Transcatheter closure of paravalvular defects using a purpose-specific occluder.

OBJECTIVES: This study sought to describe a method of paravalvular leak closure using a purpose-specific occlusion device.

BACKGROUND: Transcatheter closure of paravalvular leaks has been hampered by technical challenges, the limitations of available imaging modalities, and the lack of closure devices specifically designed for this purpose.

METHODS: Patients with severe symptomatic paravalvular regurgitation at high risk for repeat surgery underwent transcatheter leak closure. Both left ventricular puncture and retrograde transfemoral approaches were used with fluoroscopic and 3-dimensional transesophageal guidance. A purpose-specific occluder (Vascular Plug III, AGA Medical Corp., Plymouth, Minnesota) was used.

RESULTS: Five patients with severe prosthetic mitral and aortic paravalvular leaks underwent attempted closure. Implantation of the device was successfully accomplished in all. In 1 patient, the plug interfered with closure of a mechanical valve leaflet and was removed and replaced with an alternate device. Complications included pericardial bleeding in 2 patients with a transapical approach. There was no procedural mortality. At a median follow-up of 191 days (interquartile range [IQR] 169 to 203 days) all patients were alive. New York Heart Association functional class fell from 4 (IQR 3 to 4) to 2 (IQR 2 to 3), hemoglobin rose from 89 g/l (IQR 87 to 108 g/l) to 115 g/l (IQR 104 to 118 g/l), creatinine fell from 109 micromol/l (IQR 106 to 132 micromol/l) to 89 micromol/l (IQR 89 to 126 micromol/l). Median echocardiographic follow-up at 58 days (IQR 56 to 70 days) reported residual regurgitation to be reduced from grade 4 to grade 2 (IQR 1.5 to 2.25).

CONCLUSIONS: Closure of mitral and aortic prosthetic paravalvular leaks with the Vascular Plug III using either a transapical (mitral) or a retrograde (aortic) approach appears promising.