Left Subclavian Artery Revascularization With In Situ Laser Fenestration During Thoracic Endovascular Aortic Repair for Acute Complicated or High-Risk Type B Aortic Dissection: Results of the LLTEVAR Trial.

2025-12-16
Journal of the American Heart Association 14(24)
- Zhiyou Peng
- Siyuan Liang
- Rong Zhang
- Peng Qiu
- Minyi Yin
- Guang Liu
- Xiaobing Liu
- Xinwu Lu
- Kaichuang Ye

PubMed: 41368828
DOI: 10.1161/jaha.125.041720

Study Design

Type: Clinical Trial
Sample size: n = 100
Population: 100 patients with acute complicated or high-risk acute type B aortic dissection (TBAD) (mean age, 60.5±12.6 years) enrolled at 5 vascular centers
Methods: Prospective, single-arm, multicenter study; in situ laser-assisted fenestration for LSA revascularization during TEVAR
Blinding: Open-label
Duration: within 30 days after the procedure

Large Human Trial

Background

Coverage of the left subclavian artery (LSA) during thoracic endovascular aortic repair (TEVAR) for type B aortic dissection (TBAD) increases the risk of major adverse events (MAEs). In situ laser-assisted fenestration allows for LSA revascularization in both elective and urgent settings, yet its safety and efficacy lack robust multicenter data.

Methods

LLTEVAR (LSA Revascularization With Laser-Assisted Fenestration During TEVAR) was a prospective, single-arm, multicenter study that enrolled patients with acute complicated or high-risk acute TBAD. The primary safety end point was freedom from composite MAEs (mortality, stroke, myocardial infarction, paraplegia, type Ia endoleak, and retrograde aortic dissection/intramural hematoma) within 30 days after the procedure. Univariate and multivariable analyses identified risk factors for composite MAEs.

Results

A total of 100 patients (mean age, 60.5±12.6 years) were enrolled at 5 vascular centers between July 2018 and September 2021. The technical success rate of LSA fenestration was 98.0% (98/100). The 30-day primary safety end point was 86.0%. Complicated TBAD (OR, 4.04; 95% CI, 1.05-15.59; P=0.04) and type II/III aortic arch (OR, 4.61; 95% CI, 1.18-17.95; P=0.03) were significantly associated with a higher risk of composite MAEs within 30 days.

Conclusion

In situ laser-assisted fenestration for LSA revascularization during TEVAR demonstrates favorable procedural success and acceptable short-term outcomes in patients with acute TBAD. However, periprocedural MAEs remain a critical consideration, particularly in those with complicated TBAD with type II/III aortic arch anatomy. Further studies with comparative groups and long-term follow-up are warranted to validate these outcomes.

Registration

URL: https://clinicaltrials.gov; Unique Identifier: NCT03845829.