Implantation of a catheter-based self-expanding pulmonary valve in congenital heart surgery: results of a pilot study.

Objective: Dilatation of RV outflow after surgical patch repair represents a problem for seating a percutaneous valve. We present the data of a new catheter-based, self-expanding tissue valve with a diameter up to 31 mm.

Methods: 7 Patients (median 9 years, range 2 to 24 years) with severe PR due to RV outflow tract dilatation after patch repair or percutaneous procedures were treated with a catheter-based, self-expanding porcine pulmonary valve (Biointegral®). Valve diameter ranged between 15 and 29 mm. Maximum follow-up was 40 months. Patients were postoperatively assessed on day 1 and 6 months after the procedure, including physical examination, 12 lead electrocardiography and cross-sectional echocardiography with color Doppler.

Results: Valve implantation was successful in all patients. Implantation was performed using three different routes: RVOT after partial sternotomy, pulmonary artery after mini-thoracotomy, or via the RV apex. Median follow-up was 25 months (5-40) identifying no significant morbidity and no death. Echocardiography revealed competent valves, no paravalvular leaks, no valve migration and no significant gradient in the RVOT.

Conclusions: The new, self-expanding, catheter-based pulmonary valve is easy to implant via an antegrade (RVOT, RV) or retrograde approach (PA) even in dilated RV outflow tracts. The procedure can be done without CPB under echocardiographic guidance.