Results of the Valiant Mona LSA early feasibility study for descending thoracic aneurysms

摘要: Objective Stent graft coverage of the left subclavian artery (LSA) may be required to achieve an adequate landing zone in up 40% descending thoracic aneurysms (DTAs). The Valiant Mona LSA Thoracic Graft System (Medtronic, Santa Rosa, Calif) consists a main stent and branch designed maintain patency while diverting circulation through encroaching aneurysm. Participating United States Food Drug Administration's new Innovation Pathway, this first-in-human, early feasibility study evaluates clinical experience patients with DTAs where proximal necessitates coverage. Methods This premarket, nonrandomized, single-arm prospective recruited nine (age 72.9 ± 7.6 years). Primary end points were aneurysm-related mortality, stroke, paraplegia, arm/hand ischemia, treatment success. Neurologic events assessed by imaging independent neurologists. Inclusion criteria DTA or penetrating aortic ulcer have distance ≥10 mm between common carotid LSA. Mean aneurysm diameter was 53.7 ± 10.0 mm. indication for repair saccular five fusiform four. Seven at American Society Anesthesiologists Physical Status Classification III/IV. Results All received one (diameter 28 42 mm) 10 14 mm). To extend device distally, commercial Captivia implanted seven patients. No uncorrected endoleaks observed implant procedure. Four developed before discharge four eight evaluable Two identified as type II two undetermined type. endoleak resulted secondary intervention. Technical success, defined investigational plan, achieved all intraoperatively, success 1 month. There no major, disabling strokes. minor nondisabling strokes reported three ≤30 days (days 1, 5, 24). date, there been reports death, arm rupture, conversion open surgery, endovascular surgical revascularization. Conclusions system demonstrates technical relative safety, durability its initial use Midterm results are expected monitored regular intervals 5 years.