scholarly journals Clinical effectiveness of primary prevention implantable cardioverter-defibrillators: results of the EU-CERT-ICD controlled multicentre cohort study

2020 ◽  
Vol 41 (36) ◽  
pp. 3437-3447 ◽  
Author(s):  
Markus Zabel ◽  
Rik Willems ◽  
Andrzej Lubinski ◽  
Axel Bauer ◽  
Josep Brugada ◽  
...  
Keyword(s):  
Cohort Study ◽  
Primary Prevention ◽  
Clinical Effectiveness ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Chronic Obstructive ◽  
Implantable Cardioverter Defibrillators ◽  
Icd Implantation ◽  
Ventricular Ejection Fraction ◽  
Cardioverter Defibrillators

Abstract Aims The EUropean Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter-Defibrillators (EU-CERT-ICD), a prospective investigator-initiated, controlled cohort study, was conducted in 44 centres and 15 European countries. It aimed to assess current clinical effectiveness of primary prevention ICD therapy. Methods and results We recruited 2327 patients with ischaemic cardiomyopathy (ICM) or dilated cardiomyopathy (DCM) and guideline indications for prophylactic ICD implantation. Primary endpoint was all-cause mortality. Clinical characteristics, medications, resting, and 12-lead Holter electrocardiograms (ECGs) were documented at enrolment baseline. Baseline and follow-up (FU) data from 2247 patients were analysable, 1516 patients before first ICD implantation (ICD group) and 731 patients without ICD serving as controls. Multivariable models and propensity scoring for adjustment were used to compare the two groups for mortality. During mean FU of 2.4 ± 1.1 years, 342 deaths occurred (6.3%/years annualized mortality, 5.6%/years in the ICD group vs. 9.2%/years in controls), favouring ICD treatment [unadjusted hazard ratio (HR) 0.682, 95% confidence interval (CI) 0.537–0.865, P = 0.0016]. Multivariable mortality predictors included age, left ventricular ejection fraction (LVEF), New York Heart Association class <III, and chronic obstructive pulmonary disease. Adjusted mortality associated with ICD vs. control was 27% lower (HR 0.731, 95% CI 0.569–0.938, P = 0.0140). Subgroup analyses indicated no ICD benefit in diabetics (adjusted HR = 0.945, P = 0.7797, P for interaction = 0.0887) or those aged ≥75 years (adjusted HR 1.063, P = 0.8206, P for interaction = 0.0902). Conclusion In contemporary ICM/DCM patients (LVEF ≤35%, narrow QRS), primary prophylactic ICD treatment was associated with a 27% lower mortality after adjustment. There appear to be patients with less survival advantage, such as older patients or diabetics.

Abstract 107: Predictors and Frequency of ICD Implantation for Primary Prevention in ICD Eligible Patients: Results from a Prospective Multicenter Registry

2012 ◽  
Vol 5 (suppl_1) ◽  
Author(s):  
Rory Hachamovitch ◽  
Benjamin Nutter ◽  
Manuel D Cerqueira ◽  
Keyword(s):  
Heart Failure ◽  
Primary Prevention ◽  
Left Ventricular ◽  
Myocardial Imaging ◽  
Left Ventricular Ejection ◽  
Study Cohort ◽  
Icd Implantation ◽  
Ventricular Ejection Fraction ◽  
Multicenter Registry

Background . The use of implantable cardiac defibrillators has been associated with improved survival in several well-defined patient (pt) subsets. Its utilization for primary prevention in eligible pts, however, is unclear. We sought to examine the frequency of ICD implantation (ICD-IMP) for primary prevention in a cohort prospectively enrolled in a prospective, multicenter registry of ICD candidates. Methods . We identified 961 pts enrolled in the AdreView Myocardial Imaging for Risk Evaluation in Heart Failure (ADMIRE-HF) study, a prospective, multicenter study evaluating the prognostic usefulness of 123I-mIBG scintigraphy in a heart failure population. Inclusion criteria limited patients to those meeting guideline criteria for ICD implantation; these criteria included left ventricular ejection fraction ≤35% and New York Heart Association functional class II-III. We excluded pts with an ICD at the time of enrollment, leaving a study cohort of 934 patients. Pts were followed up for 24 months after enrollment. Pts undergoing ICD-IMP after enrollment for secondary prevention were censored at the time of intervention. The association between ICD-IMP utilization and demographic, clinical, laboratory, and imaging data was examined using Cox proportional hazards analysis (CPH). Results . Of 934 pts, 196 (21%) were referred for ICD-IMP over a mean follow-up of 612±242 days. Implantations occurred 167±164 days after enrollment. Patients referred for ICD were younger (61±12 vs. 63±12), but did not differ with respect to proportion female (17% vs. 21%), African-American race (12% vs. 15%), diabetics (37% vs. 36%) (All p=NS). The frequency of ICD-IMP did not differ as a function of age, race, sex, LVEF, or imaging result (All p=NS). CPH revealed that a model including age, race, sex, diabetes, smoking, BMI, NYHA class, hypertension, heart failure etiology, and prior MI identified none of these as predictive of ICD-IMP. Conclusion: This analysis of prospective registry data reveals that in patients who are guideline-defined candidates for ICD-IMP, only about one in five receive an ICD over a two year follow-up interval. Multivariable modeling failed to identify any factor associated with ICD use.

Abstract 16238: Mortality and Predictors of Appropriate ICD Therapy in Japanese Primary Prevention Patients: A 13-year Experience Based on the MADIT2 Criteria

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Yoshimori An ◽  
Kenji Ando ◽  
Michio Nagashima ◽  
Masato Fukunaga ◽  
Kenichi Hiroshima ◽  
...  
Keyword(s):  
Primary Prevention ◽  
Cox Regression ◽  
Biventricular Pacing ◽  
Nyha Class ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Icd Implantation ◽  
Ventricular Ejection Fraction ◽  
Icd Therapy

Background: There are still limited data on the mortality for a long-term follow-up and the clinical factors influencing appropriate therapies in Japanese patients with implantable cardioverter-defibrillator (ICD) for primary prevention, who satisfied the criteria in Multicenter Automatic Defibrillator Implantation Trial 2 (MADIT2). Methods: Between January 2000 and December 2012, a total of 436 patients without prior ventricular arrhythmic event underwent ICD implantation for primary prevention at our institution. Among these patients, we enrolled consecutive 122 patients (69±10 years, male: 84%, biventricular-pacing: 54%, median follow-up: 1390 days) who met the MADIT2 criteria; left ventricular ejection fraction (LVEF) ≤30% with ischemic heart disease, more than 4 weeks after myocardial infarction. Results: At the 3 years of follow-up, the mortality rate (21%) was comparable with that of the original MADIT2 ICD group (20%). The Kaplan-Meier event rate for appropriate ICD therapy (shock and anti-tachycardia pacing therapy) (35%) was also similar to that of the original MADIT2 ICD group (32%). Multivariate analysis by Cox regression model revealed that left ventricular diastolic diameter (LVDd) ≥60mm (Hazard Ratio [HR]: 1.65, 95% Confidence Interval [CI]: 1.16-2.14, P=0.004) and non-sustained ventricular tachycardia (NSVT) (HR: 1.55, 95%CI: 1.13-2.15, P=0.007) were independent predictors for appropriate ICD therapy. On the other hand, LVEF, NYHA class, biventricular-pacing, amiodarone or inducibility of ventricular arrhythmia was not associated with appropriate ICD therapy. Conclusion: Appropriate ICD therapy was delivered in Japanese primary prevention patients as often as in the original MADIT2 ICD group and strongly predicted by dilated left ventricle and NSVT.

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