Insights From a Multidisciplinary Introduction of the MANTA Vascular Closure Device

Area of Science:

• Cardiovascular Interventions
• Vascular Access Management
• Medical Device Technology

Background:

• The collagen-based MANTA vascular closure device is approved for large-bore femoral artery access.
• Large-bore access is crucial for advanced cardiovascular procedures.

Purpose of the Study:

• To report insights from the initial 100 cardiovascular procedures utilizing the MANTA closure device.
• To analyze complications associated with MANTA device use in large-bore femoral access.

Main Methods:

• Retrospective analysis of 100 consecutive cardiovascular procedures using the MANTA device.
• Complications assessed using Valve Academic Research Consortium-2 criteria.
• Bleeding duration and device-related events were recorded.

Main Results:

• 122 MANTA devices were used in 100 patients undergoing TAVR, EVAR, or Impella support.
• Immediate hemostasis achieved in 70% and within 5 minutes in 87% of patients.
• 7 major and 4 minor complications occurred, including bleeding, occlusion, and pseudoaneurysm; higher incidence in patients with PAD and narrow arteries (<6mm).

Conclusions:

• MANTA device offers effective closure for large-bore femoral access in cardiovascular procedures.
• Identified 3 distinct failure mechanisms: toggle elevation, incomplete plug apposition, and pseudoaneurysm formation.
• Strategies to mitigate complications and improve outcomes are discussed, emphasizing patient selection and technique.