BACKGROUND: The recent expansion of indications for prophylactic implantable cardioverter-defibrillator (ICD) placement in subjects with nonischemic dilated cardiomyopathy has raised concerns about the cost-effectiveness of this therapy. OBJECTIVES: The purpose of this study was to identify low-risk patients with nonischemic dilated cardiomyopathy who may not require prophylactic ICD placement. METHODS: This was a prospective study of 274 participants in the Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) trial, a randomized controlled trial that evaluated the role of prophylactic ICD placement in patients with nonischemic dilated cardiomyopathy. The patients underwent 24-hour Holter recording for analysis of heart rate variability (HRV). The primary HRV variable was the standard deviation of normal R-R intervals (SDNN). Patients with atrial fibrillation and frequent ventricular ectopy (>25% of beats) were excluded from HRV analysis (23% of patients). SDNN was categorized in tertiles, and Kaplan-Meier analysis was performed to compare survival in the three tertiles and excluded patients. RESULTS:The study population was 73% male, with a mean age of 59 +/- 12 years and mean left ventricular ejection fraction of 21% +/- 6%. After 3-year follow-up, significant differences in mortality rates were observed: SDNN >113 ms: 0 (0%), SDNN 81-113 ms: 5 (7%), SDNN <81 ms: 7 (10%), excluded patients: 11 (17%) (P = .03). There were no deaths in the tertile with SDNN >113 ms regardless of treatment assignment (ICD vs control). CONCLUSION:Patients with nonischemic dilated cardiomyopathy and preserved HRV have an excellent prognosis and may not benefit from prophylactic ICD placement. Patients with severely depressed HRV and patients who are excluded from HRV analysis because of atrial fibrillation and frequent ventricular ectopy have the highest mortality.
RCT Entities:
BACKGROUND: The recent expansion of indications for prophylactic implantable cardioverter-defibrillator (ICD) placement in subjects with nonischemic dilated cardiomyopathy has raised concerns about the cost-effectiveness of this therapy. OBJECTIVES: The purpose of this study was to identify low-risk patients with nonischemic dilated cardiomyopathy who may not require prophylactic ICD placement. METHODS: This was a prospective study of 274 participants in the Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) trial, a randomized controlled trial that evaluated the role of prophylactic ICD placement in patients with nonischemic dilated cardiomyopathy. The patients underwent 24-hour Holter recording for analysis of heart rate variability (HRV). The primary HRV variable was the standard deviation of normal R-R intervals (SDNN). Patients with atrial fibrillation and frequent ventricular ectopy (>25% of beats) were excluded from HRV analysis (23% of patients). SDNN was categorized in tertiles, and Kaplan-Meier analysis was performed to compare survival in the three tertiles and excluded patients. RESULTS: The study population was 73% male, with a mean age of 59 +/- 12 years and mean left ventricular ejection fraction of 21% +/- 6%. After 3-year follow-up, significant differences in mortality rates were observed: SDNN >113 ms: 0 (0%), SDNN 81-113 ms: 5 (7%), SDNN <81 ms: 7 (10%), excluded patients: 11 (17%) (P = .03). There were no deaths in the tertile with SDNN >113 ms regardless of treatment assignment (ICD vs control). CONCLUSION:Patients with nonischemic dilated cardiomyopathy and preserved HRV have an excellent prognosis and may not benefit from prophylactic ICD placement. Patients with severely depressed HRV and patients who are excluded from HRV analysis because of atrial fibrillation and frequent ventricular ectopy have the highest mortality.
Authors: Tamara O Thomas; John L Jefferies; Angela Lorts; Jeffrey B Anderson; Zhiqian Gao; D Woodrow Benson; Kan N Hor; Linda H Cripe; Elaine M Urbina Journal: Pediatr Cardiol Date: 2014-11-16 Impact factor: 1.655
Authors: Jonathan S Steinberg; Niraj Varma; Iwona Cygankiewicz; Peter Aziz; Paweł Balsam; Adrian Baranchuk; Daniel J Cantillon; Polychronis Dilaveris; Sergio J Dubner; Nabil El-Sherif; Jaroslaw Krol; Malgorzata Kurpesa; Maria Teresa La Rovere; Suave S Lobodzinski; Emanuela T Locati; Suneet Mittal; Brian Olshansky; Ewa Piotrowicz; Leslie Saxon; Peter H Stone; Larisa Tereshchenko; Mintu P Turakhia; Gioia Turitto; Neil J Wimmer; Richard L Verrier; Wojciech Zareba; Ryszard Piotrowicz Journal: Ann Noninvasive Electrocardiol Date: 2017-05 Impact factor: 1.468
Authors: Deeptankar DeMazumder; Worawan B Limpitikul; Miguel Dorante; Swati Dey; Bhasha Mukhopadhyay; Yiyi Zhang; J Randall Moorman; Alan Cheng; Ronald D Berger; Eliseo Guallar; Steven R Jones; Gordon F Tomaselli Journal: Europace Date: 2016-04-04 Impact factor: 5.214