%) recipients (hazard ratio, 0.77; 95% confidence interval, 0.32-1.81; P = .54), a finding that was unchanged when adjusted for recipient age.
• There were no significant differences in survival to hospital discharge (93.4% DBD vs. 94.5% DCD; HR, 0.72; 95% CI, 0.26-1.99; P = .53), to 30 days (95.1% DBD vs. 96.7% DCD; HR, 0.67; 95% CI, 0.22-2.05; P = .48), or to 6 months (92.8% DBD vs. 94.3% DCD; HR, 0.68; 95% CI, 0.25-1.85; P = .45) after transplantation.
• The incidence of severe PGD was similar between groups (5.7% DCD vs. 5.7% DBD; HR, 1.00; 95% CI, 0.41-2.4; P = .99).
• There were no significant between-group differences in other outcomes, including incidence of treated rejection and cases of cardiac allograft vasculopathy of grade 1 or greater on the International Society for scale at 1 year.

IN PRACTICE:

“Our findings add to the growing body of evidence in support of DCD heart transplantation,” the authors write, potentially expanding the heart donor pool. They note that outcomes remained similar between groups despite higher-risk patients being overrepresented in the DCD cohort.

In an accompanying editorial, Sean P. Pinney, MD, Center for Cardiovascular Health, Icahn School of Medicine at Mount Sinai, New York, and a colleague called the results “impressive” and “encouraging,” although there are still “important unknowns,” including longer-term outcomes, the financial impact of DCD, and whether results can be replicated in other centers.

“These results provide confidence that DCD can be safely and effectively performed without compromising outcomes, at least in a large-volume center of excellence,” and help provide evidence “to support the spreading acceptance of DCD among heart transplant programs.”

SOURCE:

The study was conducted by Hasan K. Siddiqi, MD, department of medicine, Vanderbilt University Medical Center, Nashville, Tenn., and colleagues. It was published online in the Journal of the American College of Cardiology.

LIMITATIONS:

The study was conducted at a single center and had a retrospective design and a modest sample size that prevented adjustment for all potentially confounding variables. Meaningful differences among DCD recipients could not be explored with regard to organ recovery technique, and small but statistically meaningful differences in outcomes could not be detected, the authors note. Follow-up was limited to 1 year after transplantation.

DISCLOSURES:

The authors report no relevant conflicts of interest. Dr. Pinney has received consulting fees from Abbott, ADI, Ancora, CareDx, ImpulseDynamics, Medtronic, Nuwellis, Procyrion, Restore Medical, Transmedics, and Valgen Medtech.

A version of this article first appeared on Medscape.com.

TOPLINE:

There are no significant differences in 1-year mortality, survival to hospital discharge, severe primary graft dysfunction (PGD), and other outcomes post heart transplant between patients who receive a heart obtained by donation after circulatory death (DCD) and patients who receive a heart by donation after brain death (DBD), a new study has shown.

METHODOLOGY:

• The retrospective review included 385 patients (median age, 57.4 years; 26% women; 72.5% White) who underwent a heart transplant at Vanderbilt University Medical Center from January 2020 to January 2023. Of these, 263 received DBD hearts, and 122 received DCD hearts.
• In the DCD group, 17% of hearts were recovered by use of ex vivo machine perfusion (EVP), and 83% by use of normothermic regional perfusion followed by static cold storage; 4% of DBD hearts were recovered by use of EVP, and 96% by use of static cold storage.
• The primary outcome was survival at 1 year after transplantation; key secondary outcomes included survival to hospital discharge, survival at 30 days and 6 months after transplantation, and severe PGD.

TAKEAWAY:

• There was no difference in 1-year post-transplant survival between DCD (94.3%) and DBD (92.4%) recipients (hazard ratio, 0.77; 95% confidence interval, 0.32-1.81; P = .54), a finding that was unchanged when adjusted for recipient age.
• There were no significant differences in survival to hospital discharge (93.4% DBD vs. 94.5% DCD; HR, 0.72; 95% CI, 0.26-1.99; P = .53), to 30 days (95.1% DBD vs. 96.7% DCD; HR, 0.67; 95% CI, 0.22-2.05; P = .48), or to 6 months (92.8% DBD vs. 94.3% DCD; HR, 0.68; 95% CI, 0.25-1.85; P = .45) after transplantation.
• The incidence of severe PGD was similar between groups (5.7% DCD vs. 5.7% DBD; HR, 1.00; 95% CI, 0.41-2.4; P = .99).
• There were no significant between-group differences in other outcomes, including incidence of treated rejection and cases of cardiac allograft vasculopathy of grade 1 or greater on the International Society for scale at 1 year.

IN PRACTICE:

“Our findings add to the growing body of evidence in support of DCD heart transplantation,” the authors write, potentially expanding the heart donor pool. They note that outcomes remained similar between groups despite higher-risk patients being overrepresented in the DCD cohort.

In an accompanying editorial, Sean P. Pinney, MD, Center for Cardiovascular Health, Icahn School of Medicine at Mount Sinai, New York, and a colleague called the results “impressive” and “encouraging,” although there are still “important unknowns,” including longer-term outcomes, the financial impact of DCD, and whether results can be replicated in other centers.

“These results provide confidence that DCD can be safely and effectively performed without compromising outcomes, at least in a large-volume center of excellence,” and help provide evidence “to support the spreading acceptance of DCD among heart transplant programs.”

SOURCE:

The study was conducted by Hasan K. Siddiqi, MD, department of medicine, Vanderbilt University Medical Center, Nashville, Tenn., and colleagues. It was published online in the Journal of the American College of Cardiology.

LIMITATIONS:

The study was conducted at a single center and had a retrospective design and a modest sample size that prevented adjustment for all potentially confounding variables. Meaningful differences among DCD recipients could not be explored with regard to organ recovery technique, and small but statistically meaningful differences in outcomes could not be detected, the authors note. Follow-up was limited to 1 year after transplantation.

DISCLOSURES:

The authors report no relevant conflicts of interest. Dr. Pinney has received consulting fees from Abbott, ADI, Ancora, CareDx, ImpulseDynamics, Medtronic, Nuwellis, Procyrion, Restore Medical, Transmedics, and Valgen Medtech.

A version of this article first appeared on Medscape.com.

Datascope/Maquet/Getinge has announced a recall of the Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABPs) because they may shut down unexpectedly due to electrical failures in the power management board or solenoid board (power source path).

“Using an affected pump may cause serious adverse health events, including unstable blood pressure, injury (e.g., inadequate blood supply or a vital organ injury), and death,” the Food and Drug Administration said in the recall notice.

FDA_icon3_web.jpg

The FDA has identified this as a class I recall, the most serious type of recall due to the risk for serious injury or death. To date, Datascope/Maquet/Getinge received 26 complaints, but no reports of injuries or death.

The devices are indicated for acute coronary syndrome, cardiac and noncardiac surgery, and complications of heart failure in adults.

The recall includes a total of 4,586 Cardiosave Hybrid or Rescue IABP units distributed from March 2, 2012, to May 19, 2023. Product model numbers for the recalled Cardiosave Hybrid and Cardiosave Rescue are available online.

On June 5, Datascope/Maquet/Getinge sent an “important medical device advisory” to all affected customers. The letter advises customers to be sure there is an alternative IABP available to continue therapy and provide alternative hemodynamic support if there is no other means to continue counterpulsation therapy.

Customers with questions about this recall should contact their company representative or call technical support at 1-888-943-8872, Monday through Friday, between 8:00 a.m. and 6:00 p.m. ET.

Last March, Datascope/Getinge recalled 2,300 Cardiosave Hybrid or Rescue IABPs because the coiled cable connecting the display and base on some units may fail, causing an unexpected shutdown without warnings or alarms to alert the user.

The Cardiosave IABPs have also been previously flagged by the FDA for subpar battery performance and fluid leaks.

Any adverse events or suspected adverse events related to the recalled Cardiosave Hybrid/Rescue IABPs should be reported to the FDA through MedWatch, its adverse event reporting program.
 

A version of this article appeared on Medscape.com.

Datascope/Maquet/Getinge has announced a recall of the Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABPs) because they may shut down unexpectedly due to electrical failures in the power management board or solenoid board (power source path).

“Using an affected pump may cause serious adverse health events, including unstable blood pressure, injury (e.g., inadequate blood supply or a vital organ injury), and death,” the Food and Drug Administration said in the recall notice.

FDA_icon3_web.jpg

The FDA has identified this as a class I recall, the most serious type of recall due to the risk for serious injury or death. To date, Datascope/Maquet/Getinge received 26 complaints, but no reports of injuries or death.

The devices are indicated for acute coronary syndrome, cardiac and noncardiac surgery, and complications of heart failure in adults.

The recall includes a total of 4,586 Cardiosave Hybrid or Rescue IABP units distributed from March 2, 2012, to May 19, 2023. Product model numbers for the recalled Cardiosave Hybrid and Cardiosave Rescue are available online.

On June 5, Datascope/Maquet/Getinge sent an “important medical device advisory” to all affected customers. The letter advises customers to be sure there is an alternative IABP available to continue therapy and provide alternative hemodynamic support if there is no other means to continue counterpulsation therapy.

Customers with questions about this recall should contact their company representative or call technical support at 1-888-943-8872, Monday through Friday, between 8:00 a.m. and 6:00 p.m. ET.

Last March, Datascope/Getinge recalled 2,300 Cardiosave Hybrid or Rescue IABPs because the coiled cable connecting the display and base on some units may fail, causing an unexpected shutdown without warnings or alarms to alert the user.

The Cardiosave IABPs have also been previously flagged by the FDA for subpar battery performance and fluid leaks.

Any adverse events or suspected adverse events related to the recalled Cardiosave Hybrid/Rescue IABPs should be reported to the FDA through MedWatch, its adverse event reporting program.
 

A version of this article appeared on Medscape.com.

Datascope/Maquet/Getinge has announced a recall of the Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABPs) because they may shut down unexpectedly due to electrical failures in the power management board or solenoid board (power source path).

“Using an affected pump may cause serious adverse health events, including unstable blood pressure, injury (e.g., inadequate blood supply or a vital organ injury), and death,” the Food and Drug Administration said in the recall notice.

FDA_icon3_web.jpg

The FDA has identified this as a class I recall, the most serious type of recall due to the risk for serious injury or death. To date, Datascope/Maquet/Getinge received 26 complaints, but no reports of injuries or death.

The devices are indicated for acute coronary syndrome, cardiac and noncardiac surgery, and complications of heart failure in adults.

The recall includes a total of 4,586 Cardiosave Hybrid or Rescue IABP units distributed from March 2, 2012, to May 19, 2023. Product model numbers for the recalled Cardiosave Hybrid and Cardiosave Rescue are available online.

On June 5, Datascope/Maquet/Getinge sent an “important medical device advisory” to all affected customers. The letter advises customers to be sure there is an alternative IABP available to continue therapy and provide alternative hemodynamic support if there is no other means to continue counterpulsation therapy.

Customers with questions about this recall should contact their company representative or call technical support at 1-888-943-8872, Monday through Friday, between 8:00 a.m. and 6:00 p.m. ET.

Last March, Datascope/Getinge recalled 2,300 Cardiosave Hybrid or Rescue IABPs because the coiled cable connecting the display and base on some units may fail, causing an unexpected shutdown without warnings or alarms to alert the user.

The Cardiosave IABPs have also been previously flagged by the FDA for subpar battery performance and fluid leaks.

Any adverse events or suspected adverse events related to the recalled Cardiosave Hybrid/Rescue IABPs should be reported to the FDA through MedWatch, its adverse event reporting program.
 

A version of this article appeared on Medscape.com.

The Cleveland Clinic is once again the No. 1 hospital for cardiology and heart surgery, according to U.S. News & World Report’s latest rankings.
 

In the magazine’s 2023-2024 list, Cedars-Sinai Medical Center, Los Angeles, takes over the No. 2 spot from Mayo Clinic, Rochester, Minn., which dropped to No. 3. Cedars-Sinai held the No. 3 on the 2022-2023 rankings.

Mount Sinai Hospital in New York City holds the No. 4 spot in 2023-2024, up from No. 6; NYU Langone Hospitals, New York, continue to hold the No. 5 spot.

New York–Presbyterian Hospital–Columbia and Cornell in New York City is No. 6, down from No. 4 i.

Northwestern Medicine-Northwestern Memorial Hospital in Chicago takes over the No. 7 spot (up from No. 8), while Massachusetts General Hospital in Boston holds the No. 8 (down from No. 7).

Stanford (Calif.) Health Care–Stanford Hospital holds the No. 9 spot, the same as 2, and Lenox Hill Hospital at Northwell Health in New York is No. 10 on the list.

U.S. News evaluated 779 hospitals and ranked the top 50 that care for patients with challenging heart and vascular cases, including heart transplants; implantation of cardiac devices, such as pacemakers and defibrillators; major chest procedures and patients with cardiovascular disease and other complex conditions, such as endocarditis; and heart failure and circulatory issues.

“Consumers want useful resources to help them assess which hospital can best meet their specific care needs,” Ben Harder, chief of health analysis and managing editor at U.S. News, said in a statement.

“The 2023-2024 Best Hospitals rankings offer patients and the physicians with whom they consult a data-driven source for comparing performance in outcomes, patient satisfaction, and other metrics that matter to them,” Mr. Harder said.
 

Best hospitals overall honor roll

In 2023-2024, as in prior years, U.S. News also recognized Honor Roll hospitals that have excelled across multiple areas of care. However, in 2023-2024, for the first time, there is no ordinal ranking of hospitals making honor roll.

In a letter to hospital leaders, U.S. News explained that the major change in format came after months of deliberation, feedback from health care organizations and professionals, and an analysis of how consumers navigate their website.

Ordinal ranking of hospitals that make the honor roll “obscures the fact that all of the Honor Roll hospitals have attained the highest standard of care in the nation,” the letter reads.

With the new format, honor roll hospitals are listed in alphabetical order. In 2023-2024, there are 22.

• Barnes-Jewish Hospital, St. Louis
• Brigham and Women’s Hospital, Boston
• Cedars-Sinai Medical Center, Los Angeles
• Cleveland Clinic
• Hospitals of the University of Pennsylvania–Penn Medicine, Philadelphia
• Houston Methodist Hospital
• Johns Hopkins Hospital, Baltimore
• Massachusetts General Hospital, Boston
• Mayo Clinic, Rochester, Minn.
• Mount Sinai Hospital, New York
• New York–Presbyterian Hospital–Columbia and Cornell
• North Shore University Hospital at Northwell Health, Manhasset, N.Y.
• Northwestern Memorial Hospital, Chicago
• NYU Langone Hospitals, New York
• Rush University Medical Center, Chicago
• Stanford (Calif.) Health Care–Stanford Hospital
• UC San Diego Health–La Jolla (Calif.) and Hillcrest Hospitals
• UCLA Medical Center, Los Angeles
• UCSF Health–UCSF Medical Center, San Francisco
• University of Michigan Health, Ann Arbor
• UT Southwestern Medical Center, Dallas
• Vanderbilt University Medical Center, Nashville, Tenn.

According to U.S. News, to keep pace with consumers’ needs and the ever-evolving landscape of health care, “several refinements” are reflected in the latest best hospitals rankings.

These include the introduction of outpatient outcomes in key specialty rankings and surgical ratings, the expanded inclusion of other outpatient data, an increased weight on objective quality measures, and a reduced weight on expert opinion.

In addition, hospital profiles on the U.S. News website feature refined health equity measures, including a new measure of racial disparities in outcomes.

The full report for best hospitals, best specialty hospitals, and methodology is available online.

A version of this article first appeared on Medscape.com.

The Cleveland Clinic is once again the No. 1 hospital for cardiology and heart surgery, according to U.S. News & World Report’s latest rankings.
 

In the magazine’s 2023-2024 list, Cedars-Sinai Medical Center, Los Angeles, takes over the No. 2 spot from Mayo Clinic, Rochester, Minn., which dropped to No. 3. Cedars-Sinai held the No. 3 on the 2022-2023 rankings.

Mount Sinai Hospital in New York City holds the No. 4 spot in 2023-2024, up from No. 6; NYU Langone Hospitals, New York, continue to hold the No. 5 spot.

New York–Presbyterian Hospital–Columbia and Cornell in New York City is No. 6, down from No. 4 i.

Northwestern Medicine-Northwestern Memorial Hospital in Chicago takes over the No. 7 spot (up from No. 8), while Massachusetts General Hospital in Boston holds the No. 8 (down from No. 7).

Stanford (Calif.) Health Care–Stanford Hospital holds the No. 9 spot, the same as 2, and Lenox Hill Hospital at Northwell Health in New York is No. 10 on the list.

U.S. News evaluated 779 hospitals and ranked the top 50 that care for patients with challenging heart and vascular cases, including heart transplants; implantation of cardiac devices, such as pacemakers and defibrillators; major chest procedures and patients with cardiovascular disease and other complex conditions, such as endocarditis; and heart failure and circulatory issues.

“Consumers want useful resources to help them assess which hospital can best meet their specific care needs,” Ben Harder, chief of health analysis and managing editor at U.S. News, said in a statement.

“The 2023-2024 Best Hospitals rankings offer patients and the physicians with whom they consult a data-driven source for comparing performance in outcomes, patient satisfaction, and other metrics that matter to them,” Mr. Harder said.
 

Best hospitals overall honor roll

In 2023-2024, as in prior years, U.S. News also recognized Honor Roll hospitals that have excelled across multiple areas of care. However, in 2023-2024, for the first time, there is no ordinal ranking of hospitals making honor roll.

In a letter to hospital leaders, U.S. News explained that the major change in format came after months of deliberation, feedback from health care organizations and professionals, and an analysis of how consumers navigate their website.

Ordinal ranking of hospitals that make the honor roll “obscures the fact that all of the Honor Roll hospitals have attained the highest standard of care in the nation,” the letter reads.

With the new format, honor roll hospitals are listed in alphabetical order. In 2023-2024, there are 22.

• Barnes-Jewish Hospital, St. Louis
• Brigham and Women’s Hospital, Boston
• Cedars-Sinai Medical Center, Los Angeles
• Cleveland Clinic
• Hospitals of the University of Pennsylvania–Penn Medicine, Philadelphia
• Houston Methodist Hospital
• Johns Hopkins Hospital, Baltimore
• Massachusetts General Hospital, Boston
• Mayo Clinic, Rochester, Minn.
• Mount Sinai Hospital, New York
• New York–Presbyterian Hospital–Columbia and Cornell
• North Shore University Hospital at Northwell Health, Manhasset, N.Y.
• Northwestern Memorial Hospital, Chicago
• NYU Langone Hospitals, New York
• Rush University Medical Center, Chicago
• Stanford (Calif.) Health Care–Stanford Hospital
• UC San Diego Health–La Jolla (Calif.) and Hillcrest Hospitals
• UCLA Medical Center, Los Angeles
• UCSF Health–UCSF Medical Center, San Francisco
• University of Michigan Health, Ann Arbor
• UT Southwestern Medical Center, Dallas
• Vanderbilt University Medical Center, Nashville, Tenn.

According to U.S. News, to keep pace with consumers’ needs and the ever-evolving landscape of health care, “several refinements” are reflected in the latest best hospitals rankings.

These include the introduction of outpatient outcomes in key specialty rankings and surgical ratings, the expanded inclusion of other outpatient data, an increased weight on objective quality measures, and a reduced weight on expert opinion.

In addition, hospital profiles on the U.S. News website feature refined health equity measures, including a new measure of racial disparities in outcomes.

The full report for best hospitals, best specialty hospitals, and methodology is available online.

A version of this article first appeared on Medscape.com.

The Cleveland Clinic is once again the No. 1 hospital for cardiology and heart surgery, according to U.S. News & World Report’s latest rankings.
 

In the magazine’s 2023-2024 list, Cedars-Sinai Medical Center, Los Angeles, takes over the No. 2 spot from Mayo Clinic, Rochester, Minn., which dropped to No. 3. Cedars-Sinai held the No. 3 on the 2022-2023 rankings.

Mount Sinai Hospital in New York City holds the No. 4 spot in 2023-2024, up from No. 6; NYU Langone Hospitals, New York, continue to hold the No. 5 spot.

New York–Presbyterian Hospital–Columbia and Cornell in New York City is No. 6, down from No. 4 i.

Northwestern Medicine-Northwestern Memorial Hospital in Chicago takes over the No. 7 spot (up from No. 8), while Massachusetts General Hospital in Boston holds the No. 8 (down from No. 7).

Stanford (Calif.) Health Care–Stanford Hospital holds the No. 9 spot, the same as 2, and Lenox Hill Hospital at Northwell Health in New York is No. 10 on the list.

U.S. News evaluated 779 hospitals and ranked the top 50 that care for patients with challenging heart and vascular cases, including heart transplants; implantation of cardiac devices, such as pacemakers and defibrillators; major chest procedures and patients with cardiovascular disease and other complex conditions, such as endocarditis; and heart failure and circulatory issues.

“Consumers want useful resources to help them assess which hospital can best meet their specific care needs,” Ben Harder, chief of health analysis and managing editor at U.S. News, said in a statement.

“The 2023-2024 Best Hospitals rankings offer patients and the physicians with whom they consult a data-driven source for comparing performance in outcomes, patient satisfaction, and other metrics that matter to them,” Mr. Harder said.
 

Best hospitals overall honor roll

In 2023-2024, as in prior years, U.S. News also recognized Honor Roll hospitals that have excelled across multiple areas of care. However, in 2023-2024, for the first time, there is no ordinal ranking of hospitals making honor roll.

In a letter to hospital leaders, U.S. News explained that the major change in format came after months of deliberation, feedback from health care organizations and professionals, and an analysis of how consumers navigate their website.

Ordinal ranking of hospitals that make the honor roll “obscures the fact that all of the Honor Roll hospitals have attained the highest standard of care in the nation,” the letter reads.

With the new format, honor roll hospitals are listed in alphabetical order. In 2023-2024, there are 22.

• Barnes-Jewish Hospital, St. Louis
• Brigham and Women’s Hospital, Boston
• Cedars-Sinai Medical Center, Los Angeles
• Cleveland Clinic
• Hospitals of the University of Pennsylvania–Penn Medicine, Philadelphia
• Houston Methodist Hospital
• Johns Hopkins Hospital, Baltimore
• Massachusetts General Hospital, Boston
• Mayo Clinic, Rochester, Minn.
• Mount Sinai Hospital, New York
• New York–Presbyterian Hospital–Columbia and Cornell
• North Shore University Hospital at Northwell Health, Manhasset, N.Y.
• Northwestern Memorial Hospital, Chicago
• NYU Langone Hospitals, New York
• Rush University Medical Center, Chicago
• Stanford (Calif.) Health Care–Stanford Hospital
• UC San Diego Health–La Jolla (Calif.) and Hillcrest Hospitals
• UCLA Medical Center, Los Angeles
• UCSF Health–UCSF Medical Center, San Francisco
• University of Michigan Health, Ann Arbor
• UT Southwestern Medical Center, Dallas
• Vanderbilt University Medical Center, Nashville, Tenn.

According to U.S. News, to keep pace with consumers’ needs and the ever-evolving landscape of health care, “several refinements” are reflected in the latest best hospitals rankings.

These include the introduction of outpatient outcomes in key specialty rankings and surgical ratings, the expanded inclusion of other outpatient data, an increased weight on objective quality measures, and a reduced weight on expert opinion.

In addition, hospital profiles on the U.S. News website feature refined health equity measures, including a new measure of racial disparities in outcomes.

The full report for best hospitals, best specialty hospitals, and methodology is available online.

A version of this article first appeared on Medscape.com.

The American Heart Association outlines “considerations” on the management of acute postoperative myocardial ischemia (PMI) after cardiac surgery in a scientific statement.

Although an infrequent event, acute PMI following cardiac surgery can rapidly evolve and become a potentially life-threatening complication, the writing group, led by Mario Gaudino, MD, PhD, with Weill Cornell Medicine, New York, points out.

The new statement was published online in Circulation.

Data show that the incidence of postoperative myocardial infarction after cardiac surgery ranges from 0.3% to 9.8% after isolated coronary artery bypass graft (CABG) surgery and 0.7% to 11.8% after concomitant valvular surgery. For isolated mitral valve surgery, incidence ranges from 1.7% to 2.2%.

Short-term mortality is elevated among patients with acute PMI, irrespective of the type of surgery. Reported mortality rates range from 5.1% to 24%; the evidence on long-term mortality has been mixed.

Graft-related factors are the most common cause of PMI after CABG, but other factors may contribute, including technical factors, competitive flow, suture entrapment, or coronary artery distortion, as well as non–graft related factors.


 

Prompt diagnosis and treatment important

Currently, there is no consensus definition of PMI. Elevations in cardiac biomarkers may not be reliable for diagnosis after surgery, and pain management regimens may mask symptoms of ischemia, the writing group notes.

Given the difficulty in diagnosis, it’s important to maintain a “high index of suspicion for acute PMI in all patients undergoing cardiac surgery because timely diagnosis and treatment are key to a good clinical outcome,” they write.

Delay in urgent angiography has been associated with higher mortality; thus, a low threshold for action is encouraged for patients with suspected acute PMI.

Indications for urgent angiography include new ECG changes, chest pain with ongoing signs of ischemia, cardiac imaging abnormalities, cardiac rhythm abnormalities, significant elevations in cardiac biomarkers, and low cardiac output syndrome despite postoperative pressor support.

Patients with acute PMI and low cardiac output syndrome may require mechanical support when first-line treatment fails.

The writing group says fast and effective reperfusion of the ischemic zone, which is generally achieved by percutaneous intervention and, less often, by repeat surgery, is the key to a good clinical outcome.

The statement was prepared by the volunteer writing group on behalf of the AHA Council on Cardiovascular Surgery and Anesthesia; Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; and Stroke Council.

The research had no commercial funding. Disclosures for the writing group are listed with the original article.

A version of this article originally appeared on Medscape.com.

The American Heart Association outlines “considerations” on the management of acute postoperative myocardial ischemia (PMI) after cardiac surgery in a scientific statement.

Although an infrequent event, acute PMI following cardiac surgery can rapidly evolve and become a potentially life-threatening complication, the writing group, led by Mario Gaudino, MD, PhD, with Weill Cornell Medicine, New York, points out.

The new statement was published online in Circulation.

Data show that the incidence of postoperative myocardial infarction after cardiac surgery ranges from 0.3% to 9.8% after isolated coronary artery bypass graft (CABG) surgery and 0.7% to 11.8% after concomitant valvular surgery. For isolated mitral valve surgery, incidence ranges from 1.7% to 2.2%.

Short-term mortality is elevated among patients with acute PMI, irrespective of the type of surgery. Reported mortality rates range from 5.1% to 24%; the evidence on long-term mortality has been mixed.

Graft-related factors are the most common cause of PMI after CABG, but other factors may contribute, including technical factors, competitive flow, suture entrapment, or coronary artery distortion, as well as non–graft related factors.


 

Prompt diagnosis and treatment important

Currently, there is no consensus definition of PMI. Elevations in cardiac biomarkers may not be reliable for diagnosis after surgery, and pain management regimens may mask symptoms of ischemia, the writing group notes.

Given the difficulty in diagnosis, it’s important to maintain a “high index of suspicion for acute PMI in all patients undergoing cardiac surgery because timely diagnosis and treatment are key to a good clinical outcome,” they write.

Delay in urgent angiography has been associated with higher mortality; thus, a low threshold for action is encouraged for patients with suspected acute PMI.

Indications for urgent angiography include new ECG changes, chest pain with ongoing signs of ischemia, cardiac imaging abnormalities, cardiac rhythm abnormalities, significant elevations in cardiac biomarkers, and low cardiac output syndrome despite postoperative pressor support.

Patients with acute PMI and low cardiac output syndrome may require mechanical support when first-line treatment fails.

The writing group says fast and effective reperfusion of the ischemic zone, which is generally achieved by percutaneous intervention and, less often, by repeat surgery, is the key to a good clinical outcome.

The statement was prepared by the volunteer writing group on behalf of the AHA Council on Cardiovascular Surgery and Anesthesia; Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; and Stroke Council.

The research had no commercial funding. Disclosures for the writing group are listed with the original article.

A version of this article originally appeared on Medscape.com.

The American Heart Association outlines “considerations” on the management of acute postoperative myocardial ischemia (PMI) after cardiac surgery in a scientific statement.

Although an infrequent event, acute PMI following cardiac surgery can rapidly evolve and become a potentially life-threatening complication, the writing group, led by Mario Gaudino, MD, PhD, with Weill Cornell Medicine, New York, points out.

The new statement was published online in Circulation.

Data show that the incidence of postoperative myocardial infarction after cardiac surgery ranges from 0.3% to 9.8% after isolated coronary artery bypass graft (CABG) surgery and 0.7% to 11.8% after concomitant valvular surgery. For isolated mitral valve surgery, incidence ranges from 1.7% to 2.2%.

Short-term mortality is elevated among patients with acute PMI, irrespective of the type of surgery. Reported mortality rates range from 5.1% to 24%; the evidence on long-term mortality has been mixed.

Graft-related factors are the most common cause of PMI after CABG, but other factors may contribute, including technical factors, competitive flow, suture entrapment, or coronary artery distortion, as well as non–graft related factors.


 

Prompt diagnosis and treatment important

Currently, there is no consensus definition of PMI. Elevations in cardiac biomarkers may not be reliable for diagnosis after surgery, and pain management regimens may mask symptoms of ischemia, the writing group notes.

Given the difficulty in diagnosis, it’s important to maintain a “high index of suspicion for acute PMI in all patients undergoing cardiac surgery because timely diagnosis and treatment are key to a good clinical outcome,” they write.

Delay in urgent angiography has been associated with higher mortality; thus, a low threshold for action is encouraged for patients with suspected acute PMI.

Indications for urgent angiography include new ECG changes, chest pain with ongoing signs of ischemia, cardiac imaging abnormalities, cardiac rhythm abnormalities, significant elevations in cardiac biomarkers, and low cardiac output syndrome despite postoperative pressor support.

Patients with acute PMI and low cardiac output syndrome may require mechanical support when first-line treatment fails.

The writing group says fast and effective reperfusion of the ischemic zone, which is generally achieved by percutaneous intervention and, less often, by repeat surgery, is the key to a good clinical outcome.

The statement was prepared by the volunteer writing group on behalf of the AHA Council on Cardiovascular Surgery and Anesthesia; Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; and Stroke Council.

The research had no commercial funding. Disclosures for the writing group are listed with the original article.

A version of this article originally appeared on Medscape.com.

Heart transplantation using the new strategy of donation after circulatory death (DCD) resulted in similar 6-month survival among recipients as the traditional method of using hearts donated after brain death (DBD) in the first randomized trial comparing the two approaches.

“This randomized trial showing recipient survival with DCD to be similar to DBD should lead to DCD becoming the standard of care alongside DBD,” lead author Jacob Schroder, MD, surgical director, heart transplantation program, Duke University Medical Center, Durham, N.C., said in an interview.

“This should enable many more heart transplants to take place and for us to be able to cast the net further and wider for donors,” he said.

The trial was published online in the New England Journal of Medicine.

Dr. Schroder estimated that only around one-fifth of the 120 U.S. heart transplant centers currently carry out DCD transplants, but he is hopeful that the publication of this study will encourage more transplant centers to do these DCD procedures.

“The problem is there are many low-volume heart transplant centers, which may not be keen to do DCD transplants as they are a bit more complicated and expensive than DBD heart transplants,” he said. “But we need to look at the big picture of how many lives can be saved by increasing the number of heart transplant procedures and the money saved by getting more patients off the waiting list.”

The authors explain that heart transplantation has traditionally been limited to the use of hearts obtained from donors after brain death, which allows in situ assessment of cardiac function and of the suitability for transplantation of the donor allograft before surgical procurement.

But because the need for heart transplants far exceeds the availability of suitable donors, the use of DCD hearts has been investigated and this approach is now being pursued in many countries. In the DCD approach, the heart will have stopped beating in the donor, and perfusion techniques are used to restart the organ.

There are two different approaches to restarting the heart in DCD. The first approach involves the heart being removed from the donor and reanimated, preserved, assessed, and transported with the use of a portable extracorporeal perfusion and preservation system (Organ Care System, TransMedics). The second involves restarting the heart in the donor’s body for evaluation before removal and transportation under the traditional cold storage method used for donations after brain death.

The current trial was designed to compare clinical outcomes in patients who had received a heart from a circulatory death donor using the portable extracorporeal perfusion method for DCD transplantation, with outcomes from the traditional method of heart transplantation using organs donated after brain death.

For the randomized, noninferiority trial, adult candidates for heart transplantation were assigned to receive a heart after the circulatory death of the donor or a heart from a donor after brain death if that heart was available first (circulatory-death group) or to receive only a heart that had been preserved with the use of traditional cold storage after the brain death of the donor (brain-death group).

The primary end point was the risk-adjusted survival at 6 months in the as-treated circulatory-death group, as compared with the brain-death group. The primary safety end point was serious adverse events associated with the heart graft at 30 days after transplantation.

A total of 180 patients underwent transplantation, 90 of whom received a heart donated after circulatory death and 90 who received a heart donated after brain death. A total of 166 transplant recipients were included in the as-treated primary analysis (80 who received a heart from a circulatory-death donor and 86 who received a heart from a brain-death donor).

The risk-adjusted 6-month survival in the as-treated population was 94% among recipients of a heart from a circulatory-death donor, as compared with 90% among recipients of a heart from a brain-death donor (P < .001 for noninferiority).

There were no substantial between-group differences in the mean per-patient number of serious adverse events associated with the heart graft at 30 days after transplantation.

Of 101 hearts from circulatory-death donors that were preserved with the use of the perfusion system, 90 were successfully transplanted according to the criteria for lactate trend and overall contractility of the donor heart, which resulted in overall utilization percentage of 89%.

More patients who received a heart from a circulatory-death donor had moderate or severe primary graft dysfunction (22%) than those who received a heart from a brain-death donor (10%). However, graft failure that resulted in retransplantation occurred in two (2.3%) patients who received a heart from a brain-death donor versus zero patients who received a heart from a circulatory-death donor.

The researchers note that the higher incidence of primary graft dysfunction in the circulatory-death group is expected, given the period of warm ischemia that occurs in this approach. But they point out that this did not affect patient or graft survival at 30 days or 1 year.

“Primary graft dysfunction is when the heart doesn’t fully work immediately after transplant and some mechanical support is needed,” Dr. Schroder commented to this news organization. “This occurred more often in the DCD group, but this mechanical support is only temporary, and generally only needed for a day or two.

“It looks like it might take the heart a little longer to start fully functioning after DCD, but our results show this doesn’t seem to affect recipient survival.”

He added: “We’ve started to become more comfortable with DCD. Sometimes it may take a little longer to get the heart working properly on its own, but the rate of mechanical support is now much lower than when we first started doing these procedures. And cardiac MRI on the recipient patients before discharge have shown that the DCD hearts are not more damaged than those from DBD donors.”

The authors also report that there were six donor hearts in the DCD group for which there were protocol deviations of functional warm ischemic time greater than 30 minutes or continuously rising lactate levels and these hearts did not show primary graft dysfunction.

On this observation, Dr. Schroder said: “I think we need to do more work on understanding the ischemic time limits. The current 30 minutes time limit was estimated in animal studies. We need to look more closely at data from actual DCD transplants. While 30 minutes may be too long for a heart from an older donor, the heart from a younger donor may be fine for a longer period of ischemic time as it will be healthier.”


 

“Exciting” results

In an editorial, Nancy K. Sweitzer, MD, PhD, vice chair of clinical research, department of medicine, and director of clinical research, division of cardiology, Washington University in St. Louis, describes the results of the current study as “exciting,” adding that, “They clearly show the feasibility and safety of transplantation of hearts from circulatory-death donors.”

However, Dr. Sweitzer points out that the sickest patients in the study – those who were United Network for Organ Sharing (UNOS) status 1 and 2 – were more likely to receive a DBD heart and the more stable patients (UNOS 3-6) were more likely to receive a DCD heart.

“This imbalance undoubtedly contributed to the success of the trial in meeting its noninferiority end point. Whether transplantation of hearts from circulatory-death donors is truly safe in our sickest patients with heart failure is not clear,” she says.

However, she concludes, “Although caution and continuous evaluation of data are warranted, the increased use of hearts from circulatory-death donors appears to be safe in the hands of experienced transplantation teams and will launch an exciting phase of learning and improvement.”

“A safely expanded pool of heart donors has the potential to increase fairness and equity in heart transplantation, allowing more persons with heart failure to have access to this lifesaving therapy,” she adds. “Organ donors and transplantation teams will save increasing numbers of lives with this most precious gift.”

The current study was supported by TransMedics. Dr. Schroder reports no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Heart transplantation using the new strategy of donation after circulatory death (DCD) resulted in similar 6-month survival among recipients as the traditional method of using hearts donated after brain death (DBD) in the first randomized trial comparing the two approaches.

“This randomized trial showing recipient survival with DCD to be similar to DBD should lead to DCD becoming the standard of care alongside DBD,” lead author Jacob Schroder, MD, surgical director, heart transplantation program, Duke University Medical Center, Durham, N.C., said in an interview.

“This should enable many more heart transplants to take place and for us to be able to cast the net further and wider for donors,” he said.

The trial was published online in the New England Journal of Medicine.

Dr. Schroder estimated that only around one-fifth of the 120 U.S. heart transplant centers currently carry out DCD transplants, but he is hopeful that the publication of this study will encourage more transplant centers to do these DCD procedures.

“The problem is there are many low-volume heart transplant centers, which may not be keen to do DCD transplants as they are a bit more complicated and expensive than DBD heart transplants,” he said. “But we need to look at the big picture of how many lives can be saved by increasing the number of heart transplant procedures and the money saved by getting more patients off the waiting list.”

The authors explain that heart transplantation has traditionally been limited to the use of hearts obtained from donors after brain death, which allows in situ assessment of cardiac function and of the suitability for transplantation of the donor allograft before surgical procurement.

But because the need for heart transplants far exceeds the availability of suitable donors, the use of DCD hearts has been investigated and this approach is now being pursued in many countries. In the DCD approach, the heart will have stopped beating in the donor, and perfusion techniques are used to restart the organ.

There are two different approaches to restarting the heart in DCD. The first approach involves the heart being removed from the donor and reanimated, preserved, assessed, and transported with the use of a portable extracorporeal perfusion and preservation system (Organ Care System, TransMedics). The second involves restarting the heart in the donor’s body for evaluation before removal and transportation under the traditional cold storage method used for donations after brain death.

The current trial was designed to compare clinical outcomes in patients who had received a heart from a circulatory death donor using the portable extracorporeal perfusion method for DCD transplantation, with outcomes from the traditional method of heart transplantation using organs donated after brain death.

For the randomized, noninferiority trial, adult candidates for heart transplantation were assigned to receive a heart after the circulatory death of the donor or a heart from a donor after brain death if that heart was available first (circulatory-death group) or to receive only a heart that had been preserved with the use of traditional cold storage after the brain death of the donor (brain-death group).

The primary end point was the risk-adjusted survival at 6 months in the as-treated circulatory-death group, as compared with the brain-death group. The primary safety end point was serious adverse events associated with the heart graft at 30 days after transplantation.

A total of 180 patients underwent transplantation, 90 of whom received a heart donated after circulatory death and 90 who received a heart donated after brain death. A total of 166 transplant recipients were included in the as-treated primary analysis (80 who received a heart from a circulatory-death donor and 86 who received a heart from a brain-death donor).

The risk-adjusted 6-month survival in the as-treated population was 94% among recipients of a heart from a circulatory-death donor, as compared with 90% among recipients of a heart from a brain-death donor (P < .001 for noninferiority).

There were no substantial between-group differences in the mean per-patient number of serious adverse events associated with the heart graft at 30 days after transplantation.

Of 101 hearts from circulatory-death donors that were preserved with the use of the perfusion system, 90 were successfully transplanted according to the criteria for lactate trend and overall contractility of the donor heart, which resulted in overall utilization percentage of 89%.

More patients who received a heart from a circulatory-death donor had moderate or severe primary graft dysfunction (22%) than those who received a heart from a brain-death donor (10%). However, graft failure that resulted in retransplantation occurred in two (2.3%) patients who received a heart from a brain-death donor versus zero patients who received a heart from a circulatory-death donor.

The researchers note that the higher incidence of primary graft dysfunction in the circulatory-death group is expected, given the period of warm ischemia that occurs in this approach. But they point out that this did not affect patient or graft survival at 30 days or 1 year.

“Primary graft dysfunction is when the heart doesn’t fully work immediately after transplant and some mechanical support is needed,” Dr. Schroder commented to this news organization. “This occurred more often in the DCD group, but this mechanical support is only temporary, and generally only needed for a day or two.

“It looks like it might take the heart a little longer to start fully functioning after DCD, but our results show this doesn’t seem to affect recipient survival.”

He added: “We’ve started to become more comfortable with DCD. Sometimes it may take a little longer to get the heart working properly on its own, but the rate of mechanical support is now much lower than when we first started doing these procedures. And cardiac MRI on the recipient patients before discharge have shown that the DCD hearts are not more damaged than those from DBD donors.”

The authors also report that there were six donor hearts in the DCD group for which there were protocol deviations of functional warm ischemic time greater than 30 minutes or continuously rising lactate levels and these hearts did not show primary graft dysfunction.

On this observation, Dr. Schroder said: “I think we need to do more work on understanding the ischemic time limits. The current 30 minutes time limit was estimated in animal studies. We need to look more closely at data from actual DCD transplants. While 30 minutes may be too long for a heart from an older donor, the heart from a younger donor may be fine for a longer period of ischemic time as it will be healthier.”


 

“Exciting” results

In an editorial, Nancy K. Sweitzer, MD, PhD, vice chair of clinical research, department of medicine, and director of clinical research, division of cardiology, Washington University in St. Louis, describes the results of the current study as “exciting,” adding that, “They clearly show the feasibility and safety of transplantation of hearts from circulatory-death donors.”

However, Dr. Sweitzer points out that the sickest patients in the study – those who were United Network for Organ Sharing (UNOS) status 1 and 2 – were more likely to receive a DBD heart and the more stable patients (UNOS 3-6) were more likely to receive a DCD heart.

“This imbalance undoubtedly contributed to the success of the trial in meeting its noninferiority end point. Whether transplantation of hearts from circulatory-death donors is truly safe in our sickest patients with heart failure is not clear,” she says.

However, she concludes, “Although caution and continuous evaluation of data are warranted, the increased use of hearts from circulatory-death donors appears to be safe in the hands of experienced transplantation teams and will launch an exciting phase of learning and improvement.”

“A safely expanded pool of heart donors has the potential to increase fairness and equity in heart transplantation, allowing more persons with heart failure to have access to this lifesaving therapy,” she adds. “Organ donors and transplantation teams will save increasing numbers of lives with this most precious gift.”

The current study was supported by TransMedics. Dr. Schroder reports no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Heart transplantation using the new strategy of donation after circulatory death (DCD) resulted in similar 6-month survival among recipients as the traditional method of using hearts donated after brain death (DBD) in the first randomized trial comparing the two approaches.

“This randomized trial showing recipient survival with DCD to be similar to DBD should lead to DCD becoming the standard of care alongside DBD,” lead author Jacob Schroder, MD, surgical director, heart transplantation program, Duke University Medical Center, Durham, N.C., said in an interview.

“This should enable many more heart transplants to take place and for us to be able to cast the net further and wider for donors,” he said.

The trial was published online in the New England Journal of Medicine.

Dr. Schroder estimated that only around one-fifth of the 120 U.S. heart transplant centers currently carry out DCD transplants, but he is hopeful that the publication of this study will encourage more transplant centers to do these DCD procedures.

“The problem is there are many low-volume heart transplant centers, which may not be keen to do DCD transplants as they are a bit more complicated and expensive than DBD heart transplants,” he said. “But we need to look at the big picture of how many lives can be saved by increasing the number of heart transplant procedures and the money saved by getting more patients off the waiting list.”

The authors explain that heart transplantation has traditionally been limited to the use of hearts obtained from donors after brain death, which allows in situ assessment of cardiac function and of the suitability for transplantation of the donor allograft before surgical procurement.

But because the need for heart transplants far exceeds the availability of suitable donors, the use of DCD hearts has been investigated and this approach is now being pursued in many countries. In the DCD approach, the heart will have stopped beating in the donor, and perfusion techniques are used to restart the organ.

There are two different approaches to restarting the heart in DCD. The first approach involves the heart being removed from the donor and reanimated, preserved, assessed, and transported with the use of a portable extracorporeal perfusion and preservation system (Organ Care System, TransMedics). The second involves restarting the heart in the donor’s body for evaluation before removal and transportation under the traditional cold storage method used for donations after brain death.

The current trial was designed to compare clinical outcomes in patients who had received a heart from a circulatory death donor using the portable extracorporeal perfusion method for DCD transplantation, with outcomes from the traditional method of heart transplantation using organs donated after brain death.

For the randomized, noninferiority trial, adult candidates for heart transplantation were assigned to receive a heart after the circulatory death of the donor or a heart from a donor after brain death if that heart was available first (circulatory-death group) or to receive only a heart that had been preserved with the use of traditional cold storage after the brain death of the donor (brain-death group).

The primary end point was the risk-adjusted survival at 6 months in the as-treated circulatory-death group, as compared with the brain-death group. The primary safety end point was serious adverse events associated with the heart graft at 30 days after transplantation.

A total of 180 patients underwent transplantation, 90 of whom received a heart donated after circulatory death and 90 who received a heart donated after brain death. A total of 166 transplant recipients were included in the as-treated primary analysis (80 who received a heart from a circulatory-death donor and 86 who received a heart from a brain-death donor).

The risk-adjusted 6-month survival in the as-treated population was 94% among recipients of a heart from a circulatory-death donor, as compared with 90% among recipients of a heart from a brain-death donor (P < .001 for noninferiority).

There were no substantial between-group differences in the mean per-patient number of serious adverse events associated with the heart graft at 30 days after transplantation.

Of 101 hearts from circulatory-death donors that were preserved with the use of the perfusion system, 90 were successfully transplanted according to the criteria for lactate trend and overall contractility of the donor heart, which resulted in overall utilization percentage of 89%.

More patients who received a heart from a circulatory-death donor had moderate or severe primary graft dysfunction (22%) than those who received a heart from a brain-death donor (10%). However, graft failure that resulted in retransplantation occurred in two (2.3%) patients who received a heart from a brain-death donor versus zero patients who received a heart from a circulatory-death donor.

The researchers note that the higher incidence of primary graft dysfunction in the circulatory-death group is expected, given the period of warm ischemia that occurs in this approach. But they point out that this did not affect patient or graft survival at 30 days or 1 year.

“Primary graft dysfunction is when the heart doesn’t fully work immediately after transplant and some mechanical support is needed,” Dr. Schroder commented to this news organization. “This occurred more often in the DCD group, but this mechanical support is only temporary, and generally only needed for a day or two.

“It looks like it might take the heart a little longer to start fully functioning after DCD, but our results show this doesn’t seem to affect recipient survival.”

He added: “We’ve started to become more comfortable with DCD. Sometimes it may take a little longer to get the heart working properly on its own, but the rate of mechanical support is now much lower than when we first started doing these procedures. And cardiac MRI on the recipient patients before discharge have shown that the DCD hearts are not more damaged than those from DBD donors.”

The authors also report that there were six donor hearts in the DCD group for which there were protocol deviations of functional warm ischemic time greater than 30 minutes or continuously rising lactate levels and these hearts did not show primary graft dysfunction.

On this observation, Dr. Schroder said: “I think we need to do more work on understanding the ischemic time limits. The current 30 minutes time limit was estimated in animal studies. We need to look more closely at data from actual DCD transplants. While 30 minutes may be too long for a heart from an older donor, the heart from a younger donor may be fine for a longer period of ischemic time as it will be healthier.”


 

“Exciting” results

In an editorial, Nancy K. Sweitzer, MD, PhD, vice chair of clinical research, department of medicine, and director of clinical research, division of cardiology, Washington University in St. Louis, describes the results of the current study as “exciting,” adding that, “They clearly show the feasibility and safety of transplantation of hearts from circulatory-death donors.”

However, Dr. Sweitzer points out that the sickest patients in the study – those who were United Network for Organ Sharing (UNOS) status 1 and 2 – were more likely to receive a DBD heart and the more stable patients (UNOS 3-6) were more likely to receive a DCD heart.

“This imbalance undoubtedly contributed to the success of the trial in meeting its noninferiority end point. Whether transplantation of hearts from circulatory-death donors is truly safe in our sickest patients with heart failure is not clear,” she says.

However, she concludes, “Although caution and continuous evaluation of data are warranted, the increased use of hearts from circulatory-death donors appears to be safe in the hands of experienced transplantation teams and will launch an exciting phase of learning and improvement.”

“A safely expanded pool of heart donors has the potential to increase fairness and equity in heart transplantation, allowing more persons with heart failure to have access to this lifesaving therapy,” she adds. “Organ donors and transplantation teams will save increasing numbers of lives with this most precious gift.”

The current study was supported by TransMedics. Dr. Schroder reports no relevant financial relationships.

A version of this article first appeared on Medscape.com.

In a first-of-its-kind in utero surgery, researchers have successfully repaired a cerebrovascular malformation, which often leads to heart failure, severe brain injury, or possibly death soon after birth.
 

The team from Boston Children’s Hospital and Brigham and Women’s Hospital used ultrasound guidance to repair the vein of Galen malformation, which causes excessively high blood flow, resulting in both neurologic and cardiac complications. 

The surgery was performed in a fetus at 34 weeks’ gestational age, with remarkable results. Since birth, the baby girl, who was identified in utero as being at high risk of suffering serious complications of the malformation, has required no medication to treat heart failure and no postnatal surgery.

Repeated echocardiograms after birth displayed marked improvement in cardiac output, and brain MRI showed no brain injury and a normal neurologic exam.

“This is incredibly exciting. The hope is that this baby, and others with this condition who receive this in utero surgery in future, will go on to have a normal life,” lead researcher Darren B. Orbach, MD, PhD, said in an interview.

“We were thrilled to see that the aggressive decline usually seen after birth simply did not appear. We are pleased to report that at 6 weeks, the infant is progressing remarkably well, on no medications, eating normally, gaining weight and is back home. There are no signs of any negative effects on the brain,” he added.

Dr. Orbach, codirector of the Cerebrovascular Surgery & Interventions Center at Boston Children’s Hospital, and colleagues described this first case report of the in utero vein of Galen malformation repair in a research letter, published online in the journal Stroke.
 

Vein of Galen malformation

Dr. Orbach explained that vein of Galen malformation, which occurs in around 1 in every 60,000 births, is a cerebrovascular anomaly in which the arterial system is directly connected to the venous system rather than to capillaries that are necessary to slow blood flow and deliver oxygen to surrounding brain tissue.

“The arterial and venous systems are fundamentally very different. The arterial system is high pressure, high flow; while the venous system is low pressure, low flow. They shouldn’t be directly connected,” he noted.

The vein of Galen malformation is the most extreme version of such an anomaly. Developing in early gestation, it is associated with a large increase in blood flow through the brain which grows over time and can sometimes result in twice the total cardiac output of the body or even more, Dr. Orbach said.

The placenta is believed to be protective as most babies don’t have overt physiologic problems in utero, but they can run into crisis after birth, with the abnormally high blood flow causing an immense stress to the heart.

Babies typically present with heart failure as their first major symptom soon after birth, Dr. Orbach said. “Although the anatomical problem is in the brain, the clinical manifestation is high-output heart failure. The heart is trying to do double its normal work, pumping the blood to the malformation and immediately back to the heart and that blood is not performing any useful function.

“These newborns can get very sick. They need multiple medications to support their cardiovascular system and we need to do procedures to try and reduce the blood flow,” he explained. 

Brain injury is also a common problem. “The brain circulation is very abnormal. The blood is being shunted through the malformation rather than circulating through the brain tissue which can become ischemic,” Dr. Orbach commented.

“The babies who get sick would have a very high mortality (up to 90%) without expert care. Even those who do receive expert care at a specialty center have a mortality rate of 30% to 40% and those who survive have a high risk of neurologic and cognitive impairment,” he added.

The current treatment for babies born with the condition involves transarterial embolization, by which a catheter is inserted into the arterial system to enable the malformation to be occluded by various techniques. 

But Dr. Orbach pointed out that some babies are born too sick to have the postnatal intervention. “The heart failure and brain injury is so overwhelming that no matter what we do, we cannot reverse it, and these babies normally do not survive. What we are doing with the fetal surgery is trying to help those babies who cannot be treated with the current postnatal approach,” he said.

The first stage of this research involved trying to identify these very-high-risk babies in utero, and the researchers found that on fetal MRI a particular measurement of one of the venous sinuses that drains the main malformation was a good predictor of how the baby would fare after birth. The babies predicted to do poorly from this test are the targets for the fetal surgery.

The technique used for the postnatal intervention is too technically challenging to perform in utero. “So we have developed a different approach for the in utero surgery that involves navigating into the accepting vein in the malformation with a needle under ultrasound guidance, and then packing the vein with metal coils to dramatically reduce the blood flow,” Dr. Orbach explained.

This procedure was performed in this first patient on March 15. The surgery was part of a clinical trial that is planned to include 20 cases in total.

“The immediate goal is to see whether we can transform those fetuses who are at very high risk of getting sick after birth into babies who do well in the [neonatal] ICU and are able to be sent home for elective treatment at a few months of age,” Dr. Orbach noted. “The study is continuing as it is vital that we continue and show efficacy and safety in other patients as well,” he added.

Dr. Orbach said the results of this first case were extremely encouraging. “Each stage was exciting – the technical success of the procedure, and then seeing the [blood] flow diminish on the ultrasound right there during the procedure; then the next day we did a fetal echocardiogram, and we could see that the abnormal cardiac output was dramatically reduced, and a fetal MRI scan also showed the malformation was already coming down in size.”

The baby was born prematurely 2 days after the procedure because of ruptured membranes with a birth weight of 1.9 kg (4.2 lb). She has not required any cardiovascular support or postnatal embolization.

“We were waiting with bated breath until the baby was born to see how she did clinically. I was trying to be conservative in my expectations, but it was quickly apparent that she was going to do great,” he said. Now at home, she has some oxygen treatment for the first few weeks, “but right now her neurological status is completely intact and essentially she looks like any other baby,” Dr. Orbach commented.

It is not yet known whether the infant will need any additional procedures. “We will follow her closely and make a decision on whether further treatment is needed based on whether the malformation is growing or not,” Dr. Orbach said. Longer term follow-up will also assess secondary problems sometimes seen, such as learning problems and seizures.

Although other fetal surgeries are now routinely performed, this is believed to be the first in utero surgery aimed at the cerebrovascular system.

“There were a lot of uncertainties,” Dr. Orbach said. “We didn’t even know if we would be able to see our instruments on ultrasound.” To model the procedure, the researchers had a phantom fetal skull and brain constructed with a vein of Galen malformation, which was key to obtaining Food and Drug Administration approval for the study.

If the study shows success in the other patients too, the technique could be rolled out to other centers. “There definitely needs to be fetal surgery and neurointerventional teams familiar with vein of Galen malformation in place, and ready to manage complications after delivery regardless of outcome. But we are not the only center with those capabilities, so if our trial pans out, yes, the hope is that other teams in specialist children’s hospitals around the world could do this too,” he added.
 

Pioneering work

Commenting on the case report in an American Heart Association press release, Colin Derdeyn, MD, a neurointerventional radiologist at University of Iowa Health Care, Iowa City, who performs vein of Galen malformation embolizations on neonates, said: “The key advance here is to intervene before the physiologic events of birth can cause life-threatening heart failure.”

Dr. Derdeyn, who is a past chair of the American Heart Association’s Stroke Council, cautioned that one successful case is not enough experience to conclude that the risks of this procedure are worth the benefits.

But, he added: “The positive hemodynamic changes that they observed in utero and after birth – reduction in flow, reduction in size of the draining vein, reversal of the abnormal reversed flow in the aorta – are really encouraging. These are some of the most exciting and surprising aspects of this case report. This is pioneering work being done in a very careful and responsible way.”

The study was funded by a grant from the Sage Schermerhorn Chair for Image-Guided Therapy.

A version of this article first appeared on Medscape.com.

In a first-of-its-kind in utero surgery, researchers have successfully repaired a cerebrovascular malformation, which often leads to heart failure, severe brain injury, or possibly death soon after birth.
 

The team from Boston Children’s Hospital and Brigham and Women’s Hospital used ultrasound guidance to repair the vein of Galen malformation, which causes excessively high blood flow, resulting in both neurologic and cardiac complications. 

The surgery was performed in a fetus at 34 weeks’ gestational age, with remarkable results. Since birth, the baby girl, who was identified in utero as being at high risk of suffering serious complications of the malformation, has required no medication to treat heart failure and no postnatal surgery.

Repeated echocardiograms after birth displayed marked improvement in cardiac output, and brain MRI showed no brain injury and a normal neurologic exam.

“This is incredibly exciting. The hope is that this baby, and others with this condition who receive this in utero surgery in future, will go on to have a normal life,” lead researcher Darren B. Orbach, MD, PhD, said in an interview.

“We were thrilled to see that the aggressive decline usually seen after birth simply did not appear. We are pleased to report that at 6 weeks, the infant is progressing remarkably well, on no medications, eating normally, gaining weight and is back home. There are no signs of any negative effects on the brain,” he added.

Dr. Orbach, codirector of the Cerebrovascular Surgery & Interventions Center at Boston Children’s Hospital, and colleagues described this first case report of the in utero vein of Galen malformation repair in a research letter, published online in the journal Stroke.
 

Vein of Galen malformation

Dr. Orbach explained that vein of Galen malformation, which occurs in around 1 in every 60,000 births, is a cerebrovascular anomaly in which the arterial system is directly connected to the venous system rather than to capillaries that are necessary to slow blood flow and deliver oxygen to surrounding brain tissue.

“The arterial and venous systems are fundamentally very different. The arterial system is high pressure, high flow; while the venous system is low pressure, low flow. They shouldn’t be directly connected,” he noted.

The vein of Galen malformation is the most extreme version of such an anomaly. Developing in early gestation, it is associated with a large increase in blood flow through the brain which grows over time and can sometimes result in twice the total cardiac output of the body or even more, Dr. Orbach said.

The placenta is believed to be protective as most babies don’t have overt physiologic problems in utero, but they can run into crisis after birth, with the abnormally high blood flow causing an immense stress to the heart.

Babies typically present with heart failure as their first major symptom soon after birth, Dr. Orbach said. “Although the anatomical problem is in the brain, the clinical manifestation is high-output heart failure. The heart is trying to do double its normal work, pumping the blood to the malformation and immediately back to the heart and that blood is not performing any useful function.

“These newborns can get very sick. They need multiple medications to support their cardiovascular system and we need to do procedures to try and reduce the blood flow,” he explained. 

Brain injury is also a common problem. “The brain circulation is very abnormal. The blood is being shunted through the malformation rather than circulating through the brain tissue which can become ischemic,” Dr. Orbach commented.

“The babies who get sick would have a very high mortality (up to 90%) without expert care. Even those who do receive expert care at a specialty center have a mortality rate of 30% to 40% and those who survive have a high risk of neurologic and cognitive impairment,” he added.

The current treatment for babies born with the condition involves transarterial embolization, by which a catheter is inserted into the arterial system to enable the malformation to be occluded by various techniques. 

But Dr. Orbach pointed out that some babies are born too sick to have the postnatal intervention. “The heart failure and brain injury is so overwhelming that no matter what we do, we cannot reverse it, and these babies normally do not survive. What we are doing with the fetal surgery is trying to help those babies who cannot be treated with the current postnatal approach,” he said.

The first stage of this research involved trying to identify these very-high-risk babies in utero, and the researchers found that on fetal MRI a particular measurement of one of the venous sinuses that drains the main malformation was a good predictor of how the baby would fare after birth. The babies predicted to do poorly from this test are the targets for the fetal surgery.

The technique used for the postnatal intervention is too technically challenging to perform in utero. “So we have developed a different approach for the in utero surgery that involves navigating into the accepting vein in the malformation with a needle under ultrasound guidance, and then packing the vein with metal coils to dramatically reduce the blood flow,” Dr. Orbach explained.

This procedure was performed in this first patient on March 15. The surgery was part of a clinical trial that is planned to include 20 cases in total.

“The immediate goal is to see whether we can transform those fetuses who are at very high risk of getting sick after birth into babies who do well in the [neonatal] ICU and are able to be sent home for elective treatment at a few months of age,” Dr. Orbach noted. “The study is continuing as it is vital that we continue and show efficacy and safety in other patients as well,” he added.

Dr. Orbach said the results of this first case were extremely encouraging. “Each stage was exciting – the technical success of the procedure, and then seeing the [blood] flow diminish on the ultrasound right there during the procedure; then the next day we did a fetal echocardiogram, and we could see that the abnormal cardiac output was dramatically reduced, and a fetal MRI scan also showed the malformation was already coming down in size.”

The baby was born prematurely 2 days after the procedure because of ruptured membranes with a birth weight of 1.9 kg (4.2 lb). She has not required any cardiovascular support or postnatal embolization.

“We were waiting with bated breath until the baby was born to see how she did clinically. I was trying to be conservative in my expectations, but it was quickly apparent that she was going to do great,” he said. Now at home, she has some oxygen treatment for the first few weeks, “but right now her neurological status is completely intact and essentially she looks like any other baby,” Dr. Orbach commented.

It is not yet known whether the infant will need any additional procedures. “We will follow her closely and make a decision on whether further treatment is needed based on whether the malformation is growing or not,” Dr. Orbach said. Longer term follow-up will also assess secondary problems sometimes seen, such as learning problems and seizures.

Although other fetal surgeries are now routinely performed, this is believed to be the first in utero surgery aimed at the cerebrovascular system.

“There were a lot of uncertainties,” Dr. Orbach said. “We didn’t even know if we would be able to see our instruments on ultrasound.” To model the procedure, the researchers had a phantom fetal skull and brain constructed with a vein of Galen malformation, which was key to obtaining Food and Drug Administration approval for the study.

If the study shows success in the other patients too, the technique could be rolled out to other centers. “There definitely needs to be fetal surgery and neurointerventional teams familiar with vein of Galen malformation in place, and ready to manage complications after delivery regardless of outcome. But we are not the only center with those capabilities, so if our trial pans out, yes, the hope is that other teams in specialist children’s hospitals around the world could do this too,” he added.
 

Pioneering work

Commenting on the case report in an American Heart Association press release, Colin Derdeyn, MD, a neurointerventional radiologist at University of Iowa Health Care, Iowa City, who performs vein of Galen malformation embolizations on neonates, said: “The key advance here is to intervene before the physiologic events of birth can cause life-threatening heart failure.”

Dr. Derdeyn, who is a past chair of the American Heart Association’s Stroke Council, cautioned that one successful case is not enough experience to conclude that the risks of this procedure are worth the benefits.

But, he added: “The positive hemodynamic changes that they observed in utero and after birth – reduction in flow, reduction in size of the draining vein, reversal of the abnormal reversed flow in the aorta – are really encouraging. These are some of the most exciting and surprising aspects of this case report. This is pioneering work being done in a very careful and responsible way.”

The study was funded by a grant from the Sage Schermerhorn Chair for Image-Guided Therapy.

A version of this article first appeared on Medscape.com.

In a first-of-its-kind in utero surgery, researchers have successfully repaired a cerebrovascular malformation, which often leads to heart failure, severe brain injury, or possibly death soon after birth.
 

The team from Boston Children’s Hospital and Brigham and Women’s Hospital used ultrasound guidance to repair the vein of Galen malformation, which causes excessively high blood flow, resulting in both neurologic and cardiac complications. 

The surgery was performed in a fetus at 34 weeks’ gestational age, with remarkable results. Since birth, the baby girl, who was identified in utero as being at high risk of suffering serious complications of the malformation, has required no medication to treat heart failure and no postnatal surgery.

Repeated echocardiograms after birth displayed marked improvement in cardiac output, and brain MRI showed no brain injury and a normal neurologic exam.

“This is incredibly exciting. The hope is that this baby, and others with this condition who receive this in utero surgery in future, will go on to have a normal life,” lead researcher Darren B. Orbach, MD, PhD, said in an interview.

“We were thrilled to see that the aggressive decline usually seen after birth simply did not appear. We are pleased to report that at 6 weeks, the infant is progressing remarkably well, on no medications, eating normally, gaining weight and is back home. There are no signs of any negative effects on the brain,” he added.

Dr. Orbach, codirector of the Cerebrovascular Surgery & Interventions Center at Boston Children’s Hospital, and colleagues described this first case report of the in utero vein of Galen malformation repair in a research letter, published online in the journal Stroke.
 

Vein of Galen malformation

Dr. Orbach explained that vein of Galen malformation, which occurs in around 1 in every 60,000 births, is a cerebrovascular anomaly in which the arterial system is directly connected to the venous system rather than to capillaries that are necessary to slow blood flow and deliver oxygen to surrounding brain tissue.

“The arterial and venous systems are fundamentally very different. The arterial system is high pressure, high flow; while the venous system is low pressure, low flow. They shouldn’t be directly connected,” he noted.

The vein of Galen malformation is the most extreme version of such an anomaly. Developing in early gestation, it is associated with a large increase in blood flow through the brain which grows over time and can sometimes result in twice the total cardiac output of the body or even more, Dr. Orbach said.

The placenta is believed to be protective as most babies don’t have overt physiologic problems in utero, but they can run into crisis after birth, with the abnormally high blood flow causing an immense stress to the heart.

Babies typically present with heart failure as their first major symptom soon after birth, Dr. Orbach said. “Although the anatomical problem is in the brain, the clinical manifestation is high-output heart failure. The heart is trying to do double its normal work, pumping the blood to the malformation and immediately back to the heart and that blood is not performing any useful function.

“These newborns can get very sick. They need multiple medications to support their cardiovascular system and we need to do procedures to try and reduce the blood flow,” he explained. 

Brain injury is also a common problem. “The brain circulation is very abnormal. The blood is being shunted through the malformation rather than circulating through the brain tissue which can become ischemic,” Dr. Orbach commented.

“The babies who get sick would have a very high mortality (up to 90%) without expert care. Even those who do receive expert care at a specialty center have a mortality rate of 30% to 40% and those who survive have a high risk of neurologic and cognitive impairment,” he added.

The current treatment for babies born with the condition involves transarterial embolization, by which a catheter is inserted into the arterial system to enable the malformation to be occluded by various techniques. 

But Dr. Orbach pointed out that some babies are born too sick to have the postnatal intervention. “The heart failure and brain injury is so overwhelming that no matter what we do, we cannot reverse it, and these babies normally do not survive. What we are doing with the fetal surgery is trying to help those babies who cannot be treated with the current postnatal approach,” he said.

The first stage of this research involved trying to identify these very-high-risk babies in utero, and the researchers found that on fetal MRI a particular measurement of one of the venous sinuses that drains the main malformation was a good predictor of how the baby would fare after birth. The babies predicted to do poorly from this test are the targets for the fetal surgery.

The technique used for the postnatal intervention is too technically challenging to perform in utero. “So we have developed a different approach for the in utero surgery that involves navigating into the accepting vein in the malformation with a needle under ultrasound guidance, and then packing the vein with metal coils to dramatically reduce the blood flow,” Dr. Orbach explained.

This procedure was performed in this first patient on March 15. The surgery was part of a clinical trial that is planned to include 20 cases in total.

“The immediate goal is to see whether we can transform those fetuses who are at very high risk of getting sick after birth into babies who do well in the [neonatal] ICU and are able to be sent home for elective treatment at a few months of age,” Dr. Orbach noted. “The study is continuing as it is vital that we continue and show efficacy and safety in other patients as well,” he added.

Dr. Orbach said the results of this first case were extremely encouraging. “Each stage was exciting – the technical success of the procedure, and then seeing the [blood] flow diminish on the ultrasound right there during the procedure; then the next day we did a fetal echocardiogram, and we could see that the abnormal cardiac output was dramatically reduced, and a fetal MRI scan also showed the malformation was already coming down in size.”

The baby was born prematurely 2 days after the procedure because of ruptured membranes with a birth weight of 1.9 kg (4.2 lb). She has not required any cardiovascular support or postnatal embolization.

“We were waiting with bated breath until the baby was born to see how she did clinically. I was trying to be conservative in my expectations, but it was quickly apparent that she was going to do great,” he said. Now at home, she has some oxygen treatment for the first few weeks, “but right now her neurological status is completely intact and essentially she looks like any other baby,” Dr. Orbach commented.

It is not yet known whether the infant will need any additional procedures. “We will follow her closely and make a decision on whether further treatment is needed based on whether the malformation is growing or not,” Dr. Orbach said. Longer term follow-up will also assess secondary problems sometimes seen, such as learning problems and seizures.

Although other fetal surgeries are now routinely performed, this is believed to be the first in utero surgery aimed at the cerebrovascular system.

“There were a lot of uncertainties,” Dr. Orbach said. “We didn’t even know if we would be able to see our instruments on ultrasound.” To model the procedure, the researchers had a phantom fetal skull and brain constructed with a vein of Galen malformation, which was key to obtaining Food and Drug Administration approval for the study.

If the study shows success in the other patients too, the technique could be rolled out to other centers. “There definitely needs to be fetal surgery and neurointerventional teams familiar with vein of Galen malformation in place, and ready to manage complications after delivery regardless of outcome. But we are not the only center with those capabilities, so if our trial pans out, yes, the hope is that other teams in specialist children’s hospitals around the world could do this too,” he added.
 

Pioneering work

Commenting on the case report in an American Heart Association press release, Colin Derdeyn, MD, a neurointerventional radiologist at University of Iowa Health Care, Iowa City, who performs vein of Galen malformation embolizations on neonates, said: “The key advance here is to intervene before the physiologic events of birth can cause life-threatening heart failure.”

Dr. Derdeyn, who is a past chair of the American Heart Association’s Stroke Council, cautioned that one successful case is not enough experience to conclude that the risks of this procedure are worth the benefits.

But, he added: “The positive hemodynamic changes that they observed in utero and after birth – reduction in flow, reduction in size of the draining vein, reversal of the abnormal reversed flow in the aorta – are really encouraging. These are some of the most exciting and surprising aspects of this case report. This is pioneering work being done in a very careful and responsible way.”

The study was funded by a grant from the Sage Schermerhorn Chair for Image-Guided Therapy.

A version of this article first appeared on Medscape.com.

Prediction models that incorporate more than just treatment status could rank order heart transplant candidates by urgency more effectively than the current system, a modeling study suggests.

Since 2018, the U.S. heart transplant allocation system has ranked heart candidates according to six treatment-based “statuses” (up from three used previously), ignoring many objective patient characteristics, the authors write.

Their study showed no significant difference in survival between statuses four and six, and status five had lower survival than status four.

“We expected multivariable prediction models to outperform the six-status system when it comes to rank ordering patients by how likely they are to die on the wait list (medical urgency),” William F. Parker, MD, MS, PhD, of the University of Chicago, told this news organization.

“However, we were surprised to see that the statuses were out of order,” he said. “Status five patients are more urgent than status three or status four patients,” mainly because most are in renal failure and listed for multiorgan transplantation with a kidney.

Objective physiologic measurements, such as glomerular filtration rate (GFR), had high variable importance, offering a minimally invasive measurement with predictive power in assessing medical urgency. Therefore, including GFR and other variables such as extracorporeal membrane oxygenation (ECMO) could improve the accuracy of the allocation system in identifying the most medically urgent candidates, Dr. Parker and colleagues suggest.

The study was published online in JACC: Heart Failure.
 

‘Moderate ability’ to rank order

The investigators assessed the effectiveness of the standard six-status ranking system and several novel prediction models in identifying the most urgent heart transplant candidates. The primary outcome was death before receipt of a heart transplant.

The final data set contained 32,294 candidates (mean age, 53 years; 74%, men); 27,200 made up the prepolicy training set and 5,094 were included in the postpolicy test set.

The team evaluated the accuracy of the six-status system using Harrell’s C-index and log-rank tests of Kaplan-Meier estimated survival by status for candidates listed after the policy change (November 2018 to March 2020) in the Scientific Registry of Transplant Recipients data set.

They then developed Cox proportional hazards models and random survival forest models using prepolicy data (2010-2017). Predictor variables included age, diagnosis, laboratory measurements, hemodynamics, and supportive treatment at the time of listing.

They found that the six-status ranking at listing has had “moderate ability” to rank order candidates.

As Dr. Parker indicated, statuses four and six had no significant difference in survival, and status five had lower survival than status four.

The investigators’ multivariable prediction models derived with prepolicy data ranked candidates correctly more often than the six-status rankings. Objective physiologic measurements, such as GFR and ECMO, were identified as having significant importance with regard to ranking by urgency.

“The novel prediction models we developed … could be implemented by the Organ Procurement and Transplantation Network (OPTN) as allocation policy and would be better than the status quo,” Dr. Parker said. “However, I think we could do even better using the newer data collected after 2018.” 
 

Modifications underway

The OPTN Heart Transplantation Committee is currently working on developing a new framework for allocating deceased donor hearts called Continuous Distribution.

“The six-tiered system works well, and it better stratifies the most medically urgent candidates than the previous allocation framework,” the leadership of the United Network for Organ Sharing Heart Transplantation Committee, including Chair Richard C. Daly, MD, Mayo Clinic; Vice-Chair Jondavid Menteer, MD, University of Southern California, Los Angeles; and former Chair Shelley Hall, MD, Baylor University Medical Center, told this news organization.

“That said, it is always appropriate to review and adjust variables that affect the medical urgency attribute for heart allocation.”

The new framework will change how patients are prioritized, they said. “Continuous distribution will consider all patient factors, including medical urgency, together to determine the order of an organ offer, and no single factor will decide an organ match.

“The goal is to increase fairness by moving to a points-based allocation framework that allows candidates to be compared using a single score composed of multiple factors.

“Furthermore,” they added, “continuous distribution provides a framework that will allow modifications of the criteria defining medical urgency (and other attributes of allocation) to a finer degree than the current policy. … Once continuous distribution is in place and the OPTN has policy monitoring data, the committee may consider and model different ways of defining medical urgency.”

Kiran K. Khush, MD, of Stanford (Calif.) University School of Medicine, coauthor of a related commentary, elaborated. “The composite allocation score (CAS) will consist of a ‘points-based system,’ in which candidates will be assigned points based on (1) medical urgency, (2) anticipated posttransplant survival, (3) candidate biology (eg., special characteristics that may result in higher prioritization, such as blood type O and allosensitization), (4) access (eg., prior living donor, pediatric patient), and (5) placement efficacy (travel, proximity).”

Candidates will be assigned points based on these categories, and will be rank ordered for each donor offer.

Dr. Khush and colleagues propose that a multivariable model – such as the ones described in the study – would be the best way to assign points for medical urgency.

“This system will be more equitable than the current system,” Dr. Khush said, “because it will better prioritize the sickest candidates while improving access for patients who are currently at a disadvantage [for example, blood O, highly sensitized patients], and will also remove artificial geographic boundaries [for example, the current 500-mile rule for heart allocation].”
 

Going further

Jesse D. Schold, PhD, of the University of Colorado at Denver, Aurora, raises concerns about other aspects of the heart allocation system in another related commentary.

“One big issue with our data in transplantation … is that, while it is very comprehensive for capturing transplant candidates and recipients, there is no data collection for patients and processes of care for patients prior to wait list placement,” he told this news organization. This phase of care is subject to wide variation in practice, he said, “and is likely as important as any to patients – the ability to be referred, evaluated, and placed on a waiting list.”

Report cards that measure quality of care after wait list placement ignore key phases prior to wait list placement, he said. “This may have the unintended consequences of limiting access to care and to the waiting list for patients perceived to be at higher risk, or the use of higher-risk donors, despite their potential survival advantage.

“In contrast,” he said, “quality report cards that incentivize treatment for all patients who may benefit would likely have a greater beneficial impact on patients with end-organ disease.”

There is also significant risk of underlying differences in patient populations between centers, despite the use of multivariable models, he added. This heterogeneity “may not be reflected accurately in the report cards [which] have significant impact for regulatory review, private payer contracting, and center reputation.”

Some of these concerns may be addressed in the new OPTN Modernization Initiative, according to David Bowman, a public affairs specialist at the Health Resources and Services Administration. One of the goals of the initiative “is to ensure that the OPTN Board of Directors is high functioning, has greater independence, and represents the diversity of communities served by the OPTN,” he told this news organization. “Strengthened governance will lead to effective policy development and implementation, and enhanced transparency and accountability of the process.”

Addressing another concern about the system, Savitri Fedson, MD, of the Michael E. DeBakey VA Medical Center and Baylor College of Medicine, Houston, wonders in a related editorial whether organ donors and recipients should know more about each other, and if so, could that reverse the ongoing downward trend in organ acceptance?

Although some organizations are in favor of sharing more information, Dr. Fedson notes that “less information may have the greater benefit.” She writes, “We might realize that the simplest approach is often the best: a fulsome thank you for the donor’s gift that is willingly given to a stranger without expectation of payment, and on the recipient side, the knowledge that an organ is of good quality.

“The transplant patient can be comforted with the understanding that the risk of disease transmission, while not zero, is low, and that their survival following acceptance of an organ is better than languishing on a waiting list.”

The study received no commercial funding. Dr. Parker, Dr. Khush, Dr. Schold, and Dr. Fedson report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Prediction models that incorporate more than just treatment status could rank order heart transplant candidates by urgency more effectively than the current system, a modeling study suggests.

Since 2018, the U.S. heart transplant allocation system has ranked heart candidates according to six treatment-based “statuses” (up from three used previously), ignoring many objective patient characteristics, the authors write.

Their study showed no significant difference in survival between statuses four and six, and status five had lower survival than status four.

“We expected multivariable prediction models to outperform the six-status system when it comes to rank ordering patients by how likely they are to die on the wait list (medical urgency),” William F. Parker, MD, MS, PhD, of the University of Chicago, told this news organization.

“However, we were surprised to see that the statuses were out of order,” he said. “Status five patients are more urgent than status three or status four patients,” mainly because most are in renal failure and listed for multiorgan transplantation with a kidney.

Objective physiologic measurements, such as glomerular filtration rate (GFR), had high variable importance, offering a minimally invasive measurement with predictive power in assessing medical urgency. Therefore, including GFR and other variables such as extracorporeal membrane oxygenation (ECMO) could improve the accuracy of the allocation system in identifying the most medically urgent candidates, Dr. Parker and colleagues suggest.

The study was published online in JACC: Heart Failure.
 

‘Moderate ability’ to rank order

The investigators assessed the effectiveness of the standard six-status ranking system and several novel prediction models in identifying the most urgent heart transplant candidates. The primary outcome was death before receipt of a heart transplant.

The final data set contained 32,294 candidates (mean age, 53 years; 74%, men); 27,200 made up the prepolicy training set and 5,094 were included in the postpolicy test set.

The team evaluated the accuracy of the six-status system using Harrell’s C-index and log-rank tests of Kaplan-Meier estimated survival by status for candidates listed after the policy change (November 2018 to March 2020) in the Scientific Registry of Transplant Recipients data set.

They then developed Cox proportional hazards models and random survival forest models using prepolicy data (2010-2017). Predictor variables included age, diagnosis, laboratory measurements, hemodynamics, and supportive treatment at the time of listing.

They found that the six-status ranking at listing has had “moderate ability” to rank order candidates.

As Dr. Parker indicated, statuses four and six had no significant difference in survival, and status five had lower survival than status four.

The investigators’ multivariable prediction models derived with prepolicy data ranked candidates correctly more often than the six-status rankings. Objective physiologic measurements, such as GFR and ECMO, were identified as having significant importance with regard to ranking by urgency.

“The novel prediction models we developed … could be implemented by the Organ Procurement and Transplantation Network (OPTN) as allocation policy and would be better than the status quo,” Dr. Parker said. “However, I think we could do even better using the newer data collected after 2018.” 
 

Modifications underway

The OPTN Heart Transplantation Committee is currently working on developing a new framework for allocating deceased donor hearts called Continuous Distribution.

“The six-tiered system works well, and it better stratifies the most medically urgent candidates than the previous allocation framework,” the leadership of the United Network for Organ Sharing Heart Transplantation Committee, including Chair Richard C. Daly, MD, Mayo Clinic; Vice-Chair Jondavid Menteer, MD, University of Southern California, Los Angeles; and former Chair Shelley Hall, MD, Baylor University Medical Center, told this news organization.

“That said, it is always appropriate to review and adjust variables that affect the medical urgency attribute for heart allocation.”

The new framework will change how patients are prioritized, they said. “Continuous distribution will consider all patient factors, including medical urgency, together to determine the order of an organ offer, and no single factor will decide an organ match.

“The goal is to increase fairness by moving to a points-based allocation framework that allows candidates to be compared using a single score composed of multiple factors.

“Furthermore,” they added, “continuous distribution provides a framework that will allow modifications of the criteria defining medical urgency (and other attributes of allocation) to a finer degree than the current policy. … Once continuous distribution is in place and the OPTN has policy monitoring data, the committee may consider and model different ways of defining medical urgency.”

Kiran K. Khush, MD, of Stanford (Calif.) University School of Medicine, coauthor of a related commentary, elaborated. “The composite allocation score (CAS) will consist of a ‘points-based system,’ in which candidates will be assigned points based on (1) medical urgency, (2) anticipated posttransplant survival, (3) candidate biology (eg., special characteristics that may result in higher prioritization, such as blood type O and allosensitization), (4) access (eg., prior living donor, pediatric patient), and (5) placement efficacy (travel, proximity).”

Candidates will be assigned points based on these categories, and will be rank ordered for each donor offer.

Dr. Khush and colleagues propose that a multivariable model – such as the ones described in the study – would be the best way to assign points for medical urgency.

“This system will be more equitable than the current system,” Dr. Khush said, “because it will better prioritize the sickest candidates while improving access for patients who are currently at a disadvantage [for example, blood O, highly sensitized patients], and will also remove artificial geographic boundaries [for example, the current 500-mile rule for heart allocation].”
 

Going further

Jesse D. Schold, PhD, of the University of Colorado at Denver, Aurora, raises concerns about other aspects of the heart allocation system in another related commentary.

“One big issue with our data in transplantation … is that, while it is very comprehensive for capturing transplant candidates and recipients, there is no data collection for patients and processes of care for patients prior to wait list placement,” he told this news organization. This phase of care is subject to wide variation in practice, he said, “and is likely as important as any to patients – the ability to be referred, evaluated, and placed on a waiting list.”

Report cards that measure quality of care after wait list placement ignore key phases prior to wait list placement, he said. “This may have the unintended consequences of limiting access to care and to the waiting list for patients perceived to be at higher risk, or the use of higher-risk donors, despite their potential survival advantage.

“In contrast,” he said, “quality report cards that incentivize treatment for all patients who may benefit would likely have a greater beneficial impact on patients with end-organ disease.”

There is also significant risk of underlying differences in patient populations between centers, despite the use of multivariable models, he added. This heterogeneity “may not be reflected accurately in the report cards [which] have significant impact for regulatory review, private payer contracting, and center reputation.”

Some of these concerns may be addressed in the new OPTN Modernization Initiative, according to David Bowman, a public affairs specialist at the Health Resources and Services Administration. One of the goals of the initiative “is to ensure that the OPTN Board of Directors is high functioning, has greater independence, and represents the diversity of communities served by the OPTN,” he told this news organization. “Strengthened governance will lead to effective policy development and implementation, and enhanced transparency and accountability of the process.”

Addressing another concern about the system, Savitri Fedson, MD, of the Michael E. DeBakey VA Medical Center and Baylor College of Medicine, Houston, wonders in a related editorial whether organ donors and recipients should know more about each other, and if so, could that reverse the ongoing downward trend in organ acceptance?

Although some organizations are in favor of sharing more information, Dr. Fedson notes that “less information may have the greater benefit.” She writes, “We might realize that the simplest approach is often the best: a fulsome thank you for the donor’s gift that is willingly given to a stranger without expectation of payment, and on the recipient side, the knowledge that an organ is of good quality.

“The transplant patient can be comforted with the understanding that the risk of disease transmission, while not zero, is low, and that their survival following acceptance of an organ is better than languishing on a waiting list.”

The study received no commercial funding. Dr. Parker, Dr. Khush, Dr. Schold, and Dr. Fedson report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Prediction models that incorporate more than just treatment status could rank order heart transplant candidates by urgency more effectively than the current system, a modeling study suggests.

Since 2018, the U.S. heart transplant allocation system has ranked heart candidates according to six treatment-based “statuses” (up from three used previously), ignoring many objective patient characteristics, the authors write.

Their study showed no significant difference in survival between statuses four and six, and status five had lower survival than status four.

“We expected multivariable prediction models to outperform the six-status system when it comes to rank ordering patients by how likely they are to die on the wait list (medical urgency),” William F. Parker, MD, MS, PhD, of the University of Chicago, told this news organization.

“However, we were surprised to see that the statuses were out of order,” he said. “Status five patients are more urgent than status three or status four patients,” mainly because most are in renal failure and listed for multiorgan transplantation with a kidney.

Objective physiologic measurements, such as glomerular filtration rate (GFR), had high variable importance, offering a minimally invasive measurement with predictive power in assessing medical urgency. Therefore, including GFR and other variables such as extracorporeal membrane oxygenation (ECMO) could improve the accuracy of the allocation system in identifying the most medically urgent candidates, Dr. Parker and colleagues suggest.

The study was published online in JACC: Heart Failure.
 

‘Moderate ability’ to rank order

The investigators assessed the effectiveness of the standard six-status ranking system and several novel prediction models in identifying the most urgent heart transplant candidates. The primary outcome was death before receipt of a heart transplant.

The final data set contained 32,294 candidates (mean age, 53 years; 74%, men); 27,200 made up the prepolicy training set and 5,094 were included in the postpolicy test set.

The team evaluated the accuracy of the six-status system using Harrell’s C-index and log-rank tests of Kaplan-Meier estimated survival by status for candidates listed after the policy change (November 2018 to March 2020) in the Scientific Registry of Transplant Recipients data set.

They then developed Cox proportional hazards models and random survival forest models using prepolicy data (2010-2017). Predictor variables included age, diagnosis, laboratory measurements, hemodynamics, and supportive treatment at the time of listing.

They found that the six-status ranking at listing has had “moderate ability” to rank order candidates.

As Dr. Parker indicated, statuses four and six had no significant difference in survival, and status five had lower survival than status four.

The investigators’ multivariable prediction models derived with prepolicy data ranked candidates correctly more often than the six-status rankings. Objective physiologic measurements, such as GFR and ECMO, were identified as having significant importance with regard to ranking by urgency.

“The novel prediction models we developed … could be implemented by the Organ Procurement and Transplantation Network (OPTN) as allocation policy and would be better than the status quo,” Dr. Parker said. “However, I think we could do even better using the newer data collected after 2018.” 
 

Modifications underway

The OPTN Heart Transplantation Committee is currently working on developing a new framework for allocating deceased donor hearts called Continuous Distribution.

“The six-tiered system works well, and it better stratifies the most medically urgent candidates than the previous allocation framework,” the leadership of the United Network for Organ Sharing Heart Transplantation Committee, including Chair Richard C. Daly, MD, Mayo Clinic; Vice-Chair Jondavid Menteer, MD, University of Southern California, Los Angeles; and former Chair Shelley Hall, MD, Baylor University Medical Center, told this news organization.

“That said, it is always appropriate to review and adjust variables that affect the medical urgency attribute for heart allocation.”

The new framework will change how patients are prioritized, they said. “Continuous distribution will consider all patient factors, including medical urgency, together to determine the order of an organ offer, and no single factor will decide an organ match.

“The goal is to increase fairness by moving to a points-based allocation framework that allows candidates to be compared using a single score composed of multiple factors.

“Furthermore,” they added, “continuous distribution provides a framework that will allow modifications of the criteria defining medical urgency (and other attributes of allocation) to a finer degree than the current policy. … Once continuous distribution is in place and the OPTN has policy monitoring data, the committee may consider and model different ways of defining medical urgency.”

Kiran K. Khush, MD, of Stanford (Calif.) University School of Medicine, coauthor of a related commentary, elaborated. “The composite allocation score (CAS) will consist of a ‘points-based system,’ in which candidates will be assigned points based on (1) medical urgency, (2) anticipated posttransplant survival, (3) candidate biology (eg., special characteristics that may result in higher prioritization, such as blood type O and allosensitization), (4) access (eg., prior living donor, pediatric patient), and (5) placement efficacy (travel, proximity).”

Candidates will be assigned points based on these categories, and will be rank ordered for each donor offer.

Dr. Khush and colleagues propose that a multivariable model – such as the ones described in the study – would be the best way to assign points for medical urgency.

“This system will be more equitable than the current system,” Dr. Khush said, “because it will better prioritize the sickest candidates while improving access for patients who are currently at a disadvantage [for example, blood O, highly sensitized patients], and will also remove artificial geographic boundaries [for example, the current 500-mile rule for heart allocation].”
 

Going further

Jesse D. Schold, PhD, of the University of Colorado at Denver, Aurora, raises concerns about other aspects of the heart allocation system in another related commentary.

“One big issue with our data in transplantation … is that, while it is very comprehensive for capturing transplant candidates and recipients, there is no data collection for patients and processes of care for patients prior to wait list placement,” he told this news organization. This phase of care is subject to wide variation in practice, he said, “and is likely as important as any to patients – the ability to be referred, evaluated, and placed on a waiting list.”

Report cards that measure quality of care after wait list placement ignore key phases prior to wait list placement, he said. “This may have the unintended consequences of limiting access to care and to the waiting list for patients perceived to be at higher risk, or the use of higher-risk donors, despite their potential survival advantage.

“In contrast,” he said, “quality report cards that incentivize treatment for all patients who may benefit would likely have a greater beneficial impact on patients with end-organ disease.”

There is also significant risk of underlying differences in patient populations between centers, despite the use of multivariable models, he added. This heterogeneity “may not be reflected accurately in the report cards [which] have significant impact for regulatory review, private payer contracting, and center reputation.”

Some of these concerns may be addressed in the new OPTN Modernization Initiative, according to David Bowman, a public affairs specialist at the Health Resources and Services Administration. One of the goals of the initiative “is to ensure that the OPTN Board of Directors is high functioning, has greater independence, and represents the diversity of communities served by the OPTN,” he told this news organization. “Strengthened governance will lead to effective policy development and implementation, and enhanced transparency and accountability of the process.”

Addressing another concern about the system, Savitri Fedson, MD, of the Michael E. DeBakey VA Medical Center and Baylor College of Medicine, Houston, wonders in a related editorial whether organ donors and recipients should know more about each other, and if so, could that reverse the ongoing downward trend in organ acceptance?

Although some organizations are in favor of sharing more information, Dr. Fedson notes that “less information may have the greater benefit.” She writes, “We might realize that the simplest approach is often the best: a fulsome thank you for the donor’s gift that is willingly given to a stranger without expectation of payment, and on the recipient side, the knowledge that an organ is of good quality.

“The transplant patient can be comforted with the understanding that the risk of disease transmission, while not zero, is low, and that their survival following acceptance of an organ is better than languishing on a waiting list.”

The study received no commercial funding. Dr. Parker, Dr. Khush, Dr. Schold, and Dr. Fedson report no relevant financial relationships.

A version of this article first appeared on Medscape.com.