Two-Year Target Vessel-related Outcomes Following Use of Off-the-Shelf Branched Endografts for the Treatment of Thoracoabdominal Aortic Aneurysms.

Tsilimparis, Nikolaos; Bosiers, Michel; Resch, Timothy; Torsello, Giovanni; Austermann, Martin; Rohlffs, Fiona; Coates, Brandon; Yeh, Chyon; Kölbel, Tilo (2023). Two-Year Target Vessel-related Outcomes Following Use of Off-the-Shelf Branched Endografts for the Treatment of Thoracoabdominal Aortic Aneurysms. Journal of vascular surgery, 78(2), pp. 289-298. Elsevier 10.1016/j.jvs.2023.03.498

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OBJECTIVES

To assess clinical outcomes and target vessel patency through 2 years following thoracoabdominal aortic aneurysms (TAAA) repair with the off-the-shelf Zenith® t-Branch® Thoracoabdominal Endovascular Graft (William Cook Europe, Bjaeverskov, Denmark).

METHODS

This post-market, observational study was conducted at 3 European sites with ambispective enrollment from 2012-2017. Patients underwent endovascular TAAA repair with the t-Branch graft and bridging stent grafts (BSGs) for the celiac (CA), superior mesenteric (SMA), left renal (LRA), and/or right renal arteries (RRA). Follow-up was through 2 years per sites' standard of care. Procedural and 1-year results were reported previously.

RESULTS

Eighty patients (mean age 71.0±7.4 years, 70.0% men) were enrolled; 6 patients had symptomatic TAAAs and 15 patients had contained ruptures. Technical success was achieved in 98.8% (79/80) of patients. Median follow-up was 22.2 months (IQR: 9.2-25.1 months). At 24 months, Kaplan-Meier (KM) freedom from all-cause and aneurysm-related mortality were 78.5% and 98.6%, respectively. Beyond 12 months, 38 adverse events occurred in 20 patients, including 2 aortic ruptures (1 study aneurysm and 1 non-study aneurysm) and 6 deaths (none aneurysm-related, as reported by the site). Compared with postprocedure, maximum aneurysm diameter decreased (>5 mm) in 84.6% (44/52), remained unchanged in 3.8% (2/52), and increased (>5 mm) in 11.5% (6/52) of patients with imaging follow-up after 12 months. No conversions to open repair, and no t-Branch graft or other endograft component migration or integrity issues were reported. No loss of patency was reported in the t-Branch or iliac limb grafts throughout the study. Throughout study duration, 4 patients had 5 imaging-reported BSG compressions, none of which required secondary intervention. KM freedom from secondary intervention was 76.3% at 24 months. Fourteen target vessel-related secondary interventions were performed, primarily consisting of stent placement for endoleak, stenosis, or occlusion. KM freedom from loss of primary patency were 94.8%, 100%, 91.3%, and 89.3% for the CA, SMA, LRA, and RRA, respectively, at 24 months. KM freedom from loss of secondary patency in the CA, SMA, LRA, and RRA were 96.3%, 100%, 98.2%, and 98.3% at 24 months. A total of 298 vessels were targeted of which 12 were occluded over the study period.

CONCLUSIONS

Primary and secondary target vessel patency rates through 2 years demonstrated durable repair with the t-Branch graft in patients treated for symptomatic or asymptomatic thoracoabdominal aortic aneurysms.

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