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

Tobias Rheude (München)1, W.-K. Kim (Bad Nauheim)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 (Hamburg)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)3, T. Pilgrim (Bern)3, M. Joner (München)1

1Deutsches Herzzentrum München Klinik für Herz- und Kreislauferkrankungen München, Deutschland; 2Kerckhoff Klinik GmbH Abteilung für Kardiologie Bad Nauheim, 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, Kardiologie und Intensivmedizin Dresden, Deutschland; 7Universitätsklinikum Regensburg Regensburg, Deutschland; 8Herzzentrum Leipzig - Universität Leipzig Klinik für Innere Medizin/Kardiologie Leipzig, Deutschland; 9HELIOS Klinik für Herzchirugie Karlsruhe Karlsruhe, Deutschland; 10Universitäres Herz- und Gefäßzentrum Hamburg Klinik und Poliklinik für Herz- und Gefäßchirurgie Hamburg, 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 Herzzentrum Luzern, Schweiz; 14Augustinum Klinik München Kardiologie und Intensivmedizin München, Deutschland; 15Universitätsklinikum Frankfurt Klinik für Thorax-, Herz- und Thorakale Gefäßchirurgie Frankfurt am Main, Deutschland


: 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.  

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