Arterial Closure Devices Research Articles

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

BackgroundHemostatic 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 presentationThe 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.ConclusionsMBF 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.

Transradial and Transfemoral Access for Retrograde Chronic Total Occlusion Percutaneous Coronary Interventions: A Comparison of the Clinical Features and Prognostic Implications.

The research was carried out to determine and compare the efficiency of completely transradial access (cTRA) and transfemoral access (TFA) in retrograde chronic total occlusion (CTO) percutaneous coronary intervention (PCI). The cases of retrograde chronic total occlusion (CTO) percutaneous coronary intervention usually need the dual access. The transradial method is now used more frequently in CTO PCI, and improves the safety of CTO PCI. This retrospective, observational study was carried out in a single center. Participants were patients who underwent dual-access retrograde CTO PCI from January 2017 to October 2023, categorized into two groups: cTRA (biradial access) and TFA (bifemoral, or combined radial and femoral access). All patients in the cTRA group received conventional radial access. All punctures of the femoral artery were performed without fluoroscopic or ultrasound guidance. None of the patients in the TFA group accepted any arterial closure devices. Clinical, angiographic and procedural characteristics and the occurrence of in-hospital major adverse cardiovascular events (MACE) of the cTRA and TFA procedures were recorded. This research involved 187 CTO PCI procedures with dual access, of which 88 were done using cTRA and the rest (99) were carried out through TFA. The J-CTO (Multicenter Chronic Total Occlusion Registry of Japan) score was lower in the cTRA group than TFA group (2.1± 0.6 vs 3.0± 0.8; P <0.001). The technical success (84.1% vs 82.8%; P= 0.817), procedural success (80.7% vs 79.8%; P= 0.906) and in-hospital MACE rates (5.7% vs 4.0%; P= 0.510) were the same for both groups. For a J-CTO score of 3 or higher, technical success rate was significantly lower in the cTRA group than the TFA group (58.1% vs 74.2%; P < 0.001). In the retrograde CTO PCI, the percentages of success and in-hospital MACE were similar for both cTRA and TFA. Meanwhile, cTRA may be used for simpler lesions (J-CTO score < 3) as compared to TFA.

Percutaneous Versus Surgical Femoral Cannulation in Minimally Invasive Cardiac Surgery: A Systematic Review and Meta-Analysis.

Minimally invasive cardiac surgery (MICS) is increasing worldwide. In most cases, the surgical technique includes cannulation of the groin for the establishment of cardiopulmonary bypass, requiring a second surgical incision (SC) for exposure and cannulation of the femoral vessels. With the introduction of arterial closure devices, percutaneous cannulation (PC) of the groin has become a possible alternative. We performed a meta-analysis and systematic review to compare clinical endpoints between the patients who underwent PC and SC for MICS. Three databases were assessed. The primary outcome was any access site complication. Secondary outcomes were perioperative mortality, any wound complication, any vascular complication, lymphatic complications, femoral/iliac stenosis, stroke, procedural duration, and hospital length of stay (LOS). A random effects model was performed. A total of 5 studies with 2,038 patients were included. When compared with PC, patients who underwent SC showed a higher incidence of any access site complication (odds ratio [OR] = 3.09, 95% confidence interval [CI]: 1.87 to 5.10, P < 0.01), any wound complication (OR = 10.10, 95% CI: 3.31 to 30.85, P < 0.01), lymphatic complication (OR = 9.37, 95% CI: 2.15 to 40.81, P < 0.01), and longer procedural duration (standardized mean difference = 0.31, 95% CI: 0.12 to 0.51, P < 0.01). There was no significant difference between the 2 groups regarding perioperative mortality, any vascular complication, femoral/iliac stenosis, stroke, or hospital LOS. The analysis suggests that surgical groin cannulation in MICS is associated with a higher incidence of any access site complication (especially wound complication and lymphatic fistula) and with a longer procedural time compared with PC. There was no difference in perioperative mortality.

Access site complications in thoracic endovascular aortic repair

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

Safety and efficacy of the CELT ACD femoral arteriotomy closure device in the office-based laboratory.

Manual compression remains the gold standard for achieving hemostasis for percutaneous common femoral artery access. However, it requires prolonged bedrest and 20 to 30minutes or more of compression for hemostasis. Current arterial closure devices have emerged in recent years, but patients still require prolonged bedrest and time to ambulation and discharge, and these devices are associated with significant access device complications, including hematoma, retroperitoneal bleeding, transfusion requirement, pseudoaneurysm, arteriovenous fistula, and arterial thrombosis. A novel femoral access closure device, the CELT ACD (Vasorum Ltd, Dublin, Ireland), has been previously shown to reduce these complication rates and allow rapid hemostasis, require little or no bedrest, and shortened time to ambulation and discharge. This is especially advantageous in the outpatient setting. We report our initial experience with this device. A prospective single-center single-arm study was performed in an office-based laboratory setting to assess the safety and efficacy of the CELT ACD closure device. Patients underwent diagnostic and therapeutic peripheral arterial procedures from retrograde or antegrade common femoral artery access. Primary endpoints include device deployment success, time to hemostasis, and major or minor complications. Secondary endpoints include time to ambulation and time to discharge. Major complications were defined as bleeding requiring hospitalization or blood transfusion, device embolization, pseudoaneurysm formation, and limb ischemia. Minor complications were defined as bleeding not requiring hospitalization/blood transfusion, device malfunction, and access site infection. A total of 442 patients were enrolled with common femoral access only. Median age was 78years (range, 48-91years), and 64% were male. Heparin was given in all cases, with median heparin dose of 6000 units (range, 3000-10,000 units). Protamine reversal was used in 10 cases due to minor soft tissue bleeding. Average time to hemostasis was 12.1seconds (±13.2seconds), time to ambulation was 17.1minutes (±5.2minutes), and time to discharge was 31.7minutes (±8.9minutes). All devices (100%) were deployed successfully. No major complications occurred (0%). Ten minor complications (2.3%) occurred; all were minor soft tissue bleeding from the access site that resolved with protamine reversal of heparin and manual compression. The CELT ACD closure device is safe and easily deployed with a very low complication rate, and significantly reduces time to hemostasis, ambulation, and discharge in patients undergoing peripheral arterial intervention from a common femoral artery approach in the office-based laboratory setting. This is a promising device that deserves further evaluation.

Management of arterial trauma during central venous catheter insertion using a percutaneous suture-mediated closure device (Perclose ProGlide): a report of two cases and literature review

We evaluated the safest approach to treat catheter-related cervicothoracic arterial injuries by reviewing two inadvertent arterial injury cases during central venous catheter insertion and their related complications at an intensive care unit. In the first case, C-arm angiography confirmed accidental catheter placement in the right subclavian artery (SCA). In the second case, accidental catheter placement in the right common carotid artery was confirmed via computed tomography angiography of the neck and chest. The catheter was connected to a high-pressure arterial bag in both cases. The Perclose ProGlide Suture-Mediated Closure System (Abbott Laboratories, IL, USA) was used and successfully operated the two cases of iatrogenic SCA and carotid artery injuries. A follow-up bedside ultrasound at 2 and 6 hours postoperatively revealed normal Doppler waveforms in the inadvertent arterial injury and distal arteries without hematoma at the puncture site in both cases. In conclusion, for inadvertent artery puncture, which occurs in &lt;12% of jugular and subclavian venous procedures, the endovascular approach using a covered stent appears to be safe for treating the accidental catheter placement in the carotid artery, although some cases of post-procedure stroke have been reported. In this regard, the percutaneous arterial suture device (Perclose ProGlide) offers an almost 100% success rate and lowers morbidity and mortality rates compared with open surgical and endovascular approaches for treating iatrogenic SCA and carotid artery injuries. These two cases highlight the effectiveness of minimally invasive percutaneous arterial closure devices in treating this infrequent but potentially lethal injury.

Percutaneous versus open surgical cannulation for minimal invasive cardiac surgery; immediate postprocedural outcome analysis.

Open surgical cannulation (SC) is traditionally used for cardiopulmonary bypass cannulation in minimally invasive cardiac surgery (MICS). The percutaneous cannulation (PC) technique using arterial closure devices has also been used in select centers. The aim of this study was to compare outcomes between patients undergoing the PC or SC approach, with a particular focus on cannulation-related groin complications. A retrospective analysis of patients undergoing MICS at our institution between January 2018 and April 2022 was performed. Starting from June 2020, 3 surgeons at our institution started using the PC approach. For patients in the PC group, a primary suture-based technique (ProGlide) complemented by a small-sized plug-based closure device (AngioSeal) was used. The primary end point of the study was groin complications following the procedures. A total of 524 patients underwent MICS through a right lateral minithoracotomy during the study time period. Of these, 88 patients (17%) were cannulated using PC approach and 436 (83%) using SC approach. The total number of cannulation-related groin complications was greater in the SC group (4% vs 0%, P=.05). Propensity score matching resulted in 2 comparable groups, with 172 patients in the SC group and 86 patients in the PC group. The number of groin complications remained greater in the SC group (P=.05). In-hospital mortality was comparable between groups (1% PC vs 0% SC, P=.3). The PC approach is a safe cannulation technique for patients undergoing MICS. It minimizes postoperative groin complications with no obvious negative impact on outcomes.

Femoral Artery Closure Devices vs Manual Compression During Cardiac Catheterization and Percutaneous Coronary Intervention.

Femoral arterial access remains widely used despite recent increase in radial access for cardiac catheterization and percutaneous coronary intervention (PCI). Various femoral artery closure devices have been developed and are commonly used to shorten vascular closure times, with variable rates of vascular complications observed in clinical trials. We sought to examine the rates of contemporary outcomes during diagnostic catheterization and PCI with the most common femoral artery closure devices. We identified patients who had undergone either diagnostic catheterization alone (n = 14,401) or PCI (n = 11,712) through femoral artery access in the Indiana University Health Multicenter Cardiac Cath registry. We compared outcomes according to closure type: manual compression, Angio-Seal, Perclose, or Mynx. Access complications and bleeding outcomes were measured according to National Cardiovascular Data​Registry standard definitions. The use of any vascular closure device as compared to manual femoral arterial access hold was associated with a significant reduction in vascular access complications and bleeding events in patients who underwent PCI. No significant difference in access-site complications was observed for diagnostic catheterization alone. Among closure devices, Perclose and Angio-Seal had a lower rate of hematoma than Mynx. The use of femoral artery access closure devices is associated with a reduction in vascular access complication rates as compared to manual femoral artery compression in patients who undergo PCI.

Safety and Efficacy of the CELT ACD Femoral Arteriotomy Closure Device in the Office-based Laboratory

Manual compression remains the gold standard for achieving hemostasis for percutaneous common femoral artery access. However, it requires prolonged bed rest and 20-30 minutes or more of compression for hemostasis. Current arterial closure devices have emerged in recent years, but they are still associated with significant access device complications, including hematoma, retroperitoneal bleeding, transfusion requirement, pseudoaneurysm, arteriovenous fistula, and arterial thrombosis. A novel femoral access closure device, the CELT ACD (Vasorum Ltd), has been previously shown to reduce these complication rates and allow rapid hemostasis and time to ambulation and discharge.

Percutaneous Access for Large Bore Aortic Devices: A Single-Center Experience of a Preferential Approach

Percutaneous access for endovascular abdominal and thoracic aortic interventions might offer significant benefits to patients compared with open access. Safe arterial closure has been made possible by the increasing availability of novel closures devices. We have reported our single-center experience with the preferential use of a percutaneous suture-mediated arterial closure device.

Comparison of Application Effects of Different Hemostasis Methods After Ischemic Cerebrovascular Intervention.

ObjectiveTo explore the effects of two different hemostasis methods, namely, arterial compression devices and vascular closure devices, in the ischemic cerebrovascular intervention to provide a theoretical basis for clinical selection of hemostasis methods.MethodsA total of 302 patients who underwent ischemic cerebrovascular intervention in our hospital from January 2016 to December 2020 were selected as the research subjects and randomly divided into the control group (n = 151) and the observation group (n = 151). The patients in both groups underwent cerebrovascular intervention. The patients in the control group were treated with an artery compressor for hemostasis after the operation, while those in the observation group were treated with vascular closure devices for hemostasis. The hemostatic indexes and vascular parameters at the puncture site before and after the operation were compared between the two groups. The comfort level of the patients was assessed at 6, 12, and 24 h after the operation with the Kolcaba Comfort Scale score, and the postoperative complications were recorded.ResultsThere was no significant difference in the success rate of hemostasis between the two groups (p > 0.05). The hemostatic time and immobilization time of (2.69 ± 0.62) min and (4.82 ± 0.93) h in the observation group were lower than those in the control group with (16.24 ± 3.58) min and (7.94 ± 1.86) h (p < 0.05). The differences in the minimum inner diameter of the puncture site and its nearby vessels and the peak velocity of blood flow between the two groups before and after the operation were not statistically significant within or between groups (p > 0.05). The scores of the Kolcaba comfort scale in the observation group (80.16 ± 8.49) and (93.65 ± 9.26) at 6 and 12 h, respectively, after the operation, were higher than those in the control groups (72.08 ± 7.54) and (85.49 ± 8.63) (p < 0.05). The 24 h postoperative Kolcaba comfort scale score was (97.54 ± 9.86) in the observation group and (96.82 ± 9.64) in the control group, and the difference was not statistically significant (p > 0.05). In the control group, there were 7 cases of dysuria, 12 cases of low back pain, 14 cases of sleep disorder, 20 cases of mental stress, and 5 cases of wound bleeding, and the total incidence of complications was 38.41% (58/151). In the observation group, there were 4 cases of dysuria, 8 cases of low back pain, 10 cases of sleep disorder, 14 cases of mental stress, and 3 cases of wound bleeding, and the total incidence of complications was 25.83% (39/151). The total incidence of complications in the observation group was lower than that in the control group (p < 0.05).ConclusionFor patients with ischemic cerebrovascular disease undergoing femoral artery puncture intervention, the use of vascular closure devices can stop the bleeding quickly, which can significantly shorten the bleeding time, and the postoperative braking time of patients is short, with high comfort and fewer complications.

Vascular Complications Among Patients Undergoing Trans-femoral Transcatheter Aortic Valve Implantation: Prostar vs ProGlide Parallel Technique.

Reliable femoral artery closure devices are essential for the success of trans-femoral Transcatheter Aortic Valve Implantation (TAVI) procedures. Accordingly, device choice might affect vascular complications and bleeding rates. This was a retrospective analysis, comparing vascular complication rates among patients who underwent trans-femoral TAVI with vascular access closure using either the ProGlide parallel suture or Prostar closure devices. We included 191 patients: 106 were treated with Prostar and 85 with ProGlide. The ProGlide group had higher rate of diabetes, chronic kidney disease, peripheral arterial disease, and significantly smaller femoral arteries that were treated via larger sheaths. Valve Academic Research Consortium (VARC)-2 major complications were similar between the groups. (4.7% for ProGlide vs 3.8% for Prostar, P=1), with similar incidence of closure device failure (2 vs 3, P=1). No differences were found after univariant analysis and propensity-score matching in the incidence of major and minor bleeding nor in the rate of in-hospital mortality between ProGlide and Prostar (4.7 vs 2.8%, P=.7, 1.2 vs 2.8%, P=.63, and 1.2 vs .0%, P=.45, respectively). Parallel suture technique using two ProGlide sutures showed comparable rates of vascular complications to the Prostar closure device in higher risk population of TAVI patients.

470 Percutaneous arterial closure devices and ultrasound-guided trans-femoral puncture observational investigation: insights from the PETRONIO registry

Abstract Aims To evaluate the safety of a single and combined use of ultrasound-guided femoral puncture (U) and percutaneous arterial closure devices (P) in femoral artery procedures (FAP) compared to fluoroscopic guidance (F) and manual compression (M) in a large radial-focused interventional centre. U and P, taken individually, have improved safety in femoral arterial access procedures compared to traditional techniques. Methods and results All FAP performed between July 2017 and December 2018 in our centre were divided into three phases: (i) control period with F and M mainly performed; (ii) phase out period where U and P were introduced; and (iii) intervention period where a 6-month expertise on the novel techniques was acquired. The overall population was further stratified into subgroups: F/M, U/M, F/P, and U/P. The primary study endpoint was in-hospital access site bleeding events (BE) according to the BARC criteria. The secondary endpoint was vascular site complications (VASC). 418 procedures (14%) out of 3025 were performed via FA access during the study period. The overall access-site in-hospital BE were 97 (23%). Decreasing rates of BE (phase 1: n = 46, 29%; phase 2: n = 38, 22% e phase 3: n = 13, 15%; P = 0.027) and VASC were observed during the three periods. BE occurred significantly more often in F/M group (F/M: n = 48; 32%; U/M: n = 12, 16%; F/P: n = 18, 21%; U/P: n = 19, 17%; P = 0.008). F/M subgroup was an independent predictor of BE both in multivariable analysis and propensity score matching analysis. Conclusions The introduction of ultrasound-guided femoral puncture and percutaneous arterial closure devices has reduced access site bleeding with a progressive improvement after the first 6 months learning period.

Outcomes of Same-Day Discharge with Manual Compression and 5F Sheath Compatible Devices for Lower Extremity Arterial Endovascular Treatment

For same-day discharge lower extremity arterial disease (LEAD) endovascular procedures, femoral manual compression could be an alternative to arterial closure devices. The aim of this study was to assess the security and efficacy of same-day discharge after manual compression in patients treated for LEAD endovascular revascularization with 5F sheath. FREEDOM OP was a national multicenter, prospective, single arm study. Patients with symptomatic LEAD (Rutherford 2-5) and eligible for same-day discharge were included. The primary endpoint was the total in-hospital admission rate, which includes overnight surveillance and rehospitalization rate at 1 month. Between September 2017 and August 2019, 114 patients were included. The mean age of the patients was 66 ± 10 years and most of them were claudicant (103; 94%). Mainly femoropopliteal lesions were treated (178; 70%) and the technical success was 97%. One hundred forty-two 5F stents and fifty one 5F drug coated balloon were delivered. The mean manual compression duration was 13 ± 4 min. Major access-related complications rate was 4.5%. Total in-hospital admission rate was 11%. Seven patients had overnight surveillance and 5 were rehospitalized (2 for the target lesion). No rehospitalisation was carried out within 24 hr after discharge. No major cardiovascular event, including death, was observed. The patients were significantly improved in term of clinical status (P < 0.0001) and hemodynamic (P < 0.0001) in comparison to baseline. FREEDOM OP showed that manual compression is feasible and safe for same-day discharge after LEAD revascularization with 5F sheath femoral approach.

Percutaneous artErial closure devices and ultrasound-guided Trans-femoRal puncture ObservatioNal InvestigatiOn: Insights from the PETRONIO registry.

To evaluate the safety of a single and combined use of ultrasound-guided femoral puncture (U) and percutaneous arterial closure devices (P) in femoral artery procedures (FAP) compared to fluoroscopic guidance (F) and manual compression (M) in a large radial-focused interventional centre. U and P, taken individually, have improved safety in femoral arterial access procedures compared to traditional techniques. All FAP performed between July 2017 and December 2018 in our centre were divided into three phases: (a) control period with F and M mainly performed; (b) phase out period where U and P were introduced; (c) intervention period where a 6-month expertise on the novel techniques was acquired. The overall population was further stratified into subgroups: F/M, U/M, F/P, U/P. The primary study endpoint was in-hospital access site bleeding events (BE) according to the BARC criteria. The secondary endpoint was vascular site complications (VASC). Four hundred eighteen procedures (14%) out of 3025 were performed via FA access during the study period. The overall access-site in-hospital BE were 97 (23%). Decreasing rates of BE (phase 1: n=46, 29%; phase 2: n=38, 22% e phase 3: n=13, 15%; p=0.027) and VASC were observed during the three periods. BE occurred significantly more often in F/M group (F/M: n=48; 32%; U/M: n=12, 16%; F/P: n=18, 21%; U/P: n=19, 17%; p=0.008). F/M subgroup was an independent predictor of BE both in multivariable analysis and propensity score matching analysis. The introduction of ultrasound-guided femoral puncture and percutaneous arterial closure devices has reduced access site bleedings with a progressive improvement after the first 6months learning period.

Iatrogenous puncture of the aortic arch closed with ProGlide.

An 89-year-old woman was referred to our hospital owing to syncope caused by an atrioventricular conduction disease. She presented with a past medical history of hypertension, dyslipidemia, and depression. A temporary balloon-tipped pacemaker electrode was inserted in the emergency department through the right jugular vein. Jugular catheter placement is a routine procedure. Several authors recommend the use of ultrasound guidance to avoid complications, such as arterial injury. Saugle et al1Saugle B. Scheeren T.W.L. Teboul J.L. Ultrasound-guided central venous catheter placement: a structured review and recommendations for clinical practice.Crit Care. 2017; 21: 225Crossref PubMed Scopus (135) Google Scholar reviewed the literature and described six steps to perform ultrasound-guided jugular catheter placement: identify the anatomy of the insertion site and localize the vessels, confirm the patency of the jugular vein with a compression test, use real-time ultrasound guidance for puncture of the vein, confirm needle position in the vein, confirm the wire position, and confirm the catheter position in the vein. In our case, a percutaneous echocardiography-guided puncture of the jugular vein was made; however, once the 6F sheath was placed inside, an arterial flow was obtained from the sheath; therefore, the on-call cardiologist considered it to be placed in the carotid artery. Upon examination, an abnormally oblique position of the sheath was observed in the patient's neck (A). Doppler ultrasound examination revealed no contact between the sheath and the supra-aortic trunks. Arteriography was performed through the sheath, revealing an introducer placed in the aortic arch (B and C/Cover). After a multidisciplinary consensus, owing to the patient's age and the difficulty of open sheath withdrawal, a percutaneous artery closure device was used. Under general anesthesia and controlled hypotension, the 6F sheath was removed and the aortic arch was closed with a ProGlide (Abbott Laboratories, Chicago, Ill). A computed tomography scan after the procedure revealed a hematoma at the superior mediastinum close to supra-aortic trunks without signs of bleeding (D). The patient was admitted to the coronary unit with strict control of the blood pressure. After 48 hours, a permanent pacemaker was inserted. One week later, the patient was discharged home. The patient provided consent for the publication of her case details and imaging. Inadvertent arterial puncture during central venous catheter placement is a well-known complication.2Bowdle A. Vascular complications of central venous catheter placement: evidence-based methods for prevention and treatment.J Cardiothorac Vasc Anesth. 2014; 28: 358-368Abstract Full Text Full Text PDF PubMed Scopus (70) Google Scholar In the majority of cases of misplaced jugular catheters, the carotid artery is punctured. Accidental aortic arch puncture is a rare complication and its treatment includes open surgery with median sternotomy.3Sellem M.I. Al-Hashemy A.A. Al-Naemi A. Ectopic intra-aortic insertion of a subclavian central venous catheter: case report and review of the literature.J Thorac Cardiovasc Surg. 2004; 127: 1515-1516Abstract Full Text Full Text PDF PubMed Scopus (5) Google Scholar Since the advent of percutaneous closures, some authors have described their use in the management of accidental artery puncture.4Pikwer A. Acosta S. Kölbel T. Malina M. Sonesson B. Akeson J. Management of inadvertent arterial catheterisation associated with central venous access procedures.Eur J Vasc Endovasc Surg. 2009; 38: 707-714Abstract Full Text Full Text PDF PubMed Scopus (53) Google Scholar We found one case in the literature where an aortic arch puncture was treated with a percutaneous closure. In this case, the puncture of the aorta was done during subclavian catheter placement and they used Angio-Seal Vascular Closure Device (St Jude Medical, Saint Paul, Minn).5Leijdekkers V.J. Go H.L.S. Legemate D.A. Reekers J.A. The use of percutaneous closure device for closure of an accidental puncture of the aortic arch; a simple solution for a difficult problem.Eur J Vasc Endovasc Surg. 2006; 32: 94-96Abstract Full Text Full Text PDF PubMed Scopus (7) Google Scholar In our case, there was no option for open repair owing to patients comorbidities. We preferred to use a suture-mediated closure system (ProGlide) because we have experience using this system in peripheral arteries. This case highlights that complications may occur and, even though there is no indication for the use of the ProGlide system in aortic puncture, we have to be able to individualize the treatment plan for this patients without other available options. The authors thank Dr Bernat Lloret Villas for his expertise and assistance with patient management.

4:21 PM Abstract No. 51 Safety and efficacy of arterial closure devices following antegrade femoral access: a case-control study

Vascular closure device (VCD) use following antegrade femoral access is not indicated by the Food and Drug Administration, and may present unique anatomic challenges relative to retrograde access. We compared safety and efficacy of three devices between antegrade and retrograde access cohorts undergoing percutaneous intervention. A consecutive series of 107 limbs in 84 patients underwent VCD arteriotomy closure following percutaneous revascularization using an antegrade approach (VCD-A). These were compared with a contemporaneous control group of 402 limbs in 306 patients who underwent closure following retrograde access (VCD-R) (n = 509) during revascularization and/or embolization procedures. Device deployment success, patient time to ambulation, and major/minor complications were compared between the two groups. Antegrade closure was attempted in the VCD-A cohort using 53 StarClose (Abbott, Santa Clara, CA), 35 Perclose (Abbott), and 19 Angio-Seal (Terumo, Somerset, NJ) devices. Hemostasis (without supplemental manual compression) was achieved in 86/107 (80.4%) limbs. In the VCD-R group, closure was attempted using 215 StarClose, 120 Perclose, and 67 Angio-Seal devices, with hemostasis achieved in 357/402 (88.8%) limbs without supplemental manual compression. Device deployment failure occurred in 7/107 (6.5%) of VCD-A patients and 20/402 (5.0%) of VCD-R patients (P = 0.48). Femoral pseudoaneurysm developed in 1/107 and 1/402 of VCD-A and VCD-R patients (P = 0.38). Major hematoma requiring further intervention developed in 1/107 and 1/402 of VCD-A and VCD-R patients (P = 0.38), and minor hematoma not requiring further intervention developed in 3/107 and 8/402 of the VCD-A and VCD-R (P = 0.71). Mean time to ambulation was 204.1 minutes in the VCD-A group and 204.8 minutes in VCD-R (P = 0.97). In both VCD-R and VCD-A groups, the StarClose, Perclose, and Angio-Seal devices were associated with similar rates of deployment failure (P = 0.080; P = 0.67). Antegrade femoral closure among the studied devices was associated with high rates of technical success and low complications, similar to retrograde closure. Time to ambulation was similar among VCD-A and VCD-R groups.Tabled 1ComplicationVCD-R (n = 402)VCD-A (n = 107)PDevice failure2070.48Pseudoaneurysm110.38Major hematoma110.38Minor hematoma830.71Supplemental manual compression25140.030 Open table in a new tab

Contemporary Use and Outcomes of Arterial Closure Devices After Percutaneous Coronary Intervention: Insights From the Veterans Affairs Clinical Assessment, Reporting, and Tracking Program.

BackgroundArterial closure devices reduce the length of bedrest after invasive cardiac procedures via the femoral approach, but there are conflicting data on their association with major bleeding and vascular complications. We thus sought to evaluate the contemporary use of femoral arterial closure devices and their association with major bleeding among patients undergoing percutaneous coronary intervention.Methods and ResultsWe identified patients undergoing percutaneous intervention via the femoral approach within the Veterans Affairs Healthcare System from December 2004 through September 2018. The association between arterial closure device use and major bleeding was evaluated using both propensity matching and instrumental variable analyses, incorporating contrast‐induced nephropathy as a falsification end point. We identified 132 373 percutaneous coronary interventions performed by 681 operators, with closure device use increasing 1.2% each year (linear trend P<0.001). In a propensity‐matched cohort, closure devices were associated with a 1.1% reduction in periprocedural bleeding (95% CI, −1.5% to −0.6%). Closure devices were also associated with a numerical decrease in contrast‐inducted nephropathy that did not reach statistical significance (−0.6%; 95% CI, −1.3% to 0.1%). In an instrumental variable analysis of closure device use, there was no difference in the bleeding rate between those who received a closure device and those who did not (0.2%; 95% CI, −0.9% to 1.2%).ConclusionsArterial closure devices are associated with a reduction in major bleeding within a propensity‐matched cohort. This association dissipates in an instrumental variable analysis, highlighting some of the methodologic limitations of comparative effectiveness research in observational analyses.

Antegrade Common Femoral Artery Closure Device Use Is Safe and Associated With Decreased Complications

Antegrade access (AA) of the common femoral artery is often used for ipsilateral infrainguinal peripheral vascular intervention. However, the use of closure devices (CDs) for AA is still considered outside the instructions for use. We hypothesized that CD use for AA would not be associated with an increased odds of access site complications. The Vascular Quality Initiative was examined from 2010 to 2019 for infrainguinal peripheral vascular interventions with common femoral artery AA. Patients who had a cutdown or multiple access sites were excluded. Cases were then stratified into whether a CD was used or not. Hierarchical multivariable logistic regressions controlling for hospital-level variation were used to examine the independent association between CD use and access site complications while controlling for confounders meeting < .01 on univariate analyses for the outcome. A sensitivity analysis using coarsened exact matching was performed using factors different between treatment groups to reduce residual confounding. Overall, 11,562 cases were identified, and 5693 (49.2%) used a CD. Patients treated with a CD were less likely to be white (74.1% vs 75.2%), to have coronary artery disease (29.7% vs 33.4%), to use aspirin (68.7% vs 72.4%), and to be reversed with protamine (15.5% vs 25.6%; all P < .05). CD patients were more likely to be obese (31.6% vs 27.0%) and to have an elective operation (82.6% vs 80.1%), ultrasound-guided access (75.5% vs 60.6%), and larger access sheath (6.0F ± 1.0F vs 5.5F ± 1.0F; P < .05 for all). CD cases were less likely to develop any access site hematoma (2.55% vs 3.53%; P < .01) or a hematoma requiring reintervention (0.63% vs 1.26%; P < .01) and had no difference in access site stenosis or occlusion (0.30% vs 0.22%; P = .47) compared with no CD. On multivariable adjusted analysis, CD cases had significantly decreased odds for development of any access site hematoma (odds ratio, 0.75; 95% confidence interval, 0.59-0.95) and a hematoma requiring intervention (odds ratio, 0.56; 95% confidence interval, 0.38-0.81; Table I). A sensitivity analysis after coarsened exact matching confirmed these findings (Table II). In this nationally representative sample, CDs placed outside instructions for use for AA were safe and associated with lower odds of hematoma. CDs for AA may improve AA outcomes with a potential to decrease health care utilization associated with sheath removal.Table IUnmatched multivariable analysis of access complications comparing the use of closure devices (CDs)ComplicationOR95% CIP valueAny hematomaa0.750.59-0.95.02Hematoma requiring interventionb0.560.38-0.81<.01Stenosis or occlusionc1.430.60-3.39.41CI, Confidence interval; OR, odds ratio.Boldface entries indicate statistical significance (P < .05).aAdjusted for age, sex, elective operation, volume of contrast material used, history of diabetes, prior major amputation, prior inflow stent or angioplasty, and prior infrainguinal bypass.bAdjusted for age, sex, elective operation, congestive heart failure, and prior infrainguinal bypass.cAdjusted for elective operation and history of coronary artery bypass graft or percutaneous coronary intervention. Open table in a new tab Table IIMatcheda multivariable analysesComplicationOR95% CIP valueAny hematomab0.740.54-1.00.05Hematoma requiring interventionc0.540.29-0.99.05Stenosis or occlusiond0.970.28-3.42.96CI, Confidence interval; OR, odds ratio.aMatched for white, obese, coronary artery disease, congestive heart failure, aspirin use, history of coronary artery bypass graft or percutaneous coronary intervention, prior major amputation, prior inflow stent or angioplasty, prior infrainguinal bypass, elective operation, ultrasound-guided access, largest access sheath used, and heparin reversal with protamine.bAdjusted for age, sex, elective operation, volume of contrast material used, history of diabetes, prior major amputation, prior inflow stent or angioplasty, and prior infrainguinal bypass.cAdjusted for age, sex, elective operation, congestive heart failure, and prior infrainguinal bypass.dAdjusted for elective operation and history of coronary artery bypass graft or percutaneous coronary intervention. Open table in a new tab

An update on the use of an arterial closure device following femoral arterial puncture in children.

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. To retrospectively evaluate the safety and efficacy of the Angio-Seal in a pediatric population. 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. During the study period, 48 additional Angio-Seal devices were deployed in 41 consecutive patients. Five patients were excluded for being older than 18years. The mean age of the patients was 13.3years (range: 4-18years) with 18 patients female. The mean common femoral artery diameter was 5.98mm in short axis diameter (range: 4-9mm). 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. 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.