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

2017 ◽  
Vol 7 (1-2) ◽  
pp. 53-64 ◽  
Author(s):  
M. Asif Taqi ◽  
Syed A. Quadri ◽  
Ajit S. Puri ◽  
Brian F. Fitzsimmons ◽  
Jianhua Nancy Jin ◽  
...  
Keyword(s):  
Coil Embolization ◽  
Rating Scale ◽  
Thrombus Formation ◽  
Balloon Catheter ◽  
Multicenter Trial ◽  
Occlusion Balloon ◽  
Complete Obliteration ◽  
The Usa ◽  
The Mean ◽  
Occlusion Balloon Catheter

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.

Induction of thrombolysis and prevention of thrombus formation by local drug delivery with a double-occlusion balloon catheter

1996 ◽  
Vol 11 (3) ◽  
pp. 123-132 ◽  
Author(s):  
Takanobu Tomaru ◽  
Yoshiharu Fujimori ◽  
Fumitaka Nakamura ◽  
Naoto Aoki ◽  
Yoshimitsu Sakamoto ◽  
...  
Keyword(s):  
Drug Delivery ◽  
Thrombus Formation ◽  
Balloon Catheter ◽  
Local Drug Delivery ◽  
Occlusion Balloon ◽  
Occlusion Balloon Catheter

scholarly journals Early experience with a novel net temporary bridging device (Cascade) to assist endovascular coil embolization of intracranial aneurysms

2020 ◽  
pp. 1-9
Author(s):  
Alejandro Tomasello ◽  
David Hernandez ◽  
Laura Ludovica Gramegna ◽  
Sonia Aixut ◽  
Roger Barranco Pons ◽  
...  
Keyword(s):  
Coil Embolization ◽  
Intracranial Aneurysms ◽  
Type I ◽  
Type Ii ◽  
Unruptured Aneurysms ◽  
Complete Obliteration ◽  
Acute Subarachnoid Hemorrhage ◽  
Endovascular Coil Embolization ◽  
The Mean

OBJECTIVEThe goal of this study was to evaluate the effectiveness and safety of a new noncompletely occlusive net-assisted remodeling technique in which the Cascade net device is used for temporary bridging of intracranial aneurysms.METHODSBetween July 2018 and May 2019, patients underwent coil embolization with the Cascade net device within 4 centers in Europe. Analysis of angiographic (modified Raymond-Roy classification [MRRC]) and clinical outcomes data was conducted immediately following treatment and at the 6-month follow-up.RESULTSFifteen patients were included in the study (mean age 58 ± 13 years, 11/15 [73.3%] female). Ten patients had unruptured aneurysms, and 5 presented with ruptured aneurysms with acute subarachnoid hemorrhage. The mean aneurysm dome length was 6.27 ± 2.33 mm and the mean neck width was 3.64 ± 1.19 mm. Immediately postprocedure, MRRC type I (complete obliteration) was achieved in 11 patients (73.3%), whereas a type II (residual neck) was achieved in 4 patients (26.7%). Follow-up examination was performed in 7/15 patients and showed stabilization of aneurysm closure with no thromboembolic complications and only 1 patient with an increased MRRC score (from I to II) due to coil compression.CONCLUSIONSInitial experience shows that the use of a new noncompletely occlusive net-assisted remodeling technique with the Cascade net device may be safe and effective for endovascular coil embolization of intracranial aneurysms.

scholarly journals Gastric Artery Embolization: Studying Effects of Catheter Type and Injection Method on Bead Distributions within a Benchtop Arterial Model

2020 ◽  
Author(s):  
Shaphan R Jernigan ◽  
Jason A Osborne ◽  
Gregory D Buckner
Keyword(s):  
Balloon Catheter ◽  
Arterial System ◽  
Injection Method ◽  
Occlusion Balloon ◽  
Method Effect ◽  
Injection Methods ◽  
Computer Controlled ◽  
Micro Catheter ◽  
Targeting Accuracy ◽  
Occlusion Balloon Catheter

Abstract Aims: To investigate the effect of catheter type and injection method on microsphere distributions, specifically vessel targeting accuracy. Materials and Methods: The study utilized three catheter types (a standard micro-catheter, a Surefire anti-reflux catheter, and an Endobar occlusion balloon catheter) and both manual and computer-controlled injection schemes. A closed-loop, dynamically pressurized surrogate arterial system was assembled to replicate arterial flow for bariatric embolization procedures. Four vessel branches immediately distal to the injection site were targeted for embolization. Embolic microspheres were injected into the model using three catheter types (a standard micro-catheter, a Surefire anti-reflux catheter, and an Endobar occlusion balloon catheter) and both manual and computer-controlled injections. Results: Across all injection methods, the catheter effect on the proportion of microspheres to target vessels (vs. non-target vessels) was significant (p=0.005). The catheter effect on the number of non-target vessels embolized was significant (p=0.059). Across all catheter types, the injection method effect was not statistically significant for either of two outcome measures (percent microspheres to target vessels: p=0.265, number of non-target vessels embolized: p=0.148). Conclusion: Catheter type had a significant effect on targeting accuracy across all injection methods. The Endobar catheter exhibited a higher targeting accuracy in pairwise comparisons with the other two injection catheters across all injection schemes and when considering the Endobar catheter with the manifold injection method vs. each of the catheters with the manual injection method; the differences were significant in 3 of 4 analyses. The injection method effect was not statistically significant across all catheter types and when considering the Endobar catheter/Endobar manifold combination vs. Endobar catheter injections with manual and pressure-replicated methods.

scholarly journals TransForm occlusion balloon catheter for the treatment of intracranial aneurysms, initial experience

2015 ◽  
Vol 21 (2) ◽  
pp. 155-160 ◽  
Author(s):  
Bruno Bartolini ◽  
Raphaël Blanc ◽  
Silvia Pistocchi ◽  
Hocine Redjem ◽  
Gabriele Ciccio ◽  
...  
Keyword(s):  
Intracranial Aneurysms ◽  
Balloon Catheter ◽  
Mass Effect ◽  
Initial Experience ◽  
Neck Size ◽  
Occlusion Balloon ◽  
Balloon Catheters ◽  
Clinical Complications ◽  
Small Series ◽  
Occlusion Balloon Catheter

Introduction The technique of balloon remodeling allows the endovascular treatment of wide-neck intracranial aneurysms. For many years the only available devices were the Hyperform and the Hyperglide balloon catheters. Recently, other companies have developed newer devices, single or dual-lumen. We present our initial experience with the TransForm occlusion balloon catheter for the treatment of intracranial aneurysms. Methods We retrospectively analysed from our prospectively gathered aneurysm database all aneurysms that were treated with balloon remodelling using TransForm occlusion balloon catheters from January 2013 to February 2014. We assessed patient demographics, morphological features of the aneurysms, procedure feasibility, technical and clinical complications. Results Thirty-three patients harbouring 36 intracranial saccular aneurysms were treated during 33 procedures. Clinical finding were: 15 incidental discovery, 13 subarachnoid haemorrhage (SAH), five aneurysms with mass effect, one ruptured aneurysm with SAH and mass effect, one recanalisation and one intraparenchymal haematoma. Thirty-five aneurysms were in the anterior and one in the posterior circulation. Mean dome and neck size were, respectively, 5.8 mm and 3.6 mm. Twenty-three aneurysms were treated with TransForm C and 13 with TransForm SC. We had two procedural thromboembolic complications, without permanent clinical events. No early rebleeding occurred. Conclusions In our small series, the TransForm occlusion balloon catheter seems to be safe and effective for the treatment of intracranial aneurysms, in ruptured and unruptured cases.

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