Early Multicenter Outcomes of Dedicated Transcatheter Aortic Valve Replacement for Left Ventricular Assist Device‐Associated Pure Aortic Regurgitation

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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Journal
Artificial Organs
Published
2026-08-25
DOI
https://doi.org/10.1111/aor.70226
Primary Topic
Mechanical Circulatory Support Devices
Type
article
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article

Early Multicenter Outcomes of Dedicated Transcatheter Aortic Valve Replacement for Left Ventricular Assist Device‐Associated Pure Aortic Regurgitation

Arseniy Goncharov, Isabell Anna Just, Hristian Hinkov, Axel Unbehaun et al.
Artificial Organs
Mechanical Circulatory Support Devices
article

Early Multicenter Outcomes of Dedicated Transcatheter Aortic Valve Replacement for Left Ventricular Assist Device‐Associated Pure Aortic Regurgitation

Arseniy Goncharov, Isabell Anna Just, Hristian Hinkov, Axel Unbehaun, Lauren S. Ranard, Dean J. Kereiakes, Torsten P. Vahl, Dhairya Patel, Sara Yousefzada, Tanja K. Rudolph, Christoph Klein, Evgenij Potapov, Santiago Garcia, Raj R. Makkar
article en

Abstract

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.

Artificial Organs
Columbia University Irving Medical Center (US), Heart and Diabetes Center North Rhine-Westphalia (DE), Humboldt-Universität zu Berlin (DE), Deutsches Herzzentrum der Charité (DE), German Centre for Cardiovascular Research (DE), Cedars-Sinai Smidt Heart Institute (US), Christ Hospital (US), Freie Universität Berlin (DE), Charité - Universitätsmedizin Berlin (DE)
Good health and well-being
Openalex Percentile: Top 19%
Mechanical Circulatory Support Devices
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