Ciceri Elisa, Lozupone Emilio, Milani Matteo, Piano Mariangela, Caldiera Valentina, Vitiello Alessio, Muto Mario, Giordano Flavio, Erta Marco, Comelli Simone, Nuzzi Paolo, Divenuto Ignazio, Stanca Carmelo, Venturi Fabrizio, Romano Giuseppe, Boghi Andrea, Comelli Chiara, Paladini Adriana, Pauciulo Alfredo, Remida Paolo, Patassini Mirko, Zimatore Domenico Sergio, Messina Raffaella, Pero Guglielmo, Faragò Giuseppe, Quilici Luca, Gola Giuliano, Gallesio Ivan, Natrella Massimiliano, Sicignano Carmine, D'agostino Vincenzo, Giorgianni Andrea, Chirico Claudio, La Tessa Giuseppe Maria Ernesto, Augelli Raffaele, Plebani Mauro, Bersano Anna, Ganci Giuseppe, Riccietti Chiara
Neurosurgery, Foundation IRCCS Carlo Besta Neurological Institute, Milano, Italy.
Department of Neuroradiology, Hospital Vito Fazzi, Lecce, Apulia, Italy.
Interv Neuroradiol. 2025 Jun 9:15910199251341643. doi: 10.1177/15910199251341643.
BackgroundThe introduction of flow diverters (FDs) has revolutionized the treatment of complex intracranial aneurysms; subsequent surface modifications have extended their indications to ruptured, bifurcation, and distal aneurysms. The aim of this study is to assess the real-world feasibility and safety of HPC surface-modified devices in the treatment of ruptured and unruptured aneurysms.MethodsThis independent, multicenter, prospective observational study evaluated the outcomes of patients treated with implanted Phenox p64 or p48 MW-HPC-FDs between 2020 and 2022. The sub-analysis of the procedures, complications (clinical and technical), and additional treatment requirements assessed the devices' feasibility and safety in the peri-procedural period.ResultsOne hundred and forty aneurysms (35% ruptured and 65% unruptured) were treated in 140 patients (37 females and 103 males) using 153 HPC-FDs (111 p64 and 42 p48): 100 aneurysms were saccular (71%), 22 dissecting (16%), 13 fusiform (9%), and five blister-like (3.6%). The successful deployment rate was 97.9%. The overall peri-procedural mortality rate was 9%, including three device-related deaths (2.2%); the overall morbidity rate was 12.1% (6.4% severe, 3.6% mild, and 2.1% asymptomatic adverse events); 4.4% of the clinical adverse events were certainly device related, and 2.2% were probably device related.ConclusionsThe use of p64 and p48 HPC-FDs is highly feasible and acceptably safe, although further data are needed to assess the impact of the coating on safety in emergency and elective procedures.
背景
血流导向装置（FDs）的引入彻底改变了复杂颅内动脉瘤的治疗方式；随后的表面改性将其适应证扩展至破裂性、分叉处和远端动脉瘤。本研究的目的是评估经高孔隙率涂层（HPC）表面改性的装置在治疗破裂性和未破裂性动脉瘤方面的真实世界可行性和安全性。
方法
这项独立的、多中心的前瞻性观察性研究评估了2020年至2022年间植入Phenox p64或p48 MW-HPC-FDs治疗的患者的结局。对手术过程、并发症（临床和技术方面）以及额外治疗需求的亚分析评估了这些装置在围手术期的可行性和安全性。
结果
140例患者（37例女性和103例男性）使用153枚HPC-FDs（111枚p64和42枚p48）治疗了140个动脉瘤（35%为破裂性，65%为未破裂性）：100个动脉瘤为囊状（71%），22个为夹层性（16%），13个为梭形（9%），5个为水泡样（3.6%）。成功植入率为97.9%。围手术期总死亡率为9%，包括3例与装置相关的死亡（2.2%）；总发病率为12.1%（6.4%为严重，3.6%为轻度，2.1%为无症状不良事件）；4.4%的临床不良事件肯定与装置相关，2.2%可能与装置相关。
结论
使用p64和p48 HPC-FDs具有高度可行性且安全性可接受，尽管需要进一步的数据来评估涂层在急诊和择期手术中对安全性的影响。
