Early experience of percutaneous paravalvular leak closure using a novel Occlutech occluder

Aims: Paravalvular regurgitation is an important complication of mitral valve replacement. Although surgical repair is mostly recommended, it is associated with significant morbidity. On the other hand, percutaneous closure is a less invasive alternative approach. Percutaneous approaches to treatment of paravalvular prosthetic regurgitation have emerged recently. One of them is the Occlutech Paravalvular Leak Device. The aim of this study was to evaluate early and midterm outcomes of percutaneous paravalvular leak closure utilising a novel occluder. Methods and results: Twenty-one consecutive symptomatic patients who had moderate or severe paravalvular prosthetic regurgitation on transoesophageal echocardiography were included in the study. All the patients were clinically evaluated and found inoperable for surgery. They underwent transapical repair with the Occlutech Paravalvular Leak Device. The patients were followed for 17±5 months. Attempts were made to rectify 41 defects in 21 patients with 100% success. Mean procedure time was 76±40 min and fluoroscopy time was 44±37 min. Early post-procedural outcome was uneventful in all cases, with ≥1 grade reduction in regurgitation in all of the patients. There was no mortality during hospital stay. There was one case of haemothorax in one patient and one case of pneumothorax in another. Post-implantation 90-day follow-up data were obtained for 19 patients, and 12-month data were obtained for 12 patients. No deaths due to any cause, stroke or surgery for prosthetic impingement, worsening or relapse of paravalvular leak during follow-up were recorded. One patient underwent reintervention and was treated successfully with the same occluder 11 months after the index procedure. Conclusions: The novel Occlutech Paravalvular Leak Device, which was designed specifically for mitral and aortic paravalvular regurgitation, is an additional, useful tool in the device armamentarium for the treatment of PVL.