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December 9, 2019

Outcomes Published From Large Case Series of Complex AAA Treated With Terumo Aortic’s Fenestrated Anaconda Endograft

December 9, 2019—Findings from an assessment of the technical and clinical outcomes of the Fenestrated Anaconda endograft device (Terumo Aortic) in a large international case series were published online ahead of print in Journal of Vascular Surgery (JVS) by Arne de Niet, MD, et al, on behalf of the Fenestrated Anaconda Study Group.

In JVS, the study investigators concluded that the custom-made Fenestrated Anaconda endograft is a valuable option for the treatment of abdominal aortic aneurysms (AAAs). They noted that a procedural type Ia endoleak was seen relatively frequently but spontaneously resolved in most cases.

According to the investigators, information on the Fenestrated Anaconda device has been previously limited to case series with a small sample size. For this study, the investigators approached all worldwide centers that have treated more than 15 AAAs or type IV thoracoabdominal aortic aneurysm patients with the Fenestrated Anaconda endograft. Main outcome parameters were procedural technical success, postoperative and follow-up clinical outcome for endoleaks, target vessel patency, reintervention rate, and patient survival.

As summarized in JVS, the study was composed of 335 consecutive cases treated at 11 sites between June 2010 and May 2018. Patients were treated for short-neck infrarenal (n = 98), juxtarenal (n = 191), or suprarenal (n = 27) AAAs, or type IV thoracoabdominal aortic aneurysms (n = 19). The mean age was 73.6 ± 4.6 years (292 men). Endografts contained a total of 920 fenestrations, with a mean of 2.7 ± 0.8 fenestrations per case. Technical success was 88.4% (primary, 82.7%; assisted primary, 5.7%).

The investigators reported that a procedural type IA endoleak was observed in 6.9% of cases, with 82.6% spontaneously disappearing during early follow-up.

The development of a type Ia endoleak was associated with greater neck angulation (odds ratio [OR], 0.94; P = .01), three fenestrations (OR, 42.7; P = .01), and the presence of augmented proximal rings (OR, 0.17; P = .03).

With a median follow-up of 1.2 years (interquartile range, 0.4–2.6), the investigators found the following:

  • Mean estimated glomerular filtration rate deteriorated from 67.6 ± 19.3 mL/min/1.73 m2 preoperatively to 59.3 ± 22.7 mL/min/1.73 m2 at latest follow-up (P = .00).
  • Freedom from AAA growth was 97.9% ± 0.9% (n = 190) at 1 year and 86.4% ± 3.0% (n = 68) at 3 years.
  • Freedom from AAA rupture was 99.7% ± 0.3% (n = 191) at 1 year and 99.1% ± 0.7% (n = 68) at 3 years.
  • Endoleak-free survival, excluding spontaneously resolved procedural endoleaks, was 73.4% ± 2.6% (n = 143) at 1 year and 65.6% ± 3.4% (n = 45) at 3 years.
  • Target vessel patency was 96.4% ± 0.7% (n = 493) at 1 year and 92.7% ± 1.4% (n = 156) at 3 years.
  • There were 75 reinterventions performed in 64 cases (19.1%), of which 25 cases were for an endoleak.
  • Reintervention-free survival was 83.6% ± 2.2% (n = 190) at 1 year and 71.0% ± 3.7% (n = 68) at 3 years.

Additionally, there were no deaths observed during the procedure, extending within 24 hours postoperatively. Within 30 days, 14 patients (4.2%) died. During follow-up, another 39 patients (11.6%) died. Three deaths were considered AAA related (one rupture, one endograft infection, and one bilateral renal artery occlusion). The estimated cumulative survival rate was 89.8% ± 1.8% (n = 191) at 1 year and 79.2% ± 3.0% (n = 68) at 3 years, reported the investigators in JVS.

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