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      Novel aneurysm neck reconstruction device: initial experience in an experimental preclinical bifurcation aneurysm model

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          Abstract

          Introduction

          Treatment of wide-necked bifurcation aneurysms often poses procedural and long-term outcome challenges. The initial preclinical experience with the Pulsar Vascular Aneurysm Neck Reconstruction Device (PVANRD) in a canine bifurcation model is described.

          Methods

          Experimental bifurcation vein pouch aneurysms were surgically created in the carotid arteries of eight dogs. Endovascular coiling of the aneurysms with assistance of the PVANRD was performed in all cases with acute performance compared with Y-stenting.

          Results

          Twelve devices were deployed in the eight cases. Deployment of the devices was straightforward and successfully protected the parent artery and maintained patency of the bifurcation in all cases, despite the use of oversized coils.

          Conclusion

          The PVANRD is a novel bifurcation stent that facilitates treatment of wide-necked bifurcation aneurysms compared with currently available adjunctive devices.

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          International subarachnoid aneurysm trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomised comparison of effects on survival, dependency, seizures, rebleeding, subgroups, and aneurysm occlusion.

          Andrew J. Molyneux, Richard Kerr, Ly-Mee Yu … (2005)
          Two types of treatment are being used for patients with ruptured intracranial aneurysms: endovascular detachable-coil treatment or craniotomy and clipping. We undertook a randomised, multicentre trial to compare these treatments in patients who were suitable for either treatment because the relative safety and efficacy of these approaches had not been established. Here we present clinical outcomes 1 year after treatment. 2143 patients with ruptured intracranial aneurysms, who were admitted to 42 neurosurgical centres, mainly in the UK and Europe, took part in the trial. They were randomly assigned to neurosurgical clipping (n=1070) or endovascular coiling (n=1073). The primary outcome was death or dependence at 1 year (defined by a modified Rankin scale of 3-6). Secondary outcomes included rebleeding from the treated aneurysm and risk of seizures. Long-term follow up continues. Analysis was in accordance with the randomised treatment. We report the 1-year outcomes for 1063 of 1073 patients allocated to endovascular treatment, and 1055 of 1070 patients allocated to neurosurgical treatment. 250 (23.5%) of 1063 patients allocated to endovascular treatment were dead or dependent at 1 year, compared with 326 (30.9%) of 1055 patients allocated to neurosurgery, an absolute risk reduction of 7.4% (95% CI 3.6-11.2, p=0.0001). The early survival advantage was maintained for up to 7 years and was significant (log rank p=0.03). The risk of epilepsy was substantially lower in patients allocated to endovascular treatment, but the risk of late rebleeding was higher. In patients with ruptured intracranial aneurysms suitable for both treatments, endovascular coiling is more likely to result in independent survival at 1 year than neurosurgical clipping; the survival benefit continues for at least 7 years. The risk of late rebleeding is low, but is more common after endovascular coiling than after neurosurgical clipping.
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            International Subarachnoid Aneurysm Trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomised trial.

            Andrew J. Molyneux, Richard Kerr, Irene Stratton … (2002)
            Endovascular detachable coil treatment is being increasingly used as an alternative to craniotomy and clipping for some ruptured intracranial aneurysms, although the relative benefits of these two approaches have yet to be established. We undertook a randomised, multicentre trial to compare the safety and efficacy of endovascular coiling with standard neurosurgical clipping for such aneurysms judged to be suitable for both treatments. We enrolled 2143 patients with ruptured intracranial aneurysms and randomly assigned them to neurosurgical clipping (n=1070) or endovascular treatment by detachable platinum coils (n=1073). Clinical outcomes were assessed at 2 months and at 1 year with interim ascertainment of rebleeds and death. The primary outcome was the proportion of patients with a modified Rankin scale score of 3-6 (dependency or death) at 1 year. Trial recruitment was stopped by the steering committee after a planned interim analysis. Analysis was per protocol. 190 of 801 (23.7%) patients allocated endovascular treatment were dependent or dead at 1 year compared with 243 of 793 (30.6%) allocated neurosurgical treatment (p=0.0019). The relative and absolute risk reductions in dependency or death after allocation to an endovascular versus neurosurgical treatment were 22.6% (95% CI 8.9-34.2) and 6.9% (2.5-11.3), respectively. The risk of rebleeding from the ruptured aneurysm after 1 year was two per 1276 and zero per 1081 patient-years for patients allocated endovascular and neurosurgical treatment, respectively. In patients with a ruptured intracranial aneurysm, for which endovascular coiling and neurosurgical clipping are therapeutic options, the outcome in terms of survival free of disability at 1 year is significantly better with endovascular coiling. The data available to date suggest that the long-term risks of further bleeding from the treated aneurysm are low with either therapy, although somewhat more frequent with endovascular coiling.
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              Guglielmi detachable coil embolization of cerebral aneurysms: 11 years' experience.

              Neil Martin, Y. Pierre Gobin, J Frazee … (2003)
              The authors report on their 11 years' experience with embolization of cerebral aneurysms using Guglielmi Detachable Coil (GDC) technology and on the attendant anatomical and clinical outcomes. Since December 1990, 818 patients harboring 916 aneurysms were treated with GDC embolization at University of California at Los Angeles Medical Center. For comparative purposes, the patients were divided into two groups: Group A included their initial 5 years' experience with 230 patients harboring 251 aneurysms and Group B included the later 6 years' experience with 588 patients harboring 665 aneurysms. Angiographically demonstrated complete occlusion was achieved in 55% of aneurysms and a neck remnant was displayed in 35.4% of lesions. Incomplete embolization was performed in 3.5% of aneurysms, and in 5% occlusion was attempted unsuccessfully. A comparison between the two groups revealed a higher complete embolization rate in patients in Group B compared with that in Group A patients (56.8 and 50.2%, respectively). The overall morbidity/mortality rate was 9.4%. Angiographic follow ups were obtained in 53.4% of cases of aneurysms, and recanalization was exhibited in 26.1% of aneurysms in Group A and 17.2% of those in Group B. The overall recanalization rate was 20.9%. Note that recanalization was related to the size of the dome and neck of the aneurysm. Overall incidence of delayed aneurysm rupture was 1.6%, a rate that improved in the past 5 years to 0.5%. Ten of 12 delayed ruptures occurred in large or giant aneurysms. The clinical and postembolization outcomes in patients treated with the GDC system have improved in the past 5 years. Aneurysm recanalization, however, is still a major limitation of current GDC therapy. Follow-up angiography is mandatory after GDC embolization of cerebral aneurysms. Further technical and device improvements are mandatory to overcome current GDC limitations.
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                Author and article information

                Journal
                Journal ID (nlm-ta): J Neurointerv Surg
                Journal ID (iso-abbrev): J Neurointerv Surg
                Journal ID (publisher-id): jnis
                Journal ID (hwp): neurintsurg
                Title: Journal of Neurointerventional Surgery
                Publisher: BMJ Group (BMA House, Tavistock Square, London, WC1H 9JR )
                ISSN (Print): 1759-8478
                ISSN (Electronic): 1759-8486
                Publication date (Print): July 2013
                Publication date (Electronic): 3 February 2012
                Volume: 5
                Issue: 4
                Pages: 346-350
                Affiliations
                [1 ]Department of Radiology, Stroke and Cerebrovascular Center, Medical University of South Carolina, Charleston, South Carolina, USA
                [2 ]Department of Neurosciences, Stroke and Cerebrovascular Center, Medical University of South Carolina, Charleston, South Carolina, USA
                [3 ]Division of Interventional Neuroradiology, Department of Radiological Sciences, Ronald Reagan UCLA Medical Center, Los Angeles, California, USA
                [4 ]Department of Neurological Surgery, Stony Brook University Medical Center, Stony Brook, New York, USA
                [5 ]Department of Neurosurgery, Stroke and Cerebrovascular Center, The Catholic University of Korea, Incheon, Korea
                [6 ]Division of Neurosurgery, Royal University Hospital, University of Saskatchewan, Saskatoon, Saskatchewan
                Author notes
                [Correspondence to ] Dr Aquilla Turk, Stroke and Cerebrovascular Center, Department of Radiology, Medical University of South Carolina, 96 Jonathan Lucas Street, Suite 337F CSB, Charleston, SC 29466, USA; turk@ 123456musc.edu
                Article
                Publisher ID: neurintsurg-2012-010312
                DOI: 10.1136/neurintsurg-2012-010312
                PMC ID: 3686258
                PubMed ID: 22661600
                SO-VID: 7d31a5dc-2f3d-44ec-bc7c-e125cd6badc5
                Copyright © Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions
                License:

                This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/3.0/ and http://creativecommons.org/licenses/by-nc/3.0/legalcode

                History
                Date received : 14 February 2012
                Date revision received : 26 April 2012
                Date accepted : 7 May 2012
                Categories
                Subject: 1506
                Subject: New Devices
                Subject: 1548
                Series title: Original research
                Custom metadata
                special-feature unlocked

                ScienceOpen disciplines: Surgery
                Keywords: aneurysm,wide-necked,reconstruction,device,stent,artery,mri,ct,vein,thrombectomy,spine,subarachnoid,coil,angioplasty,arteriovenous malformation,flow diverter,spinal cord,navigation,complication,balloon,thrombolysis,stroke
                Data availability:
                ScienceOpen disciplines: Surgery
                Keywords: aneurysm, wide-necked, reconstruction, device, stent, artery, mri, ct, vein, thrombectomy, spine, subarachnoid, coil, angioplasty, arteriovenous malformation, flow diverter, spinal cord, navigation, complication, balloon, thrombolysis, stroke

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