Safety and Efficacy of the StarClose Vascular Closure System following 8-Fr Sheath Placement for Intra-Aortic Balloon Pump: A Single-Center Analysis of 42 Consecutive Patients

Abstract

Objective: To assess the safety and efficacy of the StarClose device following intra-aortic balloon pump (IABP) counterpulsation using 8-Fr femoral sheaths. Subjects and Methods: From June 2008 to August 2012, 42 consecutive patients who received IABP implantation via common femoral artery (CFA) punctures with an 8-Fr sheath (which were then sealed with the StarClose Vascular Closure System at the bedside) were included in this retrospective single-arm study. All the patients underwent duplex control of the puncture site 24 h after deployment of the device, in order to determine the presence or absence of vascular complications including hematoma, pseudoaneurysm, arteriovenous fistula and arterial/venous thrombosis or stenosis. The safety end points were the vascular complications during the hospital stay, and the efficacy end points included device and procedure success. Results: The procedure success rate was 92.9% (39/42) and the device success rate was 88.1% (37/42). Major vascular complications occurred in 3 (7.1%) patients; 1 developed a massive hematoma >10 cm which was managed by blood transfusion and surgical reconstruction, and the other 2 developed pseudoaneurysm which was cured by ultrasound-guided thrombin injection or manual compression. Minor vascular complications occurred in 5 (11.9%) patients, including blood oozing in 2, hematoma <5 cm in 2 and severe pain in the remaining patient. Conclusion: CFA closure with the StarClose device was safe, feasible and effective in patients undergoing IABP support using 8-Fr sheath sizes.