Clemens Maria Schirmer, Albert J Yoo, Alejandro M Spiotta, Ian Kaminsky, Amer Alshekhlee, Robert M Starke, Andrew Nicholson, Osama O Zaidat, Bradley Bohnstedt, Marios-Nikos Psychogios, Ryan Viets, Kaiz S Asif, Christopher J Stapleton, Alim P Mitha, Oded Goren
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Primary outcomes were adequate occlusion (Raymond-Roy Occlusion Classification, RROC I/II) at 1 year, serious adverse events (SAEs) within 24 hours, and device-related SAEs up to 7 days (or discharge).</p><p><strong>Results: </strong>A total of 572 patients (mean age 59.5 years, 72.6% female) were enrolled between November 2019 and August 2022. Among target IAs, 39.9% were ruptured, 78.7% saccular, 54.1% wide-necked, and 11.2% previously treated, with 37.1% located in the internal carotid artery and 30.6% in the anterior cerebral artery. The mean size was 6.6±3.45 mm. Unassisted coiling was used in 50.7% of cases. Adjunctive therapy included stent-assisted coiling (28.8%), balloon-assisted coiling (17.7%), and flow diverters or medications (5.6%). The mean packing density was 34%. RROC I/II was 87.4% immediately post-procedure and 92.4% at 1 year. The retreatment rate was 9.8%, and recanalization was 12.7% at 1 year. SAEs rate within 24 hours was 9.3%. Device-related SAEs occurred in 1.1% of patients. The rate of major ipsilateral stroke was 1.7%.</p><p><strong>Conclusion: </strong>Penumbra's WAVE coils resulted in high packing density and effective and durable embolization of IAs in a diverse, real-world population, supporting coiling as the standard of care for IA treatment.</p><p><strong>Trial registration number: </strong>NCT04106583.</p>","PeriodicalId":16411,"journal":{"name":"Journal of NeuroInterventional Surgery","volume":" ","pages":""},"PeriodicalIF":4.3000,"publicationDate":"2025-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Intracranial aneurysm embolization using Penumbra fill and finish coils: 1-year results of a prospective, real-world, multicenter SURF study.\",\"authors\":\"Clemens Maria Schirmer, Albert J Yoo, Alejandro M Spiotta, Ian Kaminsky, Amer Alshekhlee, Robert M Starke, Andrew Nicholson, Osama O Zaidat, Bradley Bohnstedt, Marios-Nikos Psychogios, Ryan Viets, Kaiz S Asif, Christopher J Stapleton, Alim P Mitha, Oded Goren\",\"doi\":\"10.1136/jnis-2025-023633\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>SURF was a prospective, multicenter, single-arm, observational study with core lab adjudication of radiographic data, assessing embolization of intracranial aneurysms (IAs) using WAVE Extra Soft Coils as part of SMART Coil System.</p><p><strong>Methods: </strong>Adults undergoing IA embolization with the SMART Coil System (Penumbra, Inc.) comprising <u>></u>75% of implanted coils and WAVE as the final finishing coil were enrolled at 43 global centers. Primary outcomes were adequate occlusion (Raymond-Roy Occlusion Classification, RROC I/II) at 1 year, serious adverse events (SAEs) within 24 hours, and device-related SAEs up to 7 days (or discharge).</p><p><strong>Results: </strong>A total of 572 patients (mean age 59.5 years, 72.6% female) were enrolled between November 2019 and August 2022. Among target IAs, 39.9% were ruptured, 78.7% saccular, 54.1% wide-necked, and 11.2% previously treated, with 37.1% located in the internal carotid artery and 30.6% in the anterior cerebral artery. The mean size was 6.6±3.45 mm. Unassisted coiling was used in 50.7% of cases. Adjunctive therapy included stent-assisted coiling (28.8%), balloon-assisted coiling (17.7%), and flow diverters or medications (5.6%). The mean packing density was 34%. RROC I/II was 87.4% immediately post-procedure and 92.4% at 1 year. The retreatment rate was 9.8%, and recanalization was 12.7% at 1 year. SAEs rate within 24 hours was 9.3%. Device-related SAEs occurred in 1.1% of patients. 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引用次数: 0
摘要
背景：SURF是一项前瞻性、多中心、单臂、观察性研究，核心实验室判定影像学数据，评估使用WAVE Extra Soft Coil作为SMART Coil系统的一部分栓塞颅内动脉瘤（IAs）的效果。方法：在43个全球中心招募了使用SMART线圈系统（半影公司）进行IA栓塞的成年人，该系统包含bbb75%的植入线圈和WAVE作为最后的完成线圈。主要结局是1年的充分闭塞（Raymond-Roy闭塞分类，RROC I/II）， 24小时内的严重不良事件（SAEs），以及器械相关的SAEs长达7天（或出院）。结果：在2019年11月至2022年8月期间，共有572例患者入组，平均年龄59.5岁，其中72.6%为女性。在目标IAs中，39.9%为破裂，78.7%为囊状，54.1%为宽颈，11.2%为先前治疗过的IAs，其中37.1%位于颈内动脉，30.6%位于大脑前动脉。平均大小为6.6±3.45 mm。50.7%的病例使用无辅助卷取。辅助治疗包括支架辅助盘绕（28.8%）、球囊辅助盘绕（17.7%）和分流器或药物（5.6%）。平均填料密度为34%。术后即刻RROC I/II为87.4%，1年时为92.4%。1年再治疗率为9.8%，再通率为12.7%。24小时内sa发生率为9.3%。器械相关的SAEs发生率为1.1%。同侧脑卒中发生率为1.7%。结论：Penumbra的WAVE线圈在不同的现实世界人群中实现了高填充密度和有效持久的IAs栓塞，支持线圈作为IA治疗的标准护理。试验注册号：NCT04106583。
Intracranial aneurysm embolization using Penumbra fill and finish coils: 1-year results of a prospective, real-world, multicenter SURF study.
Background: SURF was a prospective, multicenter, single-arm, observational study with core lab adjudication of radiographic data, assessing embolization of intracranial aneurysms (IAs) using WAVE Extra Soft Coils as part of SMART Coil System.
Methods: Adults undergoing IA embolization with the SMART Coil System (Penumbra, Inc.) comprising >75% of implanted coils and WAVE as the final finishing coil were enrolled at 43 global centers. Primary outcomes were adequate occlusion (Raymond-Roy Occlusion Classification, RROC I/II) at 1 year, serious adverse events (SAEs) within 24 hours, and device-related SAEs up to 7 days (or discharge).
Results: A total of 572 patients (mean age 59.5 years, 72.6% female) were enrolled between November 2019 and August 2022. Among target IAs, 39.9% were ruptured, 78.7% saccular, 54.1% wide-necked, and 11.2% previously treated, with 37.1% located in the internal carotid artery and 30.6% in the anterior cerebral artery. The mean size was 6.6±3.45 mm. Unassisted coiling was used in 50.7% of cases. Adjunctive therapy included stent-assisted coiling (28.8%), balloon-assisted coiling (17.7%), and flow diverters or medications (5.6%). The mean packing density was 34%. RROC I/II was 87.4% immediately post-procedure and 92.4% at 1 year. The retreatment rate was 9.8%, and recanalization was 12.7% at 1 year. SAEs rate within 24 hours was 9.3%. Device-related SAEs occurred in 1.1% of patients. The rate of major ipsilateral stroke was 1.7%.
Conclusion: Penumbra's WAVE coils resulted in high packing density and effective and durable embolization of IAs in a diverse, real-world population, supporting coiling as the standard of care for IA treatment.
期刊介绍：
The Journal of NeuroInterventional Surgery (JNIS) is a leading peer review journal for scientific research and literature pertaining to the field of neurointerventional surgery. The journal launch follows growing professional interest in neurointerventional techniques for the treatment of a range of neurological and vascular problems including stroke, aneurysms, brain tumors, and spinal compression.The journal is owned by SNIS and is also the official journal of the Interventional Chapter of the Australian and New Zealand Society of Neuroradiology (ANZSNR), the Canadian Interventional Neuro Group, the Hong Kong Neurological Society (HKNS) and the Neuroradiological Society of Taiwan.
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