Survival and arrhythmic risk among ischemic and non-ischemic heart failure patients with prophylactic implantable cardioverter defibrillator only therapy: A propensity score-matched analysis
Introduction
Prophylactic implantable cardioverter defibrillator (ICD) is a leading therapy in preventing sudden cardiac death (SCD) in heart failure (HF) patients with impaired left ventricular ejection fraction (LVEF) [1]. Randomized clinical trials (RCTs) have consistently shown that ICD therapy reduces morbidity and mortality as part of primary prevention strategy [[2], [3], [4], [5]]. Nevertheless, concerns about the benefit in non-ischemic HF patients emerged since the first trials, as sudden death from arrhythmia but not all cause mortality was decreased by prophylactic implantation in non-ischemic cardiomyopathy (NICM) patients [3,6]. The discussion arose again, particularly after the publication of the DANISH trial, in which ICD did not significantly decrease the rates of all-cause death in NICM patients, even though SCD was effectively reduced [7]. The addition of cardiac resynchronization therapy (CRT) to an ICD device (58% of patients in both arms of DANISH trial carried CRT devices) not only modifies the possibilities to improve LVEF, especially in non-ischemic candidates, but can also reduce morbidity and mortality outcomes [[8], [9], [10], [11]]. Pooled data from meta-analysis demonstrated, even after elimination of CRT trials, that ICD-only therapy accomplished a reduction in total mortality ranging between 26% and 31% in NICM patients [12,13]. Translation of this evidence into real-world increased the controversy, as several reports suggested that the efficacy of prophylactic ICD for HF patients with reduced LVEF seemed to be similar among RCTs and clinical practice. However, the same problem appeared, as population in these studies is heterogeneous and all of them include patients with wide QRS and high percentages of CRT carriers [[14], [15], [16], [17], [18]].
The present study tries to assess whether survival differs between ischemic and non-ischemic HF patients after ICD implant for primary prevention strategy. We also sought to define the rates of all-cause death and arrhythmia free survival, along with factors to be predictive of both events in a real-life cohort of ICD-only candidates (narrow QRS complex). Finally we try to look for specific predictors of mortality in ischemic and non-ischemic populations.
Section snippets
Patient selection
The present study was developed within the framework of the Scientific Cooperation Platform (SCOOP) supported within the UMBRELLA observational study (ClinicalTrials.gov/NCT01561144), which is a voluntary registry promoted by Medtronic Iberica that includes patients with Medtronic ICDs and follows them by remote monitoring (CareLink®) for both primary and secondary prevention. The institutional review board of the participating centers approved patient inclusion and all patients provided
Patient characteristics
We identified 782 patients in the UMBRELLA database who met the inclusion criteria and none of the exclusion criteria. First ICD implantation was performed from March 2006 until August 2015 in 23 different Spanish hospitals. Ischemic cardiomyopathy (ICM) accounted for 556 patients (71% of total population) while NICM was the etiology in the remaining 226 cases (29%). The baseline clinical characteristics of the overall population and propensity-matched patients are summarized in Table 1. As
Discussion
The present study composed of a nationwide cohort of ICD-only patients focuses on the prognostic role that cardiomyopathy etiology plays regarding all-cause death and arrhythmic risk. All-cause mortality rates among ischemic and non-ischemic HF patients, receiving an ICD for primary prevention, were similar. Predictors of all-cause mortality were age, COPD, DM and previous HF admission, for the entire population, whereas AF and CKD were associated with death only in NICM patients. Moreover,
Conclusions
All-cause death and arrhythmia free survival among ischemic and non-ischemic HF patients undergoing ICD-only implant for primary prevention strategy are similar. Thus the benefit should not be restricted to ischemic patients. Age, DM and COPD strongly predict an increased mortality risk, whereas AF and CKD emerged as specific predictors in NICM patients. Although appropriate ICD therapies were associated with a lower survival, delayed programming appeared as a protective factor.
In HF patients
Disclosures
None of the authors declare any potential conflict of interest.
Funding sources
No funding sources were needed.
Acknowledgments
The authors acknowledge the Spanish Scoop team, especially Alba García, Esther Sastre, and Cristina Álvarez.
References (31)
- et al.
Prediction of mortality in clinical practice for medicare patients undergoing defibrillator implantation for primary prevention of sudden cardiac death
J. Am. Coll. Cardiol.
(2012) - et al.
Development and validation of a risk score to predict early mortality in recipients of implantable cardioverter-defibrillators
Heart Rhythm
(2012) - et al.
Temporal trends in long-term mortality of patients with acute heart failure: data from 1985–2008
Int. J. Cardiol. Neth.
(2016) - et al.
Risk stratification for primary implantation of a cardioverter-defibrillator in patients with ischemic left ventricular dysfunction
J. Am. Coll. Cardiol.
(2008) - et al.
Applicability of a risk score for prediction of the long-term (8-year) benefit of the implantable cardioverter-defibrillator
J. Am. Coll. Cardiol.
(2012) - et al.
Myocardial tissue characterization by cardiac magnetic resonance imaging using T1 mapping predicts ventricular arrhythmia in ischemic and non-ischemic cardiomyopathy patients with implantable cardioverter-defibrillators
Heart Rhythm
(2015) - et al.
Factors influencing appropriate firing of the implanted defibrillator for ventricular tachycardia/fibrillation: findings from the Multicenter Automatic Defibrillator Implantation Trial II (MADIT-II)
J. Am. Coll. Cardiol.
(2005) - et al.
Strategic programming of detection and therapy parameters in implantable cardioverter-defibrillators reduces shocks in primary prevention patients: results from the PREPARE (Primary Prevention Parameters Evaluation) study
J. Am. Coll. Cardiol.
(2008) - et al.
Impact of prolonged implantable cardioverter-defibrillator arrhythmia detection times on outcomes: a meta-analysis
Heart Rhythm
(2014) - et al.
ESC guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: the task force for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death of the Europe
Eur. Heart J. Engl.
(2015)
Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction
N. Engl. J. Med.
Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure
N. Engl. J. Med.
A randomized study of the prevention of sudden death in patients with coronary artery disease. Multicenter Unsustained Tachycardia Trial Investigators
N. Engl. J. Med.
Improved survival with an implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmia. Multicenter Automatic Defibrillator Implantation Trial Investigators
N. Engl. J. Med.
Prophylactic defibrillator implantation in patients with nonischemic dilated cardiomyopathy
N. Engl. J. Med.
Cited by (2)
Comparison of Mortality and Readmission in Non-Ischemic Versus Ischemic Cardiomyopathy After Implantable Cardioverter-Defibrillator Implantation
2020, American Journal of CardiologyCitation Excerpt :Our results were consistent with those of a recent smaller and more limited study of approximately 5,000 patients (2,181 with NICM and 3,304 with ICM) that found higher mortality in ICM patients that persisted in multivariable analysis (adjusted HR 1.31, CI 1.06 to 1.61, p = 0.01) and after propensity score matching.17 In contrast, a smaller study of 310 propensity-matched patients (556 with ICM and 226 with NICM) found no significant difference in mortality (19.4% vs 20%, p = 0.38),16 but had low statistical power for modest differences. Our study is larger than these previous studies, including 99,052 patients (68,458 ICM and 31,044 NICM) with greater statistical power to detect differences.
Long-term outcomes after prophylactic ICD and CRT-D implantation in nonischemic patients: Analysis from a nationwide database of daily remote-monitoring transmissions
2019, Journal of Cardiovascular Electrophysiology
- 1
This author takes responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation.