Transcatheter aortic valve implantation (TAVI) has expanded the options for the treatment of severe aortic stenosis, particularly in patients for whom the surgical risk of valve replacement is felt to be prohibitive. Prior studies have demonstrated TAVI reduces mortality relative to medical management among patients unable to undergo valve surgery. Among patients considered to be at high surgical risk, TAVI has been shown to have similar 1-year survival compared to surgery, but associated with a higher rate of stroke. In this study of the CoreValve self-expanding transcatheter bioprosthethic valve, patients deemed to be at high surgical risk (estimated risk of death ≥ 15% within 30 days of surgery) were randomized in a 1:1 fashion to either TAVI or surgical valve replacement. The primary end-point was mortality at 1 year. A total of 795 patients were randomized at 45 experienced US centers. Although the trial was powered for non-inferiority, TAVI demonstrated an absolute 1-year mortality reduction of 4.9% (14.2% vs. 19.1%) demonstrating not only non-inferiority (P<0.001), but actual superiority (P=0.04). In additional analyses, paravalvular leak was more common in TAVI patients, while quality of life indices and rates of stroke were similar in TAVI and surgical patients.
In this study of the CoreValve bioprosthesis, 1-year survival was greater among patients with severe aortic stenosis and high operative risk treated with TAVI in comparison to conventional surgical valve replacement. We now await studies evaluating the outcome of TAVI in lower risk patients with severe aortic stenosis.
Summarized by Steven M. Bradley and Hussain Contractor
- Adams DH, Popma JJ, Reardon MJ, Yakubov SJ, Coselli JS, Deeb GM, Gleason TG, Buchbinder M, Hermiller J Jr, Kleiman NS, Chetcuti S, Heiser J, Merhi W, Zorn G, Tadros P, Robinson N, Petrossian G, Hughes GC, Harrison JK, Conte J, Maini B, Mumtaz M, Chenoweth S and Oh JK. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014 May 8;370(19):1790-8.