Implementation, feasibility, and acceptability of quality of life therapy to improve positive emotions among patients with implantable cardioverter defibrillators.
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ABSTRACT:
SUBMITTER: Carroll AJ
PROVIDER: S-EPMC7554076 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Implantable cardioverter-defibrillators (ICDs) are increasingly used for primary prevention after randomized, controlled trials demonstrating that they reduce the risk of death in patients with left ventricular systolic dysfunction. The extent to which the clinical characteristics and long-term outcomes of unselected, community-based patients with left ventricular systolic dysfunction undergoing primary prevention ICD implantation in a real-world setting compare with those enrolled in the randomized, controlled trials is not well characterized. This study is being conducted to address these questions.The study cohort includes consecutive patients undergoing primary prevention ICD placement between January 1, 2006 and December 31, 2009 in 7 health plans. Baseline clinical characteristics were acquired from the National Cardiovascular Data Registry ICD Registry. Longitudinal data collection is underway, and will include hospitalization, mortality, and resource use from standardized health plan data archives. Data regarding ICD therapies will be obtained through chart abstraction and adjudicated by a panel of experts in device therapy. Compared with the populations of primary prevention ICD therapy randomized, controlled trials, the cohort (n=2621) is on average significantly older (by 2.5-6.5 years), more often female, more often from racial and ethnic minority groups, and has a higher burden of coexisting conditions. The cohort is similar, however, to a national population undergoing primary prevention ICD placement.Patients undergoing primary prevention ICD implantation in this study differ from those enrolled in the randomized, controlled trials that established the efficacy of ICDs. Understanding a broad range of health outcomes, including ICD therapies, will provide patients, clinicians, and policy makers with contemporary data to inform decision-making.
| S-EPMC3526187 | biostudies-literature
Project description:BACKGROUND:Evidence for the benefit of implantable cardioverter defibrillators (ICD) in preventing sudden cardiac death (SCD) in older adults is mixed; age alone may not predict benefit. Frailty may help identify patients in whom an ICD does not improve overall mortality risk. METHODS:Structured search of PubMed, Embase, Web of Science, and Cochrane Central Register of Controlled Trials on 1/31/2019, without language restriction, with terms for ICD, frailty, and mortality. Frailty was defined broadly using any validated single component (e.g., walking speed, weight loss) or multi-component tool (e.g., cumulative deficit index). Each study was assessed for quality and risk of bias. RESULTS:We identified and screened 2649 titles, reviewed 280 abstracts, and extracted 71 articles. Nine articles, including two RCTs, one prospective cohort, and six retrospective cohort studies met all criteria. The most common reason for exclusion was a lack of frailty definition. Frailty definitions were heterogeneous, including cumulative deficit models, low weight, and walking speed. Follow-up time for mortality differed: from days to >?6 years. All studies indicated that mortality was higher amongst individuals identified as frail, regardless of definition. In one RCT, slow walkers did not benefit from ICD therapy after 3 years. A cohort of 83,792 Medicare beneficiaries in an ICD registry reported higher 1-year mortality following ICD in those with frailty or dementia. Four studies reported an association between being underweight and increased mortality following ICD placement. CONCLUSION:Existing literature suggests that individuals with frailty may not benefit from ICD placement for primary prevention of SCD.
| S-EPMC6816602 | biostudies-literature
Project description:The Secura ICD and Consulta CRT-D are the first defibrillators to have automatic right atrial (RA), right ventricular (RV), and left ventricular (LV) capture management (CM). Complete CM was evaluated in an implantable cardioverter defibrillator (ICD) population.Two prospective clinical studies were conducted in 28 centres in Europe and Israel. Automatic CM data were compared with manual threshold measurements, the CM applicability was determined, and adjustments to pacing outputs were analysed. In total, 160 patients [age 64.6 +/- 10.4 years, 77% male, 80 ICD and 80 cardiac resynchronization therapy defibrillator (CRT-D)] were included. The differences between automatic and manual measurements were </=0.25 V in 97% (RA CM) and 96% (RV CM) and were all within the safety margin. Fully automatic CM measurements were available within 1 week prior to the 3-month visit in 90% (RA), 99% (RV), and 97% (LV) of the patients. Results indicated increased output (threshold >2.5 V) due to raised RA threshold in seven (4.4%), high RV threshold in nine (5.6%), and high LV threshold in three patients (3.8%). All high threshold detections and all automatic modulations of pacing output were adjudicated appropriate.Complete CM adjusts pacing output appropriately, permitting a reduction in office visits while it may maximize device longevity. The study was registered at ClinicalTrials.gov identifiers: NCT00526227 and NCT00526162.
| S-EPMC2875184 | biostudies-literature
Project description:BackgroundPrimary prevention implantable cardioverter defibrillators (ICDs) reduce all-cause mortality, but the benefits are heterogeneous. Current risk stratification based on left ventricular ejection fraction has limited discrimination power. We hypothesize that biomarkers for inflammation, neurohumoral activation, and cardiac injury can predict appropriate shocks and all-cause mortality in patients with primary prevention ICDs.Methods and resultsThe Prospective Observational Study of Implantable Cardioverter Defibrillators (PROSe-ICD) enrolled 1189 patients with systolic heart failure who underwent ICD implantation for primary prevention of sudden cardiac death. The primary end point was an ICD shock for adjudicated ventricular tachyarrhythmia. The secondary end point was all-cause mortality. After a median follow-up of 4.0 years, 137 subjects experienced an appropriate ICD shock and 343 participants died (incidence rates of 3.2 and 5.8 per 100 person-years, respectively). In multivariable-adjusted models, higher interleukin-6 levels increased the risk of appropriate ICD shocks. In contrast, C-reactive protein, interleukin-6, tumor necrosis factor-α receptor II, pro-brain natriuretic peptide (pro-BNP), and cardiac troponin T showed significant linear trends for increased risk of all-cause mortality across quartiles. A score combining these 5 biomarkers identified patients who were much more likely to die than to receive an appropriate shock from the ICD.ConclusionsAn increase in serum biomarkers of inflammation, neurohumoral activation, and myocardial injury increased the risk for death but poorly predicted the likelihood of an ICD shock. These findings highlight the potential importance of serum-based biomarkers in identifying patients who are unlikely to benefit from primary prevention ICDs.Clinical trial registration urlclinicaltrials.gov; Unique Identifier: NCT00733590.
| S-EPMC4336541 | biostudies-literature
Project description:ObjectivesThe purpose of this study was to assess the benefit of primary prevention implantable cardioverter defibrillators (ICDs) in women.BackgroundClinical trials of primary prevention ICDs enrolled a limited number of women.MethodsUsing a propensity score method, we matched 490 women ≥65 years of age who received an ICD during a hospitalization for heart failure in the National Cardiovascular Data Registry ICD Registry from January 1, 2006, through December 31, 2007, to 490 ICD-eligible women without an ICD hospitalized for heart failure in the Get With The Guidelines for Heart Failure database from January 1, 2006, through December 31, 2009. The primary endpoint was all-cause mortality obtained from the Medicare Claims Database. An identical analysis was conducted in men.ResultsMedian follow-up for patients with an ICD was 4.6 years versus 3.2 years for patients with no ICD. Compared with women with no ICD, those with an ICD were younger and less frequently white. In the matched cohorts, the survival of women with an ICD was significantly longer than that of women without an ICD (adjusted hazard ratio: 0.79, 95% confidence interval: 0.66 to 0.95; p = 0.013). Similarly, men with an ICD had longer survival than men without an ICD (adjusted hazard ratio: 0.73, 95% confidence interval: 0.65 to 0.83; p < 0.0001). There was no interaction between sex and the presence of an ICD with respect to survival (p = 0.44).ConclusionsAmong older women with left ventricular dysfunction, a primary prevention ICD was associated with a significant survival benefit that was nearly identical to that seen in men. These findings support the use of primary prevention ICDs in eligible patients regardless of sex.
| S-EPMC4461749 | biostudies-literature
Project description:In the era of communication technology, new options are now available for following-up patients implanted with pacemakers (PMs) and defibrillators (ICDs). Most major companies offer devices with wireless capabilities that communicate automatically with home transmitters, which then relay data to the physician, thereby allowing remote patient follow-up and monitoring. These systems are being widely used in the USA for remote follow-up, and have been more recently introduced in Europe, where their adoption is increasing. In this article, we describe the currently existing systems, review the available evidence in the literature regarding remote follow-up and monitoring of PMs and ICDs, and finally discuss some unresolved issues.
| S-EPMC2686319 | biostudies-other
Project description:AimsTo report 5-year outcomes of EFFORTLESS registry patients with early generation subcutaneous implantable cardioverter-defibrillator (S-ICD) devices.Methods and resultsKaplan-Meier, trend and multivariable analyses were performed for mortality and late (years 2-5) complications, appropriate shock (AS) and inappropriate shock (IAS) rates. Nine hundred and eighty-four of 994 enrolled patients with diverse diagnoses (28% female, 48 ± 17 years, body mass index 27 ± 6 kg/m2, ejection fraction 43 ± 18%) underwent S-ICD implantation. Median follow-up was 5.1 years (interquartile range 4.7-5.5 years). All-cause mortality was 9.3% (95% confidence interval 7.2-11.3%) at 5 years; 703 patients remained in follow-up on study completion, 171 withdrew including 87 (8.8%) with device explanted, and 65 (6.6%) lost to follow-up. Of the explants, only 20 (2.0%) patients needed a transvenous device for pacing indications. First and final shock efficacy for discrete ventricular arrhythmias was consistent at 90% and 98%, respectively, with storm episode final shock efficacy at 95.2%. Time to therapy remained unaltered. Overall 1- and 5-year complication rates were 8.9% and 15.2%, respectively. Early complications did not predict later complications. There were no structural lead failures. Inappropriate shock rates at 1 and 5 years were 8.7% and 16.9%, respectively. Self-terminating inappropriately sensed episodes predicted late IAS. Predictors of late AS included self-terminating appropriately sensed episodes and earlier AS.ConclusionIn this diverse S-ICD registry population, spontaneous shock efficacy was consistently high over 5 years. Very few patients underwent S-ICD replacement with a transvenous device for pacing indications. Treated and self-terminating arrhythmic episodes predict future shock events, which should encourage more personalized device optimization.
| S-EPMC9156377 | biostudies-literature
Project description:BackgroundClinical trials of implantable cardioverter defibrillators (ICDs) for primary prevention enrolled a limited number of women. We sought to examine clinical practice data to compare survival rates among women with heart failure with or without a primary prevention ICD.Methods and resultsWe linked data from 264 US hospitals included in the Get With The Guidelines for Heart Failure registry with data from the Centers for Medicare and Medicaid Services. From these sources, we propensity score matched 430 women with heart failure who received a primary prevention ICD to 430 women who did not; we further adjusted using a Cox proportional hazards model. Median follow-up was 3.4 and 3.0 years. For comparison, we matched 859 men receiving an ICD with 859 who did not; median follow-up was 3.9 versus 2.9 years. In the matched cohorts, an ICD was associated with similarly better survival in women (hazard ratio, 0.78; 95% confidence interval, 0.66-0.92; P=0.003) and men (hazard ratio, 0.76; 95% confidence interval, 0.67-0.87 P<0.001). There was no interaction between sex and presence of an ICD with respect to survival (P=0.79).ConclusionsAmong patients with heart failure with reduced left ventricular ejection fraction, a primary prevention ICD was associated with a significant survival advantage among women and among men. These findings support guideline-directed use of primary prevention ICDs in eligible patients.
| S-EPMC4712727 | biostudies-literature
Project description:ObjectivesDecisions regarding implantable cardioverter defibrillators (ICDs) must consider information about presumed health-related quality of life (HRQL). The purpose of the study was to assess HRQL in patients with ICD and compare it to a Swedish age-matched and sex-matched population.DesignCross-sectional observational trial.SettingSwedish ICD cohort.InterventionsShort form 36 (SF-36) questionnaires from ICD recipients implanted 2007-2017 (response rate 77.2%) were analysed using Mann-Whitney U test and effect size (ES).ResultsIn total, 223 patients (mean age 71.1±9.7 years, 82.1% men) were included. In most SF-36 domains (physical functioning (PF), role physical, general health (GH), vitality, social functioning and mental health), the score for patients with ICD was significantly lower (ES range 0.23-0.41, ie, small difference) than norms, except for bodily pain and role emotional. Both the physical component summary (PCS) and the mental component summary (MCS) scores had ES=0.31. Men and women had similar scores. Primary and secondary prevention patients scored similarly, except for worse GH in primary prevention (p=0.016, ES=0.35). Atrial fibrillation was associated with worse PF (ES=0.41) and PCS (ES=0.38). Appropriate therapy, inappropriate shock or complications requiring surgery were not associated with lower scores in any domain. In primary prevention due to ischaemic versus non-ischaemic cardiomyopathy, no domain was significantly different. PCS decreased with higher age strata (p=0.002) in contrast to MCS (p=0.986).ConclusionsPatients with ICDs have lower physical and mental HRQL than age-matched and sex-matched norms; however, the ESs are small. HRQL is similar regardless of sex, primary/secondary prevention indication, appropriate therapy, inappropriate shock or complications, but decreases with advancing age.
| S-EPMC8273444 | biostudies-literature
Project description:BACKGROUND:The risk of death or appropriate therapy varies widely among recipients of implantable cardioverter-defibrillators (ICDs). The goals of this study were to develop a risk prediction tool that jointly considers future outcome probabilities of ICD shock and death. METHODS AND RESULTS:We performed a secondary analysis of patients receiving ICDs as part of the SCD-HeFT trial (Sudden Cardiac Death in Heart Failure Trial). We applied an illness-death regression model to jointly model both ICD shocks and death under the semi-competing risks framework, which predicts for each patient their probability of having received ICD shocks, dying, or both at any given point in time. Among 803 ICD recipients (mean age, 60 years; 23% women) followed for a median of 41.1 months, 430 (53.5%) patients completed the study without dying or receiving an ICD shock, 206 (25.7%) received at least 1 shock but survived, 113 (14.1%) died before experiencing a shock, and 54 (6.7%) received at least 1 shock and subsequently died. Predicted outcome probabilities based on baseline demographic and clinical variables reveal substantial heterogeneity in joint shock and death risks, both between patients at each time point and for each single patient across time. Overall, predictive performance for ICD shock and death individually was adequate, based on area under the curve at 5 years of 0.65 for shocks and of 0.79 for death. CONCLUSIONS:Our analysis of outcomes after ICD implantation provides an alternative predictive model for individual risk of death or ICD shocks. If validated, this may provide a useful tool for individualized counseling regarding likely outcomes after device implantation, while also informing the design of further studies to focus the clinical effectiveness and cost-effectiveness of ICD therapy. CLINICAL TRIAL REGISTRATION:URL: https://www.clinicaltrials.gov. Unique identifier: NCT00000609.
| S-EPMC6697057 | biostudies-literature