Transcatheter pulmonary valve implantation using the Edwards SAPIEN transcatheter heart valve

Conduits placed in the right ventricular outflow tract (RVOT) have limited longevity which often requires increasingly complex reoperations. Transcatheter pulmonary valve implantation improves conduit hemodynamics through a minimally invasive approach. We present data for 7 patients treated with the Edwards SAPIEN transcatheter heart valve (THV).

Patients' ranged in age from 16 to 52 years, one was female, and all had NYHA class II-III symptoms. Patients had pulmonary homografts that had been placed 2-25 years earlier during the Ross procedure (n = 4), repaired double outlet right ventricle with situs inversus (n = 1), or Rastelli repair for D-TGA, pulmonary atresia, and ventricular septal defect (n = 2). Patients had either severe pulmonary stenosis and/or moderate to severe pulmonary regurgitation.

All patients had successful percutaneous implantation of the 23 mm SAPIEN THV under general anesthesia. Fluoroscopy times ranged from 16 to 49 mins and procedure times ranged from 110 to 237 mins. The RV:systemic pressure ratio decreased from 78 +/- 18 to 39 +/- 8%, the RVOT gradient improved from 60.7 +/- 24.3 to 14.9 +/- 6.9 mm Hg, no patients had pulmonary insufficiency, and all patients had symptom improvement. At a maximum follow-up of 3.5 years (median 22.5 months), Doppler peak gradients ranged from 7-36 mm Hg, and there is no evidence of late stent fracture or structural valve failure.

The SAPIEN THV can be used successfully in the treatment of patients with right ventricle to pulmonary artery homograft failure. The valve is durable to at least 3.5 years without stent fracture or regurgitation. Clinical trials are underway to assess the long-term safety and efficacy of this valve.