September 19, 2016
DISSECTION Evaluates Medtronic's Valiant Captivia Thoracic Stent Graft at 3 Years in Complicated Type B Aortic Dissections
September 20, 2016—Ali Azizzadeh, MD, presented findings from the Medtronic DISSECTION trial during the second Late-Breaking Trials session at VIVA 16, the 14th annual Vascular InterVentional Advances meeting, which was sponsored by VIVA Physicians, Inc. and held September 18–22, 2016 at the Wynn Las Vegas in Las Vegas, Nevada.
The United States DISSECTION investigational device exemption trial evaluated endovascular treatment with the Valiant Captivia thoracic stent graft (Medtronic plc) in acute, complicated type B aortic dissection patients. The trial's background, as Dr. Azizzadeh noted, is that acute type B aortic dissection complicated by malperfusion or contained rupture carries a high risk of spontaneous death. Patients with acute, complicated type B aortic dissections are reported to have a > 50% likelihood of dying from this disease.
DISSECTION was designed as a multicenter, prospective, nonrandomized, pivotal trial with planned 5-year follow-up. The primary safety endpoint was all-cause mortality within 30 days from the index procedure.
As summarized by Dr. Azizzadeh, between June 2010 and May 2012, 50 patients with acute, complicated type B aortic dissection were enrolled in the trial at 16 clinical sites in the United States.
At 3 years, 32 of the 50 patients were eligible for follow-up, with 28 patients completing their 3-year follow-up (87.5%). Through 3 years, there have been no postindex ruptures or conversions to open surgical repair.
Dr. Azizzadeh reported that true lumen diameter over the stented region (or endograft segment) remained stable or increased in 92.3% of patients, the false lumen diameter remained stable or decreased in 69.3%, and the false lumen was partially or completely thrombosed in 75% of patients.
One death occurred between years 2 and 3; the cause of death was sepsis and was adjudicated by the clinical events committee as unrelated to the device, the procedure, or the dissection (death occurred on postindex procedure day 812).
Through 3 years, freedom from all-cause mortality was 79.4%, and freedom from dissection-related mortality was 90%. Only one dissection-related death occurred between day 27 and 3 years of follow-up.
Midterm results of the Valiant thoracic stent graft in the treatment of acute, complicated type B aortic dissection are encouraging, while longer-term outcomes are needed to assess the durability of TEVAR in this indication, concluded Dr. Azizzadeh at VIVA 16.