Addressing major deficiencies of its early version counterparts, the Sapien 3, a third-generation transcatheter valve, has demonstrated significant improvement in terms of ease of use, accuracy of positioning, and paravalvular sealing, according to study published Nov. 24 in the Journal of the American College of Cardiology.

Since its development, transcatheter aortic valve replacement (TAVR) has become a widespread alternative to open surgical aortic valve replacement. While subsequent studies have demonstrated its superiority to surgery for high-risk patients, limitations such as vascular complications, stroke, and paravalvular leaks resulting in aortic regurgitation have restricted TAVR to patients only categorized under a high or high-intermediate risk for surgery.

Potentially lowering the procedure's risk profile is the newly developed Sapien 3 transcatheter heart valve, which incorporates a balloon-expandable cobalt-chromium frame with bovine pericardial leaflets and an external fabric seal. Reporting the first multicenter experience with the device, the study, led by John Webb, MD, FACC, St. Paul's Hospital, University of British Columbia, Vancouver, Canada, enrolled 150 patients at 16 sites in Europe and Canada. Results showed that with a transfemoral approach chosen in 64 percent and alternative access (transapical/direct aortic) in the remainder, after 30 days paravalvular regurgitation measured none to mild in 96.4 percent and moderate in 3.5 percent (no patient experienced severe regurgitation). More importantly, transfemoral implantation was associated with low mortality (2.1 percent), no disabling stroke (0.0 percent) and fully percutaneous access and closure in 95.8 percent. Non-transfemoral alternative access was associated with a higher rate of mortality (11.6 percent) and stroke (5.6 percent).

The authors conclude that "the rates of mortality and stroke with transfemoral access are among the lowest reported and support further evaluation as an alternative to open surgery in intermediate-risk patients."

"One can now envision that this and other third-generation TAVR devices will move this procedure into low intermediate- and truly low-risk patients," writes Howard Herrmann, MD, FACC, Perelman School of Medicine at the University of Pennsylvania, in a commenting editorial. "TAVR may then become the treatment of choice for the majority of patients with severe and symptomatic aortic stenosis. However, the excitement that this new device provides to the TAVR community should be tempered by the lack of data on long-term durability, a permanent pacemaker rate higher than observed with previous balloon-expandable valves, and the residual mild aortic regurgitation rate. Nonetheless, the bar has been raised and a new standard for TAVR results has been set."

Keywords: Aortic Valve Insufficiency, Aortic Valve Stenosis, Chromium, Cobalt, Heart Valve Prosthesis, Stroke

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