Prospective Nonrandomized Trial of Manual Compression and Angio-Seal and Starclose Arterial Closure Devices in Common Femoral Punctures

Abstract

We compared the use of manual compression and Angio-Seal and Starclose arterial closure devices to achieve hemostasis following common femoral artery (CFA) punctures in order to evaluate safety and efficacy. A prospective nonrandomized, single-center study was carried out on all patients undergoing CFA punctures over 1 year. Hemostasis was achieved using manual compression in 108 cases, Angio-Seal in 167 cases, and Starclose in 151 cases. Device-failure rates were low and not significantly different in the two groups (manual compression and closure devices; p = 0.8). There were significantly more Starclose (11.9%) patients compared to Angio-Seal (2.4%), with successful initial deployment subsequently requiring additional manual compression to achieve hemostasis (p < 0.0001). A significant number of very thin patients failed to achieve hemostasis (p = 0.014). Major complications were seen in 2.9% of Angio-Seal, 1.9% of Starclose, and 3.7% of manual compression patients, with no significant difference demonstrated; 4.7% of the major complications were seen in female patients compared to 1.3% in males (p = 0.0415). All three methods showed comparable safety and efficacy. Very thin patients are more likely to have failed hemostasis with the Starclose device, although this did not translate into an increased complication rate. There is a significant increased risk of major puncture-site complications in women with peripheral vascular disease.

Transcatheter Arterial Embolization for Postpartum Hemorrhage: Indications, Technique, Results, and Complications

“…It may be assumed that arterial closure devices may be useful in women with severe coagulation abnormalities, but their use has not been specifically reported in TAE for PPH [61].…”

Cutaneous migration of the StarClose® device

“…The recently introduced StarClose vascular closing device, in contrast, completes a circumferential extravascular puncture closure [3]. Prospective randomized, as well as observational studies have demonstrated safety and efficacy of the system in subjects undergoing diagnostic and interventional arterial catheterizations [3][4][5]. Duplex ultrasound examinations found no statistical differences in access site complications between the StarClose 1 and manual compression groups [6].…”

Common femoral artery stenosis after deployment of vascular clip closure device

“…In the interventional arm of the CLIP study [1], major vascular complications occurred in 1.1% of StarClose subjects. Ratnam et al [3] reported 3 major complications (1.9%) in their StarClose group, which included a pseudoaneurysm requiring thrombin injection, a large hematoma which required blood transfusion and surgical evacuation, and an ischemic ipsilateral lower limb 2 days later which led to a femoro-femoral crossover graft for external iliac artery occlusion. Of interest, they excluded patients for StarClose with artery diameters <6 mm.…”