Complications of a percutaneous suture-mediated closure device versus manual compression for arteriotomy closure: a case-controlled study.

PURPOSE: To evaluate the incidence and types of complications encountered with use of a percutaneous suture-mediated closure device versus manual compression for arteriotomy closure in a retrospective case-controlled study.

MATERIALS AND METHODS: The authors identified 100 consecutive patients, 15 men and 85 women 21-85 years of age (mean, 50 years), between December 2000 and July 2001 in whom the Closer percutaneous suture-mediated closure device was used during 65 uterine artery embolization (UAE) procedures, 11 hepatic chemoembolization procedures, nine diagnostic angiography procedures, seven peripheral vascular interventions, six visceral arterial interventions, and two thrombolysis procedures. An age-, sex-, and procedure-matched control population was identified in which manual compression was performed. Procedure reports and clinical charts were reviewed for the presence of puncture-site complications, as categorized according to Society of Interventional Radiology reporting standards, and for risk factors and comorbid conditions (hypertension, diabetes, stroke, smoking, and coronary artery disease). Follow-up visits and imaging studies were reviewed for patients with complications.

RESULTS: In the Closer group, there were seven device failures, four minor complications, and three major complications. Minor complications included two groin hematomas and two cases of persistent pain at the arteriotomy site. Three major complications consisted of two cases of external iliac artery dissection, one with distal embolization, and one case of common femoral artery (CFA) occlusion and distal embolization. All major complications occurred in women undergoing UAE. One patient required thromboendarterectomy and patch angioplasty to repair the CFA occlusion, as well as amputation of a gangrenous toe. In the manual-compression group, there was one minor complication (a groin hematoma) and no major complications. There were significantly more complications in the Closer group than in the manual compression group (P =.02).

CONCLUSIONS: Significantly more complications were associated with use of a percutaneous suture-mediated closure device than with manual compression for arteriotomy-site hemostasis. Major complications and associated morbidity may be seen with use of percutaneous suture-mediated closure devices. In particular, an unexpectedly high frequency of device-related complications was demonstrated in young women undergoing UAE.