Trifecta St. Jude Medical (R) Aortic Valve In Pulmonary Position

Introduction: To evaluate an aortic pericardial valve for pulmonary valve (PV) regurgitation after repair of congenital heart defects.Methods: From July 2012 to June 2016 71 patients, mean age 24 +/- 13 years (four to years) underwent PV implantation of aortic pericardial valve, mean interval after previous repair = 21 +/- 10 years (two to 47 years). Previous surgery at mean age 3.2 +/- 7.2 years (one day to 49 years): tetralogy of Fallot repair in 83% (59/71), pulmonary valvotomy in 11% (8/71), relief of right ventricular outflow tract (RVOT) obstruction in 6% (4/71). Pre-operative echo-cardiography and MRI showed severe PV regurgitation in 97% (69/71), moderate in 3% (2/71) with associated RVOT obstruction. MRI and knowledge-based reconstruction 3D volumetry (KBR-3D-volumetry) showed mean PV regurgitation = 42 +/- 9% (20-58%), mean indexed RV end-diastolic volume = 169 +/- 33 (130-265) ml m(-2) BSA and mean ejection fraction (EF) = 46 +/- 8% (33-61%). Cardio-pulmonary exercise showed mean peak O-2/uptake = 24 +/- 8 ml kg(-1) min(-1) (14-45 ml kg(-1) min(-1)), predicted max O-2/uptake 66 +/- 17% (26-97%). Pre-operative NYHA class was I in 17% (12/71) patients, II in 70% (50/71) and III in 13% (9/71).Results: Mean cardio-pulmonary bypass duration was 95 +/- 30' (38-190'), mean aortic cross-clamp in 23% (16/71) 46 +/- 31' (8-95'), with 77% (55/71) implantations without aortic cross-clamp. Size of implanted PV: 21 mm in seven patients, 23 mm in 33, 25 mm in 23, and 27 mm in eight. The z-score of the implanted PV was -0.16 +/- 0.80 (-1.6 to 2.5), effective orifice area indexed (for BSA) of native PV was 1.5 +/- 0.2 (1.2 to -2.1) vs. implanted PV 1.2 +/- 0.3 (0.76 to 2.5) (p = ns). In 76% (54/71) patients surgical RV modelling was associated. Mean duration of mechanical ventilation was 6 +/- 5 h (0-26 h), mean ICU stay 21 +/- 11 h (12-64 h), mean hospital stay 6 +/- 3 days (three to 19 days). In mean follow-up = 25 +/- 14 months (six to 53 months) there were no early/late deaths, no need for cardiac intervention/re-operation, no valve-related complications, thrombosis or endocarditis. Last echocardiography showed absent PV regurgitation in 87.3% (62/71) patients, trivial/mild degree in 11.3% (8/71), moderate degree in 1.45% (1/71), mean max peak velocity through RVOT 1.6 +/- 0.4 (1.0-2.4) m s(-1). Mean indexed RV end-diastolic volume at MRI/KBR-3D-volumetry was 96 +/- 20 (63-151) ml m(-2) BSA, lower than pre-operatively (p < 0.001), and mean EF = 55 +/- 4% (49-61%), higher than pre-operatively (p < 0.05). Almost all patients (99% = 70/71) remain in NYHA class I, 1.45% = 1/71 in class II.Conclusion: (a) Aortic pericardial valve is implantable in PV position with an easy and reproducible surgical technique; (b) valve size adequate for patient BSA can be implanted with simultaneous RV remodelling; (c) medium-term outcomes are good with maintained PV function, RV dimensions significantly reduced and EF significantly improved; (d) adequate valve size will allow later percutaneous valve-in-valve implantation.