Clinical outcomes after transcatheter aortic valve replacement using valve Academic Research Consortium definitions

A weighted meta-analysis of 3,519 patients from 16 studies

Philippe Genereux, Stuart J. Head, Nicolas M. Van Mieghem, Susheel Kodali, Ajay J. Kirtane, Ke Xu, Craig Smith, Patrick W. Serruys, A. Pieter Kappetein, Martin B. Leon

Research output: Contribution to journalArticle

355 Citations (Scopus)

Abstract

Objectives: This study sought to perform a weighted meta-analysis to determine the rates of major outcomes after transcatheter aortic valve replacement (TAVR) using Valve Academic Research Consortium (VARC) definitions and to evaluate their current use in the literature. Background: Recently, the published VARC definitions have helped to add uniformity to reporting outcomes after TAVR. Methods: A comprehensive search of multiple electronic databases from January 1, 2011, through October 12, 2011, was conducted using predefined criteria. We included studies reporting at least 1 outcome using VARC definitions. Results: A total of 16 studies including 3,519 patients met inclusion criteria and were included in the analysis. The pooled estimate rates of outcomes were determined according to VARC's definitions: device success, 92.1% (95% confidence interval [CI]: 88.7% to 95.5%); all-cause 30-day mortality, 7.8% (95% CI: 5.5% to 11.1%); myocardial infarction, 1.1% (95% CI: 0.2% to 2.0%); acute kidney injury stage II/III, 7.5% (95% CI: 5.1% to 11.4%); life-threatening bleeding, 15.6% (95% CI: 11.7% to 20.7%); major vascular complications, 11.9% (95% CI: 8.6% to 16.4%); major stroke, 3.2% (95% CI: 2.1% to 4.8%); and new permanent pacemaker implantation, 13.9% (95% CI: 10.6% to 18.9%). Medtronic CoreValve prosthesis use was associated with a significant higher rate of new permanent pacemaker implantation compared with the Edwards prosthesis (28.9% [95% CI: 23.0% to 36.0%] vs. 4.9% [95% CI: 3.9% to 6.2%], p < 0.0001). The 30-day safety composite endpoint rate was 32.7% (95% CI: 27.5% to 38.8%) and the 1-year total mortality rate was 22.1% (95% CI: 17.9% to 26.9%). Conclusions: VARC definitions have already been used by the TAVR clinical research community, establishing a new standard for reporting clinical outcomes. Future revisions of the VARC definitions are needed based on evolving TAVR clinical experiences.

Original languageEnglish (US)
Pages (from-to)2317-2326
Number of pages10
JournalJournal of the American College of Cardiology
Volume59
Issue number25
DOIs
StatePublished - Jun 19 2012
Externally publishedYes

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Meta-Analysis
Confidence Intervals
Research
Prostheses and Implants
Transcatheter Aortic Valve Replacement
Mortality
Acute Kidney Injury
Blood Vessels
Stroke
Myocardial Infarction
Databases
Hemorrhage
Safety
Equipment and Supplies

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Genereux, Philippe ; Head, Stuart J. ; Van Mieghem, Nicolas M. ; Kodali, Susheel ; Kirtane, Ajay J. ; Xu, Ke ; Smith, Craig ; Serruys, Patrick W. ; Kappetein, A. Pieter ; Leon, Martin B. / Clinical outcomes after transcatheter aortic valve replacement using valve Academic Research Consortium definitions : A weighted meta-analysis of 3,519 patients from 16 studies. In: Journal of the American College of Cardiology. 2012 ; Vol. 59, No. 25. pp. 2317-2326.
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title = "Clinical outcomes after transcatheter aortic valve replacement using valve Academic Research Consortium definitions: A weighted meta-analysis of 3,519 patients from 16 studies",
abstract = "Objectives: This study sought to perform a weighted meta-analysis to determine the rates of major outcomes after transcatheter aortic valve replacement (TAVR) using Valve Academic Research Consortium (VARC) definitions and to evaluate their current use in the literature. Background: Recently, the published VARC definitions have helped to add uniformity to reporting outcomes after TAVR. Methods: A comprehensive search of multiple electronic databases from January 1, 2011, through October 12, 2011, was conducted using predefined criteria. We included studies reporting at least 1 outcome using VARC definitions. Results: A total of 16 studies including 3,519 patients met inclusion criteria and were included in the analysis. The pooled estimate rates of outcomes were determined according to VARC's definitions: device success, 92.1{\%} (95{\%} confidence interval [CI]: 88.7{\%} to 95.5{\%}); all-cause 30-day mortality, 7.8{\%} (95{\%} CI: 5.5{\%} to 11.1{\%}); myocardial infarction, 1.1{\%} (95{\%} CI: 0.2{\%} to 2.0{\%}); acute kidney injury stage II/III, 7.5{\%} (95{\%} CI: 5.1{\%} to 11.4{\%}); life-threatening bleeding, 15.6{\%} (95{\%} CI: 11.7{\%} to 20.7{\%}); major vascular complications, 11.9{\%} (95{\%} CI: 8.6{\%} to 16.4{\%}); major stroke, 3.2{\%} (95{\%} CI: 2.1{\%} to 4.8{\%}); and new permanent pacemaker implantation, 13.9{\%} (95{\%} CI: 10.6{\%} to 18.9{\%}). Medtronic CoreValve prosthesis use was associated with a significant higher rate of new permanent pacemaker implantation compared with the Edwards prosthesis (28.9{\%} [95{\%} CI: 23.0{\%} to 36.0{\%}] vs. 4.9{\%} [95{\%} CI: 3.9{\%} to 6.2{\%}], p < 0.0001). The 30-day safety composite endpoint rate was 32.7{\%} (95{\%} CI: 27.5{\%} to 38.8{\%}) and the 1-year total mortality rate was 22.1{\%} (95{\%} CI: 17.9{\%} to 26.9{\%}). Conclusions: VARC definitions have already been used by the TAVR clinical research community, establishing a new standard for reporting clinical outcomes. Future revisions of the VARC definitions are needed based on evolving TAVR clinical experiences.",
author = "Philippe Genereux and Head, {Stuart J.} and {Van Mieghem}, {Nicolas M.} and Susheel Kodali and Kirtane, {Ajay J.} and Ke Xu and Craig Smith and Serruys, {Patrick W.} and Kappetein, {A. Pieter} and Leon, {Martin B.}",
year = "2012",
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Clinical outcomes after transcatheter aortic valve replacement using valve Academic Research Consortium definitions : A weighted meta-analysis of 3,519 patients from 16 studies. / Genereux, Philippe; Head, Stuart J.; Van Mieghem, Nicolas M.; Kodali, Susheel; Kirtane, Ajay J.; Xu, Ke; Smith, Craig; Serruys, Patrick W.; Kappetein, A. Pieter; Leon, Martin B.

In: Journal of the American College of Cardiology, Vol. 59, No. 25, 19.06.2012, p. 2317-2326.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Clinical outcomes after transcatheter aortic valve replacement using valve Academic Research Consortium definitions

T2 - A weighted meta-analysis of 3,519 patients from 16 studies

AU - Genereux, Philippe

AU - Head, Stuart J.

AU - Van Mieghem, Nicolas M.

AU - Kodali, Susheel

AU - Kirtane, Ajay J.

AU - Xu, Ke

AU - Smith, Craig

AU - Serruys, Patrick W.

AU - Kappetein, A. Pieter

AU - Leon, Martin B.

PY - 2012/6/19

Y1 - 2012/6/19

N2 - Objectives: This study sought to perform a weighted meta-analysis to determine the rates of major outcomes after transcatheter aortic valve replacement (TAVR) using Valve Academic Research Consortium (VARC) definitions and to evaluate their current use in the literature. Background: Recently, the published VARC definitions have helped to add uniformity to reporting outcomes after TAVR. Methods: A comprehensive search of multiple electronic databases from January 1, 2011, through October 12, 2011, was conducted using predefined criteria. We included studies reporting at least 1 outcome using VARC definitions. Results: A total of 16 studies including 3,519 patients met inclusion criteria and were included in the analysis. The pooled estimate rates of outcomes were determined according to VARC's definitions: device success, 92.1% (95% confidence interval [CI]: 88.7% to 95.5%); all-cause 30-day mortality, 7.8% (95% CI: 5.5% to 11.1%); myocardial infarction, 1.1% (95% CI: 0.2% to 2.0%); acute kidney injury stage II/III, 7.5% (95% CI: 5.1% to 11.4%); life-threatening bleeding, 15.6% (95% CI: 11.7% to 20.7%); major vascular complications, 11.9% (95% CI: 8.6% to 16.4%); major stroke, 3.2% (95% CI: 2.1% to 4.8%); and new permanent pacemaker implantation, 13.9% (95% CI: 10.6% to 18.9%). Medtronic CoreValve prosthesis use was associated with a significant higher rate of new permanent pacemaker implantation compared with the Edwards prosthesis (28.9% [95% CI: 23.0% to 36.0%] vs. 4.9% [95% CI: 3.9% to 6.2%], p < 0.0001). The 30-day safety composite endpoint rate was 32.7% (95% CI: 27.5% to 38.8%) and the 1-year total mortality rate was 22.1% (95% CI: 17.9% to 26.9%). Conclusions: VARC definitions have already been used by the TAVR clinical research community, establishing a new standard for reporting clinical outcomes. Future revisions of the VARC definitions are needed based on evolving TAVR clinical experiences.

AB - Objectives: This study sought to perform a weighted meta-analysis to determine the rates of major outcomes after transcatheter aortic valve replacement (TAVR) using Valve Academic Research Consortium (VARC) definitions and to evaluate their current use in the literature. Background: Recently, the published VARC definitions have helped to add uniformity to reporting outcomes after TAVR. Methods: A comprehensive search of multiple electronic databases from January 1, 2011, through October 12, 2011, was conducted using predefined criteria. We included studies reporting at least 1 outcome using VARC definitions. Results: A total of 16 studies including 3,519 patients met inclusion criteria and were included in the analysis. The pooled estimate rates of outcomes were determined according to VARC's definitions: device success, 92.1% (95% confidence interval [CI]: 88.7% to 95.5%); all-cause 30-day mortality, 7.8% (95% CI: 5.5% to 11.1%); myocardial infarction, 1.1% (95% CI: 0.2% to 2.0%); acute kidney injury stage II/III, 7.5% (95% CI: 5.1% to 11.4%); life-threatening bleeding, 15.6% (95% CI: 11.7% to 20.7%); major vascular complications, 11.9% (95% CI: 8.6% to 16.4%); major stroke, 3.2% (95% CI: 2.1% to 4.8%); and new permanent pacemaker implantation, 13.9% (95% CI: 10.6% to 18.9%). Medtronic CoreValve prosthesis use was associated with a significant higher rate of new permanent pacemaker implantation compared with the Edwards prosthesis (28.9% [95% CI: 23.0% to 36.0%] vs. 4.9% [95% CI: 3.9% to 6.2%], p < 0.0001). The 30-day safety composite endpoint rate was 32.7% (95% CI: 27.5% to 38.8%) and the 1-year total mortality rate was 22.1% (95% CI: 17.9% to 26.9%). Conclusions: VARC definitions have already been used by the TAVR clinical research community, establishing a new standard for reporting clinical outcomes. Future revisions of the VARC definitions are needed based on evolving TAVR clinical experiences.

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