Predictors of incomplete aneurysm occlusion after treatment with the Pipeline Embolization Device: PREMIER trial 1 year analysis

2021 ◽  
pp. neurintsurg-2021-018054
Author(s):  
Ricardo A Hanel ◽  
Andre Monteiro ◽  
Peter K Nelson ◽  
Demetrius K Lopes ◽  
David F Kallmes

BackgroundFlow diverters have revolutionized the treatment of intracranial aneurysms. Nevertheless, some aneurysms fail to occlude with flow diversion. The Prospective Study on Embolization of Intracranial Aneurysms with the Pipeline Device (PREMIER) was a prospective, multicenter and single-arm trial of small and medium wide-necked unruptured aneurysms. In the current study, we evaluate the predictors of treatment failure in the PREMIER cohort.MethodsWe analyzed PREMIER patients who had incomplete occlusion (Raymond-Roy >1) at 1 year angiographic follow-up and compared them with those who achieved Raymond-Roy 1, aiming to identify predictors of treatment failure.Results25 aneurysms demonstrated incomplete occlusion at 1 year. There was a median reduction of 0.9 mm (IQR 0.41–2.43) in maximum diameter between pre-procedure and 1 year measurements, with no aneurysmal hemorrhage. Patients with incomplete occlusion were significantly older than those with complete occlusion (p=0.011). Smoking (p=0.045) and C6 segment location (p=0.005) were significantly associated with complete occlusion, while location at V4 (p=0.01) and C7 (p=0.007) and involvement of a side branch (p<0.001) were significantly associated with incomplete occlusion. In multivariable logistic regression, significant predictors of incomplete occlusion were non-smoker status (adjusted OR 4.49, 95% CI 1.11 to 18.09; p=0.03) and side branch involvement (adjusted OR 11.68, 95% CI 3.84 to 35.50; p<0.0001), while C6 location had reduced odds of incomplete occlusion (adjusted OR 0.29, 95% CI 0.10 to 0.84; p=0.02).ConclusionsThe results of our study are consistent with previous retrospective series and warrant consideration for technique adaptations to achieve higher occlusion rates. Further follow-up is needed to assess progression of aneurysm occlusion and clinical behavior in these cases.

Neurosurgery ◽  
2009 ◽  
Vol 64 (5) ◽  
pp. E865-E875 ◽  
Author(s):  
Ronie L. Piske ◽  
Luis H. Kanashiro ◽  
Eric Paschoal ◽  
Celso Agner ◽  
Sergio S. Lima ◽  
...  

Abstract OBJECTIVE We report our results using Onyx HD-500 (Micro Therapeutics, Inc., Irvine, CA) in the endovascular treatment of wide-neck intracranial aneurysms, which have a high rate of incomplete occlusion and recanalization with platinum coils. METHODS Sixty-nine patients with 84 aneurysms were treated. Most of the aneurysms were located in the anterior circulation (80 of 84 aneurysms), were unruptured (74 of 84 aneurysms), and were incidental. Ten presented with subarachnoid hemorrhage, and 15 were symptomatic. All aneurysms had wide necks (neck &gt;4 mm and/or dome-to-neck ratio &lt;1.5). Fifty aneurysms were small (&lt;12 mm), 30 were large (12 to &lt;25 mm) and 4 were giant. Angiographic follow-up was available for 65 of the 84 aneurysms at 6 months, for 31 of the 84 aneurysms at 18 months, and for 5 of the 84 aneurysms at 36 months. RESULTS Complete aneurysm occlusion was seen in 65.5% of aneurysms on immediate control, in 84.6% at 6 months, and in 90.3% at 18 months. The rates of complete occlusion were 74%, 95.1%, and 95.2% for small aneurysms and 53.3%, 70%, and 80% for large aneurysms at the same follow-up periods. Progression from incomplete to complete occlusion was seen in 68.2% of all aneurysms, with a higher percentage in small aneurysms (90.9%). Aneurysm recanalization was observed in 3 patients (4.6%), with retreatment in 2 patients (3.3%). Procedural mortality was 2.9%. Overall morbidity was 7.2%. CONCLUSION Onyx embolization of intracranial wide-neck aneurysms is safe and effective. Morbidity and mortality rates are similar to those of other current endovascular techniques. Larger samples and longer follow-up periods are necessary.


2021 ◽  
pp. neurintsurg-2021-017445
Author(s):  
Huibin Kang ◽  
Bin Luo ◽  
Jianmin Liu ◽  
Hongqi Zhang ◽  
Tianxiao Li ◽  
...  

BackgroundAlthough coiling with a flow diverter may provide immediate dome protection, no studies have evaluated the effect on complications of postoperative occlusion degree immediately postoperatively. The purpose of this study was to determine whether postoperative occlusion degree immediately after flow-diverter placement with adjunctive coiling was associated with complications.MethodsAll patients’ data were collected from the post-market multi-center cohort study of embolization of intracranial aneurysms with a pipeline embolization device (PED) in China (PLUS) registry. We divided patients into those treated with a PED alone (PED-only (PO) group), those treated with a PED with coils and incomplete occlusion (PED + coils + incomplete occlusion (PCIO) group), and those treated with a PED with coils and complete occlusion (PED + coils + complete occlusion (PCCO) group).ResultsWe evaluated 1171 consecutive patients with 1322 aneurysms treated with a PED: 685 aneurysms were treated with PO, 444 with PCIO, and 193 with PCCO. The PCCO group had a higher rate of aneurysm occlusion at the last follow-up than the PCIO and PO groups (P<0.0001). Multivariate analysis of the predictors of ischemic stroke and modified Rankin Scale score (mRS) deterioration showed that PCCO was an independent predictor of ischemic stroke (HR, 2.03; 95% CI, 1.12 to 3.67; P=0.019) and mRS deterioration (HR, 2.59; 95% CI, 1.57 to 4.26; P<0.0001).ConclusionsAlthough postoperative complete occlusion with a PED and adjunctive coiling can increase the rate of aneurysm occlusion, this approach may also increase the risk of ischemic stroke and lead to poor postoperative functional outcomes.


2019 ◽  
Vol 25 (6) ◽  
pp. 671-680 ◽  
Author(s):  
Junfan Chen ◽  
Yisen Zhang ◽  
Zhongbin Tian ◽  
Wenqiang Li ◽  
Qianqian Zhang ◽  
...  

Background Intracranial aneurysms are increasingly being treated by the placement of flow diverters; however, the factors affecting the outcome of aneurysms treated using flow diverters remain unclarified. Methods The present study investigated 94 aneurysms treated with pipeline embolisation device placement, and used a computational fluid dynamics method to explore the factors influencing the outcome of aneurysms. Results Seventy-six completely occluded aneurysms and 18 incompletely occluded aneurysms were analysed. Before treatment, inflow jets were found in 13 (72.2%) aneurysms in the incompletely occluded group and 34 (44.7%) in the completely occluded group ( P = 0.292). After deployment of the pipeline embolisation device, inflow jets remained in nine (50%) aneurysms in the incompletely occluded group and nine (11.8%) in the completely occluded group ( P = 0.001). In the incompletely occluded group, regions with inflow jets after treatment corresponded with the patent areas shown on follow-up digital subtraction angiography. The mean reduction ratios of velocity in the whole aneurysm and on the neck plane were lower in the incompletely occluded than in the completely occluded group ( P = 0.003; P = 0.017). Multivariate analysis revealed that the only independent risk factors for incomplete aneurysm occlusion were the reduction ratios of velocity (in the whole aneurysm, threshold 0.362, P = 0.005; on the neck plane, threshold 0.273, P = 0.015). Conclusions After pipeline embolisation device placement, reduction ratios of velocity in the whole aneurysm of less than 0.362 and on the neck plane of less than 0.273 are significantly associated with a greater risk of aneurysm incomplete occlusion. In addition, the persistence of inflow jets in aneurysms is associated with incomplete occlusion in the inflow jet area.


BMC Neurology ◽  
2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Keun Young Park ◽  
Chang Ki Jang ◽  
Jae Whan Lee ◽  
Dong Joon Kim ◽  
Byung Moon Kim ◽  
...  

Abstract Background The purpose of this study was to report our preliminary experience of stent-assisted coiling (SAC) of wide-necked intracranial aneurysms with a single microcatheter in patients with parent arteries that were small-caliber, with stenosis, or a very tortuous course. Methods Between March 2018 and December 2018, we treated 394 aneurysms in 359 patients with endovascular treatment. Among 197 aneurysms treated by SAC, there were 16 cases (all wide-necked unruptured aneurysms) treated by SAC with a single microcatheter and a Neuroform Atlas stent. Follow-up angiography was performed at 6 to 12 months after SAC, and clinical follow-up was performed from 6 to 12 months in all patients. Results The reasons for SAC with a single 0.0165-in. microcatheter were small-caliber (n = 4), stenosis (n = 2), and very tortuous course (n = 10) of the parent arteries. There was no complication related to delivering or deploying the Neuroform Atlas stent as well as no failure of selecting aneurysm by cell-through technique. All patients had a modified Rankin score of 0 at discharge and at follow-up. Initial angiographic results showed six cases (37.5%) of complete occlusion. In follow-up angiographies, 12 cases (75.0%) achieved compete occlusion. Conclusion When performing SAC of wide-necked intracranial aneurysms in parent arteries with small-caliber, stenosis, or a very tortuous course, cell-through SAC using a single microcatheter and a Neuroform Atlas stent within a 5 Fr- (or smaller) guiding or intermediate catheter might be a useful option.


2020 ◽  
Vol 132 (5) ◽  
pp. 1598-1605 ◽  
Author(s):  
Georgios A. Maragkos ◽  
Luis C. Ascanio ◽  
Mohamed M. Salem ◽  
Sricharan Gopakumar ◽  
Santiago Gomez-Paz ◽  
...  

OBJECTIVEThe Pipeline embolization device (PED) is a routine choice for the endovascular treatment of select intracranial aneurysms. Its success is based on the high rates of aneurysm occlusion, followed by near-zero recanalization probability once occlusion has occurred. Therefore, identification of patient factors predictive of incomplete occlusion on the last angiographic follow-up is critical to its success.METHODSA multicenter retrospective cohort analysis was conducted on consecutive patients treated with a PED for unruptured aneurysms in 3 academic institutions in the US. Patients with angiographic follow-up were selected to identify the factors associated with incomplete occlusion.RESULTSAmong all 3 participating institutions a total of 523 PED placement procedures were identified. There were 284 procedures for 316 aneurysms, which had radiographic follow-up and were included in this analysis (median age 58 years; female-to-male ratio 4.2:1). Complete occlusion (100% occlusion) was noted in 76.6% of aneurysms, whereas incomplete occlusion (≤ 99% occlusion) at last follow-up was identified in 23.4%. After accounting for factor collinearity and confounding, multivariable analysis identified older age (> 70 years; OR 4.46, 95% CI 2.30–8.65, p < 0.001); higher maximal diameter (≥ 15 mm; OR 3.29, 95% CI 1.43–7.55, p = 0.005); and fusiform morphology (OR 2.89, 95% CI 1.06–7.85, p = 0.038) to be independently associated with higher rates of incomplete occlusion at last follow-up. Thromboembolic complications were noted in 1.4% and hemorrhagic complications were found in 0.7% of procedures.CONCLUSIONSIncomplete aneurysm occlusion following placement of a PED was independently associated with age > 70 years, aneurysm diameter ≥ 15 mm, and fusiform morphology. Such predictive factors can be used to guide individualized treatment selection and counseling in patients undergoing cerebrovascular neurosurgery.


2016 ◽  
Vol 9 (1) ◽  
pp. 77-87 ◽  
Author(s):  
Marta Aguilar Perez ◽  
Pervinder Bhogal ◽  
Rosa Martinez Moreno ◽  
Hansjörg Bäzner ◽  
Oliver Ganslandt ◽  
...  

ObjectiveTo report our initial experience with the Medina Embolic Device (MED) in unruptured intracranial aneurysms either as sole treatment or in conjunction with additional devices.Methods15 consecutive patients (6 women, 9 men) with unruptured aneurysms were treated between September 2015 and April 2016. The aneurysm fundus measured at least 5 mm. We evaluated the angiographic appearances of treated aneurysms at the end of the procedure and at follow-up, the clinical status, complications, and requirement for adjunctive devices.ResultsThe MED was successfully deployed in all but one case and adjunctive devices were required in 10 cases. Aneurysm locations were middle cerebral artery bifurcation (n=3), internal carotid artery (ICA) bifurcation (n=1), supraclinoid ICA (n=5), posterior communicating artery (n=1), anterior communicating artery (n=2), cavernous ICA (n=2), distal basilar sidewall (n=1), basilar tip (n=1). Three patients had complications although none could be attributed to the MED. Immediate angiographic results were modified Raymond-Roy classification (mRRC) I=1, mRRC II=5, mRRC IIIa=3, mRRC IIIb=5, and one patient showed contrast stasis within the fundus of the aneurysm. Follow-up angiography was available in 11 patients, with four showing complete aneurysm exclusion, six with stable remnants and one patient with an enlarging neck remnant.ConclusionsThe MED represents a major step forward in the treatment of intracranial aneurysms. It can result in rapid exclusion of an aneurysm from the circulation and has a good safety profile. We believe that the true value of the MED will be in combining its use with adjunctive devices such as endoluminal flow diverters that will result in rapid aneurysmal exclusion.


BMC Neurology ◽  
2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Jianhe Yue ◽  
Yuan Xie ◽  
Xiaolin Zhang ◽  
Yongxiang Jiang ◽  
Weifu Chen ◽  
...  

Abstract Background Incomplete aneurysmal occlusion is a common feature of immediate posttreatment angiography. The safety and outcomes of acutely ruptured intracranial aneurysms (RIAs) with incomplete occlusion after stent-assisted coiling (SAC) and no-stent coiling (NSC) have not been well clarified. Progressive occlusion of stents can promote the complete occlusion of intracranial aneurysms (IAs), but it remains to be determined if progressive occlusion in acutely RIAs with incomplete occlusion after coiling may be enhanced by protective stenting. This study aimed to evaluate the safety and outcomes of those aneurysms after SAC and NSC; And to discover whether the stents can promote progressive aneurysm occlusion in such lesions or not. Methods We reviewed 199 patients with acutely RIAs underwent endovascular coiling and developed incomplete occlusion in the past seven years. The patients’ clinical and imaging information were recorded and analyzed. Univariate and multivariate analyses were performed to determine the association of recurrence rate with potential risk factors. Results SAC group had wider aneurysms neck (3.471 mm vs 2.830 mm, P = 0.009) and smaller dome-to-neck ratio (1.536 vs 2.111, P = 0.001) than in NSC group. There was no significant difference between the two groups in total procedure-related complications rate (31.7% vs 23.5%, P = 0.195), procedure-related mortality (6.9% vs 2.0%, P = 0.170) and modified Rankin Scale (mRS) score at 6-month follow-up (P > 0.05). However, SAC group had significantly higher ischemic complications rate (21.8% vs 8.2%, P = 0.007) and complete occlusion rate (65.6% vs 48.3%, P = 0.020), and lower recurrence rate (15.6% vs 28.1%, P = 0.042) than NSC group based on 6-month follow-up angiograms. Additionally, Multivariable analysis showed NSC was an independent risk factor for aneurysm recurrence (Odds Ratio [OR]: 4.061; P = 0.018). Conclusions Acutely RIAs with incomplete occlusion after SAC is associated with higher complications rate and mortality, but has an acceptable safety profile and similar clinical outcome compared to NSC, as well as gives patients superior angiography outcome by progressive occlusion of stents.


1973 ◽  
Vol 39 (6) ◽  
pp. 690-693 ◽  
Author(s):  
Sidney A. Hollin ◽  
Robert E. Decker

✓ The authors report postoperative angiographic results in a series of 50 patients who had undergone microsurgery for intracranial aneurysms. The aneurysmal body and fundus were obliterated in every case. The neck was visualized postoperatively in three cases, or 6%; in one of these, later follow-up angiography demonstrated subsequent total aneurysm occlusion. No postoperative rebleeding occurred. The incidence of postoperative occlusion of the parent vessel was small, with complete occlusion in only one case and partial branch occlusion in another. These results confirm the impression that a high degree of accuracy in clip placement is possible with microsurgical technique. Routine postoperative angiography does not appear to be necessary if the surgeon has become skilled in the use of the microscope for aneurysm surgery.


2015 ◽  
Vol 21 (1) ◽  
pp. 50-54 ◽  
Author(s):  
Gaurav Jindal ◽  
Timothy Miller ◽  
Narlin Beaty ◽  
Ajit Puri ◽  
Dheeraj Gandhi

This study reports our initial clinical experience treating very small intracranial aneurysms using only Target® Nano™ coils. Retrospective angiographic and clinical analysis was performed on a non-randomized single arm registry of all intracranial aneurysms treated with only Target® Nano™ coils (1 mm and 1.5 mm diameter only) during a 12 month period at two academic hospitals. Fourteen patients with 14 intracranial aneurysms were treated. The maximum diameter of saccular aneurysms treated ranged from 1.5 to 3.5 mm; minimum aneurysm diameter was 1.1 to 2 mm. The immediate complete aneurysm occlusion rate was 86% (12/14), and a small residual within the aneurysm was seen in 14% (2/14) of cases. Packing density from coils ranged between 24% and 83% (mean 51%). The immediate complication rate was 0% (0/14). The angiographic/MR angiography follow-up period was 22 to 70 weeks (mean 37 weeks) with an overall complete occlusion rate of 9/11 (81%), recurrence in 18% (2/11), and lack of follow-up in three cases, two due to death during hospitalization and one procedure not yet due for imaging follow-up. Both patients who died presented with brain aneurysm ruptures prior to treatment. Both recurrences were retreated with repeat coiling procedures. Our initial results using only Target® Nano™ coils for the endovascular treatment of very small intracranial aneurysms have demonstrated initial good safety and efficacy profiles.


2012 ◽  
Vol 73 (suppl_1) ◽  
pp. ons80-ons85 ◽  
Author(s):  
Ketan R. Bulsara ◽  
Gregory A. Kuzmik ◽  
Ryan Hebert ◽  
Vincent Cheung ◽  
Charles C. Matouk ◽  
...  

Abstract BACKGROUND: Small, blister-like aneurysms (BLAs), by virtue of their unique morphology, are difficult to treat with conventional modalities. The use of oversized self-expanding stents as monotherapy for BLAs is a relatively new and promising concept that warrants further investigation. OBJECTIVE: To clarify the role of oversized self-expanding stents as monotherapy for BLAs. METHODS: Five consecutive patients were treated for BLAs with oversized self-expanding stents alone by the senior author (K.R.B.). We report on their clinical and radiographic outcomes. RESULTS: All 5 patients in our series were discharged in good clinical condition. Complete aneurysm occlusion was observed in all patients at the time of most recent radiographic follow-up. Mean follow-up time was 13.6 months (range, 1 month to 4.5 years). CONCLUSION: The use of oversized self-expanding stents to redirect flow away from aneurysms is an effective option for patients with BLAs. This approach represents an alternative to the use of flow diverters.


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