Usefulness of Predilation Before Transcatheter Aortic Valve Implantation

Abstract

Balloon predilation is historically considered a requirement before performing transcatheter aortic valve implantation (TAVI). As the procedure has evolved, it has been questioned whether it is actually needed, but data are lacking on mid-term outcomes. The aim of this study was to evaluate the effect of balloon predilation before TAVI. A total of 517 patients who underwent transfemoral TAVI from November 2007 to October 2015 were analyzed. The devices implanted included the Medtronic CoreValve (n = 216), Medtronic Evolut R (n = 30), Edwards SAPIEN XT (n = 210), and Edwards SAPIEN 3 (n = 61). Patients were divided into 2 groups depending on whether pre-implantation balloon aortic valvuloplasty (pre-BAV) was performed (n = 326) or not (n = 191). Major adverse cardiac and cerebrovascular events (MACCE) were primarily evaluated. Propensity score matching was used to adjust for differences in baseline characteristics and potential confounders (n = 113 pairs). In the overall cohort, patients without pre-BAV had a significantly higher MACCE rate at 30 days, driven by a higher incidence of stroke (0.3% pre-BAV vs 3.7% no-pre-BAV, p <0.01). MACCE and mortality at 1 year were, however, similar in both groups. Independent predictors of MACCE at 1 year included serum creatinine, NYHA class 3 to 4, logistic European System for Cardiac Operative Risk Evaluation, and postdilation. Of note, the postdilation rate was higher in the no-pre-BAV group (21.5% pre-BAV vs 35.6% no-pre-BAV, p <0.001). After propensity score matching, there were no differences in MACCE between the 2 groups. In conclusion, this study showed that, in selected patients and with specific transcatheter valves, TAVI without pre-BAV appears to be associated with similar mid-term outcomes compared with TAVI with pre-BAV, but it may increase the need for postdilation.