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

Herbert G Kroon1, Pim A L Tonino2, Mikko Savontaus3

  • 1Department of Cardiology, Erasmus University Medical Center, Rotterdam, The Netherlands.

Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions
|December 21, 2020
PubMed
Summary

The MANTA Vascular Closure Device (VCD) demonstrated safety and effectiveness for large bore arteriotomy closure in real-world settings. This study evaluated its performance across 10 centers, confirming its utility in complex percutaneous procedures.

Keywords:
transcatheter valve implantationvascular closurevascular complications

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Area of Science:

  • Cardiovascular Interventions
  • Medical Device Technology
  • Vascular Surgery

Background:

  • The MANTA Vascular Closure Device (VCD) is a novel plug-based system designed for closing large arteriotomies.
  • Large bore percutaneous procedures, such as Transcatheter aortic valve replacement (TAVR), require effective methods for arterial access site closure.

Purpose of the Study:

  • To evaluate the real-world safety and performance of the MANTA VCD.
  • To assess the incidence of vascular complications and time to hemostasis following large bore percutaneous procedures using the MANTA VCD.

Main Methods:

  • A prospective study conducted across 10 centers involving patients undergoing transfemoral large bore percutaneous procedures.
  • Exclusion criteria included severe vessel calcification, tortuosity, obesity, or high blood pressure.
  • Primary endpoints were time to hemostasis and major/minor vascular complications assessed by an independent clinical event committee using VARC-2 criteria.

Main Results:

  • 500 patients were enrolled, primarily undergoing TAVR (N=496).
  • Major access site complications occurred in 4% of patients, and minor complications in 5.6%.
  • Median time to hemostasis was 50 seconds. Independent predictors for complications included femoral artery calcification, groin scarring, longer procedure duration, female gender, and hypertension.

Conclusions:

  • The MANTA VCD is a safe and effective device for managing large bore arteriotomy closure in real-world clinical practice.
  • The study supports the use of MANTA VCD in various large bore percutaneous procedures, with identified risk factors for complications.