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:AimsLeft ventricular ejection fraction (LVEF) is suboptimal as a sole marker for predicting sudden cardiac death (SCD). Machine learning (ML) provides new opportunities for personalized predictions using complex, multimodal data. This study aimed to determine if risk stratification for implantable cardioverter-defibrillator (ICD) implantation can be improved by ML models that combine clinical variables with 12-lead electrocardiograms (ECG) time-series features.Methods and resultsA multicentre study of 1010 patients (64.9 ± 10.8 years, 26.8% female) with ischaemic, dilated, or non-ischaemic cardiomyopathy, and LVEF ≤ 35% implanted with an ICD between 2007 and 2021 for primary prevention of SCD in two academic hospitals was performed. For each patient, a raw 12-lead, 10-s ECG was obtained within 90 days before ICD implantation, and clinical details were collected. Supervised ML models were trained and validated on a development cohort (n = 550) from Hospital A to predict ICD non-arrhythmic mortality at three-year follow-up (i.e. mortality without prior appropriate ICD-therapy). Model performance was evaluated on an external patient cohort from Hospital B (n = 460). At three-year follow-up, 16.0% of patients had died, with 72.8% meeting criteria for non-arrhythmic mortality. Extreme gradient boosting models identified patients with non-arrhythmic mortality with an area under the receiver operating characteristic curve (AUROC) of 0.90 [95% confidence intervals (CI) 0.80-1.00] during internal validation. In the external cohort, the AUROC was 0.79 (95% CI 0.75-0.84).ConclusionsML models combining ECG time-series features and clinical variables were able to predict non-arrhythmic mortality within three years after device implantation in a primary prevention population, with robust performance in an independent cohort.
| S-EPMC10516624 | 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: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: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:BackgroundThe benefit of implantable cardioverter-defibrillator (ICD) in elderly patients has been questioned. In the present study, we aimed to analyse the outcome of patients of different age groups with ICD implantation.MethodsWe included all patients who received an ICD in our hospital from 2011 to 2020. Primary endpoints were (1) death from any cause and (2) appropriate ICD therapy (antitachycardia pacing/shock). A "benefit of ICD implantation" was defined as appropriate ICD therapy before death from any cause/or survival. "No benefit of ICD implantation" was defined as death from any cause without prior appropriate ICD therapy.ResultsA total of 422 patients received an ICD (primary prophylaxis n = 323, secondary prophylaxis n = 99). At the time of implantation, 35 patients (8%) were >80 years and 106 patients were >75 years (25%). During the study period of 4.2 ± 3 years, benefit of ICD occurred in 89 patients (21%) and no benefit in 84 patients (20%). In primary prevention, the proportion of patients who had a benefit from ICD implantation decreased with increasing age, and there were no patients who benefited from ICD therapy in the group of patients >80 years. In secondary prophylaxis, the proportion of patients with a benefit from ICD implantation ranged from 20% to 30% in all age groups.ConclusionOur study suggests that the indication of primary prophylactic ICD in elderly and very old patients should be critically assessed. On the other hand, no patient should be denied secondary prophylactic ICD implantation because of age.
| S-EPMC10826786 | biostudies-literature
Project description:BackgroundThere are conflicting data on the impact of implantable cardioverter-defibrillator (ICD) shocks on subsequent mortality.ObjectivesThe aim of this study was to determine whether the arrhythmic substrate leading to ICD therapy or the therapy itself increases mortality.MethodsThe study cohort included 5,516 ICD recipients who were enrolled in 5 landmark ICD trials (MADIT-II, MADIT-RISK, MADIT-CRT, MADIT-RIT, RAID). The authors evaluated the association of device therapy with subsequent mortality in 4 separate time-dependent models: model I, type of ICD therapy; model II, type of arrhythmia for which ICD therapy was delivered; model III, combined assessment of all arrhythmia and therapy types during follow-up; and model IV, incremental risk associated with repeated ICD shocks.ResultsWhen analyzed by the type of ICD therapy (model I), a first appropriate ICD shock was associated with increased risk of subsequent mortality with or without concomitant occurrence of inappropriate shock during follow-up (hazard ratio [HR]: 2.78 and 2.31; p < 0.001 and p = 0.12), whereas inappropriate shock alone was not associated with mortality risk (HR: 1.23; p = 0.42). Similarly, ICD therapy for ventricular tachycardia (VT) ≥200 beats/min or ventricular fibrillation (VF) (model II) was associated with increased risk of death with or without concomitant therapy for VT <200 beats/min (HRs: 2.25 and 2.62; both p < 0.001), whereas appropriate therapy for VT <200 beats/min or inappropriate therapy (regardless of etiology) did not reach statistical significance (all p > 0.10). Combined assessment of all therapy and arrhythmia types during follow-up (model III) showed that appropriate ICD shocks for VF, shocks for fast VT (≥200 beats/min) without prior antitachycardia pacing (ATP), as well as shocks for fast VT delivered after failed ATP, were associated with the highest risk of subsequent death (HR: all >2.8; p < 0.001). Finally, 2 or more ICD appropriate shocks were not associated with incremental risk to the first appropriate ICD shock (model IV).ConclusionThe combined data from 5 landmark ICD trials suggest that the underlying arrhythmic substrate rather than the ICD therapy is the more important determinant of mortality in ICD recipients.
| S-EPMC8142936 | 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