Article: A Prospective Multicenter Trial of the TransForm Occlusion Balloon Catheter: Trial Design and Results
2017 Volume 7, Issue 1-2, Page(s) 53–64
Abstract: ... a contributing factor. Vessel rupture occurred in 1/81 (1.2%) of the cases, but was unrelated to TOBC use ...
| Institution | California Institute of Neuroscience and Los Robles Hospital and Medical Center, Thousand Oaks, CA Department of Radiology, University of Massachusetts Medical School and UMass Memorial Medical Center, Worcester, MA Departments of Neurology, Neurosurgery and Radiology, Medical College of Wisconsin and Froedtert Hospital, Milwaukee, WI Department of Interventional Neuroradiology, West Virginia University Hospital, Morgantown, WV, and Baptist Health Lexington/Central Baptist Hospital, Lexington, KY, USA Department of Neuroradiology, Hospital Universitario Donostia, San Sebastian, Spain Department of Neurological Surgery, The Ohio State University Wexner Medical Center, Columbus, OH Neurointerventional Surgery, California Pacific Medical Center, San Francisco, CA Department of Biostatistics, Stryker Neurovascular, Fremont, CA, and Departments of Endovascular Neurosurgery and Stroke, St. Vincent Mercy Medical Center, Toledo, OH, USA |
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| 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. |
| Keywords | Balloon-assisted coil embolization ; Balloon-assisted coiling ; TransForm Occlusion Balloon Catheter ; Single-lumen balloon ; Intracranial aneurysms ; Trial ; covid19 |
| Language | English |
| Publishing date | 2017-11-15 |
| Publisher | S. Karger AG |
| Publishing place | Basel, Switzerland |
| Document type | Article |
| Note | Original Paper |
| ZDB-ID | 2662855-7 |
| ISSN | 1664-5545 ; 1664-9737 ; 1664-5545 |
| ISSN (online) | 1664-5545 |
| ISSN | 1664-9737 ; 1664-5545 |
| DOI | 10.1159/000481518 |
| Database | Karger publisher's database |
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