Five Year Outcomes from the US Pivotal Trial of Valiant Captivia Stent Graft for Blunt Aortic Injury

Abstract Background The RESCUE study, evaluating thoracic endovascular repair (TEVAR) using the Valiant Captivia endograft for blunt thoracic aortic injury (BTAI) reported promising 30-day outcomes. We now describe 5 years of follow up of this cohort. Methods 50 patients (mean age 40.7±17.4 years, 76% male, mean injury severity score=38±14.4) were treated for BTAI (2010-2012) with this endograft. 70% (n=35) of BTAI extent was grade III or higher. Extent of arch repair required full (40%) or partial (18%) left subclavian artery coverage. At 5 years, clinical and imaging compliance was 90.3% (28/31) and 67.7% (21/31) respectively. Results 30-day mortality was 8%. Three additional patients expired of non-device related causes (respiratory failure, infection, metastatic cancer) through 5-year follow-up yielding a Kaplan Meier survival of 85.2% through 5 years. No stroke nor spinal cord ischemia was observed at 5 years. Two type II endoleaks seen at 30 days resolved spontaneously, and no additional endoleaks were described in the study cohort through 5 years. No secondary endovascular procedures or conversion to open surgery were reported through 5 years. Four subjects underwent left subclavian revascularization for symptomatic indications. Finally, complete exclusion of the traumatic injury was maintained with no incidences of stent graft kinking, fracture, loss of patency, or migration through 5 years in all patients. Conclusions This multicenter clinical trial describes excellent 5-year outcomes and durable exclusion of blunt thoracic aortic injury using a novel stent graft system. TEVAR with this endograft appears to be a safe and effective treatment option for patients with BTAI.