Perceived Benefits of Implantable Cardioverter Defibrillator Implantation among Heart Failure Patients and Its Relation to Quality of Life: A Cross-Sectional Study.
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ABSTRACT: Introduction
Patients with heart failure (HF) and implantable cardioverter defibrillators (ICDs) may misunderstand the indication of ICDs due to unsatisfactory information. The goal of this study is to evaluate the patient perspective of ICD indication and its relation to quality of life, as well as to identify probable communication gaps between doctors and ICD receivers.Methods
A total of 119 patients with HF who were implanted with a single-chamber ICD were evaluated in outpatient clinics. Patients with cardiac resynchronization therapy-defibrillators were not included in the study. In a questionnaire, patients were asked about the indication of the ICD procedure and classified according to the perceived benefits.Results
This study showed that most of the patients (n = 92, 77.3%) believed that ICD was implanted for improvement of heart dysfunction or for symptom relief. According to the perceived benefit groups, physical function, general health, vitality, and role physical scores were significantly lower in the symptom relief group (p < 0.05).Conclusion
Patients with HF and ICD mostly believed that the cardioverter defibrillator implanted for improving heart function or symptom relief. Doctors play a significant role when a patient is first referred for ICD because less-informed patients are more prone to misunderstand the procedure's benefits. Moreover, unfulfilled expectations may lead to loss of confidence in applied therapies and result in poor health outcomes.
SUBMITTER: Balci KG
PROVIDER: S-EPMC4675745 | biostudies-literature |
REPOSITORIES: biostudies-literature
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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:Guideline-directed medical therapy (GDMT) for heart failure with reduced ejection fraction (HFrEF) is recommended before primary prevention implantable cardioverter-defibrillator (ICD) placement. Adherence to this recommendation and associated outcomes are unknown. OBJECTIVES:This study examined the use of GDMT (?1 prescription filled for both a renin-angiotensin inhibitor [RAI] and a heart failure-approved beta-blocker [HFBB]) within 90 days before primary prevention ICD placement in patients with HFrEF. METHODS:Data from the National Cardiovascular Data Registry ICD Registry were merged with a 40% random sample of Medicare administrative data. Prescription fills for recipients of primary prevention ICD between 2007 and 2011 were examined, analyzing GDMT overall and for each U.S. hospital referral region. We identified characteristics associated with GDMT and the association with 1-year mortality. RESULTS:Among 19,733 patients with HFrEF and primary prevention ICD, 61.1% filled any GDMT before implantation. Across hospital referral regions, GDMT was applied in 51% to 71%. The strongest predictors of any GDMT included absence of chronic renal disease or nonsustained ventricular tachycardia, low-income prescription benefits subsidy, and less recent left ventricular ejection fraction evaluation. Patients receiving GDMT versus those without had a lower 1-year mortality rate after ICD implantation (11.1% vs. 16.2%), even after adjustment for comorbidities, left ventricular ejection fraction, and functional heart failure class. CONCLUSIONS:Rates of GDMT for HFrEF before primary prevention ICD implantation were low, and failure to achieve GDMT was associated with significantly decreased 1-year survival.
| S-EPMC4780248 | 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:Background Outcomes data in patients with cardiac amyloidosis after implantable cardioverter-defibrillator (ICD) implantation are limited. We compared outcomes of patients with ICDs implanted for cardiac amyloidosis versus nonischemic cardiomyopathies (NICMs) and evaluated factors associated with mortality among patients with cardiac amyloidosis. Methods and Results Using National Cardiovascular Data Registry's ICD Registry data between April 1, 2010 and December 31, 2015, we created a 1:5 propensity-matched cohort of patients implanted with ICDs with cardiac amyloidosis and NICM. We compared mortality between those with cardiac amyloidosis and matched patients with NICM using Kaplan-Meier survival curves and Cox proportional hazards models. We also evaluated risk factors associated with 1-year mortality in patients with cardiac amyloidosis using multivariable Cox proportional hazards regression models. Among 472 patients with cardiac amyloidosis and 2360 patients with propensity-matched NICMs, 1-year mortality was significantly higher in patients with cardiac amyloidosis compared with patients with NICMs (26.9% versus 11.3%, P<0.001). After adjustment for covariates, cardiac amyloidosis was associated with a significantly higher risk of all-cause mortality (hazard ratio [HR], 1.80; 95% CI, 1.56-2.08). In a multivariable analysis of patients with cardiac amyloidosis, several factors were significantly associated with mortality: syncope (HR, 1.78; 95% CI, 1.22-2.59), ventricular tachycardia (HR, 1.65; 95% CI, 1.15-2.38), cerebrovascular disease (HR, 2.03; 95% CI, 1.28-3.23), diabetes mellitus (HR, 1.55; 95% CI, 1.05-2.27), creatinine = 1.6 to 2.5 g/dL (HR, 1.99; 95% CI, 1.32-3.02), and creatinine >2.5 (HR, 4.34; 95% CI, 2.72-6.93). Conclusions Mortality after ICD implantation is significantly higher in patients with cardiac amyloidosis than in patients with propensity-matched NICMs. Factors associated with death among patients with cardiac amyloidosis include prior syncope, ventricular tachycardia, cerebrovascular disease, diabetes mellitus, and impaired renal function.
| S-EPMC7726970 | biostudies-literature
Project description: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.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 benefits of ICD treatment in the primary prevention Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT). In the placebo arm, predicted 4-year mortality grouped into 5 equal-sized risk groups varied from 12% to 50% (c statistic=0.71), whereas the proportion of SCD in those same risk groups decreased from 52% to 24% of all deaths. ICD treatment decreased relative risk of SCD by 88% in the lowest-risk group versus 24% in the highest-risk group (P=0.009 for interaction) and decreased relative risk of total mortality by 54% in the lowest-risk group versus no benefit (2%) in the highest-risk group (P=0.014 for interaction). Absolute 4-year mortality reductions were 6.6%, 8.8%, 10.6%, 14.0%, and -4.9% across risk quintiles. In highest-risk patients (predicted annual mortality >20%), no benefit of ICD treatment was seen. Projected over each patient's predicted lifespan, ICD treatment added 6.3, 4.1, 3.0, 1.9, and 0.2 additional years of life in the lowest- to highest-risk groups, respectively.A clinical risk prediction model identified subsets of moderately symptomatic heart failure patients in SCD-HeFT in whom single-lead ICD therapy was of no benefit and other subsets in which benefit was substantial.
| S-EPMC3774781 | biostudies-literature
Project description:BackgroundAdult congenital heart disease (ACHD) patients can benefit from a subcutaneous implantable cardioverter-defibrillator (S-ICD).ObjectiveThe purpose of this study was to assess left- and right-sided S-ICD eligibility in ACHD patients, use machine learning to predict S-ICD eligibility in ACHD patients, and transform 12-lead electrocardiogram (ECG) to S-ICD 3-lead ECG, and vice versa.MethodsACHD outpatients (n = 101; age 42 ± 14 years; 52% female; 85% white; left ventricular ejection fraction [LVEF] 56% ± 9%) were enrolled in a prospective study. Supine and standing 12-lead ECG were recorded simultaneously with a right- and left-sided S-ICD 3-lead ECG. Peak-to-peak QRS and T amplitudes; RR, PR, QT, QTc, and QRS intervals; Tmax, and R/Tmax (31 predictor variables) were tested. Model selection, training, and testing were performed using supine ECG datasets. Validation was performed using standing ECG datasets and an out-of-sample non-ACHD population (n = 68; age 54 ± 16 years; 54% female; 94% white; LVEF 61% ± 8%).ResultsForty percent of participants were ineligible for S-ICD. Tetralogy of Fallot patients passed right-sided screening (57%) more often than left-sided screening (21%; McNemar χ2P = .025). Female participants had greater odds of eligibility (adjusted odds ratio [OR] 5.9; 95% confidence interval [CI] 1.6-21.7; P = .008). Validation of the ridge models was satisfactory for standing left-sided (receiver operating characteristic area under the curve [ROC AUC] 0.687; 95% CI 0.582-0.791) and right-sided (ROC AUC 0.655; 95% CI 0.549-0.762) S-ICD eligibility prediction. Validation of transformation matrices showed satisfactory agreement (<0.1 mV difference).ConclusionNearly half of the contemporary ACHD population is ineligible for S-ICD. The odds of S-ICD eligibility are greater for female than for male ACHD patients. Machine learning prediction of S-ICD eligibility can be used for screening of S-ICD candidates.
| S-EPMC7197388 | biostudies-literature
Project description:Background: There are sparse data on the utilization rate of implantable cardioverter-defibrillator (ICD) and its beneficial effects in Korean patients with heart failure with reduced left ventricular ejection fraction (LVEF).Methods: Among 5,625 acute heart failure (AHF) patients from 10 tertiary university hospitals across Korea, 485 patients with reassessed LVEF ? 35% at least 3 months after the index admission were enrolled in this study. The ICD implantation during the follow-up was evaluated. Mortality was compared between patients with ICDs and age-, sex-, and follow-up duration matched control patients.Results: Among 485 patients potentially indicated for an ICD for primary prevention, only 56 patients (11.5%) underwent ICD implantation during the follow-up. Patients with ICD showed a significantly lower all-cause mortality compared with their matched control population: adjusted hazard ratio (HR) (95% confidence interval [CI]) = 0.39 (0.16-0.92), P = 0.032. The mortality rate was still lower in the ICD group after excluding patients with cardiac resynchronization therapy (adjusted HR [95% CI] = 0.09 [0.01-0.63], P = 0.015). According to the subgroup analysis for ischemic heart failure, there was a significantly lower all-cause mortality in the ICD group than in the no-ICD group (HR [95% CI] = 0.20 [0.06-0.72], P = 0.013), with a borderline statistical significance (interaction P = 0.069).Conclusion: Follow-up data of this large, multicenter registry suggests a significant under-utilization of ICD in Korean heart failure patients with reduced LVEF. Survival analysis implies that previously proven survival benefit of ICD in clinical trials could be extrapolated to Korean patients.Trial registration: ClinicalTrials.gov Identifier: NCT01389843.
| S-EPMC7707927 | biostudies-literature
Project description:BackgroundThe effect of implantable cardioverter-defibrillator (ICD) therapy in patients with heart failure with reduced ejection fraction (HFrEF) and diabetes is not fully elucidated.MethodsWe examined the effect of ICD therapy on sudden cardiac death, cardiovascular death and all-cause mortality, according to diabetes status at baseline in the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT). The outcomes were analyzed by use of cumulative incidence curves and Cox regressions models.ResultsOf the 1676 patients randomized to an ICD or placebo, 540 (32%) had diabetes at baseline. Patients with diabetes were slightly older (61 vs 58 years) and were more often in NYHA class III (37% vs 28%). ICD therapy did not reduce the risk of sudden cardiac death in HFrEF patients with diabetes (HR = 0.85; 95% CI 0.52-1.40); even though these patients had a higher risk of sudden cardiac death compared to patients without diabetes (HR = 1.73 95% CI 1.22-2.47). By contrast, ICD therapy did reduce sudden cardiac death in HFrEF patients without diabetes (HR = 0.26; 95% CI 0.15-0.46); Pinteraction=0.002. The findings for cardiovascular and all-cause death were similar.ConclusionICD therapy did not reduce the risk of sudden cardiac death (or, as a consequence, all-cause death) in HFrEF patients with diabetes. Conversely, an ICD reduced the risk of sudden death in patients without diabetes, irrespective of etiology.
| S-EPMC6652172 | biostudies-literature
Project description:BackgroundHeart failure (HF) is the terminal stage of all cardiovascular events. Although implantable cardioverter defibrillator (ICD) therapies have reduced mortality among the high-risk HF population, it is necessary to determine whether certain factors can predict mortality even after cardiac device implantation. Growth stimulation expressed gene 2 (ST2) is an emerging biomarker for HF patient stratification in different clinical settings.AimsThis study aimed to investigate the relationship between baseline soluble ST2 (sST2) levels in serum and the clinical outcomes of high-risk HF patients with device implantation.MethodsBetween January 2017 and August 2018, we prospectively recruited consecutive patients implanted with an ICD for heart failure, with LVEF ≤35% as recommended, and analyzed the basic characteristics, baseline serum sST2, and NT-proBNP levels, with at least 1-year follow-up. All-cause mortality was the primary endpoint.ResultsDuring a 643-day follow-up, all-cause mortality occurred in 16 of 150 patients (10.67%). Incidence of all-cause mortality increased significantly in patients with sST2 levels above 34.98846 ng/ml (16.00% vs. 5.33%, P = 0.034). After adjusting the model (age, gender, device implantation, prevention of sudden death, LVEDD, LVEF, WBC and CLBBB, hsTNT, etiology, and eGFR) and the model combined with NT-proBNP, the risk of all-cause death was increased by 2.5% and 1.9%, respectively, per ng/ml of sST2. The best sST2 cutoff for predicting all-cause death was 43.42671 ng/ml (area under the curve: 0.72, sensitive: 0.69, and specificity: 0.69). Compared to patients with sST2 levels below 43.42671 ng/ml, the risk of all-cause mortality was higher in those with values above the threshold (5.1% vs. 21.2%, P = 0.002). ST2 level ≥43.42671 ng/ml was an independent predictor of all-cause mortality (HR: 3.30 [95% CI 1.02-10.67]). Age (HR: 1.06 [95% CI: 1.01-1.12]) and increased NT-proBNP per 100 (HR: 1.02 [95% CI: 1.01-1.03]) were also associated with all-cause mortality in ICD patients.ConclusionssST2 level was associated with risk of all-cause mortality, and a threshold of 43.43 ng/ml showed good distinguishing performance to predict all-cause mortality in patients with severe heart failure, recommended for ICD implantation. Patients with sST2 levels more than 43.42671 ng/ml even after ICD implantation should therefore be monitored carefully.
| S-EPMC7685860 | 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