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Cardiologists’ incomes bounce back from pandemic: Survey
The financial struggles created by the pandemic have eased somewhat, but physicians are still facing an array of challenges, including increased workloads and longer hours. All in all, however, things seem to be looking up.
More than 13,000 physicians in more than 29 specialties shared information about their incomes and other aspects of their careers in a survey conducted by Medscape. The responses showed a trend back to something like normal after the initial blow of the COVID-19 pandemic.
As the profession began to recover from the pandemic, cardiologists reported that their incomes increased in 2021, reaching an average of $490,000 for the year, up from $459,000 the previous year. This was in keeping with physicians in other specialties. “Compensation for most physicians is trending back up, as demands for physicians accelerates,” said James Taylor, group president and chief operating officer of AMN Healthcare’s Physician & Leadership Solutions Division. “The market for physicians has done a complete 180 over just 7 or 8 months.” And though inflation is on everyone’s mind these days, rising salaries have helped physicians keep up with rising prices.
Despite the increase in income (and the accompanying increased workload), nearly 30% of cardiologists have taken on extra work, most of that being medical work, but a few did report unrelated side hustles. This may be due not to a shortfall in income, but rather to a desire to pad the coffers for the future. Lauren Podnos, a financial planner with Wealth Care, a firm that specializes in working with physicians and other health care professionals, points out that many physicians like to build wealth as quickly as possible as a hedge against possible burnout later on. “With physicians,” she said, “we work to get to the point where they have the freedom to do whatever they want – cut back and work part-time or transition into another career – so if they do burn out, they have other options.”
Though physician pay rose overall, not all cardiologists enjoyed a boost in income. However, those who did lose ground did not always lay the blame on COVID-19: General pay cuts were mentioned, for example. For physicians overall, a gender pay gap still remains, with men averaging $373,000 per year, in contrast to women who make $282,000. With more women moving into higher-paying specialties, the gap has narrowed somewhat in recent years, and industry leaders are making efforts to accelerate that trend. “A great many of the specialty organizations have efforts underway not just to increase the number of women in specialties but also to address gender pay gaps and bias in evaluations during residency and fellowship,” said Ron Holder, chief operating officer of the Medical Group Management Association (MGMA).
Incentive bonuses helped bump up income as well. Overall, 57% of physicians receive some kind of incentive bonus; the average for cardiologists was $85,000 last year, up from $71,000 the prior year. While such bonuses can certainly help the bottom line, they’re not always an unmitigated good. A 2021 study found that incentive programs can cause people to prioritize time spent at work and with work colleagues at the expense of family and personal relationships, a potentially troubling finding with so many physicians struggling with depression and burnout. “There’s been a lot of previous evidence showing that the more time we spend with our loved ones the happier we are,” said Julia Hur, PhD, assistant professor of management and organizations at New York University’s Stern School of Business, and lead author of the study. “The core argument of this study is about attention, and performance incentives create an attentional fixation on money,” she said, “causing people to spend more time with work colleagues and people who are helpful to their careers. And that takes away from time for family and friends.”
Still rewarding
Getting paid well is one thing; feeling that you’re being paid well is another. Only 57% of cardiologists who responded to the survey said they felt they were fairly compensated for their work. This puts them at roughly the middle of the pack of specialties. Contrast that with physicians in public health and preventive medicine who topped the charts on this one, with 72% of these doctors feeling that they were being paid fairly for their work.
However, cardiology did rank at the top of specialties whose members said they would choose medicine if they had a chance to do it again, though that number was down from the previous year (81% in 2021 versus 86% in 2020). Of cardiologists surveyed, 88% would choose cardiology if they got a do-over.
Cardiologists spend an average of 16.4 hours each week on paperwork and administration. That’s only slightly higher than the average for all specialties, about 15.5 hours a week. Despite billing hassles and low reimbursement rates, 80% of cardiologists polled say they plan to continue taking new and existing Medicare and Medicaid patients. Though 17% said they could or would drop low-paying insurers, 83% said they could not do that for business, ethical, or other reasons.
Despite its many headaches, medicine is still a rewarding profession. The most rewarding aspects cited by cardiologists were relationships with patients (34%), being good at their work (23%), and knowing they’re making the world a better place (21%). Though this is mostly in line with previous surveys, in recent years physicians have increasingly cited making the world a better place as a key motivation and reward.
The most challenging part of the job? This will not come as a surprise: Having so many rules and regulations. This was the reason given by 26% of respondents. But a close second – at 21% – was having to work long hours. One positive development is that cardiologists are making peace with their EHR systems. Only 10% said this was the most challenging part of the job (the same percentage that cited dealing with difficult patients as most challenging).
The financial struggles created by the pandemic have eased somewhat, but physicians are still facing an array of challenges, including increased workloads and longer hours. All in all, however, things seem to be looking up.
More than 13,000 physicians in more than 29 specialties shared information about their incomes and other aspects of their careers in a survey conducted by Medscape. The responses showed a trend back to something like normal after the initial blow of the COVID-19 pandemic.
As the profession began to recover from the pandemic, cardiologists reported that their incomes increased in 2021, reaching an average of $490,000 for the year, up from $459,000 the previous year. This was in keeping with physicians in other specialties. “Compensation for most physicians is trending back up, as demands for physicians accelerates,” said James Taylor, group president and chief operating officer of AMN Healthcare’s Physician & Leadership Solutions Division. “The market for physicians has done a complete 180 over just 7 or 8 months.” And though inflation is on everyone’s mind these days, rising salaries have helped physicians keep up with rising prices.
Despite the increase in income (and the accompanying increased workload), nearly 30% of cardiologists have taken on extra work, most of that being medical work, but a few did report unrelated side hustles. This may be due not to a shortfall in income, but rather to a desire to pad the coffers for the future. Lauren Podnos, a financial planner with Wealth Care, a firm that specializes in working with physicians and other health care professionals, points out that many physicians like to build wealth as quickly as possible as a hedge against possible burnout later on. “With physicians,” she said, “we work to get to the point where they have the freedom to do whatever they want – cut back and work part-time or transition into another career – so if they do burn out, they have other options.”
Though physician pay rose overall, not all cardiologists enjoyed a boost in income. However, those who did lose ground did not always lay the blame on COVID-19: General pay cuts were mentioned, for example. For physicians overall, a gender pay gap still remains, with men averaging $373,000 per year, in contrast to women who make $282,000. With more women moving into higher-paying specialties, the gap has narrowed somewhat in recent years, and industry leaders are making efforts to accelerate that trend. “A great many of the specialty organizations have efforts underway not just to increase the number of women in specialties but also to address gender pay gaps and bias in evaluations during residency and fellowship,” said Ron Holder, chief operating officer of the Medical Group Management Association (MGMA).
Incentive bonuses helped bump up income as well. Overall, 57% of physicians receive some kind of incentive bonus; the average for cardiologists was $85,000 last year, up from $71,000 the prior year. While such bonuses can certainly help the bottom line, they’re not always an unmitigated good. A 2021 study found that incentive programs can cause people to prioritize time spent at work and with work colleagues at the expense of family and personal relationships, a potentially troubling finding with so many physicians struggling with depression and burnout. “There’s been a lot of previous evidence showing that the more time we spend with our loved ones the happier we are,” said Julia Hur, PhD, assistant professor of management and organizations at New York University’s Stern School of Business, and lead author of the study. “The core argument of this study is about attention, and performance incentives create an attentional fixation on money,” she said, “causing people to spend more time with work colleagues and people who are helpful to their careers. And that takes away from time for family and friends.”
Still rewarding
Getting paid well is one thing; feeling that you’re being paid well is another. Only 57% of cardiologists who responded to the survey said they felt they were fairly compensated for their work. This puts them at roughly the middle of the pack of specialties. Contrast that with physicians in public health and preventive medicine who topped the charts on this one, with 72% of these doctors feeling that they were being paid fairly for their work.
However, cardiology did rank at the top of specialties whose members said they would choose medicine if they had a chance to do it again, though that number was down from the previous year (81% in 2021 versus 86% in 2020). Of cardiologists surveyed, 88% would choose cardiology if they got a do-over.
Cardiologists spend an average of 16.4 hours each week on paperwork and administration. That’s only slightly higher than the average for all specialties, about 15.5 hours a week. Despite billing hassles and low reimbursement rates, 80% of cardiologists polled say they plan to continue taking new and existing Medicare and Medicaid patients. Though 17% said they could or would drop low-paying insurers, 83% said they could not do that for business, ethical, or other reasons.
Despite its many headaches, medicine is still a rewarding profession. The most rewarding aspects cited by cardiologists were relationships with patients (34%), being good at their work (23%), and knowing they’re making the world a better place (21%). Though this is mostly in line with previous surveys, in recent years physicians have increasingly cited making the world a better place as a key motivation and reward.
The most challenging part of the job? This will not come as a surprise: Having so many rules and regulations. This was the reason given by 26% of respondents. But a close second – at 21% – was having to work long hours. One positive development is that cardiologists are making peace with their EHR systems. Only 10% said this was the most challenging part of the job (the same percentage that cited dealing with difficult patients as most challenging).
The financial struggles created by the pandemic have eased somewhat, but physicians are still facing an array of challenges, including increased workloads and longer hours. All in all, however, things seem to be looking up.
More than 13,000 physicians in more than 29 specialties shared information about their incomes and other aspects of their careers in a survey conducted by Medscape. The responses showed a trend back to something like normal after the initial blow of the COVID-19 pandemic.
As the profession began to recover from the pandemic, cardiologists reported that their incomes increased in 2021, reaching an average of $490,000 for the year, up from $459,000 the previous year. This was in keeping with physicians in other specialties. “Compensation for most physicians is trending back up, as demands for physicians accelerates,” said James Taylor, group president and chief operating officer of AMN Healthcare’s Physician & Leadership Solutions Division. “The market for physicians has done a complete 180 over just 7 or 8 months.” And though inflation is on everyone’s mind these days, rising salaries have helped physicians keep up with rising prices.
Despite the increase in income (and the accompanying increased workload), nearly 30% of cardiologists have taken on extra work, most of that being medical work, but a few did report unrelated side hustles. This may be due not to a shortfall in income, but rather to a desire to pad the coffers for the future. Lauren Podnos, a financial planner with Wealth Care, a firm that specializes in working with physicians and other health care professionals, points out that many physicians like to build wealth as quickly as possible as a hedge against possible burnout later on. “With physicians,” she said, “we work to get to the point where they have the freedom to do whatever they want – cut back and work part-time or transition into another career – so if they do burn out, they have other options.”
Though physician pay rose overall, not all cardiologists enjoyed a boost in income. However, those who did lose ground did not always lay the blame on COVID-19: General pay cuts were mentioned, for example. For physicians overall, a gender pay gap still remains, with men averaging $373,000 per year, in contrast to women who make $282,000. With more women moving into higher-paying specialties, the gap has narrowed somewhat in recent years, and industry leaders are making efforts to accelerate that trend. “A great many of the specialty organizations have efforts underway not just to increase the number of women in specialties but also to address gender pay gaps and bias in evaluations during residency and fellowship,” said Ron Holder, chief operating officer of the Medical Group Management Association (MGMA).
Incentive bonuses helped bump up income as well. Overall, 57% of physicians receive some kind of incentive bonus; the average for cardiologists was $85,000 last year, up from $71,000 the prior year. While such bonuses can certainly help the bottom line, they’re not always an unmitigated good. A 2021 study found that incentive programs can cause people to prioritize time spent at work and with work colleagues at the expense of family and personal relationships, a potentially troubling finding with so many physicians struggling with depression and burnout. “There’s been a lot of previous evidence showing that the more time we spend with our loved ones the happier we are,” said Julia Hur, PhD, assistant professor of management and organizations at New York University’s Stern School of Business, and lead author of the study. “The core argument of this study is about attention, and performance incentives create an attentional fixation on money,” she said, “causing people to spend more time with work colleagues and people who are helpful to their careers. And that takes away from time for family and friends.”
Still rewarding
Getting paid well is one thing; feeling that you’re being paid well is another. Only 57% of cardiologists who responded to the survey said they felt they were fairly compensated for their work. This puts them at roughly the middle of the pack of specialties. Contrast that with physicians in public health and preventive medicine who topped the charts on this one, with 72% of these doctors feeling that they were being paid fairly for their work.
However, cardiology did rank at the top of specialties whose members said they would choose medicine if they had a chance to do it again, though that number was down from the previous year (81% in 2021 versus 86% in 2020). Of cardiologists surveyed, 88% would choose cardiology if they got a do-over.
Cardiologists spend an average of 16.4 hours each week on paperwork and administration. That’s only slightly higher than the average for all specialties, about 15.5 hours a week. Despite billing hassles and low reimbursement rates, 80% of cardiologists polled say they plan to continue taking new and existing Medicare and Medicaid patients. Though 17% said they could or would drop low-paying insurers, 83% said they could not do that for business, ethical, or other reasons.
Despite its many headaches, medicine is still a rewarding profession. The most rewarding aspects cited by cardiologists were relationships with patients (34%), being good at their work (23%), and knowing they’re making the world a better place (21%). Though this is mostly in line with previous surveys, in recent years physicians have increasingly cited making the world a better place as a key motivation and reward.
The most challenging part of the job? This will not come as a surprise: Having so many rules and regulations. This was the reason given by 26% of respondents. But a close second – at 21% – was having to work long hours. One positive development is that cardiologists are making peace with their EHR systems. Only 10% said this was the most challenging part of the job (the same percentage that cited dealing with difficult patients as most challenging).
Interventional imagers take on central role and more radiation
Interventional echocardiographers have become an increasingly critical part of the structural heart team but may be paying the price in terms of radiation exposure, a new study suggests.
Results showed that interventional echocardiographers receive threefold higher head-level radiation doses than interventional cardiologists during left atrial appendage occlusion (LAAO) closures and 11-fold higher doses during mitral valve transcatheter edge-to-edge repair (TEER).
“Over the last 5-10 years there’s been exponential growth in these two procedures, TEER and LAAO, and while that’s been very exciting, I think there hasn’t been as much research into how to protect these individuals,” lead author David A. McNamara, MD, MPH, Spectrum Health, Grand Rapids, Mich., told this news organization.
The study was published in JAMA Network Open.
Previous studies have focused largely on radiation exposure and mitigation efforts during coronary interventions, but the room set-up for LAAO and TEER and shielding techniques to mitigate radiation exposure are vastly different, he noted.
A 2017 study reported that radiation exposure was significantly higher for imaging specialists than structural heart specialists and varied by procedure type.
For the current study, Dr. McNamara, an echocardiographer by training, and colleagues collected data from 30 consecutive LAAO and 30 consecutive TEER procedures performed at their institution between July 2016 and January 2018.
Interventional imagers, interventional cardiologists, and sonographers all wore a lead skirt, apron, and thyroid collar, as well as a dosimeter to collect radiation data.
Interventional cardiologists stood immediately adjacent to the procedure table and used a ceiling-mounted, upper-body lead shield and a lower-body shield extending from the table to the floor. The echocardiographer stood at the patient’s head and used a mobile accessory shield raised to a height that allowed the imager to extend their arms over the shield to manipulate a transesophageal echocardiogram probe throughout the case.
The median fluoroscopy time was 9.2 minutes for LAAO and 20.9 minutes for TEER. The median air kerma was 164 mGy and 109 mGy, respectively.
Interventional echocardiographers received a median per case radiation dose of 10.6 µSv, compared with 2.1 µSv for interventional cardiologists. The result was similar for TEER (10.5 vs. 0.9 µSv) and LAAO (10.6 vs. 3.5 µSv; P < .001 for all).
The odds of interventional echocardiographers having a radiation dose greater than 20 µSV were 7.5 times greater than for interventional cardiologists (P < .001).
“It’s not the direction of the association, but really the magnitude is what surprised us,” observed Dr. McNamara.
The team was pleasantly surprised, he said, that sonographers, a “vastly understudied group,” received significantly lower median radiation doses than interventional imagers during LAAO (0.2 µSV) and TEER procedures (0.0 µSv; P < .001 for both).
The average distances from the radiation source were 26 cm (10.2 inches) for the echocardiographer, 36 cm (14.2 inches) for the interventional cardiologist, and 250 cm (8.2 feet) for the sonographer.
“These folks [sonographers] were much further away than both the physicians performing these cases, and that is what we hypothesize drove their very low rates, but that should also help inform our mitigation techniques for physicians and for all other cath lab members in the room,” Dr. McNamara said.
He noted that Spectrum Health has been at the forefront in terms of research into radiation exposure and mitigation, has good institutional radiation safety education, and used dose-lowering fluoroscopy systems (AlluraClarity, Philips) with real-time image noise reduction technology and a frame rate of 15 frames per second for the study. “So we’re hopeful that this actually represents a somewhat best-case scenario for what is being done at multiple institutions throughout the nation.”
Nevertheless, there is a huge amount of variability in radiation exposure, Dr. McNamara observed. “First and foremost, we really just have to identify our problem and highlight that this is something that needs some advocacy from our [professional] groups.”
Sunil Rao, MD, the newly minted president of the Society of Cardiovascular Angiography and Interventions (SCAI), said, “This is a really important study, because it expands the potential occupational hazards outside of what we traditionally think of as the team that does interventional procedures ... we have to recognize that the procedures we’re doing in the cath lab have changed.”
“Showing that our colleagues are getting 3-10 times radiation exposure is a really important piece of information to have out there. I think it’s really sort of a call to action,” Dr. Rao, professor of medicine at Duke University, Durham, N.C., told this news organization.
Nevertheless, he observed that practices have shifted somewhat since the study and that interventional cardiologists working with imaging physicians are more cognizant of radiation exposure issues.
“When I talk with our folks here that are doing structural heart procedures, they’re making sure that they’re not stepping on the fluoro pedal while the echocardiographer is manipulating the TE probe,” Dr. Rao said. “The echocardiographer is oftentimes using a much bigger shield than what was described in the study, and remember there’s an exponential decrease in the radiation exposure by distance, so they’re stepping back during the fluoroscopy time.”
Although the volume of TEER and LAAO procedures, as well as tricuspid interventions, will continue to climb, Dr. Rao said he expects radiation exposure to the imaging cardiologist will fall thanks to greater use of newer-generation imaging systems with dose-reduction features and better shielding strategies.
He noted that several of SCAI’s “best practices” documents call attention to radiation safety and that SCAI is creating a pathway where imaging cardiologists can become fellows of the society, which was traditionally reserved for interventionalists.
Still, imaging and cardiovascular societies have yet to endorse standardized safety procedures for interventional imagers, nor is information routinely collected on radiation exposure in national registries.
“We just don’t have the budgets or the interest nationally to do that kind of thing, so it has to be done locally,” Dr. Rao said. “And the person who I think is responsible for that is really the cath lab director and the cath lab nurse manager, who really should work hand-in-glove to make sure that radiation safety is at the top of the priority list.”
The study was funded by the Frederik Meijer Heart & Vascular Institute, Spectrum Health, and by Corindus. The funding sources had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, approval of the manuscript; and the decision to submit the manuscript for publication. Senior author Ryan Madder, MD, reports receiving research support, speaker honoraria, and grants, and serving on the advisory board of Corindus. No other disclosures were reported.
A version of this article first appeared on Medscape.com.
Interventional echocardiographers have become an increasingly critical part of the structural heart team but may be paying the price in terms of radiation exposure, a new study suggests.
Results showed that interventional echocardiographers receive threefold higher head-level radiation doses than interventional cardiologists during left atrial appendage occlusion (LAAO) closures and 11-fold higher doses during mitral valve transcatheter edge-to-edge repair (TEER).
“Over the last 5-10 years there’s been exponential growth in these two procedures, TEER and LAAO, and while that’s been very exciting, I think there hasn’t been as much research into how to protect these individuals,” lead author David A. McNamara, MD, MPH, Spectrum Health, Grand Rapids, Mich., told this news organization.
The study was published in JAMA Network Open.
Previous studies have focused largely on radiation exposure and mitigation efforts during coronary interventions, but the room set-up for LAAO and TEER and shielding techniques to mitigate radiation exposure are vastly different, he noted.
A 2017 study reported that radiation exposure was significantly higher for imaging specialists than structural heart specialists and varied by procedure type.
For the current study, Dr. McNamara, an echocardiographer by training, and colleagues collected data from 30 consecutive LAAO and 30 consecutive TEER procedures performed at their institution between July 2016 and January 2018.
Interventional imagers, interventional cardiologists, and sonographers all wore a lead skirt, apron, and thyroid collar, as well as a dosimeter to collect radiation data.
Interventional cardiologists stood immediately adjacent to the procedure table and used a ceiling-mounted, upper-body lead shield and a lower-body shield extending from the table to the floor. The echocardiographer stood at the patient’s head and used a mobile accessory shield raised to a height that allowed the imager to extend their arms over the shield to manipulate a transesophageal echocardiogram probe throughout the case.
The median fluoroscopy time was 9.2 minutes for LAAO and 20.9 minutes for TEER. The median air kerma was 164 mGy and 109 mGy, respectively.
Interventional echocardiographers received a median per case radiation dose of 10.6 µSv, compared with 2.1 µSv for interventional cardiologists. The result was similar for TEER (10.5 vs. 0.9 µSv) and LAAO (10.6 vs. 3.5 µSv; P < .001 for all).
The odds of interventional echocardiographers having a radiation dose greater than 20 µSV were 7.5 times greater than for interventional cardiologists (P < .001).
“It’s not the direction of the association, but really the magnitude is what surprised us,” observed Dr. McNamara.
The team was pleasantly surprised, he said, that sonographers, a “vastly understudied group,” received significantly lower median radiation doses than interventional imagers during LAAO (0.2 µSV) and TEER procedures (0.0 µSv; P < .001 for both).
The average distances from the radiation source were 26 cm (10.2 inches) for the echocardiographer, 36 cm (14.2 inches) for the interventional cardiologist, and 250 cm (8.2 feet) for the sonographer.
“These folks [sonographers] were much further away than both the physicians performing these cases, and that is what we hypothesize drove their very low rates, but that should also help inform our mitigation techniques for physicians and for all other cath lab members in the room,” Dr. McNamara said.
He noted that Spectrum Health has been at the forefront in terms of research into radiation exposure and mitigation, has good institutional radiation safety education, and used dose-lowering fluoroscopy systems (AlluraClarity, Philips) with real-time image noise reduction technology and a frame rate of 15 frames per second for the study. “So we’re hopeful that this actually represents a somewhat best-case scenario for what is being done at multiple institutions throughout the nation.”
Nevertheless, there is a huge amount of variability in radiation exposure, Dr. McNamara observed. “First and foremost, we really just have to identify our problem and highlight that this is something that needs some advocacy from our [professional] groups.”
Sunil Rao, MD, the newly minted president of the Society of Cardiovascular Angiography and Interventions (SCAI), said, “This is a really important study, because it expands the potential occupational hazards outside of what we traditionally think of as the team that does interventional procedures ... we have to recognize that the procedures we’re doing in the cath lab have changed.”
“Showing that our colleagues are getting 3-10 times radiation exposure is a really important piece of information to have out there. I think it’s really sort of a call to action,” Dr. Rao, professor of medicine at Duke University, Durham, N.C., told this news organization.
Nevertheless, he observed that practices have shifted somewhat since the study and that interventional cardiologists working with imaging physicians are more cognizant of radiation exposure issues.
“When I talk with our folks here that are doing structural heart procedures, they’re making sure that they’re not stepping on the fluoro pedal while the echocardiographer is manipulating the TE probe,” Dr. Rao said. “The echocardiographer is oftentimes using a much bigger shield than what was described in the study, and remember there’s an exponential decrease in the radiation exposure by distance, so they’re stepping back during the fluoroscopy time.”
Although the volume of TEER and LAAO procedures, as well as tricuspid interventions, will continue to climb, Dr. Rao said he expects radiation exposure to the imaging cardiologist will fall thanks to greater use of newer-generation imaging systems with dose-reduction features and better shielding strategies.
He noted that several of SCAI’s “best practices” documents call attention to radiation safety and that SCAI is creating a pathway where imaging cardiologists can become fellows of the society, which was traditionally reserved for interventionalists.
Still, imaging and cardiovascular societies have yet to endorse standardized safety procedures for interventional imagers, nor is information routinely collected on radiation exposure in national registries.
“We just don’t have the budgets or the interest nationally to do that kind of thing, so it has to be done locally,” Dr. Rao said. “And the person who I think is responsible for that is really the cath lab director and the cath lab nurse manager, who really should work hand-in-glove to make sure that radiation safety is at the top of the priority list.”
The study was funded by the Frederik Meijer Heart & Vascular Institute, Spectrum Health, and by Corindus. The funding sources had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, approval of the manuscript; and the decision to submit the manuscript for publication. Senior author Ryan Madder, MD, reports receiving research support, speaker honoraria, and grants, and serving on the advisory board of Corindus. No other disclosures were reported.
A version of this article first appeared on Medscape.com.
Interventional echocardiographers have become an increasingly critical part of the structural heart team but may be paying the price in terms of radiation exposure, a new study suggests.
Results showed that interventional echocardiographers receive threefold higher head-level radiation doses than interventional cardiologists during left atrial appendage occlusion (LAAO) closures and 11-fold higher doses during mitral valve transcatheter edge-to-edge repair (TEER).
“Over the last 5-10 years there’s been exponential growth in these two procedures, TEER and LAAO, and while that’s been very exciting, I think there hasn’t been as much research into how to protect these individuals,” lead author David A. McNamara, MD, MPH, Spectrum Health, Grand Rapids, Mich., told this news organization.
The study was published in JAMA Network Open.
Previous studies have focused largely on radiation exposure and mitigation efforts during coronary interventions, but the room set-up for LAAO and TEER and shielding techniques to mitigate radiation exposure are vastly different, he noted.
A 2017 study reported that radiation exposure was significantly higher for imaging specialists than structural heart specialists and varied by procedure type.
For the current study, Dr. McNamara, an echocardiographer by training, and colleagues collected data from 30 consecutive LAAO and 30 consecutive TEER procedures performed at their institution between July 2016 and January 2018.
Interventional imagers, interventional cardiologists, and sonographers all wore a lead skirt, apron, and thyroid collar, as well as a dosimeter to collect radiation data.
Interventional cardiologists stood immediately adjacent to the procedure table and used a ceiling-mounted, upper-body lead shield and a lower-body shield extending from the table to the floor. The echocardiographer stood at the patient’s head and used a mobile accessory shield raised to a height that allowed the imager to extend their arms over the shield to manipulate a transesophageal echocardiogram probe throughout the case.
The median fluoroscopy time was 9.2 minutes for LAAO and 20.9 minutes for TEER. The median air kerma was 164 mGy and 109 mGy, respectively.
Interventional echocardiographers received a median per case radiation dose of 10.6 µSv, compared with 2.1 µSv for interventional cardiologists. The result was similar for TEER (10.5 vs. 0.9 µSv) and LAAO (10.6 vs. 3.5 µSv; P < .001 for all).
The odds of interventional echocardiographers having a radiation dose greater than 20 µSV were 7.5 times greater than for interventional cardiologists (P < .001).
“It’s not the direction of the association, but really the magnitude is what surprised us,” observed Dr. McNamara.
The team was pleasantly surprised, he said, that sonographers, a “vastly understudied group,” received significantly lower median radiation doses than interventional imagers during LAAO (0.2 µSV) and TEER procedures (0.0 µSv; P < .001 for both).
The average distances from the radiation source were 26 cm (10.2 inches) for the echocardiographer, 36 cm (14.2 inches) for the interventional cardiologist, and 250 cm (8.2 feet) for the sonographer.
“These folks [sonographers] were much further away than both the physicians performing these cases, and that is what we hypothesize drove their very low rates, but that should also help inform our mitigation techniques for physicians and for all other cath lab members in the room,” Dr. McNamara said.
He noted that Spectrum Health has been at the forefront in terms of research into radiation exposure and mitigation, has good institutional radiation safety education, and used dose-lowering fluoroscopy systems (AlluraClarity, Philips) with real-time image noise reduction technology and a frame rate of 15 frames per second for the study. “So we’re hopeful that this actually represents a somewhat best-case scenario for what is being done at multiple institutions throughout the nation.”
Nevertheless, there is a huge amount of variability in radiation exposure, Dr. McNamara observed. “First and foremost, we really just have to identify our problem and highlight that this is something that needs some advocacy from our [professional] groups.”
Sunil Rao, MD, the newly minted president of the Society of Cardiovascular Angiography and Interventions (SCAI), said, “This is a really important study, because it expands the potential occupational hazards outside of what we traditionally think of as the team that does interventional procedures ... we have to recognize that the procedures we’re doing in the cath lab have changed.”
“Showing that our colleagues are getting 3-10 times radiation exposure is a really important piece of information to have out there. I think it’s really sort of a call to action,” Dr. Rao, professor of medicine at Duke University, Durham, N.C., told this news organization.
Nevertheless, he observed that practices have shifted somewhat since the study and that interventional cardiologists working with imaging physicians are more cognizant of radiation exposure issues.
“When I talk with our folks here that are doing structural heart procedures, they’re making sure that they’re not stepping on the fluoro pedal while the echocardiographer is manipulating the TE probe,” Dr. Rao said. “The echocardiographer is oftentimes using a much bigger shield than what was described in the study, and remember there’s an exponential decrease in the radiation exposure by distance, so they’re stepping back during the fluoroscopy time.”
Although the volume of TEER and LAAO procedures, as well as tricuspid interventions, will continue to climb, Dr. Rao said he expects radiation exposure to the imaging cardiologist will fall thanks to greater use of newer-generation imaging systems with dose-reduction features and better shielding strategies.
He noted that several of SCAI’s “best practices” documents call attention to radiation safety and that SCAI is creating a pathway where imaging cardiologists can become fellows of the society, which was traditionally reserved for interventionalists.
Still, imaging and cardiovascular societies have yet to endorse standardized safety procedures for interventional imagers, nor is information routinely collected on radiation exposure in national registries.
“We just don’t have the budgets or the interest nationally to do that kind of thing, so it has to be done locally,” Dr. Rao said. “And the person who I think is responsible for that is really the cath lab director and the cath lab nurse manager, who really should work hand-in-glove to make sure that radiation safety is at the top of the priority list.”
The study was funded by the Frederik Meijer Heart & Vascular Institute, Spectrum Health, and by Corindus. The funding sources had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, approval of the manuscript; and the decision to submit the manuscript for publication. Senior author Ryan Madder, MD, reports receiving research support, speaker honoraria, and grants, and serving on the advisory board of Corindus. No other disclosures were reported.
A version of this article first appeared on Medscape.com.
Transplanted pig hearts functioned normally in deceased persons on ventilator support
A team of surgeons successfully transplanted genetically engineered pig hearts into two recently deceased people whose bodies were being maintained on ventilatory support – not in the hope of restoring life, but as a proof-of-concept experiment in xenotransplantation that could eventually help to ease the critical shortage of donor organs.
The surgeries were performed on June 16 and July 6, 2022, using porcine hearts from animals genetically engineered to prevent organ rejection and promote adaptive immunity by human recipients
without utilizing unapproved devices or techniques or medications,” said Nader Moazami, MD, surgical director of heart transplantation and chief of the division of heart and lung transplantation and mechanical circulatory support at NYU Langone Health, New York.
Through 72 hours of postoperative monitoring “we evaluated the heart for functionality and the heart function was completely normal with excellent contractility,” he said at a press briefing announcing early results of the experimental program.
He acknowledged that for the first of the two procedures some surgical modification of the pig heart was required, primarily because of size differences between the donor and recipient.
“Nevertheless, we learned a tremendous amount from the first operation, and when that experience was translated into the second operation it even performed better,” he said.
Alex Reyentovich, MD, medical director of heart transplantation and director of the NYU Langone advanced heart failure program noted that “there are 6 million individuals with heart failure in the United States. About 100,000 of those individuals have end-stage heart failure, and we only do about 3,500 heart transplants a year in the United States, so we have a tremendous deficiency in organs, and there are many people dying waiting for a heart.”
Infection protocols
To date there has been only one xenotransplant of a genetically modified pig heart into a living human recipient, David Bennett Sr., age 57. The surgery, performed at the University of Maryland in January 2022, was initially successful, with the patient able to sit up in bed a few days after the procedure, and the heart performing like a “rock star” according to transplant surgeon Bartley Griffith, MD.
However, Mr. Bennett died 2 months after the procedure from compromise of the organ by an as yet undetermined cause, of which one may have been the heart's infection by porcine cytomegalovirus (CMV).
The NYU team, mindful of this potential setback, used more sensitive assays to screen the donor organs for porcine CMV, and implemented protocols to prevent and to monitor for potential zoonotic transmission of porcine endogenous retrovirus.
The procedure used a dedicated operating room and equipment that will not be used for clinical procedures, the team emphasized.
An organ transplant specialist who was not involved in the study commented that there can be unwelcome surprises even with the most rigorous infection prophylaxis protocols.
“I think these are important steps, but they don’t resolve the question of infectious risk. Sometimes viruses or latent infections are only manifested later,” said Jay A. Fishman, MD, associate director of the Massachusetts General Hospital Transplant Center and director of the transplant infectious diseases and compromised host program at the hospital, which is in Boston.
“I think these are important steps, but as you may recall from the Maryland heart transplant experience, when porcine cytomegalovirus was activated, it was a long way into that patient’s course, and so we just don’t know whether something would have been reactivated later,” he said in an interview.
Dr. Fishman noted that experience with xenotransplantation at the University of Maryland and other centers has suggested that immunosuppressive regimens used for human-to-human transplants may not be suited for animal-to-human grafts.
The hearts were taken from pigs genetically modified with knockouts of four porcine genes to prevent rejection – including a gene for a growth hormone that would otherwise cause the heart to continue to expand in the recipient’s chest – and with the addition of six human transgenes encoding for expression of proteins regulating biologic pathways that might be disrupted by incompatibilities across species.
Vietnam veteran
The organ recipients were recently deceased patients who had expressed the clear wish to be organ donors but whose organs were for clinical reasons unsuitable for transplant.
The first recipient was Lawrence Kelly, a Vietnam War veteran and welder who died from heart failure at the age of 72.
“He was an organ donor, and would be so happy to know how much his contribution to this research will help people like him with this heart disease. He was a hero his whole life, and he went out a hero,” said Alice Michael, Mr. Kelly’s partner of 33 years, who also spoke at the briefing.
“It was, I think, one of the most incredible things to see a pig heart pounding away and beating inside the chest of a human being,” said Robert A. Montgomery, MD, DPhil, director of the NYU Transplant Institute, and himself a heart transplant recipient.
Dr. Fishman said he had no relevant conflicts of interest.
This article was updated on 7/12/22 and 7/14/22.
A team of surgeons successfully transplanted genetically engineered pig hearts into two recently deceased people whose bodies were being maintained on ventilatory support – not in the hope of restoring life, but as a proof-of-concept experiment in xenotransplantation that could eventually help to ease the critical shortage of donor organs.
The surgeries were performed on June 16 and July 6, 2022, using porcine hearts from animals genetically engineered to prevent organ rejection and promote adaptive immunity by human recipients
without utilizing unapproved devices or techniques or medications,” said Nader Moazami, MD, surgical director of heart transplantation and chief of the division of heart and lung transplantation and mechanical circulatory support at NYU Langone Health, New York.
Through 72 hours of postoperative monitoring “we evaluated the heart for functionality and the heart function was completely normal with excellent contractility,” he said at a press briefing announcing early results of the experimental program.
He acknowledged that for the first of the two procedures some surgical modification of the pig heart was required, primarily because of size differences between the donor and recipient.
“Nevertheless, we learned a tremendous amount from the first operation, and when that experience was translated into the second operation it even performed better,” he said.
Alex Reyentovich, MD, medical director of heart transplantation and director of the NYU Langone advanced heart failure program noted that “there are 6 million individuals with heart failure in the United States. About 100,000 of those individuals have end-stage heart failure, and we only do about 3,500 heart transplants a year in the United States, so we have a tremendous deficiency in organs, and there are many people dying waiting for a heart.”
Infection protocols
To date there has been only one xenotransplant of a genetically modified pig heart into a living human recipient, David Bennett Sr., age 57. The surgery, performed at the University of Maryland in January 2022, was initially successful, with the patient able to sit up in bed a few days after the procedure, and the heart performing like a “rock star” according to transplant surgeon Bartley Griffith, MD.
However, Mr. Bennett died 2 months after the procedure from compromise of the organ by an as yet undetermined cause, of which one may have been the heart's infection by porcine cytomegalovirus (CMV).
The NYU team, mindful of this potential setback, used more sensitive assays to screen the donor organs for porcine CMV, and implemented protocols to prevent and to monitor for potential zoonotic transmission of porcine endogenous retrovirus.
The procedure used a dedicated operating room and equipment that will not be used for clinical procedures, the team emphasized.
An organ transplant specialist who was not involved in the study commented that there can be unwelcome surprises even with the most rigorous infection prophylaxis protocols.
“I think these are important steps, but they don’t resolve the question of infectious risk. Sometimes viruses or latent infections are only manifested later,” said Jay A. Fishman, MD, associate director of the Massachusetts General Hospital Transplant Center and director of the transplant infectious diseases and compromised host program at the hospital, which is in Boston.
“I think these are important steps, but as you may recall from the Maryland heart transplant experience, when porcine cytomegalovirus was activated, it was a long way into that patient’s course, and so we just don’t know whether something would have been reactivated later,” he said in an interview.
Dr. Fishman noted that experience with xenotransplantation at the University of Maryland and other centers has suggested that immunosuppressive regimens used for human-to-human transplants may not be suited for animal-to-human grafts.
The hearts were taken from pigs genetically modified with knockouts of four porcine genes to prevent rejection – including a gene for a growth hormone that would otherwise cause the heart to continue to expand in the recipient’s chest – and with the addition of six human transgenes encoding for expression of proteins regulating biologic pathways that might be disrupted by incompatibilities across species.
Vietnam veteran
The organ recipients were recently deceased patients who had expressed the clear wish to be organ donors but whose organs were for clinical reasons unsuitable for transplant.
The first recipient was Lawrence Kelly, a Vietnam War veteran and welder who died from heart failure at the age of 72.
“He was an organ donor, and would be so happy to know how much his contribution to this research will help people like him with this heart disease. He was a hero his whole life, and he went out a hero,” said Alice Michael, Mr. Kelly’s partner of 33 years, who also spoke at the briefing.
“It was, I think, one of the most incredible things to see a pig heart pounding away and beating inside the chest of a human being,” said Robert A. Montgomery, MD, DPhil, director of the NYU Transplant Institute, and himself a heart transplant recipient.
Dr. Fishman said he had no relevant conflicts of interest.
This article was updated on 7/12/22 and 7/14/22.
A team of surgeons successfully transplanted genetically engineered pig hearts into two recently deceased people whose bodies were being maintained on ventilatory support – not in the hope of restoring life, but as a proof-of-concept experiment in xenotransplantation that could eventually help to ease the critical shortage of donor organs.
The surgeries were performed on June 16 and July 6, 2022, using porcine hearts from animals genetically engineered to prevent organ rejection and promote adaptive immunity by human recipients
without utilizing unapproved devices or techniques or medications,” said Nader Moazami, MD, surgical director of heart transplantation and chief of the division of heart and lung transplantation and mechanical circulatory support at NYU Langone Health, New York.
Through 72 hours of postoperative monitoring “we evaluated the heart for functionality and the heart function was completely normal with excellent contractility,” he said at a press briefing announcing early results of the experimental program.
He acknowledged that for the first of the two procedures some surgical modification of the pig heart was required, primarily because of size differences between the donor and recipient.
“Nevertheless, we learned a tremendous amount from the first operation, and when that experience was translated into the second operation it even performed better,” he said.
Alex Reyentovich, MD, medical director of heart transplantation and director of the NYU Langone advanced heart failure program noted that “there are 6 million individuals with heart failure in the United States. About 100,000 of those individuals have end-stage heart failure, and we only do about 3,500 heart transplants a year in the United States, so we have a tremendous deficiency in organs, and there are many people dying waiting for a heart.”
Infection protocols
To date there has been only one xenotransplant of a genetically modified pig heart into a living human recipient, David Bennett Sr., age 57. The surgery, performed at the University of Maryland in January 2022, was initially successful, with the patient able to sit up in bed a few days after the procedure, and the heart performing like a “rock star” according to transplant surgeon Bartley Griffith, MD.
However, Mr. Bennett died 2 months after the procedure from compromise of the organ by an as yet undetermined cause, of which one may have been the heart's infection by porcine cytomegalovirus (CMV).
The NYU team, mindful of this potential setback, used more sensitive assays to screen the donor organs for porcine CMV, and implemented protocols to prevent and to monitor for potential zoonotic transmission of porcine endogenous retrovirus.
The procedure used a dedicated operating room and equipment that will not be used for clinical procedures, the team emphasized.
An organ transplant specialist who was not involved in the study commented that there can be unwelcome surprises even with the most rigorous infection prophylaxis protocols.
“I think these are important steps, but they don’t resolve the question of infectious risk. Sometimes viruses or latent infections are only manifested later,” said Jay A. Fishman, MD, associate director of the Massachusetts General Hospital Transplant Center and director of the transplant infectious diseases and compromised host program at the hospital, which is in Boston.
“I think these are important steps, but as you may recall from the Maryland heart transplant experience, when porcine cytomegalovirus was activated, it was a long way into that patient’s course, and so we just don’t know whether something would have been reactivated later,” he said in an interview.
Dr. Fishman noted that experience with xenotransplantation at the University of Maryland and other centers has suggested that immunosuppressive regimens used for human-to-human transplants may not be suited for animal-to-human grafts.
The hearts were taken from pigs genetically modified with knockouts of four porcine genes to prevent rejection – including a gene for a growth hormone that would otherwise cause the heart to continue to expand in the recipient’s chest – and with the addition of six human transgenes encoding for expression of proteins regulating biologic pathways that might be disrupted by incompatibilities across species.
Vietnam veteran
The organ recipients were recently deceased patients who had expressed the clear wish to be organ donors but whose organs were for clinical reasons unsuitable for transplant.
The first recipient was Lawrence Kelly, a Vietnam War veteran and welder who died from heart failure at the age of 72.
“He was an organ donor, and would be so happy to know how much his contribution to this research will help people like him with this heart disease. He was a hero his whole life, and he went out a hero,” said Alice Michael, Mr. Kelly’s partner of 33 years, who also spoke at the briefing.
“It was, I think, one of the most incredible things to see a pig heart pounding away and beating inside the chest of a human being,” said Robert A. Montgomery, MD, DPhil, director of the NYU Transplant Institute, and himself a heart transplant recipient.
Dr. Fishman said he had no relevant conflicts of interest.
This article was updated on 7/12/22 and 7/14/22.
Access to certified stroke centers divided by race, income
Hospitals in low-income and rural areas of the United States are much less likely to adopt stroke certification than hospitals in high-income and urban communities, a new study shows.
Further, other results showed that, after adjustment for population and hospital size, access to stroke-certified hospitals is significantly lower in Black, racially segregated communities.
The study was published online in JAMA Neurology.
Noting that stroke-certified hospitals provide higher-quality stroke care, the authors, led by Yu-Chu Shen, PhD, Naval Postgraduate School, Monterey, Calif., conclude that: “Our findings suggest that structural inequities in stroke care may be an important consideration in eliminating stroke disparities for vulnerable populations.”
In an audio interview on the JAMA Neurology website, senior author Renee Y. Hsia, MD, University of California, San Francisco, said: “Our findings show there are clear disparities in which communities are getting access to stroke certified hospitals.”
She called for more help for hospitals in underserved areas to obtain stroke certification.
Dr. Hsia explained that hospitals can seek certification at their own expense and that although stroke care is expensive, it is also lucrative in terms of reimbursement. So it tends to be the private for-profit hospitals that seek these certifications. “If you are a county hospital on a really tight budget, you’re not going to have the extra cash on hand to be applying for stroke certification,” she commented.
This can result in an increase in hospitals with stroke certification – but not in the areas that need it the most.
Dr. Hsia points out that this has happened in cardiac care. One study showed a 44% increase in hospitals providing percutaneous coronary intervention over a 10-year period, but the percentage of the population that had better access increased by less than 1%.
“In general, in the United States we have a mentality that ‘more is better,’ and because there is no government regulation in health care, any time a hospital applies for these specialized services we just generally think that’s a good thing. But this might not always be the case,” Dr. Hsia noted. “We have a very market-based approach, and this doesn’t lead to equity. It leads to profit maximization, and that is not synonymous with what’s good for patients or populations.”
She suggested that in future the process of certification should include some consideration of how it will affect population-based equity.
“Rather than rubber stamping an application just because hospitals have certain resources, we need to ask what the benefit is of providing this service,” Dr. Hsia said. “Does this community really need it? If not, maybe we should invest these resources into helping a hospital in a community that needs it more.”
Dr. Hsia explained that she and her colleagues conducted their study to investigate whether there were structural issues that might be contributing to disparities in stroke care.
“We like to think emergency stroke care is equitable. Anyone can call 911 or go the emergency room. But, actually, there is a big disparity on who receives what type of care,” she said. “We know Black patients are less likely to receive thrombolytics and mechanical thrombectomy compared to White patents. And wealthy patients are more likely to receive thrombectomy compared to patients from the poorest zip codes.”
She said there is a tendency to think this is a result of some sort of bias on the part of health care professionals. “We wanted to look deep down in the system and whether the built environment of health care supply and geographic distribution of services contributed to access and treatment inequities.”
The study combined a dataset of hospital stroke certification from all general acute nonfederal hospitals in the continental United States from January 2009 to December 2019. National, hospital, and census data were used to identify historically underserved communities by racial and ethnic composition, income distribution, and rurality.
A total of 4,984 hospitals were assessed. Results showed that over the 11-year study period, the number of hospitals with stroke certification grew from 961 (19%) to 1,763 (36%).
Without controlling for population and hospital size, hospitals in predominantly Black, racially segregated areas were 1.67-fold more likely to adopt stroke care of any level than those in predominantly non-Black, racially segregated areas (hazard ratio, 1.67; 95% confidence interval, 1.41-1.97).
However, after adjustment for population and hospital size, the likelihood of adopting stroke care among hospitals serving Black, racially segregated communities was significantly lower than among those serving non-Black, racially segregated communities (HR, 0.74; 95% CI, 0.62-0.89).
“In other words, on a per-capita basis, a hospital serving a predominantly Black, racially segregated community was 26% less likely to adopt stroke certification of any level than a hospital in a predominantly non-Black, racially segregated community,” the authors state.
In terms of socioeconomic factors, hospitals serving low-income, economically integrated (HR, 0.23) and low-income, economically segregated (HR, 0.29) areas were far less likely to adopt any level of stroke care certification than hospitals serving high-income areas, regardless of income segregation.
Rural hospitals were also much less likely to adopt any level of stroke care than urban hospitals (HR, 0.10).
“Our results suggest that it might be necessary to incentivize hospitals operating in underserved communities to seek stroke certification or to entice hospitals with higher propensity to adopt stroke care to operate in such communities so access at the per-patient level becomes more equitable,” the authors say.
This project was supported by the Pilot Project Award from the National Bureau of Economic Research Center for Aging and Health Research, funded by the National Institute on Aging and by the National Center for Advancing Translational Sciences, National Institutes of Health. Dr. Shen and Dr. Hsia have received grants from the National Institute of Aging and the National Heart, Lung, and Blood Institute.
A version of this article first appeared on Medscape.com.
Hospitals in low-income and rural areas of the United States are much less likely to adopt stroke certification than hospitals in high-income and urban communities, a new study shows.
Further, other results showed that, after adjustment for population and hospital size, access to stroke-certified hospitals is significantly lower in Black, racially segregated communities.
The study was published online in JAMA Neurology.
Noting that stroke-certified hospitals provide higher-quality stroke care, the authors, led by Yu-Chu Shen, PhD, Naval Postgraduate School, Monterey, Calif., conclude that: “Our findings suggest that structural inequities in stroke care may be an important consideration in eliminating stroke disparities for vulnerable populations.”
In an audio interview on the JAMA Neurology website, senior author Renee Y. Hsia, MD, University of California, San Francisco, said: “Our findings show there are clear disparities in which communities are getting access to stroke certified hospitals.”
She called for more help for hospitals in underserved areas to obtain stroke certification.
Dr. Hsia explained that hospitals can seek certification at their own expense and that although stroke care is expensive, it is also lucrative in terms of reimbursement. So it tends to be the private for-profit hospitals that seek these certifications. “If you are a county hospital on a really tight budget, you’re not going to have the extra cash on hand to be applying for stroke certification,” she commented.
This can result in an increase in hospitals with stroke certification – but not in the areas that need it the most.
Dr. Hsia points out that this has happened in cardiac care. One study showed a 44% increase in hospitals providing percutaneous coronary intervention over a 10-year period, but the percentage of the population that had better access increased by less than 1%.
“In general, in the United States we have a mentality that ‘more is better,’ and because there is no government regulation in health care, any time a hospital applies for these specialized services we just generally think that’s a good thing. But this might not always be the case,” Dr. Hsia noted. “We have a very market-based approach, and this doesn’t lead to equity. It leads to profit maximization, and that is not synonymous with what’s good for patients or populations.”
She suggested that in future the process of certification should include some consideration of how it will affect population-based equity.
“Rather than rubber stamping an application just because hospitals have certain resources, we need to ask what the benefit is of providing this service,” Dr. Hsia said. “Does this community really need it? If not, maybe we should invest these resources into helping a hospital in a community that needs it more.”
Dr. Hsia explained that she and her colleagues conducted their study to investigate whether there were structural issues that might be contributing to disparities in stroke care.
“We like to think emergency stroke care is equitable. Anyone can call 911 or go the emergency room. But, actually, there is a big disparity on who receives what type of care,” she said. “We know Black patients are less likely to receive thrombolytics and mechanical thrombectomy compared to White patents. And wealthy patients are more likely to receive thrombectomy compared to patients from the poorest zip codes.”
She said there is a tendency to think this is a result of some sort of bias on the part of health care professionals. “We wanted to look deep down in the system and whether the built environment of health care supply and geographic distribution of services contributed to access and treatment inequities.”
The study combined a dataset of hospital stroke certification from all general acute nonfederal hospitals in the continental United States from January 2009 to December 2019. National, hospital, and census data were used to identify historically underserved communities by racial and ethnic composition, income distribution, and rurality.
A total of 4,984 hospitals were assessed. Results showed that over the 11-year study period, the number of hospitals with stroke certification grew from 961 (19%) to 1,763 (36%).
Without controlling for population and hospital size, hospitals in predominantly Black, racially segregated areas were 1.67-fold more likely to adopt stroke care of any level than those in predominantly non-Black, racially segregated areas (hazard ratio, 1.67; 95% confidence interval, 1.41-1.97).
However, after adjustment for population and hospital size, the likelihood of adopting stroke care among hospitals serving Black, racially segregated communities was significantly lower than among those serving non-Black, racially segregated communities (HR, 0.74; 95% CI, 0.62-0.89).
“In other words, on a per-capita basis, a hospital serving a predominantly Black, racially segregated community was 26% less likely to adopt stroke certification of any level than a hospital in a predominantly non-Black, racially segregated community,” the authors state.
In terms of socioeconomic factors, hospitals serving low-income, economically integrated (HR, 0.23) and low-income, economically segregated (HR, 0.29) areas were far less likely to adopt any level of stroke care certification than hospitals serving high-income areas, regardless of income segregation.
Rural hospitals were also much less likely to adopt any level of stroke care than urban hospitals (HR, 0.10).
“Our results suggest that it might be necessary to incentivize hospitals operating in underserved communities to seek stroke certification or to entice hospitals with higher propensity to adopt stroke care to operate in such communities so access at the per-patient level becomes more equitable,” the authors say.
This project was supported by the Pilot Project Award from the National Bureau of Economic Research Center for Aging and Health Research, funded by the National Institute on Aging and by the National Center for Advancing Translational Sciences, National Institutes of Health. Dr. Shen and Dr. Hsia have received grants from the National Institute of Aging and the National Heart, Lung, and Blood Institute.
A version of this article first appeared on Medscape.com.
Hospitals in low-income and rural areas of the United States are much less likely to adopt stroke certification than hospitals in high-income and urban communities, a new study shows.
Further, other results showed that, after adjustment for population and hospital size, access to stroke-certified hospitals is significantly lower in Black, racially segregated communities.
The study was published online in JAMA Neurology.
Noting that stroke-certified hospitals provide higher-quality stroke care, the authors, led by Yu-Chu Shen, PhD, Naval Postgraduate School, Monterey, Calif., conclude that: “Our findings suggest that structural inequities in stroke care may be an important consideration in eliminating stroke disparities for vulnerable populations.”
In an audio interview on the JAMA Neurology website, senior author Renee Y. Hsia, MD, University of California, San Francisco, said: “Our findings show there are clear disparities in which communities are getting access to stroke certified hospitals.”
She called for more help for hospitals in underserved areas to obtain stroke certification.
Dr. Hsia explained that hospitals can seek certification at their own expense and that although stroke care is expensive, it is also lucrative in terms of reimbursement. So it tends to be the private for-profit hospitals that seek these certifications. “If you are a county hospital on a really tight budget, you’re not going to have the extra cash on hand to be applying for stroke certification,” she commented.
This can result in an increase in hospitals with stroke certification – but not in the areas that need it the most.
Dr. Hsia points out that this has happened in cardiac care. One study showed a 44% increase in hospitals providing percutaneous coronary intervention over a 10-year period, but the percentage of the population that had better access increased by less than 1%.
“In general, in the United States we have a mentality that ‘more is better,’ and because there is no government regulation in health care, any time a hospital applies for these specialized services we just generally think that’s a good thing. But this might not always be the case,” Dr. Hsia noted. “We have a very market-based approach, and this doesn’t lead to equity. It leads to profit maximization, and that is not synonymous with what’s good for patients or populations.”
She suggested that in future the process of certification should include some consideration of how it will affect population-based equity.
“Rather than rubber stamping an application just because hospitals have certain resources, we need to ask what the benefit is of providing this service,” Dr. Hsia said. “Does this community really need it? If not, maybe we should invest these resources into helping a hospital in a community that needs it more.”
Dr. Hsia explained that she and her colleagues conducted their study to investigate whether there were structural issues that might be contributing to disparities in stroke care.
“We like to think emergency stroke care is equitable. Anyone can call 911 or go the emergency room. But, actually, there is a big disparity on who receives what type of care,” she said. “We know Black patients are less likely to receive thrombolytics and mechanical thrombectomy compared to White patents. And wealthy patients are more likely to receive thrombectomy compared to patients from the poorest zip codes.”
She said there is a tendency to think this is a result of some sort of bias on the part of health care professionals. “We wanted to look deep down in the system and whether the built environment of health care supply and geographic distribution of services contributed to access and treatment inequities.”
The study combined a dataset of hospital stroke certification from all general acute nonfederal hospitals in the continental United States from January 2009 to December 2019. National, hospital, and census data were used to identify historically underserved communities by racial and ethnic composition, income distribution, and rurality.
A total of 4,984 hospitals were assessed. Results showed that over the 11-year study period, the number of hospitals with stroke certification grew from 961 (19%) to 1,763 (36%).
Without controlling for population and hospital size, hospitals in predominantly Black, racially segregated areas were 1.67-fold more likely to adopt stroke care of any level than those in predominantly non-Black, racially segregated areas (hazard ratio, 1.67; 95% confidence interval, 1.41-1.97).
However, after adjustment for population and hospital size, the likelihood of adopting stroke care among hospitals serving Black, racially segregated communities was significantly lower than among those serving non-Black, racially segregated communities (HR, 0.74; 95% CI, 0.62-0.89).
“In other words, on a per-capita basis, a hospital serving a predominantly Black, racially segregated community was 26% less likely to adopt stroke certification of any level than a hospital in a predominantly non-Black, racially segregated community,” the authors state.
In terms of socioeconomic factors, hospitals serving low-income, economically integrated (HR, 0.23) and low-income, economically segregated (HR, 0.29) areas were far less likely to adopt any level of stroke care certification than hospitals serving high-income areas, regardless of income segregation.
Rural hospitals were also much less likely to adopt any level of stroke care than urban hospitals (HR, 0.10).
“Our results suggest that it might be necessary to incentivize hospitals operating in underserved communities to seek stroke certification or to entice hospitals with higher propensity to adopt stroke care to operate in such communities so access at the per-patient level becomes more equitable,” the authors say.
This project was supported by the Pilot Project Award from the National Bureau of Economic Research Center for Aging and Health Research, funded by the National Institute on Aging and by the National Center for Advancing Translational Sciences, National Institutes of Health. Dr. Shen and Dr. Hsia have received grants from the National Institute of Aging and the National Heart, Lung, and Blood Institute.
A version of this article first appeared on Medscape.com.
Heart attack care not equal for women and people of color
Radiating chest pain, shortness of breath, nausea, lightheadedness. Everyone knows the telltale signs of a myocardial infarction. Yet a new study shows that despite this widespread recognition, heart attacks aren’t attended to quickly across the board. Historically, the study says, women and people of color wait longer to access emergency care for a heart attack.
Researchers from the University of California, San Francisco published these findings in the Annals of Emergency Medicine. The study used the Office of Statewide Health Planning and Development dataset to gather information on 453,136 cases of heart attack in California between 2005 and 2015. They found that over time, differences in timely treatment between the demographics narrowed, but the gap still existed.
The study defined timely treatment as receiving care for a heart attack within 3 days of admission to a hospital. Women and people of color were found to wait 3 days or more to receive care than their White male counterparts. A disparity of this sort can cause ripples of health effects across society, ripples that doctors should be aware of, says lead author Juan Carlos Montoy, MD. Dr. Montoy was “sadly surprised by our findings that disparities for women and for Black patients only decreased slightly or not at all over time.”
In the study, the team separated the dataset between the two primary types of heart attack: ST-segment elevation myocardial infarction (STEMI), caused by blood vessel blockage, and non–ST-segment elevation myocardial infarction (NSTEMI), caused by a narrowing or temporary blockage of the artery.
Regardless of the type of heart attack, the standard first step in treatment is a coronary angiogram. After finding out where blood flow is disrupted using the angiogram, a physician can proceed with treatment.
But when looking back, the team found that it took a while for many patients to receive this first step in treatment. In 2005, 50% of men and 35.7% of women with STEMI and 45% of men and 33.1% of women with NSTEMI had a timely angiography. In the same year, 46% of White patients and 31.2% of Black patients with STEMI underwent timely angiography.
By 2015, timely treatment increased across the board, but there were still discrepancies, with 76.7% of men and 66.8% of women with STEMI undergoing timely angiography and 56.3% of men and 45.9% of women with NSTEMI undergoing timely angiography. Also in 2015, 75.2% of White patients and 69.2% of Black patients underwent timely angiography for STEMI.
Although differences in care decreased between the demographics, the gap still exists. Whereas this dataset only extends to 2015, this trend may still persist today, says Robert Glatter, MD, an emergency medicine physician at Lenox Hill Hospital, New York, who was not involved in the study. Therefore, physicians need to consider this bias when treating patients. “The bottom line is that we continue to have much work to do to achieve equality in managing not only medical conditions but treating people who have them equally,” Dr. Glatter said.
“Raising awareness of ongoing inequality in care related to gender and ethnic disparities is critical to drive change in our institutions,” he emphasized. “We simply cannot accept the status quo.”
The study was funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health. Dr. Glatter and the authors declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Radiating chest pain, shortness of breath, nausea, lightheadedness. Everyone knows the telltale signs of a myocardial infarction. Yet a new study shows that despite this widespread recognition, heart attacks aren’t attended to quickly across the board. Historically, the study says, women and people of color wait longer to access emergency care for a heart attack.
Researchers from the University of California, San Francisco published these findings in the Annals of Emergency Medicine. The study used the Office of Statewide Health Planning and Development dataset to gather information on 453,136 cases of heart attack in California between 2005 and 2015. They found that over time, differences in timely treatment between the demographics narrowed, but the gap still existed.
The study defined timely treatment as receiving care for a heart attack within 3 days of admission to a hospital. Women and people of color were found to wait 3 days or more to receive care than their White male counterparts. A disparity of this sort can cause ripples of health effects across society, ripples that doctors should be aware of, says lead author Juan Carlos Montoy, MD. Dr. Montoy was “sadly surprised by our findings that disparities for women and for Black patients only decreased slightly or not at all over time.”
In the study, the team separated the dataset between the two primary types of heart attack: ST-segment elevation myocardial infarction (STEMI), caused by blood vessel blockage, and non–ST-segment elevation myocardial infarction (NSTEMI), caused by a narrowing or temporary blockage of the artery.
Regardless of the type of heart attack, the standard first step in treatment is a coronary angiogram. After finding out where blood flow is disrupted using the angiogram, a physician can proceed with treatment.
But when looking back, the team found that it took a while for many patients to receive this first step in treatment. In 2005, 50% of men and 35.7% of women with STEMI and 45% of men and 33.1% of women with NSTEMI had a timely angiography. In the same year, 46% of White patients and 31.2% of Black patients with STEMI underwent timely angiography.
By 2015, timely treatment increased across the board, but there were still discrepancies, with 76.7% of men and 66.8% of women with STEMI undergoing timely angiography and 56.3% of men and 45.9% of women with NSTEMI undergoing timely angiography. Also in 2015, 75.2% of White patients and 69.2% of Black patients underwent timely angiography for STEMI.
Although differences in care decreased between the demographics, the gap still exists. Whereas this dataset only extends to 2015, this trend may still persist today, says Robert Glatter, MD, an emergency medicine physician at Lenox Hill Hospital, New York, who was not involved in the study. Therefore, physicians need to consider this bias when treating patients. “The bottom line is that we continue to have much work to do to achieve equality in managing not only medical conditions but treating people who have them equally,” Dr. Glatter said.
“Raising awareness of ongoing inequality in care related to gender and ethnic disparities is critical to drive change in our institutions,” he emphasized. “We simply cannot accept the status quo.”
The study was funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health. Dr. Glatter and the authors declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Radiating chest pain, shortness of breath, nausea, lightheadedness. Everyone knows the telltale signs of a myocardial infarction. Yet a new study shows that despite this widespread recognition, heart attacks aren’t attended to quickly across the board. Historically, the study says, women and people of color wait longer to access emergency care for a heart attack.
Researchers from the University of California, San Francisco published these findings in the Annals of Emergency Medicine. The study used the Office of Statewide Health Planning and Development dataset to gather information on 453,136 cases of heart attack in California between 2005 and 2015. They found that over time, differences in timely treatment between the demographics narrowed, but the gap still existed.
The study defined timely treatment as receiving care for a heart attack within 3 days of admission to a hospital. Women and people of color were found to wait 3 days or more to receive care than their White male counterparts. A disparity of this sort can cause ripples of health effects across society, ripples that doctors should be aware of, says lead author Juan Carlos Montoy, MD. Dr. Montoy was “sadly surprised by our findings that disparities for women and for Black patients only decreased slightly or not at all over time.”
In the study, the team separated the dataset between the two primary types of heart attack: ST-segment elevation myocardial infarction (STEMI), caused by blood vessel blockage, and non–ST-segment elevation myocardial infarction (NSTEMI), caused by a narrowing or temporary blockage of the artery.
Regardless of the type of heart attack, the standard first step in treatment is a coronary angiogram. After finding out where blood flow is disrupted using the angiogram, a physician can proceed with treatment.
But when looking back, the team found that it took a while for many patients to receive this first step in treatment. In 2005, 50% of men and 35.7% of women with STEMI and 45% of men and 33.1% of women with NSTEMI had a timely angiography. In the same year, 46% of White patients and 31.2% of Black patients with STEMI underwent timely angiography.
By 2015, timely treatment increased across the board, but there were still discrepancies, with 76.7% of men and 66.8% of women with STEMI undergoing timely angiography and 56.3% of men and 45.9% of women with NSTEMI undergoing timely angiography. Also in 2015, 75.2% of White patients and 69.2% of Black patients underwent timely angiography for STEMI.
Although differences in care decreased between the demographics, the gap still exists. Whereas this dataset only extends to 2015, this trend may still persist today, says Robert Glatter, MD, an emergency medicine physician at Lenox Hill Hospital, New York, who was not involved in the study. Therefore, physicians need to consider this bias when treating patients. “The bottom line is that we continue to have much work to do to achieve equality in managing not only medical conditions but treating people who have them equally,” Dr. Glatter said.
“Raising awareness of ongoing inequality in care related to gender and ethnic disparities is critical to drive change in our institutions,” he emphasized. “We simply cannot accept the status quo.”
The study was funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health. Dr. Glatter and the authors declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM ANNALS OF EMERGENCY MEDICINE
Nordic walking bests other workouts on functional outcome in CVD
Nordic walking was significantly better at improving functional capacity than were moderate- to vigorous-intensity continuous training and high-intensity interval training (HIIT) in a single-center randomized controlled trial.
Participants who did Nordic walking saw better improvements in functional capacity, measured via the 6-minute walk test distances, than did individuals doing either of the other exercise strategies (interaction effect, P = .010).
From baseline to 26 weeks, the average changes in 6-minute walk test distance were 55.6 m and 59.9 m for moderate- to vigorous-intensity continuous training and HIIT, respectively, but 94.2 m in the Nordic walking group, reported Tasuku Terada, PhD, University of Ottawa Heart Institute, Ontario, and colleagues.
Previous research looked at these results at the end of a 12-week supervised exercise intervention and showed that although all three strategies were safe and had positive effects on physical and mental health in these patients, Nordic walking had a better effect in raising the 6-minute walk test scores than did moderate- to vigorous-intensity continuous training and HIIT, the researchers noted.
“This study is a follow-up on the previous study to show that Nordic walking had greater sustained effects even after the observation phase,” from 12 to 26 weeks, Dr. Terada said in an interview.
“Exercise is a medicine to improve the health of patients, but unfortunately, sometimes it is not as often utilized,” Dr. Terada told this news organization.
Giving patients additional exercise modalities is beneficial because not everyone likes HIIT workouts or long continuous walking, Dr. Terada said. “So, if that’s the case, we can recommend Nordic walking as another type of exercise and expect a similar or good impact in functional capacity.”
The results were published online in the Canadian Journal of Cardiology.
“I think it honestly supports the idea that, as many other studies show, physical activity and exercise improve functional capacity no matter how you measure it and have beneficial effects on mental health and quality of life and particularly depression as well,” Carl “Chip” Lavie, MD, University of Queensland, New Orleans, who coauthored an editorial accompanying the publication, said in an interview.
“Clinicians need to get patients to do the type of exercise that they are going to do. A lot of people ask what’s the best exercise, and the best exercise is one that the person is going to do,” Dr. Lavie said.
Nordic walking is an enhanced form of walking that engages the upper and lower body musculatures, noted Dr. Lavie.
“With regard to Nordic walking, I think that now adds an additional option that many people wouldn’t have thought about. For many of the patients that have issues that are musculoskeletal, issues with posture, gait, or balance, using the poles can be a way to allow them to walk much better and increase their speed, and as they do that, they become fitter,” Dr. Lavie continued.
Moreover, these findings support the use of Nordic walking in cardiac rehabilitation programs, the editorialists noted.
Cardiac rehabilitation
The study examined patients with coronary artery disease who underwent cardiac revascularization. They were then referred by their physicians to cardiac rehabilitation.
Participants were randomly assigned to one of the following intervention groups: Nordic walking (n = 30), moderate- to vigorous-intensity continuous training (n = 27), and HIIT (n = 29) for a 12-week period. There was then an additional 14-week observation period after the exercise program. Mean age was 60 years across the intervention groups.
The research team analyzed the extent of participants’ depression with Beck Depression Inventory–II, quality of life with Short Form–36 and HeartQoL, and functional capacity with a 6-minute walk test. They assessed functional capacity, depression, and quality of life at baseline, 12 weeks, and 26 weeks.
Using linear mixed models with extended measures, the study authors evaluated sustained effects, which were between week 12 and week 26, and prolonged effects, which were between baseline and week 26.
From baseline to 26 weeks, participants saw significantly better outcomes in quality of life, depression symptoms, and 6-minute walk test (P < .05).
Physical quality of life and 6-minute walk test distance rose significantly between weeks 12 and 26 (P < .05).
Notably, at week 26, all training groups achieved the minimal clinical threshold difference of 54 m, although participants in the Nordic walking cohort demonstrated significantly greater improvement in outcomes.
Other data indicated the following:
- From baseline to week 12, physical activity levels rose significantly, and this improvement was sustained through the observation period.
- During the observation period, mental component summary significantly declined while physical component summary outcomes improved.
- After completion of cardiac rehabilitation, functional capacity continued to increase significantly.
- Moderate- to vigorous-intensity continuous training, HIIT, and Nordic walking had positive and significant prolonged effects on depression symptoms and general and disease-specific quality of life, with no differences in the extent of improvements between exercise types.
Some limitations of the study include the fact that women comprised a small portion of the study group, which limits the generalizability of these data, the cohort was recruited from a single medical facility, and there was a short follow-up time, the researchers noted.
“Further research is warranted to investigate the efficacy and integration of Nordic walking into home-based exercise after supervised cardiac rehabilitation for maintenance of physical and mental health,” the editorialists concluded.
Dr. Terada, Dr. Lavie, and Dr. Taylor reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Nordic walking was significantly better at improving functional capacity than were moderate- to vigorous-intensity continuous training and high-intensity interval training (HIIT) in a single-center randomized controlled trial.
Participants who did Nordic walking saw better improvements in functional capacity, measured via the 6-minute walk test distances, than did individuals doing either of the other exercise strategies (interaction effect, P = .010).
From baseline to 26 weeks, the average changes in 6-minute walk test distance were 55.6 m and 59.9 m for moderate- to vigorous-intensity continuous training and HIIT, respectively, but 94.2 m in the Nordic walking group, reported Tasuku Terada, PhD, University of Ottawa Heart Institute, Ontario, and colleagues.
Previous research looked at these results at the end of a 12-week supervised exercise intervention and showed that although all three strategies were safe and had positive effects on physical and mental health in these patients, Nordic walking had a better effect in raising the 6-minute walk test scores than did moderate- to vigorous-intensity continuous training and HIIT, the researchers noted.
“This study is a follow-up on the previous study to show that Nordic walking had greater sustained effects even after the observation phase,” from 12 to 26 weeks, Dr. Terada said in an interview.
“Exercise is a medicine to improve the health of patients, but unfortunately, sometimes it is not as often utilized,” Dr. Terada told this news organization.
Giving patients additional exercise modalities is beneficial because not everyone likes HIIT workouts or long continuous walking, Dr. Terada said. “So, if that’s the case, we can recommend Nordic walking as another type of exercise and expect a similar or good impact in functional capacity.”
The results were published online in the Canadian Journal of Cardiology.
“I think it honestly supports the idea that, as many other studies show, physical activity and exercise improve functional capacity no matter how you measure it and have beneficial effects on mental health and quality of life and particularly depression as well,” Carl “Chip” Lavie, MD, University of Queensland, New Orleans, who coauthored an editorial accompanying the publication, said in an interview.
“Clinicians need to get patients to do the type of exercise that they are going to do. A lot of people ask what’s the best exercise, and the best exercise is one that the person is going to do,” Dr. Lavie said.
Nordic walking is an enhanced form of walking that engages the upper and lower body musculatures, noted Dr. Lavie.
“With regard to Nordic walking, I think that now adds an additional option that many people wouldn’t have thought about. For many of the patients that have issues that are musculoskeletal, issues with posture, gait, or balance, using the poles can be a way to allow them to walk much better and increase their speed, and as they do that, they become fitter,” Dr. Lavie continued.
Moreover, these findings support the use of Nordic walking in cardiac rehabilitation programs, the editorialists noted.
Cardiac rehabilitation
The study examined patients with coronary artery disease who underwent cardiac revascularization. They were then referred by their physicians to cardiac rehabilitation.
Participants were randomly assigned to one of the following intervention groups: Nordic walking (n = 30), moderate- to vigorous-intensity continuous training (n = 27), and HIIT (n = 29) for a 12-week period. There was then an additional 14-week observation period after the exercise program. Mean age was 60 years across the intervention groups.
The research team analyzed the extent of participants’ depression with Beck Depression Inventory–II, quality of life with Short Form–36 and HeartQoL, and functional capacity with a 6-minute walk test. They assessed functional capacity, depression, and quality of life at baseline, 12 weeks, and 26 weeks.
Using linear mixed models with extended measures, the study authors evaluated sustained effects, which were between week 12 and week 26, and prolonged effects, which were between baseline and week 26.
From baseline to 26 weeks, participants saw significantly better outcomes in quality of life, depression symptoms, and 6-minute walk test (P < .05).
Physical quality of life and 6-minute walk test distance rose significantly between weeks 12 and 26 (P < .05).
Notably, at week 26, all training groups achieved the minimal clinical threshold difference of 54 m, although participants in the Nordic walking cohort demonstrated significantly greater improvement in outcomes.
Other data indicated the following:
- From baseline to week 12, physical activity levels rose significantly, and this improvement was sustained through the observation period.
- During the observation period, mental component summary significantly declined while physical component summary outcomes improved.
- After completion of cardiac rehabilitation, functional capacity continued to increase significantly.
- Moderate- to vigorous-intensity continuous training, HIIT, and Nordic walking had positive and significant prolonged effects on depression symptoms and general and disease-specific quality of life, with no differences in the extent of improvements between exercise types.
Some limitations of the study include the fact that women comprised a small portion of the study group, which limits the generalizability of these data, the cohort was recruited from a single medical facility, and there was a short follow-up time, the researchers noted.
“Further research is warranted to investigate the efficacy and integration of Nordic walking into home-based exercise after supervised cardiac rehabilitation for maintenance of physical and mental health,” the editorialists concluded.
Dr. Terada, Dr. Lavie, and Dr. Taylor reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Nordic walking was significantly better at improving functional capacity than were moderate- to vigorous-intensity continuous training and high-intensity interval training (HIIT) in a single-center randomized controlled trial.
Participants who did Nordic walking saw better improvements in functional capacity, measured via the 6-minute walk test distances, than did individuals doing either of the other exercise strategies (interaction effect, P = .010).
From baseline to 26 weeks, the average changes in 6-minute walk test distance were 55.6 m and 59.9 m for moderate- to vigorous-intensity continuous training and HIIT, respectively, but 94.2 m in the Nordic walking group, reported Tasuku Terada, PhD, University of Ottawa Heart Institute, Ontario, and colleagues.
Previous research looked at these results at the end of a 12-week supervised exercise intervention and showed that although all three strategies were safe and had positive effects on physical and mental health in these patients, Nordic walking had a better effect in raising the 6-minute walk test scores than did moderate- to vigorous-intensity continuous training and HIIT, the researchers noted.
“This study is a follow-up on the previous study to show that Nordic walking had greater sustained effects even after the observation phase,” from 12 to 26 weeks, Dr. Terada said in an interview.
“Exercise is a medicine to improve the health of patients, but unfortunately, sometimes it is not as often utilized,” Dr. Terada told this news organization.
Giving patients additional exercise modalities is beneficial because not everyone likes HIIT workouts or long continuous walking, Dr. Terada said. “So, if that’s the case, we can recommend Nordic walking as another type of exercise and expect a similar or good impact in functional capacity.”
The results were published online in the Canadian Journal of Cardiology.
“I think it honestly supports the idea that, as many other studies show, physical activity and exercise improve functional capacity no matter how you measure it and have beneficial effects on mental health and quality of life and particularly depression as well,” Carl “Chip” Lavie, MD, University of Queensland, New Orleans, who coauthored an editorial accompanying the publication, said in an interview.
“Clinicians need to get patients to do the type of exercise that they are going to do. A lot of people ask what’s the best exercise, and the best exercise is one that the person is going to do,” Dr. Lavie said.
Nordic walking is an enhanced form of walking that engages the upper and lower body musculatures, noted Dr. Lavie.
“With regard to Nordic walking, I think that now adds an additional option that many people wouldn’t have thought about. For many of the patients that have issues that are musculoskeletal, issues with posture, gait, or balance, using the poles can be a way to allow them to walk much better and increase their speed, and as they do that, they become fitter,” Dr. Lavie continued.
Moreover, these findings support the use of Nordic walking in cardiac rehabilitation programs, the editorialists noted.
Cardiac rehabilitation
The study examined patients with coronary artery disease who underwent cardiac revascularization. They were then referred by their physicians to cardiac rehabilitation.
Participants were randomly assigned to one of the following intervention groups: Nordic walking (n = 30), moderate- to vigorous-intensity continuous training (n = 27), and HIIT (n = 29) for a 12-week period. There was then an additional 14-week observation period after the exercise program. Mean age was 60 years across the intervention groups.
The research team analyzed the extent of participants’ depression with Beck Depression Inventory–II, quality of life with Short Form–36 and HeartQoL, and functional capacity with a 6-minute walk test. They assessed functional capacity, depression, and quality of life at baseline, 12 weeks, and 26 weeks.
Using linear mixed models with extended measures, the study authors evaluated sustained effects, which were between week 12 and week 26, and prolonged effects, which were between baseline and week 26.
From baseline to 26 weeks, participants saw significantly better outcomes in quality of life, depression symptoms, and 6-minute walk test (P < .05).
Physical quality of life and 6-minute walk test distance rose significantly between weeks 12 and 26 (P < .05).
Notably, at week 26, all training groups achieved the minimal clinical threshold difference of 54 m, although participants in the Nordic walking cohort demonstrated significantly greater improvement in outcomes.
Other data indicated the following:
- From baseline to week 12, physical activity levels rose significantly, and this improvement was sustained through the observation period.
- During the observation period, mental component summary significantly declined while physical component summary outcomes improved.
- After completion of cardiac rehabilitation, functional capacity continued to increase significantly.
- Moderate- to vigorous-intensity continuous training, HIIT, and Nordic walking had positive and significant prolonged effects on depression symptoms and general and disease-specific quality of life, with no differences in the extent of improvements between exercise types.
Some limitations of the study include the fact that women comprised a small portion of the study group, which limits the generalizability of these data, the cohort was recruited from a single medical facility, and there was a short follow-up time, the researchers noted.
“Further research is warranted to investigate the efficacy and integration of Nordic walking into home-based exercise after supervised cardiac rehabilitation for maintenance of physical and mental health,” the editorialists concluded.
Dr. Terada, Dr. Lavie, and Dr. Taylor reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE CANADIAN JOURNAL OF CARDIOLOGY
Early cardiac rehab as effective as later start after sternotomy
Cardiac rehabilitation (CR) started 2 weeks after sternotomy for a cardiac procedure was noninferior to usual care, in which CR starts 6 weeks after the procedure, with a greater improvement in 6-minute walk test outcomes, a randomized study suggests.
There was no difference in adverse events between groups, although the researchers pointed out that the study was not powered specifically for safety outcomes.
“Cardiac surgical techniques have evolved significantly over the last 60 years, leading to improved survival and shorter hospital stays,” Gordon McGregor, PhD, University of Warwick, Coventry, England, told this news organization. “However, sternal precautions and rehabilitation guidelines have not changed accordingly. There has never been a guideline based on empirical evidence to support rehabilitation professionals working with cardiac surgery patients after median sternotomy.”
“By adopting a progressive individualized approach,” he added, “cardiac surgery sternotomy patients can start cardiac rehabilitation up to 4 weeks earlier than current guidance, and thus potentially complete their recovery sooner.”
Results of the Early Initiation of Poststernotomy Cardiac Rehabilitation Exercise Training study were published online in JAMA Cardiology.
In the study, Dr. McGregor and colleagues randomly assigned 158 patients (mean age, 63 years; 84% men) to 8 weeks of 1-hour, twice-weekly supervised CR exercise training starting 2 weeks (early) or 6 weeks (usual care) after sternotomy.
The primary outcome was change in the 6-minute walk test distance from baseline to 10 or 14 weeks after sternotomy, respectively, and 12 months after randomization.
For usual care, training followed British standards: a warm-up with light cardiovascular and mobility exercises; continuous moderate-intensity cardiovascular exercise; a cooldown; functional exercises using resistance machines and free weights; and upper-body exercises designed to prevent sternal and leg wound pain and complications.
There are no specific outpatient CR exercise guidelines for early CR, so study participants followed an individualized exercise program for the first 2-3 weeks after surgery, starting with light mobility and moderate-intensity cardiovascular training when they could do those exercises with minimal discomfort. They then progressed to current British standards, as per usual care.
Forty patients were lost to follow-up, largely because of the pandemic; about half the participants in each group were included in the primary analysis.
Early CR was not inferior to usual care, the authors wrote. The mean change in 6-minute walk distance from baseline to completion of CR was 28 meters greater in the early group than in the usual-care group, and was achieved 4 weeks earlier in the recovery timeline.
Secondary outcomes (functional fitness and quality of life) improved in both groups and between-group differences were not statistically significant, indicating the noninferiority of early CR, the authors noted.
Safety not proven
There were more adverse events in the early group than in the usual-care group (58 vs. 46) and more serious adverse events (18 vs. 14), but fewer deaths (1 vs. 2).
Although there was no between-group difference in the likelihood of having an adverse or serious adverse event, Dr. McGregor acknowledged that the study was “not powered specifically for safety outcomes.” He added that “there is the potential to run a very large multination definitive superiority [randomized, controlled trial] with safety as the primary outcome; however, a very large sample would be required.”
Meanwhile, he said, “we can say with some degree of certainty that early CR was likely as safe as usual-care CR. In the United Kingdom, we work closely with the British Association for Cardiovascular Prevention and Rehabilitation and the Association of Chartered Physiotherapists in Cardiovascular Rehabilitation, who will incorporate our findings in their guidelines and training courses.”
Questions remain
Asked to comment on the study, John Larry, MD, medical director of cardiology and cardiac rehabilitation at the Ohio State University Wexner Medical Center East Hospital, Columbus, said: “For those under time pressure to return to work, [early CR] could be an advantage to allow more rehab time and improved stamina prior to their return-to-work date.”
That said, he noted, “we typically delay any significant upper-body training activities for 8-10 weeks to avoid impact on healing of the sternum. Thus ... starting sooner would limit the amount of time a patient would have to engage in any upper-body resistance training. Many lose upper body strength after surgery, so this is an important part of the recovery/rehab process.”
Matthew Tomey, MD, director of the cardiac intensive care unit, Mount Sinai Morningside, New York, advised “caution” when interpreting the findings, stating that “there was no evident difference in the primary outcome measure of functional capacity by 14 weeks, and the trial was not designed to directly assess impact on either social functioning or economic productivity.”
“I would be interested to [see] more comprehensive data on safety in a larger, more diverse sample of postoperative patients,” he said, “as well as evidence to indicate clear advantage of an earlier start for patient-centered outcomes specifically after cardiac surgery.
“Perhaps the greatest challenges to full realization of the benefits of CR in practice have been gaps in referral and gaps in enrollment,” he added. “It is incumbent upon us as clinicians to counsel our patients and to provide appropriate referrals.”
The study was supported by the Medical and Life Sciences Research Fund and the Jeremy Pilcher Memorial Fund. No conflicts of interest were reported.
A version of this article first appeared on Medscape.com.
Cardiac rehabilitation (CR) started 2 weeks after sternotomy for a cardiac procedure was noninferior to usual care, in which CR starts 6 weeks after the procedure, with a greater improvement in 6-minute walk test outcomes, a randomized study suggests.
There was no difference in adverse events between groups, although the researchers pointed out that the study was not powered specifically for safety outcomes.
“Cardiac surgical techniques have evolved significantly over the last 60 years, leading to improved survival and shorter hospital stays,” Gordon McGregor, PhD, University of Warwick, Coventry, England, told this news organization. “However, sternal precautions and rehabilitation guidelines have not changed accordingly. There has never been a guideline based on empirical evidence to support rehabilitation professionals working with cardiac surgery patients after median sternotomy.”
“By adopting a progressive individualized approach,” he added, “cardiac surgery sternotomy patients can start cardiac rehabilitation up to 4 weeks earlier than current guidance, and thus potentially complete their recovery sooner.”
Results of the Early Initiation of Poststernotomy Cardiac Rehabilitation Exercise Training study were published online in JAMA Cardiology.
In the study, Dr. McGregor and colleagues randomly assigned 158 patients (mean age, 63 years; 84% men) to 8 weeks of 1-hour, twice-weekly supervised CR exercise training starting 2 weeks (early) or 6 weeks (usual care) after sternotomy.
The primary outcome was change in the 6-minute walk test distance from baseline to 10 or 14 weeks after sternotomy, respectively, and 12 months after randomization.
For usual care, training followed British standards: a warm-up with light cardiovascular and mobility exercises; continuous moderate-intensity cardiovascular exercise; a cooldown; functional exercises using resistance machines and free weights; and upper-body exercises designed to prevent sternal and leg wound pain and complications.
There are no specific outpatient CR exercise guidelines for early CR, so study participants followed an individualized exercise program for the first 2-3 weeks after surgery, starting with light mobility and moderate-intensity cardiovascular training when they could do those exercises with minimal discomfort. They then progressed to current British standards, as per usual care.
Forty patients were lost to follow-up, largely because of the pandemic; about half the participants in each group were included in the primary analysis.
Early CR was not inferior to usual care, the authors wrote. The mean change in 6-minute walk distance from baseline to completion of CR was 28 meters greater in the early group than in the usual-care group, and was achieved 4 weeks earlier in the recovery timeline.
Secondary outcomes (functional fitness and quality of life) improved in both groups and between-group differences were not statistically significant, indicating the noninferiority of early CR, the authors noted.
Safety not proven
There were more adverse events in the early group than in the usual-care group (58 vs. 46) and more serious adverse events (18 vs. 14), but fewer deaths (1 vs. 2).
Although there was no between-group difference in the likelihood of having an adverse or serious adverse event, Dr. McGregor acknowledged that the study was “not powered specifically for safety outcomes.” He added that “there is the potential to run a very large multination definitive superiority [randomized, controlled trial] with safety as the primary outcome; however, a very large sample would be required.”
Meanwhile, he said, “we can say with some degree of certainty that early CR was likely as safe as usual-care CR. In the United Kingdom, we work closely with the British Association for Cardiovascular Prevention and Rehabilitation and the Association of Chartered Physiotherapists in Cardiovascular Rehabilitation, who will incorporate our findings in their guidelines and training courses.”
Questions remain
Asked to comment on the study, John Larry, MD, medical director of cardiology and cardiac rehabilitation at the Ohio State University Wexner Medical Center East Hospital, Columbus, said: “For those under time pressure to return to work, [early CR] could be an advantage to allow more rehab time and improved stamina prior to their return-to-work date.”
That said, he noted, “we typically delay any significant upper-body training activities for 8-10 weeks to avoid impact on healing of the sternum. Thus ... starting sooner would limit the amount of time a patient would have to engage in any upper-body resistance training. Many lose upper body strength after surgery, so this is an important part of the recovery/rehab process.”
Matthew Tomey, MD, director of the cardiac intensive care unit, Mount Sinai Morningside, New York, advised “caution” when interpreting the findings, stating that “there was no evident difference in the primary outcome measure of functional capacity by 14 weeks, and the trial was not designed to directly assess impact on either social functioning or economic productivity.”
“I would be interested to [see] more comprehensive data on safety in a larger, more diverse sample of postoperative patients,” he said, “as well as evidence to indicate clear advantage of an earlier start for patient-centered outcomes specifically after cardiac surgery.
“Perhaps the greatest challenges to full realization of the benefits of CR in practice have been gaps in referral and gaps in enrollment,” he added. “It is incumbent upon us as clinicians to counsel our patients and to provide appropriate referrals.”
The study was supported by the Medical and Life Sciences Research Fund and the Jeremy Pilcher Memorial Fund. No conflicts of interest were reported.
A version of this article first appeared on Medscape.com.
Cardiac rehabilitation (CR) started 2 weeks after sternotomy for a cardiac procedure was noninferior to usual care, in which CR starts 6 weeks after the procedure, with a greater improvement in 6-minute walk test outcomes, a randomized study suggests.
There was no difference in adverse events between groups, although the researchers pointed out that the study was not powered specifically for safety outcomes.
“Cardiac surgical techniques have evolved significantly over the last 60 years, leading to improved survival and shorter hospital stays,” Gordon McGregor, PhD, University of Warwick, Coventry, England, told this news organization. “However, sternal precautions and rehabilitation guidelines have not changed accordingly. There has never been a guideline based on empirical evidence to support rehabilitation professionals working with cardiac surgery patients after median sternotomy.”
“By adopting a progressive individualized approach,” he added, “cardiac surgery sternotomy patients can start cardiac rehabilitation up to 4 weeks earlier than current guidance, and thus potentially complete their recovery sooner.”
Results of the Early Initiation of Poststernotomy Cardiac Rehabilitation Exercise Training study were published online in JAMA Cardiology.
In the study, Dr. McGregor and colleagues randomly assigned 158 patients (mean age, 63 years; 84% men) to 8 weeks of 1-hour, twice-weekly supervised CR exercise training starting 2 weeks (early) or 6 weeks (usual care) after sternotomy.
The primary outcome was change in the 6-minute walk test distance from baseline to 10 or 14 weeks after sternotomy, respectively, and 12 months after randomization.
For usual care, training followed British standards: a warm-up with light cardiovascular and mobility exercises; continuous moderate-intensity cardiovascular exercise; a cooldown; functional exercises using resistance machines and free weights; and upper-body exercises designed to prevent sternal and leg wound pain and complications.
There are no specific outpatient CR exercise guidelines for early CR, so study participants followed an individualized exercise program for the first 2-3 weeks after surgery, starting with light mobility and moderate-intensity cardiovascular training when they could do those exercises with minimal discomfort. They then progressed to current British standards, as per usual care.
Forty patients were lost to follow-up, largely because of the pandemic; about half the participants in each group were included in the primary analysis.
Early CR was not inferior to usual care, the authors wrote. The mean change in 6-minute walk distance from baseline to completion of CR was 28 meters greater in the early group than in the usual-care group, and was achieved 4 weeks earlier in the recovery timeline.
Secondary outcomes (functional fitness and quality of life) improved in both groups and between-group differences were not statistically significant, indicating the noninferiority of early CR, the authors noted.
Safety not proven
There were more adverse events in the early group than in the usual-care group (58 vs. 46) and more serious adverse events (18 vs. 14), but fewer deaths (1 vs. 2).
Although there was no between-group difference in the likelihood of having an adverse or serious adverse event, Dr. McGregor acknowledged that the study was “not powered specifically for safety outcomes.” He added that “there is the potential to run a very large multination definitive superiority [randomized, controlled trial] with safety as the primary outcome; however, a very large sample would be required.”
Meanwhile, he said, “we can say with some degree of certainty that early CR was likely as safe as usual-care CR. In the United Kingdom, we work closely with the British Association for Cardiovascular Prevention and Rehabilitation and the Association of Chartered Physiotherapists in Cardiovascular Rehabilitation, who will incorporate our findings in their guidelines and training courses.”
Questions remain
Asked to comment on the study, John Larry, MD, medical director of cardiology and cardiac rehabilitation at the Ohio State University Wexner Medical Center East Hospital, Columbus, said: “For those under time pressure to return to work, [early CR] could be an advantage to allow more rehab time and improved stamina prior to their return-to-work date.”
That said, he noted, “we typically delay any significant upper-body training activities for 8-10 weeks to avoid impact on healing of the sternum. Thus ... starting sooner would limit the amount of time a patient would have to engage in any upper-body resistance training. Many lose upper body strength after surgery, so this is an important part of the recovery/rehab process.”
Matthew Tomey, MD, director of the cardiac intensive care unit, Mount Sinai Morningside, New York, advised “caution” when interpreting the findings, stating that “there was no evident difference in the primary outcome measure of functional capacity by 14 weeks, and the trial was not designed to directly assess impact on either social functioning or economic productivity.”
“I would be interested to [see] more comprehensive data on safety in a larger, more diverse sample of postoperative patients,” he said, “as well as evidence to indicate clear advantage of an earlier start for patient-centered outcomes specifically after cardiac surgery.
“Perhaps the greatest challenges to full realization of the benefits of CR in practice have been gaps in referral and gaps in enrollment,” he added. “It is incumbent upon us as clinicians to counsel our patients and to provide appropriate referrals.”
The study was supported by the Medical and Life Sciences Research Fund and the Jeremy Pilcher Memorial Fund. No conflicts of interest were reported.
A version of this article first appeared on Medscape.com.
FROM JAMA CARDIOLOGY
Women benefit but lag behind in intracoronary imaging in PCI
A real-world analysis reveals that women are consistently less likely to undergo intracoronary imaging as part of percutaneous coronary intervention (PCI), even though it benefits both sexes equally.
Results from nearly all PCIs performed in England and Wales between 2006 and 2019 showed the absolute rate of intracoronary imaging with either intravascular ultrasound (IVUS) or optical coherence tomography (OCT) was 5% lower in the later study years among women at 14.5%, compared with 19.6% in men (P < .001).
After adjustment, female sex was an independent predictor of lower intracoronary imaging use (odds ratio, 0.93; 95% confidence interval, 0.91-0.96), according to the study, published in JACC: Cardiovascular Interventions.
“One of the thoughts I had when we were running this analysis was, well, maybe the indications for that imaging, as recommended by guidelines, are less common in women,” Mamas Mamas, MD, told this news organization. “So what we did was to look at just cases where imaging is recommended by the EAPCI [European Association of Percutaneous Coronary Intervention].”
Again, the use of intracoronary imaging was consistently lower among women than among men for all of the following EAPCI-recommended indications:
- Acute coronary syndrome: 11.6% vs. 12.3% (P < .01).
- Stent thrombosis: 30.9% vs. 34.9% (P < .01).
- Long lesions: 13.1% vs. 16.3% (P < .01).
- Chronic total occlusions: 16.2% vs. 18.3% (P < .01).
- Left main stem PCI: 55.1% vs. 57.5% (P < .01).
- In-stent restenosis: 28.0% vs. 30.7%.
- Calcified lesions: 36.6% vs. 40.1% (P < .01).
- Renal disease: 17.4% vs. 19.5% (P < .01).
As to what might be driving the lower use, Dr. Mamas dismissed the argument that women undergo much simpler PCI, which wouldn’t benefit from imaging. Women do have smaller coronary arteries, however, and there is a belief that it’s easier to eyeball the size of vessels that are smaller rather than larger.
“I’m not convinced that’s entirely true,” he said. “I don’t have a good answer for you, I’m afraid. I don’t really know why we’re seeing it. I just think it’s one of those disparities that is important to highlight.”
Central to this belief is that the benefits of intracoronary imaging were found to be similar in men and women. Intracoronary imaging was associated with lower adjusted odds of in-hospital mortality (OR, 0.56; 95% CI, 0.48-0.64) and major adverse cardiac and cerebrovascular events (OR, 0.83; 95% CI, 0.76-0.91) in women and men (OR, 0.48; 95% CI, 0.44-0.53 and OR, 0.75; 95% CI, 0.71-0.80, respectively), compared with nonimaging groups.
“This really should be a call to arms, particularly given that we show this disparity persists, even in guideline-recommended cases where we should be using it,” said Dr. Mamas, from the Keele (England) Cardiovascular Research Group, Keele University, and Royal Stoke University Hospital, Stoke-on-Trent, England.
“Actually, I would argue that we should be using more imaging in women than men anyway because many of the presentations for acute coronary syndromes in women, like spontaneous coronary artery dissection or MINOCA [MI with nonobstructive coronary arteries], you often need intracoronary imaging to make that kind of diagnosis,” he observed.
Getting worse, not better
Previous studies have shown that women are less likely than men in acute coronary syndromes to receive the transradial approach and P2Y12 inhibitors, but none have specifically looked at intracoronary imaging, Dr. Mamas said.
To fill the gap, the researchers drew on data from 994,478 patients in the British Cardiovascular Intervention Society registry, of whom, 8.4% of 738,616 men and 7.9% of 255,862 women received intracoronary imaging.
Women in the imaging group were older, more likely to be an ethnic minority, and more likely to undergo PCI for non–ST-segment elevation MI than their male counterparts.
One of the more surprising findings was that rates of IVUS and OCT were superimposable between the sexes at the start of the study but quickly diverged starting in around 2012, when the technology took off, Dr. Mamas said. In the most recent data, use was about 3% lower in women overall and rising to 6% in those with stable angina.
“Whilst the disparities between men and women are significant, the bigger question is why are we using so little imaging in guideline-recommended cases where there is a benefit?” he said.
Possible actionable items, he suggested, include providing older physicians who didn’t have access to intracoronary imaging during their training with opportunities in their cath lab or with industry sponsors to increase their skills and confidence. Intracoronary imaging use could also be routinely captured in U.S. and European PCI registries and used as a quality metric.
“In left main, you see a massive difference between centers, and that’s the kind of data that drives discussion,” Dr. Mamas said. “If we start reporting quality metrics, such as radial use, intracoronary imaging, P2Y12 inhibitors by center, then you’ve got something to benchmark centers against.”
Nathaniel Smilowitz, MD, an interventional cardiologist at New York Langone Health, who was not associated with the study, said that it’s troubling to see that the utilization intravascular imaging is so low, despite randomized trials and large meta-analyses showing a mortality benefit associated with its use in PCI.
“Even among men, only 19.6% in the later years were getting intravascular imaging performed to guide their coronary intervention, so one out of five,” he said. “There are opportunities to improve.”
Dr. Smilowitz said he’s also perplexed as to why adoption would be lower in women but that the findings echo those in other domains where women receive less intensive cardiovascular therapy.
“There’s no biological, really plausible, mechanism as to why the need for intravascular imaging would be lower and, particularly, because they showed in stent thrombosis, for example, where intravascular imaging is tremendously important, there were still sex differences,” he said. “So even with clear indications for imaging, women just received the optimal therapy less often than men. It’s disappointing.”
Dr. Smilowitz agreed that there may be a need to incorporate intravascular imaging into metrics, which are reported back to physicians, potentially even for comparisons with peers or regional rates to incentivize physicians to improve uptake.
“As a society, we’ve been quite slow to integrate intravascular imaging to guide PCI and we can do better,” he said.
A version of this article first appeared on Medscape.com.
A real-world analysis reveals that women are consistently less likely to undergo intracoronary imaging as part of percutaneous coronary intervention (PCI), even though it benefits both sexes equally.
Results from nearly all PCIs performed in England and Wales between 2006 and 2019 showed the absolute rate of intracoronary imaging with either intravascular ultrasound (IVUS) or optical coherence tomography (OCT) was 5% lower in the later study years among women at 14.5%, compared with 19.6% in men (P < .001).
After adjustment, female sex was an independent predictor of lower intracoronary imaging use (odds ratio, 0.93; 95% confidence interval, 0.91-0.96), according to the study, published in JACC: Cardiovascular Interventions.
“One of the thoughts I had when we were running this analysis was, well, maybe the indications for that imaging, as recommended by guidelines, are less common in women,” Mamas Mamas, MD, told this news organization. “So what we did was to look at just cases where imaging is recommended by the EAPCI [European Association of Percutaneous Coronary Intervention].”
Again, the use of intracoronary imaging was consistently lower among women than among men for all of the following EAPCI-recommended indications:
- Acute coronary syndrome: 11.6% vs. 12.3% (P < .01).
- Stent thrombosis: 30.9% vs. 34.9% (P < .01).
- Long lesions: 13.1% vs. 16.3% (P < .01).
- Chronic total occlusions: 16.2% vs. 18.3% (P < .01).
- Left main stem PCI: 55.1% vs. 57.5% (P < .01).
- In-stent restenosis: 28.0% vs. 30.7%.
- Calcified lesions: 36.6% vs. 40.1% (P < .01).
- Renal disease: 17.4% vs. 19.5% (P < .01).
As to what might be driving the lower use, Dr. Mamas dismissed the argument that women undergo much simpler PCI, which wouldn’t benefit from imaging. Women do have smaller coronary arteries, however, and there is a belief that it’s easier to eyeball the size of vessels that are smaller rather than larger.
“I’m not convinced that’s entirely true,” he said. “I don’t have a good answer for you, I’m afraid. I don’t really know why we’re seeing it. I just think it’s one of those disparities that is important to highlight.”
Central to this belief is that the benefits of intracoronary imaging were found to be similar in men and women. Intracoronary imaging was associated with lower adjusted odds of in-hospital mortality (OR, 0.56; 95% CI, 0.48-0.64) and major adverse cardiac and cerebrovascular events (OR, 0.83; 95% CI, 0.76-0.91) in women and men (OR, 0.48; 95% CI, 0.44-0.53 and OR, 0.75; 95% CI, 0.71-0.80, respectively), compared with nonimaging groups.
“This really should be a call to arms, particularly given that we show this disparity persists, even in guideline-recommended cases where we should be using it,” said Dr. Mamas, from the Keele (England) Cardiovascular Research Group, Keele University, and Royal Stoke University Hospital, Stoke-on-Trent, England.
“Actually, I would argue that we should be using more imaging in women than men anyway because many of the presentations for acute coronary syndromes in women, like spontaneous coronary artery dissection or MINOCA [MI with nonobstructive coronary arteries], you often need intracoronary imaging to make that kind of diagnosis,” he observed.
Getting worse, not better
Previous studies have shown that women are less likely than men in acute coronary syndromes to receive the transradial approach and P2Y12 inhibitors, but none have specifically looked at intracoronary imaging, Dr. Mamas said.
To fill the gap, the researchers drew on data from 994,478 patients in the British Cardiovascular Intervention Society registry, of whom, 8.4% of 738,616 men and 7.9% of 255,862 women received intracoronary imaging.
Women in the imaging group were older, more likely to be an ethnic minority, and more likely to undergo PCI for non–ST-segment elevation MI than their male counterparts.
One of the more surprising findings was that rates of IVUS and OCT were superimposable between the sexes at the start of the study but quickly diverged starting in around 2012, when the technology took off, Dr. Mamas said. In the most recent data, use was about 3% lower in women overall and rising to 6% in those with stable angina.
“Whilst the disparities between men and women are significant, the bigger question is why are we using so little imaging in guideline-recommended cases where there is a benefit?” he said.
Possible actionable items, he suggested, include providing older physicians who didn’t have access to intracoronary imaging during their training with opportunities in their cath lab or with industry sponsors to increase their skills and confidence. Intracoronary imaging use could also be routinely captured in U.S. and European PCI registries and used as a quality metric.
“In left main, you see a massive difference between centers, and that’s the kind of data that drives discussion,” Dr. Mamas said. “If we start reporting quality metrics, such as radial use, intracoronary imaging, P2Y12 inhibitors by center, then you’ve got something to benchmark centers against.”
Nathaniel Smilowitz, MD, an interventional cardiologist at New York Langone Health, who was not associated with the study, said that it’s troubling to see that the utilization intravascular imaging is so low, despite randomized trials and large meta-analyses showing a mortality benefit associated with its use in PCI.
“Even among men, only 19.6% in the later years were getting intravascular imaging performed to guide their coronary intervention, so one out of five,” he said. “There are opportunities to improve.”
Dr. Smilowitz said he’s also perplexed as to why adoption would be lower in women but that the findings echo those in other domains where women receive less intensive cardiovascular therapy.
“There’s no biological, really plausible, mechanism as to why the need for intravascular imaging would be lower and, particularly, because they showed in stent thrombosis, for example, where intravascular imaging is tremendously important, there were still sex differences,” he said. “So even with clear indications for imaging, women just received the optimal therapy less often than men. It’s disappointing.”
Dr. Smilowitz agreed that there may be a need to incorporate intravascular imaging into metrics, which are reported back to physicians, potentially even for comparisons with peers or regional rates to incentivize physicians to improve uptake.
“As a society, we’ve been quite slow to integrate intravascular imaging to guide PCI and we can do better,” he said.
A version of this article first appeared on Medscape.com.
A real-world analysis reveals that women are consistently less likely to undergo intracoronary imaging as part of percutaneous coronary intervention (PCI), even though it benefits both sexes equally.
Results from nearly all PCIs performed in England and Wales between 2006 and 2019 showed the absolute rate of intracoronary imaging with either intravascular ultrasound (IVUS) or optical coherence tomography (OCT) was 5% lower in the later study years among women at 14.5%, compared with 19.6% in men (P < .001).
After adjustment, female sex was an independent predictor of lower intracoronary imaging use (odds ratio, 0.93; 95% confidence interval, 0.91-0.96), according to the study, published in JACC: Cardiovascular Interventions.
“One of the thoughts I had when we were running this analysis was, well, maybe the indications for that imaging, as recommended by guidelines, are less common in women,” Mamas Mamas, MD, told this news organization. “So what we did was to look at just cases where imaging is recommended by the EAPCI [European Association of Percutaneous Coronary Intervention].”
Again, the use of intracoronary imaging was consistently lower among women than among men for all of the following EAPCI-recommended indications:
- Acute coronary syndrome: 11.6% vs. 12.3% (P < .01).
- Stent thrombosis: 30.9% vs. 34.9% (P < .01).
- Long lesions: 13.1% vs. 16.3% (P < .01).
- Chronic total occlusions: 16.2% vs. 18.3% (P < .01).
- Left main stem PCI: 55.1% vs. 57.5% (P < .01).
- In-stent restenosis: 28.0% vs. 30.7%.
- Calcified lesions: 36.6% vs. 40.1% (P < .01).
- Renal disease: 17.4% vs. 19.5% (P < .01).
As to what might be driving the lower use, Dr. Mamas dismissed the argument that women undergo much simpler PCI, which wouldn’t benefit from imaging. Women do have smaller coronary arteries, however, and there is a belief that it’s easier to eyeball the size of vessels that are smaller rather than larger.
“I’m not convinced that’s entirely true,” he said. “I don’t have a good answer for you, I’m afraid. I don’t really know why we’re seeing it. I just think it’s one of those disparities that is important to highlight.”
Central to this belief is that the benefits of intracoronary imaging were found to be similar in men and women. Intracoronary imaging was associated with lower adjusted odds of in-hospital mortality (OR, 0.56; 95% CI, 0.48-0.64) and major adverse cardiac and cerebrovascular events (OR, 0.83; 95% CI, 0.76-0.91) in women and men (OR, 0.48; 95% CI, 0.44-0.53 and OR, 0.75; 95% CI, 0.71-0.80, respectively), compared with nonimaging groups.
“This really should be a call to arms, particularly given that we show this disparity persists, even in guideline-recommended cases where we should be using it,” said Dr. Mamas, from the Keele (England) Cardiovascular Research Group, Keele University, and Royal Stoke University Hospital, Stoke-on-Trent, England.
“Actually, I would argue that we should be using more imaging in women than men anyway because many of the presentations for acute coronary syndromes in women, like spontaneous coronary artery dissection or MINOCA [MI with nonobstructive coronary arteries], you often need intracoronary imaging to make that kind of diagnosis,” he observed.
Getting worse, not better
Previous studies have shown that women are less likely than men in acute coronary syndromes to receive the transradial approach and P2Y12 inhibitors, but none have specifically looked at intracoronary imaging, Dr. Mamas said.
To fill the gap, the researchers drew on data from 994,478 patients in the British Cardiovascular Intervention Society registry, of whom, 8.4% of 738,616 men and 7.9% of 255,862 women received intracoronary imaging.
Women in the imaging group were older, more likely to be an ethnic minority, and more likely to undergo PCI for non–ST-segment elevation MI than their male counterparts.
One of the more surprising findings was that rates of IVUS and OCT were superimposable between the sexes at the start of the study but quickly diverged starting in around 2012, when the technology took off, Dr. Mamas said. In the most recent data, use was about 3% lower in women overall and rising to 6% in those with stable angina.
“Whilst the disparities between men and women are significant, the bigger question is why are we using so little imaging in guideline-recommended cases where there is a benefit?” he said.
Possible actionable items, he suggested, include providing older physicians who didn’t have access to intracoronary imaging during their training with opportunities in their cath lab or with industry sponsors to increase their skills and confidence. Intracoronary imaging use could also be routinely captured in U.S. and European PCI registries and used as a quality metric.
“In left main, you see a massive difference between centers, and that’s the kind of data that drives discussion,” Dr. Mamas said. “If we start reporting quality metrics, such as radial use, intracoronary imaging, P2Y12 inhibitors by center, then you’ve got something to benchmark centers against.”
Nathaniel Smilowitz, MD, an interventional cardiologist at New York Langone Health, who was not associated with the study, said that it’s troubling to see that the utilization intravascular imaging is so low, despite randomized trials and large meta-analyses showing a mortality benefit associated with its use in PCI.
“Even among men, only 19.6% in the later years were getting intravascular imaging performed to guide their coronary intervention, so one out of five,” he said. “There are opportunities to improve.”
Dr. Smilowitz said he’s also perplexed as to why adoption would be lower in women but that the findings echo those in other domains where women receive less intensive cardiovascular therapy.
“There’s no biological, really plausible, mechanism as to why the need for intravascular imaging would be lower and, particularly, because they showed in stent thrombosis, for example, where intravascular imaging is tremendously important, there were still sex differences,” he said. “So even with clear indications for imaging, women just received the optimal therapy less often than men. It’s disappointing.”
Dr. Smilowitz agreed that there may be a need to incorporate intravascular imaging into metrics, which are reported back to physicians, potentially even for comparisons with peers or regional rates to incentivize physicians to improve uptake.
“As a society, we’ve been quite slow to integrate intravascular imaging to guide PCI and we can do better,” he said.
A version of this article first appeared on Medscape.com.
FROM JACC: CARDIOVASCULAR INTERVENTIONS
Pig-heart transplant case published with new details, insights
It’s a given that the case of David Bennett, Sr, and his transplanted, genetically modified porcine heart will have a lot to teach, and the peer-reviewed publication this week lends welcome authority to some of its earliest lessons.
Mr. Bennett lived for 2 months after receiving the heart in the pioneering surgery, and the new case report compiles the available clinical, anatomic, and histologic evidence and other potential clues to the underlying cause or causes of death.
It also describes a mystery that came to light at autopsy: a grossly enlarged heart attributable to pervasive interstitial edema, and at the cellular level, a peculiar pattern of myocardial damage that included microvascular deterioration and, potentially as a result, cellular necrosis, according to the new report.
The myocardium itself was described as “thickened and stiff,” consistent with the “diastolic heart failure” that characterized Mr. Bennett’s final 10 days and the likely convergence of several underlying processes. Missing, however, was any conventional sign of graft rejection as it is understood clinically or in animal models, the report states.
If a form of tissue rejection was the cause of graft failure, any implicating cellular evidence may simply have been unrecognizable, given the unprecedented nature of the first pig-to-human heart transplantation, the donor animal’s multiple anti-inflammatory gene deletions, and partly investigational immunosuppression regimen, speculated Bartley P. Griffith, MD, University of Maryland, College Park.
“I’m betting against it being a fulminant rejection,” he told this news organization, “because we saw nothing like the [characteristic] platelet deposition or thrombosis of the capillaries.”
Dr. Griffith, who performed the xenotransplant surgery and led Mr. Bennett’s postoperative care, is lead author on the case report published in the New England Journal of Medicine. “Additional studies are underway to characterize the pathophysiologic mechanisms that resulted in this damage,” the report states.
The report builds on recent meeting presentations on the case, which, as previously reported, gave cursory details regarding the organ damage and other clinical developments during and after the surgery, including evidence that the transplanted heart contained porcine cytomegalovirus (PCMV).
Similar details also appeared in a third-person account based in part on personal communication with Dr. Griffith. The cardiac XTx review that focused on this University of Maryland experience was published June 15 in JACC: Basic to Translational Science, with lead author Jacinthe Boulet, MD, CM, Brigham and Women’s Hospital Heart, Boston.
“The question of how to move XTx forward remains uncertain, and appropriate selection of patients for experimental XTx will be one of the most important challenges to be addressed. The first issue we must contend with is whether we are ready to move to the next XTx in a human. We strongly believe this to be the case,” the review states. “Once early experience is gained, with successive iterations of XTx, the bar for success can be raised with maturation of the technology.”
Evidence has so far not implicated several other potential mechanisms underlying the graft failure that had been the focus of early speculations. For example, the transplanted pig heart was infected with PCMV, as previously reported. Mr. Bennett showed traces of PCMV DNA in his circulation, but no actual virus in his native cells. Still, PCMV remains a suspect.
Mr. Bennett also received intravenous immunoglobulin (IVIG) on several occasions to fight rejection, and also severe infections, including a nasty episode of sepsis. A reaction to the IVIG, derived from pooled donor antibodies, could potentially have caused the unusual myocardial damage seen by the University of Maryland team, Dr. Griffith observed. Alternatively, the damage might have been partly related to the patient’s overall severely diminished condition even before the transplant surgery or his rocky postoperative clinical course.
Indeed, Mr. Bennett’s condition worsened dramatically on postoperative day 50, and echocardiography showed a striking degree of myocardial wall thickening and heart enlargement, determined to be from edema. “The heart got amazingly stiff but maintained a systolic function that wasn›t too terrible, even to the very end. But his heart seemed as though it had swollen overnight,” Dr. Griffith said. “We had never seen that type of process, the suddenness of this swelling, in our nonhuman primate studies.”
The damage to the heart muscle appeared irreversible, based on myocardial biopsy results, so the decision was made to withdraw life support 60 days after the transplant surgery, the report notes.
Among the experience’s apparent lessons for future cardiac xenotransplantation, Dr. Griffith said, would be to select patients for the surgery who are in a bit more robust condition than Mr. Bennett was, who are perhaps ambulatory, not sarcopenic, and not recently on prolonged mechanical circulatory support. “We’re going to try to pick a patient who, on the front end, is less critically ill but who is just as likely not to benefit from continued medical therapy” and who isn’t a candidate for conventional heart transplantation, he said.
Because of universal efforts to manage conditions like diabetes, hypertension, and vascular disease in the population, and “because these conditions cause many of the cases of organ failure and fuel demand for transplantation, one might wonder whether the advances reported by Dr. Griffith and colleagues presage a decreasing demand for organ transplantation,” speculates an accompanying editorialfrom Jeffrey L. Platt, MD, and Marilia Cascalho, MD, PhD, University of Michigan, Ann Arbor.
“We think the answer is no. Since aging is associated with progressive decline in the function of the heart, kidneys, and other organs, advances that extend life expectancy will ultimately increase the prevalence of organ failure and potentially the demand for transplantation.”
The donor pig was developed and provided by Revivicor, and the investigational KPL-404 antibody drug used in the experience was provided by Kiniksa. Other disclosures for the case report and editorial from Dr. Platt and Dr. Cascalho are available at NEJM.com. Dr. Boulet reports no relevant relationships; disclosures for the other authors are in their report.
A version of this article first appeared on Medscape.com.
It’s a given that the case of David Bennett, Sr, and his transplanted, genetically modified porcine heart will have a lot to teach, and the peer-reviewed publication this week lends welcome authority to some of its earliest lessons.
Mr. Bennett lived for 2 months after receiving the heart in the pioneering surgery, and the new case report compiles the available clinical, anatomic, and histologic evidence and other potential clues to the underlying cause or causes of death.
It also describes a mystery that came to light at autopsy: a grossly enlarged heart attributable to pervasive interstitial edema, and at the cellular level, a peculiar pattern of myocardial damage that included microvascular deterioration and, potentially as a result, cellular necrosis, according to the new report.
The myocardium itself was described as “thickened and stiff,” consistent with the “diastolic heart failure” that characterized Mr. Bennett’s final 10 days and the likely convergence of several underlying processes. Missing, however, was any conventional sign of graft rejection as it is understood clinically or in animal models, the report states.
If a form of tissue rejection was the cause of graft failure, any implicating cellular evidence may simply have been unrecognizable, given the unprecedented nature of the first pig-to-human heart transplantation, the donor animal’s multiple anti-inflammatory gene deletions, and partly investigational immunosuppression regimen, speculated Bartley P. Griffith, MD, University of Maryland, College Park.
“I’m betting against it being a fulminant rejection,” he told this news organization, “because we saw nothing like the [characteristic] platelet deposition or thrombosis of the capillaries.”
Dr. Griffith, who performed the xenotransplant surgery and led Mr. Bennett’s postoperative care, is lead author on the case report published in the New England Journal of Medicine. “Additional studies are underway to characterize the pathophysiologic mechanisms that resulted in this damage,” the report states.
The report builds on recent meeting presentations on the case, which, as previously reported, gave cursory details regarding the organ damage and other clinical developments during and after the surgery, including evidence that the transplanted heart contained porcine cytomegalovirus (PCMV).
Similar details also appeared in a third-person account based in part on personal communication with Dr. Griffith. The cardiac XTx review that focused on this University of Maryland experience was published June 15 in JACC: Basic to Translational Science, with lead author Jacinthe Boulet, MD, CM, Brigham and Women’s Hospital Heart, Boston.
“The question of how to move XTx forward remains uncertain, and appropriate selection of patients for experimental XTx will be one of the most important challenges to be addressed. The first issue we must contend with is whether we are ready to move to the next XTx in a human. We strongly believe this to be the case,” the review states. “Once early experience is gained, with successive iterations of XTx, the bar for success can be raised with maturation of the technology.”
Evidence has so far not implicated several other potential mechanisms underlying the graft failure that had been the focus of early speculations. For example, the transplanted pig heart was infected with PCMV, as previously reported. Mr. Bennett showed traces of PCMV DNA in his circulation, but no actual virus in his native cells. Still, PCMV remains a suspect.
Mr. Bennett also received intravenous immunoglobulin (IVIG) on several occasions to fight rejection, and also severe infections, including a nasty episode of sepsis. A reaction to the IVIG, derived from pooled donor antibodies, could potentially have caused the unusual myocardial damage seen by the University of Maryland team, Dr. Griffith observed. Alternatively, the damage might have been partly related to the patient’s overall severely diminished condition even before the transplant surgery or his rocky postoperative clinical course.
Indeed, Mr. Bennett’s condition worsened dramatically on postoperative day 50, and echocardiography showed a striking degree of myocardial wall thickening and heart enlargement, determined to be from edema. “The heart got amazingly stiff but maintained a systolic function that wasn›t too terrible, even to the very end. But his heart seemed as though it had swollen overnight,” Dr. Griffith said. “We had never seen that type of process, the suddenness of this swelling, in our nonhuman primate studies.”
The damage to the heart muscle appeared irreversible, based on myocardial biopsy results, so the decision was made to withdraw life support 60 days after the transplant surgery, the report notes.
Among the experience’s apparent lessons for future cardiac xenotransplantation, Dr. Griffith said, would be to select patients for the surgery who are in a bit more robust condition than Mr. Bennett was, who are perhaps ambulatory, not sarcopenic, and not recently on prolonged mechanical circulatory support. “We’re going to try to pick a patient who, on the front end, is less critically ill but who is just as likely not to benefit from continued medical therapy” and who isn’t a candidate for conventional heart transplantation, he said.
Because of universal efforts to manage conditions like diabetes, hypertension, and vascular disease in the population, and “because these conditions cause many of the cases of organ failure and fuel demand for transplantation, one might wonder whether the advances reported by Dr. Griffith and colleagues presage a decreasing demand for organ transplantation,” speculates an accompanying editorialfrom Jeffrey L. Platt, MD, and Marilia Cascalho, MD, PhD, University of Michigan, Ann Arbor.
“We think the answer is no. Since aging is associated with progressive decline in the function of the heart, kidneys, and other organs, advances that extend life expectancy will ultimately increase the prevalence of organ failure and potentially the demand for transplantation.”
The donor pig was developed and provided by Revivicor, and the investigational KPL-404 antibody drug used in the experience was provided by Kiniksa. Other disclosures for the case report and editorial from Dr. Platt and Dr. Cascalho are available at NEJM.com. Dr. Boulet reports no relevant relationships; disclosures for the other authors are in their report.
A version of this article first appeared on Medscape.com.
It’s a given that the case of David Bennett, Sr, and his transplanted, genetically modified porcine heart will have a lot to teach, and the peer-reviewed publication this week lends welcome authority to some of its earliest lessons.
Mr. Bennett lived for 2 months after receiving the heart in the pioneering surgery, and the new case report compiles the available clinical, anatomic, and histologic evidence and other potential clues to the underlying cause or causes of death.
It also describes a mystery that came to light at autopsy: a grossly enlarged heart attributable to pervasive interstitial edema, and at the cellular level, a peculiar pattern of myocardial damage that included microvascular deterioration and, potentially as a result, cellular necrosis, according to the new report.
The myocardium itself was described as “thickened and stiff,” consistent with the “diastolic heart failure” that characterized Mr. Bennett’s final 10 days and the likely convergence of several underlying processes. Missing, however, was any conventional sign of graft rejection as it is understood clinically or in animal models, the report states.
If a form of tissue rejection was the cause of graft failure, any implicating cellular evidence may simply have been unrecognizable, given the unprecedented nature of the first pig-to-human heart transplantation, the donor animal’s multiple anti-inflammatory gene deletions, and partly investigational immunosuppression regimen, speculated Bartley P. Griffith, MD, University of Maryland, College Park.
“I’m betting against it being a fulminant rejection,” he told this news organization, “because we saw nothing like the [characteristic] platelet deposition or thrombosis of the capillaries.”
Dr. Griffith, who performed the xenotransplant surgery and led Mr. Bennett’s postoperative care, is lead author on the case report published in the New England Journal of Medicine. “Additional studies are underway to characterize the pathophysiologic mechanisms that resulted in this damage,” the report states.
The report builds on recent meeting presentations on the case, which, as previously reported, gave cursory details regarding the organ damage and other clinical developments during and after the surgery, including evidence that the transplanted heart contained porcine cytomegalovirus (PCMV).
Similar details also appeared in a third-person account based in part on personal communication with Dr. Griffith. The cardiac XTx review that focused on this University of Maryland experience was published June 15 in JACC: Basic to Translational Science, with lead author Jacinthe Boulet, MD, CM, Brigham and Women’s Hospital Heart, Boston.
“The question of how to move XTx forward remains uncertain, and appropriate selection of patients for experimental XTx will be one of the most important challenges to be addressed. The first issue we must contend with is whether we are ready to move to the next XTx in a human. We strongly believe this to be the case,” the review states. “Once early experience is gained, with successive iterations of XTx, the bar for success can be raised with maturation of the technology.”
Evidence has so far not implicated several other potential mechanisms underlying the graft failure that had been the focus of early speculations. For example, the transplanted pig heart was infected with PCMV, as previously reported. Mr. Bennett showed traces of PCMV DNA in his circulation, but no actual virus in his native cells. Still, PCMV remains a suspect.
Mr. Bennett also received intravenous immunoglobulin (IVIG) on several occasions to fight rejection, and also severe infections, including a nasty episode of sepsis. A reaction to the IVIG, derived from pooled donor antibodies, could potentially have caused the unusual myocardial damage seen by the University of Maryland team, Dr. Griffith observed. Alternatively, the damage might have been partly related to the patient’s overall severely diminished condition even before the transplant surgery or his rocky postoperative clinical course.
Indeed, Mr. Bennett’s condition worsened dramatically on postoperative day 50, and echocardiography showed a striking degree of myocardial wall thickening and heart enlargement, determined to be from edema. “The heart got amazingly stiff but maintained a systolic function that wasn›t too terrible, even to the very end. But his heart seemed as though it had swollen overnight,” Dr. Griffith said. “We had never seen that type of process, the suddenness of this swelling, in our nonhuman primate studies.”
The damage to the heart muscle appeared irreversible, based on myocardial biopsy results, so the decision was made to withdraw life support 60 days after the transplant surgery, the report notes.
Among the experience’s apparent lessons for future cardiac xenotransplantation, Dr. Griffith said, would be to select patients for the surgery who are in a bit more robust condition than Mr. Bennett was, who are perhaps ambulatory, not sarcopenic, and not recently on prolonged mechanical circulatory support. “We’re going to try to pick a patient who, on the front end, is less critically ill but who is just as likely not to benefit from continued medical therapy” and who isn’t a candidate for conventional heart transplantation, he said.
Because of universal efforts to manage conditions like diabetes, hypertension, and vascular disease in the population, and “because these conditions cause many of the cases of organ failure and fuel demand for transplantation, one might wonder whether the advances reported by Dr. Griffith and colleagues presage a decreasing demand for organ transplantation,” speculates an accompanying editorialfrom Jeffrey L. Platt, MD, and Marilia Cascalho, MD, PhD, University of Michigan, Ann Arbor.
“We think the answer is no. Since aging is associated with progressive decline in the function of the heart, kidneys, and other organs, advances that extend life expectancy will ultimately increase the prevalence of organ failure and potentially the demand for transplantation.”
The donor pig was developed and provided by Revivicor, and the investigational KPL-404 antibody drug used in the experience was provided by Kiniksa. Other disclosures for the case report and editorial from Dr. Platt and Dr. Cascalho are available at NEJM.com. Dr. Boulet reports no relevant relationships; disclosures for the other authors are in their report.
A version of this article first appeared on Medscape.com.
Class I recall for Medtronic’s HeartWare HVAD batteries
Medtronic is recalling a single lot of HeartWare Ventricular Assist Device (HVAD) System batteries because of welding defects that may cause separation of the two cell battery packs used to power the system, according to an alert on the Food and Drug Administration website.
“The welding defect may cause the battery to malfunction and no longer provide power or prevent the battery from holding a full charge or properly recharging,” the FDA said.
The agency has identified this as a class I recall, the most serious type because of the potential for serious injury or death.
Medtronic reports one death associated with this recall and two complaints in the affected lot.
Back in April, as reported by this news organization, Medtronic alerted providers that patients implanted with the Medtronic HVAD System who develop pump thrombosis could have a welding defect in the internal pump that causes the pump to malfunction.
The batteries from the recalled lot have a model number of 1650DE, were manufactured from April 13 to 19, 2021 and distributed from April 20 to July 19, 2021. The recall affects a total of 429 devices.
On May 5, 2022, Medtronic sent an urgent medical device correction notice to customers asking them to identify and quarantine all affected batteries and notify affected patients. The notice includes a patient template to help communicate directly with patients.
It also includes a customer confirmation form to initiate an exchange. The completed form should be returned to [email protected].
Medtronic is replacing the affected batteries with new product and has implemented actions to improve control of the welding process.
The Medtronic HVAD System was approved as a bridge to heart transplantation in 2012. Since then, it’s been fraught with problems.
Earlier in June, the company announced it was stopping all sales of the device and advised physicians to stop implanting it, as reported by this news organization.
Problems related to the Medtronic HVAD System should be reported to the FDA’s MedWatch program.
A version of this article first appeared on Medscape.com.
Medtronic is recalling a single lot of HeartWare Ventricular Assist Device (HVAD) System batteries because of welding defects that may cause separation of the two cell battery packs used to power the system, according to an alert on the Food and Drug Administration website.
“The welding defect may cause the battery to malfunction and no longer provide power or prevent the battery from holding a full charge or properly recharging,” the FDA said.
The agency has identified this as a class I recall, the most serious type because of the potential for serious injury or death.
Medtronic reports one death associated with this recall and two complaints in the affected lot.
Back in April, as reported by this news organization, Medtronic alerted providers that patients implanted with the Medtronic HVAD System who develop pump thrombosis could have a welding defect in the internal pump that causes the pump to malfunction.
The batteries from the recalled lot have a model number of 1650DE, were manufactured from April 13 to 19, 2021 and distributed from April 20 to July 19, 2021. The recall affects a total of 429 devices.
On May 5, 2022, Medtronic sent an urgent medical device correction notice to customers asking them to identify and quarantine all affected batteries and notify affected patients. The notice includes a patient template to help communicate directly with patients.
It also includes a customer confirmation form to initiate an exchange. The completed form should be returned to [email protected].
Medtronic is replacing the affected batteries with new product and has implemented actions to improve control of the welding process.
The Medtronic HVAD System was approved as a bridge to heart transplantation in 2012. Since then, it’s been fraught with problems.
Earlier in June, the company announced it was stopping all sales of the device and advised physicians to stop implanting it, as reported by this news organization.
Problems related to the Medtronic HVAD System should be reported to the FDA’s MedWatch program.
A version of this article first appeared on Medscape.com.
Medtronic is recalling a single lot of HeartWare Ventricular Assist Device (HVAD) System batteries because of welding defects that may cause separation of the two cell battery packs used to power the system, according to an alert on the Food and Drug Administration website.
“The welding defect may cause the battery to malfunction and no longer provide power or prevent the battery from holding a full charge or properly recharging,” the FDA said.
The agency has identified this as a class I recall, the most serious type because of the potential for serious injury or death.
Medtronic reports one death associated with this recall and two complaints in the affected lot.
Back in April, as reported by this news organization, Medtronic alerted providers that patients implanted with the Medtronic HVAD System who develop pump thrombosis could have a welding defect in the internal pump that causes the pump to malfunction.
The batteries from the recalled lot have a model number of 1650DE, were manufactured from April 13 to 19, 2021 and distributed from April 20 to July 19, 2021. The recall affects a total of 429 devices.
On May 5, 2022, Medtronic sent an urgent medical device correction notice to customers asking them to identify and quarantine all affected batteries and notify affected patients. The notice includes a patient template to help communicate directly with patients.
It also includes a customer confirmation form to initiate an exchange. The completed form should be returned to [email protected].
Medtronic is replacing the affected batteries with new product and has implemented actions to improve control of the welding process.
The Medtronic HVAD System was approved as a bridge to heart transplantation in 2012. Since then, it’s been fraught with problems.
Earlier in June, the company announced it was stopping all sales of the device and advised physicians to stop implanting it, as reported by this news organization.
Problems related to the Medtronic HVAD System should be reported to the FDA’s MedWatch program.
A version of this article first appeared on Medscape.com.