Immediate sealing of arterial puncture sites after cardiac catheterization and coronary interventions: initial U.S. feasibility trial using the Duett vascular closure device

Catheter Cardiovasc Interv. 2000 May;50(1):96-102. doi: 10.1002/(sici)1522-726x(200005)50:1<96::aid-ccd21>3.0.co;2-v.

Abstract

The aim of this first U.S. feasibility study was to investigate the safety and efficacy of a novel vascular sealing device, Duett, following percutaneous endovascular procedures. Immediately following a catheterization procedure, the sealing device was deployed at the femoral arterial access site in 43 patients (diagnostic 29, intervention 11, intervention + abciximab 3). Patients were followed up at 1 month with clinical assessment, ankle-brachial index measurement, and Doppler ultrasound of the treated femoral artery puncture site. Successful hemostasis was achieved with the Duett alone in 42/43 (97.7%) patients. There was one uncomplicated crossover to manual compression. The time to hemostasis was 4.0+/-1.5, 6.9+/-4.2, and 5.8+/-1.2 min for diagnostic, interventional, and abciximab patients, respectively. At 1-month follow-up, one patient (2.3%) required ultrasound-guided compression for treatment of a pseudoaneurysm. There were no other major complications. This novel vascular sealing device appears to achieve rapid and safe hemostasis successfully immediately following a wide range of percutaneous endovascular procedures.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Analysis of Variance
  • Angioplasty, Balloon, Coronary / methods
  • Cardiac Catheterization / methods
  • Catheters, Indwelling / adverse effects*
  • Equipment Design
  • Feasibility Studies
  • Female
  • Femoral Artery / injuries*
  • Follow-Up Studies
  • Hemorrhage / etiology
  • Hemorrhage / prevention & control*
  • Hemostatic Techniques / instrumentation*
  • Humans
  • Male
  • Middle Aged
  • Probability
  • Prospective Studies
  • Punctures / adverse effects
  • Sensitivity and Specificity
  • Tissue Adhesives*

Substances

  • Tissue Adhesives