ArticleClinical research in cardiology : official journal of the German Cardiac Society2019
Transaxillary transcatheter aortic valve implantation utilizing a novel vascular closure device with resorbable collagen material: a feasibility study.
Article in Clinical research in cardiology : official journal of the German Cardiac Society, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04589962 (SUrgical Versus PERcutaneous AXillary Artery International Registry A Physician-initiated, International, Multicentric, Retrospective, Observational, Voluntary Registry - SUPER AXA International Registry), which is not on this map. Cited by 4 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
SUrgical Versus PERcutaneous AXillary Artery International Registry A Physician-initiated, International, Multicentric, Retrospective, Observational, Voluntary Registry - SUPER AXA International Registry
Who cites it
4 citing papers in PubMed, 12 citations in OpenAlex.
- Intravascular Lithotripsy-Assisted Transfemoral Transcatheter Aortic Valve Implantation in Patients with Severe Iliofemoral Calcifications: Expanding Transfemoral Indications.Journal of clinical medicine · 2024Article
- Procedural success in transaxillary transcatheter aortic valve implantation according to type of transcatheter heart valve: results from the multicenter TAXI registry.Clinical research in cardiology : official journal of the German Cardiac Society · 2024Article
- Machine learning-based risk prediction of intrahospital clinical outcomes in patients undergoing TAVI.Clinical research in cardiology : official journal of the German Cardiac Society · 2021Article
- A Novel Plug-Based Vascular Closure Device for Percutaneous Femoral Artery Closure in Patients Undergoing Minimally-Invasive Valve Surgery.Frontiers in cardiovascular medicine · 2021Article
Corrections and comments
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Authors and funding
9 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesWe herein aimed to evaluate technical feasibility of transaxillary (Tax) transcatheter aortic valve implantation (TAVI) utilizing a novel vascular closure device with a resorbable collagen plug and absence of suture material.
methodsBetween 05/2018 and 8/2018, eight patients (76.0 ± 5.9 years, 62.5% male, logEuroSCORE I 23.6 ± 4.7) received Tax-TAVI using the MANTA™ vascular closure device. Implanted transcatheter heart valves consisted of Edwards Sapien 3, NVT Allegra, Medtronic CoreValve EvolutR and SJM Portico.
resultsPuncture location depth was variable (3.5-7.5 cm). The left subclavian artery was used in five cases, the right subclavian artery in three cases. Low-pressure balloon-angioplasty for vessel closure was performed in 5/8 patients. VARC-2 defined device success was met in all patients. Major access site complication occurred in one patient with aneurysma spurium of the subclavian artery and consecutive stent implantation on postoperative day 5.
conclusionThe MANTA™ device is applicable in Tax-TAVI, with potential particular advantages regarding easiness of use and marked access for subsequent interventions in case of vascular complications. Before conclusions regarding clinical efficacy and safety can be made, the device has to be evaluated in larger patient cohorts.
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