Maximizing survival benefit with primary prevention implantable cardioverter-defibrillator therapy in a heart failure population.
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ABSTRACT:
SUBMITTER: Levy WC
PROVIDER: S-EPMC3774781 | biostudies-literature | 2009 Sep
REPOSITORIES: biostudies-literature
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Maximizing survival benefit with primary prevention implantable cardioverter-defibrillator therapy in a heart failure population.
Levy Wayne C WC Lee Kerry L KL Hellkamp Anne S AS Poole Jeanne E JE Mozaffarian Dariush D Linker David T DT Maggioni Aldo P AP Anand Inder I Poole-Wilson Philip A PA Fishbein Daniel P DP Johnson George G Anderson Jill J Mark Daniel B DB Bardy Gust H GH
Circulation 20090824 10
<h4>Background</h4>Although implantable cardioverter-defibrillator (ICD) therapy reduces mortality in moderately symptomatic heart failure patients with an ejection fraction <or=35%, many such patients do not require ICD shocks over long-term follow-up.<h4>Methods and results</h4>Using a modification of a previously validated risk prediction model based on routine clinical variables, we examined the relationship between baseline predicted mortality risk and the relative and absolute survival ben ...[more]
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Project description:Implantable cardioverter-defibrillators and cardiac resynchronization therapy-defibrillators (ICD/CRT-Ds) are evidence-based preventative treatments for many patients with heart failure (HF), yet large numbers of eligible patients remain untreated. It is uncertain if localities with more frequent ICD/CRT-D use have had better rates of HF survival.To determine if US Hospital Referral Regions (HRRs) with larger increases in the rate of ICD/CRT-D utilization during 2002 to 2007 also had commensurate increases in HF survival.Retrospective cohort.Medicare beneficiaries age 66 to 80 nonelectively hospitalized for HF from 2002 to 2007.Each HRR's annual ICD/CRT-D rate was estimated from the cohort's Medicare procedure claims. Survival duration was determined from Medicare mortality records. HRR-year-level panel regression models were estimated to assess whether an HRR's ICD/CRT-D rate predicted HF survival, adjusting for baseline differences in survival across HRRs and secular trends.A total of 883,002 HF patients were propensity-score matched within HRR across 2002 to 2007. Across HRRs, growth in ICD/CRT-D use among such patients varied from 1 to 12 percentage points. Regression models indicated that a 1 percentage point increase in an HRR's ICD/CRT-D utilization among hospitalized HF patients was associated with an increase in 1-year survival of 0.12% [95% confidence interval (CI), 0.03%-0.21%, P=0.009] and with a 0.26% increase in HF survival at 2 years (95% CI, 0.14%-0.37%, P<0.001).Localities with greater increases in ICD/CRT-D utilization from 2002 to 2007 also had greater improvements in HF survival. Areas with persistently low ICD/CRT-D use may be good targets for programs designed to increase the evidence-based use of defibrillators.
| S-EPMC4829060 | biostudies-literature
Project description:Background One third of primary prevention implantable cardioverter-defibrillator patients receive appropriate therapy, but all remain at risk of defibrillator complications. Information on these complications in contemporary cohorts is limited. This study assessed complications and their risk factors after defibrillator implantation in a Dutch nationwide prospective registry cohort and forecasts the potential reduction in complications under distinct scenarios of updated indication criteria. Methods and Results Complications in a prospective multicenter registry cohort of 1442 primary implantable cardioverter-defibrillator implant patients were classified as major or minor. The potential for reducing complications was derived from a newly developed prediction model of appropriate therapy to identify patients with a low probability of benefitting from the implantable cardioverter-defibrillator. During a follow-up of 2.2 years (interquartile range, 2.0-2.6 years), 228 complications occurred in 195 patients (13.6%), with 113 patients (7.8%) experiencing at least one major complication. Most common ones were lead related (n=93) and infection (n=18). Minor complications occurred in 6.8% of patients, with lead-related (n=47) and pocket-related (n=40) complications as the most prevailing ones. A surgical reintervention or additional hospitalization was required in 53% or 61% of complications, respectively. Complications were strongly associated with device type. Application of stricter implant indication results in a comparable proportional reduction of (major) complications. Conclusions One in 13 patients experiences at least one major implantable cardioverter-defibrillator-related complication, and many patients undergo a surgical reintervention. Complications are related to defibrillator implantations, and these should be discussed with the patient. Stricter implant indication criteria and careful selection of device type implanted may have significant clinical and financial benefits.
| S-EPMC8174382 | biostudies-literature
Project description:BackgroundThe efficacy of implantable cardioverter defibrillators (ICDs) for primary prevention is controversial in patients with nonischemic heart failure (HF). We evaluated the mortality and predictors of mortality in patients with prophylactic ICD implantation for ischemic and nonischemic HF.MethodsFrom 2008 to 2017, 1097 patients (667, nonischemic HF and 430, ischemic HF) who underwent prophylactic ICD implantation, were identified from the Korean National Health Insurance Service database. We used propensity score overlap weighting to correct the differences between two groups.ResultsThose with ischemic HF were older (67.0 ± 10.1 vs 61.8 ± 14.2 years), more often male (71.4% vs 63.7%), and had more comorbidities than patients with nonischemic HF. During a median follow-up of 37.3 months (interquartile range [IQR], 14.2-53.8 months), all-cause mortality was higher in unweighted patients with ischemic HF than in those with nonischemic HF (10.9 vs 6.4 per 100 person-years; hazard ratio [HR], 1.74; 95% confidence interval [CI], 1.38-2.20; P < .001). However, after weighting, the annual all-cause mortality rate was similar in both groups (9.5 vs 8.8 per 100 person-years), with no significant difference in the risk of all-cause mortality (HR, 1.08; 95% CI, 0.68-1.71; P = .755). Older age and chronic kidney disease were independent predictors of all-cause mortality in both groups. There was no significant difference in cardiac and noncardiac mortality between the weighted nonischemic and ischemic HF groups.ConclusionsThe all-cause, cardiac, and noncardiac mortality rates were similar between patients with nonischemic and ischemic HF who underwent prophylactic ICD implantation.
| S-EPMC8637096 | biostudies-literature
Project description:Guidelines recommend that implantable cardioverter-defibrillator (ICD) candidates have an estimated longevity of ?1 year. Longevity can be affected by chronic kidney disease (CKD).Using the National Cardiovascular Data Registry ICD registry linked with the Social Security Death Master File, we assessed the rate of death after primary prevention ICD placement between January 1, 2006, and December 31, 2007, according to CKD stage. Using Cox models, we identified factors associated with death among patients with CKD. Compared with patients without CKD (n=26,056), those with CKD (n=21,226) were older, less commonly men, more often white, and more frequently had comorbid illness. Compared with patients without CKD, patients with a glomerular filtration rate 30 to 60, glomerular filtration rate <30, and end-stage renal disease on dialysis had a higher risk of death after ICD placement (hazard ratio, 2.08; 95% confidence interval, 1.99-2.18; P<0.0001; hazard ratio, 4.20; 95% confidence interval, 3.92-4.50; P<0.0001; and hazard ratio, 4.80; 95% confidence interval, 4.46-5.17; P<0.0001, respectively). Corresponding 1-year death rates were 4.4%, 9.1%, 20.2%, and 22.4%. Among patients with CKD, factors associated with increased risk of death included CKD severity, age >65 years, heart failure symptoms, diabetes mellitus, lung disease, serum sodium <140 mEq/L, atrial fibrillation or flutter, and a lower ejection fraction.The risk of death after primary prevention ICD placement is proportional to CKD severity. Among patients with CKD, several factors are prognostically significant and could inform clinical decision making on primary prevention ICD candidacy.
| S-EPMC4206571 | biostudies-literature
Project description:BACKGROUND:Landmark studies have demonstrated the safety and efficacy of implantable cardioverter-defibrillators (ICDs) in selected stable ambulatory patients with heart failure (HF) with a reduced ejection fraction receiving optimal medical therapy. It is not known whether a recent hospitalization for HF before ICD placement is associated with subsequent outcomes. METHODS:A post hoc analysis was performed of Medicare beneficiaries enrolled in the National Cardiovascular Data Registry's ICD Registry with a known diagnosis of HF and an ejection fraction ≤35% underdoing a new ICD placement for primary prevention. Patients were grouped based on the timing of ICD placement from the last hospitalization for HF. The association between timing of ICD placement and outcomes was assessed by using multivariable logistic regression models. RESULTS:The final analytic cohort included 81 180 patients undergoing initial ICD placement for primary prevention who were currently hospitalized for HF (n=11 563, 14%), hospitalized for HF within 3 months (n=6252, 8%), or hospitalized for HF >3 months previously or had no previous hospitalizations for HF (n=63 365, 78%). Patients currently or recently hospitalized for HF had a higher unadjusted composite periprocedural complication rate (2.60% versus 1.71% versus 1.25%, P<0.001). After adjusting for potential confounders, patients currently hospitalized for HF were at higher risk for death (odds ratio, 2.25; 95% CI, 2.02-2.52; P <0.001) and all-cause readmission (odds ratio, 1.89; 95% CI, 1.79-1.99; P <0.001) at 90 days. CONCLUSION:Older patients currently or recently hospitalized for HF undergoing initial ICD placement for primary prevention experienced a higher rate of periprocedural complications and were at increased risk of death in comparison with those receiving an ICD without recent HF hospitalization. Additional prospective, real-world, pragmatic, comparative effectiveness studies should be conducted to define the optimal timing of ICD placement.
| S-EPMC6931009 | biostudies-literature
Project description:Randomized clinical trials have shown that implantable cardioverter-defibrillator (ICD) therapy saves lives. Whether the survival of patients who received an ICD in primary prevention clinical trials differs from that of trial-eligible patients receiving a primary prevention ICD in clinical practice is unknown.To determine whether trial-eligible patients who received a primary prevention ICD as documented in a large national registry have a survival rate that differs from the survival rate of similar patients who received an ICD in the 2 largest primary prevention clinical trials, MADIT-II (n = 742) and SCD-HeFT (n = 829).Retrospective analysis of data for patients enrolled in the National Cardiovascular Data Registry ICD Registry between January 1, 2006, and December 31, 2007, meeting the MADIT-II criteria (2464 propensity score-matched patients) or the SCD-HeFT criteria (3352 propensity score-matched patients). Mortality data for the registry patients were collected through December 31, 2009.Cox proportional hazards models were used to compare mortality from any cause.The median follow-up time in MADIT-II, SCD-HeFT, and the ICD Registry was 19.5, 46.1, and 35.2 months, respectively. Compared with patients enrolled in the clinical trials, patients in the ICD Registry were significantly older and had a higher burden of comorbidities. In the matched cohorts, there was no significant difference in survival between MADIT-II-like patients in the registry and MADIT-II patients randomized to receive an ICD (2-year mortality rates: 13.9% and 15.6%, respectively; adjusted ICD Registry vs trial hazard ratio, 1.06; 95% CI, 0.85-1.31; P = .62). Likewise, the survival among SCD-HeFT-like patients in the registry was not significantly different from survival among patients randomized to receive ICD therapy in SCD-HeFT (3-year mortality rates: 17.3% and 17.4%, respectively; adjusted registry vs trial hazard ratio, 1.16; 95% CI, 0.97-1.38; P = .11).There was no significant difference in survival between clinical trial patients randomized to receive an ICD and a similar group of clinical registry patients who received a primary prevention ICD. Our findings support the continued use of primary prevention ICDs in similar patients seen in clinical practice.clinicaltrials.gov Identifier: NCT00000609.
| S-EPMC3638257 | biostudies-literature
Project description:BackgroundPrediction of which heart failure patients are most likely to die of sudden death vs. non-sudden death is an important factor in determining who will benefit the most from an ICD.ObjectiveWe developed the Seattle Proportional Risk Model (SPRM) to estimate the proportion of total mortality due to sudden death. We prospectively validated the model in HF-ACTION and tested whether the ICD benefit varied with the SPRM.MethodsAmong 2331 patients enrolled, 1947 patients were retained for analysis over a median follow-up of 2.5 years. The SPRM was calculated using age, gender, diabetes, BMI, SBP, EF, NYHA, sodium, creatinine, and digoxin use.ResultsICD use (ICD or CRT-D) was present prior to death in 1204 patients (62%). SPRM was predictive of sudden death vs. non-sudden death in those without an ICD (P=0.002). The hazard ratio representing ICD versus no ICD was 0.63 for all-cause mortality (P=0.0002). The ICD benefit varied with the SPRM for all-cause mortality (P=0.001), with a greater benefit in those with a higher conditional probability of sudden death.ConclusionsIn an ambulatory NYHA II-IV HF population and EF ≤35%, the SPRM was predictive of the proportional risk of sudden vs. non-sudden death. ICDs were associated with a decreased risk of all-cause mortality by 37% and the ICD benefit varied with the SPRM. The SPRM may have utility in risk stratifying patients for a primary prevention ICD.
| S-EPMC5441395 | biostudies-literature
Project description:The impact of patient age on the risks of death or rehospitalization after primary prevention implantable cardioverter-defibrillator (ICD) placement is uncertain.Data from 5 major ICD trials were merged: the Multicenter Automatic Defibrillator Implantation Trial I (MADIT-I), the Multicenter UnSustained Tachycardia Trial (MUSTT), the Multicenter Automatic Defibrillator Implantation Trial II (MADIT-II), the Defibrillators in Nonischemic Cardiomyopathy Treatment Evaluation Trial (DEFINITE), and the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT). Median age at enrollment was 62 (interquartile range 53-70) years. Compared with their younger counterparts, older patients had a greater burden of comorbid illness. In unadjusted exploratory analyses, ICD recipients were less likely to die than nonrecipients in all age groups: among patients aged <55 years: hazard ratio 0.48, 95% posterior credible interval 0.33 to 0.69; among patients aged 55 to 64 years: hazard ratio 0.69, 95% posterior credible interval 0.53 to 0.90; among patients aged 65 to 74 years: hazard ratio 0.67, 95% posterior credible interval, 0.53 to 0.85; and among patients aged ?75 years: hazard ratio 0.54, 95% posterior credible interval 0.37 to 0.78. Sample sizes were limited among patients aged ?75 years. In adjusted Bayesian-Weibull modeling, point estimates indicate ICD efficacy persists but is attenuated with increasing age. There was evidence of an interaction between age and ICD treatment on survival (two-sided posterior tail probability of no interaction <0.01). Using an adjusted Bayesian logistic regression model, there was no evidence of an interaction between age and ICD treatment on rehospitalization (two-sided posterior tail probability of no interaction 0.44).In this analysis, the survival benefit of the ICD exists but is attenuated with increasing age. The latter finding may be because of the higher burden of comorbid illness, competing causes of death, or limited sample size of older patients. There was no evidence that age modifies the association between ICD treatment and rehospitalization.
| S-EPMC4408540 | biostudies-literature
Project description:AimsThe benefit of prophylactic implantable cardioverter-defibrillator (ICD) is not uniform due to differences in the risk of life-threatening ventricular tachycardia (VT)/ventricular fibrillation (VF) and non-arrhythmic mortality. We aimed to develop an ICD benefit prediction score that integrates the competing risks.Methods and resultsThe study population comprised all 4531 patients enrolled in the MADIT trials. Best-subsets Fine and Gray regression analysis was used to develop prognostic models for VT (≥200 b.p.m.)/VF vs. non-arrhythmic mortality (defined as death without prior sustained VT/VF). Eight predictors of VT/VF (male, age < 75 years, prior non-sustained VT, heart rate > 75 b.p.m., systolic blood pressure < 140 mmHg, ejection fraction ≤ 25%, myocardial infarction, and atrialarrhythmia) and 7 predictors of non-arrhythmic mortality (age ≥ 75 years, diabetes mellitus, body mass index < 23 kg/m2, ejection fraction ≤ 25%, New York Heart Association ≥II, ICD vs. cardiac resynchronization therapy with defibrillator, and atrial arrhythmia) were identified. The two scores were combined to create three MADIT-ICD benefit groups. In the highest benefit group, the 3-year predicted risk of VT/VF was three-fold higher than the risk of non-arrhythmic mortality (20% vs. 7%, P < 0.001). In the intermediate benefit group, the difference in the corresponding predicted risks was attenuated (15% vs. 9%, P < 0.01). In the lowest benefit group, the 3-year predicted risk of VT/VF was similar to the risk of non-arrhythmic mortality (11% vs. 12%, P = 0.41). A personalized ICD benefit score was developed based on the distribution of the two competing risks scores in the study population (https://is.gd/madit). Internal and external validation confirmed model stability.ConclusionsWe propose the novel MADIT-ICD benefit score that predicts the likelihood of prophylactic ICD benefit through personalized assessment of the risk of VT/VF weighed against the risk of non-arrhythmic mortality.
| S-EPMC8088341 | biostudies-literature
Project description:Aims:Prospective data regarding the role of implantable cardioverter-defibrillator (ICD) for the primary prevention of sudden cardiac death in patients with long QT syndrome (LQTS) is scarce. Herein, we explore the prospective Rochester LQTS ICD registry to assess the risk for appropriate shock in primary prevention in a real-world setting. Methods and results:We studied 212 LQTS patients that had ICD implantation for primary prevention. Best-subsets proportional-hazards regression analysis was used to identify clinical variables that were associated with the first appropriate shock. Conditional models of Prentice, Williams, and Peterson were utilized for the analysis of recurrent appropriate shocks. During a median follow-up of 9.2?±?4.9?years, there were 42 patients who experienced at least one appropriate shock and the cumulative probability of appropriate shock at 8?years was 22%. QTc???550 ms [hazard ratio (HR) 3.94, confidence interval (CI) 2.08-7.46; P?<?0.001) and prior syncope on ?-blockers (HR 1.92, CI 1.01-3.65; P?=?0.047) were associated with increased risk of appropriate shock. History of syncope while on ?-blocker treatment (HR 1.87, CI 1.28-2.72; P?=?0.001), QTc 500-549 ms (HR 1.68, CI 1.10-2.81; P?=?0.048), and QTc???550 ms (HR 3.66, CI 2.34-5.72; P?<?0.001) were associated with increased risk for recurrent appropriate shocks, while ?-blockers were not protective (HR 1.03, CI 0.63-1.68, P?=?0.917). LQT2 (HR 2.10, CI 1.22-3.61; P?=?0.008) and multiple mutations (HR 2.87, CI 1.49-5.53; P?=?0.002) were associated with higher risk for recurrent shocks as compared with LQT1. Conclusion:In this prospective ICD registry, we identified clinical and genetic variables that were associated appropriate shock risk. These data can be used for risk stratification in high-risk patients evaluated for primary prevention with ICD.
| S-EPMC6365807 | biostudies-literature