冠心病患者植入除颤器前稳定型室性心动过速的导管消融（VTACH）：一项多中心随机对照试验。
Catheter ablation of stable ventricular tachycardia before defibrillator implantation in patients with coronary heart disease (VTACH): a multicentre randomised controlled trial.
机构信息
Hanseatisches Herzzentrum, Asklepios Klinik St Georg, Hamburg, Germany.
出版信息
Lancet. 2010 Jan 2;375(9708):31-40. doi: 10.1016/S0140-6736(09)61755-4.
BACKGROUND
In patients with ventricular tachycardia (VT) and a history of myocardial infarction, intervention with an implantable cardioverter defibrillator (ICD) can prevent sudden cardiac death and thereby reduce total mortality. However, ICD shocks are painful and do not provide complete protection against sudden cardiac death. We assessed the potential benefit of catheter ablation before implantation of a cardioverter defibrillator.
METHODS
The Ventricular Tachycardia Ablation in Coronary Heart Disease (VTACH) study was a prospective, open, randomised controlled trial, undertaken in 16 centres in four European countries. Patients aged 18-80 years were eligible for enrolment if they had stable VT, previous myocardial infarction, and reduced left-ventricular ejection fraction (LVEF; <or=50%). 110 patients were randomly allocated in a 1:1 ratio to receive catheter ablation and an ICD (ablation group, n=54) or ICD alone (control group, n=56). Randomisation was done by computer-generated randomly permuted blocks and stratified by centre and LVEF (<or=30% or >30%). Patients were followed up for at least 1 year. The primary endpoint was the time to first recurrence of VT or ventricular fibrillation (VF). Analysis was by intention to treat (ITT). This study is registered with ClinicalTrials.gov, number NCT00919373.
FINDINGS
107 patients were included in the ITT population (ablation group, n=52; control group, n=55). Two patients (one in each group) withdrew consent immediately after randomisation without any follow-up data and one patient (ablation group) was excluded because of a protocol violaton. Mean follow-up was 22.5 months (SD 9.0). Time to recurrence of VT or VF was longer in the ablation group (median 18.6 months [lower quartile 2.4, upper quartile not determinable]) than in the control group (5.9 months [IQR 0.8-26.7]). At 2 years, estimates for survival free from VT or VF were 47% in the ablation group and 29% in the control group (hazard ratio 0.61; 95% CI 0.37-0.99; p=0.045). Complications related to the ablation procedure occurred in two patients; no deaths occurred within 30 days after ablation. 15 device-related complications requiring surgical intervention occurred in 13 patients (ablation group, four; control group, nine). Nine patients died during the study (ablation group, five; control group, four).
INTERPRETATION
Prophylactic VT ablation before defibrillator implantation seemed to prolong time to recurrence of VT in patients with stable VT, previous myocardial infarction, and reduced LVEF. Prophylactic catheter ablation should therefore be considered before implantation of a cardioverter defibrillator in such patients.
FUNDING
St Jude Medical.
背景
在患有室性心动过速（VT）和心肌梗死病史的患者中，植入式心脏复律除颤器（ICD）的干预可以预防心脏性猝死并降低总死亡率。然而，ICD 电击是痛苦的，并且不能提供对心脏性猝死的完全保护。我们评估了在植入心脏复律除颤器之前导管消融的潜在益处。
方法
在这项前瞻性、开放、随机对照试验中，将患有稳定型 VT、既往心肌梗死和左心室射血分数（LVEF；≤50%）降低的 16 个欧洲国家的 16 个中心的患者纳入研究。年龄在 18-80 岁之间的患者符合入组条件，如果他们患有稳定型 VT、既往心肌梗死和左心室射血分数（LVEF；≤50%）。110 例患者按 1:1 比例随机分为导管消融+ICD 组（消融组，n=54）和 ICD 组（对照组，n=56）。随机分配采用计算机生成的随机排列块和按中心和 LVEF（≤30%或>30%）分层。患者至少随访 1 年。主要终点是首次 VT 或室颤（VF）复发的时间。分析采用意向治疗（ITT）。这项研究在 ClinicalTrials.gov 注册，编号为 NCT00919373。
结果
在 ITT 人群中，有 107 例患者入组（消融组，n=52；对照组，n=55）。2 例患者（每组各 1 例）在随机分组后立即撤回同意意见，没有任何随访数据，1 例患者（消融组）因违反方案而被排除。平均随访时间为 22.5 个月（SD 9.0）。消融组 VT 或 VF 复发时间长于对照组（中位时间 18.6 个月[下四分位数 2.4，上四分位数未确定]）。在 2 年时，消融组无 VT 或 VF 生存的估计值为 47%，对照组为 29%（风险比 0.61；95%CI 0.37-0.99；p=0.045）。消融相关并发症发生在 2 例患者中；消融后 30 天内无死亡。13 例患者发生了 15 例与设备相关的并发症，需要手术干预（消融组 4 例，对照组 9 例）。研究期间有 9 例患者死亡（消融组 5 例，对照组 4 例）。
结论
在患有稳定型 VT、既往心肌梗死和 LVEF 降低的患者中，在植入 ICD 之前预防性 VT 消融似乎可以延长 VT 复发的时间。因此，在这些患者中，应考虑在植入心脏复律除颤器之前进行导管消融。
研究资金
圣犹达医疗公司。
Zotero 插件