Scepter Balloon Research Articles

Use of the Scepter Dual-Lumen Balloon Catheter for Transarterial Onyx Embolization of Cranial Dural Arteriovenous Fistulas

Dual-lumen balloon microcatheters allow for controlled anterograde flow of Onyx while providing proximal flow arrest, thereby obviating the need for a second microcatheter or Onyx plug formation. We sought to assess the safety and efficiency of the Scepter dual-lumen balloon microcatheter in trans arterial Onyx embolization of intracranial dural arteriovenous fistulas (DAVFs). We conducted a retrospective study of 36 patients with cranial DAVFs in which a Scepter balloon microcatheter was used between 2016 and2023. Our study comprised 36 patients, mostly male (n= 23, 63.8%) with a mean age of 60.8 years. Most DAVFs were in the occipital lobe (n= 24, 66.7%), and 50% had external carotid artery supply from the occipital artery. Eighteen (50%) of DAVFs were Cognard type III and IV, respectively. About one third (33.3%, n= 12) of the DAVFs drained into the transverse sigmoid junction, and 27.7% (n= 10) had direct cortical venous drainage into supratentorial or posterior fossa veins. Complete occlusion was obtained in 22 (61.1%) patients while partial occlusion was observed in 14 (38.9%) patients. One patient (2.8%) developed a retroperitoneal hematoma. At final follow-up, complete occlusion was observed in 21 (77.8%) and partial occlusion was observed in 8 (22.2%). Recurrence was observed in 4/30 (13.3%) patients, and retreatment was required in 6 (18.75%) cases. At midterm follow-up, our study showed low morbidity and modest complete occlusion rates using the Scepter for transarterial Onyx embolization of high-grade DAVFs.

Endovascular balloon usage in endoscopic third ventriculostomy for hydrocephalus during a national shortage: case series and technical note

Endoscopic third ventriculostomy (ETV) is a well-established surgical technique for treating hydrocephalus. Many providers have transitioned to utilizing the specialized Neuroballoon for the stoma dilation in ETV; however, these devices are intermittently unavailable during supply chain shortages. We present the experience of employing cardiac angioplasty and neurovascular balloons as substitutes for the Neuroballoon in 3 patients. The scepter balloon (Microvention), priced at $1800 compared to the standard $300 Neuroballoon (Integra), proved effective, but its pliability presented technical challenges. The substantial cost differential compared to a Neuroballoon ($300) raises economic considerations. The Cardiac TREK balloon (Abbott) was similarly effective, while also being easier to manage endoscopically and cheaper at $158. These experiences support the viability of non-neuroendoscopic specialized balloons as alternatives for ETV dilation of the floor of tuber cinereum.

Technique to "Trap" a Segment of the Middle Meningeal Artery for Embolization of a Carotid Cavernous Fistula: 2-Dimensional Operative Video.

Transvenous embolization is the favored treatment for indirect carotid-cavernous fistulas (CCFs). However, transarterial embolization can be used as an alternative method when the venous route is inaccessible. We present the case of a 47-yr-old woman with a history of diplopia, headaches, and sixth cranial nerve (CN-VI) palsy who presented with acute worsening of headache and ophthalmoplegia and rise of intraocular pressures. Angiography demonstrated a left indirect CCF (dural arteriovenous malformation) with multiple arterial feeders from the internal carotid artery as well as the middle meningeal artery (MMA) (Barrow type D). Transvenous approach was attempted first but was unsuccessful due to difficult access to the cavernous sinus. Thus, transarterial embolization through the MMA feeding branches was planned. To avoid occluding distal branches of the MMA by Onyx, we coiled it distally. In addition, we used a scepter balloon proximally to prevent the reflux of Onyx into potential collaterals to cranial nerves from proximal MMA. After trapping a segment of the MMA, Onyx was injected into the CCF fistula through the small MMA feeders. A postembolization arteriogram showed obliteration of the CCF. The patient developed mild left facial nerve paresis on the first postoperative day (thought to be related to partial embolization of tiny arteries in the facial canal), which was resolving in the course of hospitalization. She remained neurologically stable, and was discharged on the third postoperative day. To the best of our knowledge, this is the first report of transarterial embolization of CCF by distal coiling and proximal ballooning to trap a segment of an artery. The authors hereby confirm that informed consent was obtained from the patient after thorough discussion of the procedure's rationale, risks, benefits, and alternatives.

Evaluation of the differences in pressure applied to the vessel wall by different types of balloon remodeling microcatheters in an experimental model.

We examined compliance differences among balloon remodeling microcatheters, which have not been established previously. Straight and 120° angulated vascular models were created in a 3 mm diameter tube with 3 mm hole (vascular model A), a tube with a 4 mm hole (vascular model B), and a 4 mm diameter tube (vascular model C). We compared the pressure exerted when each balloon was herniated 1 or 2 mm between three compliant balloons (SHOURYU SR, TransForm C, and Scepter C) and four super-compliant balloons (HyperForm, SHOURYU HR, TransForm SC, and Scepter XC). In vascular model A, there was a significant difference in the pressure exerted by compliant balloons and super-compliant balloons in both the straight and angulated models. In the straight model (1 and 2 mm), the lowest pressure was exerted by HyperForm (super-compliant balloons group) and SHOURYU SR (compliant balloons group). The lowest pressure was exerted in the angulated model by HyperForm (super-compliant balloons group) and Scepter C (compliant balloons group). The Scepter balloon exerted higher pressure in the straight model than other balloon remodeling microcatheters but less in the angulated model. In vascular model B, the pressure decreased in all balloons compared with model A. In vascular model C, the pressure increased in all balloons compared with model A. Pressure differed across balloon remodeling microcatheters. In addition, vessel shape and diameter, and hole size, affected the results. Our findings can help select balloon remodeling microcatheters.

Recurrent massive hemoptysis in a patient with cystic fibrosis: balloon assisted Onyx embolization after bronchial artery coil recanalization

BackgroundAlthough not standard of care, Cystic Fibrosis patients with recurrent hemoptysis occasionally have coil embolization of bronchial arteries. In the event of recanalization of these arteries in this specific subset of patients, the presence of indwelling coils makes the prospect of conventional particle embolization more difficult, preventing both adequate catheterization of the coiled segment and reflux of the particles.Case presentationIn this report, we describe a case of bronchial artery embolization of a complex Cystic Fibrosis patient with massive hemoptysis from recanalized coiled bronchial arteries utilizing a Scepter Balloon Catheter® (Microvention Terumo, USA) in administration of the liquid embolic agent Onyx® (Medtronic, USA).ConclusionsThe Scepter occlusion balloon catheter allowed for careful placement of the tip within the interstices of the pre-existing coils, allowing for Onyx injection directly into the coil mass without reflux, reconfirming the benefits of Onyx embolization in bronchial artery embolization and providing evidence that the Scepter occlusion balloon catheter should be added to the armamentarium of devices used in complex bronchial artery embolization for Cystic Fibrosis patients with massive hemoptysis.

Modified Balloon-in-Stent Technique for Circumferential Vertebral Artery Dissecting Aneurysm

Treatment for circumferential vertebral artery dissecting aneurysms (VADAs) remains challenging. Stent-assisted coil embolization is the most common treatment technique. However, this approach presents high rates of incomplete occlusion and recurrence, often requiring the addition of second or third stents for reconstruction. A flow diverter may achieve favorable clinical outcomes, but it cannot result in immediate aneurysm occlusion and is limited by strict antiplatelets and expensive price. We report excellent results of a 1-stage modified balloon-in-stent technique for circumferential VADA. A total of 12 patients were treated with the modified balloon-in-stent technique for VADAs. A homogeneous coil was used to fill the aneurysm sac, followed by deployment of 1 self-expandable stent and in-stent Scepter balloon angioplasty. Clinical presentations, outcomes, and imaging results were evaluated over at least 2 years of follow-up. Our 12 patients were examined during a mean follow-up period of 36.2 months (range, 2-5 years). The initial symptoms presented included subarachnoid hemorrhage (5 of 12; 41.7%), ischemia (3 of 12; 25.0%), and nonischemia (4 of 12; 33.3%). The modified BIS technique and coil embolization were successful in all patients. No technique-related complications or recanalization occurred during follow-up. We demonstrated an innovative modified BIS technique to treat circumferential VADA by using a coiling basket followed by the deployment of a self-expandable stent and in-stent Scepter balloon angioplasty. This strategy is safe, feasible, and cost effective and was not associated with recurrence or complications over at least 2 years of follow-up.

Comparing Occlusive Balloon Performance Using 3-Dimensional Printed Models of Intracranial Aneurysmal Defects

Balloon remodeling microcatheters are essential in assisting endovascular coiling of brain aneurysms, but the performance and pressure requirements of different balloon types when used in aneurysmal defects are currently unknown. We used Tinkercad (Autodesk, Montreal, Quebec) to create model vessels with aneurysmal defects and 3-dimensionally printed these designs with polylactic acid using the Ultimaker2 (Ultimaker, Geldermalsen, Netherlands). We constructed a pressurized box capable of reaching physiologic pressures that housed our vessels and then tested compliant remodeling balloons under fluoroscopy from 3 manufacturers: Hyperglide (Medtronic, Minneapolis, Minnesota, USA), Transform (Stryker Neurovascular, Fremont, California, USA), and Scepter C (Microvention, Tustin, California, USA). Each balloon was inflated to a nominal and supranominal point at each defect, and at each inflation the maximum diameter of the balloon and internal balloon pressure were recorded. The Phillips Intellivue (Phillips, Amsterdam, The Netherlands) monitor was adapted for internal balloon pressure monitoring. A multivariate linear regression analysis was performed to model balloon compliance (balloon diameter divided by pressure). Multivariate regression modeling demonstrated the Scepter balloon had significantly greater compliance compared with both the Hyperglide and Transform balloons (P < 0.001). In addition, we found that Scepter balloons had higher compliance in larger defects compared with the other types of balloons and performance differences based on vessel size. Scepter balloons require less pressure compared with their counterparts to adequately deform through model defects, specifically in larger aneurysm necks in smaller vessel diameters. This result could inform operators of optimal balloon type and size when trying to minimize balloon pressure in fragile brain aneurysms.

Embolization of a Complex Facial Arteriovenous Malformation, Balloon-Assisted Flow Arrest, and Controlled n-BCA Injection with Dextrose Push Technique: 2-Dimensional Operative Video.

N-butyl cyanoacrylate glue (n-BCA, Cerenovus, Irvine, California) is commonly used to treat arteriovenous malformation (AVM). Even though Onyx (ethylene vinyl alcohol, Medtronic, Dublin, Ireland) presents more controlled injection, n-BCA is colorless, thus preferable for treatment of superficial facial malformations. N-BCA injection into AVM can result in premature distal migration or early precipitation and reflux into the feeder vessels. Here we describe a trans-arterial balloon assisted technique embolization of a complex facial AVM with n-BCA. A 22-yr-old female with chronic oral/gum bleeding presented with a complex facial AVM. She underwent selective transarterial n-BCA balloon assisted treatment with dextrose push. Informed written consent was obtained. A Scepter dual lumen balloon (MicroVention, Aliso Viejo, California) and a Prowler microcatheter (Cerenovus) were introduced via a 6-French Envoy guide catheter (Cerenovus) selectively into the AVM feeder. The balloon was positioned 3 cm proximal to the Prowler microcatheter tip and fully inflated to create flow arrest. Diluted 25% concentration of n-BCA in Ethiodol Oil was injected through the Prowler microcatheter. The distal migration of the n-BCA was modulated with simultaneous injection of Dextrose 5% in water via the Scepter balloon. This resulted in a controlled glue injection without early distal glue migration (because of the flow arrest) nor early proximal glue precipitation or reflux (because of the dextrose infusion), obtaining complete cure of the complex facial AVM. Glue embolization with flow arrest and dextrose push allows well controlled injection, and it represents a valid option also for high flow vascular lesions.

Adjunct to Embolize the High-Flow Fistula Part of Arteriovenous Malformation Using a Double-Lumen Balloon Catheter

The purpose of this study is to report our initial experience of Onyx embolization of the high-flow fistula part of arteriovenous malformation (AVM) using a double-lumen balloon catheter. A Scepter C balloon catheter was used in 2 patients with AVMs associated with high-flow fistulas. The fistulas were located in the anterior cerebral artery and the middle cerebral artery. Onyx embolization was successful in 2 cases, resulting in elimination of the high-flow fistula part of the AVM. There were no treatment-related events. The double-lumen Scepter balloon appears to be a safe and convenient device for Onyx embolization of high-flow fistulas.

脳動脈瘤コイル塞栓術におけるScepter バルーンカテーテルの使用経験

脳動脈瘤コイル塞栓術におけるScepter バルーンカテーテルの使用経験

Initial Experience with the New Double-lumen Scepter Balloon Catheter for Treatment of Wide-necked Aneurysms

ObjectiveA new double-lumen balloon catheter was being developed for the treatment of cerebral aneurysms. The purpose of this study is to report our initial experience of a double-lumen balloon catheter for the treatment of wide-necked aneurysms.Materials and MethodsSeventeen patients (mean age, 63 years; range, 45-80 years) with wide-necked, with or without a branch-incorporated aneurysms, (10 ruptured and 9 unruptured) were treated with balloon-assisted coil embolization using a double-lumen balloon catheter (Scepter C™ or Scepter XC™) for 7 months after being introduced to our country. Locations of the aneurysms were posterior communicating artery (n = 7), anterior communicating artery or A2 (n = 7), middle cerebral artery (MCA) bifurcation (n = 3), basilar artery tip (n = 1) and anterior choroidal artery (n = 1). The initial clinical and angiographic outcomes were retrospectively evaluated.ResultsCoil embolization was successfully completed in all 19 aneurysms, resulting in complete occlusions (n = 18) or residual neck (n = 1). In one procedure, a thrombus formation was detected at the neck portion of the ruptured MCA bifurcation aneurysm near to the end of the procedure. It was completely resolved with an intra-arterial infusion of Glycoprotein IIb/IIIa inhibitor (Tirofiban, 1.0 mg) without any clinical sequela. There were no treatment-related events in the remaining 18 aneurysms. At discharge, functional neurological state improved in 11 patients (10 patients with ruptured aneurysm and 1 with unruptured aneurysm presenting with mass symptoms) and 6 patients with unruptured aneurysms had no newly developed symptoms.ConclusionIn this preliminary case series, the newly developed double-lumen Scepter balloon appears to be a safe and convenient device for coil embolization of wide-necked aneurysms.