title: Health status after transcatheter aortic valve replacement in patients at extreme surgical risk: results from the CoreValve U.S. trial.
abstract: OBJECTIVE
  The purpose of this study was to characterize health status outcomes after transcatheter aortic valve replacement (TAVR) with a self-expanding bioprosthesis among patients at extreme surgical risk and to identify pre-procedural patient characteristics associated with a poor outcome.
  
  
  BACKGROUND
  For many patients considering TAVR, improvement in quality of life may be of even greater importance than prolonged survival.
  
  
  METHODS
  Patients with severe, symptomatic aortic stenosis who were considered to be at prohibitive risk for surgical aortic valve replacement were enrolled in the single-arm CoreValve U.S. Extreme Risk Study. Health status was assessed at baseline and at 1, 6, and 12 months after TAVR using the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Short Form-12, and the EuroQol-5D. The overall summary scale of the KCCQ (range 0 to 100; higher scores = better health) was the primary health status outcome. A poor outcome after TAVR was defined as death, a KCCQ overall summary score (OS) <45, or a decline in KCCQ-OS of 10 points at 6-month follow-up.
  
  
  RESULTS
  A total of 471 patients underwent TAVR via the transfemoral approach, of whom 436 (93%) completed the baseline health status survey. All health status measures demonstrated considerable impairment at baseline. After TAVR, there was substantial improvement in both disease-specific and generic health status measures, with an increase in the KCCQ-OS of 23.9 points (95% confidence interval [CI]: 20.3 to 27.5 points) at 1 month, 27.4 points (95% CI: 24.2 to 30.6 points) at 6 months, 27.4 points (95% CI: 24.1 to 30.8 points) at 12 months, along with substantial increases in Short Form-12 scores and EuroQol-5D utilities (all p < 0.003 compared with baseline). Nonetheless, 39% of patients had a poor outcome after TAVR. Baseline factors independently associated with poor outcome included wheelchair dependency, lower mean aortic valve gradient, prior coronary artery bypass grafting, oxygen dependency, very high predicted mortality with surgical aortic valve replacement, and low serum albumin.
  
  
  CONCLUSIONS
  Among patients with severe aortic stenosis, TAVR with a self-expanding bioprosthesis resulted in substantial improvements in both disease-specific and generic health-related quality of life, but there remained a large minority of patients who died or had very poor quality of life despite TAVR. Predictive models based on a combination of clinical factors as well as disability and frailty may provide insight into the optimal patient population for whom TAVR is beneficial. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902).
authors.affiliation: Erasmus University Medical Center, Rotterdam, the Netherlands; Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City, Missouri.
authors.forename: Ruben L
authors.initials: RL
authors.lastname: Osnabrugge
authors.affiliation: Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City, Missouri.
authors.forename: Suzanne V
authors.initials: SV
authors.lastname: Arnold
authors.affiliation: Lahey Hospital & Medical Center, Burlington, Massachusetts; Harvard Clinical Research Institute, Boston, Massachusetts.
authors.forename: Matthew R
authors.initials: MR
authors.lastname: Reynolds
authors.affiliation: Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City, Missouri.
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Magnuson
authors.affiliation: Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City, Missouri.
authors.forename: Kaijun
authors.initials: K
authors.lastname: Wang
authors.affiliation: Pacific Coast Cardiac and Vascular Surgeons, Redwood City, California.
authors.forename: Vincent A
authors.initials: VA
authors.lastname: Gaudiani
authors.affiliation: Baylor Heart and Vascular Hospital, Dallas, Texas.
authors.forename: Robert C
authors.initials: RC
authors.lastname: Stoler
authors.affiliation: Department of Cardiothoracic Surgery, Stanford University, Stanford, California.
authors.forename: Thomas A
authors.initials: TA
authors.lastname: Burdon
authors.affiliation: Methodist DeBakey Heart & Vascular Center, Houston, Texas.
authors.forename: Neal
authors.initials: N
authors.lastname: Kleiman
authors.affiliation: Methodist DeBakey Heart & Vascular Center, Houston, Texas.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Reardon
authors.affiliation: Mount Sinai Medical Center, New York, New York.
authors.forename: David H
authors.initials: DH
authors.lastname: Adams
authors.affiliation: Beth Israel Deaconess Medical Center, Boston, Massachusetts.
authors.forename: Jeffrey J
authors.initials: JJ
authors.lastname: Popma
authors.affiliation: Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City, Missouri. Electronic address: dcohen@saint-lukes.org.
authors.forename: David J
authors.initials: DJ
authors.lastname: Cohen
mesh_terms: D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000601:surgery*; D001705:Bioprosthesis; D005260:Female; D006304:Health Status; D006801:Humans; D008297:Male; D011788:Quality of Life; D012306:Risk; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D015996:Survival Rate; D065467:Transcatheter Aortic Valve Replacement; D016896:Treatment Outcome; D014481:United States
keywords: aortic stenosis; heart valves; quality of life; transcatheter aortic valve replacement