NEW YORK CITY — A transcatheter aortic valve replacement (TAVR) system could work as a last resort for patients with left ventricular assist device (LVAD)-associated aortic regurgitation (AR), according to a retrospective study.
Among 28 patients with clinically significant LVAD-associated AR undergoing urgent-, emergent-, or compassionate-use TAVR with the Trilogy device, the procedural success rate was 93%; there were two cases of emergent valve-in-valve (one due to migration, and one due to significant paravalvular leak).
No major vascular complications, emergency cardiac surgery, new acute kidney injury, new pacemaker, or stroke occurred. By 30 days, there was one death due to failure to wean from extracorporeal membrane oxygenation (ECMO), while 96.4% of the cohort were free from inotropes and mechanical circulatory support, reported Ravi Ramana, DO, of Heart Care Centers of Illinois in Palos Park.
The JenaValve TAVR device for LVAD-associated AR thus appeared safe and feasible, Ramana told the audience at the New York Valves annual meeting hosted by the Cardiovascular Research Foundation.
In addition, the rate of 1-year mortality was 7.3% (8.3% with compassionate use and 6.2% with emergency use).
“Despite significant hemo-metabolic derangement,” Ramana said, “many patients can clinically improve if or when LVAD-AR is successfully treated. Of note, right ventricular dysfunction remains common and is difficult to manage in the setting of significant AR.”
He noted that the prospective JENA-VAD IDE study, planned for 50 participants with LVADs and significant AR, is expected to report this fall.
Session discussant Mahesh Madhavan, MD, of NewYork-Presbyterian/Columbia University Irving Medical Center in New York City, cautioned that the TAVR operators involved have been “extremely experienced” and their good outcomes are not necessarily widely generalizable.
“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 said. “However, that being said, as mentioned, this is obviously a challenging patient population. We’re eagerly awaiting the prospective study.”
Ramana cited the need for emergent therapy for LVAD-associated AR, which occurs in 10% to 30% of cases within a year of LVAD implant.
The pathophysiology of LVAD-associated AR is related to a reduced aortic valve opening and prolonged valve closure resulting in leaflet stasis, commissural fusion, and cusp remodeling, among other factors, he explained. LVAD-associated AR occurs in systole and diastole due to constant unloading of the left ventricle; therefore, expert recommendations say to intervene when AR is graded as moderate.
The options include surgery or a percutaneous plug. Off-label TAVR with other devices has produced suboptimal results: one in three requires a second valve due to migration or paravalvular leak, according to Ramana.
Meanwhile, the JenaValve Trilogy device met the primary safety and efficacy endpoints for patients with symptomatic severe native AR who were at high risk for surgery in the ALIGN-AR study. FDA approved for the treatment of symptomatic severe AR this year, JenaValve differs from TAVR systems in its direct attachment to the native aortic leaflets without relying on annular calcification for anchoring.
Participating sites in ALIGN-AR were allowed to treat LVAD patients outside the trial when no comparable or satisfactory alternative therapy options were available, Ramana said.
The resulting JENA-VAD NOW Registry thus included 28 patients with LVAD-associated AR across a dozen U.S. sites, split between emergency-use (57%) and compassionate-use (43%) TAVR.
Median age was 67 years, and 39% were women. Most had a HeartMate 3 LVAD (89%), with a minority implanted with a HeartMate II (7%) or HeartWare (4%). Forty-three percent of patients presented with right ventricular dysfunction, and the proportions on pre-procedure inotropes and veno-arterial ECMO were 29% and 7%, respectively.
Median time from LVAD implant to TAVR was just under 3 years. Median follow-up was 1.26 years.
Ramana acknowledged the considerable limitations of the analysis, including the patient selection and inherent selection bias of the retrospective study. There was also a small sample, and cases were limited mainly to one LVAD device with experienced JenaValve Trilogy operators and LVAD centers.
