scholarly journals Diversion-p64: results from an international, prospective, multicenter, single-arm post-market study to assess the safety and effectiveness of the p64 flow modulation device

2021 ◽  
pp. neurintsurg-2021-017809
Author(s):  
Alain Bonafe ◽  
Marta Aguilar Perez ◽  
Hans Henkes ◽  
Pedro Lylyk ◽  
Carlos Bleise ◽  
...  
Keyword(s):  
Safety Data ◽  
Anterior Circulation ◽  
Eligibility Criteria ◽  
Flow Modulation ◽  
Post Market ◽  
Safety Endpoint ◽  
Aneurysm Occlusion ◽  
Permanent Morbidity ◽  
Primary Safety Endpoint

BackgroundThe use of flow diversion to treat intracranial aneurysms has increased in recent years.ObjectiveTo assess the safety and angiographic efficacy of the p64 flow modulation device.MethodsDiversion-p64 is an international, prospective, multicenter, single-arm, study conducted at 26 centers. The p64 flow modulation device was used to treat anterior circulation aneurysms between December 2015 and January 2019. The primary safety endpoint was the incidence of major stroke or neurologic death at 3–6 months, with the primary efficacy endpoint being complete aneurysm occlusion (Raymond-Roy Occlusion Classification 1) on follow-up angiography.ResultsA total of 420 patients met the eligibility criteria and underwent treatment with the p64 flow modulation device (mean age 55±12.0 years, 86.2% female). Mean aneurysm dome width was 6.99±5.28 mm and neck width 4.47±2.28 mm. Mean number of devices implanted per patient was 1.06±0.47, with adjunctive coiling performed in 14.0% of the cases. At the second angiographic follow-up (mean 375±73 days), available for 343 patients (81.7%), complete aneurysm occlusion was seen in 287 (83.7%) patients. Safety data were available for 413 patients (98.3%) at the first follow-up (mean 145±43 days) with a composite morbidity/mortality rate of 2.42% (n=10).ConclusionsDiversion-p64 is the largest prospective study using the p64 flow modulation device. The results of this study demonstrate that the device has a high efficacy and carries a low rate of mortality and permanent morbidity.

scholarly journals Comparative Safety and Efficacy of Left Atrial Appendage Occlusion with the Watchman Device and Amplatzer Cardiac Plug: Results of the Russian National Registry

2020 ◽  
Vol 2020 ◽  
pp. 1-7
Author(s):  
Karapet Davtyan ◽  
Georgiy Simonyan ◽  
Arpi Topchyan ◽  
Andrey Kalemberg ◽  
Alexander Romanov ◽  
...  
Keyword(s):  
Left Atrial ◽  
Left Atrial Appendage ◽  
Primary Efficacy ◽  
Left Atrial Appendage Occlusion ◽  
Safety Endpoint ◽  
Watchman Device ◽  
Comparative Safety ◽  
Major Adverse Events ◽  
Primary Safety Endpoint

Purpose. This multicenter, prospective registry evaluated the comparative safety and efficacy of left atrial appendage occlusion (LAAO) using the Watchman device (WD) and the Amplatzer Cardiac Plug (ACP) in patients with nonvalvular atrial fibrillation (NVAF) in real-world clinical practice in Russia. Methods. The study included data from 200 consecutive NVAF patients ( 66.8 ± 7.8 years, 44.5% female, median CHA2DS2VASc 4, median HAS-BLED 3) who had undergone LAAO implantation using WD ( n = 108 ) or ACP ( n = 92 ) from September 2015 to December 2017 in 5 medical centers in Russia. The primary safety endpoint was the procedure-related major adverse events, and the primary efficacy endpoint was the composite of thromboembolic events, device thrombosis, hemorrhagic events, and unexplained death during the 12-month follow-up. Results. Successful LAAO was performed in all 92 (100%) patients with ACP and 105 (97.2%) with WD ( p = 0.053 ). At 12 months, primary safety endpoint occurred in 6.5% of patients in the ACP group with no events in the WD group (6.5% vs. 0%, p = 0.008 ). During the 12-month follow-up, the primary efficacy endpoint has occurred in 8.3% of patients in the WD group ( n = 9 ) and 1.1% of patients in the ACP group ( n = 1 ) ( p = 0.016 ). Conclusions. In this multicenter prospective registry, LAA closure with the WD was associated with significantly higher thromboembolic events rate in NVAF patients. Patients, receiving the ACP, had more procedure-related major adverse events. However, further multicenter studies are necessary to evaluate these findings.

scholarly journals Periprocedural to 1-year safety and efficacy outcomes with the Pipeline Embolization Device with Shield technology for intracranial aneurysms: a prospective, post-market, multi-center study

2020 ◽  
Vol 12 (11) ◽  
pp. 1107-1112 ◽  
Author(s):  
Hal Rice ◽  
Mario Martínez Galdámez ◽  
Markus Holtmannspötter ◽  
Laurent Spelle ◽  
Konstantinos Lagios ◽  
...  
Keyword(s):  
Intracranial Aneurysms ◽  
Neurological Complications ◽  
Parent Artery ◽  
Unique Identifier ◽  
Clinical Trial Registration ◽  
Pipeline Embolization Device ◽  
Link Type ◽  
Post Market ◽  
Safety Endpoint ◽  
Primary Safety Endpoint

BackgroundThe first and second generations of the Pipeline Embolization Device (PED) have been widely adopted for the treatment of intracranial aneurysms (IAs) due to their high associated occlusion rates and low morbidity and mortality. The objective of this study was to evaluate the safety and effectiveness of the third- generation Pipeline Shield device (PED-Shield) for the treatment of IAs.MethodsThe SHIELD study was a prospective, single-arm, multicenter, post-market, observational study evaluating the PED-Shield device for the treatment of IAs. The primary efficacy endpoint was complete aneurysm occlusion without significant parent artery stenosis or retreatment at 1-year post-procedure and the primary safety endpoint was major stroke in the territory supplied by the treated artery or neurological death.ResultsOf 205 subjects who consented across 21 sites, 204 subjects with 204 target aneurysms were ultimately treated (mean age 54.8±12.81 years, 81.4% [166/204] female). Technical success (ie, deployment of the PED-Shield) was achieved in 98.0% (200/204) of subjects with a mean number of 1.1±0.34 devices per subject and a single device used in 86.8% (177/204) of subjects. The primary effectiveness endpoint was met in 71.7% (143/200) of subjects while the primary safety endpoint occurred in six (2.9%) subjects, two (1.0%) of which led to neurological death.ConclusionsThe findings of the SHIELD study support the safety and effectiveness of the PED-Shield for IA treatment, evidenced by high occlusion rates and low rates of neurological complications in the study population.Clinical trial registration-URLhttp://www.clinicaltrials.gov. Unique identifier: NCT02719522.

scholarly journals Multi-centric European post-market follow-up study of the Neuroform Atlas Stent System: primary results

2021 ◽  
pp. neurintsurg-2021-017849
Author(s):  
Pierre-Henri Lefevre ◽  
Peter Schramm ◽  
André Kemmling ◽  
Xavier Barreau ◽  
Gaultier Marnat ◽  
...  
Keyword(s):  
Medium Size ◽  
Mri Imaging ◽  
Clinical Trial Registration ◽  
Multicentric Study ◽  
Aneurysm Neck ◽  
Stent System ◽  
Safety Endpoint ◽  
Primary Safety Endpoint ◽  
Major Stroke

BackgroundFew prospective series have described the safety and effectiveness of the Neuroform Atlas Stent System. We aimed to investigate the efficacy and safety of the device in patients treated for unruptured aneurysm.MethodsATLAS EU PMCF is a consecutive, prospective, multicentric study that included patients with unruptured saccular aneurysm of all sizes. Follow-up visits were scheduled at 3–6 months and 12–16 months with digital subtraction angiography (DSA) or MRI imaging follow-up as per the site standard of care. The primary efficacy endpoint was adequate aneurysm occlusion (Raymond Roy occlusion grade I and II) on 12 month angiography. The primary safety endpoint was any major stroke or ipsilateral stroke or neurological death within 12 months.ResultsOf the 106 patients consented, 105 were treated with at least one Neuroform Atlas stent. There was a failed implantation attempt in 1 patient, 85 patients received lateral stenting, and 19 patients received Y-stenting. Mean aneurysm neck size was 4.2 mm (range 1.9–33 mm). Adequate occlusion was observed in 95.1% immediately after the procedure and in 98.9% of cases at 1 year DSA follow-up. Overall, 1.0% (1/102; 95% CI 0.0% to 5.3%) of patients experienced a primary safety endpoint of major stroke. Three minor strokes resulted in a modified Rankin Scale score of 2.ConclusionsIn this multicentric, prospective study, stent-assisted coiling of medium size unruptured aneurysms with the Neuroform Atlas stent resulted in a favorable rate of satisfactory occlusion. In our findings, the use of the Y-stenting technique was associated with increased rates of procedural complications.Clinical trial registrationhttps://clinicaltrials.gov/ct2/show/NCT02783339.

Use of the Pipeline embolization device for recurrent and residual cerebral aneurysms: a safety and efficacy analysis with short-term follow-up

2016 ◽  
Vol 9 (12) ◽  
pp. 1208-1213 ◽  
Author(s):  
Anna Luisa Kühn ◽  
Katyucia de Macedo Rodrigues ◽  
J Diego Lozano ◽  
David E Rex ◽  
Francesco Massari ◽  
...  
Keyword(s):  
Intimal Hyperplasia ◽  
Cerebral Aneurysms ◽  
Device Performance ◽  
Anterior Circulation ◽  
Pipeline Embolization Device ◽  
Safety And Efficacy ◽  
Efficacy Analysis ◽  
Unruptured Intracranial Aneurysms ◽  
Aneurysm Occlusion

ObjectiveEvaluation of the safety and efficacy of the Pipeline embolization device (PED) when used as second-line treatment for recurrent or residual, pretreated ruptured and unruptured intracranial aneurysms (IAs).MethodsRetrospective review of our database to include all patients who were treated with a PED for recurrent or residual IAs following surgical clipping or coiling. We evaluated neurological outcome and angiograms at discharge, 6- and 12-months’ follow-up and assessed intimal hyperplasia at follow-up.ResultsTwenty-four patients met our inclusion criteria. Most IAs were located in the anterior circulation (n=21). No change of preprocedure modified Rankin Scale score was seen at discharge or at any scheduled follow-up. Complete or near-complete aneurysm occlusion on 6- and 12-month angiograms was seen in 94.4% (17/18 cases) and 93.3% (14/15 cases), respectively. Complete or near-complete occlusion was seen in 100% of previously ruptured and 85.7% (6/7 cases) and 83.3% (5/6 cases) of previously unruptured cases at the 6- and 12-months’ follow-up, respectively. One case of moderate intimal hyperplasia was observed at 6 months and decreased to mild at the 12-months’ follow-up. No difference in device performance was observed among pretreated unruptured or ruptured IAs.ConclusionsTreatment of recurrent or residual IAs with a PED after previous coiling or clipping is feasible and safe. There is no difference in device performance between ruptured or unruptured IAs.

Predictors of cerebral aneurysm persistence and occlusion after flow diversion: a single-institution series of 445 cases with angiographic follow-up

2018 ◽  
Vol 130 (1) ◽  
pp. 259-267 ◽  
Author(s):  
Matthew T. Bender ◽  
Geoffrey P. Colby ◽  
Li-Mei Lin ◽  
Bowen Jiang ◽  
Erick M. Westbroek ◽  
...  
Keyword(s):  
Cerebral Artery ◽  
Flow Diversion ◽  
Single Institution ◽  
Anterior Circulation ◽  
Complete Occlusion ◽  
Aneurysm Size ◽  
Branch Vessel ◽  
Aneurysm Occlusion ◽  
Anterior Circulation Aneurysms

OBJECTIVEFlow diversion requires neointimal stent overgrowth to deliver aneurysm occlusion. The existing literature on aneurysm occlusion is limited by heterogeneous follow-up, variable antiplatelet regimens, noninvasive imaging modalities, and nonstandard occlusion assessment. Using a large, single-center cohort with low attrition and standardized antiplatelet tapering, the authors evaluated outcomes after flow diversion of anterior circulation aneurysms to identify predictors of occlusion and aneurysm persistence.METHODSData from a prospective, IRB-approved database was analyzed for all patients with anterior circulation aneurysms treated by flow diversion with the Pipeline embolization device (PED) at the authors’ institution. Follow-up consisted of catheter cerebral angiography at 6 and 12 months postembolization. Clopidogrel was discontinued at 6 months and aspirin was reduced to 81 mg daily at 12 months. Occlusion was graded as complete, trace filling, entry remnant, or aneurysm filling. Multivariate logistic regression was performed to identify predictors of aneurysm persistence.RESULTSFollow-up catheter angiography studies were available for 445 (91%) of 491 PED procedures performed for anterior circulation aneurysms between August 2011 and August 2016. Three hundred eighty-seven patients accounted for these 445 lesions with follow-up angiography. The population was 84% female; mean age was 56 years and mean aneurysm size was 6.6 mm. Aneurysms arose from the internal carotid artery (83%), anterior cerebral artery (13%), and middle cerebral artery (4%). Morphology was saccular in 90% of the lesions, and 18% of the aneurysms has been previously treated. Overall, complete occlusion was achieved in 82% of cases at a mean follow-up of 14 months. Complete occlusion was achieved in 72%, 78%, and 87% at 6, 12, and 24 months, respectively. At 12 months, adjunctive coiling predicted occlusion (OR 0.260, p = 0.036), while male sex (OR 2.923, p = 0.032), aneurysm size (OR 3.584, p = 0.011), and incorporation of a branch vessel (OR 2.206, p = 0.035) predicted persistence. Notable variables that did not predict aneurysm occlusion were prior treatments, vessel of origin, fusiform morphology, and number of devices used.CONCLUSIONSThis is the largest single-institution study showing high rates of anterior circulation aneurysm occlusion after Pipeline embolization. Predictors of persistence after flow diversion included increasing aneurysm size and incorporated branch vessel, whereas adjunctive coiling predicted occlusion.

EVALUATION OF ONYX HD-500 EMBOLIC SYSTEM IN THE TREATMENT OF 84 WIDE-NECK INTRACRANIAL ANEURYSMS

Neurosurgery ◽  
2009 ◽  
Vol 64 (5) ◽  
pp. E865-E875 ◽  
Author(s):  
Ronie L. Piske ◽  
Luis H. Kanashiro ◽  
Eric Paschoal ◽  
Celso Agner ◽  
Sergio S. Lima ◽  
...  
Keyword(s):  
Intracranial Aneurysms ◽  
High Rate ◽  
Anterior Circulation ◽  
Complete Occlusion ◽  
Aneurysm Occlusion ◽  
Incomplete Occlusion ◽  
Wide Neck ◽  
Small Aneurysms ◽  
Platinum Coils

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 >4 mm and/or dome-to-neck ratio <1.5). Fifty aneurysms were small (<12 mm), 30 were large (12 to <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.

scholarly journals Endovascular Management of Intradural Berry Aneurysms

2000 ◽  
Vol 6 (1) ◽  
pp. 27-39 ◽  
Author(s):  
A. Fuse ◽  
G. Rodesch ◽  
H. Alvarez ◽  
P. Lasjaunias
Keyword(s):  
Intracranial Haemorrhage ◽  
Female Dominance ◽  
Endovascular Management ◽  
Anterior Circulation ◽  
Technical Risks ◽  
Permanent Morbidity ◽  
Occlusion Rate ◽  
One Year ◽  
Arterial Aneurysms

Endovascular management of intracranial arterial aneurysms (AA) is well described and performed by many teams. The aim of this work is to review a series of consecutive cases treated in our institution and to compare to the data available in the literature. 225 AA were seen in Bicêtre between 1993 and 1998 in 203 patients. 201 of them (in 180 patients) were treated by our group. The endovascular treatment, its indications, results and complications have been reviewed and studied. The clinical follow-up of the patients has been evaluated. A female dominance was noted (64.5%) with a mean age of patients of 44.3 years. 65.6% of patients were treated in the acute phase after intracranial haemorrhage, 72% of them being Hunt and Hess grade 1 or 2. Most of these AA (73.6%) were located in the anterior circulation. In 86.1% of cases the AA was smaller than 10 mm. 85.6% of the AA needed only one session of endovascular therapy. No mortality occurred in the group of unruptured AA. Overall management mortality was 11% in ruptured AA (3.5% in HH1–2, 30.3% in HH3–5). Technical or transient complications occured in 11.6% of cases, but permanent morbidity was seen in 3.1% of cases. Control angiograms were performed 3 months and one year after therapy. In doubtful cases a control at 6 months was also performed. 100% occlusion rate was noted in 60.8% of cases; 22.8% of AA were occluded between 90–99%, and 13.3% between 80–90%. Only 3.1% of AA had an occlusion rate of less than 80%. One patient with a ruptured basilar tip AA which was partially coiled regrew and rebled three months after. The patient declined the recommended complementary surgery. Clinical follow up of patients with ruptured AA treated by embolisation shows satisfactory results with 8., 5% of GOS 1–2, 3.4% of GOS 3–4, and 11% of GOS 5 (mortality). Overpacking of the AA may not be necessary to protect patients from (re)bleeds over time. The related technical risks and increased costs of dense overpacking do not seem justified. Secondary thrombosis of the ruptured AA after coiling is more often seen than coil compaction. Analysis of the AA architecture and recognition of false aneurysms are mandatory in order to obtain good clinico-morphological logical results.

Endovascular treatment of basilar tip aneurysms using electrolytically detachable coils

1996 ◽  
Vol 84 (3) ◽  
pp. 393-399 ◽  
Author(s):  
Cameron G. McDougall ◽  
Van V. Halbach ◽  
Christopher F. Dowd ◽  
Randall T. Higashida ◽  
Donald W. Larsen ◽  
...  
Keyword(s):  
Initial Treatment ◽  
Content Type ◽  
Initial Treatment Period ◽  
Long Term Follow Up ◽  
Detachable Coils ◽  
Aneurysm Occlusion ◽  
Permanent Morbidity ◽  
Fine Print

✓ Preliminary experience using electrolytically detachable coils to treat basilar tip aneurysms in 33 patients is described. The most frequent presentation was subarachnoid hemorrhage (SAH) in 23 patients. All patients were referred after neurosurgical assessment and exclusion as candidates for surgical clipping of their aneurysms. At the time of initial treatment complete aneurysm occlusion was achieved in seven (21.2%) of 33 patients. In 17 of the patients (51.5%), greater than 90% but less than 100% aneurysm occlusion was achieved. Angiographic follow up (mean 11.7 months) was available in 19 patients. At follow-up angiography four (21%) of 19 aneurysms were 100% occluded and 12 (63.2%) of 19 were more than 90% but less than 100% occluded. The mean clinical follow-up time in treated patients surviving beyond the initial treatment period is 15 months. One patient suffered major permanent morbidity from thrombosis of the basilar tip region a few hours after coil placement. One patient treated following SAH experienced further hemorrhage 6 months later. No other patient suffered direct or indirect permanent morbidity as a consequence of this method of treatment. The authors believe that this technique is a reasonable alternative for patients who are not candidates for conventional surgical treatment or in whom such treatment has failed. This study's follow-up period is brief and greater experience with long-term follow-up study is mandatory.

scholarly journals Flow Diversion for Intracranial Aneurysms Beyond the Circle of Willis

2021 ◽  
Vol 12 ◽  
Author(s):  
Jinlu Yu ◽  
Xianli Lv
Keyword(s):  
Intracranial Aneurysms ◽  
Circle Of Willis ◽  
Flow Diversion ◽  
Arterial Phase ◽  
Parent Artery ◽  
Anterior Circulation ◽  
Aneurysm Neck ◽  
Therapeutic Outcomes ◽  
Aneurysm Occlusion

Background: Few reports have shown the therapeutic outcomes of flow diversion (FD) for intracranial aneurysms beyond the circle of Willis, and the efficacy of this technique remains unclear.Materials and methods: A retrospective study was performed on 22 consecutive patients, diagnosed with intracranial aneurysms beyond the circle of Willis, and treated with pipeline embolization device (PED) (Medtronic, Irvine, California, USA) between January 2015 and December 2019.Result: The 22 patients were between 16 and 66 years old (mean 44.5 ± 12.7 years), and six patients were male (27.3%, 6/22). Twenty-two patients had 23 aneurysms. The 23 aneurysms were 3–25 mm in diameter (12.2 ± 7.1 mm on average). The diameter of the parent artery was 1.3–3.0 mm (2.0 ± 0.6 mm on average). The 23 aneurysms were located as follows: 17 (73.9%, 17/23) were in the anterior circulation, and 6 (26.1%, 6/23) were in the posterior circulation. PED deployment was technically successful in all cases. Two overlapping PEDs were used to cover the aneurysm neck in 3 cases. One PED was used to overlap the two tandem P1 and P2 aneurysms. Other cases were treated with single PED. Coil assistance was used to treat 7 aneurysms, including 4 recurrent aneurysms and 3 new cases requiring coiling assistance during PED deployment. There were no cases of complications during PED deployment. All patients were available at the follow-up (mean, 10.9 ± 11.4 months). All patients presented with a modified Rankin Score (mRS) of 0. During angiographic follow-up, complete embolization was observed in 22 aneurysms in 21 patients, and one patient had subtotal embolization with the prolongation of stasis in the arterial phase.Conclusion: PED deployment for intracranial aneurysms beyond the circle of Willis is feasible and effective, with high rates of aneurysm occlusion.

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