Clinical Performance of the Low Profile Zenith Alpha Abdominal Endovascular Graft: 2 Year Results from the ZEPHYR Registry.

Autor: Hatzl J; Department of Vascular and Endovascular Surgery, University Hospital Heidelberg, Heidelberg, Germany. Electronic address: johannes.hatzl@web.de., van Basten Batenburg M; Department of Vascular Surgery, Catharina Hospital, Eindhoven, the Netherlands., Yeung KK; Department of Vascular Surgery, Amsterdam UMC, Location VU Medical Centre, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands., Fioole B; Department of Vascular Surgery, Maasstad Hospital, Rotterdam, the Netherlands., Verhoeven E; Department of Vascular and Endovascular Surgery, Paracelsus Medical University, Nuremberg, Germany., Lauwers G; Department of Vascular and Thoracic Surgery, Ziekenhuis Oost-Limburg, Genk, Belgium., Kölbel T; German Aortic Centre Hamburg, Department of Vascular Medicine, University Medical Centre Eppendorf, Hamburg, Germany., Wever JJ; Departments of Vascular Surgery and Interventional Radiology, Haga Hospital, The Hague, the Netherlands., Scheinert D; Department of Angiology, University Hospital Leipzig, Leipzig, Germany., Van den Eynde W; Department of Vascular and Thoracic Surgery, Imelda Hospital, Bonheiden, Belgium., Rouhani G; Section of Vascular and Endovascular Surgery, Klinikum Frankfurt Höchst, Frankfurt, Germany., Mees BME; Department of Vascular Surgery, Maastricht University Medical Centre, Maastricht, the Netherlands., Vermassen F; Department of Vascular Surgery, Ghent University Hospital, Ghent, Belgium., Schelzig H; Department of Vascular and Endovascular Surgery, Heinrich-Heine-University Medical Centre Düsseldorf, Düsseldorf, Germany., Böckler D; Department of Vascular and Endovascular Surgery, University Hospital Heidelberg, Heidelberg, Germany., Cuypers PWM; Department of Vascular Surgery, Catharina Hospital, Eindhoven, the Netherlands.
Jazyk: angličtina
Zdroj: European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery [Eur J Vasc Endovasc Surg] 2024 Jul; Vol. 68 (1), pp. 40-48. Date of Electronic Publication: 2024 Mar 13.
DOI: 10.1016/j.ejvs.2024.03.004
Abstrakt: Objective: The midterm outcomes of the low profile Zenith Alpha Abdominal Endovascular Graft from the ZEnith alPHa for aneurYsm Repair (ZEPHYR) registry are reported.
Methods: The ZEPHYR registry is a physician initiated, multicentre, non-randomised, core laboratory controlled, prospective registry. Inclusion criteria were patients with a non-ruptured abdominal aortic aneurysm with a maximum diameter ≥ 50 mm or enlargement > 5 mm within 6 months, with a site reported infrarenal neck length of ≥ 10 mm and with the intention to electively implant the Zenith Alpha abdominal endograft. Patients from 14 sites across Germany, Belgium, and the Netherlands were included. The primary endpoint was treatment success, defined as technical success and clinical success. Technical success was defined as successful delivery and deployment of the endograft in the planned position without unintentional coverage of internal iliac or renal arteries, with successful removal of the delivery system. Clinical success was defined as freedom from aneurysm sac expansion > 5 mm, type I or type III endoleaks, aneurysm rupture, stent graft migration > 10 mm, open conversion, and stent graft occlusion.
Results: Three hundred and forty-seven patients were included in the ZEPHYR registry. The median clinical follow up was 743 days (interquartile range [IQR] 657, 806) with a median imaging follow up of 725 days (IQR 408, 788). Treatment success at 6 months, 1, and 2 years was 92.5%, 90.4%, and 85.3%, respectively. Freedom from secondary intervention was 94.3%, 93.4%, and 86.9%, respectively. The predominant reason for secondary intervention was limb complications. Freedom from limb occlusion (per patient) at 6 months, 1, and 2 years was 97.2%, 95.8%, and 92.5%, respectively. Univariable and multivariable Cox regression analyses could not identify any independent predictor for limb complications.
Conclusion: While treatment success is comparable with other commercially available grafts, the rate of limb complications at 2 years is of concern. The manufacturer's instructions for use should be followed closely. Further studies are necessary to investigate the root cause of the increased rate of limb complications with the Zenith Alpha Abdominal Endovascular Graft.
(Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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