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

BACKGROUND: Perclose ProGlide (PPG) Suture-Mediated Closure System™ is safe and can reduce time to hemostasis following procedures requiring arterial access. AIMS: 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). METHODS: 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. RESULTS: 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. CONCLUSION: 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 suture-mediated closure system after transfemoral transcatheter aortic valve implantation: A single-center real-world experience.

BACKGROUND: 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. AIMS: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

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.

PURPOSE: This single-center study aimed to assess patients who underwent intentional percutaneous endovascular aortic aneurysm repair (pEVAR) with Hybrid Technique combining a single Perclose (Abbott, Abbott Park, Illinois) Suture-Mediated Closure Device + single Angio-Seal VIP 8F (Terumo, Tokyo, Japan) and compare outcomes with the standard Dual Perclose technique. Materials and Methods: Consecutive elective pEVAR patients treated from November 2022 to November 2023, with healthy femoral accesses and introducer sheaths ≤20 French (F) outer diameter, were included. Coin-toss randomization determined whether a combination of single Perclose Device + single Angio-Seal VIP 8F (Hybrid Technique) or the standard double Perclose Devices (Dual Perclose) was used. In Hybrid Technique, a single Perclose device was positioned at 12 o'clock; a single Angio-Seal VIP 8F was placed after sheaths removal. Dual Perclose followed standard procedure. Primary endpoints included immediate hemostasis, sheath diameter differences, access conversion rate, technical success, and cost analysis. RESULTS: The study involved 60 pEVAR patients (median age=78, interquartile range [IQR]=72-85 years) within the inclusion criteria. In 14 (24%) cases, only 1 femoral access was studied. There were 106 pEVAR accesses, with 58 (54.7%) in the Hybrid Technique group and 48 (45.3%) in the Dual Perclose group. Both groups exhibited homogeneity in pre-operative characteristics and sheath diameter (Hybrid Technique-16F vs Dual Perclose-18F; p=0.202). Immediate hemostasis was achieved in 100% of the Hybrid Technique group vs 87.5% for the Dual Perclose group (p=0.006). Surgical access conversion was unnecessary. Technical success was 100%, with all 6 femoral bleeding cases after Dual Perclose resolved endovascularly, using additional devices. Cost analysis showed a median cost of 330 euros (IQR=0) for the Hybrid Technique group vs 384 euros (IQR=360-456) for the Dual Perclose group (p<0.001). Thirty-day mortality was 3%, in 2 fragile patients, without access-related complications. Multivariate analysis identified Dual Perclose access (odds ratio [OR]=35.6; 95% confidence interval [CI]=18.3-36.8; p<0.001) and obesity (OR=19.7; 95% CI=1.4-23.9.5; p<0.001) as independent risk factors for immediate hemostasis failure. Median follow-up was 134 days (IQR=41-227), with 1 Hybrid Technique case (2%) successfully treated with thrombin injection for a small femoral pseudoaneurysm after 62 days. CONCLUSIONS: The elective Hybrid Technique with combination of single Perclose Device + single Angio-Seal VIP 8F during pEVAR in selected patients appears to be non-inferior to the standard Dual Perclose procedure. It demonstrates a positive trend in reducing immediate hemostasis failure and costs. Both procedures achieved technical success and avoiding surgical access conversions. CLINICAL IMPACT: This study introduces a novel elective hybrid technique combining a single Perclose device with a single Angio-Seal VIP 8Fr for percutaneous endovascular abdominal aortic interventions. Results for hybrid technique showed 100% technical success and efficient immediate hemostasis, while costing less than standard dual Perclose procedure. Both procedures did not require surgical conversions. Despite being a single-center study, it demonstrates potential benefits of the intentional application of this hybrid technique towards minimally invasiveness. Obesity and dual Perclose technique were identified as independent risk factors for hemostasis failure, reaffirming the hybrid technique procedure's efficacy as well as and non-inferiority to standard procedure.

A single center study of the efficacy and safety of Pro-Glide used for closure in thoracic endovascular aortic repair in patients with previous groin intervention.

BACKGROUND: This study aimed to evaluate the efficacy and safety of Pro-Glide, a suture-mediated vascular closure device, regarding technical success and complications in patients who had undergone aortic intervention and had previous groin intervention (PGI). METHODS: One hundred and thirty-five patients who underwent percutaneous thoracic endovascular aortic repair via the femoral artery and were closed with the Pro-Glide device were analyzed retrospectively. PGI was defined as a history of open surgical access to the femoral artery or wide sheath (>18 F) placement due to endovascular or valvular intervention. The patients were divided into two groups 38 cases with PGI and 97 cases without PGI. RESULTS: The overall success rate of closure of the femoral artery with Pro-Glide was not statistically significant between the two groups (93.8% vs 92.1%, p = .711). Sheath sizes were compared between the groups and PGI (+) group had significantly higher sheath sizes compared to PGI (-) group (24.3 ± 1.1 F vs 23.8 ± 1.0 F, p = .011). Three patients in the PGI (+) group and six patients in the PGI (-) group experienced technical failure of the percutaneous femoral approach. Femoral complications were seen after the procedures in four patients in the PGI (+) group and four in the PGI (-) group. The PGI (+) group had a higher complication rate when compared to the PGI (-) group; however, this was not statistically significant (p = .181). CONCLUSION: The present study was conducted on a significantly larger sample compared to previous studies and the findings suggest that the Pro-Glide vascular closure device is a safe option for patients with a history of PGI and may not be considered as a contraindication.

Ambulatory pulmonary vein isolation workflow using the Perclose ProglideTM suture-mediated vascular closure device: the PRO-PVI study.

AIMS: The leading reason for delayed discharge after pulmonary vein isolation (PVI) is vascular complications. This study aimed to evaluate feasibility, safety, and efficacy of the Perclose Proglide™ suture-mediated vascular closure in ambulatory PVI, report complications, patient satisfaction, and cost of this approach. METHODS AND RESULTS: Patients scheduled for PVI were enrolled prospectively in an observational design. Feasibility was assessed as % discharged the day of procedure. Efficacy was analysed as acute access site closure rate, time to reach haemostasis, time to ambulate, and time to discharge. Safety analysis consisted of vascular complications at 30 days. Cost analysis was reported using direct and indirect cost analysis. A 1:1 propensity matched control cohort was used for comparing time to discharge to usual workflow. Of 50 enrolled patients, 96% were discharged on the same day. 100% of devices were successfully deployed. Immediate (<1 min) haemostasis was reached in 30 patients (62.5%). Mean time to discharge was 5:48 ± 1:03 h (vs. 10:16 ± 1:21 h in the matched cohort, P < 0.0001). Patients reported high level of satisfaction with the post-operative time. No major vascular complication occurred. Cost analysis showed a neutral impact compared to the standard of care. CONCLUSION: The use of the closure device for femoral venous access after PVI led to safe discharge of patients within 6 h from the intervention in 96% of the population. This approach could minimize the overcrowding of healthcare facilities. The gain in post-operative recovery time improved patients' satisfaction and balanced the economic cost of the device.

Efficacy and safety of Proglide use and early discharge after atrial fibrillation ablation compared to standard approach. PROFA trial.

BACKGROUND AND OBJECTIVES: The common practice after atrial fibrillation ablation is to admit patients for an overnight stay. The aim of this study was to compare a strategy of vascular suture mediated closure system utilization and early discharge (strategy A) compared to traditional closure and overnight hospitalization (strategy B) regarding feasibility, safety, quality of life and health care cost effectiveness. METHODS AND RESULTS: Hundred patients were randomized to compare both strategies. No clinical differences were reported except diabetes mellitus. Six patients (6%) had and emergency visit or were admitted in the first 30 days after procedure. Three occurred in strategy A versus three in strategy B (p = 1) (p < .005 for non-inferiority). Forty out of 50 patients (80%) were safely discharged in a time frame of 3 h and 42 patients (84%) were discharged in the same day of the procedure in strategy A. Time to discharge was shorter in strategy A compared to strategy B. (5.89 ± 7.47 h vs. 27.09 ± 2.29 p < .005). No differences were obtained in quality-of-life outcomes. Mean (95% CI) euros cost saving per patient in strategy A was 379.16 ± 93.55 p < .001. Ten acute complications (10% patients CI 95% 4.02%-15.98%) were reported during the trial. Seven (14% CI 95% 4.04%-23.96%) occurred in strategy A patients versus 3 (6% CI 95% 0.8%-12.8%) in strategy B. (p = .182) CONCLUSION: A strategy of vascular suture mediated closure system utilization and early discharge was feasible, reduced time to discharge, saved costs and was not associated with more complications or admissions/emergency visits in a 30-day time frame after procedure compared to a strategy of regular admission and discharge after overnight stay. There were no differences regarding quality-of-life parameters between both strategies.

Treatment of inadvertent cervical arterial catheterization: Single-center experience.

OBJECTIVES: Inadvertent arterial catheterization can occur during transjugular central venous catheter insertion and should be promptly treated to prevent serious consequences. Although many treatment modalities are available, no exist guidelines regarding the selection of treatment. We aimed to describe our experience with the treatment of 11 patients who underwent inadvertent cervical arterial catheterization and propose an algorithm for the selection of treatment methods. METHODS: We retrospectively identified all patients who were treated for inadvertent arterial catheterization at our center between January 2016 and March 2021. We reviewed patient profiles, images, treatment methods, and follow-up data. RESULTS: Eleven patients were included (eight men and three women, age: 36-73 years). Ten catheter misplacements were in the right common carotid artery. The remaining catheter was inserted into the right subclavian artery after penetrating the right common carotid artery. Two catheters were 5-Fr and nine catheters were 11.5-Fr. Two patients underwent manual compressions, three underwent open surgery, three underwent stent-graft repairs, and four underwent Perclose Proglide closure. Clinical success was achieved in all 11 patients. Primary technical success was achieved in 10 patients. In one patient, unsuccessful manual compression was followed by successful stent-graft repair; the manual compression failed to prevent bleeding, possibly because of the long-term oral administration of aspirin for coronary heart disease. The mean follow-up was 5.4 months (range, 1-12 months). The overall mortality rate was zero, and no vascular or neurological events occurred. CONCLUSIONS: The existing data show that the current protocol for the treatment of inadvertent cervical arterial catheterization at our center is safe and effective. However, the data are insufficient and require further clinical validation.

Percutaneous VA-ECMO from Cannulation to Decannulation: Novel Use of a Vascular Closure Device in Pediatrics.

VA-ECMO can be lifesaving in cardiogenic shock in children. While surgical vascular repair is the current standard of care for decannulation, it comes with notable risks. We present a series of eight patients who underwent decannulation with a collagen plug-based vascular closure device (MANTA) for the common femoral artery. Seven of the patients were successfully decannulated without access site-related vascular complications. One required conversion to surgical cut-down with arterial repair due to device failure. This series demonstrates the successful use of the MANTA device in percutaneous VA-ECMO decannulation in the pediatric population, while highlighting potential technical challenges for success.

Outcomes comparison between percutaneous decannulation with perclose ProGlide and surgical decannulation of veno-arterial extracorporeal membrane oxygenation.

OBJECTIVE: Our study aimed to compare the decannulation-related outcomes of two different decannulation methods in patients who underwent veno-arterial extracorporeal membrane oxygenation (VA-ECMO) support, namely percutaneous decannulation with Perclose ProGlide device and conventional surgical repair. BACKGROUND: Surgical vascular repair is a standard strategy when ECMO is to be terminated and sometimes associated with severe complications. Percutaneous decannulation using Perclose ProGlide has been reported to be feasible and safe in selected patients, but there is a paucity of literature to make systematic comparisons between the two decannulation methods. METHODS: 41 patients who were supported with VA-ECMO for refractory cardiogenic shock, cardiac arrest, or escort of complex interventions from December 2018 to December 2021 were enrolled. Of these, 30 underwent percutaneous Perclose ProGlide decannulation and 11 underwent surgical repair. The clinical characteristics and complication rates were analyzed. RESULTS: Patients in the two groups showed a similar incidence of vascular-related complications, such as acute lower limb ischemia, major bleeding, severe hematoma, pseudoaneurysm, and arteriovenous fistula [20% versus 18.2%, p=.896]. The incidence of groin infection and delayed healing was significantly higher in the surgical removal group [3.3% versus 36.4%, p=.014]. CONCLUSIONS: Percutaneous decannulation of veno-arterial extracorporeal membrane oxygenation with the Perclose ProGlide device is a feasible and safe technique that simplifies the decannulation process, shortens the hospitalization duration, and lowers the potential risk of groin infection and delayed wound healing.

Preclosure of large bore venous access sites in patients undergoing transcatheter mitral replacement and repair.

OBJECTIVE: We aim to report on the efficacy and safety of large bore venous access (LBVA) preclosure with Perclose™ (Abbott Vascular Devices) suture-mediated device use following transcatheter edge-to-edge (TEER) and replacement (TMVR). BACKGROUND: Patients requiring TEER and TMVR require LBVA. Clinical outcome data on the use of suture-mediated devices for LBVA site closure are limited. METHODS: Between 2012 and 2019, 354 consecutive high-risk patients with mitral valvular heart disease underwent TEER (n = 287) with MitraClip and TMVR (n = 67) with Edwards Sapien Valves. Patients had LBVA with 24 or 16 French sheaths. All patients underwent preclosure of LBVA except for one that underwent manual hemostasis. RESULTS: There were no closure device failures. None of the cases required surgical repair of the access site following venous preclosure. Two cases had large hematomas (>6 cm) following Perclose in each group. Six cases had small hematomas (<6 cm and >2 cm) with three in each group. There was one major bleeding using Mitral Valve Academic Research Consortium 2 definition (retroperitoneal bleed from arterial puncture) unrelated to the venous closure. Transfusion related to vascular access complication was required in five cases. There were two immediate acute deep venous thromboses postprocedure; one of which occurred after preclosure. There were no arteriovenous malformations, pseudoaneurysms, or access site infections reported following Perclose. CONCLUSION: In this large sample size analysis, Proglide preclosure technique is a feasible and safe alternative approach to achieving hemostasis after removal of LBVA sheaths in patients undergoing TEER and TMVR. Randomized trials are needed to compare the different modalities of hemostasis.

A novel technique for postclosure of large-bore sheaths using two Perclose devices.

OBJECTIVES: This study aimed to assess the feasibility, efficacy, and safety of a novel percutaneous postprocedure closure technique for large arterial sheath removal with the use of two Perclose ProGlide (Abbott Vascular Devices, Redwood City, CA) devices. BACKGROUND: Postprocedural closing of large-bore arteriotomies using the Perclose system can be difficult given the subsequent inability of the device to capture sufficient wall tissue. METHODS: Our study was a single-center retrospective analysis of 22 consecutive patients who underwent large arteriotomy closure via the postclosure technique with a 12-16-Fr sheath. Efficacy endpoints included successful deployment of the system and hemostasis. Safety endpoints included the incidence of major or minor vascular complications as defined by the Vascular Academic Research Consortium-2 (VARC-2) definitions at 30-day follow-up. RESULTS: The postclosure technique resulted in 100% technical success rate and no postprocedural bleeding or vascular complications. CONCLUSION: Postclosure technique is a safe, highly effective, and feasible percutaneous method to achieve large-bore arteriotomy hemostasis with low rates of major bleeding or vascular complications and favorable early outcome.

MANTA versus Perclose for large-bore vessel closure: The evidence continues to grow.

The MANTA is a new, easy-to-use, collagen plug-based vascular closure device specifically designed for large-bore arteriotomy closure. The authors report on their experience comparing the MANTA device with the Perclose ProGlide technique in patients undergoing transcatheter aortic valve replacement. They found similar rates of success and vascular complications with both devices, suggesting that MANTA is a suitable option for these patients. It remains to be determined whether one device will emerge as the ideal choice for most patients. Device cost is a significant barrier to widespread adoption, but price has decreased recently.

An Effective Method for Percutaneous Removal of Venoarterial Extracorporeal Membrane Oxygenation by a Combination of Balloon Dilatation in Endovascular Therapy and the Perclose Proglide™ Closure Device.

BACKGROUND: Venoarterial extracorporeal membrane oxygenation (VA-ECMO) can be undertaken surgically, but there are various problems with this method. METHODS AND CASE REPORT: We removed the arterial cannula of VA-ECMO percutaneously by combining intravascular balloon dilatation and the Perclose ProGlide™ (PP) closure device in a short amount of time and the extent of bleeding was extremely small. Simultaneously, the venous cannula was removed by suturing and manual compression. We report a series of cases of percutaneous removal of VA-ECMO using intravascular balloon dilatation and PP. CONCLUSIONS: By using this method, VA-ECMO removal was possible in a very short amount of time with minimal invasiveness.

Cost-minimization study of the percutaneous approach to endovascular aortic aneurysm repair.

OBJECTIVE: Percutaneous access for endovascular aortic aneurysm repair (P-EVAR) is less invasive compared with surgical access for endovascular aortic aneurysm repair (S-EVAR). P-EVAR has been associated with shorter recovery and fewer wound complications. However, vascular closure devices (VCDs) are costly, and the economic effects of P-EVAR have important implications for resource allocation. The objective of our study was to estimate the differences in the costs between P-EVAR and S-EVAR. METHODS: We used a decision tree to analyze the costs from a payer perspective throughout the course of the index hospitalization. The probabilities, relative risks, and mean difference summary measures were obtained from a systematic review and meta-analysis. We modelled differences in surgical site infection, lymphocele, and the length of hospitalization. Cost parameters were derived from the 2014 National Inpatient Sample using "International Classification of Diseases, 9th Revision, Clinical Modification" codes. Attributable costs were estimated using generalized linear models adjusted by age, sex, and comorbidities. A sensitivity analysis was performed to determine the robustness of the results. RESULTS: A total of 6876 abdominal and thoracic EVARs were identified. P-EVAR resulted in a mean cost savings of $751 per procedure. The mean costs for P-EVAR were $1287 (95% confidence interval [CI], $884-$1835) and for S-EVAR were $2038 (95% CI, $757-$4280). P-EVAR procedures were converted to open procedures in 4.3% of the cases. The P-EVAR patients had a difference of -1.4 days (95% CI, -0.12 to -2.68) in the length of hospitalization at a cost of $1190/d (standard error, $298). The cost savings of P-EVAR was primarily driven by the cost differences in the length of hospitalization. In the base case, four VCDs were used per P-EVAR at $200/device. In the two-way sensitivity analysis, P-EVAR resulted in cost savings, even when 1.5 times more VCDs had been used per procedure and the cost of each VCD was 1.5 times greater. In our probabilistic sensitivity analysis, P-EVAR was the cost savings strategy for 82.6% of 10,000 Monte Carlo simulations when simultaneously varying parameters across their uncertainty ranges. CONCLUSIONS: P-EVAR had lower costs compared with S-EVAR and could result in dramatic cost savings if extrapolated to the number of aortic aneurysms repaired. Our analysis was a conservative estimate that did not account for the improved quality of life after P-EVAR.

Off-label use of Proglide percutaneous closure device in iatrogenic arterial catheterizations: Our experience.

INTRODUCTION: Incidental arterial puncture is one of the main complications associated with central venous catheter placement. Manual compression to achieve hemostasis in subclavian and carotid artery punctures is often ineffective because of the anatomical arterial position. Accidental cannulation has traditionally been treated with open surgery or endovascular treatment, but such procedures are not exempt from complications. OBJECTIVES: Report our experience with ultrasound-guided off-label use of Perclose ProGlide (Abbott Vascular Inc., Santa Clara, CA, USA) in patients with iatrogenic arterial cannulation. METHODS: Six unstable patients with accidental arterial catheterization during placement of a central venous catheter: five of them in the subclavian artery and one in the right common carotid artery. Ultrasound-guided percutaneous closure was performed at bedside using a Perclose ProGlide (Abbott Vascular Inc., Santa Clara, CA, USA). RESULTS: All patients underwent duplex ultrasound 6, 12, 24, and 48 h postprocedure, and no complications associated with percutaneous closure (embolism, ischemia, stenosis, or arterial occlusion, bleeding, pseudoaneurysm, etc.) were described. CONCLUSIONS: Accidental artery puncture during central venous catheterization is an uncommon situation but can be effectively managed by using percutaneous vascular closure device. It is a reliable alternative that should be considered as a first-line approach before endovascular or open surgery, specially in patients with unstable conditions in which it is possible to be performed without transfer to an operation room.

A systematic review of vascular closure devices for femoral artery puncture sites.

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

Postclose technique for large sheath arterial access using perclose(TM) in emergency endovascular repair.

The "Preclose technique" using a perclose device has recently become widely used in various percutaneous procedures requiring a large access sheath. However, the post-procedural application of the perclose(TM) to the large sheath arteriotomy is more challenging because of the risk of bleeding and difficulty of device application. This report introduces a novel post-procedural closing technique of large 22 Fr arterial sheath access using perclose devices.

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

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

Clinical outcomes of the post-closure technique for arteriotomy closure with the Impella cardiac power percutaneous left ventricular assist device.

With the increasing utilization of endovascular mechanical circulatory support devices, such as the Impella CP (Abiomed), there is a need for standardized guidelines for its safe removal. Development of the Perclose post-closure technique was facilitated by the introduction of a new Impella repositioning sheath in 2019, which enabled re-access to the sidearm and stylet, rewiring of the access artery, and Impella sheath removal. Our retrospective single-center study included all patients undergoing Perclose post-closure technique for vascular access closure after Impella removal between 2018 and 2024. Forty-six patients, with a mean age of 63.8 years, predominantly male (82.6%), were included in the analysis. Indications for Impella placement included complex percutaneous coronary intervention (34.8%) and cardiogenic shock (CS) (heart failure-CS: 32.6%, myocardial infarction-CS: 21.7%). Clinically relevant complications were encountered in less than 5% of cases. No instances of covered stent placement, fasciotomy, amputation, or access site infections were reported. Our study underscores the safety of the Perclose post-closure technique following Impella removal in a diverse cohort of patients, with an overall clinically significant complication rate of less than 5%. The Perclose post-closure technique is a reliable and well-tolerated method for vascular access closure in patients undergoing Impella support.

Safety and feasibility of a novel total percutaneous post-closure technique after bedside Impella decannulation in patients with cardiogenic shock.

OBJECTIVES: The Impella (Abiomed) is a widely used percutaneous mechanical circulatory support device for high-risk percutaneous coronary intervention in patients with cardiogenic shock. This study aimed to determine the safety and feasibility of a non-angio-guided post-closure approach using the Perclose ProGlide (Abbott) to decannulate the Impella in the intensive care unit. METHODS: This retrospective study included consecutive patients who were successfully weaned from mechanical circulatory support using the Impella device between April 2019 and April 2022 at Hamamatsu University School of Medicine. Fifteen patients underwent complete post-closure of the femoral artery access sites at the bedside. Technical success of the post-closure hemostasis technique was defined as no evidence of bleeding or additional medical procedures after manual compression. The safety endpoints comprised the Valve Academic Research Consortium-3 and Bleeding Academic Research Consortium criteria. RESULTS: All patients achieved successful hemostasis with this novel technique without surgical conversion. There was no significant bleeding; however, procedure-related vessel occlusion was observed in 1 patient who was recanalized with balloon angioplasty. CONCLUSIONS: Bedside post-closure using the Perclose ProGlide device is a safe and feasible alternative to manual compression and surgical removal of the Impella device with low bleeding or vascular complications rates.