Santini F, Gatti G, Casali G, Pessotto R, Mazzucco A
Division of Cardiac Surgery, University of Verona Medical School.
G Ital Cardiol. 1999 Jul;29(7):790-5.
The aim of the study was to evaluate our clinical experience with the CarboMedics Heart Valve Prosthesis.
Between October 1991 and December 1997, six hundred seventy-two consecutive patients (361 men, 54%; 311 women, 46%; mean age 57 +/- 12 year, range 6-73 years) underwent mechanical valve implantation at the Division of Cardiac Surgery of the University of Verona. Preoperatively, 69% of the patients were in NYHA FC III or IV. Eighty-one patients (12%) had undergone a previous cardiac operation and 14.5% had an ejection fraction less than 35%. We performed an aortic valve replacement in 309 patients (78 valved-conduits for replacement of the entire aortic root), a mitral valve replacement in 250, and a double valve in 113. 52 patients (8%) underwent associated myocardial revascularization.
Early mortality was 2.8% (5/309 aortic, 1.6%; 11/250 mitral, 4.4%; 3/113 double, 2.6%). Late mortality was 4.4%. Actuarial survival at 5 years was 89.3% (aortic, 91.1%, mitral 86.4%, double 90.5%). Thromboembolism occurred in 26 patients (3.9%) and major hemorrhagic events in 20 (3%). Nine patients (1.3%) required a reoperation, in 3 cases (0.4%) after endocarditis (Staphylococcus epidermidis). No structural deterioration occurred in our series.
Our study appears to confirm the safety and reliability of the CarboMedics mechanical valve prosthesis, even in old age groups. This bileaflet prosthesis demonstrates no structural deterioration, a low incidence of complications, and good hemodynamic performance.
本研究的目的是评估我们使用CarboMedics心脏瓣膜假体的临床经验。
1991年10月至1997年12月期间，672例连续患者（361例男性，占54%；311例女性，占46%；平均年龄57±12岁，范围6 - 73岁）在维罗纳大学心脏外科接受了机械瓣膜植入术。术前，69%的患者处于纽约心脏协会（NYHA）心功能分级III级或IV级。81例患者（12%）曾接受过心脏手术，14.5%的患者射血分数低于35%。我们对309例患者进行了主动脉瓣置换术（其中78例使用带瓣管道置换整个主动脉根部），250例进行了二尖瓣置换术，113例进行了双瓣膜置换术。52例患者（8%）同时接受了心肌血运重建术。
早期死亡率为2.8%（主动脉瓣置换术患者中5/309，占1.6%；二尖瓣置换术患者中11/250，占4.4%；双瓣膜置换术患者中3/113，占2.6%）。晚期死亡率为4.4%。5年时的精算生存率为89.3%（主动脉瓣置换术患者为91.1%，二尖瓣置换术患者为86.4%，双瓣膜置换术患者为90.5%）。26例患者（3.9%）发生血栓栓塞，20例患者（3%）发生大出血事件。9例患者（1.3%）需要再次手术，其中3例（0.4%）是在发生心内膜炎（表皮葡萄球菌感染）后。我们的系列研究中未出现结构恶化情况。
我们的研究似乎证实了CarboMedics机械瓣膜假体的安全性和可靠性，即使在老年人群中也是如此。这种双叶瓣膜假体未出现结构恶化，并发症发生率低，且血流动力学性能良好。
