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Is Lp(a) a marker for aortic calcium onset?
Lipoprotein(a) has long been thought to be a potential marker of aortic valve disease, and the population-based Rotterdam Study in the Netherlands has reported that Lp(a) has a strong association with new-onset aortic valve calcium (AVC), but not necessarily with progression of aortic valve disease.
Reporting in the European Heart Journal, the study authors analyzed data on 922 participants in the Rotterdam Study whose Lp(a) was measured along with a computed tomography scan upon enrollment, followed by CT scan 14 years later. At baseline, 702 participants didn’t have AVC, but the follow-up scan identified new-onset AVC in 415 (59.1%).
The investigators found an association between Lp(a) concentration and baseline AVC, with an odds ratio of 1.43 for each 50 mg/dL higher Lp(a) (95% confidence interval, 1.15-1.79), as well as new-onset AVC, with an OR of 1.30 for each 50 mg/dL increase in Lp(a) (95% CI, 1.02-1.65). However, the study found no association between rising Lp(a) levels and AVC progression; it found only an association between baseline AVC score and progression (P < .001).
‘Trigger’ for calcification but not progression
“This suggests that Lp(a) is an important trigger in the initiation of aortic valve calcification, but once the valve is calcified, disease progression may be primarily driven by other factors such as the baseline calcium burden of the valve and likely other unknown factors,” senior study author Daniel Bos, MD, PhD, said in e-mailed comments.
Dr. Bos and coauthors claim this is the first study to show that even minor AVC progresses independently of Lp(a).
“There are previous studies that showed a possible relationship between Lp(a) [and] progression of aortic valve calcium,” he said. “Our study suggests that the most meaningful benefit of Lp(a) lowering may actually be prior to the onset of aortic valve calcification.”
While no treatments have been approved for lowering Lp(a), the study findings could be meaningful if trials, including the ongoing phase 3 Lp(a) HORIZON trial of the investigational antisense agent pelacarsen (NCT04023552), show promising results, Dr. Bos said. Citing Lp(a) HORIZON, he said, “If the study shows Lp(a) lowering leads to a reduction in incident cardiovascular disease, similar strategies may be applied to prevent, rather than slow down, progression of aortic valve calcification.”
Dr. Bos called the Rotterdam Study results “an important first pointer into that direction.” He added, “We will need randomized trials to provide a definitive answer to the question whether Lp(a) lowering may prevent aortic valve calcium.”
Focus on AVC is study ‘weakness’
The study findings raise a key question for clinical trials of investigative Lp(a)-lowering therapies as well as how to use those therapies to treat aortic valve disease, said Christie Ballantyne, MD, chief of cardiology at Baylor College of Medicine in Houston.
The findings could be “problematic” for these clinical trials, he said. “This study is just looking at calcium progression,” Dr. Ballantyne noted. “What we want to know about clinically is the progression to aortic stenosis, and then in particular to progression from mild disease to moderate or severe disease, because once you get into more severe disease, one has to do an intervention with either surgery or TAVR [transcatheter aortic valve replacement].”
He considered the study’s focus on AVC rather than aortic valve function a weakness and noted that only 14 study participants had TAVR. “We’re going to need much bigger numbers to look into this question of progression, including progression to severe diseases,” he said.
However, the Rotterdam Study showed the importance of CT in evaluating AVC, which can easily be done in other trials to further explore the association between Lp(a) and AVC, Dr. Ballantyne said.
Dr. Bos has no relevant disclosures. Study coauthors disclosed relationships with Amgen, Sanofi, Reservlogix, Athera, Experio, Novartis and Ionis Pharmaceuticals. Dr. Ballantyne disclosed relationships with Amgen and Novartis.
Lipoprotein(a) has long been thought to be a potential marker of aortic valve disease, and the population-based Rotterdam Study in the Netherlands has reported that Lp(a) has a strong association with new-onset aortic valve calcium (AVC), but not necessarily with progression of aortic valve disease.
Reporting in the European Heart Journal, the study authors analyzed data on 922 participants in the Rotterdam Study whose Lp(a) was measured along with a computed tomography scan upon enrollment, followed by CT scan 14 years later. At baseline, 702 participants didn’t have AVC, but the follow-up scan identified new-onset AVC in 415 (59.1%).
The investigators found an association between Lp(a) concentration and baseline AVC, with an odds ratio of 1.43 for each 50 mg/dL higher Lp(a) (95% confidence interval, 1.15-1.79), as well as new-onset AVC, with an OR of 1.30 for each 50 mg/dL increase in Lp(a) (95% CI, 1.02-1.65). However, the study found no association between rising Lp(a) levels and AVC progression; it found only an association between baseline AVC score and progression (P < .001).
‘Trigger’ for calcification but not progression
“This suggests that Lp(a) is an important trigger in the initiation of aortic valve calcification, but once the valve is calcified, disease progression may be primarily driven by other factors such as the baseline calcium burden of the valve and likely other unknown factors,” senior study author Daniel Bos, MD, PhD, said in e-mailed comments.
Dr. Bos and coauthors claim this is the first study to show that even minor AVC progresses independently of Lp(a).
“There are previous studies that showed a possible relationship between Lp(a) [and] progression of aortic valve calcium,” he said. “Our study suggests that the most meaningful benefit of Lp(a) lowering may actually be prior to the onset of aortic valve calcification.”
While no treatments have been approved for lowering Lp(a), the study findings could be meaningful if trials, including the ongoing phase 3 Lp(a) HORIZON trial of the investigational antisense agent pelacarsen (NCT04023552), show promising results, Dr. Bos said. Citing Lp(a) HORIZON, he said, “If the study shows Lp(a) lowering leads to a reduction in incident cardiovascular disease, similar strategies may be applied to prevent, rather than slow down, progression of aortic valve calcification.”
Dr. Bos called the Rotterdam Study results “an important first pointer into that direction.” He added, “We will need randomized trials to provide a definitive answer to the question whether Lp(a) lowering may prevent aortic valve calcium.”
Focus on AVC is study ‘weakness’
The study findings raise a key question for clinical trials of investigative Lp(a)-lowering therapies as well as how to use those therapies to treat aortic valve disease, said Christie Ballantyne, MD, chief of cardiology at Baylor College of Medicine in Houston.
The findings could be “problematic” for these clinical trials, he said. “This study is just looking at calcium progression,” Dr. Ballantyne noted. “What we want to know about clinically is the progression to aortic stenosis, and then in particular to progression from mild disease to moderate or severe disease, because once you get into more severe disease, one has to do an intervention with either surgery or TAVR [transcatheter aortic valve replacement].”
He considered the study’s focus on AVC rather than aortic valve function a weakness and noted that only 14 study participants had TAVR. “We’re going to need much bigger numbers to look into this question of progression, including progression to severe diseases,” he said.
However, the Rotterdam Study showed the importance of CT in evaluating AVC, which can easily be done in other trials to further explore the association between Lp(a) and AVC, Dr. Ballantyne said.
Dr. Bos has no relevant disclosures. Study coauthors disclosed relationships with Amgen, Sanofi, Reservlogix, Athera, Experio, Novartis and Ionis Pharmaceuticals. Dr. Ballantyne disclosed relationships with Amgen and Novartis.
Lipoprotein(a) has long been thought to be a potential marker of aortic valve disease, and the population-based Rotterdam Study in the Netherlands has reported that Lp(a) has a strong association with new-onset aortic valve calcium (AVC), but not necessarily with progression of aortic valve disease.
Reporting in the European Heart Journal, the study authors analyzed data on 922 participants in the Rotterdam Study whose Lp(a) was measured along with a computed tomography scan upon enrollment, followed by CT scan 14 years later. At baseline, 702 participants didn’t have AVC, but the follow-up scan identified new-onset AVC in 415 (59.1%).
The investigators found an association between Lp(a) concentration and baseline AVC, with an odds ratio of 1.43 for each 50 mg/dL higher Lp(a) (95% confidence interval, 1.15-1.79), as well as new-onset AVC, with an OR of 1.30 for each 50 mg/dL increase in Lp(a) (95% CI, 1.02-1.65). However, the study found no association between rising Lp(a) levels and AVC progression; it found only an association between baseline AVC score and progression (P < .001).
‘Trigger’ for calcification but not progression
“This suggests that Lp(a) is an important trigger in the initiation of aortic valve calcification, but once the valve is calcified, disease progression may be primarily driven by other factors such as the baseline calcium burden of the valve and likely other unknown factors,” senior study author Daniel Bos, MD, PhD, said in e-mailed comments.
Dr. Bos and coauthors claim this is the first study to show that even minor AVC progresses independently of Lp(a).
“There are previous studies that showed a possible relationship between Lp(a) [and] progression of aortic valve calcium,” he said. “Our study suggests that the most meaningful benefit of Lp(a) lowering may actually be prior to the onset of aortic valve calcification.”
While no treatments have been approved for lowering Lp(a), the study findings could be meaningful if trials, including the ongoing phase 3 Lp(a) HORIZON trial of the investigational antisense agent pelacarsen (NCT04023552), show promising results, Dr. Bos said. Citing Lp(a) HORIZON, he said, “If the study shows Lp(a) lowering leads to a reduction in incident cardiovascular disease, similar strategies may be applied to prevent, rather than slow down, progression of aortic valve calcification.”
Dr. Bos called the Rotterdam Study results “an important first pointer into that direction.” He added, “We will need randomized trials to provide a definitive answer to the question whether Lp(a) lowering may prevent aortic valve calcium.”
Focus on AVC is study ‘weakness’
The study findings raise a key question for clinical trials of investigative Lp(a)-lowering therapies as well as how to use those therapies to treat aortic valve disease, said Christie Ballantyne, MD, chief of cardiology at Baylor College of Medicine in Houston.
The findings could be “problematic” for these clinical trials, he said. “This study is just looking at calcium progression,” Dr. Ballantyne noted. “What we want to know about clinically is the progression to aortic stenosis, and then in particular to progression from mild disease to moderate or severe disease, because once you get into more severe disease, one has to do an intervention with either surgery or TAVR [transcatheter aortic valve replacement].”
He considered the study’s focus on AVC rather than aortic valve function a weakness and noted that only 14 study participants had TAVR. “We’re going to need much bigger numbers to look into this question of progression, including progression to severe diseases,” he said.
However, the Rotterdam Study showed the importance of CT in evaluating AVC, which can easily be done in other trials to further explore the association between Lp(a) and AVC, Dr. Ballantyne said.
Dr. Bos has no relevant disclosures. Study coauthors disclosed relationships with Amgen, Sanofi, Reservlogix, Athera, Experio, Novartis and Ionis Pharmaceuticals. Dr. Ballantyne disclosed relationships with Amgen and Novartis.
FROM THE EUROPEAN HEART JOURNAL
RADIANCE II: Positive signal for ultrasound renal denervation
Top-line results released on July 26 from the RADIANCE II trial show the Paradise ultrasound renal denervation system significantly reduces daytime ambulatory systolic blood pressure, compared with a sham procedure at 2 months in patients with mild to moderate uncontrolled hypertension.
The trial was conducted in 224 patients who were previously treated with up to two medications and were randomized while off medication at more than 60 centers in 8 countries. No further details or results were provided.
The pivotal RADIANCE II trial, required for FDA approval, is the third and largest randomized, sham-controlled study following positive results reported by RADIANCE-HTN SOLO and RADIANCE-HTN TRIO, ReCor Medical and its subsidiary Otsuka Medical Devices noted in the announcement.
The field of renal denervation fell out of favor after the largest trial in 535 patients, SYMPLICITY HTN-3, failed to show a significant reduction in systolic blood pressure at 6 months, compared with sham control in resistant hypertension.
A version of this article first appeared on Medscape.com.
Top-line results released on July 26 from the RADIANCE II trial show the Paradise ultrasound renal denervation system significantly reduces daytime ambulatory systolic blood pressure, compared with a sham procedure at 2 months in patients with mild to moderate uncontrolled hypertension.
The trial was conducted in 224 patients who were previously treated with up to two medications and were randomized while off medication at more than 60 centers in 8 countries. No further details or results were provided.
The pivotal RADIANCE II trial, required for FDA approval, is the third and largest randomized, sham-controlled study following positive results reported by RADIANCE-HTN SOLO and RADIANCE-HTN TRIO, ReCor Medical and its subsidiary Otsuka Medical Devices noted in the announcement.
The field of renal denervation fell out of favor after the largest trial in 535 patients, SYMPLICITY HTN-3, failed to show a significant reduction in systolic blood pressure at 6 months, compared with sham control in resistant hypertension.
A version of this article first appeared on Medscape.com.
Top-line results released on July 26 from the RADIANCE II trial show the Paradise ultrasound renal denervation system significantly reduces daytime ambulatory systolic blood pressure, compared with a sham procedure at 2 months in patients with mild to moderate uncontrolled hypertension.
The trial was conducted in 224 patients who were previously treated with up to two medications and were randomized while off medication at more than 60 centers in 8 countries. No further details or results were provided.
The pivotal RADIANCE II trial, required for FDA approval, is the third and largest randomized, sham-controlled study following positive results reported by RADIANCE-HTN SOLO and RADIANCE-HTN TRIO, ReCor Medical and its subsidiary Otsuka Medical Devices noted in the announcement.
The field of renal denervation fell out of favor after the largest trial in 535 patients, SYMPLICITY HTN-3, failed to show a significant reduction in systolic blood pressure at 6 months, compared with sham control in resistant hypertension.
A version of this article first appeared on Medscape.com.
‘Case closed’: Bridging thrombolysis remains ‘gold standard’ in stroke thrombectomy
Two new noninferiority trials address the controversial question of whether thrombolytic therapy can be omitted for acute ischemic stroke in patients undergoing endovascular thrombectomy for large-vessel occlusion.
Both trials show better outcomes when standard bridging thrombolytic therapy is used before thrombectomy, with comparable safety.
The results of SWIFT-DIRECT and DIRECT-SAFE were published online June 22 in The Lancet.
“The case appears closed. Bypass intravenous thrombolysis is highly unlikely to be noninferior to standard care by a clinically acceptable margin for most patients,” writes Pooja Khatri, MD, MSc, department of neurology, University of Cincinnati, in a linked comment.
SWIFT-DIRECT
SWIFT-DIRECT enrolled 408 patients (median age 72; 51% women) with acute stroke due to large vessel occlusion admitted to stroke centers in Europe and Canada. Half were randomly allocated to thrombectomy alone and half to intravenous alteplase and thrombectomy.
Successful reperfusion was less common in patients who had thrombectomy alone (91% vs. 96%; risk difference −5.1%; 95% confidence interval, −10.2 to 0.0, P = .047).
With combination therapy, more patients achieved functional independence with a modified Rankin scale score of 0-2 at 90 days (65% vs. 57%; adjusted risk difference −7.3%; 95% CI, −16·6 to 2·1, lower limit of one-sided 95% CI, −15·1%, crossing the noninferiority margin of −12%).
“Despite a very liberal noninferiority margin and strict inclusion and exclusion criteria aimed at studying a population most likely to benefit from thrombectomy alone, point estimates directionally favored intravenous thrombolysis plus thrombectomy,” Urs Fischer, MD, cochair of the Stroke Center, University Hospital Basel, Switzerland, told this news organization.
“Furthermore, we could demonstrate that overall reperfusion rates were extremely high and yet significantly better in patients receiving intravenous thrombolysis plus thrombectomy than in patients treated with thrombectomy alone, a finding which has not been shown before,” Dr. Fischer said.
There was no significant difference in the risk of symptomatic intracranial bleeding (3% with combination therapy and 2% with thrombectomy alone).
Based on the results, in patients suitable for thrombolysis, skipping it before thrombectomy “is not justified,” the study team concludes.
DIRECT-SAFE
DIRECT-SAFE enrolled 295 patients (median age 69; 43% women) with stroke and large vessel occlusion from Australia, New Zealand, China, and Vietnam, with half undergoing direct thrombectomy and half bridging therapy first.
Functional independence (modified Rankin Scale 0-2 or return to baseline at 90 days) was more common in the bridging group (61% vs. 55%).
Safety outcomes were similar between groups. Symptomatic intracerebral hemorrhage occurred in 2 (1%) patients in the direct group and 1 (1%) patient in the bridging group. There were 22 (15%) deaths in the direct group and 24 in the bridging group.
“There has been concern across the world regarding cost of treatment, together with fears of increasing bleeding risk or clot migration with intravenous thrombolytic,” lead investigator Peter Mitchell, MBBS, director, NeuroIntervention Service, The Royal Melbourne Hospital, Parkville, Victoria, Australia, told this news organization.
“We showed that patients in the bridging treatment arm had better outcomes across the entire study, especially in Asian region patients” and therefore remains “the gold standard,” Dr. Mitchell said.
To date, six published trials have addressed this question of endovascular therapy alone or with thrombolysis – SKIP, DIRECT-MT, MR CLEAN NO IV, SWIFT-DIRECT, and DIRECT-SAFE.
Dr. Fischer said the SWIFT-DIRECT study group plans to perform an individual participant data meta-analysis known as Improving Reperfusion Strategies in Ischemic Stroke (IRIS) of all six trials to see whether there are subgroups of patients in whom thrombectomy alone is as effective as thrombolysis plus thrombectomy.
Subgroups of interest, he said, include patients with early ischemic signs on imaging, those at increased risk for hemorrhagic complications, and patients with a high clot burden.
SWIFT-DIRECT was funding by Medtronic and University Hospital Bern. DIRECT-SAFE was funded by Australian National Health and Medical Research Council and Stryker USA. A complete list of author disclosures is available with the original articles.
A version of this article first appeared on Medscape.com.
Two new noninferiority trials address the controversial question of whether thrombolytic therapy can be omitted for acute ischemic stroke in patients undergoing endovascular thrombectomy for large-vessel occlusion.
Both trials show better outcomes when standard bridging thrombolytic therapy is used before thrombectomy, with comparable safety.
The results of SWIFT-DIRECT and DIRECT-SAFE were published online June 22 in The Lancet.
“The case appears closed. Bypass intravenous thrombolysis is highly unlikely to be noninferior to standard care by a clinically acceptable margin for most patients,” writes Pooja Khatri, MD, MSc, department of neurology, University of Cincinnati, in a linked comment.
SWIFT-DIRECT
SWIFT-DIRECT enrolled 408 patients (median age 72; 51% women) with acute stroke due to large vessel occlusion admitted to stroke centers in Europe and Canada. Half were randomly allocated to thrombectomy alone and half to intravenous alteplase and thrombectomy.
Successful reperfusion was less common in patients who had thrombectomy alone (91% vs. 96%; risk difference −5.1%; 95% confidence interval, −10.2 to 0.0, P = .047).
With combination therapy, more patients achieved functional independence with a modified Rankin scale score of 0-2 at 90 days (65% vs. 57%; adjusted risk difference −7.3%; 95% CI, −16·6 to 2·1, lower limit of one-sided 95% CI, −15·1%, crossing the noninferiority margin of −12%).
“Despite a very liberal noninferiority margin and strict inclusion and exclusion criteria aimed at studying a population most likely to benefit from thrombectomy alone, point estimates directionally favored intravenous thrombolysis plus thrombectomy,” Urs Fischer, MD, cochair of the Stroke Center, University Hospital Basel, Switzerland, told this news organization.
“Furthermore, we could demonstrate that overall reperfusion rates were extremely high and yet significantly better in patients receiving intravenous thrombolysis plus thrombectomy than in patients treated with thrombectomy alone, a finding which has not been shown before,” Dr. Fischer said.
There was no significant difference in the risk of symptomatic intracranial bleeding (3% with combination therapy and 2% with thrombectomy alone).
Based on the results, in patients suitable for thrombolysis, skipping it before thrombectomy “is not justified,” the study team concludes.
DIRECT-SAFE
DIRECT-SAFE enrolled 295 patients (median age 69; 43% women) with stroke and large vessel occlusion from Australia, New Zealand, China, and Vietnam, with half undergoing direct thrombectomy and half bridging therapy first.
Functional independence (modified Rankin Scale 0-2 or return to baseline at 90 days) was more common in the bridging group (61% vs. 55%).
Safety outcomes were similar between groups. Symptomatic intracerebral hemorrhage occurred in 2 (1%) patients in the direct group and 1 (1%) patient in the bridging group. There were 22 (15%) deaths in the direct group and 24 in the bridging group.
“There has been concern across the world regarding cost of treatment, together with fears of increasing bleeding risk or clot migration with intravenous thrombolytic,” lead investigator Peter Mitchell, MBBS, director, NeuroIntervention Service, The Royal Melbourne Hospital, Parkville, Victoria, Australia, told this news organization.
“We showed that patients in the bridging treatment arm had better outcomes across the entire study, especially in Asian region patients” and therefore remains “the gold standard,” Dr. Mitchell said.
To date, six published trials have addressed this question of endovascular therapy alone or with thrombolysis – SKIP, DIRECT-MT, MR CLEAN NO IV, SWIFT-DIRECT, and DIRECT-SAFE.
Dr. Fischer said the SWIFT-DIRECT study group plans to perform an individual participant data meta-analysis known as Improving Reperfusion Strategies in Ischemic Stroke (IRIS) of all six trials to see whether there are subgroups of patients in whom thrombectomy alone is as effective as thrombolysis plus thrombectomy.
Subgroups of interest, he said, include patients with early ischemic signs on imaging, those at increased risk for hemorrhagic complications, and patients with a high clot burden.
SWIFT-DIRECT was funding by Medtronic and University Hospital Bern. DIRECT-SAFE was funded by Australian National Health and Medical Research Council and Stryker USA. A complete list of author disclosures is available with the original articles.
A version of this article first appeared on Medscape.com.
Two new noninferiority trials address the controversial question of whether thrombolytic therapy can be omitted for acute ischemic stroke in patients undergoing endovascular thrombectomy for large-vessel occlusion.
Both trials show better outcomes when standard bridging thrombolytic therapy is used before thrombectomy, with comparable safety.
The results of SWIFT-DIRECT and DIRECT-SAFE were published online June 22 in The Lancet.
“The case appears closed. Bypass intravenous thrombolysis is highly unlikely to be noninferior to standard care by a clinically acceptable margin for most patients,” writes Pooja Khatri, MD, MSc, department of neurology, University of Cincinnati, in a linked comment.
SWIFT-DIRECT
SWIFT-DIRECT enrolled 408 patients (median age 72; 51% women) with acute stroke due to large vessel occlusion admitted to stroke centers in Europe and Canada. Half were randomly allocated to thrombectomy alone and half to intravenous alteplase and thrombectomy.
Successful reperfusion was less common in patients who had thrombectomy alone (91% vs. 96%; risk difference −5.1%; 95% confidence interval, −10.2 to 0.0, P = .047).
With combination therapy, more patients achieved functional independence with a modified Rankin scale score of 0-2 at 90 days (65% vs. 57%; adjusted risk difference −7.3%; 95% CI, −16·6 to 2·1, lower limit of one-sided 95% CI, −15·1%, crossing the noninferiority margin of −12%).
“Despite a very liberal noninferiority margin and strict inclusion and exclusion criteria aimed at studying a population most likely to benefit from thrombectomy alone, point estimates directionally favored intravenous thrombolysis plus thrombectomy,” Urs Fischer, MD, cochair of the Stroke Center, University Hospital Basel, Switzerland, told this news organization.
“Furthermore, we could demonstrate that overall reperfusion rates were extremely high and yet significantly better in patients receiving intravenous thrombolysis plus thrombectomy than in patients treated with thrombectomy alone, a finding which has not been shown before,” Dr. Fischer said.
There was no significant difference in the risk of symptomatic intracranial bleeding (3% with combination therapy and 2% with thrombectomy alone).
Based on the results, in patients suitable for thrombolysis, skipping it before thrombectomy “is not justified,” the study team concludes.
DIRECT-SAFE
DIRECT-SAFE enrolled 295 patients (median age 69; 43% women) with stroke and large vessel occlusion from Australia, New Zealand, China, and Vietnam, with half undergoing direct thrombectomy and half bridging therapy first.
Functional independence (modified Rankin Scale 0-2 or return to baseline at 90 days) was more common in the bridging group (61% vs. 55%).
Safety outcomes were similar between groups. Symptomatic intracerebral hemorrhage occurred in 2 (1%) patients in the direct group and 1 (1%) patient in the bridging group. There were 22 (15%) deaths in the direct group and 24 in the bridging group.
“There has been concern across the world regarding cost of treatment, together with fears of increasing bleeding risk or clot migration with intravenous thrombolytic,” lead investigator Peter Mitchell, MBBS, director, NeuroIntervention Service, The Royal Melbourne Hospital, Parkville, Victoria, Australia, told this news organization.
“We showed that patients in the bridging treatment arm had better outcomes across the entire study, especially in Asian region patients” and therefore remains “the gold standard,” Dr. Mitchell said.
To date, six published trials have addressed this question of endovascular therapy alone or with thrombolysis – SKIP, DIRECT-MT, MR CLEAN NO IV, SWIFT-DIRECT, and DIRECT-SAFE.
Dr. Fischer said the SWIFT-DIRECT study group plans to perform an individual participant data meta-analysis known as Improving Reperfusion Strategies in Ischemic Stroke (IRIS) of all six trials to see whether there are subgroups of patients in whom thrombectomy alone is as effective as thrombolysis plus thrombectomy.
Subgroups of interest, he said, include patients with early ischemic signs on imaging, those at increased risk for hemorrhagic complications, and patients with a high clot burden.
SWIFT-DIRECT was funding by Medtronic and University Hospital Bern. DIRECT-SAFE was funded by Australian National Health and Medical Research Council and Stryker USA. A complete list of author disclosures is available with the original articles.
A version of this article first appeared on Medscape.com.
FROM THE LANCET
‘Stunning variation’ in CV test, procedure costs revealed at top U.S. hospitals
Wide variation in the cost of common cardiovascular (CV) tests and procedures, from stress tests to coronary interventions, was revealed in a cross-sectional analysis based on publicly available data from 20 top-ranked hospitals in the United States.
The analysis also suggested a low level of compliance with the 2021 Hospital Price Transparency Final Rule among the 20 centers.
“The variation we found in payer-negotiated prices for identical cardiovascular tests and procedures was stunning,” Rishi K. Wadhera, MD, MPP, MPhil, Beth Israel Deaconess Medical Center, Boston, told this news organization.
“For example, there was a 10-fold difference in the median price of an echocardiogram, and these differences were even larger for common procedures” such as percutaneous coronary intervention (PCI) and pacemaker implantation, he said. “It’s hard to argue that this variation reflects quality of care, given that we looked at a top group of highly ranked hospitals.”
“Even more striking was how the price of a cardiovascular test within the very same hospital could differ across commercial insurance companies,” he said. “For example, the price of a stress test varied 5-fold in one hospital, and in another hospital, more than 4-fold for a coronary angiogram.”
Dr. Wadhera is senior author on the study published online as a research letter in JAMA Internal Medicine, with lead author Andrew S. Oseran, MD, MBA, also from Beth Israel Deaconess Medical Center.
Difficulties with data, interpretation
The researchers looked at payer and self-pay cash prices for noninvasive and invasive CV tests and procedures at the U.S. News & World Report 2021 top 20–ranked U.S. hospitals, based in part on Current Procedural Terminology codes.
Price differences among the hospitals were derived from median negotiated prices for each test and procedure at the centers across all payers. The interquartile ratio (IQR) of prices for each test or procedure across payers was used to evaluate within-hospital price variation.
“Only 80% of the hospitals reported prices for some cardiovascular tests and procedures,” Dr. Wadhera said. “For the most part, even among the hospitals that did report this information, it was extremely challenging to navigate and interpret the data provided.”
Further, the team found that only 7 of the 20 hospitals reported prices for all CV tests and procedures. Centers that did not post prices for some tests or procedures are named in the report’s Figure 1 and Figure 2.
The number of insurance plans listed for each test or procedure ranged from 1 to 432 in the analysis. Median prices ranged from $204 to $2,588 for an echocardiogram, $463 to $3,230 for a stress test, $2,821 to $9,382 for right heart catheterization, $2,868 to $9,203 for a coronary angiogram, $657 to $25,521 for a PCI, and $506 to $20,002 for pacemaker implantation, the report states.
A similar pattern was seen for self-pay cash prices.
Within-hospital variation also ranged broadly. For example, the widest IQR ranges were $3,143-$12,926 for a right heart catheterization, $4,011-$14,486 for a coronary angiogram, $11,325-$23,392 for a PCI, and $8,474-$22,694 for pacemaker implantation.
The report cites a number of limitations to the analysis, among those, the need to rely on the hospitals themselves for data quality and accuracy.
‘More needed besides transparency’
“As a means to better understand health care costs, many opined that full price transparency would leverage market dynamics and result in lower costs,” observed Clyde W. Yancy, MD, MSc, professor of medicine and chief of cardiology at Northwestern Medicine, Chicago. The findings “by an expert group of outcomes scientists make clear that more is needed besides price transparency to lower cost,” he said in an interview.
That said, he added, “there are sufficient variations and allowances made for data collection that it is preferable to hold the current findings circumspect at best. Importantly, the voice of the hospitals does not appear.”
Although “price variation among the top 20 hospitals is substantial,” he observed, “without a better assessment of root cause, actual charge capture, prevailing market dynamics – especially nursing and ancillary staff costs – and the general influence of inflation, it is too difficult to emerge with a precise interpretation.”
Across the 20 hospitals, “there are likely to be 20 different business models,” he added, with negotiated prices reflecting “at least regional, if not institutional, variations.”
“These are complex issues. The several-fold price differences in standard procedures are a concern and an area worth further study with the intention of lowering health care costs,” Dr. Yancy said. “But clearly our next efforts should not address lowering prices per se but understanding how prices are set [and] the connection with reimbursement and actual payments.”
Dr. Wadhera discloses receiving personal fees from Abbott and CVS Health unrelated to the current study; disclosures for the other authors are in the report. Dr. Yancy is deputy editor of JAMA Cardiology.
A version of this article first appeared on Medscape.com.
Wide variation in the cost of common cardiovascular (CV) tests and procedures, from stress tests to coronary interventions, was revealed in a cross-sectional analysis based on publicly available data from 20 top-ranked hospitals in the United States.
The analysis also suggested a low level of compliance with the 2021 Hospital Price Transparency Final Rule among the 20 centers.
“The variation we found in payer-negotiated prices for identical cardiovascular tests and procedures was stunning,” Rishi K. Wadhera, MD, MPP, MPhil, Beth Israel Deaconess Medical Center, Boston, told this news organization.
“For example, there was a 10-fold difference in the median price of an echocardiogram, and these differences were even larger for common procedures” such as percutaneous coronary intervention (PCI) and pacemaker implantation, he said. “It’s hard to argue that this variation reflects quality of care, given that we looked at a top group of highly ranked hospitals.”
“Even more striking was how the price of a cardiovascular test within the very same hospital could differ across commercial insurance companies,” he said. “For example, the price of a stress test varied 5-fold in one hospital, and in another hospital, more than 4-fold for a coronary angiogram.”
Dr. Wadhera is senior author on the study published online as a research letter in JAMA Internal Medicine, with lead author Andrew S. Oseran, MD, MBA, also from Beth Israel Deaconess Medical Center.
Difficulties with data, interpretation
The researchers looked at payer and self-pay cash prices for noninvasive and invasive CV tests and procedures at the U.S. News & World Report 2021 top 20–ranked U.S. hospitals, based in part on Current Procedural Terminology codes.
Price differences among the hospitals were derived from median negotiated prices for each test and procedure at the centers across all payers. The interquartile ratio (IQR) of prices for each test or procedure across payers was used to evaluate within-hospital price variation.
“Only 80% of the hospitals reported prices for some cardiovascular tests and procedures,” Dr. Wadhera said. “For the most part, even among the hospitals that did report this information, it was extremely challenging to navigate and interpret the data provided.”
Further, the team found that only 7 of the 20 hospitals reported prices for all CV tests and procedures. Centers that did not post prices for some tests or procedures are named in the report’s Figure 1 and Figure 2.
The number of insurance plans listed for each test or procedure ranged from 1 to 432 in the analysis. Median prices ranged from $204 to $2,588 for an echocardiogram, $463 to $3,230 for a stress test, $2,821 to $9,382 for right heart catheterization, $2,868 to $9,203 for a coronary angiogram, $657 to $25,521 for a PCI, and $506 to $20,002 for pacemaker implantation, the report states.
A similar pattern was seen for self-pay cash prices.
Within-hospital variation also ranged broadly. For example, the widest IQR ranges were $3,143-$12,926 for a right heart catheterization, $4,011-$14,486 for a coronary angiogram, $11,325-$23,392 for a PCI, and $8,474-$22,694 for pacemaker implantation.
The report cites a number of limitations to the analysis, among those, the need to rely on the hospitals themselves for data quality and accuracy.
‘More needed besides transparency’
“As a means to better understand health care costs, many opined that full price transparency would leverage market dynamics and result in lower costs,” observed Clyde W. Yancy, MD, MSc, professor of medicine and chief of cardiology at Northwestern Medicine, Chicago. The findings “by an expert group of outcomes scientists make clear that more is needed besides price transparency to lower cost,” he said in an interview.
That said, he added, “there are sufficient variations and allowances made for data collection that it is preferable to hold the current findings circumspect at best. Importantly, the voice of the hospitals does not appear.”
Although “price variation among the top 20 hospitals is substantial,” he observed, “without a better assessment of root cause, actual charge capture, prevailing market dynamics – especially nursing and ancillary staff costs – and the general influence of inflation, it is too difficult to emerge with a precise interpretation.”
Across the 20 hospitals, “there are likely to be 20 different business models,” he added, with negotiated prices reflecting “at least regional, if not institutional, variations.”
“These are complex issues. The several-fold price differences in standard procedures are a concern and an area worth further study with the intention of lowering health care costs,” Dr. Yancy said. “But clearly our next efforts should not address lowering prices per se but understanding how prices are set [and] the connection with reimbursement and actual payments.”
Dr. Wadhera discloses receiving personal fees from Abbott and CVS Health unrelated to the current study; disclosures for the other authors are in the report. Dr. Yancy is deputy editor of JAMA Cardiology.
A version of this article first appeared on Medscape.com.
Wide variation in the cost of common cardiovascular (CV) tests and procedures, from stress tests to coronary interventions, was revealed in a cross-sectional analysis based on publicly available data from 20 top-ranked hospitals in the United States.
The analysis also suggested a low level of compliance with the 2021 Hospital Price Transparency Final Rule among the 20 centers.
“The variation we found in payer-negotiated prices for identical cardiovascular tests and procedures was stunning,” Rishi K. Wadhera, MD, MPP, MPhil, Beth Israel Deaconess Medical Center, Boston, told this news organization.
“For example, there was a 10-fold difference in the median price of an echocardiogram, and these differences were even larger for common procedures” such as percutaneous coronary intervention (PCI) and pacemaker implantation, he said. “It’s hard to argue that this variation reflects quality of care, given that we looked at a top group of highly ranked hospitals.”
“Even more striking was how the price of a cardiovascular test within the very same hospital could differ across commercial insurance companies,” he said. “For example, the price of a stress test varied 5-fold in one hospital, and in another hospital, more than 4-fold for a coronary angiogram.”
Dr. Wadhera is senior author on the study published online as a research letter in JAMA Internal Medicine, with lead author Andrew S. Oseran, MD, MBA, also from Beth Israel Deaconess Medical Center.
Difficulties with data, interpretation
The researchers looked at payer and self-pay cash prices for noninvasive and invasive CV tests and procedures at the U.S. News & World Report 2021 top 20–ranked U.S. hospitals, based in part on Current Procedural Terminology codes.
Price differences among the hospitals were derived from median negotiated prices for each test and procedure at the centers across all payers. The interquartile ratio (IQR) of prices for each test or procedure across payers was used to evaluate within-hospital price variation.
“Only 80% of the hospitals reported prices for some cardiovascular tests and procedures,” Dr. Wadhera said. “For the most part, even among the hospitals that did report this information, it was extremely challenging to navigate and interpret the data provided.”
Further, the team found that only 7 of the 20 hospitals reported prices for all CV tests and procedures. Centers that did not post prices for some tests or procedures are named in the report’s Figure 1 and Figure 2.
The number of insurance plans listed for each test or procedure ranged from 1 to 432 in the analysis. Median prices ranged from $204 to $2,588 for an echocardiogram, $463 to $3,230 for a stress test, $2,821 to $9,382 for right heart catheterization, $2,868 to $9,203 for a coronary angiogram, $657 to $25,521 for a PCI, and $506 to $20,002 for pacemaker implantation, the report states.
A similar pattern was seen for self-pay cash prices.
Within-hospital variation also ranged broadly. For example, the widest IQR ranges were $3,143-$12,926 for a right heart catheterization, $4,011-$14,486 for a coronary angiogram, $11,325-$23,392 for a PCI, and $8,474-$22,694 for pacemaker implantation.
The report cites a number of limitations to the analysis, among those, the need to rely on the hospitals themselves for data quality and accuracy.
‘More needed besides transparency’
“As a means to better understand health care costs, many opined that full price transparency would leverage market dynamics and result in lower costs,” observed Clyde W. Yancy, MD, MSc, professor of medicine and chief of cardiology at Northwestern Medicine, Chicago. The findings “by an expert group of outcomes scientists make clear that more is needed besides price transparency to lower cost,” he said in an interview.
That said, he added, “there are sufficient variations and allowances made for data collection that it is preferable to hold the current findings circumspect at best. Importantly, the voice of the hospitals does not appear.”
Although “price variation among the top 20 hospitals is substantial,” he observed, “without a better assessment of root cause, actual charge capture, prevailing market dynamics – especially nursing and ancillary staff costs – and the general influence of inflation, it is too difficult to emerge with a precise interpretation.”
Across the 20 hospitals, “there are likely to be 20 different business models,” he added, with negotiated prices reflecting “at least regional, if not institutional, variations.”
“These are complex issues. The several-fold price differences in standard procedures are a concern and an area worth further study with the intention of lowering health care costs,” Dr. Yancy said. “But clearly our next efforts should not address lowering prices per se but understanding how prices are set [and] the connection with reimbursement and actual payments.”
Dr. Wadhera discloses receiving personal fees from Abbott and CVS Health unrelated to the current study; disclosures for the other authors are in the report. Dr. Yancy is deputy editor of JAMA Cardiology.
A version of this article first appeared on Medscape.com.
Pig heart transplants and the ethical challenges that lie ahead
The long-struggling field of cardiac xenotransplantation has had a very good year.
In January, the University of Maryland made history by keeping a 57-year-old man deemed too sick for a human heart transplant alive for 2 months with a genetically engineered pig heart. On July 12, New York University surgeons reported that heart function was “completely normal with excellent contractility” in two brain-dead patients with pig hearts beating in their chests for 72 hours.
The NYU team approached the project with a decedent model in mind and, after discussions with their IRB equivalent, settled on a 72-hour window because that’s the time they typically keep people ventilated when trying to place their organs, explained Robert A. Montgomery, MD, DPhil, director of the NYU Langone Transplant Institute.
“There’s no real ethical argument for that,” he said in an interview. The consideration is what the family is willing to do when trying to balance doing “something very altruistic and good versus having closure.”
Some families have religious beliefs that burial or interment has to occur very rapidly, whereas others, including one of the family donors, were willing to have the research go on much longer, Dr. Montgomery said. Indeed, the next protocol is being written to consider maintaining the bodies for 2-4 weeks.
“People do vary and you have to kind of accommodate that variation,” he said. “For some people, this isn’t going to be what they’re going to want and that’s why you have to go through the consent process.”
Informed authorization
Arthur L. Caplan, PhD, director of medical ethics at the NYU Langone Medical Center, said the Uniform Anatomical Gift Act recognizes an individual’s right to be an organ donor for transplant and research, but it “mentions nothing about maintaining you in a dead state artificially for research purposes.”
“It’s a major shift in what people are thinking about doing when they die or their relatives die,” he said.
Because organ donation is controlled at the state, not federal, level, the possibility of donating organs for xenotransplantation, like medical aid in dying, will vary between states, observed Dr. Caplan. The best way to ensure that patients whose organs are found to be unsuitable for transplantation have the option is to change state laws.
He noted that cases are already springing up where people are requesting postmortem sperm or egg donations without direct consents from the person who died. “So we have this new area opening up of handling the use of the dead body and we need to bring the law into sync with the possibilities that are out there.”
In terms of informed authorization (informed consent is reserved for the living), Dr. Caplan said there should be written evidence the person wanted to be a donor and, while not required by law, all survivors should give their permission and understand what’s going to be done in terms of the experiment, such as the use of animal parts, when the body will be returned, and the possibility of zoonotic viral infection.
“They have to fully accept that the person is dead and we’re just maintaining them artificially,” he said. “There’s no maintaining anyone who’s alive. That’s a source of a lot of confusion.”
Special committees also need to be appointed with voices from people in organ procurement, law, theology, and patient groups to monitor practice to ensure people who have given permission understood the process, that families have their questions answered independent of the research team, and that clear limits are set on how long experiments will last.
As to what those limits should be: “I think in terms of a week or 2,” Dr. Caplan said. “Obviously we could maintain bodies longer and people have. But I think, culturally in our society, going much past that starts to perhaps stress emotionally, psychologically, family and friends about getting closure.”
“I’m not as comfortable when people say things like, ‘How about 2 months?’ ” he said. “That’s a long time to sort of accept the fact that somebody has died but you can’t complete all the things that go along with the death.”
Dr. Caplan is also uncomfortable with the use of one-off emergency authorizations, as used for Maryland resident David Bennett Sr., who was rejected for standard heart transplantation and required mechanical circulatory support to stay alive.
“It’s too premature, I believe, even to try and rescue someone,” he said. “We need to learn more from the deceased models.”
A better model
Dr. Montgomery noted that primates are very imperfect models for predicting what’s going to happen in humans, and that in order to do xenotransplantation in living humans, there are only two pathways – the one-off emergency authorization or a clinical phase 1 trial.
The decedent model, he said, “will make human trials safer because it’s an intermediate step. You don’t have a living human’s life on the line when you’re trying to do iterative changes and improve the procedure.”
The team, for example, omitted a perfusion pump that was used in the Maryland case and would likely have made its way into phase 1 trials based on baboon data that suggested it was important to have the heart on the pump for hours before it was transplanted, he said. “We didn’t do any of that. We just did it like we would do a regular heart transplant and it started right up, immediately, and started to work.”
The researchers did not release details on the immunosuppression regimen, but noted that, unlike Maryland, they also did not use the experimental anti-CD40 antibody to tamp down the recipients’ immune system.
Although Mr. Bennett’s autopsy did not show any conventional sign of graft rejection, the transplanted pig heart was infected with porcine cytomegalovirus (PCMV) and Mr. Bennett showed traces of DNA from PCMV in his circulation.
Nailing down safety
Dr. Montgomery said he wouldn’t rule out xenotransplantation in a living human, but that the safety issues need to be nailed down. “I think that the tests used on the pig that was the donor for the Bennett case were not sensitive enough for latent virus, and that’s how it slipped through. So there was a bit of going back to the drawing board, really looking at each of the tests, and being sure we had the sensitivity to pick up a latent virus.”
He noted that United Therapeutics, which funded the research and provided the engineered pigs through its subsidiary Revivicor, has created and validated a more sensitive polymerase chain reaction test that covers some 35 different pathogens, microbes, and parasites. NYU has also developed its own platform to repeat the testing and for monitoring after the transplant. “The ones that we’re currently using would have picked up the virus.”
Stuart Russell, MD, a professor of medicine who specializes in advanced HF at Duke University, Durham, N.C., said “the biggest thing from my perspective is those two amazing families that were willing let this happen. ... If 20 years from now, this is what we’re doing, it’s related to these families being this generous at a really tough time in their lives.”
Dr. Russell said he awaits publication of the data on what the pathology of the heart looks like, but that the experiments “help to give us a lot of reassurance that we don’t need to worry about hyperacute rejection,” which by definition is going to happen in the first 24-48 hours.
That said, longer-term data is essential to potential safety issues. Notably, among the 10 genetic modifications made to the pigs, four were porcine gene knockouts, including a growth hormone receptor knockout to prevent abnormal organ growth inside the recipient’s chest. As a result, the organs seem to be small for the age of the pig and just don’t grow that well, admitted Dr. Montgomery, who said they are currently analyzing this with echocardiography.
Dr. Russell said this may create a sizing issue, but also “if you have a heart that’s more stressed in the pig, from the point of being a donor, maybe it’s not as good a heart as if it was growing normally. But that kind of stuff, I think, is going to take more than two cases and longer-term data to sort out.”
Sharon Hunt, MD, professor emerita, Stanford (Calif.) University Medical Center, and past president of the International Society for Heart Lung Transplantation, said it’s not the technical aspects, but the biology of xenotransplantation that’s really daunting.
“It’s not the physical act of doing it, like they needed a bigger heart or a smaller heart. Those are technical problems but they’ll manage them,” she said. “The big problem is biological – and the bottom line is we don’t really know. We may have overcome hyperacute rejection, which is great, but the rest remains to be seen.”
Dr. Hunt, who worked with heart transplantation pioneer Norman Shumway, MD, and spent decades caring for patients after transplantation, said most families will consent to 24 or 48 hours or even a week of experimentation on a brain-dead loved one, but what the transplant community wants to know is whether this is workable for many months.
“So the fact that the xenotransplant works for 72 hours, yeah, that’s groovy. But, you know, the answer is kind of ‘so what,’ ” she said. “I’d like to see this go for months, like they were trying to do in the human in Maryland.”
For phase 1 trials, even longer-term survival with or without rejection or with rejection that’s treatable is needed, Dr. Hunt suggested.
“We haven’t seen that yet. The Maryland people were very valiant but they lost the cause,” she said. “There’s just so much more to do before we have a viable model to start anything like a phase 1 trial. I’d love it if that happens in my lifetime, but I’m not sure it’s going to.”
Dr. Russell and Dr. Hunt reported no relevant financial relationships. Dr. Caplan reported serving as a director, officer, partner, employee, advisor, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position) and is a contributing author and adviser for Medscape.
A version of this article first appeared on Medscape.com.
The long-struggling field of cardiac xenotransplantation has had a very good year.
In January, the University of Maryland made history by keeping a 57-year-old man deemed too sick for a human heart transplant alive for 2 months with a genetically engineered pig heart. On July 12, New York University surgeons reported that heart function was “completely normal with excellent contractility” in two brain-dead patients with pig hearts beating in their chests for 72 hours.
The NYU team approached the project with a decedent model in mind and, after discussions with their IRB equivalent, settled on a 72-hour window because that’s the time they typically keep people ventilated when trying to place their organs, explained Robert A. Montgomery, MD, DPhil, director of the NYU Langone Transplant Institute.
“There’s no real ethical argument for that,” he said in an interview. The consideration is what the family is willing to do when trying to balance doing “something very altruistic and good versus having closure.”
Some families have religious beliefs that burial or interment has to occur very rapidly, whereas others, including one of the family donors, were willing to have the research go on much longer, Dr. Montgomery said. Indeed, the next protocol is being written to consider maintaining the bodies for 2-4 weeks.
“People do vary and you have to kind of accommodate that variation,” he said. “For some people, this isn’t going to be what they’re going to want and that’s why you have to go through the consent process.”
Informed authorization
Arthur L. Caplan, PhD, director of medical ethics at the NYU Langone Medical Center, said the Uniform Anatomical Gift Act recognizes an individual’s right to be an organ donor for transplant and research, but it “mentions nothing about maintaining you in a dead state artificially for research purposes.”
“It’s a major shift in what people are thinking about doing when they die or their relatives die,” he said.
Because organ donation is controlled at the state, not federal, level, the possibility of donating organs for xenotransplantation, like medical aid in dying, will vary between states, observed Dr. Caplan. The best way to ensure that patients whose organs are found to be unsuitable for transplantation have the option is to change state laws.
He noted that cases are already springing up where people are requesting postmortem sperm or egg donations without direct consents from the person who died. “So we have this new area opening up of handling the use of the dead body and we need to bring the law into sync with the possibilities that are out there.”
In terms of informed authorization (informed consent is reserved for the living), Dr. Caplan said there should be written evidence the person wanted to be a donor and, while not required by law, all survivors should give their permission and understand what’s going to be done in terms of the experiment, such as the use of animal parts, when the body will be returned, and the possibility of zoonotic viral infection.
“They have to fully accept that the person is dead and we’re just maintaining them artificially,” he said. “There’s no maintaining anyone who’s alive. That’s a source of a lot of confusion.”
Special committees also need to be appointed with voices from people in organ procurement, law, theology, and patient groups to monitor practice to ensure people who have given permission understood the process, that families have their questions answered independent of the research team, and that clear limits are set on how long experiments will last.
As to what those limits should be: “I think in terms of a week or 2,” Dr. Caplan said. “Obviously we could maintain bodies longer and people have. But I think, culturally in our society, going much past that starts to perhaps stress emotionally, psychologically, family and friends about getting closure.”
“I’m not as comfortable when people say things like, ‘How about 2 months?’ ” he said. “That’s a long time to sort of accept the fact that somebody has died but you can’t complete all the things that go along with the death.”
Dr. Caplan is also uncomfortable with the use of one-off emergency authorizations, as used for Maryland resident David Bennett Sr., who was rejected for standard heart transplantation and required mechanical circulatory support to stay alive.
“It’s too premature, I believe, even to try and rescue someone,” he said. “We need to learn more from the deceased models.”
A better model
Dr. Montgomery noted that primates are very imperfect models for predicting what’s going to happen in humans, and that in order to do xenotransplantation in living humans, there are only two pathways – the one-off emergency authorization or a clinical phase 1 trial.
The decedent model, he said, “will make human trials safer because it’s an intermediate step. You don’t have a living human’s life on the line when you’re trying to do iterative changes and improve the procedure.”
The team, for example, omitted a perfusion pump that was used in the Maryland case and would likely have made its way into phase 1 trials based on baboon data that suggested it was important to have the heart on the pump for hours before it was transplanted, he said. “We didn’t do any of that. We just did it like we would do a regular heart transplant and it started right up, immediately, and started to work.”
The researchers did not release details on the immunosuppression regimen, but noted that, unlike Maryland, they also did not use the experimental anti-CD40 antibody to tamp down the recipients’ immune system.
Although Mr. Bennett’s autopsy did not show any conventional sign of graft rejection, the transplanted pig heart was infected with porcine cytomegalovirus (PCMV) and Mr. Bennett showed traces of DNA from PCMV in his circulation.
Nailing down safety
Dr. Montgomery said he wouldn’t rule out xenotransplantation in a living human, but that the safety issues need to be nailed down. “I think that the tests used on the pig that was the donor for the Bennett case were not sensitive enough for latent virus, and that’s how it slipped through. So there was a bit of going back to the drawing board, really looking at each of the tests, and being sure we had the sensitivity to pick up a latent virus.”
He noted that United Therapeutics, which funded the research and provided the engineered pigs through its subsidiary Revivicor, has created and validated a more sensitive polymerase chain reaction test that covers some 35 different pathogens, microbes, and parasites. NYU has also developed its own platform to repeat the testing and for monitoring after the transplant. “The ones that we’re currently using would have picked up the virus.”
Stuart Russell, MD, a professor of medicine who specializes in advanced HF at Duke University, Durham, N.C., said “the biggest thing from my perspective is those two amazing families that were willing let this happen. ... If 20 years from now, this is what we’re doing, it’s related to these families being this generous at a really tough time in their lives.”
Dr. Russell said he awaits publication of the data on what the pathology of the heart looks like, but that the experiments “help to give us a lot of reassurance that we don’t need to worry about hyperacute rejection,” which by definition is going to happen in the first 24-48 hours.
That said, longer-term data is essential to potential safety issues. Notably, among the 10 genetic modifications made to the pigs, four were porcine gene knockouts, including a growth hormone receptor knockout to prevent abnormal organ growth inside the recipient’s chest. As a result, the organs seem to be small for the age of the pig and just don’t grow that well, admitted Dr. Montgomery, who said they are currently analyzing this with echocardiography.
Dr. Russell said this may create a sizing issue, but also “if you have a heart that’s more stressed in the pig, from the point of being a donor, maybe it’s not as good a heart as if it was growing normally. But that kind of stuff, I think, is going to take more than two cases and longer-term data to sort out.”
Sharon Hunt, MD, professor emerita, Stanford (Calif.) University Medical Center, and past president of the International Society for Heart Lung Transplantation, said it’s not the technical aspects, but the biology of xenotransplantation that’s really daunting.
“It’s not the physical act of doing it, like they needed a bigger heart or a smaller heart. Those are technical problems but they’ll manage them,” she said. “The big problem is biological – and the bottom line is we don’t really know. We may have overcome hyperacute rejection, which is great, but the rest remains to be seen.”
Dr. Hunt, who worked with heart transplantation pioneer Norman Shumway, MD, and spent decades caring for patients after transplantation, said most families will consent to 24 or 48 hours or even a week of experimentation on a brain-dead loved one, but what the transplant community wants to know is whether this is workable for many months.
“So the fact that the xenotransplant works for 72 hours, yeah, that’s groovy. But, you know, the answer is kind of ‘so what,’ ” she said. “I’d like to see this go for months, like they were trying to do in the human in Maryland.”
For phase 1 trials, even longer-term survival with or without rejection or with rejection that’s treatable is needed, Dr. Hunt suggested.
“We haven’t seen that yet. The Maryland people were very valiant but they lost the cause,” she said. “There’s just so much more to do before we have a viable model to start anything like a phase 1 trial. I’d love it if that happens in my lifetime, but I’m not sure it’s going to.”
Dr. Russell and Dr. Hunt reported no relevant financial relationships. Dr. Caplan reported serving as a director, officer, partner, employee, advisor, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position) and is a contributing author and adviser for Medscape.
A version of this article first appeared on Medscape.com.
The long-struggling field of cardiac xenotransplantation has had a very good year.
In January, the University of Maryland made history by keeping a 57-year-old man deemed too sick for a human heart transplant alive for 2 months with a genetically engineered pig heart. On July 12, New York University surgeons reported that heart function was “completely normal with excellent contractility” in two brain-dead patients with pig hearts beating in their chests for 72 hours.
The NYU team approached the project with a decedent model in mind and, after discussions with their IRB equivalent, settled on a 72-hour window because that’s the time they typically keep people ventilated when trying to place their organs, explained Robert A. Montgomery, MD, DPhil, director of the NYU Langone Transplant Institute.
“There’s no real ethical argument for that,” he said in an interview. The consideration is what the family is willing to do when trying to balance doing “something very altruistic and good versus having closure.”
Some families have religious beliefs that burial or interment has to occur very rapidly, whereas others, including one of the family donors, were willing to have the research go on much longer, Dr. Montgomery said. Indeed, the next protocol is being written to consider maintaining the bodies for 2-4 weeks.
“People do vary and you have to kind of accommodate that variation,” he said. “For some people, this isn’t going to be what they’re going to want and that’s why you have to go through the consent process.”
Informed authorization
Arthur L. Caplan, PhD, director of medical ethics at the NYU Langone Medical Center, said the Uniform Anatomical Gift Act recognizes an individual’s right to be an organ donor for transplant and research, but it “mentions nothing about maintaining you in a dead state artificially for research purposes.”
“It’s a major shift in what people are thinking about doing when they die or their relatives die,” he said.
Because organ donation is controlled at the state, not federal, level, the possibility of donating organs for xenotransplantation, like medical aid in dying, will vary between states, observed Dr. Caplan. The best way to ensure that patients whose organs are found to be unsuitable for transplantation have the option is to change state laws.
He noted that cases are already springing up where people are requesting postmortem sperm or egg donations without direct consents from the person who died. “So we have this new area opening up of handling the use of the dead body and we need to bring the law into sync with the possibilities that are out there.”
In terms of informed authorization (informed consent is reserved for the living), Dr. Caplan said there should be written evidence the person wanted to be a donor and, while not required by law, all survivors should give their permission and understand what’s going to be done in terms of the experiment, such as the use of animal parts, when the body will be returned, and the possibility of zoonotic viral infection.
“They have to fully accept that the person is dead and we’re just maintaining them artificially,” he said. “There’s no maintaining anyone who’s alive. That’s a source of a lot of confusion.”
Special committees also need to be appointed with voices from people in organ procurement, law, theology, and patient groups to monitor practice to ensure people who have given permission understood the process, that families have their questions answered independent of the research team, and that clear limits are set on how long experiments will last.
As to what those limits should be: “I think in terms of a week or 2,” Dr. Caplan said. “Obviously we could maintain bodies longer and people have. But I think, culturally in our society, going much past that starts to perhaps stress emotionally, psychologically, family and friends about getting closure.”
“I’m not as comfortable when people say things like, ‘How about 2 months?’ ” he said. “That’s a long time to sort of accept the fact that somebody has died but you can’t complete all the things that go along with the death.”
Dr. Caplan is also uncomfortable with the use of one-off emergency authorizations, as used for Maryland resident David Bennett Sr., who was rejected for standard heart transplantation and required mechanical circulatory support to stay alive.
“It’s too premature, I believe, even to try and rescue someone,” he said. “We need to learn more from the deceased models.”
A better model
Dr. Montgomery noted that primates are very imperfect models for predicting what’s going to happen in humans, and that in order to do xenotransplantation in living humans, there are only two pathways – the one-off emergency authorization or a clinical phase 1 trial.
The decedent model, he said, “will make human trials safer because it’s an intermediate step. You don’t have a living human’s life on the line when you’re trying to do iterative changes and improve the procedure.”
The team, for example, omitted a perfusion pump that was used in the Maryland case and would likely have made its way into phase 1 trials based on baboon data that suggested it was important to have the heart on the pump for hours before it was transplanted, he said. “We didn’t do any of that. We just did it like we would do a regular heart transplant and it started right up, immediately, and started to work.”
The researchers did not release details on the immunosuppression regimen, but noted that, unlike Maryland, they also did not use the experimental anti-CD40 antibody to tamp down the recipients’ immune system.
Although Mr. Bennett’s autopsy did not show any conventional sign of graft rejection, the transplanted pig heart was infected with porcine cytomegalovirus (PCMV) and Mr. Bennett showed traces of DNA from PCMV in his circulation.
Nailing down safety
Dr. Montgomery said he wouldn’t rule out xenotransplantation in a living human, but that the safety issues need to be nailed down. “I think that the tests used on the pig that was the donor for the Bennett case were not sensitive enough for latent virus, and that’s how it slipped through. So there was a bit of going back to the drawing board, really looking at each of the tests, and being sure we had the sensitivity to pick up a latent virus.”
He noted that United Therapeutics, which funded the research and provided the engineered pigs through its subsidiary Revivicor, has created and validated a more sensitive polymerase chain reaction test that covers some 35 different pathogens, microbes, and parasites. NYU has also developed its own platform to repeat the testing and for monitoring after the transplant. “The ones that we’re currently using would have picked up the virus.”
Stuart Russell, MD, a professor of medicine who specializes in advanced HF at Duke University, Durham, N.C., said “the biggest thing from my perspective is those two amazing families that were willing let this happen. ... If 20 years from now, this is what we’re doing, it’s related to these families being this generous at a really tough time in their lives.”
Dr. Russell said he awaits publication of the data on what the pathology of the heart looks like, but that the experiments “help to give us a lot of reassurance that we don’t need to worry about hyperacute rejection,” which by definition is going to happen in the first 24-48 hours.
That said, longer-term data is essential to potential safety issues. Notably, among the 10 genetic modifications made to the pigs, four were porcine gene knockouts, including a growth hormone receptor knockout to prevent abnormal organ growth inside the recipient’s chest. As a result, the organs seem to be small for the age of the pig and just don’t grow that well, admitted Dr. Montgomery, who said they are currently analyzing this with echocardiography.
Dr. Russell said this may create a sizing issue, but also “if you have a heart that’s more stressed in the pig, from the point of being a donor, maybe it’s not as good a heart as if it was growing normally. But that kind of stuff, I think, is going to take more than two cases and longer-term data to sort out.”
Sharon Hunt, MD, professor emerita, Stanford (Calif.) University Medical Center, and past president of the International Society for Heart Lung Transplantation, said it’s not the technical aspects, but the biology of xenotransplantation that’s really daunting.
“It’s not the physical act of doing it, like they needed a bigger heart or a smaller heart. Those are technical problems but they’ll manage them,” she said. “The big problem is biological – and the bottom line is we don’t really know. We may have overcome hyperacute rejection, which is great, but the rest remains to be seen.”
Dr. Hunt, who worked with heart transplantation pioneer Norman Shumway, MD, and spent decades caring for patients after transplantation, said most families will consent to 24 or 48 hours or even a week of experimentation on a brain-dead loved one, but what the transplant community wants to know is whether this is workable for many months.
“So the fact that the xenotransplant works for 72 hours, yeah, that’s groovy. But, you know, the answer is kind of ‘so what,’ ” she said. “I’d like to see this go for months, like they were trying to do in the human in Maryland.”
For phase 1 trials, even longer-term survival with or without rejection or with rejection that’s treatable is needed, Dr. Hunt suggested.
“We haven’t seen that yet. The Maryland people were very valiant but they lost the cause,” she said. “There’s just so much more to do before we have a viable model to start anything like a phase 1 trial. I’d love it if that happens in my lifetime, but I’m not sure it’s going to.”
Dr. Russell and Dr. Hunt reported no relevant financial relationships. Dr. Caplan reported serving as a director, officer, partner, employee, advisor, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position) and is a contributing author and adviser for Medscape.
A version of this article first appeared on Medscape.com.
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