Rationale and design of the NODE-303 study: evaluating the safety of symptom-prompted, self-administered etripamil for paroxysmal supraventricular tachycardia episodes in real-world settings.

BACKGROUND: Paroxysmal supraventricular tachycardia (PSVT) is a common episodic arrhythmia characterized by unpredictable onset and burdensome symptoms including palpitations, dizziness, chest pain, distress, and shortness of breath. Treatment of acute episodes of PSVT in the clinical setting consists of intravenous adenosine, beta-blockers, and calcium channel blockers (CCBs). Etripamil is an intranasally self-administered L-type CCB in development for acute treatment of AV-nodal dependent PSVT in a nonmedical supervised setting. METHODS: This paper summarizes the rationale and study design of NODE-303 that will assess the efficacy and safety of etripamil. In the randomized, double-blinded, placebo-controlled, Phase 3 RAPID trial, etripamil was superior to placebo in the conversion of single PSVT episodes by 30 minutes post initial dose when administered in the nonhealthcare setting; this study required a mandatory and observed test dosing prior to randomization. The primary objective of NODE-303 is to evaluate the safety of symptom-prompted, self-administered etripamil for multiple PSVT episodes in real-world settings, without the need for test dosing prior to first use during PSVT. Secondary endpoints include efficacy and disease burden. Upon perceiving a PSVT episode, the patient applies an electrocardiographic monitor, performs a vagal maneuver, and, if the vagal maneuver is unsuccessful, self-administers etripamil 70 mg, with an optional repeat dose if symptoms do not resolve within 10 minutes after the first dose. A patient may treat up to four PSVT episodes during the study. Adverse events are recorded as treatment-emergent if they occur within 24 hours after the administration of etripamil. RESULTS: Efficacy endpoints include time to conversion to sinus rhythm within 30 and 60 minutes after etripamil administration, and the proportion of patients who convert at 3, 5, 10, 20, 30, and 60 minutes. Patient-reported outcomes are captured by the Brief Illness Perception Questionnaire, the Cardiac Anxiety Questionnaire, the Short Form Health Survey 36, the Treatment Satisfaction Questionnaire for Medication and a PSVT survey. CONCLUSIONS: Overall, these data will support the development of a potentially paradigm-changing long-term management strategy for recurrent PSVT.

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.

Facilitating Shared Decision Making Among Black Patients at Risk for Sudden Cardiac Arrest : A Randomized Clinical Trial.

BACKGROUND: Racial disparities in implantable cardioverter-defibrillator (ICD) implantation are multifactorial and are partly explained by higher refusal rates. OBJECTIVE: To assess the effectiveness of a video decision support tool for Black patients eligible for an ICD. DESIGN: Multicenter, randomized clinical trial conducted between September 2016 and April 2020. (ClinicalTrials.gov: NCT02819973). SETTING: Fourteen academic and community-based electrophysiology clinics in the United States. PARTICIPANTS: Black adults with heart failure who were eligible for a primary prevention ICD. INTERVENTION: An encounter-based video decision support tool or usual care. MEASUREMENTS: The primary outcome was the decision regarding ICD implantation. Additional outcomes included patient knowledge, decisional conflict, ICD implantation within 90 days, the effect of racial concordance on outcomes, and the time patients spent with clinicians. RESULTS: Of the 330 randomly assigned patients, 311 contributed data for the primary outcome. Among those randomly assigned to the video group, assent to ICD implantation was 58.6% compared with 59.4% in the usual care group (difference, -0.8 percentage point [95% CI, -13.2 to 11.1 percentage points]). Compared with usual care, participants in the video group had a higher mean knowledge score (difference, 0.7 [CI, 0.2 to 1.1]) and a similar decisional conflict score (difference, -2.6 [CI, -5.7 to 0.4]). The ICD implantation rate within 90 days was 65.7%, with no differences by intervention. Participants randomly assigned to the video group spent less time with their clinician than those in the usual care group (mean, 22.1 vs. 27.0 minutes; difference, -4.9 minutes [CI, -9.4 to -0.3 minutes]). Racial concordance between video and study participants did not affect study outcomes. LIMITATION: The Centers for Medicare & Medicaid Services implemented a requirement for shared decision making for ICD implantation during the study. CONCLUSION: A video-based decision support tool increased patient knowledge but did not increase assent to ICD implantation. PRIMARY FUNDING SOURCE: Patient-Centered Outcomes Research Institute.

The GUIDE-HF trial of pulmonary artery pressure monitoring in heart failure: impact of the COVID-19 pandemic.

AIMS: During the coronavirus disease 2019 (COVID-19) pandemic, important changes in heart failure (HF) event rates have been widely reported, but few data address potential causes for these changes; several possibilities were examined in the GUIDE-HF study. METHODS AND RESULTS: From 15 March 2018 to 20 December 2019, patients were randomized to haemodynamic-guided management (treatment) vs. control for 12 months, with a primary endpoint of all-cause mortality plus HF events. Pre-COVID-19, the primary endpoint rate was 0.553 vs. 0.682 events/patient-year in the treatment vs. control group [hazard ratio (HR) 0.81, P = 0.049]. Treatment difference was no longer evident during COVID-19 (HR 1.11, P = 0.526), with a 21% decrease in the control group (0.536 events/patient-year) and no change in the treatment group (0.597 events/patient-year). Data reflecting provider-, disease-, and patient-dependent factors that might change the primary endpoint rate during COVID-19 were examined. Subject contact frequency was similar in the treatment vs. control group before and during COVID-19. During COVID-19, the monthly rate of medication changes fell 19.2% in the treatment vs. 10.7% in the control group to levels not different between groups (P = 0.362). COVID-19 was infrequent and not different between groups. Pulmonary artery pressure area under the curve decreased -98 mmHg-days in the treatment group vs. -100 mmHg-days in the controls (P = 0.867). Patient compliance with the study protocol was maintained during COVID-19 in both groups. CONCLUSION: During COVID-19, the primary event rate decreased in the controls and remained low in the treatment group, resulting in an effacement of group differences that were present pre-COVID-19. These outcomes did not result from changes in provider- or disease-dependent factors; pulmonary artery pressure decreased despite fewer medication changes, suggesting that patient-dependent factors played an important role in these outcomes. Clinical Trials.gov: NCT03387813.

Haemodynamic-guided management of heart failure (GUIDE-HF): a randomised controlled trial.

BACKGROUND: Previous studies have suggested that haemodynamic-guided management using an implantable pulmonary artery pressure monitor reduces heart failure hospitalisations in patients with moderately symptomatic (New York Heart Association [NYHA] functional class III) chronic heart failure and a hospitalisation in the past year, irrespective of ejection fraction. It is unclear if these benefits extend to patients with mild (NYHA functional class II) or severe (NYHA functional class IV) symptoms of heart failure or to patients with elevated natriuretic peptides without a recent heart failure hospitalisation. This trial was designed to evaluate whether haemodynamic-guided management using remote pulmonary artery pressure monitoring could reduce heart failure events and mortality in patients with heart failure across the spectrum of symptom severity (NYHA funational class II-IV), including those with elevated natriuretic peptides but without a recent heart failure hospitalisation. METHODS: The randomised arm of the haemodynamic-GUIDEed management of Heart Failure (GUIDE-HF) trial was a multicentre, single-blind study at 118 centres in the USA and Canada. Following successful implantation of a pulmonary artery pressure monitor, patients with all ejection fractions, NYHA functional class II-IV chronic heart failure, and either a recent heart failure hospitalisation or elevated natriuretic peptides (based on a-priori thresholds) were randomly assigned (1:1) to either haemodynamic-guided heart failure management based on pulmonary artery pressure or a usual care control group. Patients were masked to their study group assignment. Investigators were aware of treatment assignment but did not have access to pulmonary artery pressure data for control patients. The primary endpoint was a composite of all-cause mortality and total heart failure events (heart failure hospitalisations and urgent heart failure hospital visits) at 12 months assessed in all randomly assigned patients. Safety was assessed in all patients. A pre-COVID-19 impact analysis for the primary and secondary outcomes was prespecified. This study is registered with ClinicalTrials.gov, NCT03387813. FINDINGS: Between March 15, 2018, and Dec 20, 2019, 1022 patients were enrolled, with 1000 patients implanted successfully, and follow-up was completed on Jan 8, 2021. There were 253 primary endpoint events (0·563 per patient-year) among 497 patients in the haemodynamic-guided management group (treatment group) and 289 (0·640 per patient-year) in 503 patients in the control group (hazard ratio [HR] 0·88, 95% CI 0·74-1·05; p=0·16). A prespecified COVID-19 sensitivity analysis using a time-dependent variable to compare events before COVID-19 and during the pandemic suggested a treatment interaction (pinteraction=0·11) due to a change in the primary endpoint event rate during the pandemic phase of the trial, warranting a pre-COVID-19 impact analysis. In the pre-COVID-19 impact analysis, there were 177 primary events (0·553 per patient-year) in the intervention group and 224 events (0·682 per patient-year) in the control group (HR 0·81, 95% CI 0·66-1·00; p=0·049). This difference in primary events almost disappeared during COVID-19, with a 21% decrease in the control group (0·536 per patient-year) relative to pre-COVID-19, virtually no change in the treatment group (0·597 per patient-year), and no difference between groups (HR 1·11, 95% CI 0·80-1·55; p=0·53). The cumulative incidence of heart failure events was not reduced by haemodynamic-guided management (0·85, 0·70-1·03; p=0·096) in the overall study analysis but was significantly decreased in the pre-COVID-19 impact analysis (0·76, 0·61-0·95; p=0·014). 1014 (99%) of 1022 patients had freedom from device or system-related complications. INTERPRETATION: Haemodynamic-guided management of heart failure did not result in a lower composite endpoint rate of mortality and total heart failure events compared with the control group in the overall study analysis. However, a pre-COVID-19 impact analysis indicated a possible benefit of haemodynamic-guided management on the primary outcome in the pre-COVID-19 period, primarily driven by a lower heart failure hospitalisation rate compared with the control group. FUNDING: Abbott.

The ENHANCE-AF clinical trial to evaluate an atrial fibrillation shared decision-making pathway: Rationale and study design.

INTRODUCTION: Shared decision making (SDM) may result in treatment plans that best reflect the goals and wishes of patients, increasing patient satisfaction with the decision-making process. There is a knowledge gap to support the use of decision aids in SDM for anticoagulation therapy in patients with atrial fibrillation (AF). We describe the development and testing of a new decision aid, including a multicenter, randomized, controlled, 2-arm, open-label ENHANCE-AF clinical trial (Engaging Patients to Help Achieve Increased Patient Choice and Engagement for AF Stroke Prevention) to evaluate its effectiveness in 1,200 participants. METHODS: Participants will be randomized to either usual care or to a SDM pathway incorporating a digital tool designed to simplify the complex concepts surrounding AF in conjunction with a clinician tool and a non-clinician navigator to guide the participants through each step of the tool. The participant-determined primary outcome for this study is the Decisional Conflict Scale, measured at 1 month after the index visit during which a decision was made regarding anticoagulation use. Secondary outcomes at both 1 and 6 months will include other decision making related scales as well as participant and clinician satisfaction, oral anticoagulation adherence, and a composite rate of major bleeding, death, stroke, or transient ischemic attack. The study will be conducted at four sites selected for their ability to enroll participants of varying racial and ethnic backgrounds, health literacy, and language skills. Participants will be followed in the study for 6 months. CONCLUSIONS: The results of the ENHANCE-AF trial will determine whether a decision aid facilitates high quality shared decision making in anticoagulation discussions for stroke reduction in AF. An improved shared decision-making experience may allow patients to make decisions better aligned with their personal values and preferences, while improving overall AF care.

A systematic meta-review of systematic reviews about interprofessional collaboration: facilitators, barriers, and outcomes.

Interprofessional collaboration (IPC) is a practice model to promote healthcare quality. Since the World Health Organization highlighted the importance of IPC in 2010, a large volume of IPC-related research has been published. Multiple systematic reviews have been conducted to synthesize the literature from varying perspectives. Although systematic reviews are a compelling approach to synthesizing primary research, a systematic meta-review was needed to summarize the systematic reviews to offer information for healthcare professionals, researchers, and policymakers. This systematic meta-review was designed to synthesize the systematic reviews of IPC, emphasizing the IPC-related facilitators, barriers, and outcomes between 2010 and 2020. An electronic search for systematic reviews was performed in December 2020. The databases searched included PubMed, CINAHL, PsycINFO, and Cochrane Database of Systematic Reviews. Thirty-six systematic reviews met the inclusion criteria. Factors facilitating or impeding IPC were classified into three levels: organization, team, and individual. Major outcomes related to patients, healthcare professionals, and organizations. The facilitators, barriers, and outcomes are mutually interrelated. Highly effective collaboration is a process from relationship building to working together and collaborating. Improving IPC requires organizational, teams, and individuals' combined efforts. When highly effective collaborations occur, all stakeholders can benefit - organizations, professionals, and patients.

Measurement of patient confidence in self-management of atrial fibrillation: Initial validation of the Confidence in Atrial fibriLlation Management (CALM) Scale.

BACKGROUND: The patient experience of atrial fibrillation (AF) involves several daily self-care behaviors and ongoing confidence to manage their condition. Currently, no standardized self-report measure of AF patient confidence exists. The purpose of this study is to provide preliminary support for the reliability and validity of a newly developed confidence in AF management measure. METHODS: This study provides preliminary analysis of the Confidence in Atrial FibriLlation Management (CALM) scale, which was rationally developed to measure patient confidence related to self-management of AF. The scale was provided to a sample of AF patients N = 120, (59% male) electronically through a patient education platform. Principal component analysis (PCA) and Cronbach's α were employed to provide preliminary assessment of the validity and reliability of the measure. RESULTS: PCA identified a four-factor solution. Internal consistency of the CALM was considered excellent with Cronbach's α = .910. Additional PCA confirmed the value of a single factor solution to produce a total confidence score for improved utility and ease of clinical interpretation. CONCLUSIONS: Initial assessment of a novel scale measuring patient confidence in managing AF provided promising reliability and validity. Patient confidence in self-management of AF may prove useful as a key marker and endpoint of the patient experience beyond QOL.

Out of Hospital Sudden Death in a Rural Population: Low Rates of ICD Underutilization Among Decedents.

BACKGROUND: Implantable cardioverter defibrillators (ICDs) reduce mortality in patients at risk for life-threatening arrhythmias. Implantation of ICDs in rural or economically disadvantaged populations is suspected to be low. This study examined Out of Hospital Premature Natural Death (OHPND) and electronic medical record (EMR) data to identify rates of non-implantation of ICDs among decedents in eastern North Carolina. METHODS: OHPND cases in 2016 were identified using mortality data and matched with EMRs. Those meeting criteria for ICD implantation based on chart review were adjudicated by two electrophysiologists to determine whether they qualified for implantation. Comorbidity burden was established using Charlson's Comorbidity Index (CCI). RESULTS: Out of 1316 OHPND cases, 967 (73.4%) had EMR records. Chart review identified 70 (7.2%) potential ICD candidates with a LVEF ≤35 of which 5 (7.1%) did not meet criteria because LVEF subsequently improved. Of the remaining 65 patients, 32 (49.2%) already received an ICD, and 33 patients (50.7%) met criteria but had not received one. Reasons for non-implantation included: limited life expectancy secondary to comorbidities, principally chronic kidney disease (CKD) (N = 11, 17%), physician non-adherence to guidelines (N = 9, 14%), loss to follow-up (N = 7, 11%), patient refusal (N = 5, 8%), and death before commencing medical therapy (N = 1, 2%). Among our cohort of 967 individuals who died unexpectedly, nine (0.9%) patients may have avoided death with an ICD. CONCLUSION: This study using decedent data shows low rates of ICD-underutilization in a rural population and emphasizes the role of advanced comorbidities such as CKD in ICD-underutilization.

The impact of the COVID-19 pandemic on physical and mental health in the two largest economies in the world: a comparison between the United States and China.

The broad impact of the COVID-19 on self-reported daily behaviors and health in Chinese and US samples remains unknown. This study aimed to compare physical and mental health between people from the United States (U.S.) and China, and to correlate mental health parameters with variables relating to physical symptoms, knowledge about COVID-19, and precautionary health behaviors. To minimize risk of exposure, respondents were electronically invited by existing study respondents or by data sourcing software and surveys were completed via online survey platforms. Information was collected on demographics, physical symptoms, contact history, knowledge about COVID-19, psychologic parameters (i.e. IES-R; DASS-21), and health behaviors. The study included a total of 1445 respondents (584 U.S.; 861 China). Overall, Americans reported more physical symptoms, contact history, and perceived likelihood of contracting COVID-19. Americans reported more stress and depressive symptoms, while Chinese reported higher acute-traumatic stress symptoms. Differences were identified regarding face mask use and desires for COVID-19 related health information, with differential mental health implications. Physical symptoms that were possibly COVID-19 related were associated with adverse mental health. Overall, American and Chinese participants reported different mental and physical health parameters, health behaviors, precautionary measures, and knowledge of COVID-19; different risk and protective factors were also identified.

Increased Quality of Life Among Newly Diagnosed Patients With Heart Failure With Reduced Ejection Fraction in the Months After Initiation of Guideline-Directed Medical Therapy and Wearable Cardioverter Defibrillator Prescription.

BACKGROUND: The patient experience of heart failure involves a multi-impact symptom response with functional limitations, psychological changes, and significant treatment burden. OBJECTIVE: The aim of this study was to examine the change in patient-reported outcomes in newly diagnosed patients with heart failure and reduced ejection fraction (HFrEF) prescribed a wearable cardioverter defibrillator. METHODS: Adults hospitalized for new-onset heart failure, due to ischemic or nonischemic cardiomyopathy, and prescribed a wearable cardioverter defibrillator within 10 days post discharge were approached for inclusion. Participants completed the Kansas City Cardiomyopathy Questionnaire at 3 time points: baseline, day 90, and day 180. RESULTS: A total of 210 patients (26% female) were included. All Kansas City Cardiomyopathy Questionnaire subscales (physical limitation, symptom frequency, quality of life, and social limitation) showed improvement from baseline to day 90 (all Ps < .001). Only quality of life continued to improve from day 90 to day 180 (P < .001). By day 90, nearly 70% of patients showed an improvement in quality of life (67.9%, n = 91), and by day 180, more than 80% (82.8%, n = 111) reported a net improvement. Five patients (3.7%) reported a net decrease, and 18 patients (13.4%) had no net change in quality of life during the 180-day period. CONCLUSION: Patient-reported quality of life improved significantly among patients newly diagnosed with HFrEF and prescribed a wearable cardioverter defibrillator. These results suggest that pursuing guideline-directed medical therapy for HFrEF, while being protected by the wearable cardioverter defibrillator, is likely to provide symptom relief and improve quality of life.

Collaborative care for the wearable cardioverter defibrillator patient: Getting the patient and medical team "vested and active".

Patients with a reduced ejection fraction of 35% or less and a history of myocardial infarction (MI) are at increased risk of sudden cardiac death (SCD). These patients have a class I indication for an implantable cardioverter-defibrillator after allowing time for medical therapy optimization and potential cardiac recovery. The rates of SCD are highest in this "gap" period early after a cardiac event, and the wearable cardioverter-defibrillator (WCD) is an intervention that can be used to protect against SCD during this time period. There has been a clinical trial that randomized patients with a reduced ejection fraction at the time of MI to a WCD versus control. Results of the trial showed no statistically significant difference in the primary endpoint of SCD. There are many intricacies to the interpretation of the trial, including the importance of patient adherence to WCD therapy, which is affected by the patient experience and psychological factors. Patients with a new cardiomyopathy are affected by a mix of psychological factors, including the feeling of safety and protection from a WCD contrasted by the WCD providing a reminder of awareness and fear of ventricular arrhythmias and SCD. Beyond the capabilities of a WCD to defibrillate a life-threatening ventricular arrhythmia, the device can also provide activity and heart failure diagnostics monitoring. Patients need to be engaged in shared decision-making conversations about a WCD, so that patients can make a decision based on their own values construct, ultimately increasing adherence among the patients that want a WCD.

Patient and Partner Sexual Concerns During the First Year After an Implantable Cardioverter Defibrillator: A Secondary Analysis of the P+P Randomized Clinical Trial.

BACKGROUND: Sexual concerns and changes in sexual activity are common among patients and their intimate partners after an implantable cardioverter defibrillator (ICD). AIMS: Our aims were to (i) describe patient and partner sexual activity and related concerns from the time of an initial ICD implant through 12-month follow-up and (ii) identify factors predictive of return to sexual activity and fears associated with sexual activity. METHODS: This secondary descriptive analysis was conducted with data from a randomized controlled trial (2009-2015) designed to compare 2 interventions for patients (Patient-Only) and for patients and their partners (Patient+Partner) after implant of an initial ICD. The sample included 105 patients and their intimate partners who reported sexual activity during the 24 months before ICD implant. OUTCOMES: The Sexual Concerns Inventory was used to assess sexual activity and related concerns. RESULTS: Study participants comprised 72% male and were of mean age 65.6 ± 10.6 years; partners comprised 64% female and were of mean age 63 ± 11.6 years. Sexual activity increased after ICD: 73% of patients reported no sexual intercourse during 2 months before study enrollment, whereas only 46% reported no sexual intercourse during the 2 months before 12-month follow-up. Reductions in sexual concerns were evident 1 month after implant, with continued reductions through 12 months (patient 6.48 ± 4.03 to 5.22 ± 3.38, P = .004; partner 6.93 ± 4.01 to 5.2 ± 3.56, P < .001). Patient physical health predicted sexual activity 3 months after implant placement (P = .04); general ICD concerns (P < .001) predicted patient ICD-related sexual fears at 3 months. At 12 months, baseline general ICD concerns (P < .02) predicted sexual fears. CLINICAL IMPLICATIONS: ICD patients and partners report low levels of sexual activity at the time of initial ICD implant, with reported increases in sexual activity over the 12-month recovery period: Sexual concerns were highest immediately after ICD implant. STRENGTHS & LIMITATIONS: Notably, the major strengths of this study were the repeated measures and longitudinal study design; the main limitation of the study was the lack of a "usual care" control group. CONCLUSION: Sexual activity at the time of an initial ICD implant is low, and sexual concerns are most prominent for both patients and partners immediately after implant placement. Baseline physical health predicts subsequent sexual activity at 3 months, while general ICD-related worry predicts sexual fears at 3 and 12 months. Streur MM, Rosman LA, Sears SF, et al. Patient and Partner Sexual Concerns During the First Year After an Implantable Cardioverter Defibrillator: A Secondary Analysis of the P+P Randomized Clinical Trial. J Sex Med 2020;17:892-902.

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.

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.

Cognitive performance in patients with implantable cardioverter defibrillators: Associations with objective sleep duration, age and anxiety.

Sleep disturbance and anxiety are highly prevalent in patients with implantable cardiac defibrillators (ICDs). There is limited research, however, on the associations between cognitive performance and sleep parameters, age and anxiety. Forty-one patients with ICDs and self-reported sleep disturbance completed 14 days of actigraphy (Mage  = 60.3, SD = 12.3) measuring total sleep time (TST), and a computerized cognitive test battery measuring processing speed and attention (i.e. simple reaction time and symbol digit modality task [SDMT]) and executive function (i.e. flanker task, letter series task and N-back task). Multiple regressions determined whether independent effects of TST, age and anxiety, as well as interactive effects of TST and age, predicted cognitive performance. TST predicted performance on two tasks of executive function (i.e. letter series and N-back task), as well as an attentional vigilance and processing speed task (i.e. SDMT), and this did not depend on patient age. On letter series, N-back and SDMT, longer TST predicted better performance. Increasing age was a predictor of worse performance on SDMT and flanker tasks. No other predictors were associated with task performance. Results show that sleep duration, not anxiety, may be an important predictor of higher-order cognitive functioning and lower-order tasks measuring processing speed and attention in ICD patients, with longer sleep duration showing greater benefit for performance.

Measuring ICD shock anxiety: Status update on the Florida Shock Anxiety Scale after over a decade of use.

INTRODUCTION: Approximately 44% of patients with implantable cardioverter defibrillators (ICDs) experience some form of shock anxiety, associated with cardiac fear, physical inactivity, and increased morbidity and mortality. The Florida Shock Anxiety Scale (FSAS) was created to measure ICD-specific fears for a more precise target of patient psychologic distress and potential need for intervention. The current paper describes results from a focused literature review of studies using FSAS over the past 15 years, with the aim of summarizing its current reliability and validity, associated outcomes, and potential future directions for its clinical and research implementation. METHODS: In this review, 26 peer-reviewed articles were analyzed and selected from an in-depth literature search of two electronic databases. RESULTS: The reliability and validity of FSAS has been upheld since its initial validation and remain positive. The majority of studies used FSAS as an assessment tool to evaluate a clinical need for psychologic support or psychoeducation. The most frequently reported predictors of FSAS shock anxiety include experience of shock, appropriate and inappropriate, and number of shocks experienced. Common correlates of higher FSAS scores include lower device-related knowledge, lower perceived support from healthcare providers, greater posttraumatic stress disorder symptoms, and negative attitudes about device dependency. Younger age and female gender are also associated with increased shock anxiety. CONCLUSIONS: Since 2006, FSAS has been widely represented as a valid and reliable assessment tool for quantifying device-related anxiety in ICD recipients in diverse populations. Future directions for FSAS should explore its potential role in support of measurement-based care.