Clinical Outcomes With a Repositionable Self-Expanding Transcatheter Aortic Valve Prosthesis
Eberhard GrubeNicolas M. Van MieghemThomas ModineJohan BosmansGanesh ManoharanAxel LinkeWerner ScholtzDidier TchétchéRamiro TrilloClaudia FiorinaAntony WaltonChristopher J. MalkinJae K. OhHongyan QiaoStephan WindeckerEberhard GrubeEberhard GrubeStephan WindeckerJohan BosmansThomas ModineNicolas M. Van MieghemA. SinhalRobert GooleyTony WaltonGerald YongJohan BosmansJohn G. WebbMichael ChuSam RadhakrishnanAntonio DagerMarian BrannyDidier TchétchéThomas ModineEmmanuel TeígerBernard ChevalierDominique HimbertGerhard SchymikTobias ZeusChristoph JensenTienush RassafStephan FichtlschererGeorg NickenigAxel LinkeJörg KempfertWerner ScholtzAxel HarnathRuth H. StrasserChristian FrerkerKonstantinos SpargiasBéla MerkelyCorrado TamburinoAntonio ColomboAnna Sonia PetronioClaudia FiorinaFrancesco BedogniGiovanni AmorosoJan van der HeijdenNicolas M. Van MieghemPim A.L. ToninoPedro Echeverria BelizAdam WitkowskiVasco Gama RibeiroMoheeb AbdullahHellmuth WeichRamiro TrilloJosé Marı́a Hernández Garcı́aCésar Morı́sAnders JönssonChristopher J. MalkinSaib KhogaliDavid Hildick‐Smith
Key result
Repositionable self-expanding TAVR yields ~99% procedural success with low 30-day mortality and disabling stroke.
Why the study?
Clinical outcomes in large patient populations from real-world clinical practice with a next-generation self-expanding transcatheter aortic valve are lacking.
Key Points
- To assess the clinical outcomes and device performance of a next-generation repositionable, self-expanding transcatheter heart valve in routine clinical practice for severe symptomatic aortic stenosis.
- Prospective, multicenter interventional study (FORWARD Study, NCT02592369) conducted across 53 centers on 4 continents.
- Attempted transcatheter aortic valve replacement in 1,038 patients with symptomatic, severe aortic stenosis between January 2016 and December 2016.
- Evaluated endpoints via an independent clinical events committee using Valve Academic Research Consortium-2 criteria and an independent echocardiographic core laboratory.
- A single valve was successfully deployed in the intended anatomical position in 98.9% of patients, with the repositioning feature utilized in 25.8%.
- At 30 days, all-cause mortality was 1.9%, disabling stroke was 1.8%, new pacemaker implantation was 17.5%, and the expected-to-observed early surgical mortality ratio was 0.35.
- At discharge, the mean aortic valve gradient was 8.5 ± 5.6 mm Hg, and moderate or severe aortic regurgitation occurred in 1.9% of patients.
Population
1,038 patients with symptomatic, severe AS at 53 centers on 4 continents
Comparison
TAVR with a next-generation self-expanding THV system
Design
Prospective, single-arm, multinational, multicenter, observational study
Follow-up
30 days
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“TAVR is a rapidly evolving technology and an established therapy for patients with severe, symptomatic aortic stenosis who are at high or extreme risk for conventional surgery and was recently shown to be noninferior to surgical aortic valve replacement in the intermediate-risk patients treated with balloon expandable and self-expanding valves”
CHChristian HengstenbergCardiologist, Technical University Munich
“The way forward requires randomized comparisons to determine the true comparative effectiveness of each [transcatheter heart valve] in our armamentarium. This will enable us to better customize [transcatheter heart valve] therapy, and ultimately, to offer better care to our patients.”
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).
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Cite This Study
Grube et al. (2017) studied this question. TAVR with a repositionable self-expanding valve in severe aortic stenosis demonstrated high procedural success (98.9%) with 30-day all-cause mortality of 1.9% and disabling stroke of 1.8%.