Surgically placed valve conduits in the pulmonic position often require multiple reoperations. Percutaneous replacement of the pulmonic valve is an attractive option to provide relief of patient symptoms， improve hemodynamic function， and avoid the mortality and morbidity of repeat open heart surgeries. We report on the initial results of an FDA approved feasibility study of a percutaneous placement of the Edwards Sapien™ Percutaneous Heart Valve (PHV) in the pulmonic position.

    Between April-December 2008， 11 patients (8 males/3 females) with a regurgitant and/or stenotic pulmonary valve conduit underwent transcatheter insertion of the 23 (10 patients) or 26 mm Edwards Sapien™ PHV into the pulmonic position using a 24-26 Fr percutaneous femoral venous sheath. Patient age ranged from 14-71 yrs. 8/11 patients had previously undergone placement of a stent in the pulmonic conduit to relieve significant conduit obstruction and therefore had severe pulmonic regurgitation (PR). At cath， the mean gradient across the stent pre-intervention was 37.5±7.6 mm Hg. 10/11 (91%) valves were successfully delivered using an antegrade percutaneous technique. One valve could not be properly seated， requiring surgical removal， and a 26 mm valve was implanted using the “perventricular” technique (both performed without bypass). There were no deaths or adverse events within 30 days. Gradient across the valve decreased to a mean of 16.4±7.6 mm Hg. All 11 patients demonstrated improved valve function (decrease in PR to mild or less) on immediate post-implantation angiography and intracardiac echocardiograhy. At 30-day follow-up， all patients reported improvement in symptoms. By transthoracic echocardiogram， the mean gradient across the valve was 22.6±11.6 mmHg. There was trivial or mild PR in 4 patients and the rest had no PR.

    Our initial experience using the Edwards Sapien™ PHV demonstrates the procedure to be safe and effective in subjects with regurgitant/stenotic pulmonary valve conduits. Further patient enrollment and clinical follow-up is ongoing to adequately assess functional improvement， freedom from adverse cardiac events， and longevity of the implanted valve.