Background and purpose The Medina embolization device (MED) is a new flow disruption device combining the design of a detachable coil with an intrasaccular flow disrupter. Safety and short-term angiographic effectiveness of this device have recently been reported. However, long-term angiographic results are lacking. We report herein the 18 months’ angiographic outcome in patients treated for a wide-neck intracranial aneurysm with the MED.
Materials and methods Nineteen patients (17 female, mean age 50 years) with 20 wide-neck intracranial aneurysms (six ruptured; 14 unruptured) were treated by the MED between January 2015 and June 2016. Procedure-related complications were systematically recorded; discharge and 6–9 months' follow-up modified Rankin Scale scores were assessed. Angiographic mid-term and long-term follow-up were performed with a mean delay of 6.4±1.5 months (n=16 aneurysms) and 17.7±4.2 months (n=15 aneurysms), respectively. Occlusion rates were evaluated after the procedure and at the mid-term and long-term follow-up using the Roy-Raymond scale.
Results Embolization with the MED was feasible in all except two cases (2/20, 10%). One per-procedural perforation was recorded (1/20, 5%) and one MED deployment failed because of the aneurysm’s shape (1/20, 5%). Three cases of thromboembolic complications were observed (3/20, 15%). Only one thromboembolic complication was responsible for clinical sequelae. Grade A occlusion rate was 61% (11/18) after the procedure, 75% at 6 months' follow-up (12/16), and 80% (12/15) at long-term follow-up. Two cases (2/18, 11%) of recanalization at mid-term were documented angiographically. No recanalization occurred between the mid-term and long-term follow-up.
Conclusion MED is a hybrid embolization device, combining properties of a conventional coil with those of an intrasaccular flow disrupter. Our series focusing on long-term angiographic follow-up shows a satisfactory long-term occlusion rate. Larger series with longer angiographic follow-up times are warranted to confirm these preliminary results.
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Contributors FC and N-AS contributed to the design and conception of the work. FC, N-AS, CB, SVP, BM, and MD contributed to the acquisition of data for the work. IH, FC, N-AS, and ES contributed to the analysis and interpretation of data for the work. All authors contributed to drafting or revising the work, approved the final version to be published, and are accountable for all aspects of the work.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests FC is a consultant for Medtronic (paid lectures), Balt (paid lectures), Guerbet (paid lecture), and Codman Neurovascular (study core laboratory). N-AS is a consultant for Medtronic, Balt Extrusion, and Microvention (fee or honorarium) and has stock/stock options for Medina.
Patient consent Not required.
Ethics approval Pitié-Salpêtrière Hospital ethic committee.
Provenance and peer review Not commissioned; externally peer reviewed.