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.
- flow diverter
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Contributors Contributorship Statement: Conception: EO, VMP, AKW, TK, HR; clinical data: EO, VMP, TK, HR, LDV, JMK, IR, KDB, HK; imaging review and follow up: EO, VMP, TK, JKM, HR, KDB, HK, AKW, ALC; writing: EO, VMP, AKW; review: EO, JMK, AKW, ALC, HR, LDV, HK, KDB, TK, VMP.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests VMP is a consultant for Stryker, Balt, Medtronic, and Cerenovous and holds a grant from Philips Healthcare.TK is a consultant for Medtronic, Stryker, and Penumbra and is a stockholder in Marblehead Inc. AKW has research grant from Philips Medical; serves as a consultant for Stryker and Phenox; is a stockholder of InNeuroCo, EpiEP, Neural Analytics, Rist, Analytics 4 Life, and ThrombX; and is on the Speakers’ Bureau for SCENT trial (Surpass Intracranial Aneurysm Embolization System Pivotal Trial to Treat Large or Giant Wide Neck Aneurysms) presentations. ALC is consultant and proctor for Stryker, Medtronic, and Microvention and is on the Medical Advisory Board for InNeuroCo. HR is a consultant and proctor for, and receives educational support from, Stryker, Medtronic, Philips, Microvention, and Penumbra. All other Authors have no disclosures.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement All data relevant to the study are included in the article or uploaded as supplementary information. All data from this study are included in the manuscript.