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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
Study Questions:
What are the rates of major outcomes after transcatheter aortic valve replacement (TAVR) using Valve Academic Research Consortium (VARC) definitions, and their current use in the literature?
Methods:
A comprehensive search of multiple electronic databases from January 1, 2011, through October 12, 2011, was conducted using predefined criteria. The authors included studies reporting at least one 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], 88.7-95.5%); all-cause 30-day mortality, 7.8% (95% CI, 5.5-11.1%); myocardial infarction, 1.1% (95% CI, 0.2-2.0%); acute kidney injury stage II/III, 7.5% (95% CI, 5.1-11.4%); life-threatening bleeding, 15.6% (95% CI, 11.7-20.7%); major vascular complications, 11.9% (95% CI, 8.6-16.4%); major stroke, 3.2% (95% CI, 2.1-4.8%); and new permanent pacemaker implantation, 13.9% (95% CI, 10.6-18.9%). Medtronic CoreValve prosthesis use was associated with a significantly higher rate of new permanent pacemaker implantation compared with the Edwards prosthesis (28.9% [95% CI, 23.0-36.0%] vs. 4.9% [95% CI, 3.9-6.2%], p < 0.0001). The 30-day safety composite endpoint rate was 32.7% (95% CI, 27.5-38.8%), and the 1-year total mortality rate was 22.1% (95% CI, 17.9-26.9%).
Conclusions:
The authors concluded that VARC definitions have already been used by the TAVR clinical research community, establishing a new standard for reporting clinical outcomes.
Perspective:
The primary study findings are that the VARC definitions have already been widely used by the TAVR community since their introduction earlier this year, and these definitions have established an important uniformity for outcomes after TAVR. However, refinement and modifications of the current VARC definitions may be needed, which are in progress. Furthermore, appropriate recognition and ascertaining, reporting, and adjudication of outcomes should be reinforced and will ensure that TAVR study results are a valid reflection of ‘real-world’ clinical events.
Keywords: Heart Valve Prosthesis, Myocardial Infarction, Stroke, Acute Kidney Injury, Confidence Intervals, Hemorrhage
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