Fenestrated and branched endovascular aneurysm repair (FEVAR/BEVAR) using supra-coeliac sealing zones and four-vessel designs is safe can be performed with “excellent” early outcomes according to data from a study presented at the Vascular Annual Meeting (9–11 June, National Harbor, USA).
At 30-day follow-up, there was no mortality and rates of major adverse events such as permanent paraplegia, dialysis, branch occlusion and type Ia endoleak were as low as <1%, according to Gustavo S Oderich, Mayo Clinic, Rochester, USA, who presented the data.
Oderich told the audience that more than 20,000 FEVAR/BEVAR implantations have been completed worldwide to date, with technical success rates of >95% and mortality rates of 1–5% for pararenal and 5–10% for thoracoabdominal aortic aneurysms. “However,” he continued, “the progression of aortic disease may lead to migration and endoleaks in patients with vulnerable aortic necks.” The aim of this investigation was to investigate FEVAR/BEVAR outcomes using designs based on supra-coeliac sealing zones. The stents used were of either an off-the-shelf design (t-Branch, Cook Medical) or a patient-specific stent based on the Cook fenestrated and branched platform (see Figure 1).
One hundred and sixty-nine patients were initially enrolled, of which 127 were included in Oderich and colleagues’ >30-day follow-up. Forty-seven (37%) of these patients were treated for pararenal aneurysms, 42 (33%) for type IV thoracoabdominal aortic aneurysms and 38 (30%) for type I–III thoracoabdominal aortic aneurysms. The mean age of the patients was 75±10 years and 91 (72%) were male. Overall there was “a high prevalence of cardiovascular risk factors,” Oderich said. There were few differences between the three groups, with the exception of a higher rate of congestive heart failure (n=9, 21%, p=0.06) in the type IV thoracoabdominal aortic aneurysm group, and more aortic repairs (n=21, 55%, p<0.001) in the type I–III thoracoabdominal aortic aneurysm group. The average aneurysm diameter was 59±17mm.
Oderich noted that 496 renal-mesentertic arteries were incorporated—an average of 3.9 per patient. Furthermore, 87% (111) of patients had four-vessel incorporation. In the pararenal and type IV thoracoabdominal groups, just below 90% of vessels were incorporated by fenestrations, whereas in the type I–III thoracoabdominal group, 67% of vessels were incorporated by directional branches.
The overall technical success was 99.5% and there was no 30-day mortality. Across all three groups, the major adverse event rate was 21%. The most common adverse events were decreased estimated glomerular filtration rate (eGFR) >50% (n=12, 9%), blood loss >1L (n=10, 8%) and myocardial infarction (n=9, 7%). One patient (<1%) required temporary dialysis, and paraplegia was reported in two patients (one temporary and one permanent).
Mean follow-up was 9.2±7 months (range 1–26 months). Patient survival was 96% at one year and was similar across the groups, with no ruptures, aortic-related deaths or conversions to open repair. Freedom from reintervention at one year across all groups was approximately 86%. By one-year follow-up, there had been 14 (11%) aortic-related interventions, one of which was a type Ia endoleak as a result of device in-folding, which was successfully treated. There were eight (6%) non-aortic reinterventions.
Branch instability—a composite of branch-related rupture, death, occlusion or reintervention—was 93% at one year, and similar in all three groups. Branch instability rates were significantly lower for renal targets than for coeliac and mesenteric artery targets (89% vs. 93%, respectively; p=0.024).
Primary vessel patency was 96% and secondary vessel patency was 98%. There were four (0.8%) vessel target occlusions, all of which affected renal targets. Oderich reported that primary and secondary patency rates were lower for renal targets than for mesenteric targets, with no difference between fenestrations and branches. “However,” he said, “when we analysed renal targets as a separate category, there was a trend towards lower primary and secondary patency rates for branches compared to fenestrations.”
On the back of these promising early data, “Long-term follow-up is needed to assess the impact of four-vessel designs in device-related complications and aortic disease progression,” Oderich suggested.