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).
OBJECTIVE: 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.
CONCLUSIONS: 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.

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.

UNASSIGNED: Vascular access closure is essential in large-bore arteriotomy procedures, such as transcatheter aortic valve replacement. ​Suture-based devices are frequently used for vascular access closure. MANTA (Teleflex) is a collagen plug-based device used to achieve hemostasis with evolving efficacy and safety data. This study aimed to evaluate plug-based versus suture-based closure devices following large-bore arteriotomy procedures.
UNASSIGNED: We conducted a systematic review searching PubMed, Cochrane Library, and ClinicalTrials.gov (inception through November 2021) for studies evaluating plug-based versus suture-based closure devices following large-bore arteriotomy procedures. We performed a meta-analysis comparing the length of stay, device failure, mortality, bleeding, and vascular complications between these 2 types of devices.
UNASSIGNED: Eleven studies (2 randomized controlled trials and 9 observational studies) with a total of 3123 patients were included in this analysis. Compared with suture-based devices, plug-based devices were associated with a significant decrease in the length of stay (standardized mean difference: -0.14; 95% CI, -0.25 to -0.03) and vascular closure device failure (odds ratio, 0.63; 95% CI, 0.44-0.91) following the procedure. There were no significant differences in all-cause mortality, major or minor bleeding, and major or minor vascular complications between plug-based and suture-based closure devices.
UNASSIGNED: Plug-based vascular closure devices were associated with a shorter length of stay and lower risk of device failure following large-bore arteriotomy procedures without differences in mortality, bleeding, or vascular complications than suture-based closure devices.

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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.

BACKGROUND: 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).
CONCLUSIONS: Following AF ablation, femoral venous hemostasis with a VCD was associated with reduced complications compared with hemostasis without a VCD.

UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.

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.

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.
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.

OBJECTIVE: Simplified ablation technologies for pulmonary vein isolation (PVI) are increasingly performed worldwide. One of the most common complications following PVI are vascular access-related complications. Lately, venous closure systems (VCSs) were introduced into clinical practice, aiming to reduce the time of bed rest, to increase the patients\' comfort, and to reduce vascular access-related complications. The aim of the present study is to compare the safety and efficacy of using a VCS to achieve haemostasis following single-shot PVI to the actual standard of care [figure-of-eight suture and manual compression (MC)].
RESULTS: This is a prospective, multicentre, randomized, controlled, open-label trial performed at three German centres. Patients were randomized 1:1 to undergo haemostasis either by means of VCS (VCS group) or of a figure-of-eight suture and MC (F8 group). The primary efficacy endpoint was the time to ambulation, while the primary safety endpoint was the incidence of major periprocedural adverse events until hospital discharge. A total of 125 patients were randomized. The baseline characteristics were similar between the groups. The VCS group showed a shorter time to ambulation [109.0 (82.0, 160.0) vs. 269.0 (243.8, 340.5) min; P < 0.001], shorter time to haemostasis [1 (1, 2) vs. 5 (2, 10) min; P < 0.001], and shorter time to discharge eligibility [270 (270, 270) vs. 340 (300, 458) min; P < 0.001]. No major vascular access-related complication was reported in either group. A trend towards a lower incidence of minor vascular access-related complications on the day of procedure was observed in the VCS group [7 (11.1%) vs. 15 (24.2%); P = 0.063] as compared to the control group.
CONCLUSIONS: Following AF ablation, the use of a VCS results in a significantly shorter time to ambulation, time to haemostasis, and time to discharge eligibility. No major vascular access-related complications were identified. The use of MC and a figure-of-eight suture showed a trend towards a higher incidence of minor vascular access-related complications.