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.