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

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.

Fig. 1

a TransForm™ Occlusion Balloon Catheter with a catheter length of 150 cm, proximal outer diameter of 2.8 Fr, distal outer diameter of 2.7 Fr, distal tip of 3.25 mm, and fluoro-saver marker 94 cm from the distal tip. b 4 × 10 mm HyperGlide with four proximally located inflation and deflation ports as compared to a 4 × 10 mm TransForm Occlusion Balloon Catheter with micromachined slits for inflation and deflation (designed to allow for faster deflation, the use of higher contrast levels, increased visibility, and reduced procedure times).

Fig. 2

a Image of left middle cerebral artery (MCA) aneurysm before embolization. b Image showing balloon inflation within the stent, demonstrating visibility and comfortability to the fusiform shape. c Image obtained after coil embolization of the left MCA, showing complete obliteration. d Image of a basilar tip aneurysm before embolization. e Image during coil embolization. f Image obtained after coil embolization of the basilar tip, showing complete obliteration.

Fig. 3

a Image of a posterior communicating artery (PCOM) aneurysm before embolization. b Image during coil embolization, demonstrating the stability and visibility of the TOBC procedure. c Image obtained after coil embolization of the PCOM aneurysm, showing complete obliteration.