Long Term Outcome after Application of the Angio-Seal Vascular Closure Device in Minipigs.
ABSTRACT: Minipigs are frequently used in (neuro-)interventional research. Longitudinal experiments may require repeated vessel access via the femoral artery. Anticoagulation and incompliance of the animals necessitates the use of a vascular closure device (VCD). The effects of the Angio-Seal VCD in minipigs were longitudinally assessed. Minipig (42±8.4 kg body weight) femoral arteries were sealed using the 8F (n = 6) or 6F (n = 7) Angio-Seal VCD. The pre-interventional femoral artery diameter was 5.1±0.4 mm (4.3-5.8 mm). Sealed puncture sites were analysed angiographically as well as by computed tomography angiography (CTA) for a mean period of 14.1±8.0 weeks (1-22 weeks). All animals were constantly treated with acetylsalicylic acid (ASS) (450 mg/d (n = 7) or 100 mg/d (n = 1)) and clopidogrel (75 mg/d (n = 8)). Non-instrumented (n = 2) and arteries sealed using the VCD (n = 2) were examined histologically. No postoperative hemorrhagic complications were observed. Three arteries were occluded after VCD placement (1 animal diagnosed after 4 weeks (8F), 2 animals after 1 week (6F)) and remained so until the end of the experiments after 22, 12 and 4 weeks, respectively. In one artery a 50% stenosis 8 weeks after application of a 6F Angio-Seal was detected. In 69.2% (n = 9) the VCD was applied without complications. Histopathological analysis of the sealed arterial segments showed subtotal obliteration of the vessel lumen, formation of collagenous tissue and partial damage of the internal elastic lamina. The Angio-Seal VCD prevents relevant hemorrhagic complications in minipigs treated with dual platelet inhibition, but is associated with increased vessel occlusion rates.
Project description:In this case series, we share our experience of total percutaneous closure of large arteriotomies using combination of vascular closure devices (VCD). A total of six patients with seven sites for endovascular repair were taken for total percutaneous endovascular aortic repair. Ten femoral arteriotomies (26 French (F) = 2, 24 F = 1, 22 F = 3, 20 F = 1, 18 F = 1 &16 F = 2) were successfully closed with 26 Perclose™ and 07 Angio-seal™ devices. There were no local site complications or VCD failure in any of our patients.
Project description:A 55-year-old male with peripheral arterial disease underwent angioplasty of the right lower limb arteries via antegrade femoral access. Angio-Seal® closure device was used to treat the puncture site, whereby the intravascular sealing anchor accidentally embolized into the malleolar region of the right posterior tibial artery. Successful retrieval of the anchor was accomplished by a SpiderFX embolic protection device. This technique may be a useful approach to retrieve embolized foreign bodies via endovascular access.
Project description:Iatrogenic common femoral artery pseudoaneurysm is a well-known vascular access complication of angiography and transfemoral intervention. Thrombin injection is a well-accepted technique in treating these pseudoaneurysms but possess a significant risk of distal lower extremity thrombosis leading to severe consequences. Several case reports described the novel approach to closing these pseudoaneurysms via a retrograde deployment of an Angio-Seal vascular closure device. We describe a case of a successful treatment of refractory iatrogenic femoral artery pseudoaneurysm using Amplatzer vascular plugs following unsuccessful retrograde deployment of an Angio-Seal vascular closure device.
Project description:Perclose Closure Device (Abbott-Vascular) was attempted for femoral artery (FA) access site closure by an experienced operator. The device was felt to snap as it was pushed through the previously scarred skin and subcutaneous tissue. Perclose had broken into two pieces with the proximal portion outside the body and the distal portion embolizing to lie in the FA to distal aorta. The left FA was accessed through 8F sheath and 4-8mm Basket snare passed through a 6F multipurpose guiding catheter. The tip of the broken Perclose was caught with the snare and pulled out. The Perclose has a distal flexible sheath that is overmolded directly onto the proximal rigid guide. This junction of sheath and guide may be a weak point. Accidental pressure applied at this weak point in any Perclose device during deployment can cause breakage. Awareness of this rare complication is important for safety.
Project description:Electrosurgical vessel sealing has been demonstrated to have benefits for both patients and practitioners, but significant variation in the strength of the seal continues to be a concern. This study aims to examine the variation in electrosurgical seal quality along the length of a porcine common carotid artery and explore the relationships between seal quality, vessel size and morphology. Additionally, the study aimed to investigate the minimum safety threshold for successful seals and the influence of vessel characteristics on meeting this requirement. A total of 35 porcine carotid arteries were sealed using the PlasmaKinetic Open Seal device (Gyrus). Each seal was burst pressure tested and a sample taken for staining with elastin van Gieson's stain, with morphological quantification using image processing software ImageJ. With increasing distance from the bifurcation, there was an increase in seal strength and a reduction in both elastin content and vessel outer diameter. A significant correlation was found between burst pressure with both outer diameter (p < 0.0001) and elastin content (p = 0.001). When considering the safe limits of operation, vessels of less than 5 mm in outer diameter were shown to consistently produce a seal of a sufficient strength (burst pressure > 360 mmHg) irrespective of vessel morphology.
Project description:Background:Iatrogenic perforation of the right ventricle (RV) is a rare but recognized complication of pericardiocentesis. Treatment strategies for RV perforation include surgical repair and percutaneous closure. In this case report, we describe the use of an angio-seal vascular closure device (Terumo Interventional Systems) to seal an iatrogenic RV perforation secondary to incorrect placement of a pericardial drain. Case summary:A 55-year-old female presented with an anterior ST-elevation myocardial infarction. Coronary angiography demonstrated occlusion of the left anterior descending artery. The patient went on to have primary percutaneous coronary intervention and both the left anterior descending and D1 were wired. During kissing balloon inflation, the Sion Blue wire migrated distally in the D1 causing an Ellis type 3 wire tip perforation in the distal D1. Emergency pericardiocentesis was performed however the 8 French (8?Fr) pericardial drain was inadvertently inserted into the RV. It was decided to attempt percutaneous closure with an 8?Fr angio-seal in the catheter lab under echocardiographic and fluoroscopic guidance. Our patient did not demonstrate any recurrence of pericardial effusion on repeat echocardiography over 60?days post-procedure. Discussion:Our patient did not demonstrate any recurrence of pericardial effusion on repeat echocardiography over 60?days post-procedure. We feel that the angio-seal vascular closure device represents an effective, minimally invasive treatment for this rare but potentially catastrophic complication of pericardiocentesis. In this case, the technique spared our patient a sternotomy with its associated morbidity.
Project description:To analyze differences of access-site complications related to the height of femoral arterial puncture and the use of a vascular closure device (VCD) following percutaneous coronary intervention (PCI).A subgroup of the FERARI study being treated by femoral arterial access and valuable inguinal angiography before implantation of a VCD were included. Inguinal angiographies were systematically reviewed by two independent cardiologists to determine the correct height of femoral arterial puncture. Bleeding complications were documented within 30 days after PCI and were categorized according to BARC, TIMI, GUSTO and FERARI classifications.Femoral access point imaging was available in 95 patients compared to 105 patients without. The common femoral artery (CFA) was the most accessed artery in 41%, followed by the femoral arterial bifurcation (39%) and lower access sites distally from the femoral arterial bifurcation (low puncture: 20%). No differences were observed regarding indication of PCI, procedural data and anticoagulation therapies in relation to the heights of femoral arterial access (p?>?0.05). Despite using VCD, arterial puncture at the CFA resulted in numerically highest numbers of overall bleedings (62%) compared to femoral arterial bifurcation (41%) (p?=?0.059). 58% of bleedings occurred after arterial puncture below the femoral bifurcation (low puncture). Though no significant differences of bleedings regarding classifications of BARC, GUSTO, TIMI and FERARI as well as other vascular endpoints were observed regarding puncture height.The present analysis demonstrates no significant differences of bleeding complications in relation to the height of femoral arterial puncture and subsequent use of a VCD.
Project description:Bleeding events after percutaneous coronary interventions (PCI) are associated with patients' age, gender, and the presence of chronic kidney disease, antithrombotic treatment, as well as arterial access site. Patients being treated by PCI using radial access site are associated with an improved prognosis. However, the safety of femoral closure devices has never been compared to radial compression devices following PCI. Therefore, the aim of this study is to evaluate the safety of femoral closure compared to radial compression devices in patients treated by PCI envisaging access site bleedings as well as short- and long-term prognostic outcomes.The Femoral Closure versus Radial Compression Devices Related to Percutaneous Coronary Interventions (FERARI) study is a single-center observational study comparing 400 consecutive patients undergoing PCI either using radial compression devices (TR Band™) or femoral closure devices (Angio-Seal™) at the corresponding access site. The primary outcome consists of the occurrence of vascular complications at the arterial access site, including major bleedings as defined by common classification systems. Secondary outcomes consist of the occurrence of adverse cardiac events, including all-cause mortality, target lesion revascularization, and target vessel revascularization during 30 days and 12 months of follow-up.Study enrollment was initiated in February 2014. The enrollment phase is expected to last until May 2015.The FERARI study intends to comparatively evaluate the safety and prognostic outcome of patients being treated by radial or femoral arterial closure devices following PCI during daily clinical practice.
Project description:X-ray fluoroscopy is the gold standard for coronary diagnostics and intervention. Magnetic resonance imaging is a radiation-free alternative to x-ray with excellent soft tissue contrast in arbitrary slice orientation. Here, we assessed real-time MRI-guided coronary interventions from femoral access using newly designed MRI technologies. Six Goettingen minipigs were used to investigate coronary intervention using real-time MRI. Catheters were custom-designed and equipped with an active receive tip-coil to improve visibility and navigation capabilities. Using modified standard clinical 5?F catheters, intubation of the left coronary ostium was successful in all animals. For the purpose of MR-guided coronary interventions, a custom-designed 8?F catheter was used. In spite of the large catheter size, and therefore limited steerability, intubation of the left coronary ostium was successful in 3 of 6 animals within seconds. Thereafter, real-time guided implantation of a non-metallic vascular scaffold into coronary arteries was possible. This study demonstrates that real-time MRI-guided coronary catheterization and intervention via femoral access is possible without the use of any contrast agents or radiation, including placement of non-metallic vascular scaffolds into coronary arteries. Further development, especially in catheter and guidewire technology, will be required to drive forward routine MR-guided coronary interventions as an alternative to x-ray fluoroscopy.
Project description:Background:Highly calcific stenosis located in common femoral artery (CFA) represents a difficult target for endovascular treatment due to the possible need for stent implantation in that area. Case summary:A 63-year-old man with history of coronary artery disease and previous multiple percutaneous transluminal angioplasties for peripheral artery disease (PAD) was admitted for recent onset left lower limb pain at rest with severe activity restriction (Leriche-Fontaine Class III and Rutherford Class III-IV). The angio-computed tomography scan showed a highly calcific stenosis of left CFA. The patient underwent lithoplasty balloon angioplasty followed by drug-eluting balloon inflation with excellent angiographic result and complete blood flow restoration. No procedural complications occurred. Discussion:Highly calcified stenosis in PAD represents a huge challenge for endovascular treatment as not all lower extremity arteries are suitable for stenting because of compressive and torsional forces associated with stent fracture and restenosis. Lithoplasty is a new technology allowing effective blood flow restoration while minimizing vessel injury.