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

Gianluca Pontone¹, Andrea Igoren Guaricci², Laura Fusini³, Andrea Baggiano⁴, Marco Guglielmo⁵, Giuseppe Muscogiuri⁵, Alessandra Volpe⁵, Raffaele Abete⁶, Giovanni Aquaro⁷, Andrea Barison⁷, Jan Bogaert⁸, Giovanni Camastra⁹, Samuela Carigi¹⁰, Nazario Carrabba¹¹, Grazia Casavecchia¹², Stefano Censi¹³, Gloria Cicala¹⁴, Carlo N De Cecco¹⁵, Manuel De Lazzari¹⁶, Gabriella Di Giovine⁶, Mauro Di Roma¹⁷, Monica Dobrovie⁸, Marta Focardi¹⁸, Nicola Gaibazzi¹⁹, Annalaura Gismondi¹⁸, Matteo Gravina²⁰, Chiara Lanzillo²¹, Massimo Lombardi²², Valentina Lorenzoni²³, Jordi Lozano-Torres²⁴, Chiara Martini²⁵, Francesca Marzo¹⁰, Ambra Masi²⁶, Riccardo Memeo²⁷, Claudio Moro²⁸, Alberto Nese²⁹, Alessandro Palumbo¹⁴, Anna Giulia Pavon³⁰, Patrizia Pedrotti²⁶, Martina Perazzolo Marra¹⁶, Silvia Pica²², Silvia Pradella³¹, Cristina Presicci¹⁴, Mark G Rabbat³², Claudia Raineri³³, José F Rodriguez-Palomares²⁴, Stefano Sbarbati³⁴, U Joseph Schoepf³⁵, Angelo Squeri¹³, Nicola Sverzellati¹⁴, Rolf Symons⁸, Emily Tat³⁶, Mauro Timpani³⁷, Giancarlo Todiere⁷, Adele Valentini³⁸, Akos Varga-Szemes³⁵, Pier-Giorgio Masci³⁹, Juerg Schwitter⁴⁰

Affiliations

¹ Centro Cardiologico Monzino IRCCS, Milan, Italy; Department of Biomedical, Surgical and Dental Sciences, University of Milan, Milan, Italy. Electronic address: gianluca.pontone@ccfm.it.
² University Cardiology Unit, Interdisciplinary Department of Medicine, University of Bari Aldo Moro, Bari, Italy.
³ Centro Cardiologico Monzino IRCCS, Milan, Italy; Department of Electronics, Information and Bioengineering, Politecnico di Milano, Milan, Italy.
⁴ Centro Cardiologico Monzino IRCCS, Milan, Italy; Cardiovascular Section, Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.
⁵ Centro Cardiologico Monzino IRCCS, Milan, Italy.
⁶ Department of Cardiology, Policlinico di Monza, Monza, Italy.
⁷ U.O.C. Risonanza Magnetica per Immagini, Fondazione G. Monasterio CNR-Regione Toscana Pisa, Pisa, Italy.
⁸ Department of Radiology, University Hospital Leuven, Leuven, Belgium.
⁹ Cardiac Department, Vannini Hospital Rome, Rome, Italy.
¹⁰ Department of Cardiology, Infermi Hospital, Rimini, Italy.
¹¹ Cardiovascular and Thoracic Department, Careggi Hospital, Florence, Italy.
¹² Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy.
¹³ Maria Cecilia Hospital, GVM Care and Research, Cotignola (RA), Italy.
¹⁴ Scienze Radiologiche, Department of Medicine and Surgery, University of Parma, Parma, Italy.
¹⁵ Division of Cardiothoracic Imaging, Emory University, Atlanta, Georgia, USA.
¹⁶ Department of Cardiac, Thoracic, Vascular Sciences and Public Health University of Padua Medical School, Padova, Italy.
¹⁷ Radiology Department, Policlinico Casilino, Rome, Italy.
¹⁸ Department of Medical Biotechnologies, Division of Cardiology, University of Siena, Siena, Italy.
¹⁹ Department of Cardiology, Azienda Ospedaliero-Universitaria, Parma, Italy.
²⁰ Department of Radiology, University of Foggia, Foggia, Italy.
²¹ Cardiology Department, Policlinico Casilino, Rome, Italy.
²² Multimodality Cardiac Imaging Section, IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy.
²³ Institute of Management, Scuola Superiore Sant'Anna, Pisa, Italy.
²⁴ Hospital Universitari Vall d'Hebron, Department of Cardiology, Vall d'Hebron Institut de Recerca (VHIR), Universitat Autònoma de Barcelona, Barcelona, Spain, Centro de Investigación Biomédica en Red-CV, CIBER CV, Spain.
²⁵ Department of Diagnostic, Parma University Hospital, Parma, Italy; Department of Medicine and Surgery, University of Parma, Parma, Italy.
²⁶ De Gasperis' Cardio Center, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.
²⁷ Department of Biomedical, Surgical and Dental Sciences, University of Milan, Milan, Italy.
²⁸ Department of Cardiology, ASST Monza, P.O. Desio, Italy.
²⁹ Dipartimento Neuro-Cardiovascolare, Ospedale Ca' Foncello Treviso, Treviso, Italy.
³⁰ Cardiovascular Department, CMR Center, University Hospital Lausanne, CHUV, Lausanne, Switzerland.
³¹ Department of Radiology, Careggi Hospital, Florence, Italy.
³² Loyola University of Chicago, Chicago, Illinois, USA; Edward Hines Jr VA Hospital, Hines, Illinois, USA.
³³ Cardiovascular Section, Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.
³⁴ Radiology Department, Vannini Hospital Rome, Rome, Italy.
³⁵ Division of Cardiovascular Imaging, Department of Radiology and Radiological Science, Medical University of South Carolina, Charleston, South Carolina, USA.
³⁶ Loyola University of Chicago, Chicago, Illinois, USA.
³⁷ U.O.C. Radiologia, "F. Spaziani" Hospital, Frosinone, Italy.
³⁸ Department of Radiology, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.
³⁹ School of Biomedical Engineering and Imaging Sciences, King's College London, London, United Kingdom.
⁴⁰ Cardiovascular Department, CMR Center, University Hospital Lausanne, CHUV, Lausanne, Switzerland; Faculty of Medicine and Biology, University of Lausanne, UniL, Lausanne, Switzerland.

PMID: 37227329
DOI: 10.1016/j.jcmg.2023.03.015

Free article

Multicenter Study

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

Gianluca Pontone et al. JACC Cardiovasc Imaging. 2023 Nov.

Free article

. 2023 Nov;16(11):1387-1400.

doi: 10.1016/j.jcmg.2023.03.015. Epub 2023 May 24.

Authors

Affiliations

¹ Centro Cardiologico Monzino IRCCS, Milan, Italy; Department of Biomedical, Surgical and Dental Sciences, University of Milan, Milan, Italy. Electronic address: gianluca.pontone@ccfm.it.
² University Cardiology Unit, Interdisciplinary Department of Medicine, University of Bari Aldo Moro, Bari, Italy.
³ Centro Cardiologico Monzino IRCCS, Milan, Italy; Department of Electronics, Information and Bioengineering, Politecnico di Milano, Milan, Italy.
⁴ Centro Cardiologico Monzino IRCCS, Milan, Italy; Cardiovascular Section, Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.
⁵ Centro Cardiologico Monzino IRCCS, Milan, Italy.
⁶ Department of Cardiology, Policlinico di Monza, Monza, Italy.
⁷ U.O.C. Risonanza Magnetica per Immagini, Fondazione G. Monasterio CNR-Regione Toscana Pisa, Pisa, Italy.
⁸ Department of Radiology, University Hospital Leuven, Leuven, Belgium.
⁹ Cardiac Department, Vannini Hospital Rome, Rome, Italy.
¹⁰ Department of Cardiology, Infermi Hospital, Rimini, Italy.
¹¹ Cardiovascular and Thoracic Department, Careggi Hospital, Florence, Italy.
¹² Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy.
¹³ Maria Cecilia Hospital, GVM Care and Research, Cotignola (RA), Italy.
¹⁴ Scienze Radiologiche, Department of Medicine and Surgery, University of Parma, Parma, Italy.
¹⁵ Division of Cardiothoracic Imaging, Emory University, Atlanta, Georgia, USA.
¹⁶ Department of Cardiac, Thoracic, Vascular Sciences and Public Health University of Padua Medical School, Padova, Italy.
¹⁷ Radiology Department, Policlinico Casilino, Rome, Italy.
¹⁸ Department of Medical Biotechnologies, Division of Cardiology, University of Siena, Siena, Italy.
¹⁹ Department of Cardiology, Azienda Ospedaliero-Universitaria, Parma, Italy.
²⁰ Department of Radiology, University of Foggia, Foggia, Italy.
²¹ Cardiology Department, Policlinico Casilino, Rome, Italy.
²² Multimodality Cardiac Imaging Section, IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy.
²³ Institute of Management, Scuola Superiore Sant'Anna, Pisa, Italy.
²⁴ Hospital Universitari Vall d'Hebron, Department of Cardiology, Vall d'Hebron Institut de Recerca (VHIR), Universitat Autònoma de Barcelona, Barcelona, Spain, Centro de Investigación Biomédica en Red-CV, CIBER CV, Spain.
²⁵ Department of Diagnostic, Parma University Hospital, Parma, Italy; Department of Medicine and Surgery, University of Parma, Parma, Italy.
²⁶ De Gasperis' Cardio Center, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.
²⁷ Department of Biomedical, Surgical and Dental Sciences, University of Milan, Milan, Italy.
²⁸ Department of Cardiology, ASST Monza, P.O. Desio, Italy.
²⁹ Dipartimento Neuro-Cardiovascolare, Ospedale Ca' Foncello Treviso, Treviso, Italy.
³⁰ Cardiovascular Department, CMR Center, University Hospital Lausanne, CHUV, Lausanne, Switzerland.
³¹ Department of Radiology, Careggi Hospital, Florence, Italy.
³² Loyola University of Chicago, Chicago, Illinois, USA; Edward Hines Jr VA Hospital, Hines, Illinois, USA.
³³ Cardiovascular Section, Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.
³⁴ Radiology Department, Vannini Hospital Rome, Rome, Italy.
³⁵ Division of Cardiovascular Imaging, Department of Radiology and Radiological Science, Medical University of South Carolina, Charleston, South Carolina, USA.
³⁶ Loyola University of Chicago, Chicago, Illinois, USA.
³⁷ U.O.C. Radiologia, "F. Spaziani" Hospital, Frosinone, Italy.
³⁸ Department of Radiology, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.
³⁹ School of Biomedical Engineering and Imaging Sciences, King's College London, London, United Kingdom.
⁴⁰ Cardiovascular Department, CMR Center, University Hospital Lausanne, CHUV, Lausanne, Switzerland; Faculty of Medicine and Biology, University of Lausanne, UniL, Lausanne, Switzerland.

PMID: 37227329
DOI: 10.1016/j.jcmg.2023.03.015

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.

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Conflict of interest statement

Funding Support and Author Disclosures The Italian Ministry of Health, Rome, Italy (RC 2017 R659/17-CCM698) has provided funding for this study. Dr De Cecco has received a grant from Siemens. Dr Pontone has received institutional fees from General Electric, Bracco, Heartflow, Medtronic, Bayer, and Bhoeringher. Dr Schwitter has received research support from Bayer Healthcare Switzerland. Dr Schoepf has received grants from Astellas, Bayer, General Electric, and Siemens Healthcare; personal fees from Guerbet; and speaking honoraria from Heartflow. Dr Varga-Szemes has received grants from Siemens Healthcare and personal fees from Elucid Bioimaging. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Comment in

Improving Risk Stratification of Sudden Death in Cardiomyopathy: Can Magnetic Resonance Help Beyond Ejection Fraction?
Chahal CAA, Khanji MY. Chahal CAA, et al. JACC Cardiovasc Imaging. 2023 Nov;16(11):1401-1403. doi: 10.1016/j.jcmg.2023.06.009. Epub 2023 Jul 19. JACC Cardiovasc Imaging. 2023. PMID: 37480905 No abstract available.

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

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

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Conflict of interest statement

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