Key result
Mitra-Spacer reduces FMR and bridges to surgery at 8 months despite device thrombosis.
Why the study?
A novel adjustable spacer device for transcatheter treatment of functional mitral regurgitation was evaluated for feasibility and clinical outcomes.
Case Report (n=1)
First-in-man use of the Mitra-Spacer demonstrated feasibility for reducing FMR and bridging to surgery, though device-related thrombosis occurred.
May bridge select FMR patients to LVEF recovery; hypothesis-generating for spacer durability and thrombosis prevention.
We report the first-in-man implantation of the Mitra-Spacer. The device was implanted transapically. FMR was reduced to moderate. At two months, while in NYHA Class II, LVEF had improved, but FMR increased and 2 mL was added, reducing FMR to mild. Despite anticoagulation, thrombi developed around the device and the valve was replaced at eight months. The Mitra-Spacer successfully bridged this patient to surgery after LVEF had recovered.
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Silaschi et al. (2017) conducted a case report in Functional mitral regurgitation (n=1). Mitra-Spacer was evaluated on Reduction of functional mitral regurgitation and clinical course. The Mitra-Spacer successfully reduced functional mitral regurgitation and bridged the patient to surgery at eight months, although thrombi developed around the device despite anticoagulation.
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