美敦力马赛克猪生物瓣：12 年性能评估。

Medtronic Mosaic porcine bioprosthesis: assessment of 12-year performance.

机构信息

University of British Columbia, Vancouver, British Columbia, Canada.

出版信息

J Thorac Cardiovasc Surg. 2011 Aug;142(2):302-7.e2. doi: 10.1016/j.jtcvs.2010.08.090. Epub 2011 Feb 1.

DOI:10.1016/j.jtcvs.2010.08.090

PMID:21277591

Abstract

BACKGROUND

The Mosaic porcine bioprosthesis (Medtronic, Inc, Minneapolis, Minn) was approved in 2000 by the US Food and Drug Administration. Clinical performance was evaluated in 6 centers.

METHODS

From 1994 to 2000, 797 patients (mean age 69 years) had aortic valve replacement (AVR) and 232 (mean 67 years) had mitral valve replacement (MVR). Concomitant coronary artery bypass grafting was performed with aortic valve replacement (45.4%) and mitral valve replacement (43.5%). Mean follow-ups were 7.5 years for aortic position and 7.3 years for mitral position.

RESULTS

Early mortalities were 2.8% for AVR and 3.0% for MVR. Late mortalities were 4.2%/patient-year for AVR and 5.1%/patient-year for MVR. Overall 12-year survivals were 55.8% ± 3.7% for AVR and 43.9% ± 7.4% for MVR. Twelve-year freedoms from valve-related mortality were 87.1% ± 3.1% for AVR and 82.5% ± 7.7% for MVR. Twelve-year freedoms from reoperation were 84.0% ± 3.3% for AVR and 82.5% ± 7.5% for MVR. Freedoms from structural valve deterioration (SVD) by explant reoperation at 12 years for AVR were 93.3% ± 2.6% for patients at least 60 years old and 75.9% ± 9.3% for patients younger than 60 years. Freedoms from SVD by explant reoperation at 10 years for MVR were 95.3% ± 7.8% for patients at least 70 years old and 84.0% ± 9.3% for patients younger than 70 years. Hemodynamic performance data at 1 year for AVR (sizes 21-27 mm) were mean systolic gradient range 13.7 ± 4.8 to 10.3 ± 3.2 mm Hg and effective orifice area range 1.5 ± 0.3 to 2.5 ± 0.4 cm(2). For MVR (sizes 25-31 mm), data were mean diastolic gradient range 6.7 ± 1.7 to 3.7 ± 0.9 mm Hg and effective orifice area range 1.9 ± 0.3 to 2.4 ± 0.6 cm(2).

CONCLUSIONS

Overall performance of Mosaic porcine bioprosthesis to 12 years is satisfactory. Freedoms from SVD by explant reoperation were most satisfactory for aortic position in patients at least 60 years old and mitral position in patients at least 70 years old. Overall actuarial freedom from SVD by explant reoperation is encouraging for patients with MVR.

摘要

背景

Mosaic 猪生物瓣（美敦力公司，明尼苏达州明尼阿波利斯）于 2000 年获得美国食品和药物管理局批准。在 6 个中心评估了临床性能。

方法

从 1994 年到 2000 年，797 例患者（平均年龄 69 岁）接受了主动脉瓣置换术（AVR），232 例（平均年龄 67 岁）接受了二尖瓣置换术（MVR）。AVR 时行冠状动脉旁路移植术（CABG）（45.4%），MVR 时行 CABG（43.5%）。AVR 的平均随访时间为 7.5 年，MVR 的平均随访时间为 7.3 年。

结果

AVR 的早期死亡率为 2.8%，MVR 的早期死亡率为 3.0%。AVR 的晚期死亡率为 4.2%/患者年，MVR 的晚期死亡率为 5.1%/患者年。12 年总体生存率为 AVR 55.8%±3.7%，MVR 43.9%±7.4%。AVR 瓣膜相关死亡率 12 年无复发率为 87.1%±3.1%，MVR 为 82.5%±7.7%。AVR 再手术 12 年无复发性为 84.0%±3.3%，MVR 为 82.5%±7.5%。AVR 因结构性瓣膜退化（SVD）行再次瓣膜置换术 12 年无复发率，≥60 岁患者为 93.3%±2.6%，＜60 岁患者为 75.9%±9.3%。MVR 因 SVD 行再次瓣膜置换术 10 年无复发率，≥70 岁患者为 95.3%±7.8%，＜70 岁患者为 84.0%±9.3%。AVR（21-27mm 大小）1 年时的血流动力学性能数据为平均收缩期梯度范围 13.7±4.8 至 10.3±3.2mmHg，有效瓣口面积范围 1.5±0.3 至 2.5±0.4cm²。MVR（25-31mm 大小）数据为平均舒张期梯度范围 6.7±1.7 至 3.7±0.9mmHg，有效瓣口面积范围 1.9±0.3 至 2.4±0.6cm²。