Çekirge, Saruhan

Background The anterior communicating artery (AComm) region is the most common site of intracranial aneurysms, with increased rupture risk compared with other locations. Overall, flow diverters present as a safe and efficacious treatment for intracranial aneurysms, but there is paucity of data for their use in the treatment of unruptured AComm aneurysms. We present the largest multicentric analysis evaluating the outcomes of flow diverters in AComm aneurysm treatment. Methods Databases from 10 centers were retrospectively reviewed for unruptured AComm aneurysms treated with flow diverters. Demographics, clinical presentation, radiographic characteristics, procedural complications, and outcomes were assessed. Results A total of 144 patients harboring 147 AComm aneurysms were treated between January 2012 and December 2021. Seventy-four were women (51.4%) and median age was 60 (IQR 50–67) years. All were unruptured AComm aneurysms. Half of the cohort had similar anterior cerebral artery sizes (51.4%). The most common morphology was saccular (94.6%), with a branch involvement in 32.7% of cases. Median vessel diameter was 2.4 mm, and the Pipeline Flex was the most prevalent device (32.7%). Median follow-up time was 17 months, with complete occlusion in 86.4% at the last follow-up. Functional independence (modified Rankin Scale score 0–2) was reported in 95.1%. Intraprocedural complications occurred in 5.6%, and postoperative complications were noted in 9.7% of cases. Combined major complication and mortality rate was 2.1%. Conclusions Our study suggests that flow diverters are a useful treatment for AComm aneurysms. Mid-term results indicated favorable aneurysm occlusion with a good safety profile. Additional prospective studies with longer follow-up periods and independent adjudication are warranted to better assess these results.

Abstract BACKGROUND The safety of Pipeline TM Embolization Device (PED; Medtronic Inc, Dublin, Ireland) in posterior circulation aneurysms is still controversial. OBJECTIVE To study complications associated with the treatment of posterior circulation aneurysms by conducting a subgroup analysis from the International Retrospective Study of PED registry. METHODS Data from 91 consecutive patients with 95 posterior circulation aneurysms at 17 centers between July 2008 to February 2013 were analyzed. The primary endpoint was defined as any complication leading to neurological morbidity or death. The outcome predictors were calculated using Kaplan–Meier and Cox regression methods. RESULTS The mean aneurysm size was 13.8 mm. Aneurysm types were saccular (36.8%), fusiform (29.5%), dissecting (28.4%), and others (5.3%). The median follow-up was 21.1 mo. Twelve (13.2%) patients encountered a primary endpoint event. In multivariate analysis for the primary endpoint, use of ≥3 PEDs and fusiform shape compared with other shapes had hazard ratios (HRs) of 7.77 (95% confidence interval [CI], 2.48-25.86; P = .0007) and 3.48 (95% CI, 1.06-13.39; P = .0488), respectively. The multivariate HR of aneurysm size for neurological morbidity after PED implantation was 1.11 (95% CI, 1.04-1.18; P = .0015), and HRs of ruptured aneurysm and age for neurological mortality were 8.1 (95% CI, 1.31-41.26; P = .0197) and 1.07 (95% CI, 1.02-1.15; P = .0262), respectively. Basilar artery aneurysm had an HR of 3.54 (95% CI, 1.12-14.18, P = .0529) in the univariate analysis for major outcomes. CONCLUSION PED implantation may be considered for the treatment of posterior circulation aneurysms, especially of saccular or dissecting type. Our major complications appear to be comparable to those reported previously after clipping and coiling in the literature. Neurointerventionists should consider the shape, size, rupture, and location of complex posterior circulation aneurysms as well as age and PED number before the PED placement.

The proliferation of new endovascular devices and therapeutic strategies calls for a prudent and rational evaluation of their clinical benefit. This evaluation must be done in an effective manner and in collaboration with industry. Such research initiative requires organisational and methodological support to survive and thrive in a competitive environment. We propose the formation of an international consortium, an academic alliance committed to the pursuit of effective neurovascular therapies. Such a consortium would be dedicated to the design and execution of basic science, device development and clinical trials. The Consortium is owned and operated by its members. Members are international leaders in neurointerventional research and clinical practice. The Consortium brings competency, knowledge, and expertise to industry as well as to its membership across a spectrum of research initiatives such as: expedited review of clinical trials, protocol development, surveys and systematic reviews; laboratory expertise and support for research design and grant applications to public agencies. Once objectives and protocols are approved, the Consortium provides a stable network of centers capable of timely realization of clinical trials or preclinical investigations in an optimal environment. The Consortium is a non-profit organization. The potential revenue generated from client-sponsored financial agreements will be re-directed to the academic and research objectives of the organization. The Consortium wishes to work in concert with industry, to support emerging trends in neurovascular therapeutic development. The Consortium is a realistic endeavour optimally structured to promote excellence through scientific appraisal of our treatments, and to accelerate technical progress while maximizing patients' safety and welfare.

OBJECTIVEThe authors performed a pooled analysis of 3 studies—IntrePED (International Retrospective Study of the Pipeline Embolization Device), PUFS (Pipeline for Uncoilable or Failed Aneurysms Study), and ASPIRe (Aneurysm Study of Pipeline in an Observational Registry)—in order to assess angiographic outcomes and clinical safety of the Pipeline embolization device (PED).METHODSIntrePED was a retrospective study, while PUFS and ASPIRe were prospective studies. For each patient included in these studies, the authors collected baseline demographic data, aneurysm characteristics, and procedural details. The primary outcomes for this combined analysis were clinical outcomes, including neurological morbidity and mortality and major ipsilateral intracranial hemorrhage and ischemic stroke. The secondary outcomes were angiographic occlusion rates, which were available for ASPIRe and PUFS only.RESULTSA total of 1092 patients with 1221 aneurysms were included across the 3 studies. The mean aneurysm size was 12.0 ± 7.8 mm and the mean neck size was 6.6 ± 4.8 mm. The major ipsilateral ischemic stroke rate was 3.7% (40/1091). The major ipsilateral intracranial hemorrhage rate was 2.0% (22/1091). The major neurological morbidity rate was 5.7% (62/1091). The neurological mortality rate was 3.3% (36/1091). The combined major morbidity and neurological mortality rate was 7.1% (78/1091). The complete occlusion rates were 75.0% at 180 days (111/148) and 85.5% at 1 year (94/110). The overall aneurysm retreatment rate was 3.0% (33/1091) at a mean follow-up time of 10.2 ± 10.8 months.CONCLUSIONSEndovascular treatment of intracranial aneurysms with the PED is safe and effective. Angiographic occlusion rates progressed with follow-up. Rates of stroke, hemorrhage, morbidity and mortality, and retreatment were low, especially given the fact that the aneurysms treated were generally large and wide necked.

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 latter event limited to giant aneurysms. Disclosures D. Kallmes: 1; C; MicroVention, Sequent, Benvenue, eV3. 2; C; General Electric, Codman, eV3. E. Boccardi: None. A. Bonafe: None. S. Cekirge: None. D. Fiorella: 2; C; Pipeline proctor, consultant, (<10K, EV3). R. Hanel: None. P. Jabbour: None. E. Levy: None. D. Lopes: 6; C; Receives compensation for training & proctoring for Pipeline devices. P. Lylyk: None. C. McDougall: None. A. Siddiqui: None. I. Szikora: None. H. Woo: None.