TY - JOUR
T1 - Prospective Multicenter Study of the Low-Profile Relay Stent-Graft in Patients with Thoracic Aortic Disease
T2 - The Regeneration Study
AU - Riambau, Vicenç
AU - Giudice, Rocco
AU - Trabattoni, Piero
AU - Llagostera, Secundino
AU - Fadda, Gianfranco
AU - Lenti, Massimo
AU - García, Iván
AU - Maeso, Jordi
AU - Blanco, Carla
AU - Verzini, Fabio
PY - 2019/7
Y1 - 2019/7
N2 - Background: To evaluate the early safety and clinical performance of the new low-profile RelayPro Thoracic Stent-Graft System in patients with thoracic aortic disease. Methods: This was an international, prospective, single-arm study in patients diagnosed with thoracic aorta disease (aneurysm, pseudoaneurysm, dissection, penetrating atherosclerotic ulcer, or intramural hematoma) and treated with a RelayPro stent-graft (in bare stent and/or nonbare stent configurations). The primary endpoints were freedom from aneurysm or dissection-related mortality and stent-graft performance. Results: A total of 31 patients were treated with the RelayPro thoracic stent-graft between 2014 and 2015 at 8 sites in Italy and Spain. Mean age was 72.1 (±10.2) years and 77% were male, 74% with hypertension, and 42% with a history of smoking. Twenty-four (77%) had aneurysms (fusiform in 46%, saccular in 42%, pseudoaneurysm in 12%); 5 (16%) had penetrating atherosclerotic ulcer; and 2 (6%) had chronic Type B dissection. Mean vascular access diameter was 9.1 mm (6–13 mm); 7 patients (23%) had vascular access of 7 mm or less. Technical success was 100% (primary, 90%; assisted primary, 10%). Freedom from aneurysm/dissection-related mortality through 30 days was 100%. Freedom from device-related major adverse events through 30 days was 94%. At 1 year, there was 1 (3%) type Ib and 1 (3%) type II endoleak, 1 (3%) nonaneurysm-related late death, and 1 (3%) secondary intervention (to correct type Ib endoleak). Conclusions: The RelayPro has a 3–4 French profile reduction to allow endovascular repair of thoracic aortic disease in patients with smaller anatomies. This study shows good initial stent-graft performance and a favorable early safety profile.
AB - Background: To evaluate the early safety and clinical performance of the new low-profile RelayPro Thoracic Stent-Graft System in patients with thoracic aortic disease. Methods: This was an international, prospective, single-arm study in patients diagnosed with thoracic aorta disease (aneurysm, pseudoaneurysm, dissection, penetrating atherosclerotic ulcer, or intramural hematoma) and treated with a RelayPro stent-graft (in bare stent and/or nonbare stent configurations). The primary endpoints were freedom from aneurysm or dissection-related mortality and stent-graft performance. Results: A total of 31 patients were treated with the RelayPro thoracic stent-graft between 2014 and 2015 at 8 sites in Italy and Spain. Mean age was 72.1 (±10.2) years and 77% were male, 74% with hypertension, and 42% with a history of smoking. Twenty-four (77%) had aneurysms (fusiform in 46%, saccular in 42%, pseudoaneurysm in 12%); 5 (16%) had penetrating atherosclerotic ulcer; and 2 (6%) had chronic Type B dissection. Mean vascular access diameter was 9.1 mm (6–13 mm); 7 patients (23%) had vascular access of 7 mm or less. Technical success was 100% (primary, 90%; assisted primary, 10%). Freedom from aneurysm/dissection-related mortality through 30 days was 100%. Freedom from device-related major adverse events through 30 days was 94%. At 1 year, there was 1 (3%) type Ib and 1 (3%) type II endoleak, 1 (3%) nonaneurysm-related late death, and 1 (3%) secondary intervention (to correct type Ib endoleak). Conclusions: The RelayPro has a 3–4 French profile reduction to allow endovascular repair of thoracic aortic disease in patients with smaller anatomies. This study shows good initial stent-graft performance and a favorable early safety profile.
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U2 - 10.1016/j.avsg.2018.10.017
DO - 10.1016/j.avsg.2018.10.017
M3 - Article
C2 - 30684621
AN - SCOPUS:85063052946
VL - 58
SP - 180
EP - 189
JO - Annals of Vascular Surgery
JF - Annals of Vascular Surgery
SN - 0890-5096
ER -