Priori Silvia G, Auricchio Angelo, Nisam Seah, Yong Patrick
Molecular Cardiology, IRCCS Fondazione Maugeri, Pavia, Italy.
J Cardiovasc Electrophysiol. 2009 Feb;20(2):164-70. doi: 10.1111/j.1540-8167.2008.01291.x. Epub 2008 Sep 17.
The decision of whether and when to replace a device in response to an "advisory" letter requires careful consideration, because device replacement carries related risks and is influenced by the clinical characteristics of the patient.
The risk/benefit of device replacement depends on four parameters: expected annual sudden cardiac death rate; residual device life; difference in failure rate between the device listed on the advisory letter and the replacement device; and the replacement procedure mortality risk. Using these four factors, we have developed an equation that provides the "number needed to replace" (NNR) to save one life. Per our model, patients implanted with a device with a failure rate approaching 1% and a probability of requiring device intervention >or=25% per year-in particular, pacemaker-dependent patients-have an NNR <250. Pacemaker-dependent patients, with devices having three or more years longevity, but with device failure rates >or=0.5%, have an NNR <100. Patients with arrhythmic risk <or=2.5% per year and those with devices having failure rates <0.1% have a high NNR and stand more risk to be harmed than benefited from device replacement.
Pacemaker-dependent patients and those with high arrhythmic risk (>or=25% annually) when having "advisory" devices with high failure rate (>or=1%) have an NNR <250 and, hence, could be considered for device replacement. Conversely, patients with arrhythmic risk <or=2.5% per year and those with devices having failure rates <or=0.1% have a high NNR or even risk of "harm" from device replacement. In all the intermediate cases, the NNR will quantify the benefit/risk ratio of replacement, thus helping physicians and patients decide on the preferred approach. The NNR methodology proposed here is also applicable to advisory notices issued to leads, but the high morbidity associated with lead replacement will generally rule out interventions to replace leads.
根据“咨询”信函决定是否以及何时更换设备需要仔细考虑，因为设备更换存在相关风险，且受患者临床特征影响。
设备更换的风险/益处取决于四个参数：预期年度心脏性猝死率；设备剩余寿命；咨询信函中列出的设备与更换设备之间的故障率差异；以及更换手术的死亡风险。利用这四个因素，我们推导出了一个方程，该方程可得出挽救一条生命所需的“更换数量”（NNR）。根据我们的模型，植入故障率接近1%且每年需要进行设备干预的概率≥25%的设备的患者——尤其是依赖起搏器的患者——其NNR<250。依赖起搏器的患者，其设备使用寿命超过三年，但设备故障率≥0.5%，其NNR<100。每年心律失常风险≤2.5%的患者以及设备故障率<0.1% 的患者，其NNR较高，且因设备更换而受到伤害的风险大于受益。
依赖起搏器的患者以及每年心律失常风险较高（≥25%）且拥有高故障率（≥1%）的“咨询”设备的患者，其NNR<250，因此可考虑进行设备更换。相反，每年心律失常风险≤2.5%的患者以及设备故障率≤0.1%的患者，其NNR较高，甚至可能因设备更换而面临“伤害”风险。在所有中间情况下，NNR将量化更换的益处/风险比，从而帮助医生和患者决定首选方法。这里提出的NNR方法也适用于发给导线的咨询通知，但导线更换相关的高发病率通常会排除更换导线的干预措施。
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