PURPOSE: The Medina Embolic Device (MED) is a new intrasaccular device with promising early results. Previously we documented our initial experience of this device both alone and in combination with other devices including flow diverter stents (FDS). We sought to determine the effect of the MED + FDS strategy for the treatment of selected aneurysms. MATERIALS AND METHODS: We performed a retrospective analysis of prospectively collected data to identify all patients with aneurysms treated using both the MED and intraluminal FDS. We present our technical success rate, early and mid-term angiographic follow-up, and clinical outcome data. RESULTS: We identified 25 non-consecutive patients. The treatment was staged in 9 patients and in a single session 16 patients. The average age was 61±12.8 years (range 40–82). The average fundus height was 11±3.6 mm and average fundus width was 10.1±3.4 mm. In the staged cohort (n=9) at delayed angiography (mean 10 mths) 8 aneurysms (89%) showed complete exclusion (mRRC 1) and in one patient there was a parent vessel occlusion. In the simultaneous cohort delayed angiography (n=10, mean 8.1 months) demonstrated complete occlusion (mRRC 1) in 6 aneurysms (60%), 3 neck remnants (mRRC 2) (30%) and 1 patient (10%) showed persistent aneurysmal filling (mRRC 3a). There were 5 complications with permanent morbidity (mRS >2) in two patients. There were no mortalities. CONCLUSION: The MED can be successfully used in combination with intraluminal FDS and in selected aneurysms this may represent an alternative to FDS and adjunctive coiling.
Aneurysm ; Angiography ; Cohort Studies ; Follow-Up Studies ; Humans ; Intracranial Aneurysm* ; Mortality ; Neck ; Parents ; Prospective Studies ; Retrospective Studies ; Stents

Background: and Purpose The Save ChildS Study demonstrated that endovascular thrombectomy (EVT) is a safe treatment option for pediatric stroke patients with large vessel occlusions (LVOs) with high recanalization rates. Our aim was to determine the long-term cost, health consequences and cost-effectiveness of EVT in this patient population. Methods: In this retrospective study, a decision-analytic Markov model estimated lifetime costs and quality-adjusted life years (QALYs). Early outcome parameters were based on the entire Save ChildS Study to model the EVT group. As no randomized data exist, the Save ChildS patient subgroup with unsuccessful recanalization was used to model the standard of care group. For modeling of lifetime estimates, pediatric and adult input parameters were obtained from the current literature. The analysis was conducted in a United States setting applying healthcare and societal perspectives. Probabilistic sensitivity analyses were performed. The willingness-to-pay threshold was set to $100,000 per QALY. Results: The model results yielded EVT as the dominant (cost-effective as well as cost-saving) strategy for pediatric stroke patients. The incremental effectiveness for the average age of 11.3 years at first stroke in the Save ChildS Study was determined as an additional 4.02 lifetime QALYs, with lifetime cost-savings that amounted to $169,982 from a healthcare perspective and $254,110 when applying a societal perspective. Acceptability rates for EVT were 96.60% and 96.66% for the healthcare and societal perspectives. Conclusions EVT for pediatric stroke patients with LVOs resulted in added QALY and reduced lifetime costs. Based on the available data in the Save ChildS Study, EVT is very likely to be a cost-effective treatment strategy for childhood stroke.