美敦力镶嵌式猪生物假体：至六年的研究中心经验

Jamieson W R Eric, Fradet Guy J, MacNab Joan S, Burr Lawrence H, Stanford Elizabeth A, Janusz Michael T, Abel James G, Germann Eva, Cheung Anson

University of British Columbia, Vancouver, Canada.

J Heart Valve Dis. 2005 Jan;14(1):54-63.

BACKGROUND AND AIM OF THE STUDY

The findings of this single-center experience with the Medtronic Mosaic porcine bioprosthesis were evaluated to determine the clinical performance of the valve.

METHODS

Between 1994 and 2000, a total of 657 patients was implanted with the prosthesis. Aortic valve replacement (AVR) was performed in 415 patients (mean age 70.5+/-10.7 years; range: 26-89 years) and mitral valve replacement (MVR) in 242 patients (mean age 70.5+/-9.5 years; range: 19-86 years). Concomitant coronary artery bypass (CAB) was performed in 51.1% and 46.7% of AVR and MVR patients, respectively. The majority of patients were aged over 70 years (59.8% AVR, 58.7% MVR).

RESULTS

Survival at six years was 73.0+/-2.4% after AVR, and 74.0+/-5% after MVR (p = NS). Actual freedom from valve-related mortality at six years was 98+/-1% for AVR and 96+/-1% for MVR; freedom from overall thromboembolism (TE) was 86+/-3% for AVR and 89+/-2% for MVR. After AVR, 42 thromboembolic events occurred in 39 patients (23 minor; 14 major; three reversible ischemic neurologic deficits (RIND); two thrombosis). After AVR, the late TE rate was 2.1% per pt-yr, and the major rate 0.6% per pt-yr (exclusive of thrombosis). The overall TE rate after AVR was 2.9% per pt-yr (major rate 1% per pt-yr). After MVR, 25 events occurred in 24 patients (10 minor; eight major; five RIND; two thrombosis). After MVR, the late TE rate was 2.6% per pt-yr, and the major rate 0.7% per pt-yr (exclusive of thrombosis). The overall TE rate after MVR was 3.5% per pt-yr (major rate 1.1% per pt-yr). There were four cases of structural valve deterioration (SVD) (two each after AVR and MVR). Reoperation was performed in three of four cases of thrombosis, and in two of four cases of SVD.

CONCLUSION

The Medtronic Mosaic porcine bioprosthesis is safe and effective. The rate of SVD after six years was low, being zero in the aortic position of patients aged >60 years, and zero also in the mitral position of patients aged <60 years. The incidence of early and late thromboembolism was contributed to by the advanced age of the patient population.

研究背景与目的

评估美敦力镶嵌猪生物瓣膜单中心应用的结果，以确定该瓣膜的临床性能。

方法

1994年至2000年期间，共有657例患者植入了该瓣膜。415例患者接受主动脉瓣置换术（AVR）（平均年龄70.5±10.7岁；范围：26 - 89岁），242例患者接受二尖瓣置换术（MVR）（平均年龄70.5±9.5岁；范围：19 - 86岁）。分别有51.1%的AVR患者和46.7%的MVR患者同时进行了冠状动脉搭桥术（CAB）。大多数患者年龄超过70岁（AVR患者中占59.8%，MVR患者中占58.7%）。

结果

AVR术后六年生存率为73.0±2.4%，MVR术后为74.0±5%（p = 无显著差异）。AVR术后六年实际无瓣膜相关死亡率为98±1%，MVR术后为96±1%；无总体血栓栓塞（TE）发生率，AVR术后为86±3%，MVR术后为89±2%。AVR术后，39例患者发生42次血栓栓塞事件（23次轻微；14次严重；3次可逆性缺血性神经功能缺损（RIND）；2次血栓形成）。AVR术后，晚期TE发生率为每年每患者2.1%，严重发生率为每年每患者0.6%（不包括血栓形成）。AVR术后总体TE发生率为每年每患者2.9%（严重发生率为每年每患者1%）。MVR术后，24例患者发生25次事件（10次轻微；8次严重；5次RIND；2次血栓形成）。MVR术后，晚期TE发生率为每年每患者2.6%，严重发生率为每年每患者0.7%（不包括血栓形成）。MVR术后总体TE发生率为每年每患者3.5%（严重发生率为每年每患者1.1%）。有4例结构性瓣膜退变（SVD）（AVR和MVR术后各2例）。4例血栓形成患者中有3例进行了再次手术，4例SVD患者中有2例进行了再次手术。