Versatile use of catheter systems for deployment of the Pipeline embolization device: a comparison of biaxial and triaxial catheter systems

2020 ◽  
Vol 12 (6) ◽  
pp. 585-590
Author(s):  
Kunal Vakharia ◽  
Muhammad Waqas ◽  
Hakeem J Shakir ◽  
Felix Chin ◽  
Joelle N Hartke ◽  
...  

BackgroundA Pipeline embolization device (PED; Medtronic, Dublin, Ireland) can be deployed using either a biaxial or a triaxial catheter delivery system.ObjectiveTo compare the use of these two catheter delivery systems for intracranial aneurysm treatment with the PED.MethodsA retrospective study of patients undergoing PED deployment with biaxial or triaxial catheter systems between 2014 and 2016 was conducted. Experienced neurointerventionalists performed the procedures. Patients who received multiple PEDs or adjunctive coils were excluded. The two groups were compared for PED deployment time, total fluoroscopy time, patient radiation exposure, complications, and cost.ResultsEighty-two patients with 89 intracranial aneurysms were treated with one PED each. In 49 cases, PEDs were deployed using biaxial access; triaxial access was used in 33 cases. Time (min) from guide catheter run to PED deployment was significantly shorter in the biaxial group (24.0±18.7 vs 38.4±31.1, P=0.006) as was fluoroscopy time (28.8±23.0 vs 50.3±27.1, P=0.001). Peak radiation skin exposure (mGy) in the biaxial group was less than in the triaxial group (1243.7±808.2 vs 2074.6±1505.6, P=0.003). No statistically significant differences were observed in transient and permanent complication rates or modified Rankin Scale scores at 30 days. The triaxial access system cost more than the biaxial access system (average $3285 vs $1790, respectively). Occlusion rates at last follow-up (mean 6 months) were similar between the two systems (average 88.1%: biaxial, 89.2%: triaxial).ConclusionOur results indicate near-equivalent safety and effectiveness between biaxial and triaxial approaches. Some reductions in cost and procedure time were noted with the biaxial system.

2018 ◽  
Vol 2018 ◽  
pp. 1-10 ◽  
Author(s):  
Ali H. Hachem ◽  
Joseph E. Marine ◽  
Housam A. Tahboub ◽  
Sana Kamdar ◽  
Shaffi Kanjwal ◽  
...  

Background. Pulmonary vein isolation is commonly performed using radiofrequency energy with cryoablation gaining acceptance. We performed a meta-analysis of randomized controlled trials which compared radiofrequency versus cryoablation for patients with atrial fibrillation. Methods. A systematic search strategy identified both published and unpublished articles from inception to November 10, 2016, in multiple databases. The primary outcomes for this meta-analysis were long-term freedom from atrial fibrillation at 12-month follow-up and overall postoperative complication rates. For all included studies, the methodological quality was assessed through the Cochrane Collaboration’s tool for risk of bias. Results. A total of 247 articles were identified with eight being included in this review as they satisfied the prespecified inclusion criteria. Overall, there was no significant difference in freedom from atrial fibrillation at ≥12-month follow-up between those receiving cryoballoon and radiofrequency ablation, respectively (OR = 0.98, CI = 0.67–1.43, I2 = 56%, p=0.90). Additionally, the secondary outcomes of duration of ablation, fluoroscopy time, and ablation time failed to reach significance. Cryoballoon ablation had significantly greater odds of postoperative phrenic nerve injury at 12-month follow-up. Conclusions. Our meta-analysis suggests that cryoballoon ablation provides comparable benefits with regard to freedom from atrial fibrillation at medium-term follow-up, fluoroscopy time, ablation time, operative duration, and overall complication rate in comparison to radiofrequency ablation.


2014 ◽  
Vol 8 (1) ◽  
pp. 30-37 ◽  
Author(s):  
Ramsey Ashour ◽  
Stephen Dodson ◽  
M Ali Aziz-Sultan

BackgroundIntracranial blister aneurysms are rare lesions that are notoriously more difficult to treat than typical saccular aneurysms. High complication rates associated with surgery have sparked considerable interest in endovascular techniques, though not well-studied, to treat blister aneurysms.ObjectiveTo evaluate our experience using various endovascular approaches to treat blister aneurysms.MethodsAll consecutive blister aneurysms treated using an endovascular approach by the study authors over a 3-year period were retrospectively analyzed. A literature review was also performed.ResultsNine patients with blister aneurysms underwent 11 endovascular interventions. In various combinations, stents were used in 8/11, coils in 5/11, and Onyx in 3/11 procedures. At mean angiographic follow-up of 200 days, 8/9 aneurysms were completely occluded by endovascular means alone requiring no further treatment and 1/9 aneurysms required surgical bypass/trapping after one failed surgical and two failed endovascular treatments. At mean clinical follow-up of 416 days, modified Rankin Scale scores were improved in six patients, stable in two, and worsened in one patient. One complication occurred in 11 procedures (9%), resulting in a permanent neurologic deficit. No unintended endovascular parent vessel sacrifice, intraprocedural aneurysmal ruptures, antiplatelet-related complications, post-treatment aneurysmal re-ruptures, or deaths occurred.ConclusionThis series highlights both the spectrum and limitations of endovascular techniques currently used to treat blister aneurysms, including a novel application of stent-assisted Onyx embolization. Long-term follow-up and experience in larger studies are required to better define the role of endovascular therapy in the management of these difficult lesions.


2008 ◽  
Vol 109 (6) ◽  
pp. 1083-1090 ◽  
Author(s):  
Xianli Lv ◽  
Chuhan Jiang ◽  
Youxiang Li ◽  
Zhongxue Wu

Object Use of the Onyx liquid embolic system has become an option for treating dural arteriovenous fistulas (DAVFs) because of its advantageous nonadhesive and cohesive properties. However, the complication rates associated with the use of this system have not been reported. The authors present their initial experience of the risks related to transarterial embolization using this system. Methods Between February 2005 and February 2007, 31 patients with DAVFs were treated at Beijing Tiantan Hospital. Transarterial embolization using Onyx-18 was performed as a preoperative adjunct or as definitive therapy. The demographic characteristics, angiographic features, clinical presentation, treatment, and outcome of the patients were reviewed. Clinical follow-up status was supplemented by telephone interviews to determine Glasgow Outcome Scale scores. Results In 19 patients (61.3%) there was complete angiographic evidence of elimination of the shunts and resolution of the symptoms. The remaining 12 patients were treated successfully but did not attain complete embolization and had residual shunting. Adverse events occurred in 5 of 31 patients, with 3 DAVFs located at the tentorium, 1 at the inferior petrosal sinus, and 1 at the cavernous sinus. Complications included trigeminocardiac reflex in 2 patients (6.5%), hemifacial hypesthesia in 3 patients (9.7%), hemifacial palsy in 2 patients (6.5%), jaw pain in 1 patient (3.2%), posterior fossa infarction in 1 patient (3.2%), and microcatheter gluing in 1 patient (3.2%). At the last follow-up examination, all patients had returned to an independent clinical status. Conclusions Although a complete resolution of symptoms can be achieved with transarterial embolization using the Onyx liquid embolic system, the potential for serious complications exists with this procedure, necessitating the participation of a skilled neurointerventionalist.


Neurosurgery ◽  
2013 ◽  
Vol 73 (1) ◽  
pp. 113-120 ◽  
Author(s):  
Pascal Jabbour ◽  
Nohra Chalouhi ◽  
Stavropoula Tjoumakaris ◽  
L. Fernando Gonzalez ◽  
Aaron S. Dumont ◽  
...  

Abstract BACKGROUND: The Pipeline Embolization Device (PED) has emerged as a promising treatment for intracranial aneurysms. OBJECTIVE: To assess the safety and efficacy of the PED, to analyze the effect of operator experience on the complication rate, and to identify predictors of complications and obliteration. METHODS: A total of 109 patients with 120 aneurysms were treated with PED at our institution. The patient population was divided into 3 consecutive equal groups to assess whether overall and major complication rates decreased over time: group 1, patients 1 through 37; group 2, patients 38 through 73; and group 3, patients 74 through 109. RESULTS: The number of PEDs used was 1.40 per aneurysm. Symptomatic and major procedure-related complications occurred in 11% and 3.7% of patients, respectively. The rate of complications decreased from 16.2% in group 1 to 5.6% in group 3, and the rate of major complications fell dramatically from 10.8% in group 1 to 0% in groups 2 and 3 (P < .05). Procedure time significantly decreased over time (P = .04). In multivariate analysis, previously treated aneurysms were predictive of procedural complications (P = .02). At the latest follow-up, 65.8% of aneurysms were completely occluded, 9.6% were nearly completely occluded, and 24.6% were incompletely occluded. In multivariate analysis, fusiform aneurysms (P = .05) and shorter angiographic follow-up (P = .03) were negative predictors of aneurysm obliteration. CONCLUSION: PED therapy may have an acceptable safety-efficacy profile. The risk of complications appears to decrease dramatically with physician experience, supporting the existence of a learning curve. Patients with previously treated aneurysms have higher complication rates, whereas fusiform aneurysms achieve lower obliteration rates.


2008 ◽  
Vol 63 (suppl_1) ◽  
pp. ONS73-ONS80 ◽  
Author(s):  
Gregory J. Velat ◽  
John F. Reavey-Cantwell ◽  
Christopher Sistrom ◽  
David Smullen ◽  
Gregory L. Fautheree ◽  
...  

Abstract Objective: Intracranial arteriovenous malformations (AVM) may be managed through staged preoperative embolization and resection. Two commonly used liquid embolics are N-butyl cyanoacrylate (nBCA; Cordis Microvascular, Inc., New Brunswick, NJ) and Onyx (ev3, Inc., Irvine, CA). We sought to compare the utility of these agents in terms of fluoroscopy and procedure times. Methods: All intracranial AVMs embolized from 2002 to 2006 at the University of Florida were included in this study. Patients were stratified into three treatment groups: nBCA, Onyx, and patients who received both nBCA and Onyx during separate embolizations. Cohorts were compared by sex, age, Spetzler-Martin grade, AVM volume, fluoroscopy time, procedure time, surgical blood loss, and complications. Results: A total of 182 embolizations were performed on 88 patients (nBCA, 60 patients and 106 procedures; Onyx, 20 patients and 43 procedures; and nBCA/Onyx, eight patients and 16 nBCA and 17 Onyx procedures). There were no significant differences in patient demographics, AVM volumes, and Spetzler-Martin grades. Mean fluoroscopy and procedure times were increased for Onyx (57 min; 2.6 h) compared with nBCA (37 min; 2.1 h) embolizations (P < 0.0001 and P = 0.001, respectively). Cumulative mean fluoroscopy time was increased for Onyx (135 min) and nBCA/Onyx (180 min) cohorts relative to nBCA (64 min; P < 0.0001). Cumulative mean procedure time was increased in the nBCA/Onyx group (10.4 h) compared with nBCA (3.7 h) and Onyx (5.4 h; P< 0.0001). Seventy patients (80%) underwent AVM resection. No significant differences in surgical blood loss or complication rates were observed among the cohorts. Conclusion: Onyx AVM embolization requires increased fluoroscopy and procedure times compared with nBCA. Further investigation is necessary to justify increased radiation exposure and procedure time associated with Onyx.


2016 ◽  
Vol 9 (2) ◽  
pp. 188-191 ◽  
Author(s):  
Elizabeth J Le ◽  
Timothy Miller ◽  
Yafell Serulle ◽  
Ravishankar Shivashankar ◽  
Gaurav Jindal ◽  
...  

BackgroundFlow diversion with the Pipeline embolization device is a well-established method of intracranial aneurysm treatment. However, deployment of the first-generation device (Pipeline Classic) can be technically challenging. The Pipeline Flex contains the same flow-diverting stent with a modified delivery system.ObjectiveTo compare procedural outcomes between the first-generation device (Pipeline Classic) and the Pipeline Flex.MethodsThirty-eight of the first 40 consecutive patients who underwent intracranial aneurysm treatment with the Pipeline Flex and 58 of the most recent 60 consecutive patients who underwent treatment with the Pipeline Classic at our institution were evaluated. Patient demographics, aneurysm characteristics, technical procedural details, and early outcomes were analyzed.ResultsThe two groups were comparable for age, gender, and location of target aneurysms. Use of Pipeline Flex decreased procedure time by 44.2 min (p≤0.001) and fluoroscopy time by 22.0 min (p=0.001) compared with the Pipeline Classic. Similarly, radiation exposure was less in the Flex group with a mean difference of 3473.5 Gy cm2 (p=0.002), while contrast usage was decreased with a mean difference of 22.3 mL (p=0.007). These differences remained significant in multivariate regression analysis. Finally, the rate of device deployment failure was lower in the Flex group (7.1%) than in the Classic group (23.9%) (p=0.034).ConclusionsUse of Pipeline Flex significantly reduces the total procedure and fluoroscopy time, contrast usage, patient radiation exposure, and proportion of recaptured devices in comparison with the Pipeline Classic, probably owing to an enhanced delivery system that allows for more reliable and controlled deployment.


Neurosurgery ◽  
2014 ◽  
Vol 76 (2) ◽  
pp. 165-172 ◽  
Author(s):  
Nohra Chalouhi ◽  
Mario Zanaty ◽  
Alex Whiting ◽  
Stavropoula Tjoumakaris ◽  
David Hasan ◽  
...  

ABSTRACT BACKGROUND: The pipeline embolization device (PED) has been used for treatment of unruptured aneurysms. Little is known about the use of the PED in ruptured aneurysms. OBJECTIVE: To assess the safety and efficacy of the PED in ruptured intracranial aneurysms. METHODS: This is a case series with prospective data collection on 20 patients with freshly ruptured aneurysms who were treated with PED (with or without adjunctive coiling) at 2 cerebrovascular centers. Patients were loaded with aspirin and clopidogrel or received an infusion of tirofiban intraoperatively. RESULTS: Hunt and Hess grades were I in 7 patients (35%), II in 9 (45%), and III in 4 (20%). The mean duration from hemorrhage to PED placement was 7 ± 7.0 days. A single device was used in all but 1 patient (95%). The procedure was staged in 20%. There was only 1 complication (5%); this was a fatal intraoperative aneurysm dome rupture that occurred during adjunctive coil deployment. Adjunctive coiling was used in 30%. No patient required an invasive procedure after PED placement. Follow-up angiography (mean, 5.3 ± 4.2 months; range, 2-12 months) showed 100% occlusion in 12 (80%) and incomplete occlusion in 3 patients (20%). At latest follow-up, 19 patients achieved a favorable outcome (modified rankin scale 0–2). CONCLUSION: In our preliminary experience, treatment of ruptured aneurysms with the PED was associated with low complication rates, high occlusion rates, and favorable outcomes. These findings suggest that PED may be a safe and effective option for patients with favorable Hunt and Hess grades and aneurysms difficult to treat with conventional methods.


2017 ◽  
Vol 33 (S1) ◽  
pp. 204-205
Author(s):  
Gongru Wang ◽  
Yingyao Chen ◽  
Lizheng Shi ◽  
Danni Chen ◽  
Hui Sun

INTRODUCTION:Pulmonary vein isolation (PVI) is a new effective treatment for atrial fibrillation (AF) (1). The standard of care for ablation methods using radiofrequency (RF) is time-consuming and technically challenging (2), and restricted to a few specialized centers, which causes the limited availability of ablation therapy (3). Therefore, cryoballoon (CB) ablation has been developed to shorten and simplify the procedure. The objective of this systematic literature review and meta-analysis was to compare the effectiveness of cryoballoon ablation (CBA) with radiofrequency ablation (RFA) for the treatment of AF.METHODS:We searched the Cochrane Library and PubMed from 2009 to October 2016 to screen the eligible literature according to the inclusion and exclusion criteria. The effectiveness measures were the acute pulmonary vein (PV) isolation rate, procedure time, complications and the proportion of patients free from AF (follow-up > 3 months). Meta-analysis and descriptive statistics were used in this study.RESULTS:A total of seventeen articles with 5,806 cases (2,288 from CBA group, 3,518 from RFA group) from seven different countries were reviewed and analyzed. Pooled analyses indicated that CBA was more beneficial in terms of procedural time (Standard mean difference, SMD = -.501; 95%CI: -.893– -.109; P<.05) for RFA; but the acute PV isolation rate (Odds ratio, OR = .06; 95 percent Confidence Interval, CI: .03–.13; P < .05) in RFA was higher than for CBA; also, after median follow-up of 14 months (range 9–28 months), the proportion of patients free from AF (OR = .965; 95 percent CI:.859—1.085; P = .554) and the total complication rates (OR = .937; 95 percent CI:.753–1.167; P = .562) were not significantly different between CBA and RFA.In the four randomized controlled trials (RCTs) of the seventeen studies, the proportion of patients free from AF (OR = .951; 95 percent CI:.752–1.202; P = .672) and the complications (OR = 1.521; 95 percent CI:.570–4.058; P = .402) were not significantly different between CBA and RFA.CONCLUSIONS:Overall, compared with RFA for the treatment of patients with AF, CBA had similar clinical effectiveness on the proportion of people free from AF and the number of complications, and yet greater improvement in total procedure time referred for CBA and higher acute PVI rate referred for RFA.


Neurosurgery ◽  
2016 ◽  
Vol 80 (1) ◽  
pp. 40-48 ◽  
Author(s):  
Tibor Becske ◽  
Waleed Brinjikji ◽  
Matthew B. Potts ◽  
David F. Kallmes ◽  
Maksim Shapiro ◽  
...  

Abstract BACKGROUND: Early and mid-term safety and efficacy of aneurysm treatment with the Pipeline Embolization Device (PED) has been well demonstrated in prior studies. OBJECTIVE: To present 5-yr follow-up for patients treated in the Pipeline for Uncoilable or Failed Aneurysms clinical trial. METHODS: In our prospective, multicenter trial, 109 complex internal carotid artery (ICA) aneurysms in 107 subjects were treated with the PED. Patients were followed per a standardized protocol at 180 d and 1, 3, and 5 yr. Aneurysm occlusion, in-stent stenosis, modified Rankin Scale scores, and complications were recorded. RESULTS: The primary endpoint of complete aneurysm occlusion at 180 d (73.6%) was previously reported. Aneurysm occlusion for those patients with angiographic follow-up progressively increased over time to 86.8% (79/91), 93.4% (71/76), and 95.2% (60/63) at 1, 3, and 5 yr, respectively. Six aneurysms (5.7%) were retreated. New serious device-related events at 1, 3, and 5 yr were noted in 1% (1/96), 3.5% (3/85), and 0% (0/81) of subjects. There were 4 (3.7%) reported deaths in our trial. Seventy-eight (96.3%) of 81 patients with 5-yr clinical follow-up had modified Rankin Scale scores ≤2. No delayed neurological deaths or hemorrhagic or ischemic cerebrovascular events were reported beyond 6 mo. No recanalization of a previously occluded aneurysm was observed. CONCLUSION: Our 5-yr findings demonstrate that PED is a safe and effective treatment for large and giant wide-necked aneurysms of the intracranial ICA, with high rates of complete occlusion and low rates of delayed adverse events.


2020 ◽  
pp. 152660282096302
Author(s):  
Zoltán Ruzsa ◽  
Ádám Csavajda ◽  
Balázs Nemes ◽  
Mónika Deák ◽  
Péter Sótonyi ◽  
...  

Purpose: To compare the acute success and complication rates of distal radial (DR) vs proximal radial (PR) artery access for superficial femoral artery (SFA) interventions. Materials and Methods: Between 2016 and 2019, 195 consecutive patients with symptomatic SFA stenosis were treated via DR (n=38) or PR (n=157) access using a sheathless guide. Secondary access was achieved through the pedal artery when necessary. The main outcomes were technical success, major adverse events (MAEs), and access site complications. Secondary outcomes were treatment success, fluoroscopy time, radiation dose, procedure time, and crossover rate to another puncture site. Results: Overall technical success was achieved in 188 patients (96.4%): 37 of 38 patients (97.3%) in the DR group and 151 of 157 patients (96.2%) in the PR group (p=0.9). Dual (transradial and transpedal) access was used in 14 patients (36.8%) in the DR group and 28 patients (18.9%) in the PR group (p<0.01). Chronic total occlusions were recanalized in 25 of 26 DR patients (96.1%) and in 79 of 81 PR patients (92.6%) (p=0.57). The crossover rate to femoral access was 0% in the DR group vs 3.2% in the PR group (p=0.59). Stents were implanted in the SFA in 15 DR patients (39.4%) and in 39 patients (24.8%) in the PR group (p=0.1). The contrast volume, fluoroscopy time, radiation dose, and procedure time were not statistically different between the DR and PR groups, nor were the rates of access site complications (2.6% and 7.0%, respectively). The cumulative incidences of MAE at 6 months in the DR and PR groups were 15.7% vs 14.6%, respectively (p=0.8). Conclusion: SFA interventions can be safely and effectively performed using PR or DR access with acceptable morbidity and a high technical success rate. DR access is associated with few access site complications.


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