One-year Results Of A Flowdynamics Dense Mesh Stent For Residual Dissection After Proximal Repair: A Multicenter, Prospective, Randomized Study
West China Hospital， Sichuan University, Chengdu, China.
BACKGROUND: Negative remodeling of distal aorta due to residual dissection significantly impacts long-term outcomes of dissection patients after proximal open/endovascular repair of acute aortic dissection. Branched/fenestrated aortic stents are technically demanding and the results of first generation of multilayer flow modulator for tackling this clinical scenario is less satisfactory.
METHODS: Patients with non-chronic residual dissection involving visceral branches after proximal repair of aortic dissection were prospectively enrolled in three centers (Chictr.org.cn ChiCTR1900023638). Eligible patients were randomly assigned (1:1) to FDMS group and control group. The primary endpoint was distal aortic remodeling, aortic-related events and patency of visceral branches at 1 year.
RESULTS: Totally 112 patients were enrolled, and baseline characteristics of 56 patients in both FDMS and control groups were comparable. Mean follow-up period was 11.79±1.21 months, ranging from 6 to 12 months. Three patients in the FDMS group died from none-device/aorta related reasons after surgery. No aortic-related adverse events were observed in both groups, and all visceral arterial branches were patent in the FDMS group. Favorable distal aortic remodeling in terms of increased area of true lumen (102.58±39.30 vs. 47.61±63.28 mm2 at the level of renal artery, 126.95±79.66 vs. 31.79±49.68 mm2 at the level of bifurcation of common iliac arteries, p<0.05) and decreased area of false lumen at the level of renal artery (-103.22±84.21 vs. -15.38±121.16 mm2, p<0.05) were observed in the MFM group compared to those parameters in the control group.
CONCLUSIONS: This newly-designed FDMS for endovascular repair of residual dissection is safe and effective in terms of 12-month mortality and morbidity, favorable distal aortic remodeling and patency of visceral branches.
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