Clin Res Cardiol (2023). https://doi.org/10.1007/s00392-023-02180-w

Assessment of Implantation Depth with JenaValve Trilogy System in Patients with Severe Aortic Regurgitation

H. S. Wienemann1, A. R. Tamm2, M. Geyer2, A. Goncharov3, S. Bleiziffer4, E. Kuhn5, S. Baldus6, T. K. Rudolph3, M. Adam1

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; 4Klinik für Thorax- und Kardiovaskularchirurgie, Herz- und Diabeteszentrum NRW, Bad Oeynhausen; 5Klinik für Herzchirurgie, herzchirurgische Intensivmedizin und Thoraxchirurgie, Universitätsklinikum Köln, Köln; 6Klinik für Kardiologie, Angiologie, Pneumologie und Internistische Intensivmedizin, Herzzentrum der Universität zu Köln, Köln;

Background: Transcatheter aortic valve implantation (TAVI) is an increasingly considered treatment option for patients with severe pure aortic regurgitation (AR). The JenaValve Trilogy system (JenaValve Technology, Irvine, CA) is the only CE-approved TAVI device. Preliminary data demonstrate excellent hemodynamic performance with strikingly low incidence of paravalvular regurgitation. Nonetheless, the rate of new permanent pacemaker implantation (PPI) – in line with previous study regarding TAVI in AR – remains a substantial issue. Multiple non-modifiable and modifiable risk factors elevate the risk of new PPI. Lower implantation depth (ID) might lead to interference with the cardiac conduction system and need of PPI in patients with severe aortic valve stenosis. However, the impact of ID on the rate of new PPI in patients with severe AR is unknown. Methods: Thirty-three patients with severe pure AR undergoing TAVI with JenaValve and available post-TAVI angiograms were included in this preliminary study. All procedures were performed using the transfemoral approach. A marker catheter was used for calibration, post-TAVI angiograms were used to assess the distance from the lower edge of the non-coronary cusp to the ventricular end of the JenaValve device to measure the prosthesis ID. The fluoroscopic projection for aortography was not standardized. Results: The mean age was 75±10 years, and 39 % of patients were female. Nine (27.2%) of the included patients required a new PPI at discharge. Both groups did not statistically differ with regard to prior right bundle branch block (No PPI: 0 (0%) vs new PPI 1 (11%); P = 0.27), prior left bundle branch block (No PPI: 4 (17%) vs new PPI 1 (11%); P > 0.99), atrial fibrillation (No PPI: 12 (50%) vs new PPI 5 (56%); P > 0.99). The mean aortic annular area was significantly higher in patients with no need for PPI 521.4±72.4 mm², whereas in patient with new PPI it was 453.8±66.3 mm² (P = 0.029). Mean ID was 6.09±1.2 mm in patient without requirement of PPI and 6.08±1.9 mm in patients requiring PPI (Figure 1). Reduction to none or trace paravalvular regurgitation was achieved in all patients. Conclusion: In this preliminary study, ID was not associated with PPI in the the JenaValve Trilogy system when treating severe AR. Figure 1. Assessment of implantation depth using angiograms in patients with or without new permanent pacemaker implantation (PPI)

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