Randomized trial comparing Quixil surgical sealant with Kaltostat hemostatic dressing to control suture line bleeding after carotid endarterectomy with ePTFE patch reconstruction

Abstract

Following carotid endarterectomy (CEA), patch angioplasty provides a significant reduction in the risk of perioperative complications. The expanded polytetrafluoroethylene (ePTFE) patch is strong, is resistant to infection, and has low thrombogenicity; but it remains unpopular because of its tendency of prolonged bleeding at the suture line. We aimed to investigate whether the application of Quixil sealant to the suture line could improve the time to achieve hemostasis and reduce local blood loss when compared to a standard topical hemostat Kaltostat. A prospective, randomized trial of 20 patients undergoing CEA was undertaken. Patients were randomized to receive either Quixil sealant (treatment group) or topical Kaltostat (controls) as a hemostatic agent to the patch suture line. Hemostasis was defined as no bleeding at the suture line for 1 minute. Statistical analysis was performed using the Mann-Whitney test. The two groups had a similar age and sex distribution. The mean age was 71 years, and there were seven men and three women in each group. The time to achieve hemostasis was significantly lower in the Quixil group (median 2.5 minutes, range 1-4 minutes) compared to the controls (median 17 minutes, range 7-59 minutes) (p < 0.001). Blood loss after clamp release was also significantly reduced in the Quixil group; median 24.5 ml (range 5.5-105.0 ml) versus 203 ml (range 54.5-817.0 ml) (p < 0.001). This study has demonstrated that Quixil human surgical sealant is an effective sealant of ePTFE patch suture holes and does not compromise the patch repair. It could be used during other vascular procedures involving ePTFE.