SS23. Outcome of an Off-the-Shelf Device for Treating Juxtarenal Aneurysm: Lessons From the Ventana Trial

Abstract

Treatment of juxtarenal and short-neck infrarenal aneurysms can be successfully performed with fenestrated endografts. Our objective in this report was to summarize an initial experience with an “off-the-shelf” fenestrated technology and to inform vascular specialists about the outcomes for these patients following a decision to halt enrollment in the trial related to concerns regarding endograft performance. There were 125 patients treated at 27 institutions as part of an initial feasibility and pivotal trial designed to assess the safety, feasibility, and performance of an endograft designed to treat juxtarenal and pararenal aneurysms without the need for patient-specific customization of the endograft. Patient anatomy was not amenable to therapy with standard infrarenal endografts and was assessed by a core laboratory and independent physician for appropriateness of application of this novel technology. Patients were assessed in the hospital and at 1 month, 6 months, and 12 months and annually thereafter with computed tomography and physical examination, with core laboratory evaluation of imaging studies for assessment of renal artery status, device integrity, endoleak, device migration, and aneurysm size and morphology. Early data with this graft revealed a high rate of technical success (98%) and low perioperative mortality (1%) and renal failure (4.8%). Procedural technical success was 97%. Mean follow-up is now 42.9 months for patients in pilot and feasibility trials outside the United States and 39.8 months for those patients enrolled in the pivotal trial in the United States. Whereas freedom from rupture has been high both outside the United States and in the United States, reintervention has been necessary for renal issues (29% in the United States, 21% outside the United States) and endoleak (9.2% in the United States, 25% outside the United States) at a rate higher than anticipated. Aneurysm-related death has occurred in three patients (2.4%) during follow-up. Off-the-shelf technology with early cannulation of the renal arteries and single-system deployment for delivery of aortic and branch devices allows simple, quick device deployment. However, long-term success of this type of device will require significant modifications to the system to allow reduced need for secondary intervention and improved long-term device performance.