INTRODUCTION: Vascular closure devices (VCDs) are designed to achieve rapid hemostasis during percutaneous coronary and peripheral vascular procedures. Studies demonstrate that VCDs improve time to hemostasis (TTH) and time to ambulation (TTA) in comparison to standard manual compression. The available products, however, typically have 13-17 steps in their application, often require hemostatic collagen or other agents as part of the process, and can result in significant scarring at the puncture site that can impact future access. The aim of this study was to investigate the performance of a three-step, novel VCD for access site TTH, short-term and long-term histology, and a first-in-man clinical study.
MATERIALS AND METHODS: This study evaluated AbsorbaSeal™ (CyndRx, LLC, Brentwood, Tennessee), a simple, three-step, VCD with bio-absorbable components. Following an institutional review board (IRB) approval, a 6-F sheath was placed directly into the porcine aorta, AbsorbaSeal™ was used to seal the puncture site, and a measure of total time of deployment (TTD) and TTH was performed, as well as histologic evaluation at 30, 60, and 180 days. A complement activation test was performed to determine the potential for activation of the complement system as a mediator of inflammation. The test was performed by directly incubating the VCDs AbsorbaSeal™ and Angio-Seal™ (Terumo Interventional Systems, Tokyo, Japan) in human serum. Serum samples were removed after 30, 60, and 90 minutes and tested for the presence and amount of complement protein SC5b-9. In the first in-man trial, the device was deployed in anticoagulated patients undergoing interventional vascular procedures. The TTH, estimated blood loss, patient pain scores, and procedural and follow-up complications were recorded.
RESULTS: In the acute and chronic porcine studies, TTD averaged 25 seconds (17-29 seconds). Vascular control was immediate, yielding a TTH of effectively zero seconds. Histologic evaluation demonstrated complete endothelial coverage of the device by 30 days without evidence of bleeding, clotting, or inflammation. At 60 days, the significant mass of the device had dissolved and normal appearing collagen surrounded the devices with essentially no inflammatory response. By six months, all but one microscopic segment of one of the devices had been absorbed with normal appearing vascular endothelium, and no, or minimal, scarring appreciated. The complement test demonstrated that the AbsorbaSeal™ had similar, or lower, complement concentrations than the negative controls and significantly less than Angio-Seal™. This supported the histologic findings of minimal to no inflammation. The VCD was deployed in 20 patients undergoing interventional vascular procedures. The mean TTH was 2.3 ± 1.5 minutes. Estimated blood loss was 11.7 mL ± 3.5 mL, and no significant hematoma was noted. Post-procedure pain scores were low, with a mean of 1.4 ± 0.8 on a 0-10 pain rating scale. There were no perioperative complications and no adverse events at follow-up.
CONCLUSIONS: The AbsorbaSeal™ is safe and simple to use for vascular closure after interventional vascular procedures with favorable outcomes including a short TTH, minimal procedural blood loss, low postoperative pain scores, and no perioperative complications or adverse effects. Histologic evaluation reveals rapid device absorption and little scar formation both short- and long-term. A direct study of complement activation supports that AbsorbaSeal™ evokes a minimal inflammatory response that is significantly less than Angioseal.
|Number of pages||7|
|Journal||Surgical technology international|
|State||Published - 12 Oct 2017|