HyperForm Balloon Research Articles

Treatment of dural arteriovenous fistula by balloon-assisted transarterial embolization with Onyx

ObjectiveThis study evaluated the feasibility, safety, and efficacy of embolization of dural arteriovenous fistula via a very small, short feeding artery with the assistance of a balloon placed proximal to the tip of the microcatheter, such that the balloon serves as a plug. MethodsEight patients who underwent treatment of DAVF by balloon-assisted transarterial embolization with Onyx were retrospectively reviewed. Gender, age, angiography findings, procedure details, clinical and angiographic outcomes, complications, and follow-up were recorded and analyzed. ResultsNine embolization procedures were performed in eight male patients via extracranial arteries. Balloon-assisted embolization was successful in all eight patients. A Hyperglide balloon was used in five patients, and a Hyperform balloon was used in three patients. Angiographic resolution of the fistula was achieved in all patients without complications. All patients recovered uneventfully. During the follow-up period of 7–19 months, all patients were asymptomatic except for one patient who experienced mild headaches. ConclusionsTreatment of DAVF by balloon-assisted embolization with Onyx achieved promising results, even in patients with very small and short feeding arteries. This technique allowed the treatment of DAVF cases where other techniques have failed.

E-069 Intentional Partial Embolisation for Dome Protection of Ruptured Complex Bifurcation Cerebral Aneurysms with Onyx HD500 is Feasible Prior to Delayed Definitive Treatment

IntroductionIntentional partial coiling dome protection of ruptured cerebral aneurysms was recently reported to prevent acute rebleeding in SAH patients. There are potential disadvantages to this technique including difficulty keeping coil...

HyperForm balloon microcatheterはワンタッチスライド開閉機能が付いたYコネクターのホイール操作で拡張される

【目的】脳動脈瘤に対するHyperForm（eV3 Neurovascular, Irvine, CA, USA）を用いたバルーン支援によるコイル塞栓術において，ワンタッチスライド開閉機能が付いたYコネクターのサムホイールでガイドワイヤーを固定する際にバルーンが拡張する現象を確認したので，操作上の注意事項を含めて報告する．【方法】2011年4月から2012年12月の間，当施設で24例の脳動脈瘤に対してHyperFormを用いたバルーン支援によるコイル塞栓術を施行した．HyperForm に接続するYコネクターは，13例にワンタッチスライド開閉機能が付いたYコネクターを使用し，11例は従来の絞り型のバルブによるYコネクターを使用した．【結果】HyperFormのセットアップ時にワンタッチスライド開閉機能が付いたYコネクターのサムホイールを回してワイヤーを固定すると，全例にバルーンの拡張を認めた．従来の絞り型のバルブによるYコネクターで同様の操作を行ったが，バルーンの拡張は認めなかった．【結論】ワンタッチスライド開閉機能が付いたYコネクターは，デバイスの出し入れが多くなる症例では同部からの出血を減らすメリットがあるが，先端開口部をガイドワイヤーで閉鎖して拡張させるシングルルーメンのバルーンカテーテルに使用すると，サムホイールを回すことでカテーテルの内圧を上昇させて予期しないバルーンの拡張を来す危険性がある．

A 6-Fr guiding catheter (Slim Guide®) for use with multiple microdevices

Background:We developed a new 6-Fr guiding catheter (Slim Guide®) that features a large lumen (0.072 inch) for performing advanced techniques as are required in patients with wide-necked aneurysms whose treatment with a single microcatheter is difficult.Methods:The Slim Guide was used to address 30 saccular and 20 dissecting aneurysms. All 50 patients presented with subarachnoid hemorrhage. To perform the advanced techniques we used SL-10® or Excel 14® and Hyperform® balloon microcatheters.Results:Of the 30 patients with saccular aneurysms, 20 were treated with the double microcatheter- and the other 10 with the balloon assist technique. All 20 patients with dissecting aneurysms were treated with the double microcatheter technique. We encountered slight interference during the treatment of one saccular aneurysm with the balloon assist technique using the Slim Guide guiding catheter; another patient with a saccular aneurysm treated with the balloon assist technique suffered a minor transient ischemic complication.Conclusions:With the Slim Guide, the risks inherent in the application of advanced techniques may be decreased. Its use facilitates the coil embolization of aneurysms that pose treatment challenges.

Balloon-assisted coiling of the proximal lobule of a paraophthalmic aneurysm causing panhypopituitarism: Technical case report

Background:We describe an intra-aneurysmal balloon-assisted technique to limit the coil volume in a large bilobulated paraophthalmic aneurysm. Our intent was to reduce the mass effect and presenting symptoms of diabetes insipidus (DI) with hypopituitarism.Case Description:A 32-year-old woman presented with symptoms of DI and her work-up demonstrated hypopituitarism and partial bitemporal visual field defects. Cerebral angiography revealed a large paraophthalmic aneurysm with two distinctive lobules, projecting toward the pituitary fossa. The patient declined craniotomy but consented for endovascular treatment. The plan was to limit the embolization to the proximal lobule only. Initially, we used a dual microcatheter technique with a microcatheter in each lobule. A framing coil in the distal lobule did not prevent coil migration from the proximal lobule. Instead, we elected to use a Hyperform balloon in the distal lobule and were able to successfully coil the proximal lobule only. Her 3-year follow-up angiogram revealed a completely occluded aneurysm. The patient experienced resolution of the DI and improvement of her visual fields. However, she remained in hypopituitarism.Conclusion:Intra-aneurysmal balloon-assisted coiling of proximal aneurysmal lobules might be an alternative for the reduction of mass effect related to the coil mass. Careful follow-up is needed because subtotal occlusion carries a future risk of growth, recanalization and rupture. Unruptured intracranial carotid aneurysms can present with reversible DI and usually permanent pituitary disturbances.

Balloon-augmented Onyx embolization of a dural arteriovenous fistula arising from the neuromeningeal trunk of the ascending pharyngeal artery: technical report

IntroductionIntracranial dural arteriovenous fistulas (dAVFs) with perimedullary drainage are an uncommon but well-recognized lesion that can lead to spinal cord edema. The authors present a case of a foramen magnum...

Intraaneurysmal balloon assistance for navigation across a wide-necked aneurysm

Endovascular obliteration of wide-necked aneurysms may be precluded by the inability to navigate across the aneurysm neck. The authors present a technique in which a Hyperform balloon is inflated within the aneurysm and used as a contact surface to "bounce" the remodeling balloon across the aneurysm neck. They have successfully used this technique in 3 patients to efficiently overcome vessel tortuosity, aneurysmal dead space, and balloon prolapse, allowing for obliteration of large, wide-necked aneurysms.

HyperForm balloon remodeling in the endovascular treatment of anterior cerebral, middle cerebral, and anterior communicating artery aneurysms: clinical and angiographic follow-up results in 800 consecutive patients

The purpose of this paper was to present the safety, efficacy, and clinical/angiographic follow-up results of HyperForm balloon-assisted endosaccular coil occlusion of distal anterior circulation bifurcation aneurysms. Over a 7-year period, the authors treated 864 middle cerebral artery, distal anterior cerebral artery bifurcation, and anterior communicating artery aneurysms by means of coil embolization with HyperForm balloon assistance in 800 patients. In 37 aneurysms, 2 HyperForm balloons were used simultaneously for remodeling. The overall mortality rate was 7.1%, including 1.4% procedural mortality. Various neurological deficits were present at discharge in 8.9% of the patients, and 4.4% had permanent disabling morbidity 6 months posttreatment (modified Rankin Scale score ≥ 2). Thromboembolic complications developed during the treatment of 15 aneurysms (1.7%) causing morbidity or mortality in 10 cases (1.3%). There were 14 intraoperative perforations (1.6%). In all 14 cases, the HyperForm balloon saved patients from severe bleeding. The perforation led to morbidity or mortality in 3 cases (0.4%); there were no negative consequences in 11. There were 726 patients with 757 aneurysms (87.6%) available for follow-up. Control angiograms were obtained at 6 months in 386 patients, at 1 year in 267, and at 2 years in 104, revealing an 82% complete obliteration rate according to the most recent follow-up angiograms. The satisfactory results obtained in this experience demonstrate that HyperForm balloon remodeling provides strong benefits for the endovascular management of middle cerebral, anterior cerebral, and anterior communicating artery aneurysms without increasing the risk of treatment. Not only does this technique allow for the safe treatment of these aneurysms, but it also expands the indications of endovascular treatment to include aneurysms that otherwise cannot be treated with simple coil embolization.

Endovascular Treatment of Wide-Necked Intracranial Aneurysms Using Balloon-Assisted Technique with HyperForm Balloon

To assess the feasibility, safety, and effectiveness of the balloon-assisted technique with HyperForm balloon in the endovascular treatment of wide-necked intracranial aneurysms. A total of 34 patients with 34 wide-necked intracranial aneurysms were treated with endovascular coil embolization using balloon-assisted technique with Hyperform balloon. Twenty-nine aneurysms (85.3%) were located in the anterior circulation. The group of patients was comprised of 16 men and 18 women, aged 33 to 72 years (mean : 60.6 years). The size of aneurysms was in the range of 2.0 to 22.0 mm (mean 5.5 mm) and one of neck was 2.0 to 11.9 mm (mean 3.8 mm). The dome to neck ratio was ranged from 0.83 to 1.43 (1.15). Sixteen patients were treated for unruptured aneurysms and the remaining 18 presented with a subarachnoid hemorrhage. In the 34 aneurysms treated by the remodeling technique with HyperForm balloon, immediate angiographic results consisted of total occlusion in 31 cases (91.2%) and partial occlusion in three cases (8.8%). There were five procedure-related complications (14.7%), including two coil protrusions and three thromboembolisms; Except one patient, all were successfully resolved without permanent neurologic deficit. No new bleeding occurred during the follow-up. Twenty patients (59%) underwent angiographic follow-up from 2 to 33 months (mean 9.2 months) after treatment. Focal recanalization with coil compaction of the neck portion was observed in 5 cases (25%). Only one case showed major recanalization and underwent stent-assisted coil embolization. The balloon-assisted technique with Hyperform balloon is a feasible, safe, and effective endovascular treatment of wide-necked cerebral aneurysms.

DOUBLE-BALLOON TRAPPING TECHNIQUE FOR EMBOLIZATION OF A LARGE WIDE-NECKED SUPERIOR CEREBELLAR ARTERY ANEURYSM

To describe a novel double-balloon trapping technique for endovascular embolization of a broad-based saccular aneurysm of the superior cerebellar artery. A 62-year-old man with a history of diabetes, coronary artery disease, and smoking presented with a syncopal episode. Catheter angiography revealed a large (11.7 x 9.4 x 11.2 mm) right superior cerebellar artery (SCA) aneurysm with a 7-mm neck, incorporating the origin of the right SCA. An endovascular double-balloon trapping technique was used. Using bilateral groin access and bilateral vertebral artery guide catheters, a 4 x 20 mm HyperGlide balloon (ev3 Neurovascular, Irvine, CA) was placed across the neck of the aneurysm, and a 4 x 7 mm HyperForm balloon (ev3 Endovascular Inc., Plymouth, MN) was placed within the aneurysm. The aneurysm was catheterized with an Echelon 14 microcatheter (ev3 Endovascular Inc.). The inflated HyperGlide balloon was used to protect the parent basilar artery and "trap" the smaller HyperForm balloon within the aneurysm. The HyperForm balloon was inflated within the aneurysm and gently retracted to protect the origin of the SCA at the aneurysm neck. The aneurysm was coiled with the balloons inflated. A 4.5 x 20 mm Neuroform stent (Boston Scientific, Natick, MA) was deployed across the aneurysm neck. Final procedural angiography showed near complete occlusion of the aneurysm and preservation of flow in the SCA. Follow-up angiography at 8 months showed progressive thrombosis with complete occlusion of the aneurysm, preserved patency of the SCA, and anatomic reconstruction of the native artery. The patient remained neurologically normal at the time of the follow-up evaluation. Double-balloon trapping is a novel endovascular technique that can be used to treat wide-necked aneurysms and maintain patency of side branches incorporated into the aneurysm neck.

Endovascular treatment of wide-necked intracranial aneurysms using of “remodeling technique” with the HyperForm balloon

Aneurysms with wide-necked or a large neck/fundus ratio, especially located on an arterial bifurcation or a small artery, are challenges for interventional neuroradiologist because of the risk of coil migration or coil protrusion into the parent vessels. Our study was designed to improve the efficacy and safety of the "remodeling technique" with the HyperForm balloon for these difficult aneurysms and was confirmed by a follow-up result. From June 2004 to September 2006, forty-two patients (20 men, 22 women) with wide-necked or large neck/fundus ratio aneurysms were treated by using the "remodeling technique" with the HyperForm balloon. Forty wide-necked aneurysms were successfully treated with the HyperForm balloon remodeling technique with only two failed cases. Final results consisted of total occlusion in 34 cases (80.9%), subtotal in 4 (9.5%) and incomplete in 2 (4.8%). One aneurysmal rupture occurred, but no clinical consequence was shown. No thromboembolic events were observed during treatment. Final angiographic follow-up time ranged from 3 to 18 months. The "remodeling technique" with the HyperForm balloon is a very useful tool in the treatment of wide-necked or unfavorable neck/fundus ratio intracranial aneurysms-located on an arterial bifurcation or a small artery and, especially, located on the bifurcation of a large artery and a small one. In our experience, this technique provided a safe and efficient treatment for difficult aneurysms when the standard remodeling technique might have failed.

HyperForm Balloon-Assisted Endovascular Neck Bypass Technique to Perform Balloon or Stent-Assisted Treatment of Cerebral Aneurysms

We describe a technique to bypass aneurysm neck using the HyperForm balloon to perform balloon- or stent-assisted endovascular treatment of complex large or giant aneurysms with very wide neck in which other methods would fail to obtain an access distal to the aneurysm.

ＨｙｐｅｒＦｏｒｍ ｂａｌｌｏｏｎを用いたｒｅｍｏｄｅｌｉｎｇ ｔｅｃｈｎｉｑｕｅを併用した脳動脈瘤の塞栓術

ＨｙｐｅｒＦｏｒｍ ｂａｌｌｏｏｎを用いたｒｅｍｏｄｅｌｉｎｇ ｔｅｃｈｎｉｑｕｅを併用した脳動脈瘤の塞栓術

Balloon or Stent-Assisted Coil Embolization for Acutely Ruptured Wide-Necked Aneurysms

In this paper, we report five cases with acutely ruptured wide-necked aneurysms, which were treated with coil embolization using a balloon or stent-assisted technique. Balloon-assisted coil embolization using Equinox balloon, Commodore balloon, and Hyperform balloon were performed for four patients and stent-assisted coil embolization using BX velocity for one patient. We discuss problems of coil embolization for acutely ruptured wide-necked aneurysms with a balloon or stent-assisted technique.

ＨｙｐｅｒＦｏｒｍ ｏｃｃｌｕｓｉｏｎ ｂａｌｌｏｏｎ ｓｙｓｔｍを使用した脳動脈瘤の瘤内塞栓術

After the publication of ISAT trial, intraaneurysmal coil embolization has become more widely used for treatment of aneurysm. There are, however, some disadvantages in intraaneurysmal coil embolization. One is how to treat wide neck aneurysm. Among several solutions, such as 3D coils and double catheter technique, neck plasty technique is the most effective method at present. A new balloon catheter, HyperForm balloon occlusion system (HyperForm), for neck plasty technique has recently been developed. This balloon, with a maximum diameter of 7 mm, is so soft that it is called supercompliant. We report our experiences using the balloon. The cases in this study were 13 aneurysms in 12 patients in whom intraaneurysmal coil embolization was performed using HyperForm. The site of the aneurysm was internal carotid artery (ICA) in 6, basilar bifurcation in 5, and middle cerebral artery (MCA) in 2. The procedure itself is similar to ordinary neck plasty method. Most different fashion is in the situation of basilar bifurcation aneurysm. Many basilar bifurcation aneurysms dominantly saddle one of the posterior cerebral arteries (PCAs). We usually try to navigate a neck plasty balloon through the PCA that is saddled more by aneurysm. However, during this procedure the guidewire tends to migrate inside the aneurysm. In other words, the less important it is to preserve the PCA, the easier it is to canulate. HyperForm inflates irregularly as if the balloon itself is searching for space. Thanks to this characteristic of HyperForm, the important PCA can be protected even as the HyperForm is navigated through the less important PCA. Therefore, HyperForm is very useful for intraaneurysmal embolization of basilar bifurcation aneurysm. Another possible advantage of HyperForm is its larger diameter. The largest diameter of the previously used balloon was 4.5 mm, but HyperForm has a maximum diameter of 7 mm, which is useful for ICA aneurysm. However, because of its softness, HyperForm tends to jump during treatment of ICA aneurysm. There were 2 complications in this series. Both were perforations by the guide wire, one was aneurysm and the other was perforator, in the treatment of MCA aneurysm. In conclusion, HyperForm is very useful for neck plasty technique, especially in treatment of wide neck basilar bifurcation aneurysm.

Hyperform Remodeling Balloon for the Balloon Occlusion Test of Persistent Primitive Trigeminal Artery Aneurysm-Case Report-

A 17-year-old woman presented with a rare aneurysm at the junction of the persistent primitive trigeminal artery (PPTA) and the internal carotid artery (ICA) manifesting as left abducens nerve paresis. The aneurysm and the ICA were both successfully occluded with coils. The balloon occlusion test used the HyperForm balloon microcatheter to seal the PPTA and ICA, which is very important to determine the optimal treatment strategy for a PPTA aneurysm.

Barcelona 1994, Annual Meeting of the Spanish Society of Neuroradiology, a Souvenir

In this paper, we report five cases with acutely ruptured wide-necked aneurysms, which were treated with coil embolization using a balloon or stent-assisted technique. Balloon-assisted coil embolization using Equinox balloon, Commodore balloon, and Hyperform balloon were performed for four patients and stent-assisted coil embolization using BX velocity for one patient. We discuss problems of coil embolization for acutely ruptured wide-necked aneurysms with a balloon or stent-assisted technique.