St. Paul's Hospital & Royal Columbian Hospital, University of British Columbia, 486 Burrard Building, 1081 Burrard Street, Vancouver, BC, Vancouver, BC, Canada V6Z 1Y6.
Eur J Cardiothorac Surg. 2009 Nov;36(5):818-24. doi: 10.1016/j.ejcts.2009.05.020. Epub 2009 Aug 22.
Advancing life expectancy with the increased prevalence of aortic valve degenerative disease brings the need for an aortic bioprosthesis with excellent haemodynamic performance and comparable durability. The Mitroflow bioprosthesis has been on the worldwide market, except in the United States, since 1982, while the current model (1991) has only recently gained regulatory approval in the latter country. This study was primarily performed to determine the durability of the current Mitroflow bioprosthesis.
The contemporary Mitroflow bioprosthesis was implanted in 381 patients in three centres. The mean age was 76.4 years (range 53-91 years) and the mean follow-up period was 5.4+/-3.4 years, a total of 2048.7 years of evaluation. Prosthesis-patient mismatch (PPM) was classified by reference effective orifice area index categories: normal > or = 0.85 cm(2) m(-2) (53.9%), mild 0.84-0.76 cm(2) m(-2) (33.9%), moderate < or = 0.75-0.66 cm(2) m(-2) (11.7%) and severe < or = 0.65 cm(2) m(-2) (0.5%).
The survival, at 10 years, was 39.9+/-7.9% for 50-69 years, 27.0+/-3.7% for 70-79 years and 16.6+/-4.4% for > or = 80 years (p=0.011). There was a trend (p=0.063) influencing survival for moderate-to-severe PPM. Of the independent predictors influencing survival--moderate-to-severe projected effective orifice area index (pEOAI) (Hazard Ratio (HR) 1.6, p=0.0142) and left ventricular dysfunction (ejection fraction < 35%) (HR 1.9, p=0.0193) were included. The 10-year freedom from structural valve deterioration (SVD) at explant assessing the same age groups as survival was not different (p=0.081). The 10-year actual/actuarial freedom from SVD, at explant was for > or = 60 years--94.4+/-1.4% (85.2+/-3.9%), for > or = 65 years--94.2+/-1.4% (85.0+/-4.0%), for 61-70 years--97.4+/-2.6% (95.7+/-4.3%) and for > 70 years--94.0+/-1.5% (83.2+/-4.6%).
The Mitroflow external mounted, pericardial aortic bioprosthesis with documented excellent haemodynamics (especially for the small aortic root), demonstrates that prosthesis-patient mismatch in moderate and severe categories can essentially be eliminated, with durability performance comparable to other heterograft (porcine and pericardial) bioprostheses.
随着主动脉瓣退行性疾病发病率的增加，人们期望延长预期寿命，这就需要一种具有出色血流动力学性能和可比较耐久性的生物主动脉瓣。Mitroflow 生物瓣自 1982 年以来一直在全球范围内使用，除了美国之外，而当前的模型（1991 年）最近才在美国获得监管部门的批准。本研究主要旨在确定当前 Mitroflow 生物瓣的耐久性。
在三个中心，将现代 Mitroflow 生物瓣植入 381 例患者中。平均年龄为 76.4 岁（53-91 岁），平均随访时间为 5.4+/-3.4 年，总共评估了 2048.7 年。通过参考有效瓣口面积指数类别对瓣-患者不匹配（PPM）进行分类：正常>或=0.85cm²/m²（53.9%），轻度 0.84-0.76cm²/m²（33.9%），中度<或=0.75-0.66cm²/m²（11.7%）和严重<或=0.65cm²/m²（0.5%）。
10 年生存率为 50-69 岁为 39.9+/-7.9%，70-79 岁为 27.0+/-3.7%，>或=80 岁为 16.6+/-4.4%（p=0.011）。对于中度至重度 PPM，存在趋势（p=0.063）影响生存率。影响生存率的独立预测因素包括中度至重度预测有效瓣口面积指数（pEOAI）（危险比（HR）1.6，p=0.0142）和左心室功能障碍（射血分数<35%）（HR 1.9，p=0.0193）。在评估与生存相同年龄组的结构瓣恶化（SVD）的 10 年无瓣失败率方面，结果没有差异（p=0.081）。在实际/实际瓣 SVD 10 年无瓣失败率方面，>或=60 岁为 94.4+/-1.4%（85.2+/-3.9%），>或=65 岁为 94.2+/-1.4%（85.0+/-4.0%），61-70 岁为 97.4+/-2.6%（95.7+/-4.3%），>70 岁为 94.0+/-1.5%（83.2+/-4.6%）。
Mitroflow 外部安装的心包主动脉生物瓣具有出色的血流动力学记录（特别是对于小主动脉根部），表明中度和重度类别中的瓣-患者不匹配基本上可以消除，耐用性与其他同种异体（猪和心包）生物瓣相当。
