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Observational Study
. 2017 Aug 15;70(7):845-853.
doi: 10.1016/j.jacc.2017.06.045.

Clinical Outcomes With a Repositionable Self-Expanding Transcatheter Aortic Valve Prosthesis: The International FORWARD Study

Eberhard Grube  1 , Nicolas M Van Mieghem  2 , Sabine Bleiziffer  3 , Thomas Modine  4 , Johan Bosmans  5 , Ganesh Manoharan  6 , Axel Linke  7 , Werner Scholtz  8 , Didier Tchétché  9 , Ariel Finkelstein  10 , Ramiro Trillo  11 , Claudia Fiorina  12 , Antony Walton  13 , Christopher J Malkin  14 , Jae K Oh  15 , Hongyan Qiao  16 , Stephan Windecker  17 ; FORWARD Study Investigators
Collaborators, Affiliations
Free article
Observational Study

Clinical Outcomes With a Repositionable Self-Expanding Transcatheter Aortic Valve Prosthesis: The International FORWARD Study

Eberhard Grube et al. J Am Coll Cardiol. .
Free article

Abstract

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. (CoreValve Evolut R FORWARD Study [FORWARD]; NCT02592369).

Keywords: aortic stenosis; degenerative valve; transcatheter aortic valve replacement.

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Comment in

  • A Move FORWARD in the Evolution of TAVR?
    Hengstenberg C, Husser O. Hengstenberg C, et al. J Am Coll Cardiol. 2017 Aug 15;70(7):854-856. doi: 10.1016/j.jacc.2017.06.056. J Am Coll Cardiol. 2017. PMID: 28797354 No abstract available.

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