Background Transcatheter aortic valve replacement (TAVR) prolongs survival in high-risk patients with severe aortic stenosis. However, its functional and quality-of-life benefits have not been established. Purpose To evaluate the changes in functional status and quality of life after TAVR. Data Sources MEDLINE, Embase, and Cochrane Central Register of Controlled Trials from January 1, 2002, to September 30, 2013. Study Selection Studies of TAVR that reported the New York Heart Association (NYHA) class, Short-Form (SF)-12/36 physical and mental component summary (points), or other measures of functional status. Data Extraction Two reviewers independently extracted the mean change (follow-up – baseline) in primary outcomes. Due to substantial heterogeneity, data were not pooled; the range (minimum, maximum) 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 6–11 months (range: −0.8, −2.1), 12–23 months (−0.8, −2.1), 24–35 months (−1.2, −2.6), and ≥36 months (−1.2, −1.6). The improvement in SF-12/36 physical component score was clinically important over 12 months (4.9, 26.9), while the change in mental component score was smaller (1.0, 8.9). Clinically important improvements were observed in other disease-specific measures and 6-minute walk test, but less consistently seen in general health measures. Limitations Comparative evidence is limited by few head-to-head studies of functional outcomes. Survivor bias may have overestimated the benefits. Conclusions TAVR 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.
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