Treatment of Ruptured Blister-Like Aneurysms with the FRED Flow Diverter: A Multicenter Experience.
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ABSTRACT: Background and purpose
Treatment of ruptured blister-like aneurysms is technically challenging. This study aimed at analyzing the safety and efficacy of the Flow-Redirection Endoluminal Device (FRED) in the treatment of ruptured blister-like aneurysms.Materials and methods
In a retrospective multicenter study, all patients treated with the FRED due to a ruptured intracranial blister-like aneurysm between January 2013 and May 2019 were analyzed. The primary end points for clinical safety were mRS 0-2 at 6 months after treatment and the absence of major ipsilateral stroke or death. The primary end points for efficacy were the absence of rebleeding after treatment and complete angiographic occlusion according to the O'Kelly-Marotta classification at 6 months after treatment.Results
In total, 30 patients with 30 ruptured blister-like aneurysms were treated. Immediate complete aneurysm obliteration (O'Kelly-Marotta classification D) with the FRED was achieved in 10 patients (33%). Of the 26 patients with follow-up, complete obliteration was achieved in 21 patients (80%) after 6 months and in 24 patients (92%) in the final follow-up (median, 22 months). Twenty-three patients (77%) achieved mRS 0-2 at 6 months. Major stroke or death occurred in 17%. Two patients died due to pneumonia, and 2 patients died due to infarction following cerebral vasospasm. There was no case of rebleeding after FRED implantation. There was 1 case of delayed asymptomatic stent occlusion.Conclusions
Treatment of ruptured blister-like aneurysms with the FRED is safe and effective.
SUBMITTER: Mohlenbruch MA
PROVIDER: S-EPMC7963259 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Background and purposeVarious endovascular techniques have been applied to treat blister-like aneurysms. We performed a systematic review to evaluate endovascular treatment for ruptured blister-like aneurysms.Materials and methodsWe performed a comprehensive literature search and subgroup analyses to compare deconstructive versus reconstructive techniques and flow diversion versus other reconstructive options.ResultsThirty-one studies with 265 procedures for ruptured blister-like aneurysms were included. Endovascular treatment was associated with a 72.8% (95% CI, 64.2%-81.5%) mid- to long-term occlusion rate and a 19.3% (95% CI, 13.6%-25.1%) retreatment rate. Mid- to long-term neurologic outcome was good in 76.2% (95% CI, 68.9%-8.4%) of patients. Two hundred forty procedures (90.6%) were reconstructive techniques (coiling, stent-assisted coiling, overlapped stent placement, flow diversion) and 25 treatments (9.4%) were deconstructive. Deconstructive techniques had higher rates of initial complete occlusion than reconstructive techniques (77.3% versus 33.0%, P = .0003) but a higher risk for perioperative stroke (29.1% versus 5.0%, P = .04). There was no difference in good mid- to long-term neurologic outcome between groups, with 76.2% for the reconstructive group versus 79.9% for the deconstructive group (P = .30). Of 240 reconstructive procedures, 62 (25.8%) involved flow-diverter stents, with higher rates of mid- to long-term complete occlusion than other reconstructive techniques (90.8% versus 67.9%, P = .03) and a lower rate of retreatment (6.6% versus 30.7%, P < .0001).ConclusionsEndovascular treatment of ruptured blister-like aneurysms is associated with high rates of complete occlusion and good mid- to long-term neurologic outcomes in most patients. Deconstructive techniques are associated with higher occlusion rates but a higher risk of perioperative ischemic stroke. In the reconstructive group, flow diversion carries a higher level of complete occlusion and similar clinical outcomes.
| S-EPMC7964271 | biostudies-literature
Project description:Background and purposeFlow-diverter stents are emerging for the endovascular treatment of difficult-to-treat or otherwise untreatable cerebral aneurysms (wide-neck, fusiform, dissecting, blisterlike, or giant). We assessed the clinical safety and efficacy of the Flow-Redirection Endoluminal Device.Materials and methodsThis was an institutional review board-approved single-center observational clinical study in 29 patients with 34 aneurysms elected to be treated by endovascular intervention. After providing informed consent, patients were included according to the following criteria: aneurysm fundus-to-neck ratio <2 or neck diameter >4 mm, fusiform, dissecting, or giant aneurysms. The primary end point for clinical safety was the absence of death, absence of major or minor stroke, and absence of transient ischemic attack. The primary end point for treatment efficacy was complete angiographic occlusion according to the O'Kelly Marotta grading scale immediately after the procedure and at follow-up after 3 and 6 months (O'Kelly Marotta D: complete occlusion).ResultsThe Flow-Redirection Intraluminal Device deployment was technically successful in all cases. In 26/29 (89%) of patients, the primary end point of safety was reached; in the 3 remaining patients, 1 disabling ischemic stroke and 2 minor strokes with complete recovery at follow-up were observed. Angiographic (DSA and MRA) and clinical follow-up were available after 3 months in 29/29 (100%) and after 6 months in 25/29 (86%) patients (after 6 months, only MRA follow-up was performed according to our study protocol and institutional standard). At 3-month follow-up, complete occlusion was reached in 19/34 aneurysms (O'Kelly Marotta D: 19/34; 56%). At 6-month follow-up, aneurysm occlusion was complete in 22/30 aneurysms (O'Kelly Marotta D: 22/30; 73%).ConclusionsDeployment of the Flow-Redirection Intraluminal Device flow-diverter stent is safe and effective in the treatment of difficult-to-treat or otherwise untreatable intracranial aneurysms.
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Project description:Background and purposeFlow diverters for the treatment of posterior circulation aneurysms remain controversial. We aimed to identify factors contributing to outcome measures in patients treated with the Surpass flow diverter for aneurysms in this location.Materials and methodsWe conducted an observational study of 53 patients who underwent flow-diverter treatment for posterior circulation aneurysms at 15 centers. Key outcome measures were mortality, complete aneurysm occlusion, and modified Rankin Scale score at follow-up.ResultsAt follow-up (median, 11.3 months; interquartile range, 5.9-12.7 months), 9 patients had died, resulting in an all-cause mortality rate of 17.3% (95% CI, 7%-27.6%); 7 deaths (14%) were directly related to the procedure and none occurred in patients with a baseline mRS score of zero. After adjusting for covariates, a baseline mRS of 3-5 was more significantly (P = .003) associated with a higher hazard ratio for death than a baseline mRS of 0-2 (hazard ratio, 17.11; 95% CI, 2.69-109.02). After adjusting for follow-up duration, a 1-point increase in the baseline mRS was significantly (P < .001) associated with higher values of mRS at follow-up (odds ratio, 2.93; 95% CI, 1.79-4.79). Follow-up angiography in 44 patients (median, 11.3 months; interquartile range, 5.9-12.7 months) showed complete aneurysm occlusion in 29 (66%; 95% CI, 50.1%-79.5%).ConclusionsClinical results of flow-diverter treatment of posterior circulation aneurysms depend very much on patient selection. In this study, poorer outcomes were related to the treatment of aneurysms in patients with higher baseline mRS scores. Angiographic results showed a high occlusion rate for this subset of complex aneurysms.
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Project description:Background and purposeFD stent placement is a promising therapy for challenging intracranial aneurysms. Long-term evaluations about angiographic and morphologic results are still missing. This is the aim of this multicenter series.Materials and methodsWe report our experience and 1-year FU in a retrospective chart review of 65 consecutive subjects with 77 unruptured or recanalized aneurysms that were treated with Silk FD stents at 6 centers in France. Both angiographic and clinical results were recorded before treatment and at 6 and 12 months after treatment. At the 12-month FU, relationships between angiographic aneurysm occlusion and shrinkage of the thrombosed aneurysm sac were evaluated.ResultsStent deployment was achieved in 64 cases (98.5%) and failed in 1 case (1.5%). Seven misdeployments of the Silk stent caused the occlusion of 6 parent arteries. Overall acute/subacute procedural morbidity was 7.7%, and mortality was zero. Delayed complications were observed in 10.9% of subjects. At the 6-month FU, permanent morbidity was 7.8% and mortality was 3%. Complete occlusion occurred within 6 months in 68% of aneurysms and within 12 months after treatment in 84.5% of aneurysms. At the 12-month FU, in angiographically complete occluded aneurysms, MR imaging/CT analysis showed the complete disappearance of the thrombosed aneurysm in 30% of cases and partial shrinkage in 52%; furthermore, thrombosed aneurysms were stable in 11% of cases and enlarged in 7%.ConclusionsThe Silk stent is an effective tool for the treatment of challenging aneurysms because it allows complete occlusion in most cases 1 year after treatment. Permanent morbidity was 7.8%, and mortality was 3%.
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Project description:Background and Purpose: Flow diversion is increasingly used as an endovascular treatment for intracranial aneurysms. In this retrospective multicenter study, we analyzed the safety and efficacy of the treatment of intracranial, unruptured, or previously treated but recanalized aneurysms using Flow Re-Direction Endoluminal Device (FRED) Jr with emphasis on midterm results. Materials and Methods: Clinical and radiological records of 150 patients harboring 159 aneurysms treated with FRED Jr at six centers between October 2014 and February 2020 were reviewed and consecutively included. Clinical outcome was measured by using the modified Rankin Scale (mRS). Anatomical results were assessed according to the O'Kelly-Marotta (OKM) scale and the Cekirge-Saatci Classification (CSC) scale. Results: The overall complication rate was 24/159 (16%). Thrombotic-ischemic events occurred in 18/159 treatments (11%). These resulted in long-term neurological sequelae in two patients (1%) with worsening from pre-treatment mRS 0-2 and mRS 4 after treatment. Complete or near-complete occlusion of the treated aneurysm according to the OKM scale was reached in 54% (85/158) at 6-month, in 68% (90/133) at 1-year, and in 83% (77/93) at 2-year follow-up, respectively. The rates of narrowing or occlusion of a vessel branch originating from the treated aneurysm according to the CSC scale were 11% (12/108) at 6-month, 20% (17/87) at 1-year, and 23% (13/57) at 2-year follow-up, respectively, with all cases being asymptomatic. Conclusions: In this retrospective multicenter study, FRED Jr was safe and effective in the midterm occlusion of cerebral aneurysms. Most importantly, it was associated with a high rate of good clinical outcome.
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Project description:Background and purposeBBA is a rare type of intracranial aneurysm that is difficult to treat both surgically and endovascularly and is often associated with a high degree of morbidity/mortality. The aim of this study was to present clinical and angiographic results, as well as antiplatelet/anticoagulation regimens, of endovascular BBA treatment by using predominantly stent-assisted coil embolization.Materials and methodsThirteen patients (men/women, 6/7; mean age, 49.3 years) with ruptured BBAs were included from 2 different institutions. Angiographic findings, treatment strategies, anticoagulation/antiplatelet protocols, and clinical (mRS) and angiographic outcome were retrospectively analyzed.ResultsEleven BBAs were located in the supraclinoid ICA, and 2 on the basilar artery trunk. Nine of 13 were ≤3 mm in the largest diameter, and 8/13 showed early growth before treatment. Primary stent-assisted coiling was performed in 11/13 patients, double stents and PAO in 1 patient, each. Early complementary treatment was required in 3 patients, including PAO in 2. In stent-placement procedures, altered periprocedural antiplatelet (11/12) and postprocedural heparin (6/12) protocols were used without evidence of thromboembolic events. Two patients had early rehemorrhage, including 1 major fatal SAH. Twelve of 13 BBAs showed complete or progressive occlusion at late angiographic follow-up. Clinical midterm outcome was good (mRS scores, 0-2) in 12/13 patients.ConclusionsStent-assisted coiling of ruptured BBAs is technically challenging but can be done with good midterm results. Reduced periprocedural and postprocedural antiplatelet/anticoagulation protocols may be used with a low reasonable risk of thromboembolic complications. However, regrowth/rerupture remains a problem underlining the importance of early angiographic follow-up and re-treatment, including PAO if necessary.
| S-EPMC7965868 | biostudies-literature
Project description:BackgroundFlow diversion is now an established technique to treat unruptured intracranial aneurysms not readily amenable to endovascular coil embolization or open microsurgical occlusion. The role of flow-diverting devices in treating ruptured aneurysms is less clear.PurposeTo estimate rates of angiographic occlusion and good clinical outcome in patients with ruptured intracranial aneurysms treated with flow-diverting devices.Data sourcesSystematic review of Ovid MEDLINE, PubMed, Cochrane databases, and EMBASE from inception to December 2015 for articles that included ruptured aneurysms treated with flow diversion.Study selectionOne hundred seventy-two records were screened, of which 20 articles contained sufficient patient and outcome data for inclusion.Data analysisClinical and radiologic characteristics, procedural details, and outcomes were extracted from these reports. Aggregated occlusion rates and clinical outcomes were analyzed by using the Fisher exact test (statistical significance, α = .05).Data synthesisComplete occlusion of the aneurysm was achieved in 90% of patients, and favorable clinical outcome was attained in 81%. Aneurysm size greater than 7 mm was associated with less favorable clinical outcomes (P = .027). Aneurysm size greater than 2 cm was associated with a greater risk of rerupture after treatment (P < .001).LimitationsObservational studies and case reports may be affected by reporting bias.ConclusionsAlthough not recommended as a first-line treatment, the use of flow diverters to treat ruptured intracranial aneurysms may allow high rates of angiographic occlusion and good clinical outcome in carefully selected patients. Aneurysm size contributes to treatment risk because the rerupture rate following treatment is higher for aneurysms larger than 2 cm.
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Project description:Cerebral aneurysms are a major risk factor for intracranial bleeding with devastating consequences for the patient. One recently established treatment is the implantation of flow-diverters (FD). Methods to predict their treatment success before or directly after implantation are not well investigated yet. The aim of this work was to quantitatively study hemodynamic parameters in patient-specific models of treated cerebral aneurysms and its correlation with the clinical outcome. Hemodynamics were evaluated using both computational fluid dynamics (CFD) and phase contrast (PC) MRI. CFD simulations and in vitro MRI measurements were done under similar flow conditions and results of both methods were comparatively analyzed. For preoperative and postoperative distribution of hemodynamic parameters, CFD simulations and PC-MRI velocity measurements showed similar results. In both cases where no occlusion of the aneurysm was observed after six months, a flow reduction of about 30-50% was found, while in the clinically successful case with complete occlusion of the aneurysm after 6 months, the flow reduction was about 80%. No vortex was observed in any of the three models after treatment. The results are in agreement with recent studies suggesting that CFD simulations can predict post-treatment aneurysm flow alteration already before implantation of a FD and PC-MRI could validate the predicted hemodynamic changes right after implantation of a FD.
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