MIDTERM OUTCOMES OF A PROSPECTIVE, NONRANDOMIZED STUDY TO EVALUATE ENDOVASCULAR REPAIR OF COMPLEX AORTIC ANEURYSMS USING FENESTRATED AND BRANCHED ENDOGRAFTS
Gustavo S Oderich1, *Emanuel R Tenorio1, *Bernardo C Mendes2, *Guilherme B Lima1, *Giulianna B Marcondes1, *Joshua Wong1, *Naveed U Saqib1, *Thanila A Macedo1
1University of Texas at Houston, Houston, TX;2Mayo Clinic, Rochester, MN
OBJECTIVE(S): To investigate the mid-term outcomes of fenestrated and branched endovascular aortic repair (FB-EVAR) of pararenal (PRA) and thoracoabdominal aortic aneurysms (TAAAs).METHODS: 430 patients (302 male, mean age 74±8 years old) treated by FB-EVAR were enrolled in a prospective, non-randomized physician-sponsored investigational device exemption study. End-points were adjudicated by an independent clinical event committee including 30-day mortality and major adverse events (MAEs), freedom from all-cause and aortic-related mortality, target vessel patency, and freedom from re-intervention and target vessel instability, defined by any target-related mortality, rupture, or re-intervention.RESULTS: There were 133 PRAs and 297 TAAAs with 1657 renal-mesenteric arteries incorporated by fenestrations or directional branches (3.9±0.5 vessels/patient). At 30-days, there were five (1%) deaths. MAEs included new-onset dialysis in eight patients (2%), permanent paraplegia or stroke in 10 patients each (2.5%), and respiratory failure requiring tracheostomy in two patients (0.5%). After a mean follow up of 26±20 months, there were two (0.5%) aortic-related deaths from SMA stent occlusion or complications of open arch repair. At 3-years, freedom from all-cause and aortic-related mortality were 78±3% and 98±1%. Freedom from re-intervention was 73±3%, primary target vessel patency was 95±1% and freedom from target vessel instability was 92±1% at the same interval. One patient (0.2%) had aneurysm rupture due to a type III endoleak, which was successfully treated using endovascular repair.CONCLUSIONS: FB-EVAR is safe and effective for treatment of PRA and TAAAs with low rate of aortic-related mortality and aneurysm rupture on mid-term follow up.
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