Two-Year Outcomes of Endovascular Repair of Isolated Thoracic Aortic Lesions Using a Single-Branch Thoracic Endograft with Left Subclavian Artery Preservation

P0361 

Abstract Submission 

G. Chad Hughes (1), Michael Dake (2), Himanshu Patel (3), Jon Matsumura (4), Jean Panneton (5), Ali Azizzadeh (6), Jason Lee (7), William Brinkman (8), Alan Lumsden (9), Chandler Long (1)

(1) Duke University Medical Center, Durham, NC, (2) University of Arizona Health Sciences, Tuscon, AZ, (3) University of Michigan Hospital, Ann Arbor, MI, (4) University of Colorado Health, Aurora, CO, (5) Sentara Vascular Specialists, Norfolk, VA, (6) Cedars-Sinai Medical Center, Los Angeles, CA, (7) Stanford University, STANFORD, CA, (8) Baylor Scott & White Health, TX, (9) Houston Methodist, Houston, TX

*G. Chad Hughes    -  Contact Me
Duke University Medical Center

Michael Dake    -  Contact Me
University of Arizona Health Sciences

*Himanshu Patel    -  Contact Me
University of Michigan Hospital

Jon Matsumura    -  Contact Me
University of Colorado Health

Jean Panneton    -  Contact Me
Sentara Vascular Specialists

Ali Azizzadeh    -  Contact Me
Cedars-Sinai Medical Center

Jason Lee    -  Contact Me
Stanford University

*William Brinkman    -  Contact Me
Baylor Scott & White Health

Alan Lumsden    -  Contact Me
Houston Methodist

Chandler Long    -  Contact Me
Duke University Medical Center

*G. Chad Hughes    -  Contact Me
Duke University Medical Center

Two-Year Outcomes of Endovascular Repair of Isolated Thoracic Aortic Lesions Using a Single-Branch Thoracic Endograft with Left Subclavian Artery Preservation

Hughes GC, Dake MD, Patel HJ, Matsumura JS, Panneton JM, Azizzadeh A, Lee JT, Brinkman WT, Lumsden AB, Long CA.

Objective. Thoracic endovascular aortic repair (TEVAR) has become the preferred management strategy for most pathologies (aneurysm, dissection, trauma, other) involving the descending thoracic aorta. When coverage of the left subclavian artery (LSA) is required during TEVAR to achieve adequate proximal landing zone (PLZ), revascularization of the LSA is recommended. Branched aortic endografts represent an alternative to surgical LSA revascularization.

Methods. Across 34 investigative sites, 13 adult patients with isolated lesions (non-aneurysm, non-dissection, non-trauma) of the descending thoracic aorta requiring zone 2 PLZ were enrolled in a nonrandomized, prospective study of a single-branched aortic endograft (Gore TAG Thoracic Branch Endoprosthesis (TBE), W.L. Gore and Associates, Flagstaff, AZ). The TBE device allows for zone 2 coverage and incorporates a single side branch for maintenance of LSA perfusion.

Results. Mean patient age was 65±13 years and 54% of patients were female. Pathologies treated included intramural hematoma (IMH) in 23% (n=3/13), penetrating aortic ulcer in 39% (n=5/13), and other isolated aortic lesion in 39% (n=5/13). Procedural technical success rate was 100%; 31% (n=4/13) of patients required distal thoracic endografting, in addition to the TBE device, for complete exclusion of their aortic pathology. Median procedure time was 142 [66,357] minutes. 30-day/in-hospital mortality, stroke, paraparesis/paraplegia, and new dialysis rates were all 0%. Through 24-month complete core laboratory adjudicated imaging follow-up, there have been no type I or III endoleaks, loss of LSA branch patency, or re-interventions. One (8%) patient, who underwent index intervention for an IMH, suffered a new acute type B dissection due to distal stent graft-induced new entry at 533 days postoperatively which resulted in aortic rupture and late death. An additional 3 (23%) patients suffered late deaths due to non-aorta related causes including cerebral hemorrhage (n=1; POD 129) and respiratory failure (n=2; POD 167 & 875). Through 24 months, no patients had aortic enlargement (>5mm) and there were no cases of wire fracture, migration, or compression.

Conclusions. Two-year results from a multi-center, prospective, non-randomized cohort study utilizing an investigational single-branched thoracic endograft for maintaining LSA perfusion in patients with isolated lesions of the descending thoracic aorta demonstrates excellent perioperative and early mid-term outcomes and avoids the need for concomitant surgical LSA revascularization in patients with appropriate anatomy. Longer-term follow up is needed to ensure continued branch graft patency and sustained protection from aortic events.

Endoluminal Prostheses