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; Yeung, Kak Khee; Fioole, Bram; Verhoeven, Eric L.G.; Lauwers, Geert; Kölbel, Tilo; Wever, Jan J.; Scheinert, Dierk; Eynde, Wouter Van den; Rouhani, Guido; Mees, Barend; Vermassen, Frank; Schelzig, Hubert; Cuypers, Philippe W.M.; Böckler, Dittmar; Katsargyris, Αthanasios; Overhagen, Hans van; Verbist, Jürgen; Schurink, Geert Willem H.; Eps, Randolph G. Statius van; Veger, Hugo T.C.; Dijk, Lukas C. van

doi:10.1016/j.avsg.2021.06.020

Cited by 4 publications

(3 citation statements)

References 19 publications

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“…[4][5][6][7][8] Zenith Alpha AAA is a new-generation low-profile endovascular graft that is already available in Europe, Australia, Canada, and Brazil; however, reports on the clinical results are currently lacking in the literature with only 1 study reporting 30 days clinical result. 11 In this report, we retrospectively evaluated consecutive 79 patients in the initial launch of Zenith Alpha AAA in Japan, and found that sac shrinkage of >5 mm was achieved in 42.2% of patients, with satisfactory freedom from late complication rate of 90.8% at 12 months. Durable repair has become a considerable topic in the EVAR procedure and is also the biggest concern with lowprofile endovascular graft.…”

Section: Discussionmentioning

confidence: 96%

“…First, even after the launch of the Zenith Alpha AAA in Europe, Australia, Canada, Brazil, and Japan, reports on the clinical results are currently lacking in the literature with only 1 study reporting 30 days clinical result. 11 Second, this was a result of all consecutive patients using Zenith Alpha AAA in the initial launch in Japan, which included the results of the learning curve of this device. Last, premature suprarenal stent barb anchoring in an angulated proximal neck is a unique pitfall not seen with other devices and should be shared with vascular interventionists.…”

Section: Limitationsmentioning

confidence: 99%

“…Multiple studies have reported the long-term data of the original Zenith AAA endovascular graft (Zenith AAA, Cook, Inc, Bloomington, Indiana) 9,10 ; however, the clinical outcomes of Zenith Alpha AAA are currently lacking in the literature with only 1 study reporting 30 days outcome. 11 The objective of this study was to retrospectively evaluate the early clinical outcomes of the Zenith Alpha AAA for the treatment of infrarenal abdominal aortic or aortoiliac aneurysms.…”

Section: Introductionmentioning

confidence: 99%

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Early Clinical Outcomes of Initial Launch of the Zenith Alpha Abdominal Endovascular Graft in Japan

et al. 2022

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Purpose: This study retrospectively evaluated the 12-month outcomes of the Zenith Alpha Abdominal Endovascular graft (Zenith Alpha AAA, Cook, Inc, Bloomington, Indiana), which was launched partially in Japan in March 2019, starting with 9 selected sites. Methods: A retrospective analysis was performed of all endovascular aneurysm repairs (EVAR) for abdominal aortic aneurysms using the Zenith Alpha AAA. Late complications were defined as any aneurysm-related events occurring >30 days after EVAR, including an aneurysm sac enlargement of >5 mm and any reinterventions performed. Endoleaks without sac enlargement or reinterventions were excluded from late complications. Results: During the study period, 79 EVARs using the Zenith Alpha AAA were performed. The mean age was 76.6±6.9 years old, 91.1% of patients were male, and the mean aneurysm diameter was 51.1±7.5 mm. Instructions for use violation was observed in 27 patients (34.2%), most frequently being a severely angulated proximal neck (>60°). There were 4 intraoperative complications, including 2 unintentional partial renal artery coverages caused by the premature anchoring of the exposed suprarenal stent barb to the aortic wall, which was a result of the design change of the top cap deletion. Since it was a partial coverage without flow impairment and since renal stenting was unsuccessful, it was left untreated and had no subsequent renal function impairment. During the mean follow-up of 444±123 days, 74 patients completed 12 months of follow-up. Freedom from late complications at 12 months was 90.8%, which included 2 limb occlusions (2.5%). Of 71 patients with a 12-month computed tomography scan, there was only 1 type 1a endoleak (1.3%), 1 sac enlargement of >5 mm (1.3%), and an aneurysm sac shrinkage of >5 mm was observed in 42.2% of patients. There was no type 3 endoleak during the follow-up. Conclusions: This study demonstrated that the new generation of low-profile Zenith Alpha AAA has satisfactory early clinical outcomes, comparable to those obtained with the conventional Zenith endovascular graft. Long-term follow-up is needed to determine whether these favorable outcomes persist.

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Section: Discussionmentioning

confidence: 96%

Section: Limitationsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Early Clinical Outcomes of Initial Launch of the Zenith Alpha Abdominal Endovascular Graft in Japan

et al. 2022

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

Hatzl,

van Basten Batenburg,

Yeung

et al. 2024

European Journal of Vascular and Endovascular Surgery

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Early and Midterm Outcomes of Endovascular Aneurysm Repair With Zenith Alpha Abdominal Stent-Graft: Results From a Multicenter Retrospective Tuscany Registry

Troisi,

Pulli,

Donato

et al. 2023

J Endovasc Ther

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Purpose: Zenith Alpha Abdominal (Cook Medical, Bloomington, IN, USA) is one of the new-generation low-profile stent-grafts with demonstrated satisfactory early and midterm clinical outcomes for endovascular treatment of abdominal aortic aneurysms (AAAs). The aim was to evaluate early and midterm results of this device in the framework of a multicenter regional retrospective registry, with the analysis of morphological factors affecting outcomes, including different limb configurations. Materials and methods: Between January 2016 and November 2021, 202 patients with AAA underwent elective endovascular aneurysm repair (EVAR) with implantation of a Zenith Alpha Abdominal in 7 centers. Early (30 day) outcomes in terms of technical and clinical success were assessed. Estimated 5 year outcomes were evaluated in terms of survival, freedom from type I/III endoleak, freedom from surgical conversion, freedom from limb graft occlusion, freedom from any device-related reintervention, and graft infection evaluation by life-table analysis (Kaplan–Meier test). A comparative analysis between different limb configurations (Zenith Spiral Z AAA iliac legs, codes ZISL vs ZSLE) was performed in terms of limb graft occlusion. Results: The 30 day technical and clinical success rates were 97.5% and 99.5%, respectively. Median follow-up period was 25.5 months (interquartile range [IQR]: 12–43.25). The 5 year survival rate was 73.6%. The estimated 5 year outcomes in terms of freedom from type I/III endoleak, freedom from surgical conversion, freedom from limb graft occlusion, freedom from any device-related reintervention, and freedom from graft infection were 88.6% (95% CI [confidence interval]: 83.4%–93.1%), 95.8% (95% CI: 92.7%–97.1%), 93.6% (95% CI: 90.2%–96.8%), 87% (95% CI: 83.3%–91.6%), and 97.7% (95% CI: 95.1%–98.9%), respectively. About limb configuration, no differences were found in terms of 5 year freedom from limb graft occlusion (ZSLE 93.4% [95% CI: 89.8%–95.5%] vs ZISL 94.3% [95% CI: 90.1%–95.9%], p=0.342; log-rank 0.903). Conclusion: Zenith Alpha Abdominal in elective EVAR offered satisfactory early and 5 year outcomes with low complication rates. Limb graft occlusion continued to be an issue. Limb configuration did not affect outcomes. Clinical Impact The authors describe satisfactory early and 5 year outcomes of Zenith Alpha Abdominal in elective endovascular aortic repair in the framework of a multicenter regional retrospective registry. At 5 years freedom from type I endoleak was 88.6%, and rate of endograft infections and conversions to open repair were very low. in the present study. Hot topic about about Zenith stent-graft still remains the limb graft occlusion with a 30-day overall rate of 2%, and estimated 5-year freedom from limb graft occlusion of 93.6%. Limb graft configuration did not affect limb graft occlusion rate. A standardized protocol including iliac stenting should be adopted to reduce kimb graft occlusion.

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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

Cited by 4 publications

References 19 publications

Early Clinical Outcomes of Initial Launch of the Zenith Alpha Abdominal Endovascular Graft in Japan

Early Clinical Outcomes of Initial Launch of the Zenith Alpha Abdominal Endovascular Graft in Japan

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

Early and Midterm Outcomes of Endovascular Aneurysm Repair With Zenith Alpha Abdominal Stent-Graft: Results From a Multicenter Retrospective Tuscany Registry

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