Profile of the Ovation ALTO abdominal stent graft for the treatment of abdominal aortic aneurysms: overview of its safety and efficacy.

INTRODUCTION: The Ovation ALTO is the next generation aortic stent graft from Endologix for the treatment of infra-renal abdominal aortic aneurysms. The device uses polymer-injected rings to create a proximal seal at the aneurysm neck. AREAS COVERED: Results from the first clinical study of the ALTO graft are analyzed and the potential benefits of the graft in minimizing post-treatment aneurysmal neck dilation discussed. The implications of the ALTO's Instructions-For-Use (IFU) and low-profile delivery system are also reviewed. EXPERT OPINION: The re-positioning of the sealing rings higher on the graft and an integrated compliant balloon are the most significant improvements on the Ovation iX, facilitating accurate placement of the proximal sealing ring and prompt balloon dilation of the polymer rings. The expansion the IFU to include neck lengths of ≥7 mm will mean more patients are eligible for infra-renal EVAR within IFU with the ALTO device. The published data on the device to date is limited. With over 1000 implants worldwide we would hope for more published data to become available. If this demonstrates similar mid-term results to that seen with the Ovation iX in arguably more hostile neck anatomy, then the Ovation ALTO is likely to be more widely used.

Fenestrated endovascular aneurysm repair: graft complexity does not predict outcome.

PURPOSE: To evaluate the outcomes of endografts designed with renal fenestrations alone vs. more complex designs that accommodate mesenteric arteries in a consecutive series of patients with pararenal aortic aneurysms undergoing endovascular aneurysm repair (EVAR). METHODS: A retrospective review of data prospectively collected over a 5-year period identified 42 consecutive patients (39 men; mean age 70±7 years) who had undergone fenestrated repair of 3 type IV thoracoabdominal aortic aneurysms (TAAA), 6 suprarenal aneurysms requiring at least 1 renal artery reimplantation, and 33 juxtarenal aneurysms with an infrarenal aortic neck <5 mm long. Operative variables and patient outcomes for complex fenestrated EVAR cases (n = 17) using endografts involving the renal, superior mesenteric, and/or celiac arteries were compared with fenestrated stent-grafts incorporating the renal arteries alone (n = 25). Major morbidity/mortality included death, myocardial infarction (MI), renal failure requiring dialysis, paraplegia, and bowel ischemia. RESULTS: Of the 95 intended target vessels, 93 (98%) were successfully cannulated and stented (mean 2.2 covered stents per patient). The 30-day mortality was 7% (n = 3), the paraplegia rate was 2% (n = 1), and MI rate was 5% (n = 2). One patient required dialysis for 3 months. Two bridging stent-grafts occluded: one immediately and another at 8 months. Complex fenestrated EVARs were associated with higher risk of major morbidity and mortality (4, 24%) compared to endografts involving the renal arteries alone (2, 8%), but this did not reach statistical significance (p = 0.20). Operation time (mean 205±50 vs. 174±48 minutes, p = 0.07), follow-up duration (mean 8.1±11 vs. 13±17 months, p = 0.29), and reintervention rates (18% vs. 24%, p = 0.72), respectively, were not significantly different between groups. CONCLUSION: In carefully selected patients with pararenal aneurysms, the inclusion of mesenteric arteries in the fenestrated graft design did not influence outcomes compared to fenestrated EVARs involving the renal arteries alone.