Thirty-Day PLIANT Results Reported for Jotec's E-liac System

October 2, 2018—Jotec GmbH, a fully owned subsidiary of CryoLife Inc., announced 30-day results of the PLIANT study of the E-liac stent graft system in patients with common iliac aneurysms. PLIANT was an observational, prospective, nonrandomized, multicenter, international study conducted in 12 hospitals throughout Europe. The study enrolled 45 patients who were due to undergo implantation with the E-liac device.

According to the company, concomitant iliac artery aneurysms are a major anatomic challenge of endovascular aortic repair (EVAR) in patients with abdominal aortic aneurysms. They exacerbate the complexity of EVAR and increase the incidence of type Ib endoleak, iliac limb occlusion, and aneurysm rupture. Jotec's E-liac stent graft system was introduced to address these issues and is indicated for patients with aortoiliac or isolated iliac aneurysms.

The purpose of the study was to examine the clinical and technical success of the E-liac side branched stent graft system when implanted in accordance with the indications for use. Data was collected at preoperative planning, intervention, before discharge, 30 ± 15 days, 12 ± 2 months, and 36 ± 2 months. All CT scans and final angiograms were analyzed by a core lab.

The company stated that the primary endpoint was aneurysm exclusion (no type I, III, IV endoleak) with primary patency of the internal iliac artery (IIA) and external iliac artery (EIA) on the E-liac implantation side, which is equivalent to the definition of clinical and technical success. Technical success was assessed at 24 hours after the index procedure whereas clinical success was determined at follow-up.

The investigators reported that the periprocedural primary patency rate of the IIA and EIA on the E-liac implantation side was 100%. Four patients had clinically relevant type Ia endoleak, three located in the infrarenal aorta and one in the common iliac artery. Two type Ia endoleaks were related to mismatch diameters of the graft and the respective landing zones.

Additionally, 30-day clinical success was achieved in 43/45 (96%) patients and three successful endovascular reinterventions were performed within 30-day follow-up. Primary patency at 30 days was 100% for the IIA and 98% for the EIA with 100% primary assisted patency in the latter.

The investigators concluded that the high clinical success rate, low number of reinterventions (2%), and excellent patency rate demonstrate the safety and feasibility of the E-liac stent graft system. Long-term results of this study will be published when available, advised Jotec.