Original ArticleOutcomes After Off-Label Use of the Pipeline Embolization Device for Intracranial Aneurysms: A Multicenter Cohort Study
Introduction
The Pipeline embolization device (PED) (Medtronic, Minneapolis, Minnesota, USA) was developed to treat large, wide-necked intracranial aneurysms.1, 2, 3 In 2011, the U.S. Food and Drug Administration (FDA) specifically approved PED for the treatment of adults (≥22 years old) with large (diameter ≥10 mm) or giant (diameter ≥25 mm), wide-necked (≥4 mm or no discernible neck) saccular aneurysms arising from petrous to superior hypophyseal segments of the internal carotid artery (ICA). The long-term clinical and angiographic outcomes of PUFS (Pipeline for Uncoilable or Failed Aneurysms) showed that PED is safe and effective for large and giant wide-necked aneurysms of the ICA. At the 5-year follow-up of PUFS, complete occlusion occurred in 90.6% of the aneurysms treated with PED.2 Several case series have also reported favorable results treating similar aneurysms with PED.3, 4, 5 Despite limited supportive data, the use of PED for indications not specified in the original FDA approval has become increasingly widespread.6, 7 Particularly common off-label uses of PED include treatment of aneurysms with previous stent-assisted coiling, ruptured aneurysms, small or medium-sized (diameter <10 mm) aneurysms, distal circulation aneurysms, posterior circulation aneurysms, fusiform aneurysms, pseudoaneurysms, and carotid-cavernous fistulas.8
Although the safety of PED has been reported, several studies highlighted some significant complications that can occur with this procedure.9, 10, 11 Possible devastating outcomes associated with the off-label use of PED (i.e., the use of PED for indications not approved by the FDA), including unexpected intraparenchymal hemorrhage, perforator infarction, postoperative aneurysm rupture, and death, have not been rigorously investigated. Owing to the limited and conflicting data, questions remain about the safety and efficacy of off-label use of PED. In this article, we report our experience with the off-label use of PED in treating intracranial aneurysms at 4 neurovascular centers.
Section snippets
Materials and Methods
We conducted a retrospective analysis on a prospectively collected database of patients whose intracranial aneurysms were treated with PED outside the FDA-approved indications between 2011 and 2015. The data were collected from 4 well-known neurovascular centers at different institutions. Each center reviewed its own radiographic images and entered data into a combined database. Institutional review board approval for use of patients' retrospective data was obtained separately from each
Baseline Characteristics
The data of 109 patients were included (83.5% women and 16.5% men). Mean patient age was 54.4 ± 12.3 years. The mean size of the aneurysm was 8.36 ± 7.36 mm. Table 1 summarizes the reasons for off-label usage. The most common reasons for off-label use were aneurysm size <10 mm (50.5%), aneurysm location (25.7%), and a combination of both size <10 mm and location (10.1%). Table 2 summarizes the aneurysm locations. The most common location of the aneurysms was in the ICA-ophthalmic segment
Discussion
Flow diverter devices have been gaining popularity in the treatment of intracranial aneurysms. Several studies have shown that their use is feasible and effective for unruptured aneurysms with complex anatomy, for which coiling or surgical intervention could be challenging.13, 14, 15, 16 Variable rates of aneurysm occlusion and complications have been reported in the literature. Brinjikji et al.10 conducted a meta-analysis that included 29 studies of flow diversion for aneurysms. The
Conclusions
Off-label use of PED has a favorable risk-to-benefit profile for appropriately selected aneurysms. Although patient selection is likely to be a major factor in achieving acceptable results with this technology, posterior circulation and fusiform aneurysms do not appear to be associated with worse clinical or angiographic outcomes. The treatment of ruptured aneurysms with PED may be a reasonable option in some cases. However, the potential adverse effects of dual antiplatelet therapy in the
References (26)
- et al.
Flow diverters for treatment of intracranial aneurysms: current status and ongoing clinical trials
J Clin Neurosci
(2011) - et al.
Meta-analysis of stent-assisted coiling versus coiling-only for the treatment of intracranial aneurysms
J Clin Neurosci
(2016) - et al.
Flow-diverter devices for intracranial aneurysms: systematic review and meta-analysis
Neurosurgery
(2013) - et al.
Long-term clinical and angiographic outcomes following Pipeline embolization device treatment of complex internal carotid artery aneurysms: five-year results of the Pipeline for Uncoilable or Failed Aneurysms Trial
Neurosurgery
(2017) - et al.
International retrospective study of the Pipeline embolization device: a multicenter aneurysm treatment study
AJNR Am J Neuroradiol
(2015) - et al.
Pipeline for uncoilable or failed aneurysms: results from a multicenter clinical trial
Radiology
(2013) - et al.
A reappraisal of the Pipeline embolization device for the treatment of posterior circulation aneurysms
J Neurointerv Surg
(2015) - et al.
Treatment of posterior circulation aneurysms with the Pipeline embolization device
Neurosurgery
(2013) - et al.
Treatment of intracranial aneurysms with Pipeline embolization device: newer applications and technical advances
Curr Treat Options Neurol
(2016) - et al.
Italian multicenter experience with flow-diverter devices for intracranial unruptured aneurysm treatment with periprocedural complications—a retrospective data analysis
Neuroradiology
(2012)
Endovascular treatment of intracranial aneurysms with flow diverters: a meta-analysis
Stroke
Aneurysm rupture after endovascular flow diversion: the possible role of persistent flows through the transition zone associated with device deformation
Interv Neuroradiol
Endovascular treatment of unruptured aneurysms
Stroke
Cited by (14)
Safety and efficacy profile of off-label use of the Pipeline Embolization Device: A systematic review and meta-analysis
2024, Journal of Stroke and Cerebrovascular DiseasesPredictors of Clinical Outcome After Treatment of Intracranial Aneurysms with the Pipeline Embolization Device
2019, World NeurosurgeryCitation Excerpt :This is in line with other recent studies in the literature.16,17 Zammar et al16 examined the outcomes of off-label aneurysms treated with PED at 4 different centers based on FDA-approved guidelines from 2011–2015. They reported an overall complication rate of 8.3%, which is lower than our overall complication rate for off-label cases of 20.8%.
Evaluating the Effectiveness of 2 Different Flow Diverter Stents Based on the Stagnation Region Formation in an Aneurysm Sac Using Lagrangian Coherent Structure
2019, World NeurosurgeryCitation Excerpt :These factors including the size, localization, and morphology of the aneurysm have an effect on the intra-aneurysmal pressure and the length of time that blood remains inside the aneurysm. This can also cause changes in blood flow for the aneurysm.60-63 Similarly, the dimension and structure of the FD and its placement inside the aneurysm affect treatment results and complications.
Morphologic Feature Elongation Can Predict Occlusion Status Following Pipeline Embolization of Intracranial Aneurysms
2018, World NeurosurgeryCitation Excerpt :The indications for use of the Pipeline embolization device (PED; Medtronic, Minneapolis, Minnesota, USA) have expanded to include a variety of aneurysm types since the device was approved by the U.S. Food and Drug Administration.1,2
Treatment of intracranial aneurysms with pipeline embolization device: a single-center experience
2024, Quantitative Imaging in Medicine and Surgery
Conflict of interest statement: The authors declare that the article content was composed in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.