Clin Res Cardiol (2022). https://doi.org/10.1007/s00392-022-02002-5
Transcatheter Aortic Valve Replacement with self-expanding devices - a multicenter propensity score matched comparison
H. S. Wienemann1, A. Hof1, S. Ludwig2, S. Zimmer3, C. Hohmann1, C. Iliadis1, M. Meertens1, S. Macherey-Meyer1, M. Halbach4, S. Bleiziffer5, T. Zeus6, G. Nickenig3, S. Baldus1, A. Sedaghat3, V. Veulemans6, N. Schofer7, T. K. Rudolph8, M. Adam1, V. Mauri1
1Klinik für Kardiologie, Angiologie, Pneumologie und Internistische Intensivmedizin, Herzzentrum der Universität zu Köln, Köln; 2Klinik für Kardiologie, Universitäres Herz- und Gefäßzentrum Hamburg GmbH, Hamburg; 3Medizinische Klinik und Poliklinik II, Universitätsklinikum Bonn, Bonn; 4Klinik III für Innere Medizin, Herzzentrum der Universität zu Köln, Köln; 5Klinik für Thorax- und Kardiovaskularchirurgie, Herz- und Diabeteszentrum NRW, Bad Oeynhausen; 6Klinik für Kardiologie, Pneumologie und Angiologie, Universitätsklinikum Düsseldorf, Düsseldorf; 7Allgemeine und Interventionelle Kardiologie, Universitäres Herz- und Gefäßzentrum Hamburg GmbH, Hamburg; 8Allgemeine und Interventionelle Kardiologie/Angiologie, Herz- und Diabeteszentrum NRW, Bad Oeynhausen;
Background: Transcatheter aortic valve implantation (TAVI) is an established interventional treatment method for aortic stenosis in the elderly population. Several self-expanding transcatheter valve systems are commercially available. However, direct comparisons of self-expanding TAVR devices in larger multicenter studies are still rare. This study sought to analyze procedural and clinical outcomes of three different self-expanding valve systems.

Methods: This observational study included patients from 5 high volume sites across Germany. A total of 5175 patients with severe aortic stenosis underwent TAVR with either the Evolut R (n=3365), Acurate neo (n=1095) or Evolut Pro (n=715) device by a transfemoral approach. To account for differences in baseline clinical parameters including degree of calcification a 1:1:1 propensity score matching was applied, resulting in 654 well matched triples.

Results: The propensity matched cohort comprised 1962 patients, with 654 patients in each of the 3 treatment groups. Overall, the mean age was 82 ±5 years, and 56 % of patients were female. Mean AV gradient was 42±16 mmHg. Comparison of procedural complications like conversion to open heart surgery (1.2% Acurate neo, 0.8% Evolut R, 1.1% Evolut Pro; p = 0.824) or valve embolization/migration (4% Acurate neo, 1.6% Evolut R, 2.3% Evolut Pro; p = 0.07) showed no significant differences.
The rate of freedom from bleeding (89.7% Acurate neo, 92.2% Evolut R, 88.8% Evolut Pro; p = 0.19) and vascular complications (84.1% Acurate neo, 89.6% Evolut R, 85.8% Evolut Pro; p = 0.06) was similar across the different groups. Compared to Evolut R and Evolut Pro, moderate or severe PVL occurred significantly more often in Acurate neo treated patients (p <0.001, Figure 1). In contrast, permanent pacemaker implantation was necessary in 8.6% of the patients in the Acurate neo group, in 15.7% of the Evolut R and 15.1% Evolut Pro treated patients (p<0.001), respectively.

Conclusion: In this propensity score matched multicenter comparison of 3 current self-expanding valves systems, TAVR with the Acurate Neo compared to Evolut R/Pro was associated with significantly higher rates of moderate/severe paravalvular leakage at discharge, but significantly lower risk of new permanent pacemaker implantation.



Figure 1. Incidence of paravalvular leak at discharge
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