Vascular Closure Devices and Complications

2021 ◽  
pp. 167-186
Author(s):  
Reza Masoomi ◽  
Sahil Khera
Keyword(s):  
Vascular Closure Devices

Use of vascular closure devices for endovascular interventions requiring a direct puncture of PETE grafts

VASA ◽  
2018 ◽  
Vol 47 (2) ◽  
pp. 119-124 ◽  
Author(s):  
Artur I. Milnerowicz ◽  
Aleksandra A. Milnerowicz ◽  
Marcin Protasiewicz ◽  
Wiktor Kuliczkowski
Keyword(s):  
Statistical Significance ◽  
Vascular Complications ◽  
Vascular Complication ◽  
Inguinal Region ◽  
Closure Device ◽  
Manual Compression ◽  
Direct Puncture ◽  
Endovascular Interventions ◽  
Vascular Closure Devices ◽  
Closure Group

Abstract. Background: Effectiveness of vascular closure devices during endovascular procedures requiring a direct puncture of a vascular prosthesis placed in the inguinal region is unknown. Patients and methods: The retrospective analysis included 134 patients with a history of polyethylene terephthalate (PETE) graft implantation in the inguinal region. In 20 (15 %) patients, haemostasis was achieved with manual compression, in 21 (16 %) with the StarClose™, and in 93 (69 %) with the AngioSeal™ device. Results: The incidence of vascular complications in the manual compression group was higher (at a threshold of statistical significance) than in the device closure group (45.0 vs. 24.5 %, p = 0.059). The difference was considered statistically significant when manual compression was compared with the AngioSeal™ closure group (45.0 vs. 13.9 %, p < 0.01). The vascular complication rate in the StarClose™ group was significantly higher than in the AngioSeal™ group (71.4 vs. 13.9 %, p < 0.000001). While haematomas were the only vascular complications observed after application of AngioSeal™, both haematomas and pseudoaneurysms were found in the StarClose™ group. Conclusions: The AngioSeal™ vascular closure device provides better local haemostasis than the StarClose™ device or manual compression during endovascular interventions requiring a direct puncture of PETE grafts

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.

Single-center experience with vascular closure devices in real-world endovascular peripheral interventions

2018 ◽  
Vol 59 (6) ◽  
Author(s):  
Bruno Freitas ◽  
Sabine Steiner ◽  
Yvonne Bausback ◽  
Holger Staab ◽  
Daniela Branzan ◽  
...  
Keyword(s):  
Real World ◽  
Single Center ◽  
Single Center Experience ◽  
Vascular Closure Devices

scholarly journals Efficacy and Safety of ProGlide Versus Prostar XL Vascular Closure Devices in Transcatheter Aortic Valve Replacement: The RISPEVA Registry

2020 ◽  
Vol 9 (21) ◽  
Author(s):  
Sergio Berti ◽  
Francesco Bedogni ◽  
Arturo Giordano ◽  
Anna S. Petronio ◽  
Alessandro Iadanza ◽  
...  
Keyword(s):  
Propensity Score ◽  
Propensity Score Analysis ◽  
Vascular Complications ◽  
Bleeding Complications ◽  
Efficacy And Safety ◽  
End Point ◽  
Transcatheter Aortic Valve ◽  
Vascular Closure Devices ◽  
Score Analysis

Background Transcatheter aortic valve replacement (TAVR) requires large‐bore access, which is associated with bleeding and vascular complications. ProGlide and Prostar XL are vascular closure devices widely used in clinical practice, but their comparative efficacy and safety in TAVR is a subject of debate, owing to conflicting results among published studies. We aimed to compare outcomes with Proglide versus Prostar XL vascular closure devices after TAVR. Methods and Results This large‐scale analysis was conducted using RISPEVA, a multicenter national prospective database of patients undergoing transfemoral TAVR treated with ProGlide versus Prostar XL vascular closure devices. Both multivariate and propensity score adjustments were performed. A total of 2583 patients were selected. Among them, 1361 received ProGlide and 1222 Prostar XL. The predefined primary end point was a composite of cardiovascular mortality, bleeding, and vascular complications assessed at 30 days and 1‐year follow‐up. At 30 days, there was a significantly greater reduction of the primary end point with ProGlide versus Prostar XL (13.8% versus 20.5%, respectively; multivariate adjusted odds ratio, 0.80 [95% CI, 0.65–0.99]; P =0.043), driven by a reduction of bleeding complications (9.1% versus 11.7%, respectively; multivariate adjusted odds ratio, 0.76 [95% CI, 0.58–0.98]; P =0.046). Propensity score analysis confirmed the significant reduction of major adverse cardiovascular events and bleeding risk with ProGlide. No significant differences in the primary end point were found between the 2 vascular closure devices at 1 year of follow‐up (multivariate adjusted hazard ratio, 0.88 [95% CI, 0.72–1.10]; P =0.902). Comparable results were obtained by propensity score analysis. During the procedure, compared with Prostar XL, ProGlide yielded significant higher device success (99.2% versus 97.5%, respectively; P =0.001). Conclusions ProGlide has superior efficacy as compared with Prostar XL in TAVR procedures and is associated with a greater reduction of composite adverse events at short‐term, driven by lower bleeding complications. Registration Information URL: clini​caltr​ials.gov ; Unique identifier: NCT02713932.

Complication rates associated with antegrade use of vascular closure devices: a systematic review and pooled analysis

2020 ◽  
Author(s):  
Sean A. Kennedy ◽  
Dheeraj K. Rajan ◽  
Paul Bassett ◽  
Kong Teng Tan ◽  
Arash Jaberi ◽  
...  
Keyword(s):  
Systematic Review ◽  
Pooled Analysis ◽  
Complication Rates ◽  
Vascular Closure Devices

Simulation training on bedside veno-arterial extracorporeal membrane oxygenation decannulation

2020 ◽  
Vol 21 (6) ◽  
pp. 1017-1022
Author(s):  
Shek Yin Au ◽  
Ka Man Fong ◽  
Kwong Shun Chan ◽  
Sai Kwong Yung ◽  
Rowlina Pui Wah Leung ◽  
...  
Keyword(s):  
Extracorporeal Membrane Oxygenation ◽  
Mechanical Circulatory Support ◽  
Simulation Training ◽  
Decompensated Heart Failure ◽  
Circulatory Support ◽  
Large Artery ◽  
The Novel ◽  
Membrane Oxygenation ◽  
Vascular Closure Devices ◽  
Large Vein

Veno-arterial extracorporeal membrane oxygenation is a form of mechanical circulatory support for patients with refractory decompensated heart failure. Blood is drawn from a large vein and pumped back to a large artery, usually a femoral artery through large bore catheters. When the heart recovers, the extracorporeal membrane oxygenation support can be terminated and the catheters are decannulated. The bleeding at the venous side can be controlled by prolonged compression; however, the arteriotomy wound needs to be repaired. Conventionally, the arteriotomy wounds require open vascular repair in the operating theater. The novel application of percutaneous vascular closure devices, which have been commonly used in vascular operations and percutaneous structural heart interventions, could be applied for closure of arteriotomy wounds at the bedside after extracorporeal membrane oxygenation support. The post-close ProGlide (Abbott Vascular) technique was shown to be safe and could potentially save time and manpower. The wounds are much smaller as compared with the conventional open repair and potentially, the chance of wound infection can be reduced. However, the success of percutaneous bedside closure requires careful prior planning and technique training. Backup plans with vascular surgeons’ standby are essential in case of failure of closure. Staffs in the extracorporeal membrane oxygenation centers need to be familiar with the preparation, the procedure as well as the device application technique for successful percutaneous closure. The long learning curve and the limited case load mean that such skills are best trained by simulation scenarios. This article described how this new technique and the team logistics can be trained by simulation.

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