Predictors of Poor Outcomes after Transcatheter Aortic Valve Replacement: Results from the PARTNER Trial
Background—Transcatheter Aortic Valve Replacement (TAVR) is a less invasive option for treatment of high-risk patients with severe aortic stenosis. We sought to identify patients at high-risk for poor outcome after TAVR, using a novel definition of outcome that integrates quality of life (QoL) with mortality.
Methods and Results—Among 2137 patients who underwent TAVR in the PARTNER trial or associated continued access registry, QoL was assessed using the Kansas City Cardiomyopathy Questionnaire-Overall Summary Scale (KCCQ-OS, range 0-100; higher=better) at baseline, 1, 6, and 12 months. A poor 6-month outcome—defined as death, KCCQ-OS<45, or ≥10-point decrease in KCCQ-OS compared with baseline—occurred in 704 patients (33%). Using a split-sample design, we developed a multivariable model to identify a parsimonious set of covariates to identify patients at high-risk for poor outcome. The model demonstrated moderate discrimination (c-index=0.66) and good calibration with the observed data; performed similarly in the separate validation cohort (c-index=0.64); and identified 211 patients (10% of the population) with a ≥50% likelihood of a poor outcome after TAVR. A second model that explored predictors of poor outcome at 1-year identified 1102 patients (52%) with ≥50% likelihood and 178 (8%) with ≥70% likelihood of a poor 1-year outcome after TAVR.
Conclusions—Using a large, multicenter cohort, we have developed and validated predictive models that can identify patients at high-risk for a poor outcome after TAVR. Although model discrimination was moderate, these models may help guide treatment choices and offer patients realistic expectations of outcomes based on their presenting characteristics.
Clinical Trial Registration Information—www.clinicaltrials.gov. Identifier: NCT00530894.
- Received November 12, 2013.
- Revision received March 10, 2014.
- Accepted April 7, 2014.