Neuroophthalmological outcomes associated with use of the Pipeline Embolization Device: analysis of the PUFS trial results

Sahlein, Daniel; Fouladvand, Mohammad; Becske, Tibor; Saatçi, Işıl; McDougall, Cameron G.; Szikora, István; Lanzino, Giuseppe; Moran, Christopher J.; Woo, Henry H.; Lopes, Demetrius K.; Berez, Aaron L.; Cher, Daniel; Siddiqui, Adnan H.; Levy, Elad I.; Albuquerque, Felipe C.; Fiorella, David; Berentei, Zsolt; Marosfői, M; Çekirge, Saruhan; Kallmes, David F.; Nelson, Peter Kim

doi:10.3171/2014.12.jns141777

Cited by 55 publications

(48 citation statements)

References 17 publications

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“…In addition, Briganti et al 30) reported that the mortality after flow diverter treatment of lesions at the same site was 4%. While simple comparison of these results is not approved, they suggest Table 2 Comparison of the patient characteristics, complication rate, and retreatment rate among the 4 papers and our study : minimum-maximum; DAE: disobliteration after embolization of ruptured aneurysm; ME: Mass effect; SAH: subarachnoid hemorrhage patients with CNP was 64% after treatment using Pipeline, 33) and it tended to be higher in those treated using Pipeline. The number of patients treated at our hospital is small, and generalization of the results is not warranted, but they suggest the possibility that aneurysms in the Bouthillier C4 and C5 segments without CNP can be treated with a low complication rate and a relatively low retreatment rate by the current coil embolization procedure.…”

Section: Discussionmentioning

confidence: 67%

Endovascular Embolization of Large Internal Carotid Artery Aneurysms: Single-center Experience with 10 Cases and Literature Review

Aoyama

Shigeta

Sato

et al. 2017

JNET

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Objective:We reviewed the treatment results of internal carotid artery (ICA) aneurysms with a maximum diameter of 10 mm or greater for the future selection of patients with indications for Pipeline Flex (Medtronic, Irvine, CA, USA). Methods:The treatment methods, treatment effects, complication rate, and retreatment rate were studied in lesions that were treated by coil embolization but are presently considered indications for treatment using Pipeline Flex among the 516 cerebral aneurysms treated at our hospital between July 2009 and May 2016. We also reviewed the literature concerning coil embolization for large and giant aneurysms and examined the results of coil embolization for aneurysms with indications for Pipeline. Results:The subjects were 10 patients consisting of 5 with asymptomatic unruptured aneurysm, 2 with symptomatic unruptured aneurysm, and 3 patients with recurrence after treatment for ruptured aneurysm. The mean size of the aneurysms was 12.8 mm (10.5-17.8 mm), and the mean follow-up period was 49.1 ± 13.4 months. The treatments were balloon-assisted coil embolization in eight patients and stent-assisted coil embolization in two patients. None showed postoperative symptomatic ischemic lesions, and the permanent morbidity was 0%. Of the two patients with symptomatic aneurysms, the symptoms were alleviated after treatment in one patient, and retreatment was necessary in one patient.In the review of the literature, comparisons were made in 69 large or giant aneurysms treated by coil embolization between those with and without indications for Pipeline. The additional treatment rate was significantly lower in the lesions with indications for Pipeline (33.3% vs. 61.9%, P = 0.02). The retreatment rate was significantly lower at 15.4%, particularly in extradural aneurysms (Bouthillier C4, 5). Conclusion:The results of this study suggest that the retreatment rate after conventional coil embolization for extradural unruptured large cerebral aneurysms was not high and that coil embolization is worth considering for asymptomatic aneurysms at these sites 10-15 mm in diameter.

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Section: Discussionmentioning

confidence: 67%

Endovascular Embolization of Large Internal Carotid Artery Aneurysms: Single-center Experience with 10 Cases and Literature Review

Aoyama

Shigeta

Sato

et al. 2017

JNET

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“…31 Most recently, Sahlein et al performed a sec ondary analysis of the Pipeline for Uncoilable or Failed Aneurysms trial and found that 40% of 98 patients with paraclinoid aneurysms had preoperative visual impair ment; however, this analysis only considered large and gi ant aneurysms. 46 The heterogeneity of the data reported in the literature demonstrates that there is no conclusive estimate for the rate of visual symptoms among patients with paraclinoid aneurysms. This metaanalysis of 39 studies with a total of 2458 patients found that 38% of pa tients with paraclinoid aneurysms presented with visual impairment across a range of aneurysm sizes, geographic regions, and referral patterns.…”

Section: Discussionmentioning

confidence: 84%

“…11,31,46 The mechanism of visual impairment is not well understood, but may result from direct mass effect of the aneurysm sac com pressing the optic nerve, inflammation, or retinal artery thrombosis. 1,18,24,28,46,49 In addition to presenting with visual symptoms, patients with intact baseline vision can develop iatrogenic visual deficits following treatment by many of these same mechanisms.…”

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confidence: 99%

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Vision outcomes in patients with paraclinoid aneurysms treated with clipping, coiling, or flow diversion: a systematic review and meta-analysis

Silva

See

Dasenbrock

et al. 2017

Neurosurgical Focus

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OBJECTIVEPatients with paraclinoid aneurysms commonly present with visual impairment. They have traditionally been treated with clipping or coiling, but flow diversion (FD) has recently been introduced as an alternative treatment modality. Although there is still initial aneurysm thrombosis, FD is hypothesized to reduce mass effect, which may decompress the optic nerve when treating patients with visually symptomatic paraclinoid aneurysms. The authors performed a meta-analysis to compare vision outcomes following clipping, coiling, or FD of paraclinoid aneurysms in patients who presented with visual impairment.METHODSA systematic literature review was performed using the PubMed and Web of Science databases. Studies published in English between 1980 and 2016 were included if they reported preoperative and postoperative visual function in at least 5 patients with visually symptomatic paraclinoid aneurysms (cavernous segment through ophthalmic segment) treated with clipping, coiling, or FD. Neuroophthalmological assessment was used when reported, but subjective patient reports or objective visual examination findings were also acceptable.RESULTSThirty-nine studies that included a total of 2458 patients (520 of whom presented with visual symptoms) met the inclusion criteria, including 307 visually symptomatic cases treated with clipping (mean follow-up 26 months), 149 treated with coiling (mean follow-up 17 months), and 64 treated with FD (mean follow-up 11 months). Postoperative vision in these patients was classified as improved, unchanged, or worsened compared with preoperative vision. A pooled analysis showed preoperative visual symptoms in 38% (95% CI 28%–50%) of patients with paraclinoid aneurysms. The authors found that vision improved in 58% (95% CI 48%–68%) of patients after clipping, 49% (95% CI 38%–59%) after coiling, and 71% (95% CI 55%–84%) after FD. Vision worsened in 11% (95% CI 7%–17%) of patients after clipping, 9% (95% CI 2%–18%) after coiling, and 5% (95% CI 0%–20%) after FD. New visual deficits were found in patients with intact baseline vision at a rate of 1% (95% CI 0%–3%) for clipping, 0% (95% CI 0%–2%) for coiling, and 0% (95% CI 0%–2%) for FD.CONCLUSIONSTo the authors’ knowledge, this is the first meta-analysis to assess vision outcomes after treatment for paraclinoid aneurysms. The authors found that 38% of patients with these aneurysms presented with visual impairment. These data also demonstrated a high rate of visual improvement after FD without a significant difference in the rate of worsened vision or iatrogenic visual impairment compared with clipping and coiling. These findings suggest that FD is an effective option for treatment of visually symptomatic paraclinoid aneurysms.

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“…21) In addition, optic neuropathy may develop from direct compression by large and giant aneurysms, resulting in VA and VF deficits. 21) The Pipeline for Uncoilable or Failed Aneurysms (PUFS) trial 21) observed a neuro-ophthalmological baseline deficit in 39 of 98 patients (39.8%) that was presumed attributable to the intracranial aneurysm, with a higher proportion of patients having aneurysms of the cavernous segment (57%) than of the petrous (0%), superior hypophyseal (22%), paraophthalmic (27%), or supraclinoid (25%) segments.…”

Section: Discussionmentioning

confidence: 99%

A Pipeline Embolization Device for the Treatment of Large and Giant Intracranial Aneurysms: Initial Experience at a Single Center

Nakae

Suzuki

Hirata

et al. 2017

JNET

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Objective: The Pipeline Embolization Device (PED) (Covidien, Irvine, CA, USA) is an endovascular microcatheter delivery system for the curative reconstruction of parent arteries harboring large/giant, wide-necked, and fusiform intracranial aneurysms. Here, we describe our initial experience with the PED to evaluate its safety, complications, and effectiveness. Results: A total of 11 complications were experienced by nine patients with a mean follow-up period of 6.5 months. Five major complications defined as ipsilateral stroke in four patients were encountered: two procedure-related ischemic strokes, one delayed ischemic stroke, and two intracerebral hemorrhages. In one patient, the symptom was persistent 3 months post-procedure. Of the other five patients with complications, four went on to recover completely 3 months post-procedure. Overall, the total complication rate for treatment with PED was 39.1% (9/23). Morbidity rate at 3 months post-procedure was 8.7% (2/23), and mortality rate 3 months post-procedure was 0%. Angiographic follow-up examination was carried out in 10 patients at 6 months and revealed no filling (0%) of aneurysm in four patients, entry remnant (<5%) in five, and subtotal filling (5%-95%) in another patient. Conclusion:The PED placement is effective therapy for the treatment of large/giant and wide-necked intracranial aneurysms. Despite the relatively low rate of permanent complications associated with the PED, it is important to note that the total complication rate was not negligible.

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Neuroophthalmological outcomes associated with use of the Pipeline Embolization Device: analysis of the PUFS trial results

Cited by 55 publications

References 17 publications

Endovascular Embolization of Large Internal Carotid Artery Aneurysms: Single-center Experience with 10 Cases and Literature Review

Endovascular Embolization of Large Internal Carotid Artery Aneurysms: Single-center Experience with 10 Cases and Literature Review

Vision outcomes in patients with paraclinoid aneurysms treated with clipping, coiling, or flow diversion: a systematic review and meta-analysis

A Pipeline Embolization Device for the Treatment of Large and Giant Intracranial Aneurysms: Initial Experience at a Single Center

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