Comparison of two self-expanding transcatheter heart valves for degenerated surgical bioprostheses: The AVENGER multicentre registry

DOI: 10.4244/EIJ-D-23-00779

Won-Keun Kim
Won-Keun Kim1,2,3, MD, PhD; Moritz Seiffert4, MD, PhD; Andreas Rück5, MD, PhD; David M. Leistner6,7, MD, PhD; Henryk Dreger7,8, MD, PhD; Hendrik Wienemann9, MD; Matti Adam9, MD, PhD; Helge Möllmann10, MD, PhD; Johannes Blumenstein10,11, MD, PhD; Clemens Eckel10,11, MD; Andrea Buono12, MD; Diego Maffeo12, MD; Antonio Messina13, MD; Andreas Holzamer14, MD; Samuel Sossalla14, MD, PhD; Marco Barbanti15, MD; Giuliano Costa15, MD; Silvia Motta15, MD; Corrado Tamburino15, MD; Ina von der Heide4, MD; Julius Glasmacher7,8, MD; Mohammad Sherif7,8, MD, PhD; Philipp Seppelt6, MD; Stephan Fichtlscherer6, MD, PhD; Thomas Walther6, MD, PhD; Fausto Castriota16, MD; Roberto Nerla16, MD; Christian Frerker17, MD, PhD; Tobias Schmidt17, MD, PhD; Alexander Wolf18, MD; Martin M. Adamaszek18, MD; Francesco Giannini19, MD; Maarten Vanhaverbeke20, MD, PhD; Stefaan Van de Walle20, MD; Francis Stammen20, MD, PhD; Stefan Toggweiler21, MD, PhD; Stephanie Brunner21, MD; Antonio Mangieri22, MD; Mauro Gitto23, MD; Gerrit Kaleschke24, MD; Vlasis Ninios25, MD; Ilias Ninios25, MD; Judith Hübner26, MD; Erion Xhepa26, MD; Matthias Renker1,2, MD; Efstratios I. Charitos2; Michael Joner26, MD, PhD; Tobias Rheude26, MD, PhD
1. Kerckhoff Heart Center, Department of Cardiology, Bad Nauheim, Germany; DZHK (German Centre for Cardiovascular Research), Partner Site Rhein/Main, Germany; 2. Kerckhoff Heart Center, Department of Cardiac Surgery, Bad Nauheim, Germany; 3. Justus-Liebig University of Giessen, Department of Cardiology, Giessen, Germany; 4. University Heart and Vascular Center Hamburg, Department of Cardiology, University Hospital Hamburg-Eppendorf (UKE), Hamburg, Germany; DZHK (German Centre for Cardiovascular Research), Partner Site Hamburg/Kiel/Lübeck, Germany; 5. Karolinska University Hospital, Department of Cardiology, Stockholm, Sweden; 6. University Heart & Vascular Center Frankfurt, Frankfurt, Germany; DZHK (German Centre for Cardiovascular Research), Partner Site Rhein/Main, Germany; 7. Deutsches Herzzentrum der Charité (DHZC), Department of Cardiology, Angiology and Intensive Care Medicine, Berlin, Germany; 8. Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany; 9. Clinic III for Internal Medicine, Faculty of Medicine and University Hospital Cologne, Cologne, Germany; 10. Department of Cardiology, St. Johannes-Hospital, Dortmund, Germany; 11. Department of Cardiology, Carl-von-Ossietzky University, Oldenburg, Germany; 12. Interventional Cardiology Unit, Cardiovascular Department, Fondazione Poliambulanza Istituto Ospedaliero, Brescia, Italy; 13. Department of Cardiothoracic Surgery, Fondazione Poliambulanza Istituto Ospedaliero, Brescia, Italy in Operative Unit of Cardiac Surgery, Poliambulanza Foundation Ospital, Brescia, Italy; 14. University of Regensburg, Medical Center, Regensburg, Germany; 15. Division of Cardiology, AOU Policlinico G. Rodolico-San Marco, Catania, Italy; 16. Maria Cecilia Hospital, GVM Care & Research, Cotignola, Italy; 17. Universitätsklinikum Schleswig-Holstein, Campus Lübeck; Department of Cardiology; Lübeck, Germany; DZHK (German Center for Cardiovascular Research), Partner Site Hamburg/Kiel/Lübeck, Germany  ; 18. Contilia Herz- und Gefässzentrum, Elisabeth Krankenhaus Essen, Essen, Germany; 19. IRCCS Galeazzi Sant’Ambrogio, Milan, Italy ; 20. AZ Delta: Campus Rumbeke, campus Brugsesteenweg Roeselare, campus Menen en campus Torhout, Belgium; 21. Heart Center Lucerne, Lucerner Kantonsspital, Lucerne, Switzerland; 22. Cardiocenter, IRCCS Humanitas Research Hospital, Rozzano-Milan, Italy; 23. Department of Biomedical Sciences, Humanitas University, Pieve Emanuele-Milan, Italy; IRCCS Humanitas Research Hospital, Rozzano-Milan, Italy; 24. Department of Cardiology III - Adult Congenital and Valvular Heart Disease University Hospital Muenster, Münster, Germany; 25. Interbalkan European Medical Center, Thessaloniki, Greece; 26. Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München, Munich, Germany; DZHK (German Center for Cardiovascular Research), Partner Site Munich Heart Alliance, Germany

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Background: There is lack of comparative data on transcatheter aortic valve implantation (TAVI) in degenerated surgical prostheses (ViV).

Aims: We sought to compare outcomes of using two self-expanding transcatheter heart valve (THV) systems for ViV.

Methods: In this retrospective multicentre registry, we included consecutive patients undergoing transfemoral ViV using either the ACURATE neo/neo2 (ACURATE group) or EVOLUT R/PRO/PRO+ (EVOLUT group). The primary outcome measure was technical success (VARC-3). Secondary outcomes were 30-day all-cause mortality, device success (VARC-3), coronary obstruction (CO) requiring intervention, rates of severe prosthesis-patient mismatch (PPM), and aortic regurgitation (AR) ≥moderate. Comparisons were made after 1:1 propensity score matching.

Results: The study cohort comprised 835 patients from 20 centers (ACURATE n=251; EVOLUT n=584). In the matched cohort (n=468), technical success (ACURATE 92.7% vs. EVOLUT 88.9%; p=0.20) and device success (69.7% vs. 73.9%; p=0.36) as well as 30-day mortality (2.8% vs. 1.6%; p=0.392) were similar between the two groups. Mean gradients and rates of severe PPM, AR ≥moderate, and CO did not differ between the groups. Technical and device success were higher for the ACURATE platform among patients with true ID >19 mm, whereas a true ID ≤19 mm was associated with higher device success - but not technical success - among EVOLUT recipients.

Conclusion: ViV TAVI using either ACURATE or EVOLUT THVs showed similar procedural outcomes. However, a true ID >19 mm was associated with higher device success among ACURATE recipients, whereas in patients with true ID ≤19 mm device success was higher when using EVOLUT.

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transcatheter aortic valve replacementvalve-in-valve procedureACURATEEVOLUTbioprosthesis
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