Percutaneous pulmonary and aortic valve insertion in Belgium: going for conditional reimbursement or waiting for further evidence?

OBJECTIVES The aim of this study was to assess current evidence supporting the use of percutaneous heart valves (PHV) in degenerative aortic valve and congenital pulmonary outflow tract disease, as compared to conservative medical therapy or traditional surgical valve replacement. METHODS A systematic review of the literature on PHV was performed. RESULTS No randomized controlled trials (RCT) on PHV have been published so far. Only observational data from series and data presented at cardiology meetings are available. Both percutaneous aortic valve (PAV) and percutaneous pulmonary valve (PPV) seem feasible in the hands of an experienced team. Safety, however, seems to be a problem in PAV, as shown by the high 30-day and 6-month mortality rates. CONCLUSIONS Due to safety concerns, PAV reimbursement is not recommended and patients should only be subjected to PAV insertion within the boundaries of an RCT. In contrast, PPV implantation seems to be a safe and promising technology for which reimbursement under strict conditions may be recommended.