European experience with Relay: a new stent graft and delivery system for thoracic and arch lesions

Abstract

Aim: Thoracic endografting is a very attractive therapeutic approach for thoracic aorta pathologies. Still some technological limitations need to be solved. Relay represents a new endograft specifically designed for thoracic aorta. The two-year clinical outcomes are presented.

Methods: RESTORE is a multicenter, European, prospective and monitored clinical registry. Patients with thoracic pathologies (acute or elective) suitable to be treated with Relay stent-graft were consecutively enrolled. Preoperative demographic data, procedure details, in hospital assessment and two year-follow-up outcomes were registered and analyzed.

Results: A cohort of 150 patients (125 males and 25 females) was included. Aneurysm was the most common pathology treated (64.7%) followed by dissections (19.3%). Overall technical success rate was 97.33%. Paraplegia rate was 3.3%, recovered paraparesis in 3.3% of the cases and stroke rate was only 0.6%. Successful reinterventions were necessary in 8.7% of the cases; one trans-thoracic intervention due to a retrograde type A dissection. The 30-day mortality rate was 10%. Four non-related mortality were recorded during surveillance. Reintervention rate during two year-follow-up was 8.9% due to two stent graft migrations, three proximal type I endoleak, four type III endoleak and five distal type I endoleaks. No open conversion was needed during follow-up. No wire form ruptures were observed during the follow-up period.

Conclusion: Relay provides a safe and accurate thoracic stent grafting for different aortic pathologies with acceptable mortality and morbidity. Associated stroke rate was clearly inferior to the expected.