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

To assess the safety and efficacy of the StarClose device following intra-aortic balloon pump [IABP] counterpulsation using 8-Fr femoral sheaths. 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. 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. CFA closure with the StarClose device was safe, feasible and effective in patients undergoing IABP support using 8-Fr sheath sizes