The Mini-Cross Prefenestration for Endovascular Repair of Aortic Arch Pathologies

Objective: To examine the feasibility, integrity, efficacy, and safety of endovascular repair of the aortic arch pathologies with the mini-cross prefenestration (MCPF) on stent grafts.Methods: First, to prove the feasibility of the MCPF, an in-vitro prefenestration experiment was conducted. Second, to examine the integrity of the MCPF stent grafts, a fatigue test was conducted. Then, the membranes and metal structures of stent grafts were examined by light microscopy and scanning electron microscopy (SEM). Third, a clinical experiment was conducted to investigate the efficacy and safety of this novel technique ( Identifier: NCT04544579).Results: All the 12 branch stents were successfully implanted and flared in vitro. After the fatigue test stimulating a 5-year cardiac cycle, no obvious disintegration or fracture was found in light microscopy or SEM. From December 2017 to February 2020, 26 patients with left subclavian arteries and/or left common carotid arteries involved received the novel technique. The endovascular repair with the MCPF was successfully performed on all the 26 (100%) patients. Eighteen (69.2%) patients underwent the reconstruction of the left subclavian artery (LSCA) only. The fenestrations of both the LSCA and left common carotid artery (LCCA) were conducted in 8 (30.8%) patients. Median operative time was 120 [interquartile range (IQR), 95-137.5] min and median revascularization time of the LSCA and LCCA was 30.5 (IQR, 22.8-42.0) s and 20.0 (IQR, 18.0-32.0) s separately. During the median follow-up duration of 38.9 (range, 18.8-44.2) months, one case needed an open surgery because of retrograde type A aortic dissection 3 months after implantation and no other complications or mortality occurred. The maximum aortic diameters were significantly decreased in patients with thoracic aortic dissection and thoracic aortic aneurysm (p < 0.05).Conclusion: The existing evidence demonstrated the safety, rapid branch artery revascularization, and positive aortic remodeling of the novel technique. Long-term observation is warranted to prove the durability.

Automated summary

This study examined the feasibility, integrity, efficacy, and safety of endovascular repair of aortic arch pathologies with the mini-cross prefenestration (MCPF) on stent grafts. Results showed successful implantation and integrity of the MCPF stent grafts. The clinical experiment demonstrated high success rates and significant reduction in aortic diameter after endovascular repair with MCPF.