Animal experiments, in-vitro study and clinical use of a new device for the endovascular treatment of intracranial wide necked bifurcation aneurysms (pCONus®)
Coil occlusion of intracranial aneurysms, both ruptured and unruptured, is safe and efficacious if patient selection and endovascular treatment are carried out adequately (Raymond et al. 1997, Roy et al. 2001, Pierot et al. 2008, Spetzler et al. 2013). A major limitation for this treatment modality is related to the geometry of the target aneurysm. A neck of ≥ 4 mm and a fundus width/neck ratio ≤ 1 mm are unfavorable for simple coiling (Brinjikji et al. 2009). Intraluminal flow diversion has solved this issue for sidewall aneurysms (Fischer et al. 2011). Intraaneurysmal flow disrupter (e.g., WEB, Sequent Medical; LUNA, nFocus/Covidien) are promising but not yet fully established devices for selected bifurcation aneurysms (Klisch et al. 2011, Pierot et al. 2012, Lubicz et al. 2013, Pierot et al. 2013). For WNBAs, the techniques to assist coil occlusion include single or crossing stent deployment and balloon remodeling (Lubicz et al. 2009, Moret et al. 1997), both requiring catheter access to at least one efferent vessel of the bifurcation. This catheterization can sometimes be difficult. Coil assist techniques without efferent vessel access include TriSpan device (Raymond et al. 2001), which is no longer available, and the deployment of self-expanding stents with their distal end inside the aneurysm, the so-called “waffle cone” technique (Horowitz et al. 2006). The stents used for the “waffle cone” technique (e.g., Solitaire AB, Covidien; Enterprise, Codman) are not optimized for this purpose and are far from ideal. pCONus® (phenox) is a dedicated neurovascular device, which was designed to address the functional needs of an extra-intrasaccular neck bridging aneurysm implant to assist the coil occlusion of WNBAs. The present thesis summarizes the in vitro study of the device, its initial use in 9 New Zealand White Rabbits as well as the angiographic and clinical results in the endovascular treatment of 50 intracranial aneurysms. In the clinical use of pCONus® we refer to the initial state of the patient, the angiographic outcome of the treatment session, possible complications and clinical outcome after the treatment. The results of the follow-up, the necessity and, if necessary, subsequent treatments, and in turn, their clinical outcome are presented elsewhere.