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Transcatheter aortic valve replacement (TAVR) has been approved by US FDA for high surgical risk and inoperable patients with severe aortic stenosis. However, there is no single large study comparing the performance of valves with respect to mortality or stroke.
To compare the 30-day mortality and stroke outcomes in TAVR patients treated with balloon expandable valve (BEV, Edwards Lifesciences Corporation, Irvine, Ca) and self-expanding valve (SEV, Medtronic CV, Luxembourg S.a.r.l.).
We performed an electronic search for studies published between 2009 and 2014 reporting clinical outcomes for BEV and SEV. Pooled odd’s ratio with 95% confidence intervals was calculated using Mantel Haenszel random effects model.
A total of 165 studies were initially selected of which 10 studies were included in the final analysis, yielding a total of 5204 patients (2779 with Edwards Valve and 2425 with CoreValve). Pooled estimate of 30-day mortality was 9.4% (493/5204) and of stroke was 1.3% (71/5204). There was no difference in the 30-day mortality between the valves (OR 1.03, 95% CI 0.76 to 1.39). There was no statistically significant difference in stroke risk (OR 1.75, 95% CI 0.96 to 3.21). Figure 1
Post-operative mortality and stroke risk appear to be similar with both valves. Large randomized controlled trials assessing clinical outcomes are warranted as these analyses may be confounded by heterogeneity in study population, baseline risk characteristics and TAVR approaches.