Abstract
BackgroundIt is unknown whether technological advancement of stent-retriever devices influences typical observational indicators of safety or effectiveness.MethodsObservational retrospective study of APERIO® (AP) vs. new generation APERIO® Hybrid (APH) (Acandis®, Pforzheim, Germany) stent-retriever device (01/2019–09/2020) for mechanical thrombectomy (MT) in large vessel occlusion (LVO) stroke. Primary effectiveness endpoint was successful recanalization eTICI (expanded Thrombolysis In Cerebral Ischemia) ≥ 2b67, primary safety endpoint was occurrence of hemorrhagic complications after MT. Secondary outcome measures were time from groin puncture to first pass and successful reperfusion, and the total number of passes needed to achieve the final recanalization result.ResultsA total of 298 patients with LVO stroke who were treated by MT matched the inclusion criteria: 148 patients (49.7%) treated with AP vs. 150 patients (50.3%) treated with new generation APH. Successful recanalization was not statistically different between both groups: 75.7% for AP vs. 79.3% for APH; p = 0.450. Postinterventional hemorrhagic complications and particularly subarachnoid hemorrhage as the entity possibly associated with stent-retriever device type was significantly less frequent in the group treated with the APH: 29.7% for AP and 16.0% for APH; p = 0.005; however, rates of symptomatic hemorrhage with clinical deterioration and in domo mortality were not statistically different. Neither the median number of stent-retriever passages needed to achieve final recanalization, time from groin puncture to first pass, time from groin puncture to final recanalization nor the number of cases in which successful recanalization could only be achieved by using a different stent-retriever as bail-out device differed between both groups.ConclusionIn the specific example of the APERIO® stent-retriever device, we observed that further technological developments of the new generation device were not associated with disadvantages with respect to typical observational indicators of safety or effectiveness.
Highlights
Mechanical thrombectomy (MT) has become the standard of care for large vessel occlusion (LVO) in acute ischemic stroke [1,2,3]
We retrospectively included all consecutive patients with acute symptomatic LVO stroke who were treated by MT at our comprehensive stroke center (University Hospital Würzburg, Germany) between January 2019 and September 2020, using either the APERIO® (AP) or the APERIO® Hybrid (APH) stent-retriever device
To account for substantial heterogeneity in how symptomatic intracranial hemorrhage is defined in the literature, we proceeded in the following manner: for all patients we applied the morphological classification of bleeding events according to the Heidelberg bleeding classification (HBC) [17], which is broadly consistent with the commonly used European cooperative acute stroke study (ECASS) II classification of hemorrhagic complications [18]
Summary
Mechanical thrombectomy (MT) has become the standard of care for large vessel occlusion (LVO) in acute ischemic stroke [1,2,3]. Over the last few years medical progress of endovascular stroke treatment has been paralleled by dynamic innovations in stent-retriever device technology. This led to both novel devices and further technical refinements of first generation devices, such as modifications in material composition and their structural design. These advancements in medical device technology and engineering represent potential improvements for interventional handling and seem promising to have positive impact on recanalization effectiveness and safety; these assumptions need to be tested by studies with observational design and/or registries. It is unknown whether technological advancement of stent-retriever devices influences typical observational indicators of safety or effectiveness
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