Suture-mediated Closure Research Articles

Efficacy and safety of percutaneous post-closure technique during the decannulation for veno-arterial extracorporeal membrane oxygenation.

In recent years, during the decannulation process for veno-arterial extracorporeal membrane oxygenation (VA-ECMO), methods for suturing the femoral artery have included the pre- and post-closure techniques. The safety and efficacy of the pre-closure technique are widely recognised; however, reports on the post-closure technique are scarce. This study aimed to evaluate the safety and efficacy of the post-closure technique using ProGlide (Abbott Healthcare, Green Oaks, IL, USA) device during VA-ECMO decannulation. We reviewed 170 patients who underwent VA-ECMO between January 2021 and June 2023. All patients had their femoral artery puncture sites closed using the post-closure technique upon decannulation. The success rate of this technique and incidence of lower limb complications were recorded and analysed. Technical success was achieved in 157 (92.4%) patients. Sixteen patients (9.4%) experienced lower limb-related complications, including 8 (4.7%) with lower limb arterial thrombosis and 11 (6.5%) with pseudo-aneurysms. Among all lower limb-related complications, four patients (2.4%) required interventional procedures. This study included 170 patients: 80 in the 'S' (15-16F) group and 90 in the 'M' (17-19F) group. In the univariate analysis of different arterial cannula sizes for in-hospital lower limb-related complications, the differences were not statistically significant (p > 0.05). The multivariate logistic model indicated that, compared to the S (15-16F) group, the M (17-19F) group was not associated with an increased rate of in-hospital lower limb-related complications. The suture-mediated closure of the femoral artery during VA-ECMO decannulation is a promising therapeutic strategy.

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

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

Investigating the effects of percutaneous endovascular aneurysm repair for abdominal aortic aneurysm on the lumen size of the common femoral artery

BackgroundPercutaneous endovascular aneurysm repair (PEVAR) is the definitive therapy of choice for abdominal aortic aneurysms worldwide. However, current literature regarding the anatomic changes in the common femoral artery (CFA) post-PEVAR is sparse and contradictory, and a significant proportion of these studies did not control for the potential confounding effects of ethnicity. Thus, this study aims to investigate the anatomical effects of PEVAR on the CFA using an Asian study cohort.MethodsBetween January 2019 and September 2023, the records of 113 patients who received PEVAR were reviewed. Groins with previous surgical interventions were excluded. The most proximate pre- and postoperative CT angiography of patients receiving PEVAR via the Perclose ProGlide™ Suture-Mediated Closure System were retrospectively analysed for changes in both the CFA inner luminal diameter (ID) and outer diameter (OD), the latter also encompassing the arterial walls. Access site complications within 3 months post-PEVAR were also recorded per patient.ResultsOne hundred seventeen groins from 60 patients were included in this study, with 1 report of pseudoaneurysm. The CFA ID exhibited a 0.167 mm decrease (p-value = 0.0403), while the OD decreased by 0.247 mm (p-value = 0.0107). This trend persisted when the data was separately analysed with the common cardiovascular risk factors of diabetes mellitus, hypertension and hyperlipidaemia.ConclusionOur analysis demonstrated a statistically significant decrease in the CFA diameters post-PEVAR. However, the percentage changes were below established flow-limiting values, as reflected by the single access site complication reported. Hence, our findings give confidence in the safety profile of this procedure, even with the reported smaller baseline CFA lumen size in Asians. Moving forward, similar longer-term studies should be considered to characterise any late postoperative effects.Graphical

Suture closure AFtEr large bore vein access (SAFE-VEIN): A randomized, prospective study of the efficacy and safety of venous closure device.

Perclose ProGlide (PPG) Suture-Mediated Closure System™ is safe and can reduce time to hemostasis following procedures requiring arterial access. We aimed to compare PPG to figure of 8 suture in patients who underwent interventional catheter procedures requiring large bore venous access (LBVA) (≥13 French). In this physician-initiated, randomized, single-center study [clinicaltrials.gov ID: NCT04632641], single-stick venous access was obtained under ultrasound guidance. Eligible patients were randomized 1:1, and 100 subjects received allocated treatment to either PPG (n = 47) or figure of 8 suture (n = 53). No femoral arterial access was used in any patient. Primary outcomes were time to achieve hemostasis (TTH) and time to ambulation (TTA). Secondary outcomes were time to discharge (TTD) and vascular-related complications and mortality. Wilcoxon rank-sum test was used to compare TTH, TTA, and TTD. TTH (minutes) was significantly lower in PPG versus figure of 8 suture [median, (Q1, Q3)] [7 (2,10) vs. 11 (10,15) respectively, p < 0.001]. TTA (minutes) was significantly lower in PPG compared to figure of 8 suture [322 (246,452) vs. 403 (353, 633) respectively, p = 0.005]. TTD (minutes) was not significantly different between the PPG and figure of 8 suture arms [1257 (1081, 1544) vs. 1338 (1171,1435), p = 0.650]. There was no difference in minor bleeding or access site hematomas between both arms. No other vascular complications or mortality were reported. PPG use had lower TTH and TTA than figure of 8 suture in a population of patients receiving LBVA procedures. This may encourage same-day discharge in these patients.

Single-Center Experience on the Elective Hybrid Combination of Single Perclose + Angio-Seal VIP 8F Compared With Standard Dual Perclose During Percutaneous Endovascular Aortic Aneurysm Repair.

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. 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. 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. 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.

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.

Collagen-Based Bailout Compared to Suture-Mediated Vascular Closure Alone During Transcatheter Aortic Valve Replacement

BackgroundHemostasis 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. MethodsData 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. ResultsA 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. ConclusionsA contemporary hybrid strategy of suture-mediated closure with collagen-mediated closure bailout reduces the risk of vascular complications among patients undergoing transfemoral TAVR.

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

BackgroundFollowing 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.MethodsThirty-six subjects (63 ± 10.7 years 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 30 days. Subjects were evaluated for clinically apparent vascular complications.ResultsMean procedure duration was 138.6 min, and the time to hemostasis was 3.1 min/access site and 9.5 min/subject. Median time to ambulation was 193.5 min, and median time to discharge was 5.95 h, with discharge as early as 2.4 h. 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 30 days. 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.ConclusionsThis 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.Graphical abstract

Efficacy and safety of post-closure technique using Perclose ProGlide/ProStyle device for large-bore mechanical circulatory support access sites

PurposeMechanical circulatory support (MCS) using a venoarterial extracorporeal membrane oxygenation (VA-ECMO) device or a catheter-type heart pump (Impella) is critical for the rescue of patients with severe cardiogenic shock. However, these MCS devices require large-bore cannula access (14-Fr and larger) at the femoral artery or vein, which often requires surgical decannulation. MethodsIn this retrospective study, we evaluated post-closure method using a percutaneous suture-mediated vascular closure system, Perclose ProGlide/ProStyle (Abbott Vascular, Lake Bluff, IL, Perclose), as an alternative procedure for MCS decannulation. Closure of 83 Impella access sites and 68 VA-ECMO access sites performed using Perclose or surgical method between January 2018 and March 2023 were evaluated. ResultsMCS decannulation using Perclose was successfully completed in all access sites without surgical hemostasis. The procedure time of ProGlide was shorter than surgical decannulation for both Impella and VA-ECMO (13 min vs. 50 min; p < 0.001, 21 min vs. 65 min; p < 0.001, respectively). There were no significant differences in the 30-day survival rate and major adverse events by decannulation including arterial dissection requiring endovascular treatment, hemorrhage requiring a large amount of red blood cell transfusion, and access site infection. ConclusionOur results suggest that the post-closure technique using the percutaneous suture-mediated closure system appears to be a safe and effective method for large-bore MCS decannulation.

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.

TCT-55 Comparison of Figure-of-8 Suture and Perclose ProGlide Suture-Mediated Closure in Large Bore Venous Access Hemostasis: A Randomized Controlled Trial

TCT-55 Comparison of Figure-of-8 Suture and Perclose ProGlide Suture-Mediated Closure in Large Bore Venous Access Hemostasis: A Randomized Controlled Trial

Suture-Mediated Intermediate and Terminal Closure When Using the Aortix Percutaneous Mechanical Circulatory Support Device.

The Aortix percutaneous mechanical circulatory support (pMCS) 18F micromechanical axial impeller-driven pump is percutaneously placed and retrieved from the descending aorta above the renal arteries. Pump deployment and retrieval use defined steps to allow suture-mediated closure around the exiting power lead and for terminal hemostasis after device retrieval after therapy. The overall procedure was validated preclinically in ovine and porcine models and has since proven reliable in a recently completed IDE feasibility study (NCT04145635). This study describes the steps of a novel technique for reliable suture-mediated vessel closure when using the Aortix pMCS device. The principal steps associated with the procedure comprised ultrasound-guided access of the femoral artery, preclose placement of 4 Perclose (Abbott) sutures, achievement of intermediate hemostasis by locking 3 of the 4 sutures around the 6F exiting power lead, breaking the 3 locked sutures to permit vessel reentry for device removal, and finally, vessel closure using the fourth preclose suture along with 1 or more postclose suture(s) to close the femoral artery using a hybrid dual-sheath technique. The standardized steps described have been developed and used over the course of 21 clinical cases by 12 operators who were initially procedurally naïve but experienced in large-bore access. Preclose and postclose suture-mediated closure is a reliable means of managing the exiting power lead of the Aortix pMCS and closing the large-bore arteriotomy after pump retrieval. The steps outlined in this study may have applicability to other procedures requiring large-bore access or using suture-mediated closure.

488 Comparison of Efficacy Between Suture-Mediated and Plug-Based Vascular Closure Devices Following Endovascular Procedures via Large-Bore Femoral Punctures

Abstract Introduction Endovascular aneurysm repair is typically performed via large-bore percutaneous femoral access; with haemostasis achieved using vascular closure devices (VCDs). Such VCDs include suture-mediated closure devices like ProGlide or plug-based such as the MANTA. We compared the efficacy of two techniques, early and late complications related to the devices. Method We undertook a retrospective analysis of a prospective database of large-bore access procedures from 2017-2022, comparing two groups by VCD used, designated Group A (ProGlide) and Group B (Manta). We classified haemostasis as Grade 1 (haemostasis without adjuncts), Grade 2 (haemostasis with adjuncts such as pressure dressings) and Grade 3 (failed haemostasis needing rescue). Grades 1 &amp; 2 were considered successful haemostasis. We used Minitab 21 for statistical analysis. Results We assessed 207 endovascular procedures with 374 large-bore accesses (243 Group A and 131 Group B). The mean age was 74.9±8 (183 males), and the average BMI was 28±5.8. 191 had EVAR and 11 TEVAR. 5% had redo groins (11 Group A and 8 Group B, p = 0.47). The average sheath outer diameter was 16±2.5F. Successful haemostasis was achieved in 91.1% (222 in Group A and 119 in Group B). 8.8% needed a rescue operation (21 in Group A and 12 in Group B, p = 0.86). Pseudoaneurysms developed in 4.8% (n = 18) and were more frequent in Grade 2 haemostasis (11 Group A and 2 Group B, p = 0.058). Conclusions The overall success rate was comparable between the two groups. However, ProGlide deployments required more adjuncts to achieve haemostasis. Pseudoaneurysm formation was more frequent with adjuncts.

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.

Comparison of percutaneous closure systems for large bore vascular access sites in endovascular procedures.

The vascular closure device (VCD) is a medical device used for achieving hemostasis of vascular access sites greater than 8 Fr. We compared complications after placement of Perclose ProGlide (Abbott Vascular, USA), a percutaneous suture-mediated closure system, with MANTA VCD (Teleflex Vascular, USA), a collagen-based closure device. This retrospective cohort study analyzed procedures performed between 2016 and 2021. We compared the incidence of bleeding complications according to the Bleeding Academic Research Consortium (BARC) and Valve Academic Research Consortium-3 (VARC-3) criteria. The comparison was made between two cohorts of patients: in the first, vascular access sites were closed with a double Perclose ProGlide system, and in the second with an 18 Fr MANTA VCD. A total of 189 patients were included in the study, out of which 63% were male and 37% were female, with a median age of 79 (72-83) years. All devices were used for femoral arterial access closure. A double Perclose ProGlide was used in 91 (48%) patients, while MANTA VCD was used in 98 patients (52%). The distribution of patients by VARC-3 and BARC bleeding criteria differs between groups (p = 0.017). A significantly higher incidence of VARC 1 (14% vs. 4%; p = 0.020) and BARC 1-2 (14% vs. 4%; p = 0.020) complications in the Perclose ProGlide cohort was observed. VARC 3 (1% vs. 5%; p = 0.213) and BARC 3b (1% vs. 5%; p = 0.213) complications showed higher, but statistically non-significant rates of major bleeding complications in the MANTA VCD cohort. The need for subsequent surgical revision did not show a significant difference between the cohorts (2% vs. 6%; p = 0.281). The Perclose ProGlide cohort was associated with a significantly higher rate of milder complications. MANTA VCD cohort had a higher rate of major bleeding complications, requiring more complex treatment with a potentially larger impact on quality of life.