Totaro Pasquale, Degno Nello, Zaidi Afzal, Youhana Aprim, Argano Vincenzo
Cardiac Surgery Division, Regional Cardiac Centre, Morriston Hospital, Swansea, United Kingdom.
J Thorac Cardiovasc Surg. 2005 Dec;130(6):1668-74. doi: 10.1016/j.jtcvs.2005.07.011. Epub 2005 Oct 26.
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).
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.
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).
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.
我们开展本研究以评估近期推出的Carpentier-Edwards PERIMOUNT Magna生物瓣（爱德华生命科学公司，加利福尼亚州欧文市）的早期血流动力学性能，并将其与传统的Carpentier-Edwards PERIMOUNT带支架生物瓣（爱德华生命科学公司）和爱德华Prima Plus猪无支架生物瓣（爱德华生命科学公司）进行比较。
63例年龄大于70岁的患者纳入了这项前瞻性随机研究。手术时，一旦测量了瓣环，在随机分组前评估三种瓣膜各自最合适的尺寸。出院前进行经胸超声心动图检查，以评估植入的不同瓣膜的术后早期血流动力学性能。
爱德华Prima Plus最合适的尺寸（24.3±1.7 mm）显著大于Carpentier-Edwards PERIMOUNT Magna（23.4±2.1 mm）和Carpentier-Edwards PERIMOUNT（22.4±1.8 mm）。然而，Carpentier-Edwards PERIMOUNT Magna最合适的尺寸显著大于Carpentier-Edwards PERIMOUNT。此外，55%的患者中Carpentier-Edwards PERIMOUNT Magna最合适的尺寸与测量的瓣环相等，而Carpentier-Edwards PERIMOUNT为25%（P<0.001）。爱德华Prima Plus的平均植入标记尺寸显著高于Carpentier-Edwards PERIMOUNT Magna和Carpentier-Edwards PERIMOUNT（分别为24.6±1.9 mm、23.1±1.9 mm和22.5±1.8 mm）。然而，Carpentier-Edwards PERIMOUNT Magna术后早期的血流动力学性能在有效瓣口面积指数（分别为1.07±0.4 cm2/m2、0.87±0.3 cm2/m2和0.80±0.2 cm2/m2）和平均峰值梯度（分别为20±6 mmHg、27±8 mmHg和28±12 mmHg）方面均优于爱德华Prima Plus和Carpentier-Edwards PERIMOUNT。
近期推出的第三代带支架生物瓣Carpentier-Edwards PERIMOUNT Magna的改进设计使得能够植入比旧一代更大的瓣膜。此外，Carpentier-Edwards PERIMOUNT Magna改善的血流动力学性能与Carpentier-Edwards PERIMOUNT和爱德华Prima Plus相比具有优势。
