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Hatzl J, Batenburg MVB, Yeung KK, et al. Thirty-day Results from the ZEPHYR Registry: Outcomes of EVAR Using the Zenith Alpha™ Abdominal Endovascular Graft for the Treatment of AAA in 347 Patients. Ann Vasc Surg. 2021;doi: 10.1016/j.avsg.2021.06.020.
Hatzl, J., Batenburg, M. V. B., Yeung, K. K., Fioole, B., Verhoeven, E., Lauwers, G., Kölbel, T., Wever, J. J., Scheinert, D., Van den Eynde, W., Rouhani, G., Mees, B. M. E., Vermassen, F., Schelzig, H., Cuypers, P. W. M., Böckler, D. (2021). Thirty-day Results from the ZEPHYR Registry: Outcomes of EVAR Using the Zenith Alpha™ Abdominal Endovascular Graft for the Treatment of AAA in 347 Patients. Annals of vascular surgery, . https://doi.org/10.1016/j.avsg.2021.06.020
Hatzl, Johannes, et al. "Thirty-day Results from the ZEPHYR Registry: Outcomes of EVAR Using the Zenith Alpha™ Abdominal Endovascular Graft for the Treatment of AAA in 347 Patients." Annals of vascular surgery vol. (2021). doi: https://doi.org/10.1016/j.avsg.2021.06.020
Hatzl J, Batenburg MVB, Yeung KK, Fioole B, Verhoeven E, Lauwers G, Kölbel T, Wever JJ, Scheinert D, Van den Eynde W, Rouhani G, Mees BME, Vermassen F, Schelzig H, Cuypers PWM, Böckler D. Thirty-day Results from the ZEPHYR Registry: Outcomes of EVAR Using the Zenith Alpha™ Abdominal Endovascular Graft for the Treatment of AAA in 347 Patients. Ann Vasc Surg. 2021 Aug 30; doi: 10.1016/j.avsg.2021.06.020. Epub 2021 Aug 30. PMID: 34474131.
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Ann Vasc Surg. 2021 Aug 30; doi: 10.1016/j.avsg.2021.06.020. Epub 2021 Aug 30.

Thirty-day Results from the ZEPHYR Registry: Outcomes of EVAR Using the Zenith Alpha™ Abdominal Endovascular Graft for the Treatment of AAA in 347 Patients.

Annals of vascular surgery

Johannes Hatzl, Michiel Van Basten Batenburg, Kak K Yeung, Bram Fioole, Eric Verhoeven, Geert Lauwers, Tilo Kölbel, Jan J Wever, Dierk Scheinert, Wouter Van den Eynde, Guido Rouhani, Barend M E Mees, Frank Vermassen, Hubert Schelzig, Philippe W M Cuypers, Dittmar Böckler,

Affiliations

  1. Department of Vascular and Endovascular Surgery, University Hospital Heidelberg, Heidelberg, Germany. Electronic address: [email protected].
  2. Department of Vascular Surgery, Catharina Hospital, Eindhoven, The Netherlands.
  3. Department of Vascular Surgery, Vrije Universiteit Medical Center, Amsterdam, The Netherlands.
  4. Department of Vascular Surgery, Maasstad Hospital, Rotterdam, The Netherlands.
  5. Department of Vascular and Endovascular Surgery, Paracelsus Medical University, Nuremberg, Germany.
  6. Department of Vascular and Thoracic Surgery, Ziekenhuis Oost-Limburg, Genk, Belgium.
  7. Department of Vascular Medicine, University Heart Center, University Hospital Hamburg-Eppendorf, Hamburg, Germany.
  8. Departments of Vascular Surgery and Interventional Radiology, Haga Hospital, The Hague, The Netherlands.
  9. Department of Angiology, University Hospital Leipzig, Leipzig, Germany.
  10. Department of Vascular and Thoracic Surgery, Imelda Hospital, Bonheiden, Belgium.
  11. Surgical Department, Klinikum Frankfurt Höchst, Frankfurt, Germany.
  12. Department of Vascular Surgery, Maastricht University Medical Centre, Maastricht, The Netherlands.
  13. Department of Vascular Surgery, Ghent University Hospital, Ghent, Belgium.
  14. Department of Vascular and Endovascular Surgery, Heinrich-Heine-University Medical Center Düsseldorf, Düsseldorf, Germany.
  15. Department of Vascular and Endovascular Surgery, University Hospital Heidelberg, Heidelberg, Germany.

PMID: 34474131 DOI: 10.1016/j.avsg.2021.06.020

Abstract

BACKGROUND: To report technical and clinical 30-day results following treatment with the Zenith Alpha™ abdominal stent graft from the ZEnith alPHa for aneurYsm Repair Registry (ZEPHYR).

METHODS: Multicenter, nonrandomized, single arm, core laboratory-controlled, prospective registry collecting data on the Zenith Alpha Abdominal Endovascular Graft being used in subjects with abdominal aortic aneurysms (AAA) from sites in Germany, Belgium, and The Netherlands between December 2016 and December 2019. Inclusion criteria were non-ruptured AAAs with a maximum diameter ≥50 mm or enlargement >5 mm over 6 months with an AAA neck length ≥10 mm (site reported). Primary outcome measure was treatment success at 30 days. Treatment success was defined as a combined endpoint consisting of technical and clinical success. Technical success was defined as successful stent graft delivery and deployment as well as successful removal of the delivery system. Clinical success at 30 days was defined as freedom from type I and III endoleak, aneurysm rupture, conversion to open surgery and stent graft occlusion.

RESULTS: Three hundred forty-seven subjects were included from 14 sites with a median age of 73.0 years (IQR 68.0-79.0). Thirty-four patients were female (9.8%). The median AAA diameter was 58.3 mm (IQR 55.0-63.5). The median proximal neck diameter was 23.6 mm (IQR 22.0-25.2) with a median proximal neck length of 24.4 mm (IQR 15.0-34.8) and a median infrarenal neck angulation of 24.5° (IQR 15.0-35.0). The right and left common iliac diameter were 16.1 mm (IQR 14.1-19.4) and 16.2 mm (IQR 14.1-19.1), respectively. The treatment success rate at 30 days was 94.8% (N = 329). Technical success was achieved in 333 patients (96.0%). The clinical success rate at 30 days was 98.8% (N = 343). Three patients had limb occlusions at 30 day follow up (0.9%). One patient had a type Ib endoleak (0.3%). Seventy percent of vascular access approaches were percutaneous. The reintervention rate was 1.7% (N = 6) within 30 days. Indications for reinterventions were a false aneurysm at puncture site (N = 1), limb complications (N = 2), stentgraft-associated renal artery occlusions (N = 2), and an external iliac artery thrombosis (N = 1).

CONCLUSIONS: Endovascular aneurysm repair using the Zenith Alpha Abdominal Endovascular Graft is effective in the short term. Long term results will be reported in the future.

Copyright © 2021 Elsevier Inc. All rights reserved.

Keywords: Abdominal; Aneurysm; Aortic Aneurysm; Blood Vessel Prosthesis, Endovascular Procedures/methods; Endovascular aneurysm repair (EVAR); Europe/epidemiology; Humans; Prospective Studies; Stents; Treatment Outcome; ZEPHYR; Zenith; abdominal aortic aneurysm (AAA); endovascular

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