scholarly journals Safety and efficacy of the Pipeline embolization device for treatment of intracranial aneurysms: a pooled analysis of 3 large studies

2017 ◽  
Vol 127 (4) ◽  
pp. 775-780 ◽  
Author(s):  
David F. Kallmes ◽  
Waleed Brinjikji ◽  
Saruhan Cekirge ◽  
David Fiorella ◽  
Ricardo A. Hanel ◽  
...  

OBJECTIVEThe authors performed a pooled analysis of 3 studies—IntrePED (International Retrospective Study of the Pipeline Embolization Device), PUFS (Pipeline for Uncoilable or Failed Aneurysms Study), and ASPIRe (Aneurysm Study of Pipeline in an Observational Registry)—in order to assess angiographic outcomes and clinical safety of the Pipeline embolization device (PED).METHODSIntrePED was a retrospective study, while PUFS and ASPIRe were prospective studies. For each patient included in these studies, the authors collected baseline demographic data, aneurysm characteristics, and procedural details. The primary outcomes for this combined analysis were clinical outcomes, including neurological morbidity and mortality and major ipsilateral intracranial hemorrhage and ischemic stroke. The secondary outcomes were angiographic occlusion rates, which were available for ASPIRe and PUFS only.RESULTSA total of 1092 patients with 1221 aneurysms were included across the 3 studies. The mean aneurysm size was 12.0 ± 7.8 mm and the mean neck size was 6.6 ± 4.8 mm. The major ipsilateral ischemic stroke rate was 3.7% (40/1091). The major ipsilateral intracranial hemorrhage rate was 2.0% (22/1091). The major neurological morbidity rate was 5.7% (62/1091). The neurological mortality rate was 3.3% (36/1091). The combined major morbidity and neurological mortality rate was 7.1% (78/1091). The complete occlusion rates were 75.0% at 180 days (111/148) and 85.5% at 1 year (94/110). The overall aneurysm retreatment rate was 3.0% (33/1091) at a mean follow-up time of 10.2 ± 10.8 months.CONCLUSIONSEndovascular treatment of intracranial aneurysms with the PED is safe and effective. Angiographic occlusion rates progressed with follow-up. Rates of stroke, hemorrhage, morbidity and mortality, and retreatment were low, especially given the fact that the aneurysms treated were generally large and wide necked.

2016 ◽  
Vol 5 (1-2) ◽  
pp. 89-99 ◽  
Author(s):  
David F. Kallmes ◽  
Waleed Brinjikji ◽  
Edoardo Boccardi ◽  
Elisa Ciceri ◽  
Orlando Diaz ◽  
...  

Background and Objective: Few prospective studies exist evaluating the safety and efficacy of the Pipeline Embolization Device (PED) in the treatment of intracranial aneurysms. The Aneurysm Study of Pipeline In an observational Registry (ASPIRe) study prospectively analyzed rates of complete aneurysm occlusion and neurologic adverse events following PED treatment of intracranial aneurysms. Materials and Methods: We performed a multicenter study prospectively evaluating patients with unruptured intracranial aneurysms treated with PED. Primary outcomes included (1) spontaneous rupture of the Pipeline-treated aneurysm; (2) spontaneous nonaneurysmal intracranial hemorrhage (ICH); (3) acute ischemic stroke; (4) parent artery stenosis, and (5) permanent cranial neuropathy. Secondary endpoints were (1) treatment success and (2) morbidity and mortality at the 6-month follow-up. Vascular imaging was evaluated at an independent core laboratory. Results: One hundred and ninety-one patients with 207 treated aneurysms were included in this registry. The mean aneurysm size was 14.5 ± 6.9 mm, and the median imaging follow-up was 7.8 months. Twenty-four aneurysms (11.6%) were small, 162 (78.3%) were large and 21 (10.1%) were giant. The median clinical follow-up time was 6.2 months. The neurological morbidity rate was 6.8% (13/191), and the neurological mortality rate was 1.6% (3/191). The combined neurological morbidity/mortality rate was 6.8% (13/191). The most common adverse events were ischemic stroke (4.7%, 9/191) and spontaneous ICH (3.7%, 7/191). The complete occlusion rate at the last follow-up was 74.8% (77/103). Conclusions: Our prospective postmarket study confirms that PED treatment of aneurysms in a heterogeneous patient population is safe with low rates of neurological morbidity and mortality. Patients with angiographic follow-up had complete occlusion rates of 75% at 8 months.


Neurosurgery ◽  
2013 ◽  
Vol 73 (2) ◽  
pp. 193-200 ◽  
Author(s):  
Ignacio Arrese ◽  
Rosario Sarabia ◽  
Rebeca Pintado ◽  
Miguel Delgado-Rodriguez

Abstract BACKGROUND: Although the introduction of flow-diverter devices (FDDs) has aroused great enthusiasm, the level of evidence supporting their use has not been systematically evaluated. OBJECTIVE: To report a systematic review of medical literature up to May 2012 on FDDs to assess the morbidity, case fatality rate, and efficacy of FDDs for intracranial aneurysms. METHODS: The literature was searched by using MEDLINE, Embase, and all Evidence-Based Medicine in the OVID database. Eligibility criteria were studies including at least 10 patients, reporting duration of follow-up and number of patients lost to follow-up, and documenting the rate of aneurysm occlusion and death and neurological complications. The endpoints were angiographic success, early and late mortality, and neurological morbidity. RESULTS: Fifteen studies were analyzed consisting of 897 patients with 1018 aneurysms. The mean value of methodological quality score was 14.4 using the STROBE score. The early mortality rate was 2.8% (95% confidence interval [CI]: 1.7-3.8; I2 = 93.4%) and the late mortality rate was 1.3% (95% CI: 0.2-2.3; I2 = 36.9%). The early neurological morbidity rate was 7.3% (95% CI: 5.7-9; I2 = 91.8%) and the late morbidity rate was 2.6% (95% CI: 1.1-4; I2 = 81.3%). The Egger test for early and late morbidity and aneurysm occlusion was <0.001. CONCLUSION: With the available data from the studies, both heterogeneity and publication biases imply that the current clinical use of FDDs is not supported by high-quality evidence. In the absence of reliable evidence, the use of FDDs in patients eligible for more conventional treatments should be restricted to controlled clinical trials.


2019 ◽  
Vol 130 (6) ◽  
pp. 1997-2004 ◽  
Author(s):  
Ryuta Nakae ◽  
Masaya Nagaishi ◽  
Yosuke Kawamura ◽  
Yoshihiro Tanaka ◽  
Akio Hyodo ◽  
...  

OBJECTIVEThe authors sought to demonstrate that hemorrhagic transformation of ischemic lesions is the main cause of delayed intracerebral hemorrhage (ICH) after Pipeline embolization device (PED) treatment and to estimate the rate of hemorrhagic transformation of new postprocedure ischemic lesions.METHODSPatients who underwent PED placement (PED group) from November 2015 to March 2017 or stent-mediated embolization (EN group) from December 2010 to October 2015 were retrospectively analyzed. Pre- and postprocedural MR images and 6-month follow-up MR images for each patient were scored for the presence of postprocedural bland ischemic and hemorrhagic lesions using diffusion-weighted MRI (DWI) and T2*-weighted MRI (T2*WI), respectively.RESULTSThe PED group comprised 28 patients with 30 intracranial aneurysms, and the EN group comprised 24 patients with 27 intracranial aneurysms. The mean number of ischemic lesions on DWI 1 day postprocedure was higher in the PED group than in the EN group (5.2 vs 2.7, p = 0.0010). The mean number of microbleeds detected on T2*WI 6 months postprocedure was higher in the PED group than in the EN group (0.6 vs 0.15, p = 0.028). A total of 36.7% of PED-treated patients exhibited new microbleeds on T2*WI at 6 months postprocedure, with at least 77.8% of these lesions representing hemorrhagic transformations of the new ischemic lesions observed on day 1 postprocedure. The rate of adjunctive coil embolization (27.3% vs 0.0%, p = 0.016) and the mean number of ischemic lesions observed 1 day postprocedure (6.6 vs 4.3, p = 0.020) were predictors of subsequent microbleeds in the PED group.CONCLUSIONSNew microbleeds detected using T2*WI at 6 months postprocedure were more common after PED treatment than after stent-mediated embolization. Approximately three-quarters of these lesions were hemorrhagic transformations of new ischemic lesions observed on day 1 postprocedure. Prevention of intraprocedural or postprocedural infarcts is necessary to reduce the risk of hemorrhagic complications following PED placement.


2013 ◽  
Vol 19 (3) ◽  
pp. 283-288 ◽  
Author(s):  
Conghui Li ◽  
Youxiang Li

This study aimed to report the results and outcome of stent-assisted coiling of ruptured wide-necked intracranial aneurysms. We retrospectively reviewed 19 consecutive patients (11 men, eight women; mean age, 59.5 years; range, 43–78 years) with acutely ruptured wide-necked intracranial aneurysms who were treated with stent-assisted coil embolization. The mean length of angiographic follow-up was 5.2 months (range, 3–10 months). There was no technique-related complication and the 30-day mortality rate was 10.5% (two of 19). There was one case of rebleeding, and clinical outcome was poor for the patient (5.3% [one of 19] who had a Glasgow Outcome Scale score of 2 at the end of the study period). Stent-assisted coiling is a feasible treatment for ruptured wide-necked intracranial aneurysms that are difficult to treat surgically or with balloon-assisted embolization.


2021 ◽  
pp. 159101992199050
Author(s):  
Erol Akgul ◽  
Hasan Bilen Onan ◽  
Irem Islek ◽  
Mehmet Tonge ◽  
Yavuz Durmus ◽  
...  

Background We assessed the safety and efficacy of flow diverter stents (FDSs) in the treatment of recanalized or residual intracranial aneurysms treated endovascularly. Materials & Methods Patients whose recanalized or residual aneurysms were treated with FDSs in five tertiary hospitals were reviewed retrospectively. The patients’ demographic data, aneurysm characteristics, types of previous treatment, and clinical complications, or serious adverse events associated with FDSs, as well as the results of neurological and angiographic follow-up assessments, were recorded. Results Eighty-six patients (37 males) with 87 aneurysms were included in this study. Eighty (91.9%) aneurysms were in the anterior and seven (8.1%) in the posterior circulation. The initial treatment methods were the primary coiling or balloon remodeling technique in 69 (79.3%) and stent-assisted coiling in 18 (20.7%) aneurysms. The endovascular procedure was successful in all patients. Complications occurred in four patients, for a total complication rate of 4.6%. A technical complication developed in one patient (1.2%). An in-stent thrombosis treated with tirofiban was seen in two cases. Late in-stent stenosis exceeding 50% was treated with balloon angioplasty in one patient. The mean length of follow-up was 21.0 months. The first angiographic follow-up (3–6 months) revealed the complete occlusion of 74 aneurysms (85.1%). While 76 aneurysms (87.4%) were occluded at the last angiographic follow-up (mean: 26.0 months), 11 aneurysms (12.6%) were still filling. Morbimortality was zero. Conclusion The drawback of endovascular treatment is aneurysmal remnants or recurrences, which is safely and durably amenable to flow diversion.


Author(s):  
Rafique Umer Harvitkar ◽  
Abhijit Joshi

Abstract Introduction Laparoscopic fundoplication (LF) has almost completely replaced the open procedure performed for gastroesophageal reflux disease (GERD) and hiatus hernia (HH). Several studies have suggested that long-term results with surgery for GERD are better than a medical line of management. In this retrospective study, we outline our experience with LF over 10 years. Also, we analyze the factors that would help us in better patient selection, thereby positively affecting the outcomes of surgery. Patients and Methods In this retrospective study, we identified 27 patients (14 females and 13 males) operated upon by a single surgeon from 2010 to 2020 at our institution. Out of these, 25 patients (12 females and 13 males) had GERD with type I HH and 2 (both females) had type II HH without GERD. The age range was 24 to 75 years. All patients had undergone oesophago-gastro-duodenoscopy (OGD scopy). A total of 25 patients had various degrees of esophagitis. Two patients had no esophagitis. These patients were analyzed for age, sex, symptoms, preoperative evaluation, exact procedure performed (Nissen’s vs. Toupet’s vs. cruroplasty + gastropexy), morbidity/mortality, and functional outcomes. They were also reviewed to examine the length of stay, length of procedure, complications, and recurrent symptoms on follow-up. Symptoms were assessed objectively with a score for six classical GERD symptoms preoperatively and on follow-up at 1-, 4- and 6-weeks postsurgery. Further evaluation was performed after 6 months and then annually for 2 years. Results 14 females (53%) and 13 males (48%) with a diagnosis of GERD (with type I HH) and type II HH were operated upon. The mean age was 46 years (24–75 years) and the mean body mass index (BMI) was 27 (18–32). The range of duration of the preoperative symptoms was 6 months to 2 years. The average operating time dropped from 130 minutes for the first 12 cases to 90 minutes for the last 15 cases. The mean hospital stay was 3 days (range: 2–4 days). In the immediate postoperative period, 72% (n = 18) of the patients reported improvement in the GERD symptoms, while 2 (8%) patients described heartburn (grade I, mild, daily) and 1 (4%) patient described bloating (grade I, daily). A total of 5 patients (20%) reported mild dysphagia to solids in the first 2 postoperative weeks. These symptoms settled down after 2 to 5 weeks of postoperative proton-pump inhibitor (PPI) therapy and by adjusting consistency of oral feeds. There was no conversion to open, and we observed no perioperative mortality. There were no patients who underwent redo surgeries in the series. Conclusion LF is a safe and highly effective procedure for a patient with symptoms of GERD, and it gives long-term relief from the symptoms. Stringent selection criteria are necessary to optimize the results of surgery. Experience is associated with a significant reduction of operating time.


Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Johanna Ospel ◽  
Michael D Hill ◽  
Nima Kashani ◽  
Arnuv Mayank ◽  
Nishita Singh ◽  
...  

Purpose: We investigated the prevalence and prognostic impact on outcome of any intracranial hemorrhage, hemorrhage morphology, type and volume in acute ischemic stroke patients undergoing mechanical thrombectomy. Methods: Prevalence of intracranial hemorrhage, hemorrhage type, morphology and volume was determined on 24h follow-up imaging (non contrast head CT or gradient-echo/susceptibility-weighted MRI). Proportions of good outcome (mRS 0-2 at 90 days) were reported for patients with vs. without any intracranial hemorrhage. Multivariable logistic regression with adjustment for key minimization variables and total infarct volume was performed to obtain adjusted effect size estimates for hemorrhage type and volume on good outcome. Results: Hemorrhage on follow up-imaging was seen in 372/1097 (33.9%) patients, among them 126 (33.9%) with hemorrhagic infarction (HI) type 1, 108 (29.0%) with HI-2, 72 /19.4%) with parenchymal hematoma (PH) type 1, 37 (10.0) with PH2, 8 (2.2%) with remote PH and 21 (5.7%) with extra-parenchymal/intraventricular hemorrhage. Good outcomes were less often achieved by patients with hemorrhage on follow-up imaging (164/369 [44.4%] vs. 500/720 [69.4%]). Any type of intracranial hemorrhage was strongly associated with decreased chances of good outcome ( adj OR 0.62 [CI 95 0.44 - 0.87]). The effect of hemorrhage was driven by both PH hemorrhage sub-type [PH-1 ( adj OR 0.39 [CI 95 0.21 - 0.72]), PH-2 ( adj OR 0.15 [CI 95 0.05 - 0.50])] and extra-parenchymal/intraventricular hemorrhage ( adj OR 0.60 (0.20-1.78) Petechial hemorrhages (HI-1 and HI-2) were not associated with poorer outcomes. Hemorrhage volume ( adj OR 0.97 [CI 95 0.05 - 0.99] per ml increase) was significantly associated with decreased chances of good outcome. Conclusion: Presence of any hemorrhage on follow-up imaging was seen in one third of patients and strongly associated with decreased chances of good outcome.


Author(s):  
Juan Vivanco‐Suarez ◽  
Alan Mendez‐Ruiz ◽  
Farooqui Mudassir ◽  
Cynthia B Zevallos ◽  
Milagros Galecio‐Castillo ◽  
...  

Introduction : Flow diversion has established itself as standard treatment of wide complex intracranial aneurysms (IA). Its recognition has been validated with positive occlusion rates and favorable clinical outcomes. The Surpass Streamline (SS) flow diverter (FD) is a braided cobalt/chromium alloy implant with 72 or 96 wires approved by the FDA in 2018. The aim of this study is to determine the safety and efficacy of the SS in a post‐marketing large US cohort. Methods : We performed a multicenter, retrospective study for consecutive patients treated with the SS FD for IA between January 2018 and June 2021 in the United States. Inclusion criteria for participants were: 1. Adults (≥ 18 years) and 2. Treatment with SS FD for IA. Primary safety end point was a major ipsilateral stroke (increase in National Institutes of Health Stroke Scale Score of ≥ 4) or neurological death within 12 months. Primary efficacy was assessed using the 3‐point Raymond‐Roy (RR) occlusion scale on digital subtraction angiography (DSA) at 6‐12‐month follow‐up. Results : A total of 276 patients with 313 aneurysms were enrolled. The median age was 59 years and 199 (72%) were females. The most common comorbidities included hypertension in 156 (57%) subjects followed by hyperlipidemia in 76 (28%) patients. One hundred and twenty‐two (44%) patients were asymptomatic while subarachnoid hemorrhage was present in only 10 (4%) patients. A total of 143 (46%) aneurysms were left‐sided. Aneurysms were located as follows: 274 (88%) were in the anterior circulation with paraophthalmic being the most common in 120 (38%) followed by petrocavernous ICA in 81 (26%); 33 (11%) aneurysms were located in the posterior circulation with basilar trunk being the most common in 14 (5%). The mean maximum aneurysm dome width was 5.77 ± 4.7 mm, neck width 4.22 ± 3.8 mm and dome to neck ratio was 1.63 ± 1.3 mm. The mean number of SS FD implanted per aneurysm was 1.06 (range 1–3) with more than one SS FD implanted in 21 (7%) aneurysms. Modified Rankin Scale (mRS) of 0–2 was present in 206/213 (97%) patients at 6–12 month follow‐up. The complete aneurysm occlusion (RR 1) rate was 145/175 (83%) among subjects who had angiographic follow‐up at 6–12 months. Major stroke and death was encountered in 7 (2%) and 5 (1.8%) of the patients respectively. Conclusions : Our data represent the largest real‐world study using SS FD. These results corroborate its post‐marketing safety and efficacy for the treatment of intracranial aneurysms showing more favorable rates to the initial experience during SCENT trial.


2018 ◽  
Vol 11 (5) ◽  
pp. 485-488 ◽  
Author(s):  
Amit Pujari ◽  
Brian Matthew Howard ◽  
Thomas P Madaelil ◽  
Susana Libhaber Skukalek ◽  
Anil K Roy ◽  
...  

BackgroundThe pipeline embolization device (PED) is approved for the treatment of large aneurysms of the proximal internal carotid artery (ICA). Its off-label application in treating aneurysms located specifically at the ICA terminus (ICA-T) has not been studied.MethodsWe conducted a retrospective chart review of patients from 2011 to 7 treated with PEDs. Out of 365 patients, 10 patients with ICA-T aneurysms were included. Patient demographics, procedural information, follow-up imaging, and clinical assessments were recorded.ResultsMean age was 46.9 years (± 8.8), and 6 (60%) patients were women. The mean maximum diameter of the aneurysms treated was 14.7 mm (± 10.7) and the mean neck diameter was 9.3 mm (± 6.6). Reasons for presentation included six incidental findings, one acute subarachnoid hemorrhage (SAH), and three patients with prior SAH. Kamran–Byrne Occlusion Scale scores for the treated aneurysms were as follows: three class IV (complete obliteration), four class III (<50% filling in both height and width for fusiform aneurysms or residual neck for saccular aneurysms), one class II fusiform aneurysm, 1 class 0 saccular aneurysm (residual aneurysm body), and one not classified due to pipeline thrombosis. Two clinically asymptomatic complications were noted: one patient who had a small distal cortical SAH post PED and one patient whose stent was found to be thrombosed on follow-up angiogram. All patients were seen in follow-up, and no patients were found to have worsening of their pre-procedure modified Rankin Scale score.ConclusionThe PED has potential for treating ICA-T aneurysms not amenable to conventional treatment strategies. Further studies are warranted to confirm the long term outcomes.


2020 ◽  
pp. 1-9
Author(s):  
Alejandro Tomasello ◽  
David Hernandez ◽  
Laura Ludovica Gramegna ◽  
Sonia Aixut ◽  
Roger Barranco Pons ◽  
...  

OBJECTIVEThe goal of this study was to evaluate the effectiveness and safety of a new noncompletely occlusive net-assisted remodeling technique in which the Cascade net device is used for temporary bridging of intracranial aneurysms.METHODSBetween July 2018 and May 2019, patients underwent coil embolization with the Cascade net device within 4 centers in Europe. Analysis of angiographic (modified Raymond-Roy classification [MRRC]) and clinical outcomes data was conducted immediately following treatment and at the 6-month follow-up.RESULTSFifteen patients were included in the study (mean age 58 ± 13 years, 11/15 [73.3%] female). Ten patients had unruptured aneurysms, and 5 presented with ruptured aneurysms with acute subarachnoid hemorrhage. The mean aneurysm dome length was 6.27 ± 2.33 mm and the mean neck width was 3.64 ± 1.19 mm. Immediately postprocedure, MRRC type I (complete obliteration) was achieved in 11 patients (73.3%), whereas a type II (residual neck) was achieved in 4 patients (26.7%). Follow-up examination was performed in 7/15 patients and showed stabilization of aneurysm closure with no thromboembolic complications and only 1 patient with an increased MRRC score (from I to II) due to coil compression.CONCLUSIONSInitial experience shows that the use of a new noncompletely occlusive net-assisted remodeling technique with the Cascade net device may be safe and effective for endovascular coil embolization of intracranial aneurysms.


Sign in / Sign up

Export Citation Format

Share Document