Registry of Aortic Diseases to Model Adverse Events and Progression (ROADMAP) in Uncomplicated Type B Aortic Dissection: Study Design and Rationale.

Purpose: To describe the design and methodological approach of a multicenter, retrospective study to externally validate a clinical and imaging-based model for predicting the risk of late adverse events in patients with initially uncomplicated type B aortic dissection (uTBAD).
Materials and Methods: The Registry of Aortic Diseases to Model Adverse Events and Progression (ROADMAP) is a collaboration between 10 academic aortic centers in North America and Europe. Two centers have previously developed and internally validated a recently developed risk prediction model. Clinical and imaging data from eight ROADMAP centers will be used for external validation. Patients with uTBAD who survived the initial hospitalization between January 1, 2001, and December 31, 2013, with follow-up until 2020, will be retrospectively identified. Clinical and imaging data from the index hospitalization and all follow-up encounters will be collected at each center and transferred to the coordinating center for analysis. Baseline and follow-up CT scans will be evaluated by cardiovascular imaging experts using a standardized technique.
Results: The primary end point is the occurrence of late adverse events, defined as aneurysm formation (≥6 cm), rapid expansion of the aorta (≥1 cm/y), fatal or nonfatal aortic rupture, new refractory pain, uncontrollable hypertension, and organ or limb malperfusion. The previously derived multivariable model will be externally validated by using Cox proportional hazards regression modeling.
Conclusion: This study will show whether a recent clinical and imaging-based risk prediction model for patients with uTBAD can be generalized to a larger population, which is an important step toward individualized risk stratification and therapy. Keywords: CT Angiography, Vascular, Aorta, Dissection, Outcomes Analysis, Aortic Dissection, MRI, TEVAR© RSNA, 2022See also the commentary by Rajiah in this issue.
Competing Interests: Disclosures of conflicts of interest: D.M. Research grant from the National Institute of Biomedical Imaging and Bioengineering (no. 5T32EB009035); consulting fees from Segmed; stock or stock options in Segmed; member of Radiology: Cardiothoracic Imaging trainee editorial board. M.J.W. Postdoctoral Fellowship Award (no. 18POST34030192) from the American Heart Association, payments to author’s institution; consulting fees from Segmed; payment from GLG, AlphaInsight, and Guidepoint for expert testimony; leadership or fiduciary role in the Society of Cardiovascular Computed Tomography, unpaid; stock or stock options in Segmed. V.L.T. Shareholder of Segmed stock or stock options. V.H. No relevant relationships. M.C. Postdoctoral Fellowship Award (no. 826389) from the American Heart Association; payment or honoraria from FASTeR as lecturer for research methodology course; owner of stock options in Arterys; employee of Arterys. K.H. Payment or honoraria from Sanofi Genzyme and Amicus for lectures, presentations, speakers bureaus, manuscript writing, or educational events; participation on a Data Safety Monitoring Board or Advisory Board for Sanofi Genzyme; associate editor for Radiology: Cardiothoracic Imaging. M.O. No relevant relationships. D.O.T. No relevant relationships. R.O.A. Consultant for Medtronic and EndoRon; member of the Society for Vascular Surgery (SVS) Diversity Equity and Inclusion Committee and council member of the SVS Young Surgeon Section; shareholder for EndoRon and Voythus. S.H. No relevant relationships. N.S.B. Radiological Society of North America Research Scholar Grant (no. RSCH1801); entitled to royalties related to licensure of intellectual property to Imbio; patents planned, issued, or pending for U.S. patent number 10,896,507, Techniques of Deformation Analysis for Quantification of Vascular Enlargement in Aneurysmal Disease. B.Y. Honoraria from seminar hosted by Medtronic. J.M.L. Honoraria from Cardiovascular Institute of Philadelphia. T.G.G. No relevant relationships. D.P. No relevant relationships. G.F. No relevant relationships. L.L. Participation on the Medtronic Thoracic Hostile Neck Club Advisory Board, Barcelona, December 20, 2021. R.H. No relevant relationships. H.A. No relevant relationships. A.E.S. Member of Radiology: Cardiothoracic Imaging editorial board. E.C. No relevant relationships. S.M.J.v.K. No relevant relationships. G.W.H.S. No relevant relationships. A.M.S. No relevant relationships. K.B. No relevant relationships. D.C.M. No relevant relationships. M.P.F. No relevant relationships. D.F. Deputy editor for Radiology: Cardiothoracic Imaging.
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