Preventive or Deferred Ablation of Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy and Implantable Defibrillator (BERLIN VT)

Abstract

Background: Catheter ablation for ventricular tachycardia (VT) reduces the recurrence of VT in patients with implantable cardioverter-defibrillators (ICDs). The appropriate timing of VT ablation and its effects on mortality and heart failure progression remain a matter of debate. In patients with life-threatening arrhythmias necessitating ICD implantation, we compared outcomes of preventive VT ablation (undertaken before ICD implantation to prevent ICD shocks for VT) and deferred ablation after 3 ICD shocks for VT. Methods: The BERLIN VT study (Preventive Ablation of Ventricular Tachycardia in Patients With Myocardial Infarction) was a prospective, open, parallel, randomized trial performed at 26 centers. Patients with stable ischemic cardiomyopathy, a left ventricular ejection fraction between 30% and 50%, and documented VT were randomly assigned 1:1 to a preventive or deferred ablation strategy. The primary outcome was a composite of all-cause death and unplanned hospitalization for either symptomatic ventricular arrhythmia or worsening heart failure. Secondary outcomes included sustained ventricular tachyarrhythmia and appropriate ICD therapy. We hypothesized that preventive ablation strategy would be superior to deferred ablation strategy in the intention-to-treat population. Results: During a mean follow-up of 396±284 days, the primary end point occurred in 25 (32.9%) of 76 patients in the preventive ablation group and 23 (27.7%) of 83 patients in the deferred ablation group (hazard ratio, 1.09 [95% CI, 0.62–1.92]; P =0.77). On the basis of prespecified criteria for interim analyses, the study was terminated early for futility. In the preventive versus deferred ablation group, 6 versus 2 patients died (7.9% versus 2.4%; P =0.18), 8 versus 2 patients were admitted for worsening heart failure (10.4% versus 2.3%; P =0.062), and 15 versus 21 patients were hospitalized for symptomatic ventricular arrhythmia (19.5% versus 25.3%; P =0.27). Among secondary outcomes, the proportions of patients with sustained ventricular tachyarrhythmia (39.7% versus 48.2%; P =0.050) and appropriate ICD therapy (34.2% versus 47.0%; P =0.020) were numerically reduced in the preventive ablation group. Conclusions: Preventive VT ablation before ICD implantation did not reduce mortality or hospitalization for arrhythmia or worsening heart failure during 1 year of follow-up compared with the deferred ablation strategy. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02501005.

First-Line Ablation of Ventricular Tachycardia in Ischemic Cardiomyopathy: Stratification of Outcomes by Left Ventricular Function

“…14,15 As expected, all of these trials had methodological differences but the major approach studied is homogenous, considering the use of first-line VT ablation in each of them and a medication-based approach in the control groups. In terms of the control groups, AADs were used in 35% of patients in the VTACH study, 32% in SMS, and 33% in BERLIN VT; however, only beta-blockers were used in SMASH VT. 5,6,15,16 All control groups were medications based except in the BERLIN VT trial, where patients were randomized to receive ablation after the third appropriate ICD shock. 15 Ultimately, 10 patients (12%) received ablation in this group, which is perhaps one of the reasons the trial showed no benefit in the ablation groupo.…”

“…13 Four randomized controlled trials have assessed the impact of first-line VT catheter ablation in the setting of ICM. 5,6,14,15 SMASH VT and VTACH trials showed improved outcomes with first-line VT ablation in patients with ICM presenting with VT. 5,6 However, the SMS and the recently published BERLIN VT trial, showed opposite results. 14,15 As expected, all of these trials had methodological differences but the major approach studied is homogenous, considering the use of first-line VT ablation in each of them and a medication-based approach in the control groups.…”

“…5,6,14,15 SMASH VT and VTACH trials showed improved outcomes with first-line VT ablation in patients with ICM presenting with VT. 5,6 However, the SMS and the recently published BERLIN VT trial, showed opposite results. 14,15 As expected, all of these trials had methodological differences but the major approach studied is homogenous, considering the use of first-line VT ablation in each of them and a medication-based approach in the control groups. In terms of the control groups, AADs were used in 35% of patients in the VTACH study, 32% in SMS, and 33% in BERLIN VT; however, only beta-blockers were used in SMASH VT. 5,6,15,16 All control groups were medications based except in the BERLIN VT trial, where patients were randomized to receive ablation after the third appropriate ICD shock.…”

Bear track hypothesis in outcomes of ventricular tachycardia ablation: Risk factor or risk marker or both for heart failure?

“…Despite we have the benefit of a preventive ablation, which has been shown in two randomized trials ( VTACH 7 and SMASH VT trials 8 ) and also a multicenter registry, 9 the recent BERLIN VT study 10 did not reduce mortality or hospitalization for VT or worsening HF between the preventive (very early) and the deferred (early) ablation group 10 . Although the VTACH study showed that there was no benefit of catheter ablation in patients with a very low ejection fraction (LVEF, <20%), 7 the BERLIN trial in lower risk patients with relatively preserved ejection fraction (LVEF, 30‐50%) detected no benefit for hard clinical outcomes, but fewer ventricular arrhythmias (VA) and implantable cardioverter‐defibrillator (ICD) interventions 10 . But this was fully compensated by early hospitalizations after ablation for worsening HF, 10 as did in current study 1 .…”

“…On the other side, it is clear and mandatory to intervene aggressively when an electrical storm occurs, although there is still a lack of clarity about triggering mechanism and role of electrical storm in accelerating mortality 11 . Therefore, the correct timing and selection of patients determine the success of VT ablation as a curative or palliative approach and a shift in our goal of VT ablation 2,10,12 . We should be able to define the optimal time when it is not too early or late to perform the ablation procedure.…”