Aortic valve replacement with the Sorin Pericarbon Freedom stentless valve: five-year follow up

Brian Nyawo, Richard Graham, Steve Hunter
Journal of Heart Valve Disease 2007, 16 (1): 42-8

BACKGROUND AND AIM OF THE STUDY: Presumed benefits from stentless bioprostheses include larger orifice areas with lower transvalvular gradients, and improved hemodynamic flow characteristics and annular mechanics. Herein are reported the results of a large series of the Sorin Pericarbon Freedom stentless valve implanted in the aortic position.

METHODS: Between July 1998 and June 2003, a total of 102 consecutive patients (58 males, 44 females; mean age 71.7+/-7.8 years; range: 28-87 years) requiring aortic valve replacement (AVR), including those undergoing concomitant procedures of coronary artery bypass, mitral valve repair and mini-maze, was recruited. The predominant lesion was aortic stenosis (n = 92; 90.2%); aortic regurgitation (AR) occurred in five patients (4.9%) (including three with endocarditis), and mixed aortic valve disease in five (4.9%). Six patients (5.9%) had undergone previous cardiac surgery. The median preoperative NYHA class was III. Thirsty-six patients (35.3%) underwent AVR alone. The mean valve size was 25 mm (range: 21-29 mm). Sixty-three patients (61.8%) had concomitant coronary artery disease that required a mean of 2.4+/-1.1 bypass grafts; three patients (3.0%) had combined AVR and mitral valve repair. The study end points observed were mortality, valve failure due to degeneration or endocarditis, reoperation, thromboembolism, transvalvular gradients and left ventricular (LV) mass regression.

RESULTS: The median follow up for all patients was 31 months (range: 12 months to 5 years). The mean total cross-clamp time was 71.7+/-17.6 min without associated procedures, and 93.9+/-19.7 min with concomitant procedures. Early mortality was 4/102 (3.8%); actuarial survival over five years was 89.2%. Freedom from thromboembolism over five years was 95.9%, from reoperation 100%, and from endocarditis 99.98%. Fifty-seven patients (56.4%) had no AR detected postoperatively, and 34 (33.3%) had trivial or mild AR. A significant decline was observed in indexed LV mass regression within six months of surgery, from 190+/-72 g/m(2) at baseline to 152+/-47 g/m(2) (p = 0.01).

CONCLUSION: In an elderly population with a high incidence of coronary artery disease, the Sorin Pericarbon Freedom stentless valve offers excellent hemodynamics, resulting in significant regression of left ventricular hypertrophy, together with acceptable operation times, morbidity and mortality in the medium term.

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