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Propensity-Matched Comparison of JenaValve Trilogy System Versus SAPIEN 3 Ultra Transcatheter Heart Valves in Patients with Severe Aortic Valve Stenosis

https://doi.org/10.1007/s00392-024-02406-5

Hendrik Simon Wienemann (Köln)1, A. R. Tamm (Mainz)2, A. Goncharov (Bad Oeynhausen)3, M. Geyer (Mainz)2, V. Mauri (Köln)1, E. Kuhn (Köln)4, S. Baldus (Köln)5, T. K. Rudolph (Bad Oeynhausen)3, M. Adam (Köln)1

1Herzzentrum der Universität zu Köln Klinik III für Innere Medizin Köln, Deutschland; 2Universitätsmedizin der Johannes Gutenberg-Universität Mainz Kardiologie 1, Zentrum für Kardiologie Mainz, Deutschland; 3Herz- und Diabeteszentrum NRW Allgemeine und Interventionelle Kardiologie/Angiologie Bad Oeynhausen, Deutschland; 4Universitätsklinikum Köln Klinik für Herzchirurgie, herzchirurgische Intensivmedizin und Thoraxchirurgie Köln, Deutschland; 5Herzzentrum der Universität zu Köln Klinik für Kardiologie, Angiologie, Pneumologie und Internistische Intensivmedizin Köln, Deutschland

 

Background: Transcatheter aortic valve implantation (TAVI) is an established treatment option for patients with symptomatic aortic valve stenosis (AS). The JenaValve Trilogy system (JVTS; JenaValve Technology, Irvine, CA) is a CE-approved, self-expanding TAVI device used for transfemoral treatment of patients with severe AS or aortic regurgitation. Preliminary data demonstrate excellent hemodynamics and minimal paravalvular regurgitation. The Sapien 3 Ultra (S3U; Edwards Lifesciences, Irvine, CA) is a newer generation, balloon-expandable TAVI device which has shown excellent efficacy outcomes. The aim of this study was to compare procedural aspects and in-hospital outcomes in patients with AS undergoing TAVI with the JVTS and S3U devices.

Methods: 42 patients with severe AS underwent transfemoral TAVI with JVTS at 6 German centers, and 381 patients underwent transfemoral TAVI for native severe AS with the S3U device at the University Hospital Cologne. One-to-one propensity score matching resulted in 41 pairs in this preliminary study. Endpoints were defined according to the Valve Academic Research Consortium (VARC)-3 criteria.

Results: The mean age was 81±14 years with 44% of the patients were female. The mean aortic perimeter was 76.82±6.15 mm, and the mean pressure gradient was 40.9±12.4 mmHg. Patients undergoing TAVI with the JVTS more frequently underwent predilatation (JVTS: 76% vs 24%; P<0.001). Procedural duration (JVTS: 78.1±37.9 min vs S3U: 54.9±23.4 min; P<0.001), radiation time (JVTS: 20.1±7.1 min vs S3U: 13.2±5.6 min; P<0.001), and contrast usage (JVTS: 150.8±71.4 ml vs S3U: 81.3±18.0 ml; P<0.001) were higher in patients treatet with the JVTS. Rates of bleeding complications (JVTS; type 1: 7.3%, type 2: 2.4% vs. S3U: type 1: 2.4%, type 2: 0%; P=0.36), vascular complications (JVTS; minor 0%, major 2.4% vs. S3U: minor 10%, major 0%; One missing case; P=0.084), and new permanent pacemaker implantation (JVTS: 2.4% vs. S3U: 7.5%; One missing case; P=0.36) showed numerical differences without reaching statistical significance in this small cohort. Mean pressure gradient at discharge was significantly lower with the JVTS (Figure 1).

Conclusion: In this preliminary study with a small number of patients, JVTS demonstrated similar safety and efficacy to S3U and exhibited excellent hemodynamic performance when treating patients with severe AS.


Figure 1.: Mean pressure gradient at discharge
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