NEW YORK CITY — Ravi Ramana, DO, of Heart Care Centers of Illinois in Palos Park, presented findings from the JENA-VAD NOW Registry at the New York Valves annual meeting hosted by the Cardiovascular Research Foundation in New York City. The presentation detailed the use of a transcatheter aortic valve replacement (TAVR) system for patients with left ventricular assist device (LVAD)-associated aortic regurgitation (AR).

The registry included 28 patients with LVAD-associated AR across a dozen U.S. sites. These patients had clinically significant LVAD-associated AR and underwent urgent, emergent, or compassionate-use TAVR with the Trilogy device. The procedural success rate was 93%, with two cases of emergent valve-in-valve procedures due to migration and paravalvular leak. The cases were split between emergency-use TAVR, accounting for 57% of cases, and compassionate-use TAVR, which made up 43%.

No major vascular complications, emergency cardiac surgery, new acute kidney injury, new pacemaker implantation, or stroke occurred during the study. By 30 days, one death was recorded due to failure to wean from extracorporeal membrane oxygenation (ECMO), and 96.4% of the cohort were free from inotropes and mechanical circulatory support. The 1-year mortality rate was 7.3%, with 8.3% in the compassionate-use group and 6.2% in the emergency-use group.

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." The JenaValve Trilogy device, which attaches directly to native aortic leaflets without relying on annular calcification for anchoring, met safety and efficacy endpoints for patients with symptomatic severe native AR at high risk for surgery in the ALIGN-AR study.

Mahesh Madhavan, MD, of NewYork-Presbyterian/Columbia University Irving Medical Center, served as a session discussant. Madhavan indicated that it would be "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." He added, "However, that being said, as mentioned, this is obviously a challenging patient population."

LVAD-associated AR occurs in 10% to 30% of cases within one year of an LVAD implant. This condition involves reduced aortic valve opening and prolonged valve closure, leading to leaflet stasis, commissural fusion, and cusp remodeling. The registry had a median patient age of 67, with 39% women. Most patients, 89%, had a HeartMate 3 LVAD, while 7% had a HeartMate II, and 4% had a HeartWare device. Additionally, 43% of patients presented with right ventricular dysfunction, 29% were on pre-procedure inotropes, and 7% were on veno-arterial ECMO.

The median time from LVAD implant to TAVR was just under 3 years, with a median follow-up period of 1.26 years. Ramana acknowledged limitations in the analysis including patient selection bias, the small sample size, and cases mainly limited to one LVAD device with experienced operators. The prospective JENA-VAD IDE study, planned for 50 participants with LVADs and significant AR, is expected to report results in the fall.