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Four-year results of a clinical trial experience of 90 endovascular aneurysm repair (EVAR) patients treated with the Altura endograft system (Lombard Medical) were presented at the 2018 VEITHsymposium (13–17 November, New York, USA) by Dainis Krievins of the Pauls Stradins Clinical University Hospital in Riga, Latvia. The trial included the first-in-human implants, with the majority of recent cases performed using the commercial version of the graft.
The trial pooled 90 patients with abdominal aortic aneurysms, enrolled between 2011 and 2015. Patient demographics and anatomy were “typical for EVAR”, Krievins said, in terms of aneurysm size, neck length, and angulation. Patients were followed up with CT and clinical evaluation at 30 days, six months, and annually post-implant for up to five years (mean follow-up time in this report was 2.7 years). The CT images were evaluated by a core lab.
“We are all familiar with the complexities of EVAR which include complex aortic and iliac anatomies which frequently require complex devices to resolve them”, Krievins said. “Gate cannulation, snaring and polymer handling can lead to complex procedures of unpredictable duration. This can make planning surgical lists around EVAR cases inefficient, impacting through and the overall costs of the procedure. The Altura stent-graft was designed to make EVAR cases a little simpler for physicians and to give better predictability for the duration of the case.”
Krievins explained Altura uses materials such as nitinol and polyester fabric to create “a very differentiated stent graft construct in the form of kissing D endografts. These grafts are repositionable during deployment, do not involve gate cannulation and their 14F delivery systems all permit injection of contrast.”
Summarising clinical events at four years, Krievins stated: “Four patients were identified with Type 1 endoleak. One patient died of unrelated causes before the leak was treated, a second case involved a substantial calcified nodule in the aortic neck and the leak did not extend into the aneurysm sac. The remaining two endoleaks have not caused significant sac expansion. At three years, the patent inferior mesenteric artery of a patient with a persistently expanding sac was embolised and bilateral distal extensions placed. At four years, the under-sized grafts that were migrating were replaced by open vascular repair.”
Krievins concluded that the Altura endograft concept has the potential to play a “major role in mainstream EVAR cases”, offering an option for EVAR day-case practice as well as ruptured aneurysm patients.
David Murray (Manchester University NHS Foundation Trust, Manchester, UK) has taken part in a UK-based clinical experience study of Altura, which has reached its three-year mark. Murray notes that in his centre, the Altura stent graft has been used in anatomically suitable patients within the indications for use only. Outlining the results, Murray tells Vascular News, “there were no Type 1 endoleaks, or groin complications in the elective cohort. With this experience the operative time was very low—less than one hour—with associated low screening (median 24 minutes) and radiation exposure (median radiation dose 3,058μGy). The majority of patients that were preselected for day-case achieved discharge in <24 hours.” With the system’s 14F profile, the majority of procedures at the UK centre were percutaneous, and more likely to be selected for day-case EVAR. The registry has recently opened a cohort to include day-case recruitment, which in time will analyse outcomes and potential cost benefits to this treatment modality.
For Murray, the Altura stent graft offers “the possibility of a simplified bimodular EVAR deployment on a 14F delivery system which, once adopted, will improve operative efficiency and provide cost-saving around inpatient stay.”