ArticleClinical research in cardiology : official journal of the German Cardiac Society2016
Applicability of next generation balloon-expandable transcatheter heart valves in aortic annuli exceeding formally approved dimensions.
Article in Clinical research in cardiology : official journal of the German Cardiac Society, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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10 citing papers in PubMed, 15 citations in OpenAlex.
- Comparison of Latest Generation Intra- and Supra-Annular Self-Expanding Transcatheter Heart Valves for Aortic Valve-in-Valve Procedures.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2025Article
- Feasibility and outcome of third-generation transcatheter aortic valve implantation in patients with extra-large aortic annulus.Clinical research in cardiology : official journal of the German Cardiac Society · 2024Article
- Valve-in-valve procedures for degenerated surgical and transcatheter aortic valve bioprostheses using a latest-generation self-expanding intra-annular transcatheter heart valve.Frontiers in cardiovascular medicine · 2023Article
- Early commercial experience with a newly designed balloon-expandable transcatheter heart valve: 30-day outcomes and implications of preprocedural computed tomography.Interactive cardiovascular and thoracic surgery · 2021Article
- TAVI for Pure Non-calcified Aortic Regurgitation Using a Self-Expandable Transcatheter Heart Valve.Frontiers in cardiovascular medicine · 2021Article
- Transcatheter aortic valve implantation in patients with bicuspid aortic valve stenosis utilizing the next-generation fully retrievable and repositionable valve system: mid-term results from a prospective multicentre registry.Clinical research in cardiology : official journal of the German Cardiac Society · 2020Article
- Transaxillary transcatheter aortic valve implantation utilizing a novel vascular closure device with resorbable collagen material: a feasibility study.Clinical research in cardiology : official journal of the German Cardiac Society · 2019Article
- Transcatheter valve-in-valve implantation (VinV-TAVR) for failed surgical aortic bioprosthetic valves.Clinical research in cardiology : official journal of the German Cardiac Society · 2019Article
- Late migration of Edwards SAPIEN 3 transcatheter heart valves: mechanisms and transcatheter treatment options for a rare phenomenon.Clinical research in cardiology : official journal of the German Cardiac Society · 2018Article
- Outcomes with a latest generation self-expandable, intra-annular, re-sheathable transcatheter heart valve system: analysis of patients with impaired left ventricular function and determinants for pacemaker implantation.Clinical research in cardiology : official journal of the German Cardiac Society · 2018Article
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11 authors at 3 institutions in 1 country.
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No grant is acknowledged in the PubMed record.
Abstract
objectivesPhysicians are frequently confronted with patients suffering from aortic stenosis with annular diameters exceeding dimensions in which currently available transcatheter heart valves (THV) are formally approved. Experience in patients receiving significantly undersized Sapien 3 (S3) THV (Edwards Lifesciences, Inc., Irvine, CA, USA) in aortic annuli up to 32 mm has not been reported so far.
methodsPatients with aortic annuli exceeding the formally determined upper size limit and who received a 29 mm S3, were identified from our database. Calcification pattern and annulus dimension were analyzed retrospectively using the 3mensio Medical Imaging software. Clinical endpoints were adjudicated in accordance with the updated standardized VARC-2 definitions.
results21 consecutive patients with aortic annuli ≥28.1 mm received a 29 mm THV. All patients were male (77.4 ± 8.1 year, logEuroSCORE I 22.5 ± 14.1 %). Multi-slice computed tomography and transesophageal echocardiography derived annular dimensions were 30.2 ± 1.5 vs. 28.8 ± 0.9 mm (p = 0.0001). Total calcium load of the aortic valves was 1327 ± 957 mm(3). Device success according to VARC-2 definitions was achieved in 100 % (21/21). All-cause 30-day mortality was 0 % (0/21). Rate of permanent pacemaker implantation was 14.3 % (3/21). No paravalvular leakage ≥ grade II was detectable.
conclusionsPreliminary experience suggests implantation of this type of THV in aortic annuli up to 32 mm to be feasible and safe, in particular calcification patterns. It does not result in a relevant incidence of PVL ≥ grade II, or increased rate of VARC-2 adjudicated clinical endpoints. Also, functional outcomes regarding transvalvular gradients or EOA demonstrate applicability of this THV in such patients.
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