Early and mid-term haemodynamic performance and clinical outcomes of St. Jude Medical Trifecta™ valve.

BACKGROUND

New models of aortic bioprostheses have proven excellent early haemodynamic profile, but their mid and long-term performance warrants further systematic assessment. The aim of this study is to report clinical and haemodynamic performance of St. Jude Medical Trifecta bioprosthesis during 5 years of implantation.

METHODS

We performed a single centre, retrospective, observational and descriptive study including all 556 individuals who underwent aortic valve replacement (AVR) with the Trifecta bioprosthesis (between July of 2011 and June of 2016). Survival and re-intervention were censored in February 2017. Postoperative ambulatory echocardiographic data was available for 490 patients. A complete clinical follow-up was available in 463 individuals (mean follow-up time, 27±17 months).

RESULTS

In our sample the mean age was 73±9 years, 57.6% were male and median European System for Cardiac Operative Risk Evaluation (EuroSCORE) II was 2.9 (interquartile range, 1.6-5.8). There were 301 (54.1%) combined procedures, mostly coronary artery bypass grafting in 170 (30.6%). Overall 30-days mortality was 5.4% (n=30) and cumulative survival at 5-years was 72.3%. There were 23 (4.3%) permanent pacemaker implantations. During follow-up, 5 (0.9%) patients presented non-structural valve dysfunction (NSVD) and 4 (0.8%) underwent reoperation due to prosthesis endocarditis. At the first ambulatory evaluation transvalvular mean gradient and effective orifice area (EOA) were 10.9±4.1 mmHg and 2.0±0.5 cm, respectively. Severe patient-prosthesis mismatch (PPM) was observed in 5 (1.1%) individuals and moderate in 52 (11.3%).

CONCLUSIONS

In a "real-world" clinical setting, our findings support the good overall mid-term haemodynamic and safety profile of the Trifecta bioprosthesis.