Prosthesis-Patient Mismatch After Aortic Valve Replacement in the PARTNER 2 Trial and Registry.

Objectives: This study aimed to compare incidence and impact of measured prosthesis-patient mismatch (PPM _M ) versus predicted PPM (PPM _P ) after surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR).
Background: TAVR studies have used measured effective orifice area indexed (EOAi) to body surface area (BSA) to define PPM, but most SAVR series have used predicted EOAi. This difference may contribute to discrepancies in incidence and outcomes of PPM between series.
Methods: The study analyzed SAVR patients from the PARTNER (Placement of Aortic Transcatheter Valves) 2A trial and TAVR patients from the PARTNER 2 SAPIEN 3 Intermediate Risk registry. PPM was classified as moderate if EOAi ≤0.85 cm ² /m ² (≤0.70 if obese: body mass index ≥30 kg/m ² ) and severe if EOAi ≤0.65 cm ² /m ² (≤0.55 if obese). PPM _M was determined by the core lab-measured EOAi on 30-day echocardiogram. PPM _P was determined by 2 methods: 1) using normal EOA reference values previously reported for each valve model and size (PPM _P1 ; n = 929 SAVR, 1,069 TAVR) indexed to BSA; and 2) using normal reference EOA predicted from aortic annulus size measured by computed tomography (PPM _P2 ; n = 864 TAVR only) indexed to BSA. Primary endpoint was the composite of 5-year all-cause death and rehospitalization.
Results: The incidence of moderate and severe PPM _P was much lower than PPM _M in both SAVR (PPM _P1 : 28.4% and 1.2% vs. PPM _M : 31.0% and 23.6%) and TAVR (PPM _P1 : 21.0% and 0.1% and PPM _P2 : 17.0% and 0% vs. PPM _M : 27.9% and 5.7%). The incidence of severe PPM _M and severe PPM _P1 was lower in TAVR versus SAVR (P < 0.001). The presence of PPM by any method was associated with higher transprosthetic gradient. Severe PPM _P1 was independently associated with events in SAVR after adjustment for sex and Society of Thoracic Surgeons score (hazard ratio: 3.18;95% CI: 1.69-5.96; P < 0.001), whereas no association was observed between PPM by any method and outcomes in TAVR.
Conclusions: EOAi measured by echocardiography results in a higher incidence of PPM following SAVR or TAVR than PPM based on predicted EOAi. Severe PPM _P is rare (<1.5%), but is associated with increased all-cause death and rehospitalization after SAVR, whereas it is absent following TAVR.
Competing Interests: Funding Support and Author Disclosures The PARTNER II trial was funded by Edwards Lifesciences. Dr Pibarot has echo core lab contracts with Edwards Lifesciences, for which he receives no direct compensation. Dr Leipsic holds institutional computed tomography core lab contracts with Edwards Lifesciences, Abbott, Medtronic; and has served as a consultant for Edwards Lifesciences. Dr Clavel has a computed tomography core lab contract with Edwards Lifesciences, for which he receives no direct compensation; and has received research grant support from Medtronic. Dr Khalique has received speaker fees from Edwards Lifesciences. Dr Abbas has served on the on the Speakers Bureau and has received research grants from Edwards Lifesciences. Dr Hahn has echo core lab contracts with Edwards Lifesciences, for which she receives no direct compensation. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
(Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)