Outcomes of Thoracic Endovascular Aortic Repair in Acute Type B Aortic Dissection: Results From the Valiant United States Investigational Device Exemption Study.
Acute type B aortic dissection complicated by malperfusion or rupture carries a risk of death. We report 30-day and 12-month results of endovascular treatment with the Valiant Captivia Thoracic Stent Graft (Medtronic, Santa Rosa, CA) in patients with acute, complicated type B aortic dissection.The Medtronic DISSECTION Trial is a prospective, nonrandomized, United States Food and Drug Administration-regulated, pivotal trial that enrolled patients at 16 United States sites between June 2010 and May 2012. Follow-up examinations were at 1, 6, and 12 months, and annually through 5 years.Fifty patients were enrolled. Mean age was 57 years (range, 18 to 83 years). Rupture was present in 20% and malperfusion in 86%. Mean time from symptom onset to procedure was 4.7 days (range, 0 to 23 days). Successful deployment and coverage of the primary entry tear was achieved in all patients. Two patients (4%) underwent open repair 5 and 56 days postprocedure for retrograde aortic dissections. Thirty-day mortality was 8% (4 of 50) and 12-month mortality was 15% (7 of 48). Spinal ischemia was 6%. Serious adverse events occurred in 23 of 49 patients within 12 months. Four patients underwent secondary endovascular procedures. Through 12 months, true lumen diameter in the stented region remained stable or increased in 93.1% (27 of 29) of patients. False lumen diameter remained stable or decreased in 22 patients and was partially or completely thrombosed in 91% (30 of 33).The initial results of the Valiant Thoracic Stent Graft in the treatment of acute type B aortic dissection are encouraging, but longer-term outcomes are needed.
Bavaria, JE; Brinkman, WT; Hughes, GC; Khoynezhad, A; Szeto, WY; Azizzadeh, A; Lee, WA; White, RA
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