Institutional experience with the Zenith Fenestrated aortic stent graft

Wang, S. Keisin; Gutwein, Ashley R.; Gupta, Alok; Lemmon, Gary W.; Sawchuk, Alan P.; Motaganahalli, Raghu L.; Murphy, Michael P.; Fajardo, Andres

doi:10.1016/j.jvs.2017.11.063

Cited by 23 publications

(17 citation statements)

References 19 publications

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“…In terms of technical and clinical success and complications (endograft, branch vessels, systemic and local), there is no difference in our series compared with literature published by centers using CBCT and fusion technology [8,[14][15][16][17].…”

Section: Discussionmentioning

confidence: 54%

Safety and Feasibility of Performing Fenestrated Endovascular Abdominal Aneurysm Repair Using a Portable C-arm Without Fusion Technology: A Single-Center Experience

Juneja

Zia

Ayad

et al. 2020

Cureus

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Most centers performing fenestrated endovascular aneurysm repair (F-EVAR) use hybrid rooms with fusion technology for mapping. We present our experience of successfully performing F-EVAR using C-arm without fusion technology. Methods During the period of January 2016 to October 2018, data were collected from a prospectively maintained F-EVAR database at our tertiary care institute. The primary endpoint was technical success, and the secondary outcomes measured were short-and midterm clinical success (both defined by the Society for Vascular Surgery reporting standards), blood loss, radiation dose, operative time, postoperative endoleaks, aneurysm rupture, endograft patency, and complications. Results We performed 11 F-EVARs during the study period in five (45.5%) males and six (54.5%) females, with a mean age of 75+8 years. All procedures were performed under general anesthesia using OEC 9900 Elite Mobile C-arm (GE Healthcare, Chicago, IL, USA) without the use of fusion technology. Three patients had planned preoperative open procedures for access due to prior cutdown or bypass. Technical success was achieved in all 11 (100%) cases. The mean length of stay was 5+2 days, and the mean follow-up was 7.5+6.5 months. The mean procedure time was 301+167 minutes, and the mean blood loss was 361+233 mL. Mean fluoroscopy time was 72+31 minutes, and the mean radiation exposure time was 2,160+930 mGy. No patients required intraoperative transfusion. Thirty-day (short term) clinical success was achieved in 10 (90.0%), cases whereas six-month (midterm) clinical success was achieved in 7 (77.7%) patients. Branch vessel patency was 11 (100%) at 30 days and 9 (81.8%) at six months, and primary endograft patency was 100% (11) at six months. We had no perioperative mortality or major adverse cardiac event at 30 days. Thirty-day postoperative morbidity included readmission for pulmonary edema from cardiac failure in one patient. Two patients had clinically insignificant silent cardiac enzyme elevation. Three patients had re-interventions performed during the mean follow-up period. Two patients developed renal stent thrombosis resulting in renal insufficiency, which is defined as an increase in creatinine concentration ≥0.5

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Section: Discussionmentioning

confidence: 54%

Safety and Feasibility of Performing Fenestrated Endovascular Abdominal Aneurysm Repair Using a Portable C-arm Without Fusion Technology: A Single-Center Experience

Juneja

Zia

Ayad

et al. 2020

Cureus

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“…A total of 209 visceral arteries were stented through main body fenestrations in these 100 patients, resulting in six instances of visceral in-stent thrombosis in the follow-up phase. 5 Not surprisingly, in the six patients with difficult anatomy in which a chimney was placed, we observed trends toward increased operative time, contrast material volume used, and radiation exposure compared with those patients who were treated with conventional ZFEN FEVAR alone.…”

Section: Discussionmentioning

confidence: 70%

“…In our experience of >100 ZFENs implanted, we have yet to observe an instance of proximal main body migration. 5 Of interest, previous investigations have reported a low rate of proximal endoleak at the time of case completion. 8,[14][15][16][17] In our series, two of the six patients were noted to have small proximal gutter leaks at the time of last intraoperative angiography.…”

Section: Discussionmentioning

confidence: 99%

“…Selection of patients, preoperative planning, intraoperative decision-making, and postoperative follow-up for our institutionally implanted FEVARs are described in detail elsewhere. 4,5 All ZFENs in this series were implanted in a hybrid operating suite with a floor-mounted, mobile C-arm (Artis zeego; Siemens Medical Solutions, Malvern, Pa) after three-dimensional centerline reconstruction (TeraRecon, Foster City, Calif) was performed for custom device design.…”

Section: Methodsmentioning

confidence: 99%

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Adjunctive visceral artery chimney in patients undergoing Zenith Fenestrated aortic repair

Wang

Drucker

Dalsing

et al. 2018

Journal of Vascular Surgery

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Objective: Visceral artery chimneys have been employed as an adjunct to endovascular aneurysm repair (EVAR) to treat short-neck infrarenal and juxtarenal aortic aneurysms for more than two decades. With the widespread introduction of fenestrated endovascular aneurysm repair by the Food and Drug Administration-approved Zenith Fenestrated endograft (ZFEN; Cook Medical, Bloomington, Ind) to the United States in 2012, clinicians gained the ability to apply the chimney technique to these custom devices for difficult anatomy. The purpose of this report was to demonstrate feasibility and to provide evidence on the performance of chimneys for the treatment of complex juxtarenal aneurysms that could not be adequately treated with ZFEN alone.Methods: A retrospective analysis was performed of a prospectively maintained institutional ZFEN database capturing 110 fenestrated endovascular aneurysm repairs from October 2012 to January 2018 to identify patients undergoing a concomitant visceral artery chimney. All patients with <12 months of follow-up were excluded from further analysis. Demographic, anatomic, intraoperative, perioperative, and follow-up characteristics were tabulated and analyzed.Results: Six patients met criteria and were included in this investigation. They were universally male with a mean age of 76.2 years at the time of ZFEN/chimney. Chimneys were placed in a total of six visceral arteries (n ¼ 1 per patient) consisting of three renal arteries, two celiac arteries, and one accessory renal artery. Mean estimated blood loss and operative time were 283 mL and 298 minutes, respectively. Technical success was achieved in all cases. Two small type IA "gutter" endoleaks were detected early; both spontaneously resolved on follow-up. We observed no instances of chimney migration, stenosis, or thrombosis perioperatively or on follow-up. Two reinterventions were performed in these six patients; these consisted of a repeated renal stent for ostial stenosis at a main body fenestration and a common femoral artery endarterectomy and patch angioplasty for an access-related common femoral artery occlusion.Conclusions: Use of ZFEN in conjunction with a singular chimney is safe, feasible, and durable in patients with difficult anatomy who do not meet instructions for use as demonstrated in this limited series. (J Vasc Surg 2018;68:1688-95.)

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“…2 We have previously reported acceptable mid-term institutional results after our first one hundred implanted ZFENs. 3 Not surprisingly, the implantation of this complex aortic stent graft, often for challenging anatomy relative to open and conventional endovascular repair, has been associated with a higher rate of late complications and reinterventions. 4 One such feared complication after ZFEN is distal migration of the bifurcated graft resulting in component separation, sac pressurization, and catastrophic rupture.…”

Section: Introductionmentioning

confidence: 99%

Aggressive Surveillance Is Needed to Detect Endoleaks and Junctional Separation between Device Components after Zenith Fenestrated Aortic Reconstruction

Wang

Lemmon

Gupta

et al. 2019

Annals of Vascular Surgery

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Junctional separation and resulting type IIIa endoleak is a well-known problem after EVAR (endovascular aneurysm repair). This complication results in sac pressurization, enlargement, and eventual rupture. In this manuscript, we review the incidence of this late finding in our experience with the Cook Zenith Fenestrated endoprosthesis (ZFEN, Bloomington, IN) Methods: A retrospective review was performed of a prospectively maintained institutional ZFEN FEVAR (fenestrated EVAR) database capturing all ZFENs implanted at a large-volume, academic hospital system. Patients who experienced junctional separation between the fenestrated main body and distal bifurcated graft (with or without type IIIa endoleak) at any time after initial endoprosthesis implantation were subject to further evaluation of imaging and medical records to abstract clinical courses. Results: In 110 ZFENs implanted from October 2012 to December 2017 followed for a mean of 1.5 years, we observed a 4.5% and 2.7% incidence of clinically significant junctional separation and type IIIa endoleak, respectively. Junctional separation was directly related to concurrent type Ib endoleak in all five patients. Three patients presented with sac enlargement. One patient did not demonstrate any evidence of clinically significant endoleak and had a decreasing sac size during follow-up imaging. The mean time to diagnosis of modular separation in these patients was 40 months. Junctional separation was captured in surveillance in two patients and reintervened upon before manifestation of endoleak. However, the remaining three patients completed modular separation resulting in rupture and emergent intervention in two and an aortic-related mortality in the other. Conclusions: Junctional separation between the fenestrated main and distal bifurcated body with the potential for type IIIa endoleak is an established complication associated with the ZFEN platform. Therefore, we advocate for maximizing aortic overlap during the index procedure followed by aggressive surveillance and treatment of stent overlap loss captured on imaging.

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Institutional experience with the Zenith Fenestrated aortic stent graft

Abstract: In our experience, FEVAR with the ZFEN system continues to be safe and effective. There is a significant rate of reintervention observed, and close monitoring is fundamental to maintaining good clinical results.

Cited by 23 publications

References 19 publications

Safety and Feasibility of Performing Fenestrated Endovascular Abdominal Aneurysm Repair Using a Portable C-arm Without Fusion Technology: A Single-Center Experience

Safety and Feasibility of Performing Fenestrated Endovascular Abdominal Aneurysm Repair Using a Portable C-arm Without Fusion Technology: A Single-Center Experience

Adjunctive visceral artery chimney in patients undergoing Zenith Fenestrated aortic repair

Aggressive Surveillance Is Needed to Detect Endoleaks and Junctional Separation between Device Components after Zenith Fenestrated Aortic Reconstruction

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