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Final Operative and Midterm Results of the European Experience in the RELAY Endovascular Registry for Thoracic Disease (RESTORE) Study
Study Questions:
How safe is a new thoracic endograft in the endovascular treatment of thoracic aortic pathology?
Methods:
RESTORE is a multicenter prospective registry in Europe involving 22 centers. The Bolton RELAY device is a flexible device with modifications made specifically for the thoracic aorta. A total of 304 patients who underwent thoracic aortic endovascular repair (TEVAR) for different pathologic indications including aneurysm (161), aortic dissection (91), penetrating ulcer (27), traumatic injury (40), and other pathologies were treated with this device. The proximal anatomic locations of treatment included the proximal aorta up to the level of the innominate artery in 7%, between the innominate and left carotid arteries in 12.5%, between the left carotid and left subclavian arteries in 24%, and in the descending thoracic aorta in the remaining 56%.
Results:
In this heterogeneous population, the rate of acute aortic pathology was 33.6%. A total of 210 patients scored ≥3 on the American Society of Anesthesiology risk profile classification. General anesthesia was used in 93% of patients. The devices were most frequently delivered via a transfemoral approach (82%). A mean of 1.3 endografts per patient was used. As noted above, the proximal landing zone was in the aortic arch in 240 (80%). The technical success rate was 97.7% irrespective of etiology. No procedure was abandoned or converted to an open repair. Early complications included mortality in 7.2% of patients, paraplegia in 2%, paraparesis in 2.3%, and stroke in 1.6% of patients. The most frequent cause of early death was multiorgan failure; 6 of 19 deaths were device related. The 2-year survival was 78.5%. Freedom from procedure- and device-related mortality at 2 years was 96%, and 95.4% of patients were free from endoleak at last follow-up.
Conclusions:
The RESTORE study supports the safety of thoracic aortic endovascular repair with the RELAY stent graft in a wide variety of thoracic aortic pathology and in all segments of the thoracic aorta.
Perspective:
This is a very large registry study evaluating the early and mid-term outcomes of a newer thoracic stent graft designed specifically for the thoracic aorta. There are certain aspects of the stent graft that allow for easier delivery and apposition in the angulated arch aorta. Although the study is quite heterogeneous with respect to the nature of patients and pathologies that were treated, it does appear that the early results with this particular endograft are very reasonable and continue to demonstrate that TEVAR represents a suitable alternative in certain patients who present with thoracic aortic disease. However, as is the case for all newer technologies, late results are most important given the potential risk for endoleak and late aneurysm rupture in the treated aortic segments.
Keywords: Registries, Thoracic Diseases, Endovascular Procedures, Follow-Up Studies, Europe, United States, Stents
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