The Carpentier-Edwards Perimount Magna aortic xenograft: a new design with an improved hemodynamic performance

Abstract

This study compares the implantation characteristics and the hemodynamic performance of the new Carpentier-Edwards Perimount Magna (CEPM) xenograft with those of the standard Perimount (CEPS) valve in the aortic position. Eighty consecutive patients surviving an aortic valve replacement with either the CEPS valve (n=40) or the CEPM prosthesis (n=40) in the supra-annular position were retrospectively reviewed. One year follow-up was complete and hemodynamic performance assessed by Doppler echocardiography. The mean valve size implanted was 21.3+/-1.7 mm (CEPS) vs. 22.2+/-1.8 mm (CEPM). The average mean pressure gradient was 13.6+/-5.1 mmHg in the CEPS group and 9.6+/-3.3 mmHg in the CEPM group (P<0.0001). Mean and peak gradients were slightly lower and the effective orifice areas (EOA) were larger for the Magna prosthesis than for the comparable standard valves: 19 mm (1.58+/-0.2 vs. 1.28+/-0.1 cm(2)), 21 mm (1.90+/-0.4 vs. 1.69+/-0.4 cm(2)), 23 mm (2.07+/-0.3 vs. 1.86+/-0.3 cm(2)), 25 mm (2.30+/-0.1 vs. 1.89+/-0.5 cm(2)). The average indexed EOA was statistically different between groups (CEPS 0.98+/-0.21 cm(2)/m(2) vs. CEPM 1.20+/-0.25 cm(2)/m(2)). Patient-prosthesis mismatch (indexed EOA<or=0.85 cm(2)/m(2)) was present in 40.7% (CEPS) vs. 16.6% (CEPM) of the patients with valve sizes <or=21 mm. Our study demonstrates that the Magna prosthesis significantly reduces the incidence of patient-prosthesis mismatch when compared to the standard Perimount valve in the aortic position.

Clinical Outcomes and Hemodynamics of the 19-mm Perimount Magna Bioprosthesis in an Aortic Position - Comparison With the 19-mm Medtronic Mosaic Ultra Valve -

“…Dalmau et al reported superior hemodynamic performance and a lower incidence of PPM with the CEP Magna than with the CEP valve. 9 EOAs were reported at 1.58±0.29 cm 2 (5 patients) for the 19-mm Magna prosthesis and 1.28±0.13 cm 2 (9 patients) for the standard 19-mm CEP prosthesis. 8 Botzenhardt et al reported superior hemodynamics with the 19-mm Magna bioprosthesis, with a mean LVAo-PG of 11.9 mmHg and EOA of 1.65 cm 2 (4 patients).…”

“…The reported EOA of 1.58 cm 2 , however, derived from a study of only 5 patients given a 19-mm Magna valve. 9 Some authors reported clinical and hemodynamic results after AVR with a 19-mm Carpentier Edwards Perimount prosthesis, which was the predecessor of the CEM valve. Sakamoto et al found significant improvements in pressure gradient and LVMI as well as an 18% prevalence of PPM after AVR with the 19-mm pericardial bioprosthesis.…”

The Complete Supraannular Concept

“…Pressure gradients of the Magna, the Mosaic, and the Soprano are in accord with findings of other groups. 1,[3][4][5][6]8,13,14,20,22,[25][26][27][28][29][30][31] There are preliminary in vivo hemodynamic data available regarding the Mosaic Ultra 10 and only 1 in vivo evaluation of the Epic, which was published previously by our group. 4 The in vitro data concerning hemodynamic gradients of the Epic and the Ultra correspond well with our results.…”

“…1,3,6,8,[25][26][27] The annulus diameter is used in 5 of the 7 in vivo studies as a comparing parameter (online supplemental Table 4). The hemodynamic gradients are low for all annulus sizes; the lowest gradients were described by Botzenhardt in patients with an annulus diameter of 22 to 23 mm (7.3 mm Hg) 27 and the highest in patients with an annulus diameter of 18 to 22 mm (13.2 mm Hg).…”

Comparison of the Clinical Outcomes and Hemodynamic Performance between the 19-Mm Mosaic and 19-Mm TrifectaTM Bioprosthesis

“…There was no significant difference in LVMI regression in Group M (30.2 g/m 2 ± 21.1 g/m 2 ) and Group T (33.0 g/m 2 ± 23.7 g/m 2 ) in the mid-term period and (p=0.77; Figure 3). Dalmau et al [8] compared outcomes after the implantation of Mosaic ® and Magna bioprostheses in a randomized study of 86 patients; the Magna bioprosthesis group had a lower mean LVAo-PG (17.1 mmHg vs. 10.2 mmHg) and larger AVA (1.69 cm 2 vs. 1.99 cm 2 ) after 1 year than the Mosaic ® bioprosthesis group; however, no significant difference in LVMI regression was observed. They concluded that small variations in prosthetic hemodynamics may not be important for LVMI regression.…”