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

JACC Cardiovasc Interv. 2024 Apr 22;17(8):979-988. doi: 10.1016/j.jcin.2024.02.014.

Abstract

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).

Keywords: Kansas City Cardiomyopathy Questionnaire; quality of life; surgical aortic valve replacement; transcatheter aortic valve replacement.

Publication types

  • Research Support, Non-U.S. Gov't
  • Randomized Controlled Trial
  • Comparative Study
  • Multicenter Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Aortic Valve Stenosis* / diagnostic imaging
  • Aortic Valve Stenosis* / physiopathology
  • Aortic Valve Stenosis* / surgery
  • Aortic Valve* / diagnostic imaging
  • Aortic Valve* / physiopathology
  • Aortic Valve* / surgery
  • Catheterization, Peripheral / adverse effects
  • Female
  • Femoral Artery*
  • Health Status*
  • Heart Valve Prosthesis Implantation / adverse effects
  • Heart Valve Prosthesis Implantation / instrumentation
  • Heart Valve Prosthesis*
  • Humans
  • Male
  • Prosthesis Design
  • Punctures
  • Quality of Life*
  • Recovery of Function*
  • Risk Assessment
  • Risk Factors
  • Severity of Illness Index*
  • Time Factors
  • Transcatheter Aortic Valve Replacement* / adverse effects
  • Transcatheter Aortic Valve Replacement* / instrumentation
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT01586910