The PROVE registry: A prospective multi-center multi-national post-market registry of a short-frame supra-annular transcatheter aortic valve

O. Dumpies (Leipzig)¹, H. Möllmann (Dortmund)², W.-K. Kim (Gießen)³, S. Bleiziffer (Bad Oeynhausen)⁴, T. K. Rudolph (Bad Oeynhausen)⁵, T. Walther (Frankfurt am Main)⁶, T. Schmitz (Essen)⁷, A. Unbehaun (Berlin)⁸, C. Klein (Berlin)⁸, P. Lauten (Bad Berka)⁹, A. Schäfer (Hannover)¹⁰, O. Husser (München)¹¹, T. Nestelberger (Birmingham)¹², N. Mangner (Dresden)¹³, J. Michel (Zürich)¹⁴, T. Zeus (Düsseldorf)¹⁵, J. Rothe (Bad Krozingen)¹⁶, M. Adam (Köln)¹⁷, S. Champagne (Massy)¹⁸, N. Doll (Bad Rothenfelde)¹⁹, S. Toggweiler (Luzern)²⁰, M. Nejjari (Saint-Denis)²¹, T. Geisler (Tübingen)²², S. Elvinger (Augsburg)²³, M. Joner (München)²⁴, W. Reents (Bad Neustadt a. d. Saale)²⁵, M. Hilker (Regensburg)²⁶, M. Götberg (Lund)²⁷, O. Brosteanu (Leipzig)²⁸, P. Neuhaus (Leipzig)²⁸, O. Soliman (Dublin)²⁹, H. Thiele (Leipzig)¹, M. Abdel-Wahab (Leipzig)^1
1Herzzentrum Leipzig - Universität Leipzig Klinik für Innere Medizin/Kardiologie Leipzig, Deutschland; ²Kath. St. Paulus Gesellschaft Klinik für Innere Medizin I Dortmund, Deutschland; ³Universitätsklinikum Gießen und Marburg GmbH Medizinische Klinik I - Kardiologie und Angiologie Gießen, Deutschland; ⁴Herz- und Diabeteszentrum NRW Klinik für Thorax- und Kardiovaskularchirurgie Bad Oeynhausen, Deutschland; ⁵Herz- und Diabeteszentrum NRW Allgemeine und Interventionelle Kardiologie/Angiologie Bad Oeynhausen, Deutschland; ⁶Universitätsklinikum Frankfurt Klinik für Thorax-, Herz- und Thorakale Gefäßchirurgie Frankfurt am Main, Deutschland; ⁷Elisabeth-Krankenhaus Essen GmbH Klinik für Kardiologie und Angiologie Essen, Deutschland; ⁸Deutsches Herzzentrum der Charite (DHZC) Klinik für Kardiologie, Angiologie und Intensivmedizin | CBF Berlin, Deutschland; ⁹Zentralklinik Bad Berka GmbH Klinik für Kardiologie und Internistische Intensivmedizin Bad Berka, Deutschland; ¹⁰Medizinische Hochschule Hannover Kardiologie und Angiologie Hannover, Deutschland; ¹¹Augustinum Klinik München Kardiologie und Intensivmedizin München, Deutschland; ¹²University of Alabama at Birmingham Department of Nutrition Sciences Birmingham, USA; ¹³Herzzentrum Dresden GmbH an der TU Dresden Klinik für Innere Medizin, Kardiologie und Intensivmedizin Dresden, Deutschland; ¹⁴Universitätsspital Zürich Klinik für Kardiologie Zürich, Schweiz; ¹⁵Universitätsklinikum Düsseldorf Klinik für Kardiologie, Pneumologie und Angiologie Düsseldorf, Deutschland; ¹⁶Universitäts-Herzzentrum Freiburg / Bad Krozingen Bad Krozingen, Deutschland; ¹⁷Herzzentrum der Universität zu Köln Klinik III für Innere Medizin Köln, Deutschland; ¹⁸Hôpital Privé Jacques Cartier Massy, Frankreich; ¹⁹Schüchtermann-Klinik Bad Rothenfelde Herzchirurgie Bad Rothenfelde, Deutschland; ²⁰Luzerner Kantonsspital Heart Center Lucerne Luzern, Schweiz; ²¹Centre Cardiologique du Nord Saint-Denis, Frankreich; ²²Universitätsklinikum Tübingen Innere Medizin III, Kardiologie und Kreislauferkrankungen Tübingen, Deutschland; ²³Universitätsklinikum Augsburg I. Medizinische Klinik Augsburg, Deutschland; ²⁴Deutsches Herzzentrum München Klinik für Herz- und Kreislauferkrankungen München, Deutschland; ²⁵RHÖN-KLINIKUM AG Campus Bad Neustadt Herzchirurgie Bad Neustadt a. d. Saale, Deutschland; ²⁶Universitätsklinikum Regensburg Regensburg, Deutschland; ²⁷Lund University Faculty of Medicine Lund, Schweden; ²⁸Universität Leipzig Zentrum für Klinische Studien Leipzig, Deutschland; ²⁹Mater Private Network Heart & Vascular Centre Dublin, Irland

Background
Early studies with the short-frame supra-annular ACURATE neo2 transcatheter heart valve (THV) reported favorable procedural and early clinical outcomes. However, the device failed to demonstrate non-inferiority at one year compared to other commercial THV platforms in the randomized US-based ACURATE IDE trial. These findings ultimately led to the market withdrawal of the ACURATE platform. In this context, the influence of patient selection, procedural volume and THV expansion have been debated. The safety and efficacy of ACURATE neo2 has not been previously evaluated in a large, prospective, real-world European population treated at experienced centers, where the device had been approved and utilized for several years.

Study methods
The PROVE trial (NCT05539573) is an investigator-initiated, prospective, observational, multi-center, multinational European registry designed to evaluate the real-world performance of the ACURATE neo2 THV. There were no specific inclusion or exclusion criteria, allowing enrollment of a broad patient population undergoing transfemoral transcatheter aortic valve implantation (TAVI) using the ACURATE neo2 valve. The primary endpoint is all-cause mortality at one year. Key secondary endpoints include technical and device success, early safety, valve hemodynamics and other clinical endpoints as defined by the Valve Academic Research Consortium-3. All imaging data, including echocardiography, computed tomography, and aortic root angiography, were assessed by an independent core laboratory (CORRIB Core Lab, Galway, Ireland), and the study includes a dedicated analysis of THV under-expansion based on fluoroscopic assessment.

Results
A total of 1,041 patients were enrolled between October 2022 and March 2024 at 26 high-volume TAVI centers across four European countries (Germany, France, Switzerland and Sweden). The cohort had a mean age of 82.6 ± 5.6 years, 65.0% were female and the median STS Score was 4.3 (interquartile range 2.7 – 7.4).  The rates of technical success, device success and early safety after 30 days were 93.3%, 86.7% and 76.5% respectively. At 12 months, the primary endpoint of all-cause mortality occurred in 9.5% (95% confidence interval [CI]: 7.8 – 11.5%) of patients. The rate of any stroke was 4.9%, procedure- or valve related rehospitalization occurred in 1.9%, and new permanent pacemaker implantation was required in 11.4% of pacemaker-naive patients. Core laboratory echocardiographic analysis showed a mean aortic gradient of 7.1 ± 3.4 mmHg, with more than mild paravalvular regurgitation in 3.2% of patients. Results of the dedicated THV under-expansion analysis will be available and presented for the first time during the meeting.  

Conclusions
In this large, contemporary, real-world European registry, the ACURATE neo2 THV demonstrated high procedural success and excellent valve hemodynamics. One-year rates of mortality, stroke, and rehospitalization were comparable to other contemporary THV platforms. The forthcoming under-expansion analysis will provide further insights into its potential impact on clinical outcomes.