November 5, 2014
DISSECTION Data Are Encouraging for Medtronic's Valiant Captivia for Treatment of Type B Dissection
November 5, 2014—VIVA Physicians, Inc. announced that Ali Azizzadeh, MD, presented findings from the United States investigational device exemption DISSECTION trial of Medtronic, Inc.’s Valiant Captivia thoracic stent graft during the late-breaking trials session at the VIVA 2014: Vascular InterVentional Advances meeting in Las Vegas, Nevada. The study evaluated the Valiant Captivia for endovascular aortic repair in acute type B aortic dissection.
An acute type B aortic dissection complicated by malperfusion or contained rupture carries a high risk of spontaneous death. Dr. Azizzadeh reported 30-day and 12-month results of endovascular treatment with the Valiant Captivia in these patients.
As summarized by the VIVA press release, DISSECTION was a multicenter, prospective, nonrandomized, pivotal trial with 5-year follow-up. The study enrolled 50 patients. Rupture was present in 20% of these patients and malperfusion in 86%. Successful delivery, deployment, and coverage of the primary entry tear were achieved in 100% of procedures. Two patients underwent open repair at 5 and 56 days postprocedure after retrograde aortic dissections (4%).
Freedom from all-cause mortality was 92% at 30 days and 86% at 12 months. There was an acceptable rate of adverse events through 12 months: 6% cerebrovascular accident, 4% paraplegia, and 2% spinal cord injury. Four patients underwent secondary endovascular procedures—three related to dissection using endograft extension and one not related to dissection using an left subclavian artery plug. There was no incidence of stent graft collapse or loss of integrity.
Through 12 months, true lumen diameter over the stented region (or endograft segment) remained stable or increased in 94.1%; false lumen diameter remained stable or decreased in 82.4%; and the false lumen was partially or completely thrombosed in 79.4% of patients.
The DISSECTION investigators concluded that these initial results of the Valiant Captivia thoracic stent graft in the treatment of acute type B aortic dissection are encouraging. They noted that longer-term outcomes are needed to assess the durability of thoracic endovascular aortic repair for this indication.