The latest updates on devices for abdominal aortic aneurysms, and a discussion on the impact of going low profile so as not to compromise on device performance, formed the mainstay of a session yesterday. There were presentations on the latest results from promising new low profile devices including the Treovance abdominal stent graft (Bolton Medical), which is being launched at CX35
Matthew Eagleton, Cleveland, USA, began the session by presenting the successful initial results seen with the Treovance device as seen even in challenging anatomies. The results were from a meta-analysis of the phase I ADVANCE and BENEFIT clinical studies.
Eagleton explained that the ADVANCE trial was a prospective, multicentre, non-randomised study carried out at five European centres with 30 patients. Similarly, the BENEFIT trial was a prospective, multicentre, non-randomised study carried out at six US centres, also with 30 patients.
Treovance is a three-piece endograft system that has a novel fixation system with redundant sealing design. It is a low profile delivery system,” he said.
“Twelve-month results of the Treovance abdominal stent graft show successful initial results, even in challenging anatomies. Thirty per cent of BENEFIT patients presented with 61-75 degrees of infrarenal angulations. One year follow-up results showed that there was 100% graft patency in the BENEFIT study and 95.2% patency in the ADVANCE study. Incidence of type I, III and V endoleak was 0% in the BENEFIT study and 4.8% (type I) in the ADVANCE study. There was a 7.1% incidence of type II endoleak in the BENEFIT study and 23.8% incidence in the ADVANCE study. There was no migration or wireform fracture in either study,” Eagleton told delegates.
With regard to demographic information for both sites, the mean age was approximately 72 years and comprised mainly of Caucasian males, with the typical demographics of those presenting with aortic aneurysmal disease. He said: “A little bit of difference in the two sites was that in the US site, there were more patients that presented with diabetes, occlusive disease and neurological complications prior to insertion of the stent graft.”
Speaking on the results, Eagleton said: “In terms of acute deployment, or how feasible delivering the system was, there was 100% successful introduction, deployment and 100% stent graft patency. In addition, there were no type I, III, or IV endoleaks, no aborted procedures and no conversions to open surgery. The procedure took a little over 100 minutes with a minimum of blood loss. The hospital stays were approximately two days in the US trial and three days in the European trial.”
He also noted that at 30 days, the mortality rate at was zero in both groups and major morbidity related to these categories was also zero.
“Procedure-related adverse events were zero in the US trial and 6.7 in the US trial. One subject experienced left buttock claudication deemed serious and procedure‐related. Another subject in the BENEFIT trial exhibited urinary retention that was deemed serious,” reported. There were no device‐related serious adverse events reported within 30 days for either study,” he said.
“Beyond 30 days, two serious device-related adverse events were reported in each trial (6.7% each). In the ADVANCE Study, there were two episodes of limb thrombosis and in the BENEFIT study, there were two episodes of thrombus formation in the limb.
Eagleton expanded on the unique redundant sealing system of the device which was first used in the RelayTEVAR system and is due to an overlap of the first two. “This system may enhance sealing in even in tortuous necks. Based on this design, the device is indicated for neck lengths of 10mm with an infrarenal angle of less than 60 degrees and in 15mm or greater with an infrarenal angle between 61 degrees and 75 degrees,” he said. He noted that the infrarenal barbs provided supplemental fixation in angulated anatomies and the suprarenal barbs provided primary proximal fixation. “Multiple fixation points provide migration resistance,” he said.
“Treovance provides a versatile solution in a low profile delivery system with an accurate deployment. The device received CE mark certification on February 28, 2013 and a phase II US trial is set to commence mid-2013,” Eagleton concluded.
Also presented at the session were the results for Zenith TX2-LP (Cook Medical) and data from the PYTHAGORAS trial, which used the Aorfix stent graft (Lombard Medical) in highly tortuous aortic and iliac anatomy.
Bolton Medical symposium
There will be a lunch symposium (12.30 to 14.00pm) today at the Red Learning Centre. The symposium entitled “Bright ideas for aortic endovascular solutions”, and it will be chaired by Roberto Chiesa, Milan, Italy and co-chaired by Colin Bicknell, London, UK. Vincent Riambau, Barcelona, Spain will present 12-month results of Treovance abdominal stent graft to start the symposium.