Author + information
- Received October 27, 2011
- Revision received February 7, 2012
- Accepted February 23, 2012
- Published online June 19, 2012.
- Philippe Généreux, MD⁎,†,
- Stuart J. Head, MSc‡,
- Nicolas M. Van Mieghem, MD§,
- Susheel Kodali, MD⁎,
- Ajay J. Kirtane, MD, SM⁎,
- Ke Xu, PhD⁎,
- Craig Smith, MD⁎,
- Patrick W. Serruys, MD, PhD§,
- A. Pieter Kappetein, MD, PhD‡ and
- Martin B. Leon, MD⁎,⁎ ()
- ↵⁎Reprint requests and correspondence:
Dr. Martin B. Leon, Columbia University Medical Center, New York–Presbyterian Hospital, 177 Fort Washington Avenue, New York, New York 10032
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.
Dr. Généreux has received speaker honoraria, consulting fees, and a research grant from Edwards Lifesciences. Dr. Kodali has received consulting fees from Edwards Lifesciences and St. Jude Medical; is on the Steering Committee for Edwards Lifesciences; is on the TAVI Advisory Board for St. Jude Medical; and is on the scientific advisory boards of Thubrikar Aortic Valve and Paieon Medical. Dr. Smith is a nonpaid member of the Scientific Advisory Board of Edwards Lifesciences; is co-PI on the PARTNER trial whose sponsor is Edwards Lifesciences and reimburses him for travel and other customary expenses. Dr. Kappetein is member of steering committee of the SURTAVI trial sponsored by Edwards Lifesciences and Medtronic Vascular. Dr. Leon is a nonpaid member of the Scientific Advisory Board of Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Drs. Généreux and Head contributed equally to this work.
- Received October 27, 2011.
- Revision received February 7, 2012.
- Accepted February 23, 2012.
- American College of Cardiology Foundation