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Physical function, psychological adjustment, and self-efficacy following sudden cardiac arrest and an initial implantable cardioverter defibrillator (ICD) in a social cognitive theory intervention: secondary analysis of a randomized control trial.

ABSTRACT:

Background

Sudden cardiac arrest (SCA) survivorship results in unique issues in return to physical and psychological function. The purpose of the study was to compare recovery across the first year between SCA survivors and other arrhythmia patients who received a first-time implantable cardioverter defibrillator (ICD) for secondary prevention, participating in a social cognitive theory (SCT) intervention.

Methods

168 (129 males, 39 females) who received an ICD for secondary prevention (SCA N = 65; other arrhythmia N = 103) were randomized to one of two study conditions: SCT intervention (N = 85) or usual care (N = 83). Outcomes were measured at baseline hospital discharge, 1, 3, 6, & 12 months: (1) Physical Function: Patient Concerns Assessment (PCA), SF-36 (PCS); (2) Psychological Adjustment: State Trait Anxiety (STAI), CES-D depression, SF-36 (MCS); (3) Self-Efficacy: Self-Efficacy (SCA-SE), Self-management Behaviors (SMB), Outcome Expectations (OE). Outcomes were compared over 12 months for intervention condition x ICD indication using general estimating equations.

Results

Participants were Caucasian (89%), mean age 63.95 ± 12.3 years, EF% 33.95 ± 13.9, BMI 28.19 ± 6.2, and Charlson Index 4.27 ± 2.3. Physical symptoms (PCA) were higher over time for SCA survivors compared to the other arrhythmia group (p = 0.04), ICD shocks were lower in SCA survivors in the SCT intervention (p = 0.01); psychological adjustment (MCS) was significantly lower in SCA survivors in the SCT intervention over 6 months, which improved at 12 months (p = 0.05); outcome expectations (OE) were significantly lower for SCA survivors in the SCT intervention (p = 0.008).

Conclusions

SCA survivors had greater number of physical symptoms, lower levels of mental health and outcome expectations over 12 months despite participation in a SCT intervention. Trial registration Clinicaltrials.gov: NCT04462887.

SUBMITTER: Dougherty CM

PROVIDER: S-EPMC9364545 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature

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Publications

Physical function, psychological adjustment, and self-efficacy following sudden cardiac arrest and an initial implantable cardioverter defibrillator (ICD) in a social cognitive theory intervention: secondary analysis of a randomized control trial.

Dougherty Cynthia M CM Liberato Ana Carolina Sauer ACS Streur Megan M MM Burr Robert L RL Kwan Ka Yee KY Zheng Tao T Auld Jon P JP Thompson Elaine A EA

BMC cardiovascular disorders 20220810 1

<h4>Background</h4>Sudden cardiac arrest (SCA) survivorship results in unique issues in return to physical and psychological function. The purpose of the study was to compare recovery across the first year between SCA survivors and other arrhythmia patients who received a first-time implantable cardioverter defibrillator (ICD) for secondary prevention, participating in a social cognitive theory (SCT) intervention.<h4>Methods</h4>168 (129 males, 39 females) who received an ICD for secondary preve ...[more]

PMID: 35948889

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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.

Project description:There are limited data describing sex specificities regarding implantable cardioverter defibrillators (ICDs) in the real-world European setting.Using a large multicenter cohort of consecutive patients referred for ICD implantation for primary prevention (2002-2012), in ischemic and nonischemic cardiomyopathy, we examined the sex differences in subjects' characteristics and outcomes. Of 5539 patients, only 837 (15.1%) were women and 53.8% received cardiac resynchronization therapy. Compared to men, women presented a significantly higher proportion of nonischemic cardiomyopathy (60.2% versus 36.2%, P<0.001), wider QRS complex width (QRS >120 ms: 74.6% versus 68.5%, P=0.003), higher New York Heart Association functional class (≥III in 54.2%♀ versus 47.8%♂, P=0.014), and lower prevalence of atrial fibrillation (18.7% versus 24.9%, P<0.001). During a 16 786 patient-years follow-up, overall, fewer appropriate therapies were observed in women (hazard ratio=0.59, 95% CI 0.45-0.76; P<0.001). By contrast, no sex-specific interaction was observed for inappropriate shocks (odds ratio ♀=0.84, 95% CI 0.50-1.39, P=0.492), early complications (odds ratio=1.00, 95% CI 0.75-1.32, P=0.992), and all-cause mortality (hazard ratio=0.87 95% CI 0.66-1.15, P=0.324). Analysis of sex-by- cardiac resynchronization therapy interaction shows than female cardiac resynchronization therapy recipients experienced fewer appropriate therapies than men (hazard ratio=0.62, 95% CI 0.50-0.77; P<0.001) and lower mortality (hazard ratio=0.68, 95% CI 0.47-0.97; P=0.034).In our real-life registry, women account for the minority of ICD recipients and presented with a different clinical profile. Whereas female cardiac resynchronization therapy recipients had a lower incidence of appropriate ICD therapies and all-cause death than their male counterparts, the observed rates of inappropriate shocks and early complications in all ICD recipients were comparable.URL: https://www.clinicaltrials.gov/. Unique identifier: NCT01992458.

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.

Project description:BackgroundDespite the potentially life-saving benefits of the implantable cardioverter-defibrillator (ICD), a significant group of patients experiences emotional distress after ICD implantation. Different psychosocial interventions have been employed to improve this condition, but previous reviews have suggested that methodological issues may limit the validity of such interventions.AimTo review the methodology of previously published studies of psychosocial interventions in ICD patients, according to CONSORT statement guidelines for non-pharmacological interventions, and provide recommendations for future research.MethodsWe electronically searched the PubMed, PsycInfo and Cochrane databases. To be included, studies needed to be published in a peer-reviewed journal between 1980 and 2008, to involve a human population aged 18+ years and to have an experimental design.ResultsTwelve studies met the eligibility criteria. Samples were generally small. Interventions were very heterogeneous; most studies used cognitive behavioural therapy (CBT) and exercise programs either as unique interventions or as part of a multi-component program. Overall, studies showed a favourable effect on anxiety (6/9) and depression (4/8). CBT appeared to be the most effective intervention. There was no effect on the number of shocks and arrhythmic events, probably because studies were not powered to detect such an effect. Physical functioning improved in the three studies evaluating this outcome. Lack of information about the indication for ICD implantation (primary vs. secondary prevention), limited or no information regarding use of anti-arrhythmic (9/12) and psychotropic (10/12) treatment, lack of assessments of providers' treatment fidelity (12/12) and patients' adherence to the intervention (11/12) were the most common methodological limitations.ConclusionsOverall, this review supports preliminary evidence of a positive effect of psychosocial interventions on anxiety and physical functioning in ICD patients. However, these initial findings must be interpreted cautiously because of important methodological limitations. Future studies should be designed as large RCTs, whose design takes into account the specific challenges associated with the evaluation of behavioural interventions.

Project description:AimsThe MADIT-ICD benefit score is used to stratify the risk of life-threatening arrhythmia and non-arrhythmic mortality. We sought to develop an implantable cardioverter defibrillator (ICD) benefit-prediction score for Japanese patients with ICDs.MethodsPatients who underwent ICD implantation as primary prophylaxis were retrospectively enrolled. Based on their MADIT-ICD benefit scores, we developed a modified MADIT-ICD benefit score adapted to the Japanese population. The primary endpoints were appropriate ICD therapy and all-cause death without appropriate ICD therapy (non-arrhythmic death). We used the Fine and Gray multivariate model and Cox proportional hazard regression to identify factors for adjusting the MADIT-ICD benefit-risk score specifically for the Japanese population. The scoring points for the original MADIT-ICD benefit score were adjusted to optimal points based on the multivariate analysis results in the population.ResultsThe study enrolled 167 patients [age, 61.9 ± 12.3 years; male individuals, 138 (82.6%); cardiac resynchronization therapy, 73 (43.7%); ischaemic cardiomyopathy, 53 (31.7%)]. Fourteen patients received anti-tachycardia pacing (ATP) therapy, and 23 received shock therapy as the initial appropriate ICD therapy. Non-arrhythmic deaths occurred in 37 patients. The original MADIT-ICD benefit score could not stratify non-arrhythmic mortality in the Japanese population. The patients were reclassified into three groups according to the modified MADIT-ICD benefit score. The modified MADIT-ICD benefit score could effectively stratify the incidence of appropriate ICD therapy and non-arrhythmic mortality. In the highest-benefit group, the 10 year cumulative rates of appropriate ICD therapy and non-arrhythmic mortality were 56.8% and 12.9%, respectively (P < 0.01). In the intermediate-benefit group, these rates were 20.2% and 40.2% (P = 0.01). In the lowest-benefit group, the incidence of non-arrhythmic deaths was 68.1%, and no patient received appropriate ICD therapy.ConclusionsThe modified MADIT-ICD benefit score may be useful for stratifying ICD candidates in the Japanese population.

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.

Dataset Information

Physical function, psychological adjustment, and self-efficacy following sudden cardiac arrest and an initial implantable cardioverter defibrillator (ICD) in a social cognitive theory intervention: secondary analysis of a randomized control trial.

Background

Methods

Results

Conclusions

Publications

Physical function, psychological adjustment, and self-efficacy following sudden cardiac arrest and an initial implantable cardioverter defibrillator (ICD) in a social cognitive theory intervention: secondary analysis of a randomized control trial.

Similar Datasets

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