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Tim E. Darsaut, Giuseppe Lanzino, M. Beatriz Lopes and Steven Newman

The term “orbital tumors” comprises a wide variety of lesions that often share the same cardinal clinical finding (exophthalmos) and clinical history. Age at presentation, associated ophthalmological findings, and radiological features, however, provide invaluable information as to the possible histological type of tumor. The present article serves as an introductory overview regarding the pathological characteristics, clinical features, radiological characteristics, and principles of treatment of orbital tumors.

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Mohamed Samy Elhammady and Roberto C. Heros

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Tim E. Darsaut and Jean Raymond

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Tim E. Darsaut and Jean Raymond

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Robert Fahed, Tim E. Darsaut, Igor Salazkin, Guylaine Gevry and Jean Raymond

OBJECTIVE

The Medina embolization device (MED) is a novel, braided self-expanding endovascular device designed to occlude aneurysms by constructing an in situ intrasaccular flow diverter. Although a single device can be positioned at the neck of simple spherical in vitro aneurysms, the best way to occlude more complex in vivo aneurysms (using multiple MEDs or a combination of MEDs and platinum coils) is currently unknown.

METHODS

Fifty-two aneurysms of 3 different types were created in 31 canines, yielding 48 patent aneurysms. Treatments were randomly allocated by drawing lots: group 1, MEDs alone (n = 16); group 2, MEDs plus standard platinum coils (n = 16); and group 3, control aneurysms treated with coils alone (n = 16). Angiographic results were scored and compared immediately following treatment completion and at 3 months. Specimens were photographed and the extent of neointimal closure of the aneurysmal neck scored, followed by histopathological analyses.

RESULTS

Angiographic scores of 0 or 1 (occlusion or near occlusion) were initially obtained in 2 of 16 (12.5%, 95% CI 1.6%–38.3%) group 1 (MEDs alone), 3 of 16 (18.7%, 95% CI 4%–45.6%) group 2 (MEDs plus coils), and 10 of 16 (62.5%, 95% CI 35.4%–84.8%) group 3 (coils alone) aneurysms (p = 0.005). At 3 months, scores of 0 or 1 were found in 11 of 16 (68.7%, 95% CI 41.3%–89.0%) group 1, 9 of 16 (56.2%, 95% CI 29.9%–80.2%) group 2, and 8 of 16 (50%, 95% CI 24.7%–75.3%) group 3 aneurysms (p = 0.82). Neointimal scores were similar for the 3 treated groups (p = 0.66).

CONCLUSION

Endovascular treatment of experimental aneurysms with MEDs or MEDs and coils showed angiographic occlusion and neointimal scores at 3 months that were similar to those achieved with standard platinum coiling.

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Ignacio Arrese and Rosario Sarabia

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Tim E. Darsaut and Jean Raymond

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David F. Kallmes, Waleed Brinjikji and Alejandro A. Rabinstein

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Elsa Magro, Jean-Christophe Gentric, Tim E. Darsaut, Daniela Ziegler, MSI, Michel W. Bojanowski and Jean Raymond

OBJECTIVE

The ARUBA study (A Randomized Trial of Unruptured Brain Arteriovenous Malformations [AVMs]) on unruptured brain AVMs has been the object of comments and editorials. In the present study the authors aim to systematically review critiques, discuss design issues, and propose a framework for future trials.

METHODS

The authors performed a systematic review of the French and English literature on the ARUBA study published between January 2006 and February 2015. The electronic search, including the Cochrane Library, MEDLINE (PubMed and Ovid), CINAHL, and EMBASE databases, was complemented by hand searching and cross-referencing. The comments were categorized as items related to the design, the conduct, and the analysis and interpretation of the trial.

RESULTS

Thirty-one articles or letters were identified. The pragmatic design, with heterogeneity of patients and lack of standardization of the treatment arm, were frequently stated concerns. The choice of outcome measures was repeatedly criticized. During the trial, low enrollment rates, selection bias, and premature interruption of enrollment were frequent comments. The short follow-up period, the lack of subgroup analyses, the lack of details on the results of the various treatments, and a contentious interpretation of results were noted at the analysis stage. A fundamental problem was the primary hypothesis testing conservative management. The authors believe that other trials are needed. Future trials could be pragmatic, test interventions stratified at the time of randomization, and look for long-term, hard clinical outcomes in a large number of patients.

CONCLUSIONS

In the authors' view, the ARUBA trial is a turning point in the history of brain AVM management; future trials should aim at integrating trial methodology and clinical care in the presence of uncertainty.

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Jean Raymond, Jean-Christophe Gentric, Tim E. Darsaut, Daniela Iancu, Miguel Chagnon, Alain Weill and Daniel Roy

OBJECTIVE

The Flow Diversion in the Treatment of Intracranial Aneurysm Trial (FIAT) was designed to guide the clinical use of flow diversion, an innovative method to treat intracranial aneurysms, within a care trial and to study safety and efficacy.

METHODS

FIAT, conducted in 3 Canadian hospitals, proposed randomized allocation to flow diversion or standard management options (observation, coil embolization, parent vessel occlusion, or clip placement), and a registry of non-randomized patients treated with flow diversion. The primary safety outcome was death or dependency (modified Rankin Scale score > 2) at 3 months, to be determined for all patients who received flow diversion at any time. The primary efficacy outcome was angiographic occlusion at 3–12 months combined with an independent clinical outcome.

RESULTS

Of 112 participating patients recruited between May 2, 2011, and February 25, 2015, 78 were randomized (39 in each arm), and 34 received flow diversion within the registry. The study was halted due to safety concerns. Twelve (16%) of 75 patients (95% CI 8.9%–26.7%) who were allocated to or received flow diversion at any time were dead (n = 8) or dependent (n = 4) at 3 months or more, crossing a predefined safety boundary. Death or dependency occurred in 5 (13.2%) of 38 patients randomly allocated and treated by flow diversion (95% CI 5.0%–28.9%) and in 5 (12.8%) of 39 patients allocated to standard treatment (95% CI 4.8%–28.2%). Efficacy was below expectations of the trial hypothesis: 16 (42.1%) of 38 patients (95% CI 26.7%–59.1%) randomly allocated to flow diversion failed to reach the primary outcome, as compared with 14 (35.9%) of 39 patients allocated to standard treatment (95% CI 21.7%–52.9%).

CONCLUSIONS

Flow diversion was not as safe and effective as hypothesized. More randomized trials are needed to determine the role of flow diversion in the management of aneurysms.

Clinical trial registration no.: NCT01349582 (clinicaltrials.gov)