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Skip Potassium After Cardiac Surgery
LONDON —
“The widespread practice of giving patients potassium after bypass heart surgery even though their blood levels are within the normal range can be abandoned,” said Benjamin O’Brien, MD, PhD, director of the Clinic for Cardioanesthesiology and Intensive Care Medicine at Charité Hospital in Berlin, Germany.
Results from the randomized TIGHT-K trial that assessed two levels of potassium supplementation were presented at the annual congress of the European Society of Cardiology.
In the tight-control group, supplementation was provided to maintain high-normal levels of potassium (> 4.5 mEq/L). In the relaxed-control group, supplementation was provided only when potassium levels fell below the low-normal threshold (< 3.6 mEq/L).
Trial Upending Popular Practice
The multinational trial involved 23 centers in Germany and the United Kingdom. All 1690 participants enrolled were scheduled to undergo a coronary artery bypass graft procedure, but Dr. O’Brien said he considers the results of TIGHT-K to be broadly applicable.
“There is no physiological basis to expect a different result in patients undergoing different types of cardiac surgery,” he said.
The primary endpoint was clinically and electrocardiography confirmed new-onset atrial fibrillation that occurred in the 5 days after the bypass procedure.
For the primary atrial fibrillation endpoint, event rates were similar in the tight-control and the relaxed-control groups (26.2% vs 27.8%); the 1.7% difference did not approach statistical significance (P = .44). The difference in dysrhythmias other than atrial fibrillation, although numerically lower in the tight-control group, was also not significant (19.1% vs 21.1%; P = .26).
There were no significant differences in several secondary endpoints, including length of hospital stay and in-patient mortality, but cost, a prespecified secondary endpoint, was approximately $120 lower per patient in the relaxed-control group than in the tight-control group (P < .001).
Lowering Cost Across Cardiac Surgeries
During the 5-day follow-up, median potassium levels were higher in the tight-control group. Levels in both groups fell gradually, but essentially in parallel, over the study period, so median potassium levels were always higher in the tight-control group than in the relaxed-control group. At the end of the observation period, mean potassium levels were 4.34 mEq/L in the tight-control group and 4.08 mEq/L in the relaxed-control group.
Prior to the development of atrial fibrillation, participants in the tight-control group received a medium of seven potassium administrations (range, 4-12), whereas those in the relaxed-control group received a medium of zero.
There were no significant differences in episodes in any subgroup evaluated, including those divided by age, sex, baseline left ventricular ejection fraction, and the absence or presence of beta blockers or loop diuretics. A per-protocol analysis also failed to show any advantage for tight potassium control.
Atrial fibrillation occurs in about one third of patients after bypass surgery, as it does after many types of cardiac surgery. Institutions often have strategies in place to reduce the risk after cardiac surgery, and potassium supplementation is one of the most common, despite the lack of supportive evidence, Dr. O’Brien said.
Narrow Window for Optimal Potassium Levels
The difference in potassium levels between the tight-control group and the relaxed-control group were modest in this study, said Subodh Verma, MD, a cardiac surgeon at St Michael’s Hospital and professor at the University of Toronto, Ontario, Canada.
However, this is unavoidable and central to the question being posed, Dr. O’Brien pointed out. Because of the risks for both hypokalemia and hyperkalemia, the window for safe supplementation is short. Current practice is to achieve high-normal levels to reduce atrial fibrillation, but TIGHT-K demonstrates this has no benefit.
The conclusion of TIGHT-K is appropriate, said Faiez Zannad, MD, PhD, professor of therapeutics in the Division of Cardiology at the University of Lorraine in Nancy, France, who praised the design and conduct of the study.
He acknowledged an unmet need for effective methods to reduce the risk for atrial fibrillation after cardiac surgery, but the ESC invited discussant said it is now necessary to look at other strategies. Several are under current evaluation, such as supplementary magnesium and the use of sodium-glucose transporter-2 inhibitors.
Although Dr. Zannad encouraged more studies of methods to reduce atrial fibrillation risk after cardiac surgery, he said that TIGHT-K has answered the question of whether potassium supplementation is beneficial.
Potassium supplementation should no longer be offered, he said, which will “reduce healthcare costs and decrease patient risk from an unnecessary intervention.”
A version of this article first appeared on Medscape.com.
LONDON —
“The widespread practice of giving patients potassium after bypass heart surgery even though their blood levels are within the normal range can be abandoned,” said Benjamin O’Brien, MD, PhD, director of the Clinic for Cardioanesthesiology and Intensive Care Medicine at Charité Hospital in Berlin, Germany.
Results from the randomized TIGHT-K trial that assessed two levels of potassium supplementation were presented at the annual congress of the European Society of Cardiology.
In the tight-control group, supplementation was provided to maintain high-normal levels of potassium (> 4.5 mEq/L). In the relaxed-control group, supplementation was provided only when potassium levels fell below the low-normal threshold (< 3.6 mEq/L).
Trial Upending Popular Practice
The multinational trial involved 23 centers in Germany and the United Kingdom. All 1690 participants enrolled were scheduled to undergo a coronary artery bypass graft procedure, but Dr. O’Brien said he considers the results of TIGHT-K to be broadly applicable.
“There is no physiological basis to expect a different result in patients undergoing different types of cardiac surgery,” he said.
The primary endpoint was clinically and electrocardiography confirmed new-onset atrial fibrillation that occurred in the 5 days after the bypass procedure.
For the primary atrial fibrillation endpoint, event rates were similar in the tight-control and the relaxed-control groups (26.2% vs 27.8%); the 1.7% difference did not approach statistical significance (P = .44). The difference in dysrhythmias other than atrial fibrillation, although numerically lower in the tight-control group, was also not significant (19.1% vs 21.1%; P = .26).
There were no significant differences in several secondary endpoints, including length of hospital stay and in-patient mortality, but cost, a prespecified secondary endpoint, was approximately $120 lower per patient in the relaxed-control group than in the tight-control group (P < .001).
Lowering Cost Across Cardiac Surgeries
During the 5-day follow-up, median potassium levels were higher in the tight-control group. Levels in both groups fell gradually, but essentially in parallel, over the study period, so median potassium levels were always higher in the tight-control group than in the relaxed-control group. At the end of the observation period, mean potassium levels were 4.34 mEq/L in the tight-control group and 4.08 mEq/L in the relaxed-control group.
Prior to the development of atrial fibrillation, participants in the tight-control group received a medium of seven potassium administrations (range, 4-12), whereas those in the relaxed-control group received a medium of zero.
There were no significant differences in episodes in any subgroup evaluated, including those divided by age, sex, baseline left ventricular ejection fraction, and the absence or presence of beta blockers or loop diuretics. A per-protocol analysis also failed to show any advantage for tight potassium control.
Atrial fibrillation occurs in about one third of patients after bypass surgery, as it does after many types of cardiac surgery. Institutions often have strategies in place to reduce the risk after cardiac surgery, and potassium supplementation is one of the most common, despite the lack of supportive evidence, Dr. O’Brien said.
Narrow Window for Optimal Potassium Levels
The difference in potassium levels between the tight-control group and the relaxed-control group were modest in this study, said Subodh Verma, MD, a cardiac surgeon at St Michael’s Hospital and professor at the University of Toronto, Ontario, Canada.
However, this is unavoidable and central to the question being posed, Dr. O’Brien pointed out. Because of the risks for both hypokalemia and hyperkalemia, the window for safe supplementation is short. Current practice is to achieve high-normal levels to reduce atrial fibrillation, but TIGHT-K demonstrates this has no benefit.
The conclusion of TIGHT-K is appropriate, said Faiez Zannad, MD, PhD, professor of therapeutics in the Division of Cardiology at the University of Lorraine in Nancy, France, who praised the design and conduct of the study.
He acknowledged an unmet need for effective methods to reduce the risk for atrial fibrillation after cardiac surgery, but the ESC invited discussant said it is now necessary to look at other strategies. Several are under current evaluation, such as supplementary magnesium and the use of sodium-glucose transporter-2 inhibitors.
Although Dr. Zannad encouraged more studies of methods to reduce atrial fibrillation risk after cardiac surgery, he said that TIGHT-K has answered the question of whether potassium supplementation is beneficial.
Potassium supplementation should no longer be offered, he said, which will “reduce healthcare costs and decrease patient risk from an unnecessary intervention.”
A version of this article first appeared on Medscape.com.
LONDON —
“The widespread practice of giving patients potassium after bypass heart surgery even though their blood levels are within the normal range can be abandoned,” said Benjamin O’Brien, MD, PhD, director of the Clinic for Cardioanesthesiology and Intensive Care Medicine at Charité Hospital in Berlin, Germany.
Results from the randomized TIGHT-K trial that assessed two levels of potassium supplementation were presented at the annual congress of the European Society of Cardiology.
In the tight-control group, supplementation was provided to maintain high-normal levels of potassium (> 4.5 mEq/L). In the relaxed-control group, supplementation was provided only when potassium levels fell below the low-normal threshold (< 3.6 mEq/L).
Trial Upending Popular Practice
The multinational trial involved 23 centers in Germany and the United Kingdom. All 1690 participants enrolled were scheduled to undergo a coronary artery bypass graft procedure, but Dr. O’Brien said he considers the results of TIGHT-K to be broadly applicable.
“There is no physiological basis to expect a different result in patients undergoing different types of cardiac surgery,” he said.
The primary endpoint was clinically and electrocardiography confirmed new-onset atrial fibrillation that occurred in the 5 days after the bypass procedure.
For the primary atrial fibrillation endpoint, event rates were similar in the tight-control and the relaxed-control groups (26.2% vs 27.8%); the 1.7% difference did not approach statistical significance (P = .44). The difference in dysrhythmias other than atrial fibrillation, although numerically lower in the tight-control group, was also not significant (19.1% vs 21.1%; P = .26).
There were no significant differences in several secondary endpoints, including length of hospital stay and in-patient mortality, but cost, a prespecified secondary endpoint, was approximately $120 lower per patient in the relaxed-control group than in the tight-control group (P < .001).
Lowering Cost Across Cardiac Surgeries
During the 5-day follow-up, median potassium levels were higher in the tight-control group. Levels in both groups fell gradually, but essentially in parallel, over the study period, so median potassium levels were always higher in the tight-control group than in the relaxed-control group. At the end of the observation period, mean potassium levels were 4.34 mEq/L in the tight-control group and 4.08 mEq/L in the relaxed-control group.
Prior to the development of atrial fibrillation, participants in the tight-control group received a medium of seven potassium administrations (range, 4-12), whereas those in the relaxed-control group received a medium of zero.
There were no significant differences in episodes in any subgroup evaluated, including those divided by age, sex, baseline left ventricular ejection fraction, and the absence or presence of beta blockers or loop diuretics. A per-protocol analysis also failed to show any advantage for tight potassium control.
Atrial fibrillation occurs in about one third of patients after bypass surgery, as it does after many types of cardiac surgery. Institutions often have strategies in place to reduce the risk after cardiac surgery, and potassium supplementation is one of the most common, despite the lack of supportive evidence, Dr. O’Brien said.
Narrow Window for Optimal Potassium Levels
The difference in potassium levels between the tight-control group and the relaxed-control group were modest in this study, said Subodh Verma, MD, a cardiac surgeon at St Michael’s Hospital and professor at the University of Toronto, Ontario, Canada.
However, this is unavoidable and central to the question being posed, Dr. O’Brien pointed out. Because of the risks for both hypokalemia and hyperkalemia, the window for safe supplementation is short. Current practice is to achieve high-normal levels to reduce atrial fibrillation, but TIGHT-K demonstrates this has no benefit.
The conclusion of TIGHT-K is appropriate, said Faiez Zannad, MD, PhD, professor of therapeutics in the Division of Cardiology at the University of Lorraine in Nancy, France, who praised the design and conduct of the study.
He acknowledged an unmet need for effective methods to reduce the risk for atrial fibrillation after cardiac surgery, but the ESC invited discussant said it is now necessary to look at other strategies. Several are under current evaluation, such as supplementary magnesium and the use of sodium-glucose transporter-2 inhibitors.
Although Dr. Zannad encouraged more studies of methods to reduce atrial fibrillation risk after cardiac surgery, he said that TIGHT-K has answered the question of whether potassium supplementation is beneficial.
Potassium supplementation should no longer be offered, he said, which will “reduce healthcare costs and decrease patient risk from an unnecessary intervention.”
A version of this article first appeared on Medscape.com.
FROM ESC CONGRESS 2024
FDA ‘Recalls’ Often Leave Targeted Medical Devices in Use
In 2016, medical device giant Abbott issued a recall for its MitraClip cardiac device — “a Class I recall, the most serious type,” the FDA said.
“Use of this device may cause serious injuries or death,” an FDA notice about the recall said.
But neither the manufacturer nor the FDA actually recalled the device or suspended its use. They allowed doctors to continue implanting the clips in leaky heart valves in what has become a common procedure.
In a notice, the manufacturer explained, “Abbott is not removing product from commercial distribution.” Rather, Abbott revised instructions for use and required doctors who implant the clips to undergo training.
“It’s very oxymoronic,” said Rita Redberg, a cardiologist at the University of California-San Francisco and former editor-in-chief of the journal JAMA Internal Medicine. “A recall makes it sound like it’s recalled. But that is not actually what it means.”
Though the FDA and federal regulations call these actions recalls, they might be described more aptly as “non-recalls.” And they have happened repeatedly in recent years. For instance, in addition to other Abbott devices, products made by Medtronic, Abiomed, and Getinge have had recalls that left them in use.
Safeguarding the Public
Recalls that leave what the FDA identifies as potentially dangerous products in the marketplace can raise the question: Do they do enough to protect the public?
There are other ways to handle recalls. In announcements about products as varied as crib bumpers, pool drain covers, bicycle helmets, and coffee mugs, the Consumer Product Safety Commission routinely alerts consumers to stop using recalled products and contact the manufacturers for refunds, repairs, or replacements. The National Highway Traffic Safety Administration regularly advises consumers to bring recalled cars back to the dealer to have them fixed. When the U.S. Department of Agriculture and the FDA announce food recalls, they routinely tell consumers to return or discard the food.
In some cases, a medical device that is the subject of a recall can be kept on the market safely because there is a simple fix, said Sanket Dhruva, a cardiologist and an associate professor at UCSF who has studied FDA oversight of devices. In other cases, recalls that don’t remove devices from the market can provide unwarranted reassurance and leave the public at risk, Dhruva said.
From 2019 through 2023, there were 338 Class I medical device recalls, 164 of which were corrections and 174 of which were removals, FDA spokesperson Amanda Hils said.
Some products undergo recall after recall while they remain on the market. Products in the MitraClip line have been the subject of three rounds of recalls, none of which removed devices from use.
“When deciding whether a recall warrants device removal from the field, the FDA considers the frequency and severity of adverse events, effectiveness of the corrective actions that have been executed, and the benefits and risks of preserving patient access to the device,” FDA spokesperson Audra Harrison said.
Where recalled devices have already been implanted, “removal” doesn’t necessarily mean removing them from patients’ bodies. “When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place,” the FDA website says.
The FDA allowed the recalled MitraClip devices to remain in use “because the agency believed that the overall benefits of the device continued to outweigh the risks and the firm’s recall strategy was appropriate and adequate,” Harrison said.
The FDA reviews the recall strategies that manufacturers propose and often provides input to ensure the public will be protected, Hils said. The agency also monitors the effectiveness of recalls and, before terminating them, makes sure the strategy was carried out, Hils said.
Abbott, the maker of MitraClip, said the device has been proven safe and effective “based on more than 20 years of clinical evidence and has profoundly improved the lives of people living with mitral regurgitation,” a condition in which blood flows backward through the heart’s mitral valve. The condition can lead to heart failure and death.
“With MitraClip, we’re addressing the needs of people with MR who often have no other options,” company spokesperson Brent Tippen said.
Speaking of the MitraClip recalls, Redberg said, “So hard to imagine these are effective actions in protecting patients.”
In 2021, for Medtronic’s StealthStation S7 cranial software, the company and the FDA sent a different message.
StealthStation is an elaborate system of screens and other equipment that guides neurosurgeons using instruments in the brain — for instance, to biopsy or cut out tumors. Drawing from CT scans, MRIs, and other imaging, it’s meant to show the location of the surgical instruments.
In connection with a Class I November 2021 recall, the FDA website said potential inaccuracies in a biopsy depth gauge could result in “life-threatening injury (such as hemorrhage, unintended tissue damage, or permanent neurological injury), which could lead to death.”
The FDA website explained what Medtronic was doing about it.
“The recalling firm will provide a warning and instructional placard to be applied to impacted systems,” the website said. “Until a software update is available, ensure you are following the instructions below to prevent the issue from occurring,” it advised doctors.
In a statement to KFF Health News, Medtronic spokesperson Erika Winkels said the safety and well-being of patients is the company’s primary concern, and certain issues “can be safely and effectively remedied with a correction on site.”
Richard Everson, a neurosurgeon and an assistant professor at UCLA, noted that the 2021 recall allowed doctors to continue using unaffected StealthStation features, a benefit for patients and facilities depending on them.
“But, I mean, then you could ask, ‘Well, why don’t they just disable the view [of the brain] that’s bugged?’” Everson said. “Why would they give you the option of looking at an inaccurate one?”
“That’s kind of a strange solution,” he said.
The FDA lists the 2021 recall as still open, explaining “not all products have been corrected or removed.”
That recall was not the last word on problems with StealthStation. Since then, the manufacturer has submitted adverse event reports to the FDA describing trouble in cases involving various versions of StealthStation.
In a September 2022 case, guidance provided by a StealthStation device was allegedly off the mark, a procedure was aborted, and, when the patient awoke, they “had almost no speech for two days,” according to a Medtronic report. In the report, Medtronic said there was “insufficient information to determine the relationship of the software to the reported issue.”
In a February 2024 case, after brain surgery, an MRI found that the operation “missed the tumor” and that other tissue was removed instead, according to a report Medtronic submitted to the FDA. In the report, Medtronic said that when a company representative tested the system, it performed as intended.
In March 2024, Medtronic recalled versions of StealthStation S8 without removing them from hospitals. The company said at the time that it would provide a software update.
“Software updates are available to correct the anomalies identified in the 2021 S7 and 2024 S8 recalls and are actively being deployed,” Medtronic’s Winkels told KFF Health News in a July email. “While the software updates for the 2021 S7 recall are complete in the US, they remain ongoing in some international regions.”
In June 2023, Abiomed issued an urgent medical device correction for its Impella 2.5 intravascular micro axial blood pump, which supports the heart. In patients with a certain type of replacement heart valve, there was a risk of “destruction of the impeller blades,” which could cause “low flow” and “embolization of the fractured impeller material,” an entry on the FDA website said.
“Clinicians are cautioned to position the Impella system carefully in patients,” the FDA website said, among other instructions.
The updated instructions “provide technical guidance to mitigate the risk of rare complications,” Abiomed spokesperson Ryan Carbain said. There were no product removals and no reports of adverse events “related to product design or manufacturing,” Carbain said.
Another set of medical devices, Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps made by Getinge of Sweden, have failed persistently, according to FDA records.
The devices — which are placed in the aorta, a major artery, to assist the heart — were the subject of eight Class I recalls from December 2022 to July 2023. All were corrections rather than removals, a KFF Health News analysis found.
In a May 2024 letter to health care providers, the FDA said that, in the previous 12 months, it had received almost 3,000 adverse event reports related to the balloon pumps. It was referring to reports of malfunctions and cases in which the products might have caused or contributed to a death or injury. Of those, 15 reportedly involved serious injury or death, the FDA said.
During the summer of 2023, the FDA noted that “alternative treatments are limited” and said the devices could continue to be used.
But, in May, the FDA changed its stance. The agency advised health care facilities to “transition away from these devices and seek alternatives, if possible.”
“These recommendations are based on our continued concerns” that the manufacturer “has not sufficiently addressed the problems and risks with these recalled devices.”
Getinge sent KFF Health News written answers from Elin Frostehav, the company’s president of Acute Care Therapies.
“There is no question that we would have liked to have solved these issues in full much earlier,” she said.
As a result of the FDA’s May action, the company “immediately paused proactive marketing” of the balloon pumps in the United States, and it is selling them only to customers who have no alternatives, Frostehav said.
“We are working with the agency to finalize remediation and product update solutions,” Frostehav said.
‘Known Possible Complications’
Abbott’s MitraClip system includes tiny clips implanted in the heart’s mitral valve and the equipment used to implant them. The apparatus features a steering mechanism with hand controls and a catheter that is threaded through a major vein, typically from an incision in the groin, to place one or more clips in the heart.
Worldwide, more than 200,000 people have been treated with MitraClip, according to an Abbott website.
The 2016 MitraClip recall described cases in which “the user was unable to separate the implantable Clip from the delivery system.”
In a news release at the time, Abbott said it had “received a small number of reports” in which that happened.
Those cases “resulted in surgical interventions to remove the delivery system or replace the mitral valve, and it is expected that any future similar incidents would also require surgery to correct the problem,” the FDA said in a 2016 notice. “There was one patient death in these cases as a result of severe comorbidities following surgery.”
Years later, something similar happened.
In February 2021, a clip was implanted in an 81-year-old patient but the doctor couldn’t separate the clip from the delivery system, according to a report Abbott filed with the FDA. The patient was transferred to surgery, where the delivery system “had to be cut down in order to detach the clip.”
The patient then underwent an operation to replace the mitral valve, and, hours later, the patient was brought back to surgery to address bleeding, the report said.
The patient “coded” the next day and died from an aortic bleed, the report said.
In the report to the FDA, the manufacturer blamed “case-specific circumstances.”
“Cardiac arrest, hemorrhage and death are listed” in the device instructions “as known possible complications associated with mitraclip procedures,” the company said. “There is no indication of a product issue with respect to manufacture, design or labeling.”
The third MitraClip recall, initiated in September 2022, cited an “increase in clip locking malfunctions.”
Most of the reported malfunctions were not associated with adverse outcomes, the FDA said then. Treatment with MitraClip “remains within the anticipated risk levels,” the company told customers.
As with the two earlier recalls, the third advised doctors to follow the device’s instructions. But the 2022 recall identified a contributing factor: the way the device was made.
“Abbott has identified a contributing cause … as a change in the material properties of one of the Clip locking components,” the company said in a 2022 letter to customers.
“Abbott is working on producing new lots with updated manufacturing processing and raw material,” the company wrote. In the same letter, Abbott told doctors that, in the meantime, they could use the devices they had in stock.
Six days later, a clip opened while locked and a patient died, according to a report the manufacturer submitted to the FDA.
“There is no evidence that death was related to the device but it was likely related to the procedure,” Abbott wrote.
Now, almost two years later, the 2022 recall remains open, according to the FDA website, and “not all products have been corrected or removed.”
KFF Health News data editor Holly K. Hacker contributed to this report.
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism.
In 2016, medical device giant Abbott issued a recall for its MitraClip cardiac device — “a Class I recall, the most serious type,” the FDA said.
“Use of this device may cause serious injuries or death,” an FDA notice about the recall said.
But neither the manufacturer nor the FDA actually recalled the device or suspended its use. They allowed doctors to continue implanting the clips in leaky heart valves in what has become a common procedure.
In a notice, the manufacturer explained, “Abbott is not removing product from commercial distribution.” Rather, Abbott revised instructions for use and required doctors who implant the clips to undergo training.
“It’s very oxymoronic,” said Rita Redberg, a cardiologist at the University of California-San Francisco and former editor-in-chief of the journal JAMA Internal Medicine. “A recall makes it sound like it’s recalled. But that is not actually what it means.”
Though the FDA and federal regulations call these actions recalls, they might be described more aptly as “non-recalls.” And they have happened repeatedly in recent years. For instance, in addition to other Abbott devices, products made by Medtronic, Abiomed, and Getinge have had recalls that left them in use.
Safeguarding the Public
Recalls that leave what the FDA identifies as potentially dangerous products in the marketplace can raise the question: Do they do enough to protect the public?
There are other ways to handle recalls. In announcements about products as varied as crib bumpers, pool drain covers, bicycle helmets, and coffee mugs, the Consumer Product Safety Commission routinely alerts consumers to stop using recalled products and contact the manufacturers for refunds, repairs, or replacements. The National Highway Traffic Safety Administration regularly advises consumers to bring recalled cars back to the dealer to have them fixed. When the U.S. Department of Agriculture and the FDA announce food recalls, they routinely tell consumers to return or discard the food.
In some cases, a medical device that is the subject of a recall can be kept on the market safely because there is a simple fix, said Sanket Dhruva, a cardiologist and an associate professor at UCSF who has studied FDA oversight of devices. In other cases, recalls that don’t remove devices from the market can provide unwarranted reassurance and leave the public at risk, Dhruva said.
From 2019 through 2023, there were 338 Class I medical device recalls, 164 of which were corrections and 174 of which were removals, FDA spokesperson Amanda Hils said.
Some products undergo recall after recall while they remain on the market. Products in the MitraClip line have been the subject of three rounds of recalls, none of which removed devices from use.
“When deciding whether a recall warrants device removal from the field, the FDA considers the frequency and severity of adverse events, effectiveness of the corrective actions that have been executed, and the benefits and risks of preserving patient access to the device,” FDA spokesperson Audra Harrison said.
Where recalled devices have already been implanted, “removal” doesn’t necessarily mean removing them from patients’ bodies. “When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place,” the FDA website says.
The FDA allowed the recalled MitraClip devices to remain in use “because the agency believed that the overall benefits of the device continued to outweigh the risks and the firm’s recall strategy was appropriate and adequate,” Harrison said.
The FDA reviews the recall strategies that manufacturers propose and often provides input to ensure the public will be protected, Hils said. The agency also monitors the effectiveness of recalls and, before terminating them, makes sure the strategy was carried out, Hils said.
Abbott, the maker of MitraClip, said the device has been proven safe and effective “based on more than 20 years of clinical evidence and has profoundly improved the lives of people living with mitral regurgitation,” a condition in which blood flows backward through the heart’s mitral valve. The condition can lead to heart failure and death.
“With MitraClip, we’re addressing the needs of people with MR who often have no other options,” company spokesperson Brent Tippen said.
Speaking of the MitraClip recalls, Redberg said, “So hard to imagine these are effective actions in protecting patients.”
In 2021, for Medtronic’s StealthStation S7 cranial software, the company and the FDA sent a different message.
StealthStation is an elaborate system of screens and other equipment that guides neurosurgeons using instruments in the brain — for instance, to biopsy or cut out tumors. Drawing from CT scans, MRIs, and other imaging, it’s meant to show the location of the surgical instruments.
In connection with a Class I November 2021 recall, the FDA website said potential inaccuracies in a biopsy depth gauge could result in “life-threatening injury (such as hemorrhage, unintended tissue damage, or permanent neurological injury), which could lead to death.”
The FDA website explained what Medtronic was doing about it.
“The recalling firm will provide a warning and instructional placard to be applied to impacted systems,” the website said. “Until a software update is available, ensure you are following the instructions below to prevent the issue from occurring,” it advised doctors.
In a statement to KFF Health News, Medtronic spokesperson Erika Winkels said the safety and well-being of patients is the company’s primary concern, and certain issues “can be safely and effectively remedied with a correction on site.”
Richard Everson, a neurosurgeon and an assistant professor at UCLA, noted that the 2021 recall allowed doctors to continue using unaffected StealthStation features, a benefit for patients and facilities depending on them.
“But, I mean, then you could ask, ‘Well, why don’t they just disable the view [of the brain] that’s bugged?’” Everson said. “Why would they give you the option of looking at an inaccurate one?”
“That’s kind of a strange solution,” he said.
The FDA lists the 2021 recall as still open, explaining “not all products have been corrected or removed.”
That recall was not the last word on problems with StealthStation. Since then, the manufacturer has submitted adverse event reports to the FDA describing trouble in cases involving various versions of StealthStation.
In a September 2022 case, guidance provided by a StealthStation device was allegedly off the mark, a procedure was aborted, and, when the patient awoke, they “had almost no speech for two days,” according to a Medtronic report. In the report, Medtronic said there was “insufficient information to determine the relationship of the software to the reported issue.”
In a February 2024 case, after brain surgery, an MRI found that the operation “missed the tumor” and that other tissue was removed instead, according to a report Medtronic submitted to the FDA. In the report, Medtronic said that when a company representative tested the system, it performed as intended.
In March 2024, Medtronic recalled versions of StealthStation S8 without removing them from hospitals. The company said at the time that it would provide a software update.
“Software updates are available to correct the anomalies identified in the 2021 S7 and 2024 S8 recalls and are actively being deployed,” Medtronic’s Winkels told KFF Health News in a July email. “While the software updates for the 2021 S7 recall are complete in the US, they remain ongoing in some international regions.”
In June 2023, Abiomed issued an urgent medical device correction for its Impella 2.5 intravascular micro axial blood pump, which supports the heart. In patients with a certain type of replacement heart valve, there was a risk of “destruction of the impeller blades,” which could cause “low flow” and “embolization of the fractured impeller material,” an entry on the FDA website said.
“Clinicians are cautioned to position the Impella system carefully in patients,” the FDA website said, among other instructions.
The updated instructions “provide technical guidance to mitigate the risk of rare complications,” Abiomed spokesperson Ryan Carbain said. There were no product removals and no reports of adverse events “related to product design or manufacturing,” Carbain said.
Another set of medical devices, Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps made by Getinge of Sweden, have failed persistently, according to FDA records.
The devices — which are placed in the aorta, a major artery, to assist the heart — were the subject of eight Class I recalls from December 2022 to July 2023. All were corrections rather than removals, a KFF Health News analysis found.
In a May 2024 letter to health care providers, the FDA said that, in the previous 12 months, it had received almost 3,000 adverse event reports related to the balloon pumps. It was referring to reports of malfunctions and cases in which the products might have caused or contributed to a death or injury. Of those, 15 reportedly involved serious injury or death, the FDA said.
During the summer of 2023, the FDA noted that “alternative treatments are limited” and said the devices could continue to be used.
But, in May, the FDA changed its stance. The agency advised health care facilities to “transition away from these devices and seek alternatives, if possible.”
“These recommendations are based on our continued concerns” that the manufacturer “has not sufficiently addressed the problems and risks with these recalled devices.”
Getinge sent KFF Health News written answers from Elin Frostehav, the company’s president of Acute Care Therapies.
“There is no question that we would have liked to have solved these issues in full much earlier,” she said.
As a result of the FDA’s May action, the company “immediately paused proactive marketing” of the balloon pumps in the United States, and it is selling them only to customers who have no alternatives, Frostehav said.
“We are working with the agency to finalize remediation and product update solutions,” Frostehav said.
‘Known Possible Complications’
Abbott’s MitraClip system includes tiny clips implanted in the heart’s mitral valve and the equipment used to implant them. The apparatus features a steering mechanism with hand controls and a catheter that is threaded through a major vein, typically from an incision in the groin, to place one or more clips in the heart.
Worldwide, more than 200,000 people have been treated with MitraClip, according to an Abbott website.
The 2016 MitraClip recall described cases in which “the user was unable to separate the implantable Clip from the delivery system.”
In a news release at the time, Abbott said it had “received a small number of reports” in which that happened.
Those cases “resulted in surgical interventions to remove the delivery system or replace the mitral valve, and it is expected that any future similar incidents would also require surgery to correct the problem,” the FDA said in a 2016 notice. “There was one patient death in these cases as a result of severe comorbidities following surgery.”
Years later, something similar happened.
In February 2021, a clip was implanted in an 81-year-old patient but the doctor couldn’t separate the clip from the delivery system, according to a report Abbott filed with the FDA. The patient was transferred to surgery, where the delivery system “had to be cut down in order to detach the clip.”
The patient then underwent an operation to replace the mitral valve, and, hours later, the patient was brought back to surgery to address bleeding, the report said.
The patient “coded” the next day and died from an aortic bleed, the report said.
In the report to the FDA, the manufacturer blamed “case-specific circumstances.”
“Cardiac arrest, hemorrhage and death are listed” in the device instructions “as known possible complications associated with mitraclip procedures,” the company said. “There is no indication of a product issue with respect to manufacture, design or labeling.”
The third MitraClip recall, initiated in September 2022, cited an “increase in clip locking malfunctions.”
Most of the reported malfunctions were not associated with adverse outcomes, the FDA said then. Treatment with MitraClip “remains within the anticipated risk levels,” the company told customers.
As with the two earlier recalls, the third advised doctors to follow the device’s instructions. But the 2022 recall identified a contributing factor: the way the device was made.
“Abbott has identified a contributing cause … as a change in the material properties of one of the Clip locking components,” the company said in a 2022 letter to customers.
“Abbott is working on producing new lots with updated manufacturing processing and raw material,” the company wrote. In the same letter, Abbott told doctors that, in the meantime, they could use the devices they had in stock.
Six days later, a clip opened while locked and a patient died, according to a report the manufacturer submitted to the FDA.
“There is no evidence that death was related to the device but it was likely related to the procedure,” Abbott wrote.
Now, almost two years later, the 2022 recall remains open, according to the FDA website, and “not all products have been corrected or removed.”
KFF Health News data editor Holly K. Hacker contributed to this report.
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism.
In 2016, medical device giant Abbott issued a recall for its MitraClip cardiac device — “a Class I recall, the most serious type,” the FDA said.
“Use of this device may cause serious injuries or death,” an FDA notice about the recall said.
But neither the manufacturer nor the FDA actually recalled the device or suspended its use. They allowed doctors to continue implanting the clips in leaky heart valves in what has become a common procedure.
In a notice, the manufacturer explained, “Abbott is not removing product from commercial distribution.” Rather, Abbott revised instructions for use and required doctors who implant the clips to undergo training.
“It’s very oxymoronic,” said Rita Redberg, a cardiologist at the University of California-San Francisco and former editor-in-chief of the journal JAMA Internal Medicine. “A recall makes it sound like it’s recalled. But that is not actually what it means.”
Though the FDA and federal regulations call these actions recalls, they might be described more aptly as “non-recalls.” And they have happened repeatedly in recent years. For instance, in addition to other Abbott devices, products made by Medtronic, Abiomed, and Getinge have had recalls that left them in use.
Safeguarding the Public
Recalls that leave what the FDA identifies as potentially dangerous products in the marketplace can raise the question: Do they do enough to protect the public?
There are other ways to handle recalls. In announcements about products as varied as crib bumpers, pool drain covers, bicycle helmets, and coffee mugs, the Consumer Product Safety Commission routinely alerts consumers to stop using recalled products and contact the manufacturers for refunds, repairs, or replacements. The National Highway Traffic Safety Administration regularly advises consumers to bring recalled cars back to the dealer to have them fixed. When the U.S. Department of Agriculture and the FDA announce food recalls, they routinely tell consumers to return or discard the food.
In some cases, a medical device that is the subject of a recall can be kept on the market safely because there is a simple fix, said Sanket Dhruva, a cardiologist and an associate professor at UCSF who has studied FDA oversight of devices. In other cases, recalls that don’t remove devices from the market can provide unwarranted reassurance and leave the public at risk, Dhruva said.
From 2019 through 2023, there were 338 Class I medical device recalls, 164 of which were corrections and 174 of which were removals, FDA spokesperson Amanda Hils said.
Some products undergo recall after recall while they remain on the market. Products in the MitraClip line have been the subject of three rounds of recalls, none of which removed devices from use.
“When deciding whether a recall warrants device removal from the field, the FDA considers the frequency and severity of adverse events, effectiveness of the corrective actions that have been executed, and the benefits and risks of preserving patient access to the device,” FDA spokesperson Audra Harrison said.
Where recalled devices have already been implanted, “removal” doesn’t necessarily mean removing them from patients’ bodies. “When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place,” the FDA website says.
The FDA allowed the recalled MitraClip devices to remain in use “because the agency believed that the overall benefits of the device continued to outweigh the risks and the firm’s recall strategy was appropriate and adequate,” Harrison said.
The FDA reviews the recall strategies that manufacturers propose and often provides input to ensure the public will be protected, Hils said. The agency also monitors the effectiveness of recalls and, before terminating them, makes sure the strategy was carried out, Hils said.
Abbott, the maker of MitraClip, said the device has been proven safe and effective “based on more than 20 years of clinical evidence and has profoundly improved the lives of people living with mitral regurgitation,” a condition in which blood flows backward through the heart’s mitral valve. The condition can lead to heart failure and death.
“With MitraClip, we’re addressing the needs of people with MR who often have no other options,” company spokesperson Brent Tippen said.
Speaking of the MitraClip recalls, Redberg said, “So hard to imagine these are effective actions in protecting patients.”
In 2021, for Medtronic’s StealthStation S7 cranial software, the company and the FDA sent a different message.
StealthStation is an elaborate system of screens and other equipment that guides neurosurgeons using instruments in the brain — for instance, to biopsy or cut out tumors. Drawing from CT scans, MRIs, and other imaging, it’s meant to show the location of the surgical instruments.
In connection with a Class I November 2021 recall, the FDA website said potential inaccuracies in a biopsy depth gauge could result in “life-threatening injury (such as hemorrhage, unintended tissue damage, or permanent neurological injury), which could lead to death.”
The FDA website explained what Medtronic was doing about it.
“The recalling firm will provide a warning and instructional placard to be applied to impacted systems,” the website said. “Until a software update is available, ensure you are following the instructions below to prevent the issue from occurring,” it advised doctors.
In a statement to KFF Health News, Medtronic spokesperson Erika Winkels said the safety and well-being of patients is the company’s primary concern, and certain issues “can be safely and effectively remedied with a correction on site.”
Richard Everson, a neurosurgeon and an assistant professor at UCLA, noted that the 2021 recall allowed doctors to continue using unaffected StealthStation features, a benefit for patients and facilities depending on them.
“But, I mean, then you could ask, ‘Well, why don’t they just disable the view [of the brain] that’s bugged?’” Everson said. “Why would they give you the option of looking at an inaccurate one?”
“That’s kind of a strange solution,” he said.
The FDA lists the 2021 recall as still open, explaining “not all products have been corrected or removed.”
That recall was not the last word on problems with StealthStation. Since then, the manufacturer has submitted adverse event reports to the FDA describing trouble in cases involving various versions of StealthStation.
In a September 2022 case, guidance provided by a StealthStation device was allegedly off the mark, a procedure was aborted, and, when the patient awoke, they “had almost no speech for two days,” according to a Medtronic report. In the report, Medtronic said there was “insufficient information to determine the relationship of the software to the reported issue.”
In a February 2024 case, after brain surgery, an MRI found that the operation “missed the tumor” and that other tissue was removed instead, according to a report Medtronic submitted to the FDA. In the report, Medtronic said that when a company representative tested the system, it performed as intended.
In March 2024, Medtronic recalled versions of StealthStation S8 without removing them from hospitals. The company said at the time that it would provide a software update.
“Software updates are available to correct the anomalies identified in the 2021 S7 and 2024 S8 recalls and are actively being deployed,” Medtronic’s Winkels told KFF Health News in a July email. “While the software updates for the 2021 S7 recall are complete in the US, they remain ongoing in some international regions.”
In June 2023, Abiomed issued an urgent medical device correction for its Impella 2.5 intravascular micro axial blood pump, which supports the heart. In patients with a certain type of replacement heart valve, there was a risk of “destruction of the impeller blades,” which could cause “low flow” and “embolization of the fractured impeller material,” an entry on the FDA website said.
“Clinicians are cautioned to position the Impella system carefully in patients,” the FDA website said, among other instructions.
The updated instructions “provide technical guidance to mitigate the risk of rare complications,” Abiomed spokesperson Ryan Carbain said. There were no product removals and no reports of adverse events “related to product design or manufacturing,” Carbain said.
Another set of medical devices, Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps made by Getinge of Sweden, have failed persistently, according to FDA records.
The devices — which are placed in the aorta, a major artery, to assist the heart — were the subject of eight Class I recalls from December 2022 to July 2023. All were corrections rather than removals, a KFF Health News analysis found.
In a May 2024 letter to health care providers, the FDA said that, in the previous 12 months, it had received almost 3,000 adverse event reports related to the balloon pumps. It was referring to reports of malfunctions and cases in which the products might have caused or contributed to a death or injury. Of those, 15 reportedly involved serious injury or death, the FDA said.
During the summer of 2023, the FDA noted that “alternative treatments are limited” and said the devices could continue to be used.
But, in May, the FDA changed its stance. The agency advised health care facilities to “transition away from these devices and seek alternatives, if possible.”
“These recommendations are based on our continued concerns” that the manufacturer “has not sufficiently addressed the problems and risks with these recalled devices.”
Getinge sent KFF Health News written answers from Elin Frostehav, the company’s president of Acute Care Therapies.
“There is no question that we would have liked to have solved these issues in full much earlier,” she said.
As a result of the FDA’s May action, the company “immediately paused proactive marketing” of the balloon pumps in the United States, and it is selling them only to customers who have no alternatives, Frostehav said.
“We are working with the agency to finalize remediation and product update solutions,” Frostehav said.
‘Known Possible Complications’
Abbott’s MitraClip system includes tiny clips implanted in the heart’s mitral valve and the equipment used to implant them. The apparatus features a steering mechanism with hand controls and a catheter that is threaded through a major vein, typically from an incision in the groin, to place one or more clips in the heart.
Worldwide, more than 200,000 people have been treated with MitraClip, according to an Abbott website.
The 2016 MitraClip recall described cases in which “the user was unable to separate the implantable Clip from the delivery system.”
In a news release at the time, Abbott said it had “received a small number of reports” in which that happened.
Those cases “resulted in surgical interventions to remove the delivery system or replace the mitral valve, and it is expected that any future similar incidents would also require surgery to correct the problem,” the FDA said in a 2016 notice. “There was one patient death in these cases as a result of severe comorbidities following surgery.”
Years later, something similar happened.
In February 2021, a clip was implanted in an 81-year-old patient but the doctor couldn’t separate the clip from the delivery system, according to a report Abbott filed with the FDA. The patient was transferred to surgery, where the delivery system “had to be cut down in order to detach the clip.”
The patient then underwent an operation to replace the mitral valve, and, hours later, the patient was brought back to surgery to address bleeding, the report said.
The patient “coded” the next day and died from an aortic bleed, the report said.
In the report to the FDA, the manufacturer blamed “case-specific circumstances.”
“Cardiac arrest, hemorrhage and death are listed” in the device instructions “as known possible complications associated with mitraclip procedures,” the company said. “There is no indication of a product issue with respect to manufacture, design or labeling.”
The third MitraClip recall, initiated in September 2022, cited an “increase in clip locking malfunctions.”
Most of the reported malfunctions were not associated with adverse outcomes, the FDA said then. Treatment with MitraClip “remains within the anticipated risk levels,” the company told customers.
As with the two earlier recalls, the third advised doctors to follow the device’s instructions. But the 2022 recall identified a contributing factor: the way the device was made.
“Abbott has identified a contributing cause … as a change in the material properties of one of the Clip locking components,” the company said in a 2022 letter to customers.
“Abbott is working on producing new lots with updated manufacturing processing and raw material,” the company wrote. In the same letter, Abbott told doctors that, in the meantime, they could use the devices they had in stock.
Six days later, a clip opened while locked and a patient died, according to a report the manufacturer submitted to the FDA.
“There is no evidence that death was related to the device but it was likely related to the procedure,” Abbott wrote.
Now, almost two years later, the 2022 recall remains open, according to the FDA website, and “not all products have been corrected or removed.”
KFF Health News data editor Holly K. Hacker contributed to this report.
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism.
Telemedicine Reduces Rehospitalization, Revascularization in Post-PCI ACS Patients
ATLANTA — Patients with acute coronary syndrome (ACS) who had a myocardial infarction or unstable angina and underwent percutaneous coronary intervention (PCI) had a 76% lower rate of hospital readmission after 6 months if they participated in a remote monitoring protocol compared with similar patients who had standard post-discharge care, results of a new trial suggest.
The TELE-ACS trial showed that at 6 months, telemedicine patients also had statistically significantly lower rates of post-discharge emergency department visits, unplanned coronary revascularizations, and cardiovascular symptoms, such as chest pain, shortness of breath and dizziness. However, the rates of major adverse cardiovascular events (MACE) were similar between the two groups. The protocol included consultation with a cardiologist who reviewed home-monitoring data.
“The team was able to aid in preventing unnecessary presentations and advised the patients to seek emergency care whenever was necessary,” Nasser Alshahrani, MSc, a clinical research fellow at Imperial College London, said while presenting the results at the American College of Cardiology meeting. “The TELE-ACS protocol provided a significant reduction in readmission rates post-ACS and other adverse events.”
The study findings were published online simultaneously in the Journal of the American College of Cardiology.
Telemedicine Protocol
The trial, conducted from January 2022 to April 2023, randomly assigned 337 patients to telemedicine or standard care when they were discharged after PCI and had at least one cardiovascular risk factor. The telemedicine protocol consisted of 12-lead electrocardiogram belt, an automated blood-pressure monitor, and a pulse oximeter.
Patients in the telemedicine arm initiated the remote monitoring protocol if they thought they had cardiac symptoms. The majority (86%) were men with what the study described as “a high preponderance of cardiovascular risk factors.” Average age was 58.1 years.
If a telemedicine patient initiated the protocol, a cardiologist remotely assessed the patient’s symptoms and channeled the patient to the appropriate care pathway, whether reassuring the patient or sending them to a primary care physician or emergency department, or to call emergency services. Patients who didn’t get a call back from the cardiologist within 15 minutes were told to seek care in the standard clinical pathway.
Telemedicine patients were given the telemonitoring package and training in how to use the devices before they were discharged. They also received three follow-up quality control calls in the first two months to ensure they were using the equipment correctly. They kept the telemonitoring equipment for 8 months, but were followed out to 9 months. Six telemedicine patients dropped out while one standard care patient withdrew from the study.
Results showed that at 6 months, telemedicine patients had statistically significantly lower rates of post-discharge emergency department visits (25% vs 37%, P < .001), unplanned coronary revascularizations (3% vs 9%, P < .01) and cardiovascular symptoms, such as chest pain, shortness of breath and dizziness (a 13% to 18% difference for each symptom, P < .01).
MACE rates were similar between the two groups.
At 9 months, 3 months after the protocol ended, 20 telemedicine patients and 50 standard-care patients were readmitted to the hospital, while 52 and 73, respectively, went to the emergency department.
The telemedicine patients also had shorter hospital stays: an average of 0.5 and 1.2 days at 6 and 9 months, respectively, vs 1.5 and 1.8 days in the standard treatment arm (P < .001 for both).
Mr. Alshahrani noted several limitations with the study, namely that 86% of participants were men, and that the intervention was only offered to people who had smartphones. “The high level of support for the telemedicine group, with prompt cardiology responses, may be challenging to replicate outside a trial setting, requiring significant investment and training,” he added.
Human Element Key
In an interview from London after the presentation, lead author Ramzi Khamis, MB ChB, PhD, said, “This was quite a basic study. Really what we did was we integrated a clinical decision-making algorithm that we perfected with some quite novel but basic technology.” Future research should strive to add a home troponin test to the protocol and an artificial intelligence component, he said.
However, Dr. Khamis noted that human interaction was key to the success of the TELE-ACS trial. “The human factor is very important here and I think it would be really interesting to have a head-to-head comparison of human interaction with remote monitoring vs an AI-driven interaction,” he said. “I have my doubts that AI would be able to beat the human factor here.”
Lawrence Phillips, MD, medical director of outpatient cardiology at NYU Langone Heart, told this news organization that the study was appropriately powered to evaluate the telemedicine protocol, and that it could serve as a template for other studies of remote monitoring in cardiology.
“I think that this study is forming the foundation of evolving telemedicine data,” he said. “It shows really interesting results, and I’m sure it’s going to be reproduced in different ways going forward.”
While other studies have shown the utility of telemedicine to decrease unnecessary hospitalizations, this study went one step further, Dr. Phillips said. “What was unique about this study was the package that they put together,” he added. “It was a combination of telehealth and being able to speak with someone when you have concerns with objective data of an electrocardiogram, blood-pressure cuff, and oxygen level assessment, which is an interesting approach having that ejective data with [a] subjective element.”
The trial received funding from the British Heart Foundation; King Khalid University, Abha, Saudi Arabia via The Saudi Arabian Cultural Bureau; Sansour Fund, Imperial Healthcare Charity; and Safwan Sobhan Fund at Imperial College London. Mr. Alshahrani and Dr. Khamis have no relevant relationships to disclose. Dr. Phillips has no relevant disclosures.
A version of this article first appeared on Medscape.com.
ATLANTA — Patients with acute coronary syndrome (ACS) who had a myocardial infarction or unstable angina and underwent percutaneous coronary intervention (PCI) had a 76% lower rate of hospital readmission after 6 months if they participated in a remote monitoring protocol compared with similar patients who had standard post-discharge care, results of a new trial suggest.
The TELE-ACS trial showed that at 6 months, telemedicine patients also had statistically significantly lower rates of post-discharge emergency department visits, unplanned coronary revascularizations, and cardiovascular symptoms, such as chest pain, shortness of breath and dizziness. However, the rates of major adverse cardiovascular events (MACE) were similar between the two groups. The protocol included consultation with a cardiologist who reviewed home-monitoring data.
“The team was able to aid in preventing unnecessary presentations and advised the patients to seek emergency care whenever was necessary,” Nasser Alshahrani, MSc, a clinical research fellow at Imperial College London, said while presenting the results at the American College of Cardiology meeting. “The TELE-ACS protocol provided a significant reduction in readmission rates post-ACS and other adverse events.”
The study findings were published online simultaneously in the Journal of the American College of Cardiology.
Telemedicine Protocol
The trial, conducted from January 2022 to April 2023, randomly assigned 337 patients to telemedicine or standard care when they were discharged after PCI and had at least one cardiovascular risk factor. The telemedicine protocol consisted of 12-lead electrocardiogram belt, an automated blood-pressure monitor, and a pulse oximeter.
Patients in the telemedicine arm initiated the remote monitoring protocol if they thought they had cardiac symptoms. The majority (86%) were men with what the study described as “a high preponderance of cardiovascular risk factors.” Average age was 58.1 years.
If a telemedicine patient initiated the protocol, a cardiologist remotely assessed the patient’s symptoms and channeled the patient to the appropriate care pathway, whether reassuring the patient or sending them to a primary care physician or emergency department, or to call emergency services. Patients who didn’t get a call back from the cardiologist within 15 minutes were told to seek care in the standard clinical pathway.
Telemedicine patients were given the telemonitoring package and training in how to use the devices before they were discharged. They also received three follow-up quality control calls in the first two months to ensure they were using the equipment correctly. They kept the telemonitoring equipment for 8 months, but were followed out to 9 months. Six telemedicine patients dropped out while one standard care patient withdrew from the study.
Results showed that at 6 months, telemedicine patients had statistically significantly lower rates of post-discharge emergency department visits (25% vs 37%, P < .001), unplanned coronary revascularizations (3% vs 9%, P < .01) and cardiovascular symptoms, such as chest pain, shortness of breath and dizziness (a 13% to 18% difference for each symptom, P < .01).
MACE rates were similar between the two groups.
At 9 months, 3 months after the protocol ended, 20 telemedicine patients and 50 standard-care patients were readmitted to the hospital, while 52 and 73, respectively, went to the emergency department.
The telemedicine patients also had shorter hospital stays: an average of 0.5 and 1.2 days at 6 and 9 months, respectively, vs 1.5 and 1.8 days in the standard treatment arm (P < .001 for both).
Mr. Alshahrani noted several limitations with the study, namely that 86% of participants were men, and that the intervention was only offered to people who had smartphones. “The high level of support for the telemedicine group, with prompt cardiology responses, may be challenging to replicate outside a trial setting, requiring significant investment and training,” he added.
Human Element Key
In an interview from London after the presentation, lead author Ramzi Khamis, MB ChB, PhD, said, “This was quite a basic study. Really what we did was we integrated a clinical decision-making algorithm that we perfected with some quite novel but basic technology.” Future research should strive to add a home troponin test to the protocol and an artificial intelligence component, he said.
However, Dr. Khamis noted that human interaction was key to the success of the TELE-ACS trial. “The human factor is very important here and I think it would be really interesting to have a head-to-head comparison of human interaction with remote monitoring vs an AI-driven interaction,” he said. “I have my doubts that AI would be able to beat the human factor here.”
Lawrence Phillips, MD, medical director of outpatient cardiology at NYU Langone Heart, told this news organization that the study was appropriately powered to evaluate the telemedicine protocol, and that it could serve as a template for other studies of remote monitoring in cardiology.
“I think that this study is forming the foundation of evolving telemedicine data,” he said. “It shows really interesting results, and I’m sure it’s going to be reproduced in different ways going forward.”
While other studies have shown the utility of telemedicine to decrease unnecessary hospitalizations, this study went one step further, Dr. Phillips said. “What was unique about this study was the package that they put together,” he added. “It was a combination of telehealth and being able to speak with someone when you have concerns with objective data of an electrocardiogram, blood-pressure cuff, and oxygen level assessment, which is an interesting approach having that ejective data with [a] subjective element.”
The trial received funding from the British Heart Foundation; King Khalid University, Abha, Saudi Arabia via The Saudi Arabian Cultural Bureau; Sansour Fund, Imperial Healthcare Charity; and Safwan Sobhan Fund at Imperial College London. Mr. Alshahrani and Dr. Khamis have no relevant relationships to disclose. Dr. Phillips has no relevant disclosures.
A version of this article first appeared on Medscape.com.
ATLANTA — Patients with acute coronary syndrome (ACS) who had a myocardial infarction or unstable angina and underwent percutaneous coronary intervention (PCI) had a 76% lower rate of hospital readmission after 6 months if they participated in a remote monitoring protocol compared with similar patients who had standard post-discharge care, results of a new trial suggest.
The TELE-ACS trial showed that at 6 months, telemedicine patients also had statistically significantly lower rates of post-discharge emergency department visits, unplanned coronary revascularizations, and cardiovascular symptoms, such as chest pain, shortness of breath and dizziness. However, the rates of major adverse cardiovascular events (MACE) were similar between the two groups. The protocol included consultation with a cardiologist who reviewed home-monitoring data.
“The team was able to aid in preventing unnecessary presentations and advised the patients to seek emergency care whenever was necessary,” Nasser Alshahrani, MSc, a clinical research fellow at Imperial College London, said while presenting the results at the American College of Cardiology meeting. “The TELE-ACS protocol provided a significant reduction in readmission rates post-ACS and other adverse events.”
The study findings were published online simultaneously in the Journal of the American College of Cardiology.
Telemedicine Protocol
The trial, conducted from January 2022 to April 2023, randomly assigned 337 patients to telemedicine or standard care when they were discharged after PCI and had at least one cardiovascular risk factor. The telemedicine protocol consisted of 12-lead electrocardiogram belt, an automated blood-pressure monitor, and a pulse oximeter.
Patients in the telemedicine arm initiated the remote monitoring protocol if they thought they had cardiac symptoms. The majority (86%) were men with what the study described as “a high preponderance of cardiovascular risk factors.” Average age was 58.1 years.
If a telemedicine patient initiated the protocol, a cardiologist remotely assessed the patient’s symptoms and channeled the patient to the appropriate care pathway, whether reassuring the patient or sending them to a primary care physician or emergency department, or to call emergency services. Patients who didn’t get a call back from the cardiologist within 15 minutes were told to seek care in the standard clinical pathway.
Telemedicine patients were given the telemonitoring package and training in how to use the devices before they were discharged. They also received three follow-up quality control calls in the first two months to ensure they were using the equipment correctly. They kept the telemonitoring equipment for 8 months, but were followed out to 9 months. Six telemedicine patients dropped out while one standard care patient withdrew from the study.
Results showed that at 6 months, telemedicine patients had statistically significantly lower rates of post-discharge emergency department visits (25% vs 37%, P < .001), unplanned coronary revascularizations (3% vs 9%, P < .01) and cardiovascular symptoms, such as chest pain, shortness of breath and dizziness (a 13% to 18% difference for each symptom, P < .01).
MACE rates were similar between the two groups.
At 9 months, 3 months after the protocol ended, 20 telemedicine patients and 50 standard-care patients were readmitted to the hospital, while 52 and 73, respectively, went to the emergency department.
The telemedicine patients also had shorter hospital stays: an average of 0.5 and 1.2 days at 6 and 9 months, respectively, vs 1.5 and 1.8 days in the standard treatment arm (P < .001 for both).
Mr. Alshahrani noted several limitations with the study, namely that 86% of participants were men, and that the intervention was only offered to people who had smartphones. “The high level of support for the telemedicine group, with prompt cardiology responses, may be challenging to replicate outside a trial setting, requiring significant investment and training,” he added.
Human Element Key
In an interview from London after the presentation, lead author Ramzi Khamis, MB ChB, PhD, said, “This was quite a basic study. Really what we did was we integrated a clinical decision-making algorithm that we perfected with some quite novel but basic technology.” Future research should strive to add a home troponin test to the protocol and an artificial intelligence component, he said.
However, Dr. Khamis noted that human interaction was key to the success of the TELE-ACS trial. “The human factor is very important here and I think it would be really interesting to have a head-to-head comparison of human interaction with remote monitoring vs an AI-driven interaction,” he said. “I have my doubts that AI would be able to beat the human factor here.”
Lawrence Phillips, MD, medical director of outpatient cardiology at NYU Langone Heart, told this news organization that the study was appropriately powered to evaluate the telemedicine protocol, and that it could serve as a template for other studies of remote monitoring in cardiology.
“I think that this study is forming the foundation of evolving telemedicine data,” he said. “It shows really interesting results, and I’m sure it’s going to be reproduced in different ways going forward.”
While other studies have shown the utility of telemedicine to decrease unnecessary hospitalizations, this study went one step further, Dr. Phillips said. “What was unique about this study was the package that they put together,” he added. “It was a combination of telehealth and being able to speak with someone when you have concerns with objective data of an electrocardiogram, blood-pressure cuff, and oxygen level assessment, which is an interesting approach having that ejective data with [a] subjective element.”
The trial received funding from the British Heart Foundation; King Khalid University, Abha, Saudi Arabia via The Saudi Arabian Cultural Bureau; Sansour Fund, Imperial Healthcare Charity; and Safwan Sobhan Fund at Imperial College London. Mr. Alshahrani and Dr. Khamis have no relevant relationships to disclose. Dr. Phillips has no relevant disclosures.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Breast implants used in double lung transplant post infection
An innovative surgical procedure combining breast implants and an artificial lung may help more patients with severe lung disease survive to receive transplants. The case was described in a press conference sponsored by Northwestern University, Evanston, Ill.
In May 2023, a surgical team at Northwestern removed both infected lungs from David “Davey” Bauer, aged 34 years, and temporarily used breast implants to hold his heart in place until new lungs were available.
In April 2023, Mr. Bauer, a longtime smoker and vaper, experienced shortness of breath. His girlfriend, Susan Gore, took him to an urgent care center, and he returned home, but “the next morning he couldn’t walk,” Ms. Gore said in the press conference. A trip to the ED yielded a diagnosis of influenza A, followed rapidly by a bacterial lung infection that proved resistant to antibiotics. Mr. Bauer had no prior medical history of serious illness, but he was soon in an intensive care unit. His condition continued to decline, and a double lung transplant was his only option.
The Northwestern Medicine Canning Thoracic Institute specializes in challenging cases, and Mr. Bauer was transferred there.
Back from the brink
Mr. Bauer made the transfer to Chicago despite being critically ill. He was in dire need of a lung transplant, and the only way to resolve his infection was to remove the lungs, said Ankit Bharat, MD, chief of thoracic surgery and director of Northwestern Medicine Canning Thoracic Institute, in the press conference.
“Something needed to be done right away,” Dr. Bharat said. Mr. Bauer’s lungs were removed and the chest cavity was extensively debrided to remove the infection.
Then it was time for outside-the-box thinking. “With the lungs taken out, we needed something to support the heart,” he said. Breast implants came to mind, and double Ds were the largest available.
In addition, the surgeons created an artificial lung system of conduits to keep Mr. Bauer’s blood pumping. “We wanted to maintain the natural blood flow in the body that would be present if the lungs were there,” Dr. Bharat explained.
Plastic surgeons at Northwestern gave Mr. Bauer’s surgical team “a crash course” in managing the breast implants, Dr. Bharat said. The team anticipated that their novel surgical solution would need to last for weeks, but Mr. Bauer’s condition improved immediately once the infected lungs were removed. He was placed on a double-lung transplant list, and the team received an offer of new lungs within 24 hours.
The breast implants were removed, the new lungs were implanted, and Bauer spent several months in the ICU before his discharge to rehabilitation therapy at the end of September, according to a Northwestern press release.
This type of procedure could help patients with infections who need transplants but are too sick to undergo them, Dr. Bharat said in the press conference. In Mr. Bauer’s case, “a lot of stars aligned,” including Bauer’s rapid improvement and the quick availability of a perfect lung match, Dr. Bharat said. Many patients don’t survive to the point of transplant.
“We were surprised how quickly he recovered once we removed the infected lungs,” Dr. Bharat noted. The quick recovery may be in part because of Bauer’s youth and relative good health, but “this was uncharted territory.”
Mr. Bauer’s case is the first use of this particular surgical technique, although the team drew on lessons learned in other surgical settings, such as removal of both lungs to prevent cross-contamination in patients with cancer, he added.
Causes and effects
As for the factors that contributed to Mr. Bauer’s initial infection, “there is a lot we don’t know, but we can try to put things together,” said Dr. Bharat. Just as many factors lined up to promote Mr. Bauer’s recovery, many factors lined up to cause the problem, including long-standing smoking and vaping. Although some still view vaping as a safer alternative to smoking, patient data and experiences do not support this claim. “We know for a fact that both of them cause harm,” he added.
Mr. Bauer started smoking cigarettes at age 21 and typically smoked a pack of cigarettes each day before switching to vaping in 2014. In addition, Mr. Bauer had not been vaccinated against the flu, and his flu infection was followed by a bacterial infection.
Bacterial infections followed by hospitalizations are not new as an effect of vaping; a series of articles described the ongoing epidemic of e-cigarette or vaping product use–associated lung injury (EVALI). Patients with EVALI often present at urgent care centers, as Bauer did, with symptoms of flu or pneumonia, and they are often given medication and sent home.
Looking ahead: “We expect that Davey will fully recover and live a normal life,” although he will remain in Chicago for another year for monitoring, said Rade Tomic, MD, pulmonologist and medical director of the Northwestern Medicine Canning Thoracic Institute lung transplant program, in the press conference.
Mr. Bauer expressed his thanks to the surgical team, who also presented him with another gift: a T-shirt with his newly chosen nickname, “DD Davey.” “I feel so blessed, I got a second chance at life,” Mr. Bauer said in the press conference. “You should not inhale anything into your lungs except oxygen.”
A version of this article first appeared on Medscape.com.
An innovative surgical procedure combining breast implants and an artificial lung may help more patients with severe lung disease survive to receive transplants. The case was described in a press conference sponsored by Northwestern University, Evanston, Ill.
In May 2023, a surgical team at Northwestern removed both infected lungs from David “Davey” Bauer, aged 34 years, and temporarily used breast implants to hold his heart in place until new lungs were available.
In April 2023, Mr. Bauer, a longtime smoker and vaper, experienced shortness of breath. His girlfriend, Susan Gore, took him to an urgent care center, and he returned home, but “the next morning he couldn’t walk,” Ms. Gore said in the press conference. A trip to the ED yielded a diagnosis of influenza A, followed rapidly by a bacterial lung infection that proved resistant to antibiotics. Mr. Bauer had no prior medical history of serious illness, but he was soon in an intensive care unit. His condition continued to decline, and a double lung transplant was his only option.
The Northwestern Medicine Canning Thoracic Institute specializes in challenging cases, and Mr. Bauer was transferred there.
Back from the brink
Mr. Bauer made the transfer to Chicago despite being critically ill. He was in dire need of a lung transplant, and the only way to resolve his infection was to remove the lungs, said Ankit Bharat, MD, chief of thoracic surgery and director of Northwestern Medicine Canning Thoracic Institute, in the press conference.
“Something needed to be done right away,” Dr. Bharat said. Mr. Bauer’s lungs were removed and the chest cavity was extensively debrided to remove the infection.
Then it was time for outside-the-box thinking. “With the lungs taken out, we needed something to support the heart,” he said. Breast implants came to mind, and double Ds were the largest available.
In addition, the surgeons created an artificial lung system of conduits to keep Mr. Bauer’s blood pumping. “We wanted to maintain the natural blood flow in the body that would be present if the lungs were there,” Dr. Bharat explained.
Plastic surgeons at Northwestern gave Mr. Bauer’s surgical team “a crash course” in managing the breast implants, Dr. Bharat said. The team anticipated that their novel surgical solution would need to last for weeks, but Mr. Bauer’s condition improved immediately once the infected lungs were removed. He was placed on a double-lung transplant list, and the team received an offer of new lungs within 24 hours.
The breast implants were removed, the new lungs were implanted, and Bauer spent several months in the ICU before his discharge to rehabilitation therapy at the end of September, according to a Northwestern press release.
This type of procedure could help patients with infections who need transplants but are too sick to undergo them, Dr. Bharat said in the press conference. In Mr. Bauer’s case, “a lot of stars aligned,” including Bauer’s rapid improvement and the quick availability of a perfect lung match, Dr. Bharat said. Many patients don’t survive to the point of transplant.
“We were surprised how quickly he recovered once we removed the infected lungs,” Dr. Bharat noted. The quick recovery may be in part because of Bauer’s youth and relative good health, but “this was uncharted territory.”
Mr. Bauer’s case is the first use of this particular surgical technique, although the team drew on lessons learned in other surgical settings, such as removal of both lungs to prevent cross-contamination in patients with cancer, he added.
Causes and effects
As for the factors that contributed to Mr. Bauer’s initial infection, “there is a lot we don’t know, but we can try to put things together,” said Dr. Bharat. Just as many factors lined up to promote Mr. Bauer’s recovery, many factors lined up to cause the problem, including long-standing smoking and vaping. Although some still view vaping as a safer alternative to smoking, patient data and experiences do not support this claim. “We know for a fact that both of them cause harm,” he added.
Mr. Bauer started smoking cigarettes at age 21 and typically smoked a pack of cigarettes each day before switching to vaping in 2014. In addition, Mr. Bauer had not been vaccinated against the flu, and his flu infection was followed by a bacterial infection.
Bacterial infections followed by hospitalizations are not new as an effect of vaping; a series of articles described the ongoing epidemic of e-cigarette or vaping product use–associated lung injury (EVALI). Patients with EVALI often present at urgent care centers, as Bauer did, with symptoms of flu or pneumonia, and they are often given medication and sent home.
Looking ahead: “We expect that Davey will fully recover and live a normal life,” although he will remain in Chicago for another year for monitoring, said Rade Tomic, MD, pulmonologist and medical director of the Northwestern Medicine Canning Thoracic Institute lung transplant program, in the press conference.
Mr. Bauer expressed his thanks to the surgical team, who also presented him with another gift: a T-shirt with his newly chosen nickname, “DD Davey.” “I feel so blessed, I got a second chance at life,” Mr. Bauer said in the press conference. “You should not inhale anything into your lungs except oxygen.”
A version of this article first appeared on Medscape.com.
An innovative surgical procedure combining breast implants and an artificial lung may help more patients with severe lung disease survive to receive transplants. The case was described in a press conference sponsored by Northwestern University, Evanston, Ill.
In May 2023, a surgical team at Northwestern removed both infected lungs from David “Davey” Bauer, aged 34 years, and temporarily used breast implants to hold his heart in place until new lungs were available.
In April 2023, Mr. Bauer, a longtime smoker and vaper, experienced shortness of breath. His girlfriend, Susan Gore, took him to an urgent care center, and he returned home, but “the next morning he couldn’t walk,” Ms. Gore said in the press conference. A trip to the ED yielded a diagnosis of influenza A, followed rapidly by a bacterial lung infection that proved resistant to antibiotics. Mr. Bauer had no prior medical history of serious illness, but he was soon in an intensive care unit. His condition continued to decline, and a double lung transplant was his only option.
The Northwestern Medicine Canning Thoracic Institute specializes in challenging cases, and Mr. Bauer was transferred there.
Back from the brink
Mr. Bauer made the transfer to Chicago despite being critically ill. He was in dire need of a lung transplant, and the only way to resolve his infection was to remove the lungs, said Ankit Bharat, MD, chief of thoracic surgery and director of Northwestern Medicine Canning Thoracic Institute, in the press conference.
“Something needed to be done right away,” Dr. Bharat said. Mr. Bauer’s lungs were removed and the chest cavity was extensively debrided to remove the infection.
Then it was time for outside-the-box thinking. “With the lungs taken out, we needed something to support the heart,” he said. Breast implants came to mind, and double Ds were the largest available.
In addition, the surgeons created an artificial lung system of conduits to keep Mr. Bauer’s blood pumping. “We wanted to maintain the natural blood flow in the body that would be present if the lungs were there,” Dr. Bharat explained.
Plastic surgeons at Northwestern gave Mr. Bauer’s surgical team “a crash course” in managing the breast implants, Dr. Bharat said. The team anticipated that their novel surgical solution would need to last for weeks, but Mr. Bauer’s condition improved immediately once the infected lungs were removed. He was placed on a double-lung transplant list, and the team received an offer of new lungs within 24 hours.
The breast implants were removed, the new lungs were implanted, and Bauer spent several months in the ICU before his discharge to rehabilitation therapy at the end of September, according to a Northwestern press release.
This type of procedure could help patients with infections who need transplants but are too sick to undergo them, Dr. Bharat said in the press conference. In Mr. Bauer’s case, “a lot of stars aligned,” including Bauer’s rapid improvement and the quick availability of a perfect lung match, Dr. Bharat said. Many patients don’t survive to the point of transplant.
“We were surprised how quickly he recovered once we removed the infected lungs,” Dr. Bharat noted. The quick recovery may be in part because of Bauer’s youth and relative good health, but “this was uncharted territory.”
Mr. Bauer’s case is the first use of this particular surgical technique, although the team drew on lessons learned in other surgical settings, such as removal of both lungs to prevent cross-contamination in patients with cancer, he added.
Causes and effects
As for the factors that contributed to Mr. Bauer’s initial infection, “there is a lot we don’t know, but we can try to put things together,” said Dr. Bharat. Just as many factors lined up to promote Mr. Bauer’s recovery, many factors lined up to cause the problem, including long-standing smoking and vaping. Although some still view vaping as a safer alternative to smoking, patient data and experiences do not support this claim. “We know for a fact that both of them cause harm,” he added.
Mr. Bauer started smoking cigarettes at age 21 and typically smoked a pack of cigarettes each day before switching to vaping in 2014. In addition, Mr. Bauer had not been vaccinated against the flu, and his flu infection was followed by a bacterial infection.
Bacterial infections followed by hospitalizations are not new as an effect of vaping; a series of articles described the ongoing epidemic of e-cigarette or vaping product use–associated lung injury (EVALI). Patients with EVALI often present at urgent care centers, as Bauer did, with symptoms of flu or pneumonia, and they are often given medication and sent home.
Looking ahead: “We expect that Davey will fully recover and live a normal life,” although he will remain in Chicago for another year for monitoring, said Rade Tomic, MD, pulmonologist and medical director of the Northwestern Medicine Canning Thoracic Institute lung transplant program, in the press conference.
Mr. Bauer expressed his thanks to the surgical team, who also presented him with another gift: a T-shirt with his newly chosen nickname, “DD Davey.” “I feel so blessed, I got a second chance at life,” Mr. Bauer said in the press conference. “You should not inhale anything into your lungs except oxygen.”
A version of this article first appeared on Medscape.com.
Second pig heart recipient dies
the University of Maryland Medical Center (UMMC), Baltimore, reported in a statement.
Mr. Faucette, a former lab tech who was turned down repeatedly for a standard allograft transplantation because of his various medical conditions, received the pig heart transplant on Sept. 20, 2023.
He first came to UMMC as a patient on Sept. 14. When he was admitted, he was in end-stage heart failure. Shortly before the surgery, his heart stopped, and he required resuscitation.
On Sept. 15, the Food and Drug Administration granted an emergency authorization for the surgery through its single-patient investigational new drug compassionate use pathway.
“My only real hope left is to go with the pig heart, the xenotransplant,” Mr. Faucette said in an interview from his hospital room a few days before his surgery. “At least now I have hope, and I have a chance.” He made “significant progress” in the month after the surgery, participating in physical therapy and spending time with family, according to the university. But in the days before his death, the heart showed signs of rejection.
“Mr. Faucette’s last wish was for us to make the most of what we have learned from our experience, so others may be guaranteed a chance for a new heart when a human organ is unavailable,” said Bartley P. Griffith, MD, who transplanted the pig heart into Mr. Faucette at UMMC. “He then told the team of doctors and nurses who gathered around him that he loved us. We will miss him tremendously.”
Muhammad M. Mohiuddin, MD, professor of surgery and scientific/program director of the Cardiac Xenotransplantation Program at the University of Maryland School of Medicine, said that “Mr. Faucette was a scientist who not only read and interpreted his own biopsies, but who understood the important contribution he was making in advancing the field.
“As with the first patient, David Bennett Sr., we intend to conduct an extensive analysis to identify factors that can be prevented in future transplants; this will allow us to continue to move forward and educate our colleagues in the field on our experience,” Dr. Mohiuddin added.
The researchers don’t plan to make further comments until their investigation is complete, a university spokesperson said in an interview.
UMMC performed the first transplant of a genetically modified pig heart in January 2022. Mr. Bennett, the recipient of that heart, survived for 60 days. The researchers published their initial findings in The New England Journal of Medicine, and then the results of their follow-up investigation in The Lancet.
A version of this article first appeared on Medscape.com.
the University of Maryland Medical Center (UMMC), Baltimore, reported in a statement.
Mr. Faucette, a former lab tech who was turned down repeatedly for a standard allograft transplantation because of his various medical conditions, received the pig heart transplant on Sept. 20, 2023.
He first came to UMMC as a patient on Sept. 14. When he was admitted, he was in end-stage heart failure. Shortly before the surgery, his heart stopped, and he required resuscitation.
On Sept. 15, the Food and Drug Administration granted an emergency authorization for the surgery through its single-patient investigational new drug compassionate use pathway.
“My only real hope left is to go with the pig heart, the xenotransplant,” Mr. Faucette said in an interview from his hospital room a few days before his surgery. “At least now I have hope, and I have a chance.” He made “significant progress” in the month after the surgery, participating in physical therapy and spending time with family, according to the university. But in the days before his death, the heart showed signs of rejection.
“Mr. Faucette’s last wish was for us to make the most of what we have learned from our experience, so others may be guaranteed a chance for a new heart when a human organ is unavailable,” said Bartley P. Griffith, MD, who transplanted the pig heart into Mr. Faucette at UMMC. “He then told the team of doctors and nurses who gathered around him that he loved us. We will miss him tremendously.”
Muhammad M. Mohiuddin, MD, professor of surgery and scientific/program director of the Cardiac Xenotransplantation Program at the University of Maryland School of Medicine, said that “Mr. Faucette was a scientist who not only read and interpreted his own biopsies, but who understood the important contribution he was making in advancing the field.
“As with the first patient, David Bennett Sr., we intend to conduct an extensive analysis to identify factors that can be prevented in future transplants; this will allow us to continue to move forward and educate our colleagues in the field on our experience,” Dr. Mohiuddin added.
The researchers don’t plan to make further comments until their investigation is complete, a university spokesperson said in an interview.
UMMC performed the first transplant of a genetically modified pig heart in January 2022. Mr. Bennett, the recipient of that heart, survived for 60 days. The researchers published their initial findings in The New England Journal of Medicine, and then the results of their follow-up investigation in The Lancet.
A version of this article first appeared on Medscape.com.
the University of Maryland Medical Center (UMMC), Baltimore, reported in a statement.
Mr. Faucette, a former lab tech who was turned down repeatedly for a standard allograft transplantation because of his various medical conditions, received the pig heart transplant on Sept. 20, 2023.
He first came to UMMC as a patient on Sept. 14. When he was admitted, he was in end-stage heart failure. Shortly before the surgery, his heart stopped, and he required resuscitation.
On Sept. 15, the Food and Drug Administration granted an emergency authorization for the surgery through its single-patient investigational new drug compassionate use pathway.
“My only real hope left is to go with the pig heart, the xenotransplant,” Mr. Faucette said in an interview from his hospital room a few days before his surgery. “At least now I have hope, and I have a chance.” He made “significant progress” in the month after the surgery, participating in physical therapy and spending time with family, according to the university. But in the days before his death, the heart showed signs of rejection.
“Mr. Faucette’s last wish was for us to make the most of what we have learned from our experience, so others may be guaranteed a chance for a new heart when a human organ is unavailable,” said Bartley P. Griffith, MD, who transplanted the pig heart into Mr. Faucette at UMMC. “He then told the team of doctors and nurses who gathered around him that he loved us. We will miss him tremendously.”
Muhammad M. Mohiuddin, MD, professor of surgery and scientific/program director of the Cardiac Xenotransplantation Program at the University of Maryland School of Medicine, said that “Mr. Faucette was a scientist who not only read and interpreted his own biopsies, but who understood the important contribution he was making in advancing the field.
“As with the first patient, David Bennett Sr., we intend to conduct an extensive analysis to identify factors that can be prevented in future transplants; this will allow us to continue to move forward and educate our colleagues in the field on our experience,” Dr. Mohiuddin added.
The researchers don’t plan to make further comments until their investigation is complete, a university spokesperson said in an interview.
UMMC performed the first transplant of a genetically modified pig heart in January 2022. Mr. Bennett, the recipient of that heart, survived for 60 days. The researchers published their initial findings in The New England Journal of Medicine, and then the results of their follow-up investigation in The Lancet.
A version of this article first appeared on Medscape.com.
More data support heart donation after circulatory death
TOPLINE:
There are no significant differences in 1-year mortality, survival to hospital discharge, severe primary graft dysfunction (PGD), and other outcomes post heart transplant between patients who receive a heart obtained by donation after circulatory death (DCD) and patients who receive a heart by donation after brain death (DBD), a new study has shown.
METHODOLOGY:
- The retrospective review included 385 patients (median age, 57.4 years; 26% women; 72.5% White) who underwent a heart transplant at Vanderbilt University Medical Center from January 2020 to January 2023. Of these, 263 received DBD hearts, and 122 received DCD hearts.
- In the DCD group, 17% of hearts were recovered by use of ex vivo machine perfusion (EVP), and 83% by use of normothermic regional perfusion followed by static cold storage; 4% of DBD hearts were recovered by use of EVP, and 96% by use of static cold storage.
- The primary outcome was survival at 1 year after transplantation; key secondary outcomes included survival to hospital discharge, survival at 30 days and 6 months after transplantation, and severe PGD.
TAKEAWAY:
- (hazard ratio, 0.77; 95% confidence interval, 0.32-1.81; P = .54), a finding that was unchanged when adjusted for recipient age.
- There were no significant differences in survival to hospital discharge (93.4% DBD vs. 94.5% DCD; HR, 0.72; 95% CI, 0.26-1.99; P = .53), to 30 days (95.1% DBD vs. 96.7% DCD; HR, 0.67; 95% CI, 0.22-2.05; P = .48), or to 6 months (92.8% DBD vs. 94.3% DCD; HR, 0.68; 95% CI, 0.25-1.85; P = .45) after transplantation.
- The incidence of severe PGD was similar between groups (5.7% DCD vs. 5.7% DBD; HR, 1.00; 95% CI, 0.41-2.4; P = .99).
- There were no significant between-group differences in other outcomes, including incidence of treated rejection and cases of cardiac allograft vasculopathy of grade 1 or greater on the International Society for scale at 1 year.
IN PRACTICE:
“Our findings add to the growing body of evidence in support of DCD heart transplantation,” the authors write, potentially expanding the heart donor pool. They note that outcomes remained similar between groups despite higher-risk patients being overrepresented in the DCD cohort.
In an accompanying editorial, Sean P. Pinney, MD, Center for Cardiovascular Health, Icahn School of Medicine at Mount Sinai, New York, and a colleague called the results “impressive” and “encouraging,” although there are still “important unknowns,” including longer-term outcomes, the financial impact of DCD, and whether results can be replicated in other centers.
“These results provide confidence that DCD can be safely and effectively performed without compromising outcomes, at least in a large-volume center of excellence,” and help provide evidence “to support the spreading acceptance of DCD among heart transplant programs.”
SOURCE:
The study was conducted by Hasan K. Siddiqi, MD, department of medicine, Vanderbilt University Medical Center, Nashville, Tenn., and colleagues. It was published online in the Journal of the American College of Cardiology.
LIMITATIONS:
The study was conducted at a single center and had a retrospective design and a modest sample size that prevented adjustment for all potentially confounding variables. Meaningful differences among DCD recipients could not be explored with regard to organ recovery technique, and small but statistically meaningful differences in outcomes could not be detected, the authors note. Follow-up was limited to 1 year after transplantation.
DISCLOSURES:
The authors report no relevant conflicts of interest. Dr. Pinney has received consulting fees from Abbott, ADI, Ancora, CareDx, ImpulseDynamics, Medtronic, Nuwellis, Procyrion, Restore Medical, Transmedics, and Valgen Medtech.
A version of this article first appeared on Medscape.com.
TOPLINE:
There are no significant differences in 1-year mortality, survival to hospital discharge, severe primary graft dysfunction (PGD), and other outcomes post heart transplant between patients who receive a heart obtained by donation after circulatory death (DCD) and patients who receive a heart by donation after brain death (DBD), a new study has shown.
METHODOLOGY:
- The retrospective review included 385 patients (median age, 57.4 years; 26% women; 72.5% White) who underwent a heart transplant at Vanderbilt University Medical Center from January 2020 to January 2023. Of these, 263 received DBD hearts, and 122 received DCD hearts.
- In the DCD group, 17% of hearts were recovered by use of ex vivo machine perfusion (EVP), and 83% by use of normothermic regional perfusion followed by static cold storage; 4% of DBD hearts were recovered by use of EVP, and 96% by use of static cold storage.
- The primary outcome was survival at 1 year after transplantation; key secondary outcomes included survival to hospital discharge, survival at 30 days and 6 months after transplantation, and severe PGD.
TAKEAWAY:
- (hazard ratio, 0.77; 95% confidence interval, 0.32-1.81; P = .54), a finding that was unchanged when adjusted for recipient age.
- There were no significant differences in survival to hospital discharge (93.4% DBD vs. 94.5% DCD; HR, 0.72; 95% CI, 0.26-1.99; P = .53), to 30 days (95.1% DBD vs. 96.7% DCD; HR, 0.67; 95% CI, 0.22-2.05; P = .48), or to 6 months (92.8% DBD vs. 94.3% DCD; HR, 0.68; 95% CI, 0.25-1.85; P = .45) after transplantation.
- The incidence of severe PGD was similar between groups (5.7% DCD vs. 5.7% DBD; HR, 1.00; 95% CI, 0.41-2.4; P = .99).
- There were no significant between-group differences in other outcomes, including incidence of treated rejection and cases of cardiac allograft vasculopathy of grade 1 or greater on the International Society for scale at 1 year.
IN PRACTICE:
“Our findings add to the growing body of evidence in support of DCD heart transplantation,” the authors write, potentially expanding the heart donor pool. They note that outcomes remained similar between groups despite higher-risk patients being overrepresented in the DCD cohort.
In an accompanying editorial, Sean P. Pinney, MD, Center for Cardiovascular Health, Icahn School of Medicine at Mount Sinai, New York, and a colleague called the results “impressive” and “encouraging,” although there are still “important unknowns,” including longer-term outcomes, the financial impact of DCD, and whether results can be replicated in other centers.
“These results provide confidence that DCD can be safely and effectively performed without compromising outcomes, at least in a large-volume center of excellence,” and help provide evidence “to support the spreading acceptance of DCD among heart transplant programs.”
SOURCE:
The study was conducted by Hasan K. Siddiqi, MD, department of medicine, Vanderbilt University Medical Center, Nashville, Tenn., and colleagues. It was published online in the Journal of the American College of Cardiology.
LIMITATIONS:
The study was conducted at a single center and had a retrospective design and a modest sample size that prevented adjustment for all potentially confounding variables. Meaningful differences among DCD recipients could not be explored with regard to organ recovery technique, and small but statistically meaningful differences in outcomes could not be detected, the authors note. Follow-up was limited to 1 year after transplantation.
DISCLOSURES:
The authors report no relevant conflicts of interest. Dr. Pinney has received consulting fees from Abbott, ADI, Ancora, CareDx, ImpulseDynamics, Medtronic, Nuwellis, Procyrion, Restore Medical, Transmedics, and Valgen Medtech.
A version of this article first appeared on Medscape.com.
TOPLINE:
There are no significant differences in 1-year mortality, survival to hospital discharge, severe primary graft dysfunction (PGD), and other outcomes post heart transplant between patients who receive a heart obtained by donation after circulatory death (DCD) and patients who receive a heart by donation after brain death (DBD), a new study has shown.
METHODOLOGY:
- The retrospective review included 385 patients (median age, 57.4 years; 26% women; 72.5% White) who underwent a heart transplant at Vanderbilt University Medical Center from January 2020 to January 2023. Of these, 263 received DBD hearts, and 122 received DCD hearts.
- In the DCD group, 17% of hearts were recovered by use of ex vivo machine perfusion (EVP), and 83% by use of normothermic regional perfusion followed by static cold storage; 4% of DBD hearts were recovered by use of EVP, and 96% by use of static cold storage.
- The primary outcome was survival at 1 year after transplantation; key secondary outcomes included survival to hospital discharge, survival at 30 days and 6 months after transplantation, and severe PGD.
TAKEAWAY:
- (hazard ratio, 0.77; 95% confidence interval, 0.32-1.81; P = .54), a finding that was unchanged when adjusted for recipient age.
- There were no significant differences in survival to hospital discharge (93.4% DBD vs. 94.5% DCD; HR, 0.72; 95% CI, 0.26-1.99; P = .53), to 30 days (95.1% DBD vs. 96.7% DCD; HR, 0.67; 95% CI, 0.22-2.05; P = .48), or to 6 months (92.8% DBD vs. 94.3% DCD; HR, 0.68; 95% CI, 0.25-1.85; P = .45) after transplantation.
- The incidence of severe PGD was similar between groups (5.7% DCD vs. 5.7% DBD; HR, 1.00; 95% CI, 0.41-2.4; P = .99).
- There were no significant between-group differences in other outcomes, including incidence of treated rejection and cases of cardiac allograft vasculopathy of grade 1 or greater on the International Society for scale at 1 year.
IN PRACTICE:
“Our findings add to the growing body of evidence in support of DCD heart transplantation,” the authors write, potentially expanding the heart donor pool. They note that outcomes remained similar between groups despite higher-risk patients being overrepresented in the DCD cohort.
In an accompanying editorial, Sean P. Pinney, MD, Center for Cardiovascular Health, Icahn School of Medicine at Mount Sinai, New York, and a colleague called the results “impressive” and “encouraging,” although there are still “important unknowns,” including longer-term outcomes, the financial impact of DCD, and whether results can be replicated in other centers.
“These results provide confidence that DCD can be safely and effectively performed without compromising outcomes, at least in a large-volume center of excellence,” and help provide evidence “to support the spreading acceptance of DCD among heart transplant programs.”
SOURCE:
The study was conducted by Hasan K. Siddiqi, MD, department of medicine, Vanderbilt University Medical Center, Nashville, Tenn., and colleagues. It was published online in the Journal of the American College of Cardiology.
LIMITATIONS:
The study was conducted at a single center and had a retrospective design and a modest sample size that prevented adjustment for all potentially confounding variables. Meaningful differences among DCD recipients could not be explored with regard to organ recovery technique, and small but statistically meaningful differences in outcomes could not be detected, the authors note. Follow-up was limited to 1 year after transplantation.
DISCLOSURES:
The authors report no relevant conflicts of interest. Dr. Pinney has received consulting fees from Abbott, ADI, Ancora, CareDx, ImpulseDynamics, Medtronic, Nuwellis, Procyrion, Restore Medical, Transmedics, and Valgen Medtech.
A version of this article first appeared on Medscape.com.
Another FDA class I recall of Cardiosave Hybrid/Rescue IABPs
due to electrical failures in the power management board or solenoid board (power source path).
“Using an affected pump may cause serious adverse health events, including unstable blood pressure, injury (e.g., inadequate blood supply or a vital organ injury), and death,” the Food and Drug Administration said in the recall notice.
The FDA has identified this as a class I recall, the most serious type of recall due to the risk for serious injury or death. To date, Datascope/Maquet/Getinge received 26 complaints, but no reports of injuries or death.
The devices are indicated for acute coronary syndrome, cardiac and noncardiac surgery, and complications of heart failure in adults.
The recall includes a total of 4,586 Cardiosave Hybrid or Rescue IABP units distributed from March 2, 2012, to May 19, 2023. Product model numbers for the recalled Cardiosave Hybrid and Cardiosave Rescue are available online.
On June 5, Datascope/Maquet/Getinge sent an “important medical device advisory” to all affected customers. The letter advises customers to be sure there is an alternative IABP available to continue therapy and provide alternative hemodynamic support if there is no other means to continue counterpulsation therapy.
Customers with questions about this recall should contact their company representative or call technical support at 1-888-943-8872, Monday through Friday, between 8:00 a.m. and 6:00 p.m. ET.
Last March, Datascope/Getinge recalled 2,300 Cardiosave Hybrid or Rescue IABPs because the coiled cable connecting the display and base on some units may fail, causing an unexpected shutdown without warnings or alarms to alert the user.
The Cardiosave IABPs have also been previously flagged by the FDA for subpar battery performance and fluid leaks.
Any adverse events or suspected adverse events related to the recalled Cardiosave Hybrid/Rescue IABPs should be reported to the FDA through MedWatch, its adverse event reporting program.
A version of this article appeared on Medscape.com.
due to electrical failures in the power management board or solenoid board (power source path).
“Using an affected pump may cause serious adverse health events, including unstable blood pressure, injury (e.g., inadequate blood supply or a vital organ injury), and death,” the Food and Drug Administration said in the recall notice.
The FDA has identified this as a class I recall, the most serious type of recall due to the risk for serious injury or death. To date, Datascope/Maquet/Getinge received 26 complaints, but no reports of injuries or death.
The devices are indicated for acute coronary syndrome, cardiac and noncardiac surgery, and complications of heart failure in adults.
The recall includes a total of 4,586 Cardiosave Hybrid or Rescue IABP units distributed from March 2, 2012, to May 19, 2023. Product model numbers for the recalled Cardiosave Hybrid and Cardiosave Rescue are available online.
On June 5, Datascope/Maquet/Getinge sent an “important medical device advisory” to all affected customers. The letter advises customers to be sure there is an alternative IABP available to continue therapy and provide alternative hemodynamic support if there is no other means to continue counterpulsation therapy.
Customers with questions about this recall should contact their company representative or call technical support at 1-888-943-8872, Monday through Friday, between 8:00 a.m. and 6:00 p.m. ET.
Last March, Datascope/Getinge recalled 2,300 Cardiosave Hybrid or Rescue IABPs because the coiled cable connecting the display and base on some units may fail, causing an unexpected shutdown without warnings or alarms to alert the user.
The Cardiosave IABPs have also been previously flagged by the FDA for subpar battery performance and fluid leaks.
Any adverse events or suspected adverse events related to the recalled Cardiosave Hybrid/Rescue IABPs should be reported to the FDA through MedWatch, its adverse event reporting program.
A version of this article appeared on Medscape.com.
due to electrical failures in the power management board or solenoid board (power source path).
“Using an affected pump may cause serious adverse health events, including unstable blood pressure, injury (e.g., inadequate blood supply or a vital organ injury), and death,” the Food and Drug Administration said in the recall notice.
The FDA has identified this as a class I recall, the most serious type of recall due to the risk for serious injury or death. To date, Datascope/Maquet/Getinge received 26 complaints, but no reports of injuries or death.
The devices are indicated for acute coronary syndrome, cardiac and noncardiac surgery, and complications of heart failure in adults.
The recall includes a total of 4,586 Cardiosave Hybrid or Rescue IABP units distributed from March 2, 2012, to May 19, 2023. Product model numbers for the recalled Cardiosave Hybrid and Cardiosave Rescue are available online.
On June 5, Datascope/Maquet/Getinge sent an “important medical device advisory” to all affected customers. The letter advises customers to be sure there is an alternative IABP available to continue therapy and provide alternative hemodynamic support if there is no other means to continue counterpulsation therapy.
Customers with questions about this recall should contact their company representative or call technical support at 1-888-943-8872, Monday through Friday, between 8:00 a.m. and 6:00 p.m. ET.
Last March, Datascope/Getinge recalled 2,300 Cardiosave Hybrid or Rescue IABPs because the coiled cable connecting the display and base on some units may fail, causing an unexpected shutdown without warnings or alarms to alert the user.
The Cardiosave IABPs have also been previously flagged by the FDA for subpar battery performance and fluid leaks.
Any adverse events or suspected adverse events related to the recalled Cardiosave Hybrid/Rescue IABPs should be reported to the FDA through MedWatch, its adverse event reporting program.
A version of this article appeared on Medscape.com.
U.S. News ranks top cardiology, heart surgery hospitals
In the magazine’s 2023-2024 list, Cedars-Sinai Medical Center, Los Angeles, takes over the No. 2 spot from Mayo Clinic, Rochester, Minn., which dropped to No. 3. Cedars-Sinai held the No. 3 on the 2022-2023 rankings.
Mount Sinai Hospital in New York City holds the No. 4 spot in 2023-2024, up from No. 6; NYU Langone Hospitals, New York, continue to hold the No. 5 spot.
New York–Presbyterian Hospital–Columbia and Cornell in New York City is No. 6, down from No. 4 i.
Northwestern Medicine-Northwestern Memorial Hospital in Chicago takes over the No. 7 spot (up from No. 8), while Massachusetts General Hospital in Boston holds the No. 8 (down from No. 7).
Stanford (Calif.) Health Care–Stanford Hospital holds the No. 9 spot, the same as 2, and Lenox Hill Hospital at Northwell Health in New York is No. 10 on the list.
U.S. News evaluated 779 hospitals and ranked the top 50 that care for patients with challenging heart and vascular cases, including heart transplants; implantation of cardiac devices, such as pacemakers and defibrillators; major chest procedures and patients with cardiovascular disease and other complex conditions, such as endocarditis; and heart failure and circulatory issues.
“Consumers want useful resources to help them assess which hospital can best meet their specific care needs,” Ben Harder, chief of health analysis and managing editor at U.S. News, said in a statement.
“The 2023-2024 Best Hospitals rankings offer patients and the physicians with whom they consult a data-driven source for comparing performance in outcomes, patient satisfaction, and other metrics that matter to them,” Mr. Harder said.
Best hospitals overall honor roll
In 2023-2024, as in prior years, U.S. News also recognized Honor Roll hospitals that have excelled across multiple areas of care. However, in 2023-2024, for the first time, there is no ordinal ranking of hospitals making honor roll.
In a letter to hospital leaders, U.S. News explained that the major change in format came after months of deliberation, feedback from health care organizations and professionals, and an analysis of how consumers navigate their website.
Ordinal ranking of hospitals that make the honor roll “obscures the fact that all of the Honor Roll hospitals have attained the highest standard of care in the nation,” the letter reads.
With the new format, honor roll hospitals are listed in alphabetical order. In 2023-2024, there are 22.
- Barnes-Jewish Hospital, St. Louis
- Brigham and Women’s Hospital, Boston
- Cedars-Sinai Medical Center, Los Angeles
- Cleveland Clinic
- Hospitals of the University of Pennsylvania–Penn Medicine, Philadelphia
- Houston Methodist Hospital
- Johns Hopkins Hospital, Baltimore
- Massachusetts General Hospital, Boston
- Mayo Clinic, Rochester, Minn.
- Mount Sinai Hospital, New York
- New York–Presbyterian Hospital–Columbia and Cornell
- North Shore University Hospital at Northwell Health, Manhasset, N.Y.
- Northwestern Memorial Hospital, Chicago
- NYU Langone Hospitals, New York
- Rush University Medical Center, Chicago
- Stanford (Calif.) Health Care–Stanford Hospital
- UC San Diego Health–La Jolla (Calif.) and Hillcrest Hospitals
- UCLA Medical Center, Los Angeles
- UCSF Health–UCSF Medical Center, San Francisco
- University of Michigan Health, Ann Arbor
- UT Southwestern Medical Center, Dallas
- Vanderbilt University Medical Center, Nashville, Tenn.
According to U.S. News, to keep pace with consumers’ needs and the ever-evolving landscape of health care, “several refinements” are reflected in the latest best hospitals rankings.
These include the introduction of outpatient outcomes in key specialty rankings and surgical ratings, the expanded inclusion of other outpatient data, an increased weight on objective quality measures, and a reduced weight on expert opinion.
In addition, hospital profiles on the U.S. News website feature refined health equity measures, including a new measure of racial disparities in outcomes.
The full report for best hospitals, best specialty hospitals, and methodology is available online.
A version of this article first appeared on Medscape.com.
In the magazine’s 2023-2024 list, Cedars-Sinai Medical Center, Los Angeles, takes over the No. 2 spot from Mayo Clinic, Rochester, Minn., which dropped to No. 3. Cedars-Sinai held the No. 3 on the 2022-2023 rankings.
Mount Sinai Hospital in New York City holds the No. 4 spot in 2023-2024, up from No. 6; NYU Langone Hospitals, New York, continue to hold the No. 5 spot.
New York–Presbyterian Hospital–Columbia and Cornell in New York City is No. 6, down from No. 4 i.
Northwestern Medicine-Northwestern Memorial Hospital in Chicago takes over the No. 7 spot (up from No. 8), while Massachusetts General Hospital in Boston holds the No. 8 (down from No. 7).
Stanford (Calif.) Health Care–Stanford Hospital holds the No. 9 spot, the same as 2, and Lenox Hill Hospital at Northwell Health in New York is No. 10 on the list.
U.S. News evaluated 779 hospitals and ranked the top 50 that care for patients with challenging heart and vascular cases, including heart transplants; implantation of cardiac devices, such as pacemakers and defibrillators; major chest procedures and patients with cardiovascular disease and other complex conditions, such as endocarditis; and heart failure and circulatory issues.
“Consumers want useful resources to help them assess which hospital can best meet their specific care needs,” Ben Harder, chief of health analysis and managing editor at U.S. News, said in a statement.
“The 2023-2024 Best Hospitals rankings offer patients and the physicians with whom they consult a data-driven source for comparing performance in outcomes, patient satisfaction, and other metrics that matter to them,” Mr. Harder said.
Best hospitals overall honor roll
In 2023-2024, as in prior years, U.S. News also recognized Honor Roll hospitals that have excelled across multiple areas of care. However, in 2023-2024, for the first time, there is no ordinal ranking of hospitals making honor roll.
In a letter to hospital leaders, U.S. News explained that the major change in format came after months of deliberation, feedback from health care organizations and professionals, and an analysis of how consumers navigate their website.
Ordinal ranking of hospitals that make the honor roll “obscures the fact that all of the Honor Roll hospitals have attained the highest standard of care in the nation,” the letter reads.
With the new format, honor roll hospitals are listed in alphabetical order. In 2023-2024, there are 22.
- Barnes-Jewish Hospital, St. Louis
- Brigham and Women’s Hospital, Boston
- Cedars-Sinai Medical Center, Los Angeles
- Cleveland Clinic
- Hospitals of the University of Pennsylvania–Penn Medicine, Philadelphia
- Houston Methodist Hospital
- Johns Hopkins Hospital, Baltimore
- Massachusetts General Hospital, Boston
- Mayo Clinic, Rochester, Minn.
- Mount Sinai Hospital, New York
- New York–Presbyterian Hospital–Columbia and Cornell
- North Shore University Hospital at Northwell Health, Manhasset, N.Y.
- Northwestern Memorial Hospital, Chicago
- NYU Langone Hospitals, New York
- Rush University Medical Center, Chicago
- Stanford (Calif.) Health Care–Stanford Hospital
- UC San Diego Health–La Jolla (Calif.) and Hillcrest Hospitals
- UCLA Medical Center, Los Angeles
- UCSF Health–UCSF Medical Center, San Francisco
- University of Michigan Health, Ann Arbor
- UT Southwestern Medical Center, Dallas
- Vanderbilt University Medical Center, Nashville, Tenn.
According to U.S. News, to keep pace with consumers’ needs and the ever-evolving landscape of health care, “several refinements” are reflected in the latest best hospitals rankings.
These include the introduction of outpatient outcomes in key specialty rankings and surgical ratings, the expanded inclusion of other outpatient data, an increased weight on objective quality measures, and a reduced weight on expert opinion.
In addition, hospital profiles on the U.S. News website feature refined health equity measures, including a new measure of racial disparities in outcomes.
The full report for best hospitals, best specialty hospitals, and methodology is available online.
A version of this article first appeared on Medscape.com.
In the magazine’s 2023-2024 list, Cedars-Sinai Medical Center, Los Angeles, takes over the No. 2 spot from Mayo Clinic, Rochester, Minn., which dropped to No. 3. Cedars-Sinai held the No. 3 on the 2022-2023 rankings.
Mount Sinai Hospital in New York City holds the No. 4 spot in 2023-2024, up from No. 6; NYU Langone Hospitals, New York, continue to hold the No. 5 spot.
New York–Presbyterian Hospital–Columbia and Cornell in New York City is No. 6, down from No. 4 i.
Northwestern Medicine-Northwestern Memorial Hospital in Chicago takes over the No. 7 spot (up from No. 8), while Massachusetts General Hospital in Boston holds the No. 8 (down from No. 7).
Stanford (Calif.) Health Care–Stanford Hospital holds the No. 9 spot, the same as 2, and Lenox Hill Hospital at Northwell Health in New York is No. 10 on the list.
U.S. News evaluated 779 hospitals and ranked the top 50 that care for patients with challenging heart and vascular cases, including heart transplants; implantation of cardiac devices, such as pacemakers and defibrillators; major chest procedures and patients with cardiovascular disease and other complex conditions, such as endocarditis; and heart failure and circulatory issues.
“Consumers want useful resources to help them assess which hospital can best meet their specific care needs,” Ben Harder, chief of health analysis and managing editor at U.S. News, said in a statement.
“The 2023-2024 Best Hospitals rankings offer patients and the physicians with whom they consult a data-driven source for comparing performance in outcomes, patient satisfaction, and other metrics that matter to them,” Mr. Harder said.
Best hospitals overall honor roll
In 2023-2024, as in prior years, U.S. News also recognized Honor Roll hospitals that have excelled across multiple areas of care. However, in 2023-2024, for the first time, there is no ordinal ranking of hospitals making honor roll.
In a letter to hospital leaders, U.S. News explained that the major change in format came after months of deliberation, feedback from health care organizations and professionals, and an analysis of how consumers navigate their website.
Ordinal ranking of hospitals that make the honor roll “obscures the fact that all of the Honor Roll hospitals have attained the highest standard of care in the nation,” the letter reads.
With the new format, honor roll hospitals are listed in alphabetical order. In 2023-2024, there are 22.
- Barnes-Jewish Hospital, St. Louis
- Brigham and Women’s Hospital, Boston
- Cedars-Sinai Medical Center, Los Angeles
- Cleveland Clinic
- Hospitals of the University of Pennsylvania–Penn Medicine, Philadelphia
- Houston Methodist Hospital
- Johns Hopkins Hospital, Baltimore
- Massachusetts General Hospital, Boston
- Mayo Clinic, Rochester, Minn.
- Mount Sinai Hospital, New York
- New York–Presbyterian Hospital–Columbia and Cornell
- North Shore University Hospital at Northwell Health, Manhasset, N.Y.
- Northwestern Memorial Hospital, Chicago
- NYU Langone Hospitals, New York
- Rush University Medical Center, Chicago
- Stanford (Calif.) Health Care–Stanford Hospital
- UC San Diego Health–La Jolla (Calif.) and Hillcrest Hospitals
- UCLA Medical Center, Los Angeles
- UCSF Health–UCSF Medical Center, San Francisco
- University of Michigan Health, Ann Arbor
- UT Southwestern Medical Center, Dallas
- Vanderbilt University Medical Center, Nashville, Tenn.
According to U.S. News, to keep pace with consumers’ needs and the ever-evolving landscape of health care, “several refinements” are reflected in the latest best hospitals rankings.
These include the introduction of outpatient outcomes in key specialty rankings and surgical ratings, the expanded inclusion of other outpatient data, an increased weight on objective quality measures, and a reduced weight on expert opinion.
In addition, hospital profiles on the U.S. News website feature refined health equity measures, including a new measure of racial disparities in outcomes.
The full report for best hospitals, best specialty hospitals, and methodology is available online.
A version of this article first appeared on Medscape.com.
New AHA statement on ischemia after cardiac surgery
The American Heart Association outlines “considerations” on the management of acute postoperative myocardial ischemia (PMI) after cardiac surgery in a scientific statement.
Although an infrequent event, acute PMI following cardiac surgery can rapidly evolve and become a potentially life-threatening complication, the writing group, led by Mario Gaudino, MD, PhD, with Weill Cornell Medicine, New York, points out.
The new statement was published online in Circulation.
Data show that the incidence of postoperative myocardial infarction after cardiac surgery ranges from 0.3% to 9.8% after isolated coronary artery bypass graft (CABG) surgery and 0.7% to 11.8% after concomitant valvular surgery. For isolated mitral valve surgery, incidence ranges from 1.7% to 2.2%.
Short-term mortality is elevated among patients with acute PMI, irrespective of the type of surgery. Reported mortality rates range from 5.1% to 24%; the evidence on long-term mortality has been mixed.
Graft-related factors are the most common cause of PMI after CABG, but other factors may contribute, including technical factors, competitive flow, suture entrapment, or coronary artery distortion, as well as non–graft related factors.
Prompt diagnosis and treatment important
Currently, there is no consensus definition of PMI. Elevations in cardiac biomarkers may not be reliable for diagnosis after surgery, and pain management regimens may mask symptoms of ischemia, the writing group notes.
because timely diagnosis and treatment are key to a good clinical outcome,” they write.
Delay in urgent angiography has been associated with higher mortality; thus, a low threshold for action is encouraged for patients with suspected acute PMI.
Indications for urgent angiography include new ECG changes, chest pain with ongoing signs of ischemia, cardiac imaging abnormalities, cardiac rhythm abnormalities, significant elevations in cardiac biomarkers, and low cardiac output syndrome despite postoperative pressor support.
Patients with acute PMI and low cardiac output syndrome may require mechanical support when first-line treatment fails.
The writing group says fast and effective reperfusion of the ischemic zone, which is generally achieved by percutaneous intervention and, less often, by repeat surgery, is the key to a good clinical outcome.
The statement was prepared by the volunteer writing group on behalf of the AHA Council on Cardiovascular Surgery and Anesthesia; Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; and Stroke Council.
The research had no commercial funding. Disclosures for the writing group are listed with the original article.
A version of this article originally appeared on Medscape.com.
The American Heart Association outlines “considerations” on the management of acute postoperative myocardial ischemia (PMI) after cardiac surgery in a scientific statement.
Although an infrequent event, acute PMI following cardiac surgery can rapidly evolve and become a potentially life-threatening complication, the writing group, led by Mario Gaudino, MD, PhD, with Weill Cornell Medicine, New York, points out.
The new statement was published online in Circulation.
Data show that the incidence of postoperative myocardial infarction after cardiac surgery ranges from 0.3% to 9.8% after isolated coronary artery bypass graft (CABG) surgery and 0.7% to 11.8% after concomitant valvular surgery. For isolated mitral valve surgery, incidence ranges from 1.7% to 2.2%.
Short-term mortality is elevated among patients with acute PMI, irrespective of the type of surgery. Reported mortality rates range from 5.1% to 24%; the evidence on long-term mortality has been mixed.
Graft-related factors are the most common cause of PMI after CABG, but other factors may contribute, including technical factors, competitive flow, suture entrapment, or coronary artery distortion, as well as non–graft related factors.
Prompt diagnosis and treatment important
Currently, there is no consensus definition of PMI. Elevations in cardiac biomarkers may not be reliable for diagnosis after surgery, and pain management regimens may mask symptoms of ischemia, the writing group notes.
because timely diagnosis and treatment are key to a good clinical outcome,” they write.
Delay in urgent angiography has been associated with higher mortality; thus, a low threshold for action is encouraged for patients with suspected acute PMI.
Indications for urgent angiography include new ECG changes, chest pain with ongoing signs of ischemia, cardiac imaging abnormalities, cardiac rhythm abnormalities, significant elevations in cardiac biomarkers, and low cardiac output syndrome despite postoperative pressor support.
Patients with acute PMI and low cardiac output syndrome may require mechanical support when first-line treatment fails.
The writing group says fast and effective reperfusion of the ischemic zone, which is generally achieved by percutaneous intervention and, less often, by repeat surgery, is the key to a good clinical outcome.
The statement was prepared by the volunteer writing group on behalf of the AHA Council on Cardiovascular Surgery and Anesthesia; Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; and Stroke Council.
The research had no commercial funding. Disclosures for the writing group are listed with the original article.
A version of this article originally appeared on Medscape.com.
The American Heart Association outlines “considerations” on the management of acute postoperative myocardial ischemia (PMI) after cardiac surgery in a scientific statement.
Although an infrequent event, acute PMI following cardiac surgery can rapidly evolve and become a potentially life-threatening complication, the writing group, led by Mario Gaudino, MD, PhD, with Weill Cornell Medicine, New York, points out.
The new statement was published online in Circulation.
Data show that the incidence of postoperative myocardial infarction after cardiac surgery ranges from 0.3% to 9.8% after isolated coronary artery bypass graft (CABG) surgery and 0.7% to 11.8% after concomitant valvular surgery. For isolated mitral valve surgery, incidence ranges from 1.7% to 2.2%.
Short-term mortality is elevated among patients with acute PMI, irrespective of the type of surgery. Reported mortality rates range from 5.1% to 24%; the evidence on long-term mortality has been mixed.
Graft-related factors are the most common cause of PMI after CABG, but other factors may contribute, including technical factors, competitive flow, suture entrapment, or coronary artery distortion, as well as non–graft related factors.
Prompt diagnosis and treatment important
Currently, there is no consensus definition of PMI. Elevations in cardiac biomarkers may not be reliable for diagnosis after surgery, and pain management regimens may mask symptoms of ischemia, the writing group notes.
because timely diagnosis and treatment are key to a good clinical outcome,” they write.
Delay in urgent angiography has been associated with higher mortality; thus, a low threshold for action is encouraged for patients with suspected acute PMI.
Indications for urgent angiography include new ECG changes, chest pain with ongoing signs of ischemia, cardiac imaging abnormalities, cardiac rhythm abnormalities, significant elevations in cardiac biomarkers, and low cardiac output syndrome despite postoperative pressor support.
Patients with acute PMI and low cardiac output syndrome may require mechanical support when first-line treatment fails.
The writing group says fast and effective reperfusion of the ischemic zone, which is generally achieved by percutaneous intervention and, less often, by repeat surgery, is the key to a good clinical outcome.
The statement was prepared by the volunteer writing group on behalf of the AHA Council on Cardiovascular Surgery and Anesthesia; Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; and Stroke Council.
The research had no commercial funding. Disclosures for the writing group are listed with the original article.
A version of this article originally appeared on Medscape.com.
FROM CIRCULATION
Survival similar with hearts donated after circulatory or brain death
in the first randomized trial comparing the two approaches.
“This randomized trial showing recipient survival with DCD to be similar to DBD should lead to DCD becoming the standard of care alongside DBD,” lead author Jacob Schroder, MD, surgical director, heart transplantation program, Duke University Medical Center, Durham, N.C., said in an interview.
“This should enable many more heart transplants to take place and for us to be able to cast the net further and wider for donors,” he said.
The trial was published online in the New England Journal of Medicine.
Dr. Schroder estimated that only around one-fifth of the 120 U.S. heart transplant centers currently carry out DCD transplants, but he is hopeful that the publication of this study will encourage more transplant centers to do these DCD procedures.
“The problem is there are many low-volume heart transplant centers, which may not be keen to do DCD transplants as they are a bit more complicated and expensive than DBD heart transplants,” he said. “But we need to look at the big picture of how many lives can be saved by increasing the number of heart transplant procedures and the money saved by getting more patients off the waiting list.”
The authors explain that heart transplantation has traditionally been limited to the use of hearts obtained from donors after brain death, which allows in situ assessment of cardiac function and of the suitability for transplantation of the donor allograft before surgical procurement.
But because the need for heart transplants far exceeds the availability of suitable donors, the use of DCD hearts has been investigated and this approach is now being pursued in many countries. In the DCD approach, the heart will have stopped beating in the donor, and perfusion techniques are used to restart the organ.
There are two different approaches to restarting the heart in DCD. The first approach involves the heart being removed from the donor and reanimated, preserved, assessed, and transported with the use of a portable extracorporeal perfusion and preservation system (Organ Care System, TransMedics). The second involves restarting the heart in the donor’s body for evaluation before removal and transportation under the traditional cold storage method used for donations after brain death.
The current trial was designed to compare clinical outcomes in patients who had received a heart from a circulatory death donor using the portable extracorporeal perfusion method for DCD transplantation, with outcomes from the traditional method of heart transplantation using organs donated after brain death.
For the randomized, noninferiority trial, adult candidates for heart transplantation were assigned to receive a heart after the circulatory death of the donor or a heart from a donor after brain death if that heart was available first (circulatory-death group) or to receive only a heart that had been preserved with the use of traditional cold storage after the brain death of the donor (brain-death group).
The primary end point was the risk-adjusted survival at 6 months in the as-treated circulatory-death group, as compared with the brain-death group. The primary safety end point was serious adverse events associated with the heart graft at 30 days after transplantation.
A total of 180 patients underwent transplantation, 90 of whom received a heart donated after circulatory death and 90 who received a heart donated after brain death. A total of 166 transplant recipients were included in the as-treated primary analysis (80 who received a heart from a circulatory-death donor and 86 who received a heart from a brain-death donor).
The risk-adjusted 6-month survival in the as-treated population was 94% among recipients of a heart from a circulatory-death donor, as compared with 90% among recipients of a heart from a brain-death donor (P < .001 for noninferiority).
There were no substantial between-group differences in the mean per-patient number of serious adverse events associated with the heart graft at 30 days after transplantation.
Of 101 hearts from circulatory-death donors that were preserved with the use of the perfusion system, 90 were successfully transplanted according to the criteria for lactate trend and overall contractility of the donor heart, which resulted in overall utilization percentage of 89%.
More patients who received a heart from a circulatory-death donor had moderate or severe primary graft dysfunction (22%) than those who received a heart from a brain-death donor (10%). However, graft failure that resulted in retransplantation occurred in two (2.3%) patients who received a heart from a brain-death donor versus zero patients who received a heart from a circulatory-death donor.
The researchers note that the higher incidence of primary graft dysfunction in the circulatory-death group is expected, given the period of warm ischemia that occurs in this approach. But they point out that this did not affect patient or graft survival at 30 days or 1 year.
“Primary graft dysfunction is when the heart doesn’t fully work immediately after transplant and some mechanical support is needed,” Dr. Schroder commented to this news organization. “This occurred more often in the DCD group, but this mechanical support is only temporary, and generally only needed for a day or two.
“It looks like it might take the heart a little longer to start fully functioning after DCD, but our results show this doesn’t seem to affect recipient survival.”
He added: “We’ve started to become more comfortable with DCD. Sometimes it may take a little longer to get the heart working properly on its own, but the rate of mechanical support is now much lower than when we first started doing these procedures. And cardiac MRI on the recipient patients before discharge have shown that the DCD hearts are not more damaged than those from DBD donors.”
The authors also report that there were six donor hearts in the DCD group for which there were protocol deviations of functional warm ischemic time greater than 30 minutes or continuously rising lactate levels and these hearts did not show primary graft dysfunction.
On this observation, Dr. Schroder said: “I think we need to do more work on understanding the ischemic time limits. The current 30 minutes time limit was estimated in animal studies. We need to look more closely at data from actual DCD transplants. While 30 minutes may be too long for a heart from an older donor, the heart from a younger donor may be fine for a longer period of ischemic time as it will be healthier.”
“Exciting” results
In an editorial, Nancy K. Sweitzer, MD, PhD, vice chair of clinical research, department of medicine, and director of clinical research, division of cardiology, Washington University in St. Louis, describes the results of the current study as “exciting,” adding that, “They clearly show the feasibility and safety of transplantation of hearts from circulatory-death donors.”
However, Dr. Sweitzer points out that the sickest patients in the study – those who were United Network for Organ Sharing (UNOS) status 1 and 2 – were more likely to receive a DBD heart and the more stable patients (UNOS 3-6) were more likely to receive a DCD heart.
“This imbalance undoubtedly contributed to the success of the trial in meeting its noninferiority end point. Whether transplantation of hearts from circulatory-death donors is truly safe in our sickest patients with heart failure is not clear,” she says.
However, she concludes, “Although caution and continuous evaluation of data are warranted, the increased use of hearts from circulatory-death donors appears to be safe in the hands of experienced transplantation teams and will launch an exciting phase of learning and improvement.”
“A safely expanded pool of heart donors has the potential to increase fairness and equity in heart transplantation, allowing more persons with heart failure to have access to this lifesaving therapy,” she adds. “Organ donors and transplantation teams will save increasing numbers of lives with this most precious gift.”
The current study was supported by TransMedics. Dr. Schroder reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
in the first randomized trial comparing the two approaches.
“This randomized trial showing recipient survival with DCD to be similar to DBD should lead to DCD becoming the standard of care alongside DBD,” lead author Jacob Schroder, MD, surgical director, heart transplantation program, Duke University Medical Center, Durham, N.C., said in an interview.
“This should enable many more heart transplants to take place and for us to be able to cast the net further and wider for donors,” he said.
The trial was published online in the New England Journal of Medicine.
Dr. Schroder estimated that only around one-fifth of the 120 U.S. heart transplant centers currently carry out DCD transplants, but he is hopeful that the publication of this study will encourage more transplant centers to do these DCD procedures.
“The problem is there are many low-volume heart transplant centers, which may not be keen to do DCD transplants as they are a bit more complicated and expensive than DBD heart transplants,” he said. “But we need to look at the big picture of how many lives can be saved by increasing the number of heart transplant procedures and the money saved by getting more patients off the waiting list.”
The authors explain that heart transplantation has traditionally been limited to the use of hearts obtained from donors after brain death, which allows in situ assessment of cardiac function and of the suitability for transplantation of the donor allograft before surgical procurement.
But because the need for heart transplants far exceeds the availability of suitable donors, the use of DCD hearts has been investigated and this approach is now being pursued in many countries. In the DCD approach, the heart will have stopped beating in the donor, and perfusion techniques are used to restart the organ.
There are two different approaches to restarting the heart in DCD. The first approach involves the heart being removed from the donor and reanimated, preserved, assessed, and transported with the use of a portable extracorporeal perfusion and preservation system (Organ Care System, TransMedics). The second involves restarting the heart in the donor’s body for evaluation before removal and transportation under the traditional cold storage method used for donations after brain death.
The current trial was designed to compare clinical outcomes in patients who had received a heart from a circulatory death donor using the portable extracorporeal perfusion method for DCD transplantation, with outcomes from the traditional method of heart transplantation using organs donated after brain death.
For the randomized, noninferiority trial, adult candidates for heart transplantation were assigned to receive a heart after the circulatory death of the donor or a heart from a donor after brain death if that heart was available first (circulatory-death group) or to receive only a heart that had been preserved with the use of traditional cold storage after the brain death of the donor (brain-death group).
The primary end point was the risk-adjusted survival at 6 months in the as-treated circulatory-death group, as compared with the brain-death group. The primary safety end point was serious adverse events associated with the heart graft at 30 days after transplantation.
A total of 180 patients underwent transplantation, 90 of whom received a heart donated after circulatory death and 90 who received a heart donated after brain death. A total of 166 transplant recipients were included in the as-treated primary analysis (80 who received a heart from a circulatory-death donor and 86 who received a heart from a brain-death donor).
The risk-adjusted 6-month survival in the as-treated population was 94% among recipients of a heart from a circulatory-death donor, as compared with 90% among recipients of a heart from a brain-death donor (P < .001 for noninferiority).
There were no substantial between-group differences in the mean per-patient number of serious adverse events associated with the heart graft at 30 days after transplantation.
Of 101 hearts from circulatory-death donors that were preserved with the use of the perfusion system, 90 were successfully transplanted according to the criteria for lactate trend and overall contractility of the donor heart, which resulted in overall utilization percentage of 89%.
More patients who received a heart from a circulatory-death donor had moderate or severe primary graft dysfunction (22%) than those who received a heart from a brain-death donor (10%). However, graft failure that resulted in retransplantation occurred in two (2.3%) patients who received a heart from a brain-death donor versus zero patients who received a heart from a circulatory-death donor.
The researchers note that the higher incidence of primary graft dysfunction in the circulatory-death group is expected, given the period of warm ischemia that occurs in this approach. But they point out that this did not affect patient or graft survival at 30 days or 1 year.
“Primary graft dysfunction is when the heart doesn’t fully work immediately after transplant and some mechanical support is needed,” Dr. Schroder commented to this news organization. “This occurred more often in the DCD group, but this mechanical support is only temporary, and generally only needed for a day or two.
“It looks like it might take the heart a little longer to start fully functioning after DCD, but our results show this doesn’t seem to affect recipient survival.”
He added: “We’ve started to become more comfortable with DCD. Sometimes it may take a little longer to get the heart working properly on its own, but the rate of mechanical support is now much lower than when we first started doing these procedures. And cardiac MRI on the recipient patients before discharge have shown that the DCD hearts are not more damaged than those from DBD donors.”
The authors also report that there were six donor hearts in the DCD group for which there were protocol deviations of functional warm ischemic time greater than 30 minutes or continuously rising lactate levels and these hearts did not show primary graft dysfunction.
On this observation, Dr. Schroder said: “I think we need to do more work on understanding the ischemic time limits. The current 30 minutes time limit was estimated in animal studies. We need to look more closely at data from actual DCD transplants. While 30 minutes may be too long for a heart from an older donor, the heart from a younger donor may be fine for a longer period of ischemic time as it will be healthier.”
“Exciting” results
In an editorial, Nancy K. Sweitzer, MD, PhD, vice chair of clinical research, department of medicine, and director of clinical research, division of cardiology, Washington University in St. Louis, describes the results of the current study as “exciting,” adding that, “They clearly show the feasibility and safety of transplantation of hearts from circulatory-death donors.”
However, Dr. Sweitzer points out that the sickest patients in the study – those who were United Network for Organ Sharing (UNOS) status 1 and 2 – were more likely to receive a DBD heart and the more stable patients (UNOS 3-6) were more likely to receive a DCD heart.
“This imbalance undoubtedly contributed to the success of the trial in meeting its noninferiority end point. Whether transplantation of hearts from circulatory-death donors is truly safe in our sickest patients with heart failure is not clear,” she says.
However, she concludes, “Although caution and continuous evaluation of data are warranted, the increased use of hearts from circulatory-death donors appears to be safe in the hands of experienced transplantation teams and will launch an exciting phase of learning and improvement.”
“A safely expanded pool of heart donors has the potential to increase fairness and equity in heart transplantation, allowing more persons with heart failure to have access to this lifesaving therapy,” she adds. “Organ donors and transplantation teams will save increasing numbers of lives with this most precious gift.”
The current study was supported by TransMedics. Dr. Schroder reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
in the first randomized trial comparing the two approaches.
“This randomized trial showing recipient survival with DCD to be similar to DBD should lead to DCD becoming the standard of care alongside DBD,” lead author Jacob Schroder, MD, surgical director, heart transplantation program, Duke University Medical Center, Durham, N.C., said in an interview.
“This should enable many more heart transplants to take place and for us to be able to cast the net further and wider for donors,” he said.
The trial was published online in the New England Journal of Medicine.
Dr. Schroder estimated that only around one-fifth of the 120 U.S. heart transplant centers currently carry out DCD transplants, but he is hopeful that the publication of this study will encourage more transplant centers to do these DCD procedures.
“The problem is there are many low-volume heart transplant centers, which may not be keen to do DCD transplants as they are a bit more complicated and expensive than DBD heart transplants,” he said. “But we need to look at the big picture of how many lives can be saved by increasing the number of heart transplant procedures and the money saved by getting more patients off the waiting list.”
The authors explain that heart transplantation has traditionally been limited to the use of hearts obtained from donors after brain death, which allows in situ assessment of cardiac function and of the suitability for transplantation of the donor allograft before surgical procurement.
But because the need for heart transplants far exceeds the availability of suitable donors, the use of DCD hearts has been investigated and this approach is now being pursued in many countries. In the DCD approach, the heart will have stopped beating in the donor, and perfusion techniques are used to restart the organ.
There are two different approaches to restarting the heart in DCD. The first approach involves the heart being removed from the donor and reanimated, preserved, assessed, and transported with the use of a portable extracorporeal perfusion and preservation system (Organ Care System, TransMedics). The second involves restarting the heart in the donor’s body for evaluation before removal and transportation under the traditional cold storage method used for donations after brain death.
The current trial was designed to compare clinical outcomes in patients who had received a heart from a circulatory death donor using the portable extracorporeal perfusion method for DCD transplantation, with outcomes from the traditional method of heart transplantation using organs donated after brain death.
For the randomized, noninferiority trial, adult candidates for heart transplantation were assigned to receive a heart after the circulatory death of the donor or a heart from a donor after brain death if that heart was available first (circulatory-death group) or to receive only a heart that had been preserved with the use of traditional cold storage after the brain death of the donor (brain-death group).
The primary end point was the risk-adjusted survival at 6 months in the as-treated circulatory-death group, as compared with the brain-death group. The primary safety end point was serious adverse events associated with the heart graft at 30 days after transplantation.
A total of 180 patients underwent transplantation, 90 of whom received a heart donated after circulatory death and 90 who received a heart donated after brain death. A total of 166 transplant recipients were included in the as-treated primary analysis (80 who received a heart from a circulatory-death donor and 86 who received a heart from a brain-death donor).
The risk-adjusted 6-month survival in the as-treated population was 94% among recipients of a heart from a circulatory-death donor, as compared with 90% among recipients of a heart from a brain-death donor (P < .001 for noninferiority).
There were no substantial between-group differences in the mean per-patient number of serious adverse events associated with the heart graft at 30 days after transplantation.
Of 101 hearts from circulatory-death donors that were preserved with the use of the perfusion system, 90 were successfully transplanted according to the criteria for lactate trend and overall contractility of the donor heart, which resulted in overall utilization percentage of 89%.
More patients who received a heart from a circulatory-death donor had moderate or severe primary graft dysfunction (22%) than those who received a heart from a brain-death donor (10%). However, graft failure that resulted in retransplantation occurred in two (2.3%) patients who received a heart from a brain-death donor versus zero patients who received a heart from a circulatory-death donor.
The researchers note that the higher incidence of primary graft dysfunction in the circulatory-death group is expected, given the period of warm ischemia that occurs in this approach. But they point out that this did not affect patient or graft survival at 30 days or 1 year.
“Primary graft dysfunction is when the heart doesn’t fully work immediately after transplant and some mechanical support is needed,” Dr. Schroder commented to this news organization. “This occurred more often in the DCD group, but this mechanical support is only temporary, and generally only needed for a day or two.
“It looks like it might take the heart a little longer to start fully functioning after DCD, but our results show this doesn’t seem to affect recipient survival.”
He added: “We’ve started to become more comfortable with DCD. Sometimes it may take a little longer to get the heart working properly on its own, but the rate of mechanical support is now much lower than when we first started doing these procedures. And cardiac MRI on the recipient patients before discharge have shown that the DCD hearts are not more damaged than those from DBD donors.”
The authors also report that there were six donor hearts in the DCD group for which there were protocol deviations of functional warm ischemic time greater than 30 minutes or continuously rising lactate levels and these hearts did not show primary graft dysfunction.
On this observation, Dr. Schroder said: “I think we need to do more work on understanding the ischemic time limits. The current 30 minutes time limit was estimated in animal studies. We need to look more closely at data from actual DCD transplants. While 30 minutes may be too long for a heart from an older donor, the heart from a younger donor may be fine for a longer period of ischemic time as it will be healthier.”
“Exciting” results
In an editorial, Nancy K. Sweitzer, MD, PhD, vice chair of clinical research, department of medicine, and director of clinical research, division of cardiology, Washington University in St. Louis, describes the results of the current study as “exciting,” adding that, “They clearly show the feasibility and safety of transplantation of hearts from circulatory-death donors.”
However, Dr. Sweitzer points out that the sickest patients in the study – those who were United Network for Organ Sharing (UNOS) status 1 and 2 – were more likely to receive a DBD heart and the more stable patients (UNOS 3-6) were more likely to receive a DCD heart.
“This imbalance undoubtedly contributed to the success of the trial in meeting its noninferiority end point. Whether transplantation of hearts from circulatory-death donors is truly safe in our sickest patients with heart failure is not clear,” she says.
However, she concludes, “Although caution and continuous evaluation of data are warranted, the increased use of hearts from circulatory-death donors appears to be safe in the hands of experienced transplantation teams and will launch an exciting phase of learning and improvement.”
“A safely expanded pool of heart donors has the potential to increase fairness and equity in heart transplantation, allowing more persons with heart failure to have access to this lifesaving therapy,” she adds. “Organ donors and transplantation teams will save increasing numbers of lives with this most precious gift.”
The current study was supported by TransMedics. Dr. Schroder reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE