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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

Background Femoral 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. Aim Monitoring the...

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Main Authors: Schröder, Jörg Walter (Author) , Mangner, Norman (Author) , Woitek, Felix J. (Author) , Markus, Kai U. (Author) , Lehrke, Michael (Author) , Vogt, Felix (Author) , Verket, Marlo (Author) , Siskos, Alexandros (Author) , Biener, Moritz (Author) , Meder, Benjamin (Author) , Van Mieghem, Nicolas M. (Author)
Format: Article (Journal)
Language:English
Published: July 1, 2025
In: Catheterization and cardiovascular interventions
Year: 2025, Volume: 106, Issue: 1, Pages: 189-195
ISSN:1522-726X
DOI:10.1002/ccd.31528
Online Access:Verlag, kostenfrei, Volltext: https://doi.org/10.1002/ccd.31528
Verlag, kostenfrei, Volltext: https://onlinelibrary.wiley.com/doi/abs/10.1002/ccd.31528
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Author Notes:Jörg W. Schröder, Norman Mangner, Felix J. Woitek, Kai U. Markus, Michael Lehrke, Felix Vogt, Marlo Verket, Alexandros Siskos, Moritz Biener, Benjamin Meder, Nicolas M. Van Mieghem
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Summary:Background Femoral 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. Aim Monitoring 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). Methods A 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.). Results Hemostasis 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%. Conclusions The 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.
Item Description:Veröffentlicht: 10 April 2025
Gesehen am 08.10.2025
Physical Description:Online Resource
ISSN:1522-726X
DOI:10.1002/ccd.31528

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