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Zvonimir Krajcer - One of the best experts on this subject based on the ideXlab platform.
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Data on plug-based large-bore arteriotomy Vascular Closure Device related access complications
'Elsevier BV', 2021Co-Authors: Rutger-jan Nuis, Joost Daemen, Peter De Jaegere, Zvonimir Krajcer, David Wood, Herbert Kroon, Maarten Van Wiechen, Darra Bigelow, Chris Buller, John WebbAbstract:This article provides supplementary tables and figures to the research article: Frequency, Impact and Predictors of Access Complications with Plug-Based Large-Bore Arteriotomy Closure - A patient level meta-analysis [1]. The data provide insight in the type and management of access complications related to the plug-based MANTA Vascular Closure Device (VCD) for large-bore catheter-based cardioVascular interventions. Since MANTA is mostly used in transcatheter aortic valve replacement (TAVR) procedures, this article also contains a sub-group analysis on TAVR procedures using contemporary valve-platforms. Further, data describing MANTA hemostasis times and mortality causes are included. For this dataset, individual patient data were derived from a European and a North American Device approval study (the Conformite Européene [CE] mark study and the investigational Device exemption SAFE-MANTA study [2,3]) in addition to a post-approval registry (the MARVEL registry [4]) covering a total of 891 patients who were enrolled between 2015 and 2019 across 28 investigational sites. Eligibility criteria were most stringent in the SAFE MANTA study (38% of patients) whereas the MARVEL registry applied liberal and only relative exclusion criteria (56% of patients). A total of 78 Roll-in cases (i.e. first or second time operator use of the MANTA VCD) who were excluded from analysis in SAFE MANTA were included in the present to evaluate a potential learning curve effect. Therefore, this dataset reflects the largest study population undergoing arteriotomy Closure with the MANTA VCD by operators at various levels of experience, which can be valuable to further build on research regarding percutaneous large-bore arteriotomy management
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pivotal clinical study to evaluate the safety and effectiveness of the manta Vascular Closure Device during percutaneous evar and tevar procedures
Journal of Endovascular Therapy, 2020Co-Authors: Zvonimir Krajcer, David A Wood, Neil E Strickman, Nelson Bernardo, Chris Metzger, Mark Aziz, Michael J Bacharach, Aravinda Nanjundappa, J H Campbell, Jason T LeeAbstract:Purpose: To evaluate the safety and effectiveness of the MANTA percutaneous Vascular Closure Device in patients undergoing percutaneous endoVascular aneurysm repair (PEVAR) or thoracic endoVascular...
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pivotal clinical study to evaluate the safety and effectiveness of the manta Vascular Closure Device during percutaneous evar and tevar procedures
Journal of Endovascular Therapy, 2020Co-Authors: Zvonimir Krajcer, David A Wood, Neil E Strickman, Nelson Bernardo, Chris Metzger, Mark Aziz, Michael J Bacharach, Aravinda Nanjundappa, John Campbell, Jason T LeeAbstract:Purpose: To evaluate the safety and effectiveness of the MANTA percutaneous Vascular Closure Device in patients undergoing percutaneous endoVascular aneurysm repair (PEVAR) or thoracic endoVascular aortic repair (TEVAR). Materials and Methods: The SAFE MANTA Study (ClinicalTrials.gov identifier NCT02908880) was a prospective, single-arm, multicenter trial in patients undergoing endoVascular interventions using large-bore sheaths (transcatheter aortic valve replacement, PEVAR, or TEVAR) at 20 sites in North America. Patient selection intended to test the MANTA Device in populations without morbid obesity, severe calcification, or a severely scarred femoral access area. Of the 263 patients enrolled in the primary analysis cohort, 53 (20.2%) patients (mean age 74.9±8.9 years; 41 men) underwent PEVAR (n=51) or TEVAR (n=2) procedures and form the cohort for this subgroup analysis. Per protocol a single MANTA Device was deployed in all PEVAR/TEVAR cases. Results: The mean time to hemostasis in the PEVAR/TEVAR cohort was 35±91 seconds, with a median time of 19 seconds vs 24 seconds in the overall SAFE MANTA population. The MANTA Device met the definition for technical success in 52 (98%) of 53 PEVAR/TEVAR cases compared with 97.7% in the overall SAFE MANTA population. One (1.9%) major complication (access-site stenosis) occurred in this subgroup compared to 14 (5.3%) events in the SAFE population. In the PEVAR/TEVAR group, 1 pseudoaneurysm was noted prior to discharge, another at 30-day follow-up, and one at 60 days. One (1.9%) of the 3 minor pseudoaneurysms was treated with ultrasound-guided compression and the other 2 required no treatment. Conclusion: The MANTA Device demonstrated a short time to hemostasis and low complication rates compared with published literature results of other percutaneous Closure Devices. Time to hemostasis and complication rates were comparable between the PEVAR/TEVAR patients and the full SAFE MANTA study cohort. The MANTA Device provides reliable Closure with a single percutaneous Device for PEVAR/TEVAR procedures.
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pivotal clinical study to evaluate the safety and effectiveness of the manta percutaneous Vascular Closure Device the safe manta study
Circulation-cardiovascular Interventions, 2019Co-Authors: David A Wood, Zvonimir Krajcer, Neil E Strickman, Chris Metzger, Mark Aziz, Ron Waksman, Lowell F Satler, Janarthanan Sathananthan, William F Fearon, Marvin H EngAbstract:Background: Open surgical Closure and small-bore suture-based preClosure Devices have limitations when used for transcatheter aortic valve replacement, percutaneous endoVascular abdominal aortic an...
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Closure of large percutaneous access sites using the prostar xl percutaneous Vascular surgery Device
Journal of Endovascular Surgery, 1999Co-Authors: Clay P Haas, Zvonimir Krajcer, Edward B DiethrichAbstract:Purpose:To report early experience using a Vascular Closure Device following endoVascular aortic aneurysmal repair in which large-bore sheaths are used.Technique:A 10F Prostar XL Percutaneous Vascular Surgery Device is used to deploy sutures around sheath entry sites up to 16F. At the completion of the procedure, the sutures are tied with a sliding knot to ensure adequate hemostasis.Conclusions:Maintaining the minimal invasiveness of the percutaneous approach to aortic endografting reduces patient discomfort and permits earlier ambulation and hospital discharge. Initial success seems to be maintained at 1 month, however, longer follow-up will be required.
Carsten H Meyer - One of the best experts on this subject based on the ideXlab platform.
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patient satisfaction after femoral arterial access site Closure using the exoseal Vascular Closure Device compared to manual compression a prospective intra individual comparative study
CardioVascular and Interventional Radiology, 2016Co-Authors: Claus Christian Pieper, Hans H Schild, Daniel Thomas, Jennifer Nadal, Winfried A Willinek, Carsten H MeyerAbstract:Purpose To intra-individually compare discomfort levels and patient satisfaction after arterial access Closure using the ExoSeal® Vascular Closure Device (VCD) and manual compression (MC) in a prospective study design.
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efficacy and time to hemostasis of antegrade femoral access Closure using the exoseal Vascular Closure Device a retrospective single center study
European Journal of Vascular and Endovascular Surgery, 2014Co-Authors: J Boschewitz, Claus Christian Pieper, Hans H Schild, Jennifer Nadal, Magnus Andersson, Carsten H MeyerAbstract:Objective To retrospectively evaluate the efficacy and time-to-hemostasis of antegrade femoral access Closure using the ExoSeal Vascular Closure Device (VCD). Design Retrospective, single-center analysis. Materials and methods Between September 2010 and February 2013, 148 ExoSeal VCD Closures (5–7F) of antegrade femoral accesses were performed in 119 patients (70 males, mean age 71.6 years, range 40–97 years). In all cases initial diagnostic angiography was performed via an 18G/3.8F retrograde femoral access, which was left in place during intervention (in-house standard) and was used to obtain control angiography after successful Closure of the antegrade access to determine hemostasis. Technical Device success was defined as ExoSeal Closure without major VCD-related complications; procedural success as hemostasis within 5 minutes. Statistical analysis was performed using a logistic regression model and correlation analyses. Results 145/148 (98.0%) ExoSeal Closures were technically successful (5F: n = 76; 6F: n = 65; 7F: n = 7). Angiographic control showed Closure after 2 minutes in 130/145 cases. In a further 14 cases hemostasis was achieved after an additional 3 minutes MC, so that Closure was successful within 5 minutes in 144/148 cases (97.3%). No major complication occurred. One minor complication was recorded in a 6F access case. Pre-interventional activated partial thromboplastin time (aPTT) was the only statistically significant predictor of necessary manual compression (MC) > 2 minutes ( p = .01), but with an odds-ratio of only 1.038. The INR showed an odds-ratio of 2.455 for need for 5 minutes MC (NS). Significant correlations were found between the need for 5 minutes MC and medication with acetylsalicylic acid ( p = .01), clopidogrel ( p p Conclusion ExoSeal Vascular Closure of antegrade femoral punctures is safe and effective with a low complication rate. Two minutes of MC are sufficient to achieve hemostasis in the majority of cases. However, in patients on antiplatelet therapy, especially after abciximab, the authors advocate prolonging MC to 5 minutes.
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feasibility of Vascular access Closure in arteries other than the common femoral artery using the exoseal Vascular Closure Device
CardioVascular and Interventional Radiology, 2014Co-Authors: Claus Christian Pieper, K Wilhelm, Hans H Schild, Carsten H MeyerAbstract:Purpose To describe the feasibility of Vascular access Closure in arteries other than the common femoral artery (CFA) using the ExoSeal Vascular Closure Device (VCD).
N. Saleh - One of the best experts on this subject based on the ideXlab platform.
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impact of percutaneous femoral arteriotomy Closure using the mantatm Device on Vascular and bleeding complications after transcatheter aortic valve replacement
Catheterization and Cardiovascular Interventions, 2018Co-Authors: Rodney De Palma, Magnus Settergren, Andreas Ruck, Rikard Linder, N. SalehAbstract:OBJECTIVES: To evaluate the feasibility of fully percutaneous Closure using a novel collagen-based Vascular Closure Device after transfemoral aortic valve replacement (TAVR). BACKGROUND: TAVR is utilized increasingly for the treatment of severe symptomatic aortic stenosis. Vascular complications related to access and Closure dominate the adverse event profile of the procedure despite progressively reducing arteriotomy caliber. The advent of a novel collagen-based Device (MANTATM ) and preliminary data suggest this could be used as a routine percutaneous Closure Device. METHODS: A prospective observational study of unselected consecutive patients undergoing TAVR in a single center. Data were collected via hospital electronic records and the SWEDEHEART registry. The primary clinical outcome was Closure success and time to hemostasis. Secondary outcomes included VARC-2 defined major and minor Vascular and bleeding complications within 30 days using suture-based Closure with Prostar-XL within the same center. RESULTS: A consecutive cohort of 346 patients underwent TAVR via the transfemoral approach. Vascular Closure with MANTATM was successful in all with a mean time to hemostasis of 42 sec (SD 115.5, range 0-600). The composite of all-cause mortality and major complications related to the main access site was similar between the groups (1.1% vs 1.9%, P = .61). Major bleeding occurred less frequently with MANTA TM (1.1% vs 7.8%, P = .02). CONCLUSION: The novel use of a collagen-based Vascular Closure Device for large caliber arteriotomy is feasible in an unselected population undergoing transfemoral TAVR and appears efficacious compared to percutaneous suture-based Closure. These data should prompt larger studies to evaluate efficacy and safety.
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percutaneous axillary arteriotomy Closure during transcatheter aortic valve replacement using the manta Device
Catheterization and Cardiovascular Interventions, 2018Co-Authors: Rodney De Palma, Magnus Settergren, Andreas Ruck, N. SalehAbstract:: Percutaneous aortic valve replacement is performed predominantly via the transfemoral approach. The transaxillary (subclavian) approach may be utilized if an alternative route access is required. Conventional access and Closure for this approach necessitates open surgical techniques. We report a nonsurgical fully percutaneous axillary TAVR using a collagen-based Vascular Closure Device.
Frederic S. Resnic - One of the best experts on this subject based on the ideXlab platform.
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registry based prospective active surveillance of medical Device safety
The New England Journal of Medicine, 2017Co-Authors: Frederic S. Resnic, Susan Robbins, Arjun Majithia, Danica Marinacdabic, Henry Ssemaganda, Kathleen Hewitt, Angelo Ponirakis, Nilsa Loyoberrios, Issam Moussa, Joseph P DrozdaAbstract:BackgroundThe 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). MethodsWe 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 transfus...
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Vascular Closure Device Failure in Contemporary Practice
JACC. Cardiovascular interventions, 2012Co-Authors: Venkatesan Vidi, Sripal Bangalore, Michael E. Matheny, Usha Govindarajulu, Sharon-lise T. Normand, Susan Robbins, Vikram Agarwal, Frederic S. ResnicAbstract:Objectives The goal of this study was to assess the frequency and predictors of Vascular Closure Device (VCD) deployment failure, and its association with Vascular complications of 3 commonly used VCDs. Background VCDs are commonly used following percutaneous coronary intervention on the basis of studies demonstrating reduced time to ambulation, increased patient comfort, and possible reduction in Vascular complications as compared with manual compression. However, limited data are available on the frequency and predictors of VCD failure, and the association of deployment failure with Vascular complications. Methods From a de-identified dataset provided by Massachusetts Department of Health, 23,813 consecutive interventional coronary procedures that used either a collagen plug–based (n = 18,533), a nitinol clip–based (n = 2,284), or a suture-based (n = 2,996) VCD between June 2005 and December 2007 were identified. The authors defined VCD failure as unsuccessful deployment or failure to achieve immediate access site hemostasis. Results Among 23,813 procedures, the VCD failed in 781 (3.3%) procedures (2.1% of collagen plug–based, 6.1% of suture-based, 9.5% of nitinol clip–based VCDs). Patients with VCD failure had an excess risk of “any” (7.7% vs. 2.8%; p Conclusions VCD failure rates vary depending upon the type of VCD used and are associated with significantly higher Vascular complications as compared with deployment successes.
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Vascular Closure Device failure frequency and implications a propensity matched analysis
Circulation-cardiovascular Interventions, 2009Co-Authors: Sripal Bangalore, Nipun Arora, Frederic S. ResnicAbstract:Background —Vascular Closure Devices (VCDs) are effective in reducing the time to ambulation for patients undergoing cardiac catheterization procedures and in reducing the risk of Vascular complications in selected patient cohorts. However, the frequency and consequence of failure of VCDs is not well defined. Methods and Results —From a prospective registry of consecutive patients undergoing cardiac catheterization at our center, 9823 patients who received either a collagen plug-based (Angio-Seal) or a suture-based (Perclose) VCD were selected for the study. VCD failure was defined as unsuccessful deployment or failure to achieve hemostasis. Major Vascular complication was defined as any retroperitoneal hemorrhage, limb ischemia, or any surgical repair. Minor Vascular complication was defined as any groin bleeding, hematoma (≥5 cm), pseudoaneurysm, or arteriovenous fistula. Any Vascular complication was defined as either a major or minor Vascular complication. Among the 9823 patients in the study, VCD failed in 268 patients (2.7%; 2.3% diagnostic versus 3.0% percutaneous coronary intervention; P =0.029). Patients with VCD failure had significantly increased risk of any (6.7% versus 1.4%; P <0.0001), major (1.9% versus 0.6%; P =0.006), or minor (6.0% versus 1.1%; P <0.0001) Vascular complication compared with the group with successful deployment of VCD. The increased risk of Vascular complication was unchanged in a propensity score-matched cohort. Conclusions —In contemporary practice, VCD failure is rare, but when it does fail, it is associated with a significant increase in the risk of Vascular complications. Patients with VCD failure should be closely monitored.
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a cost minimization analysis of the angio seal Vascular Closure Device following percutaneous coronary intervention
American Journal of Cardiology, 2007Co-Authors: Frederic S. Resnic, Nipun Arora, Michael E. Matheny, Matthew R ReynoldsAbstract:The Angio-Seal Vascular Closure Device has been shown to be safe and effective in decreasing the time to hemostasis after percutaneous coronary intervention (PCI). The health economic implications of routinely using Angio-Seal after PCI have not been explored. We performed a cost-minimization analysis comparing routine Angio-Seal use after PCI with mechanical compression using a decision analytic model. The relative probabilities of 7 Vascular access complications were derived from pooled analysis of published randomized trials. The incremental hospital cost of each Vascular complication was estimated by a matched case-control analysis of 3,943 patients who underwent PCI at our center from January 2002 and December 2004. Appropriate sensitivity and uncertainty analyses were performed. After accounting for differences in expected rates of specific complications between the 2 strategies and the incremental costs of each Vascular event, the routine use of Angio-Seal was associated with a lower cost per PCI procedure of $44. Probabilistic sensitivity analysis of all model assumptions using second-order Monte Carlo simulation confirmed the economic advantage of Angio-Seal in 74% of model replications. In conclusion, after PCI, the routine use of Angio-Seal for femoral Vascular access management was associated with net cost savings compared with mechanical compression. This cost savings was in addition to the previously demonstrated advantages of Angio-Seal in terms of patient comfort and preference.
Ibrahim Akin - One of the best experts on this subject based on the ideXlab platform.
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arterial access site complications after use of a Vascular Closure Device related to puncture height
BMC Cardiovascular Disorders, 2017Co-Authors: Benjamin Sartorius, Michael Behnes, Melike Unsal, Ursula Hoffmann, Siegfried Lang, Kambis Mashayekhi, Martin Borggrefe, Ibrahim AkinAbstract:Background To analyze differences of access-site complications related to the height of femoral arterial puncture and the use of a Vascular Closure Device (VCD) following percutaneous coronary intervention (PCI).
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Arterial access-site complications after use of a Vascular Closure Device related to puncture height
BMC Cardiovascular Disorders, 2017Co-Authors: Benjamin Sartorius, Michael Behnes, Melike Unsal, Ursula Hoffmann, Siegfried Lang, Kambis Mashayekhi, Martin Borggrefe, Ibrahim AkinAbstract:Background To analyze differences of access-site complications related to the height of femoral arterial puncture and the use of a Vascular Closure Device (VCD) following percutaneous coronary intervention (PCI). Methods A subgroup of the FERARI study being treated by femoral arterial access and valuable inguinal angiography before implantation of a VCD were included. Inguinal angiographies were systematically reviewed by two independent cardiologists to determine the correct height of femoral arterial puncture. Bleeding complications were documented within 30 days after PCI and were categorized according to BARC, TIMI, GUSTO and FERARI classifications. Results Femoral access point imaging was available in 95 patients compared to 105 patients without. The common femoral artery (CFA) was the most accessed artery in 41%, followed by the femoral arterial bifurcation (39%) and lower access sites distally from the femoral arterial bifurcation (low puncture: 20%). No differences were observed regarding indication of PCI, procedural data and anticoagulation therapies in relation to the heights of femoral arterial access ( p > 0.05). Despite using VCD, arterial puncture at the CFA resulted in numerically highest numbers of overall bleedings (62%) compared to femoral arterial bifurcation (41%) ( p = 0.059). 58% of bleedings occurred after arterial puncture below the femoral bifurcation (low puncture). Though no significant differences of bleedings regarding classifications of BARC, GUSTO, TIMI and FERARI as well as other Vascular endpoints were observed regarding puncture height. Conclusions The present analysis demonstrates no significant differences of bleeding complications in relation to the height of femoral arterial puncture and subsequent use of a VCD.
