Serial change in health-related quality of life over 1 year after transcatheter aortic valve implantation: predictors of health outcomes.

Objectives: The goal of this study was to assess serial changes in patient health-related quality of life (HRQOL) over time and identify predictors of patient benefit.

Background: Severe aortic stenosis reduces the length and quality of a patient's life. Transcatheter aortic valve implantation (TAVI) is superior to standard medical therapy and noninferior to surgical aortic valve replacement for 1-year mortality. HRQOL is an important outcome measure for which there is limited evidence in TAVI populations.

Methods: A total of 102 patients (mean age 80 ± 0.6 years; 49% male) undergoing TAVI consented to participate. Two HRQOL questionnaires-the social functioning (SF)-12v2 with physical component summaries (PCS) and mental component summaries (MCS) and the EQ-5D (with a visual analog scale [VAS])-were completed at baseline, 30 days, 6 months, and 1 year according to the recommendations of the Valve Academic Research Consortium. A SF-6D utility measure was calculated from the SF-12 survey.

Results: HRQOL significantly improved over 1 year (PCS p = 0.02; EQ-5D p = 0.02; VAS p = 0.01; SF-6D p = 0.03), becoming similar to age-adjusted U.S. population norms. The greatest change occurred from baseline to 30 days (p < 0.001), with further significant improvements to 6 months (p < 0.01). An insignificant decline occurred between 6 months and 1 year (p > 0.05), but a linear pattern of change remained for PCS, EQ-5D, and VAS (p < 0.05). Male sex (SF-6D p = 0.01) and increased operator experience (PCS, EQ-5D, and VAS p < 0.05) were independent predictors of a greater improvement in HRQOL.

Conclusions: HRQOL significantly improved early after TAVI and was maintained out to 1 year. Patient factors, procedural complications, and operator experience are predictors of health benefit at 1 year.