The Prospective, Multiple Center Study of a Novel Embedded Modular Single-Branched Stent-Graft for Type B Aortic Dissection Involving the Left Subclavian Artery.

OBJECTIVES

This study aimed to assess the midterm outcomes of a novel embedded modular single-branched stent-graft (EMSBSG) designed to preserve the left subclavian artery (LSA) of type B aortic dissection (TBAD).

METHODS

From December 2020 to November 2021, a total of 120 patients with TBAD treated with an EMSBSG were enrolled in a multicenter prospective clinical trial at 18 Chinese tertiary hospitals. Follow-up computed tomography angiography scanning was conducted at 1, 6, and 12 months postprocedure.

RESULTS

The technical success rate was 99.17% (n = 119/120), with only 1 technical failure attributed to aortic intimo-intimal intussusception. The 30-day mortality rate was 0.83% (n = 1). Thirty-day major complications included 2 cases (1.67%) of retrograde type A aortic dissection (RTAD), 3 cases (2.50%) of stroke, and 6 cases (5.22%) of Type Ia endoleaks. The median follow-up time was 12.84 (range, 11-16) months. The 1-year mortality rate was 4.17% (n = 5/120), and the follow-up patency rate of the branch section was 99.09% (n = 109/110). The overall 12-month reintervention rate was 4.17% (n = 5), including 3 RTAD cases, 2 Type I endoleaks, and 1 stent-induced new entry.

CONCLUSION

For patients with TBAD involving the LSA, the midterm outcomes are encouraging for EMSBSG as a relatively safe, effective, and noncustomized endovascular option. However, long-term outcomes warrant attention and further investigation.Clinical ImpactThe midterm outcomes indicate that EMSBSG offers a safe, and effective endovascular option for preserving the LSA in patients with TBAD. The EMSBSG achieves LSA preservation through a non-customized endovascular solution, making it particularly suitable for emergency procedures. The core innovation of EMSBSG lies in its flexible, modular Embedded design, which adapts to the anatomical characteristics of TBAD in patients.