Heart Failure

The heart from a genetically modified pig transplanted to a Maryland patient in January in a pioneering, acclaimed, and widely critiqued surgery appears to have carried an unwanted passenger.

A porcine cytomegalovirus (PCMV) in the heart had gone undetected before the operation and may or may not have been instrumental in David Bennett’s death 2 months later, according to a report published in MIT Technology Review.  

University of Maryland Medical Center

“The issue is now a subject of wide discussion among specialists, who think the infection was a potential contributor to Mr. Bennett’s death and a possible reason why the heart did not last longer,” states the article, written by staff journalist Antonio Regalado.

As described in the story, the xenotransplant saga’s new twist comes from the surgeon who performed the operation, Bartley P. Griffith, MD, University of Maryland, Baltimore, who related the PCMV finding in an April 20 online presentation hosted by the American Society of Transplantation.

Mr. Bennett’s initially promising but later turbulent clinical course, described by his surgeons and widely reported upon his death, included repeated skirmishes with infection and retaliatory adjustments to his immunosuppressant regimen. Those episodes were thought to have contributed to his death, the actual cause of which is undetermined or at least not yet reported.

“We are beginning to learn why he passed on,” Dr. Griffith said in Mr. Regalado’s article, acknowledging further that the porcine virus “maybe was the actor, or could be the actor,” that set off the events leading to Bennett’s death.

Xenotransplant specialists know that PCMV is a potential problem with pig organs and know to test for it before attempting the procedure in animal models, notes the article. It refers to a published series of pig-heart transplants to baboons in Germany. The hearts “lasted only a couple of weeks if the virus was present, while organs free from the infection could survive more than half a year.”

The heart Mr. Bennett received had been extensively screened for bacteria, viruses, and other issues that could have threatened the organ and Mr. Bennett, but the effort apparently fell short. In the MIT Technology Review story, the first author of the German baboon series speculates on how the University of Maryland team might have missed PCMV.

“The U.S. team appears to have tested the pig’s snout for the virus, but often it is lurking deeper in the tissues,” Joachim Denner, PhD, Institute of Virology, Free University of Berlin, said in the article. The virus, he contended, “can be detected and easily removed from pig populations, but unfortunately they didn’t use a good assay and didn’t detect the virus.”

That PCMV escaped detection before the operation “could now factor into some people’s questions over whether the experiment should have taken place at all,” the MIT Technology Review article proposes. “It’s a big red flag,” bioethicist Arthur Caplan, PhD, New York University, said in a quote, adding: “If doctors can’t prevent or control infection, ‘then such experiments are tough to justify.’ ”

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

The heart from a genetically modified pig transplanted to a Maryland patient in January in a pioneering, acclaimed, and widely critiqued surgery appears to have carried an unwanted passenger.

A porcine cytomegalovirus (PCMV) in the heart had gone undetected before the operation and may or may not have been instrumental in David Bennett’s death 2 months later, according to a report published in MIT Technology Review.  

University of Maryland Medical Center

“The issue is now a subject of wide discussion among specialists, who think the infection was a potential contributor to Mr. Bennett’s death and a possible reason why the heart did not last longer,” states the article, written by staff journalist Antonio Regalado.

As described in the story, the xenotransplant saga’s new twist comes from the surgeon who performed the operation, Bartley P. Griffith, MD, University of Maryland, Baltimore, who related the PCMV finding in an April 20 online presentation hosted by the American Society of Transplantation.

Mr. Bennett’s initially promising but later turbulent clinical course, described by his surgeons and widely reported upon his death, included repeated skirmishes with infection and retaliatory adjustments to his immunosuppressant regimen. Those episodes were thought to have contributed to his death, the actual cause of which is undetermined or at least not yet reported.

“We are beginning to learn why he passed on,” Dr. Griffith said in Mr. Regalado’s article, acknowledging further that the porcine virus “maybe was the actor, or could be the actor,” that set off the events leading to Bennett’s death.

Xenotransplant specialists know that PCMV is a potential problem with pig organs and know to test for it before attempting the procedure in animal models, notes the article. It refers to a published series of pig-heart transplants to baboons in Germany. The hearts “lasted only a couple of weeks if the virus was present, while organs free from the infection could survive more than half a year.”

The heart Mr. Bennett received had been extensively screened for bacteria, viruses, and other issues that could have threatened the organ and Mr. Bennett, but the effort apparently fell short. In the MIT Technology Review story, the first author of the German baboon series speculates on how the University of Maryland team might have missed PCMV.

“The U.S. team appears to have tested the pig’s snout for the virus, but often it is lurking deeper in the tissues,” Joachim Denner, PhD, Institute of Virology, Free University of Berlin, said in the article. The virus, he contended, “can be detected and easily removed from pig populations, but unfortunately they didn’t use a good assay and didn’t detect the virus.”

That PCMV escaped detection before the operation “could now factor into some people’s questions over whether the experiment should have taken place at all,” the MIT Technology Review article proposes. “It’s a big red flag,” bioethicist Arthur Caplan, PhD, New York University, said in a quote, adding: “If doctors can’t prevent or control infection, ‘then such experiments are tough to justify.’ ”

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

The heart from a genetically modified pig transplanted to a Maryland patient in January in a pioneering, acclaimed, and widely critiqued surgery appears to have carried an unwanted passenger.

A porcine cytomegalovirus (PCMV) in the heart had gone undetected before the operation and may or may not have been instrumental in David Bennett’s death 2 months later, according to a report published in MIT Technology Review.  

University of Maryland Medical Center

“The issue is now a subject of wide discussion among specialists, who think the infection was a potential contributor to Mr. Bennett’s death and a possible reason why the heart did not last longer,” states the article, written by staff journalist Antonio Regalado.

As described in the story, the xenotransplant saga’s new twist comes from the surgeon who performed the operation, Bartley P. Griffith, MD, University of Maryland, Baltimore, who related the PCMV finding in an April 20 online presentation hosted by the American Society of Transplantation.

Mr. Bennett’s initially promising but later turbulent clinical course, described by his surgeons and widely reported upon his death, included repeated skirmishes with infection and retaliatory adjustments to his immunosuppressant regimen. Those episodes were thought to have contributed to his death, the actual cause of which is undetermined or at least not yet reported.

“We are beginning to learn why he passed on,” Dr. Griffith said in Mr. Regalado’s article, acknowledging further that the porcine virus “maybe was the actor, or could be the actor,” that set off the events leading to Bennett’s death.

Xenotransplant specialists know that PCMV is a potential problem with pig organs and know to test for it before attempting the procedure in animal models, notes the article. It refers to a published series of pig-heart transplants to baboons in Germany. The hearts “lasted only a couple of weeks if the virus was present, while organs free from the infection could survive more than half a year.”

The heart Mr. Bennett received had been extensively screened for bacteria, viruses, and other issues that could have threatened the organ and Mr. Bennett, but the effort apparently fell short. In the MIT Technology Review story, the first author of the German baboon series speculates on how the University of Maryland team might have missed PCMV.

“The U.S. team appears to have tested the pig’s snout for the virus, but often it is lurking deeper in the tissues,” Joachim Denner, PhD, Institute of Virology, Free University of Berlin, said in the article. The virus, he contended, “can be detected and easily removed from pig populations, but unfortunately they didn’t use a good assay and didn’t detect the virus.”

That PCMV escaped detection before the operation “could now factor into some people’s questions over whether the experiment should have taken place at all,” the MIT Technology Review article proposes. “It’s a big red flag,” bioethicist Arthur Caplan, PhD, New York University, said in a quote, adding: “If doctors can’t prevent or control infection, ‘then such experiments are tough to justify.’ ”

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

Takotsubo syndrome, a condition that’s also been called “broken heart syndrome,” can be triggered by both positive and negative life stressors, especially in men, a new study suggests.

The findings show that although Takotsubo syndrome, a type of acute heart failure related to atypical patterns of transient left ventricular contraction abnormalities, is often triggered by negative emotional stressors, it can also stem from positive life events, something the researchers are calling “happy heart syndrome.”

In this registry study, males were more likely to experience Takotsubo syndrome from a positive life event, as were those with atypical, nonapical ballooning, reported Thomas Stiermaier, MD, of University Hospital Schleswig-Holstein in Lübeck, Germany, and colleagues.

Patients with negative and positive emotional triggers experienced similar short- and long-term outcomes, they found.

The results were published online in JACC: Heart Failure.

Previous studies have shown that Takotsubo syndrome can be related to negative emotional triggers, physical triggers such as heavy physical activity, or medical procedures (or, in some cases, neither of these), or even a combination of emotional and physical triggers, the authors said. Research shows that physical triggers are most often linked to poor outcomes.

A vast number of clinical scenarios may lead up to Takotsubo syndrome, noted Jason H. Rogers, MD, professor of cardiovascular medicine at the University of California, Davis, who commented on these findings.

“Examples would include other medical illness, such as infection or recent surgery, having a heated argument with someone, running to catch a flight at the airport, and even being awakened suddenly by a sick pet,” Dr. Rogers told this news organization.

But not all patients experience unhappy life stressors before these events occur, he added. “It is possible for patients to have happy life stressors that can lead to Takotsubo syndrome also.”

For this analysis, the research team evaluated 2,482 patients using data from the multicenter German-Italian-Spanish Takotsubo (GEIST) Registry, one of the largest of its kind. Of these patients, 910 experienced an emotional trigger; of these, 873 had negative preceding events, and 37 had pleasant preceding events. The mean age was 70 years in both groups.

The study team then compared patients with negative emotional triggers to those with positive emotional triggers, which included weddings, the birth of grandchildren, birthday parties, or anticipation of a trip or Christmas.

There was a 1.5% incidence of pleasant emotional triggers among all Takotsubo syndrome patients.

Among patients with positive prior triggers, there was a higher incidence of atypical ballooning (27.0% vs. 12.5%; P = .01), and a higher percentage of these patients were male (18.9% vs. 5.0%; P < .01) in comparison with those with negative events prior to Takotsubo syndrome.

Long-term death rates (8.8% vs. 2.7%; P = .20) and rates of in-hospital complication outcomes, including cardiogenic shock, stroke, death, or pulmonary edema (12.3% vs. 8.1%; P = .45), were similar for patients with negative preceding events and for those with positive preceding events.

Study limitations included that it cannot provide insight into the specific mechanisms of Takotsubo syndrome, it was observational, the sample size of patients in the positive events group was small, and the contributing research facilities assessed cardiac biomarker levels differently.

“Additional research efforts are needed to explore whether numerically lower cardiac-related event rates in patients with happy heart syndrome would be statistically significant in a larger sample size,” the researchers concluded.

Dr. Stiermaier reports no relevant financial relationships.

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

Takotsubo syndrome, a condition that’s also been called “broken heart syndrome,” can be triggered by both positive and negative life stressors, especially in men, a new study suggests.

The findings show that although Takotsubo syndrome, a type of acute heart failure related to atypical patterns of transient left ventricular contraction abnormalities, is often triggered by negative emotional stressors, it can also stem from positive life events, something the researchers are calling “happy heart syndrome.”

In this registry study, males were more likely to experience Takotsubo syndrome from a positive life event, as were those with atypical, nonapical ballooning, reported Thomas Stiermaier, MD, of University Hospital Schleswig-Holstein in Lübeck, Germany, and colleagues.

Patients with negative and positive emotional triggers experienced similar short- and long-term outcomes, they found.

The results were published online in JACC: Heart Failure.

Previous studies have shown that Takotsubo syndrome can be related to negative emotional triggers, physical triggers such as heavy physical activity, or medical procedures (or, in some cases, neither of these), or even a combination of emotional and physical triggers, the authors said. Research shows that physical triggers are most often linked to poor outcomes.

A vast number of clinical scenarios may lead up to Takotsubo syndrome, noted Jason H. Rogers, MD, professor of cardiovascular medicine at the University of California, Davis, who commented on these findings.

“Examples would include other medical illness, such as infection or recent surgery, having a heated argument with someone, running to catch a flight at the airport, and even being awakened suddenly by a sick pet,” Dr. Rogers told this news organization.

But not all patients experience unhappy life stressors before these events occur, he added. “It is possible for patients to have happy life stressors that can lead to Takotsubo syndrome also.”

For this analysis, the research team evaluated 2,482 patients using data from the multicenter German-Italian-Spanish Takotsubo (GEIST) Registry, one of the largest of its kind. Of these patients, 910 experienced an emotional trigger; of these, 873 had negative preceding events, and 37 had pleasant preceding events. The mean age was 70 years in both groups.

The study team then compared patients with negative emotional triggers to those with positive emotional triggers, which included weddings, the birth of grandchildren, birthday parties, or anticipation of a trip or Christmas.

There was a 1.5% incidence of pleasant emotional triggers among all Takotsubo syndrome patients.

Among patients with positive prior triggers, there was a higher incidence of atypical ballooning (27.0% vs. 12.5%; P = .01), and a higher percentage of these patients were male (18.9% vs. 5.0%; P < .01) in comparison with those with negative events prior to Takotsubo syndrome.

Long-term death rates (8.8% vs. 2.7%; P = .20) and rates of in-hospital complication outcomes, including cardiogenic shock, stroke, death, or pulmonary edema (12.3% vs. 8.1%; P = .45), were similar for patients with negative preceding events and for those with positive preceding events.

Study limitations included that it cannot provide insight into the specific mechanisms of Takotsubo syndrome, it was observational, the sample size of patients in the positive events group was small, and the contributing research facilities assessed cardiac biomarker levels differently.

“Additional research efforts are needed to explore whether numerically lower cardiac-related event rates in patients with happy heart syndrome would be statistically significant in a larger sample size,” the researchers concluded.

Dr. Stiermaier reports no relevant financial relationships.

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

Takotsubo syndrome, a condition that’s also been called “broken heart syndrome,” can be triggered by both positive and negative life stressors, especially in men, a new study suggests.

The findings show that although Takotsubo syndrome, a type of acute heart failure related to atypical patterns of transient left ventricular contraction abnormalities, is often triggered by negative emotional stressors, it can also stem from positive life events, something the researchers are calling “happy heart syndrome.”

In this registry study, males were more likely to experience Takotsubo syndrome from a positive life event, as were those with atypical, nonapical ballooning, reported Thomas Stiermaier, MD, of University Hospital Schleswig-Holstein in Lübeck, Germany, and colleagues.

Patients with negative and positive emotional triggers experienced similar short- and long-term outcomes, they found.

The results were published online in JACC: Heart Failure.

Previous studies have shown that Takotsubo syndrome can be related to negative emotional triggers, physical triggers such as heavy physical activity, or medical procedures (or, in some cases, neither of these), or even a combination of emotional and physical triggers, the authors said. Research shows that physical triggers are most often linked to poor outcomes.

A vast number of clinical scenarios may lead up to Takotsubo syndrome, noted Jason H. Rogers, MD, professor of cardiovascular medicine at the University of California, Davis, who commented on these findings.

“Examples would include other medical illness, such as infection or recent surgery, having a heated argument with someone, running to catch a flight at the airport, and even being awakened suddenly by a sick pet,” Dr. Rogers told this news organization.

But not all patients experience unhappy life stressors before these events occur, he added. “It is possible for patients to have happy life stressors that can lead to Takotsubo syndrome also.”

For this analysis, the research team evaluated 2,482 patients using data from the multicenter German-Italian-Spanish Takotsubo (GEIST) Registry, one of the largest of its kind. Of these patients, 910 experienced an emotional trigger; of these, 873 had negative preceding events, and 37 had pleasant preceding events. The mean age was 70 years in both groups.

The study team then compared patients with negative emotional triggers to those with positive emotional triggers, which included weddings, the birth of grandchildren, birthday parties, or anticipation of a trip or Christmas.

There was a 1.5% incidence of pleasant emotional triggers among all Takotsubo syndrome patients.

Among patients with positive prior triggers, there was a higher incidence of atypical ballooning (27.0% vs. 12.5%; P = .01), and a higher percentage of these patients were male (18.9% vs. 5.0%; P < .01) in comparison with those with negative events prior to Takotsubo syndrome.

Long-term death rates (8.8% vs. 2.7%; P = .20) and rates of in-hospital complication outcomes, including cardiogenic shock, stroke, death, or pulmonary edema (12.3% vs. 8.1%; P = .45), were similar for patients with negative preceding events and for those with positive preceding events.

Study limitations included that it cannot provide insight into the specific mechanisms of Takotsubo syndrome, it was observational, the sample size of patients in the positive events group was small, and the contributing research facilities assessed cardiac biomarker levels differently.

“Additional research efforts are needed to explore whether numerically lower cardiac-related event rates in patients with happy heart syndrome would be statistically significant in a larger sample size,” the researchers concluded.

Dr. Stiermaier reports no relevant financial relationships.

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

The risk for dementia goes up in patients with atrial fibrillation (AFib), but some evidence suggests that risk can be blunted with therapies that restore sinus rhythm. However, a new cohort study suggests that the treatment effect’s magnitude might depend on the rhythm control strategy. It hinted that AFib catheter ablation might be more effective than pharmacologic rhythm control alone at cutting the risk for dementia.

The case-matched study of more than 38,000 adults with AFib saw a 41% reduction (P < .0001) in risk for dementia among those who underwent catheter ablation after attempted rhythm control with antiarrhythmic drugs (AAD), compared with those managed with pharmacologic rhythm control therapy alone.

The observational study comprising 20 years of data comes with big limitations and can’t say for sure whether catheter ablation is better than AAD-only at cutting the dementia risk in AFib. But it and other evidence support the idea, which has yet to be explored in a randomized fashion.

In a secondary finding, the analysis showed a similar reduction in dementia risk from catheter ablation, compared with AAD, in women and in men by 40% and 45%, respectively (P < .0001 for both). The findings are particularly relevant “given the higher life-long risk of dementia among women and the lower likelihood that women will be offered ablation, which has been demonstrated repeatedly,” Emily P. Zeitler, MD, MHS, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, told this news organization. “I think this is another reason to try to be more generous in offering ablation to women.”

Management of AFib certainly evolved in important ways from 2000 to 2021, the period covered by the study. But a sensitivity analysis based on data from 2010 to 2021 showed “no meaningful differences” in the results, said Dr. Zeitler, who is slated to present the findings April 30 at the Heart Rhythm Society 2022 Scientific Sessions, conducted virtually and live in San Francisco.

Dr. Zeitler acknowledged that the observational study, even with its propensity-matched ablation and AAD cohorts, can only hint at a preference for ablation over AAD for lowering risk for AFib-associated dementia. “We know there’s unmeasured and unfixable confounding between those two groups, so we see this really as hypothesis-generating.”

It was “a well-done analysis,” and the conclusion that the dementia risk was lower with catheter ablation is “absolutely correct,” but only as far as the study and its limitations allow, agreed David Conen, MD, MPH, McMaster University, Hamilton, Ontario, who is not a coauthor.

“Even with propensity matching, you can get rid of some sorts of confounding, but you can never get rid of all selection bias issues.” That, he said when interviewed, takes randomized trials.

Dr. Conen, who is studying cognitive decline in AFib as a SWISS-AF trial principal investigator, pointed to a secondary finding of the analysis as evidence for such confounding. He said the ablation group’s nearly 50% drop (P < .0001) in competing risk for death, compared with patients managed with AAD, isn’t plausible.

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

The risk for dementia goes up in patients with atrial fibrillation (AFib), but some evidence suggests that risk can be blunted with therapies that restore sinus rhythm. However, a new cohort study suggests that the treatment effect’s magnitude might depend on the rhythm control strategy. It hinted that AFib catheter ablation might be more effective than pharmacologic rhythm control alone at cutting the risk for dementia.

The case-matched study of more than 38,000 adults with AFib saw a 41% reduction (P < .0001) in risk for dementia among those who underwent catheter ablation after attempted rhythm control with antiarrhythmic drugs (AAD), compared with those managed with pharmacologic rhythm control therapy alone.

The observational study comprising 20 years of data comes with big limitations and can’t say for sure whether catheter ablation is better than AAD-only at cutting the dementia risk in AFib. But it and other evidence support the idea, which has yet to be explored in a randomized fashion.

In a secondary finding, the analysis showed a similar reduction in dementia risk from catheter ablation, compared with AAD, in women and in men by 40% and 45%, respectively (P < .0001 for both). The findings are particularly relevant “given the higher life-long risk of dementia among women and the lower likelihood that women will be offered ablation, which has been demonstrated repeatedly,” Emily P. Zeitler, MD, MHS, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, told this news organization. “I think this is another reason to try to be more generous in offering ablation to women.”

Management of AFib certainly evolved in important ways from 2000 to 2021, the period covered by the study. But a sensitivity analysis based on data from 2010 to 2021 showed “no meaningful differences” in the results, said Dr. Zeitler, who is slated to present the findings April 30 at the Heart Rhythm Society 2022 Scientific Sessions, conducted virtually and live in San Francisco.

Dr. Zeitler acknowledged that the observational study, even with its propensity-matched ablation and AAD cohorts, can only hint at a preference for ablation over AAD for lowering risk for AFib-associated dementia. “We know there’s unmeasured and unfixable confounding between those two groups, so we see this really as hypothesis-generating.”

It was “a well-done analysis,” and the conclusion that the dementia risk was lower with catheter ablation is “absolutely correct,” but only as far as the study and its limitations allow, agreed David Conen, MD, MPH, McMaster University, Hamilton, Ontario, who is not a coauthor.

“Even with propensity matching, you can get rid of some sorts of confounding, but you can never get rid of all selection bias issues.” That, he said when interviewed, takes randomized trials.

Dr. Conen, who is studying cognitive decline in AFib as a SWISS-AF trial principal investigator, pointed to a secondary finding of the analysis as evidence for such confounding. He said the ablation group’s nearly 50% drop (P < .0001) in competing risk for death, compared with patients managed with AAD, isn’t plausible.

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

The risk for dementia goes up in patients with atrial fibrillation (AFib), but some evidence suggests that risk can be blunted with therapies that restore sinus rhythm. However, a new cohort study suggests that the treatment effect’s magnitude might depend on the rhythm control strategy. It hinted that AFib catheter ablation might be more effective than pharmacologic rhythm control alone at cutting the risk for dementia.

The case-matched study of more than 38,000 adults with AFib saw a 41% reduction (P < .0001) in risk for dementia among those who underwent catheter ablation after attempted rhythm control with antiarrhythmic drugs (AAD), compared with those managed with pharmacologic rhythm control therapy alone.

The observational study comprising 20 years of data comes with big limitations and can’t say for sure whether catheter ablation is better than AAD-only at cutting the dementia risk in AFib. But it and other evidence support the idea, which has yet to be explored in a randomized fashion.

In a secondary finding, the analysis showed a similar reduction in dementia risk from catheter ablation, compared with AAD, in women and in men by 40% and 45%, respectively (P < .0001 for both). The findings are particularly relevant “given the higher life-long risk of dementia among women and the lower likelihood that women will be offered ablation, which has been demonstrated repeatedly,” Emily P. Zeitler, MD, MHS, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, told this news organization. “I think this is another reason to try to be more generous in offering ablation to women.”

Management of AFib certainly evolved in important ways from 2000 to 2021, the period covered by the study. But a sensitivity analysis based on data from 2010 to 2021 showed “no meaningful differences” in the results, said Dr. Zeitler, who is slated to present the findings April 30 at the Heart Rhythm Society 2022 Scientific Sessions, conducted virtually and live in San Francisco.

Dr. Zeitler acknowledged that the observational study, even with its propensity-matched ablation and AAD cohorts, can only hint at a preference for ablation over AAD for lowering risk for AFib-associated dementia. “We know there’s unmeasured and unfixable confounding between those two groups, so we see this really as hypothesis-generating.”

It was “a well-done analysis,” and the conclusion that the dementia risk was lower with catheter ablation is “absolutely correct,” but only as far as the study and its limitations allow, agreed David Conen, MD, MPH, McMaster University, Hamilton, Ontario, who is not a coauthor.

“Even with propensity matching, you can get rid of some sorts of confounding, but you can never get rid of all selection bias issues.” That, he said when interviewed, takes randomized trials.

Dr. Conen, who is studying cognitive decline in AFib as a SWISS-AF trial principal investigator, pointed to a secondary finding of the analysis as evidence for such confounding. He said the ablation group’s nearly 50% drop (P < .0001) in competing risk for death, compared with patients managed with AAD, isn’t plausible.

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

The Society for Cardiovascular Angiography and Interventions (SCAI) has issued the first statement on best practices for percutaneous axillary arterial access and training.

The position statement helps fill a gap amid increasing use of transaxillary access as an alternative to the femoral route for large-bore transcatheter aortic valve replacement (TAVR), endovascular aortic repair (EVAR), and mechanical circulatory support.

“The need for alternative access has increased as we are using more and more TAVR for our elderly population, and EVAR has also increased,” writing committee chair Arnold H. Seto, MD, Long Beach VA Health Care System (California) said in an interview. “There’s also a set of patients who require balloon pumps for a prolonged period, and people were using balloon pumps from the axillary approach, which were not custom-designed for that purpose.”

He noted that the evidence base leans heavily on case reports and case series, and that they were approached for guidance by a vendor developing a balloon pump specific to axillary access. “So that helped spur all of us to get together and decide to write up something on this topic, which was developing, but was certainly picking up steam rapidly.”

The statement was published in the Journal of the Society for Cardiovascular Angiography and Interventions, and it reflects the consensus of experts in heart failure, interventional cardiology and radiology, and cardiothoracic and vascular surgery. It reviews anatomic considerations and risks for percutaneous axillary access and suggests techniques for insertion, closure, and complication management.

Although the femoral artery is the most frequent access site for percutaneous large-bore procedures, the document notes that this approach may be limited in 13%-20% of patients because of prior surgeries or severe aortoiliac and/or iliofemoral atherosclerotic disease, tortuosity, or calcification.

“Absolutely, the femoral should be the predominant access site,” Dr. Seto said. Whenever there is a compromised femoral artery, “the axillary artery, which is rarely involved with atherosclerosis, makes for the most optimal alternative access. Other forms of alternative access, including transcaval and transcarotid, are possible but have their own issues and difficulties.”

Axillary access has traditionally been done through an open surgical approach, which allows for direct puncture, primary arterial repair, or placement of a sidearm conduit. Percutaneous transaxillary access avoids a surgical incision and general anesthesia and, theoretically, reduces the risk of infection, he said. It also allows for better mobility for patients, for example, who may have a balloon pump in place for weeks or even a month when waiting for a bridge to transplant.

In terms of technique, key recommendations include:

• Gaining access preferably through the left axillary
• Inserting the needle directly through the pectoralis minor into the second segment of the axillary artery
• Using a shallow-needle angle of 25-30 degrees to improve access success and decrease sheath malformation, kinking, bleeding, or vessel perforation
• Using micropuncture needles to minimize trauma to adjacent tissues
• Abducting the patient’s arm to 45-90 degrees to reduce tortuosity
• Using angiographic and ultrasound techniques to optimize vascular access

The latter point was the one area of debate among the writing committee, Dr. Seto observed. “That is one of the controversies: Should we make ultrasound mandatory? ... Everybody agreed that it can be quite useful and was likely to be useful because of its success in every other access area,” he said. “But in the absence of randomized evidence, we couldn’t make it mandatory or a strong recommendation. We just had to make it one of several options for the operator.”

The document highlights the need for familiarity with potential axillary artery complications and their management, noting that the axillary is more fragile than the femoral artery and, thus, potentially more prone to complications during instrumentation.

Data from the ARMS study in 102 patients undergoing transaxillary access for mechanical hemodynamic support reported 17 procedural complications, including 10 minor access site bleeding events, one stroke, and one pseudoaneurysm. A small study of 25 complex EVAR procedures reported a perioperative access complication rate of 8%, including one axillary artery dissection and one stenosis.

“Despite the brachial plexus being around there, there’s actually rare reports of neurologic injury and certainly none that have been permanent,” Dr. Seto said. “Also, stroke risk is probably more related to your device size and type of device rather than the approach itself.”

A significant amount of the paper is also devoted to training and privileging suggestions with an emphasis on a multidisciplinary team. The writing group recommends graduate medical education programs develop training curricula in percutaneous axillary artery access.

Those already in practice should participate in a formal training program that focuses on axillary artery anatomy, training in large bore access and closure devices, and didactic training in imaging modalities as applied to the axillary artery. Training can occur hands-on or using online simulations.

They also recommend outlining the potential need or role for proctoring and call for ongoing formal professional monitoring programs to evaluate operator outcomes using local or registry data.

“From a privileging standpoint, it was important for hospitals to be equally fair, regardless of the specialty that a requesting practitioner came from,” Dr. Seto said. “In other words, treat the vascular surgeons and interventional cardiologists and radiologists equally in terms of who has the privilege to do transaxillary access.”

The SCAI position statement has been endorsed by the American College of Cardiology, the Heart Failure Society of America, the Society of Interventional Radiology, and the Vascular & Endovascular Surgery Society.

Dr. Seto reported receiving honoraria from Getinge prior to initiation of the document. Disclosures for the rest of the writing group are available with the original article.

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

The Society for Cardiovascular Angiography and Interventions (SCAI) has issued the first statement on best practices for percutaneous axillary arterial access and training.

The position statement helps fill a gap amid increasing use of transaxillary access as an alternative to the femoral route for large-bore transcatheter aortic valve replacement (TAVR), endovascular aortic repair (EVAR), and mechanical circulatory support.

“The need for alternative access has increased as we are using more and more TAVR for our elderly population, and EVAR has also increased,” writing committee chair Arnold H. Seto, MD, Long Beach VA Health Care System (California) said in an interview. “There’s also a set of patients who require balloon pumps for a prolonged period, and people were using balloon pumps from the axillary approach, which were not custom-designed for that purpose.”

He noted that the evidence base leans heavily on case reports and case series, and that they were approached for guidance by a vendor developing a balloon pump specific to axillary access. “So that helped spur all of us to get together and decide to write up something on this topic, which was developing, but was certainly picking up steam rapidly.”

The statement was published in the Journal of the Society for Cardiovascular Angiography and Interventions, and it reflects the consensus of experts in heart failure, interventional cardiology and radiology, and cardiothoracic and vascular surgery. It reviews anatomic considerations and risks for percutaneous axillary access and suggests techniques for insertion, closure, and complication management.

Although the femoral artery is the most frequent access site for percutaneous large-bore procedures, the document notes that this approach may be limited in 13%-20% of patients because of prior surgeries or severe aortoiliac and/or iliofemoral atherosclerotic disease, tortuosity, or calcification.

“Absolutely, the femoral should be the predominant access site,” Dr. Seto said. Whenever there is a compromised femoral artery, “the axillary artery, which is rarely involved with atherosclerosis, makes for the most optimal alternative access. Other forms of alternative access, including transcaval and transcarotid, are possible but have their own issues and difficulties.”

Axillary access has traditionally been done through an open surgical approach, which allows for direct puncture, primary arterial repair, or placement of a sidearm conduit. Percutaneous transaxillary access avoids a surgical incision and general anesthesia and, theoretically, reduces the risk of infection, he said. It also allows for better mobility for patients, for example, who may have a balloon pump in place for weeks or even a month when waiting for a bridge to transplant.

In terms of technique, key recommendations include:

• Gaining access preferably through the left axillary
• Inserting the needle directly through the pectoralis minor into the second segment of the axillary artery
• Using a shallow-needle angle of 25-30 degrees to improve access success and decrease sheath malformation, kinking, bleeding, or vessel perforation
• Using micropuncture needles to minimize trauma to adjacent tissues
• Abducting the patient’s arm to 45-90 degrees to reduce tortuosity
• Using angiographic and ultrasound techniques to optimize vascular access

The latter point was the one area of debate among the writing committee, Dr. Seto observed. “That is one of the controversies: Should we make ultrasound mandatory? ... Everybody agreed that it can be quite useful and was likely to be useful because of its success in every other access area,” he said. “But in the absence of randomized evidence, we couldn’t make it mandatory or a strong recommendation. We just had to make it one of several options for the operator.”

The document highlights the need for familiarity with potential axillary artery complications and their management, noting that the axillary is more fragile than the femoral artery and, thus, potentially more prone to complications during instrumentation.

Data from the ARMS study in 102 patients undergoing transaxillary access for mechanical hemodynamic support reported 17 procedural complications, including 10 minor access site bleeding events, one stroke, and one pseudoaneurysm. A small study of 25 complex EVAR procedures reported a perioperative access complication rate of 8%, including one axillary artery dissection and one stenosis.

“Despite the brachial plexus being around there, there’s actually rare reports of neurologic injury and certainly none that have been permanent,” Dr. Seto said. “Also, stroke risk is probably more related to your device size and type of device rather than the approach itself.”

A significant amount of the paper is also devoted to training and privileging suggestions with an emphasis on a multidisciplinary team. The writing group recommends graduate medical education programs develop training curricula in percutaneous axillary artery access.

Those already in practice should participate in a formal training program that focuses on axillary artery anatomy, training in large bore access and closure devices, and didactic training in imaging modalities as applied to the axillary artery. Training can occur hands-on or using online simulations.

They also recommend outlining the potential need or role for proctoring and call for ongoing formal professional monitoring programs to evaluate operator outcomes using local or registry data.

“From a privileging standpoint, it was important for hospitals to be equally fair, regardless of the specialty that a requesting practitioner came from,” Dr. Seto said. “In other words, treat the vascular surgeons and interventional cardiologists and radiologists equally in terms of who has the privilege to do transaxillary access.”

The SCAI position statement has been endorsed by the American College of Cardiology, the Heart Failure Society of America, the Society of Interventional Radiology, and the Vascular & Endovascular Surgery Society.

Dr. Seto reported receiving honoraria from Getinge prior to initiation of the document. Disclosures for the rest of the writing group are available with the original article.

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

The Society for Cardiovascular Angiography and Interventions (SCAI) has issued the first statement on best practices for percutaneous axillary arterial access and training.

The position statement helps fill a gap amid increasing use of transaxillary access as an alternative to the femoral route for large-bore transcatheter aortic valve replacement (TAVR), endovascular aortic repair (EVAR), and mechanical circulatory support.

“The need for alternative access has increased as we are using more and more TAVR for our elderly population, and EVAR has also increased,” writing committee chair Arnold H. Seto, MD, Long Beach VA Health Care System (California) said in an interview. “There’s also a set of patients who require balloon pumps for a prolonged period, and people were using balloon pumps from the axillary approach, which were not custom-designed for that purpose.”

He noted that the evidence base leans heavily on case reports and case series, and that they were approached for guidance by a vendor developing a balloon pump specific to axillary access. “So that helped spur all of us to get together and decide to write up something on this topic, which was developing, but was certainly picking up steam rapidly.”

The statement was published in the Journal of the Society for Cardiovascular Angiography and Interventions, and it reflects the consensus of experts in heart failure, interventional cardiology and radiology, and cardiothoracic and vascular surgery. It reviews anatomic considerations and risks for percutaneous axillary access and suggests techniques for insertion, closure, and complication management.

Although the femoral artery is the most frequent access site for percutaneous large-bore procedures, the document notes that this approach may be limited in 13%-20% of patients because of prior surgeries or severe aortoiliac and/or iliofemoral atherosclerotic disease, tortuosity, or calcification.

“Absolutely, the femoral should be the predominant access site,” Dr. Seto said. Whenever there is a compromised femoral artery, “the axillary artery, which is rarely involved with atherosclerosis, makes for the most optimal alternative access. Other forms of alternative access, including transcaval and transcarotid, are possible but have their own issues and difficulties.”

Axillary access has traditionally been done through an open surgical approach, which allows for direct puncture, primary arterial repair, or placement of a sidearm conduit. Percutaneous transaxillary access avoids a surgical incision and general anesthesia and, theoretically, reduces the risk of infection, he said. It also allows for better mobility for patients, for example, who may have a balloon pump in place for weeks or even a month when waiting for a bridge to transplant.

In terms of technique, key recommendations include:

• Gaining access preferably through the left axillary
• Inserting the needle directly through the pectoralis minor into the second segment of the axillary artery
• Using a shallow-needle angle of 25-30 degrees to improve access success and decrease sheath malformation, kinking, bleeding, or vessel perforation
• Using micropuncture needles to minimize trauma to adjacent tissues
• Abducting the patient’s arm to 45-90 degrees to reduce tortuosity
• Using angiographic and ultrasound techniques to optimize vascular access

The latter point was the one area of debate among the writing committee, Dr. Seto observed. “That is one of the controversies: Should we make ultrasound mandatory? ... Everybody agreed that it can be quite useful and was likely to be useful because of its success in every other access area,” he said. “But in the absence of randomized evidence, we couldn’t make it mandatory or a strong recommendation. We just had to make it one of several options for the operator.”

The document highlights the need for familiarity with potential axillary artery complications and their management, noting that the axillary is more fragile than the femoral artery and, thus, potentially more prone to complications during instrumentation.

Data from the ARMS study in 102 patients undergoing transaxillary access for mechanical hemodynamic support reported 17 procedural complications, including 10 minor access site bleeding events, one stroke, and one pseudoaneurysm. A small study of 25 complex EVAR procedures reported a perioperative access complication rate of 8%, including one axillary artery dissection and one stenosis.

“Despite the brachial plexus being around there, there’s actually rare reports of neurologic injury and certainly none that have been permanent,” Dr. Seto said. “Also, stroke risk is probably more related to your device size and type of device rather than the approach itself.”

A significant amount of the paper is also devoted to training and privileging suggestions with an emphasis on a multidisciplinary team. The writing group recommends graduate medical education programs develop training curricula in percutaneous axillary artery access.

Those already in practice should participate in a formal training program that focuses on axillary artery anatomy, training in large bore access and closure devices, and didactic training in imaging modalities as applied to the axillary artery. Training can occur hands-on or using online simulations.

They also recommend outlining the potential need or role for proctoring and call for ongoing formal professional monitoring programs to evaluate operator outcomes using local or registry data.

“From a privileging standpoint, it was important for hospitals to be equally fair, regardless of the specialty that a requesting practitioner came from,” Dr. Seto said. “In other words, treat the vascular surgeons and interventional cardiologists and radiologists equally in terms of who has the privilege to do transaxillary access.”

The SCAI position statement has been endorsed by the American College of Cardiology, the Heart Failure Society of America, the Society of Interventional Radiology, and the Vascular & Endovascular Surgery Society.

Dr. Seto reported receiving honoraria from Getinge prior to initiation of the document. Disclosures for the rest of the writing group are available with the original article.

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

The U.S. Food and Drug Administration has approved mavacamten (Camzyos, Bristol Myers Squibb) to improve functional capacity and symptoms in adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (oHCM).

Mavacamten is the first FDA-approved allosteric and reversible inhibitor selective for cardiac myosin that targets the underlying pathophysiology of the genetic disorder. It’s available in 2.5-mg, 5-mg, 10-mg, and 15-mg capsules.

“The approval of Camzyos represents a significant milestone for appropriate symptomatic obstructive HCM patients and their families, who have long awaited a new treatment option for this chronic and progressive disease,” Anjali T. Owens, MD, medical director of the Center for Inherited Cardiac Disease and assistant professor of medicine, University of Pennsylvania, Philadelphia, said in a news release.
 

‘Revolutionary’ change

The approval of mavacamten was based on data from the pivotal EXPLORER-HCM and EXPLORER-LTE (long-term extension) trial of adults with symptomatic NYHA class II-III oHCM.

In EXPLORER-HCM, treatment with mavacamten over 30 weeks led to significant improvement in exercise capacity, left ventricular outflow tract (LVOT) obstruction, NYHA functional class, and health status, as reported by this news organization.

The safety and efficacy findings seen at the end of the blinded, randomized, initial 30-week phase of EXPLORER-LTE were maintained in patients who continued treatment for a median of about 62 weeks.

Mavacamten represents “an almost revolutionary change” for the treatment of oHCM, Maya E. Guglin, MD, professor of clinical medicine and an advanced heart failure physician at Indiana University, Indianapolis, said during a press briefing earlier this month at the American College of Cardiology 2022 Scientific Session earlier this month.

“Until now, there was no good medical treatment for symptomatic oHCM. This will change the landscape, and without question it will change guidelines for treating oHCM,” Dr. Guglin said.

The product information for mavacamten includes a boxed warning citing a risk for heart failure.

Echocardiogram assessments of left ventricular ejection fraction (LVEF) are required before and during treatment.

Starting mavacamten in patients with LVEF below 55% is not recommended and the drug should be interrupted if LVEF falls below 50% at any visit or if the patient experiences heart failure symptoms or worsening clinical status.

Concomitant use of mavacamten with certain cytochrome P450 inhibitors or discontinuation of certain cytochrome P450 inducers can increase the risk for heart failure attributable to systolic dysfunction. Therefore, its use is contraindicated in patients using moderate to strong CYP2C19 inhibitors or strong CYP3A4 inhibitors, and moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers.

Because of the risk for heart failure attributable to systolic dysfunction, mavacamten is only available through the Camzyos Risk Evaluation and Mitigation Strategy (REMS) Program.

Full prescribing information is available online.

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

The U.S. Food and Drug Administration has approved mavacamten (Camzyos, Bristol Myers Squibb) to improve functional capacity and symptoms in adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (oHCM).

Mavacamten is the first FDA-approved allosteric and reversible inhibitor selective for cardiac myosin that targets the underlying pathophysiology of the genetic disorder. It’s available in 2.5-mg, 5-mg, 10-mg, and 15-mg capsules.

“The approval of Camzyos represents a significant milestone for appropriate symptomatic obstructive HCM patients and their families, who have long awaited a new treatment option for this chronic and progressive disease,” Anjali T. Owens, MD, medical director of the Center for Inherited Cardiac Disease and assistant professor of medicine, University of Pennsylvania, Philadelphia, said in a news release.
 

‘Revolutionary’ change

The approval of mavacamten was based on data from the pivotal EXPLORER-HCM and EXPLORER-LTE (long-term extension) trial of adults with symptomatic NYHA class II-III oHCM.

In EXPLORER-HCM, treatment with mavacamten over 30 weeks led to significant improvement in exercise capacity, left ventricular outflow tract (LVOT) obstruction, NYHA functional class, and health status, as reported by this news organization.

The safety and efficacy findings seen at the end of the blinded, randomized, initial 30-week phase of EXPLORER-LTE were maintained in patients who continued treatment for a median of about 62 weeks.

Mavacamten represents “an almost revolutionary change” for the treatment of oHCM, Maya E. Guglin, MD, professor of clinical medicine and an advanced heart failure physician at Indiana University, Indianapolis, said during a press briefing earlier this month at the American College of Cardiology 2022 Scientific Session earlier this month.

“Until now, there was no good medical treatment for symptomatic oHCM. This will change the landscape, and without question it will change guidelines for treating oHCM,” Dr. Guglin said.

The product information for mavacamten includes a boxed warning citing a risk for heart failure.

Echocardiogram assessments of left ventricular ejection fraction (LVEF) are required before and during treatment.

Starting mavacamten in patients with LVEF below 55% is not recommended and the drug should be interrupted if LVEF falls below 50% at any visit or if the patient experiences heart failure symptoms or worsening clinical status.

Concomitant use of mavacamten with certain cytochrome P450 inhibitors or discontinuation of certain cytochrome P450 inducers can increase the risk for heart failure attributable to systolic dysfunction. Therefore, its use is contraindicated in patients using moderate to strong CYP2C19 inhibitors or strong CYP3A4 inhibitors, and moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers.

Because of the risk for heart failure attributable to systolic dysfunction, mavacamten is only available through the Camzyos Risk Evaluation and Mitigation Strategy (REMS) Program.

Full prescribing information is available online.

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

The U.S. Food and Drug Administration has approved mavacamten (Camzyos, Bristol Myers Squibb) to improve functional capacity and symptoms in adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (oHCM).

Mavacamten is the first FDA-approved allosteric and reversible inhibitor selective for cardiac myosin that targets the underlying pathophysiology of the genetic disorder. It’s available in 2.5-mg, 5-mg, 10-mg, and 15-mg capsules.

“The approval of Camzyos represents a significant milestone for appropriate symptomatic obstructive HCM patients and their families, who have long awaited a new treatment option for this chronic and progressive disease,” Anjali T. Owens, MD, medical director of the Center for Inherited Cardiac Disease and assistant professor of medicine, University of Pennsylvania, Philadelphia, said in a news release.
 

‘Revolutionary’ change

The approval of mavacamten was based on data from the pivotal EXPLORER-HCM and EXPLORER-LTE (long-term extension) trial of adults with symptomatic NYHA class II-III oHCM.

In EXPLORER-HCM, treatment with mavacamten over 30 weeks led to significant improvement in exercise capacity, left ventricular outflow tract (LVOT) obstruction, NYHA functional class, and health status, as reported by this news organization.

The safety and efficacy findings seen at the end of the blinded, randomized, initial 30-week phase of EXPLORER-LTE were maintained in patients who continued treatment for a median of about 62 weeks.

Mavacamten represents “an almost revolutionary change” for the treatment of oHCM, Maya E. Guglin, MD, professor of clinical medicine and an advanced heart failure physician at Indiana University, Indianapolis, said during a press briefing earlier this month at the American College of Cardiology 2022 Scientific Session earlier this month.

“Until now, there was no good medical treatment for symptomatic oHCM. This will change the landscape, and without question it will change guidelines for treating oHCM,” Dr. Guglin said.

The product information for mavacamten includes a boxed warning citing a risk for heart failure.

Echocardiogram assessments of left ventricular ejection fraction (LVEF) are required before and during treatment.

Starting mavacamten in patients with LVEF below 55% is not recommended and the drug should be interrupted if LVEF falls below 50% at any visit or if the patient experiences heart failure symptoms or worsening clinical status.

Concomitant use of mavacamten with certain cytochrome P450 inhibitors or discontinuation of certain cytochrome P450 inducers can increase the risk for heart failure attributable to systolic dysfunction. Therefore, its use is contraindicated in patients using moderate to strong CYP2C19 inhibitors or strong CYP3A4 inhibitors, and moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers.

Because of the risk for heart failure attributable to systolic dysfunction, mavacamten is only available through the Camzyos Risk Evaluation and Mitigation Strategy (REMS) Program.

Full prescribing information is available online.

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

Patients implanted with the Medtronic HeartWare ventricular assist device (HVAD) System who develop pump thrombosis could have a welding defect in the internal pump causing the pump to malfunction, the Food and Drug Administration said in a letter to health care professionals. 

Medtronic has sent providers an urgent medical device notice about the pump weld defect and is trying to identify which HVAD pumps are affected.

The Medtronic HVAD System was approved as a bridge to heart transplantation in 2012. Since then, it has been fraught with problems.

This past June, the company announced it was stopping all sales of the device and advised physicians to stop implanting it, as reported by this news organization. 
 

Pump thrombosis

Medtronic has received complaints of suspected pump thrombosis in three patients with the HVAD System.

All three patients presented with one or more of the following signs or symptoms: grinding sound, transient power spikes on log files and high watt alarms, elevated lactate dehydrogenase, and low motor speed resulting in low perfusion or dizziness or lightheadedness.

Inspection of the returned pumps in these three cases identified a malfunction of the internal pump. The pumps were exchanged in all three patients. Two patients died after the pump exchange.

The FDA does not recommend the elective removal of properly functioning systems.

“Decisions about removing or exchanging the Medtronic HVAD System should be made by health care providers and patients on a case-by-case basis, considering the patient’s clinical status and surgical risks,” the agency advised.

Patients who present with one or more of the signs or symptoms of pump thrombosis should be first treated for pump thrombosis.

If symptoms fail to resolve, providers may consider whether the patient is a candidate for pump exchange, heart transplant, or pump explant for recovery, taking into account the patient’s clinical condition and surgical risks.

For patients with any of the signs and symptoms of pump thrombosis, logfiles from the controller should be uploaded to Medtronic.

The FDA is working with Medtronic to monitor for any adverse events related to pump weld defects and ensure patients with the HVAD implant continue to receive appropriate follow-up monitoring.

Problems related to the Medtronic HVAD System should be reported to the FDA’s MedWatch program.

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

Patients implanted with the Medtronic HeartWare ventricular assist device (HVAD) System who develop pump thrombosis could have a welding defect in the internal pump causing the pump to malfunction, the Food and Drug Administration said in a letter to health care professionals. 

Medtronic has sent providers an urgent medical device notice about the pump weld defect and is trying to identify which HVAD pumps are affected.

The Medtronic HVAD System was approved as a bridge to heart transplantation in 2012. Since then, it has been fraught with problems.

This past June, the company announced it was stopping all sales of the device and advised physicians to stop implanting it, as reported by this news organization. 
 

Pump thrombosis

Medtronic has received complaints of suspected pump thrombosis in three patients with the HVAD System.

All three patients presented with one or more of the following signs or symptoms: grinding sound, transient power spikes on log files and high watt alarms, elevated lactate dehydrogenase, and low motor speed resulting in low perfusion or dizziness or lightheadedness.

Inspection of the returned pumps in these three cases identified a malfunction of the internal pump. The pumps were exchanged in all three patients. Two patients died after the pump exchange.

The FDA does not recommend the elective removal of properly functioning systems.

“Decisions about removing or exchanging the Medtronic HVAD System should be made by health care providers and patients on a case-by-case basis, considering the patient’s clinical status and surgical risks,” the agency advised.

Patients who present with one or more of the signs or symptoms of pump thrombosis should be first treated for pump thrombosis.

If symptoms fail to resolve, providers may consider whether the patient is a candidate for pump exchange, heart transplant, or pump explant for recovery, taking into account the patient’s clinical condition and surgical risks.

For patients with any of the signs and symptoms of pump thrombosis, logfiles from the controller should be uploaded to Medtronic.

The FDA is working with Medtronic to monitor for any adverse events related to pump weld defects and ensure patients with the HVAD implant continue to receive appropriate follow-up monitoring.

Problems related to the Medtronic HVAD System should be reported to the FDA’s MedWatch program.

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

Patients implanted with the Medtronic HeartWare ventricular assist device (HVAD) System who develop pump thrombosis could have a welding defect in the internal pump causing the pump to malfunction, the Food and Drug Administration said in a letter to health care professionals. 

Medtronic has sent providers an urgent medical device notice about the pump weld defect and is trying to identify which HVAD pumps are affected.

The Medtronic HVAD System was approved as a bridge to heart transplantation in 2012. Since then, it has been fraught with problems.

This past June, the company announced it was stopping all sales of the device and advised physicians to stop implanting it, as reported by this news organization. 
 

Pump thrombosis

Medtronic has received complaints of suspected pump thrombosis in three patients with the HVAD System.

All three patients presented with one or more of the following signs or symptoms: grinding sound, transient power spikes on log files and high watt alarms, elevated lactate dehydrogenase, and low motor speed resulting in low perfusion or dizziness or lightheadedness.

Inspection of the returned pumps in these three cases identified a malfunction of the internal pump. The pumps were exchanged in all three patients. Two patients died after the pump exchange.

The FDA does not recommend the elective removal of properly functioning systems.

“Decisions about removing or exchanging the Medtronic HVAD System should be made by health care providers and patients on a case-by-case basis, considering the patient’s clinical status and surgical risks,” the agency advised.

Patients who present with one or more of the signs or symptoms of pump thrombosis should be first treated for pump thrombosis.

If symptoms fail to resolve, providers may consider whether the patient is a candidate for pump exchange, heart transplant, or pump explant for recovery, taking into account the patient’s clinical condition and surgical risks.

For patients with any of the signs and symptoms of pump thrombosis, logfiles from the controller should be uploaded to Medtronic.

The FDA is working with Medtronic to monitor for any adverse events related to pump weld defects and ensure patients with the HVAD implant continue to receive appropriate follow-up monitoring.

Problems related to the Medtronic HVAD System should be reported to the FDA’s MedWatch program.

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

More than half of patients taking the two highest doses of tirzepatide as a once-weekly injection lost at least 20% of their body weight in the first phase 3 trial to examine this agent in patients with obesity, but without diabetes, according to preliminary top-line results from the SURMOUNT-1 trial announced by Lilly.  

The full results will be reported at an upcoming medical conference and published at a later date, Lilly added.

There was much excitement in response to the news, but others have urged caution and noted that, even if tirzepatide is eventually approved for obesity, one of the major barriers to use in the United States will be insurance coverage.

“Wow (and a double Wow!) 52lb weight loss (22.5%) at highest dose of tirzepatide,” tweeted Sek Kathiresan, MD, a cardiologist who is cofounder of Verve Therapeutics and on leave from Harvard (@skathire).

“Thus far the challenge with GLP-1s [agonists] for management of obesity is that insurance usually isn’t covering them. This makes them unaffordable for most people,” replied James Marroquin, MD, of the University of Texas at Austin. (@Jamesmarroquin).

Yoni Freedhoff, MD, of the University of Ottawa (Ont.) who writes a column for this news organization on obesity, said if tirzepatide pans out, along with other similar agents already on the market for this indication, “the next few decades should see the pharmaceutical management of obesity rival its surgical management.”

Would compete with ‘game-changer’ semaglutide?

Tirzepatide has been dubbed a “twincretin” because it works not only as an agonist of the glucagonlike peptide-1 (GLP-1) receptor, but also of the glucose-dependent insulinotropic polypeptide (GIP) receptor. It has been much hyped based on the results of the series of SURPASS clinical trials, which have formed the basis of the application for type 2 diabetes approval, about which the U.S. Food and Drug Administration is expected to make a decision soon.

Several GLP-1 agonists are on the market for both type 2 diabetes and for obesity indications separately, including semaglutide (marketed as Wegovy for obesity, also a once-weekly injection) and liraglutide (Saxenda for obesity, a daily injection), both Novo Nordisk agents.

Wegovy was approved for weight loss in the United States last year, with doctors telling this news organization then that a third of patients who take the drug are likely to lose 20% or more of their starting weight, an outcome that approaches reductions seen with bariatric surgery.

Dr. Freedhoff said he’d like to see “reimbursement by insurers who will see these drugs serving as important ancillary treatments for the myriad of weight-responsive conditions they’re already covering.”

SURMOUNT-1 data: ‘Impressive body weight’ reductions

The new tirzepatide data come from the multicenter, randomized, double-blind, placebo-controlled SURMOUNT-1 trial, which included 2539 participants from the United States, Argentina, Brazil, China, India, Japan Mexico, Russia, and Taiwan. They had obesity or overweight plus at least one comorbidity but not diabetes. They were randomized to 5-mg, 10-mg, or 15-mg once-weekly tirzepatide or placebo injections for 18 months (72 weeks).

Efficacy was analyzed in two ways. Prior to factoring in drug discontinuation, participants taking tirzepatide experienced weight loss of 16.0% (35 lb/16 kg) with 5 mg, 21.4% (49 lb/22 kg) with 10 mg, and 22.5% (52 lb/24 kg) on 15 mg. In contrast, the placebo group lost just 2.4% of body weight (5 lb/2 kg).  

But treatment discontinuation rates because of adverse events were 4.3%, 7.1%, 6.2%, and 2.6%, for tirzepatide 5 mg, 10 mg, 15 mg, and placebo, respectively. Overall treatment discontinuation rates were 14.3%, 16.4%, 15.1%, and 26.4%, respectively.  

When efficacy was assessed regardless of treatment discontinuation, average body weight reductions were 15.0%, 19.5%, 20.9%, and 3.1% for tirzepatide 5 mg, 10 mg, 15 mg, and placebo, respectively.  

More than half of patients taking tirzepatide 10 mg and 15 mg (55% and 63%, respectively) lost at least 20% of their body weight, compared with just 1.3% taking placebo.

Overall safety and tolerability were similar to those of other GLP-1 agonists, with adverse events being gastrointestinal in nature and increasing with higher doses. Nausea affected 24.6%, 33.3%, and 31.0% of the tirzepatide 5-mg, 10-mg, and 15-mg dose groups, respectively, and vomiting was experienced by 8.3%, 10.7%, and 12.2% of patients, respectively. Diarrhea and constipation were also reported more often with the drug than placebo.

“Tirzepatide delivered impressive body weight reductions in SURMOUNT-1, which could represent an important step forward for helping the patient and physician partnership treat this complex disease,” said study investigator Louis J. Aronne, MD, director of the Comprehensive Weight Control Center and the Sanford I. Weill Professor of Metabolic Research at Weill Cornell Medicine, New York, in a press release.

Further studies are ongoing for tirzepatide as a potential treatment for obesity or overweight, according to the Lilly statement. SURMOUNT is a phase 3 global clinical development program for tirzepatide that began in late 2019 with over 5,000 people with obesity or overweight across six clinical trials. Results from SURMOUNT-2, SURMOUNT-3, and SURMOUNT-4 are expected in 2023.

Tirzepatide is also being studied as a potential treatment for nonalcoholic fatty liver disease and heart failure with preserved ejection fraction. Studies of tirzepatide in obstructive sleep apnea and of morbidity/mortality in obesity are also planned.

Dr. Aronne is cofounder, chief scientific advisor, and a member of the board of directors for Intellihealth. He is also a paid scientific advisory board member for Eli Lilly. Dr. Freedhoff has served or is serving as a director, officer, partner, employee, adviser, consultant, or trustee for the Bariatric Medical Institute and Constant Health and has received a research grant from Novo Nordisk.

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

More than half of patients taking the two highest doses of tirzepatide as a once-weekly injection lost at least 20% of their body weight in the first phase 3 trial to examine this agent in patients with obesity, but without diabetes, according to preliminary top-line results from the SURMOUNT-1 trial announced by Lilly.  

The full results will be reported at an upcoming medical conference and published at a later date, Lilly added.

There was much excitement in response to the news, but others have urged caution and noted that, even if tirzepatide is eventually approved for obesity, one of the major barriers to use in the United States will be insurance coverage.

“Wow (and a double Wow!) 52lb weight loss (22.5%) at highest dose of tirzepatide,” tweeted Sek Kathiresan, MD, a cardiologist who is cofounder of Verve Therapeutics and on leave from Harvard (@skathire).

“Thus far the challenge with GLP-1s [agonists] for management of obesity is that insurance usually isn’t covering them. This makes them unaffordable for most people,” replied James Marroquin, MD, of the University of Texas at Austin. (@Jamesmarroquin).

Yoni Freedhoff, MD, of the University of Ottawa (Ont.) who writes a column for this news organization on obesity, said if tirzepatide pans out, along with other similar agents already on the market for this indication, “the next few decades should see the pharmaceutical management of obesity rival its surgical management.”

Would compete with ‘game-changer’ semaglutide?

Tirzepatide has been dubbed a “twincretin” because it works not only as an agonist of the glucagonlike peptide-1 (GLP-1) receptor, but also of the glucose-dependent insulinotropic polypeptide (GIP) receptor. It has been much hyped based on the results of the series of SURPASS clinical trials, which have formed the basis of the application for type 2 diabetes approval, about which the U.S. Food and Drug Administration is expected to make a decision soon.

Several GLP-1 agonists are on the market for both type 2 diabetes and for obesity indications separately, including semaglutide (marketed as Wegovy for obesity, also a once-weekly injection) and liraglutide (Saxenda for obesity, a daily injection), both Novo Nordisk agents.

Wegovy was approved for weight loss in the United States last year, with doctors telling this news organization then that a third of patients who take the drug are likely to lose 20% or more of their starting weight, an outcome that approaches reductions seen with bariatric surgery.

Dr. Freedhoff said he’d like to see “reimbursement by insurers who will see these drugs serving as important ancillary treatments for the myriad of weight-responsive conditions they’re already covering.”

SURMOUNT-1 data: ‘Impressive body weight’ reductions

The new tirzepatide data come from the multicenter, randomized, double-blind, placebo-controlled SURMOUNT-1 trial, which included 2539 participants from the United States, Argentina, Brazil, China, India, Japan Mexico, Russia, and Taiwan. They had obesity or overweight plus at least one comorbidity but not diabetes. They were randomized to 5-mg, 10-mg, or 15-mg once-weekly tirzepatide or placebo injections for 18 months (72 weeks).

Efficacy was analyzed in two ways. Prior to factoring in drug discontinuation, participants taking tirzepatide experienced weight loss of 16.0% (35 lb/16 kg) with 5 mg, 21.4% (49 lb/22 kg) with 10 mg, and 22.5% (52 lb/24 kg) on 15 mg. In contrast, the placebo group lost just 2.4% of body weight (5 lb/2 kg).  

But treatment discontinuation rates because of adverse events were 4.3%, 7.1%, 6.2%, and 2.6%, for tirzepatide 5 mg, 10 mg, 15 mg, and placebo, respectively. Overall treatment discontinuation rates were 14.3%, 16.4%, 15.1%, and 26.4%, respectively.  

When efficacy was assessed regardless of treatment discontinuation, average body weight reductions were 15.0%, 19.5%, 20.9%, and 3.1% for tirzepatide 5 mg, 10 mg, 15 mg, and placebo, respectively.  

More than half of patients taking tirzepatide 10 mg and 15 mg (55% and 63%, respectively) lost at least 20% of their body weight, compared with just 1.3% taking placebo.

Overall safety and tolerability were similar to those of other GLP-1 agonists, with adverse events being gastrointestinal in nature and increasing with higher doses. Nausea affected 24.6%, 33.3%, and 31.0% of the tirzepatide 5-mg, 10-mg, and 15-mg dose groups, respectively, and vomiting was experienced by 8.3%, 10.7%, and 12.2% of patients, respectively. Diarrhea and constipation were also reported more often with the drug than placebo.

“Tirzepatide delivered impressive body weight reductions in SURMOUNT-1, which could represent an important step forward for helping the patient and physician partnership treat this complex disease,” said study investigator Louis J. Aronne, MD, director of the Comprehensive Weight Control Center and the Sanford I. Weill Professor of Metabolic Research at Weill Cornell Medicine, New York, in a press release.

Further studies are ongoing for tirzepatide as a potential treatment for obesity or overweight, according to the Lilly statement. SURMOUNT is a phase 3 global clinical development program for tirzepatide that began in late 2019 with over 5,000 people with obesity or overweight across six clinical trials. Results from SURMOUNT-2, SURMOUNT-3, and SURMOUNT-4 are expected in 2023.

Tirzepatide is also being studied as a potential treatment for nonalcoholic fatty liver disease and heart failure with preserved ejection fraction. Studies of tirzepatide in obstructive sleep apnea and of morbidity/mortality in obesity are also planned.

Dr. Aronne is cofounder, chief scientific advisor, and a member of the board of directors for Intellihealth. He is also a paid scientific advisory board member for Eli Lilly. Dr. Freedhoff has served or is serving as a director, officer, partner, employee, adviser, consultant, or trustee for the Bariatric Medical Institute and Constant Health and has received a research grant from Novo Nordisk.

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

More than half of patients taking the two highest doses of tirzepatide as a once-weekly injection lost at least 20% of their body weight in the first phase 3 trial to examine this agent in patients with obesity, but without diabetes, according to preliminary top-line results from the SURMOUNT-1 trial announced by Lilly.  

The full results will be reported at an upcoming medical conference and published at a later date, Lilly added.

There was much excitement in response to the news, but others have urged caution and noted that, even if tirzepatide is eventually approved for obesity, one of the major barriers to use in the United States will be insurance coverage.

“Wow (and a double Wow!) 52lb weight loss (22.5%) at highest dose of tirzepatide,” tweeted Sek Kathiresan, MD, a cardiologist who is cofounder of Verve Therapeutics and on leave from Harvard (@skathire).

“Thus far the challenge with GLP-1s [agonists] for management of obesity is that insurance usually isn’t covering them. This makes them unaffordable for most people,” replied James Marroquin, MD, of the University of Texas at Austin. (@Jamesmarroquin).

Yoni Freedhoff, MD, of the University of Ottawa (Ont.) who writes a column for this news organization on obesity, said if tirzepatide pans out, along with other similar agents already on the market for this indication, “the next few decades should see the pharmaceutical management of obesity rival its surgical management.”

Would compete with ‘game-changer’ semaglutide?

Tirzepatide has been dubbed a “twincretin” because it works not only as an agonist of the glucagonlike peptide-1 (GLP-1) receptor, but also of the glucose-dependent insulinotropic polypeptide (GIP) receptor. It has been much hyped based on the results of the series of SURPASS clinical trials, which have formed the basis of the application for type 2 diabetes approval, about which the U.S. Food and Drug Administration is expected to make a decision soon.

Several GLP-1 agonists are on the market for both type 2 diabetes and for obesity indications separately, including semaglutide (marketed as Wegovy for obesity, also a once-weekly injection) and liraglutide (Saxenda for obesity, a daily injection), both Novo Nordisk agents.

Wegovy was approved for weight loss in the United States last year, with doctors telling this news organization then that a third of patients who take the drug are likely to lose 20% or more of their starting weight, an outcome that approaches reductions seen with bariatric surgery.

Dr. Freedhoff said he’d like to see “reimbursement by insurers who will see these drugs serving as important ancillary treatments for the myriad of weight-responsive conditions they’re already covering.”

SURMOUNT-1 data: ‘Impressive body weight’ reductions

The new tirzepatide data come from the multicenter, randomized, double-blind, placebo-controlled SURMOUNT-1 trial, which included 2539 participants from the United States, Argentina, Brazil, China, India, Japan Mexico, Russia, and Taiwan. They had obesity or overweight plus at least one comorbidity but not diabetes. They were randomized to 5-mg, 10-mg, or 15-mg once-weekly tirzepatide or placebo injections for 18 months (72 weeks).

Efficacy was analyzed in two ways. Prior to factoring in drug discontinuation, participants taking tirzepatide experienced weight loss of 16.0% (35 lb/16 kg) with 5 mg, 21.4% (49 lb/22 kg) with 10 mg, and 22.5% (52 lb/24 kg) on 15 mg. In contrast, the placebo group lost just 2.4% of body weight (5 lb/2 kg).  

But treatment discontinuation rates because of adverse events were 4.3%, 7.1%, 6.2%, and 2.6%, for tirzepatide 5 mg, 10 mg, 15 mg, and placebo, respectively. Overall treatment discontinuation rates were 14.3%, 16.4%, 15.1%, and 26.4%, respectively.  

When efficacy was assessed regardless of treatment discontinuation, average body weight reductions were 15.0%, 19.5%, 20.9%, and 3.1% for tirzepatide 5 mg, 10 mg, 15 mg, and placebo, respectively.  

More than half of patients taking tirzepatide 10 mg and 15 mg (55% and 63%, respectively) lost at least 20% of their body weight, compared with just 1.3% taking placebo.

Overall safety and tolerability were similar to those of other GLP-1 agonists, with adverse events being gastrointestinal in nature and increasing with higher doses. Nausea affected 24.6%, 33.3%, and 31.0% of the tirzepatide 5-mg, 10-mg, and 15-mg dose groups, respectively, and vomiting was experienced by 8.3%, 10.7%, and 12.2% of patients, respectively. Diarrhea and constipation were also reported more often with the drug than placebo.

“Tirzepatide delivered impressive body weight reductions in SURMOUNT-1, which could represent an important step forward for helping the patient and physician partnership treat this complex disease,” said study investigator Louis J. Aronne, MD, director of the Comprehensive Weight Control Center and the Sanford I. Weill Professor of Metabolic Research at Weill Cornell Medicine, New York, in a press release.

Further studies are ongoing for tirzepatide as a potential treatment for obesity or overweight, according to the Lilly statement. SURMOUNT is a phase 3 global clinical development program for tirzepatide that began in late 2019 with over 5,000 people with obesity or overweight across six clinical trials. Results from SURMOUNT-2, SURMOUNT-3, and SURMOUNT-4 are expected in 2023.

Tirzepatide is also being studied as a potential treatment for nonalcoholic fatty liver disease and heart failure with preserved ejection fraction. Studies of tirzepatide in obstructive sleep apnea and of morbidity/mortality in obesity are also planned.

Dr. Aronne is cofounder, chief scientific advisor, and a member of the board of directors for Intellihealth. He is also a paid scientific advisory board member for Eli Lilly. Dr. Freedhoff has served or is serving as a director, officer, partner, employee, adviser, consultant, or trustee for the Bariatric Medical Institute and Constant Health and has received a research grant from Novo Nordisk.

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

Deaths from COVID-19 may have caught more attention lately, but heart disease remains the leading cause of death in the United States.

More than 300,000 Americans will die this year of sudden cardiac arrest (also called sudden cardiac death, or SCD), when the heart abruptly stops working.

These events happen suddenly and often without warning, making them nearly impossible to predict. But that may be changing, thanks to 3D imaging and artificial intelligence (AI) technology under study at Johns Hopkins University, Baltimore.

Svisio/Thinkstock

There, researchers are working to create more accurate and personalized models of the heart – and not just any heart, your heart, if you have heart disease.

“Right now, a clinician can only say whether a patient is at risk or not at risk for sudden death,” says Dan Popescu, PhD, a Johns Hopkins research scientist and first author of a new study on AI’s ability to predict sudden cardiac arrest. “With this new technology, you can have much more nuanced predictions of probability of an event over time.”

Put another way: With AI, clinicians may be able not only to predict if someone is at risk for sudden cardiac arrest, but also when it is most likely to happen. They can do this using a much clearer and more personalized look at the electrical “wiring” of your heart.
 

Your heart, the conductor

Your heart isn’t just a metronome responsible for keeping a steady stream of blood pumping to tissues with every beat. It’s also a conductor through which vital energy flows.

To make the heart beat, electrical impulses flow from the top to the bottom of the organ. Healthy heart cells relay this electricity seamlessly. But in a heart damaged by inflammation or a past heart attack, scar tissue will block the energy flow.

When an electrical impulse encounters a scarred area, the signal can become erratic, disrupting the set top-to-bottom path and causing irregular heartbeats (arrhythmias), which increase someone’s danger of sudden cardiac death.
 

Seeing the heart in 3D

Today’s tests offer some insights into the heart’s makeup. For example, MRI scans can reveal damaged areas. PET scans can show inflammation. And EKGs can record the heart’s electrical signals from beat to beat.

But all these technologies offer only a snapshot, showing heart health at a moment in time. They can’t predict the future. That’s why scientists at Johns Hopkins are going further to develop 3D digital replicas of a person’s heart, known as computational heart models.

Computational models are computer-simulated replicas that combine mathematics, physics, and computer science. These models have been around for a long time and are used in many fields, ranging from manufacturing to economics.

In heart medicine, these models are populated with digital “cells,” which imitate living cells and can be programmed with different electrical properties, depending on whether they are healthy or diseased.

“Currently available imaging and testing (MRIs, PETs, EKGs) give some representation of the scarring, but you cannot translate that to what is going to happen over time,” says Natalia Trayanova, PhD, of the Johns Hopkins department of biomedical engineering.

“With computational heart models, we create a dynamic digital image of the heart. We can then give the digital image an electrical stimulus and assess how the heart is able to respond. Then you can better predict what is going to happen.”

The computerized 3D models also mean better, more accurate treatment for heart conditions.

For example, a common treatment for a type of arrhythmia known as atrial fibrillation is ablation, or burning some heart tissue. Ablation stops the erratic electrical impulses causing the arrhythmia, but it can also damage otherwise healthy heart cells.

A personalized computational heart model could allow doctors to see more accurately what areas should and shouldn’t be treated for a specific patient.
 

Using deep learning AI to predict health outcomes

Dr. Trayanova’s colleague Dr. Popescu is applying deep learning and AI to do more with computerized heart models to predict the future.

In a recent paper in Nature Cardiovascular Research, the research team showed their algorithm assessed the health of 269 patients and was able to predict the chance of sudden cardiac arrest up to 10 years in advance.

“This is really the first time ever, as far as we know, where deep learning technology has been proven to analyze scarring of the heart in a successful way,” Dr. Popescu says.

Dr. Popescu and Dr. Trayanova say the AI algorithm gathers information from the 3D computational heart models with patient data like MRIs, ethnicity, age, lifestyle, and other clinical information. Analyzing all these data can produce accurate and consistent estimates about how long patients might live if they are at risk for sudden death.

“You can’t afford to be wrong. If you are wrong, you can actually impact a patient’s quality of life dramatically,” Dr. Popescu says. “Having clinicians use this technology in the decision-making process will provide confidence in a better diagnosis and prognosis.”

While the current study was specifically about patients with a particular type of heart disease, Dr. Popescu says his algorithm can also be trained to assess other health conditions.

So when might you see this being used outside of a research study? Dr. Trayanova predicts 3D imaging of heart models could be available in 2 years, but first the technique must be tested in more clinical trials – some of which are happening right now.

Adding AI to the heart models will require more studies and Food and Drug Administration approval, so the timeline is less clear. But perhaps the biggest hurdle is that after approval the technologies would need to be adopted and used by clinicians and caregivers.

“The much harder question to answer is, ‘When will doctors be perfectly comfortable with AI tools?’ And I don’t know the answer,” Dr. Popescu says. “How to use AI as an aid in the decision-making process is something that’s not currently taught.”

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

Deaths from COVID-19 may have caught more attention lately, but heart disease remains the leading cause of death in the United States.

More than 300,000 Americans will die this year of sudden cardiac arrest (also called sudden cardiac death, or SCD), when the heart abruptly stops working.

These events happen suddenly and often without warning, making them nearly impossible to predict. But that may be changing, thanks to 3D imaging and artificial intelligence (AI) technology under study at Johns Hopkins University, Baltimore.

Svisio/Thinkstock

There, researchers are working to create more accurate and personalized models of the heart – and not just any heart, your heart, if you have heart disease.

“Right now, a clinician can only say whether a patient is at risk or not at risk for sudden death,” says Dan Popescu, PhD, a Johns Hopkins research scientist and first author of a new study on AI’s ability to predict sudden cardiac arrest. “With this new technology, you can have much more nuanced predictions of probability of an event over time.”

Put another way: With AI, clinicians may be able not only to predict if someone is at risk for sudden cardiac arrest, but also when it is most likely to happen. They can do this using a much clearer and more personalized look at the electrical “wiring” of your heart.
 

Your heart, the conductor

Your heart isn’t just a metronome responsible for keeping a steady stream of blood pumping to tissues with every beat. It’s also a conductor through which vital energy flows.

To make the heart beat, electrical impulses flow from the top to the bottom of the organ. Healthy heart cells relay this electricity seamlessly. But in a heart damaged by inflammation or a past heart attack, scar tissue will block the energy flow.

When an electrical impulse encounters a scarred area, the signal can become erratic, disrupting the set top-to-bottom path and causing irregular heartbeats (arrhythmias), which increase someone’s danger of sudden cardiac death.
 

Seeing the heart in 3D

Today’s tests offer some insights into the heart’s makeup. For example, MRI scans can reveal damaged areas. PET scans can show inflammation. And EKGs can record the heart’s electrical signals from beat to beat.

But all these technologies offer only a snapshot, showing heart health at a moment in time. They can’t predict the future. That’s why scientists at Johns Hopkins are going further to develop 3D digital replicas of a person’s heart, known as computational heart models.

Computational models are computer-simulated replicas that combine mathematics, physics, and computer science. These models have been around for a long time and are used in many fields, ranging from manufacturing to economics.

In heart medicine, these models are populated with digital “cells,” which imitate living cells and can be programmed with different electrical properties, depending on whether they are healthy or diseased.

“Currently available imaging and testing (MRIs, PETs, EKGs) give some representation of the scarring, but you cannot translate that to what is going to happen over time,” says Natalia Trayanova, PhD, of the Johns Hopkins department of biomedical engineering.

“With computational heart models, we create a dynamic digital image of the heart. We can then give the digital image an electrical stimulus and assess how the heart is able to respond. Then you can better predict what is going to happen.”

The computerized 3D models also mean better, more accurate treatment for heart conditions.

For example, a common treatment for a type of arrhythmia known as atrial fibrillation is ablation, or burning some heart tissue. Ablation stops the erratic electrical impulses causing the arrhythmia, but it can also damage otherwise healthy heart cells.

A personalized computational heart model could allow doctors to see more accurately what areas should and shouldn’t be treated for a specific patient.
 

Using deep learning AI to predict health outcomes

Dr. Trayanova’s colleague Dr. Popescu is applying deep learning and AI to do more with computerized heart models to predict the future.

In a recent paper in Nature Cardiovascular Research, the research team showed their algorithm assessed the health of 269 patients and was able to predict the chance of sudden cardiac arrest up to 10 years in advance.

“This is really the first time ever, as far as we know, where deep learning technology has been proven to analyze scarring of the heart in a successful way,” Dr. Popescu says.

Dr. Popescu and Dr. Trayanova say the AI algorithm gathers information from the 3D computational heart models with patient data like MRIs, ethnicity, age, lifestyle, and other clinical information. Analyzing all these data can produce accurate and consistent estimates about how long patients might live if they are at risk for sudden death.

“You can’t afford to be wrong. If you are wrong, you can actually impact a patient’s quality of life dramatically,” Dr. Popescu says. “Having clinicians use this technology in the decision-making process will provide confidence in a better diagnosis and prognosis.”

While the current study was specifically about patients with a particular type of heart disease, Dr. Popescu says his algorithm can also be trained to assess other health conditions.

So when might you see this being used outside of a research study? Dr. Trayanova predicts 3D imaging of heart models could be available in 2 years, but first the technique must be tested in more clinical trials – some of which are happening right now.

Adding AI to the heart models will require more studies and Food and Drug Administration approval, so the timeline is less clear. But perhaps the biggest hurdle is that after approval the technologies would need to be adopted and used by clinicians and caregivers.

“The much harder question to answer is, ‘When will doctors be perfectly comfortable with AI tools?’ And I don’t know the answer,” Dr. Popescu says. “How to use AI as an aid in the decision-making process is something that’s not currently taught.”

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

Deaths from COVID-19 may have caught more attention lately, but heart disease remains the leading cause of death in the United States.

More than 300,000 Americans will die this year of sudden cardiac arrest (also called sudden cardiac death, or SCD), when the heart abruptly stops working.

These events happen suddenly and often without warning, making them nearly impossible to predict. But that may be changing, thanks to 3D imaging and artificial intelligence (AI) technology under study at Johns Hopkins University, Baltimore.

Svisio/Thinkstock

There, researchers are working to create more accurate and personalized models of the heart – and not just any heart, your heart, if you have heart disease.

“Right now, a clinician can only say whether a patient is at risk or not at risk for sudden death,” says Dan Popescu, PhD, a Johns Hopkins research scientist and first author of a new study on AI’s ability to predict sudden cardiac arrest. “With this new technology, you can have much more nuanced predictions of probability of an event over time.”

Put another way: With AI, clinicians may be able not only to predict if someone is at risk for sudden cardiac arrest, but also when it is most likely to happen. They can do this using a much clearer and more personalized look at the electrical “wiring” of your heart.
 

Your heart, the conductor

Your heart isn’t just a metronome responsible for keeping a steady stream of blood pumping to tissues with every beat. It’s also a conductor through which vital energy flows.

To make the heart beat, electrical impulses flow from the top to the bottom of the organ. Healthy heart cells relay this electricity seamlessly. But in a heart damaged by inflammation or a past heart attack, scar tissue will block the energy flow.

When an electrical impulse encounters a scarred area, the signal can become erratic, disrupting the set top-to-bottom path and causing irregular heartbeats (arrhythmias), which increase someone’s danger of sudden cardiac death.
 

Seeing the heart in 3D

Today’s tests offer some insights into the heart’s makeup. For example, MRI scans can reveal damaged areas. PET scans can show inflammation. And EKGs can record the heart’s electrical signals from beat to beat.

But all these technologies offer only a snapshot, showing heart health at a moment in time. They can’t predict the future. That’s why scientists at Johns Hopkins are going further to develop 3D digital replicas of a person’s heart, known as computational heart models.

Computational models are computer-simulated replicas that combine mathematics, physics, and computer science. These models have been around for a long time and are used in many fields, ranging from manufacturing to economics.

In heart medicine, these models are populated with digital “cells,” which imitate living cells and can be programmed with different electrical properties, depending on whether they are healthy or diseased.

“Currently available imaging and testing (MRIs, PETs, EKGs) give some representation of the scarring, but you cannot translate that to what is going to happen over time,” says Natalia Trayanova, PhD, of the Johns Hopkins department of biomedical engineering.

“With computational heart models, we create a dynamic digital image of the heart. We can then give the digital image an electrical stimulus and assess how the heart is able to respond. Then you can better predict what is going to happen.”

The computerized 3D models also mean better, more accurate treatment for heart conditions.

For example, a common treatment for a type of arrhythmia known as atrial fibrillation is ablation, or burning some heart tissue. Ablation stops the erratic electrical impulses causing the arrhythmia, but it can also damage otherwise healthy heart cells.

A personalized computational heart model could allow doctors to see more accurately what areas should and shouldn’t be treated for a specific patient.
 

Using deep learning AI to predict health outcomes

Dr. Trayanova’s colleague Dr. Popescu is applying deep learning and AI to do more with computerized heart models to predict the future.

In a recent paper in Nature Cardiovascular Research, the research team showed their algorithm assessed the health of 269 patients and was able to predict the chance of sudden cardiac arrest up to 10 years in advance.

“This is really the first time ever, as far as we know, where deep learning technology has been proven to analyze scarring of the heart in a successful way,” Dr. Popescu says.

Dr. Popescu and Dr. Trayanova say the AI algorithm gathers information from the 3D computational heart models with patient data like MRIs, ethnicity, age, lifestyle, and other clinical information. Analyzing all these data can produce accurate and consistent estimates about how long patients might live if they are at risk for sudden death.

“You can’t afford to be wrong. If you are wrong, you can actually impact a patient’s quality of life dramatically,” Dr. Popescu says. “Having clinicians use this technology in the decision-making process will provide confidence in a better diagnosis and prognosis.”

While the current study was specifically about patients with a particular type of heart disease, Dr. Popescu says his algorithm can also be trained to assess other health conditions.

So when might you see this being used outside of a research study? Dr. Trayanova predicts 3D imaging of heart models could be available in 2 years, but first the technique must be tested in more clinical trials – some of which are happening right now.

Adding AI to the heart models will require more studies and Food and Drug Administration approval, so the timeline is less clear. But perhaps the biggest hurdle is that after approval the technologies would need to be adopted and used by clinicians and caregivers.

“The much harder question to answer is, ‘When will doctors be perfectly comfortable with AI tools?’ And I don’t know the answer,” Dr. Popescu says. “How to use AI as an aid in the decision-making process is something that’s not currently taught.”

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

Pfizer is voluntarily recalling five lots of Accupril (quinapril HCI) due to unacceptable levels of a nitrosamine, N-nitroso-quinapril, a potential carcinogen, the company announced.

The Accupril recall comes one month after Pfizer recalled six lots of Accuretic (Quinapril HCI/hydrochlorathiazide) tablets for the same problem.

Accupril is indicated for the treatment of hypertension and management of heart failure when added to conventional therapy, including diuretics and/or digitalis.

To date, Pfizer is not aware of any reports of adverse events related to the Accupril recall, and the company believes the benefit/risk profile remains positive based on currently available data.

“Although long-term ingestion of N-nitroso-quinapril may be associated with a potential increased cancer risk in humans, there is no immediate risk to patients taking this medication,” the company said April 22 in a news release.

Patients currently taking the recalled products are asked to consult with their doctor about alternative treatment options.

The recalled Accupril tablets were sold in 90-count bottles distributed nationwide to wholesalers and distributors in the United States and Puerto Rico from December 2019 to April 2022. 

National drug codes (NDC), lot numbers, and expiration dates are listed in the company announcement posted on the Food and Drug Administration’s website.

Patients who are taking this product should consult with their health care provider or pharmacy to determine if they have the affected product. Those with the affected tablets should contact claims management firm Sedgwick by phone at 888-345-0481 Monday through Friday from 8 AM to 5 PM ET for instructions on how to return the product and obtain reimbursement.

Healthcare providers with questions regarding the recall can contact Pfizer by telephone at 800-438-1985, option 3, Monday through Friday from 8 AM to 9 PM ET.

Adverse reactions or quality problems related to this recall should be reported to the FDA’s MedWatch program.

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

Pfizer is voluntarily recalling five lots of Accupril (quinapril HCI) due to unacceptable levels of a nitrosamine, N-nitroso-quinapril, a potential carcinogen, the company announced.

The Accupril recall comes one month after Pfizer recalled six lots of Accuretic (Quinapril HCI/hydrochlorathiazide) tablets for the same problem.

Accupril is indicated for the treatment of hypertension and management of heart failure when added to conventional therapy, including diuretics and/or digitalis.

To date, Pfizer is not aware of any reports of adverse events related to the Accupril recall, and the company believes the benefit/risk profile remains positive based on currently available data.

“Although long-term ingestion of N-nitroso-quinapril may be associated with a potential increased cancer risk in humans, there is no immediate risk to patients taking this medication,” the company said April 22 in a news release.

Patients currently taking the recalled products are asked to consult with their doctor about alternative treatment options.

The recalled Accupril tablets were sold in 90-count bottles distributed nationwide to wholesalers and distributors in the United States and Puerto Rico from December 2019 to April 2022. 

National drug codes (NDC), lot numbers, and expiration dates are listed in the company announcement posted on the Food and Drug Administration’s website.

Patients who are taking this product should consult with their health care provider or pharmacy to determine if they have the affected product. Those with the affected tablets should contact claims management firm Sedgwick by phone at 888-345-0481 Monday through Friday from 8 AM to 5 PM ET for instructions on how to return the product and obtain reimbursement.

Healthcare providers with questions regarding the recall can contact Pfizer by telephone at 800-438-1985, option 3, Monday through Friday from 8 AM to 9 PM ET.

Adverse reactions or quality problems related to this recall should be reported to the FDA’s MedWatch program.

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

Pfizer is voluntarily recalling five lots of Accupril (quinapril HCI) due to unacceptable levels of a nitrosamine, N-nitroso-quinapril, a potential carcinogen, the company announced.

The Accupril recall comes one month after Pfizer recalled six lots of Accuretic (Quinapril HCI/hydrochlorathiazide) tablets for the same problem.

Accupril is indicated for the treatment of hypertension and management of heart failure when added to conventional therapy, including diuretics and/or digitalis.

To date, Pfizer is not aware of any reports of adverse events related to the Accupril recall, and the company believes the benefit/risk profile remains positive based on currently available data.

“Although long-term ingestion of N-nitroso-quinapril may be associated with a potential increased cancer risk in humans, there is no immediate risk to patients taking this medication,” the company said April 22 in a news release.

Patients currently taking the recalled products are asked to consult with their doctor about alternative treatment options.

The recalled Accupril tablets were sold in 90-count bottles distributed nationwide to wholesalers and distributors in the United States and Puerto Rico from December 2019 to April 2022. 

National drug codes (NDC), lot numbers, and expiration dates are listed in the company announcement posted on the Food and Drug Administration’s website.

Patients who are taking this product should consult with their health care provider or pharmacy to determine if they have the affected product. Those with the affected tablets should contact claims management firm Sedgwick by phone at 888-345-0481 Monday through Friday from 8 AM to 5 PM ET for instructions on how to return the product and obtain reimbursement.

Healthcare providers with questions regarding the recall can contact Pfizer by telephone at 800-438-1985, option 3, Monday through Friday from 8 AM to 9 PM ET.

Adverse reactions or quality problems related to this recall should be reported to the FDA’s MedWatch program.

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

Using the 2021 Kidney Disease: Improving Global Outcomes (KDIGO) guideline target of systolic blood pressure (BP) < 120 mm Hg, 66% of adults with chronic kidney disease (CKD) would be eligible for BP lowering, according to a study from Korea.

This represents an added > 10% of patients compared with two earlier guidelines, and these patients have a high risk of cardiovascular disease (CVD), Hyeok-Hee Lee, MD, Yonsei University College of Medicine, Seoul, South Korea, and colleagues reported.

London_England/Thinkstock

The study was published online  in the Journal of the American College of Cardiology.

“New candidates for BP-lowering treatment per the 2021 KDIGO guideline account for a substantial proportion of the total CKD population and bear significantly high CVD risk,” the researchers concluded.

“Undoubtedly, a multipronged approach will be required to address the swelling number of people needing more intense treatment, especially against a background of falling rates of BP control in the general community,” Alexander G. Logan, MD, of Mount Sinai Hospital, Toronto, and the University of Toronto, wrote in an accompanying editorial.

“Let’s not forget hypertension is the number one killer today,” Valentin Fuster, MD, of Icahn School of Medicine at Mount Sinai, New York, who is editor-in-chief of the Journal of the American College of Cardiology, stressed in a podcast that accompanied the article.

“Only 50% of individuals know of their blood pressure, and from this, less than half are properly treated,” he said.

“Today the details of knowing blood pressure levels appear to dominate over the huge ignorance of not knowing about blood pressure at all. Let’s think more and more about this reality,” he urged.
 

Three guidelines, two study objectives

The researchers compared three guidelines:

• The 2021 KDIGO guidelines, with a target systolic BP of < 120 mm Hg (largely based on the SPRINT trial).
• The 2012 KDIGO guidelines, with a target BP of ≤ 130/80 mm Hg for patients with albuminuria and ≤ 140/90 mm Hg for patients without albuminuria.
• The 2017 American College of Cardiology/American Heart Association (ACC/AHA) BP guideline target of < 130/80 mm Hg.

The study had two objectives:

• To examine the proportions of concordance and discordance between the three guidelines among adults with CKD based on cross-sectional data from the Korea National Health and Nutrition Examination Survey (KNHANES).
• To evaluate the association of each concordance/discordance group with cardiovascular outcomes of patients in the Korean National Health Insurance Service (NHIS) database.

For the first objective, the researchers identified 1,939 adults with CKD from the 2011-2014 survey cycles of KNHANES. Patients were a median age of 59 and 51% were men.

Comparison of the KDIGO 2021 versus 2012 BP targets showed that 50% of patients had BP above both targets; 16% had BP above the KDIGO 2021 target only; 4% had BP above the KDIGO 2012 target only; and 30% had BP control within both targets.

Comparison of the KDIGO 2021 versus 2017 ACC/AHA BP targets showed that 55% of patients had BP above both targets; 11% had BP above the KDIGO 2021 target only; 5% had BP above the 2017 ACC/AHA target only; and 29% had BP control within both targets.

For the second objective, using the NHIS database, researchers identified 412,167 adults with CKD who had routine health examinations during 2009 and 2010. The patients were a median age of 65 and 44% were men.

During a median follow-up of 10 years, the patients had 37,912 incident CVD events, defined as the first hospitalization for myocardial infarction, stroke, or heart failure, or death from CVD.

The adjusted risk of a composite CVD event was higher in patients with BP above the 2021 KDIGO target only (HR, 1.28) or above both the 2012 and 2021 KDIGO targets (HR, 1.52), compared to patients who had BP within both targets.

The adjusted risk of a composite CVD event was also higher in patients with BP above the 2021 KDIGO target only (HR, 1.18) or above both the 2021 KDIGO target and the 2017 ACC/AHA target (HR, 1.41), compared with patients who had BP within both targets.
 

Editorialist highlights three study aspects

Dr. Fuster noted three main points made by Dr. Logan.

First, the KDIGO 2021 guideline is based on office blood pressure, measured according to the procedure used in the 2017 ACC/AHA guideline. However, the SPRINT ambulatory BP ancillary study found that daytime ambulatory systolic BP was 6.8 mm Hg higher in the < 120 mm Hg group than clinic systolic BP that was measured with an automated BP device, mostly without study personnel.

Second, Dr. Logan noted that “not surprisingly, the investigators showed that the weighted proportion of adults with CKD eligible for BP lowering was highest (66.1%) according to 2021 KDIGO guideline,” compared with the two earlier guidelines.

The findings by Dr. Lee and colleagues align with those of a study that used data from the 2015-2018 U.S. NHANES to estimate the proportion of U.S. adults with CKD eligible for BP lowering according to the 2021 KDIGO guidelines, Dr. Logan added. The study found that 69% of U.S. adults (roughly 24.5 million) should correct their BP.

Third, the study in Korea showed a small percentage of patients (3%-5% of the total) had elevated diastolic BP but controlled systolic BP (< 120 mm Hg) with no increased risk of CVD compared to a reference group of patients with well-controlled BP.

“There is a paucity of evidence examining the relationship between diastolic hypertension and outcomes independently from systolic BP level in CKD patients,” Dr. Logan wrote. Similarly, Dr. Lee and colleagues identified this as an area for further research.

This work was supported by the Korea Health Technology R&D Project through the Korea Health Industry Development Institute funded by the Ministry of Health and Welfare, Republic of Korea. The authors and editorialist have reported no relevant financial relationships.

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

Using the 2021 Kidney Disease: Improving Global Outcomes (KDIGO) guideline target of systolic blood pressure (BP) < 120 mm Hg, 66% of adults with chronic kidney disease (CKD) would be eligible for BP lowering, according to a study from Korea.

This represents an added > 10% of patients compared with two earlier guidelines, and these patients have a high risk of cardiovascular disease (CVD), Hyeok-Hee Lee, MD, Yonsei University College of Medicine, Seoul, South Korea, and colleagues reported.

London_England/Thinkstock

The study was published online  in the Journal of the American College of Cardiology.

“New candidates for BP-lowering treatment per the 2021 KDIGO guideline account for a substantial proportion of the total CKD population and bear significantly high CVD risk,” the researchers concluded.

“Undoubtedly, a multipronged approach will be required to address the swelling number of people needing more intense treatment, especially against a background of falling rates of BP control in the general community,” Alexander G. Logan, MD, of Mount Sinai Hospital, Toronto, and the University of Toronto, wrote in an accompanying editorial.

“Let’s not forget hypertension is the number one killer today,” Valentin Fuster, MD, of Icahn School of Medicine at Mount Sinai, New York, who is editor-in-chief of the Journal of the American College of Cardiology, stressed in a podcast that accompanied the article.

“Only 50% of individuals know of their blood pressure, and from this, less than half are properly treated,” he said.

“Today the details of knowing blood pressure levels appear to dominate over the huge ignorance of not knowing about blood pressure at all. Let’s think more and more about this reality,” he urged.
 

Three guidelines, two study objectives

The researchers compared three guidelines:

• The 2021 KDIGO guidelines, with a target systolic BP of < 120 mm Hg (largely based on the SPRINT trial).
• The 2012 KDIGO guidelines, with a target BP of ≤ 130/80 mm Hg for patients with albuminuria and ≤ 140/90 mm Hg for patients without albuminuria.
• The 2017 American College of Cardiology/American Heart Association (ACC/AHA) BP guideline target of < 130/80 mm Hg.

The study had two objectives:

• To examine the proportions of concordance and discordance between the three guidelines among adults with CKD based on cross-sectional data from the Korea National Health and Nutrition Examination Survey (KNHANES).
• To evaluate the association of each concordance/discordance group with cardiovascular outcomes of patients in the Korean National Health Insurance Service (NHIS) database.

For the first objective, the researchers identified 1,939 adults with CKD from the 2011-2014 survey cycles of KNHANES. Patients were a median age of 59 and 51% were men.

Comparison of the KDIGO 2021 versus 2012 BP targets showed that 50% of patients had BP above both targets; 16% had BP above the KDIGO 2021 target only; 4% had BP above the KDIGO 2012 target only; and 30% had BP control within both targets.

Comparison of the KDIGO 2021 versus 2017 ACC/AHA BP targets showed that 55% of patients had BP above both targets; 11% had BP above the KDIGO 2021 target only; 5% had BP above the 2017 ACC/AHA target only; and 29% had BP control within both targets.

For the second objective, using the NHIS database, researchers identified 412,167 adults with CKD who had routine health examinations during 2009 and 2010. The patients were a median age of 65 and 44% were men.

During a median follow-up of 10 years, the patients had 37,912 incident CVD events, defined as the first hospitalization for myocardial infarction, stroke, or heart failure, or death from CVD.

The adjusted risk of a composite CVD event was higher in patients with BP above the 2021 KDIGO target only (HR, 1.28) or above both the 2012 and 2021 KDIGO targets (HR, 1.52), compared to patients who had BP within both targets.

The adjusted risk of a composite CVD event was also higher in patients with BP above the 2021 KDIGO target only (HR, 1.18) or above both the 2021 KDIGO target and the 2017 ACC/AHA target (HR, 1.41), compared with patients who had BP within both targets.
 

Editorialist highlights three study aspects

Dr. Fuster noted three main points made by Dr. Logan.

First, the KDIGO 2021 guideline is based on office blood pressure, measured according to the procedure used in the 2017 ACC/AHA guideline. However, the SPRINT ambulatory BP ancillary study found that daytime ambulatory systolic BP was 6.8 mm Hg higher in the < 120 mm Hg group than clinic systolic BP that was measured with an automated BP device, mostly without study personnel.

Second, Dr. Logan noted that “not surprisingly, the investigators showed that the weighted proportion of adults with CKD eligible for BP lowering was highest (66.1%) according to 2021 KDIGO guideline,” compared with the two earlier guidelines.

The findings by Dr. Lee and colleagues align with those of a study that used data from the 2015-2018 U.S. NHANES to estimate the proportion of U.S. adults with CKD eligible for BP lowering according to the 2021 KDIGO guidelines, Dr. Logan added. The study found that 69% of U.S. adults (roughly 24.5 million) should correct their BP.

Third, the study in Korea showed a small percentage of patients (3%-5% of the total) had elevated diastolic BP but controlled systolic BP (< 120 mm Hg) with no increased risk of CVD compared to a reference group of patients with well-controlled BP.

“There is a paucity of evidence examining the relationship between diastolic hypertension and outcomes independently from systolic BP level in CKD patients,” Dr. Logan wrote. Similarly, Dr. Lee and colleagues identified this as an area for further research.

This work was supported by the Korea Health Technology R&D Project through the Korea Health Industry Development Institute funded by the Ministry of Health and Welfare, Republic of Korea. The authors and editorialist have reported no relevant financial relationships.

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

Using the 2021 Kidney Disease: Improving Global Outcomes (KDIGO) guideline target of systolic blood pressure (BP) < 120 mm Hg, 66% of adults with chronic kidney disease (CKD) would be eligible for BP lowering, according to a study from Korea.

This represents an added > 10% of patients compared with two earlier guidelines, and these patients have a high risk of cardiovascular disease (CVD), Hyeok-Hee Lee, MD, Yonsei University College of Medicine, Seoul, South Korea, and colleagues reported.

London_England/Thinkstock

The study was published online  in the Journal of the American College of Cardiology.

“New candidates for BP-lowering treatment per the 2021 KDIGO guideline account for a substantial proportion of the total CKD population and bear significantly high CVD risk,” the researchers concluded.

“Undoubtedly, a multipronged approach will be required to address the swelling number of people needing more intense treatment, especially against a background of falling rates of BP control in the general community,” Alexander G. Logan, MD, of Mount Sinai Hospital, Toronto, and the University of Toronto, wrote in an accompanying editorial.

“Let’s not forget hypertension is the number one killer today,” Valentin Fuster, MD, of Icahn School of Medicine at Mount Sinai, New York, who is editor-in-chief of the Journal of the American College of Cardiology, stressed in a podcast that accompanied the article.

“Only 50% of individuals know of their blood pressure, and from this, less than half are properly treated,” he said.

“Today the details of knowing blood pressure levels appear to dominate over the huge ignorance of not knowing about blood pressure at all. Let’s think more and more about this reality,” he urged.
 

Three guidelines, two study objectives

The researchers compared three guidelines:

• The 2021 KDIGO guidelines, with a target systolic BP of < 120 mm Hg (largely based on the SPRINT trial).
• The 2012 KDIGO guidelines, with a target BP of ≤ 130/80 mm Hg for patients with albuminuria and ≤ 140/90 mm Hg for patients without albuminuria.
• The 2017 American College of Cardiology/American Heart Association (ACC/AHA) BP guideline target of < 130/80 mm Hg.

The study had two objectives:

• To examine the proportions of concordance and discordance between the three guidelines among adults with CKD based on cross-sectional data from the Korea National Health and Nutrition Examination Survey (KNHANES).
• To evaluate the association of each concordance/discordance group with cardiovascular outcomes of patients in the Korean National Health Insurance Service (NHIS) database.

For the first objective, the researchers identified 1,939 adults with CKD from the 2011-2014 survey cycles of KNHANES. Patients were a median age of 59 and 51% were men.

Comparison of the KDIGO 2021 versus 2012 BP targets showed that 50% of patients had BP above both targets; 16% had BP above the KDIGO 2021 target only; 4% had BP above the KDIGO 2012 target only; and 30% had BP control within both targets.

Comparison of the KDIGO 2021 versus 2017 ACC/AHA BP targets showed that 55% of patients had BP above both targets; 11% had BP above the KDIGO 2021 target only; 5% had BP above the 2017 ACC/AHA target only; and 29% had BP control within both targets.

For the second objective, using the NHIS database, researchers identified 412,167 adults with CKD who had routine health examinations during 2009 and 2010. The patients were a median age of 65 and 44% were men.

During a median follow-up of 10 years, the patients had 37,912 incident CVD events, defined as the first hospitalization for myocardial infarction, stroke, or heart failure, or death from CVD.

The adjusted risk of a composite CVD event was higher in patients with BP above the 2021 KDIGO target only (HR, 1.28) or above both the 2012 and 2021 KDIGO targets (HR, 1.52), compared to patients who had BP within both targets.

The adjusted risk of a composite CVD event was also higher in patients with BP above the 2021 KDIGO target only (HR, 1.18) or above both the 2021 KDIGO target and the 2017 ACC/AHA target (HR, 1.41), compared with patients who had BP within both targets.
 

Editorialist highlights three study aspects

Dr. Fuster noted three main points made by Dr. Logan.

First, the KDIGO 2021 guideline is based on office blood pressure, measured according to the procedure used in the 2017 ACC/AHA guideline. However, the SPRINT ambulatory BP ancillary study found that daytime ambulatory systolic BP was 6.8 mm Hg higher in the < 120 mm Hg group than clinic systolic BP that was measured with an automated BP device, mostly without study personnel.

Second, Dr. Logan noted that “not surprisingly, the investigators showed that the weighted proportion of adults with CKD eligible for BP lowering was highest (66.1%) according to 2021 KDIGO guideline,” compared with the two earlier guidelines.

The findings by Dr. Lee and colleagues align with those of a study that used data from the 2015-2018 U.S. NHANES to estimate the proportion of U.S. adults with CKD eligible for BP lowering according to the 2021 KDIGO guidelines, Dr. Logan added. The study found that 69% of U.S. adults (roughly 24.5 million) should correct their BP.

Third, the study in Korea showed a small percentage of patients (3%-5% of the total) had elevated diastolic BP but controlled systolic BP (< 120 mm Hg) with no increased risk of CVD compared to a reference group of patients with well-controlled BP.

“There is a paucity of evidence examining the relationship between diastolic hypertension and outcomes independently from systolic BP level in CKD patients,” Dr. Logan wrote. Similarly, Dr. Lee and colleagues identified this as an area for further research.

This work was supported by the Korea Health Technology R&D Project through the Korea Health Industry Development Institute funded by the Ministry of Health and Welfare, Republic of Korea. The authors and editorialist have reported no relevant financial relationships.

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