Early Experience With Modified Low-profile Devices For Fenestrated/branched Endovascular Aortic Aneurysm Repair (F-BEVAR)
Marc Salhanick, Carlos Timaran.
UT Southwestern, Dallas, TX, USA.
OBJECTIVES: F-BEVAR using physician modified endografts (PMEG) is an option for patients unfit for open repair, particularly in urgent situations. Most PMEG series describe the use of standard devices despite wide availability of low-profile devices. The design of PMEGs using low profile devices have raised concerns about the difficulties in device resheathing and the performance and potential fragility of the tightly woven fabric. The aim of this study is to report the early experience of F-BEVAR using low profile PMEGs.
METHODS: A retrospective review of all consecutive patients undergoing F-BEVAR using low-profile devices was performed. For this purpose, the Zenith Alpha thoracic stent graft (Cook Medical Inc, Bloomington, Ind) was used. Fenestrations and branches were created in the low-profile fabric of the device. Device design was planned using centerline of flow measurements and, more recently, 3D printing of aneurysm models. End points included technical success, mortality, major adverse events, device integrity, patient survival, reintervention and target vessel patency.
RESULTS: Forty-one subjects underwent F-BEVAR using low-profile devices with median age of 74 years (36-92) and average aneurysm size of 6.7±1.5cm. The majority of aneurysms were symptomatic or had evidence of rapid expansion (49%), and were juxtarenal or suprarenal (59%). Repairs included 142 fenestrations/branches with average of 3 per case. Technical success was 97%. In-hospital/30-day mortality was 5%. Access site complications were the most common complication occurring in 5 patients who required intervention (12%). Other complications included pulmonary edema (n = 1, 2%); wound infection (n = 1, 2%); type Ic endoleak (n = 1, 2%); and type IIIa endoleak (n = 1, 2%). Median follow up period was 111 days (IQR 37-298). Four patients died in the follow up period. No aneurysm-related deaths, aneurysm ruptures, or conversions were observed. No type I or type IIIb endoleaks occurred. Eight (20%) Type II endoleaks were identified. No patient's aneurysm grew >5mm. Four patients required visceral stent reinterventions (1 type Ic endoleak, 2 (5%) renal artery stenoses, 1 (2%) visceral artery stenosis). No renal failure developed requiring dialysis.
CONCLUSIONS:
Early results indicate that F-BEVAR using low-profile PMEGs may be considered for complex aortic aneurysms in patients unfit for open repair that require urgent interventions. Diligent follow-up surveillance is mandatory as long-term outcomes have not been established.
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