TY - JOUR
T1 - Prospective Registry of Embolization of Intracranial Aneurysms Using HydroSoft Coils
T2 - Results of the Japanese HydroSoft Registry
AU - JHSR Collaborators
AU - Imamura, Hirotoshi
AU - Sakai, Nobuyuki
AU - Ito, Yasushi
AU - Sakai, Chiaki
AU - Hyodo, Akio
AU - Miyachi, Shigeru
AU - Matsumaru, Yuji
AU - Yoshimura, Shinichi
AU - Abe, Toshi
AU - Yamagami, Hiroshi
AU - Hayakawa, Mikito
AU - Sato, Hiroaki
AU - Fujinaka, Toshiyuki
AU - Tanabe, Kenichiro
AU - Haraguchi, Koichi
AU - Sakamoto, Makoto
AU - Morimoto, Masashi
AU - Higashi, Toshio
AU - Sugiu, Kenji
AU - Ishii, Akira
AU - Nakahara, Ichiro
AU - Oishi, Hidenori
AU - Matsumoto, Yasushi
AU - Niimi, Yasunari
AU - Yonaha, Hirokatsu
AU - Enomoto, Yukiko
AU - Iinoshi, Tomoshi
AU - Kawanishi, Masahiko
AU - Ushikoshi, Satoshi
AU - Toma, Naoki
AU - Kiura, Sadanori
AU - Mase, Mitshuhito
AU - Izumi, Takashi
N1 - Funding Information:
Conflict of interest statement: This trial was registered with Japanese University Hospital Medical Information Network as UMIN000010342. It was funded and sponsored by Terumo Medical Corporation (Tokyo, Japan). The company was not involved in the research planning, conduct, or analysis. H. Imamura received Speakers' Bureau/Honoraria from Medtronic Co. All authors, including the corresponding author, have no conflicts of interest related to this manuscript. Conflict of interest statement: This trial was registered with Japanese University Hospital Medical Information Network as UMIN000010342. It was funded and sponsored by Terumo Medical Corporation (Tokyo, Japan). The company was not involved in the research planning, conduct, or analysis. H. Imamura received Speakers' Bureau/Honoraria from Medtronic Co. All authors, including the corresponding author, have no conflicts of interest related to this manuscript. We are very grateful to all of the participants and collaborators and to the data monitoring committee. We also thank Angela Morben, DVM, ELS, from Edanz Group (www.edanzediting.com/ac), for editing a draft of this manuscript. JHSR Collaborators (number of registered cases), Nobuyuki Sakai, Hirotoshi Imamura, Kobe City Medical Center General Hospital (17), Chiaki Sakai, Institute of Biomedical Research and Innovation (15), Yuji Matsumaru, Toranomon Hospital (14), Hiroaki Sato, Tokyo Metropolitan Hospital (11), Toshiyuki Fujinaka, Osaka University Hospital (7), Koichi Haraguchi, Hakodate Shintoshi Hospital (6), Makoto Sakamoto, Tottori University Hospital (5), Masashi Morimoto, Yokohama Shintoshi Neurosurgical Hospital (5), Toshio Higashi, Fukuoka University Hospital (4), Kenji Sugiu, Okayama University Hospital (4), Akira Ishii, Kyoto University Hospital (4), Ichiro Nakahara, Kokura Memorial Hospital (3), Hidenori Oishi, Juntendo University Hospital (3), Yasushi Matsumoto, Konan Hospital (2), Yasunari Niimi, St. Lukes International Hospital (2), Hirokatsu Yonaha, Okinawa Red Cross Hospital (2), Yukiko Enomoto, Gifu University Hospital (2), Tomoshi Iinoshi, Sapporo Medical University Hospital (2), Masahiko Kawanishi, Kagawa University Hospital (2), Akio Hyodo, Dokkyo Medical University Koshigaya Hospital (2), Satoshi Ushikoshi, National Hospital Organization Hokkaido Medical Center (2), Naoki Toma, Mie University Hospital (1), Sadanori Kiura, Hiroshima University Hospital (1), Mitshuhito Mase, Nagoya City Medical University Hospital (1), Takashi Izumi, Nagoya University Hospital (1) Conflict of interest statement: This trial was registered with Japanese University Hospital Medical Information Network as UMIN000010342. It was funded and sponsored by Terumo Medical Corporation (Tokyo, Japan). The company was not involved in the research planning, conduct, or analysis. H. Imamura received Speakers' Bureau/Honoraria from Medtronic Co. All authors, including the corresponding author, have no conflicts of interest related to this manuscript.
PY - 2019/7
Y1 - 2019/7
N2 - Background: The effect of HydroSoft coils on the prevention of recanalization and thrombosis after embolization is unclear. We herein report the results of the single-armed prospective Japanese HydroSoft Registry. Methods: Aneurysms with a diameter of <10 mm that were treated with a ≥50% length of HydroSoft coils were registered. We evaluated the safety and recanalization rate and analyzed the factors related to their recanalization and thrombosis 1 year later. Results: In total, 122 aneurysms were registered. Their mean maximum diameter and neck length were 6.4 and 3.9 mm, respectively. The mean length of the HydroSoft coils was 84.3%. No intracranial hemorrhage occurred, but 2 patients developed minor ischemic strokes. Angiographic examination immediately after the procedure showed complete obliteration, neck remnant (NR), and body filling (BF) in 20 (16.4%), 32 (26.2%), and 67 (54.9%) cases, respectively. One-year follow-up angiography showed complete obliteration, NR, and BF in 68 (55.7%), 15 (12.3%), and 15 (12.3%) cases, respectively, and 5 aneurysms (4.1%) were recanalized (4 and 1 with BF and NR as their initial angiographic result, respectively). Another 11 aneurysms still showed BF, although their thrombosis was promoted. No significant factors related to recanalization were identified. A high volume embolization ratio and small neck were significantly associated with thrombosis 1 year after embolization with HydroSoft coils. Conclusions: The safety and prevention of recanalization 1 year after the treatment appeared acceptable. The high volume embolization ratio associated with HydroSoft coils could induce progression of thrombosis for aneurysms characterized by NR and BF during the follow-up period.
AB - Background: The effect of HydroSoft coils on the prevention of recanalization and thrombosis after embolization is unclear. We herein report the results of the single-armed prospective Japanese HydroSoft Registry. Methods: Aneurysms with a diameter of <10 mm that were treated with a ≥50% length of HydroSoft coils were registered. We evaluated the safety and recanalization rate and analyzed the factors related to their recanalization and thrombosis 1 year later. Results: In total, 122 aneurysms were registered. Their mean maximum diameter and neck length were 6.4 and 3.9 mm, respectively. The mean length of the HydroSoft coils was 84.3%. No intracranial hemorrhage occurred, but 2 patients developed minor ischemic strokes. Angiographic examination immediately after the procedure showed complete obliteration, neck remnant (NR), and body filling (BF) in 20 (16.4%), 32 (26.2%), and 67 (54.9%) cases, respectively. One-year follow-up angiography showed complete obliteration, NR, and BF in 68 (55.7%), 15 (12.3%), and 15 (12.3%) cases, respectively, and 5 aneurysms (4.1%) were recanalized (4 and 1 with BF and NR as their initial angiographic result, respectively). Another 11 aneurysms still showed BF, although their thrombosis was promoted. No significant factors related to recanalization were identified. A high volume embolization ratio and small neck were significantly associated with thrombosis 1 year after embolization with HydroSoft coils. Conclusions: The safety and prevention of recanalization 1 year after the treatment appeared acceptable. The high volume embolization ratio associated with HydroSoft coils could induce progression of thrombosis for aneurysms characterized by NR and BF during the follow-up period.
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U2 - 10.1016/j.wneu.2019.03.234
DO - 10.1016/j.wneu.2019.03.234
M3 - Article
C2 - 30947007
AN - SCOPUS:85064909805
VL - 127
SP - e631-e637
JO - World Neurosurgery
JF - World Neurosurgery
SN - 1878-8750
ER -