None listed
Conditions
Brief summary
VA-ECMO is a life-saving therapy in patients with cardiovascular or respiratory failure. The use of VA-ECMO is increasing and has doubled globally in the last 5 years. Percutaneous cannulation can be achieved using ultrasound guidance, even in unfavourable clinical and/or environmental conditions. If the patient recovers and can be weaned from VA-ECMO, or if ongoing VA-ECMO support is futile and no longer meets its intended goals, withdrawal of the VA-ECMO is required. Removal of the large (15-21F) femoral arterial cannulas is typically performed in an open surgical procedure. However, surgical decannulation is associated with several complications such as bleeding, delayed wound healing and infections. In addition, there is an increased strain on healthcare resources: patients need a vascular or cardiac surgeon, general anaesthesia, theatre time with support of a perfusionist, and transport to and from the theatre. To circumvent this, manual compression and suture-based vascular closure devices have been used in VA-ECMO decannulation, but both were associated with an increased risk of bleeding (5-10%) or requiring additional steps during initial VA-ECMO cannulation. The MANTA vascular closure device is a collagen plug based device, that is increasingly used in large bore interventional therapies such as transcatheter aortic valve implantation, endovascular aneurysm repair or periprocedural of left ventricular assist devices. This is a non-randomised open-label feasibility study. We aim to include 20 patients on VA-ECMO in which decannulation of ECMO support is pursued by the treating team, to investigate the safety and feasibility of percutaneous decannulation of femoral VA-ECMO using the MANTA VCD.
Interventions
Following VA-ECMO decannulation, the MANTA Vascular Closure Device will be used for percutaneous closure of the large bore arterial cannula site (as opposed to open surgery). The percutaneous closure will be performed by an interventional cardiologist in the cardiac catheter laboratory with an intensive care specialist and cardiothoracic or vascular surgeon on standby. The intervention will be delivered once. A Teleflex Medical (device manufacturer) representative will be available to the interv
Following VA-ECMO decannulation, the MANTA Vascular Closure Device will be used for percutaneous closure of the large bore arterial cannula site (as opposed to open surgery). The percutaneous closure will be performed by an interventional cardiologist in the cardiac catheter laboratory with an intensive care specialist and cardiothoracic or vascular surgeon on standby. The intervention will be delivered once. A Teleflex Medical (device manufacturer) representative will be available to the interventional team to ensure that the device is used in keeping with manufacturer specifics.
Sponsors
Antony Walton
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Deemed appropriate by the multi-disciplinary team discussion including ICU physician, cardiothoracic surgeon, vascular surgeon, and interventional cardiologist. - Suitable vascular anatomy as established by vascular ultrasound. - Suitable body habitus (body mass index >20kg/m2 and <40 kg/m2).
Exclusion criteria
- Non femoral ECMO. - Thrombus in CFA/SFA . - Track depth on ultrasound exceeding 7cm. - Puncture site of arterial cannula close to bifurcation , or other unfavourable features such as heavily calcified CFA. - Arterial re-cannulation cases. - ECMO > 14 days in situ. - Known bleeding disorder including thrombocytopenia (platelet count <50 000 cells/µL), thrombasthenia, haemophilia, von Willebrand disease. - Cannula site infection.
Outcome results
None listed