Comparison of Exo-Seal® and Angio-Seal® for arterial puncture site closure

Ketterle, Johannes; Rittger, Harald; Helmig, Inga; Klinghammer, Lutz; Zimmermann, Stefan; Hohenforst-Schmidt, Wolfgang; Brachmann, Johannes; Nef, Holger; Achenbach, Stephan; Schlundt, Christian

doi:10.1007/s00059-015-4306-3

Cited by 9 publications

(5 citation statements)

References 35 publications

(37 reference statements)

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“…They concluded that VCDs were noninferior to MC in terms of vascular access site complications and reduced time to hemostasis. 33 Ketterle et al 16 published a prospective, single-blinded multicenter trial comparing an anchor/plug-mediated VCD (Angio-Seal) and an extravascular VCD (Exoseal) with one another, with primary end points being access site-related complications (ie, hematoma at least 5 cm in size, significant groin bleeding, pseudoaneurysm, and device failure) after coronary angiography or intervention. The results demonstrated that the incidence of hematoma was lower in the Exoseal group compared with the Angio-Seal group (1.3% vs 1.9%), that the incidence of pseudoaneurysm was lower in the Exoseal group compared with the Angio-Seal group (1.3% vs 2.5%), and that there was a trend for higher device failure rates requiring MC in the Exoseal group compared with the Angio-Seal group (5.2% vs 1.2% ; P ¼ .06).…”

Section: Discussionmentioning

confidence: 99%

“…Overall, there is a low incidence of vascular complications. 5,[13][14][15][16][17][18] Vascade Vascular Closure System (Cardiva Medical, Inc, Santa Clara, Calif; Fig 4) is a passive approximator that deploys a collagen plug over the arteriotomy, causing tamponade of the puncture site as a result of expansion of the plug. A low-profile disc abuts the wall, and a collagen plug is deployed over the arteriotomy.…”

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confidence: 99%

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A systematic review of vascular closure devices for femoral artery puncture sites

Noori

Eldrup-Jørgensen

2018

Journal of Vascular Surgery

146

114

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VCDs have shown marked improvement in patients' comfort and satisfaction as well as in time to hemostasis and ambulation after percutaneous vascular procedures. According to multiple small randomized controlled trials, meta-analyses, and a Cochrane review, complication rates, safety and efficacy, and outcomes remain comparable between VCDs and MC (12% for VCDs vs 13% for MC). VCDs have a low incidence of major complications and high success rates, which provides convenience for the practitioner and facilitates turnover of patients. VCDs have a risk of infectious (0.6% with VCDs vs 0.2% with MC) and thrombotic complications (0.3% with VCDs vs none with MC) that is small but may be increased compared with MC. It is important to balance the goals of comfort of the patient, resources of the staff, and early ambulation against periprocedural and anatomic risk factors (ie, individualize use of VCDs to specific clinical scenarios). Users must be familiar with a device and its limitations to safely and effectively achieve hemostasis after femoral artery puncture.

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Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

A systematic review of vascular closure devices for femoral artery puncture sites

Noori

Eldrup-Jørgensen

2018

Journal of Vascular Surgery

146

114

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“…Ketterle et al [ 19 ] investigated about the complications rate differences comparing an anchor/plug-mediated VCD (AngioSeal) and an extravascular VCD (Exoseal). The incidence of haematoma and pseudoaneurysm was lower in the Exoseal group compared with the AngioSeal group (1.3% vs 1.9% and 1.3% vs 2.5%, respectively).…”

Section: Discussionmentioning

confidence: 99%

Effectiveness and Safety of Different Vascular Closure Devices: Multicentre Prospective Observational study

Ierardi,

Coppola,

Renzulli

et al. 2023

Cardiovasc Intervent Radiol

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Aim The aim of this prospective, multicentre, observational study was to compare the efficacy and safety of balloon-based and non-balloon-based vascular closure devices (VCDs). Materials and Methods From March 2021 to May 2022, 2373 participants from 10 different centres were enrolled. Among them, 1672 patients with 5–7 Fr accesses were selected. Successful haemostasis, failure and safety were evaluated. Successful haemostasis was defined as the possibility to obtain complete haemostasis with the use of VCDs, without any complication. Failure management was defined as the need of manual compression. Safety was defined as the rate of complications. Cases of haematomas/pseudoaneurysms (PSA) and artero-venous fistula (AVF) were collected. Results VCDs mechanism of action is statistically significant associated with the outcome. Non-balloon-based VCDs demonstrated a statistically significant better outcome: successful haemostasis was obtained in 96.5% vs. 85.9%, of cases when compared to balloon occluders ( p < 0.001). The incidence of AVF was statistically more frequent using non-balloon occluders devices (1.57% vs 0%, p : 0.007). No significant statistical difference was found in comparing haematoma and PSA occurrence. Thrombocytopenia, coagulation deficit, BMI, diabetes mellitus and anti-coagulation were demonstrated to be independent predictors of failure management. Conclusion Our study suggests a better outcome with the same complication rate, except that for AVF incidence for non-balloon collagen plug device if compared to balloon occluders vascular closure devices. Supplementary Information The online version contains supplementary material available at 10.1007/s00270-023-03463-5.

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“…A comparative study of the efficacy of the ExoSeal extrafemoral vessel closure device with the well-validated AngioSeal plug-anchor system for vessel closure after coronary angiography and PCI showed that the use of ExoSeal was no worse than treatment with AngioSeal in terms of bleeding, hematoma, false aneurysms, and device failure. The use of ExoSeal was associated with a higher, although not significant, rate of device failure and significantly less pain as measured by the Borg scaleccone [12].…”

Section: Discussionmentioning

confidence: 81%

A prospective randomized trial was conducted to evaluate the complication rate and patient comfort using three different vascular closure strategies following coronary angiography

Kollum

2024

JCCI

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Background: The use of vascular closure devices is now common in clinical practice for femoral artery puncture, although manual compression remains the current gold standard. The development and use of vascular closure devices are aimed at improving patient comfort and avoiding complications such as hematoma, pseudoaneurysm formation, and the need for blood transfusion in the event of significant bleeding or surgical revision at the puncture site. Aims: The aim of this study is to evaluate the complication rate after femoral arterial puncture using different closure techniques. Furthermore, patient comfort will also be measured. Material and Methods: In this prospective, two-centre study, 142 patients were randomized into three groups: the Vascular Closure Device (VCD, Cordis), manual compression (MC) and External Compression Device (ECD, Maquet). The primary endpoint is combined with the evaluation of hematoma greater than 5 cm, pseudoaneurysm formation, the need for blood transfusion or relevant bleeding with a hemoglobin drop greater than 2 g/dl, the occurrence of retroperitoneal hematoma, pressure ulcers greater than grade 2, ischemia of the ipsilateral limb, or nerve damage. Follow-up visits are scheduled at 24 hours, 7 days, and 30 days. Results: The ratio of gender and pre-existing conditions within the randomized groups is almost equal. Medication before coronary angiography is comparable. Significantly more interventions are performed in the VCD group. Correspondingly, the procedure time is longer, and dual antiplatelet therapy is prescribed more often. Compression time and time to first hemostasis were significantly longer in the VCD group. The number of rebleeds after primary hemostasis is significantly higher in the ECD group. None of the enrolled patients suffered major bleeding or required a blood transfusion. No retroperitoneal hematoma was observed. Overall, there is one AV fistula in the MC group, two pseudoaneurysms in the VCD group, and one pseudoaneurysm in the ECD group. Pain was reported at significantly higher rates in the MC group than in either device group. The highest level of pain is reported within 48 hours in the MC group, and voiding dysfunction is significantly more frequent in the MC group. The same results are observed for sleep quality. Patients in the MC group reported significantly fewer hematomas greater than 5 cm at 7 days compared to patients who received a VCD. Conclusion: Our results show no significant difference in the achievement of the combined primary endpoint of all three groups. However, the rate of rebleeding after primary hemostasis is significantly lower in the VCD group, even with prolonged procedure time. There was no difference in the incidence of MACCE. Patient pain and voiding dysfunction within 24 hours are highest in the MC group. No difference is reported between 7 and 30 days.

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Comparison of Exo-Seal® and Angio-Seal® for arterial puncture site closure

Abstract: In the present study, there were no significant differences found regarding the occurrence of hematoma > 5 cm, major bleeding, false aneurysm, and device failure between Angio-Seal(®) and Exo-Seal(®) 24 h after device implantation.

Cited by 9 publications

References 35 publications

A systematic review of vascular closure devices for femoral artery puncture sites

A systematic review of vascular closure devices for femoral artery puncture sites

Effectiveness and Safety of Different Vascular Closure Devices: Multicentre Prospective Observational study

A prospective randomized trial was conducted to evaluate the complication rate and patient comfort using three different vascular closure strategies following coronary angiography

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