title: Assessment of CardiOvascular Remodelling following Endovascular aortic repair through imaging and computation: the CORE prospective observational cohort study protocol.
abstract: Thoracic aortic stent grafts are orders of magnitude stiffer than the native aorta. These devices have been associated with acute hypertension, elevated pulse pressure, cardiac remodelling and reduced coronary perfusion. However, a systematic assessment of such cardiovascular effects of thoracic endovascular aortic repair (TEVAR) is missing. The CardiOvascular Remodelling following Endovascular aortic repair (CORE) study aims to (1) quantify cardiovascular remodelling following TEVAR and compare echocardiography against MRI, the reference method; (2) validate computational modelling of cardiovascular haemodynamics following TEVAR using clinical measurements, and virtually assess the impact of more compliant stent grafts on cardiovascular haemodynamics; and (3) investigate diagnostic accuracy of ECG and serum biomarkers for cardiac remodelling compared to MRI.
  
  
  
  This is a prospective, nonrandomised, observational cohort study. We will use MRI, CT, echocardiography, intraluminal pressures, ECG, computational modelling and serum biomarkers to assess cardiovascular remodelling in two groups of patients with degenerative thoracic aneurysms or penetrating aortic ulcers: (1) patients managed with TEVAR and (2) control patients managed with medical therapy alone. Power analysis revealed a minimum total sample size of 20 patients (α=0.05, power=0.97) to observe significant left ventricular mass increase following TEVAR after 1 year. Consequently, we will include 12 patients in both groups. Advanced MRI sequences will be used to assess myocardial and aortic strain and distensibility, myocardial perfusion and aortic flow. ECG, echocardiography and serum biomarkers will be collected and compared against the imaging data. Computational models will be constructed from each patient imaging data, analysed and validated. All measurements will be collected at baseline (prior to TEVAR) and 1-year follow-up. The expected study period is 3 years.
  
  
  
  This study has been approved by the University of Michigan IRB. The results will be disseminated through scientific journals and conference presentations.
  
  
  
  NCT02735720.
authors.affiliation: Cardiovascular Center, University of Michigan Health System, Ann Arbor, Michigan, USA.|Department of Vascular Surgery, Thoracic Aortic Research Center, Policlinico San Donato IRCCS, University of Milan, Milan, Italy.
authors.forename: Foeke J H
authors.initials: FJ
authors.lastname: Nauta
authors.affiliation: Cardiovascular Center, University of Michigan Health System, Ann Arbor, Michigan, USA.|Department of Vascular Surgery, Thoracic Aortic Research Center, Policlinico San Donato IRCCS, University of Milan, Milan, Italy.
authors.forename: Arnoud V
authors.initials: AV
authors.lastname: Kamman
authors.affiliation: Department of Radiology, University of Michigan, Ann Arbor, Michigan, USA.
authors.forename: El-Sayed H
authors.initials: EH
authors.lastname: Ibrahim
authors.affiliation: Department of Radiology, University of Michigan, Ann Arbor, Michigan, USA.
authors.forename: Prachi P
authors.initials: PP
authors.lastname: Agarwal
authors.affiliation: Department of Cardiac Surgery, University of Michigan, Ann Arbor, Michigan, USA.
authors.forename: Bo
authors.initials: B
authors.lastname: Yang
authors.affiliation: Department of Cardiac Surgery, University of Michigan, Ann Arbor, Michigan, USA.
authors.forename: Karen
authors.initials: K
authors.lastname: Kim
authors.affiliation: Department of Radiology, University of Michigan, Ann Arbor, Michigan, USA.
authors.forename: David M
authors.initials: DM
authors.lastname: Williams
authors.affiliation: Department of Vascular Surgery, University of Utrecht, Utrecht, Midden-Nederland, The Netherlands.
authors.forename: Joost A
authors.initials: JA
authors.lastname: van Herwaarden
authors.affiliation: Department of Vascular Surgery, University of Utrecht, Utrecht, Midden-Nederland, The Netherlands.
authors.forename: Frans L
authors.initials: FL
authors.lastname: Moll
authors.affiliation: Cardiovascular Center, University of Michigan Health System, Ann Arbor, Michigan, USA.
authors.forename: Kim A
authors.initials: KA
authors.lastname: Eagle
authors.affiliation: Department of Vascular Surgery, Thoracic Aortic Research Center, Policlinico San Donato IRCCS, University of Milan, Milan, Italy.
authors.forename: Santi
authors.initials: S
authors.lastname: Trimarchi
authors.affiliation: Department of Cardiac Surgery, University of Michigan, Ann Arbor, Michigan, USA.
authors.forename: Himanshu J
authors.initials: HJ
authors.lastname: Patel
authors.affiliation: Departments of Biomedical Engineering and Surgery, University of Michigan, Ann Arbor, Michigan, USA.
authors.forename: C Alberto
authors.initials: CA
authors.lastname: Figueroa
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000784:Aortic Dissection / Q000601:surgery*; D017545:Aortic Aneurysm, Thoracic / Q000000981:diagnostic imaging* / Q000601:surgery*; D015415:Biomarkers / Q000097:blood*; D003198:Computer Simulation; D004452:Echocardiography; D057510:Endovascular Procedures / Q000009:adverse effects*; D005260:Female; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D008824:Michigan; D008875:Middle Aged; D008955:Models, Cardiovascular; D011446:Prospective Studies; D012107:Research Design; D018570:Risk Assessment; D015607:Stents / Q000009:adverse effects; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D020257:Ventricular Remodeling; D055815:Young Adult
chemical_list: D015415:Biomarkers
keywords: VASCULAR SURGERY