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ITALIAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY
Rivista di Chirurgia Vascolare ed Endovascolare
Italian Journal of Vascular and Endovascular Surgery 2011 Marzo;18(1):23-9
Two year follow-up results of thoracic endovascular repair with Relay Bolton endoprosthesis: the experience of the Italian participants of RESTORE I registry
Tealdi D. G., Nano G., Stegher S., Restore I Italian Collaborators
Unit of Vascular Surgery, IRCCS Policlinico San Donato, University of Milan, Milan, Italy
Aim. endovascular procedures for thoracic aorta are widely used in different pathologies: aneurysms, acute and chronic dissections, penetrating aortic ulcers, intramural hematomas, blunt trauma. The aim of this study is to present the Italian experience in the RESTORE I Registry.
Methods. RESTORE is a perspective, non randomized, European multicentric Registry designed to evaluate technical and clinical outcome from patients treated with Relay™ stent-graft. Threre hundred and four patients were enrolled all over Europe. Italy contributed with 146 patients (48%) in 8 major referral centres. The purpose of the registry was to collect data about patients undergoing thoracic graft endoprosthesis with Relay™ Bolton. Including indications were degenerative acute and chronic aneurysm, type B acute and chronic dissections, intramural hematomas, penetrating aortic ulcers, pseudoaneurysms and blunt trauma.
Results. Patients were 120 males (82.2%) and 26 females; 102 patients (70.3%) were classified as ASA class III or more. The most common aortic pathology treated was aneurysms (63.0%), followed by dissection (22.6%). Technical success was achieved in 144 patients (98.6%); 139 patients (95.21%) reported no endoleaks at discharge. No neurologic complications were found in 136 patients (93.15%): a overall spinal cord ischemia rate of 5.48% and a overall stroke rate of 1.37%. The 30-day mortality rate was 18.6% (8/43) in the acute group and 9.7% (10/103) in the chronic one. At 2 years the overall survival rate due to any cause was 68.54%.
Conclusion. Realy™ is a safe and accurate graft to treat different thoracic aorta pathologies with acceptable mortality and morbidity and with low stroke rate.