TUESDAY, April 9, 2024 (HealthDay News) – For patients with heart failure, transcatheter placement of a Ventura interarterial shunt does not improve the primary end point, according to a study presented at the annual meeting of the American College of Cardiology, held from April 6 to 8 in Atlanta.
Gregg W. Stone, M.D., from the Icahn School of Medicine at Mount Sinai in New York City, and colleagues randomly assigned heart failure patients with any left ventricular ejection fraction (LVEF) who remained symptomatic despite maximally tolerated class I treatments to transcatheter placement of the Ventura shunt or a placebo procedure. A total of 508 patients from 101 sites were randomly assigned between Oct. 24, 2018, and Oct. 19, 2022. Of the patients, 40.4 and 59.6 percent had heart failure with reduced ejection fraction (HFrEF; LVEF <40 percent) and heart failure with preserved ejection fraction (HFpEF), respectively.
The researchers observed no significant difference between the groups in terms of the primary end point (hierarchical composite ranking of death from any cause; heart transplant or left ventricular assist device; heart failure hospitalizations; worsening of outpatient heart failure events; and change in quality of life). In a subgroup analysis, patients with HFrEF who received the shunt had improvements across all outcomes assessed, while those with HFpEF who received the shunt had increased rates of death and heart failure hospitalizations. During the trial, neither group had device-related or procedure-related major adverse cardiovascular or neurologic events. All groups had a marked improvement in quality of life.
"When you examine the outcomes in patients with heart failure across a broad range of left ventricular ejection fraction, the Ventura interatrial shunt was extremely safe but did not improve outcomes compared with no treatment," Stone said in a statement. "However, in a prespecified analysis, data suggest that the shunt may be beneficial in patients with HFrEF and worsen outcomes in patients with HFpEF."
The study was funded by V-Wave Medical.
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