title: Clinical outcomes at 1 year following transcatheter aortic valve replacement.
abstract: OBJECTIVE
  Introducing new medical devices into routine practice raises concerns because patients and outcomes may differ from those in randomized trials.
  
  
  OBJECTIVE
  To update the previous report of 30-day outcomes and present 1-year outcomes following transcatheter aortic valve replacement (TAVR) in the United States.
  
  
  METHODS
  Data from the Society of Thoracic Surgeons/American College of Cardiology (STS/ACC) Transcatheter Valve Therapies Registry were linked with patient-specific Centers for Medicare & Medicaid Services (CMS) administrative claims data. At 299 US hospitals, 12 182 patients linked with CMS data underwent TAVR procedures performed from November 2011 through June 30, 2013, and the end of the follow-up period was June 30, 2014.
  
  
  METHODS
  Transcatheter aortic valve replacement.
  
  
  METHODS
  One-year outcomes including mortality, stroke, and rehospitalization were evaluated using multivariate modeling.
  
  
  RESULTS
  The median age of patients was 84 years and 52% were women, with a median STS Predicted Risk of Operative Mortality (STS PROM) score of 7.1%. Following the TAVR procedure, 59.8% were discharged to home and the 30-day mortality was 7.0% (95% CI, 6.5%-7.4%) (n = 847 deaths). In the first year after TAVR, patients were alive and out of the hospital for a median of 353 days (interquartile range, 312-359 days); 24.4% (n = 2074) of survivors were rehospitalized once and 12.5% (n = 1525) were rehospitalized twice. By 1 year, the overall mortality rate was 23.7% (95% CI, 22.8%-24.5%) (n = 2450 deaths), the stroke rate was 4.1% (95% CI, 3.7%-4.5%) (n = 455 stroke events), and the rate of the composite outcome of mortality and stroke was 26.0% (25.1%-26.8%) (n = 2719 events). Characteristics significantly associated with 1-year mortality included advanced age (hazard ratio [HR] for ≥95 vs <75 years, 1.61 [95% CI, 1.24-2.09]; HR for 85-94 years vs <75 years, 1.35 [95% CI, 1.18-1.55]; and HR for 75-84 years vs <75 years, 1.23 [95% CI, 1.08-1.41]), male sex (HR, 1.21; 95% CI, 1.12-1.31), end-stage renal disease (HR, 1.66; 95% CI, 1.41-1.95), severe chronic obstructive pulmonary disease (HR, 1.39; 95% CI, 1.25-1.55), nontransfemoral access (HR, 1.37; 95% CI, 1.27-1.48), STS PROM score greater than 15% vs less than 8% (HR, 1.82; 95% CI, 1.60-2.06), and preoperative atrial fibrillation/flutter (HR, 1.37; 95% CI, 1.27-1.48). Compared with men, women had a higher risk of stroke (HR, 1.40; 95% CI, 1.15-1.71).
  
  
  CONCLUSIONS
  Among patients undergoing TAVR in US clinical practice, at 1-year follow-up, overall mortality was 23.7%, the stroke rate was 4.1%, and the rate of the composite outcome of death and stroke was 26.0%. These findings should be helpful in discussions with patients undergoing TAVR.
authors.affiliation: Mayo Clinic, Rochester, Minnesota.
authors.forename: David R
authors.initials: DR
authors.lastname: Holmes
authors.affiliation: Duke Clinical Research Institute, Durham, North Carolina.
authors.forename: J Matthew
authors.initials: JM
authors.lastname: Brennan
authors.affiliation: Denver VA Medical Center, Denver, Colorado.
authors.forename: John S
authors.initials: JS
authors.lastname: Rumsfeld
authors.affiliation: Duke Clinical Research Institute, Durham, North Carolina.
authors.forename: David
authors.initials: D
authors.lastname: Dai
authors.affiliation: Duke Clinical Research Institute, Durham, North Carolina.
authors.forename: Sean M
authors.initials: SM
authors.lastname: O'Brien
authors.affiliation: Duke Clinical Research Institute, Durham, North Carolina.
authors.forename: Sreekanth
authors.initials: S
authors.lastname: Vemulapalli
authors.affiliation: University of Florida, Jacksonville.
authors.forename: Fred H
authors.initials: FH
authors.lastname: Edwards
authors.affiliation: University of Colorado, Denver.
authors.forename: John
authors.initials: J
authors.lastname: Carroll
authors.affiliation: Massachusetts General Hospital, Boston.
authors.forename: David
authors.initials: D
authors.lastname: Shahian
authors.affiliation: University of Colorado, Denver.
authors.forename: Fred
authors.initials: F
authors.lastname: Grover
authors.affiliation: Cleveland Clinic, Cleveland, Ohio.
authors.forename: E Murat
authors.initials: EM
authors.lastname: Tuzcu
authors.affiliation: Duke University Medical Center, Durham, North Carolina.
authors.forename: Eric D
authors.initials: ED
authors.lastname: Peterson
authors.affiliation: University of California, San Francisco.
authors.forename: Ralph G
authors.initials: RG
authors.lastname: Brindis
authors.affiliation: Baylor Scott & White Health, Plano, Texas.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Mack
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000453:epidemiology / Q000209:etiology; D006349:Heart Valve Diseases / Q000601:surgery; D006801:Humans; D015994:Incidence; D008297:Male; D017063:Outcome Assessment, Health Care; D010359:Patient Readmission / Q000706:statistics & numerical data; D011358:Product Surveillance, Postmarketing; D012042:Registries; D012307:Risk Factors; D020521:Stroke / Q000453:epidemiology / Q000209:etiology*; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects* / Q000401:mortality