Accelerated ambulation after vascular access closure device.
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ABSTRACT:
SUBMITTER: Brancheau D
PROVIDER: S-EPMC5941674 | biostudies-literature | 2018 May
REPOSITORIES: biostudies-literature
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Accelerated ambulation after vascular access closure device.
Brancheau Daniel D Sarsam Sinan S Assaad Mahmoud M Zughaib Marcel M
Therapeutic advances in cardiovascular disease 20180208 5
<h4>Background</h4>Patients who are candidates to receive an Angioseal® (St. Jude Medical) device for arteriotomy closure are allowed to ambulate 20 min after the deployment of the device. More frequently, however, patients are kept on bed rest for several hours following Angioseal® deployment. The purpose of this study was to prospectively assess patients when ambulating 20 min after Angioseal® deployment instead of prolonged best rest of 2-3 h.<h4>Methods</h4>Patients undergoing angiography fr ...[more]
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Project description:BackgroundIn patients with non-valvular atrial fibrillation, an estimated 90% of thrombi are located in the left atrial appendage. The WATCHMAN device is a left atrial appendage closure device that is an alternative therapeutic option to reduce the risk of systemic embolization in patients who are intolerant of long-term oral anticoagulation. It can be deployed in the left atrial appendage using a transseptal approach via the femoral vein. Transhepatic venous access is an alternative route for the delivery of the device in a patient with difficult vascular access.Case summaryAn 81-year-old man with persistent non-valvular atrial fibrillation, heart failure with reduced ejection fraction (HFrEF), and diabetes mellitus was deemed a poor candidate for anticoagulation due to recurrent falls and gastrointestinal bleeding. He was selected for a left atrial appendage closure. The initial procedure was aborted after significant resistance to device advancement was encountered in the right femoral vein. Lower extremity venography demonstrated totally occluded femoral and iliac veins bilaterally. The decision was made to implant the device via a transhepatic approach. The procedure had no complications and the patient was discharged on rivaroxaban and aspirin after 3 days.DiscussionTranshepatic venous access is a viable option in patients with poor femoral access for implantation of the WATCHMAN device. It can be done safely. Knowledge of this procedural alternative can greatly enhance patient care.
| S-EPMC7891241 | biostudies-literature
Project description:INTRODUCTION:Closed-chest access and closure of direct cardiac punctures may enable a range of therapeutic procedures. We evaluate the safety and feasibility of closing percutaneous direct ventricular access sites using a commercial collagen-based femoral artery closure device. METHODS:Yorkshire swine underwent percutaneous transthoracic left ventricular access (n = 13). The access port was closed using a commercial collagen-based vascular closure device (Angio-Seal, St. Jude Medical) with or without prior separation of the pericardial layers by instillation of fluid into the pericardial space ("permissive pericardial tamponade"). After initial nonsurvival feasibility experiments (n = 6); animals underwent 1-week (n = 3) or 6-week follow-up (n = 4). RESULTS:In naïve animals, the collagen plug tended to deploy outside the parietal pericardium, where it failed to accomplish hemostasis. "Permissive pericardial tamponade" was created under MRI, and accomplished early hemostasis by allowing the collagen sponge to seat on the epicardial surface inside the pericardium. After successful closure, six of seven animals accumulated a large pericardial effusion 5 ± 1 days after closure. Despite percutaneous drainage during 6-week follow-up, the large pericardial effusion recurred in half, and was lethal in one. CONCLUSIONS:A commercial collagen-based vascular closure device may achieve temporary but not durable hemostasis when closing a direct left ventricular puncture port, but only after intentional pericardial separation. These insights may contribute to development of a superior device solution. Elective clinical application of this device to close apical access ports should be avoided.
| S-EPMC3184403 | biostudies-literature
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.
| S-EPMC5314616 | biostudies-literature
Project description:The goal of this study was to assess the frequency and predictors of vascular closure device (VCD) deployment failure, and its association with vascular complications of 3 commonly used VCDs.VCDs are commonly used following percutaneous coronary intervention on the basis of studies demonstrating reduced time to ambulation, increased patient comfort, and possible reduction in vascular complications as compared with manual compression. However, limited data are available on the frequency and predictors of VCD failure, and the association of deployment failure with vascular complications.From a de-identified dataset provided by Massachusetts Department of Health, 23,813 consecutive interventional coronary procedures that used either a collagen plug-based (n = 18,533), a nitinol clip-based (n = 2,284), or a suture-based (n = 2,996) VCD between June 2005 and December 2007 were identified. The authors defined VCD failure as unsuccessful deployment or failure to achieve immediate access site hemostasis.Among 23,813 procedures, the VCD failed in 781 (3.3%) procedures (2.1% of collagen plug-based, 6.1% of suture-based, 9.5% of nitinol clip-based VCDs). Patients with VCD failure had an excess risk of "any" (7.7% vs. 2.8%; p < 0.001), major (3.3% vs. 0.8%; p < 0.001), or minor (5.8% vs. 2.1%; p < 0.001) vascular complications compared with successful VCD deployment. In a propensity score-adjusted analysis, when compared with collagen plug-based VCD (reference odds ratio [OR] = 1.0), nitinol clip-based VCD had 2-fold increased risk (OR: 2.0, 95% confidence interval [CI]: 1.8 to 2.3, p < 0.001) and suture-based VCD had 1.25-fold increased risk (OR: 1.25, 95% CI: 1.2 to 1.3, p < 0.001) for VCD failure. VCD failure was a significant predictor of subsequent vascular complications for both collagen plug-based VCD and nitinol clip-based VCD, but not for suture-based VCD.VCD failure rates vary depending upon the type of VCD used and are associated with significantly higher vascular complications as compared with deployment successes.
| S-EPMC3427601 | biostudies-literature
Project description:ObjectivesThis study sought to test safety and exploratory effectiveness of a dedicated transcaval closure device (TCD).BackgroundTranscaval access enables delivery of large-caliber devices to the aorta in patients ineligible for transfemoral arterial access. Closure of aortocaval fistulae using off-label nitinol cardiac occluders has been shown to be safe, but persistent aortocaval fistulae at exit from the catheterization lab and bleeding complications were common in a prospective study.MethodsPreclinical testing of the TCD was performed in 24 Yorkshire swine, including 10 under good laboratory practice conditions. Subsequently, subjects undergoing transcatheter aortic valve replacement for symptomatic severe aortic stenosis, ineligible for transfemoral arterial access, were enrolled in a U.S. Food and Drug Administration-approved early feasibility study of the TCD (Transmural Systems, Andover, Massachusetts). Independently adjudicated endpoints included technical, device, and procedural success, incorporating in-hospital and 30-day clinical and imaging follow-up.ResultsTranscaval access and closure in swine confirmed that at 30 days, TCDs were almost entirely endothelialized. Subsequently, 12 subjects were enrolled in the early feasibility study. Transcaval access, transcatheter aortic valve replacement, and aortocaval fistula closure was successful in all 12 subjects. The primary endpoint of technical success was met in 100% of subjects. Complete closure of the transcaval access tract was achieved in 75% of subjects at exit from the catheterization lab and in 100% of subjects at 30 days. There were zero modified Valve Academic Research Consortium-2 major vascular complications and zero Valve Academic Research Consortium-2 life-threatening or major bleeding complications related to transcaval access or the TCD.ConclusionsThe TCD achieved complete closure of the transcaval access tract in most subjects at exit from the catheterization lab and essentially eliminated transcaval-related bleeding. Dedicated devices for transcaval access and closure could enable more widespread adoption of transcaval techniques without fear of bleeding complications. (Transmural Systems Transcaval Closure Device for Transcaval Access Ports During Transcatheter Aortic Valve Replacement; NCT03432494).
| S-EPMC6930812 | biostudies-literature
Project description:ObjectiveAlthough the use of closure devices (CD) for femoral artery antegrade access (AA) is not in the instructions for use (IFU) for many devices, AA has been reported to be associated with a lower incidence of access site complications compared to manual compression alone. We hypothesized that CD use for AA would not be associated with a clinically significant increased odds of access site complications compared to CD use for retrograde access (RA).MethodsThis was a retrospective review of the Vascular Quality Initiative from 2010 to 2019 for infrainguinal peripheral vascular interventions with common femoral artery access closed with a CD. Patients who had a cutdown or multiple access sites were excluded. Cases were then stratified into whether access was antegrade or retrograde. Hierarchical multivariable logistic regressions controlling for hospital level variation were used to examine the independent association between AA and access site complications. The primary outcomes were access site hematoma, stenosis, or occlusion as defined in the VQI. The secondary outcome was the development of an access site hematoma requiring an intervention, which was defined as transfusion, thrombin injection, or surgery. Sensitivity analyses after coarsened exact matching were performed to reduce residual bias.ResultsOverall, 72,463 cases were identified and 6,070 (8.4%) had AA. Patients with AA were less likely to be smokers (27.2% vs 33.0%) or obese (31.5% vs 35.6%; all P<0.05). Patients with AA were more likely to be on dialysis (12.8% vs 10.1%) and have ultrasound-guided access (76.4% vs 66.2%; P<0.05 for all). Compared to RA, patients with AA were more likely to develop any access site hematoma (2.5% vs 1.8%; P<0.01) and a hematoma requiring intervention (0.7% vs 0.5%; P=0.03), but had no difference in access site stenosis or occlusion (0.3% vs 0.2%; P=0.21). On multivariable analyses, AA had increased odds of developing any access site hematoma (OR=1.46; 95% CI=1.22-1.76) and a hematoma requiring intervention (OR=1.48; 95% CI=1.10-1.98). Sensitivity analyses after coarsened exact matching confirmed these findings.ConclusionIn this nationally representative sample, the use of CDs for femoral access was associated with an overall low rate of access site complications. However, there was an increased odds of access site hematomas with AA. Patient selection for AA remains important and ultrasound guided access should be the standard of care for this approach.
| S-EPMC9869430 | biostudies-literature
Project description:ObjectiveRetrospective analysis of feasibility, safety and advantages of device closure of patent ductus arteriosus (PDA) using only venous access.BackgroundArterial access for transcatheter device closure of PDA has been a standard practice, but has inherent complications, especially in infants.MethodRecords of patients who underwent PDA device closure from 2004 to 2012 were reviewed. Echocardiography was used for patient selection and for assessment of procedural outcome.Result151 out of 179 patients underwent PDA device closure with venous access alone, weighing 2.2-58 kg with half <10 kg and follow up of 6 months-8 years. Fluoroscopic time ranged from 2.2 to 16 min. Immediate closure was achieved in 146 patients. Two patients had new-onset left pulmonary artery turbulence and one had residual flow.ConclusionPDA device closure without arterial access can be accomplished safely and effectively in vast majority of patients including infants.
| S-EPMC3860799 | biostudies-literature
Project description:BackgroundIatrogenic 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 summaryA 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.DiscussionOur 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.
| S-EPMC7649447 | biostudies-literature
Project description:BackgroundThe MANTA vascular closure device (VCD) is dedicated to large bore access closure and associated with favorable results in selected study populations. Anatomical predictors for access site complications are lacking.AimTo evaluate MANTA in a real-world population and identify predictors for vascular complications.MethodsAll patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) between January 2016 and May 2020 with MANTA closure were included. Baseline characteristics were collected, pre-procedural computed tomography and post-deployment femoral angiograms were analyzed for anatomical differences. The primary endpoint was a composite of access site related major and minor vascular complications at 30 days follow-up according to the VARC-2 definitions. Secondary endpoints included bleeding, time to hemostasis, procedural length and incomplete arteriotomy closure or arterial occlusion by angiography. A Cox proportional hazards model was used to compare all-cause mortality for patients with and without an access site complication.ResultsThe 512 patients underwent TAVR with MANTA access closure. Median age was 80 (IQR 75-85), 53% was male, median BMI was 26.4 kg/m2 (IQR 23.4-29.7). Access site related major- or minor vascular complication occurred in 20 (4%) and 23 (4%) of patients respectively. Median time to hemostasis was 42 s (IQR 28-98). Post deployment angiogram showed an occlusion in 24 patients (5%), incomplete closure in 60 patients (12%) or both in three patients (1%). Of these 87 patients, 36 (41%) had a vascular complication. Femoral artery diameter (OR 0.70 [0.53-0.93]), low- (OR 3.47 [1.21-10.00]) and high (OR 2.43 [1.16-5.10]) arteriotomies were independent predictors for vascular complications.ConclusionIn this contemporary TAVR population, access-site related complications occurred in 8% of patients and were mainly due to percutaneous closure device failure. Small artery diameter and off-target punctures were independent predictors.
| S-EPMC9292646 | biostudies-literature
Project description: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.
| S-EPMC5040263 | biostudies-literature