The Incidence and Management of Type 1C Endoleaks Using Investigational Fenestrated Custom-Made Devices(iCMD’s) for Fenestrated Endovascular Aneurysm Repair(FEVAR)
Robert C Allen1, David Timaran1, Ryan Meehan1, Lucyna Cieciura1, Martyn Knowles2, Carlos Timaran1
1University of Texas Southwestern, Dallas, TX;2University of North Carolina health care, chapel hill, TX
Background: Fenestrated endovascular aneurysm repair (FEVAR) has become an option for complex abdominal aortic aneurysms (AAAs).The occurrence of endoleaks is a common complication of endovascular aortic repair. With the use of fenestrated devices and stenting of the visceral vessels, the occurrence endoleaks originating from the distal attachment sites in visceral vessels has been described (type 1c endoleaks). The aim of this study is to assess our institutional incidence and management of type 1c endoleaks after FEVAR using investigational fenestrated custom-made devices (iCMDs).
Methods: A single institutional study was performed to assess the incidence of type 1c endoleaks after FEVAR using iCMD’s under a physician sponsored investigational device exemption (IDE). Type 1c endoleaks were defined as leaks that originated from lack of distal apposition of the visceral or renal stents. A retrospective review of a prospectively maintained database was performed. Preoperative demographic data, anatomic variables, and operative techniques, including target vessel diameter and stent selection were included in the study.
Results: Over a 24-month period, 48 patients (39 male [81%] and 9 females) with a median age of 72 years (interquartile range [IQR], 66-77) underwent FEVAR using iCMD’s. The median number of fenestrations was 4 (IQR,3-4). All fenestrations were stented using balloon-expandable covered stents (iCAST). Median maximum vessel diameters were as follows: celiac 8 mm (IQR, 6.7-9), SMA 8mm (IQR,6.8-8.1), right renal artery 5.7 (IQR,4.8-6.6) and left renal artery 6 (IQR, 5.4-6.4). Median stent sizes were: 8mm (IQR, 7-9), 8mm (IQR, 7-9), 6mm (IQR, 6-7), 6mm (IQR,6-7) for the celiac, SMA, right renal and left renal arteries, respectively. Type 1C endoleaks were found in 6 patients (12.5%) accounting for a total of 8 type 1c endoleaks. Type 1C endoleaks originated from the following: celiac artery (1), SMA (1), right renal artery (2), and left renal artery (4). All endoleaks were observed at the 30-day follow-up control CTA. Median time for re-intervention was 35 days (IQR, 28-41). All patients were treated with an endovascular approach using covered stents in 5 cases and in one case, an uncovered self-expandable stent. Re-interventions were successful in 83% of our patients. One patient was found to have recurrent type 1c endoleak from the left renal artery at 6 months post FEVAR. The recurrent endoleak was treated using an uncovered stent distal to the previously placed left renal stent.
Conclusions: Type 1c endoleaks may be a complication of FEVAR using iCMD’s, occurring in 12.5% of interventions in our series. All type 1C endoleaks were identified at 30 day CTA imaging. Out of all type 1C endoleaks identified, the left renal artery stent was the most common. Type 1C endoleak was an indication for re-interventation in all cases and had excellent resolution upon secondary intervention. Further investigation is required to assess predictors and strategies to prevent type 1c endoleaks when using iCMD’s for FEVAR in the management of complex AAA’s.
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