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Dedicated plug based closure for large bore access -The MARVEL prospective registry.
- Source :
-
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions [Catheter Cardiovasc Interv] 2021 May 01; Vol. 97 (6), pp. 1270-1278. Date of Electronic Publication: 2020 Dec 21. - Publication Year :
- 2021
-
Abstract
- Objectives: To study safety and performance of the MANTA Vascular closure device (VCD) under real world conditions in 10 centers.<br />Background: The MANTA is a novel plug-based device for large bore arteriotomy closure.<br />Methods: We included all eligible patients who underwent transfemoral large bore percutaneous procedures. Exclusion criteria were per operator's discretion and included severe calcification or marked tortuosity of the access vessel, presence of marked obesity/cachexia or a systolic blood pressure above 180 mmHg. The primary performance endpoint was time to hemostasis. Primary and secondary safety endpoints were major and minor access site related vascular complications up to 30 days, respectively. Vascular complications were adjudicated by an independent clinical event committee according to VARC-2 criteria. We performed multivariable logistic regression to estimate the effect of baseline and procedural characteristics on any and major vascular complications.<br />Results: Between February 2018 and July 2019 500 patients were enrolled undergoing Transcatheter aortic valve replacement (TAVR, N = 496), Balloon aortic valvuloplasty (BAV, N = 2), Mechanical circulatory support (MCS, N = 1) or Endovascular aneurysm repair (EVAR, N = 1). Mean age was 80.8 ± 6.6 years with a median STS-score of 2.7 [IQR 2.0-4.3] %. MANTA access site complications were major in 20 (4%) and minor in 28 patients (5.6%). Median time to hemostasis was 50 [IQR 20-120] sec. Severe femoral artery calcification, scar presence in groin, longer procedure duration, female gender and history of hypertension were independent predictors for vascular complications.<br />Conclusion: In this study, MANTA appeared to be a safe and effective device for large bore access closure under real-world conditions.<br /> (© 2020 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)
- Subjects :
- Aged
Aged, 80 and over
Female
Femoral Artery diagnostic imaging
Femoral Artery surgery
Hemorrhage etiology
Hemostatic Techniques adverse effects
Humans
Registries
Treatment Outcome
Aortic Aneurysm, Abdominal
Aortic Valve Stenosis surgery
Blood Vessel Prosthesis Implantation
Catheterization, Peripheral adverse effects
Endovascular Procedures
Transcatheter Aortic Valve Replacement
Vascular Closure Devices
Subjects
Details
- Language :
- English
- ISSN :
- 1522-726X
- Volume :
- 97
- Issue :
- 6
- Database :
- MEDLINE
- Journal :
- Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
- Publication Type :
- Academic Journal
- Accession number :
- 33347739
- Full Text :
- https://doi.org/10.1002/ccd.29439