Hemodynamic stability during 17 years of the Carpentier-Edwards aortic pericardial bioprosthesis
Hemodynamic stability during 17 years of the Carpentier-Edwards aortic pericardial bioprosthesis
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DOI：
10.1016/s0003-4975(02)03445-8
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发表时间：
2002-05-01
影响因子：
4.6
通讯作者：
Frater, RM
中科院分区：
文献类型：
--
作者：
Banbury, MK;Cosgrove, DM;Frater, RM
背景市售Carpentier-Edwards带支架牛心包主动脉瓣生物瓣膜（Perimount RSR）的血流动力学性能的长期稳定性未知。为了预测这种生物瓣膜的命运，我们在上市前批准队列中使用超声心动图研究检查了其长达17年的血流动力学性能。在上市前批准队列的4家机构的267例患者中，85例在17年的年度随访检查期间共接受了168项超声心动图研究。在核心超声心动图设施中对这些进行了审查和量化。纵向数据分析用于解释重复的、删失的数据。平均跨瓣压差与假体尺寸呈负相关（p = 0.01），在前10年随访期间可能（p = 0.06）略有增加，然后稳定。瓣膜尺寸越大，有效瓣口面积越大（17 = 0.01），在前10年内有所下降，然后再次开始增加。射血分数下降最小（p = 0.2）。与相当稳定的血流动力学相反，主动脉瓣返流从无稳步增加到1到2+（p = 0.005），但很少（17年时< 10%）进展到3+或4+。预计Carpentier-Edwards主动脉心包生物瓣膜具有可接受的长期跨瓣压差和有效瓣口尺寸，在植入后17年内变化很小。轻度主动脉瓣返流将逐渐发展。这种预期的血流动力学弹性支持Perimount Carpentier-Edwards牛心包支架型生物瓣膜的持续临床使用。
Background. Long-term stability of the hemodynamic performance of commercially available Carpentier-Edwards stented bovine pericardial aortic bioprostheses (Perimount RSR) is unknown. To anticipate the fate of this bioprosthesis, we examined its hemodynamic performance up to 17 years using echocardiographic studies in a Premarket Approval cohort.Methods. Of 267 patients at four institutions in the Premarket Approval cohort, 85 had a total of 168 echocardiographic studies during a 17-year period of yearly follow-up examinations. These were reviewed and quantified in a core echocardiographic facility. Longitudinal data analysis was used to account for repeated, censored data.Results. Mean transvalvular gradient was inversely related to prosthesis size (p = 0.01), and possibly (p = 0.06) increased somewhat during the first 10 years of follow-up, then stabilized. Effective orifice area was larger in larger valve sizes (17 = 0.01), declined somewhat during the first 10 years, and then began to increase again. Ejection fraction declined minimally (p = 0.2). In contrast to the rather stable hemodynamics, aortic regurgitation steadily increased from none to 1 to 2+ (p = 0.005), but rarely (< 10% at 17 years) progressed to 3+ or 4+.Conclusions. The Carpentier-Edwards aortic pericardial bioprosthesis can be anticipated to have an acceptable long-term transvalvular gradient and effective orifice size that will change trivially up to 17 years after implantation. Mild aortic regurgitation will develop progressively. This anticipated hemodynamic resilience supports continued clinical use of the Perimount Carpentier-Edwards bovine pericardial stented bioprosthesis.