Impact of paravalvular aortic regurgitation after transcatheter aortic valve implantation on survival.

OBJECTIVES: To determine whether ≥moderate paravalvular aortic regurgitation (PAR) after transcatheter aortic valve implantation (TAVI) independently impairs overall survival and how much the impact on survival is, we performed an updated meta-analysis pooling not unadjusted but adjusted hazard ratios (HRs).
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: ≥Moderate post-TAVI PAR is associated with a 2.12-fold increase in overall (≥1-year) all-cause mortality.