Fenestrated-Branched Endovascular Thoracoabdominal AA Repair
Quick Takes
- In a multicenter, prospective, nonrandomized study of elective fenestrated-branched endovascular aortic repair (FB-EVAR) in asymptomatic patients with TAAA and no aortic rupture, early mortality was 2.7% and the late (5-year) incidences of aortic-related mortality (ARM) and aortic rupture were 3.8% and 2.7%, respectively.
- The occurrence of late ARM and aortic rupture were associated with TAAA extent I-III compared to extent IV.
- There was a substantial incidence of late all-cause mortality (45.7%) and need for re-intervention (40.3%), underscoring the need for rigorous surveillance after FB-EVAR.
Study Questions:
What are the aortic-related mortality (ARM) and the risk of aortic aneurysm (AA) rupture after fenestrated-branched endovascular aortic repair (FB-EVAR) for the treatment of thoracoabdominal aortic aneurysm (TAAA)?
Methods:
Using data from the US Aortic Research Consortium (ARC), patients enrolled in eight prospective, nonrandomized, physician-sponsored investigational device exemption studies between 2005 and 2020 who underwent elective FB-EVAR of asymptomatic intact TAAA were analyzed. Patients with symptoms, ruptured aneurysm, or genetically associated aortic conditions were excluded from analysis. Primary endpoints were ARM (defined as any early mortality [30-day or in-hospital] or late mortality from aortic rupture, dissection, organ or limb malperfusion attributable to aortic disease, complications of reinterventions) and aortic rupture. Secondary endpoints were early major adverse events, TAAA life-altering events (defined as death, permanent spinal cord injury, permanent dialysis, or stroke), all-cause mortality, and secondary interventions.
Results:
A total of 1,109 patients were analyzed; 589 (53.1%) had extent I–III and 520 (46.9%) had extent IV TAAA. Median age was 73.4 years (interquartile range, 68.1–78.3 years); 368 (33.2%) were women. Early mortality was 2.7% (n = 30); congestive heart failure was associated with early mortality (odds ratio, 3.30; 95% confidence interval [CI], 1.22–8.02; p = 0.01). The incidence of early aortic rupture was 0.4% (n = 4). The incidences of early major adverse events and TAAA life-altering events were 20.4% (n = 226) and 7.7% (n = 85), respectively. There were 30 late ARMs; the 5-year cumulative incidence was 3.8% (95% CI, 2.6%–5.4%); older age and TAAA extent I–III were independently associated with late ARM (each p < 0.05). There were 14 cases of late aortic rupture; the 5-year cumulative incidence was 2.7% (95% CI, 1.2%–4.3%). Extent I–III TAAAs were associated with late aortic rupture (hazard ratio, 5.85; 95% CI, 1.31–26.2; p = 0.02). Five-year all-cause mortality was 45.7% (95% CI, 41.7%–49.4%) and 5-year cumulative incidence of secondary intervention was 40.3% (95% CI, 35.8%–44.5%).
Conclusions:
ARM and aortic rupture were uncommon after elective FB-EVAR of asymptomatic intact TAAAs. Half of the ARMs occurred early, and most of the late deaths were not aortic related. Late (5 years after FB-EVAR) all-cause mortality rate and the need for secondary interventions were 46% and 40%, respectively.
Perspective:
Endovascular repair (EVAR) has become first-line therapy for most patients with infrarenal abdominal AA, but standard EVAR is not suitable for patients with an aneurysm that involves the renal and mesenteric arteries. In contrast to standard EVAR, FB-EVAR uses fenestrations or directional branches built into the aortic stent-graft to allow treatment of TAAA involving the renal or mesenteric arteries.
This multicenter, nonrandomized, prospective study using data from the ARC found that treatment of TAAA with FB-EVAR had an early mortality of 2.7%, comparing favorably to an average 8.9% in a previously published pooled analysis for open surgical repair of TAAA extending above the celiac artery; and a 3.8% incidence of ARM at 5 years. These data support the use of FB-EVAR among selected patients at high-volume centers with expertise in their use.
The study population was limited to asymptomatic patients without aortic rupture and without an underlying genetic condition contributing to TAAA, and further studies are required to assess the outcomes of FB-EVAR in these patients. High 5-year all-cause mortality and need for reintervention underscore the need for rigorous surveillance after FB-EVAR.
Clinical Topics: Cardiac Surgery, Vascular Medicine, Aortic Surgery
Keywords: Aortic Aneurysm, Aortic Rupture, Endovascular Procedures
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