Left subclavian artery revascularization with in-situ laser fenestration during TEVAR for complicated or high-risk TBAD: results of the LLTEVAR Trial

ObjectiveThis study aimed to prospectively evaluate the safety and efficacy of left subclavian artery (LSA) revascularization via in-situ laser-assisted fenestration during thoracic endovascular aortic repair (TEVAR) for type B aortic dissection (TBAD). MethodsThis was a prospective, single-arm, multicenter study that enrolled patients with complicated or high-risk acute TBAD. The primary safety endpoint was freedom from composite major adverse events (mortality, stroke, myocardial infarction, paraplegia, type Ia endoleak) within 30 days after the procedure. Univariate and multivariate analyses determined the risk factors of composite major adverse events. The primary efficacy endpoint was freedom from all-cause death, LSA in-stent restenosis, and reintervention due to dissection progression, growth, and endoleak at 1 year after the procedure. ResultsA 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 revascularization was 98.0% (98/100). The primary safety endpoint within 30 days after the procedure was 86.0% (86/100, with 15 events occurring in 14 patients). Within 30 days after the procedure, mortality occurred in two patients, resulting in a 30-day mortality rate of 2.0% (2/100). Four patients experienced a stroke, and the rate was 4.0% (4/100). Retrograde aortic pathologies occurred in 2 patients, including one with ascending dissection treated with open repair, and the other with retrograde intramural hematoma treated with medical therapy, and the hematoma was self-resolved within 6 months. Five patients experienced type Ia endoleak, and conjunctive coil embolization were performed in 4 patients. One patient experienced paraplegia and recovered within 2 weeks. Complicated TBAD (OR, 4.98; 95%CI,1.27-19.55; P=.02) and type II/III arch (OR, 6.37; 95%CI,1.72-23.53; P=.006) significantly associated with a higher risk of composite major adverse events within 30-day after the procedure. The primary efficacy endpoint at 1 year after the procedure was 90.0%. ConclusionLeft subclavian artery revascularization with in-situ laser-assisted fenestration during TEVAR for TBAD is a successful procedure and is associated with excellent short-term outcomes. However, attention should be paid to periprocedural major adverse events, especially in complicated TBAD patients with type II/III arch.