Management of arch aneurysms with a single-branch thoracic endograft in zone 0.

BACKGROUND: We present preliminary data from a patient cohort undergoing thoracic endovascular aortic repair for Ishimaru zone 0 and 1 using a novel branched arch endograft. METHODS: This US multicenter early feasibility investigational device exemption clinical trial treated 9 patients with a mean age 72.8 ± 8.0 years (77.8% male). The endograft was designed with a single side branch designed to facilitate aortic coverage proximal to the innominate or left carotid artery while maintaining branch vessel patency. Pathology treated included fusiform (n = 2) or saccular (n = 7) aneurysm, with a maximum aortic diameter of 6.3 ± 0.7 cm. Treatment was into zone 0 in 8 patients, and zone 1 in 1 patient. RESULTS: All patients underwent initial successful first-stage supra-aortic trunk revascularization using a variety of techniques, without the occurrence of stroke. For the second thoracic endovascular aortic repair stage, median total treatment length was 20 cm. The primary end point of device delivery and branch vessel patency was achieved in 100% of patients, without 30-day mortality or spinal cord ischemia. Cerebrovascular events were observed in 2 patients through 30 days. No type I or III endoleaks were reported and all side branches were patent at 12-month imaging follow-up. CONCLUSIONS: Endovascular repair of Ishimaru zone 0 or 1 arch aortic aneurysms can be achieved with a novel branched arch endograft. Future studies will evaluate the mid-term outcomes with this device in other pathologies and further define the occurrence of postoperative neurologic events.

Branched Endovascular Therapy of the Distal Aortic Arch: Preliminary Results of the Feasibility Multicenter Trial of the Gore Thoracic Branch Endoprosthesis.

BACKGROUND: Endovascular treatment for aortic arch aneurysms often requires adjunctive use of hybrid debranching procedures to maintain branch vessel perfusion. This study describes early results with a novel branched arch endograft for total endovascular repair of distal arch aneurysms. METHODS: This US feasibility multicenter clinical trial evaluated 22 patients (mean age, 74.1 ± 10.5 years; 54.5% male) undergoing branched thoracic endovascular aortic repair in Ishimaru zone 2. This endograft was designed with a single side branch designed to facilitate aortic coverage proximal to the left subclavian artery while maintaining branch vessel patency. The pathologic features treated included fusiform (n = 10) and saccular (n = 12) aneurysms, with a mean aortic diameter of 5.7 ± 1.1 cm. The mean preoperative left-to-right brachial index was 1.0 ± 0.1. RESULTS: The mean total treatment length was 17.6 ± 8.9 cm; 8 patients were treated with a single 10-cm graft for isolated arch disease. The primary endpoint of device delivery and branch vessel patency was achieved in 100% of patients, without 30-day death, stroke, or permanent paraplegia. The median duration of hospitalization was 4.0 days. Type I endoleaks at completion angiography were observed in 4 patients, and all resolved by 1 month without reintervention. All side branches were patent at 1 month. The Kaplan-Meier survival rate at 6 months was 94.7%. CONCLUSIONS: Total endovascular repair of distal zone 2 arch aortic aneurysms can be achieved with a novel branched arch endograft. Future studies will evaluate the feasibility of this approach for aneurysms encompassing the brachiocephalic trunk and left carotid artery.