Endovascular Perclose ProGlide complication puncture site, treated successful by cutting balloon dilatation: A case report and literature review.

Perclose ProGlide were created as preferred for puncture site closure of femoral artery. Femoral artery occlusion is one of the serious device-related complications. This report presents a continuous endovascular technique combined with peripheral cutting balloon (PCB) treatment for a case of a 32s woman diagnosed with lower extremity ischaemia caused by right superficial femoral artery (SFA) occlusion following the use of the Perclose ProGlide system in minimally invasive cardiac surgery. During the primary operation, limb ischaemia symptoms were relieved with vessel perfusion and reconstruction after regular balloon dilatation. A secondary operation was conducted 6 weeks later, and the obstructive lesions were recanalised without residual stenosis after PCB dilatation. No vessel-related adverse events such as dissection, rupture or distal embolisation occurred during the perioperative period. The patient recovered uneventfully after the operation, with complete alleviation of symptoms. Follow-up computed tomography angiography 3 month post-operatively revealed an undeformed shape and excellent patency of the right SFA.

ESR Essentials: arterial vascular access and closure devices-practice recommendations by the Cardiovascular and Interventional Radiological Society of Europe.

Vascular access is the initial, very important, step of endovascular procedures. Various access sites include the common femoral artery, brachial artery, radial artery, popliteal artery, and distal tibial vessels (pedal arteries). Successful arterial access requires advanced knowledge of anatomy, as well as proper training and experience. Today, vascular access should be obtained using real-time, ultrasound guidance to reduce access time, patient discomfort, and puncture-related complications including dissection, arteriovenous communication, and bleeding. Nevertheless, high-level evidence to support this recommendation in peripheral procedures is limited and level A data are mainly derived from randomized cardiac trials investigating only radial and femoral access. Vascular closure devices (VCDs) for femoral access can be broadly categorized as active closure devices, compression assist devices, and external/topical hemostasis devices. There is high-level evidence demonstrating that their use is related to less time for ambulation and increased patient satisfaction. However, available data failed to clearly demonstrate a benefit in complications compared to standard manual compression in peripheral endovascular arterial procedures, and thrombotic and infectious complications reported following VCD use remain an issue. Heterogeneity noted in the literature, caused by the vast variety of devices, access sites, sheath sizes, clinical scenarios, and procedures, poses difficulties in data analysis and future study design. As a result, an individualized VCD use is currently suggested for ≥ 5 Fr femoral artery access not only to reduce time to hemostasis and ambulation and to improve patient comfort, but also to reduce bleeding complications in cases of femoral access with increased bleeding risk, deranged coagulation, and large-bore access, though a high level of evidence to support this later recommendation is limited. KEY POINTS: US guidance is strongly recommended for femoral access and is mandatory to obtain more challenging access. The use of VCDs for femoral hemostasis is generally safe, effective, and currently supported by level I evidence. Proper training and correct VCD choice, based on the patient's individual characteristics, are imperative to optimize outcomes.

Axillary compared to brachial access for endovascular procedures.

OBJECTIVES: Limited knowledge exists regarding access site complication rates between trans-axillary and trans-brachial approaches with sheath sizes ≥6Fr. We retrospectively reviewed our institution experience with access site complications for percutaneous trans-axillary and trans-brachial arterial interventions using sheath sizes ranging from 6Fr to 10Fr. METHODS: We examined 67 endovascular interventions performed over 18 months, restricted to sheath sizes of 6Fr to 10Fr. Procedures utilizing trans-brachial (41 cases) and trans-axillary (26 cases) approaches under sonographic guidance were included. Cases involving hemodialysis accesses and those requiring surgical cut-down were excluded. The primary outcome measure was the occurrence of major access site complications (SIR grade-II/III) within 30 days, with data collected on hemostasis method, sheath size, and complications. Statistical analysis involved ANCOVA and Fisher's exact tests, with significance set at p < .05. RESULTS: Successful percutaneous arterial access was achieved in all cases using either approach (trans-axillary or trans-brachial). Closure devices were employed in all axillary punctures and in 71% of brachial punctures. Major access site complications occurred in 7 out of 41 cases (17%) in the trans-brachial group and in 4 out of 26 cases (15%) in the trans-axillary group. However, there was no statistically significant difference in complication rates between the two groups, regardless of access site or sheath size. CONCLUSION: Trans-axillary access serves as a safe and effective upper limb access method for percutaneous endovascular procedures requiring sheath size of 7Fr or larger when compared to trans-brachial approach.

SURgical vs. PERcutaneous ACCESS in Transfemoral Transcatheter Aortic Valve Implantation (SU-PER-ACCESS Study).

Background: The transfemoral (TF) approach is the most common route in TAVI, but it is still associated with a risk of bleeding and vascular complications. The aim of this study was to compare the clinical outcomes between surgical cut-down (SC) and percutaneous (PC) approach. (2) Methods: Between January 2018 and June 2022, 774 patients underwent a transfemoral TAVI procedure. After propensity matching, 323 patients underwent TAVI in each group. (3) Results: In the matched population, 15 patients (4.6%) in the SC group vs. 34 patients in the PC group (11%) experienced minor vascular complications (p = 0.02), while no difference for major vascular complication (1.5% vs. 1.9%) were reported. The rate of minor bleeding events was higher in the percutaneous group (11% vs. 3.1%, p <.001). The SC group experienced a higher rate of non-vascular-related access complications (minor 8% vs. 1.2%; major 2.2% vs. 1.2%; p < 0.001). (4) Conclusions: SC for TF-TAVI did not alter the mortality rate at 30 days and was associated with reduced minor vascular complication and bleeding. PC showed a lower rate of non-vascular-related access complications and a lower length of stay. The specific approach should be tailored to the patient's clinical characteristics.

Importance of pseudoaneurysms after TAVI - a retrospective analysis of 2063 patients.

Background: Bifemoral arterial access is common in patients undergoing transcatheter aortic valve implantation (TAVI), with a primary treatment access (TAVI access) and a secondary non-TAVI access. Pseudoaneurysm (PSA) is an important complication of femoral arterial puncture. Major vascular complications after TAVI are well described, but little is known about PSA. Patients and methods: A total of 2063 patients underwent transfemoral TAVI between January 2014 and January 2020. Vascular ultrasound of the common femoral artery was assessed before and after TAVI. We compared patient characteristics, periprocedural risk scores, procedural characteristics, and access site bleeding events according to Valve Academic Research Consortium 3 (VARC-3) criteria, length of stay (LOS), and all-cause mortality at one year between patients with (46) and without (2017) PSA. Results: The incidence of PSA after TAVI was 2.2% (46/2063). All PSA were successfully treated with ultrasound-guided manual compression (UGMC) or thrombin injection (UGTI) without complications. Patients with PSA had lower platelet counts (210×1000/µl vs. 234×1000/µl; p<0.05), more heart failure symptoms on admission (91% vs. 25%; p<0.05), were more often treated with (N)OACs for atrial fibrillation (AF; 54% vs. 38%; p <0.05), and were less often treated with aspirin (35% vs. 51%; p<0.03). Multivariate analysis identified secondary access site (odds ratio [OR] 8.11; p<0.001) and (N)OAC therapy (OR 1.31; p = 0.037) as risk factors for PSA development. PSA is associated with VARC-3 type 1-3 access site bleeding and longer LOS (15.2 ± 11.3 d vs. 11.6 ± 8.9 d; p<0.01), but this did not affect one year mortality (17% vs. 14%; p = 0.53). Conclusions: Pseudoaneurysms are an important complication after TAVI and are associated with access site bleeding and prolonged hospital stay. (N)OAC therapy and secondary access are important risk factors. Pseudoaneurysms can be safely and effectively treated with thrombin injection and do not affect one-year mortality.

Recanalization of superficial femoral artery chronic total occlusion through retrograde popliteal approach recanalization of superficial femoral artery chronic total occlusion.

Purpose: This retrospective study aims to evaluate the safety, practicality, and efficacy of the independent retrograde popliteal approach for recanalization superficial femoral artery (SFA) occlusions when the bilateral common femoral artery approach is unavailable, such as after endovascular aneurysm repair or common iliac artery stenting. Methods: This treatment was considered for patients with contralateral iliac artery occlusion, severe iliac tortuosity, or those who had previously undergone endovascular aneurysm repair or common iliac stenting. Patients with SFA lesions extending into the P1-P2 segment of the popliteal artery or with calcification in the P3 segment were excluded. Angioplasty and stenting were conducted via the popliteal artery approach, with hemostasis at the puncture site achieved using an EXOSEAL vascular closure device. Patients were routinely followed up at 3, 6, and 12 months, and annually thereafter. Results: Forty-eight consecutive patients with SFA occlusion who underwent endovascular treatment via the retrograde popliteal artery approach were included in this study. Retrograde puncture of the popliteal artery was successful in all cases. Six-French sheaths were utilized in all procedures. The EXOSEAL vascular closure device was successfully applied in all 48 cases. No instances of pseudoaneurysms, arteriovenous fistulas, major bleeding, or embolic complications were observed. The technical success rate for SFA recanalization was 100 %. All patients experienced clinical improvement. The ankle-brachial index significantly increased from an initial 0.33 ± 0.11 at admission to 0.81 ± 0.19 at discharge (P < 0.001). The mean follow-up period was 25.1 ± 11.7 months. Kaplan-Meier analysis revealed primary patency rates of 82.5 % at 12 months and 71.8 % at 24 months. No patients required major amputation during the follow-up period. Conclusion: The endovascular treatment of SFA occlusions via the independent retrograde popliteal approach is a viable alternative, demonstrating a low incidence of puncture-related complications and a high success rate of recanalization.

Cross-Seal IDE Trial: Prospective, Multicenter, Single-Arm Study of the Cross-Seal Suture-Mediated Vascular Closure Device System.

BACKGROUND: An increasing number of interventional procedures require large-sheath technology (>12F) with a favorable outcome with endovascular rather than open surgical access. However, vascular complications are a limitation for the management of these patients. This trial aimed to determine the effectiveness and safety of the Cross-Seal suture-mediated vascular closure device in obtaining hemostasis at the target limb access site following interventional procedures using 8F to 18F procedural sheaths. METHODS: The Cross-Seal IDE trial (Investigational Device Exemption) was a prospective, single-arm, multicenter study in subjects undergoing percutaneous endovascular procedures utilizing 8F to 18F ID procedural sheaths. The primary efficacy end point was time to hemostasis at the target limb access site. The primary safety end point was freedom from major complications of the target limb access site within 30 days post procedure. RESULTS: A total of 147 subjects were enrolled between August 9, 2019, and March 12, 2020. Transcatheter aortic valve replacement was performed in 53.7% (79/147) and percutaneous endovascular abdominal/thoracic aortic aneurysm repair in 46.3% (68/147) of subjects. The mean sheath ID was 15.5±1.8 mm. The primary effectiveness end point of time to hemostasis was 0.4±1.4 minutes. An adjunctive intervention was required in 9.2% (13/142) of subjects, of which 2.1% (3/142) were surgical and 5.6% (8/142) endovascular. Technical success was achieved in 92.3% (131/142) of subjects. Freedom from major complications of the target limb access site was 94.3% (83/88). CONCLUSIONS: In selected patients undergoing percutaneous endovascular procedures utilizing 8F to 18F ID procedural sheath, Cross-Seal suture-mediated vascular closure device achieved favorable effectiveness and safety in the closure of the large-bore arteriotomy. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03756558.

A single center study of the efficacy and safety of Pro-Glide used for closure in thoracic endovascular aortic repair in patients with previous groin intervention.

BACKGROUND: This study aimed to evaluate the efficacy and safety of Pro-Glide, a suture-mediated vascular closure device, regarding technical success and complications in patients who had undergone aortic intervention and had previous groin intervention (PGI). METHODS: One hundred and thirty-five patients who underwent percutaneous thoracic endovascular aortic repair via the femoral artery and were closed with the Pro-Glide device were analyzed retrospectively. PGI was defined as a history of open surgical access to the femoral artery or wide sheath (>18 F) placement due to endovascular or valvular intervention. The patients were divided into two groups 38 cases with PGI and 97 cases without PGI. RESULTS: The overall success rate of closure of the femoral artery with Pro-Glide was not statistically significant between the two groups (93.8% vs 92.1%, p = .711). Sheath sizes were compared between the groups and PGI (+) group had significantly higher sheath sizes compared to PGI (-) group (24.3 ± 1.1 F vs 23.8 ± 1.0 F, p = .011). Three patients in the PGI (+) group and six patients in the PGI (-) group experienced technical failure of the percutaneous femoral approach. Femoral complications were seen after the procedures in four patients in the PGI (+) group and four in the PGI (-) group. The PGI (+) group had a higher complication rate when compared to the PGI (-) group; however, this was not statistically significant (p = .181). CONCLUSION: The present study was conducted on a significantly larger sample compared to previous studies and the findings suggest that the Pro-Glide vascular closure device is a safe option for patients with a history of PGI and may not be considered as a contraindication.

Access site complications in thoracic endovascular aortic repair.

BACKGROUND: Percutaneous access and use of vascular closure devices facilitate thoracic endovascular aortic repair (TEVAR) procedures during local anesthesia and allow immediate detection of signs of spinal ischemia. However, the very large bore access (usually ≥22F sheath) associated with TEVAR increases the risk of vascular complications. In this study, we sought to define the safety and feasibility of two percutaneous femoral artery closure devices during TEVAR, in terms of access site vascular complications and major, life-threatening, or fatal bleeding (≥major) within 48 hours. Access site vascular complications were defined as technical failure of vascular closure or later formation of pseudoaneurysm. METHODS: From March 2010 to December 2022, 199 transfemoral TEVAR were performed at Helsinki University Central Hospital, Finland. We retrospectively categorized these into three groups, based on surgeon preference for the access technique and femoral artery closure method: (1) surgical cut-down and vessel closure, n = 85 (42.7%), (2) percutaneous access and vascular closure with suture-based ProGlide, n = 56 (28.1%), or (3) percutaneous access and vascular closure with ultrasound-guided plug-based MANTA, n = 58 (29.1%). The primary outcome measure was technical success of vascular closure and access site vascular complications during index hospitalization. Secondary outcome measures were ≥major bleeding, early mortality, and hospital stay. RESULTS: The technical success rate was 97.6% vs 91.1% vs 93.1% for surgical cut-down, ProGlide, and MANTA, respectively (P = .213). The rate of access site vascular complication was 3.5% vs 8.9% vs 10.3%, respectively (P = .290), with two pseudoaneurysms detected postoperatively and conservatively managed in the MANTA group. The vascular closure method was not associated with increased risk of ≥major bleeding, early mortality, or hospital stay on univariate analysis. Predictors for ≥major bleeding after TEVAR in multivariable analysis were urgent procedure (odds ratio: 2.8, 95% confidence interval: 1.4-5.5; P = .003) and simultaneous aortic branch revascularization (odds ratio: 2.7, 95% confidence interval: 1.3-5.4; P = .008). CONCLUSIONS: In this study, the technical success rates of the percutaneous techniques demonstrated their feasibility during TEVAR. However, the number of access site complications for percutaneous techniques was higher compared with open approach, although the difference was not statistically significant. In the lack of evidence, the safety of the new MANTA plug-based vascular closure for TEVAR warrants further investigation.

Ultrasound-guided genitofemoral nerve block for femoral arterial access gain and closure: a randomized controlled trial.

OBJECTIVES: This study aimed to compare the analgesic efficacy and safety of the femoral branch block of the genitofemoral nerve (FBB) versus local infiltration anesthesia (LIA) for femoral arterial access gain and closure. METHODS: Eighty-two patients (age, 64.8 ± 10.9 years; female, 30.5%) undergoing endovascular procedures using 5-Fr femoral sheath were assigned to either FBB (n = 41) or LIA (n = 41). In both groups, 2% lidocaine HCL with 1:100,000 epinephrine was used as an anesthetic solution. Pain scores during access gain and closure were evaluated using a visual analog scale (score 0-10), patient satisfaction levels with the quality of anesthesia were scored on a 7-point Likert scale, and adverse events were recorded. RESULTS: The primary endpoint, pain scores during access closure, was significantly lower in the FBB group than in the LIA group (0.1 ± 0.37 vs 1.73 ± 0.92; p < 0.001). The FBB group also had significantly lower pain scores during access gain compared to the LIA group (0.83 ± 0.83 vs 2.78 ± 1.26; p < 0.001). There was an inverse relationship between pain scores and FBB after adjustment for age, gender, and body mass index (p < 0.001). FBB group reported significantly higher satisfaction with anesthesia quality compared to the LIA group (6.49 ± 0.64 vs 4.05 ± 1.05; p < 0.001). No complications were recognized in either group. CONCLUSIONS: Ultrasound-guided genitofemoral nerve blocks offered better acute pain relief and higher patient satisfaction than LIA during femoral arterial access gain and closure. CLINICAL RELEVANCE STATEMENT: In this prospective randomized controlled trial, ultrasound-guided genitofemoral nerve blocks offered better acute pain relief than local infiltration anesthesia, resulting in enhanced patient satisfaction. KEY POINTS: • FBB provided better pain relief during access gain and closure than LIA. • FBB offered higher patient satisfaction with the quality of anesthesia than LIA. • No anesthesia-related or access site complications were recognized in either treatment group.

Real-World Experience With the Angio-Seal Closure Device: Insights From Manufacturer and User Facility Device Experience Database.

PURPOSE: Angio-Seal (Terumo Medical Corporations, Somerset, New Jersey) device is indicated for femoral arteriotomy closure. Real-world published data on complications are limited. We present 1 year of safety events involving Angio-Seal from the US Food and Drug Administration's post-market surveillance database of Manufacturer and User Facility Device Experience (MAUDE). Steps for managing frequent device-related problems are discussed. MATERIALS AND METHODS: Angio-Seal MAUDE data from November 2019 to December 2020 was classified according to (1) mode of device failure, (2) complication, (3) treatment, and (4) Cardiovascular and Interventional Radiological Society of Europe (CIRSE) adverse event classification system. RESULTS: There were 715 safety events, involving Angio-Seal VIP (93.1%), Evolution (5.7%), STS Plus (1.1%), and sizes 6F (62.5%) and 8F (37.5%). Failure mode involved unrecognized use of a damaged device (43.4%), failed deployment (20.1%), failed arterial advancement (6.3%), detachment of device component (4.9%), failed retraction (3.6%), operator error (1.1%), and indeterminate (20.6%). Of total, 44.8% of events were associated with patient harm. Complications involved minor blood loss (34.1%), hematoma (5.6%), significant blood loss (1.4%), and pseudoaneurysm (1.4%). Of total, 43.3% of cases required manual compression (MC), whereas 8.8% required more advanced intervention. Interventions included surgical repair (49.2%), thrombin injection (9.5%), balloon tamponade (6.3%), covered stent (4.8%), and unspecified (30.2%). Majority of safety events were CIRSE grade 1 (92.0%), followed by grades 2 (3.1%), 3 (4.6%), and 6 (deaths, 0.3%). Minority of devices were returned for manufacturer analysis (27.8%). CONCLUSIONS: The majority of safety events were associated with minor blood loss or local hematoma and could be addressed with MC alone. Most events were attributed to damaged device; however, very few devices were returned to manufacturer for analysis. This should be encouraged to allow for root cause analysis in order to improve safety profile of devices. System-level strategies for addressing barriers to under-reporting of safety events may also be considered. CLINICAL IMPACT: Our study highlights important safety events encountered in real-world practice with Angio-Seal closure device. The MAUDE database captures real-world device malfunctions not typically appreciated in conventional clinical trials. Our study provides valuable insight for clinician-users on anticipating and managing the most common device malfunctions. Additionally, our data provide feedback for manufactures to optimize product design and direct manufacturer user training to improve safety. Finally, we hope that the study promotes system-level strategies that foster reporting of safety events and undertaking of root cause analysis.

Endoscopic removal of sinonasal hemangioma using vessel sealing device without tumor embolization.

When massive bleeding is anticipated during endoscopic sinonasal tumor removal, a vessel sealing device is useful for successful tumor removal.

Assessing the feasibility of using the antecubital vein to perform right heart catheterization in children and adults with congenital heart disease: a retrospective, observational single-center study.

BACKGROUND: Right heart catheterization (RHC) usually is performed via the femoral vein or the internal jugular vein. However, the antecubital fossa vein is a valid venous access, and it has become increasingly popular to perform right heart catheterization utilizing this access. METHODS: A retrospective, observational study was conducted to describe use of the antecubital fossa vein for right heart catheterization in adults and children with congenital heart disease (CHD). Patients who had undergone RHC via antecubital fossa vein at the authors' hospital between September 2019 and December 2022 were included. The outcomes studied were procedural failure and procedure-related adverse events. RESULTS: Fifty-two patients with CHD underwent right cardiac catheterization via an upper arm vein. The upper arm vein was unable to perform the RHC in only 2 patients (3.8%). Only 1 patient developed a minor adverse event. No irreversible and/or life-threating adverse events were detected. CONCLUSIONS: The upper arm veins are safe and effective to perform a RHC in children and adults with CHD. This approach demonstrates a high percentage of technical success, and few mild complications.

Case Report: Hybrid approach as a Rescue Treatment in a patient with vascular Ehlers-Danlos Syndrome.

Vascular Ehlers-Danlos Syndrome (vEDS) is a rare connective tissue disorder associated with COL3A1 gene mutation encoding type III collagen. Given the possible fatal prognosis if not treated timely, it is important to suspect and diagnose as soon as possible. Despite advances in endovascular technique, access point complications remain a serious challenge in patients with vEDS. Here, we describe a 30-year-old male patient who was diagnosed with vEDS after consecutive events of bilateral iliac vessels at an interval of 3 months: (1) spontaneous dissecting aneurysm of right iliac artery and (2) arteriovenous fistula between left internal iliac artery (IIA) and left common iliac vein. This patient was treated with iliac stent-grafts and overlapping femoral interposition graft (Dacron) in the 1st operation and access artery repair with surgical dissection after coil embolization of IIA and stent-graft insertion into left common to external iliac arteries in the 2nd operation. The patient has been treated with beta-blockers and anticoagulants for the management of vEDS and postoperative deep vein thrombosis, respectively. The stent-grafts in both iliac arteries and the access sites have been well-tolerated without any adverse effects for 14 months following the 2nd operation. In conclusion, given the vascular fragility and the potential for future events, additional vascular manipulation should be avoided unless it is in a life-threatening condition. In particular, meticulous hybrid interventions can be effective treatments.

Complications with the use of Angio-Seal vascular closure device and their management.

Vascular closure devices (VCDs) are being increasingly used for achieving hemostasis after diagnostic and therapeutic endovascular procedures. Although uncommon, complications may be encountered which are associated with the use of these VCDs. We report four cases where the use of Angio-Seal (Terumo, Somerset, New Jersey, USA) was followed by complications. Three cases presented with acute limb ischemia, among them, two patients had arterial occlusion at the vascular access site and one patient had embolization of the footplate anchor of the closure device. One case presented with pseudoaneurysm at the common femoral artery access site along with occlusion at origin of the superficial femoral artery. We have described the mechanism in which these complications occur and the successful management of these cases preventing potential amputation and limb loss. The risk factors which increase the risk of complications with the use of Angio-Seal VCD were reviewed and the strategy to avoid these complications with particular emphasis on the utility of ultrasound when using Angio-Seal VCD is discussed. A strategy to manage these complications has been discussed while deciding on endovascular management or surgical management, especially in patients with challenging presentation and those with multiple comorbidities making them at very high risk for surgery.

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

PURPOSE: Percutaneous access for endovascular aneurysm repair (EVAR) is commonplace, with its attendant benefits. The combination of continued reduction in device profile and evolution of vascular closure device (VCD) design drives successful and safe percutaneous EVAR. A new such VCD is the MANTA Large-Bore Closure Device designed in two iterations for closure of arterial defects from 10 to 25F. We present a prospective audit of 131 large-bore femoral closures using an 'all-comers' approach to device selection. MATERIALS AND METHODS: One hundred and thirty-one large-bore femoral arterial defects were analysed. Both 14F and 18F MANTA VCDs were deployed in this series as per instructions for use. Primary objectives were technical success, particularly successful deployment, and haemostasis achieved. Failures were denoted as failure to deploy; failure to achieve haemostasis was denoted as active bleeding, haematoma, or pseudoaneurysm formation requiring intervention. Later complications assessed were vessel occlusion/thrombosis or stenosis. RESULTS: Seventy-six patients (65 males and 11 females, age 75.2 ± 8.7 years) underwent a range of procedures including EVAR (n = 66), TEVAR (n = 2), and reinterventions (n = 8) requiring large-bore percutaneous femoral arterial access in 131 groins. Of these, the 14F MANTA VCD was used in 61 closures (defects ranging from 12 to 18F) and the 18F in 70 closures (defects ranging from 16 to 24F). Deployments achieved successful haemostasis in 120 (91.6%), and failures occurred in 11(8.4%) groins. CONCLUSIONS: This study indicates that a post-close approach using the novel MANTA Large-Bore Closure Device can be undertaken successfully to close a range of large-bore femoral arterial defects at EVAR/TEVAR with an acceptable rate of complications.

Hemostasis control after femoral percutaneous approach: A systematic review and meta-analysis.

BACKGROUND: Hemostasis control after percutaneous endovascular procedures through the femoral approach remains challenging for catheterization laboratory nurses, given method variability. OBJECTIVE: To summarize the available evidence on vascular devices efficacy dedicated to hemostasis control compared to the extrinsic compression after percutaneous procedures in the femoral vein or artery. METHODS: A systematic review with meta-analysis of randomized clinical trials was conducted. We compared different hemostasis methods in adult patients who underwent diagnostic and/or therapeutic procedures through femoral access. The databases searched were PubMed, Embase, CINAHL and Cochrane CENTRAL, and updated on 03/2022. The outcomes included hematoma, pseudoaneurysm, bleeding, minor and major vascular complication, time to hemostasis, device failure, and manual compression repetition. The risk of bias was assessed using the Cochrane Risk of Bias Tool 1.0. Pooled effect sizes on continuous, categorical and proportion variables were estimated with the random effects model. The continuous variables were summarized as the difference between means weighted by the inverse of variance (WMD), and the categorical ones by the summary of relative risks (RR), estimated by the DerSimonian and Laird method. The Freeman-Tukey method was used to estimate the summary effect of proportions. RESULTS: Fifty articles were included in the systematic review. When compared to extrinsic compression, vascular closure devices resulted in a relative risk reduction (RRR) for hematoma: RR 0.82 [95%CI 0.72 to 0.94] and in shorter time to hemostasis WMD -15.06 min [95%CI -17.56 to -12.56]; no association was observed between interventions with vascular closure devices and extrinsic compression for pseudoaneurysm, bleeding, minor and major vascular complications. Compared to extrinsic compression, sealant or gel type devices were compatible with a RRR for hematoma: RR 0.73 [95%CI 0.59 to 0.90]; and metal clip or staple type devices for pseudoaneurysm: RR 0.48 [95%CI 0.25 to 0.90]; and major vascular complication: RR 0.33 [95%CI 0.17 to 0.64]. For each 100 observations, the device failure rate for metal clip or staple was 3.28% [95%CI 1.69 to 6.27]; for suture 6.84% [95%CI 4.93 to 9.41]; for collagen 3.15% [95%CI 2.24 to 4.41]; and for sealant or gel 7.22% [95% CI 5.49 to 9.45]. CONCLUSIONS: Vascular closure devices performed better in hemostasis control. The certainty of the evidence was rated as very low to moderate. REGISTRATION: PROSPERO CRD42019140794.