Abstract 317: Outcomes after Primary Prevention Implantable Cardioverter Defibrillator Placement: Results of the Cardiovascular Research Network Longitudinal Study of Implantable Cardioverter Defibrillators

Author(s):  
Frederick A Masoudi ◽  
Alan S Go ◽  
David J Magid ◽  
Liza M Reifler ◽  
Karen A Glenn ◽  
...  

Background: Implantable cardioverter defibrillators (ICDs) are commonly used for the primary prevention of sudden cardiac death. Controversies persist, however, about outcomes in representative cohorts and in clinically important patient subgroups. Observational studies of outcomes following primary prevention ICD implantation are typically limited to relatively restricted cohorts (e.g. Medicare) or with short follow up. Methods: In the Cardiovascular Research Network (CVRN), we conducted a study in 7 integrated health care delivery systems to identify patients undergoing primary prevention ICD implantation for left ventricular systolic dysfunction between 2006-2010. Baseline procedural and clinical data were obtained from the NCDR ICD Registry; longitudinal data to ascertain outcomes after implantation were obtained through clinical health system data from the CVRN Virtual Data Warehouse. We assessed the occurrence of complications at 90 days and mortality, all-cause hospitalization, and heart failure hospitalization up to 5 years after implantation in clinical strata designated a priori. Multivariable models accounting for clustering of patients within site were used to assess the relationship between clinical variables and each outcome. Clinical variables of interest (Table) were included in all models; additional variables were assessed with forward selection to account for possible confounders. Results: Among 2953 eligible patients, median age was 69 years and 26% were women Coexisting conditions, including hypertension (74%), atrial fibrillation (32%), COPD (20%), and diabetes (42%), were common. Overall event rates (per 1000 patient years) were 110 for death, 438 for any hospitalization, and 58 for heart failure hospitalization. The association between clinically important variables and outcomes are shown in the Table. Conclusions: In a diverse population of patients undergoing ICD implantation in contemporary practice we identified specific clinical variables associated with adverse outcomes. These data can inform prognosis in clinical care and guide the design of future trials of this therapy.

2020 ◽  
Vol 41 (36) ◽  
pp. 3437-3447 ◽  
Author(s):  
Markus Zabel ◽  
Rik Willems ◽  
Andrzej Lubinski ◽  
Axel Bauer ◽  
Josep Brugada ◽  
...  

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.


Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Eloi Marijon ◽  
Rui Providencia ◽  
Pascal Defaye ◽  
Didier Klug ◽  
Daniel Gras ◽  
...  

Background: Data regarding sex specificities in the use, benefits and complications of implantable cardioverter-defibrillators (ICDs) in primary prevention in the real-world European setting are sparse. Methods: Using a large multicentric cohort of consecutive patients referred for ICD implantation for primary prevention (2002-2012), in the setting of coronary artery disease or dilated cardiomyopathy, we examined potential sex differences in subjects’ characteristics and outcomes. Results: Of 5,539 patients, only 837 (15.1%) were women and 53.8% received cardiac resynchronization therapy (CRT-D). Compared to men, women presented a significantly higher proportion of dilated cardiomyopathy (60.2% vs. 36.2%, P120ms: 74.6% vs. 68.5%, P=0.003), higher New York Heart Association functional class (2.5±0.7 vs. 2.4±0.7, P=0.003) and lower prevalence of atrial fibrillation (18.7% vs. 24.9%, P<0.001). During a 16,786 patient-years follow-up, overall, fewer appropriate therapies were observed in women (HR = 0.59, CI95% 0.45-0.76; P<0.001). By contrast, no sex-specific interaction was observed for inappropriate shocks (OR for women = 1.00, 95%CI 0.74-1.35, P=0.997) and mortality (HR = 0.87; 95%CI 0.66-1.15, P=0.324), with similar patterns of cause of deaths. Conclusion: In our real life registry, women account for the minority of ICD recipients. While female ICD recipients present with features of more severe heart failure in the setting of primary prevention of sudden cardiac death, we observed they have a 40% lower incidence of appropriate therapies.


Circulation ◽  
2017 ◽  
Vol 136 (19) ◽  
pp. 1772-1780 ◽  
Author(s):  
Marie Bayer Elming ◽  
Jens C. Nielsen ◽  
Jens Haarbo ◽  
Lars Videbæk ◽  
Eva Korup ◽  
...  

Author(s):  
Rory Hachamovitch ◽  
Benjamin Nutter ◽  
Manuel D Cerqueira ◽  

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.


2020 ◽  
Vol 41 (05) ◽  
pp. 626-640 ◽  
Author(s):  
David H. Birnie

AbstractApproximately 5% of patients with sarcoidosis will have clinically manifest cardiac involvement presenting with one or more of ventricular arrhythmias, conduction abnormalities, and heart failure. It is estimated that another 20 to 25% of pulmonary/systemic sarcoidosis patients have asymptomatic cardiac involvement (clinically silent disease). Cardiac presentations can be the first (and/or an unrecognized) manifestation of sarcoidosis in a variety of circumstances. Immunosuppression therapy (usually with corticosteroids) has been suggested for the treatment of clinically manifest cardiac sarcoidosis (CS) despite minimal data supporting it. Positron emission tomography imaging is often used to detect active disease and guide immunosuppression. Patients with clinically manifest disease often need device therapy, typically with implantable cardioverter defibrillators (ICDs). The extent of left ventricular dysfunction seems to be the most important predictor of prognosis among patients with clinically manifest CS. In the current era of earlier diagnosis, modern heart failure treatment, and use of ICD therapy, the prognosis from CS is much improved. In a recent Finnish nationwide study, 10-year cardiac survival was 92.5% in 102 patients.


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