ARISE: First-In-Human Evaluation of a Novel Stent Graft to Treat Ascending Aortic Dissection

Abstract

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.

Type A Aortic Dissection with Antegrade Intimointimal Intussusception

“…2 Endovascular stent graft repair of TAAD has been done but remains investigational. 3 While the intimal tear in TAAD is usually transverse and comprises less than half of the aortic circumference, rare cases present with circumferential dissection and intimointimal intussusception, or “telescoping,” of the aorta, as described here. 4 …”

Multimodality imaging and image guidance techniques for endovascular ascending aortic repair

“…Conventionally, ballooning after stent-deployment is performed in aneurysmal pathologies but avoided in dissections due to the risk of injury to the acutely dissected, fragile aorta, and migration of the stent-graft along the aorta. 22 No complications have been described in the most current literature 1 , 3 , 4 , 5 , 8 during ballooning in the AAo.…”

“…Recently, there has been a growing interest in endovascular treatment options for AAo pathologies. 1 , 2 , 3 , 4 Ascending aortic thoracic endovascular repair (aTEVAR) has evolved from few anecdotal cases to a treatment option with excellent technical success and encouraging outcomes in patients with prohibitive risk for conventional open repair. 5 , 6 Thoracic stent-grafts, abdominal cuffs, or custom-made grafts such as the Valiant PS-IDE (Medtronic) and Relay Non-Bare Stent (Terumo Aortic) or are most commonly used for aTEVAR in an off-label manner.…”

“… 5 , 7 , 8 , 9 Even though there are currently no devices approved by the Food and Drug Administration available, newer endovascular devices are being designed specifically for the AAo. 1 , 9 , 10 , 11…”

Endovascular Treatment of Type A Aortic Dissection: A Systematic Review and Meta-Analysis Using Reconstructed Time-to-Event Data

“…Ultimately, 20 studies met all of the inclusion criteria and were eventually included. Eight additional studies did not make it through the final selection process due to data overlap [18][19][20][21][22][23][24][25]. In total, we analyzed data from 311 patients with TAAD that underwent TEVAR (Table 1).…”