Introduction The use of FD is limited, as it requires dual antiplatelet treatment to avoid thromboembolic complications. Hydrophilic Polymer Coating (HPC) technology is developed to reduce the need for antiplatelet treatment (AT).
Aim of the study This “Real Life’ retro-prospective post-market multicenter study evaluate the use of HPC FD (p-64 or p-48) for intracranial aneurysm (IA) occlusion. The primary endpoints are safety/efficacy of the device, the secondary endpoints are patient outcome mesures, in relation to the AT.
Methods Between 2020–2022, a total of 135 (100 F/ 35 M) patients were treated. Anonymized data were recorded in a website-database, with encrypted access, according to EU privacy low. 18 Italian Center with previous experience in the use of FDs collected their data. Including criteria were: ruptured/unruptured, saccular/fusiform/dissecting IA up to 20-mm, with or without coiling, including recanalization. Flow related aneurysms (AVMs-fistulas) were excluded. A total of 147 FDs were used, 2 in 12 cases, 5 failures. Database include baseline status, procedural/post-procedural complications, outcomes (mRS score), intra/post-procedural imaging (DSA, MRA, CTA), AT and FU at 3/6/12 months.
Results Number of treatments, clinical-technical success rate, including complications at discharge and AT will be discussed. The 3-month FU will be available for all cases. Categorical data and variables will be summarized. Statistics will be done utilizing Chi-squared method.
Conclusions Although the study has inherent limitations due to its ’real life’ design, the evaluation of the data will provide important information on the safety and efficacy of HPC FD implant for IA cure.
Disclosure of Interest NO DISCLOSURE RELATED WITH THE PRESENTATION
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.