VARC Definitions Evaluated for Measuring TAVR Outcomes

April 11, 2012—A weighted meta-analysis was performed 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. The findings were published by Philippe Généreux, MD, et al online ahead of print in the Journal of the American College of Cardiology.

The investigators conducted a comprehensive search of multiple electronic databases from January 1, 2011, through October 12, 2011, using predefined criteria. They included studies reporting at least one outcome using VARC definitions. The investigators noted that the VARC definitions have helped to add uniformity to reporting outcomes after TAVR since they were first available online in January 2011 and published by Martin B. Leon, MD, at al in the European Heart Journal (2011;32:205–217).

As detailed in the Journal of the American College of Cardiology, 16 studies composed of 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%).

The investigators found that the use of the Medtronic CoreValve prosthesis (Medtronic, Inc., Minneapolis, MN) was associated with a significantly higher rate of new permanent pacemaker implantation compared with the Edwards Sapien prosthesis (Edwards Lifesciences, Irvine, CA): 28.9% (95% CI: 23.0% to 36.0%) versus 4.9% (95% CI: 3.9% to 6.2%) (P < .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%).

The investigators concluded that the VARC definitions, which have already been used by the TAVR clinical research community, establish a new standard for reporting clinical outcomes and that future revisions of the VARC definitions are needed based on evolving TAVR clinical experiences.