Early hemodynamics results of aortic valve replacement with the new St Jude Trifecta bioprosthesis

Abstract

Aortic stenosis is the most frequent acquired heart valve lesion in the Western countries. The aim of this prospective study was to evaluate the early clinical results and hemodynamic performance of the new St Jude Medical Trifecta stented bioprosthesis. One hundred consecutive patients were prospectively included in this study from April 2011 to December 2012. They underwent aortic valve replacement (AVR) with the St Jude Bioprosthesis Trifecta in our institution. The Trifecta valve is a tri-leaflet stented pericardial valve designed for supra-annular placement in the aortic position. A single cardiac surgeon operated on all the patients. Echocardiograms were performed pre-operatively and post-operatively, between 7 and 10 days to assess the hemodynamic performance of the prosthesis. The effective orifice area (EOA) of the aortic valve was calculated by the continuity equation and the mean transvalvular gradient at rest was derived from the simplified Bernoulli equation accounting for the flow velocity across the left ventricular outflow tract. A follow-up was performed at one year (100% complete). An informed consent form was signed by the patients before the intervention to allow data processing. Mean age at implantationwas 75.2 ± 7.5 ans (from 34.2 to 83.6 ans, median 71.7 ans). The sex ratio was 1.32 (Table 1). Fifty-five (55%) patients were octogenarians. The main AVR indication was aortic stenosis (n = 79). Preoperative New York Heart Association (NYHA) functional class was: I for 2 patients, II for 61 pts, III for 34 pts, and IV for 3 patients (Table 1). The preoperative cardiac rhythm was sinus for 94 patients, atrial fibrillation for 5 patients and one patient had a pacemaker. This study included 1 redo procedure. Ten patients (10%) had a poor left ventricular ejection fraction (LVEF b 35%). All prostheses were implanted in supra annular position using a continuous suture of polypropylene 2/0. The operation was elective in 98 patients and urgent in 2 patients. Forty one patients underwent a concomitant procedure, including 36 coronary artery bypass grafting (CABG) with an average of 1.16 grafts performed and the left internal thoracic artery was used for all patients. The prosthesis diameters were mainly 21 and 23 mm (Fig. 1). Operation times were for isolated AVR: 31 ± 20.2 mn for aortic cross-clamp and 45.5 ± 20.7 mn for cardiopulmonary bypass (Table 2). A de novo atrioventricular (AV) block occurred in 8 patients with only one pacemaker implantation. Acute atrial fibrillation was the most frequent post-operative complication (42%). Operativemortality (b30 days after the surgery ormore if the patient was not discharged) was 2%. One patient died after a redo procedure due to endocarditis and one because of respiratory failure. Therewere no valve related post-operative complications. Baseline mean pre-operative and post-operative LVEF were 60 ± 15% and 58± 18% respectively (ns). Themean transvalvular gradient improves significantly from 52.8 ± 15.4 mmHg pre-operatively to 10.4 ± 3.5 mmHg postoperatively (p= 0.001) (Table 3). The mean gradient was low for all bioprosthesis sizes (Fig. 2). The indexed effective orifice area (EOA) was for all diameters greater than 0.65 cm/m (Fig. 3). Only 3 trivial paravalvular leaks were observed. A trans-thoracic echocardiography was performed for fifty patients between 4 and 6 months and showed that mean gradients were stable (10.2 ± 2.5 mmHg). At one year, one non valve related death occurred. During this short follow-up, therewere novalve related complications.Ninetyninepercentof thepatientswere in NYHA class I (70%) or class II (29%). In Western countries, AVR has increased because of the increasing rate of octogenarians operated on. During this period the bioprosthesis has become the prosthesis most commonly used with almost 70% of the implantation rate compared to mechanical prostheses. This evolution could be explained by the aging population and the good bioprostheses durability [1,2]. Hemodynamic performance and long term durability are both crucial to get an ideal bioprosthesis. The Carpentier Edwards valve is the oldest bioprosthesis, implanted since 1969, and remains the “gold standard bioprosthesis” because of the extended durability studied in literature for more than 20 years [1–3]. Freedom from structural deterioration at 18 years for the porcine Carpentier–Edwards valve was 86.4% ± 1.2% and respectively 98.2% ± 0.6% for patients aged between 61 et 70 years and 90.5% ± 1.8% for patients older than