Paul Bachoo, consultant vascular surgeon, Aberdeen, UK, discussed the question of whether the Gore C3 delivery system has met the expectations for real life EVAR in a session on innovative technologies in aortic endografting at the LINC conference in Leipzig, Germany, in January. Bachoo talked about his one-year experience with the Gore C3 and presented an update on the GREAT Gore C3 registry data.
“The Gore C3 system consists of an Excluder stent graft with a new delivery system. The new handle is the innovative part that allows you to reposition the device. Repositioning involves the constraining of the trunk, disengaging the hooks and then moving the graft either vertically, horizontally, or both,” Bachoo said.
Bachoo stated that, to answer the question, it is necessary to ask what the expectations are. “I have three expectations. Firstly, I would like to use the graft for standard anatomy, otherwise referred to as within instructions for use (IFU). Secondly, as in real life things do not come is nice packages, I would also like to use the graft for challenging anatomies, outside the IFU. And thirdly, we increasingly rely on EVAR for rupture treatment,” he said.
The GREAT Gore C3 Registry is a global registry for endovascular aortic treatment, Bachoo noted. “It is not a registry specifically for aneurysms, but at present time we are referring to aneurysm data,” he added. Twelve centres are enrolling patients in this prospective registry. At the time of the presentation, data from 199 patients (88.9% male, mean age 73.1 years) had been included in the study. The primary pathology was aortic aneurysm disease (96.4%) and the C3 system was used as a primary procedure in 97.4% of the cases. The study included a range of aneurysms, neck sizes and angles. “I would highlight that there have been cases of very small, 3mm necks, and large, 95mm aneurysms, and also angled necks of greater than 90 degrees,” he said.
“In order to present data in a more illustrative fashion, we separated the data between standard versus challenging anatomy (outside the instructions for use),” Bachoo said. Challenging cases were defined as those with either a proximal neck length of 60º (n=28). All other cases were considered standard cases (n=159).
In terms of repositioning of the device, in 75% (21/28) of the challenging cases and 47.8% (79/159) of the standard cases the trunk of the device has been repositioned. He said, “There were a significant number of repositions done in the standard group. These may be related to the operators gaining experience in the repositioning process. In most instances, repositioning involved getting up closer to the renal arteries. There has been an increasing number of patients where repositioning was done to facilitate contralateral gate cannulation.” In most of the cases the operators performed only one repositioning of the device.
At 30 days, there were no deaths, migrations and endoleaks. There was one conversion to open repair.
Turning to his personal experience, Bachoo told delegates that his team had treated 36 patients with the C3 device. The mean age was 74 years, top neck maximum diameter was 24mm, mean angle was 48º (11–94º), mean maximum diameter of the aneurysm was 61mm and aneurysm neck was on average 21mm (10–31mm). “We repositioned eight times and used two cuffs, both in a planned fashion. We have used the C3 in two ruptures, and in both cases we have seen a nice seal at one month,” he said.
“The C3 is an example of innovative technology which works and has clinical utility. In challenging anatomy the repositionability facilitates controlled, confident but aggressive proximal landing, and cannulation for complex iliac anatomy. It does not increase the rates of death, migration or type I endoleak,” Bachoo told delegates.
“In our experience with the C3 device, the turn down rate has declined. Repositioning downwards seems easier. The combination of C3 plus aortic cuff in angled neck seems to offer another dimension to treatment planning, and we hope that cases falling outside the IFU may benefit from this approach.”
“To answer the question ‘Has the Gore C3 delivery system met the expectations for real life EVAR?’ unequivocally, I would say the answer is yes.”