In a multicentre study, the Aperio thrombectomy device (Acandis) demonstrated safety and efficacy as a tool for reopening occluded cerebral arteries in the setting of an acute ischaemic stroke.
According to study authors, Kallenberg et al, “Aperio is a newer thrombectomy device which was found to remove blood clots as effectively as the market leading product in an experimental study, and faster and will less distal embolisation than the other devices tested.” What they aimed to evaluate therefore, was the practicability and effectiveness of Aperio in an ‘everyday anywhere clinical setting’: in multiple centres, applied by neurovascular interventionalists with differing levels of experience.
Aperio is a non-detachable mechanical thrombectomy device with a hybrid cell design. It has an outer diameter of 4.5mm and a usable length of 30–40mm, depending on the vessel diameter. For radio-opacity the device has two elongated wire markers to support the positioning of the device and three distal device markers to indicate the distal device end and the grade of expansion.
In the study, a total of 119 patients (68 women) with acute stroke were treated at nine centres. Kallenberg and others report in the Journal of NeuroInterventional Surgery (JNIS) that the median thrombus length was 15mm and the average time from device insertion to recanalisation was 30 minutes. Blood flow restoration (TICI 2–3) was achieved in 85% of patients. In the majority of cases complete clot removal was achieved (TICI 0, 12%; TICI 1, 2%; TICI 2a, 14%; TICI 2b, 18%; TICI 3, 53%), and the median number of deployments was two.
Twelve procedural complications occurred, including one vessel perforation with subarachnoid haemorrhage, one subarachnoid haemorrhage of unknown cause, four cases of vasospasm, one device rupture, one case with subarachnoid contrast agent in post-interventional angiographic CT of unknown cause and three dissections. Embolisation of previously unaffected territories by fragmented or lost clots was not reported in any case.
The authors report some difference between this study and previous thrombectomy studies. “In this study we report the use of the Aperio thrombectomy device with its distal portion mainly deployed in vessels of ≤2mm diameter with fewer intracranial haemorrhages than with rtPA alone or with previous studies applying retrievable stent systems to treat acute stroke. In MR CLEAN there was no difference in the overall risk of any serious adverse event between the intervention group and the control group, but the risk was considerably higher than in the present study,” they write.
They add that the recanalisation rate (≥TICI 2a) of 85% is similar to that of other stent retriever trials—SWIFT (Solitaire 89%, Merci 67%); SWIFT PRIME, 88%; Trevo, 92%; Trevo II (Trevo 92%, Merci 77%); and IMS III, 73%. The difference between this Aperio study and those studies however, was that neurointerventionalists in the in those studies had to fulfil certain qualification criteria in order to participate, whereas the experience of the physicians who used the Aperio device was quite inhomogeneous.
Kallenberg et al conclude stating that the Aperio device “seems to be an effective and adequately safe tool for reopening occluded cerebral arteries in the setting of acute stroke”.