‘Post-Close’ Femoral Arterial Haemostasis at Endovascular Aneurysm Repair using a Dedicated Large-Bore Vascular Closure Device: A Prospective Real-World Audit

Chaudhuri, Arindam

doi:10.1007/s00270-023-03437-7

Cited by 3 publications

(1 citation statement)

References 30 publications

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“…Therefore, there is a pressing need for a comprehensive classification system that incorporates technical aspects and haemostasis types in VCD research. This study adopts the classification system introduced in the MANTA group [13] to evaluate access-related complications for both ProGlide and MANTA devices. Our goal is to identify complications linked to VCDs and examine the influence of calcification site and extent.…”

Section: Introductionmentioning

confidence: 99%

A Comparative Analysis of the Early and Late Complication Rates and the Effect of Calcification on the Efficacy of MANTA and ProGlide Vascular Closure Devices

Hakeem,

Najem,

Khokher

et al. 2023

Cureus

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IntroductionThe Perclose ProGlide and, more recently, MANTA Large-Bore Closure Device are commonly used vascular closure devices (VCDs) for managing large-bore vascular access haemostasis. The extent of calcification in the common femoral artery (CFA) plays a crucial role in choosing between these devices. ProGlide may face challenges with anterior calcification, while MANTA may have issues with posterior calcification. Our study compared their effectiveness, adjunct usage, calcification impact and early/late complications. MethodsA retrospective analysis of procedures involving large-bore CFA access from 2017 to 2022 was conducted. Closure was grouped according to VCD as Group A (ProGlide) and Group B (MANTA). Calcification was designated as anterior and posterior and combined on pre-operative computed tomography angiography along 10 mm segments with 0.625 mm slice thickness. The success of haemostasis was graded as Grade 1 (haemostasis without adjuncts), Grade 2 (haemostasis with adjuncts) and Grade 3 (failed haemostasis needing rescue); Grades 1 and 2 were pooled as successful haemostasis. Statistical analysis was undertaken in Minitab 21 for Windows, particularly analysing calcification and its impact on the success of haemostasis. ResultsWe evaluated 370 large-bore CFA accesses, distributed across two groups: Group A(64.9%, n=243) and Group B (35.1%, n=127), for a total of 205 endovascular procedures (93.1% (191) EVAR and 5.3% (11) TEVAR). The mean age was 74.9±8 years, predominantly males (88.2%, n=181). The average body mass index (BMI) was 28±5.8, with 20.9% (43) individuals having diabetes and 18.5% (37) current smokers. The mean sheath size OD was 16±2.5, with 4.5% (11) re-do groins in Group A and 6.2% (8) in Group B.Successful haemostasis was achieved in 91.8% (n=223) in Group A (44.8%, n=109 Grade 2) and 90.5% (n=115) in Group B (21%, n=27 Grade 2). Rescue operations were needed in 8.2% (20) in Group A and 9.1% (12) in Group B. Pseudoaneurysms developed more commonly in Grade 2 haemostasis with 9.9% (11) in Group A and 1.6% (2) in Group B (p=0.3).Anterior calcification was observed in 14.8% (36) in Group A and 18.8% (24) in Group B. In comparison, posterior calcification was present in 62.5% (152) in Group A and 66.9% (85) in Group B. Notably, calcification did not significantly impact haemostasis (p=0.79). Additional VCD deployment was necessary due to device failure in 4.5% (11) cases in Group A and 1.5% (2) cases in Group B. ConclusionThe overall success rate was comparable between the two groups. However, Group A required more adjuncts to achieve successful haemostasis. The site of calcification did not impact the efficacy of closure devices. Pseudoaneurysm formation was more frequent when adjuncts were needed.

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Section: Introductionmentioning

confidence: 99%

A Comparative Analysis of the Early and Late Complication Rates and the Effect of Calcification on the Efficacy of MANTA and ProGlide Vascular Closure Devices

Hakeem,

Najem,

Khokher

et al. 2023

Cureus

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Reply to Letter to the Editor Regarding CIRSE Standards of Practice on Varicocele Embolisation

Silipigni

Biondetti

Tsetis

et al. 2023

Cardiovasc Intervent Radiol

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Collagen-Based Vascular Closure Device Multicenter Italian Experience in Endovascular Aortic Aneurysm Repair Compared With Suture-Mediated Closure Vascular Device

Panagrosso,

Cavallo,

Bracale

et al. 2024

J Endovasc Ther

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Purpose: The Manta Vascular Closure Device is a novel collagen-based vascular closure device that has been designed specifically for closure of large-bore percutaneous arterial accesses. The aim of this retrospective study is to evaluate the immediate and 30-day outcome of Manta at the completion of endovascular aneurysm repair (EVAR) or thoracic endovascular aortic repair (TEVAR). The hypothesis is that Manta is not inferior in obtaining hemostasis compared with the Perclose ProGlide Suture-Mediated Closure System device. Materials and Methods: We recruited all the percutaneous accesses for (T)EVAR performed from January 2021 to April 2023 by all the Italian Divisions of Vascular Surgery using Manta at the time of data collection (May 2023). The primary outcome is to evaluate the incidence of complications at the puncture site after Manta implantation and at 1 month, and compare this with ProGlide. We applied the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) criteria for observational studies. Results: Overall, 524 consecutive femoral accesses for (T)EVAR procedures were collected: 355 in the Manta cohort and 169 in the ProGlide cohort, respectively. The size of the sheath was 17.2±2.7 Fr for Manta, 15.7±2.3 Fr for ProGlide (p<0.001). No statistically significant differences between the groups regarding age, sex, body mass index, ultrasound-guided access, femoral calcifications, intraoperative, and 30-day complications. Successful arterial closure at groin puncture sites for (T)EVAR using Manta is 90.5% and 93.1% using ProGlide. Freedom for any reintervention for any complication is 95.5% for Manta and 96% for ProGlide. Conclusion: The 2 vascular closure devices have proved to be similar in terms of complications, without any statistically significant difference, although the median size of the sheaths for (T)EVAR was statistically significantly larger when Manta has been used, compared with ProGlide. Clinical Impact Manta® is effective in the hemostasis of the access sites following the completion of (T)EVAR in this multicenter, retrospective, case-control study on 524 percutaneous femoral accesses. Compared to the more popular Proglide®, the average size of the introducers in the Manta® group was significantly larger than in the Proglide® group.

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‘Post-Close’ Femoral Arterial Haemostasis at Endovascular Aneurysm Repair using a Dedicated Large-Bore Vascular Closure Device: A Prospective Real-World Audit

Cited by 3 publications

References 30 publications

A Comparative Analysis of the Early and Late Complication Rates and the Effect of Calcification on the Efficacy of MANTA and ProGlide Vascular Closure Devices

A Comparative Analysis of the Early and Late Complication Rates and the Effect of Calcification on the Efficacy of MANTA and ProGlide Vascular Closure Devices

Reply to Letter to the Editor Regarding CIRSE Standards of Practice on Varicocele Embolisation

Collagen-Based Vascular Closure Device Multicenter Italian Experience in Endovascular Aortic Aneurysm Repair Compared With Suture-Mediated Closure Vascular Device

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