Transcatheter aortic valve replacement (TAVR) may confer only modest psychological and general health benefits, according to a systematic review published Feb. 18 in the Annals of Internal Medicine.
Caroline A. Kim, MD, MS, of Beth Israel Deaconess Medical Center in Boston, and colleagues conducted the review to evaluate the benefits of TAVR in a real-world setting. They wanted to take a patient-centered approach to assess outcome measures such as quality of life and functional status that may be of more value to patients than mortality.
They searched MEDLINE, EMBASE and the Cochrane Central Registry of Controlled Trials between Jan. 1, 2002, and Sept. 30, 2013, to identify TAVR studies. The studies had to include at least one of the following measures between baseline and at least six months after TAVR: New York Heart Association (NYHA) functional class; Short Form (SF)-12/36 Health Survey physical component summary (PCS) and mental component summary (MCS) scores; or other suitable measures such as the six-minute walk test, the Kansas City Cardiomyopathy Questionnaire or the Minnesota Living With Heart Failure Questionnaire.
They selected 60 observational studies and two randomized controlled clinical trials, for a total of 11,205 TAVR patients. They decided to summarize changes in primary outcomes because of the poor quality of some studies and heterogeneity.
They found a wide variation in patient clinical characteristics and the degree of improvement in functional outcomes and quality of life. “There was an overall trend that TAVR improved symptoms, physical function, and disease-specific measures of quality of life,” they wrote. “However, the benefits in psychological dimension and general health measures were often small and inconsistent.”
Most studies showed an improvement in at least one NYHA class, in some cases up to 36 months, but a few studies also reported patients with no improvement. The authors suggested that NYHA class may not be sufficiently sensitive to be used as a measure for quality of life and daily performance.
Of the studies in the review, only a few evaluated validated functional status and quality of life measures over 12 months. They reported clinically significant changes in disease-specific measures and physical measures. Improvements in psychological and general health measures were smaller, less consistent and may not have been clinically important.
Kim and colleagues pointed out that the review included few head-to-head studies, and recommended more well-designed studies comparing TAVR and alternative treatments to evaluate long-term changes in functional status and quality of life. The results would be valuable for physicians and patients in making treatment decisions, they wrote.