Second-generation unibody single-branched stent-graft for thoracic endovascular aortic repair of type B aortic dissection.

OBJECTIVES

To evaluate the safety and feasibility of thoracic endovascular repair (TEVAR) of type B aortic dissection (TBAD) with Cratos branched stent-graft.

MATERIALS AND

METHODS

A prospective, multicenter study consisting of consecutive TBAD patients across 12 centers in China who were treated with the Cratos branched stent-graft was conducted. Outcomes were reported using descriptive statistics. Overall survival, freedom from reintervention, and branch artery patency were estimated using Kaplan-Meier estimates.

RESULTS

The first enrollment started from January 2022 and ended in July 2023, with a total of 89 patients finally enrolled. All patients were diagnosed with TBAD and underwent TEVAR using the Cratos branched stent-graft. Technical success was achieved in all patients. One patient (1.1%) died of respiratory failure within the first 30 days after the operation. The rate was 1.1% for both stroke and spinal cord ischemia. The median follow-up was 369 days. Two patients (2.2%) died during follow-up, and neither death was related to the aorta. One patient had reintervention because of retrograde type A aortic dissection (RTAD). Two cases of endoleak resolved spontaneously but the one with RTAD and type Ia endoleak. Eighty-one patients completed a 12-month computed tomography angiography. The patency rate for the branch section was 95.06%. At the segment covered by the stent-graft, the complete thrombosis rate was 92.59% (75/81) at 12 months.

CONCLUSIONS

Cratos branched stent-graft was a safe and feasible device for TEVAR of TBAD. The updated device exhibited easy, safe, and accurate deployment. (Chinese Clinical Trial Register identifier: ChiCTR2200064412: ChiCTR2200064412).

KEY POINTS: Question How can thoracic endovascular aortic repair (TEVAR) for type B aortic dissection (TBAD) safely provide sufficient proximal landing while maintaining left subclavian artery perfusion? Findings The Cratos unibody single-branched stent-graft achieved high technical success, low complication rates, and excellent branch patency in treating TBAD while revascularizing the left subclavian artery. Clinical relevance The Cratos stent-graft enables one-stage, minimally invasive TEVAR for TBAD, addressing the need for safe left subclavian artery coverage and revascularization, thereby improving sealing, reducing complications, and enhancing clinical outcomes.