Feasibility, safety, and efficacy of transcatheter aortic valve replacement without balloon predilation: A systematic review and meta-analysis.

OBJECTIVES: To evaluate the feasibility, safety, and efficacy of direct transcatheter aortic valve replacement (TAVR), that is, TAVR without balloon predilation (BPD), by performing a systematic review and meta-analysis of available evidence.
BACKGROUND: Avoiding BPD during TAVR was shown to be feasible in previous studies but the risks and benefits of this technique are unknown owing to the limited number of patients included in these studies.
METHODS: We performed a systematic search for studies comparing direct TAVR vs TAVR performed with BPD. Crude risk ratios (RRs) or mean differences and 95% confidence intervals (CI) for each endpoint were calculated using random effects models.
RESULTS: Twenty studies including 3586 patients (1606 undergoing direct TAVR) were selected for the analysis. Mean device success with direct TAVR was 88% with <5% of bail-out techniques. There were no differences between direct and BPD-TAVR in short-term (in-hospital or 30-day) mortality (RR: 1.06; 95% CI: 0.78-1.43) or cerebrovascular events (RR: 0.92; 95% CI: 0.58-1.46). Direct TAVR associated with reduced moderate or severe paravalvular leak post-TAVR (RR: 0.59; 95% CI: 0.36-0.98) but not with a reduced risk of permanent pacemaker implantation (RR: 0.85, 95% CI: 0.71-1.02). A slight increase in postdilation was observed in direct transfemoral-TAVR recipients (RR: 1.2; 95% CI: 1.00-1.44).
CONCLUSION: Direct TAVR is feasible and safe. However, given the unadjusted nature of our results, uncertainties remain regarding the independent effect of direct TAVR on outcomes post-TAVR. Randomized studies are warranted to determine the potential benefits of direct TAVR.