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

Kleiman, Neal S; Van Mieghem, Nicolas M; Reardon, Michael J; Gada, Hemal; Mumtaz, Mubashir; Olsen, Peter Skov; Heiser, John; Merhi, William; Chetcuti, Stanley; Deeb, G Michael; Chawla, Atul; Kiaii, Bob; Teefy, Patrick; Chu, Michael W A; Yakubov, Steven J; Windecker, Stephan; Althouse, Andrew D; Baron, Suzanne J (2024). Quality of Life 5 Years Following Transfemoral TAVR or SAVR in Intermediate Risk Patients. JACC. Cardiovascular Interventions, 17(8), pp. 979-988. Elsevier 10.1016/j.jcin.2024.02.014

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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).

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