Hemorrhagic complications after endovascular interventions and the effectiveness of vascular closure devices

Aim. To identify the factors associated with hemorrhagic complications after endovascular interventions, as well as to assess the effectiveness of vascular closure devices.Material and methods. The study included 423 patients after endo - vascular intervention with femoral arterial access: 118 — manual compression, 305 — hemostasis using vascular closure devices (VCDs). The development of following complications was recorded: retroperitoneal hematoma, false aneurysm, arteriovenous fistula, bleeding, thigh soft-tissue hematoma. Time to hemostasis, immobilization period, and length of stay were assessed.Results. The complication rate was lower in VCD group compared to manual hemostasis (2,95 vs 11%, p=0,021). In VCD group, hemostasis characteristics significantly differed from the manual compression group: time to hemostasis — 3,1 vs 22,3 min (p=0,001), immobilization duration — 4,1 vs 20 hours (p=0,001), length of stay — 4 vs 8 days (p=0,001), respectively. The risk of complications increased with following factors: anticoagulant therapy, female sex, age >65 years, diabetes, body mass index >30 kg/m2 , vascular access calcification, introducer diameter >6 Fr, prior puncture. There were following independent predictors of complications: glycoprotein IIb/IIIa inhibitor therapy, superficial or deep femoral artery puncture.Conclusion. VCDs significantly reduces the hemorrhagic complication rate and improves hemostasis parameters as compared to manual compression.

P.142 Safety and Efficacy of Vascular Closure Devices in Interventional Radiological Procedures

Background: Vascular closure devices (VCDs) are routinely used in both neurovascular and vascular interventional procedures. The purpose of our study was to assess the safety and efficacy of the VCDs for diagnostic and therapeutic neurovascular and vascular procedures. Methods: The study was approved by the University of Manitoba research ethics board. A retrospective review was conducted of the database between January 2017 and December 2019. The data was collected from the Picture Archiving and Communication System (PACS) and collected in an excel spreadsheet. Patient demographics and clinical information was collected. Descriptive statistics and chi-squared tests were performed using STATA 13 software. A p<0.05 was considered significant. Results: VCD was used in a total of 2072 patients. VCDs were successfully deployed in 94% with 6% failure. Immediate perioperative complications were seen in 6.2% patients. The complication rates were significantly (p=0.025) associated with the type of procedure. Complications were seen significantly (p=0.044) higher in outpatients compared to inpatients and those from emergency room. Conclusions: VCDs were successfully deployed in 96VCDs were successfully deployed in 94% of the patient with 6% perioperative complications. Most of the complications were minor and complications were more commonly associated with outpatients procedures and with diagnostic vascular procedures.

AbsorbaSeal™ 5.6.7F vascular closure device: A good laboratory practice chronic study evaluating safety and efficacy in a healthy porcine model

Objectives Vascular closure devices (VCDs) are widely used for arteriotomy closure after percutaneous catheter–based procedures. In comparison to manual compression, VCDs have been associated with shorter time to hemostasis, shorter time to ambulation, and also decreased length of stay. Complexity of deployment, lack of immediate hemostasis, and residual deformity of the arterial wall remain as limitations of current VCDs. The aim of this study was to investigate the AbsorbaSeal™ 5.6.7F vascular closure device, a novel, completely bioabsorbable, intuitive, and easy to use VCD which uses a compressive, “sandwich”-type design comprising a low profile intravascular distal seal and gasket and an extravascular floating foot and proximal seal, in an open infrarenal aortic swine model. Methods Eight fully heparinized swine at a good laboratory practices facility underwent AbsorbaSeal™ 5.6.7F VCD closure of three 6F arteriotomies each in the proximal, mid, and distal infrarenal aorta. Two swine underwent harvest at each of four time cohorts: 30, 60, 90, and 120 days. Acute and chronic procedural safety and efficacy, as well as target site vascular remodeling over time, were the primary outcomes evaluated. Secondary outcome measures included local and systemic inflammatory responses, end-organ tissue analysis, and device-related complications through the follow-up periods. Histopathological evaluation was performed by a blinded pathologist. Standard statistical methods were used. Results In deployment of 24 AbsorbaSeal™ 5.6.7F VCDs, there were no device-related complications or mortalities. All deployments resulted in rapid arteriotomy seal (100% deployment success), with a mean time to hemostasis (cessation of arterial flow) of 21.5 s (median: 6.5 s) across a mean activated clotting time (ACT) of 356 s. Twenty of the 24 implant sites (83%) attained complete hemostasis within 20 s. Immediate post-implant and pre-termination angiographies at all time points were performed of all swine which demonstrated normal aortic appearance and tissue structure and normal downstream vascular beds. At 30 days, each implant’s intravascular distal seal and gasket were removed from the circulation and completely covered with a smooth neointimal layer. Minimal inflammation and no intimal or luminal thrombus were observed at any site at every time point. Conclusions AbsorbaSeal™ 5.6.7F is a safe, effective, and secure VCD that demonstrates rapid hemostasis in a fully heparinized open aortic porcine model. Removal from circulation and complete coverage of the intravascular distal seal and gasket with neointima occurred within 30 days post-implant. Natural transmural vessel healing from the arteriotomy itself with minimal inflammation was noted for each implant at every time point.

Efficacy of Vascular Closure Devices in Closing Large-Bore Sheath Arterial Sites after Treatment with Extracorporeal Life Support System

Background We retrospectively evaluated vascular complications and wound infections after surgical or percutaneous transfemoral removal of temporary extracorporeal life support systems (ECLSs). Methods A total of 83 patients were weaned from ECLS between August 2015 and September 2020. We analyzed for a composite endpoint of vascular complications and wound infections requiring negative-pressure wound therapy. Patients were divided into two groups: percutaneous group using the MANTA vascular occlusion system (VCD; Teleflex, Morrisville, North Carolina, United States) (n = 23) and surgical group (n = 60). Results The median age in the entire cohort was 67 years. Vascular complications were seen in 20% (n = 12) in the surgical group and in 13% (n = 3) in the percutaneous group (p = 0.72). A total of 32% (n = 19) in the surgical group and 9% (n = 2) in the percutaneous group (p = 0.031) had wound infections. A composite endpoint of vascular complications and wound infections showed significantly more complications in the surgical group (52%, n = 31) as compared with the percutaneous group (22%, n = 5) (p = 0.020). The median duration in the intensive care unit was 13 days for the surgical group and 12 days for the percutaneous group without any significant difference in both groups (p = 0.93). Conclusions Using the MANTA VCD for percutaneous removal of ECLS cannulas after weaning from ECLS is safe and reproducible. A composite endpoint of vascular complications and wound infections was significantly lower in the percutaneous removal group as compared with the surgical group.

Percutaneous Transgastric Duodenal Stenting and Gastrostomy Repair Using a Vascular Closure Device: Proof of Concept in a Porcine Model

Introduction. Gastroduodenal stenting is efficacious and safe in both benign and malignant foregut diseases. Transgastric duodenal stenting has been described and however requires a gastrostomy tube to remain in situ for 4 to 6 weeks post-procedure which can lead to complications. We present a technique for immediate gastric repair using a suture-mediated vascular closure device, without the need for a gastrostomy tube in porcine models. Methods. Percutaneous access into the stomach was achieved using fluoroscopy. Two or 3 Perclose Proglide devices were pre-deployed. The tract was dilated and a wire advanced into the distal duodenum. A 15.5 cm covered enteric stent was delivered through the gastrostomy, deployed and position confirmed. The gastrostomy was closed using Perclose Proglide sutures. Necropsy leak pressure measurement was performed to assess integrity of gastrostomy closure in the porcine models. Results. Two (n = 8) or 3 (n = 2) Perclose Proglide devices were deployed in ten porcine models, with 1 misfire (4.5%). Percutaneous transgastric access and stent delivery was successful in all porcine models. Mean leak pressure in the animals with adequately deployed devices was 219 mmHg (range 172 mmHg–270 mmHg). Conclusion. This study demonstrates percutaneous transgastric duodenal stenting with immediate gastric repair using suture-mediated vascular closure devices is a feasible procedure.

Access Site Complications of Peripheral Endovascular Procedures: A Large, Prospective Registry on Predictors and Consequences

Purpose The purpose of this study was to investigate predictors and consequences of acute vascular access site complications (ASCs) related to peripheral endovascular diagnostic or interventional procedures. Despite improvement of puncture techniques, access site–related morbidity and mortality is still considerable. Materials and Methods A total of 5263 participants who underwent 5385 endovascular procedures at a single center were consecutively included in this prospective, observational study. Primary outcomes were ASCs defined as composite of puncture site hematoma, pseudoaneurysm, arteriovenous fistula, and overt puncture site bleeding on the first day after procedure. Results ASCs occurred in 16.6% of peripheral endovascular procedures (78.6% hematomas, 18.9% pseudoaneurysms, 1.4% arteriovenous fistulas, 1.1% overt bleedings). Independent predictors were advanced age [odds ratio (OR) per 10 years: 1.12, p=0.004], female sex (OR men, 0.77; p=0.001), lysis (OR 3.56; p<0.001), periprocedural heparin (OR 5000 IU, 1.96; p=0.001; OR >5000 IU, 3.56; p=0.02), time to access (OR per 10 seconds, 1.01; p<0.001), sheath size (OR per French, 1.59; p<0.001), brachial artery access (OR vs retrograde transfemoral, 4.58; p<0.001), and compression only (OR Angio-Seal, 0.57, p=0.02; ProGlide, 0.36, p<0.001; FemoSeal, 0.57, p<0.001). Treatment was required in 20.2% and prolonged hospitalization in 17.7% of ASC. Three participants died from access site–related bleeding. Conclusion ASCs after peripheral endovascular procedures are associated with advanced age, female sex, periprocedural antithrombotic medication, brachial artery access, postinterventional bleeding, and nonuse of vascular closure devices.