WakeMed Health and Hospitals, Raleigh, North Carolina.
Royal Jubilee Hospital, Victoria, British Columbia, Canada.
Heart Rhythm. 2015 Mar;12(3):545-553. doi: 10.1016/j.hrthm.2014.11.002. Epub 2014 Nov 7.
Implantable cardioverter-defibrillator (ICD) shocks are associated with increased anxiety, health care utilization, and potentially mortality.
The purpose of the Shock-Less Study was to determine if providing feedback reports to physicians on their adherence to evidence-based shock reduction programming could improve their programming behavior and reduce shocks.
Shock-Less enrolled primary prevention (PP) and secondary prevention (SP) ICD patients between 2009 and 2012 at 118 study centers worldwide and followed patients longitudinally after their ICD implant. Center-specific therapy programming reports (TPRs) were delivered to each center 9 to 12 months after their first enrollment. The reports detailed adherence to evidence-based programming targets: number of intervals to detect ventricular fibrillation (VF NID), longest treatment interval (LTI), supraventricular tachycardia (SVT) discriminators (Wavelet, PR Logic), SVT limit, Lead Integrity Alert (LIA), and antitachycardia pacing (ATP). Clinicians programmed ICDs at their discretion. The primary outcome measure was the change in utilization of evidence-based shock reduction programming before (phase I, n = 2694 patients) and after initiation of the TPR (phase II, n = 1438 patients).
Patients implanted after feedback reports (phase II) were up to 20% more likely to have their ICDs programmed in line with evidence-based shock reduction programming (eg, VF NID in PP patients 30/40 in 33.5% vs 18.6%, P < .0001). Patients implanted in phase II had a lower risk of all-cause shock (adjusted hazard ratio 0.72, 95% confidence interval 0.58-0.90, P = .003).
Providing programming feedback reports improves adherence to evidence-based shock reduction programming and is associated with lower risk of ICD shocks.
植入式心脏复律除颤器(ICD)电击与焦虑增加、医疗保健利用增加以及潜在的死亡率增加有关。
无电击研究(Shock-Less Study)旨在确定向医生提供关于其遵循循证电击减少编程的反馈报告是否可以改善其编程行为并减少电击。
Shock-Less 于 2009 年至 2012 年在全球 118 个研究中心招募了一级预防(PP)和二级预防(SP)ICD 患者,并在患者植入 ICD 后对其进行纵向随访。在首次入组后 9 至 12 个月,向每个中心提供特定于中心的治疗编程报告(TPR)。报告详细说明了对循证编程目标的依从性:检测室颤(VF)的间隔数(NID),最长治疗间隔(LTI),室上性心动过速(SVT)鉴别器(Wavelet,PR Logic),SVT 限制,导联完整性警报(LIA)和抗心动过速起搏(ATP)。临床医生自行对 ICD 进行编程。主要观察指标是在开始 TPR 之前(阶段 I,n = 2694 例患者)和之后(阶段 II,n = 1438 例患者),循证电击减少编程的使用变化。
在反馈报告(阶段 II)后植入的患者,其 ICD 编程符合循证电击减少编程的可能性高达 20%(例如,PP 患者的 VF NID 为 30/40,占 33.5%,而 18.6%,P <.0001)。植入在阶段 II 的患者发生全因电击的风险较低(调整后的危险比为 0.72,95%置信区间为 0.58-0.90,P =.003)。
提供编程反馈报告可提高对循证电击减少编程的依从性,并与 ICD 电击风险降低相关。