US Food and Drug Administration, Center for Devices and Radiological Health, Division of Epidemiology, Silver Spring, MD 20993, USA.
Ann Thorac Surg. 2012 Nov;94(5):1500-8. doi: 10.1016/j.athoracsur.2012.05.068. Epub 2012 Jul 25.
Two independent reports documented substantially higher operative mortality associated with transmyocardial revascularization (TMR) when used in isolation than that reported in the premarket clinical trials. To clarify the state of the art, this article assesses temporal trends in the use of TMR, short-term and long-term outcomes, and outcomes stratified by procedure type (TMR only and TMR + coronary artery bypass graft [CABG]) and by the 2 specific TMR devices.
The study population included all patients undergoing TMR in isolation or in combination with CABG at 435 cardiothoracic hospitals in the United States participating in the Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database (ACSD) from January 2000 through November 2006 (n = 15,386). Analysis of long-term outcomes was accomplished through linkage to Medicare claims data. Short-term and long-term (7 years) adverse outcomes were assessed and compared between the 2 TMR device types.
The use of TMR in conjunction with CABG surgery is increasing. This study showed modest differences in short-term morbidity and mortality between the 2 devices. In combination with CABG, after risk adjustment, patients treated with the holmium:YAG laser (experienced a higher rate of operative mortality (3.5% vs 2.5%; adjusted hazard ratio 1.39, 95% confidence level 1.03 to 1.87) but no difference in the composite short-term rate of major morbidity or mortality, compared with the Heart Laser CO2 transmyocardial revascularization system (PLC Medical Systems, Inc, Milford, MA). However, there were no clinically meaningful differences in long-term results.
Modest differences in short-term morbidity and mortality between the 2 devices suggest the usefulness of further research.
两份独立报告记录显示，与市场前临床试验报告相比，单独使用经心肌血运重建术（TMR）的手术死亡率明显更高。为了澄清现状，本文评估了 TMR 的使用情况、短期和长期结果以及按手术类型（仅 TMR 和 TMR+冠状动脉旁路移植术[CABG]）和两种特定 TMR 设备分层的结果的时间趋势。
该研究人群包括 2000 年 1 月至 2006 年 11 月期间在美国 435 家心胸外科医院参与胸外科医师学会（STS）成人心脏手术数据库（ACSD）的所有接受 TMR 单独或与 CABG 联合治疗的患者（n=15386）。通过与医疗保险索赔数据进行链接来分析长期结果。评估并比较了两种 TMR 设备类型的短期和长期（7 年）不良结果。
TMR 与 CABG 手术联合使用的比例正在增加。本研究显示两种设备之间短期发病率和死亡率存在适度差异。与 CABG 联合使用时，经风险调整后，与 Heart Laser CO2 经心肌血运重建系统（PLC Medical Systems，Inc，Milford，MA）相比，接受钬：YAG 激光（的患者手术死亡率（3.5% vs 2.5%；调整后危险比 1.39，95%置信区间 1.03 至 1.87）更高，但短期主要发病率或死亡率的复合率没有差异。然而，长期结果没有明显差异。
两种设备之间短期发病率和死亡率的适度差异表明进一步研究的有用性。
