Abstract
This study aims 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 stentgraft along with a distal bare metal stent compared with traditional stentgrafts alone in the repair of acute, complicated type B aortic dissection (TBAD). This institutional review board-approved, single-center retrospective study reviews the medical charts of 32 patients with acute, complicated TBAD repaired at an urban academic medical center. Sixteen of these TBAD cases were repaired with the dissection stent (62.5% male; mean age, 60.3 years), and 16 were repaired with a stentgraft (87.5% male; mean age, 63.1 years). Primary outcomes evaluated include 30-day and 3-year mortality, 30-day morbidity outcomes, false lumen thrombosis, and aneurysmal degeneration. A total of 12 postoperative major adverse events occurred in the ZDES group compared with 37 events in the stentgraft group (P = .0087). Most notable major adverse events included myocardial infarction (0 of 16 ZDES; 2 of 16 stentgraft), renal ischemia (0 of 16 ZDES; 5 of 16 stentgraft), stroke and spinal cord ischemia (2 of 16 ZDES; 5 of 16 stentgraft), transient extremity ischemia (1 of 16 ZDES; 5 of 16 stentgraft), and refractory pain (0 of 16 ZDES; 8 of 16 stentgraft). At the 6-month follow-up, complete or partial thrombosis of the false lumen was noted in 100% of patients (16 of 16) in the ZDES group and in 56.3% of patients (9 of 16) in the stentgraft group. At the 12-month follow-up, complete or partial thrombosis of the false lumen was noted in three additional patients in the stentgraft group for a total of 75% of patients (12 of 16). Growth (>5 mm) of the maximum transaortic diameter was noted in 33.3% of patients (5 of 15) in the ZDES group and in 54% of patients (7 of 13) in the stentgraft group at 12 months. Thirty-day mortality occurred in one patient (6.3%) in the ZDES group, and there was no 30-day mortality in the stentgraft group. This death was related to dissection repair. Three-year mortality occurred in four patients (25%) in the stentgraft group, and there was no 3-year mortality in the ZDES group. These deaths were related to aneurysmal degeneration of the repaired aorta. This study suggests that patients with TBAD repaired with the ZDES had better aortic remodeling and false lumen thrombosis as well as decreased aneurysmal degeneration than patients treated with the stentgraft alone.
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