To date, long-term outcome data following transcatheter aortic valve replacement (TAVR) has only been available from clinical trial data. Evaluating long-term outcomes of TAVR in real-world use is important to ensure the anticipated benefits are observed in routine clinical practice. Using data from the Society of Thoracic Surgeons/American College of Cardiology (STS/ACC) Transcatheter Valve therapies registry merged with Centers for Medicare & Medicaid Services administrative claims data, this study evaluated 1-year outcomes of mortality, stroke, and rehospitalization among 12,182 patients who underwent TAVR between November 2011 and June 2013. In this cohort, the 1-year mortality rate 23.7%, the stroke rate was 4.1%, the rate of heart failure was 14.3%, and 1.4% had aortic valve reintervention. A total of 53.2% were readmitted to the hospital within 1-year. In multivariate analysis, patient characteristics associated with increased mortality included advancing age (age >95 hazard ratio [HR] 1.61; 95% confidence interval [CI] 1.24 to 2.09), male gender (HR 1.21; 95% CI 1.12 to 1.31), severe lung disease (HR 1.39; 95% CI 1.25 to 1.55), renal failure (dialysis HR 1.66; 95% CI 1.41 to 1.95) and Cr > 2mg/dL (HR 1.26; 95%CI 1.10 to 1.44), nontransfemoral access (HR 1.37; 95% CI 1.27 to 1.28), and STS Predicted Risk of Mortality (PROM) score greater than 15% compared with less than 8% (HR 1.82; 95% CI 1.60 to 2.06). In addition, the authors found the median predicted mortality for this cohort was 7.1% which was lower than the median predicted mortality for patients in the clinical trials that established the efficacy of TAVR (~11% in these prior trials).
Conclusion: The 1-year outcomes of patients undergoing TAVR are similar to outcomes seen during prior clinical trials with a 1-year mortality of 23.7% and stroke 4.1%. However, the lower predicted mortality in this observational cohort may reflect use of TAVR in a lower risk population than prior clinical trials.
Summarized by Lauren E. Thompson and Steven M. Bradley
- Holmes DR Jr, Brennan JM, Rumsfeld JS, Dai D, O’Brien SM, Vemulapalli S, Edwards FH, Carroll J, Shahian D, Grover F, Tuzcu EM, Peterson ED, Brindis RG, Mack MJ; STS/ACC TVT Registry. JAMA. 2015;313(10):1019-1028. doi:10.1001/jama.2015.1474.