Comprehensive hemodynamic performance and frequency of patient-prosthesis mismatch of the St. Jude Medical Trifecta bioprosthetic aortic valve.

BACKGROUND AND AIM OF THE STUDY

The study aim was to evaluate the performance of a new stented pericardial bioprosthesis, the Trifecta (St. Jude Medical, St. Paul, MN, USA), for aortic valve replacement (AVR) with respect to valvular hemodynamics and frequency of patient-prosthesis mismatch (PPM). PPM has been reported in a wide range of bioprosthetic valves following AVR, and has been associated with multiple adverse outcomes. It was hypothesized that the Trifecta aortic valve would have superior hemodynamics and an acceptable incidence of PPM following AVR.

METHODS

A prospective cohort study was performed between January 2010 and May 2012, following 75 patients (mean age 71.9 _ 11.1 years) who had undergone AVR with a Trifecta valve for aortic stenosis (88%) or regurgitation (12%) at the authors' institutions. Intraoperative three-dimensional and Doppler transesophageal echocardiography were used to evaluate hemodynamic variables before and after AVR, as well as pre-discharge.

RESULTS

Echocardiographic evaluation showed a preoperative average mean gradient (MG) of 40.6 ± 21.6 mmHg, an average peak gradient (PG) of 72.1 ± 19.4 mmHg, and an average effective orifice area index (EOAI) of 0.39 ± 0.20 cm2/m2. Postoperative mean pressure gradient measurements showed a postoperative average MG of 8.76 ± 3.75 mmHg (p < 0.001), an average PG of 19.4 ± 8.6 mmHg (p < 0.001), and EOAI of 1.09 ± 0.36 cm2/m2 (p < 0.001), which demonstrated a significantly improved hemodynamic performance across all valve sizes. Postoperative MG versus measured EOAI demonstrated a fairly linear relationship (R2 = 0.0703), rather than a rapid increase in MG with EOAI < 0.85 and < 0.65, as was seen with previous valve designs. Severe PPM (defined as EOAI ≤ 0.65 cm2/m2) was found in four patients (6%), while moderate PPM (EOAI > 0.65 and < 0.85 cm2/m2) was seen in 11 patients (16%).

CONCLUSION

The Trifecta pericardial valve demonstrated excellent hemodynamic performance at all valve sizes, and resulted in very low postoperative transvalvular pressure gradients and PPM, without the need for aortic root enlargement.