MANTA vascular closure device is an alternative vascular access closure device that is predominantly designed for large bore arteriotomy procedures. Its implementation to reduce morbidity and mortality following percutaneous procedures including peripheral veno-arterial (VA)-extracorporeal membrane oxygenation (ECMO) in critically ill patients with various severe clinical conditions such as refractory cardiogenic shock remains to be under scientific discussion. The use of the MANTA vascular closure device leads to a sufficient reduction in a number of post-decannulation complications such as bleeding, vascular complications, inflammatory reactions and major amputation. Furthermore, the technical success of percutaneous decannulation of VA-ECMO with the MANTA vascular closure device appears to be safe and effective. It has been reported that MANTA vascular closure device exerted a strict similarity with other vascular surgical systems in safe profile regardless of the indication for its utilization. Overall, the immobilized patients achieved a favorable recovery outcome with MANTA including safe decannulation and low risk of vascular complications. The authors suggest the use of pulse wave distal Doppler technology for early detection of these clinically relevant complications. In conclusion, MANTA vascular closure device seems to be safe and effective technical approach to provide low-risk vascular assess for a long time for severe sick individuals.

• Veno-arterial extracorporeal membrane oxygenation
• Decannulation
• Vascular complications
• MANTA vascular closure device

• endovascular aneurysm repair
• endovascular treatment/therapy
• hemostasis
• thoracic endovascular aortic repair
• vascular closure device

• maude
• reproducibility
• query
• patient safety
• medical device
• fda
• pubmed

• Reproducibility of Results
• United States
• United States Food and Drug Administration
• Humans
• Equipment and Supplies/standards

• R01 LM012854 NLM NIH HHS

• TAVR
• aortic stenosis
• self‐expanding valve

• Humans
• Heart Valve Prosthesis
• Female
• Male
• Transcatheter Aortic Valve Replacement/instrumentation
• Transcatheter Aortic Valve Replacement/adverse effects
• Registries
• Prosthesis Design
• Time Factors
• Aortic Valve/surgery
• Aortic Valve/physiopathology
• Aortic Valve/diagnostic imaging
• Aged
• Treatment Outcome
• Aged, 80 and over
• Prospective Studies
• Aortic Valve Stenosis/surgery
• Aortic Valve Stenosis/diagnostic imaging
• Aortic Valve Stenosis/physiopathology
• Risk Factors
• Recovery of Function
• Product Surveillance, Postmarketing
• Postoperative Complications/etiology
• Postoperative Complications/prevention & control
• Hemodynamics

• Medtronic

• Manta
• Vascular closure device
• endovascular aortic repair

• Humans
• Aged
• Extracorporeal Membrane Oxygenation
• Lower Extremity
• Device Removal
• Femoral Artery/surgery
• Thrombectomy

• Large-bore femoral access
• Outcomes audit
• Percutaneous EVAR
• Post-close
• Vascular closure devices

• MANTA
• ProGlide
• ProStar
• vascular closure device

To compare the safety and efficacy of manual compression versus use of the MANTA closure device for access management after Impella removal on the intensive care unit (ICU). The number of patients treated with percutaneous left ventricular assist devices (pLVAD), namely Impella and ECMO, for complex cardiac procedures or shock, is growing. However, removal of pLVAD and large bore arteriotomy closure among such patients on the ICU remains challenging, since it is associated with a high risk for bleeding and vascular complications. Patients included in a prospective registry between 2017 and 2020 were analyzed. Bleeding and vascular access site complications were assessed and adjudicated according to VARC-2 criteria. We analyzed a cohort of 87 consecutive patients, who underwent access closure after Impella removal on ICU by using either the MANTA device or manual compression. The cohort´s mean age was 66.1 ± 10.7 years and 76 patients (87%) were recovering from CS. Mean support time was 40 h (interquartile range 24–69 h). MANTA was used in 31 patients (35.6%) and manual compression was applied in 56 patients (64.4%). Overall access related bleedings were significantly lower in the MANTA group (6.5% versus 39.3% (odds ratio (OR) 0.10, 95% CI 0.01–0.50; p = 0.001), and there was no significant difference in vascular complications between the two groups (p = 0.55). Our data suggests that the application of the MANTA device directly on the ICU is safe. In addition, it seems to reduce access related bleeding without increasing the risk of vascular complications.

Among vascular closure devices (VCDs), the novel collagen plug-based MANTA VCD is the first designed for large bore percutaneous access. We aimed to assess the features and predictors of access-site vascular complications in an unselected trans-femoral transcatheter aortic valve replacement (TF-TAVR) population.

Patients undergoing large bore arteriotomy closure with 18F MANTA VCD following TF-TAVR at a large tertiary care center from September 2019 to January 2021 were prospectively analyzed. Primary Outcome was the MANTA VCD access-site-related complications according to Valve Academic Research Consortium-3 (VARC) definitions. Its incidence and predictors were evaluated.

Eighty-eight patients (median age 82 years, 48% male, 3.3 median Society of Thoracic Surgeons score) undergoing TF-TAVR were included, mostly (63%) treated with a self-expandable device and with outer diameter sizes varied from 18F to 24-F. MANTA VCD technical success rate was 98%, while 10 patients (11%) experienced MANTA VCD access-site vascular complications which included 8% of minor complications and only to 2% of major events resulting in VARC type ≥2 bleeding. Vessel occlusion/stenosis (60%), perforation (20%), and pseudoaneurysm/dissection/hematoma (20%) occurred, but all were managed without surgical treatment. Independent predictors of failure were age (p = 0.04), minimum common femoral artery diameter (CFA) (p < 0.01), sheath-to-femoral-artery ratio (SFAR) (p < 0.01), and a lower puncture height (p = 0.03). A CFA diameter <7.1 mm with a SFAR threshold of 1.01 were associated with VCD failure.

In a more comers TF-TAVR population, MANTA VCD was associated with reassuring rates of technical success and major access-site vascular complications. Avoiding lower vessel size and less puncture site distance to CFA bifurcation might further improve outcomes.