Comparison of a Pure Plug-Based Versus a Primary Suture-Based Vascular Closure Device Strategy for Transfemoral Transcatheter Aortic Valve Replacement: The CHOICE-CLOSURE Randomized Clinical Trial.

BACKGROUND: Transcatheter aortic valve replacement is an established treatment option for patients with severe symptomatic aortic stenosis and is most commonly performed through the transfemoral access route. Percutaneous access site closure can be achieved using dedicated plug-based or suture-based vascular closure device (VCD) strategies, but randomized comparative studies are scarce. METHODS: The CHOICE-CLOSURE trial (Randomized Comparison of Catheter-based Strategies for Interventional Access Site Closure during Transfemoral Transcatheter Aortic Valve Implantation) is an investigator-initiated, multicenter study, in which patients undergoing transfemoral transcatheter aortic valve replacement were randomly assigned to vascular access site closure using either a pure plug-based technique (MANTA, Teleflex) with no additional VCDs or a primary suture-based technique (ProGlide, Abbott Vascular) potentially complemented by a small plug. The primary end point consisted of access site- or access-related major and minor vascular complications during index hospitalization, defined according to the Valve Academic Research Consortium-2 criteria. Secondary end points included the rate of access site- or access-related bleeding, VCD failure, and time to hemostasis. RESULTS: A total of 516 patients were included and randomly assigned. The mean age of the study population was 80.5±6.1 years, 55.4% were male, 7.6% of patients had peripheral vascular disease, and the mean Society of Thoracic Surgeons score was 4.1±2.9%. The primary end point occurred in 19.4% (50/258) of the pure plug-based group and 12.0% (31/258) of the primary suture-based group (relative risk, 1.61 [95% CI, 1.07-2.44], P=0.029). Access site- or access-related bleeding occurred in 11.6% versus 7.4% (relative risk, 1.58 [95%CI: 0.91-2.73], P=0.133) and device failure in 4.7% versus 5.4% (relative risk, 0.86, [95% CI, 0.40-1.82], P=0.841) in the respective groups. Time to hemostasis was significantly shorter in the pure plug-based group (80 [32-180] versus 240 [174-316] seconds, P<0.001). CONCLUSIONS: Among patients treated with transfemoral transcatheter aortic valve replacement, a pure plug-based vascular closure technique using the MANTA VCD is associated with a higher rate of access site- or access-related vascular complications but a shorter time to hemostasis compared with a primary suture-based technique using the ProGlide VCD. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04459208.

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.

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.

Safety and Effectiveness of a Sequential Suture and Plug Vascular Closure Devices Technique for Large-Bore Access Closure after Percutaneous Endovascular Aneurysm Repair.

PURPOSE: To evaluate the safety and effectiveness of sequential sutures and plugged vascular closure devices (VCDs) for large-bore access closure during percutaneous access endovascular aneurysm repair (PEVAR). MATERIALS AND METHODS: Data on 16 patients who underwent PEVAR at the authors' center from January 2022 to May 2022 were retrospectively reviewed. The median age was 72 years (interquartile range [IQR], 59-75 years), with a male-to-female ratio of 3:1. All patients received sequential suture and plug VCDs using dual Exoseal after 1 Proglide for access closure. Success was defined as the ability to achieve complete hemostasis and was confirmed by ultrasonography. The patients were followed up for access-related adverse events at 30 and 90 days after the procedure, and the severity was graded according to the Society of Interventional Radiology (SIR) classification. RESULTS: Overall, 24 access sites were included. The median sheath size was 21 F (IQR, 18-23 F). The median hemostasis time was 11.0 minutes (IQR, 9.3-13.0 minutes), the median procedural time was 133.5 minutes (IQR, 102.5-151.0 minutes), and the median length of stay was 5 days (IQR, 4.0-6.8 days). The success rate was 95.8%, and a pseudoaneurysm (SIR Grade 2) developed in 1 patient, which was treated by a percutaneous injection of thrombin. No other access-related adverse events occurred, and the total adverse event rate was 4.2%. CONCLUSIONS: Placement of sequential suture and plug VCDs using 1 Proglide and dual Exoseal is a safe and effective method and may be an option for access closure during PEVAR.

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.

Percutaneous decannulation of venoarterial extracorporeal membrane oxygenation using the Manta vascular closure device: A systematic review and meta-analysis.

OBJECTIVES: To perform a systematic review and meta-analysis of the techniques and outcomes associated with percutaneous decannulation of venoarterial extracorporeal membrane oxygenation (VA-ECMO) using the Manta vascular closure device. BACKGROUND: Peripheral VA-ECMO can be used to treat critically ill patients with conditions such as refractory cardiogenic shock. After percutaneous implantation of VA-ECMO, VA-ECMO can also be decannulated completely percutaneously by using a vascular closure device. The Manta vascular closure device is a dedicated device used in the closure of large-bore arteriotomies by sandwiching the arteriotomy with an intra-arterial toggle and an extraluminal collagen plug. METHODS: We performed a thorough literature search using various electronic databases. We included studies that reported outcomes after peripheral femorofemoral VA-ECMO decannulation with the Manta vascular closure device. We performed a meta-analysis of proportions on outcome measures, including technical success, bleeding complications, vascular complications, wound complications, major amputation, and procedural-related deaths. RESULTS: We included seven studies with a total of 116 patients. The overall technical success of percutaneous decannulation of VA-ECMO with the Manta vascular closure device was 93.7%. The overall incidence of bleeding, vascular and wound complications was 1.7%, 13.8%, and 3.4%, respectively. No patient required lower limb amputation or died due to VA-ECMO decannulation. CONCLUSION: Percutaneous decannulation with the Manta vascular closure device is an effective and safe procedure that should be considered in suitable patients on VA-ECMO.

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.

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.

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.

Percutaneous decannulation of extracorporeal membrane oxygenation using a plug-based closure device.

BACKGROUND: There is limited experience of using the MANTA plug-based vascular closure device for percutaneous arterial closure of the femoral artery after venoarterial extracorporeal membrane oxygenation. OBJECTIVES: To study femoral artery complications and need for subsequent vascular interventions after percutaneous decannulation of venoarterial extracorporeal membrane oxygenation (VA ECMO) using the MANTA plug-based vascular closure device. METHODS: We studied 34 consecutive patients who underwent percutaneous decannulation of VA ECMO using the MANTA device. Primary outcomes were conversion to surgical cutdown of the groin at decannulation (immediate) or later. Secondary outcomes were type of vascular complication necessitating conversion to surgical cutdown of the groin. RESULTS: Six (17.7%) patients had to undergo immediate (n = 3) or late (n = 3) conversion to surgical cutdown of the groin. Of these, three were owing to occlusion of the common femoral artery resulting in insufficient distal perfusion and three owing to bleeding or pseudoaneurysm. The mechanism of failure was complete intravascular deployment of the MANTA device in three patients, incomplete MANTA sealing of the arteriotomy in one patient, MANTA-unrelated thrombotic occlusion in one patient, and unknown in one patient. Surgical cut-down was typically performed with concomitant catheter thrombectomy with or without patch reconstruction of the artery. CONCLUSION: Percutaneous decannulation of VA ECMO using the MANTA VCD was feasible but a substantial number of patients needed to be converted to unplanned surgical repair, owing to either closure site-located stenosis/occlusion or bleeding. If suboptimal MANTA positioning is suspected, a low threshold for conversion to surgical cutdown of the groin is recommended.

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.

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).

Vascular Closure: the ABC's.

PURPOSE OF REVIEW: Vascular access and closure is a key part of endovascular procedures, and access site-related complications are an independent predictor of adverse procedural outcomes. The purpose of this review is to discuss the methods of vascular closure including manual compression, vascular closure devices (VCDs) for both arterial and venous arteriotomies, their mechanisms, and access site-related complications. RECENT FINDINGS: Various VCDs have been approved over the last three decades. These devices have different mechanisms to achieve hemostasis and are generally categorized into active and passive approximators. Studies have largely found that they are non-inferior to manual compression. Uncomplicated vascular closure is pertinent to avoid adverse procedure-related outcomes. The emergence of VCDs has reduced time to hemostasis, facilitating early ambulation and discharge and reducing hospitalization cost with comparable complication rate to manual compression. Nonetheless, they should be used in favorable vascular anatomy and are not intended to reduce complications.

Registry-Based Prospective, Active Surveillance of Medical-Device Safety.

BACKGROUND: The process of assuring the safety of medical devices is constrained by reliance on voluntary reporting of adverse events. We evaluated a strategy of prospective, active surveillance of a national clinical registry to monitor the safety of an implantable vascular-closure device that had a suspected association with increased adverse events after percutaneous coronary intervention (PCI). METHODS: We used an integrated clinical-data surveillance system to conduct a prospective, propensity-matched analysis of the safety of the Mynx vascular-closure device, as compared with alternative approved vascular-closure devices, with data from the CathPCI Registry of the National Cardiovascular Data Registry. The primary outcome was any vascular complication, which was a composite of access-site bleeding, access-site hematoma, retroperitoneal bleeding, or any vascular complication requiring intervention. Secondary safety end points were access-site bleeding requiring treatment and postprocedural blood transfusion. RESULTS: We analyzed data from 73,124 patients who had received Mynx devices after PCI procedures with femoral access from January 1, 2011, to September 30, 2013. The Mynx device was associated with a significantly greater risk of any vascular complication than were alternative vascular-closure devices (absolute risk, 1.2% vs. 0.8%; relative risk, 1.59; 95% confidence interval [CI], 1.42 to 1.78; P<0.001); there was also a significantly greater risk of access-site bleeding (absolute risk, 0.4% vs. 0.3%; relative risk, 1.34; 95% CI, 1.10 to 1.62; P=0.001) and transfusion (absolute risk, 1.8% vs. 1.5%; relative risk, 1.23; 95% CI, 1.13 to 1.34; P<0.001). The initial alerts occurred within the first 12 months of monitoring. Relative risks were greater in three prespecified high-risk subgroups: patients with diabetes, those 70 years of age or older, and women. All safety alerts were confirmed in an independent sample of 48,992 patients from April 1, 2014, to September 30, 2015. CONCLUSIONS: A strategy of prospective, active surveillance of a clinical registry rapidly identified potential safety signals among recipients of an implantable vascular-closure device, with initial alerts occurring within the first 12 months of monitoring. (Funded by the Food and Drug Administration and others.).

Occlusion following the deployment of MANTA VCD after TAVR.

BACKGROUND: We present a complication following the deployment of the MANTA vascular closure device (VCD) following a transcatheter aortic valve replacement procedure which resulted in occlusion of the common femoral artery. AIMS: To address possible complications associated with MANTA VCD. RESULTS: This was addressed by ballooning the site from the contralateral side which re-established flow. CONCLUSION: We believe this is the first report to address this kind of complication and may prove useful as more of the MANTA devices are being used in multiple procedures.

Extravascular compared to Intravascular Femoral Closure is Associated with Less Bleeding and Similar MACE after Percutaneous Coronary Intervention.

Background: Various types of vascular closure devices (VCDs) are frequently utilized in patients undergoing percutaneous coronary intervention (PCI) in order to prevent arterial access site bleeding, which represents one of the most relevant complications associated with adverse clinical outcomes. This study aims to compare directly two mechanistically different types of femoral closure (FC) devices in patients undergoing PCI. Methods: This single-center, prospective, observational study includes consecutively patients either treated by the extravascular StarClose SE® (Abbott, Illinois, U.S.A.) or the intravascular AngioSeal™ FC (St. Jude Medical, Inc., St. Paul, MN, U.S.A.) after PCI. The primary endpoint was bleeding complications, the secondary endpoint was major adverse cardiac events (MACE) at 30 days of follow-up. Results: 200 patients in each group (StarClose SE® and AngioSeal™) were enrolled following PCI. The rates of overall and non-access site bleedings were significantly higher in the AngioSeal™ group (56%; 6%) compared to the StarClose SE® group (43.5%; 0.5%) (p = 0.012; 0.003). Additionally, complicated access site bleedings were also significantly higher in the AngioSeal™ group (p = 0.011). No significant differences of MACE were observed in both groups. However, there was a higher rate of unsuccessful implantation of the StarClose SE® (n=12, excluded from the study). Conclusions: In case of successful implantation, FC by the AngioSeal™ is associated with the higher rate of both access and non-access site bleedings, but similar rates of MACE at 30 days compared to the StarClose SE® device.

Aspiration Thrombectomy-Assisted Endovascular Retrieval of an Embolized Angio-Seal Device Causing Claudication.

The Angio-Seal vascular closure device is used to reduce time to hemostasis after femoral artery puncture. Although rare, complications associated with Angio-Seal are significant, including infection, pseudoaneurysm formation, symptomatic femoral artery stenosis, and separation and embolization, leading to limb-threatening ischemia. This report describes Angio-Seal polymer anchor embolization to the tibioperoneal trunk successfully retrieved using the 8-French Indigo Aspiration System.

Incidence of pericardial effusion after left atrial appendage closure: The impact of underlying heart rhythm-Data from the EWOLUTION study.

INTRODUCTION: Pericardial effusion/tamponade (PE/PT) is a rare but serious complication following left atrial appendage closure (LAAC). It may be speculated that LAA contraction during sinus rhythm (SR) exerts mechanical force on the device that eventually leads to PE. We sought to determine the incidence and predictors of PE following LAAC using Watchman with special emphasis on the underlying heart rhythm during implant. METHODS AND RESULTS: From 47 centers in 13 European countries 1,020 patients underwent LAAC and data on baseline rhythm were available from 1,010 patients (mean age 73 ± 9 years, 60% male, median CHA2DS2-VASc = 4). Data were collected via electronic case report forms. A Cox proportional hazard model was calculated adjusting for multiple variables: age, gender, number of recaptures, and device oversizing. During implant, 41% and 59% of patients were in SR and atrial fibrillation (AF), respectively. PE/PT rate was significantly lower in patients implanted during AF at day 30 postimplant (n = 1; 0.2% vs. n = 6; 1.5%; P = 0.02). No PE requiring intervention occurred in the AF group compared to 5 events (1.2%) in the SR group (P = 0.01). While univariate analysis identified SR and gender as predictors for PE/tamponade, multivariate analysis only showed a statistical trend for both variables. CONCLUSION: The overall incidence of PE/PT was very low after LAAC using Watchman. Although SR was not identified as an independent predictor of PE/PT, all events requiring intervention occurred in patients with SR. It may be advisable to perform an extended echocardiographic follow-up in that patient population.

Vascular complications after percutaneous mitral valve repair and venous access closure using suture or closure device.

OBJECTIVE: The aim of this study was to assess the impact of different access-site closure strategies, suture or closure device (Proglide, Abbott Vascular), on vascular and bleeding complications after percutaneous mitral valve repair (MitraClip, Abbott Vascular). BACKGROUND: Considering the high-risk profile in patients receiving percutaneous mitral valve repair, complications related to the large 24 Fr access sheath and its relation to the closure technique have not been evaluated so far. METHODS AND RESULTS: Between 2009 and 2015, 277 consecutive high-risk patients with severe mitral valve regurgitation (MR) underwent percutaneous mitral valve repair at our institution using Z-suture (n = 150) or closure device (n = 127) to close the access-site. Duplex sonography was performed in all patients. The primary endpoint was access-site related complications according to the Valve Academic Research Consortium (VARC) criteria. Secondary outcomes were the incidence of bleeding complications and mortality. Access-site related VARC2 major and minor complications were comparable after closure with Z-suture or closure device (2,7% vs 3.1%, P = 0.81 and 15,3% vs 15.7%, P = 0.92). Three patients (2%) in the suture and four patients (3.1%) in the closure device group experienced unplanned endovascular intervention at the access site. Access-site related major bleeding was observed in 4 (2.7%) suture and 4 (3.1%) closure device treated patients (P = 0.81). No access site related mortality occurred. CONCLUSION: Both Z-suture and closure device use after percutaneous mitral valve repair are feasible and safe. However, there is no benefit of one strategy over the other according to VARC2 major and minor complications.

Endovascular therapy for Angio-sealTM -related acute limb ischemia: Perioperative and long-term results.

OBJECTIVES: To investigate the perioperative and long-term outcomes of endovascular therapy for Angio-sealTM -related acute limb ischemia. BACKGROUND: Currently, limited data are available on the optimal treatment strategy for Angio-sealTM -related acute lower limb ischemia. METHODS: The prospectively maintained patient database of our institution was retrospectively searched to identify all patients who developed acute lower limb ischemia after use of the Angio-SealTM and received endovascular treatment from January 2010 to February 2016. The clinical and follow-up data were evaluated. RESULTS: Thirty-two patients with Angio-SealTM -related acute limb ischemia underwent endovascular therapy, resulting in an approximated incidence of 0.29% of all implanted devices. The overall procedural success rate was 96.9%. With regard to the patients who underwent successful endovascular treatment, the culprit lesion was located in the common femoral artery in 22 (71.0%) cases, the femoral artery bifurcation in 3 (9.7%) cases and the superficial femoral artery in 6 (19.4%) cases. Ten (31.3%) patients had thrombosis in other distal lower limb arteries ipsilateral to Angio-sealTM use. Eighteen (58.1%) patients underwent balloon angioplasty alone, while nine (29.0%) patients underwent balloon angioplasty and thrombolysis, and four (12.9%) patients underwent stent implantation. One patient suffered from minor bleeding at the site of application of the Angio-sealTM . During an average of 43.5 ± 22.9 months of follow-up, three patients with symptomatic restenosis underwent a second successful balloon angioplasty and remained asymptomatic until the last follow-up. CONCLUSIONS: Balloon angioplasty with selective thrombolysis or stent placement was safe and effective, with a low incidence of complication and restenosis. © 2017 Wiley Periodicals, Inc.