Elsevier

The Lancet

Volume 375, Issue 9708, 2–8 January 2010, Pages 31-40
The Lancet

Articles
Catheter ablation of stable ventricular tachycardia before defibrillator implantation in patients with coronary heart disease (VTACH): a multicentre randomised controlled trial

https://doi.org/10.1016/S0140-6736(09)61755-4Get rights and content

Summary

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; ≤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 (≤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.

Introduction

Patients with ventricular tachycardia (VT) and a history of myocardial infarction are at high risk of recurrent VT, ventricular fibrillation (VF), and sudden death. In patients with high risk of ventricular arrhythmia, intervention with an implantable cardioverter defibrillator (ICD) reduces rates of sudden cardiac death and total mortality compared with treatment with antiarrhythmic drugs.1, 2, 3, 4, 5 However, patients who receive ICD shocks have a decreased quality of life (especially if five or more shocks per year are delivered6) and increased mortality compared with patients who do not receive shocks, even if the shocks are inappropriate.7 Furthermore, ICDs do not prevent sudden cardiac death in 3–7% of patients.8 Drug treatment—especially amiodarone in combination with β blockers—can reduce the number of ICD interventions, but lifetime intake is necessary and it is associated with serious adverse events.9

Catheter ablation of VT can effectively reduce the number of ICD interventions, especially since the introduction of three-dimensional mapping systems that allow not only activation mapping during tachycardia but also substrate mapping during sinus rhythm.10, 11 The benefits of catheter ablation have been shown by studies in large multicentre trials.12, 13 Most recently, a three-centre study in patients with unstable VT, cardiac arrest, or syncope with inducible VT showed that the incidence of ICD interventions was lower in patients assigned to prophylactic catheter ablation plus defibrillator implantation than in patients assigned to defibrillator implantation alone.14 The Ventricular Tachycardia Ablation in Coronary Heart Disease (VTACH) study was designed to assess prophylactic VT ablation followed by implantation of a cardioverter defibrillator in patients with previous myocardial infarction, first episode of stable VT, and reduced left-ventricular function.

Section snippets

Patients

The VTACH study was a prospective, open, multicentre, randomised controlled trial. Institutional review board approval was obtained at each of the participating centres. Enrolment began in August, 2002, lasting 42 months, and follow-up was completed in January, 2006.

Patients aged 18–80 years were eligible for enrolment if they had an indication for an ICD as secondary prevention after documented stable clinical VT without any reversible cause, coronary artery disease, previous myocardial

Results

Figure 1 shows the trial profile. 110 patients were enrolled in 16 participating European centres in Germany (13 centres), Switzerland (one), Czech Republic (one), and Denmark (one). The intention-to-treat population consisted of 107 patients because two patients withdrew consent immediately after randomisation without any follow-up data and one patient with non-ischaemic VT had to be excluded from the study (violation of protocol inclusion criterion). Table 1 shows the demographic and baseline

Discussion

The VTACH trial investigated the role of prophylactic catheter ablation followed by defibrillator implantation in patients with a first episode of stable VT after myocardial infarction. In this trial, all patients were assigned to receive an ICD, even though patients with stable VT had not been included in three previous randomised trials of this device.1, 2, 3 The Antiarrhythmics Versus Implantable Defibrillators (AVID) registry showed that patients with stable VT might have a similar outcome

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