Technology assessment document
Reporting Standards for Endovascular Repair of Saccular Intracranial Cerebral Aneurysms

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Background and Purpose

The goal of this article is to provide consensus recommendations for reporting standards, terminology, and written definitions when reporting on the radiological evaluation and endovascular treatment of intracranial, cerebral aneurysms. These criteria can be used to design clinical trials, to provide uniformity of definitions for appropriate selection and stratification of patients, and to allow analysis and meta-analysis of reported data.

Methods

This article was written under the auspices of the Joint Writing Group of the Technology Assessment Committee, Society of NeuroInterventional Surgery, Society of Interventional Radiology; Joint Section on Cerebrovascular Neurosurgery of the American Association of Neurological Surgeons and Congress of Neurological Surgeons; and Section of Stroke and Interventional Neurology of the American Academy of Neurology. A computerized search of the National Library of Medicine database of literature (PubMed) from January 1991 to December 2007 was conducted with the goal to identify published endovascular cerebrovascular interventional data about the assessment and endovascular treatment of cerebral aneurysms useful as benchmarks for quality assessment. We sought to identify those risk adjustment variables that affect the likelihood of success and complications. This article offers the rationale for different clinical and technical considerations that may be important during the design of clinical trials for endovascular treatment of cerebral aneurysms. Included in this guidance article are suggestions for uniform reporting standards for such trials. These definitions and standards are primarily intended for research purposes; however, they should also be helpful in clinical practice and applicable to all publications.

Conclusions

The evaluation and treatment of brain aneurysms often involve multiple medical specialties. Recent reviews by the American Heart Association have surveyed the medical literature to develop guidelines for the clinical management of ruptured and unruptured cerebral aneurysms. Despite efforts to synthesize existing knowledge on cerebral aneurysm evaluation and treatment, significant inconsistencies remain in nomenclature and definition for research and reporting purposes. These operational definitions were selected by consensus of a multidisciplinary writing group to provide consistency for reporting on imaging in clinical trials and observational studies involving cerebral aneurysms. These definitions should help different groups to publish results that are directly comparable.

Section snippets

Historical Context: Aneurysm Reporting

The evaluation and treatment of brain aneurysms often involve multiple medical specialties. Recent reviews by the American Heart Association have surveyed the medical literature to develop guidelines for the clinical management of ruptured (1) and unruptured (2) cerebral aneurysms. Despite efforts to synthesize existing knowledge on cerebral aneurysm evaluation and treatment, significant inconsistencies remain in nomenclature and definition for research and reporting purposes.

One of the major

General Definitions

The definition of cerebral aneurysm is an abnormal focal dilatation of a cerebral artery with attenuation of the vessel wall. There are several different pathophysiological types of aneurysms that involve the cerebral arteries. These include saccular, dolichoectatic, dissecting, serpentine, traumatic, mycotic, and giant aneurysms with or without thrombosis. Saccular aneurysms are the most common and the primary focus; other types are beyond the scope of this article.

Aneurysms may coexist with

Clinical Presentation

Clinical presentation is a component of the medical and neurological history. It is a description of the clinical event(s) that directly brought the aneurysm to medical attention. Clinical presentation includes signs, symptoms, and temporally related imaging studies. Typical symptoms might include severe headache, nausea, vomiting, photophobia, and nuchal rigidity. Commonly identified signs sometimes include altered level of consciousness, focal weakness, and cranial nerve deficits. Imaging

Patient Handedness

Handedness is obtained from the neurological history and estimates hemispheric dominance potentially influencing neurological injury/disability, functional outcome, and the choice of treatment modality.

Dates of Rupture, Diagnosis, and Treatment

Date of presentation refers to the date on which patient experienced signs or symptoms leading to medical evaluation and diagnosis of the cerebral aneurysm. Date of presentation may not be the same as the date of medical evaluation or diagnosis of the aneurysm but should be temporally related. Index date is the point at which patient initially experienced symptoms referable to the aneurysm.

Imaging of Aneurysm Hemorrhage

A description of the hemorrhage location and extent must be reported. Any intraparenchymal bleeding or hematomas with mass effect must be reported. The Fisher Grading Scale (20) (Table 4) is a commonly used CT-based grading system that has prognostic significance for the development of arteriographic vasospasm and delayed ischemic neurological deficits (21).

Evidence of new acute hemorrhage (<7 days) is present if there appears to be acute blood products on CT or MRI likely to be associated with

Therapeutic Procedural Technique

Procedural techniques vary widely and must be incorporated into every report. Arterial access procedure, anesthetic technique such as general anesthesia and agents used, the use of adjunctive medications including timing, dosages, routes of administration, assays of anticoagulation or platelet function, catheters, guide wires, contrast agents, rates and volumes with routes of administration, and fluoroscopy with measure of patient exposure should be incorporated into each report. Each embolic

Summary

These definitions span a broad range of relevant clinical and radiographic parameters to be considered in research studies. These recommendations do not represent the only criteria for all reporting of research data related to cerebral aneurysms. For example, some architectural features described here are based on the consensus of a multidisciplinary panel. Moreover, additional technological advancements in imaging equipment will likely allow evaluation of cerebral hemodynamics but are

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    Dr Higashida served as a consultant to Cordis Neurovascular. Dr Nesbit received honoraria from Cordis Neurovascular and Genentech, has an ownership interest in Concentric Medical, and served as a consultant to Concentric Medical. Dr Wechsler served as a consultant to Nuevelo, Inc, and Abbott Vascular. Dr Lavine received honoraria from Cordis Neurovascular. Dr Rasmussen received honoraria from the Universities of Minnesota and Pittsburgh, Microvention/Terumo, ev3, Possis Medical/Medrad, and Micrus, has an ownership interest in Chestnut Medical, and served as a consultant to Chestnut Medical.

    Published in Stroke. 2009;40(5):e366–e379.

    Published online before print February 26, 2009, doi: 10.1161/STROKEAHA.108.527572.

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