A novel double clip-based vascular closure device in antegrade and retrograde femoral punctures: A single-center experience in peripheral non-cardiac procedures.

BACKGROUND: This retrospective study investigates the efficacy and safety of the novel Celt ACD® vascular closure device (VCD) following antegrade and retrograde common femoral artery (CFA) punctures for the treatment of peripheral artery disease in a challenging patient collective (e.g. calcifications, obesity, and anticoagulation). METHODS: A total of 208 VCDs (i.e. 100 antegrade and 108 retrograde) were deployed between October 2019 and December 2020 in a tertiary referral interventional radiology department. Fifty-two devices were undersized in relation to the introducer sheath (up to 2 Fr). Technical success and VCD related complications were evaluated in the immediate post procedure period and the following 24 h clinically. In 68% of cases, additional duplex ultrasound was performed prior to discharge. RESULTS: The overall technical success rate was 97%. Technical failures following antegrade approach were due to a too acute access angle (⩾60°), rendering it impossible to pass the applicator tip through the sheath lumen. A subgroup analysis of technical success pinpoints severe calcification as another key limiting factor in VCD use (p = 0.004). Comparing equally sized with undersized device selection (p = 0.196), direction of approach (p = 0.265), and body mass index (p = 0.184) proved to be insignificant. Five (2%, 5/208) major complications occurred: Four antegrade (i.e. one false aneurysm, one vessel laceration with retroperitoneal hemorrhage, two device migrations; 4%, 4/100) and one following retrograde access (i.e. >6 cm hematoma, 1%, 1/108)). Complications were successfully managed with manual compression or interventional procedures. CONCLUSIONS: The novel clip-based VCD proved to be effective with a low VCD related complication rate.

Complete percutaneous angio-guided approach using preclosing for venoarterial extracorporeal membrane oxygenation implantation and explantation in patients with refractory cardiogenic shock or cardiac arrest.

BACKGROUND: The approach for veno-arterial extracorporeal membrane oxygenation implantation (VA-ECMO) in patients with cardiogenic shock can be either surgical or percutaneous. Complete angio-guided percutaneous implantation and explantation could decrease vascular complications. We sought to describe the initial results of complete percutaneous angio-guided ECMO implantation and explantation using preclosing. METHODS: All consecutive patients who underwent peripheral femoro-femoral VA-ECMO percutaneous implantation for refractory cardiogenic shock or cardiac arrest were enrolled in a prospective registry (03/2018-12/2020). Percutaneous preclosing using two closing devices (Perclose ProGlide, Abbott) inserted before cannulation was used in both femoral artery and vein. Explantation was performed using a crossover technique under angiographic guidance. The occurrence of vascular complication was recorded. RESULTS: Among the 56 patients who underwent percutaneous VA-ECMO implantation for cardiogenic shock or refractory cardiac arrest, 41 underwent preclosing. Femoral vessel cannulation was successful in all patients and total cannulation time was 20 (10-40) min. Weaning from ECMO was possible in 22/41 patients (54%) and 12 (29%) patients were alive at day 30. Significant vascular complications occurred in 2/41 patients. Percutaneous decannulation was performed in 20 patients with 19/20 technical success rate. All femoral arteries and veins were properly closed using the pre-closing devices without bleeding on the angiographic control except for one patient in whom surgical closure of the artery was required. No patient required transfusion for access related significant bleeding and no other vascular complication occurred. Furthermore, no groin infection was observed after full percutaneous implantation and removal of ECMO. CONCLUSION: Emergent complete percutaneous angio-guided VA-ECMO implantation and explantation using pre-closing technique can be an attractive strategy in patients referred for refractory cardiogenic shock.

Alternative to the finger in the dike: use of the vascular closure button to control postdialysis bleeding in a haemodialysis access conduit.

OBJECTIVE: The purpose of this case series is to describe the application of a vascular closure button (VCB) for the repair of haemodialysis access bleeding. The VCB's main function is not to assist in bleeding control, but instead to provide easy access for removal of tightly placed sutures in the repair. METHODS: A retrospective review of patients undergoing ED repair of persistent bleeding from puncture sites in haemodialysis access conduits (HACs) using a VCB was conducted. Study patients were collected from ED visits to Our Lady of Lourdes Medical Center in Camden, New Jersey, USA, between May 2013 and August 2017. Patients were followed until the time of definitive repair of the underlying pathology or until the end of the study period. RESULTS: Seventeen VCBs were used to control persistent bleeding from HACs in the ED. Sixteen bleeds were the result of recent haemodialysis punctures, while one was from a bleeding site ulcer. All repairs were successful at controlling the bleeding with preserved HAC function in the ED and no delayed thrombosis. Follow-up time ranged from 1 day to 778 days. CONCLUSION: Vascular control buttons provide an effective means to control HAC postdialysis bleeding and allow for ease of suture removal without disruption of a repair with no long-term complications.

Safety and efficacy of using vascular closure devices for hemostasis on sheath removal after a transfemoral artery percutaneous coronary intervention.

AIM: To determine the efficacy of vascular closure devices (VCDs) for hemostasis following transfemoral percutaneous coronary interventions (PCIs). METHODS: This two-group pre-post-test observational study with purposive sampling enrolled 73 patients between January, 2014 and February, 2015. The patients were allocated to either the intervention (vascular closure devices group, n = 34) or the control group (manual compression [MC] group, n = 39). Questionnaires were used to assess their demographic and clinical characteristics, vascular complications, visual analogue scale score for pain, and discomfort levels. Pain and discomfort were measured before and after the PCI. RESULTS: Vascular complications were observed in 15 (44.1%) VCD patients and 13 (33.3%) MC patients, with no significant between-group difference. However, the VCD patients had a higher relative risk of bruising, hematomas, and need for further treatment. After the PCI, the pain scores and discomfort levels increased significantly in both groups, but the VCD patients had more successful hemostasis, less pain, and less physical and psychological discomfort (lower-limb numbness, shoulder pain, restlessness, and worrying about walking ability, being unable to lift heavy objects in the future, and taking time off from work). CONCLUSION: The VCDs seem to be superior to the MCs, providing more successful hemostasis, less pain and discomfort, and earlier ambulation after a transfemoral PCI. These findings aid clinical nurses in understanding the risk of vascular complications, discomfort, and pain that are associated with VCD use for improving the quality of clinical care and help clinicians in determining the appropriate hemostatic method for patients undergoing a transfemoral PCI, particularly in the Chinese population.

Closure of Large Percutaneous Femoral Venous Access Using a Modified "Figure-of-Eight" Suture.

Recent advances in different percutaneous treatments made insertion of large-caliber sheaths in the femoral veins more common. Venous punctures are historically managed by initial manual compression with subsequent application of a compression bandage and bed rest. We describe a modified "figure-of-eight" suture technique for minimizing the risk of accidental puncture of the vein while grabbing the subcutaneous tissue. We examined the safety and feasibility of this technique combined with early mobilization in a real-world setting. We performed a retrospective analysis on 56 consecutive patients undergoing percutaneous mitral valve repair using large femoral venous access. The patient population was heterogeneous and bleeding risk characteristics were common. Bleeding Academic Research Consortium Consensus (BARC)-classifiable bleeding complications occurred in eight patients (14%), BARC of two events or more in five patients (8.9%), and BARC of three or more event in only one patient (1.8%), which is a comparable success rate to large venous access closure with suture-mediated closure devices. No BARC Type 3b or BARC Type 5 bleeding occurred. During routine clinical follow-up, no groin-related problems were reported in all patients. Closure of large femoral venous access using a modified temporary subcutaneous figure-of-eight suture in combination of a light compression bandage and bed rest for 2 to 4 hours provides a safe and low-cost alternative to closure devices for early mobilization.

MANTA versus ProGlide vascular closure devices in transfemoral transcatheter aortic valve implantation.

BACKGROUND: The MANTA system is a novel vascular closure device (VCD) and its safety and efficacy were compared to the ProGlide VCD in patients undergoing transfemoral transcatheter aortic valve implantation (TAVI). METHODS: This is a retrospective study including 222 patients who underwent transfemoral TAVI at three Finnish University Hospitals. The MANTA VCD was used in 107 patients and their outcome was compared with that of 115 patients in whom the arterial access was closed with the ProGlide VCD. RESULTS: VARC-2 VCD failure occurred less frequently in the MANTA cohort (3.7% vs. 7.8%, p = 0.378), but the difference did not reach statistical significance. When adjusted for the introducer outer diameter, the MANTA cohort had similar rates of VARC-2 major vascular complications (9.3% vs. 12.2%, adjusted: p = 0.456), VARC-2 life-threatening/disabling bleeding (9.3% vs. 6.1%, adjusted: p = 0.296) and need of invasive treatment of bleeding (4.7% vs. 7.0%, adjusted: p = 0.416) compared to the ProGlide cohort. Additional VCDs were more frequently needed in the ProGlide cohort (58.3% vs. 1.9%, p < 0.0001). CONCLUSIONS: In patients undergoing transfemoral TAVI, the MANTA VCD showed a similar risk of VARC-2 vascular and bleeding complications compared to the ProGlide VCD, but it reduced significantly the need of additional VCDs for completion of hemostasis.

MynxGrip vascular closure device use in pediatric neurointerventional procedures.

OBJECTIVE The aim of this paper was assess the efficacy and safety of using the MynxGrip arterial closure device in pediatric neuroendovascular procedures where the use of closure devices remains off-label despite their validation and widespread use in adults. METHODS A retrospective review of all pediatric patients who underwent diagnostic or interventional neuroendovascular procedures at the authors' institution was performed. MynxGrip use was predicated by an adequate depth of subcutaneous tissue and common femoral artery (CFA) diameter. Patients remained on supine bedrest for 2 hours after diagnostic procedures and for 3 hours after therapeutic procedures. Patient demographics, procedural details, hemostasis status, and complications were recorded. RESULTS Over 36 months, 83 MynxGrip devices were deployed in 53 patients (23 male and 30 female patients; mean age 14 years) who underwent neuroendovascular procedures. The right-side CFA was the main point of access for most procedures. The mean CFA diameter was 6.24 mm and ranged from 4 mm to 8.5 mm. Diagnostic angiography comprised 46% of the procedures. A single device failure occurred without any sequelae; the device was extracted, and hemostasis was achieved by manual compression with the placement of a Safeguard compression device. No other immediate or delayed major complications were recorded. CONCLUSIONS MynxGrip can be used safely in the pediatric population for effective hemostasis and has the advantage of earlier mobilization.

Clinical Trial Principles and Endpoint Definitions for Paravalvular Leaks in Surgical Prosthesis.

The VARC (Valve Academic Research Consortium) for transcatheter aortic valve replacement set the standard for selecting appropriate clinical endpoints reflecting safety and effectiveness of transcatheter devices, and defining single and composite clinical endpoints for clinical trials. No such standardization exists for circumferentially sutured surgical valve paravalvular leak (PVL) closure. This document seeks to provide core principles, appropriate clinical endpoints, and endpoint definitions to be used in clinical trials of PVL closure devices. The PVL Academic Research Consortium met to review evidence and make recommendations for assessment of disease severity, data collection, and updated endpoint definitions. A 5-class grading scheme to evaluate PVL was developed in concordance with VARC recommendations. Unresolved issues in the field are outlined. The current PVL Academic Research Consortium provides recommendations for assessment of disease severity, data collection, and endpoint definitions. Future research in the field is warranted.

A Sutureless Vascular Closure Device for Emergent Bovine Xenograft Implantation.

A novel vascular staple (C-staple) was developed that does not enter the vasculature lumen during anastomoses. The objective of this study was to demonstrate C-staple safety when used with a bovine xenograft and compare efficacy of the C-staple procedure with Anastoclip surgical clips or suturing when used with a bovine xenograft. Eight sheep had an acute comparison between suturing and C-staples using both common carotid arteries. Sixteen sheep had xenograft placement in the left carotid artery, eight with C-staples and eight with Anastoclips in a chronic study. Over 6 months, Doppler ultrasound interrogation of the common carotid arteries was performed. After 6 months, arteries were evaluated histopathologically. Cross-clamp and surgical times were longer in the C-staple group than the suture group, and xenograft implantation times were statistically longer with C-staples than with Anastoclips. After 6 months, C-staple biocompatibility was similar to Anastoclips. Patency and hemodynamics of the bovine xenograft were not statistically different between the two groups. C-staples performed as well as the Anastoclips except for implant times, likely due to delivery system differences. Histological findings and clinical outcomes were no different with the two devices. Further refinements of the C-staple delivery system are necessary before proceeding to clinical trials.

Impact of closure devices on vascular complication and mortality rates in TAVI procedures.

BACKGROUND: Currently two closure devices are available for the vascular access in TAVI procedures. Their impact on vascular complications and mid-term mortality is yet unknown. METHODS: Between 2009 and 2014, 398 patients underwent TAVI TF procedures in which two different closure devices were used, Prostar® XL (n=215) and Perclose-Proglide® (n=183). In the cases with Prostar we used one device and in cases with Perclose-Proglide, two devices. The two groups were compared with respect to the criteria of the Valve Academic Research Consortium (VARC) II. The mean follow-up period was 679.7±481.8 (727) days. RESULTS: There were no significant differences in the baseline characteristics of both patient groups. In the Prostar® group, complications were more frequent (26.6% vs. 12.6%, p=0.005); in detail, these were bleeding (14.9% vs. 7.1%, [p]=0.02), suture rupture (4.7% vs. 1.3%, p=0.04), and pseudoaneurysms (10.2% vs. 1.2%, p<0.001). Multivariate regression analysis revealed two predictors for vascular complications: female sex (OR 2.3; 95% CI 1.3-3.8, p=0.002) and closure devices (OR 0.5; 95% CI 0.3-0.8, p=0.007) in favour of Proglide®. There was no significant difference in 30-day mortality (Prostar: 5.6±1.6% vs. Proglide: 4.9±1.6%). However, Kaplan-Meier survival analysis showed a significantly higher survival rate over the entire follow-up period for the Proglide® group (p=0.03). CONCLUSION: Vascular complications occurred more often in the Prostar® group. Although 30-day mortality showed no significant difference between the groups, the mortality over complete follow-up was significantly lower in the Proglide® group.

Early decision-analytic modeling - a case study on vascular closure devices.

BACKGROUND: As economic considerations become more important in healthcare reimbursement, decisions about the further development of medical innovations need to take into account not only medical need and potential clinical effectiveness, but also cost-effectiveness. Already early in the innovation process economic evaluations can support decisions on development in specific indications or patient groups by anticipating future reimbursement and implementation decisions. One potential concept for early assessment is value-based pricing. METHODS: The objective is to assess the feasibility of value-based pricing and product design for a hypothetical vascular closure device in the pre-clinical stage which aims at decreasing bleeding events. A deterministic decision-analytic model was developed to estimate the cost-effectiveness of established vascular closure devices from the perspective of the Statutory Health Insurance system. To identify early benchmarks for pricing and product design, three strategies of determining the product's value are explored: 1) savings from complications avoided by the new device; 2) valuation of the avoided complications based on an assumed willingness-to-pay-threshold (the efficiency frontier approach); 3) value associated with modifying the care pathways within which the device would be applied. RESULTS: Use of established vascular closure devices is dominated by manual compression. The hypothetical vascular closure device reduces overall complication rates at higher costs than manual compression. Maximum cost savings of only about €4 per catheterization could be realized by applying the hypothetical device. Extrapolation of an efficiency frontier is only possible for one subgroup where vascular closure devices are not a dominated strategy. Modifying care in terms of same-day discharge of patients treated with vascular closure devices could result in cost savings of €400-600 per catheterization. CONCLUSIONS: It was partially feasible to calculate value-based prices for the novel closure device which can be used to inform product design. However, modifying the care pathway may generate much more value from the payers' perspective than modifying the device per se. Manufacturers should thus explore the feasibility of combining reimbursement of their product with arrangements that make same-day discharge attractive also for hospitals. Due to the early nature of the product, the results are afflicted with substantial uncertainty.