Prospective multicenter study of the low-profile Relay stent-graft in patients with thoracic aortic disease: the RE-GENERATION study
| Autor: | Iván García, Rocco Giudice, Secundino Llagostera, Gianfranco Fadda, Massimo Lenti, Carla Blanco, Jordi Maeso, Fabio Verzini, Vicenç Riambau, Piero Trabattoni |
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| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Male
Time Factors Computed Tomography Angiography medicine.medical_treatment Aorta Thoracic 030204 cardiovascular system & hematology 030218 nuclear medicine & medical imaging Pseudoaneurysm Postoperative Complications 0302 clinical medicine Risk Factors Thoracic aorta Prospective Studies Thoracic aortic disease Aged 80 and over TEVAR thoracic endovascular aneurysm repair Endovascular Procedures Relay General Medicine Middle Aged Progression-Free Survival Dissection Italy dissection Cardiothoracic surgery Female Stents Cardiology and Cardiovascular Medicine Adult Reoperation medicine.medical_specialty RelayPro Aortic Diseases Prosthesis Design Aortography Risk Assessment Blood Vessel Prosthesis Implantation 03 medical and health sciences Aneurysm Penetrating atherosclerotic ulcer Blood vessel prosthesis medicine.artery medicine Humans cardiovascular diseases Aged stent-graft business.industry Stent medicine.disease Blood Vessel Prosthesis Surgery Spain business |
| Zdroj: | Annals of Vascular Surgery r-IGTP. Repositorio Institucional de Producción Científica del Instituto de Investigación Germans Trias i Pujol instname |
| ISSN: | 0890-5096 |
| Popis: | 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 dissectionrelated 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. |
| Databáze: | OpenAIRE |
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