Edwards SAPIEN transcatheter pulmonary valve implantation: Mid-term results from a French registry

Abstract

The Edwards SAPIEN XT and SAPIEN 3 valve have been reported for percutaneous pulmonary valve implantation (PPVI), but long-term data are not available. The aim of the study was to describe and analyze data from patients treated in France with the Edwards SAPIEN™ transcatheter heart valve (Edwards Lifesciences LLC, Irvine, CA, USA) in pulmonary position. From April 2011 to May 2017, 71 patients undergoing PPVI were consecutively included. Median age at PPVI was 26.8 years (range: 12.8–70.1). PPVI indication was pure stenosis in 33.8% of patients, pure regurgitation in 28.1% and mixed lesions in 38.1%. PPVI were successfully implemented in 68 patients (95.8%). No significant regurgitation was recorded after the procedure. Transpulmonary gradient was significantly reduced from 34.5 mmHg to 10.5 mmHg ( P < 0.0001). At one-year follow-up, death rate was 2.9% and 3 patient had a surgical reintervention (4.4%). The indication for reintervention were: one subacute endocarditis, one bioprosthesis dysfunction and one heart transplantation. For others patients, they did not show any significant valve's dysfunction. We highlighted the persistence of low gradient and absence of significant pulmonary regurgitation in long-term follow-up. Mid-term results with the Edwards SAPIEN valve in pulmonary position demonstrate a persistence of good hemodynamic results.