Safety and Feasibility of a Novel Vascular Closure Device in Neurointerventional Procedures

Taha, Ammar; Walsh, Ellen K; Wright, Kathryn; Ahmed, Iftikhar; Supakul, Nucharin; Awwad, Eric E.; Tejada, Juan

doi:10.1177/159101991301900313

Cited by 6 publications

(7 citation statements)

References 23 publications

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“…VCDs have been shown to significantly improve hemostasis and ambulation after percutaneous vascular procedures, both diagnostic and therapeutic. 1,2,4,5 Increased patient satisfaction, comfort as well as accelerated ambulation have also been reported. 6,7 Some studies have shown that certain types of VCDs are 95-100% effective in achieving hemostasis with minimal complications.…”

Section: Discussionmentioning

confidence: 97%

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Safety and effectiveness of vascular closure devices in interventional radiological procedures

et al. 2022

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Background Although it is well known that vascular closure devices (VCD) are commonly used in therapeutic interventional radiological procedures, standard use in diagnostic procedures is not as well studied. Purpose The aim of this study was to determine the real-world safety and effectiveness of the VCD in both diagnostic and therapeutic interventional radiological procedures. Materials and methods A retrospective, single center study included all patients where VCDs were used for either a diagnostic or therapeutic interventional procedure. Various demographic and clinical risk factors were recorded and examined for any significant association with successful deployment and complications. Results A total of 2072 patients were included. VCDs were successfully deployed in 95.2% of the patients with 4.8% of perioperative complications, which included minor oozing from the puncture site, small hematoma less than or equal to 5 cm, large hematoma greater than 5 cm, pain, and loss of vascular access. Therapeutic (vascular interventional radiology (VIR) and neuro-interventional radiology (NIR)) procedures (OR 3.03, 95% CI 1.51–6.09, p = 0.002), use of Angioseal (OR 5.26, 95% CI 3.13–8.33), p < 0.001), and no use of antiplatelet medications (OR 0.47, 95% CI 0.22–0.97, p = 0.041) were independently associated with successful deployment of VCDs when controlled for other risk factors. Smoking (OR 3.50, 95% CI 2.00–6.05, p = <0.001), use of antiplatelet (OR 2.01, 95% CI 1.04–3.87, p = 0.037) and use of heparin (OR 1.78, 95% CI 1.10–2.86, p = 0.018) were independently associated with higher complication rates. Conclusion VCD's were successfully deployed in 95.2% of the patients with 4.8% of perioperative minor complications.

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Section: Discussionmentioning

confidence: 97%

“…Also, many newer techniques such as using the transradial access approach 30 and different types of VCDs are being studied in small cohorts. 5 Currently, our experience with these methods is limited but ongoing vigilant, monitoring of these techniques and devices should be performed.…”

Section: Discussionmentioning

confidence: 99%

Safety and effectiveness of vascular closure devices in interventional radiological procedures

et al. 2022

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“…Larger sheath diameter is directly related to the size of the puncture breach. In addition, several researchers have reported a lower complication rate of the puncture site with the use of vascular closure devices compared with manual compression (22)(23)(24). Therefore, failure of closure increases the complications of the puncture site, including FPA.…”

Section: Discussionmentioning

confidence: 99%

A nomogram for predicting the risk of femoral pseudoaneurysm after neurointerventional procedures

Yang¹,

Zhao²,

Liu³

et al. 2022

Ann Transl Med

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Background: Because femoral pseudoaneurysm (FPA) is a dangerous complication of interventional procedures with a risk of life-threatening bleeding, our aim was to develop a predictive nomogram for FPA after neurointervention, and to suggest the best method for early identification of FPA. Methods:We searched the PubMed database for literature addressing FPA after interventional procedures to analyze the risk factors, and we also reviewed the clinical data of patients from the Department of Neurosurgery who underwent neurointerventional procedures. Selected parameters were analyzed by univariate and multivariate logistic regression analysis. A nomogram was constructed using the independent risk factors by a multivariate regression model, and was validated by bootstrap resampling method, as well as receiver operating characteristic (ROC) curve, decision curve analysis (DCA) and calibration curve. The influence on the detection rate of FPA with Doppler ultrasound was also analyzed with Fisher's exact test.Results: According to existing studies, female sex, diabetes and hypertension are major risk factors of FPA.Among 1,098 clinical patients, hypertension (P=0.044), higher body mass index (BMI) (P=0.020), larger sheath size (P=0.049), puncture site hematoma (P=0.011) and closure failure (P=0.003) were identified as independent risk factors. The nomogram including these factors showed robust discrimination [C-index, 0.916; 95% confidence interval (CI), 0.810-1.022] with an area under the curve of 0.916. DCA indicated clinical utility, and the calibration curves showed an acceptable consistency. A significant improvement in the detection rate occurred when Doppler ultrasound was utilized (P=0.031). Conclusions:The presented nomogram showed favorable predictive accuracy for FPA after neurointervention. We recommend ultrasound examination for patients at high risk of FPA evaluated by the nomogram.

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“…reported no instances of femoral artery complications based on the results of follow-up color Doppler ultrasound studies performed on 55 patients in whom the MynxGrip, the latest iteration of the Mynx VCD, was used. 38…”

Section: Discussionmentioning

confidence: 99%

Incidence of delayed angiographic femoral artery complications using the EXOSEAL vascular closure device

et al. 2015

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Background and purpose Femoral artery injuries are known complications of percutaneous vascular closure devices (VCDs). We studied the incidence of delayed femoral artery angiographic irregularities after neurointerventional procedures in which the EXOSEAL extravascular closure device was used for femoral arterial puncture closure. Methods Adult patients who underwent femoral arterial puncture closures with an EXOSEAL VCD and had a follow-up femoral artery angiogram from June 2012 through August 2013 were reviewed. A blinded radiologist compared pre-deployment and follow-up femoral arteriograms for the presence of femoral artery stenosis, dissection, pseudoaneurysm, or development of an arteriovenous fistula. Hospital records were reviewed for major or minor complications of the groin site or femoral artery. Results The EXOSEAL VCD achieved hemostasis, without evidence of a groin hematoma or requiring subsequent prolonged manual compression, in 400 of 441 closures following transfemoral arterial access, representing a device success rate of 90.7%. A total of 98 patients underwent 102 repeat angiograms following closure with the EXOSEAL VCD. The average time to the repeat angiogram was 73.5 days (range 0–488, median 28). Follow-up femoral arteriography demonstrated an irregularity in seven cases, all of which were vessel stenoses of <50%. There were no dissections, pseudoaneurysms, infections, or ischemic events in the study population. Conclusions Angiographic irregularities were seen in 6.86% of cases after closure with the EXOSEAL VCD. There were no clinically significant vascular complications. Thus, femoral artery closure with EXOSEAL carries a low risk of clinically significant delayed angiographic findings.

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Safety and Feasibility of a Novel Vascular Closure Device in Neurointerventional Procedures

Cited by 6 publications

References 23 publications

Safety and effectiveness of vascular closure devices in interventional radiological procedures

Safety and effectiveness of vascular closure devices in interventional radiological procedures

A nomogram for predicting the risk of femoral pseudoaneurysm after neurointerventional procedures

Incidence of delayed angiographic femoral artery complications using the EXOSEAL vascular closure device

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