One-year results of the Flowdynamics Dense Mesh Stent for residual dissection after proximal repair of stanford type A or type B aortic dissection: a multicenter, prospective, and randomized study.

OBJECTIVE:Negative remodeling of the distal aorta following proximal repair for acute aortic dissection has garnered growing attention. This clinical scenario has spurred the development of techniques and devices. A multicenter, prospective, and randomized controlled study was conducted with the aim of confirming the safety and effectiveness of a newly-designed flowdynamics dense mesh stent for the treatment of residual dissection after proximal repair. METHODS:Patients with nonchronic residual dissection affecting visceral branches were prospectively enrolled at three centers and randomly allocated to either the FDMS group or the control group. Primary endpoints encompassed all-cause and aortic-related mortality, while the patency of branch arteries is indeed a key focal metric. Morphological changes (diameter, area, and volume) were analyzed to demonstrate the therapeutic effect. RESULTS:One hundred twelve patients were recruited in the clinical trial, and 103 patients completed the 12-month follow-up. The rate of freedom from all-cause and aortic-related death in the FDMS group was 94.64 and 100%, respectively. All visceral branches remained patent. The FDMS group exhibited a substantial expansion in TL and a notable shrinkage in FL at the planes below renal arteries (ΔArea TL : FDMS vs. Control, 0.74±0.46 vs. 0.34±0.66 cm 2 , P <0.001; ΔArea FL : FDMS vs. Control, -0.72±1.26 vs. -0.12±0.86 cm, P =0.01) and 5 cm below renal arteries (ΔArea TL : FDMS vs. Control, 1.06±0.75 vs. 0.16±0.63 cm 2 , P <0.001; ΔArea FL : FDMS vs. Control, -0.53±1.43 vs. -0.25±1.00 cm, P =0.27). Meanwhile, the FDMS group demonstrated an increase of 22.55±11.14 cm 3 in TL ( P <0.001) and a corresponding reduction of 21.94±11.77 cm 3 in FL ( P =0.08). CONCLUSIONS:This newly-designed FDMS for endovascular repair of residual dissection following the proximal repair is demonstrated to be safe and effective at 12 months.