scholarly journals Clinical Outcomes of Ambulatory Endovascular Treatment Using 4-French and 6-French Femoral Access Strategies: The Bio4amb Multicentre Trial

2020 ◽  
Author(s):  
Marianne Brodmann ◽  
◽  
Koen Deloose ◽  
Eric Steinmetz ◽  
Olivier Regnard ◽  
...  
Keyword(s):  
Closure Device ◽  
Peripheral Vascular ◽  
Primary Analysis ◽  
Access Site ◽  
Femoral Access ◽  
Vascular Closure Devices ◽  
Total Procedure Time ◽  
American Society ◽  
Device Use ◽  
Ambulatory Procedures

Abstract Purpose Ambulatory peripheral vascular interventions have been steadily increasing. In ambulatory procedures, 4F devices might be particularly useful having the potential to reduce access-site complications; however, further evidence on their safety and efficacy is needed. Materials and Methods BIO4AMB is a prospective, non-randomized mulitcentre, non-inferiority trial conducted in 35 centres in Europe and Australia comparing the use of 4F- and 6F-compatible devices. The main exclusion criteria included an American Society of Anaesthesiologists class ≥ 4, coagulation disorders, or social isolation. The primary endpoint was access-site complications within 30 days. Results The 4F group enrolled 390 patients and the 6F group 404 patients. Baseline characteristics were similar between the groups. Vascular closure devices were used in 7.7% (4F group) and 87.6% (6F group) of patients. Patients with vascular closure device use in the 4F group were subsequently excluded from the primary analysis, resulting in 361 patients in the 4F group. Time to haemostasis was longer for the 4F group, but the total procedure time was shorter (13.2 ± 18.8 vs. 6.4 ± 8.9 min, p < 0.0001, and 39.1 ± 25.2 vs. 46.4 ± 27.6 min, p < 0.0001). Discharge on the day of the procedure was possible in 95.0% (4F group) and 94.6% (6F group) of patients. Access-site complications were similar between the groups (2.8% and 3.2%) and included predominantly groin haematomas and pseudoaneurysms. Major adverse events through 30 days occurred in 1.7% and 2.0%, respectively. Conclusions Ambulatory peripheral vascular interventions are feasible and safe. The use of 4F devices resulted in similar outcomes compared to that of 6F devices.

Outcomes of Peripheral Vascular Interventions via Retrograde Pedal Access for Chronic Limb-Threatening Ischemia in a Multicenter Registry

2020 ◽  
Vol 27 (2) ◽  
pp. 205-210 ◽  
Author(s):  
Mark Perry ◽  
Peter W. Callas ◽  
Matthew J. Alef ◽  
Daniel J. Bertges
Keyword(s):  
Major Amputation ◽  
Technical Failure ◽  
Peripheral Vascular ◽  
Technical Success ◽  
Access Site ◽  
Femoral Access ◽  
Kaplan Meier ◽  
Hazard Ratios ◽  
Cox Proportional Hazard Models ◽  
Multicenter Registry

Purpose: To describe the use and 1-year outcomes of retrograde pedal access during peripheral vascular interventions (PVI) for chronic limb-threatening ischemia (CLTI). Materials and Methods: From October 2016 to September 2017, 159 patients (mean age 71±10 years; 112 men) undergoing PVI via retrograde pedal access were enrolled in the multicenter Vascular Quality Initiative (VQI) registry. The pedal access approach included retrograde femoral (40%), antegrade femoral (26%), retrograde to antegrade femoral (22%), and pedal only (11%). A comparator group of 1972 patients (mean age 69±12 years; 1129 men) having a contralateral retrograde femoral access was established for propensity matching, which resulted in 156 patients per group. Procedure characteristics, technical success, and access site complications were compared. Major adverse limb events (MALE) and amputation-free survival (AFS) at 1 year were analyzed using the Kaplan-Meier method and Cox proportional hazard models to calculate hazard ratios (HR) and 95% confidence intervals (CI). Results: Technical failure was similar for retrograde femoral and pedal access (7% vs 13%, p=0.07). Complications were rare and included access site hematoma (2 vs 5, p=0.32) and target artery thrombosis (0 vs 2) for the femoral vs pedal access groups, respectively. The rates of MALE at 1 year were significantly lower after retrograde femoral access (24%) compared with pedal access (38%; log-rank p=0.01; HR 1.95, 95% CI 1.15 to 3.30). AFS estimates at 1 year were similar: 86% for retrograde femoral and 83% for pedal access (log-rank p=0.37; HR 1.32, 95% CI 0.73 to 2.39), as were major amputation estimates: 10% for retrograde femoral access and 13% for pedal access group (log-rank p=0.21; HR 1.58, 95% CI 0.77 to 3.26). Conclusion: In this analysis of multicenter registry data, retrograde pedal access in patients with CLTI had similar technical success and early complications in comparison with traditional contralateral retrograde femoral access. The rates of MALE were higher after pedal access but AFS was similar, indicating a tradeoff between limb salvage and repeat interventions.

scholarly journals Usefulness of a Nonsuture Closure Device in Patients Undergoing Diagnostic Coronary and Peripheral Angiography

2017 ◽  
Vol 26 (04) ◽  
pp. 228-233
Author(s):  
John Owens ◽  
Shaun Bhatty ◽  
Robert Donovan ◽  
Andrea Tordini ◽  
Peter Danyi ◽  
...  
Keyword(s):  
Closure Device ◽  
Complication Rates ◽  
Manual Compression ◽  
Access Site ◽  
Femoral Access ◽  
Peripheral Angiography ◽  
Major Complications ◽  
Increased Risk ◽  
Male Patients ◽  
To Receive

AbstractVascular access site complications can follow diagnostic coronary and peripheral angiography. We compared the complication rates of the Catalyst vascular closure device, with the complication rates after manual compression in patients undergoing diagnostic angiographic procedures via femoral access. We studied 1,470 predominantly male patients undergoing diagnostic coronary and peripheral angiography. Catalyst closure devices were used in 436 (29.7%) patients and manual compression was used in 1,034 (70.3%) patients. The former were allowed to ambulate after 2 hours, while the latter were allowed to ambulate after 6 hours. Major complications occurred in 4 (0.9%) patients who had a Catalyst device and in 14 (1.4%) patients who had manual compression (odds ratio [OR]: 0.67, 95% confidence interval [CI]: 0.22–2.1, p = 0.49). Any complications occurred in 51 (11.7%) patients who had a Catalyst closure device and in 64 (6.2%) patients who had manual compression (OR: 2, CI: 1.4–3, p < 0.01). After adjustment for other variables and for a propensity score reflecting the probability to receive the closure device, the association of major complications with the use of the closure device remained not significant (OR: 0.54, 95% CI: 0.17–1.7, p = 0.29), while the association of any complications with the use of the Catalyst device remained significant (OR: 1.9, 95% CI: 1.3–2.9, p < 0.01). The Catalyst device was not associated with an increased risk of major groin complications but was associated with an increased risk of any complications compared with manual compression. Patients receiving the closure device ambulated sooner.

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

2020 ◽  
Vol 27 (3) ◽  
pp. 414-420 ◽  
Author(s):  
Zvonimir Krajcer ◽  
David A. Wood ◽  
Neil Strickman ◽  
Nelson Bernardo ◽  
Chris Metzger ◽  
...  
Keyword(s):  
Endovascular Aneurysm Repair ◽  
Major Complication ◽  
Multicenter Trial ◽  
Closure Device ◽  
Study Cohort ◽  
Complication Rates ◽  
Vascular Closure Device ◽  
Primary Analysis ◽  
Femoral Access ◽  
Endovascular Interventions

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.

scholarly journals Safety profile of an 8F femoral arteriotomy closure using the Angio-Seal device in thrombolysed acute stroke patients undergoing thrombectomy

2018 ◽  
Vol 24 (5) ◽  
pp. 540-545
Author(s):  
James Wareham ◽  
Sebastian Luppe ◽  
Adam Youssef ◽  
Robert Crossley ◽  
Alex Mortimer
Keyword(s):  
Acute Stroke ◽  
Complication Rate ◽  
Intravenous Thrombolysis ◽  
Bleeding Complications ◽  
Closure Device ◽  
Stroke Patients ◽  
Access Site ◽  
Femoral Access ◽  
Access Site Complication ◽  
The Impact

Background The relationship between bridging thrombolysis and femoral access site complications after mechanical thrombectomy remains contested. Use of a closure device could minimise bleeding complications. This study aimed to elucidate the rate of access site complications in a cohort of patients treated using an 8F groin sheath with subsequent closure using the Angio-Seal to assess safety and the impact of bridging thrombolysis on access site complication rate. Methods All patients with large vessel occlusive stroke treated between 2014 and 2017 with thrombectomy with or without bridging thrombolysis were reviewed. A prospectively acquired departmental database was used to obtain baseline data, and the radiology information and haematology reporting systems were used to record imaging or transfusion relating to subsequent access site complications. Results Seventy-five patients treated with thrombectomy alone were compared to 70 patients treated with prior intravenous thrombolysis. All had an 8F femoral sheath placed for arterial access, and all underwent attempted haemostasis with an 8F Angio-Seal. Two patients (1.14%) suffered Angio-Seal device failure necessitating manual pressure. One patient (0.6%) suffered a small femoral pseudo-aneurysm. No retroperitoneal haemorrhage, haematoma requiring transfusion, ipsilateral deep-vein thrombosis or ipsilateral acute limb ischaemia was encountered. There was no significant difference in the rate of haemorrhagic, ischaemic or infective complications between those treated with bridging thrombolysis or thrombectomy alone. Conclusion Use of the Angio-Seal closure device for 8F femoral access is safe in acute stroke patients. Intravenous thrombolysis prior to endovascular thrombectomy does not significantly alter femoral access site complication rate if this approach is used.

scholarly journals Long Radial Sheath for Angiography of Femoral Artery Large Sheath Access Site with Vascular Closure Devices

2021 ◽  
pp. 41-45
Author(s):  
Takeshi Onizuka ◽  
Ganesh Raveendran ◽  
Carmelo J. Panetta
Keyword(s):  
Case Series ◽  
Left Ventricular ◽  
Access Site ◽  
Assist Device ◽  
Ventricular Assist ◽  
Femoral Access ◽  
Hemodynamic Support ◽  
Vascular Closure Devices ◽  
Left Ventricular Assist ◽  
Left Radial Artery

Radial access combined with hemodynamic support has the limitation of not allowing adequate angiography or delivery of peripheral balloons for managing the femoral access site after removal of the large femoral sheath.  We present a case series with use of a novel long 6 French guiding sheath via left radial artery access for angiography of the femoral access site after removal of a large sheath for left ventricular assist device with vascular closure devices.

scholarly journals Delayed Complication from a Percutaneous Vascular Closure Device following a Neuro-Interventional Procedure

2011 ◽  
Vol 17 (4) ◽  
pp. 495-500 ◽  
Author(s):  
A. Khaldi ◽  
B. Waldau ◽  
C. Skowlund ◽  
G.J. Velat ◽  
J. Mocco ◽  
...  
Keyword(s):  
Interventional Procedure ◽  
Limb Ischemia ◽  
Fistula Formation ◽  
Closure Device ◽  
Femoral Access ◽  
Jude Medical ◽  
Vascular Closure Devices ◽  
Increased Risk ◽  
Delayed Complication ◽  
Initial Procedure

Percutaneous vascular closure devices are being increasingly used as alternatives to manual compression for the closure of femoral arteriotomy after endovascular procedures as they appear to reduce time to ambulate, improve patient's comfort, and are implicated with cost saving. However, vascular closure devices have been associated with an increased risk of complications including hematoma formation, local bleeding, arteriovenous fistula formation, pseudoaneurysm and arterial leg ischemia. To our knowledge, if the above complications occur it is usually within the first 30 days after the procedure. None have been reported in a delayed fashion ten months or longer after closure. We describe a 30-year-old man with a history of a giant basilar trunk aneurysm. He was placed on aspirin and clopidogrel prior to the procedure. He had bilateral femoral access with 6 French sheaths. Following the procedure, 6 French Angio-Seals (St. Jude Medical, St. Paul, MN, USA) were used for closure of bilateral femoral arteriotomies. Ten months after the procedure, the patient kicked a metal cart and developed a large right retroperitoneal iliopsoas hematoma. There was no evidence of pseudoaneurysm. The patient was managed conservatively and his serial hematocrit stayed stable. He did not require surgical intervention. Use of percutaneous vascular closure devices is associated with complications including risk of hematoma, pseudoaneurysm, intravenous fistula, rectal peritoneal hemorrhage, limb ischemia and possible surgical repair. Most complications occur peri-procedure or within 30 days postprocedure. This is the first reported case of a delayed complication at ten months after the initial procedure. Site-related complications associated with percutaneous vascular closure devices may occur in a delayed fashion, even ten months postprocedure, so should be considered in the management of patients.

Perclose ProGlide embolization as a complication: case report and review of literature

2021 ◽  
Author(s):  
Larab L Giniyani ◽  
Yesha P Rana ◽  
Balaram Krishna J Hanumanthu ◽  
Doris Chan ◽  
Tak W Kwan
Keyword(s):  
Aortic Aneurysm ◽  
Endovascular Procedures ◽  
Closure Device ◽  
Mechanical Compression ◽  
Review Of Literature ◽  
Femoral Access ◽  
Descending Aorta ◽  
Infrarenal Aortic Aneurysm ◽  
Important Complication ◽  
Vascular Closure Devices

Background: Vascular closure devices have replaced mechanical compression for closure of femoral access sites after endovascular procedures. Case: We present an 87-year old male with symptomatic infrarenal aortic aneurysm measuring 4.8 cm presenting for elective endovascular repair of the aortic aneurysm. A Perclose ProGlide Suture-Mediated Closure was used for closure. The closure was complicated by a separation of the ProGlide device resulting in the migration of the footplate to the descending aorta. Correction required snare retrieval via radial access, and the patient recovered without complications. Discussion: We highlight an important complication of the Perclose ProGlide Suture-Mediated Closure device that is rare but important to know when performing endovascular closures with this device.

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