Rationale and design of a randomised clinical trial comparing vascular closure device and manual compression to achieve haemostasis after diagnostic coronary angiography: the Instrumental Sealing of ARterial puncture site – CLOSURE device versus manual compression (ISAR-CLOSURE) trial

2014 ◽  
Vol 10 (2) ◽  
pp. 198-203 ◽  
Author(s):  
Erion Xhepa ◽  
Robert A. Byrne ◽  
Stefanie Schulz ◽  
Sandra Helde ◽  
Senta Gewalt ◽  
...  
Vascular ◽  
2008 ◽  
Vol 16 (5) ◽  
pp. 295-296
Author(s):  
Alfried Germing ◽  
Michael Lindstaedt ◽  
Delawer Reber

This case report describes the surgical findings of a percutaneous closure device, which was used after diagnostic coronary angiography. The features of the device are described. Surgeons should be familiar with the existence of these devices to avoid complications during vascular access procedures at the level of the common femoral artery.


1995 ◽  
Vol 2 (3) ◽  
pp. 289-296 ◽  
Author(s):  
Michel Henry ◽  
Max Amor ◽  
Mohamed Allaoui ◽  
Olivier Tricoche

Purpose: Given the increasing number of percutaneously applied endovascular therapies, the incidence of access-related vascular complications can be expected to rise, particularly in association with those techniques requiring large sheaths or anticoagulation. The need exists for a safe, easy to use, and effective hemostatic technique to replace the labor-intensive method of manual compression. Methods: A bioabsorbable, sheath-delivered vascular closure device (Angio-Seal™) has been developed that deposits a small collagen plug within the arterial wall to mechanically seal the puncture defect. An anchor connected by suture to the plug is first deployed in the arterial lumen and pulled flush against the interior arterial wall to guard against intraluminal deposition of the collagen. Results: The Angio-Seal device was deployed successfully in 80 (96%) of 83 attempts involving common femoral arteries accessed for peripheral angioplasty (n = 30), coronary angiography (n = 30), and coronary angioplasty (n = 16). Three popliteal artery access sites and one femoropopliteal bypass graft were also treated. Hemostasis was immediate in 78 cases (98%); 2 sites required a 5-minute manual compression to effect a secure seal. Three devices failed to deploy, and manual pressure was used to close the puncture. Nondeployment did not cause any sequelae, and no complications were encountered with the technique. Conclusions: This novel vascular closure device is quick (< 1 minute application time) and simple to use, providing a positive seal of common femoral artery puncture sites for both peripheral and coronary interventions. It appears to be a reliable alternative to standard manual hemostasis.


1994 ◽  
Vol 24 (3) ◽  
pp. 655-662 ◽  
Author(s):  
Edoardo Camenzind ◽  
Marianne Grossholz ◽  
Philip Urban ◽  
Pierre-André Dorsaz ◽  
Dominique Didier ◽  
...  

Author(s):  
Lukasz Kmiec ◽  
Matthaeus Zerdzitzki ◽  
Christof Schmid ◽  
Kurt Debl ◽  
Samuel Sossalla ◽  
...  

Abstract Background The MANTA vascular closure device (VCD) is a novel collagen plug-based VCD for large bore arteriotomies. The current literature regarding complication rates of this device is quite variable and mostly limited to relatively small case series. Methods This study is retrospective analysis of the MANTA VCD-related main access site complications according to Valve Academic Research Consortium-2 (VARC-2) criteria during the hospital stay. Particular attention was paid to the detailed analysis of multislice computed tomography with regard to the anatomy of the access vessel and the puncture site itself. Results A total of 524 patients underwent transfemoral transcatheter aortic valve implantation (TF TAVI) including the use of the MANTA device (18F) for percutaneous vascular closure. A group of 22 patients was excluded from the study due to incomplete imaging data. During the study period, we observed 28 major (5.6%) and five minor (1.0%) MANTA device-related vascular complications. There was no patient death related to these adverse events. Female gender, vessel angulation at the puncture site, and at least moderate calcification of the dorsal vessel segment were identified as independent predictors for major complications. Conclusions The MANTA device is a feasible option for vascular closure of large bore arteriotomies in patients undergoing TF TAVI or other percutaneous transfemoral interventions. Furthermore, we have identified novel predictors for device failure/complications that should be taken into account for selection of the appropriate closure device. To our knowledge, this report is one of the largest case series analyzing the use of the MANTA VCD.


2011 ◽  
Vol 93 (6) ◽  
pp. e102-e104 ◽  
Author(s):  
T Hussain ◽  
S Al-Hamali

Groin vessels are most commonly used to obtain vascular access for angiography because of their size and accessibility. Haemostasis at the puncture site can be achieved with manual compression alone or by using a vascular closure device. We highlight the case of a 68-year-old woman who developed acute claudication in the right leg after a routine diagnostic coronary angiogram when an Angio-Seal™ device had been employed to close a relatively low arterial puncture. On exploring the common femoral artery, fragments of the device were found occluding the bifurcation. A patch angioplasty was carried out and the patient’s claudicant symptoms improved. The Angio-Seal™ device has a polylactide and polyglycolide polymer anchor, a collagen plug and a suture contained within a carrier system. Haemostasis is achieved by compressing the arterial puncture site between the anchor and the collagen plug. The manufacturer’s recommended criterion for using the device safely permits its use only for common femoral artery punctures with an internal vessel diameter of 4mm. Anatomical confirmation of the puncture site and evidence of any arterial disease or stenosis in the artery is detected on fluoroscopy during the procedure. Recent meta-analyses have cast doubt on the assumption that vascular closure devices are superior to mechanical compression alone and serious complications do occur occasionally but are under-reported. Clinicians should be aware of the potentially serious problems that may occur when deciding to employ vascular closure devices, especially with an anatomically low puncture site.


1999 ◽  
Vol 83 (12) ◽  
pp. 1658-1663 ◽  
Author(s):  
Ulrich Gerckens ◽  
Norbert Cattelaens ◽  
Elke-Gudrun Lampe ◽  
Eberhard Grube

2020 ◽  
Author(s):  
Armando Del Prete ◽  
Domenico Giovanni Della Rocca ◽  
Simone Calcagno ◽  
Riccardo Di Pietro ◽  
Giuseppe Del Prete ◽  
...  

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.


2014 ◽  
Vol 2 (3) ◽  
pp. 42
Author(s):  
Bozkurt Gulek ◽  
Onur Ergun ◽  
Turkmen Ciftci ◽  
Yavuz Kutlu ◽  
Bora Peynircioglu ◽  
...  

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