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Quality-of-Life Outcomes After TAVR
Study Questions:
What are the short- and long-term health status outcomes of patients after transcatheter aortic valve replacement (TAVR)?
Methods:
Data from the Society of Thoracic Surgeons/American College of Cardiology (STS/ACC) Transcatheter Valve Therapy (TVT) Registry were used for the present observational study. Disease-specific health status assessed at baseline, 30 days, and 1 year after TAVR were collected from patients between November 1, 2011, and March 31, 2016. Health status was assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ). This instrument includes a summary score from 0 to 100 points, with higher scores indicating less symptom burden and better quality of life. Factors associated with health status were examined at 1 year after TAVR with adjustment for baseline health status and accounting for clustering of patients with sites.
Results:
A total of 45,546 patients underwent TAVR at 412 sites and had data available on quality of life. A total of 31,636 patients had data available at 30 days (from 406 sites) including 48.3% women, and mean age was 83 years. Of the 23,612 TAVR patients who survived to 1 year, those patients at sites which had <50% completion of the KCCQ were excluded, leaving 7,014 patients from 169 sites, including 49.2% women, and mean age of 84 years. The mean (standard deviation) baseline KCCQ score was 42.3 (23.7), consistent with substantial health status impairment. Surviving patients had, on average, large improvements in health status at 30 days that persisted to 1 year. Mean improvement in the KCCQ score was 27.6 (95% confidence interval [CI], 27.3-27.9) points at 30 days and 31.9 (95% CI, 31.3-32.6) points at 1 year. Worse health status at 1 year was associated with multiple factors including 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. Overall, 62.3% of patients had a favorable outcome at 1 year (alive with reasonable quality of life, KCCQ score >60, and no significant decline from baseline). The lowest rates of improved health status at 1 year were observed among the following subgroups: those with severe lung disease (51.4%), those undergoing dialysis (47.7%), or those with very poor baseline health status (49.2%).
Conclusions:
The authors concluded that 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 one in three still had a poor outcome 1 year after TAVR. Continued efforts are needed to improve patient selection and procedural and postprocedural care to maximize health status outcomes of this evolving therapy.
Perspective:
These data suggest that TAVR patients who survive to 1 year have greater improvements than was observed in prior randomized controlled trials. However, as the authors and the accompanying editorials note, a significant number of patients were not assessed as to quality of life. An improved collection of patient-centered outcomes such as health status will assist in how we communicate risks and benefits for each patient, thus allowing patients to make more informed decisions regarding their care.
Keywords: Atrial Fibrillation, Cardiac Surgical Procedures, Diabetes Mellitus, Geriatrics, Health Status, Heart Valve Diseases, Lung Diseases, Pacemaker, Artificial, Quality of Life, Renal Dialysis, Risk Assessment, Stroke, STS/ACC TVT Registry, Transcatheter Aortic Valve Replacement
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