2017-08-15
Clinical Outcomes With a Repositionable Self-Expanding Transcatheter Aortic Valve Prosthesis
Publication
Publication
The International FORWARD Study
Journal of the American College of Cardiology , Volume 70 - Issue 7 p. 845- 853
BACKGROUND Clinical outcomes in large patient populations from real-world clinical practice with a next-generation
self-expanding transcatheter aortic valve are lacking.
OBJECTIVES This study sought to document the clinical and device performance outcomes of transcatheter aortic
valve replacement (TAVR) with a next-generation, self-expanding transcatheter heart valve (THV) system in patients
with severe symptomatic aortic stenosis (AS) in routine clinical practice.
METHODS The FORWARD (CoreValve Evolut R FORWARD) study is a prospective, single-arm, multinational, multicenter,
observational study. An independent clinical events committee adjudicated safety endpoints based on Valve
Academic Research Consortium-2 definitions. An independent echocardiographic core laboratory evaluated all echocardiograms.
From January 2016 to December 2016, TAVR with the next-generation self-expanding THV was attempted in
1,038 patients with symptomatic, severe AS at 53 centers on 4 continents.
RESULTS Mean age was 81.8 ± 6.2 years, 64.9% were women, the mean Society of Thoracic Surgeons Predicted Risk of
Mortality was 5.5 ± 4.5%, and 33.9% of patients were deemed frail. The repositioning feature of the THV was applied in
25.8% of patients. A single valve was implanted in the proper anatomic location in 98.9% of patients. The mean aortic
valve gradient was 8.5 ± 5.6 mm Hg, and moderate or severe aortic regurgitation was 1.9% at discharge. All-cause
mortality was 1.9%, and disabling stroke occurred in 1.8% at 30 days. The expected-to-observed early surgical mortality
ratio was 0.35. A pacemaker was implanted in 17.5% of patients.
CONCLUSIONS TAVR using the next-generation THV is clinically safe and effective for treating older patients
with severe AS at increased operative risk.
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doi.org/10.1016/j.jacc.2017.06.045, hdl.handle.net/1765/101055 | |
Journal of the American College of Cardiology | |
Organisation | Erasmus MC: University Medical Center Rotterdam |
Grube, E., van Mieghem, N., Bleiziffer, S., Modine, T., Bosmans, J., Manoharan, G., … Windecker, S. (2017). Clinical Outcomes With a Repositionable Self-Expanding Transcatheter Aortic Valve Prosthesis. Journal of the American College of Cardiology, 70(7), 845–853. doi:10.1016/j.jacc.2017.06.045 |