Background: The functional and quality-of-life benefits of transcatheter aortic valve replacement (TAVR) have not been established.
Purpose: To evaluate the changes in functional status and quality of life after TAVR.
Data Sources: MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials from 1 January 2002 to 30 September 2013.
Study Selection: Studies of TAVR that reported the New York Heart Association (NYHA) class, Short Form-12/36 Health Survey physical and mental component summary (points), or other measures of functional status.
Data Extraction: Two reviewers independently extracted the mean change (follow-up minus baseline) in primary outcomes. Because of substantial heterogeneity, data were not pooled; the range of mean change was summarized.
Data Synthesis: We identified 60 observational studies (56 pre–post comparison and 4 head-to-head comparative studies) and 2 randomized, controlled trials (11 205 patients). Most studies showed a clinically important decrease in NYHA class at 6 to 11 months (range, −0.8 to −2.1 classes) and 12 to 23 months (range, −0.8 to −2.1 classes). The improvement in the Short Form-12/36 Health Survey physical component score was clinically important over 12 months (range, 4.9 to 26.9 points), and the change in mental component score was smaller (range, 1.0 to 8.9 points). Clinically important improvements were seen in other disease-specific measures but were less consistently seen in general health measures.
Limitations: Comparative evidence is limited by few head-to-head studies. Survivor bias may have overestimated the benefits.
Conclusion: Transcatheter aortic valve replacement provides clinically important benefits in physical function and disease-specific measures of quality of life but modest benefits in psychological and general health measures. More comparative studies on functional status and quality of life are needed for informed treatment decision making.
Primary Funding Source: Health Resources and Services Administration and Health Resources in Action.