First clinical experience with the new Surpass Evolve flow diverter: technical and clinical considerations

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Abstract

Objective

To describe the results in patients treated with the Surpass Evolve (SE) device, the new generation of Surpass flow diverters.

Methods

Twenty-five consecutive patients (20 women, average age 58 years), with anterior or posterior circulation aneurysms treated with SEs in two early-user centers, were included. Device properties and related technical properties, imaging and clinical follow-up data, and intraprocedural, early (<30 days) and delayed (>30 days) neurological complications, further divided into minor (silent/non-permanent) and major (permanent) complications, were recorded and analyzed.

Results

Twenty-nine SEs were successfully implanted in all subjects to treat 26 aneurysms using an 0.027" microcatheter with an average of 1.2 stents per patient. No intraprocedural thromboembolic or hemorrhagic complications were seen. At clinical follow-up, 24/25 (96%) patients had a modified Rankin Score of 0–2. Mortality was 0%. Imaging follow-up, available in 22/25 (88%) patients (median follow-up time 4 months), showed a complete aneurysm occlusion in 13/23 (57%) imaged lesions. Minor, transitory neurological deficits were recorded in 5/25 (20%) patients. One (4%) major complication was seen in one patient (4%) with a left-sided hemispheric stroke on postprocedural day 4 due to an acute stent thrombosis.

Conclusions

Preliminary experience in patients demonstrates a good performance of the SE. This newly designed implant maintains the engineering characteristics of Surpass flow diverters, including precise placement due to its lower foreshortening and a high mesh density, yet can be deployed through a significantly lower-profile delivery system.

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Prospective study on embolization of intracranial aneurysms with the pipeline device: the PREMIER study 1 year results

Ricardo Hanel, David F Kallmes, Demetrius Lopes … (2019)

Background Preliminary clinical studies on the safety and efficacy of the pipeline embolization device (PED) for the treatment of small/medium aneurysms have demonstrated high occlusion rates with low complications. Objective To evaluate the safety and effectiveness of the PED for treatment of wide necked small and medium intracranial aneurysms. Methods PREMIER is a prospective, multicenter, single arm trial. Patients were treated with the PED for unruptured wide necked aneurysms, measuring ≤12 mm along the internal carotid artery or vertebral artery, between July 2014 and November 2015. At 1 year post-procedure, the primary effectiveness endpoint was complete occlusion (Raymond grade 1) without major parent vessel stenosis (≤50%) or retreatment, and the primary safety endpoint was major stroke in the territory supplied by the treated artery or neurologic death. Results A total of 141 patients were treated with PEDs (mean age 54.6±11.3 years, 87.9% (124/141) women). Mean aneurysm size was 5.0±1.92 mm, and 84.4% (119/141) measured <7 mm. PED placement was successful in 99.3% (140/141) of patients. Mean number of PEDs implanted per patient was 1.1±0.26; a single PED was used in 92.9% (131/141) of patients. At 1 year, 97.9% (138/141) of patients underwent follow-up angiography with 76.8% (106/138) of patients having met the study’s primary effectiveness endpoint. The combined major morbidity and mortality rate was 2.1% (3/140). Conclusions Treatment of wide necked small/medium aneurysms with the PED results in high rates of complete occlusion without significant parent vessel stenosis and low rates of permanent neurologic complications. Trial registration NCT02186561.

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SCENT Trial.

Philip M Meyers, Alexander Coon, Peter Kan … (2019)

Background and Purpose- To evaluate the safety and effectiveness of the Surpass Flow Diverter (Surpass; Stryker Neurovascular, Fremont, CA) in the treatment of large or giant wide-neck intracranial aneurysms at one year, we hypothesize that treatment with Surpass meets or improves on historical safety and efficacy end points. Methods- SCENT trial (Surpass Intracranial Aneurysm Embolization System Pivotal Trial to Treat Large or Giant Wide Neck Aneurysms) is a multicenter, prospective, single-arm, nonrandomized, interventional trial of the Surpass Flow Diverter for uncoilable or previously treated but failed aneurysms of the intracranial internal carotid artery extending from the petrous segment to the carotid terminus at its bifurcation into anterior and middle cerebral arteries. For enrollment in SCENT, target aneurysms had to be wide-neck (≥4 mm) and large or giant size (≥10 mm). Study results are compared with performance goals derived from a thorough review of the medical literature. The primary effectiveness end point included 3 components: complete aneurysm occlusion, absence of significant parent artery stenosis (≥50%), and no retreatment at 12 months. The primary safety end point was major ipsilateral stroke (increase in National Institutes of Health Stroke Scale score of ≥4) or neurological death within 12 months. Results- At 26 medical centers, 180 patients with 180 target aneurysms were enrolled in the modified intention-to-treat cohort. Per angiographic core lab assessment, there were 15 (8.3%) fusiform, 164 (91.1%) saccular aneurysms, and 1 (0.6%) blister aneurysm. Mean aneurysm size was 12.0 mm. Thirteen (7.4%) aneurysms were giant (≥25 mm). Fifty-eight (32.2%) aneurysms were located in the supraclinoid and distal (including posterior communicating artery) segments of the internal carotid artery. Mean procedure duration was 53.6 minutes. The device was successfully implanted in 97.8% of patients with a mean of 1.1 devices per patient. SCENT met both primary safety and effectiveness end points: 12-month primary effectiveness rate was 62.8% [(113/180); 95% CI, 55.3-69.9] and 12-month major ipsilateral stroke or neurological death rate was 8.3% [(15/180); 95% CI, 4.7-13.4]. Conclusions- Surpass provides safe and effective flow diversion of large or giant, wide-neck, intracranial internal carotid artery aneurysms. Clinical Trial Registration- URL: https://www.clinicaltrials.gov . Unique identifier: NCT01716117.

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Flow diversion for treatment of intracranial aneurysms: Mechanism and implications.

Melissa Chua, Luke Silveira, Justin A. Moore … (2019)

Flow diverters are new generation stents that have recently garnered a large amount of interest for use in treatment of intracranial aneurysms. Flow diverters reduce blood flow into the aneurysm, with redirection along the path of the parent vessel. Flow stagnation into the aneurysm and neck coverage with subsequent endothelialization are the important synergistic mechanisms by which the therapy acts. Several studies have examined the mechanisms by which flow diverters subsequently lead to aneurysm occlusion. This review aims to provide a general overview of the flow diverters and their mechanism of action and potential implications. ANN NEUROL 2019;85:793-800.