Does Timing of Ventricular Tachycardia Ablation Affect Prognosis in Patients With an Implantable Cardioverter Defibrillator? Results From the Multicenter Randomized PARTITA Trial.


Journal

Circulation
ISSN: 1524-4539
Titre abrégé: Circulation
Pays: United States
ID NLM: 0147763

Informations de publication

Date de publication:
21 06 2022
Historique:
pubmed: 5 4 2022
medline: 24 6 2022
entrez: 4 4 2022
Statut: ppublish

Résumé

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. 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. 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]; 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. URL: https://www. gov; Unique identifier: NCT01547208.

Sections du résumé

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];
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.

Identifiants

pubmed: 35369700
doi: 10.1161/CIRCULATIONAHA.122.059598
doi:

Banques de données

ClinicalTrials.gov
['NCT01547208']

Types de publication

Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1829-1838

Commentaires et corrections

Type : CommentIn
Type : CommentIn
Type : CommentIn

Auteurs

Paolo Della Bella (P)

Department of Cardiac Electrophysiology and Arrhythmology, San Raffaele University Hospital, Milan, Italy (P.D.B., F.B., P.V., G.P., A.R.).

Francesca Baratto (F)

Department of Cardiac Electrophysiology and Arrhythmology, San Raffaele University Hospital, Milan, Italy (P.D.B., F.B., P.V., G.P., A.R.).

Pasquale Vergara (P)

Department of Cardiac Electrophysiology and Arrhythmology, San Raffaele University Hospital, Milan, Italy (P.D.B., F.B., P.V., G.P., A.R.).

Patrizia Bertocchi (P)

Cardiology Department, Ospedale di Desio, Italy (P.B., S.A.R.).

Matteo Santamaria (M)

Cardiology Department, Ospedale Gemelli Molise, Campobasso, Italy (M.S.).

Pasquale Notarstefano (P)

Cardiology Department, Ospedale San Donato, Arezzo, Italy (P.N., M.N.).

Leonardo Calò (L)

Cardiology Department, Policlinico Casilino, Rome, Italy (L.C.).

Daniela Orsida (D)

Cardiology Department, A.O. Sant'Antonio Abate, Gallarate, Italy (D.O.).

Luca Tomasi (L)

Cardiology Department, Azienda Ospedaliera Universitaria Integrata Verona, Italy (L.T.).

Marcello Piacenti (M)

Cardiology Department, Fondazione G. Monasterio, Pisa, Italy (M.P.).

Stefano Sangiorgio (S)

Cardiology Department, A.O. Valtellina e Valchiavenna, Sondrio, Italy (S.S.).

Francesco Pentimalli (F)

S.S. di Elettrofisiologia Cardiaca, S.C. di Cardiologia, Ospedale S. Paolo-Savona, Italy (F.P.).

Etienne Pruvot (E)

Lausanne Hospital, Switzerland (E.P.).

João De Sousa (J)

Cardiology Department, Santa Maria University Hospital, Lisboa, Portugal (J.D.S.).

Frederic Sacher (F)

Hôpital Cardiologique du Haut-Lévêque, Bordeaux, France (F.S.).

Massimo Tritto (M)

Istituto Clinico Humanitas Mater Domini, Castellanza, Italy (M.T.).

Luca Rebellato (L)

Azienda Sanitaria Universitaria Friuli Centrale (ASUFC), Udine, Italy (L.R.).

Thomas Deneke (T)

Herz-und Gefäss-Klinik, Bad Neustadt, Germany (T.D.).

Salvo Andrea Romano (SA)

Cardiology Department, Ospedale di Desio, Italy (P.B., S.A.R.).

Martina Nesti (M)

Cardiology Department, Ospedale San Donato, Arezzo, Italy (P.N., M.N.).

Alessio Gargaro (A)

Clinical Unit, Biotronik Italia, Milan, Italy (A.G., D.G.).

Daniele Giacopelli (D)

Clinical Unit, Biotronik Italia, Milan, Italy (A.G., D.G.).
Department of Cardiac, Thoracic, Vascular Sciences & Public Health, University of Padova, Italy (D.G.).

Giovanni Peretto (G)

Department of Cardiac Electrophysiology and Arrhythmology, San Raffaele University Hospital, Milan, Italy (P.D.B., F.B., P.V., G.P., A.R.).

Andrea Radinovic (A)

Department of Cardiac Electrophysiology and Arrhythmology, San Raffaele University Hospital, Milan, Italy (P.D.B., F.B., P.V., G.P., A.R.).

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