PulseRider-assisted treatment of wide-necked intracranial bifurcation aneurysms: safety and feasibility study

2017 ◽  
Vol 127 (1) ◽  
pp. 61-68 ◽  
Author(s):  
Soumya Mukherjee ◽  
Arun Chandran ◽  
Anil Gopinathan ◽  
Mani Putharan ◽  
Tony Goddard ◽  
...  

OBJECTIVEThe goal of this study was to assess the safety and feasibility of PulseRider, a novel endovascular stent, in the treatment of intracranial bifurcation aneurysms with wide necks. The authors present the initial results of the first 10 cases in which the PulseRider device was used.METHODSPatients whose aneurysms were intended to be treated with the PulseRider device at 2 institutions in the United Kingdom were identified prospectively. Patient demographics, procedural details, immediate neurological and clinical status, and immediate angiographic outcomes and 6-month clinical and imaging follow-up were recorded prospectively.RESULTSAt the end of the procedure, all 10 patients showed complete aneurysm occlusion (Raymond Class 1). There were no significant intraprocedural complications except for an occurrence of thromboembolism without clinical sequelae. There was no occurrence of aneurysm rupture or vessel dissection. At 6-month follow-up, 7 and 3 patients had modified Rankin Scale scores of 0 and 1, respectively. All 10 patients had stable aneurysm occlusion (Raymond Class 1) and daughter vessel intraluminal patency on 6-month follow-up catheter angiography.CONCLUSIONSThe authors' early experience with the PulseRider device demonstrates that it is a safe and effective adjunct in the treatment of bifurcation aneurysms with wide necks arising at the middle cerebral artery bifurcation, anterior cerebral artery, basilar apex, and carotid terminus. It works by providing a scaffold at the neck of the bifurcation aneurysm, enabling neck remodeling and coil support while maintaining parent vessel intraluminal patency. Early clinical and radiological follow-up showed good functional outcome and stable occlusion rates, respectively. Further data are needed to assess medium- and long-term outcomes with PulseRider.

2020 ◽  
Vol 133 (6) ◽  
pp. 1756-1765 ◽  
Author(s):  
Visish M. Srinivasan ◽  
Aditya Srivatsan ◽  
Alejandro M. Spiotta ◽  
Benjamin K. Hendricks ◽  
Andrew F. Ducruet ◽  
...  

OBJECTIVETraditionally, 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.METHODSThis 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.RESULTSA 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 device-related 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.CONCLUSIONSPulseRider 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.


2016 ◽  
Vol 9 (3) ◽  
pp. 311-315 ◽  
Author(s):  
R Fahed ◽  
J C Gentric ◽  
I Salazkin ◽  
G Gevry ◽  
J Raymond ◽  
...  

BackgroundFlow diverters (FDs) are increasingly used for bifurcation aneurysms. Failure of aneurysm occlusion may be caused by residual flow maintaining patency of the jailed branch along with the aneurysm. Our aim was to test whether endovascular occlusion of the jailed branch could improve efficacy of flow diversion of bifurcation aneurysms.Materials and methodsSixteen wide-necked lingual–carotid artery bifurcation aneurysms were created in eight canines. Patent aneurysms were randomly allocated 4 weeks later to flow diversion combined with jailed branch occlusion using coils and/or Onyx (n=6) or flow diversion alone (n=8). Angiographic results of aneurysm occlusion at 3 months were scored using an ordinal scale. Pathology specimens were photographed and neointimal coverage estimated using a semiquantitative scoring system.ResultsFourteen aneurysms were patent at 1 month. FD deployment was successful in all cases but, at 3-month follow-up, three devices had prolapsed into the aneurysm. None of the bifurcation aneurysms treated with FD alone were occluded at 3 months. Endovascular branch occlusion combined with flow diversion significantly improved aneurysm occlusion rates compared with flow diversion alone (median angiographic scores 2 vs 0: p=0.0137). Flow-limiting parent vessel stenosis was not observed in any arteries. Devices were covered with thick neointima in most cases, but patent aneurysms were associated with leaks or holes in the neointima covering the aneurysm neck.ConclusionsTreatment failures following flow diversion of bifurcation aneurysms can be caused by persistent flow to the jailed branch. Branch occlusion combined with flow diversion may improve angiographic occlusion scores of a canine bifurcation aneurysm model.


2018 ◽  
Vol 24 (3) ◽  
pp. 246-253 ◽  
Author(s):  
Alejandro Santillan ◽  
Srikanth Boddu ◽  
Justin Schwarz ◽  
Ning Lin ◽  
Y Pierre Gobin ◽  
...  

Background and purpose This retrospective study evaluates the safety, effectiveness, and long-term clinical and angiographic follow-up of intracranial aneurysms treated with the Low-Profile Visualized Intraluminal Support Junior (LVIS Jr.) stent and parent vessels of diameter equal to or less than 2.5 mm. Materials and methods We included all patients treated with the LVIS Jr. stent in aneurysms with small parent vessel diameter between March 2015 and July 2017. Periprocedural adverse events, immediate aneurysm occlusion rates, and clinical and angiographic follow-up are reported. Results A total of 35 patients with 35 aneurysms were included. Ten aneurysms were ruptured (28.6%) and 25 were unruptured (71.4%). The parent arteries measured 0.9 mm to 2.5 mm in diameter (mean, 2.2 mm). Intra-procedural thromboembolic complications occurred in four patients (11.4%) and there was an intraoperative aneurysm rupture in one patient (2.8%). Immediate complete aneurysm occlusion was noted in 21 out of 35 patients (60%). Clinical follow-up ranged between one and 25 months (mean, 10.5 months) and magnetic resonance angiography follow-up ranged between four and 24 months (mean, 10.4 months). Complete aneurysm occlusion was achieved in 21 out of 29 patients (72.4%) at last angiographic follow-up (mean, 9.4 months; range four to 23 months). In-stent stenosis occurred in one out of 29 patients (3.4%), who was asymptomatic. Of the four patients with in-stent thrombosis, three patients were treated with “Y configuration” (two patients with middle cerebral artery aneurysms and one patient with an anterior communicating artery aneurysm). Mortality rate was 0%. Neurological morbidity was 2.9%. Conclusions Stenting with the LVIS Jr. stent allowed us to treat complex intracranial aneurysms with parent vessel diameter of 2.5 mm or less with an acceptable safety profile.


2019 ◽  
Vol 32 (5) ◽  
pp. 353-365 ◽  
Author(s):  
Marius G Kaschner ◽  
Bastian Kraus ◽  
Athanasios Petridis ◽  
Bernd Turowski

IntroductionBlister and dissecting aneurysms may have a different pathological background but they are commonly defined by instability of the vessel wall and bear a high risk of fatal rupture and rerupture. Lack of aneurysm sack makes treatment challenging.PurposeThe purpose of this study was to assess the safety and feasibility of endovascular treatment of intracranial blister and dissecting aneurysms.MethodsWe retrospectively analysed all patients with ruptured and unruptured blister and dissecting aneurysms treated endovascularly between 2004–2018. Procedural details, complications, morbidity/mortality, clinical favourable outcome (modified Rankin Scale ≤2) and aneurysm occlusion rates were assessed.ResultsThirty-four patients with endovascular treatment of 35 aneurysms (26 dissecting aneurysms and 9 blister aneurysms) were included. Five aneurysms were treated by parent vessel occlusion, and 30 aneurysms were treated by vessel reconstruction using stent monotherapy ( n = 9), stent-assisted coiling ( n = 7), flow diverting stents ( n = 13) and coiling + Onyx embolization ( n = 1). No aneurysm rebleeding and no procedure-related major complications or deaths occurred. There were five deaths in consequence of initial subarachnoid haemorrhage. Complete occlusion (79.2%) was detected in 19/24 aneurysms available for angiographic follow-up, and aneurysm recurrence in 2/24 (8.3%). The modified Rankin Scale ≤2 rate at mean follow-up of 15.1 months was 64.7%.ConclusionTreatment of blister and dissecting aneurysms developed from coil embolization to flow diversion with multiple stents to the usage of flow diverting stents. Results using modern flow diverting stents encourage us to effectively treat this aneurysm entity endovascularly by vessel reconstruction. Therefore, we recommend preference of vessel reconstructive techniques to parent vessel occlusion.


2018 ◽  
Vol 22 (5) ◽  
pp. 532-540 ◽  
Author(s):  
Geoffrey P. Colby ◽  
Bowen Jiang ◽  
Matthew T. Bender ◽  
Narlin B. Beaty ◽  
Erick M. Westbroek ◽  
...  

Intracranial aneurysms in the pediatric population are rare entities. The authors recently treated a 9-month-old infant with a 19-mm recurrent, previously ruptured, and coil-embolized left middle cerebral artery (MCA) pseudoaneurysm, which was treated definitively with single-stage Pipeline-assisted coil embolization. The patient was 5 months old when she underwent resection of a left temporal Grade 1 desmoplastic infantile ganglioglioma at an outside institution, which was complicated by left MCA injury with a resultant 9-mm left M1 pseudoaneurysm. Within a month, the patient had two aneurysmal rupture events and underwent emergency craniectomy for decompression and evacuation of subdural hematoma. The pseudoaneurysm initially underwent coil embolization; however, follow-up MR angiography (MRA) revealed aneurysm recanalization with saccular enlargement to 19 mm. The patient underwent successful flow diversion–assisted coil embolization at 9 months of age. At 7 months after the procedure, follow-up MRA showed complete aneurysm occlusion without evidence of in-stent thrombosis or stenosis. Experience with flow diverters in the pediatric population is still in its early phases, with the youngest reported patient being 22 months old. In this paper the authors report the first case of such a technique in an infant, whom they believe to be the youngest patient to undergo cerebral flow diversion treatment.


2019 ◽  
Vol 11 (9) ◽  
pp. 903-907 ◽  
Author(s):  
Christopher T Primiani ◽  
Zeguang Ren ◽  
Peter Kan ◽  
Ricardo Hanel ◽  
Vitor Mendes Pereira ◽  
...  

BackgroundIntracranial aneurysms located in the distal vessels are rare and remain a challenge to treat through surgical or endovascular interventions.ObjectiveTo describe a multicenter approach with flow diversion using the pipeline embolization device (PED) for treatment of distal intracranial aneurysms.MethodsCases of distal intracranial aneurysms defined as starting on or beyond the A2 anterior cerebral artery, M2 middle cerebral artery, and P2 posterior cerebral artery segments were included in the final analysis.Results65 patients with distal aneurysms treated with the PED were analyzed. Median aneurysm size at the largest diameter was 7.0 mm, 60% were of a saccular morphology, and 9/65 (13.8%) patients presented in the setting of acute rupture. Angiographic follow-up data were available for 53 patients, with a median follow-up time of 6 months: 44/53 (83%) aneurysms showed complete obliteration, 7/53 (13.2%) showed reduced filling, and 2/53 (3%) showed persistent filling. There was no association between patient characteristics, including aneurysm size (P=0.36), parent vessel diameter (P=0.27), location (P=0.81), morphology (P=0.63), ruptured status on admission (P=0.57), or evidence of angiographic occlusion at the end of the embolization procedure (P=0.49). Clinical outcome data were available for 60/65 patients: 95% (57/60) had good clinical outcome (modified Rankin Scale score of 0–2) at 3 months.ConclusionsThis large multicenter study of patients with A2, M2, and P2 distal aneurysms treated with the PED showed that flow diversion may be an effective treatment approach for this rare type of vascular pathology. The procedural compilation rate of 7.7% indicates the need for further studies as the flow diversion technology constantly evolves.


2020 ◽  
pp. 159101992094052 ◽  
Author(s):  
Raymond Pranata ◽  
Emir Yonas ◽  
Rachel Vania ◽  
Prijo Sidipratomo ◽  
Julius July

Objective PulseRider is a novel self-expanding nickel-titanium (nitinol) stent for treatment of wide-necked aneurysms, which is commonly located at the arterial branches in the brain. This systematic review and meta-analysis aims to assess the efficacy and safety of PulseRider for treatment of wide-necked intracranial aneurysm. Method We performed a systematic literature search on articles that evaluate the efficacy and safety of PulseRider-assisted coiling of the wide-necked aneurysm from several electronic databases. The primary endpoint was adequate occlusion, defined as Raymond-Roy Class I + Raymond-Roy Class II upon immediate angiography and at six-month follow-up. Results There were a total of 157 subjects from six studies. The rate of adequate occlusion on immediate angiography was 90% (95% CI, 85%–94%) and 91% (95% CI, 85%–96%) at six-month follow-up. Of these, Raymond-Roy Class I can be observed in 48% (95% CI, 41%–56%) of aneurysms immediately after coiling, and 64% (95% CI, 55%–72%) of aneurysms on six-month follow-up. Raymond-Roy Class II was found in 30% (95% CI, 23%–37%) of aneurysms immediately after coiling, and 25% (17–33) after six-month follow-up. Complications occur in 5% (95% CI, 1%–8%) of the patients. There were three intraoperative aneurysm rupture, three thrombus formation, three procedure-related posterior cerebral artery strokes, one vessel dissection, and one delayed device thrombosis. There was no procedure/device-related death. Conclusions PulseRider-assisted coiling for treatment of patients with wide-necked aneurysm reached 90% adequate occlusion rate that rises up to 91% at sixth month with 5% complication rate.


2018 ◽  
Vol 128 (4) ◽  
pp. 1028-1031
Author(s):  
Rafael Martinez-Perez ◽  
David M. Pelz ◽  
Stephen P. Lownie

The objective of this paper was to report a rare complication of basilar artery (BA) tourniquet treatment of a giant basilar tip aneurysm, and to discuss possible causes for the formation of a de novo giant posterior cerebral artery (PCA) aneurysm. A 34-year-old woman underwent satisfactory treatment of a ruptured giant basilar bifurcation aneurysm by BA ligation (Drake tourniquet) in 1985. She presented 25 years later with a new aneurysm in the left PCA, successfully treated by coil embolization. To the authors’ knowledge, this is the first case of de novo aneurysm formation on a PCA, and the first de novo aneurysm reported as a complication of BA ligation therapy by Drake tourniquet. Long-term follow-up is necessary in patients with treated cerebral aneurysms, particularly those occurring in young patients, those with multiple aneurysms, those with complex posterior circulation aneurysms, and those undergoing flow diversion or flow-altering therapies.


2014 ◽  
Vol 8 (1) ◽  
pp. 30-37 ◽  
Author(s):  
Ramsey Ashour ◽  
Stephen Dodson ◽  
M Ali Aziz-Sultan

BackgroundIntracranial blister aneurysms are rare lesions that are notoriously more difficult to treat than typical saccular aneurysms. High complication rates associated with surgery have sparked considerable interest in endovascular techniques, though not well-studied, to treat blister aneurysms.ObjectiveTo evaluate our experience using various endovascular approaches to treat blister aneurysms.MethodsAll consecutive blister aneurysms treated using an endovascular approach by the study authors over a 3-year period were retrospectively analyzed. A literature review was also performed.ResultsNine patients with blister aneurysms underwent 11 endovascular interventions. In various combinations, stents were used in 8/11, coils in 5/11, and Onyx in 3/11 procedures. At mean angiographic follow-up of 200 days, 8/9 aneurysms were completely occluded by endovascular means alone requiring no further treatment and 1/9 aneurysms required surgical bypass/trapping after one failed surgical and two failed endovascular treatments. At mean clinical follow-up of 416 days, modified Rankin Scale scores were improved in six patients, stable in two, and worsened in one patient. One complication occurred in 11 procedures (9%), resulting in a permanent neurologic deficit. No unintended endovascular parent vessel sacrifice, intraprocedural aneurysmal ruptures, antiplatelet-related complications, post-treatment aneurysmal re-ruptures, or deaths occurred.ConclusionThis series highlights both the spectrum and limitations of endovascular techniques currently used to treat blister aneurysms, including a novel application of stent-assisted Onyx embolization. Long-term follow-up and experience in larger studies are required to better define the role of endovascular therapy in the management of these difficult lesions.


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