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

Vascular ◽  
2021 ◽  
pp. 170853812110378
Author(s):  
Sullivan A Ayuso ◽  
R Caroline Shipp ◽  
Bola G Aladegbami ◽  
Delton Farquharson ◽  
Denny Lawson ◽  
...  
Keyword(s):  
Porcine Model ◽  
Secondary Outcome ◽  
Closure Device ◽  
Swine Model ◽  
Infrarenal Aorta ◽  
Vascular Closure Device ◽  
Safety And Efficacy ◽  
Vascular Closure Devices ◽  
Good Laboratory ◽  
Time Point

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.

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

2021 ◽  
pp. 155335062110310
Author(s):  
Eran Shlomovitz ◽  
Neeral R. Patel ◽  
Michele Diana ◽  
Radu Pescarus ◽  
Lee L. Swanström
Keyword(s):  
Porcine Model ◽  
Gastrostomy Tube ◽  
Closure Device ◽  
Leak Pressure ◽  
Proof Of Concept ◽  
Vascular Closure Device ◽  
Post Procedure ◽  
Vascular Closure Devices ◽  
Transgastric Access

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.

scholarly journals Cardiosphere-derived exosomal microRNAs for myocardial repair in pediatric dilated cardiomyopathy

2020 ◽  
Vol 12 (573) ◽  
pp. eabb3336 ◽  
Author(s):  
Kenta Hirai ◽  
Daiki Ousaka ◽  
Yosuke Fukushima ◽  
Maiko Kondo ◽  
Takahiro Eitoku ◽  
...  
Keyword(s):  
Cardiac Function ◽  
Dilated Cardiomyopathy ◽  
Myocardial Fibrosis ◽  
Porcine Model ◽  
Phase 1 ◽  
Secondary Outcome ◽  
Swine Model ◽  
Secondary Outcome Measure ◽  
Myocardial Repair ◽  
Reduced Ejection Fraction

Although cardiosphere-derived cells (CDCs) improve cardiac function and outcomes in patients with single ventricle physiology, little is known about their safety and therapeutic benefit in children with dilated cardiomyopathy (DCM). We aimed to determine the safety and efficacy of CDCs in a porcine model of DCM and translate the preclinical results into this patient population. A swine model of DCM using intracoronary injection of microspheres created cardiac dysfunction. Forty pigs were randomized as preclinical validation of the delivery method and CDC doses, and CDC-secreted exosome (CDCex)–mediated cardiac repair was analyzed. A phase 1 safety cohort enrolled five pediatric patients with DCM and reduced ejection fraction to receive CDC infusion. The primary endpoint was to assess safety, and the secondary outcome measure was change in cardiac function. Improved cardiac function and reduced myocardial fibrosis were noted in animals treated with CDCs compared with placebo. These functional benefits were mediated via CDCex that were highly enriched with proangiogenic and cardioprotective microRNAs (miRNAs), whereas isolated CDCex did not recapitulate these reparative effects. One-year follow-up of safety lead-in stage was completed with favorable profile and preliminary efficacy outcomes. Increased CDCex-derived miR-146a-5p expression was associated with the reduction in myocardial fibrosis via suppression of proinflammatory cytokines and transcripts. Collectively, intracoronary CDC administration is safe and improves cardiac function through CDCex in a porcine model of DCM. The safety lead-in results in patients provide a translational framework for further studies of randomized trials and CDCex-derived miRNAs as potential paracrine mediators underlying this therapeutic strategy.

E-067 Safety and efficacy of the starclose vascular closure device with use of large French femoral sheath

2012 ◽  
Vol 4 (Suppl 1) ◽  
pp. A75.2-A75
Author(s):  
J Sharma ◽  
A Kulhari ◽  
E Vargas ◽  
N Moradzadeh ◽  
R Jung ◽  
...  
Keyword(s):  
Closure Device ◽  
Vascular Closure Device ◽  
Safety And Efficacy

Safety and Efficacy of the StarClose Vascular Closure Device in More Than 1000 Consecutive Peripheral Angioplasty Procedures

2011 ◽  
Vol 18 (3) ◽  
pp. 435-443 ◽  
Author(s):  
Stavros Spiliopoulos ◽  
Konstantinos Katsanos ◽  
Dimitris Karnabatidis ◽  
Athanasios Diamantopoulos ◽  
Christeas Nikolaos ◽  
...  
Keyword(s):  
Closure Device ◽  
Vascular Closure Device ◽  
Safety And Efficacy ◽  
Peripheral Angioplasty

Management of Haemostasis with Combined Use of Vascular Closure Devices and Bivalirudin – A Review

2011 ◽  
Vol 6 (2) ◽  
pp. 177
Author(s):  
Emanuela de Cillis ◽  
Giuseppe Massimo Sangiorgi ◽  
Alessandro Santo Bortone ◽  
◽  
◽  
...  
Keyword(s):  
High Risk ◽  
Vascular Complications ◽  
Coronary Intervention ◽  
Closure Device ◽  
Vascular Closure Device ◽  
High Risk Patients ◽  
Vascular Closure Devices ◽  
Combined Use ◽  
Percutaneous Coronary ◽  
Risk Patients

Bleeding and vascular complications related to invasive cardiovascular procedures are associated with significant morbidity and mortality. The aim of this article is to evaluate the literature to determine haemostasis strategies in percutaneous coronary intervention when using bivalirudin with or without a vascular closure device. The literature data seem to underline that the combination of vascular closure devices and bivalirudin was associated with significantly lower bleeding rates. However, these strategies were less often used among high-risk patients. We recommend that prospective clinical studies are undertaken to determine the potential disadvantages of using vascular closure devices and bivalirudin in combination in high-risk patients.

Perclose Proglide™ for vascular closure

2020 ◽  
Author(s):  
Armando Del Prete ◽  
Domenico Giovanni Della Rocca ◽  
Simone Calcagno ◽  
Riccardo Di Pietro ◽  
Giuseppe Del Prete ◽  
...  
Keyword(s):  
Vascular Complications ◽  
Effective Alternative ◽  
Closure Device ◽  
Manual Compression ◽  
Vascular Closure Device ◽  
Patient Discomfort ◽  
The Past ◽  
Vascular Closure Devices

In the past 20 years, numerous percutaneous vascular closure devices have been tested and compared with manual compression and to surgical cut-down. The suture-mediated closure device Perclose ProGlide™ system (Abbott Vascular, CA, USA) emerged as a safe and effective alternative for many procedures requiring either small or large bore vascular accesses. In this review, we will discuss the characteristics of this vascular closure device and the main studies that proved its potential to reduce vascular complications, time to deambulation, time to discharge and patient discomfort.

scholarly journals SAFETY AND EFFICACY OF ANGIO-SEAL™ VASCULAR CLOSURE DEVICE FOLLOWING PERCUTANEOUS CORONARY INTERVENTION

2010 ◽  
Vol 55 (10) ◽  
pp. A216.E2045 ◽  
Author(s):  
Abdelazim Hashim ◽  
Naoyo Mori ◽  
Satish Velagapudi ◽  
Babak Haddadian ◽  
Raaid Museitif ◽  
...  
Keyword(s):  
Percutaneous Coronary Intervention ◽  
Coronary Intervention ◽  
Closure Device ◽  
Vascular Closure Device ◽  
Safety And Efficacy ◽  
Percutaneous Coronary
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