OBJECTIVE: We designed this study to evaluate the early hemodynamic performance of the recently introduced Carpentier-Edwards PERIMOUNT Magna bioprosthesis (Edwards Lifesciences, Irvine, Calif) and compare it with those of the conventional Carpentier-Edwards PERIMOUNT stented bioprosthesis (Edwards Lifesciences) and Edwards Prima Plus porcine stentless bioprosthesis (Edwards Lifesciences). METHODS:Sixty-three patients (>70 years old) were enrolled in this prospective, randomized study. At operation, once the annulus had been measured, the best size suitable was assessed for each of the three valves before random assignment. Transthoracic echocardiography was performed before discharge to evaluate early postoperative hemodynamic performances of the different valves implanted. RESULTS: The best size suitable of Edwards Prima Plus (24.3 +/- 1.7 mm) was significantly superior to those of both the Carpentier-Edwards PERIMOUNT Magna (23.4 +/- 2.1 mm) and Carpentier-Edwards PERIMOUNT (22.4 +/- 1.8 mm). The best size suitable of the Carpentier-Edwards PERIMOUNT Magna, however, was significantly superior to that of the Carpentier-Edwards PERIMOUNT. Furthermore the best size suitable of the Carpentier-Edwards PERIMOUNT Magna was equal to the measured annulus in 55% of patients, as opposed to 25% for the Carpentier-Edwards PERIMOUNT (P < .001). Mean implanted labeled size of the Edwards Prima Plus was significantly higher than those of both the Carpentier-Edwards PERIMOUNT Magna and the Carpentier-Edwards PERIMOUNT (24.6 +/- 1.9 mm, 23.1 +/- 1.9 mm, and 22.5 +/- 1.8 mm, respectively). Early postoperative hemodynamic performance of the Carpentier-Edwards PERIMOUNT Magna, however, was superior to those of both the Edwards Prima Plus and the Carpentier-Edwards PERIMOUNT in both effective orifice area index (1.07 +/- 0.4 cm2/m2, 0.87 +/- 0.3 cm2/m2, and 0.80 +/- 0.2 cm2/m2, respectively) and mean peak gradient (20 +/- 6 mm Hg, 27 +/- 8 mm Hg, and 28 +/- 12 mm Hg, respectively). CONCLUSION: The improved design of the recently introduced third-generation stented bioprosthesis Carpentier-Edwards PERIMOUNT Magna allows implantation of a significantly bigger valve than with the old generation. Furthermore, the improved hemodynamic performance of the Carpentier-Edwards PERIMOUNT Magna compares favorably with both the Carpentier-Edwards PERIMOUNT and the Edwards Prima Plus.
RCT Entities:
OBJECTIVE: We designed this study to evaluate the early hemodynamic performance of the recently introduced Carpentier-Edwards PERIMOUNT Magna bioprosthesis (Edwards Lifesciences, Irvine, Calif) and compare it with those of the conventional Carpentier-Edwards PERIMOUNT stented bioprosthesis (Edwards Lifesciences) and Edwards Prima Plus porcine stentless bioprosthesis (Edwards Lifesciences). METHODS: Sixty-three patients (>70 years old) were enrolled in this prospective, randomized study. At operation, once the annulus had been measured, the best size suitable was assessed for each of the three valves before random assignment. Transthoracic echocardiography was performed before discharge to evaluate early postoperative hemodynamic performances of the different valves implanted. RESULTS: The best size suitable of Edwards Prima Plus (24.3 +/- 1.7 mm) was significantly superior to those of both the Carpentier-Edwards PERIMOUNT Magna (23.4 +/- 2.1 mm) and Carpentier-Edwards PERIMOUNT (22.4 +/- 1.8 mm). The best size suitable of the Carpentier-Edwards PERIMOUNT Magna, however, was significantly superior to that of the Carpentier-Edwards PERIMOUNT. Furthermore the best size suitable of the Carpentier-Edwards PERIMOUNT Magna was equal to the measured annulus in 55% of patients, as opposed to 25% for the Carpentier-Edwards PERIMOUNT (P < .001). Mean implanted labeled size of the Edwards Prima Plus was significantly higher than those of both the Carpentier-Edwards PERIMOUNT Magna and the Carpentier-Edwards PERIMOUNT (24.6 +/- 1.9 mm, 23.1 +/- 1.9 mm, and 22.5 +/- 1.8 mm, respectively). Early postoperative hemodynamic performance of the Carpentier-Edwards PERIMOUNT Magna, however, was superior to those of both the Edwards Prima Plus and the Carpentier-Edwards PERIMOUNT in both effective orifice area index (1.07 +/- 0.4 cm2/m2, 0.87 +/- 0.3 cm2/m2, and 0.80 +/- 0.2 cm2/m2, respectively) and mean peak gradient (20 +/- 6 mm Hg, 27 +/- 8 mm Hg, and 28 +/- 12 mm Hg, respectively). CONCLUSION: The improved design of the recently introduced third-generation stented bioprosthesis Carpentier-Edwards PERIMOUNT Magna allows implantation of a significantly bigger valve than with the old generation. Furthermore, the improved hemodynamic performance of the Carpentier-Edwards PERIMOUNT Magna compares favorably with both the Carpentier-Edwards PERIMOUNT and the Edwards Prima Plus.
Authors: Angelo M Dell'Aquila; Dominik Schlarb; Stefan R B Schneider; Jürgen R Sindermann; Andreas Hoffmeier; Gerrit Kaleschke; Sven Martens; Andreas Rukosujew Journal: Interact Cardiovasc Thorac Surg Date: 2012-11-15
Authors: Philipp Marx; Wojciech Kowalczyk; Aydin Demircioglu; Gary Neil Brault; Hermann Wendt; Sharaf-Eldin Shehada; Konstantinos Tsagakis; Mohamed El Gabry; Heinz Jakob; Daniel Wendt Journal: Biomed Res Int Date: 2018-01-10 Impact factor: 3.411