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.

Additional Metadata
Keywords aortic stenosis, degenerative valve, transcatheter aortic valve replacement
Persistent URL dx.doi.org/10.1016/j.jacc.2017.06.045, hdl.handle.net/1765/101055
Journal Journal of the American College of Cardiology
Note for the FORWARD Study Investigators (CoreValve Evolut R FORWARD Study [FORWARD]; NCT02592369)
Citation
Grube, E, van Mieghem, N.M, Bleiziffer, S, Modine, T, Bosmans, J, Manoharan, G, … Windecker, S.W. (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