Results Reported for Implantation of Edwards Sapien Valve

February 1, 2010—Robert H. Boone, MD, et al published data for seven patients treated with the Edwards Sapien transcatheter heart valve (THV, Edwards Lifesciences Corporation, Irvine, CA) in Catheterization and Cardiovascular Interventions (2010;75:286–294).

According to the investigators, conduits placed in the right ventricular outflow tract (RVOT) have limited longevity, which often require increasingly complex reoperations; however, transcatheter pulmonary valve implantation improves conduit hemodynamics through a minimally invasive approach.

In the study, patients ranged in age from 16 to 52 years, one was a woman, and all had New York Heart Association class II to III symptoms. Patients had pulmonary homografts that had been placed 2 to 25 years earlier during a Ross procedure (n = 4), repaired double- outlet right ventricle with situs inversus (n = 1), or Rastelli repair for dextro-transposition of the great arteries, pulmonary atresia, and ventricular septal defect (n = 2). Patients had severe pulmonary stenosis and/or moderate to severe pulmonary regurgitation.

The investigators reported that all patients had successful percutaneous implantation of the 23-mm Edwards Sapien THV under general anesthesia. Fluoroscopy times ranged from 16 to 49 minutes, and procedure times ranged from 110 to 237 minutes. The RV:systemic pressure ratio decreased from 78% ± 18% to 39% ± 8%. The RVOT gradient improved from 60.7 ± 24.3 mm Hg 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 to 36 mm Hg, and there was no evidence of late stent fracture or structural valve failure.

The investigators concluded that the Edwards Sapien THV can be used successfully to treat patients with right ventricle-to-pulmonary artery homograft failure, and it 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, the investigators advised.