Clinical Outcomes at 1 Year Following Transcatheter Aortic Valve Replacement

ImportanceIntroducing new medical devices into routine practice raises concerns because patients and outcomes may differ from those in randomized trials.ObjectiveTo update the previous report of 30-day outcomes and present 1-year outcomes following transcatheter aortic valve replacement (TAVR) in the United States.Design, Setting, and ParticipantsData 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.ExposureTranscatheter aortic valve replacement.Main Outcomes and MeasuresOne-year outcomes including mortality, stroke, and rehospitalization were evaluated using multivariate modeling.ResultsThe 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,...
Source: JAMA - Category: Journals (General) Source Type: research