To assess hemodynamic disturbances to the ostia of the renal arteries generated by the implantation of EVAR with a suprarenal fixation

Lucie Salomon du Mont, Anne-Laure Parmentier, Marc Puyraveau, Frédéric Mauny, Benoit Guillon, Simon Rinckenbach, Patricia Costa, Lucie Salomon du Mont, Anne-Laure Parmentier, Marc Puyraveau, Frédéric Mauny, Benoit Guillon, Simon Rinckenbach, Patricia Costa

Abstract

Introduction: The treatment of abdominal aortic aneurysm (AAA) is increasingly performed via endovascular aneurysm repair (EVAR). Different types of fixation are possible with EVAR, i.e., below (infrarenal fixation) or above (suprarenal fixation) the renal arteries. Hemodynamic alterations in renal arterial flow with suprarenal (SR) fixation remain to be demonstrated. The IFIXEAR (Impact of Supra-renal Fixation of EVAR on Hemodynamics of Renal Arteries) study is designed to assess the hemodynamic effects at the ostia of at least 1 renal artery, generated immediately post-surgery by the implantation of an aortic stent with SR fixation.

Methods: IFIXEAR is a prospective, 2 center study. Every patient undergoing elective EVAR with SR fixation is eligible for inclusion. Patients with previous hemodynamic disturbances to the ostia of 1 of the renal arteries are not eligible. All patients undergo echocardiography and renal arteries duplex ultrasound within a month before surgery, and at 1 and 12 months after surgery. The primary endpoint is hemodynamic disturbance, defined as a peak systolic velocity greater than 120 cm/second, at the ostia of 1 of the renal arteries in the immediate postoperative period.

Ethics and dissemination: The study was approved by the Ethics Committee "Comité de Protection des Personnes Ouest V" under the number 18/019-2 on April 20, 2018. All patients provide written informed consent before inclusion. The University Hospital of Besancon is the trial sponsor. Results of the study will be submitted for publication in a peer-reviewed international medical journal.

Registration: The trial is registered with ClinicalTrials.gov (Identifier: NCT03594786, principal investigator: Dr Patricia Costa, Registered on April 24, 2018).

Conflict of interest statement

The authors have no conflict of interest.

References

    1. Delay C, Lejay A, Deglise S, et al. Should we treat abdominal aortic aneurysms from 5.0 cm in France while the cutoff is 5.5 cm in english-speaking countries? J Mal Vasc 2016;41:1–3.
    1. Budtz-Lilly J, Venermo M, Debus S, et al. Assessment of international outcomes of intact abdominal aortic aneurysm repair over 9 Years. Eur J Vasc Endovasc Surg 2017;54:13–20.
    1. Salomon du Mont L, Rinckenbach S, Besch G, et al. Evolution of practices in treatment of abdominal aortic aneurysm in France between 2006 and 2015. Ann Vasc Surg 2019;58:38–44.
    1. Wanhainen A, Verzini F, Van Herzeele I, et al. Editor's Choice - European Society for Vascular Surgery (ESVS) 2019 Clinical Practice Guidelines on the management of abdominal aorto-iliac artery aneurysms. Eur J Vasc Endovasc Surg 2019;57:8–93.
    1. Sun Z, Winder RJ, Kelly BE, et al. CT virtual intravascular endoscopy of abdominal aortic aneurysms treated with suprarenal endovascular stent grafting. Abdom Imaging 2003;28:580–7.
    1. England A, Butterfield JS, Ashleigh RJ. Incidence and effect of bare suprarenal stent struts crossing renal ostia following EVAR. Eur J Vasc Endovasc Surg Off J Eur Soc Vasc Surg 2006;32:523–8.
    1. Desgranges P, Hutin E, Kedzia C, et al. Aortic stents covering the renal arteries ostia: an animal study. J Vasc Interv Radiol JVIR 1997;8(1 Pt 1):77–82.
    1. Sun Z, Chaichana T. Investigation of the hemodynamic effect of stent wires on renal arteries in patients with abdominal aortic aneurysms treated with suprarenal stent-grafts. Cardiovasc Intervent Radiol 2009;32:647–57.
    1. Sun Z, Stevenson G. Transrenal fixation of aortic stent-grafts: short- to midterm effects on renal function--a systematic review. Radiology 2006;240:65–72.
    1. Saratzis A, Bath MF, Harrison S, et al. Long-term renal function after endovascular aneurysm repair. Clin J Am Soc Nephrol CJASN 2015;10:1930–6.
    1. Agag G, Salomon du Mont L, Leclerc B, et al. Is Suprarenal fixation of aortic stent grafts really without consequence on the renal function? Ann Vasc Surg 2017;39:90–8.
    1. Antonello M, Menegolo M, Piazza M, et al. Outcomes of endovascular aneurysm repair on renal function compared with open repair. J Vasc Surg 2013;58:886–93.
    1. Moll FL, Powell JT, Fraedrich G, et al. Management of abdominal aortic aneurysms clinical practice guidelines of the European society for vascular surgery. Eur J Vasc Endovasc Surg 2011;41: Suppl 1: S1–58.
    1. Erbel R, Aboyans V, Boileau C, et al. 2014 ESC Guidelines on the diagnosis and treatment of aortic diseases: document covering acute and chronic aortic diseases of the thoracic and abdominal aorta of the adult. The Task Force for the Diagnosis and Treatment of Aortic Diseases of the European Society of Cardiology (ESC). Eur Heart J 2014;35:2873–926.
    1. AbuRahma AF, Yacoub M. Renal imaging: duplex ultrasound, computed tomography angiography, magnetic resonance angiography, and angiography. Semin Vasc Surg 2013;26:134–43.
    1. Haute Autorité de Santé - Evaluation des Endoprothèses Aortiques Abdominales utilisées pour le traitement des anévrismes de l’aorte abdominale sous-rénale [Internet]. [cited 2017 Jun 6]. Available from: .
    1. Chan A-W, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013;158:200–7.
    1. Giordana P, Pichot O, Diard A, et al. Standards de qualité pour la pratique de l’écho-Doppler des artères rénales (version préliminaire). La Lettre du Médecin Vasculaire n 2012;19–33.
    1. Levey AS, Stevens LA, Schmid CH, et al. A new equation to estimate glomerular filtration rate. Ann Intern Med 2009;150:604–12.
    1. Lwanga SK, Lemeshow S. Sample Size Determination in Health Studies: A Practical Manual. 1991.

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