Cardiac Magnetic Resonance for Prophylactic Implantable-Cardioverter Defibrillator Therapy in Ischemic Cardiomyopathy: The DERIVATE–ICM International Registry

Gianluca Pontone; Andrea Igoren Guaricci; Laura Fusini; Andrea Baggiano; Marco Guglielmo; Giuseppe Muscogiuri; Alessandra Volpe; Raffaele Abete; Giovanni Aquaro; Andrea Barison; Jan Bogaert; Giovanni Camastra; Samuela Carigi; Nazario Carrabba; Grazia Casavecchia; Stefano Censi; Gloria Cicala; Carlo N. De Cecco; Manuel De Lazzari; Gabriella Di Giovine; Mauro Di Roma; Monica Dobrovie; Marta Focardi; Nicola Gaibazzi; Annalaura Gismondi; Matteo Gravina; Chiara Lanzillo; Massimo Lombardi; Valentina Lorenzoni; Jordi Lozano-Torres; Chiara Martini; Francesca Marzo; Ambra Masi; Riccardo Memeo; Claudio Moro; Alberto Nese; Alessandro Palumbo; Anna Giulia Pavon; Patrizia Pedrotti; Martina Perazzolo Marra; Silvia Pica; Silvia Pradella; Cristina Presicci; Mark G. Rabbat; Claudia Raineri; José F. Rodriguez-Palomares; Stefano Sbarbati; U. Joseph Schoepf; Angelo Squeri; Nicola Sverzellati; Rolf Symons; Emily Tat; Mauro Timpani; Giancarlo Todiere; Adele Valentini; Akos Varga-Szemes; Pier Giorgio Masci; Juerg Schwitter

doi:10.1016/j.jcmg.2023.03.015

Cardiac Magnetic Resonance for Prophylactic Implantable-Cardioverter Defibrillator Therapy in Ischemic Cardiomyopathy: The DERIVATE–ICM International Registry

Gianluca Pontone^*, Andrea Igoren Guaricci, Laura Fusini, Andrea Baggiano, Marco Guglielmo, Giuseppe Muscogiuri, Alessandra Volpe, Raffaele Abete, Giovanni Aquaro, Andrea Barison, Jan Bogaert, Giovanni Camastra, Samuela Carigi, Nazario Carrabba, Grazia Casavecchia, Stefano Censi, Gloria Cicala, Carlo N. De Cecco, Manuel De Lazzari, Gabriella Di GiovineMauro Di Roma, Monica Dobrovie, Marta Focardi, Nicola Gaibazzi, Annalaura Gismondi, Matteo Gravina, Chiara Lanzillo, Massimo Lombardi, Valentina Lorenzoni, Jordi Lozano-Torres, Chiara Martini, Francesca Marzo, Ambra Masi, Riccardo Memeo, Claudio Moro, Alberto Nese, Alessandro Palumbo, Anna Giulia Pavon, Patrizia Pedrotti, Martina Perazzolo Marra, Silvia Pica, Silvia Pradella, Cristina Presicci, Mark G. Rabbat, Claudia Raineri, José F. Rodriguez-Palomares, Stefano Sbarbati, U. Joseph Schoepf, Angelo Squeri, Nicola Sverzellati, Rolf Symons, Emily Tat, Mauro Timpani, Giancarlo Todiere, Adele Valentini, Akos Varga-Szemes, Pier Giorgio Masci, Juerg Schwitter

^*Corresponding author for this work

Imaging and Biomedical Engineering

Research output: Contribution to journal › Article › peer-review

18 Citations (Scopus)

Abstract

Background: Implantable cardioverter-defibrillator (ICD) therapy is the most effective prophylactic strategy against sudden cardiac death (SCD) in patients with ischemic cardiomyopathy (ICM) and left ventricle ejection fraction (LVEF) ≤35% as detected by transthoracic echocardiograpgy (TTE). This approach has been recently questioned because of the low rate of ICD interventions in patients who received implantation and the not-negligible percentage of patients who experienced SCD despite not fulfilling criteria for implantation. Objectives: The DERIVATE-ICM registry (CarDiac MagnEtic Resonance for Primary Prevention Implantable CardioVerter DebrillAtor ThErapy; NCT03352648) is an international, multicenter, and multivendor study to assess the net reclassification improvement (NRI) for the indication of ICD implantation by the use of cardiac magnetic resonance (CMR) as compared to TTE in patients with ICM. Methods: A total of 861 patients with ICM (mean age 65 ± 11 years, 86% male) with chronic heart failure and TTE-LVEF <50% participated. Major adverse arrhythmic cardiac events (MAACE) were the primary endpoints. Results: During a median follow-up of 1,054 days, MAACE occurred in 88 (10.2%). Left ventricular end-diastolic volume index (HR: 1.007 [95% CI: 1.000-1.011]; P = 0.05), CMR-LVEF (HR: 0.972 [95% CI: 0.945-0.999]; P = 0.045) and late gadolinium enhancement (LGE) mass (HR: 1.010 [95% CI: 1.002-1.018]; P = 0.015) were independent predictors of MAACE. A multiparametric CMR weighted predictive derived score identifies subjects at high risk for MAACE compared with TTE-LVEF cutoff of 35% with a NRI of 31.7% (P = 0.007). Conclusions: The DERIVATE-ICM registry is a large multicenter registry showing the additional value of CMR to stratify the risk for MAACE in a large cohort of patients with ICM compared with standard of care.

Original language	English
Pages (from-to)	1387-1400
Number of pages	14
Journal	JACC: Cardiovascular Imaging
Volume	16
Issue number	11
DOIs	https://doi.org/10.1016/j.jcmg.2023.03.015
Publication status	Published - Nov 2023

Keywords

cardiac magnetic resonance
heart failure
implantable cardioverter-defibrillator
ischemic dilated cardiomyopathy
primary prevention

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10.1016/j.jcmg.2023.03.015

Cite this

Pontone, G., Guaricci, A. I., Fusini, L., Baggiano, A., Guglielmo, M., Muscogiuri, G., Volpe, A., Abete, R., Aquaro, G., Barison, A., Bogaert, J., Camastra, G., Carigi, S., Carrabba, N., Casavecchia, G., Censi, S., Cicala, G., De Cecco, C. N., De Lazzari, M., ... Schwitter, J. (2023). Cardiac Magnetic Resonance for Prophylactic Implantable-Cardioverter Defibrillator Therapy in Ischemic Cardiomyopathy: The DERIVATE–ICM International Registry. JACC: Cardiovascular Imaging, 16(11), 1387-1400. https://doi.org/10.1016/j.jcmg.2023.03.015

@article{cffa5899fff1437cac3bfe119b42bfd7,

title = "Cardiac Magnetic Resonance for Prophylactic Implantable-Cardioverter Defibrillator Therapy in Ischemic Cardiomyopathy: The DERIVATE–ICM International Registry",

abstract = "Background: Implantable cardioverter-defibrillator (ICD) therapy is the most effective prophylactic strategy against sudden cardiac death (SCD) in patients with ischemic cardiomyopathy (ICM) and left ventricle ejection fraction (LVEF) ≤35% as detected by transthoracic echocardiograpgy (TTE). This approach has been recently questioned because of the low rate of ICD interventions in patients who received implantation and the not-negligible percentage of patients who experienced SCD despite not fulfilling criteria for implantation. Objectives: The DERIVATE-ICM registry (CarDiac MagnEtic Resonance for Primary Prevention Implantable CardioVerter DebrillAtor ThErapy; NCT03352648) is an international, multicenter, and multivendor study to assess the net reclassification improvement (NRI) for the indication of ICD implantation by the use of cardiac magnetic resonance (CMR) as compared to TTE in patients with ICM. Methods: A total of 861 patients with ICM (mean age 65 ± 11 years, 86% male) with chronic heart failure and TTE-LVEF <50% participated. Major adverse arrhythmic cardiac events (MAACE) were the primary endpoints. Results: During a median follow-up of 1,054 days, MAACE occurred in 88 (10.2%). Left ventricular end-diastolic volume index (HR: 1.007 [95% CI: 1.000-1.011]; P = 0.05), CMR-LVEF (HR: 0.972 [95% CI: 0.945-0.999]; P = 0.045) and late gadolinium enhancement (LGE) mass (HR: 1.010 [95% CI: 1.002-1.018]; P = 0.015) were independent predictors of MAACE. A multiparametric CMR weighted predictive derived score identifies subjects at high risk for MAACE compared with TTE-LVEF cutoff of 35% with a NRI of 31.7% (P = 0.007). Conclusions: The DERIVATE-ICM registry is a large multicenter registry showing the additional value of CMR to stratify the risk for MAACE in a large cohort of patients with ICM compared with standard of care.",

keywords = "cardiac magnetic resonance, heart failure, implantable cardioverter-defibrillator, ischemic dilated cardiomyopathy, primary prevention",

author = "Gianluca Pontone and Guaricci, {Andrea Igoren} and Laura Fusini and Andrea Baggiano and Marco Guglielmo and Giuseppe Muscogiuri and Alessandra Volpe and Raffaele Abete and Giovanni Aquaro and Andrea Barison and Jan Bogaert and Giovanni Camastra and Samuela Carigi and Nazario Carrabba and Grazia Casavecchia and Stefano Censi and Gloria Cicala and {De Cecco}, {Carlo N.} and {De Lazzari}, Manuel and {Di Giovine}, Gabriella and {Di Roma}, Mauro and Monica Dobrovie and Marta Focardi and Nicola Gaibazzi and Annalaura Gismondi and Matteo Gravina and Chiara Lanzillo and Massimo Lombardi and Valentina Lorenzoni and Jordi Lozano-Torres and Chiara Martini and Francesca Marzo and Ambra Masi and Riccardo Memeo and Claudio Moro and Alberto Nese and Alessandro Palumbo and Pavon, {Anna Giulia} and Patrizia Pedrotti and Marra, {Martina Perazzolo} and Silvia Pica and Silvia Pradella and Cristina Presicci and Rabbat, {Mark G.} and Claudia Raineri and Rodriguez-Palomares, {Jos{\'e} F.} and Stefano Sbarbati and Schoepf, {U. Joseph} and Angelo Squeri and Nicola Sverzellati and Rolf Symons and Emily Tat and Mauro Timpani and Giancarlo Todiere and Adele Valentini and Akos Varga-Szemes and Masci, {Pier Giorgio} and Juerg Schwitter",

note = "Funding Information: Further data will be generated by the PROFID (Implementation of Personalised Risk Prediction and Prevention of Sudden Cardiac Death After Myocardial Infarction) project 32 funded by the European Union in the setting of Horizon 2020 program. This project consists of 2 steps: 1) analysis of existing evidence from a large variety of different data sources, including national registries of postinfarction patients, registries of primary prevention ICD placement, electronic health records, and claims databases by a combination of traditional statistical methods and machine-learning techniques to develop an individual risk predictive model for SCD events; and 2) this model will be applied to large randomized clinical trials in patients with lower than and higher than 35% LVEF. Funding Information: The authors thank Giacomo Guasti, Gianmarco Avanzini, Viviana Pignatelli, Carlotta Marzi, Carlotta Milani, Francesco Bottazzo, Michael Orlandi, and Rosa Rendina (Parma); Caroline Ball (Chicago); Gerardo Ansalone (Rome); Guillem Casas (Barcelona); Riccardo Bentivegna (Palermo); Pavesi Claudia (Pavia); Toufic Khouri (Monza); Elisabetta Tonet (Ferrara); Tondi Lara (Milan); Luca Macarini (Foggia); Giovanni Rinaldi (Rimini); Renato Valenti (Florence); Benedetta Maria Natali (Siena); Claudia Zanetti (Padova); and Monia Minati (Rome). The authors extend a personal tribute to Dr Silvia Pica: a great doctor, imager, and woman. Publisher Copyright: {\textcopyright} 2023 American College of Cardiology Foundation",

year = "2023",

month = nov,

doi = "10.1016/j.jcmg.2023.03.015",

language = "English",

volume = "16",

pages = "1387--1400",

journal = "JACC: Cardiovascular Imaging",

issn = "1936-878X",

number = "11",

}

Pontone, G, Guaricci, AI, Fusini, L, Baggiano, A, Guglielmo, M, Muscogiuri, G, Volpe, A, Abete, R, Aquaro, G, Barison, A, Bogaert, J, Camastra, G, Carigi, S, Carrabba, N, Casavecchia, G, Censi, S, Cicala, G, De Cecco, CN, De Lazzari, M, Di Giovine, G, Di Roma, M, Dobrovie, M, Focardi, M, Gaibazzi, N, Gismondi, A, Gravina, M, Lanzillo, C, Lombardi, M, Lorenzoni, V, Lozano-Torres, J, Martini, C, Marzo, F, Masi, A, Memeo, R, Moro, C, Nese, A, Palumbo, A, Pavon, AG, Pedrotti, P, Marra, MP, Pica, S, Pradella, S, Presicci, C, Rabbat, MG, Raineri, C, Rodriguez-Palomares, JF, Sbarbati, S, Schoepf, UJ, Squeri, A, Sverzellati, N, Symons, R, Tat, E, Timpani, M, Todiere, G, Valentini, A, Varga-Szemes, A, Masci, PG & Schwitter, J 2023, 'Cardiac Magnetic Resonance for Prophylactic Implantable-Cardioverter Defibrillator Therapy in Ischemic Cardiomyopathy: The DERIVATE–ICM International Registry', JACC: Cardiovascular Imaging, vol. 16, no. 11, pp. 1387-1400. https://doi.org/10.1016/j.jcmg.2023.03.015

Cardiac Magnetic Resonance for Prophylactic Implantable-Cardioverter Defibrillator Therapy in Ischemic Cardiomyopathy: The DERIVATE–ICM International Registry. / Pontone, Gianluca; Guaricci, Andrea Igoren; Fusini, Laura et al.
In: JACC: Cardiovascular Imaging, Vol. 16, No. 11, 11.2023, p. 1387-1400.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Cardiac Magnetic Resonance for Prophylactic Implantable-Cardioverter Defibrillator Therapy in Ischemic Cardiomyopathy

T2 - The DERIVATE–ICM International Registry

AU - Pontone, Gianluca

AU - Guaricci, Andrea Igoren

AU - Fusini, Laura

AU - Baggiano, Andrea

AU - Guglielmo, Marco

AU - Muscogiuri, Giuseppe

AU - Volpe, Alessandra

AU - Abete, Raffaele

AU - Aquaro, Giovanni

AU - Barison, Andrea

AU - Bogaert, Jan

AU - Camastra, Giovanni

AU - Carigi, Samuela

AU - Carrabba, Nazario

AU - Casavecchia, Grazia

AU - Censi, Stefano

AU - Cicala, Gloria

AU - De Cecco, Carlo N.

AU - De Lazzari, Manuel

AU - Di Giovine, Gabriella

AU - Di Roma, Mauro

AU - Dobrovie, Monica

AU - Focardi, Marta

AU - Gaibazzi, Nicola

AU - Gismondi, Annalaura

AU - Gravina, Matteo

AU - Lanzillo, Chiara

AU - Lombardi, Massimo

AU - Lorenzoni, Valentina

AU - Lozano-Torres, Jordi

AU - Martini, Chiara

AU - Marzo, Francesca

AU - Masi, Ambra

AU - Memeo, Riccardo

AU - Moro, Claudio

AU - Nese, Alberto

AU - Palumbo, Alessandro

AU - Pavon, Anna Giulia

AU - Pedrotti, Patrizia

AU - Marra, Martina Perazzolo

AU - Pica, Silvia

AU - Pradella, Silvia

AU - Presicci, Cristina

AU - Rabbat, Mark G.

AU - Raineri, Claudia

AU - Rodriguez-Palomares, José F.

AU - Sbarbati, Stefano

AU - Schoepf, U. Joseph

AU - Squeri, Angelo

AU - Sverzellati, Nicola

AU - Symons, Rolf

AU - Tat, Emily

AU - Timpani, Mauro

AU - Todiere, Giancarlo

AU - Valentini, Adele

AU - Varga-Szemes, Akos

AU - Masci, Pier Giorgio

AU - Schwitter, Juerg

N1 - Funding Information: Further data will be generated by the PROFID (Implementation of Personalised Risk Prediction and Prevention of Sudden Cardiac Death After Myocardial Infarction) project 32 funded by the European Union in the setting of Horizon 2020 program. This project consists of 2 steps: 1) analysis of existing evidence from a large variety of different data sources, including national registries of postinfarction patients, registries of primary prevention ICD placement, electronic health records, and claims databases by a combination of traditional statistical methods and machine-learning techniques to develop an individual risk predictive model for SCD events; and 2) this model will be applied to large randomized clinical trials in patients with lower than and higher than 35% LVEF. Funding Information: The authors thank Giacomo Guasti, Gianmarco Avanzini, Viviana Pignatelli, Carlotta Marzi, Carlotta Milani, Francesco Bottazzo, Michael Orlandi, and Rosa Rendina (Parma); Caroline Ball (Chicago); Gerardo Ansalone (Rome); Guillem Casas (Barcelona); Riccardo Bentivegna (Palermo); Pavesi Claudia (Pavia); Toufic Khouri (Monza); Elisabetta Tonet (Ferrara); Tondi Lara (Milan); Luca Macarini (Foggia); Giovanni Rinaldi (Rimini); Renato Valenti (Florence); Benedetta Maria Natali (Siena); Claudia Zanetti (Padova); and Monia Minati (Rome). The authors extend a personal tribute to Dr Silvia Pica: a great doctor, imager, and woman. Publisher Copyright: © 2023 American College of Cardiology Foundation

PY - 2023/11

Y1 - 2023/11

N2 - Background: Implantable cardioverter-defibrillator (ICD) therapy is the most effective prophylactic strategy against sudden cardiac death (SCD) in patients with ischemic cardiomyopathy (ICM) and left ventricle ejection fraction (LVEF) ≤35% as detected by transthoracic echocardiograpgy (TTE). This approach has been recently questioned because of the low rate of ICD interventions in patients who received implantation and the not-negligible percentage of patients who experienced SCD despite not fulfilling criteria for implantation. Objectives: The DERIVATE-ICM registry (CarDiac MagnEtic Resonance for Primary Prevention Implantable CardioVerter DebrillAtor ThErapy; NCT03352648) is an international, multicenter, and multivendor study to assess the net reclassification improvement (NRI) for the indication of ICD implantation by the use of cardiac magnetic resonance (CMR) as compared to TTE in patients with ICM. Methods: A total of 861 patients with ICM (mean age 65 ± 11 years, 86% male) with chronic heart failure and TTE-LVEF <50% participated. Major adverse arrhythmic cardiac events (MAACE) were the primary endpoints. Results: During a median follow-up of 1,054 days, MAACE occurred in 88 (10.2%). Left ventricular end-diastolic volume index (HR: 1.007 [95% CI: 1.000-1.011]; P = 0.05), CMR-LVEF (HR: 0.972 [95% CI: 0.945-0.999]; P = 0.045) and late gadolinium enhancement (LGE) mass (HR: 1.010 [95% CI: 1.002-1.018]; P = 0.015) were independent predictors of MAACE. A multiparametric CMR weighted predictive derived score identifies subjects at high risk for MAACE compared with TTE-LVEF cutoff of 35% with a NRI of 31.7% (P = 0.007). Conclusions: The DERIVATE-ICM registry is a large multicenter registry showing the additional value of CMR to stratify the risk for MAACE in a large cohort of patients with ICM compared with standard of care.

AB - Background: Implantable cardioverter-defibrillator (ICD) therapy is the most effective prophylactic strategy against sudden cardiac death (SCD) in patients with ischemic cardiomyopathy (ICM) and left ventricle ejection fraction (LVEF) ≤35% as detected by transthoracic echocardiograpgy (TTE). This approach has been recently questioned because of the low rate of ICD interventions in patients who received implantation and the not-negligible percentage of patients who experienced SCD despite not fulfilling criteria for implantation. Objectives: The DERIVATE-ICM registry (CarDiac MagnEtic Resonance for Primary Prevention Implantable CardioVerter DebrillAtor ThErapy; NCT03352648) is an international, multicenter, and multivendor study to assess the net reclassification improvement (NRI) for the indication of ICD implantation by the use of cardiac magnetic resonance (CMR) as compared to TTE in patients with ICM. Methods: A total of 861 patients with ICM (mean age 65 ± 11 years, 86% male) with chronic heart failure and TTE-LVEF <50% participated. Major adverse arrhythmic cardiac events (MAACE) were the primary endpoints. Results: During a median follow-up of 1,054 days, MAACE occurred in 88 (10.2%). Left ventricular end-diastolic volume index (HR: 1.007 [95% CI: 1.000-1.011]; P = 0.05), CMR-LVEF (HR: 0.972 [95% CI: 0.945-0.999]; P = 0.045) and late gadolinium enhancement (LGE) mass (HR: 1.010 [95% CI: 1.002-1.018]; P = 0.015) were independent predictors of MAACE. A multiparametric CMR weighted predictive derived score identifies subjects at high risk for MAACE compared with TTE-LVEF cutoff of 35% with a NRI of 31.7% (P = 0.007). Conclusions: The DERIVATE-ICM registry is a large multicenter registry showing the additional value of CMR to stratify the risk for MAACE in a large cohort of patients with ICM compared with standard of care.

KW - cardiac magnetic resonance

KW - heart failure

KW - implantable cardioverter-defibrillator

KW - ischemic dilated cardiomyopathy

KW - primary prevention

UR - http://www.scopus.com/inward/record.url?scp=85164622311&partnerID=8YFLogxK

U2 - 10.1016/j.jcmg.2023.03.015

DO - 10.1016/j.jcmg.2023.03.015

M3 - Article

C2 - 37227329

AN - SCOPUS:85164622311

SN - 1936-878X

VL - 16

SP - 1387

EP - 1400

JO - JACC: Cardiovascular Imaging

JF - JACC: Cardiovascular Imaging

IS - 11

ER -

Cardiac Magnetic Resonance for Prophylactic Implantable-Cardioverter Defibrillator Therapy in Ischemic Cardiomyopathy: The DERIVATE–ICM International Registry

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