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Published on: May 21, 2017
Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis
Jeffrey J Popma1, David H Adams2, Michael J Reardon3
1Beth Israel Deaconess Medical Center, Boston, Massachusetts.
Insights
Transcatheter aortic valve replacement (TAVR) using the CoreValve system is safe and effective for severe aortic stenosis patients at high surgical risk. This self-expanding bioprosthesis demonstrated favorable outcomes, meeting its primary safety and efficacy endpoints.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Biomedical Engineering
Background:
- Severe aortic stenosis is a progressive condition with a poor prognosis.
- Transcatheter aortic valve replacement (TAVR) offers a potential therapeutic option for high-risk patients.
Purpose of the Study:
- To evaluate the safety and efficacy of the CoreValve transcatheter heart valve (THV) for severe aortic stenosis.
- To assess TAVR in patients with prohibitive surgical risks.
Main Methods:
- A prospective, multicenter, nonrandomized study.
- Evaluated self-expanding TAVR in 489 patients with symptomatic severe aortic stenosis.
- Primary endpoint: composite of all-cause mortality or major stroke at 12 months compared to an objective performance goal.
Main Results:
- The 12-month mortality/stroke rate was 26.0%, significantly better than the 43.0% objective performance goal (p < 0.0001).
- 12-month all-cause mortality was 24.3%; major stroke was 4.3%.
- Moderate/severe paravalvular regurgitation decreased from 10.7% at discharge to 4.2% at 12 months.
Conclusions:
- TAVR with the self-expanding CoreValve bioprosthesis is safe and effective for patients with severe aortic stenosis and prohibitive surgical risk.
- The study met its primary safety and efficacy endpoints.
- CoreValve THV provides a viable alternative to surgical valve replacement in this high-risk population.
Objectives:
This study sought to evaluate the safety and efficacy of the CoreValve transcatheter heart valve (THV) for the treatment of severe aortic stenosis in patients at extreme risk for surgery.
Background:
Untreated severe aortic stenosis is a progressive disease with a poor prognosis. Transcatheter aortic valve replacement (TAVR) with a self-expanding bioprosthesis is a potentially effective therapy.
Methods:
We performed a prospective, multicenter, nonrandomized investigation evaluating the safety and efficacy of self-expanding TAVR in patients with symptomatic severe aortic stenosis with prohibitive risks for surgery. The primary endpoint was a composite of all-cause mortality or major stroke at 12 months, which was compared with a pre-specified objective performance goal (OPG).
Results:
A total of 41 sites in the United States recruited 506 patients, of whom 489 underwent attempted treatment with the CoreValve THV. The rate of all-cause mortality or major stroke at 12 months was 26.0% (upper 2-sided 95% confidence bound: 29.9%) versus 43.0% with the OPG (p < 0.0001). Individual 30-day and 12-month events included all-cause mortality (8.4% and 24.3%, respectively) and major stroke (2.3% and 4.3%, respectively). Procedural events at 30 days included life-threatening/disabling bleeding (12.7%), major vascular complications (8.2%), and need for permanent pacemaker placement (21.6%). The frequency of moderate or severe paravalvular aortic regurgitation was lower 12 months after self-expanding TAVR (4.2%) than at discharge (10.7%; p = 0.004 for paired analysis).
Conclusions:
TAVR with a self-expanding bioprosthesis was safe and effective in patients with symptomatic severe aortic stenosis at prohibitive risk for surgical valve replacement. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902).
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