Patients undergoing TAVR show significant health status improvement at 1 year

Patients undergoing transcatheter aortic valve replacement (TAVR) had major improvements in health status 30 days and one year after the procedure, according to an observational cohort study.

At one year, 62.3 percent of patients had a favorable outcome, which the researchers defined as being alive and having a reasonable quality of life with no significant decline in quality of life.

Lead researcher Suzanne V. Arnold, MD, MHA, of Saint Luke’s Mid America Heart Institute and the University of Missouri–Kansas City, and colleagues published their results online Feb. 1 in JAMA Cardiology.

“The observed magnitude of health status improvement was similar to that seen in the pivotal clinical trials,” the researchers wrote. “Nonetheless, approximately one in three patients still had a poor outcome at one year after TAVR, half of which were attributable to death and half to poor [quality of life]. Therefore, continued efforts to optimize patient selection and refine procedural and postprocedural care to maximize health status recovery are needed to continue to improve the outcomes of these patients.”

The researchers evaluated patients with severe aortic stenosis who underwent TAVR from Nov. 1, 2011, to March 31, 2016, at more than 400 clinical sites that were part of the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (TVT) registry. CMS requires centers to participate in the TVT registry, so it includes data on most TAVR procedures in the U.S.

The researchers examined health status via the Kansas City Cardiomyopathy Questionnaire (KCCQ), a survey developed to describe and monitor symptoms, functional status and quality of life in patients with heart failure. They used the 12-item KCCQ, which measures physical limitation, symptom frequency, quality of life and social limitation. The scores range from 0 to 100, with higher scores indicating less symptom burden and better quality of life.

The 30-day analysis included 31,636 patients who survived following TAVR and completed the KCCQ at baseline and during the follow-up period. The median age was 83 years old, and 48.3 percent of patients were women.

The one-year analysis included 7,014 patients who survived following TAVR and completed the KCCQ at baseline and during the follow-up period. The median age was 84 years old, and 49.2 percent of patients were women.

At 30 days, the mean KCCQ score improved by 27.6 points to a mean of 69.9 points. Each of the domains increased by a mean of more than 20 points from baseline, with the largest improvement coming in the quality of life domain (mean improvement of 37.5 points) and the least improvement coming in the physical limitations domain (mean improvement of 21.4 points).

At one year, the mean KCCQ score was 75.9 points, which was a 31.9 point improvement from baseline. Each of the domains showed an improvement from baseline, including a 23.2 point improvement for physical limitation, 24 point improvement for symptom frequency, 35 point improvement for social limitation and 43.9 point improvement for quality of life.

At one year, the researchers found that 62.3 percent of patients had a favorable outcome. They added that a poor outcome was attributable to death in 19.4 percent of patients, persistently poor quality of life in 17.4 percent of patients and a decline in quality of life in 4.9 percent of patients.

Based on a multivariable analysis, patients who had better health status at baseline were more likely to have better health status at one year, while older age was associated with a worse one-year health status. In addition, higher ejection fraction at baseline, severe lung disease, home oxygen use, lower mean aortic valve gradient, prior stroke, diabetes, permanent pacemaker (before TAVR), atrial fibrillation and non- femoral access were associated with lower one-year KCCQ scores.

The researchers cited a few limitations of the study, including they did not have health status data at baseline and follow-up. The registry also did not include data on factors such as dementia and disability. In addition, the researchers only reported quality of life results for surviving patients, but they noted there is a high mortality rate following TAVR.

“The present study findings are encouraging and suggest that the benefits of TAVR that have been previously demonstrated within carefully designed and conducted clinical trials can be extended to the commercial TAVR population,” the researchers wrote. “In the future, investigating the factors that underlie these outcomes could allow us to maximize the benefits of this approach. For example, using risk prediction models to estimate a patient’s preprocedure likelihood of a successful outcome may allow clinicians to improve patient selection for TAVR. In addition, such models may be useful in guiding procedural and postprocedural care by targeting patients at increased risk for a poor outcome for less invasive approaches, geriatric consultation, or more intensive rehabilitation and follow-up to help maximize recovery.”