E. Boccardi

International Retrospective Study of the Pipeline Embolization Device: A Multicenter Aneurysm Treatment Study

BACKGROUND AND PURPOSE: Flow diverters are increasingly used in the endovascular treatment of intracranial aneurysms. Our aim was to determine neurologic complication rates following Pipeline Embolization Device placement for intracranial aneurysm treatment in a real-world setting. MATERIALS AND METHODS: We retrospectively evaluated all patients with intracranial aneurysms treated with the Pipeline Embolization Device between July 2008 and February 2013 in 17 centers worldwide. We defined 4 subgroups: internal carotid artery aneurysms of ≥10 mm, ICA aneurysms of <10 mm, other anterior circulation aneurysms, and posterior circulation aneurysms. Neurologic complications included spontaneous rupture, intracranial hemorrhage, ischemic stroke, permanent cranial neuropathy, and mortality. Comparisons were made with t tests or ANOVAs for continuous variables and the Pearson χ2 or Fisher exact test for categoric variables. RESULTS: In total, 793 patients with 906 aneurysms were included. The neurologic morbidity and mortality rate was 8.4% (67/793), highest in the posterior circulation group (16.4%, 9/55) and lowest in the ICA <10-mm group (4.8%, 14/294) (P = .01). The spontaneous rupture rate was 0.6% (5/793). The intracranial hemorrhage rate was 2.4% (19/793). Ischemic stroke rates were 4.7% (37/793), highest in patients with posterior circulation aneurysms (7.3%, 4/55) and lowest in the ICA <10-mm group (2.7%, 8/294) (P = .16). Neurologic mortality was 3.8% (30/793), highest in the posterior circulation group (10.9%, 6/55) and lowest in the anterior circulation ICA <10-mm group (1.4%, 4/294) (P < .01). CONCLUSIONS: Aneurysm treatment with the Pipeline Embolization Device is associated with the lowest complication rates when used to treat small ICA aneurysms. Procedure-related morbidity and mortality are higher in the treatment of posterior circulation and giant aneurysms.

Italian multicenter experience with flow-diverter devices for intracranial unruptured aneurysm treatment with periprocedural complications—a retrospective data analysis

IntroductionWe report the experiences of 25 Italian centers, analyzing intra- and periprocedural complications of endovascular treatment of intracranial aneurysms using Silk (Balt Extrusion, Montmorency, France) and pipeline embolization devices (EV3 Inc, Irvine California).MethodsTwo hundred seventy-three patients with 295 cerebral aneurysms, enrolled in 25 centers in Italy and treated with the new flow-diverter devices, were evaluated; 142 patients were treated with Silk and 130 with pipeline (in one case, both devices were used). In 14 (5.2xa0%) cases devices were used with coils. Aneurysm size was >15xa0mm in 46.9xa0%, 5–15xa0mm in 42.2xa0%, and <5xa0mm in 10.8xa0%. Aneurysm locations were supraclinoid internal carotid artery (ICA) in 163 cases (55.2xa0%), cavernous ICA in 76 (25.7xa0%), middle cerebral artery in 11 (3.7xa0%), PCoA in 6 (2xa0%), and ACoA in 2 (0.7xa0%); the vertebrobasilar system accounted for 32 cases (10.8xa0%) and PCA in 5 (1.7xa0%).ResultsTechnical adverse events occurred with 59 patients (21.6xa0%); 5 patients died after ischemic events, 10 to hemorrhagic complications, and 1 from external ventricular drain positioning. At 1xa0month, morbidity and mortality rates were 3.7xa0% and 5.9xa0%, respectivelyConclusionOur retrospective study confirms that morbidity and mortality rates in treatment with FDD of unruptured wide-neck or untreatable cerebral aneurysms do not differ from those reported in the largest series.

Surpass Flow Diverter in the Treatment of Intracranial Aneurysms: A Prospective Multicenter Study

BACKGROUND AND PURPOSE: Incomplete occlusion and recanalization of large and wide-neck brain aneurysms treated by endovascular therapy remains a challenge. We present preliminary clinical and angiographic results of an experimentally optimized Surpass flow diverter for treatment of intracranial aneurysms in a prospective, multicenter, nonrandomized, single-arm study. MATERIALS AND METHODS: At 24 centers, 165 patients with 190 intracranial aneurysms of the anterior and posterior circulations were enrolled. The primary efficacy end point was the percentage of intracranial aneurysms with 100% occlusion on 6-month DSA. The primary safety end point was neurologic death and any stroke through a minimum follow-up of 6 months. RESULTS: Successful flow-diverter delivery was achieved in 161 patients with 186 aneurysms (98%); the mean number of devices used per aneurysm was 1.05. Clinical follow-up (median, 6 months) of 150 patients (93.2%), showed that the primary safety end point occurred in 18 subjects. Permanent neurologic morbidity and mortality were 6% and 2.7%, respectively. Morbidity occurred in 4% and 7.4% of patients treated for aneurysms of the anterior and posterior circulation, respectively. Neurologic death during follow-up was observed in 1.6% and 7.4% of patients with treated intracranial aneurysms of the anterior and posterior circulation, respectively. Ischemic stroke at ≤30 days, SAH at ≤7 days, and intraparenchymal hemorrhage at ≤7 days were encountered in 3.7%, 2.5%, and 2.5% of subjects, respectively. No disabling ischemic strokes at >30 days or SAH at >7 days occurred. New or worsening cranial nerve deficit was observed in 2.7%. Follow-up angiography available in 158 (86.8%) intracranial aneurysms showed 100% occlusion in 75%. CONCLUSIONS: Clinical outcomes of the Surpass flow diverter in the treatment of intracranial aneurysms show a safety profile that is comparable with that of stent-assisted coil embolization. Angiographic results showed a high rate of intracranial aneurysm occlusion.

Aneurysm Study of Pipeline in an Observational Registry (ASPIRe)

Background and Objective: Few prospective studies exist evaluating the safety and efficacy of the Pipeline Embolization Device (PED) in the treatment of intracranial aneurysms. The Aneurysm Study of Pipeline In an observational Registry (ASPIRe) study prospectively analyzed rates of complete aneurysm occlusion and neurologic adverse events following PED treatment of intracranial aneurysms. Materials and Methods: We performed a multicenter study prospectively evaluating patients with unruptured intracranial aneurysms treated with PED. Primary outcomes included (1) spontaneous rupture of the Pipeline-treated aneurysm; (2) spontaneous nonaneurysmal intracranial hemorrhage (ICH); (3) acute ischemic stroke; (4) parent artery stenosis, and (5) permanent cranial neuropathy. Secondary endpoints were (1) treatment success and (2) morbidity and mortality at the 6-month follow-up. Vascular imaging was evaluated at an independent core laboratory. Results: One hundred and ninety-one patients with 207 treated aneurysms were included in this registry. The mean aneurysm size was 14.5 ± 6.9 mm, and the median imaging follow-up was 7.8 months. Twenty-four aneurysms (11.6%) were small, 162 (78.3%) were large and 21 (10.1%) were giant. The median clinical follow-up time was 6.2 months. The neurological morbidity rate was 6.8% (13/191), and the neurological mortality rate was 1.6% (3/191). The combined neurological morbidity/mortality rate was 6.8% (13/191). The most common adverse events were ischemic stroke (4.7%, 9/191) and spontaneous ICH (3.7%, 7/191). The complete occlusion rate at the last follow-up was 74.8% (77/103). Conclusions: Our prospective postmarket study confirms that PED treatment of aneurysms in a heterogeneous patient population is safe with low rates of neurological morbidity and mortality. Patients with angiographic follow-up had complete occlusion rates of 75% at 8 months.

Risk Factors for Ischemic Complications following Pipeline Embolization Device Treatment of Intracranial Aneurysms: Results from the IntrePED Study

This is a retrospective subanalysis of the IntrePED study, which has beenpreviously published (AJNR Am J Neuroradiol 2015;36:108–15).Seven hundred ninety-three patients with 906 treated aneurysms were enrolled. Thirty-six (4.5%) patients had postoperative acute ischemic stroke, 21 of which occurred within 1 week of the procedure. There was no difference in the rate of acute stroke between the anterior and posterior circulations. Stroke rate was 3% in patients with 1 PED, and 7% in those with 2 PEDs. With multivariate analysis, the only variable independently associated with postoperative stroke was treatment of fusiform aneurysms. Among the patients with stroke, 10 (27.0%) died and 26 (73.0%) had major neurologic morbidity. The authors conclude that acute ischemic stroke following treatment of intracranial aneurysms with the PED is an uncommon but devastating complication, with 100% of patients having major morbidity or mortality. BACKGROUND AND PURPOSE: Risk factors for acute ischemic stroke following flow-diverter treatment of intracranial aneurysms are poorly understood. Using the International Retrospective Study of Pipeline Embolization Device (IntrePED) registry, we studied demographic, aneurysm, and procedural characteristics associated with postoperative acute ischemic stroke following Pipeline Embolization Device (PED) treatment. MATERIALS AND METHODS: We identified patients in the IntrePED registry with post-PED-treatment acute ischemic stroke. The rate of postoperative acute ischemic stroke was determined by demographics, comorbidities, aneurysm characteristics, and procedure characteristics (including anticoagulation use, platelet testing, number of devices used, sheaths, and so forth). Categoric variables were compared with χ2 testing, and continuous variables were compared with the Student t test. Odds ratios and 95% confidence intervals were obtained by using univariate logistic regression. Multivariate logistic regression analysis was used to determine which factors were independently associated with postoperative stroke. RESULTS: Of 793 patients with 906 aneurysms, 36 (4.5%) patients had acute ischemic stroke. Twenty-six (72.2%) strokes occurred within 30 days of treatment (median, 3.5 days; range, 0–397 days). Ten patients died, and the remaining 26 had major neurologic morbidity. Variables associated with higher odds of acute ischemic stroke on univariate analysis included male sex, hypertension, treatment of MCA aneurysms, treatment of fusiform aneurysms, treatment of giant aneurysms, and use of multiple PEDs. However, on multivariate analysis, the only one of these variables independently associated with stroke was treatment of fusiform aneurysms (OR, 2.74; 95% CI, 1.11–6.75; P = .03). Fusiform aneurysms that were associated with stroke were significantly larger than those not associated with stroke (mean, 24.5 ± 12.5 mm versus 13.6 ± 6.8 mm; P < .001). CONCLUSIONS: Ischemic stroke following PED treatment is an uncommon-but-devastating complication. Fusiform aneurysms were the only variable independently associated with postoperative stroke.

Pipeline Embolization Device with or without Adjunctive Coil Embolization: Analysis of Complications from the IntrePED Registry

SUMMARY: Flow diversion to treat cerebral aneurysms has revolutionized neurointerventional surgery. Because the addition of coils potentially increases the time and complexity of endovascular procedures, we sought to determine whether adjunctive coil use is associated with an increase in complications. Patients in the International Retrospective Study of Pipeline Embolization Device registry were divided into those treated with the Pipeline Embolization Device alone (n = 689 patients; n = 797 aneurysms; mean aneurysm size, 10.3 ± 7.6 mm) versus those treated with the Pipeline Embolization Device and concurrent coil embolization (n = 104 patients; n = 109 aneurysms; mean aneurysm size, 13.6 ± 7.8 mm). Patient demographics and aneurysm characteristics were examined. Rates of neurologic morbidity and mortality were compared between groups. The Pipeline Embolization Device with versus without coiling required a significantly longer procedure time (135.8 ± 63.9 versus 96.7 ± 46.2 min; P < .0001) and resulted in higher neurological morbidity (12.5% versus 7.8%; P = .13). These data suggest that either strategy represents an acceptable risk profile in the treatment of complex cerebral aneurysms and warrants further investigation.

O-008 A New Generation of Flow Diverters for Endovascular Treatment of Intracranial Aneurysms - A Multicentre Preliminary Clinical and Angiographic Experience in 161 patients with 186 Aneurysms

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 coiling. Durability and high rate of progressive occlusion observed requires long-term follow-up studies. Disclosures A. Wakhloo: 2; C; Surpass Medical/Stryker. 4; C; Surpass Medical. 5; C; Surpass Medical. P. Lylyk: None. J. De Vries: 1; C; Surpass/Stryker. A. Biondi: 2; C; Surpass Medical/Stryker. C. Taschner: 2; C; Surpass Medical/Stryker. M. Hartmann: None. I. Szikora: None. L. Pierot: None. N. Sakai: None. N. Sourour: 2; C; Surpass Medical/Stryker. I. Rennie: None. M. Skalej: None. F. Mery: None. F. Turjman: None. P. Brouwer: None. E. Boccardi: None. M. Gounis: 2; C; Surpass Medical. T. Surpass User Group: None.