Paolo Della Bella1, Francesca Baratto1, Pasquale Vergara1, Patrizia Bertocchi2, Matteo Santamaria3, Pasquale Notarstefano4, Leonardo Calò5, Daniela Orsida6, Luca Tomasi7, Marcello Piacenti8, Stefano Sangiorgio9, Francesco Pentimalli10, Etienne Pruvot11, João De Sousa12, Frederic Sacher13, Massimo Tritto14, Luca Rebellato15, Thomas Deneke16, Salvo Andrea Romano2, Martina Nesti4, Alessio Gargaro17, Daniele Giacopelli17,18, Giovanni Peretto1, Andrea Radinovic1. 1. Department of Cardiac Electrophysiology and Arrhythmology, San Raffaele University Hospital, Milan, Italy (P.D.B., F.B., P.V., G.P., A.R.). 2. Cardiology Department, Ospedale di Desio, Italy (P.B., S.A.R.). 3. Cardiology Department, Ospedale Gemelli Molise, Campobasso, Italy (M.S.). 4. Cardiology Department, Ospedale San Donato, Arezzo, Italy (P.N., M.N.). 5. Cardiology Department, Policlinico Casilino, Rome, Italy (L.C.). 6. Cardiology Department, A.O. Sant'Antonio Abate, Gallarate, Italy (D.O.). 7. Cardiology Department, Azienda Ospedaliera Universitaria Integrata Verona, Italy (L.T.). 8. Cardiology Department, Fondazione G. Monasterio, Pisa, Italy (M.P.). 9. Cardiology Department, A.O. Valtellina e Valchiavenna, Sondrio, Italy (S.S.). 10. S.S. di Elettrofisiologia Cardiaca, S.C. di Cardiologia, Ospedale S. Paolo-Savona, Italy (F.P.). 11. Lausanne Hospital, Switzerland (E.P.). 12. Cardiology Department, Santa Maria University Hospital, Lisboa, Portugal (J.D.S.). 13. Hôpital Cardiologique du Haut-Lévêque, Bordeaux, France (F.S.). 14. Istituto Clinico Humanitas Mater Domini, Castellanza, Italy (M.T.). 15. Azienda Sanitaria Universitaria Friuli Centrale (ASUFC), Udine, Italy (L.R.). 16. Herz-und Gefäss-Klinik, Bad Neustadt, Germany (T.D.). 17. Clinical Unit, Biotronik Italia, Milan, Italy (A.G., D.G.). 18. Department of Cardiac, Thoracic, Vascular Sciences & Public Health, University of Padova, Italy (D.G.).
Abstract
BACKGROUND: Optimal timing for catheter ablation of ventricular tachycardia is an important unresolved issue. There are no randomized trials evaluating the benefit of ablation after the first implantable cardioverter defibrillator (ICD) shock. METHODS: We conducted a 2-phase, prospective, multicenter, randomized clinical trial. Patients with ischemic or nonischemic dilated cardiomyopathy and primary or secondary prevention indication for ICD were enrolled in an initial observational phase until first appropriate shock (phase A). After reconsenting, patients were randomly assigned 1:1 in phase B to immediate ablation (within 2 months from shock delivery) or continuation of standard therapy. The primary end point was a composite of death from any cause or hospitalization for worsening heart failure. Amiodarone intake was not allowed except for documented atrial tachyarrhythmias. On July 23, 2021, phase B of the trial was interrupted as a result of the first interim analysis on the basis of the Bayesian adaptive design. RESULTS: Of the 517 patients enrolled in phase A, 154 (30%) had ventricular tachycardia, 56 (11%) received an appropriate shock over a median follow-up of 2.4 years (interquartile range, 1.4-4.4), and 47 of 56 (84%) agreed to participate in phase B. After 24.2 (8.5-24.4) months, the primary end point occurred in 1 of 23 (4%) patients in the ablation group and 10 of 24 (42%) patients in the control group (hazard ratio, 0.11 [95% CI, 0.01-0.85]; P=0.034). The results met the prespecified termination criterion of >99% Bayesian posterior probability of superiority of treatment over standard therapy. No deaths were observed in the ablation group versus 8 deaths (33%) in the control group (P=0.004); there was 1 worsening heart failure hospitalization in the ablation group (4%) versus 4 in the control group (17%; P=0.159). ICD shocks were less frequent in the ablation group (9%) than in the control group (42%; P=0.039). CONCLUSIONS: Ventricular tachycardia ablation after first appropriate shock was associated with a reduced risk of the combined death or worsening heart failure hospitalization end point, lower mortality, and fewer ICD shocks. These findings provide support for considering ventricular tachycardia ablation after the first ICD shock. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT01547208.
BACKGROUND: Optimal timing for catheter ablation of ventricular tachycardia is an important unresolved issue. There are no randomized trials evaluating the benefit of ablation after the first implantable cardioverter defibrillator (ICD) shock. METHODS: We conducted a 2-phase, prospective, multicenter, randomized clinical trial. Patients with ischemic or nonischemic dilated cardiomyopathy and primary or secondary prevention indication for ICD were enrolled in an initial observational phase until first appropriate shock (phase A). After reconsenting, patients were randomly assigned 1:1 in phase B to immediate ablation (within 2 months from shock delivery) or continuation of standard therapy. The primary end point was a composite of death from any cause or hospitalization for worsening heart failure. Amiodarone intake was not allowed except for documented atrial tachyarrhythmias. On July 23, 2021, phase B of the trial was interrupted as a result of the first interim analysis on the basis of the Bayesian adaptive design. RESULTS: Of the 517 patients enrolled in phase A, 154 (30%) had ventricular tachycardia, 56 (11%) received an appropriate shock over a median follow-up of 2.4 years (interquartile range, 1.4-4.4), and 47 of 56 (84%) agreed to participate in phase B. After 24.2 (8.5-24.4) months, the primary end point occurred in 1 of 23 (4%) patients in the ablation group and 10 of 24 (42%) patients in the control group (hazard ratio, 0.11 [95% CI, 0.01-0.85]; P=0.034). The results met the prespecified termination criterion of >99% Bayesian posterior probability of superiority of treatment over standard therapy. No deaths were observed in the ablation group versus 8 deaths (33%) in the control group (P=0.004); there was 1 worsening heart failure hospitalization in the ablation group (4%) versus 4 in the control group (17%; P=0.159). ICD shocks were less frequent in the ablation group (9%) than in the control group (42%; P=0.039). CONCLUSIONS: Ventricular tachycardia ablation after first appropriate shock was associated with a reduced risk of the combined death or worsening heart failure hospitalization end point, lower mortality, and fewer ICD shocks. These findings provide support for considering ventricular tachycardia ablation after the first ICD shock. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT01547208.