Enhancing patient acceptance of ICD implantation through structured shared decision making: conversation is key.

BACKGROUND: Implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-D) are lifesaving treatments for patients at risk for sudden cardiac death. Effective physician-patient communication during the shared decision-making process is essential. Electrophysiologist-patient conversations were targeted to obtain objective data on the interaction, understand the conversation framework, and uncover opportunities for improved communication. METHODS: Individuals previously identified as requiring an ICD/CRT-D but declined implantation were recruited for this four-stage interview and survey-based study. Quantitative analysis of surveys and AI analysis of conversation videos was conducted to evaluate patient participant expectations, analyze feedback about the conversations with study physicians, and gauge willingness for device implantation. RESULTS: The study included 27 patients (mean age 51 years, 51.9% female) and 9 study physicians. Patients were significantly more willing to undergo ICD/CRT-D implantation after conversing with study physicians compared to their own physicians and pre-conversation surveys (mean scores: 5.0, 3.1, and 4.4 out of 7, respectively; p < 0.001). Patient participants had higher satisfaction with the study conversation, rating study physicians higher in effectiveness of explanations, responsiveness to questions, and overall quality of the conversation compared to their own physicians (all p < 0.001). CONCLUSIONS: In a cohort of patients who previously declined ICD/CRT-D implantation, patient satisfaction and willingness to undergo implantation of a guideline-directed device therapy increased significantly following a structured conversation with study physicians. Identified key elements could be integrated into user-friendly tools and educational materials to facilitate these conversations, improving patient engagement with the decision-making process and enhancing informed acceptance of indicated device therapies.

Patient-reported quality of life and acceptance of the extravascular implantable cardioverter-defibrillator: Results from pivotal study.

INTRODUCTION: The pivotal study of the extravascular implantable cardioverter-defibrillator (EV ICD) recently demonstrated primary efficacy and safety endpoints comparable to previous ICD systems. Patient experience with this novel device has not been reported. The current study examined the standardized patient-reported outcome (PRO) metrics of quality of life (QOL) and patient acceptance of the device. METHODS: The EV ICD Pivotal Study was a prospective, single-arm, nonrandomized, global, premarket approval trial. Patients completed the 12-Item Short Form Survey (SF-12) QOL surveys at baseline and at 6 months following implant. Additionally, patients completed the Florida Patient Acceptance Survey (FPAS) QOL survey at 6 months. RESULTS: From baseline to 6 months, patients within the EV ICD Pivotal Study (n = 247) reported statistically significant SF-12 improvements in physical QOL (45.4 ± 9.4 vs. 46.8 ± 9.1 respectively, p = .020) and no changes in mental QOL (49.3 ± 10.4 vs. 50.5 ± 9.7, p = .061). No differences were noted by sex, atrial fibrillation, or the experience of ICD shock. EV ICD patients reported better total FPAS patient acceptance of their ICD than TV-ICD or S-ICD patients using historical norms comparisons (80.4 ± 15.7 vs. 70.2 ± 17.8, p < .0001 for S-ICD and 73.0 ± 17.4, p = .004 for TV-ICD). CONCLUSION: The initial PROs for EV ICD patients indicated that patients had improvements in physical QOL from baseline to 6-month follow-up and markedly better overall acceptance of their ICD compared to a previous study with S-ICD and TV-ICD data. These initial results suggest that the EV ICD is evaluated positively by patients.

Efficacy of a web-based healthcare innovation to advance the quality of life and care of patients with an implantable cardioverter defibrillator (ACQUIRE-ICD): a randomized controlled trial.

AIMS: Modern clinical management of patients with an implantable cardioverter defibrillator (ICD) largely consists of remote device monitoring, although a subset is at risk of mental health issues post-implantation. We compared a 12-month web-based intervention consisting of goal setting, monitoring of patients' mental health-with a psychological intervention if needed-psychoeducational support from a nurse, and an online patient forum, with usual care on participants' device acceptance 12 months after implantation. METHODS AND RESULTS: This national, multi-site, two-arm, non-blinded, randomized, controlled, superiority trial enrolled 478 first-time ICD recipients from all 6 implantation centres in Denmark. The primary endpoint was patient device acceptance measured by the Florida Patient Acceptance Survey (FPAS; general score range = 0-100, with higher scores indicating higher device acceptance) 12 months after implantation. Secondary endpoints included symptoms of depression and anxiety. The primary endpoint of device acceptance was not different between groups at 12 months [B = -2.67, 95% confidence interval (CI) (-5.62, 0.29), P = 0.08]. Furthermore, the secondary endpoint analyses showed no significant treatment effect on either depressive [B = -0.49, 95% CI (-1.19; 0.21), P = 0.17] or anxiety symptoms [B = -0.39, 95% CI (-0.96; 0.18), P = 0.18]. CONCLUSION: The web-based intervention as supplement to usual care did not improve patient device acceptance nor symptoms of anxiety and depression compared with usual care. This specific web-based intervention thus cannot be recommended as a standardized intervention in ICD patients.

Addressing PTSD in Implantable Cardioverter Defibrillator Patients: State-of-the-Art Management of ICD Shock and PTSD.

PURPOSE OF REVIEW: This paper reviews the unique processes and treatments of post-traumatic stress in implantable cardioverter-defibrillator (ICD) patients and posits specific clinical management recommendations. RECENT FINDINGS: PTSD is a common presenting problem for a prospective ICD patient and is a common response to ICD shocks. Approximately 32% of patients with sudden cardiac arrest report significant PTSD symptoms. Following ICD shock, approximately 20% experience PTSD from the shocks. Regardless, PTSD can interrupt and undermine clinical management from a cardiologist perspective and create significant disturbance in patients and families. Few cardiology clinics are outfitted to effectively manage psychological distress, in general, and PTSD, in particular. Effective management of PTSD patients can be achieved with both direct care in the cardiac clinic, as well as indirect care via multidisciplinary consultation and expertise. The importance of emotional validation, return to physical activity, and family engagement is emphasized in current management.

The Predictor Roles of Spiritual Well-Being, Healthcare Professionals' Support and Shock Anxiety in Implantable Cardioverter-Defibrillator Device Acceptance.

Background: Acceptance of the implantable cardioverter-defibrillator (ICD) device may be affected by a variety of factors. This study aimed to investigate the predictor roles of spiritual well-being, healthcare professionals' support and shock anxiety in accepting ICD. Methods: This cross-sectional study was conducted on 100 patients with ICD. The data were collected by the Florida Patient Acceptance Scale, Florida Shock Anxiety Scale, Spiritual Well-Being Scale and Healthcare Professionals' Support Questionnaire. Results: The mean (SD) scores of patient acceptance, shock anxiety, spiritual well-being and healthcare professionals' support were 65.4 (13.56), 21.93 (8.95), 88.92 (11.78) and 76.41 (10.54), respectively. The results revealed higher acceptance among the participants with lower shock anxiety levels (r = -0.51, P < 0.001), higher mean scores of spiritual well-being (r = 0.33, P = 0.001) and higher healthcare professionals' support (r = 0.40, P < 0.01). Additionally, the results of linear regression indicated that spiritual well-being, healthcare professionals' support and shock anxiety predicted 36% of the patient acceptance variance (R = 0.61, R 2 = 0.38, adj R 2 = 0.36) and shock anxiety and healthcare professionals' support were the predictors of patient acceptance. Conclusion: The study results indicated that the patients' mean score of acceptance was relatively high. In addition, the mean scores of shock anxiety, spiritual well-being and healthcare professionals' support were low, moderate and relatively high, respectively. Conducting healthcare professionals' support interventions, spiritual therapy and reducing shock anxiety can help patients accept ICDs.

Validity and Reliability of the Japanese Version of the Florida Patient Acceptance Survey.

BACKGROUND AND PURPOSE: Patient acceptance of implantable cardioverter defibrillators (ICDs) is one of the factors influencing clinical outcomes. This study aimed to develop a Japanese version of the Florida Patient Acceptance Survey (FPAS; a measure of acceptance of ICDs), examine its reliability and validity, and test instrument reliability and ability to generate valid data in a new population. METHODS: 122 outpatients with ICD, cardiac resynchronization therapy defibrillator (CRTD) completed the FPAS, the 12-Item Short-Form Health Survey developed for the Medical Outcomes Study, and the Hospital Anxiety and Depression Scale. RESULTS: Confirmatory and exploratory factor data analyses yielded a three-factor model with nine items. This version of the FPAS had high internal consistency, both for the single factor scale and all other subscales; Cronbach's 𝛼 ranged from .78 to. 84. CONCLUSION: The scale was shown to be valid and reliable for assessing device acceptability in Japanese patients with ICD.

Respiratory polygraphy in children: Feasibility in everyday practice in an ENT department and value of automatic detection of respiratory events.

OBJECTIVES: Using respiratory polygraphy (RP) in children for diagnosis of obstructive sleep apnea/hypopnea syndrome (OSAHS) can be challenging in terms of device acceptance and sensor displacement. Automatic analysis of respiratory events has never been evaluated in a pediatric population. The primary objective of this study was to determine the feasibility of pediatric RP in routine ENT department practice. The secondary objective was to evaluate the reliability of the automatic detection of obstructive and central respiratory events in children. METHODS: A single-center retrospective study included 50 children (32 boys, 18 girls; mean age 5.5±2.3years) undergoing overnight RP in an ENT department between January and August 2016 for suspected OSAHS. Manual detection of respiratory events was performed by one ENT specialist experienced in RP interpretation, and compared to automatic analysis. RESULTS: The device was well accepted in 98% of cases. Overall signal quality was>50% in 76% of cases, with average signal quality of 70.8% (86% in patients>3 yrs, 25% in patients<3 yrs, P=0.0013). There was no significant correlation between manual and automatic analyses, except for central apnea (Spearman coefficient 0.43; P=0.0015). One hundred percent of patients presented OSAHS according to automatic detection, compared to 32% according to manual detection (P<0.005). CONCLUSIONS: Pediatric RP is feasible in routine practice in an ENT department, with good acceptance and satisfactory signal quality in children older than 3years. Automatic analysis of respiratory events in children is unreliable, except for central apnea.

Effectiveness of a comprehensive interactive eHealth intervention on patient-reported and clinical outcomes in patients with an implantable cardioverter defibrillator [ACQUIRE-ICD trial]: study protocol of a national Danish randomised controlled trial.

BACKGROUND: In Denmark and other countries, there has been a shift in the management of patients with an implantable cardioverter defibrillator (ICD) with remote device monitoring largely replacing in-hospital visits. Less patient-nurse and patient-physician interaction may lead to gaps in patients' quality of care and impede patients' adaptation to living successfully with the ICD. A comprehensive eHealth intervention that include goal-setting, monitoring of symptoms of depression, anxiety, and quality of life, psychological treatment, information provision, supportive tools, online dialogues with nursing staff and access to an online community network, may help fill these gaps and be particularly beneficial to patients who suffer from anxiety and depression. This study will evaluate the effectiveness of the ACQUIRE-ICD care innovation, a comprehensive and interactive eHealth intervention, on patient-reported and clinical outcomes. METHODS: The ACQUIRE-ICD study is a multicenter, prospective, two-arm, unblinded randomised controlled superiority trial that will enroll 478 patients implanted with a first-time ICD or ICD with cardiac synchronisation therapy (CRT-D) from the six implanting centers in Denmark. The trial will evaluate the clinical effectiveness and cost-effectiveness of the ACQUIRE-ICD care innovation, as add-on to usual care compared with usual care alone. The primary endpoint, device acceptance, assessed with the Florida Patient Acceptance Survey, is evaluated at 12 months' post implant. Secondary endpoints, evaluated at 12 and 24 months' post implant, include patient-reported outcomes, return to work, time to first ICD therapy and first hospitalisation, mortality and cost-effectiveness. DISCUSSION: The effectiveness of a comprehensive and interactive eHealth intervention that relies on patient-centred and personalised tools offered via a web-based platform targeted to patients with an ICD has not been assessed so far. The ACQUIRE-ICD care innovation promotes and facilitates that patients become active participants in the management of their disease, and as such addresses the need for a more patient-centered disease-management approach. If the care innovation proves to be beneficial to patients, it may not only increase patient empowerment and quality of life but also free up time for clinicians to care for more patients. TRIAL REGISTRATION: The trial has been registered on https://clinicaltrials.gov/ct2/show/NCT02976961 on November 30, 2016 with registration number [ NCT02976961 ].

Acceptance and psychological impact of implantable defibrillators amongst adults with congenital heart disease.

BACKGROUND: The psychological impact of implantable cardioverter defibrillators (ICDs) in adults with congenital heart disease (ACHD) has not been established. OBJECTIVE: To compare device acceptance, quality of life, anxiety and depression between ACHD patients with ICDs (ICD-Congenital), with pacemakers (PPM-Congenital), with no devices (No Device-Congenital) and non-ACHD patients with ICDs (ICD-Non-Congenital). METHODS: A total of 147 ACHD and 46 non-ACHD patients (age 45.0±14.7 years, 56.5% males) completed the Florida Patient Acceptance Survey (FPAS), the 36-item Short Form Health Survey (SF-36) and Hospital Anxiety & Depression Scale (HADS). RESULTS: ICD-Congenital patients (n=59) showed lower device acceptance compared to PPM-Congenital patients (n=41), p=0.04, and reported worse quality of life (p=0.001) and higher prevalence of depression (p=0.009) when compared to No Device-Congenital (n=47) patients. ICD-Congenital and ICD-Non-Congenital patients (n=46) showed similar mental and physical health, device acceptance, anxiety and depression. Within ICD-Congenital, patients with poorest device acceptance (FPAS <67, "Non-Acceptors") showed significantly lower mental health scores (p=0.008), and higher levels of anxiety (p=0.02) and depression (p=0.01) compared to "Acceptors" (FPAS ≥67). "Non-Acceptors" were younger at survey (p=0.006), younger at ICD implantation (p=0.01) and were less likely to have received appropriate shocks (p=0.03). CONCLUSION: Younger age and lack of appropriate ICD shocks are risk factors for poor ICD acceptance. Device acceptance is lower in adults with congenital heart disease who receive an ICD than those who receive pacemakers. Appropriate screening for anxiety and depression may be warranted for ACHD patients considered for ICD implantation or already living with ICDs.

Perceptions of healthcare professionals' support, shock anxiety and device acceptance among implantable cardioverter defibrillator recipients.

AIMS: To investigate the extent to which perceived support from healthcare professionals and shock anxiety is related to device acceptance among implantable cardioverter defibrillator recipients. BACKGROUND: Device acceptance can be influenced by several factors, one of which is shock anxiety associated with poor device acceptance. Reduced shock anxiety, as well as increased device acceptance, has been reported after psycho-educational programmes. As healthcare professionals appear to play a significant role in providing support and education during regular follow-up visits, they may constitute an important social support system that could be another factor influencing device acceptance. However, little is known about the relationship between perceived support from healthcare professionals and device acceptance among recipients. DESIGN: A cross-sectional survey design. METHODS: A sample comprising implantable cardioverter defibrillator recipients completed questionnaires assessing perceived support from healthcare professionals, shock anxiety and device acceptance. Demographic and clinical data were collected by self-report and from medical records in September-October 2010. RESULTS: The descriptive results indicated that approximately 85% of the recipients experienced high device acceptance. Regression analysis demonstrated that constructive support from healthcare professionals was positively associated with device acceptance and moderated the negative relationship between shock anxiety and device acceptance. Non-constructive support and shock anxiety had a negative statistical association with device acceptance. CONCLUSIONS: Healthcare professionals may represent a valuable constructive support system that can enhance device acceptance among implantable cardioverter defibrillator recipients, partly by preventing shock anxiety from leading to poor device acceptance. Non-constructive communication on the part of healthcare professionals could hinder device acceptance.