Perioperative Safety and Early Patient and Device Outcomes Among Subcutaneous Versus Transvenous Implantable Cardioverter Defibrillator Implantations : A Randomized, Multicenter Trial.

BACKGROUND: Implantable cardioverter defibrillators (ICDs) improve survival in patients at risk for cardiac arrest, but are associated with intravascular lead-related complications. The subcutaneous ICD (S-ICD), with no intravascular components, was developed to minimize lead-related complications. OBJECTIVE: To assess key ICD performance measures related to delivery of ICD therapy, including inappropriate ICD shocks (delivered in absence of life-threatening arrhythmia) and failed ICD shocks (which did not terminate ventricular arrhythmia). DESIGN: Randomized, multicenter trial. (ClinicalTrials.gov: NCT02881255). SETTING: The ATLAS trial. PATIENTS: 544 eligible patients (141 female) with a primary or secondary prevention indication for an ICD who were younger than age 60 years, had a cardiogenetic phenotype, or had prespecified risk factors for lead complications were electrocardiographically screened and 503 randomly assigned to S-ICD (251 patients) or transvenous ICD (TV-ICD) (252 patients). Mean follow-up was 2.5 years (SD, 1.1). Mean age was 49.0 years (SD, 11.5). MEASUREMENTS: The primary outcome was perioperative major lead-related complications. RESULTS: There was a statistically significant reduction in perioperative, lead-related complications, which occurred in 1 patient (0.4%) with an S-ICD and in 12 patients (4.8%) with TV-ICD (-4.4%; 95% CI, -6.9 to -1.9; P = 0.001). There was a trend for more inappropriate shocks with the S-ICD (hazard ratio [HR], 2.37; 95% CI, 0.98 to 5.77), but no increase in failed appropriate ICD shocks (HR, 0.61 (0.15 to 2.57). Patients in the S-ICD group had more ICD site pain, measured on a 10-point numeric rating scale, on the day of implant (4.2 ± 2.8 vs. 2.9 ± 2.2; P < 0.001) and 1 month later (1.3 ± 1.8 vs. 0.9 ± 1.5; P = 0.035). LIMITATION: At present, the ATLAS trial is underpowered to detect differences in clinical shock outcomes; however, extended follow-up is ongoing. CONCLUSION: The S-ICD reduces perioperative, lead-related complications without significantly compromising the effectiveness of ICD shocks, but with more early postoperative pain and a trend for more inappropriate shocks. PRIMARY FUNDING SOURCE: Boston Scientific.

Strategies for specialty training of healthcare professionals in low-resource settings: a systematic review on evidence from stroke care.

BACKGROUND: The greatest mortality and disability from stroke occurs in low- and middle-income countries. A significant barrier to implementation of best stroke care practices in these settings is limited availability of specialized healthcare training. We conducted a systematic review to determine the most effective methods for the provision of speciality stroke care education for hospital-based healthcare professionals in low-resource settings. METHODS: We followed the PRISMA guidelines for systematic reviews and searched PubMed, Web of Science and Scopus for original clinical research articles that described or evaluated stroke care education for hospital-based healthcare professionals in low-resource settings. Two reviewers screened titles/abstracts and then full text articles. Three reviewers critically appraised the articles selected for inclusion. RESULTS: A total of 1,182 articles were identified and eight were eligible for inclusion in this review; three were randomized controlled trials, four were non-randomized studies, and one was a descriptive study. Most studies used several approaches to education. A "train-the-trainer" approach to education was found to have the most positive clinical outcomes (lower overall complications, lengths of stay in hospital, and clinical vascular events). When used for quality improvement, the "train-the-trainer" approach increased patient reception of eligible performance measures. When technology was used to provide stroke education there was an increased frequency in diagnosis of stroke and use of antithrombotic treatment, reduced door-to-needle times, and increased support for decision making in medication prescription was reported. Task-shifting workshops for non-neurologists improved knowledge of stroke and patient care. Multidimensional education demonstrated an overall care quality improvement and increased prescriptions for evidence-based therapies, although, there were no significant differences in secondary prevention efforts, stroke reoccurrence or mortality rates. CONCLUSIONS: The "train the trainer" approach is likely the most effective strategy for specialist stroke education, while technology is also useful if resources are available to support its development and use. If resources are limited, basic knowledge education should be considered at a minimum and multidimensional training may not be as beneficial. Research into communities of practice, led by those in similar settings, may be helpful to develop educational initiatives with relevance to local contexts.

Decision Support for Implantable Cardioverter-Defibrillator Replacement: A Pilot Feasibility Randomized Controlled Trial.

BACKGROUND: Decision support can help patients facing implantable cardioverter-defibrillator (ICD) replacement understand their options and reach an informed decision reflective of their preferences. OBJECTIVE: The aim of this study was to evaluate the feasibility of a decision support intervention for patients faced with the decision to replace their ICD. METHODS: A pilot feasibility randomized trial was conducted. Patients approaching ICD battery depletion were randomized to decision support intervention or usual care. Feasibility outcomes included recruitment rates, intervention use, and completeness of data; secondary outcomes were knowledge, values-choice concordance, decisional conflict, involvement in decision making, and choice. RESULTS: A total of 30 patients were randomized to intervention (n = 15) or usual care (n = 15). The intervention was used as intended, with 2% missing data. Patients in the intervention arm had better knowledge (77.4% vs 51.1%; P = .002). By 12 months, 8 of 13 (61.5%) in the intervention arm and 10 of 14 (71.4%) in the usual care arm accepted ICD replacement; 1 per arm declined (7.7% vs 7.1%, respectively). CONCLUSION: It was feasible to deliver the intervention, collect data, despite slow recruitment. The decision support intervention has the potential to improve ICD replacement decision quality.

Preparing for patient partnership: A scoping review of patient partner engagement and evaluation in research.

BACKGROUND: Realizing patient partnership in research requires a shift from patient participation in ancillary roles to engagement as contributing members of research teams. While engaging patient partners is often discussed, impact is rarely measured. OBJECTIVE: Our primary aim was to conduct a scoping review of the impact of patient partnership on research outcomes. The secondary aim was to describe barriers and facilitators to realizing effective partnerships. SEARCH STRATEGY: A comprehensive bibliographic search was undertaken in EBSCO CINAHL, and Embase, MEDLINE and PsycINFO via Ovid. Reference lists of included articles were hand-searched. INCLUSION CRITERIA: Included studies were: (a) related to health care; (b) involved patients or proxies in the research process; and (c) reported results related to impact/evaluation of patient partnership on research outcomes. DATA EXTRACTION AND SYNTHESIS: Data were extracted from 14 studies meeting inclusion criteria using a narrative synthesis approach. MAIN RESULTS: Patient partners were involved in a range of research activities. Results highlight critical barriers and facilitators for researchers seeking to undertake patient partnerships to be aware of, such as power imbalances between patient partners and researchers, as well as valuing of patient partner roles. DISCUSSION: Addressing power dynamics in patient partner-researcher relationships and mitigating risks to patient partners through inclusive recruitment and training strategies may contribute towards effective engagement. Further guidance is needed to address evaluation strategies for patient partnerships across the continuum of patient partner involvement in research. CONCLUSIONS: Research teams can employ preparation strategies outlined in this review to support patient partnerships in their work.

Assessing Swallowing of the Breastfeeding NICU Infant Using Fiberoptic Endoscopic Evaluation of Swallowing: A Feasibility Study.

BACKGROUND: Premature infants may demonstrate feeding difficulties requiring an instrumental swallowing assessment. Fiberoptic endoscopic evaluation of swallowing (FEES) is one assessment that can evaluate bottle feeding and breastfeeding. PURPOSE: This pilot study investigated the safety and feasibility of FEES for neonatal intensive care unit (NICU) infants during breastfeeding. METHODS: The setting for this prospective, descriptive study was an urban level III NICU that provided care for premature and critically ill infants. Participants were 5 infants recruited from a convenience sample who were at least 37 weeks postmenstrual age, demonstrated feeding difficulties during a bedside feeding and swallowing examination, and were breastfeeding. Each participant received a FEES assessment while breastfeeding (FEES-B). Adverse events and vital signs including prefeeding and postfeeding respiratory rate, heart rate, and oxygen saturation level were recorded to assess safety. Visualization of milk, laryngeal penetration, and tracheal aspiration assessed feasibility. RESULTS: Participants had a mean postmenstrual age of 39.8 weeks. No adverse events, including epistaxis or laryngospasm, were reported; there were no instances of autonomic instability; and there were no statistically significant differences between prefeeding and postfeeding respiratory rate, heart rate, or oxygen saturation level. Two infants successfully breastfed during FEES-B. Human milk was observable, and laryngeal penetration was noted with 1 infant. IMPLICATION FOR PRACTICE: FEES-B was found to be safe, with limited data supporting feasibility. Infants demonstrated no physiologic instability during FEES-B, and milk was visualized in the pharynx during breastfeeding with 2 infants. IMPLICATION FOR RESEARCH: Further studies are warranted to assess effectiveness of FEES-B in infants.

Impact of nurse scientist-led digital health interventions on management of chronic conditions.

BACKGROUND: Chronic conditions are a major contributor to the burden of disease worldwide. Using innovative digital health technologies, nurse scientists are well-positioned to lead efforts to reduce the burden of chronic conditions on individuals, communities, and systems. PURPOSE: The purpose of this review was to summarize the outcomes commonly measured in nurse-led digital health interventions that target chronic conditions and pose recommendations for the education of future nurse scientists to lead these studies. METHODS: A rapid review of the literature was completed using CINAHL and Ovid Emcare. Studies were included if the research: a) was led by a nurse; b) described outcomes of a digital health intervention; and c) included any population with a prevalent chronic condition. FINDINGS: 26 studies were included in this review. Nurse-led digital health interventions are being used to support and manage a range of chronic conditions in varied settings. DISCUSSION: Digital health interventions are changing the delivery of healthcare for individuals living with chronic conditions. These interventions are bridging the gaps between the digital and physical worlds and are rapidly evolving. CONCLUSION: The recommendations posed in this review reiterate the importance of robust content and methods education for nurse scientists to address future research needs in a digital era.

Rationale and design of the randomized prospective ATLAS study: Avoid Transvenous Leads in Appropriate Subjects.

BACKGROUND: The defibrillator lead is the weakest part of the transvenous (TV) implantable cardioverter defibrillation (ICD) system and a frequent cause of morbidity. Lead dislodgement, cardiac perforation, insertion-related trauma including pneumothorax and vascular injury, are common early complications of TV-ICD implantation. Venous occlusion, tricuspid valve dysfunction, lead fracture and lead insulation failure are additional, later complications. The introduction of a totally sub-cutaneous ICD (S-ICD) may reduce these lead-related issues, patient morbidity, hospitalizations and costs. However, such benefits compared to the TV-ICD have not been demonstrated in a randomized trial. DESIGN: ATLAS (Avoid Transvenous Leads in Appropriate Subjects) is a multi-centered, randomized, open-label, parallel group trial. Patients younger than 60 years are eligible. If older than 60 years, patients are eligible if they have an inherited heart rhythm disease, or risk factors for ICD-related complication, such as hemodialysis, a history of ICD or pacemaker infection, heart valve replacement, or severe pulmonary disease. This study will determine if using an S-ICD compared to a TV-ICD reduces a primary composite outcome of perioperative complications including pulmonary or pericardial perforation, lead dislodgement or dysfunction, tricuspid regurgitation and ipsilateral venous thrombosis. Five hundred patients will be enrolled from 14 Canadian hospitals, and data collected to both early- (at 6 months) and mid-term complications (at 24 months) as well as mortality and ICD shock efficacy. SUMMARY: The ATLAS randomized trial is comparing early- and mid-term vascular and lead-related complications among S-ICD versus TV-ICD recipients who are younger or at higher risk of ICD-related complications.

Perceptions of a psychoeducation program for caregivers of persons with dementia at end of life: a qualitative study.

OBJECTIVES: Caregivers (CG) of persons with dementia have described positive and challenging experiences related to caring for a person with a neurological disease. This study explored perceived benefits and challenges of a unique psychoeducation program provided at end of life (EOL) jointly attended by current and bereaved CGs of persons with dementia, residing in a hospital Specialized Care Unit. METHOD: Semi-structured interviews were held with sixteen participants and analyzed with content analysis. RESULTS: Program benefits were perceived by CGs such as: (i) enhanced emotional well-being, (ii) increased feelings of preparedness for EOL, and (iii) personal growth into role models. Within the organization the program was perceived as promoting relationship-centered care and increasing resources. Challenges such as diverse CG preferences, day-time scheduling and limited involvement of unit staff were perceived as barriers. CONCLUSIONS: This program fills a gap in care for CGs at the critical stage of EOL with continuity into bereavement. Implications for practice include: increasing engagement of unit staff for involvement and tailoring of the program, and translation of the program into alternative settings like long-term care. Policies outlining the support needs and resources for CGs through EOL within and outside the hospital are necessary to ensure access and continuity of care.

Incorporating patients' preference diagnosis in implantable cardioverter defibrillator decision-making: a review of recent literature.

PURPOSE OF REVIEW: Strong recommendations exist for implantable cardioverter defibrillators (ICD) in appropriately selected patients. Yet, patient preferences are not often incorporated when decisions about ICD therapy are made. Literature published since 2016 was reviewed aiming to discuss current advances and ongoing challenges with ICD decision-making in adults, discuss shared decision-making (SDM) as a strategy to incorporate preference diagnoses, summarize current evidence on effective interventions to facilitate SDM, and identify opportunities for research and practice. RECENT FINDINGS: Advances in risk stratification can identify patients who will most and least likely benefit from the ICD. Interventions to support SDM are emerging. These interventions present options, the risks, and the benefits of each option, and elicit patients' values and preferences regarding possible outcomes. SUMMARY: Appropriate patient selection for initial or continued ICD therapy is multifactorial. It requires accurate clinical diagnosis using careful risk stratification and accurate preference diagnosis based upon the patient's preferences. SDM aims to unite the elements that constitute these two equally important diagnoses. High-quality decision-making will be difficult to achieve if patients lack or misunderstand information, and if evolving patient preferences are not incorporated when making decisions.

User-centered Development of a Decision Aid for Patients Facing Implantable Cardioverter-Defibrillator Replacement: A Mixed-Methods Study.

BACKGROUND: Because of battery depletion, an implantable cardioverter-defibrillator (ICD) generator requires surgical replacement every 5 to 7 years. Routine replacement is the norm without discussion with patients about whether or not to proceed. OBJECTIVE: The aim of this study was to develop a patient decision aid (PDA) for patients facing ICD replacement and plan for its implementation. METHODS: An embedded mixed-methods study was conducted using questionnaires and semistructured interviews focused on current ICD replacement practices; PDA acceptability, usability, and content; and PDA implementation. Transcripts were analyzed using constant comparative analysis. RESULTS: Eighteen PDA end users in 16 interviews characterized the current ICD replacement approach as automatic without consideration for patient preferences. The PDA was positively received, and the content was iteratively revised 4 times during the interviews. Changes were related to missing and excess information, language, and wording. The PDA was identified as a means to support a shared decision-making (SDM) process, not to be used as a standalone instrument. To shift current practices to an SDM process, participants identified that an invitation to discuss the option of ICD replacement is required-whether initiated by the patient or the clinician. CONCLUSION: Currently, the option of ICD replacement is rarely offered, and patient preferences are seldom elicited. Participants believed the PDA to be a useful intervention that could help facilitate an SDM process for patients facing ICD replacement. Preparing for implementation during the development phase will allow us to strategize effectively to overcome perceived barriers and capitalize on perceived facilitators during actual implementation.

The Caregiver Contribution to Heart Failure Self-Care (CACHS): Further Psychometric Testing of a Novel Instrument.

Caregivers (CGs) contribute important assistance with heart failure (HF) self-care, including daily maintenance, symptom monitoring, and management. Until CGs' contributions to self-care can be quantified, it is impossible to characterize it, account for its impact on patient outcomes, or perform meaningful cost analyses. The purpose of this study was to conduct psychometric testing and item reduction on the recently developed 34-item Caregiver Contribution to Heart Failure Self-care (CACHS) instrument using classical and item response theory methods. Fifty CGs (mean age 63 years ±12.84; 70% female) recruited from a HF clinic completed the CACHS in 2014 and results evaluated using classical test theory and item response theory. Items would be deleted for low (<.05) or high (>.95) endorsement, low (<.3) or high (>.7) corrected item-total correlations, significant pairwise correlation coefficients, floor or ceiling effects, relatively low latent trait and item information function levels (<1.5 and p > .5), and differential item functioning. After analysis, 14 items were excluded, resulting in a 20-item instrument (self-care maintenance eight items; monitoring seven items; and management five items). Most items demonstrated moderate to high discrimination (median 2.13, minimum .77, maximum 5.05), and appropriate item difficulty (-2.7 to 1.4). Internal consistency reliability was excellent (Cronbach α = .94, average inter-item correlation = .41) with no ceiling effects. The newly developed 20-item version of the CACHS is supported by rigorous instrument development and represents a novel instrument to measure CGs' contribution to HF self-care. © 2016 Wiley Periodicals, Inc.

Estimating the Risks and Benefits of Implantable Cardioverter Defibrillator Generator Replacement: A Systematic Review.

BACKGROUND: Every 4-7 years an implantable cardioverter defibrillator (ICD) pulse generator must be replaced surgically. This procedure is not without risk. In some cases, the risk versus benefit ratio may be against replacement. We aimed to synthesize the evidence on risks, benefits, and costs related to ICD replacement. METHODS: A systematic review was conducted using electronic databases from 2000 onward. Literature screening, quality appraisal, and data extraction were independently conducted by two reviewers. Outcomes included major and minor complications, ICD therapies, and costs, which were synthesized descriptively. RESULTS: Of 1,483 citations, 17 nonrandomized studies met criteria. Median rate of major complications was 4.05% (range 0.55-7.37%) and minor complications was 3.50% (range 0.36-7.37%). Without non-ICD control groups, the true risk reduction provided by the ICD following replacement is unknown. Following ICD replacement, annualized rate of appropriate ICD therapy was 10.52% (range 2.42-75.00%). Of these, patients without therapies during their first generator life and those no longer meeting ICD criteria received appropriate therapies at nontrivial rates. CONCLUSION: Rates of complications associated with ICD replacement are substantial. No study had nonreplacement groups, hence the true risk reduction provided by the ICD following replacement is unknown. Our analysis did not identify a subgroup at low risk of therapies following replacement. Shared discussions should occur with patients about the evidence, healthcare goals, risk tolerances, and feelings about life and death trade-offs to enable high-quality decisions about ICD replacement.

Fiberoptic Endoscopic Evaluation of Swallowing: A Multidisciplinary Alternative for Assessment of Infants With Dysphagia in the Neonatal Intensive Care Unit.

BACKGROUND: The standard procedure to assess an infant in the neonatal intensive care unit (NICU) who is suspected of aspirating on oral feedings is a videofluoroscopic swallowing study (VFSS). The VFSS has been used for more than 30 years to assess dysphagia and is considered the gold standard. However, there are challenges to the VFSS, including radiation exposure, transport to radiology, usage of barium, limited positioning options, and cost. An alternative approach is fiberoptic endoscopic evaluation of swallowing (FEES), which uses a flexible endoscope passed transnasally into the pharynx to assess anatomy, movement/sensation of structures, swallow function, and response to therapeutic interventions. Fiberoptic endoscopic evaluation of swallowing has been established as a valid tool for evaluating dysphagia and utilized as an alternative or supplement to the VFSS in both adults and children. PURPOSE: This article provides an overview of the current challenges in the NICU with assessing aspiration and introduces a multidisciplinary FEES program for bottle and breastfeeding. METHODS/SEARCH STRATEGY: A review of the literature of dysphagia, VFSS, and FEES in the adult, pediatric, infant, and neonatal populations was performed. Clinical competency standards were researched and then implemented through an internal process of validation. Finally, a best practice protocol was designed as it relates to FEES in the NICU. FINDINGS/RESULTS: Fiberoptic endoscopic evaluation of swallowing is a safe alternative to the VFSS. It can be utilized at the infant's bedside in a NICU for the diagnosis and treatment of swallowing disorders by allowing the clinician the ability to replicate a more accurate feeding experience, therefore, determining a safe feeding plan. IMPLICATIONS FOR PRACTICE: Competency and training are essential to establishing a multidisciplinary FEES program in the NICU. IMPLICATIONS FOR RESEARCH: Further research is needed to compare the efficacy and validity of FEES versus VFSS for infants in the NICU. Furthermore, evaluating the efficacy of FEES during breastfeeding is warranted.

Development of a patient decision aid for people with refractory angina: protocol for a three-phase pilot study.

BACKGROUND: Refractory angina is a severe chronic disease, defined as angina which cannot be controlled by usual treatments for heart disease. This disease is frightening, debilitating, and difficult to manage. Many people suffering refractory have inadequate pain relief, continually revisit emergency departments for help, undergo repeated cardiac investigations, and struggle with obtaining appropriate care. There is no clear framework to help people understand the risks and benefits of available treatment options in Canada. Some treatments for refractory angina are invasive, while others are not covered by provincial health insurance plans. Effective care for refractory angina sufferers in Canada is critically underdeveloped; it is important that healthcare professionals and refractory angina sufferers alike understand the treatment options and their implications. This proposal builds on the recent Canadian practice guidelines for the management of refractory angina. We propose to develop a decision support tool in order to help people suffering from refractory angina make well-informed decisions about their healthcare and reduce their uncertainty about treatment options. METHODS: This project will be conducted in three phases: a) development of the support tool with input from clinical experts, the Canadian refractory angina guidelines, and people living with refractory angina, b) pilot testing of the usability of the tool, and c) formal preliminary evaluation of the effectiveness of the support tool to help people make informed decisions about treatment options. DISCUSSION: A decision support tool for refractory angina is needed and the available data suggest that by developing such a tool, we may be able to help refractory angina sufferers better understand their condition and the effectiveness of available treatment options (in their respective clinical settings) as well as their implications (e.g. risks vs. benefits). By virtue of this tool, we may also be able to facilitate identification and inclusion of patients' values and preferences in the decision making process. This is particularly important as refractory angina is an intractable condition, necessitating that the selected course of treatment be lifelong. This study will yield a much needed patient decision aid for people living with refractory angina and pilot data to support a subsequent effectiveness study.

Impact of self-management interventions on stable angina symptoms and health-related quality of life: a meta-analysis.

BACKGROUND: Chronic stable angina (CSA) has a major negative impact on health-related quality of life (HRQL) including poor general health status, psychological distress, and inability to self-manage. METHODS: We used meta-analysis to assess the effectiveness of self-management interventions for improving stable angina symptoms, HRQL and psychological well-being. Nine trials, involving 1,282 participants in total, were included. We used standard inverse-variance random-effects meta-analysis to combine the trials. Heterogeneity between trials was evaluated using chi-square tests for the tau-squared statistic and quantified using the I2 statistic. RESULTS: There was significant improvement in the frequency of angina symptoms (Seattle Angina Questionnaire [SAQ], symptom diary) across trials, standardized mean difference (SMD): 0.30 (95% Confidence interval [CI] 0.14, 0.47), as well as reduction in the use of sublingual (SL) nitrates, SMD: -0.49 (95% CI -0.77, -0.20). Significant improvements for physical limitation (SAQ), SMD: 0.38 (95% CI 0.20, 0.55) and depression scores (Hospital Anxiety and Depression Scale), SMD: -1.38 (95% CI -2.46, -0.30) were also found. The impact of SM on anxiety was uncertain due to statistical heterogeneity across trials for this outcome, I2 = 98%. SM did not improve other HRQL dimensions including angina stability, disease perception, and treatment satisfaction. CONCLUSIONS: SM interventions significantly improve angina frequency and physical limitation; they also decrease the use of SL nitrates and improve depression in some cases. Further work is needed to make definitive conclusions about the impact of SM on cardiac-specific anxiety.

Device-specific quality of life: Results from the ATLAS trial-Avoid Transvenous Leads in Appropriate Subjects.

AIM: Patient reported outcomes (PROs) provide important insights into patients' acceptance of their medical devices. ATLAS, a randomized, multi-center, open-label clinical trial, recently reported fewer perioperative complications in S-ICD compared to TV-ICD patients. This study reports PROs, including device-specific and generic quality of life (QOL) from the ATLAS trial. METHODS AND RESULTS: Device-specific QOL was the primary PRO using the Florida Patient Acceptance Survey (FPAS) at 1-and 6-months post-implantation. Secondary outcomes included generic QOL using the Medical Outcomes Survey (SF-36) pre-implant and 6-months post-implantation. FPAS and SF-36 were analyzed using ANCOVA. Pain measured using a Numeric Rating Scale, at 1-and 6-months, anesthetic, BMI and within/between differences were analyzed using descriptive statistics and mixed-effects linear models (MLM). Of the 503 patients randomized in ATLAS, 404 had complete FPAS data to include in this analysis. Participant characteristics were balanced. There were no significant differences between S-ICD and TV-ICD for FPAS or SF-36, across timepoints. Mean total FPAS scores increased from 73.73 (16.09) to 77.05 (16.13) and 74.43 (15.35) to 78.25 (15.88) for S-ICD and TV-ICD, respectively, (p <0.001). PROs suggested that both devices were associated with good QOL. CONCLUSION: Device-specific and generic QOL were similar between S-ICD and TV-ICD groups up to 6-months post-implantation indicating that regardless of device type, both groups reported good device specific QOL in ATLAS patients. S-ICD patients reported higher pain scores at implant, but pain decreased by 6 months. The findings offer evidence that can be included during shared decision-making. The inclusion of patient partners in ATLAS provided opportunity to measure PROs that were deemed important to patients.

Risk Factors for Hospital Readmission Following Noncardiac Surgery: International Cohort Study.

Objective: To determine timing and risk factors associated with readmission within 30 days of discharge following noncardiac surgery. Background: Hospital readmission after noncardiac surgery is costly. Data on the drivers of readmission have largely been derived from single-center studies focused on a single surgical procedure with uncertainty regarding generalizability. Methods: We undertook an international (28 centers, 14 countries) prospective cohort study of a representative sample of adults ≥45 years of age who underwent noncardiac surgery. Risk factors for readmission were assessed using Cox regression (ClinicalTrials.gov, NCT00512109). Results: Of 36,657 eligible participants, 2744 (7.5%; 95% confidence interval [CI], 7.2-7.8) were readmitted within 30 days of discharge. Rates of readmission were highest in the first 7 days after discharge and declined over the follow-up period. Multivariable analyses demonstrated that 9 baseline characteristics (eg, cancer treatment in past 6 months; adjusted hazard ratio [HR], 1.44; 95% CI, 1.30-1.59), 5 baseline laboratory and physical measures (eg, estimated glomerular filtration rate or on dialysis; HR, 1.47; 95% CI, 1.24-1.75), 7 surgery types (eg, general surgery; HR, 1.86; 95% CI, 1.61-2.16), 5 index hospitalization events (eg, stroke; HR, 2.21; 95% CI, 1.24-3.94), and 3 other factors (eg, discharge to nursing home; HR, 1.61; 95% CI, 1.33-1.95) were associated with readmission. Conclusions: Readmission following noncardiac surgery is common (1 in 13 patients). We identified perioperative risk factors associated with 30-day readmission that can help frontline clinicians identify which patients are at the highest risk of readmission and target them for preventive measures.

Patients' decision making to accept or decline an implantable cardioverter defibrillator for primary prevention of sudden cardiac death.

BACKGROUND: Patients are offered implantable defibrillators (ICDs) for the prevention of sudden cardiac death (SCD). However, patients' decision-making process (DMP) of whether or not to accept an ICD has not been explored. We asked patients about their decision making when offered an ICD. DESIGN/SETTING: A grounded theory methodology was employed. Patients were recruited from three ICD centres. Those who received an ICD underwent interviews the first month after implant. Declining patients had interviews at their convenience. In-depth analysis of transcripts was completed. Identified themes were placed along process pathways in a DMP model and tested. FINDINGS: Forty-four patients consented to participate (25% women). Thirty-four accepted an ICD and 10 (23%) declined. Ages ranged from 26 to 87 (mean = 65; SD = 12.5). Participants were retired (65%), had ischaemic heart disease (64%) and some post-secondary education (52%). The DMP was triggered when patient's risk for SCD was communicated. The physician's recommendation and a new awareness SCD risk were motivators to accept the ICD. Patient's decision-making approaches fell along a continuum, from active and engaged to passive and indifferent. Patient's approaches were influenced most by the following: (i) trust; (ii) social influences and (iii) health state. CONCLUSIONS: Health-care providers need to recognize the DMP pathways in which ICD candidacy and SCD risk are understood. The factors that influence a patient's decision warrant discussion pre-implant. It is imperative that patients comprehend the meaning of ICD candidacy to make an informed decision. Participants did not recall alternatives to receiving ICD therapy.

Perceived self-efficacy and empowerment in patients at increased risk of sudden cardiac arrest.

Background: The role of multidisciplinary clinics for psychosocial care is increasingly recognized for those living with inherited cardiac conditions (ICC). In Canada, access to healthcare providers differ between clinics. Little is known about the relationship between access to specialty care and a patient's ability to cope with, and manage their condition. Methods: We leveraged the Hearts in Rhythm Organization (HiRO) to conduct a cross-sectional, community-based survey of individuals with ICC and their family members. We aimed to describe access to services, and explore the relationships between participants' characteristics, cardiac history and self-reported health status and self-efficacy (GSE: General Self-Efficacy Scale) and empowerment (GCOS-24: Genetic Counseling Outcome Scale). Results: We collected 235 responses from Canadian participants in 10 provinces and territories. Overall, 63% of participants reported involvement of a genetic counsellor in their care. Access to genetic testing was associated with greater empowerment [mean GCOS-24: 121.14 (SD = 20.53) vs. 105.68 (SD = 21.69); p = 0.004]. Uncertain genetic test results were associated with lower perceived self-efficacy (mean GSE: uncertain = 28.85 vs. positive = 33.16, negative = 34.13; p = 0.01). Low global mental health scores correlated with both lower perceived self-efficacy and empowerment scores, with only 11% of affected participants reporting involvement of psychology services in their care. Conclusion: Differences in resource accessibility, clinical history and self-reported health status impact the perceived self-efficacy and empowerment of patients with ICC. Future research evaluating interventions to improve patient outcomes is recommended.

Readability and content of patient education material related to implantable cardioverter defibrillators.

BACKGROUND: Implantable cardioverter defibrillators (ICDs) are increasingly offered to patients for primary prevention of sudden cardiac death. Candidates for ICD receive ICD-related patient education material when they make decisions to consent or decline a primary prevention ICD. Printed patient education material directed at ICD candidates has not been the focus of direct appraisal. OBJECTIVE: We evaluated the readability and content of ICD-related print education materials made available to patients who were enrolled in a study involving patient decision making for ICD from 3 ICD sites in southern Ontario, Canada. METHODS: All ICD print materials referred to during interviews and/or that were available in ICD site waiting rooms were collected for analysis. Readability testing was conducted using the "simple measurement of gobbledygook" and Fry methods. The material was evaluated according to selected plain-language criteria, thematic content analysis, and rhetoric analysis. RESULTS: Twenty-one print materials were identified and analyzed. Documents were authored by device manufacturers, tertiary care hospitals, and cardiac support organizations. Although many documents adhered to plain-language recommendations, text-reading levels were higher than recommended. Twelve major content themes were identified. Content focused heavily on the positive aspects of living with the device to the exclusion of other possible information that could be relevant to the decisions that patients made. CONCLUSIONS: Print-based patient education materials for ICD candidates are geared to a highly literate population. The focus on positive information to the exclusion of potentially negative aspects of the ICD, or alternatives to accepting 1, could influence and/or confuse patients about the purpose and implications of this medical device. Development of print materials is indicated that includes information about possible problems and that would be relevant for the multicultural and debilitated population who may require ICDs. The findings are highly relevant for nurses who care for primary prevention ICD candidates.