Transcatheter Closure of Paravalvular Defects Using a Purpose-Specific Occluder

ObjectivesThis study sought to describe a method of paravalvular leak closure using a purpose-specific occlusion device.BackgroundTranscatheter 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.MethodsPatients 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.ResultsFive 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 μmol/l (IQR 106 to 132 μmol/l) to 89 μmol/l (IQR 89 to 126 μmol/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).ConclusionsClosure of mitral and aortic prosthetic paravalvular leaks with the Vascular Plug III using either a transapical (mitral) or a retrograde (aortic) approach appears promising.