Predictors of Quality of Life, Anxiety and Acceptance in Patients with Implantable Cardioverter-Defibrillator. / Preditores de Qualidade de Vida, Ansiedade e Aceitação em Pacientes com Cardioversor-Desfibrilador Implantável.

BACKGROUND: An implantable cardioverter-defibrillator (ICD) can cause high levels of anxiety and depression, resulting in negative effects on quality of life. OBJECTIVES: To evaluate the quality of life, anxiety, and acceptance of the ICD using standardized measurement instruments and identify predictors of better responses for each of the outcomes studied. METHOD: This is a prospective cohort study with patients undergoing initial ICD implantation or reoperation to maintain the device. The study outcomes included quality of life, anxiety, and acceptance of the ICD. The change in scores (30 and 180 days) was assessed using the minimal important difference (MID). Univariate analysis and the multivariate logistic regression model were used to identify predictors of better responses, adopting a significance level of 5%. RESULTS: A total of 147 patients were included between January/2020 to June/2021, with a mean age of 55.3 ± 13.4 years and a predominance of males (72.1%). The MID for quality of life, anxiety, and ICD acceptance were observed in 33 (22.4%), 36 (24.5%) and 43 (29.3%) patients, respectively. Age equal to or greater than 60 years (OR=2.5; 95%CI=1.14-5.53; p=0.022), absence of atrial fibrillation (OR=3.8; 95%CI=1.26-11.63; p=0.017) and female gender (OR=2.2; 95%CI=1.02-4.97; p=0.045) were independent predictors of better responses to quality of life, anxiety and acceptance of the ICD, respectively. CONCLUSION: The identification of predictors for better quality of life scores, anxiety, and acceptance of the device can support the implementation of specific care for patients with a greater chance of presenting unfavorable results.

FUNDAMENTO: O cardioversor-desfibrilador implantável (CDI) pode causar níveis elevados de ansiedade e depressão, resultando em efeitos negativos na qualidade de vida. OBJETIVOS: Avaliar a qualidade de vida, a ansiedade e a aceitação do CDI por meio de instrumentos de medida padronizados e identificar preditores de melhores respostas para cada um dos desfechos estudados. MÉTODO: Coorte prospectiva com pacientes submetidos a implante inicial de CDI ou reoperação para a manutenção do dispositivo. Os desfechos do estudo incluíram: qualidade de vida, ansiedade e aceitação do CDI. A mudança nos escores (30 e 180 dias) foi avaliada por meio da diferença mínima importante (DMI). Foi utilizada a análise univariada e o modelo de regressão logística multivariada para a identificação de preditores de melhores respostas, adotando-se o nível de significância de 5%. RESULTADOS: De janeiro/2020 a junho/2021 foram incluídos 147 pacientes, com idade média de 55,3 ± 13,4 anos e predomínio do sexo masculino (72,1%). A DMI para qualidade de vida, a ansiedade e a aceitação do CDI foram observadas em 33 (22,4%), 36 (24,5%) e 43 (29,3%) pacientes, respectivamente. Idade igual ou maior que 60 anos (OR=2,5; IC 95%=1,14-5,53; p=0,022), ausência de fibrilação atrial (OR=3,8; IC 95%=1,26-11,63; p=0,017) e sexo feminino (OR=2,2; IC 95%=1,02-4,97; p=0,045) foram preditores independentes de melhores respostas para qualidade de vida, ansiedade e aceitação do CDI, respectivamente. CONCLUSÃO: A identificação de preditores para melhores escores de qualidade de vida, ansiedade e aceitação do dispositivo pode subsidiar a implementação de cuidados específicos para os pacientes com maiores chances de apresentar resultados desfavoráveis.

The effect of virtual interactive nurse-led support group intervention on fatigue, shock anxiety, and acceptance of implantable cardioverter defibrillator patients: a randomized trial.

BACKGROUND: Implantable cardioverter defibrillators (ICD), as a gold and standard treatment for fatal cardiac arrhythmia, may lead to some physical and psychological problems for the patients. Therefore, performing some interventions to reduce or eliminate these issues is crucial. This study aimed to determine the effect of virtual interactive nurse-led support group intervention on fatigue, shock anxiety, and acceptance of ICD patients. METHODS: This is a clinical trial study on 72 patients with ICD. They were randomly allocated to the intervention (n = 36) and control (n = 36) groups. A virtual interactive nurse-led support group intervention through WhasApp was performed for one month. Multidimensional fatigue inventory, Florida Shock Anxiety Scale, and Florida Patient Acceptance Scale were used. Data were analyzed to perform the analysis of data through SPSS, using independent and paired-t test, Mann-Whitney U test, Wilcoxon test, and ANCOVA. RESULTS: Before the intervention, no significant difference was observed between the two groups with regard to fatigue, shock anxiety, and ICD acceptance. However, after the intervention, a significant difference was found between the two groups with regard to fatigue, shock anxiety, and ICD acceptance (P < 0.05). CONCLUSION: This study showed that virtual interactive nurse-led support group intervention reduced fatigue and shock anxiety and improved the ICD acceptance. PRACTICE IMPLICATIONS: This flexible, accessible, and interactive nurse-led support group intervention is suggested to be used for ICD patients. TRIAL REGISTRATION: This trial was registered and approved by Iranian Registry of Clinical Trials (Trial Id: 60,738, date: (24/02/2022). ( https://www.irct.ir/trial/60738 ).

Patients with an implantable cardioverter defibrillator at risk of poorer psychological health during 24 months of follow-up (results from the Danish national DEFIB-WOMEN study).

OBJECTIVE: Identify implantable cardioverter defibrillator (ICD) patients at risk of distress (i.e., depression, anxiety, and ICD concerns) and associated risk factors. METHOD: First-time ICD patients (n = 1503) from the Danish national DEFIB-WOMEN study completed questionnaires at baseline, 3, 6, 12 and 24 months. RESULTS: Of patients with low scores on distress, only 4%-7.2% experienced an increase in distress during 24 months of follow-up (FU), while 30.5%-52.5% with increased levels were likely to maintain increased levels at FU. Higher education, higher age, female sex, and good physical functioning at baseline were associated with less depression, anxiety and ICD concerns at FU. Previous psychological problems, smoking, Type D personality, NYHA class III-IV - all assessed at baseline - and shocks during FU were associated with depression, anxiety and ICD concerns. CONCLUSIONS: Generally, patients' psychological health improved, but patients with increased baseline scores were more likely to have increased scores at FU. We need to be vigilant if patients report elevated distress, particularly if they have depression at baseline, as depression seems more persistent. Given the impact of depression on health-related quality of life and prognosis, they should be screened and monitored closely.

Patient experiences of implantable cardiac monitoring in hypertrophic cardiomyopathy: an exploratory study.

AIMS: Hypertrophic cardiomyopathy (HCM) is the most common inherited heart disease. Insertable cardiac monitors (ICMs) are increasingly used in this population to provide closer monitoring, with the potential for notification systems. However, little is known regarding the psychological impact this information may have on patients. The Abbott Confirm Rx™ ICM has the capability of connecting to the patient's smartphone to enable active participation in their care, as well as two-way communication between the patient and their care providers. This study aimed to explore individuals' experiences of having a smartphone-enabled ICM to monitor for arrhythmias in HCM. METHODS AND RESULTS: Semi-structured interviews were conducted with 10 participants. Utilizing a grounded theory approach, the interview guide was modified based on emerging themes throughout the study. Reflexive thematic analysis was applied to categorize interview data into codes and overacting themes, with each interview independently coded by two study members. Analysis revealed three key themes: (i) psychological impact, (ii) educational needs, and (iii) technology expectations. Participants reported that receiving feedback from ICM transmissions resulted in improved symptom clarity, providing reassurance, and aiding implantable cardioverter defibrillator decision-making. Some participants reported uncertainty regarding when to send manual transmissions. Lastly, participants reported the app interface did not meet expectations with regard to the amount of data available for patients. CONCLUSION: Overall, utilizing a smartphone app to facilitate two-way communication of ICM transmissions was well accepted. Future directions include addressing gaps in educational needs and improvements in the patient interface with increased access to data.

Sex differences in the course of implantable cardioverter defibrillator concerns (Results from the Danish national DEFIB-WOMEN study).

OBJECTIVE: The implantable cardioverter defibrillator (ICD) is used to treat malignant ventricular arrhythmias. Since 33% of patients experience ICD-related concerns, we examined sex differences in ICD concerns and correlates of ICD concerns during 24 months of follow-up after implantation of an ICD. METHODS: Patients from the DEFIB-WOMEN study (n = 1515; 81.6% male patients) completed questionnaires on ICD concerns, anxiety, depression, and Type D personality at five measure points (baseline, 3-, 6-, 12- and 24-months post-implantation). RESULTS: Male patients scored on average 7.0 (6.8) points on ICD concerns at the time of implantation and female patients scored on average 10.5 (8.2) points. We found statistically significant sex differences in ICD concerns at all measurement points, with female patients scoring 2.77 points (8.7% of the maximum score of 32) higher than male patients. ICD concerns decreased in both sexes the first 6 months and then levelled out. For both sexes, ICD concerns at baseline were significantly correlated with ICD concerns at 24-months follow-up. Anxiety at baseline was correlated with ICD concerns in female patients, while depression at baseline and at least one experienced shock correlated with ICD concerns in male patients. CONCLUSION: Female patients reported more ICD concerns at all measurement points compared to male patients, but for both sexes ICD concerns decreased in the first 6 months. ICD shock, anxiety, depression, and ICD concerns at baseline were correlates of ICD concerns at 24-months follow-up.

Posttraumatic stress disorder in pediatric patients with implantable cardioverter-defibrillators and their parents.

BACKGROUND: An implantable cardioverter-defibrillator (ICD) in the pediatric patient (and the precipitating events that led to ICD placement) can be traumatic for patients and their families and may lead to posttraumatic stress disorder (PTSD). OBJECTIVES: This study aimed to estimate the prevalence of PTSD in pediatric patients with an ICD and their parents and identify the factors associated with PTSD incidence. METHODS: Pediatric participants with an ICD aged 8-21 years and parents of children aged 0-21 years completed surveys that included demographic characteristics and PTSD measures. Pediatric participants completed additional psychosocial measures, such as anxiety and depression self-report questionnaires. RESULTS: Fifty youth (30% female) and 43 parents (70% female) completed the measures. Six of 50 youth (12%) met the screening criteria for a likely PTSD diagnosis, while 20 of 43 parents (47%) met the cutoff for PTSD on the screening measure. Children with PTSD were more likely to have had a secondary prevention ICD (83% vs 17%; P = .021), meet the clinical cutoff for depression (67% vs 16%; P = .005), and had higher shock anxiety scores (31.7 vs 17.9; P = .003) than children without PTSD. Female gender (57% vs 23%; P = .043) and patient depression (31% vs 5%; P = .042) were associated with PTSD in parents. CONCLUSION: Parents were found to be more likely to meet the criteria for PTSD than youth. In youth, PTSD was associated with medical and psychosocial factors, whereas PTSD in parents was associated with being female and child depression. Clinic-based screenings and management planning of emotional functioning are warranted to address psychological distress in patients and parents.

Periprocedural complications of cardiac implantable electronic device implantation in very elderly patients with cognitive impairment: A prospective study.

ABSTRACT: Very elderly people (over 80 years) with cardiac implantable electronic devices (CIEDs) indications often have a higher prevalence of aging comorbidity, among which cognitive impairment is not uncommon. This study aimed to investigate periprocedural complications of CIED implantation among very elderly patients with and without cognitive impairment. One hundred eighty patients ≥80 years of age indicated for CIED implantation were included in our study. During hospitalization, the cognitive evaluation was performed according to the Diagnostic and Statistical Manual of Mental Disorders (fifth edition). According to the cognitive test results, patients were divided into 2 groups (90 patients with normal cognitive function and 90 patients with cognitive impairment). Meanwhile, their physical parameters and laboratory measurements were completed. The procedural data and periprocedural complications were collected from both groups. The association between cognitive impairment and periprocedural complications was analyzed using univariate and multiple logistic regression analyses. During a one-month follow-up, the most frequent periprocedural complications in very elderly patients were pocket hematoma and thrombosis events. Cognitively impaired patients had a higher incidence of complications than normal cognitive patients. Multivariate regression analysis showed that cognitive impairment was positively correlated with periprocedural complications in very elderly patients. Cognitive impairment is associated with increased periprocedural complications of CIED implantation in very elderly patients.

The impact of transvenous cardioverter-defibrillator implantation on quality of life, depression and optimism in dialysis patients: report on the secondary outcome of QOL in the randomized controlled ICD2 trial.

RATIONALE: The impact of prophylactic implantable cardioverter-defibrillator (ICD) implantation on the psychological well-being of patients on dialysis is unknown. OBJECTIVE: We aimed to identify the effect of primary ICD implantation on quality of life (QoL), mood and dispositional optimism in patients undergoing dialysis. METHODS AND RESULTS: We performed a prespecified subanalysis of the randomized controlled ICD2 trial. In total, 177 patients on chronic dialysis, with an age of 55-81 years, and a left ventricular ejection fraction of ≥ 35%, were included in the per-protocol analysis. Eighty patients received an ICD for primary prevention, and 91 patients received standard care. The Short Form-36 (SF-36), Geriatric Depression Scale-15 (GDS-15), Revised Life Orientation Test (LOT-R) questionnaires were administered prior to ICD implantation (T0), and at 1-year follow-up (T1) to assess QoL, depression and optimism, respectively. The patients were predominantly male (76.0%), with a median age of 67 years. Hemodialysis was the predominant mode of dialysis (70.2%). The GDS-15 score difference (T1 - T0) was 0.5 (2.1) in the ICD group compared with 0.3 (2.2) in the control group (mean difference - 0.3; 95% CI - 1.1 to 0.6; P = 0.58). The LOT-R score difference was - 0.2 (4.1) in the ICD group compared with - 1.5 (4.0) in the control group (mean difference - 1.1 (0.8); 95% CI - 2.6 to 0.4; P = 0.17). The mean difference scores of all subscales of the SF-36 were not significantly different between randomization groups. CONCLUSIONS: In our population of patients on dialysis, ICD implantation did not affect QoL, mood or dispositional optimism significantly during 1-year follow-up. CLINICAL TRIAL REGISTRATION: Unique identifier: ISRCTN20479861. http://www.controlled-trials.com .

Sport activity in patients with cardiac implantable electronic devices: evidence and perspectives.

Demographic characteristics of patients with cardiac implantable electronic devices have significantly changed during the last few years, according to the ageing of the population and the consequent increase in the number of elderly individuals with indication for pacemaker implant and, on the other hand, to the increased number of young individuals implanted with an implantable cardioverter defibrillator for the primary prevention of sudden death. More and more often, both elderly and young patients ask the physician to deal with the device in their daily activities, which often include sport practice. This latter is advisable because of its recognized benefits on cardiovascular prevention, although there are many limitations for patients with a cardiac implantable electronic device. Hence, the need to balance the patient's request with the appropriate precautions emerging from existing evidence. The current article aims to provide an overview of the most recent data on this topic, derived from registries and observational studies. Over the years an attempt to standardize recommendations has been made, but robust evidence is still lacking. Substantial differences exist between countries based on their sports regulations. Official recommendations of European and American Scientific Societies are resumed. The future perspective is to obtain data to allow these patients a safer practice of sport activity also through technological advances in terms of device materials and programming improvement and the possibility of remote monitoring.

The INFluence of Remote monitoring on Anxiety/depRession, quality of lifE, and Device acceptance in ICD patients: a prospective, randomized, controlled, single-center trial.

BACKGROUND: Impact of telemedicine with remote patient monitoring (RPM) in implantable cardioverter-defibrillator (ICD) patients on clinical outcomes has been investigated in various clinical settings with divergent results. However, role of RPM on patient-reported-outcomes (PRO) is unclear. The INFRARED-ICD trial aimed to investigate the effect of RPM in addition to standard-of-care on PRO in a mixed ICD patient cohort. METHODS AND RESULTS: Patients were randomized to RPM (n = 92) or standard in-office-FU (n = 88) serving as control group (CTL). At baseline and on a monthly basis over 1 year, study participants completed the EQ-5D questionnaire for the primary outcome Quality of Life (QoL), the Hospital Anxiety and Depression Scale, and the Florida Patient Acceptance Survey questionnaire for secondary outcomes. Demographic characteristics (82% men, mean age 62.3 years) and PRO at baseline were not different between RPM and CTL. Primary outcome analysis showed that additional RPM was not superior to CTL with respect to QoL over 12 months [+ 1.2 vs. + 3.9 points in CTL and RPM group, respectively (p = 0.24)]. Pre-specified analyses could not identify subgroups with improved QoL by the use of RPM. Neither levels of anxiety (- 0.4 vs. - 0.3, p = 0.88), depression (+ 0.3 vs. ± 0.0, p = 0.38), nor device acceptance (+ 1.1 vs. + 1.6, p = 0.20) were influenced by additional use of RPM. CONCLUSION: The results of the present study show that PRO were not improved by RPM in addition to standard-of-care FU. Careful evaluation and planning of future trials in selected ICD patients are warranted before implementing RPM in routine practice.

Comparison of depression and anxiety among pacemaker and implantable cardioverter-defibrillator recipients: A cross-sectional study.

INTRODUCTION: Anxiety and depression among implantable cardioverter-defibrillator (ICD) recipients can lead to physical or psychological consequences and reduce the quality of life of these patients. Few studies have compared the frequency and severity of depressive and anxiety disorders in the pacemaker (PM) and ICD recipients. The aim of the present study was to compare depression and anxiety among PM and ICD recipients. METHODS: This cross-sectional study was performed on 296 patients referred to a specialized cardiology teaching hospital from October 1, 2019 to July 1, 2020. Patients were selected using convenience sampling method. RESULTS: Regarding anxiety, the results showed that the overall prevalence of anxiety in PM, ICD, and control groups was 23.5%, 28%, and 8%, respectively. Results showed no significant difference between PM and ICD recipients regarding the anxiety prevalence (p = .46). With regard to depression, the results showed that the overall prevalence of depression in the PM, ICD, and control groups was 7.1%, 23%, and 4.1%, respectively. The results showed a significant difference between PM and ICD recipients in terms of depression prevalence (p = .03). The results also showed that the prevalence of depression was significantly higher among PM and ICD recipients than the control group (p = .01). CONCLUSION: Considering the results of the present study and the high prevalence of anxiety and depression, it seems necessary to focus more on educating patients about the effectiveness of PM and ICD devices in reducing anxiety and depression.

Validity Evidence of the Brazilian Version of the Florida Shock Anxiety Scale for Patients with Implantable Cardioverter Defibrillators. / Evidências de Validade da Versão Brasileira da Florida Shock Anxiety Scale para Portadores de Cardioversor-Desfibrilador Implantável.

BACKGROUND: In spite of proven effectiveness of implantable cardioverter defibrillators (ICDs), shock therapy delivered by the device may result in increased levels of anxiety and depression, leading to deleterious effects on quality of life. OBJECTIVE: To carry out the translation, cross-cultural adaptation and validation of the Florida Shock Anxiety Scale (FSAS) scale into Brazilian Portuguese. METHODS: In this psychometric study, construct validity was performed by exploratory (EFA) and confirmatory (CFA) factor analyses, and by item response theory (IRT). The adjustment indexes of the CFA were: Robust Mean-Scaled Chi Square/df NNFI, CFI (Comparative Fit Index), GFI (Goodness Fit Index), AGFI (Adjusted Goodness Fit Index), RMSEA (Root Mean Square Error of Approximation) and RMSR (Root Mean Square of Residuals). Reliability was evaluated through Cronbach's Alpha, McDonald's Omega and Greatest Lower Bound (GLB). The analyses were carried out with the programs SPSS 23 and Factor 10.8.01. A 5 percent significance level was used. RESULTS: The final Portuguese version of the FSAS was administered to 151 ICD patients, with a mean age of 55.7 ± 14.1 years, and predominantly male. The parallel analysis indicated that the FSAS is unidimensional, with an explained variance of 64.4%. The correlations ranged from 0.31 to 0.77, factor loadings from 0.67 to 0.86, and communalities from 0.46 to 0.74. The adjustment indexes of the CFA were above the quality threshold. Satisfactory reliability evidence was provided by the FSAS. CONCLUSIONS: The FSAS-Br showed consistent validity and reliability evidence. Therefore, it can be used in ICD patients in Brazil. (Arq Bras Cardiol. 2020; 114(5):764-772).

FUNDAMENTO: A despeito da comprovada efetividade do cardioversor-desfibrilador implantável (CDI), as terapias de choque deflagradas pelo dispositivo podem causar níveis elevados de ansiedade e depressão, provocando efeitos deletérios na qualidade de vida. OBJETIVO: Realizar a tradução, adaptação transcultural e validação do instrumento Florida Shock Anxiety Scale (FSAS) para a língua portuguesa falada no Brasil. MÉTODOS: Nesse estudo psicométrico, a validade de construto foi realizada pela análise fatorial exploratória (AFE) e confirmatória (AFC) e pela Teoria de Resposta ao Item. Os índices de ajustamento da AFC foram: Robust Mean-Scaled Chi Square/df NNFI, CFI (Comparative Fit Index), GFI (Goodness Fit Index), AGFI (Adjusted Goodness Fit Index), RMSEA (Root Mean Square Error of Approximation) e RMSR (Root Mean Square of Residuals). A confiabilidade foi verificada pelo Alfa de Cronbach, Ômega de McDonald e Greatest Lower Bound. As análises foram realizadas no SPSS 23.0 e Factor 10.8.01, com nível de significância de 5%. RESULTADOS: A versão final em português do FSAS foi administrada em 151 portadores de CDI, com idade média de 55,7 ± 14,1 anos e predomínio do sexo masculino. A análise paralela indicou que o FSAS é unidimensional, com variância explicada de 64,4%. As correlações variaram de 0,31 a 0,77; as cargas fatoriais de 0,67 a 0,86 e as comunalidades de 0,46 a 0,74. Os índices de ajustamento da AFC estabeleceram-se acima dos limites de qualidade. Encontramos evidências satisfatórias de confiabilidade da escala FSAS. CONCLUSÃO: O instrumento FSAS-Br apresentou evidências consistentes de validade e confiabilidade, podendo, portanto, ser utilizado em portadores de CDI do Brasil. (Arq Bras Cardiol. 2020; 114(5):764-772).

Social cognitive intervention following an initial implantable cardioverter defibrillator: Better treatment response for secondary versus primary prevention.

BACKGROUND: The patient + partner (P+P) is a patient/partner-focused social cognitive intervention with demonstrated efficacy to improve outcomes following an initial implantable cardioverter defibrillator (ICD). Little is known about how the patient response may differ by ICD implant indication. The aim of this study was to examine the response to intervention for patients with an initial ICD by reasons for primary versus secondary ICD indication. METHOD: A longitudinal secondary analysis of data from a randomized clinical trial testing the P+P intervention examined patient health outcomes over 12 months, stratified by the indication for the ICD: primary prevention without cardiac resynchronization therapy (CRT) (1o No CRT, n = 100), primary prevention with CRT (1o CRT, n = 78), secondary prevention after cardiac arrest (2° Cardiac Arrest, n = 66), and secondary prevention for other arrhythmias (2o Other, n = 57). Outcomes included physical and mental health status (Short-Form-36 Physical Component Summary and Mental Component Summary), physical symptoms (Patient Concerns Assessment), depression (Patient-Health-Questionniare-9), and anxiety (State-Trait Anxiety Inventory). RESULTS: Participants (n = 301) were on average 64 years old, primarily male (73.7%) and Caucasian (91%) with reduced ejection fraction (34%). There were no baseline differences between ICD groups for all outcomes (P > .05). Patients in the 2° Cardiac Arrest group showed greater improvement from baseline to 3 months in physical and mental health outcomes. The 2° Cardiac Arrest group had better physical (F = 11.48, P = .004) and mental health (F = 4.34, P = .038) and less severe physical (z = 2.24, P = 0.013) and depressive symptoms (z = 2.71, P = .003) at 12 months compared to the 1o No CRT group. CONCLUSION: The P+P intervention was more effective for promoting physical and psychological health outcomes for individuals receiving an ICD for 2o prevention after cardiac arrest.

Evidências de Validade da Versão Brasileira da Florida Shock Anxiety Scale para Portadores de Cardioversor-Desfibrilador Implantável / Validity Evidence of the Brazilian Version of the Florida Shock Anxiety Scale for Patients with Implantable Cardioverter Defibrillators

Resumo Fundamento A despeito da comprovada efetividade do cardioversor-desfibrilador implantável (CDI), as terapias de choque deflagradas pelo dispositivo podem causar níveis elevados de ansiedade e depressão, provocando efeitos deletérios na qualidade de vida. Objetivo Realizar a tradução, adaptação transcultural e validação do instrumento Florida Shock Anxiety Scale (FSAS) para a língua portuguesa falada no Brasil. Métodos Nesse estudo psicométrico, a validade de construto foi realizada pela análise fatorial exploratória (AFE) e confirmatória (AFC) e pela Teoria de Resposta ao Item. Os índices de ajustamento da AFC foram: Robust Mean-Scaled Chi Square/df NNFI, CFI (Comparative Fit Index), GFI (Goodness Fit Index), AGFI (Adjusted Goodness Fit Index), RMSEA (Root Mean Square Error of Approximation) e RMSR (Root Mean Square of Residuals). A confiabilidade foi verificada pelo Alfa de Cronbach, Ômega de McDonald e Greatest Lower Bound. As análises foram realizadas no SPSS 23.0 e Factor 10.8.01, com nível de significância de 5%. Resultados A versão final em português do FSAS foi administrada em 151 portadores de CDI, com idade média de 55,7 ± 14,1 anos e predomínio do sexo masculino. A análise paralela indicou que o FSAS é unidimensional, com variância explicada de 64,4%. As correlações variaram de 0,31 a 0,77; as cargas fatoriais de 0,67 a 0,86 e as comunalidades de 0,46 a 0,74. Os índices de ajustamento da AFC estabeleceram-se acima dos limites de qualidade. Encontramos evidências satisfatórias de confiabilidade da escala FSAS. Conclusão O instrumento FSAS-Br apresentou evidências consistentes de validade e confiabilidade, podendo, portanto, ser utilizado em portadores de CDI do Brasil. (Arq Bras Cardiol. 2020; 114(5):764-772)

Abstract Background In spite of proven effectiveness of implantable cardioverter defibrillators (ICDs), shock therapy delivered by the device may result in increased levels of anxiety and depression, leading to deleterious effects on quality of life. Objective To carry out the translation, cross-cultural adaptation and validation of the Florida Shock Anxiety Scale (FSAS) scale into Brazilian Portuguese. Methods In this psychometric study, construct validity was performed by exploratory (EFA) and confirmatory (CFA) factor analyses, and by item response theory (IRT). The adjustment indexes of the CFA were: Robust Mean-Scaled Chi Square/df NNFI, CFI (Comparative Fit Index), GFI (Goodness Fit Index), AGFI (Adjusted Goodness Fit Index), RMSEA (Root Mean Square Error of Approximation) and RMSR (Root Mean Square of Residuals). Reliability was evaluated through Cronbach's Alpha, McDonald's Omega and Greatest Lower Bound (GLB). The analyses were carried out with the programs SPSS 23 and Factor 10.8.01. A 5 percent significance level was used. Results The final Portuguese version of the FSAS was administered to 151 ICD patients, with a mean age of 55.7 ± 14.1 years, and predominantly male. The parallel analysis indicated that the FSAS is unidimensional, with an explained variance of 64.4%. The correlations ranged from 0.31 to 0.77, factor loadings from 0.67 to 0.86, and communalities from 0.46 to 0.74. The adjustment indexes of the CFA were above the quality threshold. Satisfactory reliability evidence was provided by the FSAS. Conclusions The FSAS-Br showed consistent validity and reliability evidence. Therefore, it can be used in ICD patients in Brazil. (Arq Bras Cardiol. 2020; 114(5):764-772)

Quality of life and psychological co-morbidities in children and adolescents with cardiac pacemakers and implanted defibrillators: a cohort study in Eastern Germany.

INTRODUCTION: The implantation of a pacemaker or an implantable cardioverter-defibrillator during childhood may reduce quality of life and lead to mental health problems. This study aimed to evaluate potential mental health problems (i.e., depressive and anxiety symptoms) and quality of life in children with cardiac active devices in comparison to healthy peers. METHODS: We analysed data of children with pacemakers or implantable cardioverter-defibrillators aged 6-18 years. Quality of life, depressive and anxiety symptoms were assessed by standardised questionnaires. The results were compared to age-matched reference groups. RESULTS: Children with implantable cardioverter-defibrillator showed significant lower quality of life in comparison to reference group (p = 0.03), but there was no difference in quality of life between children with pacemaker and reference group. There was no significant difference in depressive symptoms between children with a cardiac rhythm device compared to reference group (self-report: p = 0.67; proxy report: p = 0.49). There was no significant difference in anxiety (p = 0.53) and depressive symptoms (p = 0.86) between children with pacemaker and children with implantable cardioverter-defibrillator. CONCLUSIONS: Living with an implantable cardioverter-defibrillator in childhood seems to decrease the patients' quality of life. Although children with pacemaker and implantable cardioverter-defibrillator don't seem to show more depressive and anxiety symptoms in comparison to their healthy peers, there still can be an increased risk for those children to develop mental health problems. Therefore, treating physicians should be aware of potential mental health problems and provide the patients and their families with appropriate therapeutic offers.

Validity of the newly developed 4-item ANXiety-scale in patients with an implantable cardioverter defibrillator: A 12-month follow-up study.

BACKGROUND: Subclinical anxiety symptoms are associated with risk of impaired mental and physical health status, ventricular tachyarrhythmias and mortality, in patients with an implantable cardioverter defibrillator (ICD). This study evaluates the validity of the brief and new 4-item Anxiety Scale (ANX4) and its predictive value in relation to health status 12-months post ICD implantation. METHODS: A total of 288 ICD patients completed the ANX4 questionnaire. Factor analysis was performed to assess the validity of the scale. In a subsample of N = 212 patients, regression analysis was performed to assess questionnaires' predictive value of health status at 12-months follow-up. RESULTS: Analyses of the ANX4 revealed a one-factor structure with a high internal consistency (α = 0.894). The ANX4 correlated significantly with existing generic and disease specific measures of anxiety symptoms STAI-S (r = 0.62), GAD-7 (r = 0.58), HADS-A (r = 0.66) and ICD related concerns (ICDC) (r = 0.44). Baseline anxiety symptoms were associated with lower levels of physical (ß = -0.276; p < .001) and mental (ß = -0.551; p < .001) health status 12-months post ICD implantation, adjusting for demographic and clinical variables. CONCLUSIONS: The 4-item ANX4 shows to be a valid measure of anxiety symptoms in ICD patients and predicts physical and mental health status up to 12 months follow-up. Further studies are warranted to replicate these findings, determine the cut-off score for clinical relevant symptoms, and whether the ANX4 can be used in other populations.

The prevalence of depression in patients living with implantable cardioverter defibrillator: a systematic review and meta-analysis.

Depression is a common disorder in patients with implantable cardioverter defibrillator (ICD). There are a variety of studies estimated the prevalence of depression in these patients. The present study aimed to investigate the prevalence of depression in patients with ICD. METHODS: In the present study, we conducted a systematic review of studies published in PubMed, Scopus, Web of Science (WoS), Medline, and EMBASE without any time filtration to obtain studies investigated the prevalence of depression in patients with ICD. Search terms consisted of "Implantable Cardioverter Defibrillator(s)" in combination with "depression," "depressive," "prevalence," "implanted cardioverter," "implantable," and "implantable defibrillator." RESULTS: We identified 15 relevant studies, comprising data from 10,182 patients with ICD from whom 2400 (23.58%) (95% CI, 15.36-31.79) had depression. The results of the subgroup analysis showed that the prevalence of depression among middle-aged patients (28.58% with confidence interval of 95%, 21.51-35.65) was higher than elderly patients (22.23% with confidence interval of 95%, 11.21-33.24) and it was not significantly correlated with the mean age of samples (P = 0.255), sample size (P = 0.686), and the publication date (P = 0.784), although there was a significant correlation between the prevalence of depression and the quality of articles so that the prevalence was decreasing with an increase in the quality (P = 0.046). CONCLUSION: Around 1 in 4 patients with ICD (23.58%) experiences depression progression after an ICD placement. This prevalence is comparable to that in the general population, and close to that of the patients with common chronic diseases.

Development of the Implantable Cardioverter Defibrillator Body Image Concerns Questionnaire.

BACKGROUND: The implantable cardioverter defibrillator (ICD) is the first-line treatment for the prevention of sudden cardiac death. Although most ICD recipients adapt well to living with the device, some struggle with ICD-related body image concerns (BICs). Because of lack of standardized questionnaires to assess BICs, we do not know the prevalence. OBJECTIVE: The aim of this study was to develop a questionnaire that assesses self-reported ICD-related BICs. METHODS: Using a sequential, qualitative multimethod approach, we developed the ICD-BIC questionnaire (ICD-BICQ) based on (1) themes from a scoping review on BICs in ICD recipients, (2) cognitive interviews with ICD recipients to evaluate the validity of items and to ascertain whether items were missing, and (3) input from healthcare professionals. A conceptual framework was created containing 4 general dimensions: (1) assessment, (2) behavior, (3) body perception, and (4) emotions. RESULTS: Implantable cardioverter defibrillator recipients (n = 8, 2 women and 6 men; age, 40-78 years), 2 specialists in questionnaire development, and healthcare professionals specialized in ICD treatment evaluated the questionnaire. After no new items or new dimensions emerged from the cognitive interviews, the final version 7 of the ICD-BICQ consisted of 39 items tapping into (1) assessment (n = 2), (2) behavior (n = 13), (3) body perception (n = 16), and emotions (n = 8). Items were assessed on a 5-point Likert-type scale. CONCLUSION: Using patient and healthcare professionals' involvement, we developed the 39-item ICD-BICQ to measure the prevalence of BICs in ICD recipients. The factor structure, construct validity, psychometric properties, and a clinically relevant cutoff for the ICD-BICQ will be evaluated in a quantitative study of ICD recipients.

An exploratory assessment of pediatric patient and parent needs after implantable cardioverter defibrillator implant.

BACKGROUND: Placement of an implantable cardioverter defibrillator (ICD) is often accompanied by psychological adjustment issues in pediatric patients and their parents. Although anxiety, depression, and lowered quality of life have been seen in these patients, no studies have investigated patient or parent reported needs. This exploratory study describes the needs of pediatric ICD patients and parents and assesses whether patient factors of age, gender, depression, and anxiety are associated with specific needs. METHODS: ICD patients ages 8-21 years and their parents completed a needs analysis survey assessing various domains of functioning. Patients also completed self-reported measures of depression and anxiety. RESULTS: Thirty-two patients (28% female) and their parents (72% mothers) completed the survey. Patients' most frequently endorsed needs involved educational issues: understanding their cardiac event/diagnosis (34%), medications (34%), and how the ICD would change their lifestyle (31%). Parents' most frequently endorsed needs involved family issues; almost half of parents (47%) were concerned about their children's frustration with their overprotectiveness and 28% were concerned with their child feeling depressed or anxious. Patients who reported feeling overprotected (12.1 ± 3.4 vs 17.4 ± 3.5 years; P = .001) were significantly younger than those who did not. Experiencing peer issues was more frequently endorsed by females than males (33% of females vs 4% of males; P = .026). CONCLUSIONS: ICD patients and parents endorsed markedly different needs. Patients focused on understanding their ICD, whereas parents were more focused on their children's emotional needs. Novel ways of educating patients about their device and clinic-based screenings of emotional functioning may serve to meet these needs.

Evaluation and acceptance of mobile-electrocardiogram use in implantable cardioverter defibrillator patients - Can I see my ECG?

BACKGROUND: Medical technologies for consumers aim to help prevent, manage, and even forecast cardiovascular events, but their emotional impact is not fully known. The value of mobile-electrocardiogram (mECG) technology to an existing group of cardiac patients is unknown. The purpose of this study was to examine the impact of readily available mECG capability for a sample of implantable cardioverter defibrillator (ICD) patients. METHODS: Patients with ICDs (N = 51) were recruited and consented in a large academic cardiology clinic. Participants were given a mECG device and asked to take a 30-ss reading at least once per day for 30 days. Technology satisfaction, cardiac anxiety, shock anxiety, and ICD device acceptance were measured pre- and post-mECG usage. RESULTS: mECG technology was regularly used (M = 36.6 readings completed per month) and positively appraised by ICD patients (mean of 4.4 out of possible 5). Self-reported symptoms of general cardiac anxiety were not significantly affected by the utilization of mECG technology. ICD specific measures were mixed with increased overall ICD device acceptance but also increased shock anxiety. CONCLUSIONS: ICD patients positively viewed and used mECG technology regularly as prescribed. However, the overall psychological impact of mECG was mixed and suggests that ICD patients may have idiosyncratic adjustments to the increased access of cardiac device data.