卡博梅迪克斯人工心脏瓣膜：1084例植入经验。

Santini Francesco, Casali Gianluca, Viscardi Francesca, Favaro Alessandro, Luciani Giovanni Battista, Pentiricci Samuele, Lusini Mario, Rossi Andrea, Mazzucco Alessandro

Divisions of Cardiac Surgery, University of Verona Medical School, Italy.

J Heart Valve Dis. 2002 Jan;11(1):121-6; discussion 27.

BACKGROUND AND AIM OF THE STUDY

The study aim was to evaluate our clinical experience with the CarboMedics heart valve prosthesis.

METHODS

Between October 1991 and December 2000, 942 consecutive patients (514 males, 428 females; mean age 58+/-11 years; range: 6-78 years) underwent mechanical valve implantation with the CarboMedics prosthesis. Preoperatively, 47% of patients were in NYHA class III and 22% in class IV; in addition, 134 patients (14.2%) had undergone a previous cardiac operation. Aortic valve replacement (AVR) was performed in 469 patients (49.8%), mitral valve replacement (MVR) in 330 (35.0%), double valve replacement (DVR) in 142 (15.1%), and isolated tricuspid valve replacement (TVR) in one patient. Eighty-eight patients (9.3%) underwent associated myocardial revascularization. Mean cardiopulmonary bypass and aortic cross-clamp times for the entire group were 107+/-39 min and 74+/-24 min, respectively.

RESULTS

Overall early mortality was 2.3% (6/469 AVR, 1.2%; 12/330 MVR, 3.6%; 4/142 DVR, 2.8%). Late mortality was 3.1% (n = 29; including 17 cardiac deaths (10 were valve-related). Mean follow up was 66+/-31 months (range: 1-109 months), and was 98% complete yielding a total follow up of 4959 years. Actuarial survival at five years for the entire group was 89.3+/-1.6% (AVR 91.1%, MVR 86.4%, DVR 90.5%). Thromboembolism occurred in 26 patients (2.8%, 0.52%/pt-year) and major hemorrhagic events in 20 (2.1%, 0.4%/pt-year). Nine patients (0.9%) required a reoperation, in three cases (0.3%) after Staphylococcus epidermidis-mediated endocarditis. No structural deterioration occurred. Among 891 survivors, 94% of the patients are currently in NYHA classes I or II (p <0.05).

CONCLUSION

This study confirmed the safety and reliability of the CarboMedics mechanical valve prosthesis, even in old age groups. This bileaflet prosthesis showed no structural deterioration, and a low incidence of overall complications.

研究背景与目的

本研究旨在评估我们使用CarboMedics心脏瓣膜假体的临床经验。

方法

1991年10月至2000年12月期间，942例连续患者（514例男性，428例女性；平均年龄58±11岁；范围：6 - 78岁）接受了CarboMedics假体机械瓣膜植入术。术前，47%的患者为纽约心脏协会（NYHA）III级，22%为IV级；此外，134例患者（14.2%）曾接受过心脏手术。469例患者（49.8%）进行了主动脉瓣置换术（AVR），330例（35.0%）进行了二尖瓣置换术（MVR），142例（15.1%）进行了双瓣膜置换术（DVR），1例患者进行了单纯三尖瓣置换术（TVR）。88例患者（9.3%）同时进行了心肌血运重建。整个组的平均体外循环时间和主动脉阻断时间分别为107±39分钟和74±24分钟。

结果

总体早期死亡率为2.3%（AVR组469例中有6例，1.2%；MVR组330例中有12例，3.6%；DVR组142例中有4例，2.8%）。晚期死亡率为3.1%（n = 29；包括17例心脏死亡（10例与瓣膜相关）。平均随访时间为66±31个月（范围：1 - 109个月），随访完成率为98%，总随访时间为4959人年。整个组五年的精算生存率为89.3±1.6%（AVR组91.1%，MVR组86.4%，DVR组90.5%）。26例患者（2.8%，0.52%/患者年）发生血栓栓塞，20例（2.1%，0.4%/患者年）发生重大出血事件。9例患者（0.9%）需要再次手术，3例（0.3%）是在表皮葡萄球菌介导的心内膜炎后。未发生结构恶化。在891例幸存者中，94%的患者目前处于NYHA I级或II级（p <0.05）。