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

Nadia Y Sutton,Niels-Derrek Schmitz

doi:10.36469/9806

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.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.

Highlights

Suture hole bleeding is a common complication of vascular graft anastomosis that has potential to prolong vascular procedures, increase costs, and compromise patient outcomes
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
In a pre-clinical study comparing the Needle hole bleeding (NHB) rate of an end-to-end synthetic expanded PTFE to synthetic ePTFE vascular graft anastomosis sutured using the HEMO-SEAL suture (C-1 needle) with the NHB rate of a standard 5.0 PROLENE polypropylene suture (C-1 needle), the HEMO-SEAL suture resulted in a 67% reduction in mean NHB rate at graft anastomosis compared to the standard PROLENE suture (NHB rate of 0.63 ±0.13 ml/min for the HEMO-SEAL PROLENE suture compared to 1.94 ±0.23 ml/min for the standard PROLENE suture).[11]

Summary

Introduction

Suture hole bleeding is a common complication of vascular graft anastomosis that has potential to prolong vascular procedures, increase costs, and compromise patient outcomes. Needle hole bleeding (NHB) is a common complication of vessel anastomosis that occurs when even ideal suturing techniques are used and has the potential to increase intra-operative blood loss, lengthen operating time, compromise patient outcomes, and increase costs.[1,2,3,4] Patients at particular risk for NHB include those with hypertension, bleeding disorders, chronic liver disease, and renal failure, and those requiring anticoagulants or platelet inhibitors for the prevention of intra-operative thrombus formation.[1,2,4,5] Use of conventional synthetic grafts such as polytetrafluoroethylene [PTFE] grafts further exacerbate NHB.[3,5,6,7,8]. In a pre-clinical study comparing the NHB rate of an end-to-end synthetic expanded PTFE (ePTFE) to synthetic ePTFE vascular graft anastomosis sutured using the HEMO-SEAL suture (C-1 needle) with the NHB rate of a standard 5.0 PROLENE polypropylene suture (C-1 needle), the HEMO-SEAL suture resulted in a 67% reduction in mean NHB rate at graft anastomosis compared to the standard PROLENE suture (NHB rate of 0.63 ±0.13 ml/min for the HEMO-SEAL PROLENE suture compared to 1.94 ±0.23 ml/min for the standard PROLENE suture).[11]

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