A novel bailout technique using myocardial biopsy forceps to grasp a dislodged angio-seal collagen with footplate.

BACKGROUND: Hemostatic devices are now frequently used in femoral artery punctures, and the Angio-Seal (Terumo, Tokyo, Japan) is one of the most commonly used devices for closure of the femoral artery because it provides rapid hemostasis. Although device failure rarely occurs, if the collagen falls into the femoral artery, it may lead to severe limb ischemia. Herein, we describe a case of a novel endovascular technique for the treatment of Angio-Seal arterial closure device failure. CASE PRESENTATION: The patient in Case 1 was a 75-year-old man with severe left limb claudication. We used a contralateral antegrade approach and used the Angio-Seal for hemostasis. However, the Angio-Seal collagen and footplate dropped and stopped at the bifurcation of the superficial femoral artery and deep femoral artery. The collagen with the footplate was caught with myocardial biotome forceps (MBF) and pulled into the external iliac artery (EIA). The distal common femoral artery (CFA) was punctured, and we delivered a 10.0- × 80-mm stent (SMART®; Cordis, USA) to the EIA from the ipsilateral sheath. The stent was deployed at the EIA and crushed the collagen. The patient in Case 2 was an 88-year-old man with rest pain in the right limb. The right CFA was punctured using an ipsilateral approach and the Angio-Seal was used for hemostasis. The Angio-Seal collagen with the footplate dropped into the bifurcation of the deep femoral artery. The collagen and footplate were caught with MBF and pulled up to the EIA. The right CFA was punctured and a 10.0- × 60-mm stent (SMART®; Cordis) was delivered from the ipsilateral sheath. The stent was deployed at the EIA and crushed the collagen with the footplate. CONCLUSIONS: MBF were used to grasp the dislodged collagen with the anchor and cover it with a stent at the iliac artery. This may be a useful bailout technique for Angio-Seal dislodgement.

Acute lower limb ischemia caused by repeat deployment of vascular closure device.

Vascular closure devices are used to facilitate faster hemostasis and earlier ambulation, improve patient comfort, and reduce length of hospital stay after percutaneous endovascular procedures. However, their use may rarely be associated with limb ischemia due to endothelial damage and arterial thrombosis. This report illustrates the case of a patient who experienced acute lower limb ischemia due to superficial femoral artery occlusion caused by repeat closure with Angio-Seal vascular closure device within 30 days in a small-caliber superficial femoral artery. The patient was surgically treated by vascular repair with a synthetic graft, and remains symptom-free in 3-year follow-up. Repeat deployment of vascular closure devices in the same access site within a period of 30 days may cause acute limb ischemia due to arterial thrombosis, especially in patients with small-caliber arteries, even in the absence of evident risk factors.

Collagen-Based Vascular Closure Device Multicenter Italian Experience in Endovascular Aortic Aneurysm Repair Compared With Suture-Mediated Closure Vascular Device.

PURPOSE: The Manta Vascular Closure Device is a novel collagen-based vascular closure device that has been designed specifically for closure of large-bore percutaneous arterial accesses. The aim of this retrospective study is to evaluate the immediate and 30-day outcome of Manta at the completion of endovascular aneurysm repair (EVAR) or thoracic endovascular aortic repair (TEVAR). The hypothesis is that Manta is not inferior in obtaining hemostasis compared with the Perclose ProGlide Suture-Mediated Closure System device. MATERIALS AND METHODS: We recruited all the percutaneous accesses for (T)EVAR performed from January 2021 to April 2023 by all the Italian Divisions of Vascular Surgery using Manta at the time of data collection (May 2023). The primary outcome is to evaluate the incidence of complications at the puncture site after Manta implantation and at 1 month, and compare this with ProGlide. We applied the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) criteria for observational studies. RESULTS: Overall, 524 consecutive femoral accesses for (T)EVAR procedures were collected: 355 in the Manta cohort and 169 in the ProGlide cohort, respectively. The size of the sheath was 17.2±2.7 Fr for Manta, 15.7±2.3 Fr for ProGlide (p<0.001). No statistically significant differences between the groups regarding age, sex, body mass index, ultrasound-guided access, femoral calcifications, intraoperative, and 30-day complications. Successful arterial closure at groin puncture sites for (T)EVAR using Manta is 90.5% and 93.1% using ProGlide. Freedom for any reintervention for any complication is 95.5% for Manta and 96% for ProGlide. CONCLUSION: The 2 vascular closure devices have proved to be similar in terms of complications, without any statistically significant difference, although the median size of the sheaths for (T)EVAR was statistically significantly larger when Manta has been used, compared with ProGlide. CLINICAL IMPACT: Manta® is effective in the hemostasis of the access sites following the completion of (T)EVAR in this multicenter, retrospective, case-control study on 524 percutaneous femoral accesses. Compared to the more popular Proglide®, the average size of the introducers in the Manta® group was significantly larger than in the Proglide® group.

A Novel Risk Score Facilitates Femoral Artery Access in Transcatheter Aortic Valve Implantation: Passage-Puncture Score.

Background: Vascular complications remain high in transfemoral transcatheter aortic valve implantation (TAVI). Careful evaluation of the femoral arteries is important to select the optimal access site. Objectives: This study sought to describe a novel risk score (the passage-puncture score) for transfemoral access using a single suture-based closure system. Methods: The passage-puncture score consists of the evaluation of 1) passage feasibility of the ilio-femoral arteries (passage score) and 2) puncture site feasibility (puncture score) based on pre-TAVI computed tomography. All patients underwent fluoroscopy-guided arterial puncture and closure with a suture-based closure system. The primary endpoint was the rate of vascular complications in discharge, including minor and major vascular complications according to the definitions of the Third Valve Academic Research Consortium. Results: From September 2020 to June 2021, transfemoral TAVI was performed in 98 of 99 patients. Passage score (right) was significantly higher in patients treated by left compared to those treated by right femoral access (3 vs. 1; p <0.001). Puncture score was significantly different between patients undergoing mid-femoral as compared to nonmid-femoral puncture (0 vs. 3, p <0.001). Minor vascular complications occurred in six (6%) patients. Conclusions: The passage-puncture score is effective in defining the optimal access site for transfemoral TAVI. The systematic evaluation has the potential to further reduce access-site complications.

Preliminary Insights Into Early Ambulation and Hemostasis After Atrial Fibrillation Ablation Using the Perclose Vascular Closure Device.

Background: The introduction of the Perclose vascular closure device (VCD) for atrial fibrillation (AF) ablation procedures in Japan is expected to facilitate early ambulation. Methods and Results: The study population comprised 554 patients undergoing AF ablation, of whom 377 successfully underwent Perclose VCD deployment at the end of the procedure. At 4 h after the procedure, 94% (353/377 patients) achieved early hemostasis and 57% (213/377 patients) achieved early ambulation. Notably, 0.5% (2/377 patients) developed acute deep vein thrombosis. Conclusions: The Perclose VCD demonstrated promising efficacy in achieving early hemostasis, potentially facilitating early ambulation and discharge in appropriate patients.

Efficacy and safety of the VASCADE® MVP venous vascular closure device in patients undergoing percutaneous left atrial appendage occlusion with WATCHMAN.

BACKGROUND: The VASCADE MVP venous vascular closure system is commonly used for percutaneous venotomy closure in catheter-based procedures utilizing sheath sizes 6-12 French. However, its application with larger sheaths such as ones required in left atrial appendage occlusion (LAAO) has yet to be explored. AIMS: This study compared the efficacy and safety of VASCADE MVP versus conventional Figure-of-8 sutures (Fo8) for femoral venotomy closure in patients undergoing Watchman LAAO. METHODS: This single-center retrospective analysis included patients who underwent post-LAAO femoral venotomy closure with either VASCADE MVP or Fo8 sutures. The primary efficacy endpoint was time to hemostasis (TTH). Primary safety endpoints were 30-day access site-related readmissions and major complications. Minor access-site-related complications were also assessed. RESULTS: 107 patients underwent post-LAAO femoral venotomy closure with VASCADE MVP, of which 101 were successful (94.4%). 99 patients underwent conventional closure with Fo8 sutures and supplemental manual pressure. Baseline characteristics were similar between groups. TTH was significantly shorter with VASCADE MVP (152.9 vs. 335.8 s, p = 0.001). Major safety outcomes were comparable. However, the conventional group experienced a higher incidence of ecchymosis (16.2% vs 4.7%, p = 0.007) and 30-day all-cause readmission (18.2% vs 8.4%, p = 0.038). CONCLUSIONS: VASCADE MVP significantly reduced TTH compared to Fo8 sutures after LAAO. While demonstrating a similar safety profile, VASCADE MVP may offer a more efficient approach to femoral vein closure in this patient population.

Procedure-Related Complication Rates With the Use of Vascular Closure Devices; Does Size Only Matter? A Large Single Centre Retrospective Study.

INTRODUCTION: Our retrospective study aimed at assessing safety of vascular closure devices (VCDs) used in a large single-centre Interventional Radiology (IR) department. Complication and deployment failure rates using collagen-based (Angio-seal) and suture-based (ProGlide) devices for common femoral artery haemostasis were compared. MATERIALS AND METHODS: Data from VCDs deployed over a 6-year period were retrospectively analysed for patient age, procedure indication, puncture mode (antegrade/retrograde), sheath size, deployment failure and complications (haematoma, pseudoaneurysm formation, limb occlusion). Numerical and statistical analysis was undertaken. RESULTS: Overall, 1321 common femoral artery punctures in 1217 patients were closed using VCDs. Failure rate using ProGlide was significantly higher when compared with Angio-seal (P=<0.001) in sheath sizes ≤8 Fr. Heparin was not administered in embolisation procedures compared with angioplasty with or without stenting. Therefore, haematoma tended to occur more frequently following angioplasty without stenting (P = 0.003) and angioplasty with stenting (P = 0.001), when compared with embolisation. Deployment failure occurred more frequently when heparin was used during the procedure (P = 0.005). CONCLUSION: Although complications relating to sheath size are well established in the literature, there remains a paucity of data assessing the impact of procedure specific factors when comparing VCDs. Our study challenges that size is the sole determinant of VCD success and invites a more holistic view of VCD deployment strategies. This study advocates continued research into the nuances of other potential confounding variables to optimise patient outcomes.

Incidence and predictors of vascular complications following transcatheter aortic valve implantation: A comparison of the MANTA and suture-based vascular closure devices.

BACKGROUND: Vascular complications post-transcatheter aortic valve implantation (TAVI) are common. Recent data regarding predictors of vascular complications are limited, particularly comparing newer plug-based devices versus traditional suture-based vascular closure devices (VCD). AIM: The primary objective was to identify characteristics that predict a higher risk of vascular complications in TAVI patients, as judged by the VARC-3 criteria, specifically comparing risk factors between suture-based vs MANTA device closure. METHODS: Retrospective analysis of patients who underwent TAVI between December 2019 and September 2023 was performed. Logistic regression and propensity score matching was performed to ascertain risk factors for vascular complications post-TAVI. RESULTS: Of the 1763 patients, there were 106 vascular complications (6%). There was a nonsignificant increased complication rate in MANTA vs suture-based device closure (8.3% vs 5.3%, p = 0.064). Among these, the most common complications were VCD failure (23%), pseudoaneurysm (20%) and arterial dissection (19%). Obesity (p = 0.021), anemia (p = 0.039) and MANTA device use (p = 0.027) were predictors of vascular complications. Within the MANTA cohort, novel oral anticoagulant (NOAC) use was predictive of vascular complications (p = 0.002). Among suture-based devices, obesity (p = 0.037) and anaemia (p = 0.017) were significant predictors. A propensity matched analysis derived 90 pairs of patients matched for age, gender, diabetes, peripheral arterial disease, NOAC use, anemia and obesity, identifying an average treatment effect of 0.039 (p = 0.04) when MANTA device closure was performed. CONCLUSION: Vascular complications in TAVI remain common. Identifying predictors such as MANTA device closure, obesity, anemia, and baseline NOAC use will allow for improved risk stratification and appropriate VCD selection in patients undergoing TAVI.

Compare efficacy and safety of autologous blood clot injection with C-clamp vascular closure device in treatment of iatrogenic pseudoaneurysm after femoral artery puncture.

INTRODUCTION: Iatrogenic femoral artery pseudoaneurysm (FAP) is a complication following femoral artery puncture, with an incidence rate of 0.2%-5.5% post-cardiac catheterization procedures. Management typically involves observation or interventional treatments such as ultrasound-guided compression (UGC) or ultrasound-guided thrombin injections. This study compares the efficacy and safety of ultrasound-guided autologous blood clot injection (UGCI) with C-clamp vascular closure device-assisted UGC in treating FAP. MATERIALS AND METHODS: Conducted at a high-volume training and research center, this prospective study enrolled patients with iatrogenic FAP post-femoral artery puncture. Patients were randomized into two treatments: UGC with a C-clamp device or UGCI. Primary endpoints were thrombosis induction within 24 h, average procedure time, and length of hospital stay (LOS). RESULTS: The study included 105 patients with 51 undergoing UGCI and 54 undergoing UGC. UGCI achieved a primary success rate of 96% versus 63% for UGC. The mean procedure duration for UGCI was significantly shorter (22 min) compared with UGC (49 min, p ⩽ 0.0001). LOS was also reduced in the UGCI group (1.5 days) compared to the UGC group (4.5 days). Complication rates were low for both procedures, with one deep vein thrombosis and one infection observed in the UGC group. CONCLUSION: UGCI demonstrated to be a safe, efficient, and faster alternative for treating iatrogenic FAPs with a higher success rate, reduced LOS, and similar low complication rates compared to UGC. This study suggests that UGCI could be considered a preferred method for the management of FAP post-femoral artery catheterization.

Angio-Seal Closure for Traumatic Left Subclavian Artery Pseudoaneurysm: A Case Report.

Subclavian artery pseudoaneurysms are rare and associated with high morbidity and mortality. Alternative approaches to open surgical repair can include endovascular repair or ultrasound-guided thrombin injection. Here, we describe a safe and novel technique of closure of a subclavian artery pseudoaneurysm with Angio-Seal that was unresponsive to thrombin injection and in a difficult location for open repair.

Comparing Obtura Vascular Closure Device to Manual Compression for Achieving Hemostasis After Percutaneous Transfemoral Procedures: A Randomized Study.

PURPOSE: This trial was designed and aimed to compare safety and efficacy of Obtura™ vascular closure device (VCD) to manual compression (MC) among patients undergoing transfemoral catheterization. MATERIAL AND METHODS: This prospective, randomized, controlled, multicenter trial of Obtura VCD against MC randomized patients in 1:1 (n=268; 134:134) ratio. Safety and efficacy were measured by primary endpoints (time to hemostasis [TTH] and deployment success) and secondary endpoints which included technical success, device-related adverse events, and time to ambulation (TTA). RESULTS: The procedural access using right femoral artery was performed in 95.52% of patients in Obtura VCD versus 96.27% in standard MC method, whereas 2.99% of patients in each group underwent left femoral access. Bilateral access was performed in 1.49% (n=2) versus 0.75% (n=1) in Obtura VCD versus MC, respectively. Both the technical success and deployment success were 100%. Patients in Obtura VCD group had shorter TTH (3.26±3.39 vs 23.95±8.24 minutes; p<0.0001) and TTA (155.44±125.32 vs 723.84±197.98 minutes; p<0.0001) than MC group. No access site complications (re-bleeding, infection, arteriovenous fistula, and transient access site nerve injury) were noted at 2-week, 1-month, and 3-month follow-ups. There were 4 (3%) and 6 (4.5%) cases of hematoma, respectively, in Obtura VCD versus MC and 1 case (0.7%) of post-procedural arterial pseudoaneurysm each in both the groups which were successfully resolved and patients were discharged with no further complications. Further follow-up was without any adverse events. CONCLUSIONS: The study demonstrated favorable safety and efficacy of Obtura™ VCD with a significantly short TTH and TTA compared to MC. CLINICAL IMPACT: In patients undergoing cardiac catheterization, vascular closure devices (VCDs) can achieve hemostasis faster after successful implantation of the device with fewer complications such as bleeding and ambulation can be achieved faster. In terms of effectiveness, Obtura VCD was found to be better than manual compression in achieving early hemostasis and higher technical and deployment success was accomplished. Obtura VCD does not require enlargement of the route through the tissues, uses the same existing arterial sheath as its conduit, and does not cause patients' access sites to feel uncomfortable while it is being deployed.

Same-day discharge after percutaneous closure of persistent foramen ovale using intracardiac echocardiography and the Gore Septal Occluder.

Aim: Periprocedural and postinterventional care of patients undergoing closure of patent foramen ovale (PFO) varies significantly across care providers. Same-day discharge (SDD) after transcatheter interventions is an evolving concept. This study aimed to assess the same-day discharge rate and incidence of complications in patients undergoing PFO closure with intracardiac echocardiography (ICE) using the Gore®Cardioform Septal Occluder (GSO) device. The secondary aim was to analyse the efficacy of femoral vein closure with Perclose ProGlide. Methods: Patients who underwent PFO closure with the GSO device at a university hospital in Stockholm, Sweden, were retrospectively included between March 1, 2017, and June 30, 2020, all with cryptogenic stroke as the indication for the procedure. All patients underwent PFO closure with conscious sedation and local anaesthesia. The indication for all patients was a cryptogenic stroke. Periprocedural imaging was performed using ICE and fluoroscopy in all patients. Patient characteristics and periprocedural data were collected from patient charts. Patients were kept on bed rest for 4-6 h post-intervention. Transthoracic echocardiography and clinical examination, including groin status, were performed before discharge. No clinical routine follow-up was performed the day following the intervention. Clinical follow-up was done by phone call two weeks after the procedure, and echocardiographic follow-up was done after 12 months. Data were analysed using linear and logistic regression models. Results: In total, 262 patients were included, of which 246 (94%) had SDD. 166 patients (63%) received the ProGlide™ system for femoral vein access closure. Post-procedural arrhythmias occurred in 17 (6%) patients, and vascular complications in 9 patients (3%). The overall closure rate at follow-up was 98.5%. 25 out of 264 patients (9.5%) had to be readmitted within the first eight weeks after PFO closure, 16 due to atrial fibrillation warranting electric cardioversion, one due to an arteriovenous fistula that was operated, four due to chest pain/pain at the access site, and four patients developed fever. There was no difference in SDD among patients who received ProGlide™ vs. patients who did not receive ProGlide™. Conclusion: SDD appears safe after transcatheter PFO closure with the GSO device with high procedural success rates. Low rates of complications and readmissions make the intervention suitable for this patient-friendly and cost-effective concept.

Closure Device Migration: An Unusual Cause of Acute Limb Ischaemia Following a Simple Endovascular Procedure.

Introduction: Acute limb ischaemia resulting from foreign body embolisation is an infrequent yet critical complication associated with vascular closure devices (VCDs). Despite the widespread use of VCDs, rare complications such as fragment emboli pose unique challenges, necessitating heightened clinical awareness. This case report presents a case of acute limb ischaemia caused by a VCD malfunction following an endovascular procedure. Report: A 70 year old male who was diagnosed with a severe claudication of the lower extremity (Rutherford III) due to right common iliac stenosis, underwent angioplasty using a FemoSeal (Terumo Ltd., Surrey, UK) to close the right femoral artery access. Two weeks later, the patient presented with acute lower limb ischaemia due to a right popliteal-tibial occlusion. Emergency surgical thrombo-embolectomy was successfully performed from a medial popliteal approach, and the thrombus, which contained a polymer disc from the VCD at its distal end, was completely removed. Discussion: Despite VCDs being proven safe and efficient, rare complications such as fragment emboli can occur, and physicians should be aware of the possible delayed onset of symptoms. Moreover, the radiolucent nature of the polymer disc in a FemoSeal complicates diagnostic imaging. While endovascular approaches exist, open surgery is a safe and effective strategy for retrieving fragments and treating the patient in acute limb ischaemia cases. Conclusion: Physicians should remain vigilant for embolic risks associated with vascular closure devices, even with suitable anatomy and following guidelines, especially considering the trend toward early ambulation and discharge.

Outcomes of vascular closure devices for femoral venous hemostasis following catheter ablation of atrial fibrillation.

INTRODUCTION: Access site complications remain common following atrial fibrillation (AF) catheter ablation. Femoral vascular closure devices (VCDs) reduce time to hemostasis compared with manual compression, although large-scale data comparing clinical outcomes between the two approaches are lacking. METHODS: Two cohorts of patients undergoing AF ablation were identified from 36 healthcare organizations using a global federated research network (TriNetX): those receiving a VCD for femoral hemostasis, and those not receiving a VCD. A 1:1 propensity score matching (PSM) model based on baseline characteristics was used to create two comparable cohorts. The primary outcome was a composite of all-cause mortality, vascular complications, bleeding events, and need for blood transfusion. Outcomes were assessed during early (within 7 days of ablation) and extended follow-up (within 8-30 days of ablation). RESULTS: After PSM, 28 872 patients were included (14 436 in each cohort). The primary composite outcome occurred less frequently in the VCD cohort during early (1.97% vs. 2.60%, odds ratio (OR) 0.76, 95% confidence interval (CI) 0.65-0.88; p < .001) and extended follow-up (1.15% vs. 1.43%, OR 0.80, 95% CI 0.65-0.98; p = .032). This was driven by a lower rate of vascular complications during early follow-up in the VCD cohort (0.83% vs. 1.26%, OR 0.66, 95% CI 0.52-0.83; p < .001), and fewer bleeding events during early (0.90% vs. 1.23%, OR 0.73, 95% CI 0.58-0.92; p = .007) and extended follow-up (0.36% vs. 0.59%, OR 0.61, 95% CI 0.43-0.86; p = .005). CONCLUSION: Following AF ablation, femoral venous hemostasis with a VCD was associated with reduced complications compared with hemostasis without a VCD.

Critical Hemorrhage Caused by a Size-Mismatched Extracorporeal Membrane Oxygenation Cannula in a Patient with Myotonic Dystrophy Type 1: A Case Report and Literature Review.

Background and Objective: Although extracorporeal membrane oxygenation (ECMO) is an essential life-saving technique for patients with refractory cardiopulmonary shock, it can be fatal in certain cases. Case Presentation: A 19-year-old girl treated with ECMO presented with acute limb ischemia 2 days after cannula removal. The decannulation was performed percutaneously by an interventional cardiologist, and the vascular surgery department was consulted after the patient developed symptoms. The first suspected diagnosis was thrombosis due to incorrect use of the closure device. However, the artery had ruptured due to the insertion of a catheter with a cannula that was larger than the patient's artery. Management and Outcome: Fortunately, excessive bleeding due to the size-mismatched cannula was prevented by an unintentional complication of the closing device, which saved the patient's life. She underwent a right common femoral artery thrombectomy and patch angioplasty. Hospital guidelines have changed regarding the surgical removal of ECMO cannulas. Discussion: This report aims to highlight the importance of two aspects that are critical to a successful outcome: individualized cannula selection followed by precise insertion and removal and postoperative evaluation of a patient's final status.

A single institution experience of the Manta closure device in endovascular aortic repair.

BACKGROUND: Majority of EVAR procedures are performed with percutaneous arterial access, unless there is severe steno-occlusive disease in the common femoral arteries (CFA). We present our experience of using MANTA closure device with a retrospective evaluation of its safety and efficacy, in the elective setting, and in the emergent setting for ruptured aortic aneurysm. DESIGN AND METHODS: Between Feb 2021 and May 2023 a total of 75 EVAR procedures were closed with a Manta device. Data was collected prospectively and analysed retrospectively. In 75 patients, 128 CFAs were closed with a Manta closure device including 4 emergent ruptured aneurysms. RESULTS: 67 male and 8 female patients with a median age of 77 years had percutaneous EVAR using Manta as a closure device. 128 CFAs were closed with Manta closure device. 3% (4/128) had deployment failures, with three requiring surgical cut down and closure. In one patient, a second Manta device deployment achieved satisfactory haemostasis. Three deployments were complicated by pseudoaneurysms of the CFA, all requiring no further interventions/treatment. No death related to severe haemorrhage from device failure. The pre- and post-procedure CFA puncture site AP diameter was recorded in a total of 106 cases with appropriate follow-up. 66% of these (70/106) had no reduction in CFA diameter post Manta closure. 34% (36/106) had some reduction of vessel AP size CFA post EVAR. No adverse features or further treatment was required due to reduction of vessel diameter in these cases (ongoing yearly surveillance). CONCLUSIONS: Manta closure device is safe and easy to deploy with an overall success rate of 97%. There is a short learning curve. Ultrasound assessment and precise puncture at the healthy section of femoral artery are the key to achieve successful haemostasis with Manta closure device. Our findings suggest there is an association of non-clinically significant mild reduction in CFA vessel AP diameter post Manta closure device, which does not require further intervention.

Passive Approximator Vascular Closure Device Use in Patients with Shallow Femoral Artery Depth Increases Puncture-site Complications in Neuroendovascular Treatment.

OBJECTIVE: Puncture-site complications in interventional radiology sometimes cause severe conditions. Vascular closure devices play an important role in preventing puncture-site complications. Vascular closure devices are divided into 2 types, the directly suturing or clipping type (active approximators) and adherent sealant types (passive approximators). However, which types of vascular closure device are the safest and most effective for achieving hemostasis remains unclear. We analyzed the efficacy of each type of vascular closure device and risk factors for puncture-site complications. METHODS: This study investigated 327 consecutive cases of neuroendovascular surgery using a transfemoral procedure during a 2-year study period. Passive approximators (Angioseal [St Jude Medical, Saint Paul, MN] and Exoseal [Cordis Corporation, Miami, FL]) were mainly used in the first half and active approximators (Perclose [Abbot Vascular, Santa Clara, CA]) in the second. We compared groups and estimated risk factors for puncture-site complications. RESULTS: All procedures were successful. Comparing groups with and without puncture-site complications, use of passive approximators and ≥3 antithrombotic medications tended to be more frequent and distance from skin to femoral artery and body mass index tended to be lower in the group with complications without significance. The cutoff for femoral artery depth calculated from a receiver operating characteristic curve was 16.43 mm. Multivariate analysis revealed ≥3 antithrombotic medications (P = 0.002, OR 15.29, 95% CI 2.76-85.76) and passive approximator use in patients with femoral artery depth <16.43 mm (P < 0.001, OR 17.08, 95% CI 2.95-57.80) were significantly higher in the group with puncture-site complications. CONCLUSIONS: Passive approximator use in patients with shallow femoral artery depth increases puncture-site complications in neuroendovascular treatment.

Preclose Versus Postclose Using Suture-Mediated Vascular Closure System for Catheter Ablation With Femoral Vein Access.

BACKGROUND: Differences in the efficacy and safety between the preclose and postclose suture-mediated vascular closure systems for femoral vein access have not been adequately studied. OBJECTIVES: This study aimed to evaluate the efficacy and safety of these 2 suturing techniques in femoral vein access. METHODS: Patients subjected to elective catheter ablation via the femoral vein using a sheath of 8- to 13-F inner diameter (n = 282) were randomized to the preclose or postclose groups for the single-suture technique using ProGlide/ProStyle (Abbott Vascular). Duplex ultrasound was performed on days 1 and 90 after the procedure to evaluate vascular complications. The primary efficacy endpoint was rebleeding requiring recompression, and the primary safety endpoint was any major complication occurring within 90 days. The secondary efficacy endpoints included time to hemostasis and time to ambulation, and the secondary safety endpoint was any minor complication occurring within 90 days. RESULTS: The preclose group demonstrated a significantly lower rebleeding rate (5 of 141 [3.5%] vs 15 of 141 [10.6%]; P = 0.03) and shorter time to hemostasis (254.0 ± 120.4 seconds vs 299.8 ± 208.2 seconds; P = 0.02) compared with the postclose group. Five patients in each group were lost to follow-up at 90 days. Incidence of major complications were similar in both groups (1 of 136 [0.7%]; P = 1.00), whereas minor complications were observed in 18 of 136 (13.2%) and 21 of 136 (15.4%) patients in the preclose and postclose groups, respectively, without a significant difference (P = 0.73). CONCLUSIONS: In femoral vein access using the single-suture technique with ProGlide/ProStyle, the preclose technique presented a higher hemostasis rate than the postclose technique, without compromising safety.