CarDiac magnEtic Resonance for prophylactic Implantable-cardioVerter defibrillAtor ThErapy in Non-Ischaemic dilated CardioMyopathy: an international Registry.
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Guaricci Andrea Igoren, Masci Pier Giorgio, Muscogiuri Giuseppe, Guglielmo Marco, Baggiano Andrea, Fusini Laura, Lorenzoni Valentina, Martini Chiara, Andreini Daniele, Pavon Anna Giulia, Aquaro Giovanni D, Barison Andrea, Todiere Giancarlo, Rabbat Mark G, Tat Emily, Raineri Claudia, Valentini Adele, Varga-Szemes Akos, Schoepf U Joseph, De Cecco Carlo N, Bogaert Jan, Dobrovie Monica, Symons Rolf, Focardi Marta, Gismondi Annalaura, Lozano-Torres Jordi, Rodriguez-Palomares Josè F, Lanzillo Chiara, Di Roma Mauro, Moro Claudio, Di Giovine Gabriella, Margonato Davide, De Lazzari Manuel, Perazzolo Marra Martina, Nese Alberto, Casavecchia Grazia, Gravina Matteo, Marzo Francesca, Carigi Samuela, Pica Silvia, Lombardi Massimo, Censi Stefano, Squeri Angelo, Palumbo Alessandro, Gaibazzi Nicola, Camastra Giovanni, Sbarbati Stefano, Pedrotti Patrizia, Masi Ambra, Carrabba Nazario, Pradella Silvia, Timpani Mauro, Cicala Gloria, Presicci Cristina, Puglisi Sara, Sverzellati Nicola, Santobuono Vincenzo Ezio, Pepi Mauro, Schwitter Juerg, Pontone Gianluca
Аннотация
METHODS AND RESULTS: In the DERIVATE registry (www.clinicaltrials.gov/registration: RCT#NCT03352648), 1000 (derivation cohort) and 508 (validation cohort) NICM patients with chronic heart failure (HF) and left ventricular ejection fraction <50% were included. All-cause mortality and major adverse arrhythmic cardiac events (MAACE) were the primary and secondary endpoints, respectively. During a median follow-up of 959 days, all-cause mortality and MAACE occurred in 72 (7%) and 93 (9%) patients, respectively. Age and >3 segments with midwall fibrosis on late gadolinium enhancement (LGE) were the only independent predictors of all-cause mortality (HR: 1.036, 95% CI: 1.0117-1.056, P < 0.001 and HR: 2.077, 95% CI: 1.211-3.562, P = 0.008, respectively). For MAACE, the independent predictors were male gender, left ventricular end-diastolic volume index by CMR (CMR-LVEDVi), and >3 segments with midwall fibrosis on LGE (HR: 2.131, 95% CI: 1.231-3.690, P = 0.007; HR: 3.161, 95% CI: 1.750-5.709, P < 0.001; and HR: 1.693, 95% CI: 1.084-2.644, P = 0.021, respectively). A composite clinical and CMR-based risk score provided a net reclassification improvement of 63.7% (P < 0.001) for MAACE occurrence when added to the model based on SOC evaluation. These findings were confirmed in the validation cohort.
CONCLUSION: In a large multicentre, multivendor cohort registry reflecting daily clinical practice in NICM work-up, a composite clinical and CMR-based risk score provides incremental prognostic value beyond SOC evaluation, which may have impact on the indication of implantable cardioverter-defibrillator implantation.