Feasibility, safety, and efficacy of a novel external compression vascular closure device: The LockeT® study.

INTRODUCTION: Hemostasis following large-bore femoral vein access remains a challenge. Manual compression has been the standard of care but requires bedside staff, prolonged bed rest, and longer length of stay. The LockeT is an external compression device that attempts to address these issues while achieving venous hemostasis. OBJECTIVES: We evaluate postprocedural hemostasis and vascular closure outcomes after using LockeT following cardiac electrophysiologic procedures. METHODS: We performed a single-center, observational study of patients who underwent vascular closure for electrophysiology procedures using LockeT. Postprocedural outcomes were subsequently analyzed. RESULTS: We studied 102 patients (N) for whom LockeT was used to close 182 separate vascular access sites (n). Common procedures were atrial fibrillation ablation (56.9%, N = 58) and left atrial appendage occlusion (28.4%, N = 29). Most often, 8-Fr [48.3% (n = 126)], 11-Fr [27.2% (n = 71)], and 8.5-Fr [16.9% (n = 44)] sheaths were used, with an average procedure time of 82.1 ± 29.4 min. Hemostasis was achieved in 97.8% (n = 187) of all LockeT cases. Time to ambulation and discharge were 3.93 ± 1.10 h and 8.1 ± 4.4 h, respectively. No major complications were noted. Postprocedurally, 52% (N = 53) of patients were discharged on the same day. There were no differences in hemostasis (p = .859) or ambulation times (p = .202) between procedure types. CONCLUSION: The LockeT can effectively close venous access sites with no major complications.

Outcomes of vascular closure devices for femoral venous hemostasis following catheter ablation of atrial fibrillation.

INTRODUCTION: Access site complications remain common following atrial fibrillation (AF) catheter ablation. Femoral vascular closure devices (VCDs) reduce time to hemostasis compared with manual compression, although large-scale data comparing clinical outcomes between the two approaches are lacking. METHODS: Two cohorts of patients undergoing AF ablation were identified from 36 healthcare organizations using a global federated research network (TriNetX): those receiving a VCD for femoral hemostasis, and those not receiving a VCD. A 1:1 propensity score matching (PSM) model based on baseline characteristics was used to create two comparable cohorts. The primary outcome was a composite of all-cause mortality, vascular complications, bleeding events, and need for blood transfusion. Outcomes were assessed during early (within 7 days of ablation) and extended follow-up (within 8-30 days of ablation). RESULTS: After PSM, 28 872 patients were included (14 436 in each cohort). The primary composite outcome occurred less frequently in the VCD cohort during early (1.97% vs. 2.60%, odds ratio (OR) 0.76, 95% confidence interval (CI) 0.65-0.88; p < .001) and extended follow-up (1.15% vs. 1.43%, OR 0.80, 95% CI 0.65-0.98; p = .032). This was driven by a lower rate of vascular complications during early follow-up in the VCD cohort (0.83% vs. 1.26%, OR 0.66, 95% CI 0.52-0.83; p < .001), and fewer bleeding events during early (0.90% vs. 1.23%, OR 0.73, 95% CI 0.58-0.92; p = .007) and extended follow-up (0.36% vs. 0.59%, OR 0.61, 95% CI 0.43-0.86; p = .005). CONCLUSION: Following AF ablation, femoral venous hemostasis with a VCD was associated with reduced complications compared with hemostasis without a VCD.

Costs, efficiency, and patient-reported outcomes associated with suture-mediated percutaneous closure for atrial fibrillation ablation: Secondary analysis of a randomized clinical trial.

INTRODUCTION: To evaluate the cost and efficiency of suture-mediated percutaneous closure (SMC) compared to manual compression (MC) after atrial fibrillation (AF) ablation. SMC has been demonstrated to be efficacious in reducing hemostasis and bedrest times after AF ablation. To date, randomized data comparing the direct and indirect cost between the two techniques have not been described. METHODS: We conducted a 1:1 randomized trial comparing SMC to MC following AF ablation. The primary endpoints have been previously published. However, secondary endpoints pertinent to indirect cost including complication rates, hospital utilization (i.e., delays in discharge, additional patient encounters, nursing utilization), pain, patient reported outcomes, as well as the direct costs of care associated with AF ablation were collected. We also performed secondary analysis of the primary endpoint to evaluate for a learning curve, and subgroups analysis comparing efficacy across different numbers of access sites and compared to those in the MC group with a figure-of-eight suture (Fo8), that could potentially have impacted the relative efficiency of the procedure. RESULTS: A total of 107 patients were randomized and included: 53 in the SMC group and 54 in MC. A learning curve was observed in the SMC group between the first and second half of the study group (p = 0.037), with no such difference in the MC group. After accounting for the number of access sites, time to hemostasis remained shorter in the SMC Group (p = 0.002). Compared to those in the Fo8 arm (n = 37), the time to hemostasis remained shorter in the SMC group (p = 0.001). Among those planned for same-day discharge, there were more delays in the MC group (31.5% vs. 11.3%, p = 0.0144). Rates of major and minor complications were similar between SMC and MC groups at discharge (p = 0.243) and 30 days (p = 1.00), as were nursing utilization, self-reported pain, and overall patient reported outcomes. The overall cost of care related to the procedure was similar between the MC and SMC groups ($56 533.65 [$45 699.47, $66 987.64] vs. $57 050.44 [$47 251.40, $66 426.34], p = 0.601). CONCLUSION: SMC has been shown to decrease time to hemostasis and ambulation and facilitate earlier same-day discharge after AF ablation without an increase in direct or indirect costs.

Clinical outcomes of MANTA closure device in percutaneous endovascular aortic aneurysm repair.

OBJECTIVE: The MANTA device is a plug-based vascular closure device (VCD) designed for large bore femoral arterial access site closure. It showed promising results in transcatheter aortic valve replacement cases. In this study, we report our results and evaluate the MANTA VCD in percutaneous endovascular aortic aneurysm repair (pEVAR). METHODS: All data of consecutive patients who underwent an elective pEVAR between October 2018 and December 2022 were retrospectively reviewed. In all patients at least one common femoral artery was intended to close with the MANTA VCD. Depending on the sheath size, the 14Fr or 18Fr MANTA VCD was used. On the preoperative computed tomography scan, the diameter of the common femoral artery (CFA) was measured and the amount of calcification based on the Peripheral Arterial Calcium Scoring System (PACSS) was scored. Primary outcome was procedural technical success. Procedural technical success was defined as placement of the MANTA closure device resulting in vascular closure with patent CFA, without requiring immediate open or endovascular surgery. The secondary outcomes were access site complications requiring reintervention and all-cause mortality at 30-day follow-up. RESULTS: In total, 152 consecutive patients underwent pEVAR with 291 common femoral artery closure procedures with the Manta VCD. Mean age was 74.1 ± 6.4 years, with a mean body mass index of 27.7 ± 4.4 kg/m2. The mean diameter of the CFA was 10.5 ± 1.9 mm. In 52.6% of the cases, there were no calcification on the preoperative computed tomography scan. The 18Fr and 14Fr Manta VCD were used 169 and 122 times, respectively. The technical success rate was 96.6%. Major vascular complications were reported in 4.5% of the cases, without any death-related events. CONCLUSIONS: This single-center retrospective cohort study analyzed the procedural technical success, major vascular complications and all-cause mortality at 30-day follow-up of the MANTA vascular closure device in 152 pEVAR patients with 291 common femoral artery closure procedures. The technical success rate was 96,6%. Major vascular complications were reported in 4.5% of the cases, without any death related events. We concluded that the MANTA device is a safe and feasible option with a high rate of technical success in patients undergoing pEVAR.

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.

Assessment of the MANTA closure device in real-life transfemoral transcatheter aortic valve replacement: A single-centre observational study.

BACKGROUND: Vascular complications increase morbidity and mortality in transcatheter aortic valve replacement (TAVR). Data involving suture-based percutaneous vascular closure devices (VCDs) have been extensive. Although promising, data regarding the efficacy and safety of the MANTA VCD (Teleflex) are scarce. We sought to assess the safety and effectiveness of the MANTA device in a real-life unselected cohort of patients undergoing transfemoral-TAVR (TF-TAVR). METHODS: This single-center retrospective observational study included a cohort of consecutive patients with severe aortic stenosis (AS) treated by our team using TAVR between January 2020 to December 2022. The primary outcome measure was access-related major and minor vascular complications according to the Valve Academic Research Consortium (VARC-3) definition criteria. RESULTS: From January 2020 to December 2022, a total of 347 patients underwent TF-TAVR were treated using the MANTA 18 Fr VCD system for vascular closure. Mean age was 82.4 ± 6.1 years (56-98 years). There were no significant differences in preoperative and procedural characteristics between patients with and without VCD-related major vascular complications. Access site-related major and minor vascular complications occurred in 20 of 347 patients (5.7%). Overall, major vascular complications occurred in 5 patients (1.4%) and device failure was seen in 17 patients (4.9%). CONCLUSION: This French real world evaluation of large-bore arteriotomy closure in TF-TAVR indicated that MANTA VCD is a feasible alternative with an acceptable low rate of access-site-related complications.

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.

Incidence and predictors of vascular complications following transcatheter aortic valve implantation: A comparison of the MANTA and suture-based vascular closure devices.

BACKGROUND: Vascular complications post-transcatheter aortic valve implantation (TAVI) are common. Recent data regarding predictors of vascular complications are limited, particularly comparing newer plug-based devices versus traditional suture-based vascular closure devices (VCD). AIM: The primary objective was to identify characteristics that predict a higher risk of vascular complications in TAVI patients, as judged by the VARC-3 criteria, specifically comparing risk factors between suture-based vs MANTA device closure. METHODS: Retrospective analysis of patients who underwent TAVI between December 2019 and September 2023 was performed. Logistic regression and propensity score matching was performed to ascertain risk factors for vascular complications post-TAVI. RESULTS: Of the 1763 patients, there were 106 vascular complications (6%). There was a nonsignificant increased complication rate in MANTA vs suture-based device closure (8.3% vs 5.3%, p = 0.064). Among these, the most common complications were VCD failure (23%), pseudoaneurysm (20%) and arterial dissection (19%). Obesity (p = 0.021), anemia (p = 0.039) and MANTA device use (p = 0.027) were predictors of vascular complications. Within the MANTA cohort, novel oral anticoagulant (NOAC) use was predictive of vascular complications (p = 0.002). Among suture-based devices, obesity (p = 0.037) and anaemia (p = 0.017) were significant predictors. A propensity matched analysis derived 90 pairs of patients matched for age, gender, diabetes, peripheral arterial disease, NOAC use, anemia and obesity, identifying an average treatment effect of 0.039 (p = 0.04) when MANTA device closure was performed. CONCLUSION: Vascular complications in TAVI remain common. Identifying predictors such as MANTA device closure, obesity, anemia, and baseline NOAC use will allow for improved risk stratification and appropriate VCD selection in patients undergoing TAVI.

Efficacy and safety of the VASCADE® MVP venous vascular closure device in patients undergoing percutaneous left atrial appendage occlusion with WATCHMAN.

BACKGROUND: The VASCADE MVP venous vascular closure system is commonly used for percutaneous venotomy closure in catheter-based procedures utilizing sheath sizes 6-12 French. However, its application with larger sheaths such as ones required in left atrial appendage occlusion (LAAO) has yet to be explored. AIMS: This study compared the efficacy and safety of VASCADE MVP versus conventional Figure-of-8 sutures (Fo8) for femoral venotomy closure in patients undergoing Watchman LAAO. METHODS: This single-center retrospective analysis included patients who underwent post-LAAO femoral venotomy closure with either VASCADE MVP or Fo8 sutures. The primary efficacy endpoint was time to hemostasis (TTH). Primary safety endpoints were 30-day access site-related readmissions and major complications. Minor access-site-related complications were also assessed. RESULTS: 107 patients underwent post-LAAO femoral venotomy closure with VASCADE MVP, of which 101 were successful (94.4%). 99 patients underwent conventional closure with Fo8 sutures and supplemental manual pressure. Baseline characteristics were similar between groups. TTH was significantly shorter with VASCADE MVP (152.9 vs. 335.8 s, p = 0.001). Major safety outcomes were comparable. However, the conventional group experienced a higher incidence of ecchymosis (16.2% vs 4.7%, p = 0.007) and 30-day all-cause readmission (18.2% vs 8.4%, p = 0.038). CONCLUSIONS: VASCADE MVP significantly reduced TTH compared to Fo8 sutures after LAAO. While demonstrating a similar safety profile, VASCADE MVP may offer a more efficient approach to femoral vein closure in this patient population.

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

BACKGROUND: 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). AIMS: The aim of this study is to assess vascular outcomes for ultrasound-guided deployment of ProGlide vascular closure devices in patients undergoing TF-TAVI. METHODS: We collected relevant clinical data of patients undergoing TAVI in a large volume centre. PRIMARY OUTCOME: main access Valve Academic Research Consortium 3 (VARC-3) major vascular complication. SECONDARY OUTCOME: 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. RESULTS: Five hundred and seventeen patients undergoing TF-TAVI were included. PRIMARY OUTCOME: In 126 (ultrasound-guided) and 391 (conventional ProGlide insertion), 0% versus 1.8% (p < 0.001) had a major VARC-3 vascular complication, respectively. SECONDARY OUTCOME: 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). CONCLUSIONS: Ultrasound-guided deployment of ProGlide for vascular closure reduced the risk of major vascular complications in a large population undergoing TAVI.

Ultrasound-guided genitofemoral nerve block for femoral arterial access gain and closure: a randomized controlled trial.

OBJECTIVES: This study aimed to compare the analgesic efficacy and safety of the femoral branch block of the genitofemoral nerve (FBB) versus local infiltration anesthesia (LIA) for femoral arterial access gain and closure. METHODS: Eighty-two patients (age, 64.8 ± 10.9 years; female, 30.5%) undergoing endovascular procedures using 5-Fr femoral sheath were assigned to either FBB (n = 41) or LIA (n = 41). In both groups, 2% lidocaine HCL with 1:100,000 epinephrine was used as an anesthetic solution. Pain scores during access gain and closure were evaluated using a visual analog scale (score 0-10), patient satisfaction levels with the quality of anesthesia were scored on a 7-point Likert scale, and adverse events were recorded. RESULTS: The primary endpoint, pain scores during access closure, was significantly lower in the FBB group than in the LIA group (0.1 ± 0.37 vs 1.73 ± 0.92; p < 0.001). The FBB group also had significantly lower pain scores during access gain compared to the LIA group (0.83 ± 0.83 vs 2.78 ± 1.26; p < 0.001). There was an inverse relationship between pain scores and FBB after adjustment for age, gender, and body mass index (p < 0.001). FBB group reported significantly higher satisfaction with anesthesia quality compared to the LIA group (6.49 ± 0.64 vs 4.05 ± 1.05; p < 0.001). No complications were recognized in either group. CONCLUSIONS: Ultrasound-guided genitofemoral nerve blocks offered better acute pain relief and higher patient satisfaction than LIA during femoral arterial access gain and closure. CLINICAL RELEVANCE STATEMENT: In this prospective randomized controlled trial, ultrasound-guided genitofemoral nerve blocks offered better acute pain relief than local infiltration anesthesia, resulting in enhanced patient satisfaction. KEY POINTS: • FBB provided better pain relief during access gain and closure than LIA. • FBB offered higher patient satisfaction with the quality of anesthesia than LIA. • No anesthesia-related or access site complications were recognized in either treatment group.

ESR Essentials: arterial vascular access and closure devices-practice recommendations by the Cardiovascular and Interventional Radiological Society of Europe.

Vascular access is the initial, very important, step of endovascular procedures. Various access sites include the common femoral artery, brachial artery, radial artery, popliteal artery, and distal tibial vessels (pedal arteries). Successful arterial access requires advanced knowledge of anatomy, as well as proper training and experience. Today, vascular access should be obtained using real-time, ultrasound guidance to reduce access time, patient discomfort, and puncture-related complications including dissection, arteriovenous communication, and bleeding. Nevertheless, high-level evidence to support this recommendation in peripheral procedures is limited and level A data are mainly derived from randomized cardiac trials investigating only radial and femoral access. Vascular closure devices (VCDs) for femoral access can be broadly categorized as active closure devices, compression assist devices, and external/topical hemostasis devices. There is high-level evidence demonstrating that their use is related to less time for ambulation and increased patient satisfaction. However, available data failed to clearly demonstrate a benefit in complications compared to standard manual compression in peripheral endovascular arterial procedures, and thrombotic and infectious complications reported following VCD use remain an issue. Heterogeneity noted in the literature, caused by the vast variety of devices, access sites, sheath sizes, clinical scenarios, and procedures, poses difficulties in data analysis and future study design. As a result, an individualized VCD use is currently suggested for ≥ 5 Fr femoral artery access not only to reduce time to hemostasis and ambulation and to improve patient comfort, but also to reduce bleeding complications in cases of femoral access with increased bleeding risk, deranged coagulation, and large-bore access, though a high level of evidence to support this later recommendation is limited. KEY POINTS: US guidance is strongly recommended for femoral access and is mandatory to obtain more challenging access. The use of VCDs for femoral hemostasis is generally safe, effective, and currently supported by level I evidence. Proper training and correct VCD choice, based on the patient's individual characteristics, are imperative to optimize outcomes.

Comparing Obtura Vascular Closure Device to Manual Compression for Achieving Hemostasis After Percutaneous Transfemoral Procedures: A Randomized Study.

PURPOSE: This trial was designed and aimed to compare safety and efficacy of Obtura™ vascular closure device (VCD) to manual compression (MC) among patients undergoing transfemoral catheterization. MATERIAL AND METHODS: This prospective, randomized, controlled, multicenter trial of Obtura VCD against MC randomized patients in 1:1 (n=268; 134:134) ratio. Safety and efficacy were measured by primary endpoints (time to hemostasis [TTH] and deployment success) and secondary endpoints which included technical success, device-related adverse events, and time to ambulation (TTA). RESULTS: The procedural access using right femoral artery was performed in 95.52% of patients in Obtura VCD versus 96.27% in standard MC method, whereas 2.99% of patients in each group underwent left femoral access. Bilateral access was performed in 1.49% (n=2) versus 0.75% (n=1) in Obtura VCD versus MC, respectively. Both the technical success and deployment success were 100%. Patients in Obtura VCD group had shorter TTH (3.26±3.39 vs 23.95±8.24 minutes; p<0.0001) and TTA (155.44±125.32 vs 723.84±197.98 minutes; p<0.0001) than MC group. No access site complications (re-bleeding, infection, arteriovenous fistula, and transient access site nerve injury) were noted at 2-week, 1-month, and 3-month follow-ups. There were 4 (3%) and 6 (4.5%) cases of hematoma, respectively, in Obtura VCD versus MC and 1 case (0.7%) of post-procedural arterial pseudoaneurysm each in both the groups which were successfully resolved and patients were discharged with no further complications. Further follow-up was without any adverse events. CONCLUSIONS: The study demonstrated favorable safety and efficacy of Obtura™ VCD with a significantly short TTH and TTA compared to MC. CLINICAL IMPACT: In patients undergoing cardiac catheterization, vascular closure devices (VCDs) can achieve hemostasis faster after successful implantation of the device with fewer complications such as bleeding and ambulation can be achieved faster. In terms of effectiveness, Obtura VCD was found to be better than manual compression in achieving early hemostasis and higher technical and deployment success was accomplished. Obtura VCD does not require enlargement of the route through the tissues, uses the same existing arterial sheath as its conduit, and does not cause patients' access sites to feel uncomfortable while it is being deployed.

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

PURPOSE: 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. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSION: 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. CLINICAL IMPACT: 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.

Venous vascular closure system vs. figure-of-eight suture following atrial fibrillation ablation: the STYLE-AF Study.

AIMS: Simplified ablation technologies for pulmonary vein isolation (PVI) are increasingly performed worldwide. One of the most common complications following PVI are vascular access-related complications. Lately, venous closure systems (VCSs) were introduced into clinical practice, aiming to reduce the time of bed rest, to increase the patients' comfort, and to reduce vascular access-related complications. The aim of the present study is to compare the safety and efficacy of using a VCS to achieve haemostasis following single-shot PVI to the actual standard of care [figure-of-eight suture and manual compression (MC)]. METHODS AND RESULTS: This is a prospective, multicentre, randomized, controlled, open-label trial performed at three German centres. Patients were randomized 1:1 to undergo haemostasis either by means of VCS (VCS group) or of a figure-of-eight suture and MC (F8 group). The primary efficacy endpoint was the time to ambulation, while the primary safety endpoint was the incidence of major periprocedural adverse events until hospital discharge. A total of 125 patients were randomized. The baseline characteristics were similar between the groups. The VCS group showed a shorter time to ambulation [109.0 (82.0, 160.0) vs. 269.0 (243.8, 340.5) min; P < 0.001], shorter time to haemostasis [1 (1, 2) vs. 5 (2, 10) min; P < 0.001], and shorter time to discharge eligibility [270 (270, 270) vs. 340 (300, 458) min; P < 0.001]. No major vascular access-related complication was reported in either group. A trend towards a lower incidence of minor vascular access-related complications on the day of procedure was observed in the VCS group [7 (11.1%) vs. 15 (24.2%); P = 0.063] as compared to the control group. CONCLUSION: Following AF ablation, the use of a VCS results in a significantly shorter time to ambulation, time to haemostasis, and time to discharge eligibility. No major vascular access-related complications were identified. The use of MC and a figure-of-eight suture showed a trend towards a higher incidence of minor vascular access-related complications.

A single institution experience of the Manta closure device in endovascular aortic repair.

BACKGROUND: Majority of EVAR procedures are performed with percutaneous arterial access, unless there is severe steno-occlusive disease in the common femoral arteries (CFA). We present our experience of using MANTA closure device with a retrospective evaluation of its safety and efficacy, in the elective setting, and in the emergent setting for ruptured aortic aneurysm. DESIGN AND METHODS: Between Feb 2021 and May 2023 a total of 75 EVAR procedures were closed with a Manta device. Data was collected prospectively and analysed retrospectively. In 75 patients, 128 CFAs were closed with a Manta closure device including 4 emergent ruptured aneurysms. RESULTS: 67 male and 8 female patients with a median age of 77 years had percutaneous EVAR using Manta as a closure device. 128 CFAs were closed with Manta closure device. 3% (4/128) had deployment failures, with three requiring surgical cut down and closure. In one patient, a second Manta device deployment achieved satisfactory haemostasis. Three deployments were complicated by pseudoaneurysms of the CFA, all requiring no further interventions/treatment. No death related to severe haemorrhage from device failure. The pre- and post-procedure CFA puncture site AP diameter was recorded in a total of 106 cases with appropriate follow-up. 66% of these (70/106) had no reduction in CFA diameter post Manta closure. 34% (36/106) had some reduction of vessel AP size CFA post EVAR. No adverse features or further treatment was required due to reduction of vessel diameter in these cases (ongoing yearly surveillance). CONCLUSIONS: Manta closure device is safe and easy to deploy with an overall success rate of 97%. There is a short learning curve. Ultrasound assessment and precise puncture at the healthy section of femoral artery are the key to achieve successful haemostasis with Manta closure device. Our findings suggest there is an association of non-clinically significant mild reduction in CFA vessel AP diameter post Manta closure device, which does not require further intervention.

Axillary compared to brachial access for endovascular procedures.

OBJECTIVES: Limited knowledge exists regarding access site complication rates between trans-axillary and trans-brachial approaches with sheath sizes ≥6Fr. We retrospectively reviewed our institution experience with access site complications for percutaneous trans-axillary and trans-brachial arterial interventions using sheath sizes ranging from 6Fr to 10Fr. METHODS: We examined 67 endovascular interventions performed over 18 months, restricted to sheath sizes of 6Fr to 10Fr. Procedures utilizing trans-brachial (41 cases) and trans-axillary (26 cases) approaches under sonographic guidance were included. Cases involving hemodialysis accesses and those requiring surgical cut-down were excluded. The primary outcome measure was the occurrence of major access site complications (SIR grade-II/III) within 30 days, with data collected on hemostasis method, sheath size, and complications. Statistical analysis involved ANCOVA and Fisher's exact tests, with significance set at p < .05. RESULTS: Successful percutaneous arterial access was achieved in all cases using either approach (trans-axillary or trans-brachial). Closure devices were employed in all axillary punctures and in 71% of brachial punctures. Major access site complications occurred in 7 out of 41 cases (17%) in the trans-brachial group and in 4 out of 26 cases (15%) in the trans-axillary group. However, there was no statistically significant difference in complication rates between the two groups, regardless of access site or sheath size. CONCLUSION: Trans-axillary access serves as a safe and effective upper limb access method for percutaneous endovascular procedures requiring sheath size of 7Fr or larger when compared to trans-brachial approach.

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.

Hepatic and splenic venous access tract closure using the VASCADE vascular closure system following percutaneous intervention in patients with CHD.

BACKGROUND: Hepatic and splenic venous access are specialised techniques used to perform diagnostic and interventional procedures in the cardiac catheterisation laboratory. Bleeding events are the most commonly reported complication following hepatic or splenic venous access. The VASCADE Vascular Closure System (Cardiva Medical Inc. Santa Barbara, CA) is an approved device for closure of femoral vascular access tracts in patients ≥18 years of age. We report our experience using VASCADE to close the hepatic or splenic venous access site in the cardiac catheterisation laboratory. METHODS: This is a single centre retrospective review of all patients who had percutaneous hepatic or splenic venous access obtained in the cardiac catheterisation laboratory from March 1, 2022 through October 30, 2023 and underwent tract closure with VASCADE. RESULTS: Ten patients (six male) underwent 16 procedures (median age and weight 3.5 years and 12.5 kg) with 15 hepatic and two splenic veins accessed. Successful closure of the access tracts with VASCADE was performed in all patients. There were no major adverse events related to closure of the access sites with VASCADE. CONCLUSION: VASCADE can be used following transhepatic and trans-splenic venous access in the cardiac catheterisation laboratory to safely close the access tract and potentially reduce the risk of post-procedural bleeding complications. Further evaluation in a larger cohort of patients is needed to ensure VASCADE is safe for use and provides adequate haemostasis following hepatic or splenic venous access, particularly in children.

Comparison of percutaneous decannulation and open surgical repair for large-bore arterial access sites of extracorporeal membrane oxygenation.

INTRODUCTION: Following weaning of peripheral venoarterial extracorporeal membrane oxygenation (ECMO) support, removal of cannulas and repair of large-bore arterial sites is traditionally by open surgical repair (OSR). The use of a percutaneous vascular closure device (VCD) offers a minimally invasive alternative to OSR with potential for reduced operative complications, reduced hospital length of stay and in-hospital mortality. METHODS: A systematic review of Medline and Embase databases was conducted for studies comparing VCD-assisted decannulation with OSR following decannulation of peripheral ECMO. The primary endpoint was rate of post-procedural complications, namely wound infection and limb ischaemia. The secondary endpoint was in-hospital mortality. RESULTS: Eight studies, with a total of 685 patients, met inclusion criteria. Forty-eight percent (n = 328) of patients underwent VCD-assisted decannulation with the remainder decannulated by OSR. Pooled analysis demonstrated that patients undergoing VCD-assisted decannulation are at significantly lower risk of overall complications than surgical repair (OR 4.34; 95% CI 2.19-8.57; p < .001). Specifically, there was a substantial decrease in groin infections (OR 6.77; 95% CI 3.07-14.97; p < .001) without notable differences in limb ischaemia or pseudoaneurysm occurrence between the VCD and OSR cohorts. There was a lower incidence of intra-operative bleeding and haematoma in the VCD cohort (p < .001 and p = .002, respectively). CONCLUSION: Vascular closure device-assisted decannulation of peripheral ECMO offers a significantly reduced risk of complications, particularly groin infections and bleeding. Future research should encompass larger cohorts, randomised controlled trials, cost-benefit analyses, and the training of surgeons, cardiologists and intensivists in VCD-assisted decannulation, potentially through the integration of simulation-based training.