Acute and long-term (2-years) clinical outcomes of the CoreValve 31Â mm in large aortic annuli: A multicenter study

Introduction Little is known about the early and late performance of the 31 mm CoreValve Revalving System (CRS, Medtronic Inc., Galway, Ireland). Our aim was to compare acute and long-term results of the 31 mm CRS with other valve sizes. Methods Consecutive patients undergoing transcatheter aortic valve implantation (TAVI) with CRS in nine Italian centers were prospectively included and dichotomized according to prosthesis size in two different groups, as follows: 31 mm and other valve sizes (i.e., 23, 26, and 29 mm combined). End points were defined according to Valve Academic Research Consortium definitions. Propensity score matching was performed. Results In total, 2069 patients (n = 169 [8%] in the 31 mm group and n = 1900 [92%] in the other valve sizes group) were included. After propensity matching, the implantation of the 31 mm valve was associated with lower rates of procedural- (91.3% vs. 98.1%, p = 0.030) and device-success (88.5% vs. 97.1%, p = 0.016), longer procedural time (120 [80–180] min. vs. 90 [60–120] min., p < 0.001), and higher rates of implantation of a second valve (10.6% vs. 2.9%, respectively, p = 0.027). The rates of permanent pacemaker implantation in the 31 mm group were higher but not statistically different from other valve sizes (41.7% vs. 30.9%, respectively, p = 0.149). Significant improvement, without between-group differences, was observed in NYHA functional class. Cardiovascular death was lower in the 31 mm valve group through 2-years (3.8% vs. 13.5%, respectively, p = 0.014). Conclusions The acute performance of the 31 mm CRS was worse than other valve sizes but no negative impact was observed in long-term outcomes.