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.

Abstract

Introduction The 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 impactand early/late complications. Methods A 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. Results We 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. Conclusion The 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 ofclosure devices.Pseudoaneurysm formation was more frequent when adjuncts were needed.