A Novel Open-Vascular Single-Branched Stent Graft in Total Arch Repair of Type a Aortic Dissection--One-Year Results of a Prospective Multicenter Randomized Controlled Study

Abstract

Background : Acute type A aortic dissection (TAAD) is a life-threatening condition requiring timely surgery. Modifications in TAAD arch reconstruction are needed to improve surgical manipulation and reduce complications. This study evaluates a novel single-branched stent graft for arch reconstruction.Methods and Results : We randomly enrolled 156 patients with acute Type A Aortic Dissection (TAAD) from 8 Chinese hospitals to receive either the Fontus branched stent graft (75 patients) or the Cronus straight stent graft (81 patients) for frozen elephant trunk (FET) surgery. In the analysis of the primary endpoint, 30-day mortality was 10.7% (8/75) in the Fontus group and 11.1% (9/81) in the Cronus group, with a mortality difference of 0.44% (95% CI: -9.34% to 10.22%; non-inferiority threshold -14%). At 12 months, all-cause mortality was 16.0% in the Fontus group compared to 13.6% in the Cronus group (p = 0.670). The rates of false lumen (FL) obliteration and freedom from secondary interventions for target lesions were 90.5% and 98.4% in the Fontus group, and 92.7% and 98.6% in the Cronus group. Instrumental adverse events occurred in 5 patients in the Fontus group, while no such events occurred in the Cronus group (p = 0.024). At 1 month, dissection-associated mortality was 10.7% (8/75) in the Fontus group and 11.1% (9/81) in the Cronus group.Conclusions: This first randomized clinical study on FET repair for acute TAAD shows that the Fontus single-branched stent graft is non-inferior to the conventional straight stent graft in 1-year survival and adverse event rates.

Note:
Funding Information: This study was supported by the Clinical Research Plan of SHDC (No. SHDC2020CR6013).

Conflict of Interests: Shanghai MicroPort Endovascular MedTech (Group) Co., Ltd. provided the open vascular stent graft free of charge. The authors reported no conflicts of interest.

Ethical Approval: The study adhered to the Declaration of Helsinki and Chinese regulatory requirements. The protocol and amendments received approval from the Institutional Review Board/Ethics Committee at each participating center prior to implementation.

Keywords: type A aortic dissection, single-branched stent graft, Fontus, Sun's procedure, frozen elephant trunk