Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the MANTA Vascular Closure Device During Percutaneous EVAR and TEVAR Procedures

2020 ◽  
Vol 27 (3) ◽  
pp. 414-420 ◽  
Author(s):  
Zvonimir Krajcer ◽  
David A. Wood ◽  
Neil Strickman ◽  
Nelson Bernardo ◽  
Chris Metzger ◽  
...  
Keyword(s):  
Endovascular Aneurysm Repair ◽  
Major Complication ◽  
Multicenter Trial ◽  
Closure Device ◽  
Study Cohort ◽  
Complication Rates ◽  
Vascular Closure Device ◽  
Primary Analysis ◽  
Femoral Access ◽  
Endovascular Interventions

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.

Radial Versus Femoral Access With or Without Vascular Closure Device in Patients With Acute Myocardial Infarction

2019 ◽  
Vol 123 (5) ◽  
pp. 742-749 ◽  
Author(s):  
Namkyun Kim ◽  
Jang Hoon Lee ◽  
Se Yong Jang ◽  
Myung Hwan Bae ◽  
Dong Heon Yang ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Closure Device ◽  
Vascular Closure Device ◽  
Femoral Access

scholarly journals Usefulness of a Nonsuture Closure Device in Patients Undergoing Diagnostic Coronary and Peripheral Angiography

2017 ◽  
Vol 26 (04) ◽  
pp. 228-233
Author(s):  
John Owens ◽  
Shaun Bhatty ◽  
Robert Donovan ◽  
Andrea Tordini ◽  
Peter Danyi ◽  
...  
Keyword(s):  
Closure Device ◽  
Complication Rates ◽  
Manual Compression ◽  
Access Site ◽  
Femoral Access ◽  
Peripheral Angiography ◽  
Major Complications ◽  
Increased Risk ◽  
Male Patients ◽  
To Receive

AbstractVascular access site complications can follow diagnostic coronary and peripheral angiography. We compared the complication rates of the Catalyst vascular closure device, with the complication rates after manual compression in patients undergoing diagnostic angiographic procedures via femoral access. We studied 1,470 predominantly male patients undergoing diagnostic coronary and peripheral angiography. Catalyst closure devices were used in 436 (29.7%) patients and manual compression was used in 1,034 (70.3%) patients. The former were allowed to ambulate after 2 hours, while the latter were allowed to ambulate after 6 hours. Major complications occurred in 4 (0.9%) patients who had a Catalyst device and in 14 (1.4%) patients who had manual compression (odds ratio [OR]: 0.67, 95% confidence interval [CI]: 0.22–2.1, p = 0.49). Any complications occurred in 51 (11.7%) patients who had a Catalyst closure device and in 64 (6.2%) patients who had manual compression (OR: 2, CI: 1.4–3, p < 0.01). After adjustment for other variables and for a propensity score reflecting the probability to receive the closure device, the association of major complications with the use of the closure device remained not significant (OR: 0.54, 95% CI: 0.17–1.7, p = 0.29), while the association of any complications with the use of the Catalyst device remained significant (OR: 1.9, 95% CI: 1.3–2.9, p < 0.01). The Catalyst device was not associated with an increased risk of major groin complications but was associated with an increased risk of any complications compared with manual compression. Patients receiving the closure device ambulated sooner.

Effect of a closure device on complication rates in high-local-risk patients: Results of a randomized multicenter trial

2003 ◽  
Vol 58 (3) ◽  
pp. 285-291 ◽  
Author(s):  
Bernard Chevalier ◽  
Bernard Lancelin ◽  
Rene Koning ◽  
Michel Henry ◽  
Antoine Gommeaux ◽  
...  
Keyword(s):  
Multicenter Trial ◽  
Closure Device ◽  
Complication Rates ◽  
Risk Patients ◽  
Local Risk

scholarly journals Femoral Access With or Without Vascular Closure Device or Radial Access in Acute Coronary Syndrome

2019 ◽  
Vol 12 (20) ◽  
pp. 2116-2118 ◽  
Author(s):  
Felice Gragnano ◽  
Negar Manavifar ◽  
Giuseppe Gargiulo ◽  
Mikael Sunnåker ◽  
Roberto Galea ◽  
...  
Keyword(s):  
Acute Coronary Syndrome ◽  
Closure Device ◽  
Vascular Closure Device ◽  
Femoral Access ◽  
Coronary Syndrome ◽  
Radial Access

Safety and Efficacy of Arterial Closure Devices Following Antegrade Femoral Access: A Case–Control Study

2020 ◽  
Vol 54 (7) ◽  
pp. 612-617
Author(s):  
Louis-Xavier Barrette ◽  
Ansar Z. Vance ◽  
Mark P. Mantell ◽  
Kathleen M. Kratz ◽  
Jonas W. Redmond ◽  
...  
Keyword(s):  
Control Group ◽  
Closure Device ◽  
Consecutive Series ◽  
Complication Rates ◽  
Success Rates ◽  
Femoral Access ◽  
Safety And Efficacy ◽  
Antegrade Approach ◽  
Device Deployment ◽  
Percutaneous Revascularization

Purpose: Vascular closure device (VCD) use following antegrade femoral access may present unique challenges relative to retrograde access. We retrospectively compared safety and efficacy of these devices between antegrade and retrograde patient cohorts undergoing percutaneous intervention. Materials and Methods: Over a 5-year period, a consecutive series of 107 limbs in 84 patients underwent VCD arteriotomy closure following percutaneous revascularization using an antegrade approach (VCD-A). Device deployment success rates, time to ambulation, and complication rates were compared to a contemporaneous control group of 401 limbs in 305 patients who underwent closure following retrograde access (VCD-R) during revascularization or embolization procedures. Results: Closure was attempted in VCD-A using 53 StarClose, 35 Perclose, and 19 Angio-Seal devices. Hemostasis (without supplemental manual compression) was achieved in 86/107 (80.4%) limbs. Closure was attempted in VCD-R using 215 StarClose, 119 Perclose, and 67 Angio-Seal devices with hemostasis in 357/401 (89.0%) limbs. Device deployment failure occurred in 7/107 (6.5%) of VCD-A and 20/401 (5.0%) of VCD-R ( P = .52), independent of specific device type. Femoral pseudoaneurysm developed in 1/107 and 1/401 of VCD-A and VCD-R ( P = .31), and minor hematoma developed in 3/107 and 8/401 of the VCD-A and VCD-R ( P = .61). Mean time to ambulation was 204.1 minutes in VCD-A and 204.8 minutes in VCD-R ( P = .97). Conclusion: Antegrade femoral closure was associated with high rates of technical success and low complications, similar to retrograde closure. Time to ambulation was the same in both groups despite higher heparin doses in the antegrade patients.

Evaluation of the MANTA Vascular Closure Device in Transfemoral TAVI

2021 ◽  
Author(s):  
Lukasz Kmiec ◽  
Matthaeus Zerdzitzki ◽  
Christof Schmid ◽  
Kurt Debl ◽  
Samuel Sossalla ◽  
...  
Keyword(s):  
Academic Research ◽  
Case Series ◽  
Vascular Complications ◽  
Female Gender ◽  
Closure Device ◽  
Complication Rates ◽  
Imaging Data ◽  
Patient Death ◽  
Vascular Closure Device ◽  
Puncture Site

Abstract 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.

scholarly journals Percutaneous vascular closure device of the femoral access site after coronary interventions for acute coronary syndrome -immediate and short term follow-up

2017 ◽  
Vol 5 (3) ◽  
pp. 778 ◽  
Author(s):  
Ashraf Safiya Manzil ◽  
Sidharaj Vala ◽  
Sidharaj Vala
Keyword(s):  
Acute Coronary Syndrome ◽  
Interventional Procedure ◽  
Tertiary Care ◽  
Major Complication ◽  
Coronary Intervention ◽  
Closure Device ◽  
Short Term ◽  
Femoral Access ◽  
Coronary Syndrome

Background: Around 7 million patients undergo percutaneous interventional vascular procedures worldwide annually and this number is expected to escalate further in coming years. The aim of this study was to analyse immediate and short term follow up of patients with acute coronary syndrome (ACS) who had undergone percutaneous coronary intervention (PCI) through femoral route and closure with vascular closure device.Methods: This was non randomised, single centre study and was conducted in a tertiary care institution between January 2013 to June 2014 with 62 ACS patients undergoing femoral access invasive cardiac interventional procedure. Perclose A-T system was used in all patients as closure device. Patients were followed up to 15 days of clinical evaluation.Results: Of 62 ACS patients, 40 (64.5%) were with non-ST elevation myocardial infarction and 22 (35.5%) patients had history of unstable angina. The perclose device achieved closure within 5 to 10 minutes and all patients were kept in hospital stay for 2 to 3 days. There was one major complication of continuous bleeding, one incidence of small pseudo aneurysm, and two incidences of small hematomas with need of blood transfusion.Conclusions: This study demonstrates the ability of arterial closure device to safely and effectively achieve arterial closure in patients undergoing percutaneous intervention for ACS.

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