NEW YORK CITY — The U.S. Food and Drug Administration approved the JenaValve device this year for the treatment of symptomatic severe aortic regurgitation (AR). This approval follows evidence from studies that included its use with left ventricular assist device (LVAD)-associated AR.

A retrospective study examined the use of the Trilogy transcatheter aortic valve replacement (TAVR) system for patients with LVAD-associated AR. The study, known as the JENA-VAD NOW Registry, included 28 patients from 12 U.S. sites who underwent urgent-, emergent-, or compassionate-use TAVR with the Trilogy device. The median age of these patients was 67 years, with 39% being women. Most patients, 89%, had a HeartMate 3 LVAD; 7% had a HeartMate II LVAD, and 4% had a HeartWare LVAD. The median time from LVAD implant to TAVR was just under three years, and the median follow-up period was 1.26 years.

The procedural success rate in the study was 93%. Two cases required emergent valve-in-valve procedures: one due to migration and another due to a paravalvular leak. No major vascular complications, emergency cardiac surgery, new acute kidney injury, new pacemaker implants, or strokes occurred during the procedure. By 30 days, one death occurred due to failure to wean from extracorporeal membrane oxygenation (ECMO). Additionally, 96.4% of the cohort were free from inotropes and mechanical circulatory support by 30 days. The one-year mortality rate was 7.3%, with 8.3% for compassionate use cases and 6.2% for emergency use cases.

Ravi Ramana, a physician, stated, "Despite significant hemo-metabolic derangement, many patients can clinically improve if or when LVAD-AR is successfully treated." Ramana also said, "Of note, right ventricular dysfunction remains common and is difficult to manage in the setting of significant AR." In the study, 43% of patients presented with right ventricular dysfunction. Prior to the procedure, 29% of patients were on inotropes, and 7% were on veno-arterial ECMO.

Mahesh Madhavan, a physician, noted, "The TAVR operators involved have been extremely experienced and their good outcomes are not necessarily widely generalizable." Madhavan 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 JENA-VAD IDE study, a prospective trial involving 50 participants with LVADs and AR, is planned, with results expected in the fall.

Why It Matters

The FDA's approval of the JenaValve device this year for symptomatic severe AR provides a treatment option based on clinical studies, including those for LVAD-associated AR. LVAD-associated AR affects 10% to 30% of patients within one year of LVAD implant, resulting from reduced aortic valve opening and prolonged closure, which leads to leaflet changes. Previous off-label TAVR applications with other devices for this condition had a higher rate of requiring a second valve due to migration or paravalvular leak. The JenaValve device is designed to attach directly to the native aortic leaflets without relying on annular calcification for anchoring. However, the retrospective study that informed this use had limitations, including a small sample size, patient selection bias, and involvement of highly experienced operators, meaning its results may not be generalizable to all clinical settings.