Evidence map›Paper›PMID 40211664›Full record

Observational studyCatheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions2025

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.

Jörg W Schröder, Norman Mangner, Felix J Woitek, Kai U Markus, Michael Lehrke, Felix Vogt, Marlo Verket, Alexandros Siskos, Moritz Biener, Benjamin Meder and 1 more

Abstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Jörg W SchröderDepartment of Cardiology, Angiology and Intensive Care, University Hospital RWTH Aachen, Aachen, Germany.ORCID 0009-0006-9825-7155
Norman MangnerDepartment of Internal Medicine and Cardiology, Heart Center Dresden, University Hospital, Technische Universität Dresden, Dresden, Germany.ORCID 0000-0003-0793-7923
Felix J WoitekDepartment of Internal Medicine and Cardiology, Heart Center Dresden, University Hospital, Technische Universität Dresden, Dresden, Germany.
Kai U MarkusVYSYO GmbH, Clinical Research, Eschweiler, Germany.
Michael LehrkeDepartment of Cardiology, Angiology and Intensive Care, University Hospital RWTH Aachen, Aachen, Germany.
Felix VogtDepartment of Cardiology, Angiology and Intensive Care, University Hospital RWTH Aachen, Aachen, Germany.
Marlo VerketDepartment of Cardiology, Angiology and Intensive Care, University Hospital RWTH Aachen, Aachen, Germany.
Alexandros SiskosDepartment of Cardiology, Erasmus Medical Centre, Rotterdam, the Netherlands.
Moritz BienerDepartment of Cardiology, Angiology and Pulmonology, University Hospital Heidelberg, Heidelberg, Germany.
Benjamin MederDepartment of Cardiology, Angiology and Pulmonology, University Hospital Heidelberg, Heidelberg, Germany.
Nicolas M Van MieghemDepartment of Cardiology, Erasmus Medical Centre, Rotterdam, the Netherlands.ORCID 0000-0002-2732-1205

Funding

This study was supported by ABIOMED Europe GmbH, Germany.
6 · The paper itself

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.

Indexed as

Catheterization, PeripheralFemoral ArteryHeart-Assist DevicesHemorrhageHemostatic TechniquesVascular Closure DevicesAgedAged, 80 and overEquipment DesignFemaleHumansMaleMiddle AgedProspective StudiesPuncturesRegistriesbleedingCHIPMantaoutcomepercutaneous microaxial flow pumpplug‐based vascular closure device

Identifiers

PMID40211664
PMCPMC12231152

What Socratic holds

Textmetadata
LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.