Thoracic endovascular aortic repair with stent grafts alone or with a composite device design in patients with acute type B aortic dissection in the setting of malperfusion.
Abstract Objective The objective of this study was to compare short-term outcomes in patients who underwent thoracic endovascular aortic repair (TEVAR) with stent grafts alone or with a composite device design (stent graft plus bare-metal aortic stent) for acute type B aortic dissection in the setting of malperfusion. Methods This retrospective analysis included patients with acute (≤14 days of symptom onset) complicated type B dissection in the setting of malperfusion who were treated with stent grafts alone (TEVAR cohort) at two European institutions vs those who underwent TEVAR with a composite device design (Cook Medical, Bloomington, Ind) in the investigational STABLE I feasibility study and STABLE II pivotal study (STABLE cohort). Preoperative characteristics and 30-day outcomes (including mortality, malperfusion-related mortality, morbidity, and secondary interventions) were compared between the two groups. Results The TEVAR cohort (41 patients; mean age, 58.8 ± 12.7 years; 78.0% male) and the STABLE cohort (84 patients; mean age, 57.8 ± 11.7 years; 71.4% male) were largely similar in preoperative medical characteristics, with more STABLE patients presenting with a history of hypertension (79.8% vs 58.5%; P = .018). The TEVAR and STABLE groups had similar lengths of dissection (451.8 ± 112.7 mm vs 411.8 ± 116.4 mm; P = .10) and similar proximal and distal extent of dissection. At presentation, the two groups exhibited comparable organ system involvement in malperfusion: renal (53.7% TEVAR, 57.1% STABLE), gastrointestinal (41.5% TEVAR, 44.0% STABLE), lower extremities (34.1% TEVAR, 52.4% STABLE), and spinal cord (9.8% TEVAR, 2.4% STABLE). The 30-day rate of all-cause mortality was 17.1% (7/41) in the TEVAR group and 8.3% (7/84) in the STABLE group ( P = .22). The 30-day rate of malperfusion-related mortality (deaths from bowel/mesenteric ischemia or multiple organ failure) was 12% (5/41) in the TEVAR group and 2.4% (2/84) in the STABLE group ( P = .038). The 30-day morbidity, for the TEVAR and STABLE groups, respectively, included bowel ischemia (9.8% [4/41] vs 2.4% [2/84]; P = .09), renal failure requiring dialysis (7.3% [3/41] vs 9.5% [8/84]; P > .99), paraplegia or paraparesis (4.9% [2/41] vs 3.6% [3/84]; P = .66), and stroke (2.4% [1/41] vs 10.7% [9/84]; P = .16). The occurrence of 30-day secondary intervention was similar in the TEVAR and STABLE groups (7.3% [3/41] vs 7.1% [6/84]; P > .99). True lumen expansion in the abdominal aorta was significantly greater in the STABLE group. Conclusions In patients with acute type B aortic dissection in the setting of branch vessel malperfusion, the use of a composite device with proximal stent grafts and distal bare aortic stent appeared to result in lower malperfusion-related mortality than the use of stent grafts alone. The 30-day rates of morbidity and secondary interventions were similar between the groups.