Two-Year Results of a Multicenter Prospective Observational Study of the Zenith Spiral-Z Limb Deployed in the External Iliac Artery During Endovascular Aneurysm Repair

Fujimura, Naoki; Imazuru, Tomohiro; Matsumura, Hitoshi; Shiina, Tsuyoshi; Furuyama, Tadashi; Kaneko, Kenjiro; Uchiyama, Hidetoshi; Morikage, Noriyasu; Uchida, Takayuki; Teshima, Eiichi; Yamaoka, Terutoshi; Masuhara, Hiroshi; Ueda, Hiroyuki; Arakawa, Mamoru; Norimatsu, Togo; Obara, Hideaki; Onitsuka, Seiji

doi:10.1253/circj.cj-20-0195

Cited by 3 publications

(3 citation statements)

References 29 publications

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“…Indeed, the percentage of IFU violation observed was only 34.2% and the mean proximal neck length was 38.0±13.3 mm. These numbers are considerably better than those previously reported in Japanese studies, 19,31 probably indicating that physicians prefer using Zenith Alpha AAA in long neck cases. Furthermore, we have reported only 12 months of results, which are regarded as an early result for EVAR.…”

Section: Discussioncontrasting

confidence: 61%

“…Considering the fact that this study was conducted in the Japanese population, and 30 patients (38.0%) had limb deployment in the EIA, the present result is satisfactory and comparable with previous reports. 20,21,22,26,30,31 Among 30 patients who had limb deployed in the EIA, 9 patients had bare nitinol stent placed for the reinforcement, which may have affected the result favorably.…”

Section: Discussionmentioning

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: Discussioncontrasting

confidence: 61%

Section: Discussionmentioning

confidence: 99%

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

et al. 2022

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“…По данным систематического обзора с участием 8304 пациентов средняя совокупная смертность после поздней конверсии составила 23 % [11]. Половина от всех окклюзий бранш стент-графтов приходятся на первые 30 дней, 71 % выпадает на срок в течение 6 месяцев [12,13] и 100 % окклюзий -на срок до 2 лет с момента операции [14]. В нашем случае тромбоз бранши произошел через 30 дней после EVAR.…”

Section: результаты и обсуждениеunclassified

Surgical Treatment for Branched Endograft Thrombosis of the Abdominal Aorta

Gilemkhanov,

Plechev,

Bakirov

et al. 2023

Kreativnaâ hirurgiâ i onkologiâ

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Introduction. Endovascular intervention was firstly introduced for repairing aortic aneurysms in the early 1990s. The greatest advantage of endovascular aneurysm repair (EVAR) is its minimally-invasive character, thus implying shorter post-operative period. The operative mortality rate comprises 3.3 % (95 % CI 2.9–3.6); however, according to recent studies, the rate has declined to 1.4 % due to a rapid improvement in outcomes. According to the DREAM-trial, the incidence of a branched endograft thrombosis accounts for 6.4% within the first 30 days. The EVAR trial reports an incidence of 2.6% after the first year of follow-up. Stent bending and small distal aortic diameters (less than 20 mm) are believed to be the most common causes of endograft thrombosis.Aim. To identify the causes of complications following the abdominal aortic stent-graft repair and to determine the optimal treatment strategy.Materials and methods. The paper presents a case of 71-year-old patient with late complication after endovascular abdominal aortic repair of an infrarenal aortic aneurysm. The patient was admitted to the hospital on January 05, 2020 as an emergency due to the pain in the left lower limb. On December 03, 2019 the patient underwent endovascular abdominal aortic repair. Angiography of January 06, 2020 revealed thrombosis of the left branch of the stent graft. Thrombectomy of the brunched left stent graft, left iliac artery and balloon dilatation of the brunched left stent-graft were performed.Results and discussion. Endovascular abdominal aortic repair stands as the first choice for patients with appropriate aortic anatomy and those with significant comorbidity. Despite the significant progress in endovascular abdominal aortic repairing, the EVAR procedure is followed by a nearly fivefold increase in the 30-day reintervention rate as compared to open surgery which comprises 9.8 % according to the EVAR-I, and 18 %, according to the EVAR-II trials.Conclusion. Our multidisciplinary team consisted of vascular and endovascular surgeons managed to perform hybrid surgery, thus eliminating the EVAR-associated complication together with its cause.

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Limb Graft Occlusion Following Endovascular Aneurysm Repair for Infrarenal Abdominal Aortic Aneurysm with the Zenith Alpha, Excluder, and Endurant Devices: a Multicentre Cohort Study

Bogdanovič

Stackelberg

Lindström

et al. 2021

European Journal of Vascular and Endovascular Surgery

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WHAT THIS PAPER ADDSThis study provides real world, midterm follow up data on the performance of three major endograft systems currently in routine use, the Zenith Alpha, Excluder, and Endurant, with regards to limb graft occlusion (LGO) after standard endovascular aneurysm repair. The Zenith Alpha device, external iliac artery (EIA) diameter < 10 mm, and landing in EIA were identified as independent risk factors for LGO.Objective: Limb graft occlusion (LGO) is a serious complication after endovascular aneurysm repair (EVAR) and while device development enables treatment of increasingly complex aortic anatomy, little is known about how endograft type affects the risk of occlusion. This observational study aimed to explore the incidence of LGO after EVAR for three major endograft systems. Methods: All patients with standard EVAR as the primary intervention for infrarenal abdominal aortic aneurysm (AAA), between January 2012 and December 2018, at five Swedish vascular surgery centres, were included in this multicentre retrospective cohort study. LGO was defined as a total limb occlusion regardless of symptoms, or a treated significant stenosis. A nested case control (NCC) design with incidence density sampling of 1:3 was used for analysis of potential per-operative and morphological risk factors. Conditional logistic regression was used to estimate multivariable odds ratios (OR) with 95% confidence intervals (CI) Results: A total of 924 patients were included. The majority were male (84%), the mean age was 76 years (AE 7.5 SD), and median AAA diameter was 59 mm (IQR 55, 67). Patients were treated with Zenith Alpha (n ¼ 315, ZISL limbs), Excluder (n ¼ 152, PLC/PXC limbs), and Endurant (n ¼ 457, ETLW/ ETEW limbs). During median follow up of 37 months (IQR 21, 62), 55 occlusions occurred (5.9%); 39 with Zenith Alpha (12.4%), one with Excluder (0.7%), and 15 with Endurant (3.3%). In the NCC analysis, the Zenith Alpha device (OR 5.31, 95% CI 1.97 e 14.3), external iliac artery (EIA) landing (OR 5.91, 95% CI 1.30 e 26.7), and EIA diameter < 10 mm (OR 4.99, 95% CI 1.46 e 16.9) were associated with an increased risk of LGO. Conclusion: Endograft device type is an independent risk factor for LGO after EVAR. Specifically, the Zenith Alpha demonstrated an increased risk of LGO compared with the Endurant and Excluder devices. In addition, a narrow EIA and landing zone in EIA are also risk factors for LGO.

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Two-Year Results of a Multicenter Prospective Observational Study of the Zenith Spiral-Z Limb Deployed in the External Iliac Artery During Endovascular Aneurysm Repair

Cited by 3 publications

References 29 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

Surgical Treatment for Branched Endograft Thrombosis of the Abdominal Aorta

Limb Graft Occlusion Following Endovascular Aneurysm Repair for Infrarenal Abdominal Aortic Aneurysm with the Zenith Alpha, Excluder, and Endurant Devices: a Multicentre Cohort Study

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