A novel physician-assembled endograft for the repair of pararenal, paravisceral, Crawford type IV thoracoabdominal aortic aneurysms, and aneurysms requiring treatment after prior repair

Abstract

Objective: In the present study, we reviewed the 30-day and 1-year clinical results of the use of the investigational unitary manifold (UM) stent graft system (Sanford Health, Sioux Falls SDak) for the repair of Crawford type IV, pararenal, paravisceral, juxtarenal, and short-neck infrarenal aneurysms (<10 mm).

Methods: The present study was a single-center, multiarm, prospective review of the first 44 patients who had undergone repair of Crawford type IV, pararenal, juxtarenal, and short-neck infrarenal aneurysms (<10 mm) using the physician-modified UM under a physician-sponsored investigational device exemption. The primary end point was freedom from major adverse events at 30 days, including all-cause mortality, myocardial infarction, stroke, paraplegia, bowel ischemia, respiratory failure, and renal failure.

Results: Technical success was achieved in all 44 patients (100%), with a large number of these patients having undergone previous aortic repair (20 of 44; 45.5%). All the intended 170 visceral vessels (100%) had been successfully cannulated and stent grafted. No episodes of paraplegia or in-hospital deaths were recorded. One patient had died of aneurysm-related ischemic stroke (2.3%). The rate of transient nonclinically significant spinal cord ischemia was 4.5%. At the last follow-up, one reintervention had been required owing to branch patency from a thrombotic event. Of the 170 bridging stent grafts, 169 have remained patent through a mean follow-up of 8.8 months (range, 0-36 months). No type I or III endoleaks, migration, or component separation in the investigational device has occurred.

Conclusions: The early and midterm results with the use of the UM suggest it could be a viable option for the repair of Crawford type IV, pararenal, paravisceral, juxtarenal, and short-neck infrarenal aneurysms (<10 mm) without exposing patients to the increased risk of permanent spinal cord ischemia, renal failure, visceral vessel ischemia, or aneurysm-related mortality that results from open thoracoabdominal aortic aneurysm repair. The high technical success rate, in native and previous repairs, supports the utility of this device as a bail-out technique for failed endovascular aneurysm repair or proximal extension of disease after previous aortic repair. However, experience is limited, and this approach requires further study before widespread adoption.

Trial registration: ClinicalTrials.gov NCT02294435.

Keywords: Branched; Complex aneurysm repair; Endovascular aortic repair; Thoracoabdominal aneurysm.