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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

Standard

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

In: ANN VASC SURG, Vol. 78, 01.2022, p. 170-179.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

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 & Zephyr study group collaborators 2022, '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, vol. 78, pp. 170-179. https://doi.org/10.1016/j.avsg.2021.06.020

APA

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., & Zephyr study group collaborators (2022). 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, 78, 170-179. https://doi.org/10.1016/j.avsg.2021.06.020

Vancouver

Hatzl J, Batenburg MVB, Yeung KK, Fioole B, Verhoeven E, Lauwers G 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. 2022 Jan;78:170-179. https://doi.org/10.1016/j.avsg.2021.06.020

Bibtex

@article{70a6ba765d05425da139f976313cbcd9,
title = "Thirty-day Results from the ZEPHYR Registry: Outcomes of EVAR Using the Zenith Alpha{\texttrademark} Abdominal Endovascular Graft for the Treatment of AAA in 347 Patients",
abstract = "BACKGROUND: To report technical and clinical 30-day results following treatment with the Zenith Alpha{\texttrademark} 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.",
keywords = "Aged, Aged, 80 and over, Aneurysm, Ruptured, Aortic Aneurysm, Abdominal/surgery, Blood Vessel Prosthesis, Conversion to Open Surgery, Endoleak, Endovascular Procedures/adverse effects, Female, Humans, Male, Postoperative Complications/epidemiology, Prosthesis Design, Registries, Stents",
author = "Johannes Hatzl and Batenburg, {Michiel Van Basten} and Yeung, {Kak K} and Bram Fioole and Eric Verhoeven and Geert Lauwers and Tilo K{\"o}lbel and Wever, {Jan J} and Dierk Scheinert and {Van den Eynde}, Wouter and Guido Rouhani and Mees, {Barend M E} and Frank Vermassen and Hubert Schelzig and Cuypers, {Philippe W M} and Dittmar B{\"o}ckler and {Zephyr study group collaborators}",
note = "Copyright {\textcopyright} 2021 Elsevier Inc. All rights reserved.",
year = "2022",
month = jan,
doi = "10.1016/j.avsg.2021.06.020",
language = "English",
volume = "78",
pages = "170--179",
journal = "ANN VASC SURG",
issn = "0890-5096",
publisher = "Elsevier Inc.",

}

RIS

TY - JOUR

T1 - 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

AU - Hatzl, Johannes

AU - Batenburg, Michiel Van Basten

AU - Yeung, Kak K

AU - Fioole, Bram

AU - Verhoeven, Eric

AU - Lauwers, Geert

AU - Kölbel, Tilo

AU - Wever, Jan J

AU - Scheinert, Dierk

AU - Van den Eynde, Wouter

AU - Rouhani, Guido

AU - Mees, Barend M E

AU - Vermassen, Frank

AU - Schelzig, Hubert

AU - Cuypers, Philippe W M

AU - Böckler, Dittmar

AU - Zephyr study group collaborators

N1 - Copyright © 2021 Elsevier Inc. All rights reserved.

PY - 2022/1

Y1 - 2022/1

N2 - 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.

AB - 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.

KW - Aged

KW - Aged, 80 and over

KW - Aneurysm, Ruptured

KW - Aortic Aneurysm, Abdominal/surgery

KW - Blood Vessel Prosthesis

KW - Conversion to Open Surgery

KW - Endoleak

KW - Endovascular Procedures/adverse effects

KW - Female

KW - Humans

KW - Male

KW - Postoperative Complications/epidemiology

KW - Prosthesis Design

KW - Registries

KW - Stents

U2 - 10.1016/j.avsg.2021.06.020

DO - 10.1016/j.avsg.2021.06.020

M3 - SCORING: Journal article

C2 - 34474131

VL - 78

SP - 170

EP - 179

JO - ANN VASC SURG

JF - ANN VASC SURG

SN - 0890-5096

ER -