Recently, the published VARC definitions have helped to add uniformity to reporting outcomes after TAVR.
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.
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%).
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.