Objectives Validated through in vitro and in vivo experimental studies a new generation of flow diverters (Surpass™ FD) was evaluated for treatment of intracranial aneurysms (IA). We present our multicentre preliminary clinical and angiographic experience. Methods To achieve the calculated flow disruption between the parent artery and aneurysm, needed for a saccular thrombosis, single FDs, tailored to local haemodynamics, were placed endovascularly in parent arteries and bridging the aneurysm. Implants measured 2.5-5.3mm in diameter with a length of10–80mm. Enrolled were patients harbouring a wide range of non-acutely ruptured large and giant wide-neck, fusiform and multiple small aneurysms, blister-type aneurysms and aneurysms associated with segmental artery disease. All patients were pretreated with dual antiplatelet for at least 72 hours before surgery and continued on both agents for at least 3 months after treatment. Clinical and angiographic follow-up were typically performed at 1–3, 6, and 12 months. Results A total of 186 consecutive IA in 161 patients (mean age 57.1 years, range 28–82 years; 71% female) were treated at 23 centres. Fifty-three aneurysms were smaller than 5 mm, 64 were 5–9.9mm in diameter, 47 were10–20mm in diameter, and 22 were larger than 20mm (aneurysm diameter 10.4 ± 0.7mm, neck size 6.0 ± 0.5mm [mean ± SEM]). The aneurysms originated in 63.4% of the cases from the internal carotid artery; in 22% and 14.5% of the cases they were located in the anterior circulation distal to Circle of Willis and posterior circulation respectively. Technical success was achieved in 182 aneurysms (98%); incorrect FD placement with partial aneurysm coverage was observed in 5 aneurysms (2.7%). FDs were placed over 4 previously placed stents for coil embolisation; average number of devices used per aneurysm was 1.05. Permanent morbidity and mortality during the follow-up period of 8.7 months (range 1–24 months) including periprocedural complications were encountered in 5/134 (3.7%) and 2/134 (1.5%) of patients, respectively, within aneurysms of the anterior circulation; and 1/27 (3.7%) and 4/27 (14.8%) of patients, respectively, with posterior circulation aneurysm (one patient died from cancer, two patients died of pneumonia). Ninety-seven patients (60%) with 112 aneurysms were available for clinical and angiographic follow-up. Progressive thrombosis with complete occlusion was seen in 71% of aneurysms of the anterior circulation and 64% of aneurysms located distal to Circle of Willis and in 72% of aneurysms of the posterior circulation and included cases with improper device placement or FD covering previous stents. Occlusion in the range of range 95–100% was seen in 79%, 68% and 89% of aneurysms of the anterior circulation, aneurysms located distal to Circle of Willis and posterior circulation respectively. Conclusion Preliminary data demonstrate high safety and effectiveness profile of a new generation of FD for a wide range of IA of the anterior and posterior circulation without the need for coil...
Purpose To determine the rates of neurologic adverse events following Pipeline Embolic Device (PED) placement for intracranial aneurysm treatment. Methods A retrospective review of medical records was performed at 19 centres to identify consecutive intracranial aneurysms treated with the PED following regulatory approval for marketing the device in the given country. All patients in whom at least one PED was placed and in whom follow-up was available prior to IRB or ethics panel approval were enrolled. Three anatomic/size subgroups were defined, including 1) pre-PComm, internal carotid artery aneurysms 10mm or greater (“large ICA”), 2) ICA aneurysms >10mm and/or at/distal to the PComm region (“other anterior circulation”), and 3) posterior circulation aneurysms. “Primary safety events” included stroke, haemorrhage, parent artery stenosis, permanent cranial neuropathy, and spontaneous rupture of the target aneurysm. Severe safety events were defined as any event causing significant impairment of functioning causing the inability of the subject to carry out usual activities. Statistical analysis was performed using standard summary statistics; p-values comparing subgroups were computed using Pearson's chi-square test for discrete variables and analysis of variance for continuous variables. Results To date, 580 aneurysms, including 183 large ICA, 344 other anterior circulation, and 53 posterior circulation aneurysms have been treated and followed for a mean duration of 7.8 months (SD 7.3, range 0.1 - 40.8). 437 (76%) of 580 aneurysms were saccular and 80 (14%) were fusiform; 32 (5.5%) were classified as giant (<25mm diameter). 549 (93%) were unruptured. 241 (42%) were treated with multiple PEDs. Primary safety events were noted in 62 (12%) cases. Severe neurological events occurred in 35 (6.8%) cases, and occurred more frequently in posterior circulation aneurysms (7 (13%)) than in either large ICA or other anterior circulation aneurysms (15 (8.8%) and (13 (4.5%), respectively, p=.035). Major stroke occurred in 20 (3.9%) of 515 subjects (4.1%, 3.1%, and 7.5% in large ICA, other anterior circulation, and posterior circulation aneurysms, respectively, p=.31). Ipsilateral intracranial haemorrhage occurred in 12 (2.3%) subjects (3.5%, 1.7%, and 1.9% in large ICA, other anterior circulation, and posterior circulation aneurysms, respectively, p=.47). Spontaneous aneurysm rupture occurred in 3 (0.6%) aneurysms, all of which were giant, resulting in a 9% incidence of rupture in giant aneurysms. Mortality rate was 4.3% and was significantly higher for posterior circulation aneurysms (11.3%) as compared to anterior circulation aneurysms (3.5%, p=.019). Conclusions Preliminary data indicates that in approximately 7% of aneurysms treated with PED, substantial neurologic complications occurred, with rates of both severe neurologic events and mortality occurring significantly higher in the posterior as compared to the anterior circulation. Both ipsilateral haemorrhage and spontaneous aneurysm rupture were rare, with the la...
IntroductionWe present the in vitro and first clinical results of a novel aneurysm neck reconstruction device specifically designed to treat bifurcation aneurysms.MethodThe Pulsar Vascular Aneurysm Neck Reconstruction Device (ANRD) is a T-shaped, self-expanding, permanent implant made of nitinol with a uniquely open architecture that maintains the luminal patency of two bifurcation branches while holding a coil mass in place in the aneurysm. Utilizing in vitro aneurysm models, the following design aspects of the ANRD were optimized prior to first-in-man (FIM) use: number of nitinol struts, location of radiopaque markers, ability to position and reposition the device, pushability and microcatheter compatibility. Once the design of the ANRD was optimized and the safe delivery technique was established, the first clinical case was performed. Inclusion criteria for FIM cases includes unruptured, wide-necked intracranial aneurysms located at the basilar tip or carotid terminus with a diameter of the basilar or carotid artery appropriate for the device sizes available. FIM candidate cases were reviewed and approved by scientific advisory board members as well as the operator prior to the procedure. Clinical use of the ANRD was approved on a case-by-case basis.ResultsUnder fluoroscopic guidance, ANRDs of various sizes and designs were deployed in two basilar tip aneurysm models. The final version of the ANRD could be safely deployed in the models and the operator could steer the T-shaped device into both posterior cerebral arteries (PCAs). Following extensive in vitro testing and animal studies, the ANRD was successfully deployed in the first clinical cases. The FIM case was a female with an incidental basilar tip aneurysm, projecting anteriorly, measuring 10.3 mm in the largest diameter and 7.3 mm in the neck. Both PCAs were incorporated in the base of the aneurysm. One ANRD was delivered via a Marksman microcatheter and successfully placed at the neck of the basilar tip aneurysm. Coiling procedure was performed immediately after the placement of the ANRD. Immediate post coiling angiogram showed the tight packing of the aneurysm and the patency of both PCAs. The ANRD was stable during the coiling procedure without any radiographic signs of proximal migration by the pressure of the coil mass.ConclusionThe Pulsar Vascular ANRD provides excellent support to achieve tight coil packing in bifurcation wide-necked aneurysms. The FIM experience demonstrates the safety and feasibility of the ANRD concept. Results in the first group of patients including follow-up will be presented.Competing interestsS Tateshima: Pulsar Vascular. A Turk: Pular Vascular. R Ceratto: None. A Ferrario: None. P Lylyk: None.Abstract O-013 Figure 1
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