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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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Abstract 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.

Objective: Puncture site complications in neuro-endovascular therapy, which represent a significant cause of morbidity, are often difficult to treat. Vascular closure devices have evolved in endovascular therapy. We analyzed risk factors for puncture site complications and examined the efficacy of hemostasis methods in neuro-endovascular therapy. Methods: This retrospective, observational, single-center study was conducted from January 2021 to January 2023. We enrolled 202 puncture sites of patients who underwent neuro-endovascular therapy at Kawaguchi Municipal Medical Center and analyzed the complications requiring additional intervention. Results: There were 12 (5.94 %) puncture site complications. No patient had permanent puncture-related complications. Univariate analyses revealed that a higher risk of puncture site complications was significantly associated with multiple antiplatelet agents (p = 0.03), hypertension (p = 0.03), scheduled treatment (p

Vascular closure devices (VCD) are frequently used after endovascular interventions to attain faster hemostasis, earlier mobilization, and patient comfort compared to manual compression. VCDs are safe. However, rare complications have been reported. We report a case of an inadvertent intravascular deployment of an Angio-Seal VCD causing limb ischemia and discussing management options from our experience and the previously published cases.

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. Te 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. [ABSTRACT FROM AUTHOR]

Vascular closure devices (VCD) are frequently used after endovascular interventions to attain faster hemostasis, earlier mobilization, and patient comfort compared to manual compression. VCDs are safe. However, rare complications have been reported. We report a case of an inadvertent intravascular deployment of an Angio-Seal VCD causing limb ischemia and discussing management options from our experience and the previously published cases. [ABSTRACT FROM AUTHOR]

Purpose: Pseudoaneurysm (PSA) developing after catheter examinations is one of the most frequent vascular complications and a nonsurgical technique with utmost low risk of complications is warranted. Our aim was to investigate the technical feasibility, success, and safety of transaneurysmal occlusion of complicated post-interventional common femoral artery (CFA) PSA using the Angio-Seal Closure Device (ASCD) and a technique that we describe as the transaneurysmal (TA) maneuver. Material and Methods: We used the Angio-Seal (Terumo, Tokyo, Japan) Closure System to manage complicated PSAs in patients who would otherwise have needed surgery after failure of all conservative therapies. The TA maneuver was performed in 14 consecutive patients from July 2021 to July 2022. After ultrasound-guided puncture of the PSA close to its neck, the CFA was entered radiographically with micro-guidewires, and the neck of the PSA was closed with the ASCD after changing the sheaths and wires. All patient had to wear a pressure dressing until the next day, when successful closure was verified by sonography. Results: All procedures were performed with technical success and without any complications. No patient had to undergo surgery. All sonographies on the next day confirmed complete absence of perfusion within the PSA and normal flow conditions of the CFA and vessels below. Conclusion: The TA maneuver a promising minimally invasive procedure for closing complicated PSA of the CFA after catheter examination. [ABSTRACT FROM AUTHOR]

Amaç: Bu çalışmada, köprüleyici intravenöz trombolitik tedavi uygulanıp ardından mekanik trombektomi (MT) prosedürü uygulanan hastalarda, femoral arter giriş yerinin, Angio-Seal Vasküler Kapatma Cihazı kullanılarak kapatılmasının etkinliğini ve güvenirliğini değerlendirilmesi amaçlanmıştır.. Gereç ve Yöntem: Bu retrospektif, gözlemsel çalışma, Eylül 2018- Eylül 2021 tarihleri arasında akut iskemik inme nedeniyle başvurmuş, köprüleyici tPA (doku plazminojen aktivatörü) sonrasında mekanik trombektomi işlemi gerçekleştirilmiş ve femoral arter giriş yerleri Angio-Seal ile kapatılan toplam 97 hasta çalışmaya dahil edilerek gerçekleştirilmiştir. Temel demografik veriler, eşlik eden risk faktörleri, major ve minör komplikasyon oranlarının, kategorik değişkenlere ait frekans dağılımları ile nicel verilere ait tanımlayıcı istatistikler hesaplanarak kaydedilmiştir. Bulgular: Hastaların %96,9'unda major komplikasyon ve %97,9'unda minör komplikasyon olmadığı bulunmuştur. Tüm hastalarda kasık bölgesinde başarılı hemostaz sağlanmıştır. Major komplikasyonlar, 1 (%1) psödo-anevrizma, 1 (%1) kasık girim bölgesinde enfeksiyon, 1 (%1) Angio-Seal yerleştirmede başarısızlık olarak kaydedilmiştir. 6 Fr (French) Angio-Seal kullanılanlarda %98,2’sinde ve 8 Fr Angio-Seal kullanılanların %95,1’inde majör komplikasyon görülmemiştir. Sonuç: Köprüleyici tPA kullanılan ve MT işlemi gerçekleştirilen akut iskemik inmeli hastalarda, kasık hemostazının sağlanmasında Angio-Seal kullanımı, geniş çaplı arteriotomilerde dahil olmak üzere etkili ve güvenli bir yöntemdir.

Background: The use of vascular closure devices (VCDs) to achieve quick and safe hemostasis after femoral arterial access is widely accepted. Major complications include bleeding and occlusion of the femoral artery due to device failure, which often necessitates vascular intervention. This manuscript details our peripheral percutaneous endovascular interventional (PEI) approach for the management of femoral artery occlusion resulting from Angio-Seal (Terumo, Somerset, New Jersey, USA) VCD deployment., Methods: Consecutive patients who developed occlusive complications after Angio-Seal deployment underwent PEI to overcome specific complications. Patients' clinical and procedural characteristics, along with their short- and long-term follow-up data, were analyzed., Results: The study cohort included 40 patients who experienced Angio-Seal occlusive complications between July 2013 and September 2023. The mean age of the patients was 74 ± 10 years and 55% were female. All the patients were treated with PEI, with an overall procedural success rate of 100%. The primary approach for PEI was directional atherectomy, which was used in 35 cases (88%), followed by balloon, while a cutting balloon was used in 5 patients (13%). Stenting served as the definitive therapy in only 7 patients (18%). No procedural complications or conversions to surgery were observed. During a median follow-up of 244 (IQR = 100-707) days, none of the patients required re-intervention related to Angio-Seal occlusion and salvage intervention., Conclusion: In the management of Angi-Seal VCD-related femoral artery occlusion, the adjunctive use of directional atherectomy followed by balloon angioplasty was effective and safe, allowing re-establishment of flow with excellent long-term outcomes., (© 2024 Wiley Periodicals LLC.)

Simple Summary: Endovascular surgery is a type of image-guided minimally invasive surgery that aims to solve different types of pathologies from inside the blood vessel. This technique requires access to a peripheral vessel (vein or artery) and the navigation through the vascular system to reach the operating site, using different catheters. In horses, the main indication for endovascular therapy involves access to the common carotid artery for different purposes. Traditionally, this was performed by open dissection of the neck to reach and incise the common carotid artery, followed by vascular suture of the vessel and skin closure when the procedure was over. However, this can also be performed by percutaneous puncture of the artery, using ultrasound to guide the needle to its adequate position in the artery, as has been reported in experimental horses. Along with that, in human medicine, commercial closure systems are used to seal these arterial punctures and avoid some complications (mainly haematomas and haemorrhages). We describe our experience in a series of 11 clinical cases in which this minimally invasive way of access was used, and the puncture site was sealed with one of these devices (AngioSeal arterial closure system), reporting its first use in horses. In all cases, the artery was effectively accessed, and the planned procedure could be performed. Our haematoma/bleeding rate (16.66%) was lower than in other studies using the same type of access, even considering two failures due to incorrect use of the device. However, further studies comparing AngioSeal use to simple manual compression would be necessary to be able to recommend their routine use in horses. Background: There are different indications for endovascular surgery in horses, mainly the treatment of guttural pouch mycosis. Traditionally, these procedures are carried out by open arteriotomy of the common carotid artery (CCA), although less invasive percutaneous ultrasound-guided carotid access (PUGCA) has been described in experimental horses. In human medicine, commercial closure systems are used to seal these arterial puncture sites and reduce complications. The aims of this study are to retrospectively describe our experience with PUGCA in clinical cases and to report, for the first time, the use of the commercial vascular closure device Angio-Seal after PUGCA in horses. Methods: Retrospective study of clinical case records. Collected parameters, including the feasibility of the PUGCA and variables related to the safety and efficacy of the use of the Angio-Seal. Results: Twelve PUGCA procedures in 11 horses were included. In all cases, the artery was effectively accessed, and the planned procedure could be performed. In two cases, haematoma/bleeding due to incorrect use of the Angio-Seal was recorded. This complication rate (16.66%) was lower than that obtained in other studies using PUGCA in horses, but where the puncture was sealed by manual compression only. Main limitations: A control group of clinical cases with PUGCA but without using Angio-Seal is not available. Conclusions: Clinical data confirm previous experimental results, which showed that PUGCA is safe and effective in horses. The Angio-Seal system, regardless of possible complications due to incorrect use, can be used safely and effectively in horses. Further studies comparing arterial access site management using manual compression or Angio-Seal would be necessary to state if its routine use in horses is advisable. [ABSTRACT FROM AUTHOR]

Purpose: This study aims to evaluate the efficacy and safety of closure of the femoral artery access site using the Angio-Seal Vascular Closure Device in patients who underwent bridging intravenous thrombolytic therapy and subsequent mechanical thrombectomy (MT). Materials and Methods: The retrospective, observational study was performed in patients who were diagnosed with acute ischemic stroke and treated with MT after bridging IVT between September 2018 and September 2021. A total of 97 patients whose femoral artery access sites were closed with Angio-Seal after the procedure was performed were included in the study. Primary demographic data, accompanying risk factors, major and minor complication rates, frequency distributions of categorical variables, and descriptive statistics of quantitative data were calculated and recorded. Results: It was found that 96.9% of the patients did not have major complications, where 97.9% did not have minor complications either. Successful hemostasis was achieved in the groin region in all patients. Major complications observed were recorded as follows: 1 (1%) pseudo-aneurysm, 1 (%) inguinal incision site infection, and 1 (1%) Angio-Seal placement failure. No major complications were observed in 98.2% of those using 6 Fr (French) Angio-Seal and 95.1% of those using 8 Fr AngioSeal. Conclusion: The findings of the study indicate that Angio-Seal is an effective and safe method for providing groin hemostasis in patients with acute ischemic stroke. [ABSTRACT FROM AUTHOR]

Purpose: This single-center study aimed to assess patients who underwent intentional percutaneous endovascular aortic aneurysm repair (pEVAR) with Hybrid Technique combining a single Perclose (Abbott, Abbott Park, Illinois) Suture-Mediated Closure Device + single Angio-Seal VIP 8F (Terumo, Tokyo, Japan) and compare outcomes with the standard Dual Perclose technique. Materials and Methods: Consecutive elective pEVAR patients treated from November 2022 to November 2023, with healthy femoral accesses and introducer sheaths ≤20 French (F) outer diameter, were included. Coin-toss randomization determined whether a combination of single Perclose Device + single Angio-Seal VIP 8F (Hybrid Technique) or the standard double Perclose Devices (Dual Perclose) was used. In Hybrid Technique, a single Perclose device was positioned at 12 o'clock; a single Angio-Seal VIP 8F was placed after sheaths removal. Dual Perclose followed standard procedure. Primary endpoints included immediate hemostasis, sheath diameter differences, access conversion rate, technical success, and cost analysis., Results: The study involved 60 pEVAR patients (median age=78, interquartile range [IQR]=72-85 years) within the inclusion criteria. In 14 (24%) cases, only 1 femoral access was studied. There were 106 pEVAR accesses, with 58 (54.7%) in the Hybrid Technique group and 48 (45.3%) in the Dual Perclose group. Both groups exhibited homogeneity in pre-operative characteristics and sheath diameter (Hybrid Technique-16F vs Dual Perclose-18F; p=0.202). Immediate hemostasis was achieved in 100% of the Hybrid Technique group vs 87.5% for the Dual Perclose group (p=0.006). Surgical access conversion was unnecessary. Technical success was 100%, with all 6 femoral bleeding cases after Dual Perclose resolved endovascularly, using additional devices. Cost analysis showed a median cost of 330 euros (IQR=0) for the Hybrid Technique group vs 384 euros (IQR=360-456) for the Dual Perclose group (p<0.001). Thirty-day mortality was 3%, in 2 fragile patients, without access-related complications. Multivariate analysis identified Dual Perclose access (odds ratio [OR]=35.6; 95% confidence interval [CI]=18.3-36.8; p<0.001) and obesity (OR=19.7; 95% CI=1.4-23.9.5; p<0.001) as independent risk factors for immediate hemostasis failure. Median follow-up was 134 days (IQR=41-227), with 1 Hybrid Technique case (2%) successfully treated with thrombin injection for a small femoral pseudoaneurysm after 62 days., Conclusions: The elective Hybrid Technique with combination of single Perclose Device + single Angio-Seal VIP 8F during pEVAR in selected patients appears to be non-inferior to the standard Dual Perclose procedure. It demonstrates a positive trend in reducing immediate hemostasis failure and costs. Both procedures achieved technical success and avoiding surgical access conversions., Clinical Impact: This study introduces a novel elective hybrid technique combining a single Perclose device with a single Angio-Seal VIP 8Fr for percutaneous endovascular abdominal aortic interventions. Results for hybrid technique showed 100% technical success and efficient immediate hemostasis, while costing less than standard dual Perclose procedure. Both procedures did not require surgical conversions. Despite being a single-center study, it demonstrates potential benefits of the intentional application of this hybrid technique towards minimally invasiveness. Obesity and dual Perclose technique were identified as independent risk factors for hemostasis failure, reaffirming the hybrid technique procedure's efficacy as well as and non-inferiority to standard procedure., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Vascular complications (VCs) remain an important source of morbidity and mortality following percutaneous arterial catheterization. Vascular closure devices are popular and frequently used, but sometimes cause vessel occlusions that may require vascular surgery or complex endovascular procedures. In this case report, we describe the endovascular retrieval of an embolized Angio‐Seal device causing acute limb ischemia in a severely diseased 75‐year‐old female patient. This case highlights the endovascular technique using a snare catheter and adds another example to the growing evidence of an endovascular approach to manage vascular access site complications in comorbid patients at risk. [ABSTRACT FROM AUTHOR]

Introduction: Angio-Seal is a commonly used device for femoral hemostasis in neuroendovascular procedures. This meta-analysis investigates of the safety and efficacy of Angio-Seal in patients undergoing endovascular neurointerventional procedures. Methods: A systematic review and meta-analysis on all studies evaluating the Angio-Seal device in neurointerventional procedures from inception through 2020 were performed. We studied rates of groin hematoma, retroperitoneal hematoma, pseudoaneurysm, ipsilateral DVT, and ischemic complications. Meta-analysis was performed using the random-effects model. Results: 13 studies were included in our analysis. 2250 patients with 104 complications were found {4.5% (95% CI, 2.7%–6.3%)}. Of these complications, groin hematoma was the most common with a rate of 2.4% (95% CI, 1.1%–3.6%). Retroperitoneal hematoma {0.3% (95% CI, 0%–0.5%)}, pseudo-aneurysm {0.5% (95% CI, 0.2%–0.8%), and ipsilateral DVT {0.3% (95% CI, 0.1%–0.7%) were also not in negligible rate. The rate of other complications were as follows: vessel occlusion/stenosis; 0.2% (95% CI, 0%–0.4%), vascular surgery; 0.2% (95% CI, 0%–0.5%), and infection; 0.2% (95% CI, 0%–0.5%). One patient died as result of hemorrhagic complications {0.1% (95% CI, 0%–0.3%)}. Use of anticoagulant/antiplatelet therapy was found to be positively correlated with high risk of any groin complication and groin hematoma (p ≤.05). Female gender was associated with high risk of ipsilateral DVT (p ≤.05). Interestingly, large sheath size was associated with low risk of groin hematoma (p ≤.05). Conclusion: The safety and efficacy rate of Angio-Seal was approximately 95%. The most common complication was groin hematoma. Serious complications including retroperitoneal hematoma and femoral artery occlusion were rare. [ABSTRACT FROM AUTHOR]

Abstract Vascular complications (VCs) remain an important source of morbidity and mortality following percutaneous arterial catheterization. Vascular closure devices are popular and frequently used, but sometimes cause vessel occlusions that may require vascular surgery or complex endovascular procedures. In this case report, we describe the endovascular retrieval of an embolized Angio‐Seal device causing acute limb ischemia in a severely diseased 75‐year‐old female patient. This case highlights the endovascular technique using a snare catheter and adds another example to the growing evidence of an endovascular approach to manage vascular access site complications in comorbid patients at risk.

Iatrogenic common femoral artery pseudoaneurysm is a well-known vascular access complication of angiography and transfemoral intervention. Thrombin injection is a well-accepted technique in treating these pseudoaneurysms but possess a significant risk of distal lower extremity thrombosis leading to severe consequences. Several case reports described the novel approach to closing these pseudoaneurysms via a retrograde deployment of an Angio-Seal vascular closure device. We describe a case of a successful treatment of refractory iatrogenic femoral artery pseudoaneurysm using Amplatzer vascular plugs following unsuccessful retrograde deployment of an Angio-Seal vascular closure device.

Background: There are different indications for endovascular surgery in horses, mainly the treatment of guttural pouch mycosis. Traditionally, these procedures are carried out by open arteriotomy of the common carotid artery (CCA), although less invasive percutaneous ultrasound-guided carotid access (PUGCA) has been described in experimental horses. In human medicine, commercial closure systems are used to seal these arterial puncture sites and reduce complications. The aims of this study are to retrospectively describe our experience with PUGCA in clinical cases and to report, for the first time, the use of the commercial vascular closure device Angio-Seal after PUGCA in horses. Methods: Retrospective study of clinical case records. Collected parameters, including the feasibility of the PUGCA and variables related to the safety and efficacy of the use of the Angio-Seal. Results: Twelve PUGCA procedures in 11 horses were included. In all cases, the artery was effectively accessed, and the planned procedure could be performed. In two cases, haematoma/bleeding due to incorrect use of the Angio-Seal was recorded. This complication rate (16.66%) was lower than that obtained in other studies using PUGCA in horses, but where the puncture was sealed by manual compression only. Main limitations: A control group of clinical cases with PUGCA but without using Angio-Seal is not available. Conclusions: Clinical data confirm previous experimental results, which showed that PUGCA is safe and effective in horses. The Angio-Seal system, regardless of possible complications due to incorrect use, can be used safely and effectively in horses. Further studies comparing arterial access site management using manual compression or Angio-Seal would be necessary to state if its routine use in horses is advisable.

Background: Hemostasis for transfemoral transcatheter aortic valve replacement (TAVR) is typically achieved using a suture-mediated vascular closure device (VCD) prior to large-bore sheath insertion (preclosure technique). Recently, the addition of a hybrid closure technique using a preclose technique with the addition of a collagen-plug VCD after sheath removal in cases of failed hemostasis has been utilized., Methods: Data were collected from the Northwell TAVR registry, including 3 high-volume TAVR centers. We evaluated a preclose strategy with suture-mediated vascular closure alone ("legacy strategy") and standard bailout techniques versus a contemporary hybrid strategy of suture-mediated closure with collagen-mediated closure bailout. The primary end point was major or minor vascular complications as defined by the VARC-3 criteria., Results: A total of 1327 patients were included, of which 791 patients underwent TAVR with suture-mediated closure alone and 536 with contemporary strategy. The primary end point (major or minor vascular complication) was lower in the contemporary strategy (5.44% vs 1.31%; P < .001). Both minor (3.92% vs 1.12%; P = .002) and major (1.14% vs 0.19%; P = .0196) vascular complications were reduced and the total length of stay was less in the contemporary strategy (median of 3 days vs 2 days; P < .0001). Using multivariable analysis, we observed that vascular management strategy significantly improved the composite primary outcome when adjusted for sheath size, peripheral artery disease, carotid disease, and site of procedure. In the contemporary group, bailout collagen-plug VCD with an Angio-Seal (Terumo Medical) was used in 68 patients (12.69%) and bailout MANTA (Teleflex) was required in 4 patients (0.75%). There were no major or minor vascular complications among the patients who received bailout collagen-plug VCD., Conclusions: A contemporary hybrid strategy of suture-mediated closure with collagen-mediated closure bailout reduces the risk of vascular complications among patients undergoing transfemoral TAVR., (© 2024 Society for Cardiovascular Angiography and Interventions Foundation. Published by Elsevier Inc.)

Due to a great number of endovascular interventions, conducted over the last decades, a huge percentage of obese patients and administration of double antiplatelet therapy, manual compression (MC) is more and more frequently replaced by a vascular closure device of which the most common is Angio-Seal. The study presents a case of a 63-year-old female patient with recurrent hemorrhages of the common femoral artery (CFA), originally closed after an endovascular intervention of a popliteal artery aneurysm with the use of Angio-Seal VIP. After around 3 weeks following the original surgery, the patient at first developed a pseudoaneurysm and then septic inflammation of the femoral artery, manifested with recurrent hemorrhages from the groin. The patient was operated on many times and an implantation of an ilio-femoral bypass from the femoral vein turned out to be an effective solution. Staphylococcus epidermidis MRSA was cultured in the femoral artery wall and a histopathological examination confirmed infectious arteritis. The presented case of a rare septic complication after the application of a closure device shows that it is essential to carefully monitor surgical approach areas in patients who are quickly discharged from hospital after surgical interventions, to select treatment methods tailored for individual patients as well as implement particular surgical management. [ABSTRACT FROM AUTHOR]

Background Iatrogenic perforation of the right ventricle (RV) is a rare but recognized complication of pericardiocentesis. Treatment strategies for RV perforation include surgical repair and percutaneous closure. In this case report, we describe the use of an angio-seal vascular closure device (Terumo Interventional Systems) to seal an iatrogenic RV perforation secondary to incorrect placement of a pericardial drain. Case summary A 55-year-old female presented with an anterior ST-elevation myocardial infarction. Coronary angiography demonstrated occlusion of the left anterior descending artery. The patient went on to have primary percutaneous coronary intervention and both the left anterior descending and D1 were wired. During kissing balloon inflation, the Sion Blue wire migrated distally in the D1 causing an Ellis type 3 wire tip perforation in the distal D1. Emergency pericardiocentesis was performed however the 8 French (8 Fr) pericardial drain was inadvertently inserted into the RV. It was decided to attempt percutaneous closure with an 8 Fr angio-seal in the catheter lab under echocardiographic and fluoroscopic guidance. Our patient did not demonstrate any recurrence of pericardial effusion on repeat echocardiography over 60 days post-procedure. Discussion Our patient did not demonstrate any recurrence of pericardial effusion on repeat echocardiography over 60 days post-procedure. We feel that the angio-seal vascular closure device represents an effective, minimally invasive treatment for this rare but potentially catastrophic complication of pericardiocentesis. In this case, the technique spared our patient a sternotomy with its associated morbidity. [ABSTRACT FROM AUTHOR]

• Using a large-bore sheath introducer may increase the post-puncture bleeding. • Most hemorrhagic complications were controlled by manual compression. • None of these complications led to a decreased of the modified Rankin Scale. Various adjunctive techniques for neurointerventional procedures require a large-bore sheath introducer, but there is concern that this could result in more puncture site hemorrhagic complications despite using a vascular closure device. The purpose of this study was to assess the relationship between use of large-bore sheath introducer and post-procedural complications. Between January 2016 and April 2018, 126 neurointerventional procedures were performed in our hospital using 8 or 9 Fr sheath introducer in size and the Angio-Seal STS PLUS (St. Jude Medical, Minnetonka, USA). Hemorrhagic complications were defined as obvious swelling or bleeding at the puncture site or as extravascular bleeding detected by ultrasonography or contrast-enhanced computed tomography. The procedures were divided into a group with post-puncture bleeding (group B, n = 21) and a group without bleeding (group N, n = 105). Risk factors were compared between the groups according to the incidence of post-puncture bleeding. In addition, we assessed the outcome and approach to hemostasis in the procedures with bleeding. In result, hemorrhagic complications occurred in 21 procedures (17%), and pseudoaneurysm was detected in 4 procedures (3.2%). In 20 of group B (16%), manual compression was performed for an average of 36.4 min. One patient (0.79%) required surgical angioplasty. Risk factors for bleeding were not significantly different between the two groups. None of the patients with bleeding showed a decrease on the modified Rankin Scale. In conclusion, use of a large-bore sheath introducer may increase the incidence of post-puncture bleeding, but the outcome of this complication is acceptable. [ABSTRACT FROM AUTHOR]

Background: The use of arterial closure devices in achieving femoral hemostasis has been well documented in adults but insufficiently studied in the pediatric population. An earlier study from our institution of 40 Angio-Seal devices in 38 patients concluded that the arterial closure device is safe in children with only a single minor complication. Ongoing experience with this device at our institution, however, suggests a higher rate of complication.Objective: To retrospectively evaluate the safety and efficacy of the Angio-Seal in a pediatric population.Materials and Methods: A retrospective analysis reviewed all cases in which the Angio-Seal was deployed from June 2011 to September 2017. Peri-procedural documentation was reviewed for pre-procedure labs, clinical effectiveness in achieving hemostasis and complications related to the use of this device. Logistic regression analysis was also used to evaluate the relationship between patient demographic, vessel size and indication for angiography, and the presence or absence of complications.Results: During the study period, 48 additional Angio-Seal devices were deployed in 41 consecutive patients. Five patients were excluded for being older than 18 years. The mean age of the patients was 13.3 years (range: 4-18 years) with 18 patients female. The mean common femoral artery diameter was 5.98 mm in short axis diameter (range: 4-9 mm). Complications were present in 6/43 cases (14%) including 3 minor and 3 major complications that included additional procedures. No significant relationship was identified between vessel size, age and the indication for angiography, and the rate of complication on logistic regression analysis.Conclusion: While percutaneous arterial closure devices can be efficacious for achieving hemostasis, our experience demonstrates a higher rate of complications in children, contrary to a previous report. The deployment of such devices should be performed with prejudice in this population. [ABSTRACT FROM AUTHOR]

Objective: Vascular closure devices (VCDs), such as the Angio-Seal, a three-component hemostatic plug, have greatly facilitated the routine clinical practice in the catheterization laboratory. The manufacturer recommends a local angiogram before Angio-Seal deployment. However, from the outset, we employed a simplified routine of deploying this VCD, i.e. without use of local angiography. Methods: The Angio-Seal was employed without a preceding femoral arteriogram over 8 years in 2074 consecutive patients, 72% presenting with acute coronary syndromes and subjected to coronary angiography (n = 1032) or PCI n = 1042) via a transfemoral approach with use of heparin and dual antiplatelet therapy. Results: Deployment of the VCD was successful in 99.4%. Complete hemostasis was obtained in 98% of cases. In 14 patients, Angio-Seal deployment failed. Mean time for placement of Angio-Seal was

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., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Objective The aim of this review was to provide an up-to-date summarization of available Food and Drug Administration-approved vascular closure devices (VCDs) and to analyze current evidence comparing individual devices with one another and with manual compression (MC). The review includes indications for use, advantages and disadvantages, safety and efficacy, and outcomes. Methods A review of literature available on VCDs was conducted using PubMed and MEDLINE. Only clinical trials published within the last 10 years evaluating the efficacy of different VCDs with access obtained through common femoral artery or vein were included. All literature included in this review was published in English and used human participants. Results The search strategy yielded 34 relevant articles. These studies included procedures ranging from diagnostic catheterizations to percutaneous endovascular aneurysm repair. There is considerable heterogeneity in the studies, with a wide variety of definitions and different outcome measures. The review demonstrated that VCDs provided improvement in the patients' comfort and satisfaction as well as in the time to hemostasis and ambulation. Most studies are underpowered to show differences, but even after meta-analysis or Cochrane review, complication rates as well as safety and efficacy between devices and MC remained comparable. Conclusions VCDs have shown marked improvement in patients' comfort and satisfaction as well as in time to hemostasis and ambulation after percutaneous vascular procedures. According to multiple small randomized controlled trials, meta-analyses, and a Cochrane review, complication rates, safety and efficacy, and outcomes remain comparable between VCDs and MC (12% for VCDs vs 13% for MC). VCDs have a low incidence of major complications and high success rates, which provides convenience for the practitioner and facilitates turnover of patients. VCDs have a risk of infectious (0.6% with VCDs vs 0.2% with MC) and thrombotic complications (0.3% with VCDs vs none with MC) that is small but may be increased compared with MC. It is important to balance the goals of comfort of the patient, resources of the staff, and early ambulation against periprocedural and anatomic risk factors (ie, individualize use of VCDs to specific clinical scenarios). Users must be familiar with a device and its limitations to safely and effectively achieve hemostasis after femoral artery puncture. [ABSTRACT FROM AUTHOR]

An increasing number of PCIs are being performed worldwide. Most procedures are carried out via the radial artery; however, femoral access is still preferred in some instances, and is associated with an increased risk of complications. Since the 1990s, vascular closure devices (VCDs), such as Angio-Seal™, have largely replaced manual compression as a method to achieve haemostasis--yet the evidence supporting their use remains uncertain. The current article uses a case-study approach to examine the evidence supporting the use of Angio-Seal, and the nursing care required post procedure. Moderately strong evidence supports the use of VCDs, but small sample size, bias and heterogeneity are limitations of the studies. There is also a lack of standardised cost analysis, and little consensus regarding the length of bed rest required post procedure. No research was found assessing the optimal frequency of patient observations. [ABSTRACT FROM AUTHOR]

Background: We examined the safety and efficacy of the access-site hemostasis device Angio-Seal™ STS Plus (AS; St. Jude Medical,St. Paul, MN, USA) compared with the method of hemostasis by manual compression (MC) in neuroendovascular therapy. Method: We conducted a prospective multicenter registration study enrolling 229 patients who were scheduled to undergo endovascular treatment. Results: Of the 119 and 110 cases assigned to the AS and MC groups, 118 (99.2%) and 105 (95.5%) achieved successful hemostasis, respectively. Six AS patients and 38 MC patients had access-site hematoma (5% vs 34.5%, P < 0.001). Hemostasis time was significantly shorter in the AS group than in the MC group (4.4 min vs 150.7 min, P < 0.001). Puncture-site hematoma was significantly larger in the AS group than the MC group (5.5 cm vs 2.9 cm, P < 0.05). Patients in the AS group had a significantly shorter hospital stay than those in the MC group (8.7 days vs 13.3 days, P < 0.001); they also had a significantly shorter time before they could start to walk (23.9 h vs 52.2 h, P < 0.001). No serious adverse events were noted in either group. Minor adverse events included four cases from the AS group and two cases from the MC group. Conclusions: Use of an access-site hemostatic device resulted in quick and reliable access-site hemostasis in neuroendovascular therapy. When using AS, it is necessary to be careful when there is a possibility of a hematoma, as the hematomas, though significantly less frequent than in MC, were significantly bigger in that group. [ABSTRACT FROM AUTHOR]

Adequate and reliable hemostasis following transcatheter aortic valve implantation (TAVI) is crucial. Closure devices have improved the amount of time required to achieve hemostasis following these procedures. We retrospectively looked at TAVI procedures that achieved adequate hemostasis after use of the Angio-Seal as an adjunctive measure following use of the Perclose ProGlide system. Sixteen cases (age range, 56-91 years) were identified between January 2016 and February 2018. Half had undergone transfemoral diagnostic angiography in the same vessel used for the TAVI delivery system within the prior 1 to 63 days. Five were receiving oral anticoagulants; six, aspirin; and two, dual-antiplatelet therapy. All had undergone computed tomography angiography for sizing of iliofemoral arteries, aorta, and the aortic valve prior to TAVI. No patient experienced any significant access site-related complications or ischemic leg symptoms, and there were no reports of late vascular or access site complications. Our case series suggests that adjunctive Angio-Seal systems may be a reliable alternative for incomplete hemostasis following Perclose ProGlide systems and can serve as a "bailout" procedure for incomplete postprocedural hemostasis. [ABSTRACT FROM AUTHOR]

Objective: We describe a novel approach for the endovascular treatment of femoral artery occlusion as a result of Angio-Seal closure device deployment. Background: Angio-Seal is the most commonly used vascular closure device following percutaneous coronary and peripheral catheterizations worldwide. A rare complication of Angio-Seal deployment is an occlusion of the femoral artery leading to limb ischemia requiring revascularization. Given its unique ability to cut both atherosclerotic plaque and the Angio-Seal anchor with a collagen plug at operator-directed planes, TurboHawk/HawkOne atherectomy device can be a fast and effective approach to treat Angio-Seal-associated femoral artery occlusions. Methods: We studied 13 consecutive patients who developed Angio-Seal-associated femoral artery occlusions that occurred from 3 hours to several weeks after catheterization. These patients were successfully treated with TurboHawk/HawkOne directional atherectomy followed by balloon angioplasty with no complications. During a mean follow-up period of 20.4 ± 17.3 months, 12 patients remained claudication free with no evidence of obstructive arterial disease of the treated segment on imaging studies. One patient developed restenosis that was treated with repeat atherectomy and balloon angioplasty following which he was asymptomatic at follow-up. Conclusion: The use of directional atherectomy followed by balloon angioplasty is a quick, safe, and effective endovascular approach to treating Angio-Seal-associated femoral artery occlusions. It is associated with an excellent success rate, no complications, and good midterm outcomes. [ABSTRACT FROM AUTHOR]

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Purpose: This retrospective study evaluates the effectiveness and safety of the Angio-Seal closure device in superficial femoral artery (SFA) antegrade punctures compared to common femoral artery (CFA) antegrade punctures.Methods: Over a period of 46 months from January 2012, consecutive patients who underwent antegrade CFA or SFA punctures using Angio-Seal as a closure device in a single centre were studied. Patients were identified by reading all the individual reports on our radiology system for all patients who underwent any angiographic examination during the study period, and their individual case notes were subsequently reviewed. A retrospective analysis of prospectively collected data on patients' demographics, type of intervention, clinical indication, Angio-Seal size, haemostasis status and complications was performed.Results: Overall, 194 patients (mean (s.d.) age 74(12) years, 123(44%) males) underwent CFA or SFA antegrade punctures. A total of 228 (CFA group, n = 70, SFA group, n = 158) antegrade punctures were performed. Clinical characteristics of the two groups were comparable. Angio-Seal size 6F was deployed in 69(99%) antegrade CFA punctures and 155(98%) antegrade SFA punctures (P = 1.000). Haemostasis was achieved in 65(93%) antegrade CFA punctures compared to 156(99%) antegrade SFA punctures (P = 0.030).Conclusion: Angio-Seal closure device is safe and effective method of haemostasis both in antegrade SFA and CFA punctures with no significant complications or delayed discharge. [ABSTRACT FROM AUTHOR]

Objectives Small published series suggest a higher failure rate for Angio-Seal vascular closure device (VCD) deployment after antegrade femoral puncture, despite the need for shorter haemostasis times, early discharge, and possibly higher turnover. We seek to compare the deployment efficacy and complications of the Angio-Seal VCD between antegrade and retrograde femoral arterial deployments. Methods Radiological data was retrospectively analysed from prospective databases from the hospitals' Computerised Radiology Information System (CRIS) over 2010-2012. Angio-Seal gauge, Rutherford class (as applicable), puncture mode (used to classify deployment as antegrade/retrograde), sheath sizes, and deployment success/failures were recorded. Numerical/statistical analyses were undertaken using Microsoft Excel 10/SISA software. Results A total of 519 Angio-Seal VIP VCDs were deployed in 470 patients over 2010-2012 (13 other patients could not be analysed due to incomplete data). Sheath sizes for antegrade/retrograde femoral puncture were 5F, n = 22/9; 6F, n = 244/223; 7F, n = 1/5; 9F, n = 4/0. 8F Angio-Seal VIPs were used for 9F punctures only, 6F for the remainder. The overall deployment success rate was 93.7%. In total, 247 (91.1%) successful antegrade deployments were undertaken with 24 (8.9%) failures, compared with 229 (96.6%) successful retrograde deployments with eight (3.4%) failures. Antegrade/retrograde failures were classed as failure to deploy, n = 15/5; bleeding despite successful deployment requiring supplementary compression, n = 6/1; haematoma formation, n = 2/1; groin pain, n = 0/1; vessel stenosis, n = 1/0. Higher deployment failures were noted with antegrade deployment (p < .02, chi-square test). Conclusions Angio-Seal deployment is successful for both antegrade/retrograde femoral punctures albeit with a higher antegrade failure rate. [ABSTRACT FROM AUTHOR]

A 75-year-old woman with past medical history of coronary bypass, atrial fibrillation, mitral valve repair undergoes percutaneous coronary intervention of left circumflex artery with a drug eluting stent. An Angio-Seal vascular closure device was used post procedure to obtain hemostasis. Shortly after deployment, frank bleeding was observed necessitating manual compression at the arteriotomy site. After hemostasis was achieved, the right lower extremity was found to be pale, bluish with feeble pulses. Doppler ultrasound was emergently performed revealing decreased blood flow after mid superficial femoral artery (SFA) and an echo lucent object lodged luminally in the SFA. Patient was urgently taken to the vascular laboratory where an Angio-Seal device, including the collagen plug and anchor, was successfully removed endovascularly patient made full recovery and was discharged home the following day. [ABSTRACT FROM PUBLISHER]

Purpose: To compare complication rates of a collagen-based vascular closure device (VCD) in patients with vs. without significant peripheral artery disease (PAD). Methods: A total of 382 patients (268 men; mean age 64.6±10.8 years) undergoing either an endovascular procedure of the lower limb (PAD group, n=132) or a percutaneous coronary intervention (PCI group, n=250) via a common femoral artery access were enrolled in this prospective study if hemostasis was achieved using the collagen-based Angio-Seal. In the PCI group, significant PAD was excluded by measurement of the ankle-brachial index. Inhospital major complications (bleeding, large hematoma, pseudoaneurysm, vessel occlusion, dissection) were recorded. Results: Similar and low rates of major complications were observed in both arms of the study: 2 (1.5%) major complications in the PAD group and 3 (1.2%) in the PCI group (p=1.0). There was no significant difference in efficacy of the VCDs in the groups (PAD group 99.2% vs. 100% in PCI group, p=0.35). Conclusion: Our study shows no significant differences in the rate of major complications after utilization of a collagen-based VCD for femoral artery access site closure in patients with severe lower limb PAD compared to those without; however, complications in the PAD group tended to be more severe, with the need for surgical repair. [ABSTRACT FROM AUTHOR]

Coronary angiography is often performed via the femoral artery. Following removal of the arterial sheath, there are various methods of closing the arteriotomy. The traditional method is to use manual compression. Vascular closure devices emerged in the 1990s to promote more rapid haemostasis. This article reviews the various vascular closure devices on the market today, examining their mechanisms of action, as well as their individual advantages and disadvantages. [ABSTRACT FROM AUTHOR]

Objectives: The goal of this study was to assess the frequency and predictors of vascular closure device (VCD) deployment failure, and its association with vascular complications of 3 commonly used VCDs. Background: VCDs are commonly used following percutaneous coronary intervention on the basis of studies demonstrating reduced time to ambulation, increased patient comfort, and possible reduction in vascular complications as compared with manual compression. However, limited data are available on the frequency and predictors of VCD failure, and the association of deployment failure with vascular complications. Methods: From a de-identified dataset provided by Massachusetts Department of Health, 23,813 consecutive interventional coronary procedures that used either a collagen plug–based (n = 18,533), a nitinol clip–based (n = 2,284), or a suture-based (n = 2,996) VCD between June 2005 and December 2007 were identified. The authors defined VCD failure as unsuccessful deployment or failure to achieve immediate access site hemostasis. Results: Among 23,813 procedures, the VCD failed in 781 (3.3%) procedures (2.1% of collagen plug–based, 6.1% of suture-based, 9.5% of nitinol clip–based VCDs). Patients with VCD failure had an excess risk of “any” (7.7% vs. 2.8%; p < 0.001), major (3.3% vs. 0.8%; p < 0.001), or minor (5.8% vs. 2.1%; p < 0.001) vascular complications compared with successful VCD deployment. In a propensity score–adjusted analysis, when compared with collagen plug–based VCD (reference odds ratio [OR] = 1.0), nitinol clip–based VCD had 2-fold increased risk (OR: 2.0, 95% confidence interval [CI]: 1.8 to 2.3, p < 0.001) and suture-based VCD had 1.25-fold increased risk (OR: 1.25, 95% CI: 1.2 to 1.3, p < 0.001) for VCD failure. VCD failure was a significant predictor of subsequent vascular complications for both collagen plug–based VCD and nitinol clip–based VCD, but not for suture-based VCD. Conclusions: VCD failure rates vary depending upon the type of VCD used and are associated with significantly higher vascular complications as compared with deployment successes. [Copyright &y& Elsevier]

Bronchopleural fistula is rare and occurs most often after trauma or surgery. Conservative management and support comprise the initial treatment, but if unsuccessful, surgical closure is usually required. We describe for what is to our knowledge the first successful use of an Angio-Seal vascular closure device in a patient who was not a candidate for surgery. [ABSTRACT FROM AUTHOR]

The article presents a study on the use of vascular closure devices (VCD) in reducing ambulation time for patients on cardiac catheterization, in reducing the dangers of vascular complications, and the frequency and consequences of failures. The study concluded that in current practice VCD failure has become rare, but when it occurs, it increases the risks of vascular complications thus requiring patients with VCD to be constantly monitored.

Background: Repeated use of the Angio-Seal closure device (Daig Corporation, St. Paul, MN) before 90 days has not been demonstrated in many studies. We review our institution's experience with the Angio-Seal closure device. Objective: To evaluate the safety profile of the Angio-Seal closure device in patients who underwent multiple transarterial procedures requiring vascular closure. Method: A retrospective analysis was carried out of 25 patients treated with serial transarterial chemoinfusions who had arteriotomy closure with the Angio-Seal device. Seventy Angio-Seal deployments were done, of which 45 resticks were performed after the initial use of the Angio-Seal. The efficacy of Angio-Seal was defined by the ability of the device to help obtain hemostasis. Patients were monitored for complications. Results: Seventy Angio-Seal devices were placed in 25 patients, and the success rate was 100%. The male to female percentage composition was 88% ( n = 22) and 12% ( n = 3), respectively. Thirteen of 25 patients required one reaccess; 12 patients required several of them. The number of repeat accesses per patient was 2 to 4 in 44% ( n = 11) and 5 to 7 in 4% ( n = 1). The interval time ranged between 13 and 85 days. There were no complications. Conclusion: Our data support the safety and effectiveness of consecutive use of the Angio-Seal device in patients requiring a second arterial puncture earlier than the manufacturer's recommendations. [ABSTRACT FROM AUTHOR]

We evaluated the safety and efficacy of the Angio-Seal closure device used to close arterial puncture sites in patients who had undergone diagnostic cerebral angiography and neurointerventional procedures. A total of 1,443 Angio-Seal devices were placed in 1,099 patients in the Interventional Neuroradiology Unit between May 2005 and August 2006. Of these, 670 were interventional and 745 were diagnostic cerebral angiographic procedures. In 28 patients bilateral puncture of the femoral arteries was performed for endovascular treatment. In 167 patients 286 repeat diagnostic procedures were performed and 30 interventional procedures were followed by re-closure with an Angio-Seal device at the time of repeat puncture. The procedural success rate for antegrade closures was 99.7% for all procedures. The device failed in 5 of 745 diagnostic procedures (0.7%). Major complication occurred in one patient only (0.13%) in the diagnostic group. No minor complications were observed in this group. In the interventional group, the major complication rate was 1.4% (10 of 698 closures) and the minor complication rate was 2.4% (17 of 698 closures). However, in the subgroup of patients with cerebral aneurysms who received heparin in combination with antiplatelet agents after the procedure, the major complication rate was 5.3%, but in the carotid/vertebral stenting group it was 0.8%. Our experience in a relatively large series of patients shows that the use of the Angio-Seal STS vascular closure device is safe and effective in patients undergoing cerebral diagnostic angiography and neurointerventional procedures with an acceptable rate of complications, although the complication rate was higher in the group of patients who received heparin and/or antiplatelet medication. [ABSTRACT FROM AUTHOR]

We compared the use of manual compression and Angio-Seal and Starclose arterial closure devices to achieve hemostasis following common femoral artery (CFA) punctures in order to evaluate safety and efficacy. A prospective nonrandomized, single-center study was carried out on all patients undergoing CFA punctures over 1 year. Hemostasis was achieved using manual compression in 108 cases, Angio-Seal in 167 cases, and Starclose in 151 cases. Device-failure rates were low and not significantly different in the two groups (manual compression and closure devices; p = 0.8). There were significantly more Starclose (11.9%) patients compared to Angio-Seal (2.4%), with successful initial deployment subsequently requiring additional manual compression to achieve hemostasis ( p < 0.0001). A significant number of very thin patients failed to achieve hemostasis ( p = 0.014). Major complications were seen in 2.9% of Angio-Seal, 1.9% of Starclose, and 3.7% of manual compression patients, with no significant difference demonstrated; 4.7% of the major complications were seen in female patients compared to 1.3% in males ( p = 0.0415). All three methods showed comparable safety and efficacy. Very thin patients are more likely to have failed hemostasis with the Starclose device, although this did not translate into an increased complication rate. There is a significant increased risk of major puncture-site complications in women with peripheral vascular disease. [ABSTRACT FROM AUTHOR]