Clin Res Cardiol (2022).

First results after commercial TAVI implantation utilizing the JenaValve Trilogy system for aortic stenosis and aortic regurgitation
M. Adam1, A. R. Tamm2, H. S. Wienemann1, A. Goncharov3, R. S. von Bardeleben4, S. Bleiziffer5, E. Kuhn6, S. Baldus7, T. K. Rudolph3, H. Treede8
1Klinik III für Innere Medizin, Herzzentrum der Universität zu Köln, Köln; 2Kardiologie 1, Zentrum für Kardiologie, Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz; 3Allgemeine und Interventionelle Kardiologie/Angiologie, Herz- und Diabeteszentrum NRW, Bad Oeynhausen; 4Zentrum für Kardiologie, Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz; 5Klinik für Thorax- und Kardiovaskularchirurgie, Herz- und Diabeteszentrum NRW, Bad Oeynhausen; 6Klinik und Poliklinik für Herz- und Thoraxchirurgie, Herzzentrum, Universitätsklinikum Köln, Köln; 7Klinik für Kardiologie, Angiologie, Pneumologie und Internistische Intensivmedizin, Herzzentrum der Universität zu Köln, Köln; 8Klinik und Poliklinik für Herz-, Thorax- und Gefäßchirurgie, Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz;
Recent technological advancements and increased user experience have improved transcatheter aortic valve implantation (TAVI) treatment options. Still, TAVI therapy for patients with aortic regurgitation is off-label and might be challenging with less successful results compared to TAVI in AS patients. We examined early data of a new transfemoral TAVI system (JenaValve Trilogy), a transcatheter heart valve (THV) which carries locators allowing to “clip” the aortic leaflets and implant the THV in an anatomically correct manner.  Herein, we report the worldwide first implantation and early outcome data on TAVI patients with AR and AS who received this THV commercially.
For this analysis, 26 consecutive patients from 3 German centers were included. The selection of TAVI device was left to the heart team discretion, as the JenaValve Trilogy system has CE mark approval in Europe and patients were treated outside a study protocol. Subsequently, procedural outcomes were analyzed. Primary efficacy endpoint was technical success with mean gradient less than 20mmHg and reduction of AR >1 grade for AR patients. Combined primary safety endpoint was major adverse events (death, myocardial infarction, cardiothoracic surgery, stroke) at discharge.
Mean patient age was 80 ± 5 years, 9 (34%) patients were female, median EURO II-score was 1.67% [0.93-7.54]. 11 patients (42%) were treated for relevant AR, 12 patients (46%) were treated for AS, 3 (12%) patients were treated for mixed disease. While all AR patients showed echocardiographic signs of severe AR, mean aortic valve gradient was 42.6 ± 12mmHg for patients with aortic stenosis. Left ventricular function was impaired in 9 patients (35%), mean LV ejection fraction was 50.3 ± 11%. Mean aortic annulus perimeter was 78.8 ± 6.7mm.
In all cases, the JenaValve TAVI prosthesis was successfully implanted via transfemoral access. Postprocedural mean gradient was 5.3 ± 2.3mmHg. No residual AR was present in 13/26 patient (56.5%), no patient showed signs of moderate PVL. New permanent pacemaker implantation was performed in 2 patients (8%). Neither major vascular complications nor minor or disabling strokes were observed in any patient. No myocardial infarction, conversion to surgery or valve migration / second valve implantation occurred. Consequently, the primary efficacy endpoint was reached in 100% of patients, while a primary safety event was not reported.
This worldwide first real-world data suggest that transfemoral TAVI treatment of severe AR and AS using the Trilogy JenaValve system is safe and effective. Future studies are needed to further prove safety and efficacy in larger cohorts.