The safety and effectiveness of the Woven EndoBridge (WEB) system for the treatment of wide-necked bifurcation aneurysms: final 12-month results of the pivotal WEB Intrasaccular Therapy (WEB-IT) Study

被引：276

作者：

Arthur, Adam S. ^{[1
,2
]}

Molyneux, Andy ^{[3
]}

Coon, Alexander L. ^{[4
]}

Saatci, Isil ^{[5
,19
]}

Szikora, Istvan ^{[6
,20
]}

Baltacioglu, Feyyaz ^{[7
,21
]}

Sultan, Ali ^{[8
,22
]}

Hoit, Daniel ^{[1
,2
,15
,16
,31
]}

Almandoz, Josser E. Delgado ^{[9
]}

Elijovich, Lucas ^{[1
,10
,15
,16
,31
]}

Cekirge, Saru ^{[11
,12
]}

Byrne, James, V ^{[13
]}

Fiorella, David ^{[14
,17
]}

Arthur, Adam ^{[15
,16
,31
]}

Woo, Henry ^{[17
]}

Coon, Alexander ^{[18
]}

Colby, Geoffrey ^{[18
]}

Cekirge, Saruhan ^{[19
]}

Asadov, Ruslan ^{[21
]}

Chavali, Ram ^{[22
]}

Frerich, Kai ^{[22
]}

Delgado, Josser ^{[23
]}

Kayan, Yasha ^{[23
]}

Hanel, Ricardo ^{[24
]}

Sauvageau, Eric ^{[24
]}

Turner, Raymond ^{[25
]}

Chaudry, Imran ^{[25
]}

Spiotta, Alejandro ^{[25
]}

Turk, Aquila ^{[25
]}

Rai, Ansaar ^{[26
]}

Carpenter, Jeffrey ^{[26
]}

Boo, Sohyun ^{[26
]}

Jabbour, Pascal ^{[27
]}

Tjoumakaris, Stavropoula ^{[27
]}

Rosenwasser, Robert ^{[27
]}

Woodward, Keith ^{[28
]}

Boulos, Alan ^{[29
]}

Dalfino, John ^{[29
]}

Yamamoto, Junichi ^{[29
]}

Vora, Nirav ^{[30
]}

Budzik, Ronald ^{[30
]}

Pema, Peter ^{[30
]}

Davis, Thomas ^{[30
]}

Kallmes, David ^{[32
]}

Lanzino, Giuseppe ^{[32
]}

Cloft, Harry ^{[32
]}

Siddiqui, Adnan ^{[33
]}

Levy, Elad ^{[33
]}

Snyder, Kenneth ^{[33
]}

Lopes, Demetrius ^{[34
]}

机构：

[1] Semmes Murphey Neurol & Spine Inst, Memphis, TN USA

[2] Univ Tennessee, Hlth Sci Ctr, Neurosurg, Memphis, TN USA

[3] Univ Oxford, Nuffield Dept Surg Sci, Neurovasc & Neuroradiol Res Unit, Oxford, Oxon, England

[4] Johns Hopkins Univ, Neurosurg, Baltimore, MD USA

[5] Private Koru Hosp, Ankara, Turkey

[6] Natl Inst Clin Neurosci, Budapest, Hungary

[7] Marmara Univ, Egitim & Arastirma Hastanesi, Neuroradiol, Istanbul, Turkey

[8] Brigham & Womens Hosp, Neurosurg, 75 Francis St, Boston, MA 02115 USA

[9] Abbott NW Hosp, Intervent Neuroradiol, Minneapolis, MN USA

[10] Univ Tennessee, Hlth Sci Ctr, Neurol Neurosurg, Memphis, TN USA

[11] Koru Hosp, Radiol, Ankara, Turkey

[12] Saruhan Cekirge, Private Off, Ankara, Turkey

[13] John Radcliffe Hosp, Neuroradiol, Oxford, Oxon, England

[14] Stony Brook Univ Hosp, Stony Brook, NY USA

[15] Methodist Univ Hosp, Neurosci Inst, Memphis, TN USA

[16] Methodist Univ Hosp, Canc Ctr, Memphis, TN USA

[17] SUNY Stony Brook, Med Ctr, Stony Brook, NY 11794 USA

[18] Johns Hopkins Univ Hosp, Baltimore, MD USA

[19] Koru Hosp, Ankara, Turkey

[20] Natl Inst Neurosci, Budapest, Hungary

[21] Marmara Univ, Fac Med, Pendik Training & Res Hosp, Istanbul, Turkey

[22] Brigham & Womens Hosp, 75 Francis St, Boston, MA 02115 USA

[23] Abbott NW Hosp, Minneapolis, MN USA

[24] Baptist Med Ctr, Lyerly Neurosurg, Jacksonville, FL USA

[25] Med Univ South Carolina, Charleston, SC 29425 USA

[26] West Virginia Univ, Med Ctr, Morgantown, WV 26506 USA

[27] Thomas Jefferson Univ Hosp, Philadelphia, PA 19107 USA

[28] Ft Sanders Reg Med Ctr, Knoxville, TN USA

[29] Albany Med Ctr, Albany, NY USA

[30] Riverside Methodist Hosp, Columbus, OH 43214 USA

[31] Baptist Mem Hosp, Memphis, TN 38146 USA

[32] Mayo Clin, Rochester, MN USA

[33] Univ Buffalo, Med Ctr, Buffalo, NY USA

[34] Rush Univ, Med Ctr, Chicago, IL 60612 USA

[35] Mt Sinai Roosevelt Hosp, New York, NY USA

[36] Univ Texas Houston, Sch Med, Houston, TX USA

[37] Royal Univ Hosp, Saskatoon, SK, Canada

[38] Swedish Med Ctr, Englewood, CO 80110 USA

[39] St Josephs Hosp, Barrow Neurol Inst, Phoenix, AZ USA

[40] Univ Copenhagen, Righosp, Copenhagen, Denmark

[41] Univ Louisville Hosp, Louisville, KY USA

[42] Helios Gen Hosp, Erfurt, Germany

来源：

JOURNAL OF NEUROINTERVENTIONAL SURGERY | 2019年 / 11卷 / 09期

关键词：

PIPELINE EMBOLIZATION DEVICE; STENT-ASSISTED COILING; INTRACRANIAL ANEURYSMS; CEREBRAL ANEURYSMS; ENDOVASCULAR TREATMENT; FOLLOW-UP; COMPLICATIONS; COHORT;

D O I：

10.1136/neurintsurg-2019-014815

中图分类号：

R445 [影像诊断学];

学科分类号：

100207 ;

摘要：

Introduction The Woven EndoBridge Intrasaccular Therapy (WEB-IT) Study is a pivotal, prospective, singlearm, investigational device exemption study designed to evaluate the safety and effectiveness of the WEB device for the treatment of wide-neck bifurcation aneurysms. Methods One-hundred and fifty patients with wideneck bifurcation aneurysms were enrolled at 21 US and six international centers. Angiograms from the index procedure, and 6-month and 1-year follow-up visits were all reviewed by a core laboratory. All adverse events were reviewed and adjudicated by a clinical events adjudicator. A data monitoring committee provided oversight during the trial to ensure subject safety. Results One-hundred and forty-eight patients received the WEB implant. One (0.7%) primary safety event occurred during the study-a delayed ipsilateral parenchymal hemorrhage-on postoperative day 22. No primary safety events occurred after 30 days through 1 year. At the 12-month angiographic follow-up, 77/143 patients (53.8%) had complete aneurysm occlusion. Adequate occlusion was achieved in 121/143 (84.6%) subjects. Conclusions The prespecified safety and effectiveness endpoints for the aneurysms studied in the WEB-IT trial were met. The results of this trial suggest that the WEB device provides an option for patients with wide-neck bifurcation aneurysms that is as effective as currently available therapies and markedly safer.

引用

页码：924 / 930

页数：7

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