Percutaneous Edwards SAPIEN(™) valve implantation for significant pulmonary regurgitation after previous surgical repair with a right ventricular outflow patch.

BACKGROUND

Current indications for percutaneous pulmonary valve implantation (PPVI) are limited to patients who had their outflow tracts repaired with the use of a "full" condui-homograft. Patients after a patch repair are believed to have an unfavorable anatomy for PPVI.

OBJECTIVES

To evaluate a novel use of Edwards SAPIEN(TM) valve for percutaneous treatment of moderate and severe pulmonary regurgitation after tetralogy of Fallot (TF) repair with a right ventricular outflow (RVOT) patch.

METHODS

PPVI was intended in 10 patients (age 21-39 years, 2 ♂) with regurgitant fraction of 30-59%, measured by cardiac magnetic resonance imaging (CMRI) 16-30 years after repair with a RVOT patch. Balloon test-inflations were used for definitive measurements and location of the landing site for the valve. All RVOTs were prestented.

RESULTS

Successful valve implantation was achieved in nine patients. In one patient a bare-metal stent used for prestenting embolized into pulmonary artery. A 26-mm valve was implanted in seven and a 23-mm in two patients. CMRI at 1-2 month follow-up (n = 8) demonstrated both, sustained relief of pulmonary incompetence (regurgitant fraction = 0-14%) and significant decrease of the right ventricular end-diastolic volume indexes (from 169.9 ± 43.8 to 140.0 ± 40.3 ml/m(2) , P < 0.001). At that follow-up no adverse event occurred. No stent fractures were observed.

CONCLUSIONS

We report the first case series of patients with significant PR after a RVOT patch repair, successfully treated with a percutaneous Edwards SAPIEN(TM) valve implantation. The procedure is technically feasible and may be offered to patients with the outflow tracts larger than those limited by the Melody(®) system available currently.