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

BACKGROUND: Sudden cardiac arrest (SCA) survivorship results in unique issues in return to physical and psychological function. The purpose of the study was to compare recovery across the first year between SCA survivors and other arrhythmia patients who received a first-time implantable cardioverter defibrillator (ICD) for secondary prevention, participating in a social cognitive theory (SCT) intervention. METHODS: 168 (129 males, 39 females) who received an ICD for secondary prevention (SCA N = 65; other arrhythmia N = 103) were randomized to one of two study conditions: SCT intervention (N = 85) or usual care (N = 83). Outcomes were measured at baseline hospital discharge, 1, 3, 6, & 12 months: (1) Physical Function: Patient Concerns Assessment (PCA), SF-36 (PCS); (2) Psychological Adjustment: State Trait Anxiety (STAI), CES-D depression, SF-36 (MCS); (3) Self-Efficacy: Self-Efficacy (SCA-SE), Self-management Behaviors (SMB), Outcome Expectations (OE). Outcomes were compared over 12 months for intervention condition x ICD indication using general estimating equations. RESULTS: Participants were Caucasian (89%), mean age 63.95 ± 12.3 years, EF% 33.95 ± 13.9, BMI 28.19 ± 6.2, and Charlson Index 4.27 ± 2.3. Physical symptoms (PCA) were higher over time for SCA survivors compared to the other arrhythmia group (p = 0.04), ICD shocks were lower in SCA survivors in the SCT intervention (p = 0.01); psychological adjustment (MCS) was significantly lower in SCA survivors in the SCT intervention over 6 months, which improved at 12 months (p = 0.05); outcome expectations (OE) were significantly lower for SCA survivors in the SCT intervention (p = 0.008). CONCLUSIONS: SCA survivors had greater number of physical symptoms, lower levels of mental health and outcome expectations over 12 months despite participation in a SCT intervention. Trial registration Clinicaltrials.gov: NCT04462887.

Health-Related Quality of Life in the Spironolactone to Reduce ICD Therapy (SPIRIT) Trial.

To describe health related quality of life (HRQOL) and symptoms in the SPIRIT trial and determine effects of implantable cardioverter defibrillator (ICD) shocks on HRQOL over 24 months. Ninety participants aged 66 ± 10 years, 96% men, 75% with NYHA class II, with an ICD were randomized to spironolactone 25 mg (N = 44) or placebo (N = 46). HRQOL was measured every 6 months for 24 months using: Patient Concerns Assessment (PCA), Short Form Health Survey-Veterans Version (SF-36V), and Kansas City Cardiomyopathy Questionnaire (KCCQ). Linear mixed modeling compared changes in HRQOL over-time and ANCOVA compared HRQOL between those getting an ICD shock or not. Over 24-months, there were no differences in HRQOL between the spironolactone versus placebo groups. Those with at least one ICD shock reported significantly lower HRQOL and more symptoms at 6- and 24-months. Patients receiving one or more ICD shocks reported significant reductions in HRQOL and higher symptoms.

Intervention mediating effects of self-efficacy on patient physical and psychological health following ICD implantation.

This study examined mechanisms by which social cognitive theory (SCT) interventions influence health outcomes and the importance of involving partners in recovery following the patients' receipt of an initial implantable cardioverter defibrillator (ICD). We compared direct and indirect intervention effects on patient health outcomes with data from a randomized clinical trial involving two telephone-based interventions delivered during the first 3 months post-ICD implant by experienced trained nurses: P-only conducted only with patients, and P + P conducted with patients and their intimate partners. Each intervention included the patient-focused component. P + P also included a partner-focused intervention component. ICD-specific SCT-derived mediators included self-efficacy expectations, outcome expectations, self-management behavior, and ICD knowledge. Outcomes were assessed at discharge, 3- and 12-months post ICD implant. Patients (N = 301) were primarily Caucasian, male, 64 (± 11.9) years of age with a mean ejection fraction of 34.08 (± 14.3). Intervention effects, mediated through ICD-specific self-efficacy and outcome expectations, were stronger for P + P compared to P-only for physical function (ß = 0.04, p = 0.04; ß = 0.02, p = 0.04, respectively) and for psychological adjustment (ß = 0.06, p = 0.04; ß = 0.03, p = 0.04, respectively). SCT interventions show promise for improving ICD patient physical and psychological health outcomes through self-efficacy and outcome expectations. Including partners in post-ICD interventions may potentiate positive outcomes for patients.Trial registration number (TRN): NCT01252615 (Registration date: 12/02/2010).

Profiles of partner health linked to a partner-focused intervention following patient initial implantable cardioverter defibrillator (ICD).

This study examined differential responses among partners who participated in a RCT designed to compare two social cognitive theory interventions, one designed for patients only (P-only) and one for patients and their intimate partners (P + P). The interventions were delivered following the patient receiving an initial ICD implant. Partner health outcomes were examined longitudinally from baseline at hospital discharge to 3, 6, and 12 months. Outcomes included 6 measures: partner physical and mental health status (Short-Form-36 PCS and MCS), depression (Patient Health Questionnaire-9), anxiety (State-Trait Anxiety Inventory), caregiver burden (Oberst Caregiver Burden Scale), and self-efficacy in ICD management (Sudden Cardiac Arrest Self-efficacy scale). Growth mixture and mixed effect modeling were used to identify and compare trajectories of 6 health outcomes within the P-only and P + P arms of the study. Partners (n = 301) were on average 62 years old, female (74.1%) and Caucasian (83.4%), with few co-morbidities (mean Charlson Co-morbidity index, 0.72 ± 1.1). Two types of profiles were observed for P-only and P + P, one profile where patterns of health outcomes were generally better across 12 months and one with outcome patterns that were generally worse across time. For PCS, no significant partner differences were observed between P-only or P + P in either the better (p = 0.067) or the worse (p = 0.129) profile types. Compared to P-only, partners in the worse profile improved significantly over 12 months in MCS (p = 0.006), caregiver burden P + P (p = 0.004) and self-efficacy P + P (p = 0.041). Compared to P-only, P + P partners in the low anxiety profile improved significantly (p = 0.001) at 3 months. Partners with more psychosocial distress at hospital discharge benefited most from the P + P intervention. Among partners with generally low levels of anxiety, those in the P + P intervention compared to P-only showed greater improvement in anxiety over 12 months.

The association between indices of blood pressure waveforms (PTC1 and PTC2) and incident heart failure.

OBJECTIVES: The radial artery pulse waveform is a continuous measure of pressure throughout the cardiac cycle, and thus can provide more information than just systolic and diastolic blood pressures. New indices based on a Windkessel model of the waveform, PTC1 and PTC2, are related to arterial compliance and add information for prediction of incident cardiovascular disease (coronary heart disease, stroke, myocardial infarction) but their association with heart failure is unknown. METHODS: Among 6229 adults (mean age 62 years) from four race/ethnic groups who were initially free of clinical cardiovascular disease and heart failure in 2000-2002, we evaluated the associations of baseline PTC1 and PTC2 with incident heart failure. RESULTS: Mean ±â€Šstandard deviation PTC1 and PTC2 were 394 ±â€Š334 and 94 ±â€Š46 ms, respectively. During a median of 15.7 years follow-up, there were 357 heart failure events (148 with reduced, 150 with preserved, and 59 with unknown ejection fraction). After adjustment for traditional risk factors, the hazard ratio for heart failure per 1 standard deviation higher PTC2 was 0.73 (95% confidence interval: 0.63--0.85). Higher PTC2 was also significantly associated with lower risk of heart failure with reduced ejection fraction (hazard ratio = 0.67; 95% confidence interval: 0.56--0.80). There was no evidence of a significant association between PTC2 and heart failure with preserved ejection fraction or between PTC1 and heart failure. CONCLUSION: The PTC2 measure of the radial artery pulse waveform may represent a novel phenotype related to heart failure, especially heart failure with reduced ejection fraction.

Left Ventricular Assist Device Caregiver Experiences and Health Outcomes: A Systematic Review of Qualitative and Quantitative Studies.

BACKGROUND: Knowledge synthesis is lacking regarding outcomes and experiences of caregivers of adult patients living with continuous flow left ventricular assist devices (CF-LVAD). The purpose of this systematic review was to summarize qualitative data related to the experience of caregivers of adult patients living with CF-LVAD as well as quantitative data related to health outcomes of caregivers. METHODS AND RESULTS: Multiple databases were systematically queried for studies of qualitative experiences and quantitative health outcomes for caregivers of adult CF-LVAD recipients. Search dates were constrained to articles published between 2004 and August of 2018 because CF-LVADs were not routinely implanted before 2004. Two authors independently screened 683 articles; 15 met predetermined inclusion criteria. Eligible articles reported results from 13 studies. Of those, 8 used either qualitative or mixed methods and 5 used quantitative methods. Caregivers were primarily female (81%) and their mean age was 59 years. Qualitative studies revealed 3 overarching themes related to the caregiver role, coping strategies, and LVAD decisions. Quantitative studies revealed caregiver strain peaked between 1 and 3 months after implantation, anxiety and depression were relatively stable, mental health status improved, and physical health status was stable from before to after implantation. CONCLUSIONS: CF-LVAD caregivers experience significant, sustained emotional strain for 3 months after implantation, reporting considerable stress in meeting their personal needs and those of their loved one.

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.

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.

Sudden Cardiac Arrest Survivorship: A Scientific Statement From the American Heart Association.

Cardiac arrest systems of care are successfully coordinating community, emergency medical services, and hospital efforts to improve the process of care for patients who have had a cardiac arrest. As a result, the number of people surviving sudden cardiac arrest is increasing. However, physical, cognitive, and emotional effects of surviving cardiac arrest may linger for months or years. Systematic recommendations stop short of addressing partnerships needed to care for patients and caregivers after medical stabilization. This document expands the cardiac arrest resuscitation system of care to include patients, caregivers, and rehabilitative healthcare partnerships, which are central to cardiac arrest survivorship.

Aerobic Exercise Effects on Quality of Life and Psychological Distress After an Implantable Cardioverter Defibrillator.

PURPOSE: The purpose of this study was to evaluate quality of life (QOL), psychological function, and self-efficacy outcomes in the Anti-Arrhythmic Effects of Exercise After an ICD Trial. METHODS: In the Anti-Arrhythmic Effects of Exercise After an ICD Trial, 160 patients (124 men and 36 women) who had an implantable cardioverter defibrillator for primary (43%) or secondary (57%) prevention were randomized to exercise (EX, n = 84) or usual care (UC, n = 76). The EX consisted of 8 wk of home walking 1 hr/d 5 d/wk, followed by 16 wk of maintenance home walking for 150 min/wk. Adherence was determined from exercise logs, ambulatory HR recordings, and phone calls. Assessments were conducted at baseline, 8, and 24 wk for QOL: Patient Concerns Assessment and Short Form-36; anxiety: State Trait Anxiety Inventory; depression: Physician Health Questionnaire-Depression; and self-efficacy: Self-Efficacy for Walking Scale. RESULTS: Participants averaged 55 ± 12 yr of age with ejection fraction = 40.6 ± 15.7%. The EX significantly decreased depression severity (EX: 1.33 ± 0.64; UC: 1.51 ± 0.86, P = .05) and improved self-efficacy (EX: 7.65 ± 1.97; UC: 6.85 ± 2.40, P = .05) at 8 wk. There were no significant effects at 24 wk. Adherent exercisers had significant improvements in QOL, psychological, and self-efficacy outcomes at 8 and 24 wk compared with those who were nonadherent. There were no implantable cardioverter defibrillator shocks associated with exercise. CONCLUSIONS: The EX conferred significant effects on depression and self-efficacy at 8 wk, without effects on QOL. Adherent exercisers experienced significant improvements in outcomes over those who were nonadherent or received UC.

Multisymptom Profile Predicts Increased Risk of Poor Outcomes After Initial Placement of Implantable Cardioverter Defibrillator.

CONTEXT: Patients with implantable cardioverter defibrillators (ICDs) are at risk for multiple physical and psychological symptoms. Identification of specific symptom profiles associated with poor outcomes may elucidate novel strategies to enhance symptom management. OBJECTIVES: The objectives were to determine common symptoms after initial ICD implantation, identify classes of individuals with similar symptom profiles, describe patient characteristics associated with different symptom profiles, and determine if symptom profiles at hospital discharge predicted outcomes three and 12 months after implantation. METHODS: This was a secondary data analysis of a randomized controlled trial that compared patient + partner versus patient-only interventions designed to help patients manage symptoms, prepare for ICD shocks, and resume daily activities. Symptoms were measured with the Patient Concerns Assessment. Latent class regression analysis was used to identify symptom classes at baseline, three-month, and 12-month follow-up. Associations between patient characteristics, class membership, and outcomes were examined using chi-square, analysis of variance, and Poisson regression. RESULTS: The study included 301 patients (74% male, mean age 64 ± 11.9 years). Three classes were identified: Multi-Symptom (N = 119, 40%), Tired-Rundown (N = 130, 43%), and Mostly Asymptomatic (N = 52, 17%). Patients in the Multi-Symptom class were younger (59.9 years, P < 0.001) and reported more anxiety (P < 0.001) and depression (P < 0.01) than the other classes. Membership in the Multi-Symptom class predicted lower quality of life and resulted in nearly double the rate of hospitalizations after 12 months (P = 0.02, IRR 1.9). CONCLUSION: Evaluation of symptom profiles after ICD implantation offers a promising strategy for identifying patients at risk for poor health outcomes.

A Feasibility Trial of Two Rehabilitation Models in Severe Cardiopulmonary Illness.

PURPOSE: The purpose of this study was to compare functional capacity and daily activity between two exercise rehabilitation interventions in severe chronic obstructive pulmonary disease (COPD) or heart failure with reduced ejection fraction (HFrEF) over 6 months. Secondarily, we compared intervention groups on symptoms, depression, quality of life, and cardiopulmonary function. DESIGN/METHODS: Ninety patients with severe COPD (n = 63) or HFrEF (n = 27) were randomized to either an exercise adherence intervention or standard cardiopulmonary rehabilitation. Patients were 65-year-old male veterans who had either severe COPD (FEV1 < 50% predicted) or HFrEF (EF% < 40%). RESULTS: There were no statistically significant differences between the intervention groups or COPD or HfrEF groups on functional capacity, daily activity, symptoms, depression, quality of life, or cardiopulmonary function at 6 months. CONCLUSION: In late-stage COPD and HFrEF, functional capacity is not improved with rehabilitation interventions. CLINICAL RELEVANCE: In severe COPD and heart failure, cardiopulmonary rehabilitation conducted at home or in the outpatient setting was not beneficial.

Patient plus partner trial: A randomized controlled trial of 2 interventions to improve outcomes after an initial implantable cardioverter-defibrillator.

BACKGROUND: Interventions to improve physical and psychological outcomes in recipients with an initial implantable cardioverter-defibrillator (ICD) and their intimate partners are largely unstudied, though likely to have a major impact on adjustment to the ICD and general well-being. OBJECTIVE: The purpose of this study was to report the primary outcomes of the patient plus partner randomized controlled trial. METHODS: In a 2-group (N = 301) prospective randomized controlled trial, we compared 2 social-cognitive-based intervention programs-patient plus partner (P+P) and patient only (P only)-implemented after initial ICD implantation. The patient intervention, consisting of educational materials, nurse-delivered telephone coaching, videotape demonstrations, and access to a nurse via a 24/7 pager, was implemented in both groups. P+P also incorporated partner participation. The primary patient outcomes were symptoms and anxiety at 3 months. Other outcomes were physical function (SF-36 [Short Form 36] and ICD shocks-patient), psychological adjustment (PHQ-9 [Patient Health Questionaire-9]), relationship impact (Dyadic Adjustment Scale and Oberst Caregiving Burden Scale (DAS and OCBS) partner), self-efficacy and knowledge (Sudden Cardiac Arrest-Self Efficacy [SCA-SE], Sudden Cardiac Arrest-Outcomes Expectation [SCA-OE], and Knowledge Self-Assessment [KSA]), and health care utilization (outpatient visits and hospitalizations) at hospital discharge and 1, 3, 6, and 12 months post-ICD implantation. RESULTS: For patients, P+P compared with P only was more effective in improving symptoms (P = .02), depression (P = .006), self-efficacy (P = .02), outcome expectations (P = .03), and knowledge (P = .07). For partners, P+P was more effective in improving partner caregiver burden (P = .002), self-efficacy (P = .001), and ICD knowledge (P = .04). CONCLUSION: An intervention that integrated the partner into the patient's recovery after an ICD improved outcomes for both. Beyond survival benefits of the ICD, intervention programs designed to address both the patient and their partner living successfully with an ICD are needed and promising.

Mortality in Advanced Chronic Obstructive Pulmonary Disease and Heart Failure Following Cardiopulmonary Rehabilitation.

Cardiopulmonary rehabilitation (CR) improves physical function and quality of life (QoL) in chronic obstructive pulmonary disease (COPD) and heart failure (HF), but it is unknown if CR improves outcomes in very severe disease. This study's purpose was to describe functional capacity (6-min walk distance [6MWD], steps/day), symptoms (dyspnea, depression), QoL (Short-Form Health Survey-Veterans [SF-36 V]) and cardiopulmonary function ( N-terminal pro-brain natriuretic peptide [NT-proBNP], forced expiratory volume in 1 s [FEV1]), and derive predictors of mortality among patients with severe COPD and HF who participated in CR. METHODS AND RESULTS: In this secondary analysis of a randomized controlled trial comparing two CR methods in severe COPD and HF, 90 (COPD = 63, HF = 27) male veterans, mean age 66 ± 9.24 years, 79% Caucasian, and body mass index 31 kg/m2, were followed for 12 months after CR. The COPD group had greater functional decline than the HF group (6MWD, p = .006). Dyspnea was lower ( p = .001) and QoL higher ( p = .006) in the HF group. Mean NT-proBNP was higher in the HF group at all time points. FEV1 improved over 12 months in both groups ( p = .01). Mortality was 8.9%, 16.7%, and 37.8% at 12, 24, and 60 months, respectively. One-year predictors of mortality were baseline total steps (<3,000/day), 6MWD (<229 meters), and NT-proBNP level (>2,000 mg/pg). CONCLUSIONS: In very severe COPD and HF, risks of mortality over 12 months can predict patients unlikely to benefit from CR and should be considered at initial referral.

A Systematic Review of Exercise Training in Patients With Cardiac Implantable Devices.

PURPOSE: This systematic review identified exercise-based intervention studies in patients with cardiac implantable devices (CIDs): implantable cardioverter defibrillator (ICD), cardiac resynchronization pacemaker or defibrillator (cardiac resynchronization therapy [CRT]), or ventricular assist device (VAD) and assessed evidence for the safety and efficacy of exercise-based interventions alone or in combination with psychoeducational components. METHODS: PubMed, EMBASE, CINAHL Plus, Web of Science, Cochrane, and PEDro databases were searched from database inception to September 2016. Data were extracted and validity was assessed by 2 reviewers. Study quality was evaluated using the JADAD scale for randomized controlled trials. A total of 3991 articles for all CIDs (ICD: 1015; pacemaker: 1630; and VAD: 1346) were screened for relevance. Subsequently, 24 full-text articles (ICD: 14; CRT: 4; and VAD: 6) were deemed eligible for this review. RESULTS: Studies of aerobic exercise training demonstrated an average increase in peak oxygen uptake of 2.61 mL/kg/min, (ICD = 2.43, VAD = 2.2, and CRT = 3.2 mL/kg/min). These incremental increases were statistically significant when compared with the usual care or other comparison groups. Adverse event rates were very low at 1.1% to 2.2% for all CIDs. CONCLUSION: Exercise interventions tested to date in the CID population (ICD, CRT, and VAD) indicate that exercise training at moderate to high intensity is safe and effective in improving cardiopulmonary outcomes without adverse events. Future investigations should include a more diverse sample of participants, designs that include translation of exercise to routine practice, the destination therapy VAD population, and measurement of costs and patient-centered outcomes.

Putting the "Informed" in the informed consent process for implantable cardioverter-defibrillators: Addressing the needs of the elderly patient.

Implantable cardioverter defibrillator (ICD) management complexities challenge the ethos of fully informed consent, particularly for the typically multimorbid elderly patient considering the device for primary prevention. The Heart Rhythm Society recommends providers include discussion on the potential need for later device deactivation or nonreplacement at the time of first implant, and to revisit this at appropriate intervals. The initial consent procedure could meet this standard by incorporating the future need to discuss further such issues when the recipient's clinical condition changes to such an extent that defibrillation would no longer be beneficial. At the time of obtaining consent, some patients may lack the will or capacity to make medically complex decisions when it would be necessary for healthcare surrogate decision-makers to contribute to this process. Ensuring an appropriate level of understanding and response may be enhanced by the use of information and decision aids. With improved communication regarding the nuances of ICD therapy, device eligible patients, and those close to them, will be empowered with a better understanding of the nature, benefits, and risks of ICD implantation, allowing them to make treatment decisions consistent with their values.

Development and testing of a goals of care intervention in advanced heart failure.

AIM: The purpose of this paper is to describe the conceptual framework for a goals of care (GoC) intervention, elements, and findings of intervention feasibility, acceptability, and benefits from both patients with heart failure (HF) and their providers. BACKGROUND: Receiving care at a mechanical circulatory support center for advanced HF offers new opportunities for treatment, making the implementation of a GoC intervention timely and crucial in helping patients determine next steps in HF treatment. METHODS: The GoC intervention was designed using a self-management framework, incorporating the concepts of self-efficacy, patient activation, and patient motivation. At the conclusion of the study, open-ended exit interviews were conducted with patients and providers. Content analysis was used to derive the feasibility, acceptability, and benefits of the intervention. RESULTS: Forty-one patients with HF, with average age 58.2±11.3years, LVEF=30.3±9.7%, and New York Heart Association Functional Class (NYHA FC)=2.4±0.8, and nine HF providers participated in the study. Patient benefits from the intervention included enhanced communication with their provider and family members, increased confidence to have a conversation with the provider, and refreshed HF knowledge. Provider benefits from the intervention were facilitating a conversation with the patient and learning new information about the patient's goals and values. CONCLUSION: The GoC intervention provides an avenue to align patient goals and values with treatment choices in the context of advanced heart failure, so that patient quality of life is enhanced and costs of care can be reduced.

Feasibility of Combining Common Data Elements Across Studies to Test a Hypothesis.

PURPOSE: The purpose of this article is to describe the outcomes of a collaborative initiative to share data across five schools of nursing in order to evaluate the feasibility of collecting common data elements (CDEs) and developing a common data repository to test hypotheses of interest to nursing scientists. This initiative extended work already completed by the National Institute of Nursing Research CDE Working Group that successfully identified CDEs related to symptoms and self-management, with the goal of supporting more complex, reproducible, and patient-focused research. DESIGN: Two exemplars describing the group's efforts are presented. The first highlights a pilot study wherein data sets from various studies by the represented schools were collected retrospectively, and merging of the CDEs was attempted. The second exemplar describes the methods and results of an initiative at one school that utilized a prospective design for the collection and merging of CDEs. METHODS: Methods for identifying a common symptom to be studied across schools and for collecting the data dictionaries for the related data elements are presented for the first exemplar. The processes for defining and comparing the concepts and acceptable values, and for evaluating the potential to combine and compare the data elements are also described. Presented next are the steps undertaken in the second exemplar to prospectively identify CDEs and establish the data dictionaries. Methods for common measurement and analysis strategies are included. FINDINGS: Findings from the first exemplar indicated that without plans in place a priori to ensure the ability to combine and compare data from disparate sources, doing so retrospectively may not be possible, and as a result hypothesis testing across studies may be prohibited. Findings from the second exemplar, however, indicated that a plan developed prospectively to combine and compare data sets is feasible and conducive to merged hypothesis testing. CONCLUSIONS: Although challenges exist in combining CDEs across studies into a common data repository, a prospective, well-designed protocol for identifying, coding, and comparing CDEs is feasible and supports the development of a common data repository and the testing of important hypotheses to advance nursing science. CLINICAL RELEVANCE: Incorporating CDEs across studies will increase sample size and improve data validity, reliability, transparency, and reproducibility, all of which will increase the scientific rigor of the study and the likelihood of impacting clinical practice and patient care.

Knowledge of Implantable Cardioverter Defibrillator Purpose and Function Among Nurses in the United States.

BACKGROUND: Nurses play a crucial role in patient education and adaptation to having an implantable cardioverter defibrillator (ICD). OBJECTIVE: The aim of this study was to assess cardiology nurses' knowledge and confidence in providing education and support to ICD recipients. METHODS: A cross-sectional descriptive survey was used to assess nurses' knowledge and experience caring for ICD recipients in 2 academic medical centers in the Pacific Northwest, using an instrument developed in 2004 in the United Kingdom. RESULTS: Nurses (N = 74) worked on cardiology units or clinics, primarily held a baccalaureate degree or higher (85%), and had 16 years or more of nursing experience and 6 to 10 years of cardiology experience. The overall average knowledge score was 77%, with knowledge about modern ICD technology averaging 55%. Nurses' confidence, using 10-point scale, in preparing patients to receive an ICD implant was 6.32 ± 2.56, for preparing patients for discharge was 6.14 ± 2.43, and for providing education about ICD shocks was 6.63 ± 2.50. Nurses were most knowledgeable about factors that affect patient retention of knowledge and ICD-related environmental hazards. Nurses lacked knowledge about the basic ICD components, purpose of cardiac resynchronization, and dual-chamber ICDs. Factors associated with higher knowledge scores included past experience caring for a patient with an ICD and working in an electrophysiology outpatient clinic. CONCLUSIONS: The ICD knowledge of US nurses in 2015 was similar to that reported in the United Kingdom in 2004, with limited knowledge about the complexities of modern ICD devices. Such deficits in knowledge may affect the quality of education provided to ICD recipients in preparing them to live safely with an ICD.