What is the effect of transcatheter aortic valve replacement on the symptoms, functional status, and quality of life in unselected US patients?
In this national cohort study of 7014 patients undergoing transcatheter aortic valve replacement, surviving patients had, on average, large improvements in health status at 30 days that persisted to 1 year. Worse baseline health status, older age, severe lung disease, home oxygen use, and a lower mean aortic valve gradient were associated with worse long-term health status.
The health status benefits of transcatheter aortic valve replacement observed in carefully conducted clinical trials can be extended to the commercial US population undergoing this procedure.
In clinical trials, transcatheter aortic valve replacement (TAVR) has been shown to improve symptoms and quality of life. As this technology moves into general clinical practice, evaluation of the health status outcomes among unselected patients treated with TAVR is of critical importance.
To examine the short- and long-term health status outcomes of surviving patients after TAVR in the context of an unselected population.
Design, Setting, and Participants
This observational cohort study included patients with severe aortic stenosis who underwent TAVR in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (TVT) Registry from November 1, 2011, to March 31, 2016, at more than 450 clinical sites.
Main Outcomes and Measures
Disease-specific health status was assessed at baseline and at 30 days and 1 year after TAVR using the Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS) score (range, 0-100 points; higher scores indicate less symptom burden and better quality of life). Factors associated with health status at 1 year after TAVR were examined using multivariable linear regression, with adjustment for baseline health status and accounting for clustering of patients within sites.
The 30-day analytic sample included 31 636 patients, and the 1-year cohort included 7014 surviving patients (3454 women [49.2%] and 3560 men [50.8%]; median [interquartile range] age, 84 [78-88] years). The mean (SD) baseline KCCQ-OS score was 42.3 (23.7), indicating substantial health status impairment. Surviving patients had, on average, large improvements in health status at 30 days that persisted to 1 year, with a mean improvement in the KCCQ-OS score of 27.6 (95% CI, 27.3-27.9) points at 30 days and 31.9 (95% CI, 31.3-32.6) points at 1 year. Worse baseline health status, older age, higher ejection fraction, lung disease, home oxygen use, lower mean aortic valve gradients, prior stroke, diabetes, pacemaker use, atrial fibrillation, slow gait speed, and nonfemoral access were significantly associated with worse health status at 1 year. Overall, 62.3% of patients had a favorable outcome at 1 year (alive with reasonable quality of life [KCCQ-OS score, ≥60] and no significant decline [≥10 points] from baseline), with the lowest rates seen among patients with severe lung disease (51.4%), those undergoing dialysis (47.7%), or those with very poor baseline health status (49.2%).
Conclusions and Relevance
In a national, contemporary clinical practice cohort of unselected patients, improvement in health status after TAVR was similar to that seen in the pivotal clinical trials. Although the health status results were favorable for most patients, approximately 1 in 3 still had a poor outcome 1 year after TAVR. Continued efforts are needed to improve patient selection and procedural/postprocedural care to maximize health status outcomes of this evolving therapy.
Arnold SV, Spertus JA, Vemulapalli S, Li Z, Matsouaka RA, Baron SJ, Vora AN, Mack MJ, Reynolds MR, Rumsfeld JS, Cohen DJ. Quality-of-Life Outcomes After Transcatheter Aortic Valve Replacement in an Unselected PopulationA Report From the STS/ACC Transcatheter Valve Therapy Registry. JAMA Cardiol. Published online February 01, 2017. doi:10.1001/jamacardio.2016.5302