奥地利因斯布鲁克医科大学Axel Bauer与合作者联合研究发现，周期性复极动力学有助于指导预防性植入心律转复除颤器（ICD）的治疗决策。2019年9月1日，《柳叶刀》在线发表了这一成果。

EU-CERT-ICD是一项前瞻性、研究者发起、非随机、对照的队列研究，在15个欧盟国家的44个中心进行。2014年5月12日至2018年9月7日，共招募了1371名患者，年龄均在18岁及以上，患有缺血性或非缺血性心肌病且左心室射血分数降低（≤35%），符合ICD一级预防性植入的指南标准。

其中968名患者接受ICD植入，403名进行保守治疗。对ICD植入前一天或保守治疗患者入组当天24小时动态心电图的周期性复极动力学进行评估。ICD组中位随访了2.7年，对照组中位随访了1.2年。随访期间ICD组中138例（14%）患者死亡，对照组64例（16%）死亡。与对照组相比，ICD组的死亡率降低了43%，校正危险比为0.57。

周期性复极动力学为7.5度及以上的患者与小于7.5度的患者相比，ICD植入相关的死亡率获益更高。周期性复极动力学小于7.5度的患者需要治疗的数量为18.3，而大于7.5度的患者需要治疗的数量为3.1。

周期性复极动力学预测可降低缺血性或非缺血性心肌病患者预防性植入ICD的死亡率。

附：英文原文

Title: Prediction of mortality benefit based on periodic repolarisation dynamics in patients undergoing prophylactic implantation of a defibrillator: a prospective, controlled, multicentre cohort study

Author: Prof Axel Bauer, MD,Mathias Klemm, MD,Konstantinos D Rizas, MD,Wolfgang Hamm, MD,Lukas von Stülpnagel, MSc,Michael Dommasch, MD,Alexander Steger, MD,Prof Andrezej Lubinski, MD,Panagiota Flevari, MD,Markus Harden, MSc,Prof Tim Friede, PhD,Prof Stefan Kääb, MD,Prof Bela Merkely, MD,Prof Christian Sticherling, MD,Prof Rik Willems, MD,Prof Heikki Huikuri, MD,Prof Marek Malik, PhD,Prof Georg Schmidt, MD *,Prof Markus Zabel, MD *and theEU-CERT-ICD investigators

Issue&Volume: September 1, 2019

Summary：

Background

A small proportion of patients undergoing primary prophylactic implantation of implantable cardioverter defibrillators (ICDs) experiences malignant arrhythmias. We postulated that periodic repolarisation dynamics, a novel marker of sympathetic-activity-associated repolarisation instability, could be used to identify electrically vulnerable patients who would benefit from prophylactic implantation of ICDs by way of a reduction in mortality.

Methods

We did a prespecified substudy of EUropean Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators (EU-CERT-ICD), a prospective, investigator-initiated, non-randomised, controlled cohort study done at 44 centres in 15 EU countries. Patients aged 18 years or older with ischaemic or non-ischaemic cardiomyopathy and reduced left ventricular ejection fraction (≤35%) were eligible for inclusion if they met guideline-based criteria for primary prophylactic implantation of ICDs. Periodic repolarisation dynamics from 24-h Holter recordings were assessed blindly in patients the day before ICD implantation or on the day of study enrolment in patients who were conservatively managed. The primary endpoint was all-cause mortality. Propensity scoring and multivariable models were used to assess the interaction between periodic repolarisation dynamics and the treatment effect of ICDs on mortality.

Findings

Between May 12, 2014, and Sept 7, 2018, 1371 patients were enrolled in our study. 968 of these patients underwent ICD implantation, and 403 were treated conservatively. During follow-up (median 2·7 years [IQR 2·0–3·3] in the ICD group and 1·2 years [0·8–2·7] in the control group), 138 (14%) patients died in the ICD group and 64 (16%) patients died in the control group. We noted a 43% reduction in mortality in the ICD group compared with the control group (adjusted hazard ratio [HR] 0·57 [95% CI 0·41–0·79]; p=0·0008). Periodic repolarisation dynamics significantly predicted the treatment effect of ICDs on mortality (adjusted p=0·0307). The mortality benefits associated with ICD implantation were greater in patients with periodic repolarisation dynamics of 7·5 deg or higher (n=199; adjusted HR 0·25 [95% CI 0·13–0·47] for the ICD group vs the control group; p<0·0001) than in those with periodic repolarisation dynamics less than 7·5 deg (n=1166; adjusted HR 0·69 [95% CI 0·47–1·00]; p=0·0492; p interaction=0·0056). The number needed to treat was 18·3 (95% CI 10·6–4895·3) in patients with periodic repolarisation dynamics less than 7·5 deg and 3·1 (2·6–4·8) in those with periodic repolarisation dynamics of 7·5 deg or higher.

Interpretation

Periodic repolarisation dynamics predict mortality reductions associated with prophylactic implantation of ICDs in contemporarily treated patients with ischaemic or non-ischaemic cardiomyopathy. Periodic repolarisation dynamics could help to guide treatment decisions about prophylactic ICD implantation.