Stephan Willems1, Roland Richard Tilz2, Daniel Steven3, Stefan Kääb4, Karl Wegscheider5, László Gellér6, Christian Meyer1, Christian-Hendrik Heeger2, Andreas Metzner7, Moritz F Sinner4, Michael Schlüter8, Peter Nordbeck9, Lars Eckardt10, Harilaos Bogossian11, Arian Sultan3, Beate Wenzel12, Karl-Heinz Kuck7. 1. University Heart Center, Hamburg, Germany (S.W., C.M.). 2. University Hospital Lübeck, Med.Klinik II, and German Center for Cardiovascular Research (DZHK), partner site Hamburg/Kiel/Lübeck, Germany (R.R.T., C.-H.H.). 3. University Heart Center Cologne, Germany (D.S., A.S.). 4. Department of Medicine I, University Hospital Munich, Ludwig-Maximilian's University Munich and German Center for Cardiovascular Research (DZHK), partner site Munich Heart Alliance, Germany (S.K., M.F.S.). 5. Institute of Medical Biometry and Epidemiology, University Medical Center Eppendorf, Hamburg, Germany (K.W.). 6. Semmelweis Medical University, Budapest, Hungary (L.G.). 7. Asklepios Klinik St Georg, Hamburg, Germany (A.M., K.-H.K.). 8. Asklepios Proresearch, Hamburg, Germany (M.S.). 9. University Hospital Würzburg, Germany (P.N.). 10. University Hospital Münster, Germany (L.E.). 11. Klinikum Lüdenscheid, Witten/Herdecke University, Germany (H.B.). 12. Biotronik SE & Co. KG, Berlin, Germany (B.W.).
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.
RCT Entities:
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.
Authors: Stefanie Andreß; Tilman Stephan; Dominik Felbel; Alex Mack; Michael Baumhardt; Johannes Kersten; Dominik Buckert; Alexander Pott; Tillman Dahme; Wolfgang Rottbauer; Armin Imhof; Manuel Rattka Journal: Clin Res Cardiol Date: 2022-05-23 Impact factor: 6.138
Authors: Pier D Lambiase; Dominic A Theuns; Francis Murgatroyd; Craig Barr; Lars Eckardt; Petr Neuzil; Marcoen Scholten; Margaret Hood; Jȕrgen Kuschyk; Amy J Brisben; Nathan Carter; Timothy M Stivland; Reinoud Knops; Lucas V A Boersma Journal: Eur Heart J Date: 2022-06-01 Impact factor: 35.855