Key result
JenaValve Trilogy achieves ~93% 30-day device success in high-risk LVAD patients with pure AR.
Why the study?
Aortic regurgitation frequently complicates LVAD support with prohibitive surgical risk and conventional TAVR limitations, leaving scarce evidence for dedicated JenaValve Trilogy use.
Does TAVR with the JenaValve Trilogy system provide safe and effective treatment for pure aortic regurgitation in patients with durable LVADs?
Observational (n=30)
Yes
Does TAVR with the JenaValve Trilogy system provide safe and effective treatment for pure aortic regurgitation in patients with durable LVADs?
The JenaValve Trilogy TAVR system provides a feasible and safe treatment option with high device success for clinically significant pure aortic regurgitation in LVAD patients at prohibitive surgical risk.
Supports TAVR feasibility in LVAD patients with AR; leaves open need for randomized trials before practice change.
BACKGROUND: Aortic regurgitation (AR) is a frequent and clinically relevant complication in patients with left ventricular assist devices (LVAD), impairing circulatory support and worsening outcomes. Surgical aortic valve replacement often carries prohibitive risk in this population, while conventional transcatheter aortic valve replacement (TAVR) is limited by the lack of annular calcification. The JenaValve Trilogy is the first transfemoral TAVR system with regulatory approval for AR. Evidence on its use in LVAD patients remains scarce. METHODS: We conducted a retrospective multicenter registry of LVAD recipients undergoing JenaValve Trilogy implantation for pure AR between 2020 and 2026 at five high-volume centers in Germany and the United States. Patient characteristics, procedural details, and outcomes were analyzed. The primary endpoint was device success according to Valve Academic Research Consortium-3 (VARC-3) criteria at 30 days. Secondary endpoints included peri-procedural complications, mortality, and device-related reinterventions at follow-up. RESULTS: Thirty patients (median age 66 years, 36.7% female, median LVAD support time: four years) were included. One patient did not meet criteria for technical success, and one experienced a fatal hemorrhagic stroke on postoperative day 2, rendering device success 93.3% (28/30). 30-day mortality was 3.3% (1/30). At a median follow-up of 273 days (IQR 30-491), survival was 93.3% (28/30). CONCLUSION: This first multicenter experience demonstrates that JenaValve Trilogy provides a feasible and safe treatment option for clinically significant AR in LVAD patients at prohibitive surgical risk, with high device success and favorable short-term outcomes.
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Hinkov et al. (2026) conducted an observational in Left Ventricular Assist Device-Associated Pure Aortic Regurgitation (n=30). JenaValve Trilogy transcatheter heart valve system was evaluated on Device success according to Valve Academic Research Consortium-3 (VARC-3) criteria at 30 days. The JenaValve Trilogy transcatheter heart valve system achieved a 93.3% device success rate at 30 days in LVAD patients with pure aortic regurgitation at prohibitive surgical risk.
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