Using a balloon-expandable valve instead of a self-expandable valve may be a better option among patients undergoing transcatheter aortic valve replacement (TAVR), based on research presented March 30 at the American College of Cardiology (ACC) annual scientific session in Washington, D.C. Researchers found more device success with the balloon-expandable device and similar rates of mortality and fewer complications.
The Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: Medtronic CoreValve vs. Edwards SAPIEN XT (CHOICE) trial compared a balloon-expanding valve (the Edwards SAPIEN XT; Edwards Lifesciences) with a self-expanding valve (CoreValve; Medtronic). Investigators led by Mohamed Abdel-Wahab, MD, of the Academic Teaching Hospital of the Universities of Kiel and Hamburg in Bad Segeberg, Germany, randomized 241 patients with severe aortic stenosis at five centers in Germany to either the balloon-expanding valve group (121 participants) or the self-expanding valve group (120 participants).
The primary outcome was device success, defined as a composite endpoint that included successful vascular access, deployment of the device and retrieval of the delivery system, correct device position, intended device performance without moderate or severe regurgitation and only one valve implanted in the correct location. Secondary outcomes included cardiovascular mortality, bleeding, vascular complications, pacemaker placement after the procedure and a 30-day composite safety endpoint of mortality from any cause, major stroke and major complications.
The rate of device success was higher in the balloon-expandable valve group compared with the self-expanding valve group (95.9 percent vs. 77.5 percent). The difference was due to a significantly lower rate of residual more-than-mild regurgitation (4.1 percent vs. 18.3 percent) and a lower rate of need to implant more than one valve (0.8 percent vs. 5.8 percent).
Cardiovascular mortality at 30 days was about the same in both groups (4.1 percent in the balloon-expanding valve group and 4.3 percent in the self-expanding valve group). Bleeding and vascular complication rates were also similar, and the rates of the combined safety endpoint were 18.2 percent in the balloon-expanding valve group and 23.1 percent in the self-expanding valve group. Participants in the balloon-expandable group also needed fewer new permanent pacemakers (17.3 percent vs. 37.6 percent).
The findings were published simultaneously in the Journal of the American Medical Association.