Safety and Efficacy of a Plug-Based Vascular Closure Device After Percutaneous Microaxial Flow Pump in the Treatment of Complex and High-Risk Indicated Patients

Joerg W. Schroeder*, Norman Mangner, Felix J. Woitek, Kai U. Markus, Michael Lehrke, Felix Vogt, Marlo Verket, Alexandros Siskos, Moritz Biener, Benjamin Meder, Nicolas M. Van Mieghem

*Corresponding author for this work

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Abstract

BackgroundFemoral large-bore vascular access is an important and constantly increasing technique in interventional treatment. Temporary circulatory support in complex and high-risk indicated patients (CHIP) presents a challenge in terms of postinterventional access site closure.AimMonitoring the safety and efficacy of the MANTA system (Teleflex Inc.), a plug-based vascular closure device (PbVCD) in patients receiving a percutaneous microaxial flow pump (mAFP).MethodsA multicenter prospective all-comers registry enrolled 73 consecutive patients scheduled for PbVCD after receiving mAFP for CHIP or cardiogenic shock. The primary endpoint was the occurrence of vascular complications at the mAFP access site until discharge according to the Valve Academic Research Consortium-3 (VARC-3) definition. Secondary endpoints included the rate of procedure- or device-related bleedings, device-failures, and the time to hemostasis. Operators rated on the use of the MANTA System and the similarity compared to ANGIOSEAL (Terumo Medical Corp.).ResultsHemostasis was achieved in all 73 patients with no need for alternative treatment other than manual compression. The primary endpoint occurred in 7 (9.6%) patients with 1 (1.4%) patient suffering from a major vascular complication and 6 (8.2%) patients developing hematoma with type 2 bleeding (minor vascular complication). There was no vessel closure or thromboembolic event. In-hospital survival was 100%.ConclusionsThe PbVCD system is a safe, efficient and easy-to-use vascular closure system for large-bore vascular access in patients receiving a mAFP. Advantages and disadvantages of PbVCD and suture-based vascular closure devices (SbVCD) systems should be individually adapted according to the patient's medical history and the anatomy of the vascular constellation.
Original languageEnglish
Pages (from-to)189-195
Number of pages7
JournalCatheterization and Cardiovascular Interventions
Volume106
Issue number1
DOIs
Publication statusE-pub ahead of print - 10 Apr 2025

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© 2025 The Author(s). Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

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