Abstract
Background
The use of compliant dual lumen balloon microcatheters (CDLB) for the endovascular treatment of vascular malformations, wide neck aneurysms, and intracranial angioplasty (for vasospasm) is well documented. Navigation of 4 mm or larger CDLB within tortuous and small distal intracranial vessels can be challenging. Recently, the lower profile Scepter Mini balloon microcatheter (SMB) has been approved for use, with potential for improved intracranial navigation.
Objective
Discuss operative experience of Scepter Mini (Microvention, Aliso Viejo, CA).
Methods
We describe our initial experience with the SMB in a series of nine patients.
Results
The balloon microcatheter was used for delivery of liquid embolic in six patients (Case 1, 2, 6–9), adjunct support for delivery or positioning of the Woven Endobridge (WEB) device in two (Case 3,4), and gentle post-deployment repositioning of a WEB device in the last one (Case 5). We were able to successfully navigate the SMB over a 0.008 “micro wire to the target lesion in all the patients. We experienced initial difficulty with injecting liquid embolic in Case 2. We postulate that the SMB was in a tortuous segment of a dural vessel in this patient, and that it kinked on inflation with occlusion of the liquid embolic delivery lumen; this was overcome with slightly proximal repositioning and reinflation of the SMB.
Conclusion
Our initial experience shows that the SMB has potential to be useful in endovascular neurosurgical procedures requiring balloon assistance within smaller diameter blood vessels.
Keywords: Balloon assistance, Scepter Mini, Aneurysm, Dural arteriovenous fistulae, Brain arteriovenous malformations
Introduction
The use of compliant dual lumen balloon microcatheters for endovascular treatment of vascular malformations, and wide necked aneurysms is well documented.1–6 However, their use is sometimes limited by the small diameter and excessive tortuosity of the involved blood vessels. Additionally, limitations with microcatheter shaft length (A Maximum of 150 cm), as well as the need for an intermediate catheter further restrict their usage in very distal cranial arterial branches. The Scepter Mini (Microvention, Aliso Viejo, CA) is the lowest profile FDA approved compliant dual lumen balloon microcatheter; and it has just recently become available. We describe our initial experience with the Scepter Mini, wherein, it was used to treat various cerebrovascular pathologies in a series of nine patients.
Methods
We performed a retrospective review of a prospectively maintained HIPPA compliant database from two separate institutions, in order to identify patients in whom the Scepter Mini balloon microcatheter had been used. This review was approved by the Institutional Review Boards of the respective institutions.
Pre-operative preparation and procedure: All procedures were performed under general anesthesia. Informed consent was obtained from patients (Case 1–4, and 6–9) or their next of kin (Case 5) for each procedure. All the endovascular interventions were performed using a trans-femoral approach. All patients except one (Case 5) received 100 U/Kg initial heparin bolus followed by 1000 Unit/hour for the duration of the procedure. Case 5, with subarachnoid hemorrhage (SAH) received a 50 U/Kg bolus before Woven Endobridge (WEB), device deployment and 50 U/kg bolus after securing the aneurysm as per our institutional protocol. The SMB balloon lumen was prepped ex-vivo prior to introduction into the patient as described elsewhere.7 100% Visipaque 320 (Iodixanol) was used for balloon preparation and contrast along with a small 0.2 cc syringe supplied by the vendor. In brief, the balloon can be prepped by purging the air out without allowing pre-inflation of the balloon by slowly injecting the 100% contrast through the balloon lumen while maintaining gentle manual pressure on the balloon segment.7 In our experience with Scepter C and XC balloon, this pinch preparation technique can enhance the navigability of the balloon by keeping the balloon to a low profile.7 The SMB was then navigated over an Asahi 0.008” (Asahi Intecc, Japan)) micro wire in every instance. The 0.2 cc syringe was then used for inflation and deflation in-vivo. In five patients, an intermediate catheter was used to support the SMB during intracranial navigation, whereas, in the others, the SMB was advanced directly into a guide catheter, which was positioned within the cervical arterial vasculature. Post operatively, all the patients were closely monitored in a Neuro- Intensive care unit and discharged when stable.
Results
Case 1
A 57-year-old man presented to hospital with recurrence of an unruptured right para-falcine Borden Grade 3 Dural arteriovenous fistula (DAVF), which had initially been successfully treated using 25% Precipitating Hydrophobic Injectable Liquid (PHIL™ Microvention, Aliso Viejo, CA). This recurrence was secondary to the recruitment of new feeders from bilateral middle meningeal and superficial temporal arterial branches. We were able to navigate the SMB distally through an Envoy 6 French guide catheter until the anterior right middle meningeal artery branch until the diameter of the artery tapered to 0.9 mm. The balloon was then inflated, and curative penetration of the draining vein was achieved with injection of Ethylene Vinyl Alcohol copolymer (Onyx™ 18, Medtronic, Irvine, CA) liquid embolic system through the injection lumen of the balloon as described elsewhere (Figure 1).
Figure 1.
(a) Lateral projection from DSA performed with injection of the right external carotid artery shows a Borden Grade III falcine DAVF with cortical venous drainage (black arrow). (b) Lateral projection showing the Scepter Mini balloon inflated distally within the right middle meningeal artery feeder. (c) Lateral projection showing an Onyx cast within the draining cortical vein (double white arrows). (d) Lateral projection from DSA performed with injection of the right external carotid artery shows cure of the DAVF.
Case 2
A 33-year-old man presented with intermittent tinnitus. Further evaluation with MR imaging followed by digital subtraction angiography (DSA) revealed a right petrous-tentorial junction Borden Grade III DAVF fed by multiple right external carotid artery branches. The SMB was navigated distally into a posterior division of the right accessory meningeal artery until the diameter of the artery tapered to 0.9 mm. Following initial inflation, the balloon was noted to be focally deformed (kinked) due to the tortuosity of the vessel and the compliant nature of the balloon, and this prevented injection of Onyx™ 18 through the injection lumen. The balloon was slightly withdrawn to a more proximal position, and re-inflated with resolution of the kinking. The Onyx™ 18 was then injected without difficulty to achieve penetration of the draining vein (Figure 2). In this instance, we postulate that the balloon segment of the SMB was initially in a tortuous segment of the dural vessel, and balloon inflation and kinking at that position resulted in obstruction of the injection lumen. Postoperatively, the patient suffered from transient right 4th nerve palsy.
Figure 2.
(a) Anteroposterior (a1) and lateral (a2) projections from DSA performed with injection of the right external carotid artery show a Borden Grade III DAVF supplied by multiple branches including the posterior division of the left middle meningeal artery (MMA). (b) Initial inflation of the Scepter Mini balloon in the distal right MMA (b1) resulted in kinking of the balloon (white arrow), which resolved (b2) when the balloon was repositioned slightly proximally and repositioned (white arrowhead). (c) Anteroposterior (c1) and lateral (c2) projections from DSA performed with injection of the right ECA showed no evidence for residual fistula.
Case 3
A 57-year-old woman presented with an incidentally discovered 4. 5 × 2.8 × 2.3 mm right pericallosal aneurysm with a 2.3 mm neck. Considering her overall life expectancy and hypertension as a risk factor, she was treated with endovascular embolization; it should be noted that the patient had previously declined surgical clipping. Embolization with the WEB device was chosen considering its efficacy in achieving complete occlusion in wide neck aneurysms, as well as the low reported rates for intraoperative aneurysm perforation when compared to the balloon or stent assisted coiling techniques.8–11 The Via 21 microcatheter (Microvention, Aliso Viejo, CA) was navigated into the aneurysm sac over an Asahi 0.018” soft tip microwire. However, when initial attempts to deliver a 4 mm WEB SLS device into the aneurysm resulted in repeated herniation and displacement of the proximal end of the device and the distal microcatheter tip into the parent vessel distal to the aneurysm neck. The SMB was then inflated within the parent vessel just distal to the aneurysm neck in order to change the angle of approach of the WEB device, and to prevent the device and catheter from herniating proximally into the parent vessel. The WEB device was then safely deployed within the aneurysm (Figure 3).
Figure 3.
(a) Lateral (a1) and anteroposterior (a2) projections from DSA performed with injection of the right internal carotid artery showing an oblong pericallosal aneurysm, and (a3) image shows WEB deployment without balloon assistance with subtle device herniation at the aneurysm neck. (b) Lateral (b1) and anteroposterior (b2) projections showing deployment of the WEB device (thin white arrow) with the Scepter Mini balloon inflated (thick white arrow) to assist with deployment.
Case 4
A 4.8 × 3.6 × 3.0 mm anteriorly and inferiorly pointing anterior communicating artery aneurysm was incidentally found in a 55-year-old with history of smoking and poorly controlled hypertension. The patient was treated using a 5 × 3 mm WEB SL device, delivered through a Via 21 microcatheter, a SMB was inflated in the parent artery just distal to the neck of the aneurysm to assist with positioning of the WEB device and to prevent herniation of the device and microcatheter into the parent vessel as described above.
Case 5: A 57-year-old woman presented with Hunt Hess III, Fisher Grade IV SAH from an oblong wide necked 4.7 × 2.8 mm ruptured aneurysm at the origin of the left posterior inferior cerebellar artery (PICA). Surgical clipping, endovascular coiling and treatment with the WEB device were all considered. Treatment with the WEB device was decided based on the poor clinical status of the patient, the location of the aneurysm with high risk of injury to medullary perforators arising from the PICA, and the probability that complete aneurysm coiling may not be feasible without the placement of an intra-arterial stent. Additionally, the currently reported evidence for utilization of the WEB device in comparison with surgical clipping or aneurysm coiling for SAH was also considered.8,12–14 She was treated with placement of a 4x 3 mm WEB SL device (The WEB SLS 4, which was thought to be ideal was considered, but was not immediately available) within the aneurysm sac. Following the deployment of the WEB device, initial DSA showed a widely patent left PICA. However, delayed imaging at 20 minutes showed thrombus formation in the PICA adjacent to the proximal end of the WEB device, probably from minimal device protrusion into the PICA lumen (Figure 4, b2). This resulted in delayed occlusion of the PICA at the aneurysm neck, which was visualized on DSA images obtained 20 minutes after placement of the WEB device. We therefore advanced an SMB into the proximal PICA, and gently repositioned the WEB device further into the aneurysm by cautiously inflating the balloon, the balloon inflation also disrupted the clot. Subsequently, a bolus dose of eptifibatide was also administered into the PICA through the injection lumen of the SMB. There was rapid resolution of the thrombus with restoration of PICA patency. The patient had a small asymptomatic cerebellar cortical infarct; she was eventually discharged home without any residual neurological deficits (Figure 4).
Figure 4.
(a) Anteroposterior (a1) and lateral (a2) projections from DSA obtained with injection of the left vertebral artery reveal a lobulated and oblong left PICA aneurysm. (b) Following placement of the WEB device initial (b1) oblique DSA projections showed patency of the left PICA with less than 50% encroachment of the parent artery by the WEB device but delayed (b2) oblique projection shows occlusion of the aneurysm but also thrombus within the parent artery, which is occluded. (c) Anteroposterior (c1) and lateral (c2) projections showing inflation of the Scepter Mini balloon within the left PICA at the neck of the aneurysm. (4) Anteroposterior (d1) and lateral (d2) projections from DSA obtained after balloon inflation and injection of Eptifibatide within the left PICA showing restored patency of the artery, this was further confirmed on an oblique projection from a CT Angiogram (d3) obtained after 24 hours, where the origin of the left PICA is clearly seen to be patent (white arrow).
Case 6–9: Summary of use of Scepter Mini cases in brain arteriovenous malformations (bAVM) is described below (Table 1). Selective images of SMB use during bAVM embolization are shown in Figure 5.
Table 1.
Brain arteriovenous malformation embolization cases using Scepter Mini balloon microcatheter.
| Case | Age | Gender | Rupture status | SM grade | Pedicles embolized | Distal most position of SMB | Distal access catheter position | Pedicle diameter at SMB tip (mm) | Onyx grade | Microwire | Reflux (mm) |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 6 | 60 | F | Non ruptured | 2 | 1 | S4 | S1 | 0.9 | 18 | 0.008 Asahi | 0 |
| 7 | 21 | M | Rupture | 4 | 2 | P2/3 | V2 | 1.2, 0.9 | 18 | 0.008 Asahi | 0 |
| 8 | 15 | F | Ruptured | 3 | 1 | NA (lenticulostriate feeder) | Proximal M1 | 0.8 | 18 | 0.008 Asahi | 0 |
| 9 | 55 | M | Ruptured | 2 | 1 | P3 | V4 | 1.1 | 18 | 0.008 Asahi | 0 |
SMB: Scepter Mini balloon microcatheter, S: Superior cerebellar artery, P: Posterior Cerebral artery, V: Vertebral artery, M: Middle cerebral artery, mm: milimeter, F: Female, M: Male, SM Grade: Spetzler Martin Grade
Figure 5.
(a–d) Selective fluoroscopic images of Scepter Mini balloon microcatheter at the time of brain arteriovenous malformation embolization using Onyx 18 liquid embolic system.
Overall outcome: We were able to navigate SMB to the target lesion in all nine cases. An intermediate catheter was used to support the SMB in five patients. We experienced difficulty injecting Onyx 18 in one DAVF patient due to kinking of the balloon at the time of its initial inflation within a small tortuous Dural vessel, this resolved following proximal repositioning and reinflation of the balloon. (Case 2). We did not experience unintended balloon deflation during prolonged Onyx injections.
Discussion
Herein, we have described our initial experience with the SMB in nine patients, two with DAVFs, four with bAVM and three with intracranial aneurysms. The use of dual lumen compliant balloon microcatheters for the embolization of cranio-cervical malformations including DAVFs and bAVMs has been previously described.5,15,16 A recent study also describes use of SMB in brain arteriovenous malformations.17 Utilizing dual lumen balloon microcatheters for liquid embolic injection has been shown to be associated with reduced fluoroscopic times and better penetration of targeted nidus with liquid embolic system, as well as lower instances of microcatheter entrapment.7,18 However, the majority of vascular pedicles that are embolized in cerebrovascular malformations are less than 3 mm in size.19 The catheterization of such small and tortuous pedicles can be challenging at times with larger profile compliant balloon microcatheters such as the Scepter C and Scepter XC balloon microcatheters (Microvention, Aliso Veijo, CA); the Ascent balloon microcatheter (Codman Neurovascular, Raynham, USA) or the Eclipse balloon microcatheter (Balt, Montmorency, France). These microcatheters also require 0.014-inch diameter microwires to track, and this could result in microwire perforation of small intracranial vessels. Additionally, they have relatively larger diameters at inflation, for instance, the manual inflation working range for the Scepter C is from 2–5 mm for the Scepter XC, it is 2–6 mm. These features can sometimes predispose to inadvertent over inflation of these balloons within small and pathological Pial and Dural vessels resulting in vessel rupture with poor patient outcomes. The relatively shorter length of these larger balloon microcatheters (150 cm), as well as their frequent need for support from intermediate catheters, could also hinder their navigation into the distal cerebral vasculature, especially when compared to navigation with low profile and partly flow guided non-balloon microcatheters (e.g. Marathon, Medtronic, Irvine, CA).5,18
In contrast to previously available dual lumen balloon microcatheters, the Scepter Mini balloon microcatheter has a smaller profile, and a smaller maximum balloon inflation diameter. It is also longer at 167 cm in length; and it is navigated over an 0.008-inch micro wire (Table 2). These features should enable less traumatic and easier navigation of the Scepter Mini into the distal cerebral vasculature, and also enable safer balloon inflation. In our experience, we did find that the Scepter Mini was more navigable when compared to prior balloon microcatheters, and in 4 out of 9 instances, we did not use an intermediate catheter to support successful distal navigation. Inflation of the balloon microcatheter could also be safely carried out even within small Pial or Dural arteries without rupture of the vessels. Curiously, in one of our patients, inflation of the balloon within a tortuous dural segment resulted in deformation of the balloon rather than deformation or rupture of the vessel, albeit in a Dural vessel, suggesting improved safety and compliance for this small balloon microcatheter.
Table 2.
Comparison of Scepter dual lumen balloon microcatheters.
| Important device characteristics | Scepter C | Scepter XC | Scepter Mini |
|---|---|---|---|
| Working length | 150 cm | 150 cm | 165 cm |
| Balloon diameter | 4mm | 4mm | 2.2 mm |
| Balloon length | 1,01,520 mm | 11 mm | 9 mm |
| Inner lumen | 0.419 mm | 0.419 mm | .0254 mm – .0394 mm (Tapered inner lumen) |
| Catheter outer diameter | Proxmial = 2.8 F (0.94 mm)Distal = 2.6 F (0.87 mm) | Proxmial = 2.8 F (0.94 mm) Distal = 2.6 F (0.87 mm) | Proxmial = 2.8 F (0.94 mm) Distal = 1.6 F (0.53 mm) |
| Guidewire compatibility | 0.014” or smaller | 0.014” or smaller | 0.008” or smaller |
In this series, we also describe the use of the SMB for aneurysm neck remodeling and WEB delivery support during deployment of the WEB device (Cases 3 and 4). We used the SMB in these instances in a somewhat analogous fashion to the use of balloon microcatheters for balloon assisted coiling of intracranial aneurysms. We have also used the Scepter XC balloon in a similar fashion for deployment of the WEB device in prior instances, especially when there was an acute angulation between the long axis of the aneurysm and the parent vessel. In the patients included in this report, we chose the SMB due to the small diameter of the parent arteries, along with the smaller profile of the SMB, and its perceived greater navigability. We felt that these features could also somewhat decrease the thrombotic risk when compared with the use of larger balloon microcatheters. The WEB device was delivered in both these patients through the Via 21 microcatheter (Microvention, Aliso Viejo, CA), the large diameter of which precludes the simultaneous accommodation of any of the balloon microcatheters (including the Scepter Mini) within the lumen of currently available intermediate catheters which are used to support the Via 21 microcatheter. In both instances, we were able to easily advance the SMB external to, but alongside the intermediate catheter (both the intermediate catheter containing the Via, and SMB being advanced within an 8 French Guide catheter) into the distal intracranial vasculature without requiring a separate triaxial support system for the SMB. In contrast, during previous instances in which we had used the Scepter XC balloon microcatheter for similar assistance with WEB device deployment, we had required a second triaxial system through a separate arterial access site, especially when the Scepter XC required more distal navigation into the intracranial vasculature.
In the case of the patient with the PICA aneurysm (case 5), the small caliber and superior navigability of the SMB allowed us to successfully navigate the balloon microcatheter across the narrowed lumen of this small caliber parent artery at the aneurysm neck. We were then able to safely inflate the balloon at the neck of the aneurysm in order to gently reposition the WEB device, as well as to disrupt the thrombus. We were also able to inject Eptifibatide through the injection lumen. These maneuvers enabled us to recanalize the vessel and avoid intra-arterial stent placement, which would not have been ideal in a patient with SAH.
Our series has several limitations, such as a low number of patients, and the non-inclusion of patients with spinal vascular malformations. It should also be noted that whereas the Scepter Mini balloon microcatheter does seem to have better navigability within small distal intracranial vessels, it does not permit placement of coils4,20 or delivery of intracranial stents21,22 quite unlike the case with other dual lumen balloon microcatheters such as the Scepter C and XC. However, our series does suggest the potential for wider utilization of this low-profile dual lumen balloon microcatheter for some balloon assisted endovascular neurosurgical procedures, in which distal navigability and a smaller profile for the balloon are more important.
Conclusion
The Scepter Mini has the potential to be useful for endovascular neurosurgical procedures requiring balloon assistance in smaller diameter blood vessels. In this small series of patients, it demonstrated good navigability and safety with balloon inflation.
Footnotes
Declaration of conflicting interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Dr. Jagadeesan is a consultant for Microvention (Aliso Viejo, CA) and Medtronic (Irvine, CA), He is also a co-investigator for PHIL study sponsored by Microvention at University of Minnesota. He did not receive any funding for this project. Dr. Grande is a consultant for Medtronic (Irvine, CA) and Integra (Princeton, NJ). He is also a co-investigator for PHIL study sponsored by Microvention at University of Minnesota. He did not receive any funding for this project. Dr. Tummala is Primary investigator for PHIL study sponsored by Microvention at University of Minnesota. He also received an unrestricted education grant from Microvention. He did not receive any funding for this project. Dr. Hassan is consultant and speaker for Medtronic, Stryker, Microvention, Penumbra, Balt, Viz Ai, Scientia, Genentec, and GE Healthcare; received personal fees with Cerenovus outside of submitted work. Dr. Mehta, Dr. Tekle and Dr. Masood has no disclosures.
Funding: The author(s) received no financial support for the research, authorship, and/or publication of this article.
ORCID iDs: Tapan Mehta https://orcid.org/0000-0003-0199-3967
Ameer Hassan https://orcid.org/0000-0002-7148-7616
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