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

Domenico Mastrodicasa; Martin J Willemink; Valery L Turner; Virginia Hinostroza; Marina Codari; Kate Hanneman; Maral Ouzounian; Daniel Ocazionez Trujillo; Rana O Afifi; Sandeep Hedgire; Nicholas S Burris; Bo Yang; Joan M Lacomis; Thomas G Gleason; Davide Pacini; Gianluca Folesani; Luigi Lovato; Ricarda Hinzpeter; Hatem Alkadhi; Arthur E Stillman; Edward P Chen; Sander M J van Kuijk; Geert W H Schurink; Anna M Sailer; Kathrin Bäumler; D Craig Miller; Michael P Fischbein; Dominik Fleischmann

doi:10.1148/ryct.220039

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

Domenico Mastrodicasa, Martin J Willemink, Valery L Turner, Virginia Hinostroza, Marina Codari, Kate Hanneman, Maral Ouzounian, Daniel Ocazionez Trujillo, Rana O Afifi, Sandeep Hedgire, Nicholas S Burris, Bo Yang, Joan M Lacomis, Thomas G Gleason, Davide Pacini, Gianluca Folesani, Luigi Lovato, Ricarda Hinzpeter, Hatem Alkadhi, Arthur E StillmanEdward P Chen, Sander M J van Kuijk, Geert W H Schurink, Anna M Sailer, Kathrin Bäumler, D Craig Miller, Michael P Fischbein, Dominik Fleischmann^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

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.

Original language	English
Article number	e220039
Number of pages	7
Journal	Radiology. Cardiothoracic imaging
Volume	4
Issue number	6
DOIs	https://doi.org/10.1148/ryct.220039
Publication status	Published - Dec 2022

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10.1148/ryct.220039

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Mastrodicasa, D., Willemink, M. J., Turner, V. L., Hinostroza, V., Codari, M., Hanneman, K., Ouzounian, M., Ocazionez Trujillo, D., Afifi, R. O., Hedgire, S., Burris, N. S., Yang, B., Lacomis, J. M., Gleason, T. G., Pacini, D., Folesani, G., Lovato, L., Hinzpeter, R., Alkadhi, H., ... Fleischmann, D. (2022). Registry of Aortic Diseases to Model Adverse Events and Progression (ROADMAP) in Uncomplicated Type B Aortic Dissection: Study Design and Rationale. Radiology. Cardiothoracic imaging, 4(6), Article e220039. https://doi.org/10.1148/ryct.220039

@article{f9a0b4d0654c4921a6e667245a0b64ec,

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

abstract = "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{\textcopyright} RSNA, 2022See also the commentary by Rajiah in this issue.",

author = "Domenico Mastrodicasa and Willemink, {Martin J} and Turner, {Valery L} and Virginia Hinostroza and Marina Codari and Kate Hanneman and Maral Ouzounian and {Ocazionez Trujillo}, Daniel and Afifi, {Rana O} and Sandeep Hedgire and Burris, {Nicholas S} and Bo Yang and Lacomis, {Joan M} and Gleason, {Thomas G} and Davide Pacini and Gianluca Folesani and Luigi Lovato and Ricarda Hinzpeter and Hatem Alkadhi and Stillman, {Arthur E} and Chen, {Edward P} and {van Kuijk}, {Sander M J} and Schurink, {Geert W H} and Sailer, {Anna M} and Kathrin B{\"a}umler and Miller, {D Craig} and Fischbein, {Michael P} and Dominik Fleischmann",

note = "{\textcopyright} 2022 by the Radiological Society of North America, Inc.",

year = "2022",

month = dec,

doi = "10.1148/ryct.220039",

language = "English",

volume = "4",

journal = "Radiology. Cardiothoracic imaging",

issn = "2638-6135",

publisher = "Radiological Society of North America, Inc.",

number = "6",

}

Mastrodicasa, D, Willemink, MJ, Turner, VL, Hinostroza, V, Codari, M, Hanneman, K, Ouzounian, M, Ocazionez Trujillo, D, Afifi, RO, Hedgire, S, Burris, NS, Yang, B, Lacomis, JM, Gleason, TG, Pacini, D, Folesani, G, Lovato, L, Hinzpeter, R, Alkadhi, H, Stillman, AE, Chen, EP, van Kuijk, SMJ , Schurink, GWH, Sailer, AM, Bäumler, K, Miller, DC, Fischbein, MP & Fleischmann, D 2022, 'Registry of Aortic Diseases to Model Adverse Events and Progression (ROADMAP) in Uncomplicated Type B Aortic Dissection: Study Design and Rationale', Radiology. Cardiothoracic imaging, vol. 4, no. 6, e220039. https://doi.org/10.1148/ryct.220039

Registry of Aortic Diseases to Model Adverse Events and Progression (ROADMAP) in Uncomplicated Type B Aortic Dissection: Study Design and Rationale. / Mastrodicasa, Domenico; Willemink, Martin J; Turner, Valery L et al.
In: Radiology. Cardiothoracic imaging, Vol. 4, No. 6, e220039, 12.2022.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Registry of Aortic Diseases to Model Adverse Events and Progression (ROADMAP) in Uncomplicated Type B Aortic Dissection

T2 - Study Design and Rationale

AU - Mastrodicasa, Domenico

AU - Willemink, Martin J

AU - Turner, Valery L

AU - Hinostroza, Virginia

AU - Codari, Marina

AU - Hanneman, Kate

AU - Ouzounian, Maral

AU - Ocazionez Trujillo, Daniel

AU - Afifi, Rana O

AU - Hedgire, Sandeep

AU - Burris, Nicholas S

AU - Yang, Bo

AU - Lacomis, Joan M

AU - Gleason, Thomas G

AU - Pacini, Davide

AU - Folesani, Gianluca

AU - Lovato, Luigi

AU - Hinzpeter, Ricarda

AU - Alkadhi, Hatem

AU - Stillman, Arthur E

AU - Chen, Edward P

AU - van Kuijk, Sander M J

AU - Schurink, Geert W H

AU - Sailer, Anna M

AU - Bäumler, Kathrin

AU - Miller, D Craig

AU - Fischbein, Michael P

AU - Fleischmann, Dominik

PY - 2022/12

Y1 - 2022/12

N2 - 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.

AB - 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.

U2 - 10.1148/ryct.220039

DO - 10.1148/ryct.220039

M3 - Article

C2 - 36601455

SN - 2638-6135

VL - 4

JO - Radiology. Cardiothoracic imaging

JF - Radiology. Cardiothoracic imaging

IS - 6

M1 - e220039

ER -