Characterization, Frequency and Outcomes of Endoleaks after Fenestrated Branched Endovascular Aortic Repair (FEVAR/BEVAR)
Suyue Zhang, BS, David Timaran, MD, Marilisa Soto Gonzalez, John Rectenwald, MD, Carlos H. Timaran, M.D.
University of Texas Southwestern Medical Center, Dallas, TX, USA.
The aim of this study was to assess the type, frequency and outcomes of endoleaks after FEVAR/BEVAR using custom-made- devices (CMDs) and off-the-shelf fenestrated/branched devices.
A single institutional study was performed to assess the frequency of endoleaks after FEVAR using fenestrated/branched CMDs and off-the-shelf devices. All premanufactured investigational CMDs were used under a physician-sponsored investigational device exemption. Endoleaks were detected and characterized on duplex and CT angiography.
Over a 55-month period, 167 patients (135 men [81%] and 32 women [19%]) with a median age of 72 years (interquartile range [IQR], 67-78) underwent FEVAR using the approved Zenith Fenestrated AAA Endovascular graft (88 [53%], Zenith p-Branch (10 [6%]), Fenestrated/Branched Custom-Made-Devices (CMDs) (64[38%]) and Zenith T-Branch (6[4%]). The median number of fenestrations/branches was 4 (IQR,3-4). Endoleaks were detected in 38 patients (23%) accounting for a total of 43 endoleaks during follow-up. Twenty endoleaks occurred at 30 days, 11 at 6 months and 12 at 12 months. At 30 days, 11 (55%) were type II endoleaks, 6 (30%) type IC, 1 (5%) type 1B, and 3 (15%) were type III endoleaks. At 6 months, 1 type IB endoleak, 1 type III endoleak and 9 type II endoleaks were found. At 12 months, 2 type IC and 10 type II endoleaks were found. All type I and III endoleaks and 6 type II endoleaks underwent endovascular repair during follow-up. Only in 2 patients, endoleaks persisted after secondary interventions. Freedom from any type of endoleaks at 30 days, 6 months and 12 months was 88%, 81.4% and 75%, respectively. Adjusting for type of endoleak, freedom for type I/III endoleaks at 30 days, 6 and 12 months was 94%,93% and 92%, respectively. Freedom for type II endoleaks at 30 days, 6 and 12 months was 93%, 88% and 82%, respectively. Freedom from secondary reinterventions for endoleaks at 30 days, 6 and 12 months was 93%, 92% and 87%, respectively.
Conclusion: The frequency of endoleaks after FEVAR using different devices was 23%, of which 49% required reintervention. Type IC and II endoleaks were the most frequently found at 30 days whereas type II were the most frequent endoleaks at 12 months.
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