Introduction
The increasing utilization of Extracorporeal Membrane Oxygenation (ECMO) has underscored the necessity for a reliable, efficient, and minimally invasive vascular closure device specifically designed for ECMO decannulation. Current decannulation methods, including surgical approaches and existing vascular closure devices (VCDs), are associated with significant drawbacks such as increased thrombogenicity, prolonged operating room (OR) time, and elevated costs. Furthermore, these devices are often difficult to use, require multiple devices for effective closure, or result in device failure and severe complications such as vessel occlusion, acute limb ischemia, or infection. This study aims to develop a novel intravascular closure device for large bore IVs that is minimally invasive with low risk of thrombosis or complications.
Methods
A detailed needs assessment was conducted through interviews with key stakeholders, including cardiac and vascular surgeons, interventional cardiologists, and ECMO specialists. Specific design requirements were established: compatibility with large-bore vessels, rapid hemostasis, high safety profile, improved surgical efficiency, ease of use, and the need for only one device to be deployed. Additionally, a thorough evaluation of other market competitors, such as Perclose and Manta, was conducted to identify strengths and weaknesses.
The development process involved:
1. Stakeholder Engagement: Iterative feedback was obtained from clinical experts to refine the design and address potential complications.
2. Prototype Development: Low-fidelity prototypes were constructed to demonstrate the conceptual design and functionality of the device.
3. Design Specifications: The device is designed to be compatible with vessels up to 26 French, with a target deployment-to-hemostasis time of less than 90 seconds. Safety
measures aim for a reduced complication rate, with no significant hematoma, ischemia, thrombus, or infection.
4. Image-Guided Deployment: The device's deployment process will incorporate real-time image guidance (ultrasound or fluoroscopy) to ensure accurate placement, confirm vessel depth, and verify effective closure, enhancing procedural safety and efficacy.
Results
The proposed endovascular closure device aims to enhance patient safety, reduce procedural time, and decrease hospital stay length compared to traditional surgical decannulation methods. Key features of the device include:
• A minimally invasive approach suitable for large-bore vessel closure.
• Rapid and reliable hemostasis achieved through a novel extraluminal patch and suture mechanism.
• Integration of image-guided techniques for precise deployment and confirmation of successful vessel closure.
• Design elements that prioritize ease of use and procedural efficiency.
• Requires only one device to be deployed for effective closure.
Conclusions
This project proposes a novel solution to the challenges faced in ECMO decannulation by developing an innovative endovascular closure device. Future steps include further prototype modeling, preclinical testing, and clinical trials to validate the device's efficacy and safety, ultimately aiming for widespread clinical adoption.