Predictive Factors for Additional ProGlide Deployment in Percutaneous Endovascular Aortic Repair

Lin, Shen‐Yen; Lyu, Sin-Yi; Su, Ta‐Wei; Chu, Sung‐Yu; Chen, Chien-Ming; Hung, Chien-Fu; Chang, Ching‐Jui; Ko, Po‐Jen

doi:10.1016/j.jvir.2016.12.1219

Cited by 16 publications

(13 citation statements)

References 20 publications

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“…Technical success in pEVAR varies depending on the patient's femoral artery anatomy (calcification width, small vessel diameter), the use of large sheaths or limited operator experience. [ 4 , 6 ] Less access site complications and more than 90% technical success can be achieved with pEVAR. [ 4 ] Using the Perclose™ closure device, the total procedure time is shortened by 25 min[ 4 , 7 , 8 ] and a significant decrease is observed in local anesthesia usage, the duration of ambulation and the length of intensive care unit and hospital stay in this process.…”

Section: Discussionmentioning

confidence: 99%

Comparison of percutaneous access and open femoral cutdown in elective endovascular aortic repair of abdominal aortic aneurysms

Akbulut¹,

Ak²,

Arslan³

et al. 2022

Turk Gogus Kalp Dama

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Background: The aim of this study was to compare postoperative outcomes of percutaneous access and femoral cutdown methods for elective bifurcated endovascular abdominal aortic aneurysm repair. Methods: Between November 2013 and September 2020, a total of 152 patient (135 males, 17 females; mean age: 70.6±6, range, 57 to 87 years) who underwent endovascular repair due to infrarenal abdominal aortic aneurysm were retrospectively analyzed. According to femoral access type, the patients were grouped into two groups as the total percutaneous femoral access and open cutdown femoral access endovascular repair. Intra- and postoperative data were compared, including operative time, amount of contrast media, bleeding requiring transfusion, return to the operating room, access vessel complications, wound complications, and overall length of hospital stay. Results: Eighty-seven (57.2%) femoral cutdown access repair and 65 (42.8%) percutaneous femoral access repair cases were evaluated in the study. The two groups were comparable in terms of demographic and clinical characteristics (p>0.05), except for chronic obstructive pulmonary disease which was more frequent in the percutaneous access group (p=0.014). After adjustment, age, diabetes mellitus, chronic obstructive pulmonary disease, and obesity were not predictive of percutaneous access failure. Percutaneous femoral access was observed as the only preventing factor for wound infection (odds ratio=0.166, 95% confidence interval: 0.036-0.756; p=0.021). Conclusion: Although femoral access preference does not affect mortality and re-intervention rates, percutaneous endovascular repair reduces operation time, hospital stay, and wound site complications compared to femoral artery exposures.

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Section: Discussionmentioning

confidence: 99%

Comparison of percutaneous access and open femoral cutdown in elective endovascular aortic repair of abdominal aortic aneurysms

Akbulut¹,

Ak²,

Arslan³

et al. 2022

Turk Gogus Kalp Dama

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“…Our primary technical success, with ProGlide itself of 68.1% is lower than has been reported in most of the trials where primary technical success rates for ProGlide have varied from 71-100% after P-EVAR. 11-13 One explanation could be that this study intended to treat all-comers and have not excluded factors that have been associated with failure in other studies. Another likely explanation is that the definition of technical success differs between publications.…”

Section: Discussionmentioning

confidence: 99%

A Single Center Study of ProGlide Used for Closure of Large-Bore Puncture Holes After EVAR for AAA

Mathisen

Nilsson

Larzon

2021

Vasc Endovascular Surg

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Purpose: The objective of this study was to evaluate the primary and assisted secondary percutaneous and non-invasive technical success of the ProGlide device on all-comers in a consecutive case series of percutaneous endovascular aortic aneurysm repair (P-EVAR). Method: A single-center consecutive case series where 434 elective and acute P-EVAR procedures were registered prospectively between May 2011 and July 2017. The mean age was 74.5 years ± SD 11.4 years. 82.3% of the patients were male. All patients were pre-planned from CT angiography. Percutaneous access punctures, performed in local anesthesia in the common femoral artery, with a final introducer size between 12-22 Fr OD were included and stratified in 2 groups, 12-16 Fr and 17-22 Fr. Results: By screening 868 access groins 22 groins were excluded. Of the remaining 846 groins, intended to be treated with ProGlide, 9 groins were excluded peri-procedurally and treated with the Fascia Suture Technique or surgical cutdown. The remaining 837 groins had access closure with ProGlide, with a mean value of 2.15 devices per groin with a slight significant difference between the 2 stratification groups. Primary ProGlide technical success was achieved in 68.1% of the groins. Secondary percutaneous or non-invasive technical success was achieved in 96.9%. Here there was no statistically significant difference between the 2 stratification groups. Thirty-one (3.7%) groin complications were registered during 30-day follow-up and 17 required additional treatment. Total mortality was 2.8%. None of these deaths were related to the access site. Conclusion: ProGlide by itself has a significant failure rate in the closure of large-bore access holes on an unselected cohort of patients eligible for P-EVAR. However, together with adjunct percutaneous or non-invasive methods a success rate of 97% can be achieved. The access complication rate was lower than 4% at 30-day follow-up.

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“…The costs and late mortality consequences of these complications are significant. 20 When patients undergoing EVAR procedures experienced complications, they had a 9 times higher rate of in-hospital mortality, more than double the hospital length of stay, and a 40% increase in health care costs compared with patients who did not have complications. 21 Dedicated large-bore closure with the MANTA device may significantly reduce the cost of a variety of large-bore procedures.…”

Section: Discussionmentioning

confidence: 99%

“…Additional data from single-center studies show conflicting predictive factors for suboptimal percutaneous closure. In a retrospective analysis of 418 PEVAR/TEVAR access site closures, Lin et al 20 reported a primary technical success rate (adequate hemostasis and 2 ProGlide devices) of 87.6%. Forty-eight (11.5%) femoral access sites required at least 1 additional ProGlide device, and 4 (1%) access sites required surgical repair.…”

Section: Discussionmentioning

confidence: 99%

“…Anterior wall calcification was reported to have increased the risk of additional ProGlide device use, while other factors, such as sheath size and CFA diameter, did not seem to affect the number of devices needed. 20 Rijkee et al 10 reported an open surgical conversion rate of 6.5% (10/154 access sites) following failed percutaneous closure with the ProStar device. Reported significant indicators of conversion to surgical closure included sheath size and a ratio of sheath size to CFA diameter >0.75.…”

Section: Discussionmentioning

confidence: 99%

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Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the MANTA Vascular Closure Device During Percutaneous EVAR and TEVAR Procedures

et al. 2020

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Purpose: To evaluate the safety and effectiveness of the MANTA percutaneous vascular closure device in patients undergoing percutaneous endovascular aneurysm repair (PEVAR) or thoracic endovascular aortic repair (TEVAR). Materials and Methods: The SAFE MANTA Study ( ClinicalTrials.gov identifier NCT02908880) was a prospective, single-arm, multicenter trial in patients undergoing endovascular interventions using large-bore sheaths (transcatheter aortic valve replacement, PEVAR, or TEVAR) at 20 sites in North America. Patient selection intended to test the MANTA device in populations without morbid obesity, severe calcification, or a severely scarred femoral access area. Of the 263 patients enrolled in the primary analysis cohort, 53 (20.2%) patients (mean age 74.9±8.9 years; 41 men) underwent PEVAR (n=51) or TEVAR (n=2) procedures and form the cohort for this subgroup analysis. Per protocol a single MANTA device was deployed in all PEVAR/TEVAR cases. Results: The mean time to hemostasis in the PEVAR/TEVAR cohort was 35±91 seconds, with a median time of 19 seconds vs 24 seconds in the overall SAFE MANTA population. The MANTA device met the definition for technical success in 52 (98%) of 53 PEVAR/TEVAR cases compared with 97.7% in the overall SAFE MANTA population. One (1.9%) major complication (access-site stenosis) occurred in this subgroup compared to 14 (5.3%) events in the SAFE population. In the PEVAR/TEVAR group, 1 pseudoaneurysm was noted prior to discharge, another at 30-day follow-up, and one at 60 days. One (1.9%) of the 3 minor pseudoaneurysms was treated with ultrasound-guided compression and the other 2 required no treatment. Conclusion: The MANTA device demonstrated a short time to hemostasis and low complication rates compared with published literature results of other percutaneous closure devices. Time to hemostasis and complication rates were comparable between the PEVAR/TEVAR patients and the full SAFE MANTA study cohort. The MANTA device provides reliable closure with a single percutaneous device for PEVAR/TEVAR procedures.

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Predictive Factors for Additional ProGlide Deployment in Percutaneous Endovascular Aortic Repair

Cited by 16 publications

References 20 publications

Comparison of percutaneous access and open femoral cutdown in elective endovascular aortic repair of abdominal aortic aneurysms

Comparison of percutaneous access and open femoral cutdown in elective endovascular aortic repair of abdominal aortic aneurysms

A Single Center Study of ProGlide Used for Closure of Large-Bore Puncture Holes After EVAR for AAA

Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the MANTA Vascular Closure Device During Percutaneous EVAR and TEVAR Procedures

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