November 1, 2015
Two-Year Data Presented for Medtronic's Valiant Captivia TEVAR Device in Acute Type B Aortic Dissection
November 2, 2015—Ali Azizzadeh, MD, reported 2-year results of thoracic endovascular aortic repair with the Valiant Captivia thoracic stent graft (Medtronic) in patients with acute type B aortic dissection complicated by malperfusion or contained rupture that carried a high risk of mortality.
Dr. Azizzadeh presented the DISSECTION trial data during the first of two Late-Breaking Trials sessions at VIVA 15, the 13th annual Vascular InterVentional Advances meeting. The meeting, which is sponsored by VIVA Physicians, Inc., is being held November 2–5, 2015, at the Wynn Las Vegas in Las Vegas, Nevada. The session moderators are Michael R. Jaff, DO, and Krishna Rocha-Singh, MD.
The Medtronic DISSECTION trial, which enrolled 50 patients, was a multicenter, prospective, nonrandomized, pivotal trial with 5-year follow-up.
At 2 years, 35 patients were eligible for follow-up. There was one death between 1 and 2 years, which was adjudicated by the clinical events committee to be related to natural causes (death occurred on post–index procedure day 432). There have been no post–index procedure ruptures or conversions to surgery reported in the Medtronic DISSECTION United States investigational device exemption study.
One patient required three additional endovascular procedures to treat continued perfusion of the false lumen, of which the first procedure occurred on day 164 and the other two procedures occurred between 1 and 2 years (days 367 and 538). There were no (0%) open repairs of retrograde type A dissections between 1 and 2 years.
Between 1 and 2 years, one patient (1/37; 2.7%) experienced one or more serious adverse events, and there were no device-related adverse events reported. There was no incidence of stent graft collapse or loss of integrity.
At 2-year follow-up, true-lumen diameter over the stented region (or endograft segment) remained stable or increased in 85.7%; false-lumen diameter remained stable or decreased in 78.6%; and the false lumen was partially or completely thrombosed in 70.4% of patients. The 2-year freedom from all-cause mortality was 81.8%, and the 2-year freedom from dissection-related mortality was 90%.
The investigators concluded that these midterm results of the Valiant thoracic stent graft in the treatment of acute type B aortic dissection are encouraging, and they advised that longer-term outcomes are needed to assess the durability of thoracic endovascular aortic repair for this indication.