Prosthesis-patient mismatch following transcatheter aortic valve replacement for degenerated transcatheter aortic valves: the TRANSIT-PPM international project

Abstract

Background: A severe prosthesis-patient mismatch (PPM) is associated with adverse outcomes following transcatheter aortic valve replacement (TAVR) for de novo aortic stenosis or a failed surgical bioprosthesis. The impact of severe PPM in patients undergoing TAV-in-TAVR is unknown.

Aim: We sought to investigate the incidence and 1-year outcomes of different grades of PPM in patients undergoing TAV-in-TAVR.

Materials and methods: The TRANSIT-PPM is an international registry, including cases of degenerated TAVR treated with a second TAVR. PPM severity, as well as in-hospital, 30-day, and 1-year outcomes were defined according to the Valve Academic Research Consortium-3 (VARC-3) criteria.

Results: Among 28 centers, 155 patients were included. Severe PPM was found in 6.5% of patients, whereas moderate PPM was found in 14.2% of patients. The rate of severe PPM was higher in patients who underwent TAV-in-TAVR with a second supra-annular self-expanding (S-SE) TAVR (10%, p = 0.04). Specifically, the rate of severe PPM was significantly higher among cases of a SE TAVR implanted into a balloon-expandable (BE) device (19%, p = 0.003). At 1-year follow-up, the rate of all-cause mortality, and the rate of patients in the New York Heart Association (NYHA) class III/IV were significantly higher in the cohort of patients with severe PPM (p = 0.016 and p = 0.0001, respectively). Almost all the patients with a severe PPM after the first TAVR had a failed < 23 mm BE transcatheter heart valve (THV): the treatment with an S-SE resolved the severe PPM in the majority of the cases.

Conclusion: After TAV-in-TAVR, in a fifth of the cases, a moderate or severe PPM occurred. A severe PPM is associated with an increased 1-year all-cause mortality.

Clinical trial registration: [https://ichgcp.net/clinical-trials-registry/NCT04500964" title="See in ClinicalTrials.gov">NCT04500964].

Keywords: TAVR; TAVR in TAVR; failed TAVR; mortality; prosthesis-patient mismatch.

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2022 Testa, Casenghi, Criscione, Van Mieghem, Tchétché, Asgar, De Backer, Latib, Reimers, Stefanini, Trani, Giannini, Bartorelli, Wojakowski, Dabrowski, Jagielak, Banning, Kharbanda, Moreno, Schofer, Brinkmann, van Royen, Pinto, Serra, Segev, Giordano, Brambilla, Agnifili, Rubbio, Squillace, Oreglia, Tanja, McCabe, Abizaid, Voskuil, Teles, Zoccai, Sondergaard and Bedogni.

Figures

FIGURE 1

Rate of prosthesis-patient mismatch among the overall population (left-sided), patients treated with a second self-expanding transcatheter heart valve (THV) (top center), and patients treated with a second balloon-expandable THV (bottom center). Incidence of severe prosthesis-patient mismatch (PPM) was higher in patients with supra-annular-in-intra-annular THV (p = 0.003). Particularly, a higher rate of severe PPM was observed among the supra-annular-in-intra-annular group compared to the supra-annular-in-supra-annular or intra-annular-in-intra-annular groups (p = 0.02 and p = 0.002, respectively).

FIGURE 2

The Kaplan–Meier curves of cumulative 1-year all-cause death according to the presence of severe prosthesis-patient mismatch (PPM). The cumulative all-cause mortality rate at 1 year in patients with a severe was higher as compared with patients with moderate PPM or no PPM (log-rank p-value = 0.001). Blue line = Moderate/none PPM; Red line = Severe PPM.