Clinical impact of a new bioprosthetic aortic valve: the St. Jude Medical Trifecta™.

Background: The St. Jude Medical (SJM) Trifecta™ aortic valve was designed to face common issues such as high transvalvular pressure gradients and low effective orifice areas (EOAs), which lead to prosthesis-patient mismatch after implanting small valve sizes. To reduce the obstruction of the left ventricular outflow tract, the Trifecta™ was designed as a stented valve for supraannular placement. The aim of this study was to evaluate the early hemodynamic performance of this new valve.

Methods: Between September 2010 and February 2013, 380 patients underwent an aortic valve replacement (AVR) using the SJM Trifecta™. Patients were subsequently followed up for two years and data records were analyzed retrospectively. Mean patient age was 73 years (range 33-93 years), 58% were male. The average mean preoperative pressure gradient was 45mmHg, with an EOA of 0,73cm2. The majority of patients (62%) were in NYHA class III. Indication for AVR was valve stenosis or insufficiency in 95%, presence of endocarditis caused the AVR in 5%.

Results: The 30-day-mortality was 4% (n=16; mean log EuroSCORE 20.9%), including two intraoperative non-valve-related cardiac deaths (0.52%) and one valve-related death due to lethal aortotomy bleedings (0.26%). 25 patients died during the follow-up period, 9 of them in a valve-related manner. At discharge, no valve thromboses or prosthesis failures could be identified. The average EOA and mean pressure gradient at discharge was 1.36cm2 and 11mmHg for 19mm valves and 2.1cm2 and 7mmHg for 25mm valves.

Conclusions: The new SJM Trifecta™ demonstrates excellent early hemodynamics over all valve sizes. In particular, large EOAs and low gradients in small valves attest a satisfying outcome after implantation. Further data is needed to investigate the stableness of these results over long-term follow up.