2024-02-15 10:21:20
Chronic subdural hematoma is a common and increasing cause of disability and death. Its incidence is increasing in the context of an aging population and it should constitute the most frequent reason for cranial surgical intervention by 2030, point out Adam Arthur of the Semmes-Murphey Neurological Clinic in Memphis (Tennessee) and his colleagues, in their slideshow.
If different treatments exist, and in particular surgical, recurrences are common and moreover, the population at risk includes many elderly patients for whom surgical intervention presents significant risks, they add.
They conducted the randomized, controlled STEM trial to compare the safety and effectiveness of standard care alone (surgical or not) with those of standard care supplemented with artery embolization. middle meningeal with Squid* – a non-adhesive liquid embolic agent composed of an EVOH (ethylene vinyl alcohol) polymer dissolved in DMSO (dimethyl sulfoxide) and micronized tantalum powder.
To be included, patients had to be at least 30 years old, have a chronic subdural hematoma at least 10 mm thick in the thickest area and exerting a mass effect, as well as neurological symptoms. clear (headaches, cognitive decline, speech problems or aphasia, balance or walking problems, epileptic seizures, etc.).
The 310 patients included, recruited in four countries (France, United States, Germany and Spain) between November 2020 and May 2023, were randomized between four groups, including 189 with surgical treatment preceded or not by embolization of the the middle meningeal artery (91 and 98 patients respectively), and 121 with non-surgical management including 58 with embolization of the middle meningeal artery.
They were 73 years old on average and 70% were men.
The primary endpoint was defined by treatment failure, i.e. a residual hematoma or one that had regressed at 180 days post-intervention, a new surgical intervention during the 180 days following randomization or a stroke ( major stroke), myocardial infarction or death within this same 180-day post-randomization window.
The results show that the failure rate was 39% in patients receiving standard care alone compared to 15% in those who also received embolization of the middle meningeal artery by Squid*. The odds ratio (OR) was 3.6 and significant, in favor of the intervention combining standard care and embolization.
A subgroup analysis revealed a failure rate of 25% with surgery alone and 12% with surgery preceded by embolization (with an OR of 2.4 which was however not significant), as well as a failure rate of 59% with non-surgical treatment alone and 19% when it was supplemented with embolization (with a significant OR of 6.1).
A total of 9 deaths were recorded, including 4 in the embolization group and 5 in the control group. The researchers point out that no deaths have been attributed to the embolization procedure or the device used.
One case of major and disabling stroke was observed in the control group and none in the embolization group.
“Embolization of the middle meningeal artery is promising as an addition to surgical or medical management in the treatment of chronic subdural hematomas,” the researchers conclude.
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