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Transcaval access (TCA) is a novel alternative to the traditional transfemoral arterial approach for patients requiring large catheter-based percutaneous procedures such as transcatheter aortic valve implantation (TAVI), left ventricular assist device (LVAD) and thoracic endovascular aortic repair (TEVAR). Although there have been over 300 cases successfully performed worldwide, TCA is limited by technical challenges and safety concerns such as the lack of a purpose built closure device as demonstrated by the high transfusion rates reported in the literature. We present the first report of a partially covered self-expanding stent that takes all the anatomical challenges of this technique into consideration.
We tested our device in a controlled laboratory setting on a porcine abdominal aortic sample that was modified to include irregular surface morphology and perfused with water to endoscopically visualize deployment of the closure device. The device was introduced and deployed via a sheath at the same angulation as it would be during a real procedure utilizing TCA. Next, the vessel was perfused with pulsatile flow of heparinized porcine blood to hypertensive range. Anticoagulation was reversed with protamine, and the porcine aortic sample was checked for endovascular leak.
The device demonstrated ease of implantation under simulated TCA conditions and complete sealing with hemostasis at hypertensive pressures.
Our percutaneous transcaval closure device addresses a major concern associated with TCA. The device is a partially covered, self-expanding, nitinol stent that is deployed transversely rather than sagittally. It allows for predictable placement and affirmative hemostasis of the transcaval aortic opening. Our device represents a viable solution to the technical limitation of the transcaval access technique.
OTHER: Vascular Access