Predictors of Complications, Functional Outcome, and Morbidity in a Large Cohort Treated With Flow Diversion

Abstract

BACKGROUND A dramatic improvement in obliteration rates of large, wide-necked aneurysms has been observed after the FDA approved the Pipeline Embolization Device (PED) in 2011. OBJECTIVE To assess the predictors of complications, morbidity, and unfavorable outcomes in a large cohort of patients with aneurysms treated with PED. METHODS A retrospective chart review of a prospectively maintained database for subjects treated with flow diversion from 2010 to 2019. RESULTS A total of 598 aneurysms were treated during a period extending from 2010 to 2019 (84.28% females, mean age 55.5 yr, average aneurysm size 8.49 mm). Morbidity occurred at a rate of 5.8% and mortality at a rate of 2.2%. Ischemic stroke occurred at a rate of 3%, delayed aneurysmal rupture (DAR) at 1.2%, and distal intraparenchymal hemorrhage (DIPH) at 1.5%. On multivariate analysis, the predictor of stroke was aneurysm size >15 mm. Predictors of DAR were previous subarachnoid hemorrhage (SAH), increasing aneurysm size, and posterior circulation aneurysm. Predictors of DIPH were using more than 1 PED and baseline P2Y12 value. Predictors of in-stent stenosis were the increasing year of treatment and balloon angioplasty, whereas increasing age and previous treatment were negatively associated with in-stent stenosis. Predictors of morbidity were posterior circulation aneurysms, increasing aneurysm size, and hypertension, and incidental aneurysm diagnosis was protective for morbidity. CONCLUSION Flow diversion is a safe and effective treatment option for aneurysms. A better understanding of predictive factors of complications, morbidity, and functional outcomes is of high importance for a more accurate risk assessment.

First clinical experience with the new Surpass Evolve flow diverter: technical and clinical considerations

“…The PUFS study demonstrated a 180-day aneurysm occlusion rate of 73.6% 15. We reported a 28% rate of postdeployment angioplasty, higher than that recently reported for Pipeline (5.6%) 16. This probably reflects our extremely low threshold for performing angioplasty whenever suspecting incomplete FD apposition on VasoCT, given the demonstrated role of malapposition in delayed aneurysm healing 17.…”

Preclinical safety and efficacy evaluation of the Pipeline Vantage Embolization Device with Shield Technology

“…However, thromboembolic events due to the large metal coverage area are also documented and are not entirely mitigated, even with antiplatelet therapy. 3 The ideal characteristics of a flow diverter include optimal pore density and good wall apposition to achieve flow stagnation in the aneurysm, 4 lower overall implant thickness profile to improve endothelial coverage (scaffolding of the parent vessel and aneurysm neck), and low thrombogenic profile to mitigate thrombogenic complications, among other attributes. 5 6 The Pipeline Embolization Device has demonstrated progressive and complete aneurysm occlusion in several large clinical trials including Pipeline for Uncoilable or Failed Aneurysms (PUFs) 7 8 and more recently the Prospective Study on Embolization of Intracranial Aneurysms with the Pipeline Device (PREMIER).…”

Pipeline Embolization Device for the Treatment of Ruptured Intracerebral Aneurysms: A Multicenter Retrospective Study

“…Approximately 5% of cases exhibited incomplete PED deployment and required balloon dilatation in this study. Postoperative stent migration, in-stent stenosis, and perforator infarct are also other issues worth considering ( 14 ), and some patients even presented ischemic events after a long follow-up period (>1 year) ( 15 ). Therefore, a flow diverter may not be the first choice for treatment of acute ruptured aneurysms.…”

“…New antiplatelet drugs, such as cangrelor, which presents a fast and reliable onset of action and reversible platelet inhibition without evidence of resistance, may be a suitable alternative to oral antiplatelet drugs in the acute phase of SAH ( 31 ). The intracranial hemorrhagic complication rate was ~8% in patients who underwent stent-assisted coiling for acutely ruptured IAs ( 32 ); therefore, EVD placement before initiating antiplatelet medication is recommended to avoid hemorrhage ( 14 ). The overall incidence of ischemic complications was 5% ( 33 ), and the incidence of in-stent stenosis ranged from 3.5 to 10% for IAs with flow diversion ( 34 , 35 ).…”