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An Update on the Adjunctive Neurovascular Support of Wide-Neck Aneurysm Embolization and Reconstruction Trial: 1-Year Safety and Angiographic Results.

ABSTRACT: BACKGROUND AND PURPOSE:The safety and efficacy of the PulseRider for the treatment of wide-neck, bifurcation aneurysms at the basilar and carotid terminus locations were studied in a prospective trial, the Adjunctive Neurovascular Support of Wide-Neck Aneurysm Embolization and Reconstruction (ANSWER) trial, reporting on initial 6-month angiographic and clinical results. This report provides insight into the longer term durability and safety with 12-month data. MATERIALS AND METHODS:Aneurysms treated with the PulseRider among enrolled sites were prospectively studied. Updated 12-month data on clinical and imaging end points are included. RESULTS:Thirty-four patients were enrolled (29 women, 5 men) with a mean age of 60.9 years. The mean aneurysm height ranged from 2.4 to 15.9 mm with a mean neck size of 5.2 mm (range, 2.3-11.6 mm). At 1 year, there were no device migrations or symptomatic in-stent stenoses. Raymond-Roy I occlusion was achieved in 53% of cases at the time of treatment and progressed to 61% and 67% at 6 and 12 months, respectively. Adequate occlusion (Raymond-Roy I/II) progressed from 88% at 6 months to 90% at 12 months. No recanalizations were observed. There was 1 delayed ischemic event. Good outcome (mRS 0-2) was achieved in 90% of patients. CONCLUSIONS:The updated 1-year results from the ANSWER trial demonstrate aneurysm stability and an acceptable safety profile for aneurysms treated at the basilar apex and carotid terminus. Prospective data from a larger set of aneurysms treated at other locations are required to assess how treatment with PulseRider compares with alternatives for treating wide-neck bifurcation aneurysms.

SUBMITTER: Spiotta AM

PROVIDER: S-EPMC7410668 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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An Update on the Adjunctive Neurovascular Support of Wide-Neck Aneurysm Embolization and Reconstruction Trial: 1-Year Safety and Angiographic Results.

Spiotta A M AM Chaudry M I MI Chaudry M I MI Turner R D RD Turk A S AS Derdeyn C P CP Mocco J J Tateshima S S

AJNR. American journal of neuroradiology 20180329 5

<h4>Background and purpose</h4>The safety and efficacy of the PulseRider for the treatment of wide-neck, bifurcation aneurysms at the basilar and carotid terminus locations were studied in a prospective trial, the Adjunctive Neurovascular Support of Wide-Neck Aneurysm Embolization and Reconstruction (ANSWER) trial, reporting on initial 6-month angiographic and clinical results. This report provides insight into the longer term durability and safety with 12-month data.<h4>Materials and methods</h ...[more]

PMID: 29599174

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Project description:Background and purposeThe impact of increased aneurysm packing density on angiographic outcomes has not been studied in a randomized trial. We sought to determine the potential for larger caliber coils to achieve higher packing densities and to improve the angiographic results of embolization of intracranial aneurysms at 1 year.Materials and methodsDoes Embolization with Larger Coils Lead to Better Treatment of Aneurysms (DELTA) was an investigator-initiated multicenter prospective, parallel, randomized, controlled clinical trial. Patients had 4- to 12-mm unruptured aneurysms. Treatment allocation to either 15- (experimental) or 10-caliber coils (control group) was randomized 1:1 using a Web-based platform. The primary efficacy outcome was a major recurrence or a residual aneurysm at follow-up angiography at 12 ± 2?months adjudicated by an independent core lab blinded to the treatment allocation. Secondary outcomes included indices of treatment success and standard safety outcomes. Recruitment of 564 patients was judged necessary to show a decrease in poor outcomes from 33% to 20% with 15-caliber coils.ResultsFunding was interrupted and the trial was stopped after 210 patients were recruited between November 2013 and June 2017. On an intent-to-treat analysis, the primary outcome was reached in 37 patients allocated to 15-caliber coils and 36 patients allocated to 10-caliber coils (OR?= 0.931; 95% CI, 0.528-1.644; P?=?.885). Safety and other clinical outcomes were similar. The 15-caliber coil group had a higher mean packing density (37.0% versus 26.9%, P?=?.0001). Packing density had no effect on the primary outcome when adjusted for initial angiographic results (OR = 1.001; 95% CI, 0.981-1.022; P?=?.879).ConclusionsCoiling of aneurysms randomized to 15-caliber coils achieved higher packing densities compared with 10-caliber coils, but this had no impact on the angiographic outcomes at 1 year, which were primarily driven by aneurysm size and initial angiographic results.

Project description:Unlabelled: This study explored a new approach to enhance aneurysm (AN) neck endothelialization via erythropoietin (EPO)-induced endothelial progenitor cell (EPC) stimulation. Results suggest that EPO enhanced the endothelialization of a coiled embolization AN neck by stimulating EPCs via vascular endothelial growth factor modulation. Thus, the promotion of endothelialization with EPO provides an additional therapeutic option for preventing the recurrence of ANs. Endovascular coil embolization is an attractive therapy for cerebral ANs, but recurrence is a main problem affecting long-term outcomes. In this study, we explored a new approach to enhance AN neck endothelialization via EPO-induced EPC stimulation. Ninety adult male Sprague-Dawley rats were selected for an in vivo assay, and 60 of them underwent microsurgery to create a coiled embolization AN model. The animals were treated with EPO, and endothelial repair was assessed via flow cytometry, immunofluorescence, electronic microscopy, cytokine detection, and routine blood work. EPO improved the viability, migration, cytokine modulation, and gene expression of bone marrow-derived EPCs and the results showed that EPO increased the number of circulating EPCs and improved endothelialization compared with untreated rats (p < .05). EPO had no significant effect on the routine blood work parameters. In addition, the immunofluorescence analysis showed that the number of KDR(+) cells in the AN neck was elevated in the EPO-treated group (p < .05). Further study demonstrated that EPO promoted EPC viability and migration in vitro. The effects of EPO may be attributed to the modulation of vascular endothelial growth factor (VEGF). In particular, EPO enhanced the endothelialization of a coiled embolization AN neck by stimulating EPCs via VEGF modulation. Thus, the promotion of endothelialization with EPO provides an additional therapeutic option for preventing the recurrence of ANs.SignificanceErythropoietin (EPO) is involved in erythropoiesis and related conditions and is reported to enhance stem-cell mobilization from bone marrow while elevating stem-cell viability and function. In this study, EPO was also found to stimulate endothelial progenitor cells to induce the endothelialization of a coiled embolic aneurysm neck via vascular endothelial growth factor modulation. Endothelialization induction provides an additional therapeutic opportunity during vascular inner layer repair and remodeling. The results provide important information on the unique role EPO plays during vascular repair and remodeling.

Project description:ObjectivePrevious reports have revealed a high incidence of type II endoleak (T2EL) after endovascular aneurysm repair (EVAR). The incidence of T2EL after EVAR is reduced by pre-emptive embolization of aneurysm sac side branches (ASSB) and aneurysm sac coil embolization (ASCE). This study aimed to investigate whether different preventive interventions for T2EL were correlated with suppression of aneurysm sac expansion and reduction of the re-intervention rate.MethodsThe PubMed, Web of Science, MEDLINE and Embase databases, and conference proceedings were searched to identify articles on EVAR with or without embolization. The study was developed in line with the Participants, Interventions, Comparisons, Outcomes, and Study design principles and was conducted and reported in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines. We used network meta-analysis based on multivariate random-effects meta-analysis to indirectly compare outcomes of different strategies for embolization during EVAR.ResultsA total of 31 studies met all inclusion criteria and were included in the qualitative and quantitative syntheses. The included studies were published between 2001 and 2022 and analyzed a total of 18,542 patients, including 1,882 patients who received prophylactic embolization treatment during EVAR (experimental group) and 16,660 who did not receive prophylactic embolization during EVAR (control group). The effect of pre-emptive embolization of the inferior mesenteric artery (IMA) (IMA-ASSB) in preventing T2EL was similar (relative risk [RR] 1.01, 95% confidence interval [CI] 0.38-2.63) to the effects of non-selective embolization of ASSB (NS-ASSB) and ASCE (RR 0.88, 95% CI 0.40-1.96). IMA-ASSB showed a better clinical effect in suppressing the aneurysm sac expansion (RR 0.27, 95% CI 0.09-2.25 compared with NS-ASSB; RR 0.93, 95% CI 0.16-5.56 compared with ASCE) and reducing the re-intervention rate (RR 0.34, 95% CI 0.08-1.53 compared with NS-ASSB; RR 0.66, 95% CI 0.19-2.22 compared with ASCE). All prophylactic embolization strategies improved the clinical outcomes of EVAR.ConclusionProphylactic embolization during EVAR effectively prevents T2EL, suppresses the aneurysm sac expansion, and reduces the re-intervention rate. IMA embolization demonstrated benefits in achieving long-term aneurysm sac stability and lowering the risk of secondary surgery. NS-ASSB more effectively reduces the incidence of T2EL, while IMA embolization alone or in combination with ASCE enhances the clinical benefits of EVAR. In addition, as network meta-analysis is still an indirect method based on a refinement of existing data, more studies and evidence are still needed in the future to establish more credible conclusions.

Project description:Transarterial chemoembolization (TACE) is a form of intra-arterial catheter-based chemotherapy that selectively delivers high doses of cytotoxic drug to the tumor bed combining with the effect of ischemic necrosis induced by arterial embolization. Chemoembolization and radioembolization are at the core of the treatment of liver hepatocellular carcinoma (HCC) patients who cannot receive potentially curative therapies such as transplantation, resection or percutaneous ablation. TACE for liver cancer has been proven to be useful in local tumor control, to prevent tumor progression, prolong patients' life and control patient symptoms. Recent evidence showed in patients with single-nodule HCC of 3 cm or smaller without vascular invasion, the 5-year overall survival (OS) with TACE was similar to that with hepatic resection and radiofrequency ablation. Although being used for decades, Lipiodol(®) (Lipiodol(®) Ultra Fluid(®), Guerbet, France) remains important as a tumor-seeking and radio-opaque drug delivery vector in interventional oncology. There have been efforts to improve the delivery of chemotherapeutic agents to tumors. Drug-eluting bead (DEB) is a relatively novel drug delivery embolization system which allows for fixed dosing and the ability to release the anticancer agents in a sustained manner. Three DEBs are available, i.e., Tandem(®) (CeloNova Biosciences Inc., USA), DC-Beads(®) (BTG, UK) and HepaSphere(®) (BioSphere Medical, Inc., USA). Transarterial radioembolization (TARE) technique has been developed, and proven to be efficient and safe in advanced liver cancers and those with vascular complications. Two types of radioembolization microspheres are available i.e., SIR-Spheres(®) (Sirtex Medical Limited, Australia) and TheraSphere(®) (BTG, UK). This review describes the basic procedure of TACE, properties and efficacy of some chemoembolization systems and radioembolization agents which are commercially available and/or currently under clinical evaluation. The key clinical trials of transcatheter arterial therapy for liver cancer are summarized.

Dataset Information

An Update on the Adjunctive Neurovascular Support of Wide-Neck Aneurysm Embolization and Reconstruction Trial: 1-Year Safety and Angiographic Results.

Publications

An Update on the Adjunctive Neurovascular Support of Wide-Neck Aneurysm Embolization and Reconstruction Trial: 1-Year Safety and Angiographic Results.

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