scholarly journals Pipeline Embolization Device for Small Intracranial Aneurysms: Evaluation of Safety and Efficacy in a Multicenter Cohort

Neurosurgery ◽  
2017 ◽  
Vol 80 (4) ◽  
pp. 579-587 ◽  
Author(s):  
Christoph J. Griessenauer ◽  
Christopher S. Ogilvy ◽  
Paul M. Foreman ◽  
Michelle H. Chua ◽  
Mark R. Harrigan ◽  
...  
Keyword(s):  
Clinical Outcome ◽  
Intracranial Aneurysms ◽  
The United States ◽  
Complication Rates ◽  
Cumulative Number ◽  
Radiographic Outcome ◽  
Pipeline Embolization Device ◽  
Safety And Efficacy ◽  
Multicenter Cohort ◽  
Procedural Complications

Abstract BACKGROUND: To date, the use of the flow-diverting Pipeline Embolization Device (PED) for small intracranial aneurysms (≤ 7 mm) has been reported only in single-center series. OBJECTIVE: To evaluate the safety and efficacy of the PED in a multicenter cohort. METHODS: Five major academic institutions in the United States provided data on patient demographics, aneurysm features, and treatment characteristics of consecutive patients with aneurysms ≤ 7 mm treated with a PED between 2009 and 2015. Radiographic outcome was assessed with digital subtraction angiography. Clinical outcome was measured with the modified Rankin Scale. RESULTS: The cumulative number of aneurysms ≤ 7 mm treated with PED at the 5 institutions was 149 in 117 patients (age, 54 years [range, 29-87 years]; male to female, 1-5.9). Aneurysms were most commonly located in the paraophthalmic segment (67.1%) of the internal carotid artery. Radiographic outcome at last follow-up was available for 123 aneurysms (82.6%), with a complete occlusion rate of 87%. Thromboembolic and symptomatic procedural complications occurred in 8.7% and 6% of the aneurysms treated, respectively. There was 1 mortality (0.9%) unrelated to the PED procedure. Multivariable logistic regression identified size < 4 mm, balloon angioplasty to open the device, and simultaneous treatment of multiple aneurysms as predictors of procedural complications. Good clinical outcome was achieved in 96% of electively treated patients. CONCLUSION: In the largest series on PED for small aneurysms to date, data suggest that treatment with the flow-diverting PED is safe and efficacious, with complication rates comparable to those for traditional endovascular techniques.

scholarly journals Safety and efficacy of the Pipeline Embolization Device in 100 small intracranial aneurysms

2015 ◽  
Vol 122 (6) ◽  
pp. 1498-1502 ◽  
Author(s):  
Nohra Chalouhi ◽  
Mario Zanaty ◽  
Alex Whiting ◽  
Steven Yang ◽  
Stavropoula Tjoumakaris ◽  
...  
Keyword(s):  
Intracranial Aneurysms ◽  
Complication Rates ◽  
Anterior Circulation ◽  
Pipeline Embolization Device ◽  
Safety And Efficacy ◽  
Aneurysm Size ◽  
Long Term Follow Up ◽  
Aneurysm Occlusion ◽  
Small Aneurysms

OBJECT Flow diverters are increasingly used for treatment of intracranial aneurysms. In most series, the Pipeline Embolization Device (PED) was used for the treatment of large, giant, complex, and fusiform aneurysms. Little is known about the use of the PED in small aneurysms. The purpose of this study was to assess the safety and efficacy of the PED in small aneurysms (≤ 7 mm). METHODS A total of 100 consecutive patients were treated with the PED at the authors' institution between May 2011 and September 2013. Data on procedural safety and efficacy were retrospectively collected. RESULTS The mean aneurysm size was 5.2 ± 1.5 mm. Seven patients (7%) had sustained a subarachnoid hemorrhage. All except 5 aneurysms (95%) arose from the anterior circulation. The number of PEDs used was 1.2 per aneurysm. Symptomatic procedure-related complications occurred in 3 patients (3%): 1 distal parenchymal hemorrhage that was managed conservatively and 2 ischemic events. At the latest follow-up (mean 6.3 months), 54 (72%) aneurysms were completely occluded (100%), 10 (13%) were nearly completely occluded (≥ 90%), and 11 (15%) were incompletely occluded (< 90%). Six aneurysms (8%) required further treatment. Increasing aneurysm size (OR 3.8, 95% CI 0.99–14; p = 0.05) predicted retreatment. All patients achieved a favorable outcome (modified Rankin Scale Score 0–2) at follow-up. CONCLUSIONS In this study, treatment of small aneurysms with the PED was associated with low complication rates and high aneurysm occlusion rates. These findings suggest that the PED is a safe and effective alternative to conventional endovascular techniques for small aneurysms. Randomized trials with long-term follow-up are necessary to determine the optimal treatment that leads to the highest rate of obliteration and the best clinical outcomes.

DEFINING THE RISK OF RETREATMENT FOR ANEURYSM RECURRENCE OR RESIDUAL AFTER INITIAL TREATMENT BY ENDOVASCULAR COILING

Neurosurgery ◽  
2009 ◽  
Vol 65 (2) ◽  
pp. 311-315 ◽  
Author(s):  
Andrew J. Ringer ◽  
Rafael Rodriguez-Mercado ◽  
Erol Veznedaroglu ◽  
Elad I. Levy ◽  
Ricardo A. Hanel ◽  
...  
Keyword(s):  
Intracranial Aneurysms ◽  
Surgical Repair ◽  
The United States ◽  
Patient Treatment ◽  
Endovascular Coiling ◽  
Total Risk ◽  
Clinical Recurrence ◽  
Choice Of Treatment ◽  
Procedural Complications

Abstract OBJECTIVE Endovascular treatment of intracranial aneurysms is less invasive than surgical repair but poses a higher risk for aneurysm recurrence, which may necessitate retreatment, thus adding to the long-term risk. Cerebrovascular neurosurgeons from 8 institutions in the United States and Puerto Rico collaborated to assess the risk of retreatment for residual or recurrent aneurysms after the initial endovascular coiling. METHODS Data were prospectively recorded for 311 patients with coiled intracranial aneurysms who underwent 352 retreatment procedures after angiographic or clinical recurrence (hemorrhage after initial coiling). Results analyzed included procedural complications and procedure-related morbidity. Morbidity was classified as major (modified Rankin scale score &gt; 3) or minor, and temporary (&lt;30 days) or permanent (&gt;30 days). RESULTS Retreatment mortality was 0.85% per procedure and 0.96% per patient. Treatment-related rates were 0.32% per patient (0.28% per procedure) for permanent or temporary major disability; 1.29% for permanent minor disability (1.14% per procedure); and 1.61% for temporary minor disability (1.42% per procedure). Total risk for death or permanent major disability was 1.28% per patient and 1.13% per procedure. CONCLUSION Retreatment poses a low risk for patients with recurrences of intracranial aneurysms after initial coiling; this risk is smaller than that posed by the initial endovascular therapy. The risk of disability associated with retreatment for aneurysm recurrence after coiling must be considered prospectively in the choice of treatment but with the recognition that its effects are low in the overall management risk.

Abstract 1122‐000142: Safety and Efficacy of Surpass Streamline for Intracranial Aneurysms: A Multicenter US Real‐World Experience (SESSIA)

2021 ◽  
Vol 1 (S1) ◽  
Author(s):  
Juan Vivanco‐Suarez ◽  
Alan Mendez‐Ruiz ◽  
Farooqui Mudassir ◽  
Cynthia B Zevallos ◽  
Milagros Galecio‐Castillo ◽  
...  
Keyword(s):  
Real World ◽  
Intracranial Aneurysms ◽  
The United States ◽  
Chromium Alloy ◽  
Cobalt Chromium ◽  
Anterior Circulation ◽  
Safety And Efficacy ◽  
Post Marketing ◽  
The Mean

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.

A2, M2, P2 aneurysms and beyond: results of treatment with pipeline embolization device in 65 patients

2019 ◽  
Vol 11 (9) ◽  
pp. 903-907 ◽  
Author(s):  
Christopher T Primiani ◽  
Zeguang Ren ◽  
Peter Kan ◽  
Ricardo Hanel ◽  
Vitor Mendes Pereira ◽  
...  
Keyword(s):  
Clinical Outcome ◽  
Cerebral Artery ◽  
Intracranial Aneurysms ◽  
Flow Diversion ◽  
Vascular Pathology ◽  
Parent Vessel ◽  
Rare Type ◽  
Pipeline Embolization Device ◽  
Aneurysm Size

BackgroundIntracranial aneurysms located in the distal vessels are rare and remain a challenge to treat through surgical or endovascular interventions.ObjectiveTo describe a multicenter approach with flow diversion using the pipeline embolization device (PED) for treatment of distal intracranial aneurysms.MethodsCases of distal intracranial aneurysms defined as starting on or beyond the A2 anterior cerebral artery, M2 middle cerebral artery, and P2 posterior cerebral artery segments were included in the final analysis.Results65 patients with distal aneurysms treated with the PED were analyzed. Median aneurysm size at the largest diameter was 7.0 mm, 60% were of a saccular morphology, and 9/65 (13.8%) patients presented in the setting of acute rupture. Angiographic follow-up data were available for 53 patients, with a median follow-up time of 6 months: 44/53 (83%) aneurysms showed complete obliteration, 7/53 (13.2%) showed reduced filling, and 2/53 (3%) showed persistent filling. There was no association between patient characteristics, including aneurysm size (P=0.36), parent vessel diameter (P=0.27), location (P=0.81), morphology (P=0.63), ruptured status on admission (P=0.57), or evidence of angiographic occlusion at the end of the embolization procedure (P=0.49). Clinical outcome data were available for 60/65 patients: 95% (57/60) had good clinical outcome (modified Rankin Scale score of 0–2) at 3 months.ConclusionsThis large multicenter study of patients with A2, M2, and P2 distal aneurysms treated with the PED showed that flow diversion may be an effective treatment approach for this rare type of vascular pathology. The procedural compilation rate of 7.7% indicates the need for further studies as the flow diversion technology constantly evolves.

E-020 Safety and Efficacy of the Pipeline Embolization Device in 100 Small Intracranial Aneurysms

2014 ◽  
Vol 6 (Suppl 1) ◽  
pp. A46.3-A47
Author(s):  
N Chalouhi ◽  
M Zanaty ◽  
A Whiting ◽  
S Yang ◽  
S Tjoumakaris ◽  
...  
Keyword(s):  
Intracranial Aneurysms ◽  
Pipeline Embolization Device ◽  
Safety And Efficacy

Abstract 1122‐000060: Endovascular Treatment of Large Intracranial Aneurysms Using Large Volume Coils: Safety and Efficacy

2021 ◽  
Vol 1 (S1) ◽  
Author(s):  
Giancarlo Saal Zapata ◽  
Giancarlo Saal‐Zapata ◽  
Dante Valer‐Gonzales ◽  
Ivethe Preguntegui‐Loayza ◽  
Aaron Rodriguez‐Calienes ◽  
...  
Keyword(s):  
Clinical Outcome ◽  
Large Volume ◽  
Intracranial Aneurysms ◽  
Categorical Variables ◽  
Parent Artery ◽  
Safety And Efficacy ◽  
Maximal Diameter ◽  
Paraclinoid Aneurysms ◽  
The Mean

Introduction : Large volume coils in the treatment of intracranial aneurysms have demonstrated better packing density, shorter operative times, less number of coils per aneurysm and better cost‐effectiveness. However, most of the studies evaluated these coils in small or medium sized aneurysms. Therefore, our study aimed to determine our experience using large volume coils in the treatment of large intracranial aneurysms and determine its safety and efficacy. Methods : We retrospectively reviewed consecutive cases of intracranial aneurysms treated with Penumbra Coils 400 (PC400) at our institution between May 2016 and September 2019. Aneurysms > 12 mm in maximal diameter were selected according to the ISUIA trial. Clinical and radiological variables were collected. The modified Rankin Scale (mRS) was used to determine the clinical outcome and was dichotomized (good clinical outcome: mRS £2; poor clinical outcome: mRS >2). The Raymond Roy occlusion classification (RROC) was used to determine obliterations rates. An adequate obliteration was defined as RROC 1 or 2. Categorical variables were expressed as percentages and continuous variables as mean ± standard deviation. Stata v14 software was used for the analysis. Results : Eighteen patients harboring 18 intracranial aneurysms were treated. The mean age was 55 ± 12 years and 14 patients (78%) were women. A good preoperative clinical condition was found in 13 patients (72%). Ten aneurysms were unruptured (56%) and eight were dysplastic (44%). Paraclinoid aneurysms were the most frequently treated (61%). The mean number of coils were 6.2/aneurysm. The mean maximal diameter and neck were 18.9 ± 4.3 mm, and 5.7 ± 2.6 mm, respectively. The mean aspect ratio (AR) was 4 ± 1.9. Coiling was used in 10 cases (56%) followed by stent‐assisted coiling in 7 cases (39%) and balloon‐assisted coiling in 1 case. An immediate adequate obliteration rate was found in 8 cases (44%). Intraoperative complications occurred in two patients in which a coil loop migrated to the parent artery and a stent was placed without clinical consequences. In twelve patients (67%), angiographic follow‐up was performed. The mean follow‐up duration was 9.7 months. Nine patients (75%) showed a complete obliteration (RROC 1), whereas in three patients a residual aneurysm was still present. A good postoperative clinical outcome at discharge was found in 14 patients (78%). Procedure‐related morbidity and mortality were not reported. Conclusions : Embolization with large volume coils is a safe and effective alternative to conventional coils, with high obliteration rates at mid‐term follow‐up. Longer duration of angiographic follow‐up are needed in order to confirm the results presented here.

Long-term Economic Impact of Coiling vs Clipping for Unruptured Intracranial Aneurysms

Neurosurgery ◽  
2013 ◽  
Vol 72 (6) ◽  
pp. 1000-1013 ◽  
Author(s):  
Shivanand P. Lad ◽  
Ranjith Babu ◽  
Michael S. Rhee ◽  
Robbi L. Franklin ◽  
Beatrice Ugiliweneza ◽  
...  
Keyword(s):  
Postoperative Complications ◽  
Propensity Score ◽  
Propensity Score Matching ◽  
Intracranial Aneurysms ◽  
The United States ◽  
Endovascular Coiling ◽  
Complication Rates ◽  
Surgical Clipping ◽  
Unruptured Intracranial Aneurysms ◽  
Reoperation Rates

Abstract BACKGROUND: Treatment of unruptured intracranial aneurysms (UIAs) involves endovascular coiling or aneurysm clipping. While many studies have compared these treatment modalities with respect to various clinical outcomes, few studies have investigated the economic costs associated with each procedure. OBJECTIVE: To determine the reoperation rate, postoperative complications, and inpatient and outpatient costs associated with surgical or endovascular treatment of patients with UIAs in the United States. METHODS: We utilized the MarketScan database to examine patients who underwent surgical clipping or endovascular coiling procedures for UIAs from 2000 to 2009, comparing reoperation rates, complications, and angiogram and healthcare resource use. Propensity score matching techniques were used to match patients. RESULTS: We identified 4,504 patients with surgically treated UIAs, with propensity score matching of 3,436 patients. Reoperation rates were significantly lower in the clipping group compared to the coiling group at 1- (P &lt; .001), 2- (P &lt; .001), and 5 years (P &lt; .001) following the procedure. However, postoperative complications (immediate, 30 and 90 days) were significantly higher in those undergoing surgical clipping. Although hospital length of stay and costs were higher in the clipping group for the index procedure, the number of postoperative angiograms and outpatient services used at 1, 2, and 5 years were significantly higher in the coiling group. CONCLUSION: Though surgical clipping resulted in lower reoperation rates, it was associated with higher complication rates and initial costs. However, overall costs at 2 and 5 years were similar to endovascular coiling due to the significantly higher number of follow-up angiograms and outpatient costs in these patients.

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