Tag: stent

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Novel Delivery System Significantly Improves Technical Success and Safety of the Endovascular Clip System (eCLIPs) While Maintaining Efficacy for the Treatment of Wide-Necked Bifurcation Aneurysms

Neurosurgery 97:963–970, 2025

A prospective registry study found that the new eCLIPs electrolytic bifurcation system (eB) for wide-necked bifurcation aneurysms significantly improved technical success and safety over the prior generation, while maintaining high efficacy, with 96% satisfactory occlusion and low rates of neurological complications and retreatment.

• The eCLIPs device is an endovascular implant designed to treat wide-necked bifurcation aneurysms (WNBAs).

• This study compares two generations: the first-generation eCLIPs bifurcation remodeling system (eBRS) and the newer eCLIPs electrolytic bifurcation system (eB).

• A prospective registry included 280 patients; the eB system showed higher implantation success (92% vs 81% for eBRS, P = .007).

• Both systems achieved high rates of satisfactory aneurysm occlusion (mRROC 1+2: 96%).

• The eB system had lower all-cause (1.1%) and neurological (0.5%) death rates compared to eBRS (7% and 5%, respectively).

• Stroke and repeat procedure rates were low for both devices, with eB performing better (stroke: ~1.7%, repeat procedure: 2.2% vs 8.9% for eBRS).

• eCLIPs compares favorably in safety and efficacy to other devices like WEB and stent-assisted coiling.

• The eB system offers improved procedural success and safety, making eCLIPs a strong option for WNBAs; further studies are recommended.

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Neuroform Atlas Stent for Treatment of Middle Cerebral Artery Aneurysms

Neurosurgery 89:102–108, 2021

Heterogeneous effect of endovascular aneurysm therapy has been observed across different anatomic locations. There is a paucity of data for stent-assisted coiling of middle cerebral artery (MCA) aneurysms.

OBJECTIVE: To present the results of the MCA aneurysmgroup from the Neuroform Atlas (Stryker Neurovascular) investigational device exemption (IDE) trial.

METHODS: The Atlas IDE trial is a prospective, multicenter, single-arm, open-label study of wide-neck aneurysms (neck ≥ 4 mm or dome-to-neck ratio < 2) in the anterior circulation treated with the Neuroform Atlas Stent and approved coils. Follow-up was obtained immediately postprocedure and 2, 6, and 12 mo postoperatively.We herein describe safety and efficacy outcomes, and functional independence of the subjects with aneurysms from all segments of MCA.

RESULTS: A total of 35 patients were included (27 MCA bifurcation, 5 M1, 3 M2). The mean aneurysm size was 6.0 ± 1.8 mm, and the mean neck was 4.4 ± 1.2 mm. Technical procedural success was achieved in all patients. A total of 26 patients had follow-up digital subtraction angiography available at 12mo, with 80.8% (21/26) having complete aneurysm occlusion. Twelve-month safety data were collected for 91.4% (32/35), 8.5% (3/35) had primary safety endpoint, all 3 major ischemic strokes. Mortality occurred in 2 patients beyond 30 d unrelated to procedure (1 gallbladder cancer and 1 fentanyl intoxication). At 1 yr, modified Rankin Score was 0 to 2 in 84.4% (27/32), 3 in 9.4%, and 3 patientswere missing. Approximately 5.7% (2/35) of patients were retreated at 12 mo.

CONCLUSION: Stent-assisted coiling with the Neuroform Atlas Stent is a viable alternative to clipping for selected MCA aneurysms. Complete aneurysm occlusion rates have improved compared to historical data. Proper case selection can lead to acceptable endovascular results.

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Early postmarket results with PulseRider for treatment of wide-necked intracranial aneurysms: a multicenter experience

J Neurosurg 133:1756–1765, 2020

Traditionally, stent-assisted coiling and balloon remodeling have been the primary endovascular treatments for wide-necked intracranial aneurysms with complex morphologies. PulseRider is an aneurysm neck reconstruction device that provides parent vessel protection for aneurysm coiling. The objective of this study was to report early postmarket results with the PulseRider device.

METHODS This study was a prospective registry of patients treated with PulseRider at 13 American neurointerventional centers following FDA approval of this device. Data collected included clinical presentation, aneurysm characteristics, treatment details, and perioperative events. Follow-up data included degree of aneurysm occlusion and delayed (> 30 days after the procedure) complications.

RESULTS A total of 54 aneurysms were treated, with the same number of PulseRider devices, across 13 centers. Fourteen cases were in off-label locations (7 anterior communicating artery, 6 middle cerebral artery, and 1 A1 segment anterior cerebral artery aneurysms). The average dome/neck ratio was 1.2. Technical success was achieved in 52 cases (96.2%). Major complications included the following: 3 procedure-related posterior cerebral artery strokes, a devicerelated intraoperative aneurysm rupture, and a delayed device thrombosis. Immediately postoperative Raymond-Roy occlusion classification (RROC) class 1 was achieved in 21 cases (40.3%), class 2 in 15 (28.8%), and class 3 in 16 cases (30.7%). Additional devices were used in 3 aneurysms. For those patients with 3- or 6-month angiographic follow-up (28 patients), 18 aneurysms (64.2%) were RROC class 1 and 8 (28.5%) were RROC class 2.

CONCLUSIONS PulseRider is being used in both on- and off-label cases following FDA approval. The clinical and radiographic outcomes are comparable in real-world experience to the outcomes observed in earlier studies. Further experience is needed with the device to determine its role in the neurointerventionalist’s armamentarium, especially with regard to its off-label use.

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PulseRider for treatment of wide-necked intracranial aneurysms: a multicenter experience

J Neurosurg 133:1756–1765, 2020

Traditionally, stent-assisted coiling and balloon remodeling have been the primary endovascular treatments for wide-necked intracranial aneurysms with complex morphologies. PulseRider is an aneurysm neck reconstruction device that provides parent vessel protection for aneurysm coiling. The objective of this study was to report early postmarket results with the PulseRider device.

METHODS This study was a prospective registry of patients treated with PulseRider at 13 American neurointerventional centers following FDA approval of this device. Data collected included clinical presentation, aneurysm characteristics, treatment details, and perioperative events. Follow-up data included degree of aneurysm occlusion and delayed (> 30 days after the procedure) complications.

RESULTS A total of 54 aneurysms were treated, with the same number of PulseRider devices, across 13 centers. Fourteen cases were in off-label locations (7 anterior communicating artery, 6 middle cerebral artery, and 1 A1 segment anterior cerebral artery aneurysms). The average dome/neck ratio was 1.2. Technical success was achieved in 52 cases (96.2%). Major complications included the following: 3 procedure-related posterior cerebral artery strokes, a devicerelated intraoperative aneurysm rupture, and a delayed device thrombosis. Immediately postoperative Raymond-Roy occlusion classification (RROC) class 1 was achieved in 21 cases (40.3%), class 2 in 15 (28.8%), and class 3 in 16 cases (30.7%). Additional devices were used in 3 aneurysms. For those patients with 3- or 6-month angiographic follow-up (28 patients), 18 aneurysms (64.2%) were RROC class 1 and 8 (28.5%) were RROC class 2.

CONCLUSIONS PulseRider is being used in both on- and off-label cases following FDA approval. The clinical and radiographic outcomes are comparable in real-world experience to the outcomes observed in earlier studies. Further experience is needed with the device to determine its role in the neurointerventionalist’s armamentarium, especially with regard to its off-label use.

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Diffusion-weighted imaging–detected ischemic lesions associated with flow-diverting stents in intracranial aneurysms

Diffusion-weighted imaging–detected ischemic lesions associated with flow-diverting stents in intracranial aneurysms

J Neurosurg 122:627–636, 2015

It was initially considered safe for flow-diverting stents to cover the ostia of branching vessels during endovascular procedures for the treatment of intracranial aneurysms. As more recent evidence suggests, however, their use is not always free of ischemic concerns in terms of covered arterial ostia. The authors sought to determine the frequency of silent and clinically evident diffusion-weighted imaging (DWI)–detected abnormalities related to stent placement as a means of elucidating potential clinical risks.

Methods This is a prospective single-center study on a series of patients with intracranial aneurysms that were treated with flow-diverting stents. All patients systematically underwent an MRI protocol that included DWI before treatment, between 24 and 48 hours postprocedure, and 3 months postembolization. Effectiveness of anticoagulation treatment was assessed for all patients. Lesions seen on DWI were correlated to the parent artery and the side-branch territories and were statistically analyzed in relation to their time of occurrence and clinical presentation. The authors compared the DWI findings in these patients to findings obtained in patients treated with a stent-assisted coiling technique during the same time period.

Results Over the course of 18 consecutive months, 38 consecutive patients (7 males and 31 females) with 49 intracranial aneurysms were treated using flow-diverting stents. Overall, 81.6% of the DWI spots found remained clinically silent during the follow-up period. Five ischemic clinical complications (13.2%) occurred in the postprocedural period. No statistically significant correlation could be established between DWI spots or aneurysm location and clinical complications or follow-up modified Rankin Scale score at 3 months. The complication rate was 7.8% (n = 3) at the 3-month follow-up, and mortality was 0%. Compared with stent-assisted coiling, use of flow-diverting stents showed a statistically significant correlation with silent DWI findings postintervention.

Conclusions Lesions seen on DWI resulting from the procedure are far more common than anticipated, but the technique remains safe and effective, providing an interesting alternative for “difficult” aneurysms, regardless of location. Late-occurring DWI-detected lesions distal to side arterial branches imply a local pressure gradient drop, related to flow competition by collateral networks. Further research is needed to assess the extent and significance of these events.

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Suboccipital endoscopic management of the entrapped fourth ventricle

Suboccipital endoscopic management of the entrapped fourth ventricle- technical note

Acta Neurochir (2013) 155:1957–1963

Entrapped fourth ventricle is the result of both inlet aqueduct and outlet fourth ventricular midline and lateral foraminae obstruction. It occurs as a sequalae of intracranial hemorrhagic or inflammatory disease condition. Usually it presents after previous shunting for communicating hydrocephalus with a period of improvement, after which manifestations of posterior fossa expanding process appear. The diagnosis of this rare condition is easy considering the patient past history and the recent clinical state, together with the midline CSF density of the dilated fourth ventricle in either the CT or MR images. The treatment options for this condition include open and endoscopic approaches together with the traditional ventricular to extracranial CSF diversionary procedures.

Objective The aim of the study was to adopt a procedure for treatment of entrapped fourth ventricle that carries the advantage of the minimally invasive technique thus avoiding the complications of the traditional opened and shunt surgeries as well as decreasing multiple procedures due to aqueduct restenosis or stent fall.

Methods Thirteen patients with symptomatic entrapped fourth ventricle underwent suboccipital endoscopic trans–fourth ventricular aqueductoplasty from May 2007 till November 2011. The Gabb endoscopic system was used and aqueductoplasty was performed using 3F Fogarty balloon followed by stent placement. Nine patients were females. The mean age was 3.6 years and the mean follow up period was 23 months. All cases had a previous one or two supratentorial VP shunt placement.

Results Short stent was used in eight patients. During the follow up, stent migration occurred in five of them. Three of these five patients developed posterior fossa compression manifestations due to aqueduct restenosis. Long stent from the aqueduct till the bur hole site for these three patients and the following five patients was used. All cases showed both clinical and radiologic improvement. Apart from the stent migration, no procedure-related complications were encountered.

Conclusion Endoscopic suboccipital paramedian aqueductoplasty with the use of a stent is a safe and effective surgical option that—in our opinion—should stand as the first line treatment for the entrapped fourth ventricle. Long stent is better used after aqueductoplasty to avoid the restenosis if no stent is used or stent fall after short stents. However, good case selection, familiarity with this fairly common endoscopic approach and longer follow-up is needed for obtaining an optimal result.

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Safety and Efficacy of Endovascular Treatment of Basilar Tip Aneurysms by Coiling With and Without Stent Assistance: A Review of 235 Cases

Neurosurgery 71:785–794, 2012

Endovascular therapy is now the preferred treatment option for basilar tip aneurysms (BTAs).

OBJECTIVE: To compare the safety and efficacy of common endovascular techniques in the treatment of BTAs.

METHODS: A retrospective review was conducted of 235 patients with BTAs treated with endovascular means in our institution between 2004 and 2011. Categorization was based on the presence and type of stent assistance (none, single, and Y stenting). The rates of perioperative complications, recanalization, rehemorrhage, and retreatment were analyzed.

RESULTS: A total of 147 patients were treated with coil embolization and 88 patients with stent-assisted coiling (72 single stents, 16 Y stents). Thromboembolic complications occurred in 6.8% of patients in both groups. There was no associated mortality. Angiographic follow-up (mean, 23.5 months) was available in 172 patients (77.1%). Stented patients had significantly lower recanalization (17.2% vs 38.9%; P = .003) and retreatment (7.8% vs 27.8%; P = .002) rates compared with nonstented patients. Four rehemorrhages (2.7%) occurred in the coiled group, whereas none were noted in the stented group (P = .3). In paired comparisons, lower recanalization (8.3% vs 19.2%; P = .21) and retreatment (0% vs 9.6%; P = .19) rates were seen in the Y-stent group compared with the single-stent group. Thromboembolic complications occurred in 6.9% and 6.2% of patients in the single-stent and Y-stent groups, respectively (P = .91). In multivariate analysis, larger aneurysms, nonstented aneurysms, incomplete initial occlusion, and subarachnoid hemorrhage were predictors of aneurysm recanalization.

CONCLUSION: Stent-assisted coiling has significantly lower recurrence, retreatment, and rehemorrhage rates than coiling alone for the treatment of BTAs. Y stenting has the highest efficacy with low complication rates.

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Dural sinus stents for idiopathic intracranial hypertension

J Neurosurg 116:538–548, 2012. DOI: 10.3171/2011.10.JNS101410

The use of unilateral dural sinus stent placement in patients with idiopathic intracranial hypertension (IIH) has been described by multiple investigators. To date there is a paucity of information on the angiographic and hemodynamic outcome of these procedures. The object of this study was to define the clinical, angiographic, and hemodynamic outcome of placement of unilateral dural sinus stents to treat intracranial venous hypertension in a subgroup of patients meeting the diagnostic criteria for IIH.

Methods. Eighteen consecutive patients with a clinical diagnosis of IIH were treated with unilateral stent placement in the transverse-sigmoid junction region. All patients had papilledema. All 12 female patients had headaches; 1 of 6 males had headaches previously that disappeared after weight loss. Seventeen patients had elevated opening pressures at lumbar puncture. Twelve patients had opening pressures of 33–55 cm H2O. All patients underwent diagnostic cerebral arteriography that showed venous outflow compromise by filling defects in the transverse-sigmoid junction region. All patients underwent intracranial selective venous pressure measurements across the filling defects. Follow-up arteriography was performed in 16 patients and follow-up venography/venous pressure measurements were performed in 15 patients.

Results. Initial pressure gradients across the filling defects ranged from 10.5 to 39 mm Hg. Nineteen stent procedures were performed in 18 patients. One patient underwent repeat stent placement for hemodynamic failure. Pressure gradients were reduced in every instance and ranged from 0 to 7 mm Hg after stenting. Fifteen of 16 patients in whom ophthalmological follow-up was performed experienced disappearance of papilledema. Follow-up arteriography in 16 patients at 5–99 months (mean 25.3 months, median 18.5 months) showed patency of all stents without in-stent restenosis. Two patients had filling defects immediately above the stent. Four other patients developed transverse sinus narrowing above the stent without filling defects. One of these patients underwent repeat stent placement because of hemodynamic deterioration. Two of the other 3 patients had hemodynamic deterioration with recurrent pressure gradients of 10.5 and 18 mm Hg.

Conclusions. All stents remained patent without restenosis. Stent placement is durable and successfully eliminates papilledema in appropriately selected patients. Continuing hemodynamic success in this series was 80%, and was 87% with repeat stent placement in 1 patient.

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Efficacy of endovascular stenting in dural venous sinus stenosis for the treatment of idiopathic intracranial hypertension

Neurosurg Focus 27 (5):E14, 2009.DOI: 10.3171/2009.9.FOCUS09165

Multiple pathophysiological mechanisms have been proposed for the increased intracranial pressure observed in idiopathic intracranial hypertension (IIH). The condition is well characterized, with intractable headaches, visual obscurations, and papilledema as dominant features, mainly affecting obese women. With the advent of MR venography and increased use of cerebral angiography, there has been recent emphasis on the significant number of patients with IIH found to have associated nonthrombotic dural venous sinus stenosis. This has led to a renewed interest in endovascular stenting as a treatment for IIH. However, the assumption that venous stenosis leads to a high pressure gradient that decreases CSF resorption through arachnoid villi requires further evidence.

In this paper, the authors analyze the published results to date of dural venous sinus stenting in patients with IIH. They also present a case from their institution for illustration.

The pathophysiological mechanism in IIH requires further elucidation, but venous sinus stenosis with subsequent intracranial hypertension appears to be an important mechanism in at least a subgroup of patients with IIH. Among these patients, 78% had complete relief or improvement of their main presenting symptoms after endovascular stenting.

Resolution or improvement in papilledema was seen in 85.1% of patients.

Endovascular stenting should be considered whenever venous sinus stenosis is diagnosed in patients with IIH.

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