Purpose: To assess the safety and efficacy of the StarClose device following peripheral vascular interventions employing 7-F and 8-F femoral sheaths.
Methods: From May 2006 to December 2007, 226 consecutive patients (143 men; mean age 69 years, range 36-92) underwent 231 groin punctures (150 with a 7-F sheath and 81 with an 8-F sheath) that were sealed with the StarClose Vascular Closure System. All the patients underwent duplex control of the puncture site 24 hours after deployment of the device to determine the presence of vascular complications (hematoma, pseudoaneurysm, arteriovenous fistula, and arterial/venous thrombosis or stenosis). Endpoints were major vascular complications during the hospital stay, device success (hemostasis using the StarClose device alone or with <5 minutes of adjunctive compression and freedom from major vascular complications), and procedure success (hemostasis established using any method and freedom from major vascular complications).
Results: Procedural success was 96.0% (144/150) for the 7-F group and 97.5% (79/81) in the 8-F group. Device success was achieved in 91.3% (137/150) of the 7-F group and 90.1% (73/81) the 8-F group. Major vascular complications occurred in 4.1% (6/150) of the 7-F group: 1 patient developed massive retroperitoneal hematoma that required blood transfusion and surgical evacuation, 2 patients presented new ipsilateral lower extremity ischemia requiring revascularization, and 3 other patients developed pseudoaneurysm treated by ultrasound-guided compression or thrombin injection. In the 8-F group, only 2 (2.5%) patients had a major complication: 1 developed a high-grade stenosis of the punctured femoral artery that required angioplasty and the other developed massive retroperitoneal hematoma followed by blood transfusion and surgical evacuation. Minor complications occurred at a rate of 11.3% (17/150) in the 7-F group and 9.9% (8/81) in the 8-F group.
Conclusion: Common femoral artery closure with the StarClose device following peripheral vascular procedures utilizing 7-F and 8-F sheath sizes is feasible, with few device-specific complications. A randomized trial of a larger number of patients comparing standard compression methods and StarClose is warranted.