Long-term outcomes of patient-prosthesis mismatch after transcatheter aortic valve implantation: A sub-analysis of the randomized SCOPE-1 trial

T. Rheude (München)¹, W.-K. Kim (Gießen)², J. Lanz (Bern)³, H. Möllmann (Dortmund)⁴, C. Burgdorf (Bad Bevensen)⁵, A. Linke (Dresden)⁶, M. Hilker (Regensburg)⁷, H. Thiele (Leipzig)⁸, L. Conzelmann (Karlsruhe)⁹, L. Conradi (Köln)¹⁰, S. Kerber (Bad Neustadt a. d. Saale)¹¹, C. Thilo (Rosenheim)¹², S. Toggweiler (Luzern)¹³, O. Husser (München)¹⁴, T. Walther (Frankfurt am Main)¹⁵, S. Windecker (Bern)¹⁶, T. Pilgrim (Bern)³, M. Joner (München)^1
1Deutsches Herzzentrum München Klinik für Herz- und Kreislauferkrankungen München, Deutschland; ²Universitätsklinikum Gießen und Marburg GmbH Medizinische Klinik I - Kardiologie und Angiologie Gießen, Deutschland; ³Inselspital - Universitätsspital Bern Bern, Schweiz; ⁴Kath. St. Paulus Gesellschaft Klinik für Innere Medizin I Dortmund, Deutschland; ⁵Herz- und Gefäßzentrum Bad Bevensen Klinik für Kardiologie Bad Bevensen, Deutschland; ⁶Herzzentrum Dresden GmbH an der TU Dresden Klinik für Innere Medizin und Kardiologie Dresden, Deutschland; ⁷Universitätsklinikum Regensburg Regensburg, Deutschland; ⁸Herzzentrum Leipzig - Universität Leipzig Klinik für Innere Medizin/Kardiologie Leipzig, Deutschland; ⁹HELIOS Klinik für Herzchirugie Karlsruhe Karlsruhe, Deutschland; ¹⁰Universitätsklinikum Köln Klinik und Poliklinik für Herzchirurgie Köln, Deutschland; ¹¹RHÖN-KLINIKUM AG Campus Bad Neustadt Kardiologie Bad Neustadt a. d. Saale, Deutschland; ¹²RoMed Klinikum Rosenheim Medizinische Klinik I - Kardiologie Rosenheim, Deutschland; ¹³Luzerner Kantonsspital Heart Center Lucerne Luzern, Schweiz; ¹⁴Augustinum Klinik München Kardiologie und Intensivmedizin München, Deutschland; ¹⁵Universitätsklinikum Frankfurt Klinik für Thorax-, Herz- und Thorakale Gefäßchirurgie Frankfurt am Main, Deutschland; ¹⁶Inselspital - Universitätsspital Bern Universitätsklinik für Kardiologie Bern, Schweiz

Aims: The clinical impact of patient-prosthesis mismatch (PPM) after transcatheter aortic valve implantation (TAVI) remains controversial and may vary with different transcatheter heart valve (THV) platforms and accumulate with extended follow-up. To compare the frequency of PPM after TAVI using a self-expanding or a balloon-expandable THV platform and investigate the long-term clinical impact of PPM up to three years.

 

Methods: Patients with severe aortic stenosis were randomized to transfemoral TAVI with ACURATE neo (NEO) or SAPIEN 3 (S3) in the SCOPE I (Safety and Efficacy of the Symetis ACURATE Neo/TF Compared to the Edwards SAPIEN 3 Bioprosthesis) randomized controlled trial. PPM was determined by the core laboratory-measured iEOA on 30-day echocardiogram. All patients were stratified according to the presence of moderate (0.65-0.85 or 0.55-0.70 cm²/m² if BMI ≥ 30 kg/m²) or severe (≤0.65 or ≤0.55 cm²/m² if BMI ≥ 30 kg/m²) PPM according to updated VARC-3 criteria. Additionally, PPM was assessed according to annulus dimensions. A small aortic annulus was defined as computed tomography-derived annulus area <400 mm². Clinical outcomes were compared using COX proportional hazard in the as-treated population.

 

Results: A total of 701 patients were included. The frequency of any PPM was 41.9% (moderate 28.1% (208/701); severe 12.3% (86/701). PPM was more frequent with S3 (any PPM 53.5%; moderate PPM 35.5%; severe PPM 18.0%) compared with NEO (any PPM 29.9%; moderate PPM 23.6%; severe PPM 6.3%; p<0.001). Likewise, PPM was more frequent with S3 compared with NEO in patients with small annuli (any PPM S3 58.3% vs NEO 34.7%; p<0.001; moderate PPM S3 35.9% vs NEO 25.5%; p=0.110; severe PPM S3 22.3% vs NEO 9.2%; p=0.011) as well as non-small annuli (any PPM S3 53.9% vs NEO 27.9%; p<0.001; moderate PPM S3 35.3% vs NEO 22.7%; p=0.002; severe PPM S3 16.3% vs NEO 5.2%; p<0.001). Of note, at 3 years, all-cause mortality did not differ in patients with versus without PPM (hazard ratio 1.2, 95% CI 0.9-1.6; p=0.32).

 

Conclusions: PPM was frequent after TAVI with higher rates in patients treated with balloon-expandable valves. Mortality rates were not increased in patients with PPM at extended follow-up up to three years after TAVI.