Quality of Life 5 Years Following Transfemoral TAVR or SAVR in Intermediate Risk Patients.

BACKGROUND

Symptomatic patients with severe aortic stenosis (AS) at high risk for surgical aortic valve replacement (SAVR) sustain comparable improvements in health status over 5 years after transcatheter aortic valve replacement (TAVR) or SAVR. Whether a similar long-term benefit is observed among intermediate-risk AS patients is unknown.

OBJECTIVES

The purpose of this study was to assess health status outcomes through 5 years in intermediate risk patients treated with a self-expanding TAVR prosthesis or SAVR using data from the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial.

METHODS

Intermediate-risk patients randomized to transfemoral TAVR or SAVR in the SURTAVI trial had disease-specific health status assessed at baseline, 30 days, and annually to 5 years using the Kansas City Cardiomyopathy Questionnaire (KCCQ). Health status was compared between groups using fixed effects repeated measures modelling.

RESULTS

Of the 1,584 patients (TAVR, n = 805; SAVR, n = 779) included in the analysis, health status improved more rapidly after TAVR compared with SAVR. However, by 1 year, both groups experienced large health status benefits (mean change in KCCQ-Overall Summary Score (KCCQ-OS) from baseline: TAVR: 20.5 ± 22.4; SAVR: 20.5 ± 22.2). This benefit was sustained, albeit modestly attenuated, at 5 years (mean change in KCCQ-OS from baseline: TAVR: 15.4 ± 25.1; SAVR: 14.3 ± 24.2). There were no significant differences in health status between the cohorts at 1 year or beyond. Similar findings were observed in the KCCQ subscales, although a substantial attenuation of benefit was noted in the physical limitation subscale over time in both groups.

CONCLUSIONS

In intermediate-risk AS patients, both transfemoral TAVR and SAVR resulted in comparable and durable health status benefits to 5 years. Further research is necessary to elucidate the mechanisms for the small decline in health status noted at 5 years compared with 1 year in both groups. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement [SURTAVI]; NCT01586910).

Informations de copyright

Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Funding Support and Author Disclosures Medtronic funded the trial. Dr Kleiman is a consultant for Medtronic, Abbott, and Boston Scientific; and receives grant support from Medtronic. Dr Van Mieghem has received grant support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic; and advisory fees from Abbott, Boston Scientific, Pulse Cath BV, and Medtronic. Dr Reardon has received institutional fees from Medtronic for consulting and providing educational services. Dr Gada serves as a consultant to Abbott Vascular, Bard, Inc., Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Mumtaz serves as a consultant to and receives honoraria and research grants from Edwards Lifesciences, the Japanese Organization for Medical Device Development, Medtronic, Triflex, and Foldax. Dr Chetcuti has received personal fees from Medtronic; has received grants from Edwards Lifesciences, Boston Scientific, and Jena; and serves on advisory boards for Biotrace and Jena Valve. Dr Deeb has received grant support from Medtronic; and personal fees from Medtronic outside the submitted work. Dr Chawla is a proctor for Medtronic. Dr Kiaii is a consultant and speaker for Medtronic, Johnson & Johnson, and Abbott. Dr Chu has received speaker honoraria from Medtronic, Edwards Lifesciences, Terumo Aortic, and Artivion. Dr Yakubov has received grants from Boston Scientific and Medtronic. Dr Windecker has received institutional research, travel, or educational grants from Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Braun, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardinal Health, CardioValve, Cordis Medical, Corflow Therapeutics, CSL Behring, Daiichi-Sankyo, Edwards Lifesciences, Farapulse Inc. Fumedica, Guerbet, Idorsia, Inari Medical, InfraRedx, Janssen-Cilag, Johnson & Johnson, Medalliance, Medicure, Medtronic, Merck Sharp & Dohme, Miracor Medical, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pharming Tech. Pfizer, Polares, Regeneron, Sanofi, Servier, Sinomed, Terumo, Vifor, and V-Wave; has served as an advisory board member and/or member of the steering/executive group of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Boston Scientific, Biotronik, Bristol Myers Squibb, Edwards Lifesciences, MedAlliance, Medtronic, Novartis, Polares, Recardio, Sinomed, Terumo, and V-Wave with payments to the institution; and is also member of the steering/executive committee group of several investigator-initiated trials that receive funding by industry without impact on his personal remuneration. Dr Althouse is a shareholder and employee of Medtronic plc. Dr Baron has received research support from Boston Scientific and Abiomed, consulting/advisory board fees from Medtronic, Biotronik, Shockwave, and Zoll Medical; and speaker honoraria from Zoll Medical, Edwards Lifesciences, Boston Scientific, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.