International Centre for Circulatory Health, National Heart Lung Institute, Imperial College, St. Mary's Hospital, London W2 1LA, UK
International Centre for Circulatory Health, National Heart Lung Institute, Imperial College, St. Mary's Hospital, London W2 1LA, UK.
Eur Heart J. 2015 Jul 7;36(26):1676-88. doi: 10.1093/eurheartj/ehv102. Epub 2015 Apr 23.
In at-risk patients with left ventricular dysfunction, implantable cardioverter defibrillators (ICDs) prolong life. Implantable cardioverter defibrillators are increasingly implanted for primary prevention and therefore into lower risk patients. Trial data have demonstrated the benefit of these devices but does not provide an estimate of potential lifespan-gain over longer time periods, e.g. a patient's lifespan.
Using data from landmark ICD trials, lifespan-gain was plotted against baseline annual mortality in the individual trials. Lifespan-gain was then extrapolated to a time-horizon of >20 years while adjusting for increasing 'competing' risk from ageing and non-sudden cardiac death (pump failure).
At 3 years, directly observed lifespan-gain was strongly dependent on baseline event rate (r = 0.94, P < 0.001). However, projecting beyond the duration of the trial, lifespan-gain increases rapidly and non-linearly with time. At 3 years, it averages 1.7 months, but by 10 years up to 9-fold more. Lifespan-gain over time horizons >20 years were greatest in lower risk patients (∼5 life-years for 5% baseline mortality, ∼2 life-years for 15% baseline mortality). Increased competing risks significantly reduce lifespan-gain from ICD implantation.
While high-risk patients may show the greatest short-term gain, the dramatic growth of lifespan-gain over time means that it is the lower risk patients, e.g. primary prevention ICD implantation, who gain the most life-years over their lifetime. Benefit is underestimated when only trial data are assessed as trials can only maintain randomization over limited periods. Lifespan-gain may be further increased through advances in ICD device programming.
在左心室功能障碍的高危患者中,植入式心脏复律除颤器(ICD)可延长寿命。ICD 越来越多地用于一级预防,因此也应用于风险较低的患者。试验数据表明了这些设备的益处,但并未提供更长时间内潜在寿命延长的估计,例如患者的寿命。
使用来自标志性 ICD 试验的数据,根据个体试验中的基线年度死亡率绘制寿命延长图。然后,在调整因衰老和非猝死性心脏死亡(泵衰竭)导致的“竞争”风险增加的情况下,将寿命延长外推至>20 年的时间范围。
在 3 年时,直接观察到的寿命延长与基线事件率密切相关(r = 0.94,P < 0.001)。然而,超过试验持续时间进行预测时,寿命延长会迅速且呈非线性增加。在 3 年时,平均为 1.7 个月,但在 10 年时增加了 9 倍以上。在>20 年的时间范围内,风险较低的患者的寿命延长时间最长(5%的基线死亡率为 5 年寿命,15%的基线死亡率为 2 年寿命)。竞争风险的增加显著降低了 ICD 植入的寿命延长。
虽然高危患者可能会显示出最大的短期获益,但随着时间的推移,寿命延长呈指数级增长,这意味着风险较低的患者,例如一级预防 ICD 植入,在其一生中获得的寿命延长最多。仅评估试验数据会低估获益,因为试验只能在有限的时间内维持随机化。通过改进 ICD 设备编程,寿命延长可能会进一步增加。