Endovascular aortic aneurysm repair with the Zenith endograft in patients with ectatic iliac arteries

Carlos H. Timaran, Evan C. Lipsitz, Frank J. Veith, Timothy Chuter, Roy K. Greenberg, Takao Ohki, Lorraine A. Nolte, Scott A. Snyder

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Abstract

Endovascular aortic aneurysm repair (EVAR) in patients with ectatic iliac arteries is feasible; however, most studies have reported experience from single institutions where distal flare techniques with endograft components were used on an "off-label basis." The Zenith endovascular graft allows adequate seal in ectatic common iliac arteries (CIAs) with diameters up to 20 mm. To determine whether large or ectatic CIAs are a risk factor for early and late endograft failure, we analyzed data from the Zenith U.S. multicenter trial. Among 352 patients receiving the endograft in the Zenith u.s. clinical study, 156 patients (44%) had at least one ectatic iliac artery (maximum diameter between 14 and 20 mm), whereas 22 (6.3%) had bilateral CIAs of normal diameter (< 14 mm). Variables analyzed included those defined by the reporting standards for EVAR (SVS/AAVS) as well as iliac-related outcome and indications for secondary iliac interventions. Univariate (Kaplan-Meier [KM] receiver operating characteristics curve, and Cox regression analyses were used to determine the association between CIA diameter and iliac-related complications. The median follow-up period was 24 months. Technical success was similar (>99%) for patients with ectatic and normal CIAs. Only one late type I distal endoleak was reported and was attributed to failure of distal iliac seal in a patient with ectatic CIAs. Freedom from iliac-related secondary intervention (IRSI) was not significantly different between the groups (KM, log-rank test, p = 0.98) with rates at 1, 12, and 24 months of 98%, 97%, and 95% for patients with ectatic CIAs, and 100%, 95%, and 95% for patients with normal iliac arteries, respectively. Moreover, Cox regression analysis revealed that the maximum CIA diameter was not a significant predictor of freedom from IRSI (hazard ratio, 0.98; 95% confidence interval, 0.7-1.4; p = 0.98). In patients with large CIAs, indications for IRSI included distal type I endoleak (1, 0.6%), type III endoleak (1, 0.6%), graft limb occlusion (4, 2.6%), and device stenosis (1, 0.6%). The only IRSI in a patient with normal CIAs was performed for device stenosis (4.6%). In conclusion, the Zenith endograft is effective for EVAR in patients with ectatic CIAs. Moreover, the presence of large CIAs was not associated with an increased risk of adverse iliac-related outcome or subsequent IRSI. Long-term surveillance, however, is mandatory, as IRSIs may be necessary.

Original languageEnglish (US)
Pages (from-to)161-166
Number of pages6
JournalAnnals of Vascular Surgery
Volume19
Issue number2
DOIs
StatePublished - Feb 2005

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Aortic Aneurysm
Iliac Artery
Endoleak
Pathologic Constriction
Transplants
Equipment and Supplies
Multicenter Studies

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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Endovascular aortic aneurysm repair with the Zenith endograft in patients with ectatic iliac arteries. / Timaran, Carlos H.; Lipsitz, Evan C.; Veith, Frank J.; Chuter, Timothy; Greenberg, Roy K.; Ohki, Takao; Nolte, Lorraine A.; Snyder, Scott A.

In: Annals of Vascular Surgery, Vol. 19, No. 2, 02.2005, p. 161-166.

Research output: Contribution to journalArticle

Timaran, CH, Lipsitz, EC, Veith, FJ, Chuter, T, Greenberg, RK, Ohki, T, Nolte, LA & Snyder, SA 2005, 'Endovascular aortic aneurysm repair with the Zenith endograft in patients with ectatic iliac arteries', Annals of Vascular Surgery, vol. 19, no. 2, pp. 161-166. https://doi.org/10.1007/s10016-004-0157-8
Timaran, Carlos H. ; Lipsitz, Evan C. ; Veith, Frank J. ; Chuter, Timothy ; Greenberg, Roy K. ; Ohki, Takao ; Nolte, Lorraine A. ; Snyder, Scott A. / Endovascular aortic aneurysm repair with the Zenith endograft in patients with ectatic iliac arteries. In: Annals of Vascular Surgery. 2005 ; Vol. 19, No. 2. pp. 161-166.
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abstract = "Endovascular aortic aneurysm repair (EVAR) in patients with ectatic iliac arteries is feasible; however, most studies have reported experience from single institutions where distal flare techniques with endograft components were used on an {"}off-label basis.{"} The Zenith endovascular graft allows adequate seal in ectatic common iliac arteries (CIAs) with diameters up to 20 mm. To determine whether large or ectatic CIAs are a risk factor for early and late endograft failure, we analyzed data from the Zenith U.S. multicenter trial. Among 352 patients receiving the endograft in the Zenith u.s. clinical study, 156 patients (44{\%}) had at least one ectatic iliac artery (maximum diameter between 14 and 20 mm), whereas 22 (6.3{\%}) had bilateral CIAs of normal diameter (< 14 mm). Variables analyzed included those defined by the reporting standards for EVAR (SVS/AAVS) as well as iliac-related outcome and indications for secondary iliac interventions. Univariate (Kaplan-Meier [KM] receiver operating characteristics curve, and Cox regression analyses were used to determine the association between CIA diameter and iliac-related complications. The median follow-up period was 24 months. Technical success was similar (>99{\%}) for patients with ectatic and normal CIAs. Only one late type I distal endoleak was reported and was attributed to failure of distal iliac seal in a patient with ectatic CIAs. Freedom from iliac-related secondary intervention (IRSI) was not significantly different between the groups (KM, log-rank test, p = 0.98) with rates at 1, 12, and 24 months of 98{\%}, 97{\%}, and 95{\%} for patients with ectatic CIAs, and 100{\%}, 95{\%}, and 95{\%} for patients with normal iliac arteries, respectively. Moreover, Cox regression analysis revealed that the maximum CIA diameter was not a significant predictor of freedom from IRSI (hazard ratio, 0.98; 95{\%} confidence interval, 0.7-1.4; p = 0.98). In patients with large CIAs, indications for IRSI included distal type I endoleak (1, 0.6{\%}), type III endoleak (1, 0.6{\%}), graft limb occlusion (4, 2.6{\%}), and device stenosis (1, 0.6{\%}). The only IRSI in a patient with normal CIAs was performed for device stenosis (4.6{\%}). In conclusion, the Zenith endograft is effective for EVAR in patients with ectatic CIAs. Moreover, the presence of large CIAs was not associated with an increased risk of adverse iliac-related outcome or subsequent IRSI. Long-term surveillance, however, is mandatory, as IRSIs may be necessary.",
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AU - Timaran, Carlos H.

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AU - Greenberg, Roy K.

AU - Ohki, Takao

AU - Nolte, Lorraine A.

AU - Snyder, Scott A.

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N2 - Endovascular aortic aneurysm repair (EVAR) in patients with ectatic iliac arteries is feasible; however, most studies have reported experience from single institutions where distal flare techniques with endograft components were used on an "off-label basis." The Zenith endovascular graft allows adequate seal in ectatic common iliac arteries (CIAs) with diameters up to 20 mm. To determine whether large or ectatic CIAs are a risk factor for early and late endograft failure, we analyzed data from the Zenith U.S. multicenter trial. Among 352 patients receiving the endograft in the Zenith u.s. clinical study, 156 patients (44%) had at least one ectatic iliac artery (maximum diameter between 14 and 20 mm), whereas 22 (6.3%) had bilateral CIAs of normal diameter (< 14 mm). Variables analyzed included those defined by the reporting standards for EVAR (SVS/AAVS) as well as iliac-related outcome and indications for secondary iliac interventions. Univariate (Kaplan-Meier [KM] receiver operating characteristics curve, and Cox regression analyses were used to determine the association between CIA diameter and iliac-related complications. The median follow-up period was 24 months. Technical success was similar (>99%) for patients with ectatic and normal CIAs. Only one late type I distal endoleak was reported and was attributed to failure of distal iliac seal in a patient with ectatic CIAs. Freedom from iliac-related secondary intervention (IRSI) was not significantly different between the groups (KM, log-rank test, p = 0.98) with rates at 1, 12, and 24 months of 98%, 97%, and 95% for patients with ectatic CIAs, and 100%, 95%, and 95% for patients with normal iliac arteries, respectively. Moreover, Cox regression analysis revealed that the maximum CIA diameter was not a significant predictor of freedom from IRSI (hazard ratio, 0.98; 95% confidence interval, 0.7-1.4; p = 0.98). In patients with large CIAs, indications for IRSI included distal type I endoleak (1, 0.6%), type III endoleak (1, 0.6%), graft limb occlusion (4, 2.6%), and device stenosis (1, 0.6%). The only IRSI in a patient with normal CIAs was performed for device stenosis (4.6%). In conclusion, the Zenith endograft is effective for EVAR in patients with ectatic CIAs. Moreover, the presence of large CIAs was not associated with an increased risk of adverse iliac-related outcome or subsequent IRSI. Long-term surveillance, however, is mandatory, as IRSIs may be necessary.

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