TY - JOUR
T1 - Acute and long-term (2-years) clinical outcomes of the CoreValve 31 mm in large aortic annuli
T2 - A multicenter study
AU - Attizzani, Guilherme F.
AU - Ohno, Yohei
AU - Latib, Azeem
AU - Petronio, Anna Sonia
AU - Giannini, Cristina
AU - Ettori, Federica
AU - Curello, Salvatore
AU - Bedogni, Francesco
AU - Todaro, Denise
AU - Brambilla, Nedy
AU - Bruschi, Giuseppe
AU - Colombo, Paola
AU - Presbitero, Patrizia
AU - Fiorilli, Rosario
AU - Poli, Arnaldo
AU - Martina, Paola
AU - Colombo, Antonio
AU - Barbanti, Marco
AU - Tamburino, Corrado
N1 - Publisher Copyright:
© 2016 Elsevier Ireland Ltd
PY - 2017/1/15
Y1 - 2017/1/15
N2 - 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.
AB - 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.
KW - CoreValve
KW - Large annulus
KW - TAVI
KW - TAVR
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U2 - 10.1016/j.ijcard.2016.10.104
DO - 10.1016/j.ijcard.2016.10.104
M3 - Article
C2 - 27816304
AN - SCOPUS:85004091917
SN - 0167-5273
VL - 227
SP - 543
EP - 549
JO - International Journal of Cardiology
JF - International Journal of Cardiology
ER -