Dedicated plug based closure for large bore access –The MARVEL prospective registry

Autor: Janarthanan Sathananthan, Mika Laine, Stefan Toggweiler, Jur ten Berg, Noriaki Moriyama, Federico Moccetti, Christian Juhl Terkelsen, Mikko Savontaus, Ton Slagboom, Peter P de Jaegere, Herbert Kroon, Evald Høj Christiansen, Nicolas M. Van Mieghem, David A. Wood, Giovanni Amoroso, Livia L. Gheorghe, John G. Webb, Guus R. G. Brueren, Pim A.L. Tonino, Markus Malmberg, Joost Daemen
Přispěvatelé: HUS Heart and Lung Center, Kardiologian yksikkö, Helsinki University Hospital Area, Department of Medicine, Cardiology
Jazyk: angličtina
Rok vydání: 2020
Předmět:
vascular complications
Percutaneous
DEVICES
IMPACT
medicine.medical_treatment
030204 cardiovascular system & hematology
Balloon
Endovascular aneurysm repair
DISEASE
Original Studies
0302 clinical medicine
Valve replacement
Vascular closure device
030212 general & internal medicine
TRANSCATHETER
Registries
Aged
80 and over
AORTIC-VALVE IMPLANTATION
Endovascular Procedures
General Medicine
Aortic valvuloplasty
REPLACEMENT
Femoral Artery
Treatment Outcome
Female
Cardiology and Cardiovascular Medicine
Vascular Closure Devices
medicine.medical_specialty
Arteriotomy
Hemorrhage
Valvular and Structural Heart Diseases
Transcatheter Aortic Valve Replacement
03 medical and health sciences
Blood Vessel Prosthesis Implantation
SDG 3 - Good Health and Well-being
transcatheter valve implantation
Catheterization
Peripheral
medicine
Humans
Radiology
Nuclear Medicine and imaging
Aged
business.industry
Hemostatic Techniques
Aortic Valve Stenosis
Surgery
vascular closure
Hemostasis
3121 General medicine
internal medicine and other clinical medicine
business
MULTIDISCIPLINARY
Aortic Aneurysm
Abdominal
Zdroj: Catheterization and Cardiovascular Interventions
Kroon, H G, Tonino, P A L, Savontaus, M, Amoroso, G, Laine, M, Christiansen, E H, Toggweiler, S, Ten Berg, J, Sathananthan, J, Daemen, J, de Jaegere, P P, Brueren, G B R G, Malmberg, M, Slagboom, T, Moriyama, N, Terkelsen, C J, Moccetti, F, Gheorghe, L, Webb, J, Wood, D & Van Mieghem, N M 2021, ' Dedicated plug based closure for large bore access-The MARVEL prospective registry ', Catheterization and Cardiovascular Interventions, vol. 97, no. 6, pp. 1270-1278 . https://doi.org/10.1002/ccd.29439
Catheterization and Cardiovascular Interventions, 97(6), 1270-1278. Wiley-Liss Inc.
ISSN: 1522-726X
1522-1946
DOI: 10.1002/ccd.29439
Popis: OBJECTIVES: To study safety and performance of the MANTA Vascular closure device (VCD) under real world conditions in 10 centers.BACKGROUND: The MANTA is a novel plug-based device for large bore arteriotomy closure.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.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.CONCLUSION: In this study, MANTA appeared to be a safe and effective device for large bore access closure under real-world conditions.
Databáze: OpenAIRE
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