Outcomes of routine use of percutaneous access with large-bore introducer sheaths (&gt;21F outer diameter) during endovascular aneurysm repair

Melloni, Andrea; Grandi, Alessandro; Spelta, Sara; Salvati, Serafina; Loschi, Diletta; Lembo, Rosalba; Melissano, Germano; Chiesa, Roberto; Bertoglio, Luca

doi:10.1016/j.jvs.2020.04.504

Cited by 19 publications

(6 citation statements)

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“…Earlier performed studies described the presence of a groin scar and PAD as a risk factor for failure of percutaneous access. 7,10,21,23 We were not able to confirm the presence of a groin scar as a risk factor for percutaneous access failure.…”

Section: Discussionmentioning

confidence: 61%

“…However, increasing sheath size was close to be a significant risk factor for both conversion to open approach and postinterventional access complications. 13,22,23 Importantly, previous surgical femoral artery exposure or repair was not associated with technical access failure or access complications. The main device access site was a significant predictor for failure of percutaneous access and postinterventional access complications.…”

Section: Discussionmentioning

confidence: 89%

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Safety of Percutaneous Femoral Access for Endovascular Aortic Aneurysm Repair Through Previously Surgically Exposed or Repaired Femoral Arteries

et al. 2022

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Objective: Percutaneous femoral artery access is being increasingly used in endovascular aortic repair (EVAR). The technique can be challenging in patients with previously surgically exposed or repaired femoral arteries because of excessive scar tissue. However, a successful percutaneous approach may cause less morbidity than a “re-do” open femoral approach. The aim of this study was to assess the impact of prior open surgical femoral exposure on technical success and clinical outcomes of percutaneous approach. Methods: This study retrospectively reviewed the clinical data of patients who underwent percutaneous EVAR between 2010 and 2020 at 2 major aortic centers. Patients were divided into 2 groups (with or without prior open surgical femoral access) for analysis of clinical outcomes. Only punctures with sheaths ≥12Fr were included for analysis. The access and (pre)closure techniques were similar in both institutions. Primary end points were intraoperative technical success, access-related revision, and access complications. A multivariate analysis was performed to identify determinants of conversion to open approach and femoral access complications in intact and re-do groins. Results: A total of 632 patients underwent percutaneous (complex) EVAR: 98 had prior open surgical femoral access and 534 patients underwent de novo femoral percutaneous access. A total of 1099 femoral artery punctures were performed: 149 in re-do and 950 in intact groins. The extent of endovascular repair included 159 infrarenal, 82 thoracic, 368 fenestrated/branched, and 23 iliac branch devices. No significant differences were seen in technical success (re-do 93.3% vs intact 95.3%, p=0.311), access-related surgical revision (0.7% vs 0.6%, p=0.950), and access complications (2.7% vs 4.0%, p=0.443). For the whole group, significant predictors for access complications in multivariate analyses were main access site (odds ratio [OR] 2.39; 95% confidence interval [CI] 1.07%–5.35%; p=0.033) and increase of the procedure time per hour (OR 1.65; 95% CI 1.34%–2.04%; p<0.001), while increase in sheath-vessel ratio had a protective effect (OR 0.33; 95% CI 0.127%–0.85%; p=0.021). Surgical conversion was predicted by main access site (OR 2.32; 95% CI 1.28%–4.19%; p=0.007) and calcification of 50% to 75% of the circumference of the access vessel (OR 3.29; 95% CI 1.38%–7.86%; p=0.005). Conclusion: Within our population prior open surgical femoral artery exposure or repair had no negative impact on the technical success and clinical outcomes of percutaneous (complex) endovascular aortic aneurysm repair.

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Section: Discussionmentioning

confidence: 61%

Section: Discussionmentioning

confidence: 89%

Safety of Percutaneous Femoral Access for Endovascular Aortic Aneurysm Repair Through Previously Surgically Exposed or Repaired Femoral Arteries

et al. 2022

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“…ProGlide studies report varying success rates, ranging from a 96.2% success rate [2] to conflicting findings regarding sheath sizes, from no significant difference in complications between ≤21 Fr and >21 Fr [15] to some studies reporting higher failure rates with sheath sizes ≥16 Fr, possibly due to device positioning challenges and an increased incidence of pseudoaneurysms [5,16]. Complications, assessed through angiography and VARC-2 criteria, reveal minor complications (14%) and pseudoaneurysms (1%) [17].…”

Section: Discussionmentioning

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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“…30 Blood loss could also lead to an impairment in SC perfusion, and transfusions are routinely employed to expand circulatory volume while maintaining Hb levels above 10 g/dL, as suggested by experiences from high-volume centers and in international surgical societies' position papers. [31][32][33][34] Moreover, sac thrombosis, particularly in large aneurysms, can contribute to reduce circulating Hb levels and platelet count due to consumption coagulopathy. 35 Volume repletion together with "permissive hypertension" with MAP above 80 mmHg is part of the multimodal approach to prevent SCI, with the use of vasoactive amines if necessary.…”

Section: Discussionmentioning

confidence: 99%

Spinal Cord Ischemia After Thoracoabdominal Aortic Aneurysms Endovascular Repair: From the Italian Multicenter Fenestrated/Branched Endovascular Aneurysm Repair Registry

et al. 2022

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Purpose: The aim of this study is to report an Italian multicenter experience analyzing the incidence and the risk factors associated with spinal cord ischemia (SCI) in a large cohort of thoracoabdominal aortic aneurysms (TAAAs) treated by fenestrated-branched endovascular aneurysm repair (F-/B-EVAR). Materials and Methods: All consecutive patients undergoing F-/B-EVAR in 4 Italian university centers between 2008 and 2019 were prospectively recorded and retrospectively analyzed. Spinal cord ischemia, 30 day/in-hospital adverse events, and mortality were assessed as early outcomes. Risk factors for SCI were determined by multivariable analysis. Results: A total of 351 patients received F-/B-EVAR for a TAAA. Twenty-eight (8.0%) patients died within 30 postoperative days or during the hospitalization. Regarding SCI, 47 patients (13.4%) developed neurological symptoms related to spinal cord impaired perfusion. Among them, 17 (4.8%) had a major permanent impairment. The multivariable analysis identified that SCI was associated with Crawford extent I to III (odds ratio [OR]: 20.90, p=0.004, 95% confidence interval [CI]=2.69–162.57), and with endovascular procedures performed for ruptured TAAA (OR: 5.74, p=0.010, 95% CI=1.53–21.57). Spinal cord ischemia was also significantly associated with a grade 3 bleeding during the visceral stage (OR: 4.34, p=0.005, 95% CI=1.55–12.16) and a grade 2 renal insufficiency at 30 days (OR: 7.45, p=0.002, 95% CI=2.12–26.18). Conclusion: The present study indicates that SCI is still an open issue after extent I to III TAAA endovascular repair, while its incidence in extent IV TAAA and pararenal/juxtarenal aneurysms is rare. Thoracoabdominal aortic aneurysms extension, urgent TAAA repair for rupture, severe bleeding, and 30 day renal insufficiency have been identified as significant risk factors for SCI. In the presence of such factors, adjunctive strategies may be considered to reduce SCI rates, while in low-risk patients invasive or potentially-risky maneuvers might not be justified.

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Outcomes of routine use of percutaneous access with large-bore introducer sheaths (>21F outer diameter) during endovascular aneurysm repair

Cited by 19 publications

References 30 publications

Safety of Percutaneous Femoral Access for Endovascular Aortic Aneurysm Repair Through Previously Surgically Exposed or Repaired Femoral Arteries

Safety of Percutaneous Femoral Access for Endovascular Aortic Aneurysm Repair Through Previously Surgically Exposed or Repaired Femoral Arteries

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

Spinal Cord Ischemia After Thoracoabdominal Aortic Aneurysms Endovascular Repair: From the Italian Multicenter Fenestrated/Branched Endovascular Aneurysm Repair Registry

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