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Three-year results of the INNOVATION study confirm earlier “very promising” findings

The INNOVATION study found that the rate of freedom proximal type I endoleaks and the rate of freedom from reintervention in patients who underwent endovascular aortic aneurysm repair (EVAR) with the Incraft (Cordis) device was, respectively, 100% and 95%, at three years. In this interview, CX Daily News speaks to Giovanni Pratesi (Florence, Italy)—who presented the data at CX yesterday—about Incraft and the three-year results.

How does the Incraft stent graft differ from other EVAR devices?

It is a new-generation stent graft system with unique features that have been specifically designed to overcome the limitations of current stent grafts. For example, the ultra-low profile integrated delivery system (14F OD) offers excellent navigational opportunities in challenging access vessels. Additionally, the micrometric deployment system allows for accurate placement—either at proximal and distal attachment site. Bilateral in-situ length adjustment, up to 3cm, permits you to customise every implant on the single patient anatomy. Therefore, the Incraft system, according to the “few-fits-most” concept, is able to cover a large spectrum of anatomies with only 23 product codes, four main bodies and 19 iliac limbs.


What are the main results of the INNOVATION study at three years?

The three-year results of the INNOVATION study have confirmed the very promising one- and two-year outcomes of the study. These data show, at three years, the device is associated with 100% freedom from type Ia and III endoleaks, stent-graft migrations, and device- or procedure-related major adverse events. They also show that the rate of limb patency is 97.8%, with only one case of limb occlusion. Other findings from the three-year data indicate that there is a significant reduction in mean aortic aneurysm diameter, up to 15 mm, compared with two-year data, a freedom from sac increase of 95.6% and freedom from stent fractures of 97.7%. Core lab analysis has identified two cases of aneurysm sac enlargement—both associated with a persistent type II endoleak—and one case of stent fracture, but these events did not appear to have any clinical consequences.


What other data were included in your presentation?

I specifically addressed endograft durability and anatomical preservation in my analysis of the Innovation study. Data from core lab analysis have confirmed the excellent stent graft stability that has already been observed during follow-up. A median proximal migration of 2mm was observed at three-year compared with the one-month computed tomography (CT) scan. The same result was achieved in terms of distal migration with a median change of 1.1mm and 2mm on the right and left side respectively, compared with the one-month CT scan.

Aortic neck diameter, neck angulation and iliac artery diameter, compared with one-month CT scan, were analysed at three years to review endograft influence on anatomic changes during follow-up. The observed 1mm proximal neck dilatation and 2mm iliac artery dilatation, combined with the 0.6 degree changes for infrarenal neck angulation and 2.4 degree for suprarenal neck angulation, confirmed the excellent stent graft conformability to the preoperative anatomy.


What were the main take-home messages from your presentation?

These data confirm the very promising earlier outcomes of Incraft stent graft system and add new evidence regarding its effectiveness in terms of anatomy preservation with a 100% freedom from both proximal aortic neck and iliac dilatation, and from proximal supra- and infrarenal aortic neck angulation changes.

2015-07-11T02:23:23+00:00