Carotid to subclavian bypass and Amplatzer vascular plug subclavian endovascular occlusion before thoracic open or endovascular repair

Objective: The aim of this study was to evaluate the safety and effectiveness of endovascular occlusion of the prevertebral subclavian artery (SA) using an Amplatzer vascular plug after prophylactic revascularization with carotid-subclavian bypass (CSB) in the setting of endovascular thoracic stent grafting or open arch repair with frozen elephant trunk. Methods: All patients who underwent SA plug embolization (SAPE) and CSB from September 2009 to December 2018 were enrolled in a registered study (SAPE study: clinicaltrials.gov NCT03620006). The primary end point was technical success, defined as complete occlusion of the origin of the SA, and how it was influenced by SA anatomy. The secondary end points were access vessel complications, cerebrovascular events, and CSB patency. Results: The 101 SAPE procedures were performed using a type I (35 patients) or a type II (66 patients) Amplatzer vascular plug. A percutaneous ipsilateral upper extremity access was used in 66% of patients and a radial artery access was used in 50% of procedures. The 30-day primary technical success rate was 95% (five patients received an additional plug during the index); five type IC endoleaks were observed and successfully treated either with surgical ligation (in open arch repair procedures) or secondary embolization procedure (thoracic endovascular aneurysm repair group). Three access vessel complications (3%) were recorded with percutaneous brachial approach. At a median follow-up time of 11 months (range, 2-19 months), no new-onset type IC endoleak was observed, and the CSB patency rate was 97%. Conclusions: SAPE after CSB is feasible and safe, and has low incidence of type IC endoleaks. Further device developments are needed to better adapt to the subclavian anatomy.