M Asif Taqi1, Syed A Quadri1, Ajit S Puri2, Brian F Fitzsimmons3, Jianhua Nancy Jin4, Ansaar T Rai5, Curtis A Given6, Javier Masso7, Ciaran J Powers8, Joey D English9, Osama O Zaidat10. 1. California Institute of Neuroscience and Los Robles Hospital and Medical Center, Thousand Oaks, California, USA. 2. Department of Radiology, University of Massachusetts Medical School and UMass Memorial Medical Center, Worcester, Massachusetts, USA. 3. Department of Neurology, Neurosurgery and Radiology, Medical College of Wisconsin and Froedtert Hospital, Milwaukee, Wisconsin, USA. 4. Department of Biostatistics, Stryker Neurovascular, Fremont, California, USA. 5. Department of Interventional Neuroradiology, West Virginia University Hospital, Morgantown, West Virginia, USA. 6. Baptist Health Lexington/Central Baptist Hospital, Lexington, Kentucky, USA. 7. Department of Neuroradiology, Hospital Universitario Donostia, San Sebastian, Spain. 8. Department of Neurological Surgery, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA. 9. Neurointerventional Surgery, California Pacific Medical Center, San Francisco, California, USA. 10. Department of Endovascular Neurosurgery and Stroke, St. Vincent Mercy Medical Center, Toledo, Ohio, USA.
Abstract
BACKGROUND AND PURPOSE: Adjunctive treatments like balloon-assisted coil embolization (BACE) and stent-assisted coil embolization play a major role in the treatment of wide-neck and large intracranial aneurysms. The TransForm™ Occlusion Balloon Catheter (TOBC) registry is intended to evaluate the safety, efficacy, and efficiency of BACE using the TOBC. METHOD AND STUDY DESIGN: The TOBC registry is a prospective multicenter registry trial. Seven sites in the USA and 1 site in Spain participated and enrolled 81 patients. RESULTS: The performance and safety of the TOBC was evaluated based on scoring for different variables. Scores were measured using a semiquantitative rating scale (1 = excellent, 5 = poor). The mean scores for these variables were as follows: visibility under fluoroscopy, 1.8; ability to reach the intended site, 1.6; stability during first positioning, 1.5; stability during inflation, 1.6; stability during deflation, 1.6; ability to temporarily stop flow, 1.6; and ability to assist in coil embolization, 1.7. The mean inflation and deflation times were 4.9 and 5.6 s, respectively. Complete obliteration of the aneurysm (Raymond class I) was achieved in 69.4% of the BACE cases. Thrombus formation occurred in 4/81 (4.8%) of the cases. In all cases, the thrombus resolved with medications, no patient suffered an infarction, and an underlying hypercoagulable state from subarachnoid hemorrhage was considered a contributing factor. Vessel rupture occurred in 1/81 (1.2%) of the cases, but was unrelated to TOBC use. CONCLUSION: BACE using the TOBC is safe and effective. All variables assessed for performance showed good-to-excellent results.
BACKGROUND AND PURPOSE: Adjunctive treatments like balloon-assisted coil embolization (BACE) and stent-assisted coil embolization play a major role in the treatment of wide-neck and large intracranial aneurysms. The TransForm™ Occlusion Balloon Catheter (TOBC) registry is intended to evaluate the safety, efficacy, and efficiency of BACE using the TOBC. METHOD AND STUDY DESIGN: The TOBC registry is a prospective multicenter registry trial. Seven sites in the USA and 1 site in Spain participated and enrolled 81 patients. RESULTS: The performance and safety of the TOBC was evaluated based on scoring for different variables. Scores were measured using a semiquantitative rating scale (1 = excellent, 5 = poor). The mean scores for these variables were as follows: visibility under fluoroscopy, 1.8; ability to reach the intended site, 1.6; stability during first positioning, 1.5; stability during inflation, 1.6; stability during deflation, 1.6; ability to temporarily stop flow, 1.6; and ability to assist in coil embolization, 1.7. The mean inflation and deflation times were 4.9 and 5.6 s, respectively. Complete obliteration of the aneurysm (Raymond class I) was achieved in 69.4% of the BACE cases. Thrombus formation occurred in 4/81 (4.8%) of the cases. In all cases, the thrombus resolved with medications, no patient suffered an infarction, and an underlying hypercoagulable state from subarachnoid hemorrhage was considered a contributing factor. Vessel rupture occurred in 1/81 (1.2%) of the cases, but was unrelated to TOBC use. CONCLUSION: BACE using the TOBC is safe and effective. All variables assessed for performance showed good-to-excellent results.
Authors: Andrew J Molyneux; Richard S C Kerr; Ly-Mee Yu; Mike Clarke; Mary Sneade; Julia A Yarnold; Peter Sandercock Journal: Lancet Date: 2005 Sep 3-9 Impact factor: 79.321
Authors: James Fowler; Brian Fiani; Syed A Quadri; Vladimir Cortez; Mudassir Frooqui; Atif Zafar; Fahad Shabbir Ahmed; Asad Ikram; Anirudh Ramachandran; Javed Siddiqi Journal: Case Rep Neurol Med Date: 2018-10-04