Multi-Center Experience with Unitary Stent Graft System for Endovascular Debranched Aortic Repair of Various Thoracoabdominal Aortopathies

Stevan S Pupovac; Valentina Restrepo-Espinosa; Julia Fayanne Chen; Mina Zaky; Geoffrey A Answini; Patrick W Kelly; Prashanth Vallabhajosyula; Naiem Nassiri

doi:10.1016/j.athoracsur.2025.05.026

Multi-Center Experience with Unitary Stent Graft System for Endovascular Debranched Aortic Repair of Various Thoracoabdominal Aortopathies

Ann Thorac Surg. 2025 Jun 6:S0003-4975(25)00493-X. doi: 10.1016/j.athoracsur.2025.05.026. Online ahead of print.

Authors

Stevan S Pupovac¹, Valentina Restrepo-Espinosa², Julia Fayanne Chen³, Mina Zaky⁴, Geoffrey A Answini⁵, Patrick W Kelly⁶, Prashanth Vallabhajosyula⁴, Naiem Nassiri⁷

Affiliations

¹ Division of Cardiac Surgery, Department of Surgery, Yale New Haven Health, New Haven, CT; Northwell Health, New Hyde Park, NY.
² Section of Hematology, Department of Internal Medicine, Yale University, New Haven, CT.
³ Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, Yale New Haven Health, New Haven, CT.
⁴ Division of Cardiac Surgery, Department of Surgery, Yale New Haven Health, New Haven, CT.
⁵ Division of Cardiovascular Surgery, Department of Surgery, Christ Hospital, Cincinnati, OH.
⁶ Department of Vascular Surgery, Sanford Vascular Associates, Sanford Health, Sioux Falls, SD.
⁷ Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, Yale New Haven Health, New Haven, CT; Vascular and Endovascular Surgery, The Vascular Care Group, Darien, CT. Electronic address: naiemn@gmail.com.

PMID: 40484210
DOI: 10.1016/j.athoracsur.2025.05.026

Abstract

Background: This multi-center study analyzes the safety and feasibility of the unitary stent graft (USG) for endovascular debranched aortic repair (EDAR) of various complex thoracoabdominal aortopathies.

Methods: 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 EVAR. Two investigational device exemption databases(G140207, G170036) and one pre-submission 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.

Results: There were 2(1.4%) short neck infrarenal aneurysms; 2(1.4%) Type I, 9(6.5%) Type II, 6(4.3%) Type III, 99(71.2%) Type IV, and 3(2.2%) Type V Crawford thoracoabdominal aortic aneurysms, and 18(12.9%) chronic dissections. Technical success was 100%, with 98.7%(primary) and 99.8%(secondary) patency rates at 30 days. Thirty-day mortality was 3.6%. At median follow up (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%.

Conclusions: 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.