Safety and efficacy of a 6 French perclose arterial suturing device following percutaneous coronary interventions: a pilot evaluation

J Invasive Cardiol. 2002 Dec;14(12):741-5.

Abstract

Background: Arterial access site management after percutaneous coronary intervention (PCI) is a matter of increasing importance in this era of potent antiplatelet pharmacotherapy. We evaluated the safety and efficacy of a 6 French (Fr) Perclose suturing device in achieving rapid hemostasis of the access site after PCI and thus improving patient comfort.

Methods: The 6 Fr Perclose (Prostar) device consists of a suture-based closure device delivered via introducer sheath designed for suturing of the arteriotomy puncture site. Over a 3-month period, the device was used in 48 consecutive PCI treated patients (age, 62 13 years; 70% male; 44% post myocardial infarction) and in-hospital groin complication rate was compared to 48 consecutive patients (age, 64 12 years; 64% male; 33% post myocardial infarction) who had manual compression hemostasis.

Results: Antiplatelet glycoprotein IIb/IIIa antagonists were used more frequently during and following the procedure in 58% of Perclose-treated patients versus 42% of the manual compression group (p = 0.019). Leg immobilization duration was 3 4 hours in all patients sutured by the device; in patients with manual compression, the sheath was removed at an average of 4.8 2.5 hours after termination of the PCI and an additional 6 hours of leg immobilization were subsequently required. No difference in overall major complication rate was found between groups (6.2% in suture-mediated patients versus 9.3% in manual compression group; p = 0.60). In 3 patients (6.2%) treated using the device, adjunctive manual compression was required in addition to groin suturing due to technical failure or residual oozing from the arteriotomy site.

Conclusion: The 6 Fr Perclose device can be safely used to achieve rapid hemostasis and the device may hasten bed mobilization of PCI-treated patients despite frequent use of potent antiplatelet pharmacotherapy during coronary interventions.

Publication types

  • Comparative Study
  • Evaluation Study

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Angioplasty, Balloon, Coronary / methods*
  • Coronary Angiography
  • Coronary Stenosis / diagnostic imaging
  • Coronary Stenosis / therapy*
  • Equipment Design
  • Equipment Safety
  • Female
  • Femoral Artery
  • Hemostasis, Surgical / instrumentation*
  • Humans
  • Male
  • Middle Aged
  • Pilot Projects
  • Probability
  • Prognosis
  • Punctures
  • Sensitivity and Specificity
  • Severity of Illness Index
  • Suture Techniques / instrumentation*
  • Treatment Outcome