Abstract
ObjectiveAlthough proximal neck dilatation following infrarenal endovascular aneurysm repair (EVAR) is common and is associated with proximal graft failure, little is known about sealing zone dilatation and its clinical relevance following fenestrated EVAR (FEVAR). We studied proximal seal dilatation (PSD) dynamics following FEVAR and assessed its clinical significance. MethodsWe included all consecutive patients treated for a juxta-/supra-renal aneurysm with fenestrated EVAR using the Zenith Fenestrated Endovascular Graft (Cook Medical, Bloomington, Ind) from 2008 to 2018 in two large teaching hospitals in the Netherlands. The primary outcome was PSD over time and was determined using a linear mixed-effects model. Secondary outcomes included associations for early PSD and difference in aortic dilatation at the level of the covered stent compared with the bare stent. Proximal seal-related adverse events were also obtained. ResultsOur cohort included 84 patients with a median computed tomography angiography follow-up time of 24.5 months (interquartile range [IQR], 17-42 months). Maximum aneurysm diameter was 60.1 mm (IQR, 56.9-67.2 mm). Mean proximal seal diameter at baseline was 26.2 mm (standard deviation [SD], ±2.8 mm), mean stent oversizing was 20.1% (SD, ±9.1%), and mean proximal seal length was 29.5 mm (SD, ±11.7 mm). Proximal seal dilatation of 1.7 mm (95% confidence interval [CI], 1.4-2.1 mm) was found in the first year, decelerating thereafter (second year, 0.9 mm/year; 95% CI, 0.7-1.1 mm/y). Over 10% PSD at 1 year occurred in 22 patients (27%) and was associated with stent graft oversizing (odds ratio, 1.1; 95% CI, 1.03-1.2; P = .008) and a lower number of target vessels (four fenestrations/ref two fenestrations: odds ratio, 0.13; 95% CI, 0.02-0.74; P = .029). At last available imaging, dilatation difference was higher at the level of the covered stent compared with the bare stent (3.0 mm [IQR, 1.3-5.1 mm] vs 1.6 mm [IQR, 0.8-2.5 mm]; P < .001). During the study period, only one patient (1.2%) developed a proximal seal-related adverse event (type IA endoleak). ConclusionsPSD is present following FEVAR, occurring at a faster rate in the first year and subsequently decelerating thereafter, similarly to neck dilatation after standard infrarenal EVAR. Although its clinical implication seems to remain limited in the first years following implantation, further research is required to assess the effect of PSD on long-term FEVAR outcomes.
Highlights
MethodsWe included all consecutive patients treated for a juxta-/supra-renal aneurysm with fenestrated endovascular aneurysm repair (EVAR) using the Zenith Fenestrated Endovascular Graft (Cook Medical, Bloomington, Ind) from 2008 to 2018 in two large teaching hospitals in the Netherlands
proximal seal dilatation (PSD) is present following fenestrated EVAR (FEVAR), occurring at a faster rate in the first year and subsequently decelerating thereafter, to neck dilatation after standard infrarenal endovascular aneurysm repair (EVAR)
From the Department of Vascular Surgery, Erasmus University Medical Center, Rotterdama; the Department of Surgery, Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Bostonb; the Department of Vascular Surgery, Erasmus University Medical Centre, Rotterdamc; the Department of Angiology and Vascular Surgery, Hospital do Divino Espírito Santo, Ponta Delgada, Azoresd; the Department of Anesthesiology, Erasmus University Medical Center, Rotterdame; the Department of Angiology and Vascular Surgery, Centro Hospitalar Universitário de Lisboa Central, Lisbonf; and the Department of Vascular Surgery, Maasstad Hospital, Rotterdam.g Author conflict of interest: H.V. is a consultant for Medtronic, WL Gore, Terumo, Endologix, and Philips
Summary
We included all consecutive patients treated for a juxta-/supra-renal aneurysm with fenestrated EVAR using the Zenith Fenestrated Endovascular Graft (Cook Medical, Bloomington, Ind) from 2008 to 2018 in two large teaching hospitals in the Netherlands. We performed a retrospective cohort study, including all eligible patients undergoing elective repair with the Zenith fenestrated endovascular graft (ZFEN; Cook Medical, Bloomington, Ind) for degenerative/non-atherosclerotic (no aortopathy/ mycotic/known connective tissue disorders) AAA at two large teaching hospitals in the Netherlands (Erasmus University Medical Center and Maasstad Hospital) between 2008 and 2018. In one of the hospitals, all aneurysm patients are offered genetic screening, and none of the included patients were found to have known connective tissue disorders. (Supplementary Fig, online only) thoraco-abdominal aortic aneurysms treated with FEVAR (n 1⁄4 4) were excluded due to the location of the proximal sealing zone in a different segment of the aorta. This study conforms to the Declaration of Helsinki in research ethics with the study protocol being approved by both hospitals’ institutional and ethical review boards
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