BACKGROUND: Preimplantation balloon aortic valvuloplasty (BAV) is considered a routine procedure during transcatheter aortic valve implantation (TAVI) to facilitate prosthesis implantation and expansion; however, it has been speculated that fewer embolic events and/or less hemodynamic instability may occur if TAVI is performed without preimplantation BAV. The aim of this study was to systematically review the clinical outcomes associated with TAVI undertaken without preimplantation BAV. METHODS AND RESULTS: We conducted a search of Medline and Embase to identify studies that evaluated patients who underwent TAVI with or without preimplantation BAV for predilation. Pooled analysis and random-effects meta-analyses were used to estimate the rate and risk of adverse outcomes. Sixteen studies involving 1395 patients (674 with and 721 without preimplantation BAV) fulfilled the inclusion criteria. Crude device success was achieved in 94% (1311 of 1395), and 30-day all-cause mortality occurred in 6% (72 of 1282) of patients. Meta-analyses evaluating outcomes of strategies with and without preimplantation BAV showed no statistically significant differences in terms of mortality (relative risk [RR] 0.61, 95% CI 0.32-1.14, P=0.12), safety composite end point (RR 0.85, 95% CI 0.62-1.18, P=0.34), moderate to severe paravalvular leaks (RR 0.68, 95% CI 0.23-1.99, P=0.48), need for postdilation (RR 0.86, 95% CI 0.66-1.13, P=0.58), stroke and/or transient ischemic attack (RR 0.72, 95% CI 0.30-1.71, P=0.45), and permanent pacemaker implantation (RR 0.80, 95% CI 0.49-1.30, P=0.37). CONCLUSIONS: Our analysis suggests that TAVI procedures with or without preimplantation BAV were associated with similar outcomes for a number of clinically relevant end points. Further studies including a large number of patients are needed to ascertain the impact of TAVI without preimplantation BAV as a standard practice.