Access site complications in thoracic endovascular aortic repair.

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

Comparison of MANTA versus Perclose Prostyle large-bore vascular closure devices during transcatheter aortic valve implantation.

BACKGROUND: New vascular closure devices (VCD) are being introduced for achieving hemostasis after transcatheter aortic valve implantation (TAVI). However, no safety or efficacy data have been published compared to other contemporary VCD. AIM: To compare the safety and efficacy of suture-based Perclose Prostyle as compared to plug-based MANTA device. METHODS: A total of 408 consecutive TAVI patients from two high volume TAVI centers were included in the present study. Patients were grouped according to VCD: Prostyle versus MANTA. Propensity score matching (PSM) and multivariable analysis were utilized to compare clinical endpoints between the two groups. The primary endpoint was any vascular complication (VC) according to VARC-3 criteria. RESULTS: After PSM, a total of 264 patients were analyzed, of them 132 in each group. Overall baseline characteristics of the two groups were comparable. Primary end-point was similar between MANTA as compared to Prostyle (16.7% vs. 15.3% respectively, p = 0.888). The main driver for VC among MANTA group were minor vascular complications (15.2%). Conversely, minor and major VC contributed equally to the primary endpoint among Prostyle group (7.6%) (p = 0.013). No outcome predictors were identified in multivariate analysis. CONCLUSIONS: VCD for transfemoral TAVI using the new-generation Prostyle device or the MANTA device achieved comparable VARC-3 VC rates.

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.

Enhancing Arterial Closure in Endovascular Aortic Procedures: The Efficacy of Echo-Guided ProGlide Technique.

BACKGROUND: Endovascular aortic surgery is increasingly becoming the standard treatment. Percutaneous access preclosing systems appear to be effective and notably the Proglide (PG). We aimed to prospectively assess the clinical effectiveness of combining ultrasound-guided femoral puncture with ultrasound-guided PG deployment. METHODS: Our single-center study consecutively included patients managed at a tertiary center from May to September 2023, undergoing endovascular aortic surgery. The placement of PG was performed under ultrasound guidance. Preoperative patient characteristics were evaluated using preoperative computed tomography scans. Clinical and technical success were defined, respectively, as the ability to achieve complete hemostasis confirmed by ultrasound 48 hr postprocedure and as the successful placement of a PG under ultrasound guidance contributing to final hemostasis. RESULTS: Twenty patients were included over a 6-month period, totaling 34 common femoral arteries (CFAs). Fourteen were male, with an average age of 72.8 ± 8.2 years. Among the 34 CFA, CFA had diameter of 12.05 ± 2.4 mm and a depth of 38.0 ± 13.4 mm. The mean introducer sheath diameter was 6.2 ± 1.5 mm with a sheath to femoral artery ratio of 0.54 ± 0.18. Successful Proglide placement under ultrasound guidance was achieved in 100% of cases. No PG failure occurred. Clinical and technical success were, respectively, of 95% and 100%. One small pseudoaneurysm was observed at 48 hr treated medically. No CFA access reintervention was required. CONCLUSIONS: The technique of ultrasound-guided PG deployment in aortic surgery is a safe and effective method for achieving hemostasis. It effectively prevents PG failures at a lower cost.

Cutting balloon for femoral arterial and venus obstructions due to suture-based closure devices: Case series.

Suture-based vascular closure devices have been shown to be effective in hemostasis for procedures with vascular access. However, iatrogenic vascular occlusion may occur. The cutting balloon (CB) is a noncompliant balloon wrapped with 3-4 microsurgical blades that are intended to modify vascular lesions, but it may also be utilized to cut and release endovascular sutures. We report two cases in which the CB was employed as a bailout strategy to alleviate suture-related vascular occlusion after transcatheter aortic valve replacement. The CB can be effectively utilized to resolve suture-related vascular occlusion.

Alternative Application Technique for the MANTA Vascular Closure Device for Percutaneous Large-Bore Arterial Access Closure: The Fluoroscopic DOT Technique.

BACKGROUND: Vascular complications are a cause of increased morbidity and mortality when performing percutaneous procedures requiring large-bore arterial access. MANTA vascular closure device (VCD) is currently the only large-bore VCD using an intraluminal foot plate and an extraluminal collagen plug. The traditional depth locator approach might be compromised in; emergent cases without the required measurements, cases of hematoma formation, or other patient, procedure, or operator-specific variables. Furthermore, this technique can be used for postclosure in cases without the required measurement of depth. We describe vascular outcomes using fluoroscopy (fluoroscopic DOT technique) rather than traditional depth locator approach for vascular closure with the MANTA VCD. METHODS: Fifty patients who underwent transcatheter aortic valve implantation (TAVI) were retrospectively analyzed using fluoroscopic DOT technique with 18F MANTA VCD between May and August 2021. All patients >18 years of age who qualified for transfemoral TAVI were included. Access was obtained with ultrasound guidance with vessel diameter of at least > 6 mm and free from anterior vessel wall calcification. Patient related factors and primary outcomes of access site bleeding and acute flow-limited limb ischemia requiring intervention were prospectively analyzed. Furthermore, 1 patient who failed hemostasis with suture-mediated VCD had successful hemostasis with fluoroscopic DOT technique as dry postclosure after balloon aortic valvuloplasty. RESULTS: In total, 50 patients were analyzed with a mean age of 81 years and majority were male (56%). Majority had comorbidities of hypertension (88%) and hyperlipidemia (94%), 24% had peripheral arterial disease, 38% coronary artery disease, and 58% were former smokers. Importantly, 40% were obese with an average body mass index (BMI) of 29 kg/m2. There were no bleeding or ischemic limb complications post MANTA VCD deployment using the fluoroscopic DOT technique. Furthermore, none of the patients required peripheral intervention from index procedure to 1 month post verified during their 1-month post TAVR follow-up. CONCLUSION: Fluoroscopic DOT technique using the MANTA VCD is highly reproducible and allows hemostasis in a predictable manner for procedures requiring large-bore arterial access in the absence of MANTA depth measurement.

Off-Label Use of the 8-F Angio-Seal for Closure of Greater than 8-F Common Femoral Arterial Access: A Systematic Review and Meta-Analysis.

PURPOSE: To evaluate the safety of >8-F access closures using 8-F Angio-Seal. MATERIALS AND METHODS: An electronic search was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 guidelines using Web of Science, Embase, Scopus, and PubMed databases from inception until January 17, 2022. Actionable and nonactionable bleeding events were defined in conjugation with the Bleeding Academic Research Consortium definition. Prevalence rates with corresponding 95% CIs were calculated using R software version 4.2.2. Eight articles, with 422 patients, were included in the analysis. RESULTS: The overall groin adverse event rate was 5.92% (95% CI, 3.01-11.34). The most commonly reported adverse events were any bleeding (5.74%; 95% CI, 3.23-10.00) (nonactionable bleeding, 0.96% [95% CI, 0.10-8.30]; actionable bleeding, 2.30% [95% CI, 0.89-5.84]), pseudoaneurysm (1.18%; 95% CI, 0.49-2.81), and groin hematoma (1.28%; 95% CI, 0.23-6.79). The least commonly reported adverse events were device failure and vessel occlusion/stenosis, with rates 0.29% (95% CI, 0.01-7.41) and 0.45% (95% CI, 0.02-7.74), respectively. No studies recorded events regarding the following adverse events: mortality, infection, deep venous thrombosis, and retroperitoneal hematoma. Moreover, the results showed significant differences, based on the sheath size used, in actionable bleeding (P = .04) and the rate of need for surgical repair (P < .01). CONCLUSIONS: Common femoral artery access of >8-F can be effectively closed with the Angio-Seal with comparable outcomes to those of <8 F; however, larger access approaching 14 F is associated with a significant increase in morbidity. Further safety is needed, especially for the larger access sizes.

The Use of Vascular Closure Devices for Brachial Artery Access: A Systematic Review and Meta-Analysis.

PURPOSE: To estimate the rates of technical success and adverse events of vascular closure devices (VCDs) in the brachial artery and compare the rates of adverse events with manual compression. MATERIALS AND METHODS: MEDLINE and Embase were searched for observational studies examining VCDs in the brachial artery. Meta-analyses were performed using random effects for the following outcomes: (a) technical success, (b) hematoma at the access site, (c) pseudoaneurysm, (d) local neurological adverse events, and (e) total number of adverse events. A pairwise meta-analysis compared VCD with manual compression for the outcomes of hematoma and the total number of adverse events. RESULTS: Of 1,761 eligible records, 16 studies including 510 access sites were included. Primary procedures performed were peripheral arterial disease interventions, percutaneous coronary intervention, and endovascular thrombectomy for ischemic stroke. The technical success rate was 93% (95% CI, 87%-96%; I2 = 47%). Data on the following adverse events were obtained via meta-analysis: (a) hematoma, 9% (5%-15%; I2 = 54%); (b) stenosis or occlusion at access site, 3% (1%-14%; I2 = 51%); (c) infection, 0% (0%-5%; I2 = 0%); (d) pseudoaneurysm, 4% (1%-13%; I2 = 61%); (e) local neurological adverse events, 5% (2%-13%; I2 = 54%); and (f) total number of adverse events, 15% (10%-22%; I2 = 51%). Angio-Seal success rate was 96% (93%-98%; I2 = 0%), whereas the ExoSeal success rate was 93% (69%-99%; I2 = 61%). When comparing VCD and manual compression, there was no difference in hematoma formation (relative risk, 0.75; 95% CI, 0.35-1.63; I2 = 0%; P = .47) or the total number of adverse events (relative risk, 0.75; 95% CI, 0.35-1.58; I2 = 76%; P = .45). CONCLUSIONS: Despite being off-label, studies suggest that VCDs in the brachial artery have a high technical success rate. There was no significant difference in adverse events between VCDs and manual compression in the brachial artery.

Costs and Budget Impact of Collagen-Based Vascular Closure Device Versus Manual Compression Following Peripheral Endovascular Procedures.

BACKGROUND: The objective of this study was to evaluate the annual costs and budget impact of using a vascular closure device to achieve hemostasis following femoral access endovascular procedures in England, compared with manual compression. METHODS: A budget impact model was developed in Microsoft® Excel, based on the estimated number of peripheral endovascular procedures eligible for day-case management performed annually by the National Health Service in England. The clinical effectiveness of vascular closure devices was captured based on the requirement for inpatient stays and the incidence of complications. Data for endovascular procedures, time to hemostasis, length of hospital stay, and complications were collected from public sources and the published literature. There were no patients involved in this study. Model outcomes are reported as estimated number of bed days and annual costs to the National Health Service for all peripheral endovascular procedures in England, and the average cost per procedure. The robustness of the model was tested in a sensitivity analysis. RESULTS: The model estimated savings for the National Health Service of up to £4.5 million annually if vascular closure devices were used in every procedure instead of manual compression. The model estimated an average cost saving of £176 per procedure for vascular closure devices over manual compression, primarily due to fewer inpatient stays. The sensitivity analysis demonstrated that the proportion of day-case procedures for vascular closure devices and manual compression was a key driver of costs and savings. CONCLUSIONS: The use of vascular closure devices for achieving hemostasis after peripheral endovascular procedures may be associated with lower resource use and cost burden, compared with manual compression, based on shorter time to hemostasis and ambulation and an increased likelihood of a day-case procedure.

Evaluation of the MANTA Vascular Closure Device in Transfemoral TAVI.

BACKGROUND: The MANTA vascular closure device (VCD) is a novel collagen plug-based VCD for large bore arteriotomies. The current literature regarding complication rates of this device is quite variable and mostly limited to relatively small case series. METHODS: This study is retrospective analysis of the MANTA VCD-related main access site complications according to Valve Academic Research Consortium-2 (VARC-2) criteria during the hospital stay. Particular attention was paid to the detailed analysis of multislice computed tomography with regard to the anatomy of the access vessel and the puncture site itself. RESULTS: A total of 524 patients underwent transfemoral transcatheter aortic valve implantation (TF TAVI) including the use of the MANTA device (18F) for percutaneous vascular closure. A group of 22 patients was excluded from the study due to incomplete imaging data. During the study period, we observed 28 major (5.6%) and five minor (1.0%) MANTA device-related vascular complications. There was no patient death related to these adverse events. Female gender, vessel angulation at the puncture site, and at least moderate calcification of the dorsal vessel segment were identified as independent predictors for major complications. CONCLUSIONS: The MANTA device is a feasible option for vascular closure of large bore arteriotomies in patients undergoing TF TAVI or other percutaneous transfemoral interventions. Furthermore, we have identified novel predictors for device failure/complications that should be taken into account for selection of the appropriate closure device. To our knowledge, this report is one of the largest case series analyzing the use of the MANTA VCD.

Safety and efficacy of the Mynx Control vascular closure device in peripheral arterial procedures: A prospective study.

OBJECTIVES: This article aims to present a prospective study investigating the safety and efficacy of the Mynx Control extravascular closure device (Cordis Corporation, FL, USA), for femoral arterial closure in patients undergoing peripheral arterial procedures. METHODS: Between January 2020 and February 2021, 100 Mynx Control devices were deployed in 91 consecutive patients (mean age: 67.5 ± 16.9 years) who underwent peripheral arterial procedures. We used ultrasound and/or fluoroscopy during Mynx Control deployment and ultrasound post-procedure to detect complications. Femoral artery punctures included 62 (62%) antegrade and 38 (38%) retrograde punctures. The mean activated clotting time at time of device deployment was 221s. The primary endpoints were technical success, device failure, and complication rates up to 30 days. RESULTS: A 5F vascular sheath was used in 43 cases (43%) (36 (36%) 6F and 21 (21%) 7F). The majority of our cases had antegrade access (62%). Overall technical success rate was 97% in both antegrade and retrograde cases. In total, there were 4 minor complications: 3 (3%) cases of pseudoaneurysm and 1 (1%) case of haematoma. No major complications were recorded post-procedure or 30 days post index procedure. CONCLUSION: The Mynx Control vascular closure device is safe and effective in achieving haemostasis in patients undergoing antegrade and retrograde peripheral angioplasty procedures.

Access site complications are uncommon with vascular closure devices or manual compression after lower extremity revascularization.

OBJECTIVE: Vascular closure devices (VCDs) and manual compression (MC) are used to achieve hemostasis after peripheral vascular interventions (PVIs). We sought to compare perioperative outcomes between MC and four VCDs after PVI in a multicenter setting. METHODS: The Vascular Quality Initiative was queried for all lower extremity PVIs with common femoral artery access performed from 2010 to 2020. The VCDs included were MynxGrip (Cordis, Santa Clara, CA), StarClose SE (Abbott Vascular, Redwood City, CA), Angio-Seal (Terumo, Somerset, NJ), and Perclose ProGlide (Abbott Vascular). In a blinded fashion, these four VCDs (labeled A, B, C, and D) were compared to MC for baseline characteristics, procedural details, and outcomes (access site hematoma and stenosis/occlusion). Those with a sheath size >8F were excluded. Propensity score matching (1:1) was performed. Univariable and multivariable analyses were completed for unmatched and matched data. RESULTS: A total of 84,172 lower extremity PVIs were identified. Of these, 32,013 (38%) had used MC and 52,159 (62%) had used VCDs (A, 12,675; B, 6224; C, 19,872; D, 13,388). The average age was 68.7 years, and 60.4% of the patients were men. The most common indications for intervention were claudication (43.8%) and tissue loss (40.1%). Compared with MC, VCDs were used more often for patients with obesity, diabetes, and end-stage renal disease (P < .001 for all). VCDs were used less often for patients with hypertension, chronic obstructive pulmonary disease, coronary artery disease, prior percutaneous coronary and extremity interventions, and major amputation (P < .001 for all). VCD use was more common than MC during femoropopliteal (73% vs 63.8%) and tibial (33.8% vs 22.3%) interventions but less common with iliac interventions (20.6% vs 34.7%; P < .001 for all). Protamine was used less often with VCDs (19.1% vs 25.6%; P < .001). Overall, 2003 hematomas had developed (2.4%), of which 278 (13.9%) had required thrombin or surgical intervention. Compared with MC, the use of any VCD had resulted in fewer hematomas (1.7% vs 3.6%; P < .001) and fewer hematomas requiring intervention (0.2% vs 0.5%; P < .001). When divided by hemostatic technique, the rate of the development of any hematoma was as follows: MC, 3.6%; VCD A, 1.4%; VCD B, 1.2%; VCD C, 2.3%; and VCD D, 1.1% (P < .001). The rate of hematomas requiring intervention was as follows: MC, 0.5%; VCD A, 0.2%; VCD B, 0.2%; VCD C, 0.3%; and VCD D, 0.1% (P < .001). Access site stenosis/occlusion was similar between the MC and any VCD groups (0.2% vs 0.2%; P = .12). Multivariable analysis demonstrated that any VCD use and the use of the individual VCDs compared with MC were independently associated with the development of fewer hematomas. The incidence of access site stenosis/occlusion was similar between the use of any VCD and MC. The matched analysis revealed similar findings. CONCLUSIONS: Although the overall rates of hematomas requiring intervention were low regardless of hemostatic technique, VCD use, irrespective of type, compared favorably with MC, with significantly fewer access site complications after PVI.

Case series of closure devices complications.

Vascular closure devices (VCD) are effective at achieving hemostasis. VCD failure is attributed to underlying arterial disease, leading to a hazardous situation for obtaining contralateral femoral access. Radial-to-peripheral (R2P) access has emerged as a safe option to rescue these procedural complications. Here, we present two cases of VCD failure rescue utilizing R2P and outline this approach step-by-step.

Real-world VASCADE closure device versus manual compression use and outcomes in patients with severe common femoral artery disease.

BACKGROUND: The VASCADE closure device deploys an extravascular collagen plug. Its use in those with access site disease undergoing peripheral vascular intervention (PVI) is unknown. We aimed to evaluate the efficacy and safety of the VASCADE closure device compared to manual compression (MC) in patients with moderate femoral access site disease. METHODS: We performed a single-center, retrospective review of patients undergoing PVI with at least moderate access site disease. Our institutional database was linked to the Vascular Quality Initiative database, and 200 patients were selected from a 1:1 propensity-matched cohort. Data on procedural metrics and outcomes up to 30-days were abstracted. RESULTS: There were 103 procedures that used VASCADE and 97 used MC. Baseline variables were similar between groups. The mean age was 68.2 ± 11.2 years and 37.6% were women. Closing mean activated clotting time (ACT) was shorter in VASCADE (198 s VASCADE vs. 213 s MC; p = 0.018). There was a nonsignificant decrease in external compression device use with VASCADE (VASCADE 19.0% vs. MC 28.1%; p = 0.15). At 30-days, there was a nonsignificant reduction in hematoma with VASCADE (3.8% vs. 7.8% MC; p = 0.25) and no difference in retroperitoneal bleeding (0.5%). Pseudoaneurysm rate was similar (1.3% VASCADE vs. 1.7% MC; p = 0.79). The 30-day mortality rate was similar between the two groups and not related to the procedure (1.3% VASCADE vs. 0.9% MC; p = 0.79). CONCLUSION: In patients undergoing PVI with at least moderate access site disease, safety and efficacy after using VASCADE was comparable with MC.

Safe and rapid radial hemostasis achieved using a novel topical hemostatic patch: Results of a first-in-human pilot study using hydrophobically modified polysaccharide-chitosan.

BACKGROUND: The transradial approach (TRA) for catheter interventions decreases vascular complications and bleeding versus transfemoral approach. Reducing time to hemostasis and preventing radial artery occlusion (RAO) following TRA are important and incompletely realized aspirations. OBJECTIVES: This first-in-human study sought to evaluate the efficacy of a novel, topically applied compound (hydrophobically modified polysaccharide-chitosan, hm-P) plus minimal required pneumatic compression, to achieve rapid radial arterial hemostasis in post-TRA procedures compared with de facto standards. MATERIALS AND METHODS: About 50 adult patients undergoing 6 French diagnostic TRA procedures were prospectively enrolled. At procedure completion, a topical hm-P impregnated patch was placed over the dermotomy and TR Band (TRB) compression was applied to the access site. This patch was used as part of a novel rapid deflation protocol with a primary outcome of time to hemostasis. Photographic and vascular ultrasound evaluation of the radial artery was performed to evaluate the procedural site. RESULTS: Time to hemostasis was 40.5 min (IQR: 38-50 min) with the majority of patients (n = 39, 78%) not requiring reinflation. Patients with bleeding requiring TRB reinflation were more likely to have low body weight and liver dysfunction, with absence of hypertension and LV dysfunction. The rate of RAO was 0% with predischarge radial artery patency documented in all patients using vascular ultrasound. One superficial hematoma was noted. No late bleeding events or cutaneous reactions were reported in the study follow-up. CONCLUSIONS: Topical application of hm-P in conjunction with pneumatic compression was safe and resulted in rapid and predictable hemostasis at the arterial puncture site.

Single versus double Perclose techniques for vascular closure during transfemoral transcatheter aortic valve replacement.

INTRODUCTION: The preferred approach for transcatheter aortic valve replacement (TAVR) is transfemoral. There has been widespread adoption of the Perclose ProglideTM device for vascular closure. Typically, two devices are deployed before upsizing the access sheath in the "preclose technique." Prior investigations have compared the use of a single device versus double device technique, but none have shown significant clinical benefit to either approach. METHODS: Five hundred and six patients underwent transfemoral TAVR (TF-TAVR) with single or double Perclose devices for vascular closure from July 2015 to February 2020. A retrospective review was conducted, and propensity-matched analyses were used to account for differences in baseline characteristics. RESULTS: In the matched analysis, there were 251 patients in the single Perclose group and 238 in the double. There was a statistically significant improvement in overall procedural success using the single closure device (94.6% vs. 88.5%, p = 0.009) This was defined as intraprocedural hemostatic control, lack of contrast extravasation, arterial dissection, occlusion, or stenosis >50% in the final crossover angiogram, as well as unimpaired limb perfusion without claudication throughout the index hospitalization. There was also a significant improvement in arterial dissection rates (0.6% vs. 4.6%, p = 0.004), stenosis >50% (1.3% vs. 4.4%, p = 0.028), and Valve Academic Research Consortium major vascular complications (1.8% vs. 4.9%, p = 0.038). CONCLUSION: A single Perclose device is a safe means of vascular closure during TF-TAVR and may have important clinical benefits compared to the commonly used two-device technique.

Imaging-Guided Deployment of a Balloon-Based Vascular Closure Device in Routine Clinical Practice.

This study evaluated the feasibility and safety of imaging-guided deployment of a Mynx Control device (Cordis, Miami Lakes, Florida) at the femoral access. A total of 201 Mynx devices were used under imaging guidance in 137 patients (mean age, 64.18 years ± 13.8; male, 68.6%) between June 2020 and February 2022. A 5-F sheath was used in 176 (87.6%) procedures, a 6-F sheath was used in 17 (8.5%) procedures, and a 7-F sheath was used in 8 (4%) procedures. Indicator errors occurred in 9 (4.5%) procedures. However, technical success was achieved via manipulation under imaging guidance in all procedures. The mean time to hemostasis was 3.3 minutes ± 0.5, and the clinical success rate was 100%. The mean length of hospital stay was 7 days ± 7.5. After 4 (2%) procedures, small hematomas reabsorbed spontaneously. Imaging-guided deployment of a Mynx Control device is a feasible and safe option for access site closure. Even after an indicator error, successful hemostasis was achieved via real-time interaction.

The Use of an Inflatable Adhesive External Compression Device for Maintenance of Hemostasis following Angiography in Children.

PURPOSE: To assess the safety and efficacy of the posthemostasis use of an inflatable adhesive external compression device (SafeGuard) following angiography in children performed under general anesthesia. MATERIALS AND METHODS: Medical records of 74 children (43 females) with a mean age of 8.9 years (range, 0.4-18.0 years) and mean weight of 44.0 kg (range, 7.3-115.7 kg) in whom an inflatable adhesive external compression device was used for maintaining hemostasis following angiography under general anesthesia were retrospectively reviewed. After establishing hemostasis with manual compression, the device was applied and inflated over the arteriotomy. The patients were assessed for access-related adverse events in the recovery unit and during postprocedural follow-up. RESULTS: The inflatable adhesive external compression device was utilized to maintain hemostasis following 181 angiography procedures. The mean length of the procedure was 396 minutes. The common femoral artery (n = 170, 93.9%) was the most common access, using 4-5-F vascular sheath (n = 118, 65.2%) or 3-5-F sheathless (n = 8, 12.7%) catheters. The mean time to deflation was 93 minutes. There were no adverse events other than minor bleeding from the arteriotomy after deflation (n = 2, 1.1%) and early deflation of the device because of pain (n = 1, <1%). Follow-up ultrasonography (n = 109 procedures, 60.2% at a mean follow-up of 2.2 years) demonstrated patency of the access artery. CONCLUSIONS: The use of an inflatable adhesive external compression device following angiography in children to maintain hemostasis during the emergence phase of anesthesia and recovery period is safe and effective. The use of this simple device may reduce the need for postprocedural sedation and facilitate early discharge.

Comparison of MynxGrip vascular closure device and manual compression for closure after femoral access angiography: a randomized controlled trial: the closure devices used in every day practice study, CLOSE-UP III trial.

BACKGROUND: Complications related to femoral artery access for coronary angiography (CAG) is a safety concern. Vascular closure devices (VCDs) have been developed to reduce the rate of complications after femoral artery access. We compared the safety and efficacy of the MynxGrip VCD versus manual compression (MC) after femoral access CAG in a randomized controlled trial. METHODS: The study was a randomized, single center, non-blinded, two-arm non-inferiority trial. The study was stopped prematurely because of low inclusion rate. RESULTS: We randomized 869 patients to closure with the MynxGrip VCD or MC and 865 entered analyses. The incidence of the primary endpoint of major adverse vascular events (MAVE) after 30 days was 1.2% in the MynxGrip group and 0% in the MC group (p = 0.06). The median time to hemostasis was 4 [3:5] minutes and 10 [7:11] minutes in the MynxGrip group and MC group, respectively (p < 0.0001). The corresponding median times to mobilization was 73 [65:87] minutes and 76 [70:88] minutes (p = 0.01). CONCLUSIONS: MAVE was rare after closure of femoral arterial access by both the MynxGrip VCD and MC. We found a numerical difference in favour of MC but this did not reach statistical significance. Time to hemostasis was shorter in the MynxGrip group when compared to the MC group. TRIAL REGISTRATION: The study was approved by the local medical ethics committee and registered at clinicaltrials.org (ClinicalTrials identifier: NCT02237430 11/09/2014).

Management of Peripheral Vascular Interventions in an Ambulatory Setting: A Single-Center Retrospective Analysis.

BACKGROUND: The development of minimally invasive devices to treat peripheral artery disease led to a reduction of complications, particularly of the puncture or access site. Subsequently, the number of ambulatory procedures increased, saving costs and resources. This analysis was performed to provide data on patients treated with 4 French (F) compatible devices in ambulatory and in-hospital settings. METHODS: This is a single-center retrospective analysis of prospectively collected data. Consecutive patients who received peripheral vascular interventions from 2013 to 2015 were included. Data were extracted from electronic patients' files; data until the time of last contact were collected. Arterial puncture was performed under ultrasound guidance; 4F compatible devices ought to be selected and compression devices were used to seal the puncture site. The primary outcome was the rate of ambulatory failure in the ambulatory group. RESULTS: A total of 219 patients (68.5% male, 69.5 ± 12.8 years) were included in the analysis. Thereof 71 patients with 80 procedures were hospitalized, predominantly for social reasons (42/80, 52.5%) or emergency conditions (18/80, 22.5%). In the ambulatory group (148 patients), 183 procedures were performed, thereof 92.9% (170/183) with a 4F compatible equipment. Procedural success was 91.8% (168/183) in the ambulatory group and 82.5% (66/80) in the hospitalized group (P = 0.027). Patients in an ambulatory setting were younger and more frequently males. Ambulatory success was 99.2% (181/183). One puncture site complication was observed in each group but no other procedural complication, and all patients were alive after 1 month. In the ambulatory group, the mean follow-up was of 148 ± 260 days and in the hospitalized group, the mean follow-up was of 126 ± 199 days; no patient died during follow-up in the ambulatory group but 3 patients died in the hospitalized group. CONCLUSIONS: Ambulatory endovascular procedures can be safely performed in a large proportion of patients with peripheral artery disease.