NEW YORK CITY — Ravi Ramana presented new clinical data on the use of JenaValve's Trilogy Transcatheter Aortic Valve Replacement (TAVR) device in patients with left ventricular assist device (LVAD)-associated aortic regurgitation at the New York Valves annual meeting in New York City.

The JENA-VAD NOW Registry, a retrospective study at 12 U.S. sites, analyzed 28 patients who underwent urgent, emergent, or compassionate-use TAVR with the Trilogy device. The procedural success rate for this cohort was 93%. Two cases involved emergent valve-in-valve procedures, one due to migration and one due to paravalvular leak. No major vascular complications, emergency cardiac surgery, new acute kidney injury, new pacemaker implantation, or stroke occurred.

By 30 days, one death was recorded, attributed to failure to wean from extracorporeal membrane oxygenation. At the same mark, 96.4% of the cohort were free from inotropes and mechanical circulatory support. The 1-year mortality rate for the overall group was 7.3%.

Ramana stated, "Despite significant hemo-metabolic derangement, many patients can clinically improve if or when LVAD-AR is successfully treated." He also noted, "Of note, right ventricular dysfunction remains common and is difficult to manage in the setting of significant AR." Ramana acknowledged limitations in the analysis, including patient selection, inherent selection bias due to the retrospective nature of the study, the small sample size, and the concentration of cases at experienced centers.

Mahesh Madhavan stated that the TAVR operators involved were "extremely experienced," suggesting their good outcomes might not be widely generalizable. He added, "Importantly, it's also going to be very critical to understand the rates of valve thrombosis in this setting, where the hemodynamics around the aortic valve are very different from a patient without an LVAD." The study's patient population had a median age of 67 years, and 39% were women.