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  • Assessment of CardiOvascular Remodelling following Endovascular aortic repair through imaging and computation: the CORE prospective observational cohort study protocol

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Surgery
Protocol
Assessment of CardiOvascular Remodelling following Endovascular aortic repair through imaging and computation: the CORE prospective observational cohort study protocol
  1. Foeke J H Nauta1,2,
  2. Arnoud V Kamman1,2,
  3. El-Sayed H Ibrahim3,
  4. Prachi P Agarwal3,
  5. Bo Yang4,
  6. Karen Kim4,
  7. David M Williams3,
  8. Joost A van Herwaarden5,
  9. Frans L Moll5,
  10. Kim A Eagle1,
  11. Santi Trimarchi2,
  12. Himanshu J Patel4,
  13. C Alberto Figueroa6
  1. 1Cardiovascular Center, University of Michigan Health System, Ann Arbor, Michigan, USA
  2. 2Department of Vascular Surgery, Thoracic Aortic Research Center, Policlinico San Donato IRCCS, University of Milan, Milan, Italy
  3. 3Department of Radiology, University of Michigan, Ann Arbor, Michigan, USA
  4. 4Department of Cardiac Surgery, University of Michigan, Ann Arbor, Michigan, USA
  5. 5Department of Vascular Surgery, University of Utrecht, Utrecht, Midden-Nederland, The Netherlands
  6. 6Departments of Biomedical Engineering and Surgery, University of Michigan, Ann Arbor, Michigan, USA
  1. Correspondence to Dr Foeke J H Nauta; fnauta{at}med.umich.edu

Abstract

Introduction 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.

Methods and analysis 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.

Ethics and dissemination This study has been approved by the University of Michigan IRB. The results will be disseminated through scientific journals and conference presentations.

Trial registration number NCT02735720.

  • VASCULAR SURGERY

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2016-012270

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    Footnotes

    • Contributors FJHN, JAvH, FLM, ST and CAF conceived of the study. FJHN, E-SHI, PPA, JAvH, FLM, KAE, HJP and CAF planned the study. FJHN, AVK, E-SHI, PPA, BY, KK, DMW, HJP and CAF will be responsible for data collection, quality analysis and storage. The initial draft of the present manuscript was created by FJHN and AVK and circulated among the authors for critical revision. All authors approved the final version of the manuscript.

    • Funding This work was supported by the University of Michigan Frankel Cardiovascular Center, Ann and Bob Aikens, the Edward B. Diethrich M.D. professorship, Joe D. Morris Professorship, David Hamilton Fund and Phil Jenkins Breakthrough Fund, and the European Research Council under the European Union's Seventh Framework Programme (FP/2007–2013) with grant number 307532.

    • Competing interests None declared.

    • Ethics approval University of Michigan Institutional Review Board.

    • Provenance and peer review Not commissioned; externally peer reviewed.