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SAPIEN 3: Results strong for next-generation transcatheter valve at 30 days
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PARIS — New data presented here indicate very low rates of mortality, stroke and access-site complications at 30 days with the next-generation Sapien 3 transcatheter valve.
The Sapien 3 transcatheter heart valve (Edwards Lifesciences) features a frame designed for an ultra-low profile, an outer skirt to minimize paravalvular leak and large top-row cells to facilitate coronary access, according to John Webb, MD, McLeod Professor of Heart Valve Intervention, University of British Columbia, Vancouver, Canada, and investigator of the SAPIEN 3 trial.
For the study, Webb and colleagues enrolled 150 patients from 16 sites in Europe and North America to determine the safety and efficacy of the Sapien 3 valve. The prospective, multicenter, nonrandomized study included 50 patients at high risk — defined as STS score ≥8 or logistic EuroSCORE ≥15 — and 100 patients at high or intermediate risk, which was defined as an STS score of ≥4 to <8 or logistic EuroSCORE ≥10 to <15.
The primary endpoint was all-cause mortality at 30 days post-procedure and secondary endpoints were technical success and safety, efficacy and echocardiographic endpoints.
Overall, 96 patients were treated with transcatheter aortic valve replacement via the transfemoral (TF) route and 54 were treated via the transapical or transaortic (TAA) route.
At 30 days, the primary endpoint was reported in 4.7% of patients (TF, 1.1% vs. TAA, 11.1%). Stroke was 2.7% (TF, 1% vs. TAA, 5.6%) and major vascular complications were 6% (TF, 5.2% vs. TAA, 7.4%).
The rate of no/trace paravalvular aortic regurgitation was 72.4% (TF, 68.8% vs. TAA, 72.4%), mild aortic regurgitation was 24.1% (TF, 28.6% vs. TAA, 15.4%) and moderate aortic regurgitation was 3.4% (TF, 2.6% vs. TAA, 5.1%). There were no observed cases of severe aortic regurgitation in either group.
The rates of all-cause mortality and aortic regurgitation are among the best reported in any registry, Webb said at a press conference.
Additionally, a new permanent pacemaker was implanted in 13.3% of patients (TF, 12.5% vs. TAA, 14.8%), a higher rate than has been reported with the Sapien XT valve, Webb said at a press conference; this difference is likely due to the longer length of the Sapien 3 device vs. the Sapien XT device, Webb said.
“The SAPIEN 3 valve may enable treatment of intermediate-risk patients with aortic stenosis,” Webb concluded. – by Brian Ellis
For more information:
Webb J. Hot line: Late-breaking trials and innovations. Presented at: EuroPCR; May 20-23, 2014; Paris.
Disclosure: Webb reports serving as a consultant for Edwards Lifesciences.
Perspective
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Paul D. Williams, MD
These data are similar to what we’ve experienced in the six Sapien 3 cases performed at our center to date. Sapien 3 is a smaller device than Sapien XT, and the delivery system is now 14F with the smaller valves. We’ve had cases that wouldn’t have been possible with the XT valve, including very small iliac peripheral vascular disease; previously, this wouldn’t have been listed for the transfemoral approach, as we would have had to perform via the transapical or transaortic route.
So far, only one patient from our center had a small amount of aortic regurgitation and the rest had none. That is a substantial improvement compared with the XT device. In terms of delivery, the Sapien 3 valve is a little bit easier to use, featuring modifications to the handle that allow you to put a bit more flex on the tip of the catheter, which is good for horizontal aortas and more unfavorable aortic anatomy.
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