Transapical paravalvular leakage closure in high surgical risk patients: procedural outcomes and mortality

Purpose: Significant periprosthetic paravalvular leak (PVL) can have serious clinical consequences. Initially, reoperation was the only solution with a high mortality rate. Recently, efforts for transcatheter closure have been made. We evaluate the feasibility and safety of transcatheter device PVL closure using a transapical approach in a consecutive series of high-risk surgical patients. Methods: All consecutive patients who underwent transcatheter PVL closure in our centre from October 2009 to December 2012, were included. All procedures were carried out in the catheterization laboratory under general anesthesia, using a small anterolateral thoracotomy to expose the apex. Access was provided with a 9-French sheath. Three-dimensional transesophageal echocardiography was used to guide the operator and evaluate the severity of regurgitation immediate after implantation. Procedural success was defined according to the valve academic research consortium-2 consensus document. Mortality was registered at 6 and 12 months. Results: In total, 36 consecutive patients (mean age 67,2±12,1 years, 69,4% male) with severe symptomatic PVL in mitral (n = 28) or aortic (n = 8) position, underwent transapical PVL closure. NYHA functional class was ≥ 3 in 100%. Preprocedural median logistic EuroSCORE was 25,8% (IQR 31,4) and STS score was 24,7% (IQR 19,7). Procedural success was achieved in 88,9% of the patients. Mean procedure time was 94,0±33,0 minutes with a fluoroscopic time of 25,1±12,6 minutes. There were 2 procedural deaths. Rethoracotomy was performed in 11.1% because of bleeding complications. The survival rates at 6 and 12 months after PVL closure were 79,3% (n = 29) and 60,9% (n = 23), respectively. Conclusions: Transapical paravalvular leakage closure in high-risk patients is safe and technically feasible, and might be an attractive alternative for re-do surgery.