title: Serial change in health-related quality of life over 1 year after transcatheter aortic valve implantation: predictors of health outcomes.
abstract: OBJECTIVE
  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.
authors.affiliation: Multidisciplinary Cardiovascular Research Centre, Leeds Institute of Genetics, Health and Therapeutics, University of Leeds, Leeds, UK.
authors.forename: Timothy A
authors.initials: TA
authors.lastname: Fairbairn
authors.forename: David M
authors.initials: DM
authors.lastname: Meads
authors.forename: Adam N
authors.initials: AN
authors.lastname: Mather
authors.forename: Manish
authors.initials: M
authors.lastname: Motwani
authors.forename: Sue
authors.initials: S
authors.lastname: Pavitt
authors.forename: Sven
authors.initials: S
authors.lastname: Plein
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Blackman
authors.forename: John P
authors.initials: JP
authors.lastname: Greenwood
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000503:physiopathology*; D001024:Aortic Valve Stenosis / Q000503:physiopathology / Q000628:therapy; D003251:Constriction, Pathologic / Q000473:pathology; D005260:Female; D006304:Health Status; D006350:Heart Valve Prosthesis; D006801:Humans; D008297:Male; D017063:Outcome Assessment, Health Care; D011788:Quality of Life; D012737:Sex Factors; D011795:Surveys and Questionnaires; D013997:Time Factors