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Comparison of the FemoSeal Vascular Closure Device With Manual Compression After Femoral Artery Puncture - Post-hoc

Nader Mankerious, Katharina Mayer, Senta M Gewalt

  • 1ISAResearch Center, Deutsches Herzzentrum München, Lazarettstr. 36, 80636 Munich, Germany. schuepke@dhm.mhn.de.

The Journal of Invasive Cardiology
|May 16, 2018
PubMed

Insights

The FemoSeal vascular closure device (VCD) significantly reduces vascular complications and hematomas after cardiac catheterization compared to manual compression. It also shortens the time to hemostasis, improving patient outcomes.

Area of Science:

  • Cardiology
  • Vascular Surgery
  • Medical Devices

Background:

  • Limited evidence exists comparing contemporary vascular closure devices (VCDs) to manual compression.
  • Assessing FemoSeal VCD performance in transfemoral diagnostic angiography is crucial.

Purpose of the Study:

  • To evaluate the safety and efficacy of the FemoSeal VCD versus manual compression for arteriotomy closure.
  • To compare access-site vascular complications and time to hemostasis.

Main Methods:

  • Subanalysis of 3018 patients from the ISAR-CLOSURE trial undergoing transfemoral diagnostic coronary angiography.
  • Randomized assignment to FemoSeal VCD or manual compression.
  • Primary endpoint: composite of access-site vascular complications at 30 days; Secondary endpoints: time to hemostasis, repeat manual compression.

Main Results:

  • FemoSeal VCD group showed lower vascular access-site complications (6.0% vs 7.9%, P=.04), primarily due to fewer hematomas (4.3% vs 6.8%, P<.01).
  • Time to hemostasis was significantly shorter with FemoSeal VCD (0.5 min vs 10 min, P<.001).
  • Pseudoaneurysm rates were similar (1.5% vs 1.5%, P=.88), but repeat manual compression was higher with FemoSeal VCD (1.5% vs 0.7%, P=.03).

Conclusions:

  • FemoSeal VCD use in transfemoral diagnostic coronary angiography reduces vascular access-site complications, particularly hematomas, compared to manual compression.
  • FemoSeal VCD significantly shortens time to hemostasis.
  • The device offers a safe and effective alternative to manual compression for arteriotomy closure.
Abstract

Keywords:
coronary angiographyfemoral accessrandomized clinical trialvascular closure device

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