Multicenter Experience With the Unitary Stent Graft System for Endovascular Debranched Aortic Repair of Various Thoracoabdominal Aortopathies.

Abstract

This multicenter study analyzes the safety and feasibility of the unitary stent graft (USG) for endovascular debranched aortic repair (EDAR) of various complex thoracoabdominal aortopathies. EDAR was performed on 139 patients with thoracoabdominal aortic aneurysms at prohibitive risk for open surgery. Patients were included regardless of presentation, aneurysm/dissection extent, or spinal cord event history. The USG was assembled with the Medtronic Endurant II platform and Gore Viabhan stents to separate flow proximal to zone 6 into a visceral and an infrarenal limb, facilitating endoluminal bypasses to target mesenteric and renal vessels and infrarenal endovascular aneurysm repair. Two investigational device exemption databases (G140207 and G170036) and 1 presubmission database (Q222702) were prospectively maintained and retrospectively reviewed for mortality, 30-day major adverse events, technical success, and treatment success, assessed through clinical follow-up with imaging. There were 2 short neck infrarenal aneurysms (1.4%), 2 type I (1.4%), 9 type II (6.5%), 6 type III (4.3%), 99 type IV (71.2%), and 3 type V (2.2%) Crawford thoracoabdominal aortic aneurysms, and 18 chronic dissections (12.9%). Technical success was 100%, with 98.7% primary and 99.8% secondary patency rates at 30 days. Thirty-day mortality was 3.6%. At a median follow-up of 360 days, target vessel patency rates were 97.2% (primary) and 98.6% (secondary), mortality rates were 23.0% (all-cause) and 3.6% (aneurysm-related). Major adverse events included paraplegia (0.7%), stroke (4.3%), bowel ischemia (2.9%), renal failure (1.4%), myocardial infarction (4.3%), and respiratory failure (15.8%). Median hospital stay was 7 days. Reintervention rate within 365 days was 3.6%. USG is a safe and effective option for EDAR of various thoracoabdominal aortopathies, including failed prior repairs, in patients at prohibitive risk for open surgery.