Early haemodynamic performance of a latest generation supra-annular aortic bioprosthesis: experience from a large single-centre series.

OBJECTIVES: The St Jude Medical (SJM) Trifecta bioprosthesis is a recently introduced stented trileaflet pericardial valve designed for supra-annular replacement of the aortic valve (AVR). We sought to evaluate the short-term clinical outcome and haemodynamic performance of the Trifecta valve after AVR. METHODS: A total of 837 patients with severe symptomatic aortic valve stenosis or regurgitation underwent AVR with the SJM Trifecta aortic valve prosthesis between January 2009 and March 2013. All intra- and postoperative data were collected prospectively. At discharge, transthoracic echocardiography was performed. A complete set of echocardiographic data was available in 723 patients. RESULTS: Adjusted mean systolic pressure gradients (MPGs) for valve sizes 19 (n = 37/4.4%), 21 (n = 192/22.9%), 23 (n = 263/31.4%), 25 (n = 202/24.1%), 27 (n = 100/11.9%) and 29 mm (n = 42/5.0%) were 8.6 ± 1.1, 8.7 ± 0.4, 7.2 ± 0.3, 6.2 ± 0.3, 5.6 ± 0.3 and 3.9 ± 0.4 mmHg, respectively. Mean effective orifice area (EOA) for valve sizes 19, 21, 23, 25, 27 and 29 mm were 1.5 ± 0.09, 1.6 ± 0.04, 1.9 ± 0.03, 2.0 ± 0.03, 2.2 ± 0.05 and 2.7 ± 0.01 cm(2), respectively. No patient-prosthesis mismatch (PPM) was seen in 71.3% of patients (EOAI >0.85 cm(2)/m(2)). Moderate mismatch (EOAI 0.65-0.85 cm(2)/m(2)) was observed in 23.9% of patients, whereas severe PPM (EOAI <0.65 cm(2)/m(2)) occurred in 4.4% of patients. No malfunction of the prosthesis, endocarditis, valve thrombosis or relevant aortic regurgitation necessitating surgical revision was observed until discharge. CONCLUSIONS: The SJM Trifecta valve reveals an excellent early haemodynamic performance with low residual MPGs and a low incidence of PPM. Studies with longitudinal clinical and echocardiographic assessments with longer term follow-up evaluation including a comparison with other contemporary bioprostheses are needed.

Twenty-Seven-Year Experience With the St. Jude Medical Biocor Bioprosthesis in the Aortic Position.

BACKGROUND: The aim of this study was to evaluate the long-term performance of the St. Jude Medical Biocor porcine stented bioprosthesis in the aortic position. METHODS: From January 1985 to December 1996, 455 patients underwent aortic valve replacement with the St. Jude Medical Biocor prosthesis at the German Heart Center Munich. Mean age at time of operation was 72.5 ± 9 years. In all, 172 patients (37.8%) underwent concomitant coronary artery bypass grafting and 20 patients (4.4%) had had previous cardiac surgery. Event-free rates are given as mean ± SD. Adverse events were recorded according to the guidelines for reporting morbidity and mortality after cardiac valvular operations. RESULTS: Follow-up was complete in 93.4%. Mean follow-up time was 8.4 ± 5.6 years, with a total of 3,834 patient-years and a maximum of 27.4 years. Thirty patients were lost to follow-up after a mean of 9.2 ± 4.1 years. Overall survival rate at 10 and 15 years was 43.3% ± 2.4% and 19.2% ± 2.0%, respectively. Freedom from structural valve deterioration at 10 and 15 years was 92.1% ± 1.7% and 84.8% ± 3.0%, respectively. Freedom from valve-related reoperation at 10 and 15 years was 90.6 ± 1.7% and 86.3 ± 2.5%, respectively. Twenty-four patients needed reoperation for structural valve deterioration, 9 patients for endocarditis, 3 patients for paravalvular leakage, and 2 patients for aortic root aneurysm. At 15 years, freedom from major bleeding was 91.0% ± 2.0% and freedom from thromboembolism was 72.2% ± 2.8%. CONCLUSIONS: This study represents the longest follow-up for the St. Jude Medical Biocor prosthesis and shows an excellent durability with a low incidence of valve-related complications.

Matched Comparison of Two Different Biological Prostheses for Complete Supra-annular Aortic Valve Replacement.

Objective The aim of this retrospective study was to evaluate the hemodynamic performance of the St. Jude Medical Trifecta (SJM Trifecta; St. Jude Medical, St Paul, Minnesota, United States) and the Carpentier-Edwards Perimount Magna Ease (CEPM Ease; Edwards Lifesciences, Irvine, California, United States) bioprostheses early postoperative and at 1 year. Methods From October 2007 to October 2008, a total of 61 consecutive patients underwent aortic valve replacement (AVR) with the CEPM Ease prosthesis. From a prospective cohort of 201 patients (March 2011 to January 2012) who received AVR with the SJM Trifecta valve, a matched group of 51 patients was selected. Matching was conducted 1:1 by ejection fraction, gender, age, and body surface area. A Hegar dilator was used to define the aortic tissue annulus diameter. Data were grouped on the basis of the patient's tissue annulus diameter (≤22 mm; 23-24 mm; ≥25 mm). Results Early postoperative and at 1 year mean pressure gradients (MPGs) in the various groups ranged from 7.2 ± 4.6 to 7.1 ± 2.4 mm Hg and from 10.0 ± 4.3 to 8.0 ± 2.8 mm Hg in the SJM Trifecta group and from 18.0 ± 5.0 to 12.1 ± 3.6 mm Hg and from 17.7 ± 4.5 to 11.8 ± 3.2 mm Hg in the CEPM Ease group, respectively. Likewise, effective orifice areas (EOAs) ranged from 1.7 ± 0.5 to 2.0 ± 0.5 cm(2) and from 1.5 ± 0.3 to 1.7 ± 0.4 cm(2) in the SJM Trifecta group and from 1.3 ± 0.5 to 1.9 ± 0.5 cm(2) and from 1.2 ± 0.3 to 1.8 ± 0.3 cm(2) in the CEPM Ease group, respectively. A marked left ventricular mass (LVM) regression across all annulus sizes was noted in both groups. Severe patient-prosthesis mismatch (PPM) was infrequent overall. Conclusion The SJM Trifecta valve showed lower MPGs early postoperative and at 1 year as well as higher EOA and effective orifice area index early postoperative. No significant differences were detected with regard to LVM regression and PPM.