Databases including MEDLINE and EMBASE were searched through January 2016 using PubMed and OVID. Search terms included paravalvular or perivalvular; regurgitation, leak, or leakage; percutaneous, transcatheter, transluminal, transarterial, transapical, transaortic, transcarotid, transaxillary, transsubclavian, transiliac, transfemoral, or transiliofemoral; and aortic valve. Studies considered for inclusion met the following criteria: the design was an observational comparative study; the study population was patients undergoing TAVI; patients were divided into ≥ moderate and ≤ mild post-TAVI PAR; outcomes included ≥ 1-year all-cause mortality; and the adjustment method was a multivariate Cox proportional hazards analysis. An adjusted HR with its 95% confidence interval (CI) for ≥ moderate post-TAVI PAR was abstracted from each individual study.
Our search identified 17 eligible studies including a total of 15,131 patients. A pooled analysis of all the 17 studies demonstrated a statistically significant 2.12-fold increase in mortality with ≥ moderate PAR (HR, 2.12; 95% CI, 1.79 to 2.51; p < 0.00001). Exclusion of any single study from the meta-analysis did not substantively alter the overall result disfavoring ≥ moderate PAR. Although the statistical tests suggested funnel plot asymmetry, the corrected effect estimate from the trim-and-fill method demonstrated still a statistically significant 1.83-fold risk of mortality with ≥ moderate PAR.
≥ Moderate post-TAVI PAR is associated with a 2.12-fold increase in overall (≥ 1-year) all-cause mortality.