TY - JOUR
T1 - ARISE
T2 - First-In-Human Evaluation of a Novel Stent Graft to Treat Ascending Aortic Dissection
AU - Roselli, Eric E.
AU - Atkins, Marvin D.
AU - Brinkman, William
AU - Coselli, Joseph
AU - Desai, Nimesh
AU - Estrera, Anthony
AU - Johnston, Douglas R.
AU - Patel, Himanshu
AU - Preventza, Ourania
AU - Vargo, Patrick R.
AU - Fleischman, Fernando
AU - Taylor, Bradley S.
AU - Reardon, Michael J.
N1 - Publisher Copyright:
© The Author(s) 2022.
PY - 2022
Y1 - 2022
N2 - Background: Operative mortality for type A aortic dissection is still 10–20% at centers of excellence. Additionally, 10–20% are not considered as viable candidates for open surgical repair and not offered life-saving emergency surgery. ARISE is a multicenter investigation evaluating the novel GORE® Ascending Stent Graft (ASG; Flagstaff, AZ). Objective: The purpose of this study is to assess early feasibility of using these investigational devices to treat ascending aortic dissection. Methods: This a prospective, multicenter, non-randomized, single-arm study that enrolls patients at high surgical risk with appropriate anatomical requirements based on computed tomography imaging at 7 of 9 US sites. Devices are delivered transfemorally under fluoroscopic guidance. Primary endpoint is all-cause mortality at 30 days. Secondary endpoints include major adverse cardiovascular and cerebrovascular events (MACCE) at 30 days, 6 months, and 12 months. Results: Nineteen patients were enrolled with a mean age of 75.7 years (range 47–91) and 11 (57.9%) were female. Ten (52.6%) had DeBakey type I disease, and the rest were type II. Sixteen (84.2%) of the patients were acute. Patients were treated with safe access, (7/19 (36.8%) percutaneous, 10/19 (52.6%) transfemoral, 2/19 (10.5%) iliac conduit), delivery, and deployment completed in all cases. Median procedure time was 154 mins (range 52–392) and median contrast used was 111 mL (range 75–200). MACCE at 30 days occurred in 5 patients including mortality 3/19 (15.8%), disabling stroke in 1/19 (5.3%), and myocardial infarction in 1/19 (5.3%). Conclusion: Results from the ARISE early feasibility study of a specific ascending stent graft device to treat ascending aortic dissection are promising.
AB - Background: Operative mortality for type A aortic dissection is still 10–20% at centers of excellence. Additionally, 10–20% are not considered as viable candidates for open surgical repair and not offered life-saving emergency surgery. ARISE is a multicenter investigation evaluating the novel GORE® Ascending Stent Graft (ASG; Flagstaff, AZ). Objective: The purpose of this study is to assess early feasibility of using these investigational devices to treat ascending aortic dissection. Methods: This a prospective, multicenter, non-randomized, single-arm study that enrolls patients at high surgical risk with appropriate anatomical requirements based on computed tomography imaging at 7 of 9 US sites. Devices are delivered transfemorally under fluoroscopic guidance. Primary endpoint is all-cause mortality at 30 days. Secondary endpoints include major adverse cardiovascular and cerebrovascular events (MACCE) at 30 days, 6 months, and 12 months. Results: Nineteen patients were enrolled with a mean age of 75.7 years (range 47–91) and 11 (57.9%) were female. Ten (52.6%) had DeBakey type I disease, and the rest were type II. Sixteen (84.2%) of the patients were acute. Patients were treated with safe access, (7/19 (36.8%) percutaneous, 10/19 (52.6%) transfemoral, 2/19 (10.5%) iliac conduit), delivery, and deployment completed in all cases. Median procedure time was 154 mins (range 52–392) and median contrast used was 111 mL (range 75–200). MACCE at 30 days occurred in 5 patients including mortality 3/19 (15.8%), disabling stroke in 1/19 (5.3%), and myocardial infarction in 1/19 (5.3%). Conclusion: Results from the ARISE early feasibility study of a specific ascending stent graft device to treat ascending aortic dissection are promising.
KW - aortic dissection
KW - ARISE
KW - ascending aorta
KW - stent graft
KW - TEVAR
UR - http://www.scopus.com/inward/record.url?scp=85130980769&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85130980769&partnerID=8YFLogxK
U2 - 10.1177/15266028221095018
DO - 10.1177/15266028221095018
M3 - Article
C2 - 35587698
AN - SCOPUS:85130980769
JO - Journal of Endovascular Therapy
JF - Journal of Endovascular Therapy
SN - 1526-6028
ER -