Outcomes of patients with acute complicated type B aortic dissections repaired with the Zenith dissection endovascular system compared to aortic stent graft

Abstract

Objectives

We aim to evaluate the safety and effectiveness of the Zenith Dissection Endovascular System (ZDES; Zenith TX2 Dissection Endovascular Graft with Pro-Form and Zenith Dissection Endovascular Stent), which uses a proximal stent graft along with a distal bare metal stent compared to traditional stent grafts in the repair of acute, complicated Type B Aortic Dissection (AcTBAD).

Methods

This retrospective study reviews the medical charts of 32 patients with AcTBAD repaired at a single urban academic medical center. 16 of these AcTBAD cases were repaired with the ZDES (87.5% male; mean age, 63.1 years), and 16 were repaired with stent grafts (62.5% male; mean age, 60.6 years). Outcomes include 30-day morbidity, false lumen thrombosis and aneurysmal degeneration at 6 months and 1 year, thirty-day and three-year mortality, and freedom from secondary surgical intervention.

Results

Twelve total postoperative adverse events occurred in the ZDES group compared to 37 in the stent graft group (p = .046). The notable adverse events included renal insufficiency (p = .04) and refractory pain (p = .002). At the 6-month follow-up, complete or partial false lumen thrombosis was noted in 100% of patients (16/16) in the ZDES group and 56.3% of patients (9/16) in the stent graft group (p < .01). At the 12-month follow-up, complete or partial thrombosis of the false lumen was noted in 1 additional patient in the stent graft group for a total of 62.6% of patients (10/16; p = .018). Growth (>5 mm) of the maximum transaortic diameter at 12 months was noted in 33.3% of patients (5/15) in the ZDES group and 54% of patients (7/13) in the stent graft group (p = .45). Thirty-day mortality occurred in one patient in the ZDES group and no patients in the stent graft group (p = 1.0). Three-year mortality occurred in four patients in the stent graft group and no patients in the ZDES group (p = .11). Although more patients in the ZDES group underwent secondary intervention to address aortic growth, there were no differences between the two groups in freedom from any secondary intervention at 365 days post-procedure (p = .13).

Conclusions

Patients treated with ZDES had fewer post-procedural adverse events. Although the use of the ZDES had favorable false lumen thrombosis at 6 and 12 months, the device was not associated with a statistically significant change in transaortic diameter. Our single institution study demonstrated that ZDES has favorable clinical outcomes, but further investigation is needed to better understand aortic remodeling in the distally stented regions. Additionally, further research is necessary to explore the incidence of endoleaks associated with ZDES to optimize long-term patient outcomes.

Keywords

TEVAR AcTBAD ZDES stent graft false lumen thrombosis aneurysmal degeneration

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