Suleiman Mahmoud, Goldenberg Ilan, Haim Moti, Schliamser Jorge E, Boulos Monther, Ilan Michael, Swissa Moshe, Gavrielov-Yusim Natalie, Fuchs Therese, Amit Guy, Glikson Michael
Rambam Medical Center, Haifa.
Israeli Association for Cardiovascular Trials, Sheba Medical Center, Tel Hashomer.
Heart Rhythm. 2014 Mar;11(3):435-41. doi: 10.1016/j.hrthm.2013.12.003. Epub 2013 Dec 4.
Elderly patients are underrepresented in clinical trials of device therapy.
To provide real-world data regarding outcomes associated with device-based therapy in a large cohort of elderly patients enrolled in the Israeli ICD Registry.
Between July 2010 and June 2012, a total of 2807 consecutive patients undergoing implanted cardioverter-defibrillator/cardiac resynchronization therapy-defibrillator (ICD/CRT-D) implantation were prospectively enrolled in the Israeli ICD Registry. For the present analysis, patients were categorized into 3 age groups: ≤60 years (n = 1378 [49%]), 61-75 years (n = 863 [31%]), and >75 years (n = 566 [20%]).
Elderly patients (>75 years of age) had more comorbid conditions and were more likely to undergo CRT-D implantation (all P < .01). However, the rate of device-related complications associated with surgical reinterventions at 1 year was <3% regardless of age (P = .70 for the comparison among the 3 age groups). Multivariate analysis showed that the risk of heart failure or death and of appropriate ICD therapy for ventricular arrhythmias was significantly increased with increasing age among patients who received an ICD. In contrast, the age-related increase in the risk of all end points was attenuated among patients who received CRT-D devices (all P values for age-by-device-type interactions are <.05).
In a real-world scenario, elderly patients (>75 years of age) comprise approximately 20% of the ICD/CRT-D recipients and experience a device reintervention rate similar to that of their younger counterparts. Our data suggest that the association between advanced age and adverse clinical outcomes is attenuated in elderly patients implanted with CRT-D devices.
老年患者在器械治疗的临床试验中所占比例不足。
提供关于以色列植入式心律转复除颤器(ICD)登记处登记的大量老年患者中基于器械治疗相关结局的真实世界数据。
2010年7月至2012年6月期间,共有2807例连续接受植入式心律转复除颤器/心脏再同步治疗除颤器(ICD/CRT-D)植入的患者前瞻性纳入以色列ICD登记处。在本次分析中,患者被分为3个年龄组:≤60岁(n = 1378 [49%])、61 - 75岁(n = 863 [31%])和>75岁(n = 566 [20%])。
老年患者(>75岁)合并症更多,更有可能接受CRT-D植入(所有P <.01)。然而,无论年龄大小,1年时与手术再次干预相关的器械相关并发症发生率<3%(3个年龄组之间比较,P =.70)。多变量分析显示,接受ICD的患者中,随着年龄增加,心力衰竭或死亡以及ICD对室性心律失常进行恰当治疗的风险显著增加。相比之下,接受CRT-D器械的患者中,所有终点事件风险随年龄增加的趋势减弱(年龄与器械类型交互作用的所有P值<.05)。
在真实世界中,老年患者(>75岁)约占ICD/CRT-D接受者的20%,其器械再次干预率与年轻患者相似。我们的数据表明,植入CRT-D器械的老年患者中,高龄与不良临床结局之间的关联减弱。