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

Int J Cardiol. 2017 Jan 15:227:543-549. doi: 10.1016/j.ijcard.2016.10.104. Epub 2016 Nov 1.

Abstract

Introduction: Little is known about the early and late performance of the 31mm CoreValve Revalving System (CRS, Medtronic Inc., Galway, Ireland). Our aim was to compare acute and long-term results of the 31mm 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: 31mm and other valve sizes (i.e., 23, 26, and 29mm 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 31mm group and n=1900 [92%] in the other valve sizes group) were included. After propensity matching, the implantation of the 31mm 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 31mm 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 31mm valve group through 2-years (3.8% vs. 13.5%, respectively, p=0.014).

Conclusions: The acute performance of the 31mm CRS was worse than other valve sizes but no negative impact was observed in long-term outcomes.

Keywords: CoreValve; Large annulus; TAVI; TAVR.

Publication types

  • Comparative Study
  • Multicenter Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Analysis of Variance
  • Aortic Valve / physiopathology*
  • Aortic Valve / surgery
  • Aortic Valve Stenosis / diagnostic imaging
  • Aortic Valve Stenosis / mortality
  • Aortic Valve Stenosis / surgery*
  • Bioprosthesis*
  • Cohort Studies
  • Female
  • Follow-Up Studies
  • Heart Valve Prosthesis*
  • Humans
  • Italy
  • Kaplan-Meier Estimate
  • Male
  • Propensity Score
  • Prospective Studies
  • Prosthesis Design
  • Prosthesis Failure
  • Risk Assessment
  • Severity of Illness Index
  • Statistics, Nonparametric
  • Survival Analysis
  • Time Factors
  • Transcatheter Aortic Valve Replacement / methods*
  • Transcatheter Aortic Valve Replacement / mortality
  • Treatment Outcome