PipelineTM Embolization Device Research Articles

Abstract TMP3: Long-term Outcomes From The Pipeline Embolization Devices For The Treatment Of Intracranial Aneurysms (PEDESTRIAN) Registry With Ped Shield Sub-analysis

Background: Prospective studies have established the safety and efficacy of the Pipeline TM Embolization Device (PED) for treatment of intracranial aneurysms (IA). Objective: To investigate long-term outcomes from the Pipeline Embolization Devices for the Treatment of Intracranial Aneurysms (PEDESTRIAN) Registry. Methods: The PEDESTRIAN registry data was retrospectively reviewed, which included patients (March 2006-July2019) with complex IAs treated with PED. The primary angiographic endpoint was complete occlusion and long-term stability. Clinical and radiological follow-up was performed at 3-6 months, 12 months, and yearly thereafter. Results: A total of 835 patients (mean age 55.9±14.7 years; 80.0% female) with 1,000 aneurysms were included. Aneurysms varied in size: 64.6% were small (≤10mm), 25.6% were large (11-24mm), and 9.8% were giant (≥25mm). A total of 1,214 PEDs were deployed. Follow-up angiography was available for 85.1% of patients with 776 aneurysms at 24.6±25.0 months (mean). Complete occlusion was demonstrated in 75.8% of aneurysms at 12-months, 92.9% at 2-4 years, and 96.4% at >5 years. During the post-procedural period, mRS remained stable or improved in 96.2% of patients, with stability or improvement in 99.1% of patients >5 years. The overall major morbidity and neurological mortality rate was 5.8%. At multivariate analysis, age (HR 1.04; 95% CI 1.01-1.07, p=0.002) and non-saccular morphology (HR 2.91; 95% CI 1.06-7.97, p=0.038) were identified as independent predictors of mRs worsening. We found a trend towards lower rates of thromboembolic complications since the implementation of prasugrel, with 26 (4.4%) patients on clopidogrel developing stroke compared with 4 (1.6%) patients on prasugrel (OR 2.74; 95% CI 0.95-7.95, p=0.06). Trend towards less thromboembolic complications with PED Shield N= 3/213 (1,4%) OR 0.38 (95% CI o.12; 1.27), p value=0.11 Conclusion: This study demonstrated high rates of long-term complete aneurysm occlusion, stable or improved functional outcomes, and low rates of complications and mortality. Clinical and angiographic outcomes improved over long-term follow-up, demonstrating endovascular treatment of IA with PED is safe and effective.

Pipeline Embolization Devices for the Treatment of Intracranial Aneurysms, Single-Center Registry: Long-Term Angiographic and Clinical Outcomes from 1000 Aneurysms.

BACKGROUNDProspective studies have established the safety and efficacy of the PipelineTM Embolization Device (PED; Medtronic) for treatment of intracranial aneurysms (IA).OBJECTIVETo investigate long-term outcomes from the Pipeline Embolization Devices for the Treatment of Intracranial Aneurysms (PEDESTRIAN) Registry.METHODSThe PEDESTRIAN Registry data were retrospectively reviewed, which included patients (March 2006 to July 2019) with complex IAs treated with PED. Patients with unfavorable anatomy and/or recurrence following previous treatment were included and excluded those with acute subarachnoid hemorrhage. The primary angiographic endpoint was complete occlusion and long-term stability. Clinical and radiological follow-up was performed at 3 to 6 mo, 12 mo, and yearly thereafter.RESULTSA total of 835 patients (mean age 55.9 ± 14.7 yr; 80.0% female) with 1000 aneurysms were included. Aneurysms varied in size: 64.6% were small (≤10 mm), 25.6% were large (11-24 mm), and 9.8% were giant (≥25 mm). A total of 1214 PEDs were deployed. Follow-up angiography was available for 85.1% of patients with 776 aneurysms at 24.6 ± 25.0 mo (mean). Complete occlusion was demonstrated in 75.8% of aneurysms at 12 mo, 92.9% at 2 to 4 yr, and 96.4% at >5 yr. During the postprocedural period, modified Rankin Scale scores remained stable or improved in 96.2% of patients, with stability or improvement in 99.1% of patients >5 yr. The overall major morbidity and neurological mortality rate was 5.8%.CONCLUSIONThis study demonstrated high rates of long-term complete aneurysm occlusion, stable or improved functional outcomes, and low rates of complications and mortality. Clinical and angiographic outcomes improved over long-term follow-up, demonstrating that endovascular treatment of IA with PED is safe and effective.

Abstract MP8: Long Term Angiographic and Clinical Outcomes From 1,000 Aneurysms Treated With the Pipeline Embolization Device

Background and Purpose: Prospective studies have established the safety and efficacy of the Pipeline TM Embolization Device (PED) for the treatment of intracranial aneurysms (IA). Here, we report long-term outcomes from The Pipeline Embolization Devices for the Treatment of Intracranial Aneurysms (PEDESTRIAN) Registry. Methods: This was a retrospective review of prospectively collected data from the PEDESTRIAN registry. Between March 2006 and July 2019, consecutive patients with complex IA were treated with PED at one center in Argentina. Patients with unfavorable anatomy and/or recurrence following previous treatment were included, and those with acute subarachnoid hemorrhage (SAH) were excluded. The primary angiographic endpoint was complete occlusion and long-term stability. Clinical and angiographic follow-up was performed at 3-6 months, 12 months, and yearly thereafter. Results: A total of 835 patients (mean age 55.9±14.7 years; 80% [671/835] female) with 1,000 aneurysms were included. The majority (64.6%) of aneurysms were small (≤10mm), 25.6% were large (11-24mm), and 9.8% were giant (≥25mm). A total of 1,214 PEDs were deployed, with a single device deployed in 84.2% of aneurysms. Follow-up angiography was available for 85.1% of patients with 776 aneurysms at mean 24.6±25.0 months. Complete Raymond Roy I occlusion was demonstrated in 75.8% (588/776) of aneurysms at 12-months, 92.9% (300/323) at 2-4 years, and 96.4% (159/165) at >5 years. During the post-procedural period, mRS remained stable or improved in 96.2% of patients, with stability or improvement in 99.1% of patients in the longer term. The overall major morbidity and neurological mortality rate was 5.8% (44/835), and the all-cause mortality rate was 4.6% (38/835). Conclusions: Endovascular treatment of IA with PED is safe and effective, with rates of complete occlusion, complications, and mortality comparable to previous prospective studies. Serial angiographic follow-up showed high and increasing occlusion rates, with stable occlusion of all cases at 13 years.

Endovascular Reconstruction Utilizing Flow Diversion Stenting in a Patient With Bilateral Giant Cavernous Internal Carotid Artery Aneurysms

Bilateral giant cerebral aneurysms are exceedingly rare. Giant aneurysms of the internal carotid artery (ICA) carry a poor prognosis if untreated. Flow diversion is an endovascular technique whereby a device is placed in the parent blood vessel to divert blood flow away from the aneurysm and is an available treatment for giant aneurysms. A 69-year-old woman presented with progressive diplopia and was found to have bilateral ICA aneurysms. She had stenting of the left ICA aneurysm with improvement of her symptoms and no complications. Five years post procedure, she presented with recurrent diplopia and was found to have enlargement of the previously seen right-sided cavernous ICA aneurysm, which was treated with another flow diversion stent with no complications. Endoluminal reconstruction/flow diversion with Pipeline™ Embolization Device (PED) has emerged as an alternative to traditional endosaccular coiling and parent artery occlusion. We report a case of bilateral cavernous carotid giant aneurysms treated with flow diversion and demonstrate that flow diversion stenting using the PED is a safe and reliable treatment for bilateral giant ICA aneurysms. We encourage interventionists to consider this technique in patients with giant intracranial aneurysms. J Neurol Res. 2020;10(4):136-139 doi: https://doi.org/10.14740/jnr593

The Evolution of Flow-Diverting Stents for Cerebral Aneurysms; Historical Review, Modern Application, Complications, and Future Direction.

In spite of the developing endovascular era, large (15–25 mm) and giant (>25 mm) wide-neck cerebral aneurysms remained technically challenging. Intracranial flow-diverting stents (FDS) were developed to address these challenges by targeting aneurysm hemodynamics to promote aneurysm occlusion. In 2011, the first FDS approved for use in the United States market. Shortly thereafter, the Pipeline of Uncoilable or Failed Aneurysms (PUFS) study was published demonstrating high efficacy and a similar complication profile to other intracranial stents. The initial FDA instructions for use (IFU) limited its use to patients 22 years old or older with wide-necked large or giant aneurysms of the internal carotid artery (ICA) from the petrous segment to superior hypophyseal artery/ophthalmic segment. Expanded IFU was tested in the Prospective Study on Embolization of Intracranial Aneurysms with PipelineTM Embolization Device (PREMIER) trial. With further post-approval clinical data, the United States FDA expanded the IFU to include patients with small or medium, wide-necked saccular or fusiform aneurysms from the petrous ICA to the ICA terminus. However, IFU is more restrictive in South Korea than in United States. Several systematic reviews and meta-analyses have sought to evaluate the overall efficacy of FDS for the treatment of cerebral aneurysms and consistently identify FDS as an effective technique for the treatment of aneurysms broadly with complication rates similar to other traditional techniques. A growing body of literature has demonstrated high efficacy of FDS for small aneurysms; distal artery aneurysms; non-saccular aneurysms posterior circulation aneurysms and complication rates similar to traditional techniques. In the short interval since the Pipeline Embolization Device was first introduced, FDS has been firmly entrenched as a powerful tool in the endovascular armamentarium. As new FDS are developed, established FDS are refined, and delivery systems are improved the uses for FDS will only expand further. Researchers continue to work to optimize the mechanical characteristics of the FDS themselves, aiming to optimize deploy ability and efficacy. With expanded use for small to medium aneurysms and posterior circulation aneurysms, FDS technology is firmly entrenched as a powerful tool to treat challenging aneurysms, both primarily and as an adjunct to coil embolization. With the aforementioned advances, the ease of FDS deployment will improve and complication rates will be further minimized. This will only further establish FDS deployment as a key strategy in the treatment of cerebral aneurysms.

Flow Diversion for Intracranial Aneurysm Treatment: Trials Involving Flow Diverters and Long-Term Outcomes.

Flow diverters (FDs) have changed the management of brain aneurysms; not only for complex aneurysms (giant, fusiform and blister) refractory to conventional therapies, but also for unruptured lesions previously managed by traditional surgical or coil-based endovascular methods. Since 2011 when the PipelineTM Embolization Device (Medtronic) was cleared by the Food and Drug Administration for adults with large or giant wide-neck intracranial aneurysms of the internal carotid artery proximal to the posterior communicating segment, the role of flow diversion for aneurysm treatment has expanded-supported by favorably low complication and high cure rates compared with alternative treatments. Here we review the key clinical trials and the long term outcomes that have demonstrated safety and efficacy of minimized porosity endoluminal devices in the treatment of cerebral aneurysms.

Morbidity and Mortality in Patients With Posterior Circulation Aneurysms Treated With the Pipeline Embolization Device: A Subgroup Analysis of the International Retrospective Study of the Pipeline Embolization Device.

The safety of PipelineTM Embolization Device (PED; Medtronic Inc, Dublin, Ireland) in posterior circulation aneurysms is still controversial. To study complications associated with the treatment of posterior circulation aneurysms by conducting a subgroup analysis from the International Retrospective Study of PED registry. 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. 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. 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.

Comparison of 3D TOF MR angiographic accuracy in predicting Raymond grade of flow-diverted versus coiled intracranial aneurysms

The accuracy of 3D time of Flight Magnetic Resonance Angiography (TOF MRA) has been studied extensively for following coiled intracranial aneurysms. It is used by many clinicians for non-invasive follow-up because of its adequate sensitivity in predicting aneurysmal recanalization compared to diagnostic cerebral angiography. The data on the accuracy of 3D TOF MRA for the Pipeline™ Embolization Device (PED) are sparse. In a retrospective chart review, we compared the accuracy of 3D TOF MRA of PED to coil embolization at our institution. 3D TOF MRA had a lower sensitivity and positive predictive value in detecting aneurysmal filling in PED-treated versus coiled aneurysms (57% versus 87% and 80% versus 100%, respectively). Analysis of discrepancies between conventional diagnostic angiography and 3D TOF MRA revealed that 3D TOF MRA was inaccurate in the setting of small residual necks and slow residual filling of the dome with fluid–fluid layers. Therefore, contrasted studies such as contrast-enhanced MRA may be preferred for non-invasively following PED-treated aneurysms to increase accuracy.

Endovascular treatment of intracraneal aneurysm with pipeline embolization device: experience in four centres in Barcelona

Flow diverters represent a useful tool in the treatment of fusiform aneurysms and wide-neck saccular aneurysms which until the advent of this technology were problematic to treat. Pipeline™ Embolization Device (PED) has been described in several series showing high rates of occlusion and being relatively safe.Objective: Shows the experience in four different neurointerventional centres in Barcelona with the PED (Covidien) between February 2010 and October 2013.Methods: We reviewed retrospectively patients treated with PED in four neurointerventional centres in Barcelona between February 2010 and October 2013.Results: Forty-two patients (89.4%) with non-ruptured aneurysms and five (10.6%) post-SAH were treated, with a mean age of 51 years (range 26–76). We treated 67 aneurysms with a mean of 1.4 1–3 PED per patient. We have no mortality and three post-procedural complications with clinical consequences, two of them severe with intracranial haemorrhage and the other with anterior choroidal artery thrombosis. Follow-up was in 45 patients (65 aneurysm) achieving complete occlusion in 90.8% at 12 months of follow-up. Two aneurysms which remained without any changes were distal and fusiform including main bifurcations (3.1%).Conclusion: Treatment by PED of fusiform or wide-neck saccular aneurysms is associated with high rates of occlusion after six and 12 months. Correct selection of the patients, aneurysms and also specific characteristics of the Pipeline device should be known in order to select the best therapeutic option. Our findings suggest that the indication must be judged case by case in the selection of suitable patients for PED therapy.

P-005 Evaluation of an Automatic Detection and Segmentation Tool for Flow Diverters (Pipeline™ Embolization Device) from C-arm CT Images

PurposeIn addition to stent-assisted coiling, endovascular treatment of intracranial aneurysms using flow diverters, like the Pipeline™ Embolization Device (PED), has become a viable treatment option. Visualization of the device after...

Pipeline™ Embolization Device for the Treatment of Complex Intracranial Aneurysms

As part of its Medical Technologies Evaluation Programme, the National Institute of Health and Clinical Excellence (NICE) invited the manufacturer, Covidien, to provide clinical and economic evidence for the evaluation of the Pipeline™ embolization device (PED) for the treatment of complex intracranial aneurysms. Cedar; a consortium between Cardiff and Vale University Health Board and Cardiff University, was commissioned to act as an External Assessment Centre (EAC) for NICE to independently critique the manufacturers’ submissions. This article gives an overview of the evidence provided, the findings of the EAC and the final guidance published by NICE.The scope issued by NICE considered PED as the intervention in a patient population with complex unruptured intracranial aneurysms (IAs), specifically large/giant, wide-necked and fusiform aneurysms. The comparator treatments identified were stent-assisted coiling, parent vessel occlusion, neurosurgical techniques and conservative management. The manufacturer claimed that PED fulfils a currently unmet clinical need in the treatment of large or giant, wide-necked or fusiform IAs.Thirteen studies were identified by the manufacturer as being relevant to the decision problem, with two of these included for data extraction. The EAC identified 16 studies as relevant, three of which had been published after the manufacturer’s search. Data extraction was carried out on these studies as, although many were low level research comprising of case reports and case series, they provided useful, pertinent safety and outcome data.No relevant economic studies of the device were identified; therefore, a new economic model was designed by the manufacturer. The base-case scenario provided recognized the costs of PED to be higher than the costs for endovascular parent vessel occlusion, neurosurgical parent vessel occlusion, neurosurgical clipping and conservative management. However, PED was found to be cost saving compared with stent-assisted coiling, with a saving of £13,110 per patient.Analysis of the clinical data suggested that treatment with PED has high rates of clinical success with high rates of aneurysm occlusion and acceptable adverse events for the patient population. Economic evidence suggested that the costs in the base-case for PED may have been underestimated, meaning that PED would only become cost saving in patients who would otherwise require treatment with 32 coils or more. NICE Medical Technologies Guidance MTG10, issued in May 2012, recommends the adoption of PED in selected patients within the UK National Health Service (NHS).