Transcatheter Aortic Valve Replacement Using the JenaValve Trilogy Heart Valve System for Clinically Significant Aortic Regurgitation in Patients With Left Ventricular Assist Devices (JENA-VAD)

doi:10.1016/j.jacc.2026.10.059

JENA-VAD

Patient / Population Intervention / Exposition Vergleich Endpunkt

In patients with a left ventricular assist device and aortic regurgitation, TAVR with the JenaValve Trilogy system achieved high technical and device success without early death, stroke or moderate or severe residual regurgitation.

N

50Patienten

Design

Prospective, single-arm, multicentre US study (JenaValve; 14 sites) of TAVR with the JenaValve Trilogy system for clinically significant aortic regurgitation in patients with a continuous-flow LVAD

Endpunkt

Device success and safety components at 30 days (VARC)

ErgebnisTechnical and device success was 96.0% (95% CI 86.3-99.5). Freedom from any component event of the VARC-3 early safety composite was 90.0% (95% CI 78.2-96.7). There was no early death, stroke, or moderate or severe residual AR. Two transient ischaemic attacks occurred in patients without valve abnormalities. Beyond 30 days, cardiovascular death occurred in one patient (day 86). Of 12 patients with follow-up CT or transoesophageal echocardiography, 11 (including 3 within 30 days) had leaflet thickening or thrombosis. Leaflet thickening or thrombosis on clinically indicated CT occurred in 22%, representing a lower bound.

Ramana R, Uriel N, et al. J Am Coll Cardiol. 2026; published online 3 November. 10.1016/j.jacc.2026.10.059

Diskussion & Kritik

This prospective study shows that a dedicated transcatheter valve can be implanted in patients with a left ventricular assist device with high technical and device success and no early death, stroke, or moderate or severe residual regurgitation. It is single-arm, so it cannot say how the valve compares with medical management, surgery or other devices. Follow-up is short and the endpoints are procedural and early safety measures, not survival or heart failure outcomes over time. Leaflet thickening or thrombosis was found in most patients who had imaging, but imaging was only clinically indicated, so the true rate and its effect on valve durability remain unknown.