Keele Research Repository

Objectives: Pre-implantation balloon-aortic valvuloplasty (BAV) is considered 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 hemodynamic instability may occur if TAVI is performed without pre-implantation BAV. Hence, the aim of the study was to systematically review the clinical outcomes associated with TAVI undertaken without pre-implantation BAV. Methods and Results: We conducted a search of MEDLINE and EMBASE to identify studies that evaluated patients who underwent TAVI with/without pre-implantation 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 (674/721 with/without preimplantation BAV) fulfilled the inclusion criteria. Crude device success was achieved in 94% (1311/1395) and 30-day all-cause mortality occurred in 6% (72/1282) of patients. Meta-analyses evaluating outcomes between pre-implantation BAV versus without BAV strategies showed no statistically significant differences in terms of mortality (risk ratio [RR]: 0.61, 95% confidence interval [CI]: 0.32-1.14, P=0.12), safety composite endpoint (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). Conclusion: Our analysis suggests that TAVI procedures with or without pre-implantation BAV were associated with similar outcomes in a number of clinically relevant endpoints. Further Disclaimer: The manuscript and its contents are confidential, intended for journal review purposes only, and not to be further disclosed. JAHA/2015/003191-R1 3 studies including a significant number of patients are needed to ascertain the impact of TAVI without pre-implantation BAV as a standard practice.