Suture-mediated Closure Device Research Articles

Diagnostic Value of Femoral Vein Flow Pattern for Detecting Incidental Valve Ligation by Suture-Mediated Closure Device.

Diagnostic Value of Femoral Vein Flow Pattern for Detecting Incidental Valve Ligation by Suture-Mediated Closure Device.

Single suture-mediated closure system after transfemoral transcatheter aortic valve implantation: A single-center real-world experience.

Despite the use of two crossed Perclose ProGlide™ (Abbott Vascular Devices) is the most widespread technique to close the main arterial access in transfemoral transcatheter aortic valve implantation (TF-TAVI), the safest and most effective strategy still remains much debated. The aim of the present study was to evaluate the performance of a single Perclose ProGlide suture-mediated closure device to obtain femoral hemostasis after sheathless implantation of self-expanding transcatheter heart valves through their 14 F-equivalent fix delivery systems. This prospective observational study included 439 patients undergoing TF-TAVI at the "Montevergine" Clinic of Mercogliano, Italy. All patients underwent hemostasis of the large-bore access using a single Perclose ProGlide with preclose technique, after sheathless implantation of self-expanding transcatheter heart valves through 14 F-equivalent fix delivery systems. A multidetector computed tomography analysis of size, tortuosity, atherosclerotic, and calcification burdens of the ilio-femoral access route was made by a dedicated corelab. Vascular complications (VCs), percutaneous closure device (PCD) failure, and bleedings were adjudicated by a clinical events committee. A total of 81 different VCs were observed in 60 patients (13.7%); among these, 41 (5% of patients) were categorized as major. PCD failure occurred in 14 patients (3.2%). At the logistic regression analysis, no predictors of PCD failure have been identified. This registry suggests that the use of a single suture-mediated closure device could be considered a safe and efficient technique to achieve access site hemostasis in patients undergoing TF-TAVI through 14 F-equivalent fix delivery systems.

Ultrasound-guided deployment of ProGlide™ device in transfemoral transcatheter aortic valve implantation and risk reduction of vascular complications: A propensity-matched cohort study.

ProGlide is a percutaneous suture-mediated closure device used in arterial and venous closure following percutaneous intervention. Risk of vascular complications from use, particularly related to failure in hemostasis, or acute vessel closure, remains significant and often related to improper suture deployment. We describe a technique of ultrasound-guided ProGlide deployment in transfemoral transcatheter aortic valve implantation (TF-TAVI). The aim of this study is to assess vascular outcomes for ultrasound-guided deployment of ProGlide vascular closure devices in patients undergoing TF-TAVI. We collected relevant clinical data of patients undergoing TAVI in a large volume centre. main access Valve Academic Research Consortium 3 (VARC-3) major vascular complication. any major/minor VARC-3 vascular complication, its type (bleed or ischemia), and treatment required (medical, percutaneous, or surgical). We performed inverse weighting propensity score analysis to compare the population undergoing ultrasound-guided versus conventional ProGlide deployment for main TAVI access. Ultrasound technique for ProGlide insertion was performed as described below. Five hundred and seventeen patients undergoing TF-TAVI were included. In 126 (ultrasound-guided) and 391 (conventional ProGlide insertion), 0% versus 1.8% (p < 0.001) had a major VARC-3 vascular complication, respectively. 0.8% (one minor VARC-3 bleed) vs 4.1% (13 bleeds and three occlusions) had any VARC-3 vascular complication (major and minor) (p < 0.001). Surgical treatment of vascular complication was required in 0.8% versus 1.3% (p = NS). Ultrasound-guided deployment of ProGlide for vascular closure reduced the risk of major vascular complications in a large population undergoing TAVI.

Safety of multi-access site venous closure following catheter ablation of atrial fibrillation and flutter.

Following catheter ablation, vascular access management involves potential complications and prolonged recovery. Recently, suture-mediated closure (SMC) devices were approved for venous access procedures. The objective of this study is to evaluate the safety of a commercially available SMC for multiple access site venous closure by duplex ultrasound (DUS) in asymptomatic subjects with non-visible complications. Thirty-six subjects (63 ± 10.7years old, 12 female) were enrolled. Following catheter ablation for atrial fibrillation, all subjects had SMC of every venous access site. Subjects underwent DUS of femoral veins and arteries. DUS was performed at discharge, and again at 30days. Subjects were evaluated for clinically apparent vascular complications. Mean procedure duration was 138.6min, and the time to hemostasis was 3.1min/access site and 9.5min/subject. Median time to ambulation was 193.5min, and median time to discharge was 5.95h, with discharge as early as 2.4h. A median of 2 sheaths/vein and a median of 2 SMC devices/vein were used. There were no major complications and a 16.7% (6/36) minor complication rate at discharge. All complications resolved at 30days. The complication rate was not higher in patients with 2 SMC per access site as compared to the patients who just received 1 SMC per access site. This study demonstrates the safety of multi-access closure using SMC, following catheter ablation procedures, for closure of sites that use sheath sizes from ≤ 8F to ≥ 15F and for those that use 2 or more SMCs per access site.

Transaneurysmal Access with Suture-Mediated Closure Device to Treat Iatrogenic Common Femoral Artery Pseudoaneurysm under Ultrasound Guidance: A Novel Technique

AbstractWe describe three cases that were complicated by access site-related common femoral artery pseudoaneurysm following therapeutic endovascular procedures. In all the cases, presentation was with painful swelling in the right groin that was tender and pulsatile on palpation; further evaluation with color Doppler ultrasound revealed pseudoaneurysm at the access site in common femoral artery. Ultrasound-guided transaneurysmal access was obtained and ProStyle (Abbott Vascular, Redwood City, California, United States) suture-mediated device was used to treat the pseudoaneurysm safely and successfully.

Real-time ultrasound-guided hemostasis using suture-mediated closure device.

Suture-mediated hemostasis device takes a long time to train and have limitations in finding appropriate compression point depending on the tactile sense of the hands. If the appropriate compression point is determined using ultrasound and the instrument is used under ultrasound guidance, it is expected to reduce the technical failure and additional manual compression. This retrospective study included 104 patients in whom the ProGlide vascular closure device (Abbott Vascular, Redwood City, CA, USA) was deployed to close common femoral artery access between January 2022 and June 2022. Ultrasound-guided hemostasis was performed in 54 patients and 50 conventional hemostasis was performed. We analyzed the medical records (procedure, patient body mass index, coagulation function, visual imaging, ultrasound imaging, time to achieve hemostasis) and post-treatment medical records (progress records, nursing records) to investigate the technical success rate and complications (hematoma, pseudoaneurysm formation, SFA occlusion, access site infection) of the procedure. Technical success rate was 52/54 (Ultrasound guided group) and 47/50 (conventional group), respectively (p > 0.05). Mean hemostasis time was 271 s (US guided group) and 317 s (conventional group), respectively (p > 0.05). Additional manual compression was applied in 7/54 (US guided group) and 15/50 (conventional group) (p < 0.05). In both groups, complications such as hematoma formation, access site infection and SFA occlusion did not occur. Using ultrasound guidance when using the suture mediated closing device reduces the frequency of additional manual compression without increased risk of complication.

Abstract 17847: Typical Right Atrial Flutter Ablation Using Subclavian Venous Access in Patients With Interrupted or Occluded Inferior Vena Cava

Introduction: Ablation for typical atrial flutter (AFL) traditionally involves vascular access from the femoral vein to facilitate advancing catheters through the Inferior Vena Cava (IVC) to the right atrium (RA). In patients with interrupted or occluded IVC, this procedure is challenging to perform. We report a case series of typical right AFL ablation using subclavian access in interrupted or occluded IVC. Cases: A 63-year-old female with typical AFL refractory to medical therapy was referred for radiofrequency ablation (RFA). She had a history of surgically corrected atrial septal defect at age 4 years with known IVC interruption draining into RA via an azygous venous extension. Another case involved a 41-year-old male with quadriplegia and typical AFL who underwent an attempted RFA from femoral access that was aborted due to massive thrombosis of IVC. Decision making: In both cases, two sheaths were placed into the left subclavian venous system using ultrasound guidance. A coronary sinus catheter and irrigated tip ablation catheter were advanced into the coronary sinus and RA respectively. Additionally, in the second case, an intracardiac echocardiography probe was inserted via separate venous access. Using the electroanatomic mapping system, entrainment and activation mapping confirmed a tricuspid isthmus-dependent AFL. RFA was performed using an open irrigated RFA catheter in a linear fashion resulting in the termination of the tachycardia to sinus rhythm. In the first case, ablation extended from the tricuspid annulus to the os of the hepatic vein at the 06:00 position. Post ablation, hemostasis was achieved using a suture-mediated closure device. At follow-up, both patients were asymptomatic without evidence of AFL on extended-duration cardiac monitoring. Conclusion: In patients with interrupted or occluded IVC, the subclavian veins can be accessed for mapping and ablation of typical AFL when traditional femoral venous access is challenging.

Comparison of Figure-of-Eight Suture and Perclose ProGlide Suture-Mediated Closure in Large Bore Venous Access Hemostasis: A Randomized Controlled Trial

Suture-mediated closure device and Figure-of-Eight suture are commonly used to achieve hemostasis after use of large bore venous access. Although both methods of closure are commonly used in clinical practice, a head-to-head comparison in a controlled setting has not been performed. Patients presenting to a single center for elective left atrial appendage occlusion or transcatheter edge-to-edge mitral valve repair were randomized to large bore venous closure using the Perclose ProGlide suture-based closure or a Figure-of-Eight suture closure. The patients were followed for 1month after the procedure. Primary outcome, a composite of access site large ecchymosis, hematoma, infection, pain, need for unscheduled venous ultrasound and need for transfusion, was compared between the 2 arms. A total of 40 patients were randomized in a 1:1 fashion to the 2 venous closure strategies. Baseline characteristics were similar between the 2 groups. Perclose ProGlide arm required use of more devices for hemostasis (1.5 ± 0.5 vs 1 ± 0 respectively, p <0.0001), and there was a significant difference in the cost of closure device ($367.00 ± 122.00 vs $1.00 ± 0 respectively, p <0.001). At 1month post-procedure, the primary outcome occurred in 4 patients (20%) in the Perclose arm and 7 (35%) patients in the Figure-of-Eight arm, a difference that was not statistically significant (p=0.48). Time to hemostasis between Figure-of-Eight and Perclose arms did not reach statistical significance (2.5 ± 2.1 vs 3.7 ± 2.3, p=0.09). In conclusion, both Perclose ProGlide suture-based device and Figure-of-Eight closure are equally feasible and safe for patients who underwent large bore venous access. Figure-of-Eight-based closure is more cost effective.

Analysis of Determinants for Suture-mediated Closure Device Failure During EVAR Procedures.

Endovascular aortic repair (EVAR) for elective and emergency infrarenal aortic pathologies is the primary approach for treatment nowadays. During such procedure, the suture-mediated closure device (SMCD) (Perclose ProGlideTM, Abbott Laboratories, Chicago, IL, USA) is commonly used. This study aimed to identify potential contributors for SMCD failure in a patient cohort of elective and emergency EVAR. Archived medical records from patients who underwent EVAR for aortic pathologies in elective and emergency setting at the University Hospital Düsseldorf, Germany were included. Patient's co-morbidities, access vessel morphologies and hemostasis-related blood parameters were evaluated on their association with SMCD failure applying different statistical methods. A total of 71 patients (139 femoral accesses) was included. The mean age was 73.5 ± 8.4years. Overall SMCD failure rate was 4.3%, 4.1% for elective and 5.9% for emergency cases, respectively. Total procedure time was longer for the SMCD failure group (323 ± 117.8min vs 171 ± 43.7min). The calcification status of the common femoral artery (CFA), the diameter of the aortic bifurcation, and dual anti-platelet therapy (DAPT) on the medication plan prior to the procedure were associated with SMCD failure. Univariate binary logistic regression analysis nominated several potentially relevant predictors for SMCD failure who underwent subsequent multivariable binary logistic regression analysis. Here, DAPT on the medication plan was identified as being promising in predicting SMCD failure (OR 30.5), while anterior plaque formation in the CFA maintained as only statistically relevant determinant (OR 44.9). This study confirms the CFA calcification status to be associated with SMCD failure. Although discontinued prior to endovascular treatment, DAPT was also found to be associated with SMCD failure. Our results may advocate to perform obligatory platelet testing prior to EVAR to maximize patient safety.

Suture-mediated closure devices for percutaneous endovascular abdominal aneurysm repair.

Endovascular procedures such as endovascular aneurysm repair or transcatheter aortic valve implantation have become very common because of reduced patient traumatisation and the ability to use shorter or local anaesthesia. In these procedures large-bore sheath devices are used. Access with percutaneous closure is an alternative method to surgical cutdown in groins. The aim of the study was to assess the correlation between sheath size and unsuccessful haemostasis. In addition, the effectiveness of haemostasis after a percutaneous procedure and the number and type of complications were evaluated. There were 202 patients included in the study. Patients with abdominal aortic aneurysm were qualified to percutaneous aortic stentgraft implantation with Perclose Proglide preclosure technique. There were 384 access sites performed with 12F to 22F sheaths during aortic stentgraft implantation with Perclose Proglide (Abbott Vascular, Santa Clara, CA, USA) preclosure technique. High effectiveness of haemostasis (98%), low percentage of short- and mid-term complications (2.6%), and infinitesimal number of surgical conversions (n = 5) were stated in the study. There was no correlation between diameter of used introducer sheath and lack of haemostasis observed (Fisher-Freeman-Halton test; p = 0.122). No relationship between diameter of introducer sheath and number of closure devices was observed (c2 = 2.436; df = 5; p = 0.786). Large-bore device percutaneous procedures with closure devices are effective and safe. High effectiveness of haemostasis (98%) was observed in the study group, with a low percentage of complications (2.6%). There was no correlation between size of the vascular access and the lack of haemostasis found in the study.

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 Approach in Endovascular Aortic Procedures Using a Suture-Mediated Closure Device.

The purpose of this study is to assess the efficacy of a suture-mediated closure device during percutaneous endovascular aortic repair. A single-center, retrospective analysis of patients undergoing endovascular repair for infrarenal, thoracic and thoracoabdominal aortic aneurysms and aortic dissections via percutaneous femoral access between April 2017 and June 2021 was performed. The primary endpoint of the study was the efficacy and technical success of the Perclose ProGlide closure device during percutaneous endovascular procedures. The secondary endpoints were intraoperative and postoperative inguinal and vascular complications during and after device use. A total of 376 punctures were performed in 263 patients with the deployment of the ProGlide vascular closure system. Twenty-two cases involved percutaneous re-puncture as part of a staged procedure. The primary and secondary technical success rates were 93.1% (350/376) and 94.7% (356/376), respectively. In 20 patients (5.3%), intraoperative femoral exposure due to complications was required. Postoperative complications occurred in 13 cases (3.5%), 2 of which required surgical reintervention. There was no statistical significance between the type of endovascular procedure and primary technical success (p = 0.56). The introduction of larger-diameter sheaths was not associated with increased intraoperative and postoperative complication rates (p = 0.75 and p = 0.78, respectively). Percutaneous re-puncture of the vascular access site did not result in a lower overall technical success rate (20/22, 90.9% primary technical success rate, p = 0.67; 21/22, 95.5% secondary technical success rate, p = 0.86) or an increased number of perioperative complications (1/22, 4.5% intraoperative complications, p = 0.86; 2/22, 9.1% postoperative complications, p = 0.13). The application of the ProGlide closure system is a safe and efficient method to achieve hemostasis during percutaneous endovascular aortic repair. Complex aortic pathologies, which often require a staged approach with re-puncture, can also be successfully treated with this closure system.

Manual Compression versus Suture-Mediated Closure Device Technique for VA-ECMO Decannulation.

Background The impact of devices for vessel closure on the safety and efficacy of cannula removal in VA-ECMO patients is unknown. Methods We retrospectively analyzed 180 consecutive patients weaned from VA-ECMO after cardiac arrest or cardiogenic shock from January 2012 to June 2020. In the first period (historical technique group), from January 2012 to December 2018, primary decannulation strategy was manual compression. In the second period (current technique group), from January 2019 to June 2020, decannulation was performed either by a conventional approach with manual compression or by a suture-mediated closure device technique. Results A femoral compression system was necessary in 71% of patients in the historical group compared to 39% in the current technique group (p < 0.01). Vascular surgery was performed in 12% in the historical cohort and 2% in the current technique cohort, which indicated a clear trend, albeit it did not reach significance (p = 0.07). Conclusion We illustrated that a suture-mediated closure device technique for VA-ECMO decannulation was feasible, safe, and may have reduced the need of surgical interventions compared to manual compression alone.

Feasibility and clinical efficacy of double suture-mediated closure device technique for hemostasis during positioning of miniaturized wireless pacemaker.

The miniaturized transcatheter pacing system (TPS) implant is performed using a 27 Fr sheath. Achieving femoral vein access hemostasis after sheath removal is of utmost importance. Feasibility and clinical effectiveness of double device-based suture-mediated closure technique (DualPerclose) were evaluated. Patients undergoing TPS positioning and treated with DualPerclose technique at our institution were considered. Feasibility of the DualPerclose technique included the rates of effective initial device suture fixation and effective hemostasis after sheath removal. Clinical efficacy considered intraprocedural and periprocedural bleeding events as well as midterm access site vascular injury assessed at 3months using lower limb vascular ultrasonography. Data on all follow-up major adverse events were also collected. All patients (n = 83 patients; mean age 82.3 ± 7.1years, 67.5% male gender, 85.5%, with structural heart disease, mean left ventricular ejection fraction 54.0 ± 9.6%, renal impairment in 31.3%) who underwent TPS positioning between November 2015 and February 2020 were considered. TPS positioning was successful in all patients. In 82 patients, the DualPerclose approach was utilized: 13 patients (15.8%) required > 2 devices to obtain effective fixing of 2 sutures; complete immediate hemostasis was achieved in 80 patients (97.6%). One (1.2%) severe groin-related bleeding event occurred. At midterm, 1 (1.2%) mildly symptomatic arteriovenous fistula was diagnosed (conservative treatment). Over a median follow-up of 22 (IQR 10-35.5) months, 14 (17.1%) major adverse events were recorded, including 1 loss of capture requiring TPS replacement and 5 deaths. Femoral vein access closure using dual Perclose Proglide devices during TPS is feasible and clinically effective.

Use of Suture-Mediated Closure Devices for Closure of Punctures in Prosthetic Patches or Grafts is Associated With High Rates of Technical Success and Low Complication Rates.

Despite the increasing use of endovascular techniques in the management of peripheral vascular disease, there is little data on the safety of percutaneous closure devices in punctures of synthetic vascular material. Our paper sought to address this paucity in the literature by reviewing the incidence of complications occurring in patients in whom the ProGlide device was utilised to achieve haemostasis post-percutaneous puncture of vascular patches and graft materials. A retrospective review of patient records was conducted at a tertiary referral centre. Patients who had undergone percutaneous punctures of prosthetic bypass grafts or patch angioplasties between January 2011 and December 2020 were identified from a prospectively collected database. Medical records and post-procedural imaging were reviewed to assess the occurrence of post-procedural complications such as pseudoaneurysms, puncture site stenosis and further interventions for access complications. A total of 73 punctures of prosthetic material were performed in 42 patients, of which 39 utilised ProGlides. Median age of included patients was 72years. There was male predominance in the cohort (69.8%), and most punctures (87.3%) were through polyurethane patches. Device success rate was 95%, and no patients required open repair. There was a low incidence of complications, with no patients developing pseudoaneurysms, arteriovenous fistulas, ischaemic limbs or > 50% stenosis when either manual pressure or the ProGlide device was used to achieve haemostasis. Furthermore, there were no returns to theatre or further interventions performed for access site complications. The use of the ProGlide closure device has a low incidence of complications and its safety appears to be equivalent to manual compression when used to achieve haemostasis in percutaneous punctures of synthetic vascular material in select patients. To our knowledge, this is the only article to date to assess the safety of the ProGlide in this setting.

Percutaneous transaxillary access for endovascular aortic procedures in the multicenter international PAXA registry

BackgroundThe aim of the study was to demonstrate the safety and effectiveness of a suture-mediated vascular closure device to perform hemostasis after an axillary artery access during endovascular procedures on the aortic valve, the aorta and its side branches. MethodsA physician-initiated, international, multicenter, retrospective registry was designed to evaluate the success rate (VARC-2 reporting standards) of percutaneous transaxillary access closure with a suture-mediated closure device. Secondary end points were minor access vascular complications, transient peripheral nerve injury, stroke, and influence on periprocedural outcomes of puncture technique. ResultsThree hundred thirty-one patients (median age, 76 years; 69.2% males) in 11 centers received a percutaneous transaxillary access during endovascular cardiac (n = 166) or vascular (n = 165) procedures. The closure success rate was 84.6%, with 5 open conversions (1.5%), 45 adjunctive endovascular procedures (13.6%), and 1 nerve injury (0.3%). Secondary closure success was obtained in 325 patients (98%) after 7 bare stenting, 37 covered stenting, and 1 thrombin injection. Introducer sheaths 16F or larger (odds ratio, 3.70; 95% confidence interval, 1.22-11.42) and balloon-assisted hemostasis (odds ratio, 4.45; 95% confidence interval, 1.27-15.68) were associated with closure failure. A threshold of five percutaneous axillary accesses was associated with decreased rates of open conversion, but not with increased primary closure success. Primary closure success was 90.3% in the 175 patients with sheaths smaller than 16F, performed after the first 5 procedures in each center. Temporary nerve injury and stroke were observed in 2% and 4% of patients, respectively. ConclusionsPercutaneous transaxillary aortic procedures, in selected patients, can be performed with low rates of open conversion. The need for additional endovascular bailout procedures is not negligible when introducers sheaths 16F or larger are required.

The Effect of Suture-Mediated Closure Device on Hemostasis in Patients after Transfemoral Cardiac Procedures - an Evidence-Based Practice

Patients who used manual compression after transfemoral cardiac procedures could suffer from several problems. The suture-mediated closure device may be proven as an effective alternative, offering earlier sheath removal, and potentially a reduction in vascular complications. The aim of this study was to discover empirical bases and clinical application of suture-mediated closure devices on hemostasis in patients after transfemoral cardiac procedures. This study was applied on evidence-based practice in the clinical setting. The search process for evidence-based practices used 3 databases such as MEDLINE, PubMed, and Web of Science, obtaining 14 studies published between 2000 and 2016. The studies selected were assessed by two reviewers for their methodological quality and level of evidence prior to inclusion in the review. Research subjects were patients at the age of ≥ 20 years old who suffered from coronary artery disease and required transfemoral cardiac procedures. This study was implemented in a Medical Intensive Care Unit, Changhua Christian Hospital. The hemostasis status was evaluated based on two categories of, bleeding or not bleeding. Six patients were included in this study. Most of the patients were male with average age of 69.33 ± 11.70 years old. Hypertension, diabetes mellitus, and hyperlipidemia were their common history of diseases. Based on the evaluation outcome, five patients showed hemostasis status and only one patient had bleeding after the compression procedures. This study concludes that the suture-mediated closure device is effective for patients after transfemoral cardiac procedures to reach hemostasis status quickly based on clinical evaluation.

Successful treatment of a femoral pseudoaneurysm by ultrasonographically‐guided application of a suture‐mediated closure device

We treated successfully a man with a femoral artery pseudoaneurysm by ultrasonography-guided application of a suture-mediated closure device. Radiography was not needed, as a guide wire was placed into the femoral artery along the rupture under ultrasonographic guidance alone, and the femoral artery was then sutured with the vascular closure device. The pseudoaneurysm was then completely resolved. This novel approach, which minimizes risks and costs, may be a safe and acceptable option to control iatrogenic pseudoaneurysms, especially when thrombin injection is not feasible.

Clinical efficacy and safety of the PRO-glide device as a sUture-mediated ClosurE in Thoracic EndoVascular Aortic Repair in patients with previous groin intervention (from the PRODUCE-TEVAR Trial).

While the percutaneous approach is increasingly preferred, suture-mediated closure devices have been put into clinical practice to close the femoral artery during procedures requiring a large-sized introducer. However, scar in the groin is considered a contraindication or an exclusion criterion for percutaneous procedures. The aim of our study was to investigate the outcomes and safety of Pro-Glide device as suture-mediated closure device in patients who underwent thoracic endovascular aortic repair with percutaneous femoral access ≥22 F who had previous groin intervention. A total of 73 patients who underwent endovascular repair with percutaneous femoral access were retrospectively included in the study. Previous groin intervention was defined as history of open surgical access or large sheath insertion (>18 F) to femoral artery because of endovascular or valvular intervention. Patients were divided into two groups as who had previous groin intervention PGI (+) and had not PGI (-). A total of 73 patients [60 male (82.2%)] were included in the study. Seventeen patients had PGI, and 56 did not. When groups were compared in terms of sheath sizes, a significantly higher sheath sizes were used in PGI (+) patients (24.5 ± 1.1 F vs. 23.8 ± 0.9 F, p = 0.005). The overall success rate in the femoral approach with pre-close technique was statistically insignificant between two groups (94.1% vs. 96.4%, p = 0.55). One patient in PGI (+) group and two patients in PGI (-) had technical failure for percutaneous femoral approach. One patient (5.9%) in PGI (+) group and one patient (1.8%) in PGI (-) group had femoral complications after the procedures; however, there was no significant difference between the groups in terms of complications (5.9% vs. 1.8%, p = 0.13). Pro-Glide device may be a safe and less invasive method for femoral access in patients with PGI and might not be considered as a contraindication for patients with history of PGI.

Ultrasound-Guided Percutaneous Arterial Puncture and Closure Device Training in a Pulsatile Model

The current study assesses the feasibility of in vitro practice of percutaneous puncture techniques in a pulsatile flow-model. Prospective, controlled, randomized study. The percutaneous access to endovascular aortic repair is considered safe, but success rates may be dependent on surgeon experience with the technique. Fourteen vascular surgery trainees and consultants were enrolled and randomized to a study or control group with both groups receiving instructions by a tutor on how to perform ultrasound guided percutaneous puncture and closure using a suture-mediated closure device. The study group received additional hands-on training on a pulsatile flowmodel of the groin and the performance of both groups was then graded. Study group participants were timed during and after their training on the model. The study group achieved higher overall grading than the control group on a 5-point scale with higher scores indicating a better performance (mean overall scores 4.0 ± 0.7 versus 2.8 ± 1.0, respectively; p = 0.03). Experienced participants (more than 20 punctures performed before the study) achieved higher overall scores than trainees (3.8 ± 0.4 versus 2.5 ± 0.8, respectively; p = 0.01). Five participants in the study group could deploy and close the ProGlide closure device correctly without the help of a tutor while being graded (71% in the study versus 0% in the control group; p = 0.02). Study group participants improved their overall score from 3.2 ± 0.9 to 4.0 ± 0.7 during training (p = 0.02). Time needed to complete the puncture and closure reduced from 456 seconds on average before, to 302 seconds after training (p < 0.001). Study group participants could improve their overall score while working on the simulator. More experienced participants performed better during the simulation, which may indicate the model to be life-like and a potential skills assessment tool. Simulation training may be a valuable adjunct to traditional forms of training when teaching an endovascular technique but is limited by its reliance on simulators and demo devices.