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Related Concept Videos

Aneurysm III: Interprofessional Care01:26

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Aneurysm management involves either conservative medical therapy or surgical intervention, depending on the size and symptoms of the aneurysm. Conservative management is generally reserved for smaller, asymptomatic aneurysms, while larger or symptomatic aneurysms often necessitate surgical repair.Conservative Medical TherapyFor small, asymptomatic aneurysms, particularly abdominal aortic aneurysms (AAA) less than 5.5 centimeters in diameter, conservative medical therapy is recommended. This...
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Development of a Murine Model for Femoral Artery Anastomotic Stenosis
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Suture- or Plug-Based Large-Bore Arteriotomy Closure: A Pilot Randomized Controlled Trial.

Maarten P van Wiechen1, Didier Tchétché2, Joris F Ooms1

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

JACC. Cardiovascular Interventions
|December 28, 2020
PubMed
Summary

Plug-based vascular closure devices (VCDs) were not superior to suture-based VCDs for transcatheter aortic valve replacement (TAVR). While plug-based closure required fewer bailouts, it necessitated different types of interventions.

Keywords:
MANTAProGlidetranscatheter aortic valve replacementvascular closure devicesvascular complications

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Area of Science:

  • Cardiovascular Medicine
  • Interventional Cardiology
  • Medical Devices

Background:

  • Vascular complications are a significant concern following transcatheter aortic valve replacement (TAVR).
  • Vascular closure device (VCD) failure is frequently associated with these complications.

Purpose of the Study:

  • To compare the efficacy and safety of a plug-based VCD (MANTA) versus a suture-based VCD (ProGlide) in TAVR procedures.
  • To evaluate access site-related vascular complications and bleeding events.

Main Methods:

  • A pilot randomized controlled trial (MASH trial) involving 210 TAVR patients.
  • Comparison of MANTA VCD against ProGlide VCD.
  • Primary endpoint: access site-related major or minor vascular complications at 30 days; secondary endpoints included bleeding, time to hemostasis, and modified VCD failure.

Main Results:

  • No significant difference in the primary endpoint of vascular complications between MANTA and ProGlide (10% vs. 4%, p=0.16).
  • Similar rates of clinically significant access site bleeding (9% vs. 6%, p=0.57).
  • Modified VCD failure was significantly lower with MANTA (20% vs. 40%, p<0.01), though MANTA required more covered stents and surgical bailouts.

Conclusions:

  • Plug-based large-bore arteriotomy closure is not superior to suture-based closure in TAVR.
  • Plug-based closure may require fewer, but different types of, bailout interventions compared to suture-based methods.