Early outcomes of endovascular repairs of the aortic arch using thoracic branch endoprosthesis

Objective The only commercially available branched thoracic endoprosthesis (TBE) for treatment of the aortic arch was released in 2022. Limited data outside of clinical trial results have been reported. This study describes the demographics, anatomic details, and outcomes for patients treated for zone 0-2 using TBE outside of a clinical trial. Methods All patients treated using TBE for zone 0-2 were included. Patients treated as part of the clinical trial for zone 0-1 (6) were excluded. Patient demographics, comorbidities, anatomic and operative details, and outcomes were reported. Outcomes and survival were then compared between groups. Results Of 40 patients, 6 patients underwent repair of zone 0, 3 of zone 1, and 31 of zone 2. There were no differences in demographics, comorbidities, or operative details by zone of treatment; however, the frequency of genetic aortopathy differed (Zone 0: 0%, Zone 1: 67%, Zone 2: 6.4%, p<0.01). 73% of patients were treated for dissection vs 27% with isolated aneurysms. 2.5% of patients were treated for rupture, 22% were treated for symptomatic aneurysms, and 75% were treated electively. 48% of repairs included a proximal cuff and 83% received distal extension. Technical success was achieved in 100% of patients. Mean fluoroscopy time was 18 minutes and median fluoroscopy dose was 416 mGy. 60% of patients had prior aortic ascending/arch repair. TBE was planned as part of a complete thoracoabdominal repair in 45% of patients. 30-day mortality was 2.5% overall, with a single death in a Zone 0 patient that occurred at day 1 due to a myocardial infarction. There were no reinterventions within 30 days. All other outcomes were similar. The 30-day stroke rate was 5.0%. The strokes occurred at day 6 (zone 1) and day 15 (zone 2), however both were due to occlusion of a prior proximal surgical bypass and unrelated to the TBE side branch or embolization. Specifically, both patients had occlusion of a branch of their prior zone 1 or zone 2 arch replacement. An endoleak occurred in 7.5% of patients at 30-day follow-up (Type II: 5.0%, Unknown: 2.5%). At a mean follow-up of 6.6 months, 100% of side branches were patent. Conclusions Repair of the aortic arch including TBE can be performed electively and urgently with acceptable stroke and death rates. TBE provides a valuable tool for patients requiring complete repair of a thoracoabdominal aneurysm. Continued investigation is underway to assess long-term safety and efficacy outside of the clinical trial.