scholarly journals The RISE trial: A Randomized Trial on Intra-Saccular Endobridge devices

2019 ◽  
Vol 26 (1) ◽  
pp. 61-67 ◽  
Author(s):  
Jean Raymond ◽  
Anne-Christine Januel ◽  
Daniela Iancu ◽  
Daniel Roy ◽  
Alain Weill ◽  
...  

Background Wide-necked bifurcation aneurysms (WNBA) are a difficult subset of aneurysms to successfully repair endovascularly, and a number of treatment adjuncts have been designed to improve on the results of coiling, including stenting and flow diversion of the parent vessel. Surgical clipping is commonly performed for certain WNBAs, such as middle cerebral aneurysms, in some centres. Intra-saccular flow diversion (ISFD) using the Woven Endo-Bridge (WEB) or similar devices, has been developed as a new endovascular alternative to coiling for WNBAs. Meta-analyses of case series suggest satisfactory results, both in terms of safety and efficacy, but in the absence of randomized evidence, whether ISFD leads to better outcomes for patients with WNBA remains unknown. There is a need to offer ISFD within the context of a randomized care trial. Methods The proposed trial is a multicentre, randomized controlled care trial comparing ISFD and best conventional management option (surgical or endovascular), as determined by the treating physician prior to randomized allocation. At least 250 patients will be recruited in at least 10 centres over a four-year period, and followed for one year, to show that ISFD can increase the incidence of successful therapy from 75 to 90% of patients, defined as complete or near-complete occlusion of the aneurysm AND a good clinical outcome (mRS ≤ 2) at one year. The trial will be followed by an independent data safety monitoring committee to assure the safety of participants. Conclusion Introduction of intra-saccular flow diversion can be accomplished within a care trial context.

2016 ◽  
Vol 23 (1) ◽  
pp. 34-40 ◽  
Author(s):  
Sophia F Shakur ◽  
Victor A Aletich ◽  
Sepideh Amin-Hanjani ◽  
Ahmed E Hussein ◽  
Fady T Charbel ◽  
...  

Background Pipeline embolization devices (PEDs) are commonly used for endovascular treatment of cerebral aneurysms but can be associated with delayed ipsilateral intraparenchymal hemorrhage. Although intra-aneurysmal hemodynamic changes have been studied, parent vessel and intracranial hemodynamics after PED use are unknown. We examine the impact of flow diversion on parent artery and distal intracranial hemodynamics. Method Patients with internal carotid cerebral aneurysms treated with PED who had flow volume rate, flow velocities, pulsatility index, resistance index, Lindegaard ratio, and wall shear stress (WSS) obtained after treatment using quantitative magnetic resonance angiography were reviewed. Means were compared between ipsilateral and contralateral internal carotid artery (ICA) and middle cerebral artery (MCA) using paired t tests. Results A total of 18 patients were included. Mean flow volume rate was lower in the ipsilateral versus contralateral ICA ( p = 0.04) but tended to be higher in the ipsilateral versus contralateral MCA ( p = 0.08). Lindegaard ratio was higher ipsilateral to the PED in diastole ( p = 0.05). Although there was no significant difference in flow velocities, pulsatility or resistance indices, and WSS, the two cases in our cohort with hemorrhagic complications did display significant changes in MCA flows and MCA WSS. Conclusion PED placement appears to alter the elasticity of the stented ICA segment, with lower flows in the ipsilateral versus contralateral ICA. Conversely, MCA flows and MCA WSS are higher in the ipsilateral MCA among patients with hemorrhage after PED placement, suggesting the role of disrupted distal hemodynamics in delayed ipsilateral intraparenchymal hemorrhage.


2017 ◽  
Vol 18 (2) ◽  
pp. 177-185 ◽  
Author(s):  
Wesley J. Rose ◽  
Jan M. Sargeant ◽  
W. J. Brad Hanna ◽  
David Kelton ◽  
Dianna M. Wolfe ◽  
...  

AbstractAcupuncture has become increasingly popular in veterinary medicine. Within the scientific literature there is debate regarding its efficacy. Due to the complex nature of acupuncture, a scoping review was undertaken to identify and categorize the evidence related to acupuncture in companion animals (dogs, cats, and horses). Our search identified 843 relevant citations. Narrative reviews represented the largest proportion of studies (43%). We identified 179 experimental studies and 175 case reports/case series that examined the efficacy of acupuncture. Dogs were the most common subjects in the experimental trials. The most common indication for use was musculoskeletal conditions, and the most commonly evaluated outcome categories among experimental trials were pain and cardiovascular parameters. The limited number of controlled trials and the breadth of indications for use, outcome categories, and types of acupuncture evaluated present challenges for future systematic reviews or meta-analyses. There is a need for high-quality randomized controlled trials addressing the most common clinical uses of acupuncture, and using consistent and clinically relevant outcomes, to inform conclusions regarding the efficacy of acupuncture in companion animals.


2018 ◽  
Vol 2 (1) ◽  
pp. 16-21
Author(s):  
F. Salle ◽  
A. Jaume ◽  
G. Castelluccio ◽  
E. Spagnuolo

Abstract The ideal treatment for intracranial aneurysms has been highly controversial in the last few decades. It is particularly difficult to decide between clipping vs. coiling when it comes to an aneurysm that has already been treated. The authors performed a review of the literature published in the last ten years amongst the main neurosurgical publications and make recommendations based on this evidence and the surgical experience of the eldest author of this paper (ES). A series of cases of recurrent, incompletely coiled aneurysms treated with surgery is presented. Conclusions: aneurysms with a convenient configuration and location for either clipping or coiling might be better managed by surgical clipping in young patients considering that this treatment achieves higher rates of occlusion with a lower incidence of rebleeding. In elderly patients, each case must be discussed.


Neurosurgery ◽  
2018 ◽  
Vol 83 (4) ◽  
pp. 790-799 ◽  
Author(s):  
Adam N Wallace ◽  
Jonathan A Grossberg ◽  
Josser E Delgado Almandoz ◽  
Mudassar Kamran ◽  
Anil K Roy ◽  
...  

Abstract BACKGROUND Flow diversion of posterior cerebral artery (PCA) aneurysms has not been widely reported, possibly owing to concerns regarding parent vessel size and branch vessel coverage. OBJECTIVE To examine the safety and effectiveness of PCA aneurysm flow diverter treatment. METHODS Retrospective review of PCA aneurysms treated with the Pipeline Embolization Device (PED; Medtronic Inc, Dublin, Ireland) at 3 neurovascular centers, including periprocedural complications and clinical and angiographic outcomes. Systematic review of the literature identified published reports of PCA aneurysms treated with flow diversion. Rates of aneurysm occlusion and complications were calculated, and outcomes of saccular and fusiform aneurysm treatments were compared. RESULTS Ten PCA aneurysms in 9 patients were treated with the PED. There were 2 intraprocedural thromboembolic events (20%), including 1 symptomatic infarction and 1 delayed PED thrombosis. Eight of 10 patients returned to or improved from their baseline functional status. Complete aneurysm occlusion with parent vessel preservation was achieved in 75% (6/8) of cases at mean follow-up of 16.7 mo. Eleven of 12 (92%) major branch vessels covered by a PED remained patent. Including the present study, systematic review of 15 studies found a complete aneurysm occlusion rate of 88% (30/34) and complication rate of 26% (10/38), including 5 symptomatic ischemic strokes (13%; 5/38). Fusiform aneurysms more frequently completely occluded compared with saccular aneurysms (100% vs 70%; P = .03) but were associated with a higher complication rate (43% vs 9%; P = .06). CONCLUSION The safety and effectiveness profile of flow diverter treatment of PCA aneurysms may be acceptable in select cases.


Author(s):  
Yahia M Lodi ◽  
Varun V Reddy ◽  
Adam Cloud ◽  
Zara T Lodi ◽  
Ravi Pande

Introduction : Flow diversion (FD) of the cerebral aneurysms (CA) are performed either by trans femoral or transradial approach. Safety and feasibility of an alternative option such as direct Carotid artery Cutdown (DCAC) and FD for the treatment of the CA in a situation when tradition approaches are not feasible is not well described. Methods : Retrospective review. Results : First patient; 67 years old man with history of hypertension, hyperlipidemia, smoking, and stenting of the aortic arch aneurysm was diagnosed with symptomatic bilateral ICA DSA buy a CT angiography. Right ICA DSA was in multi‐level extending from cervical carotid artery to the skull base measured 19 × 15 × 20 mm and the left was 16 × 9 × 22 mm. Considering the severity of the disease and the presence of symptoms, planned for a DCAC by vascular surgeon followed by FD by neurovascular surgeon (NES) in a staged fashion. A 6F sheath was placed from right common carotid artery (CCA) to right ICA by a vascular surgeon. A CAT5 catheter was navigated to the ICA beyond DSA. FD was achieved using Surpass streamline measuring 4 × 50 mm x2 and a 5 × 40 mm. The DCAC site was sutured by vascular surgeon and patient was extubated. Using similar techniques, Left‐sided DPA was repaired using 5 × 50 mm surpass streamline flow diverter in 3 months. Second patient; 75 years old women’s let ICA opththalmic (ICA‐O) aneurysm grown from 8 mm to 12 mm with headaches. TF and TR approaches failed, underwent DCAC and FD with pipeline flex (PF) 5 × 30 mm using phenom plus and phenom XT27 microcatheter. Third patient; 65 years old women with LICA‐0 9 mm symptomatic aneurysm with occlusions femoral and radial arteries due to smoking underwent FD with PF of 4 × 30 mm. There were no clinical events, first patient’s right ICA radiographic dissection was repaired by VS prior to extubation. Patients were discharged home in 48 hours with NIHSS 0 and achieved baseline mRS. Patients were continued full antiplatelets for six months followed by an 81 mg baby aspirin and 75 mg of clopidogrel. Follow‐up MR angiogram demonstrate complete obligations of the aneurysms without stenosis. Conclusions : Our case series demonstrate that DCAC for the FD of the intracranial aneurysm is feasible and safe when performed carefully and in coordination with a multidisciplinary team. Further studies are required.


2020 ◽  
Vol 28 (3) ◽  
pp. 230949902094408
Author(s):  
Andrew M Suchowersky ◽  
Martin Hua ◽  
Peter Lorentzos ◽  
L Andrew Ashton

Introduction: There has been a global trend towards individually packaged screws for orthopaedic operations. Traditional practice makes use of screw caddies that require re-sterilization. Individually wrapped screws (IWS) are purported to decrease infection rates and avoid the deleterious effects of repeated screw sterilizations, despite marginal evidence. This review aimed to evaluate the safety, effectiveness and economics of screw caddies with IWS. Material and methods: The literature was surveyed in a systematic fashion between 1998 and 2017 and all relevant health technology assessments, systematic reviews, meta-analyses, randomized controlled trials, cohort studies, case-controlled studies and case series were sought. Any benefits or otherwise of IWS over screw caddies were then evaluated in the areas of safety, effectiveness and economics. Results: Two level III-3 papers suggested the use of caddies at least as safe as individual screws. Four level III-2 papers demonstrated that screws from caddies were as effective as individual alternatives, while a level III-3 paper reported that individual screws were significantly more expensive than screw caddies. Cost increases to our regional health service from ankle open reduction and internal fixations alone of at least $50,112 (AUD) per annum were calculated. Conclusions: From the results obtained, the authors recommend the continued use of screw caddies for orthopaedic procedures.


2017 ◽  
Vol 6 (3-4) ◽  
pp. 135-146 ◽  
Author(s):  
Li-Mei Lin ◽  
Rajiv R. Iyer ◽  
Matthew T. Bender ◽  
Thomas Monarch ◽  
Geoffrey P. Colby ◽  
...  

Background: Postsurgical clipping aneurysm recurrences or residuals can be difficult to manage with either traditional open microsurgical approaches or endosaccular coiling. Endoluminal parent vessel reconstruction with flow diversion may be an ideal method for treating these recurrences by avoiding reoperative surgery or intraprocedural aneurysm rupture with aneurysm access. Method: We retrospectively reviewed a single-center aneurysm database identifying all anterior communicating artery (ACom) region aneurysms with recurrences after microsurgical clipping. Cases subsequently treated with Pipeline embolization device (PED) were identified for analysis. Results: Nine PED neurointerventions were performed for the treatment of 6 ACom region recurrent aneurysms after surgical clipping (ACom, n = 4 and A1-A2 junction, n = 2). Of the 6 aneurysms treated, 4 were previously ruptured. Mean patient age was 59.5 ± 6.9 years (range 50-67 years). Mean aneurysm size was 5.1 ± 2.2 mm (range 3-9 mm). Mean fluoroscopy time was 44.1 ± 12.4 min. A single PED, deployed from ipsilateral A2 to ipsilateral A1, was used in 6 cases. No instances of periprocedural complications were encountered. Angiographic follow-up was available in all aneurysms; 5 of these 6 (83%) demonstrated complete aneurysm occlusion. Conclusion: Flow diversion with PED can be a safe and efficacious treatment approach for recurrent ACom region aneurysms after surgical clipping.


Author(s):  
CR Pasarikovski ◽  
J Ku ◽  
J Ramjist ◽  
Y Dobashi ◽  
SM Priola ◽  
...  

Background: The mechanism of aneurysmal healing after flow-diversion treatment of cerebral aneurysms remains unknown. The purpose of this research to is to utilize a novel technology called endovascular optical coherence tomography (OCT) to characterise and improve our understanding of aneurysmal healing after flow-diversion using a rabbit aneurysm model. Methods: Saccular aneurysms were created in 10 New Zealand white rabbits. The aneurysms were treated with a flow-diverting stent 28 days after creation. OCT and histopathologic examinations included: luminal thrombosis, endothelial loss, inflammation, fibrin, smooth muscle cell loss, disruption of the internal and external elastic lamina, and tunica adventitia changes Results: OCT revealed endothelialization across the stent, appearing to originate from the parent vessel, along with small amounts of thrombus on the stent-struts. Minimal thrombus was visualized within the aneurysm sac. Histologic examination revealed that OCT can accurately define endothelialization across the sent, and define patent segments across the neck. Conclusions: Aneurysmal healing appears to originate at the parent vessel/stent interface, and use the stent as a scaffold to grow across the neck of the aneurysm. Minimal thrombus was visualized within the aneurysm sac, with ongoing flow observed in the setting of incomplete neck endothelialization. This technology has great potential for assessing aneurysmal healing in real-time.


2011 ◽  
Vol 17 (2) ◽  
pp. 147-153 ◽  
Author(s):  
J. Raymond ◽  
T.E. Darsaut ◽  
F. Guilbert ◽  
A. Weill ◽  
D. Roy

Intracranial aneurysms, particularly large and giant, fusiform or recurrent aneurysms are increasingly treated with flow diverters (FDs), a recently introduced and approved neurovascular device. While some rare cases may not be treated any other way, in most patients a more conventional, conservative, or validated approach such as coiling, parent vessel occlusion, or surgical clipping exists. Only a randomized clinical trial can answer the question of which treatment option leads to better patient outcomes. We report the design of the FIAT study, a clinical care trial aiming to compare angiographic and clinical outcomes following treatment with a Flow-Diverter or with the best conventional treatment option. The FIAT study will include both a randomized and a registry portion. Patients will be proposed randomization to either FD stenting or best conventional treatment option (observation, coiling, stenting, or clipping) as determined by the treating physician. FIAT will recruit a total of 338 patients, to show that i) FD stenting can be performed with an ‘acceptable’ immediate complication rate of less than 15% morbidity and mortality (defined as mRS > 2); ii) FD stenting can increase from 75 to 90% the proportion of patients with a “good outcome”, defined as complete or near-complete occlusion of the aneurysm AND a good clinical outcome (mRS ≤ 2) at one year, as compared to the best conventional option. The FIAT study provides a scientific and ethical context to care for patients eligible for flow-diversion therapy.


2021 ◽  
Author(s):  
Kenichiro Suyama ◽  
Ichiro Nakahara ◽  
Shoji Matsumoto ◽  
Yoshio Suyama ◽  
Jun Morioka ◽  
...  

Abstract Purpose The Flow Re-direction Endoluminal Device (FRED) has recently become available for flow diversion in Japan. We have encountered cases that failed to deploy the FRED. In this study, we report our initial experience with the FRED for cerebral aneurysms and clarify the causes of failed FRED deployment. Methods A retrospective data analysis was performed to identify patients treated with the FRED between June 2020 and March 2021. Follow-up digital subtraction angiography was performed at 3 and 6 months and assessed using the O’Kelly-Marotta (OKM) grading scale. Results Thirty-nine aneurysms in 36 patients (average age: 54.4 years) were treated with the FRED. The average sizes of the dome and neck were 9.9 mm and 5.2 mm, respectively. In nine patients, additional coiling was performed. In one patient (2.6%), proximal vessel injury caused direct carotid-cavernous fistula during deployment. Ischaemic complications were encountered in one patient (2.6%) with transient symptoms. Angiographic follow-up at 6 months revealed OKM grade C or D in 86.6% of patients. FRED deployment was successful in 35 (92.1%) procedures. In the failure group, the differences between the FRED and the minimum vessel diameter (P = 0.04) and the rate of the parent vessel having an S-shaped curve (P = 0.04) were greater than those in the success group. Conclusions Flow diversion using the FRED is effective and safe for treating cerebral aneurysms. The use of the FRED for patients with an S-shaped curve in the parent vessel and oversizing of more than 2 mm should be considered carefully.


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