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Interatrial shunts may benefit some heart failure patients but may harm others
Mount Sinai-led study identifies types of heart failure in which devices may be most useful

(Atlanta, Georgia – April 6, 2024) – Interatrial shunts (test devices that create a small pathway for blood to flow from the left side of the heart to the right side of the heart to improve heart failure symptoms and outcomes) may be beneficial for heart failure patients with reduced left ventricular ejection fraction (LVEF) exists, but it can be harmful or even fatal for heart failure patients with preserved LVEF, a new Mount Sinai-led study shows.

Results from the RELIEVE-HF trial were presented on Saturday, April 6, during the opening late testing session of the American College of Cardiology’s Scientific Sessions. This is the first study to analyze the impact of interatrial shunts in patients with both interatrial shunts. They were the first to show different results between the two groups, with a reduction and maintenance of LVEF.

“Although further studies are needed to confirm our observations, our results strongly suggest that heart failure patients with reduced LVEF may benefit from these devices.” said Dr. Greg W. Stone, one of RELIEVE-HF’s principal investigators, and the outcome of the trial.

“Additionally, this study serves as a warning to cardiologists: interatrial shunt treatment in heart failure patients with preserved LVEF may increase hospitalization for heart failure and even mortality. “This is especially true in regions such as Europe, where a number of interatrial shunt devices have already been approved for general use, based on early, small-scale studies,” said Mt. added Dr. Stone, MD, Sinai Health System’s academic director. He majored in medicine (cardiology) and population health sciences and policy at the Icahn School of Medicine at Mount Sinai.

Interatrial shunts are small (5 to 10 millimeters in diameter) permanent devices that are placed in the heart through a minimally invasive catheter-based procedure to connect the left and right atria. The shunt allows blood to flow from left to right, reducing high pressure in the left atrium that can cause shortness of breath and hospitalization for heart failure.

About half of people with heart failure maintain LVEF, which means the left ventricle pumps at least 50 percent of its normal blood volume. In these patients, the left ventricle of the heart is too stiff to fill properly with blood. Another type of heart failure, low LVEF, causes the heart’s left ventricle to pump blood below normal levels, causing her ejection fraction to be below 40%. Patients with an LVEF of 40-50% were previously considered to have preserved ejection fraction, but now they are often classified as having a “mildly reduced” LVEF. I am.

In the trial, researchers randomly assigned 508 patients with symptomatic heart failure at 101 sites in 11 countries between October 2018 and October 2022. Within the study group, 205 patients had decreased LVEF (below 40 percent) and 303 patients had maintained LVEF (greater than 40 percent). . About half of the patients in each group received a Ventura interatrial shunt (manufactured by V-Wave Medical), and the other half received a placebo treatment that was unknown to patients, families, and health care providers. Patients were studied for up to 2 years after treatment, with a median follow-up of 22 months.

The researchers identified device-related or procedure-related adverse cardiac events (all-cause death, stroke, systemic embolism, need for open-heart surgery, or need for major endovascular surgical repair) during the 30-day period. The safety of the procedure was analyzed, defined as the incidence of. LVEF group reduced and preserved. Hospitalization due to heart failure. Worsening of heart failure symptoms or events at home. and improved quality of life. The effectiveness of this procedure is determined by factors, from most to least important, including all-cause mortality, heart transplantation or left ventricular assist device implantation, hospitalization for heart failure, and worsening of heart failure symptoms requiring medical attention. It was evaluated. Change in quality of life from baseline outside the hospital setting as measured by the Kansas City Cardiomyopathy Questionnaire. Overall summary score with up to 2 years of follow-up. The last enrolled patient will be evaluated upon reaching 1 year of follow-up after randomization. .

Throughout the study, there were no device- or procedure-related safety adverse events within 30 days or 2 years, demonstrating the safety of the interatrial shunt. Analysis of all patient outcomes showed no overall improvement in primary efficacy endpoints, including changes in prognosis or quality of life. However, outcomes depended on whether patients’ LVEF decreased or was maintained. Among patients with reduced LVEF, 49% had annual adverse cardiovascular events after shunt treatment, compared with 88.6% in patients treated with placebo, a 45% reduction is statistically very strong. Ta. Significant (P<0.0001). In contrast, among patients with preserved LVEF, 60.2% of patients experienced an adverse cardiovascular event per year after shunt treatment compared with 35.9% in the placebo group, a 68% increase ( P=0.0001).

More specifically, the cardiovascular benefits of shunting in patients with reduced LVEF were driven by a 48% reduction in heart failure hospitalizations. Worsening cardiovascular outcomes in LVEF-preserved patients was associated with a 224% increase in all-cause mortality and a 105% increase in heart failure hospitalizations in shunt patients.

“When we started this study, we didn’t know whether outcomes would be similar for patients with reduced LVEF and those with preserved LVEF. We were surprised by the differences,” says Dr. Stone. “Heart failure patients with an LVEF of 40% or less have a poor prognosis and often cannot tolerate drug therapy. Interatrial shunt treatment has the potential to significantly improve their lives. These results support our findings. Conversely, our results justify the use of interatrial shunts in patients with heart failure with LVEF greater than 40 percent. It raises questions about safety.”

The RELIEVE-HF study was funded by V-Wave Ltd., Caesarea, Israel.

Mount Sinai is a world leader in cardiology and heart surgery

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It is part of the Mount Sinai Health System, New York City’s largest academic health system, encompassing eight hospitals, a leading medical school, and an expansive network of outpatient services throughout the greater New York region. We advance medicine and health through unparalleled education and translational research and discovery, providing the safest, highest quality, most accessible and fair, and best value care of any health system in the nation. We provide The health system includes approximately 7,400 primary and specialty care physicians. 13 joint venture ambulatory surgery centers in his five boroughs: New York City, Westchester, Long Island and Florida. More than 30 community health centers are affiliated. Hospitals within the system are consistently ranked. newsweek‘s® “World’s Best Smart Hospital” and US News & World Report‘s® “Best Hospital” and “Best Children’s Hospital.”mount sinai hospital US News & World Report‘s® 2023-2024 “Best Hospitals” Honor Roll.

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