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

A multicenter study

Guilherme F Attizzani, Yohei Ohno, Azeem Latib, Anna Sonia Petronio, Cristina Giannini, Federica Ettori, Salvatore Curello, Francesco Bedogni, Denise Todaro, Nedy Brambilla, Giuseppe Bruschi, Paola Colombo, Patrizia Presbitero, Rosario Fiorilli, Arnaldo Poli, Paola Martina, Antonio Colombo, Marco Barbanti, Corrado Tamburino

Research output: Contribution to journalArticle

6 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)543-549
Number of pages7
JournalInternational Journal of Cardiology
Volume227
DOIs
Publication statusPublished - Jan 15 2017

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Multicenter Studies
Propensity Score
Ireland
Prostheses and Implants
Equipment and Supplies
Research
Transcatheter Aortic Valve Replacement

Keywords

  • Aged
  • Aged, 80 and over
  • Analysis of Variance
  • Aortic Valve/physiopathology
  • Aortic Valve Stenosis/diagnostic imaging
  • 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
  • Treatment Outcome

Cite this

Acute and long-term (2-years) clinical outcomes of the CoreValve 31mm in large aortic annuli : A multicenter study. / Attizzani, Guilherme F; Ohno, Yohei; Latib, Azeem; Petronio, Anna Sonia; Giannini, Cristina; Ettori, Federica; Curello, Salvatore; Bedogni, Francesco; Todaro, Denise; Brambilla, Nedy; Bruschi, Giuseppe; Colombo, Paola; Presbitero, Patrizia; Fiorilli, Rosario; Poli, Arnaldo; Martina, Paola; Colombo, Antonio; Barbanti, Marco; Tamburino, Corrado.

In: International Journal of Cardiology, Vol. 227, 15.01.2017, p. 543-549.

Research output: Contribution to journalArticle

Attizzani, GF, Ohno, Y, Latib, A, Petronio, AS, Giannini, C, Ettori, F, Curello, S, Bedogni, F, Todaro, D, Brambilla, N, Bruschi, G, Colombo, P, Presbitero, P, Fiorilli, R, Poli, A, Martina, P, Colombo, A, Barbanti, M & Tamburino, C 2017, 'Acute and long-term (2-years) clinical outcomes of the CoreValve 31mm in large aortic annuli: A multicenter study', International Journal of Cardiology, vol. 227, pp. 543-549. https://doi.org/10.1016/j.ijcard.2016.10.104
Attizzani, Guilherme F ; Ohno, Yohei ; Latib, Azeem ; Petronio, Anna Sonia ; Giannini, Cristina ; Ettori, Federica ; Curello, Salvatore ; Bedogni, Francesco ; Todaro, Denise ; Brambilla, Nedy ; Bruschi, Giuseppe ; Colombo, Paola ; Presbitero, Patrizia ; Fiorilli, Rosario ; Poli, Arnaldo ; Martina, Paola ; Colombo, Antonio ; Barbanti, Marco ; Tamburino, Corrado. / Acute and long-term (2-years) clinical outcomes of the CoreValve 31mm in large aortic annuli : A multicenter study. In: International Journal of Cardiology. 2017 ; Vol. 227. pp. 543-549.
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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.",
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TY - JOUR

T1 - Acute and long-term (2-years) clinical outcomes of the CoreValve 31mm 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 - Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

PY - 2017/1/15

Y1 - 2017/1/15

N2 - 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.

AB - 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.

KW - Aged

KW - Aged, 80 and over

KW - Analysis of Variance

KW - Aortic Valve/physiopathology

KW - Aortic Valve Stenosis/diagnostic imaging

KW - Bioprosthesis

KW - Cohort Studies

KW - Female

KW - Follow-Up Studies

KW - Heart Valve Prosthesis

KW - Humans

KW - Italy

KW - Kaplan-Meier Estimate

KW - Male

KW - Propensity Score

KW - Prospective Studies

KW - Prosthesis Design

KW - Prosthesis Failure

KW - Risk Assessment

KW - Severity of Illness Index

KW - Statistics, Nonparametric

KW - Survival Analysis

KW - Time Factors

KW - Transcatheter Aortic Valve Replacement/methods

KW - Treatment Outcome

U2 - 10.1016/j.ijcard.2016.10.104

DO - 10.1016/j.ijcard.2016.10.104

M3 - Article

VL - 227

SP - 543

EP - 549

JO - International Journal of Cardiology

JF - International Journal of Cardiology

SN - 0167-5273

ER -