Why the study?
Operative mortality for type A aortic dissection remains 10-20% and 10-20% of patients are not viable candidates for open surgical repair, motivating an early feasibility assessment of the novel GORE Ascending Stent Graft.
Does the GORE Ascending Stent Graft improve outcomes in high surgical risk patients with ascending aortic dissection?
Does the GORE Ascending Stent Graft improve outcomes in high surgical risk patients with ascending aortic dissection?
The first-in-human ARISE study demonstrates early feasibility of a novel ascending stent graft for treating ascending aortic dissection in high-risk patients, with a 15.8% 30-day mortality rate.
Answers are grounded in this paper and cite their sources.
Early feasibility in small high-risk cohort warrants caution; leaves open safety and efficacy of ascending aortic stent grafts.
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.
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Roselli et al. (2022) studied this question.
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