Journal article
Clinical Outcomes With a Repositionable Self-Expanding Transcatheter Aortic Valve Prosthesis: The International FORWARD Study.
- Grube E Department of Medicine, University of Bonn, Bonn, Germany. Electronic address: grubee@aol.com.
- Van Mieghem NM Department of Cardiology, Erasmus Medical Centre Rotterdam, Rotterdam, the Netherlands.
- Bleiziffer S Department of Cardiovascular Surgery, German Heart Center, Munich, Germany.
- Modine T Department of Cardiovascular Surgery, Lille University Hospital, Lille, France.
- Bosmans J Department of Cardiology, University Hospital Antwerp, Antwerp, Belgium.
- Manoharan G Regional Cardiology Department, Royal Victoria Hospital, Belfast, United Kingdom.
- Linke A Department of Internal Medicine/Cardiology, Heart Centre, University of Leipzig, Leipzig, Germany.
- Scholtz W Department of Interventional Cardiology, Heart and Diabetes Centre, NRW Bad Oeynhausen, Bad Oeynhausen, Germany.
- Tchétché D Department of Cardiology, Clinique Pasteur Toulouse, Toulouse, France.
- Finkelstein A Department of Cardiology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
- Trillo R Department of Cardiology, Complejo Hospitalario Universitario de Santiago de Compostela, Santiago de Compostela, Spain.
- Fiorina C Cardiothoracic Department, Spedali Civili Brescia, Brescia, Italy.
- Walton A Department of Cardiology, The Alfred Hospital, Melbourne, Victoria, Australia.
- Malkin CJ Department of Cardiology, Leeds General Infirmary, Leeds, United Kingdom.
- Oh JK Mayo Clinic, Rochester, Minnesota.
- Qiao H Statistical Services, Medtronic, Minneapolis, Minnesota.
- Windecker S Department of Cardiology, University Hospital Bern, Bern, Switzerland.
- 2017-08-12
Published in:
- Journal of the American College of Cardiology. - 2017
aortic stenosis
degenerative valve
transcatheter aortic valve replacement
Aged, 80 and over
Aortic Valve Stenosis
Cause of Death
Echocardiography
Female
Follow-Up Studies
Global Health
Heart Valve Prosthesis
Humans
Male
Multidetector Computed Tomography
Prospective Studies
Prosthesis Design
Risk Factors
Severity of Illness Index
Survival Rate
Time Factors
Transcatheter Aortic Valve Replacement
Treatment Outcome
English
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).
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).
- Language
-
- English
- Open access status
- bronze
- Identifiers
-
- DOI 10.1016/j.jacc.2017.06.045
- PMID 28797353
- Persistent URL
- https://folia.unifr.ch/global/documents/201287
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