Performance of the SJM Trifecta Bioprosthetic Aortic Valve



In July 2014 Daniel M. Bethencourt, MD along with 5 other providers published a paper in the Journal of Heart Valve Disease called “Comprehensive Hemodynamic Performance and Frequency of Patient-Prosthesis Mismatch of the St. Jude Medical Bioprosthetic Aortic Valve” 

TrifectaEach year, aortic valve replacement (AVR) is performed in almost 50,000 patients in the United States (1). Prosthesis-patient mismatch (PPM) occurs when the effective orifice area (EOA) of a normally functioning aortic prosthesis is too small in relation to the patient’s cardiac output requirements, resulting in high transvalvular pressure gradients. Moderate and severe PPM – defined as an indexed EOA (EOAI) ≤0.85 cm2
/m2 – appears to be variably present following AVR, with reported incidence rates ranging from 30.7% to 53.7% (2-7). PPM presents the left ventricle with a higher resistance to overcome, and can be demonstrated by high transvalvular pressure gradients on echocardiography. This increased afterload seems to underlie the reason behind a slower regression of left ventricular mass and an adverse overall prognosis in patients with PPM (8-10).  Over the past half-century, the manufacture of artificial heart valves has undergone tremendous changes, with more than 80 models having been introduced since 1950. In 2011, a new-generation pericardial tissue valve, the Trifecta™ (St. Jude Medical, St. Paul, MN, USA), was introduced and approved by the FDA for the use in AVR (11). The Trifecta valve is a three-leaflet stented pericardial valve designed for supra-annular placement in the aortic position. The stent, excluding the true supra-annular sewing cuff, is covered with porcine pericardial tissue and the valve leaflets are manufactured using bovine pericardial tissue, which is wrapped around the intrinsically distensible titanium stent, rather than mounted inside. Overall, the design is aimed at maximizing valve hemodynamics while minimizing leaflet stresses (12). Previous studies with the Trifecta valve have suggested that hemodynamic performance, EOAs and mean transvalvular pressure gradients may be improved, especially in patients requiring small bioprosthetic valve sizes (13). Thus, it was hypothesized that the short-term hemodynamic performance of the Trifecta stented pericardial tissue bioprosthesis for AVR would have superior hemodynamics and an acceptable incidence of PPM.

Read the full publication here