Title

A Prospective Multicenter Trial of the TransForm Occlusion Balloon Catheter: Trial Design and Results

UMMS Affiliation

Department of Radiology

Publication Date

2-1-2018

Document Type

Article

Disciplines

Neurology | Radiology

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, Intracranial aneurysms, Single-lumen balloon, TransForm Occlusion Balloon Catheter, Trial

DOI of Published Version

10.1159/000481518

Source

Interv Neurol. 2018 Feb;7(1-2):53-64. doi: 10.1159/000481518. Epub 2017 Nov 15. Link to article on publisher's site

Journal/Book/Conference Title

Interventional neurology

Related Resources

Link to Article in PubMed

PubMed ID

29628946

Share

COinS