Real-world Bleeding Outcomes and Costs Following Vascular Graft Anastomosis Using PROLENE Sutures with HEMO-SEAL Technology in Patients Undergoing Abdominal Aortic Aneurysm Repair

Abstract

Background: Suture hole bleeding is a common complication of vascular graft anastomosis that has potential to prolong vascular procedures, increase costs, and compromise patient outcomes.</p> Objectives: Compare real-world bleeding-related outcomes and costs following vascular anastomosis using PROLENE sutures with HEMO-SEAL technology (HEMO-SEAL sutures) compared with standard PROLENE sutures in patients receiving abdominal aortic aneurysm (AAA) repair in the United States. Methods: AAA repair procedures using hemostats and either HEMO-SEAL sutures or standard PROLENE sutures were identified from 2009 to 2013 using the Premier Healthcare Database. The primary outcome was the number and cost of hemostat units. Secondary outcomes were number and cost of sutures, bleeding complications, and transfusions. Results: A total of 5082 discharges for AAA repairs using hemostats and HEMO-SEAL sutures or standard PROLENE sutures were identified. HEMO-SEAL sutures were used in 79 (1.6%) discharges, standard PROLENE sutures were used in 4946 (97.3%); both sutures (excluded from the analysis) were used in 57 (1.1%). Discharge demographics were similar across suture groups, with the exception of disease severity; the HEMO-SEAL suture group had a higher proportion of minor discharges and a lower proportion of extreme discharges compared with the standard PROLENE suture group. Mean number of hemostat units used per discharge (2.34 vs 3.30; median = 2.0 in both groups; p=0.026) and median hemostat costs per discharge ($111 vs $186; p<0.01) were significantly lower in the HEMO-SEAL suture group compared with the standard PROLENE suture group. Fewer sutures per discharge (p<0.0001), lower mean costs of sutures per discharge, higher median costs of sutures per discharge (p=0.0045), and fewer transfusions (0.0019) were also seen in the HEMO-SEAL suture group compared with the standard PROLENE suture group. No statistically significant difference in bleeding complications was observed between suture groups. Conclusion: The results indicate that real-world use of HEMO-SEAL sutures may be associated with reduced hemostat usage and costs, and reduced bleeding that requires additional hemostats and/or transfusions.