Why the study?
Does the Carpentier-Edwards Perimount Magna bioprosthesis improve early clinical and hemodynamic performance in patients undergoing aortic valve replacement?
Does the Carpentier-Edwards Perimount Magna bioprosthesis improve early clinical and hemodynamic performance in patients undergoing aortic valve replacement?
The Carpentier-Edwards Perimount Magna bioprosthesis demonstrates satisfactory early hemodynamic performance and clinical outcomes in patients undergoing aortic valve replacement.
May support early AVR use; leaves open randomized confirmation of durability and comparisons.
Objective: The Carpentier-Edwards Perimount Magna is a new stented pericardial bioprosthesis designed to supraannular implantation in order to increase the effective orifice area and allows for valve upsizing. The aim of this study was to evaluate the early clinical and hemodynamic performance of this new valve substitute. Methods: Between March 2003 and December 2004, 80 consecutive patients (40 with aortic stenosis, 15 with aortic incompetence and 25 with combined disease) underwent AVR with the CE Perimount Magna bioprosthesis. Forty-two underwent isolated AVR and 38 had concomitant procedures (26 CABG, 9 ascending aorta repair and 3 tricuspid valve repair). Mean age at implant was 74±4 years. Clinical and echocardiographic assessment (peak and mean pressure gradients, effective orifice areas and indexed EOA) were performed at a mean of 9 months postoperatively. Results: Thirty-day mortality was 5%, none valve-related. During follow-up there were two non cardiac deaths and one reoperation for prosthetic valve endocarditis. Echocardiographic data at rest are shown in the table. Patient-prosthesis mismacht (IEAO ≤ 0.85cm 2 /m 2 ) was present in 12% of the patients with valve sizes ≤21mm. Echocardiographic results: Size PPG (mm Hg) MPG (mm Hg) EOA (cm2) IEOA (cm2/m2) 19 (n=14) 26.3±9.7 17.8±9.4 1.51±0.30 1.00±0.22 21 (n=28) 19.0±5.8 10.2±3.4 1.86±0.47 1.11±0.30 23 (n=25) 18.9±6.6 10.1±3.7 2.02±0.36 1.18±0.24 25 (n=11) 15.2±4.8 7.8±2.8 2.29±0.44 1.29±0.31 Conclusions: The CE Perimount Magna bioprosthesis is easy to implant. Its design allows taking maximal advantage of the aortic orifice. Clinical and hemodynamic performance is highly satisfactory at the short-term, supporting continued clinical use of this bioprosthesis.
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Dalmau et al. (2006) studied this question.
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