European experience with Relay: a new stent graft and delivery system for thoracic and arch lesions
Riambau, V.; Zipfel, B.; Esteban, C.; Verhagen, H.J.M.; Riambau, V.; Tealdi, D.G.; Czerny, M.; Funovics, M.; Schoder, M.; Goicolea, J.; Palanca, A.M.; Lopez-Minguez, J.R.; Coppi, G.; Kaskarelis, I.; Mangialardi, N.; Muños, A.; Garcia, I.; Doblas, M.; Vecchiati, E.; Emilia, R.; Ferro, C.; Passerone, G.; Martinelli, L.; Royo, J.; Rousseau, H.é; Berti, S.; Sassi, C.; Ricci, C.; Chiesa, R.
Journal of Cardiovascular Surgery 49(4): 407-415
2008
ISSN/ISBN: 0021-9509 PMID: 18665104 Document Number: 620241
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. 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. 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. 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.