Decreased Noise and Identification of Very Low Voltage Signals Using a Novel Electrophysiology Recording System.

Aims: The interpretation of intracardiac electrograms recorded from conventional electrophysiology recording systems is frequently impacted by powerline (50/60 Hz) noise and distortion due to notch filtering. This study compares unipolar electrograms recorded simultaneously from a conventional electrophysiology recording system and one of two 3D mapping systems (control system) with those from a novel system (ECGenius, CathVision ApS) designed to reduce noise without the need for conventional filtering. Methods: Unipolar electrograms were recorded simultaneously from nine consecutive patients undergoing catheter ablation for AF (five patients), atrioventricular nodal re-entrant tachycardia (three patients), or ventricular tachycardia (one patient) over the course of 1 week in 2020. Results: The noise spectral power of the novel system (49-51 Hz) was 6.1 ± 6.2 times lower than that of the control system. Saturation artefact following pacing (duration 97 ± 85 ms) occurred in eight control recordings and no novel system recordings (p<0.001). High frequency, low amplitude signals and fractionated electrograms apparent on unfiltered novel system unipolar recordings were not present on control recordings. Control system notch filtering obscured His bundle electrograms observable without such filtering using the novel system and induced electrogram distortion that was not present on novel system recordings. Signal saturation occurred in five of seven control system recordings but none of the novel system recordings. Conclusion: In this study, novel system recordings exhibited less noise and fewer signal artefacts than the conventional control system and did not require notch filtering that distorted electrograms on control recordings. The novel recording system provided superior electrogram data not apparent with conventional systems.

Validation of the Burden Transfer Inventory-abbreviated and examination across veterinary medicine positions and settings in the United States.

Background: Burden transfer, when veterinary client caregiver burden underlies stressful encounters with providers, elevates risk for occupational distress in veterinary medicine. To date, burden transfer has been primarily examined in veterinarians working in general practice, using methods that are time consuming. The current work validates an abbreviated Burden Transfer Inventory (BTI-A) and explores burden transfer across positions of employment and veterinary settings. Methods: Participants completed online measures of burden transfer, stress and burnout. A BTI-A with items representing each BTI domain was created with an initial validation sample (n = 1151 veterinarians). Confirmatory psychometric analyses were conducted in a cross-validation sample (n = 440 veterinarians and support staff), followed by exploration of the BTI and BTI-A across veterinary settings and position of employment. Results: The BTI-A correlated with the full-length BTI (r = 0.89-0.96) shows good internal consistency (α = 0.72-0.88) and 1-month test-retest reliability (r = 0.69-0.74). The BTI-A correlated significantly (p < 0.001) with stress and burnout. Exploratory comparisons suggested group differences including greater reactivity in general compared to specialty referral/emergency practice (p = 0.02). Conclusion: The BTI-A can be used in place of the original measure when brevity is important. Use of the BTI-A may help guide allied mental health professionals in providing support for wellbeing in veterinary healthcare team members.

Caregiver burden, treatment complexity, and the veterinarian-client relationship in owners of dog with skin disease.

BACKGROUND: Increasing complexity of treatment plans is associated with higher levels of caregiver burden in owners of dogs with skin disease. It is possible that elevated caregiver burden resulting from treatment complexity could, in turn, affect the veterinarian-client relationship. HYPOTHESES/OBJECTIVES: We expected that treatment complexity, caregiver burden, and the client's perception of the veterinarian-client relationship would be related to each other. We also expected an indirect effect of caregiver burden on the cross-sectional association between treatment complexity and the veterinarian-client relationship, and that this effect would be robust to adjustment for the dog's skin disease course and severity. PARTICIPANTS: Participants were 349 owners of dogs with skin disease recruited through online consumer panels. MATERIALS AND METHODS: Cross-sectional online assessments were completed for caregiver burden, treatment plan complexity, veterinarian-client relationship, and skin disease course and severity. Demographic information also was collected. RESULTS: The indirect effect of caregiver burden on the relationship between treatment complexity and veterinarian-client relationship was statistically significant, accounting for 42.76% of the variance in the model. After controlling for disease severity and course, that effect remained statistically significant, accounting for 37.76% of the variance. CONCLUSIONS AND CLINICAL IMPORTANCE: Findings support the notion that greater treatment complexity is related to the owner's perception of the veterinarian-client relationship via caregiver burden. Efforts to reduce caregiver burden by using the simplest effective treatment may benefit the veterinarian-client relationship.

Contexte - La complexité croissante des plans de traitement est associée à des niveaux plus élevés de fardeau pour les soignants propriétaires de chiens atteints de maladies de peau. Il est possible que le fardeau élevé des soignants résultant de la complexité du traitement pourrait, à son tour, affecter la relation vétérinaire-client. Hypothèses/Objectifs - Nous nous attendions à ce que la complexité du traitement, le fardeau des soignants et la perception du client de la relation vétérinaire-client seraient liés les uns aux autres. Nous nous attendions également à un effet indirect de le fardeau du soignant sur l'association transversale entre la complexité du traitement et le vétérinaire-client relation, et que cet effet serait robuste à l'ajustement de l'évolution et de la gravité de la maladie de peau du chien. Participants - Les participants étaient 349 propriétaires de chiens atteints de maladies de la peau recrutés par le biais de consommateurs en ligne panneaux. Matériels et méthodes - Des évaluations transversales en ligne ont été réalisées pour le fardeau des soignants, le traitement la complexité du plan, la relation vétérinaire-client et l'évolution et la gravité des maladies de la peau. Informations démographiques a également été collecté. Résultats - L'effet indirect du fardeau des soignants sur la relation entre la complexité du traitement et le vétérinaire-la relation client était statistiquement significative, représentant 42,76 % de la variance du modèle. Après contrôle pour la gravité et l'évolution de la maladie, cet effet est resté statistiquement significatif, représentant 37,76 % des la variance. Conclusions et importance clinique - Les résultats appuient l'idée qu'une plus grande complexité du traitement est liée à la perception du propriétaire de la relation vétérinaire-client via le fardeau des soignants. Efforts pour réduire le soignant fardeau en utilisant le traitement efficace le plus simple peut être bénéfique pour la relation vétérinaire-client.

Contexto - O aumento da complexidade dos planos de tratamento está associado a altos níveis de sobrecarga do cuidador de cães com doenças de pele. É possível que a sobrecarga do cuidador elevada resultante da complexidade da terapia possa, desta forma, afetar a relação veterinário-cliente. Hipótese/Objetivos - Nós imaginamos que a complexidade do tratamento, a sobrecarga do cuidador, e a percepção do cliente da relação veterinário-cliente estariam relacionadas. Nós também imaginamos que poderia uma mediação da sobrecarga do cuidador na associação transversal entre a complexidade do tratamento e a relação veterinário-cliente, e que este efeito seria robusto para ajustar o curso e a gravidade da doença de pele do cão. Participantes - Os participantes foram 349 tutores de cães com doença de pele recrutados através de formulários online. Materiais e métodos - Avaliações transversais online foram preenchidas para sobrecarga do cuidador, complexidade do plano de tratamento, relação veterinário-cliente, e curso da doença de pele e gravidade. Dados demográficos também foram coletados. Resultados - O efeito indireto da sobrecarga do cuidador na relação entre a complexidade do tratamento e a relação veterinário-cliente foi significativamente significativa, sendo responsável por 42,76% da variância no modelo. Após controlar para gravidade da doença e curso, esse efeito permaneceu estatisticamente significativo, respondendo por 37,76% da variância. Conclusões e importância clínica - Os achados corroboram com a ideia de que a complexidade do tratamento está relacionada à percepção do tutor sobre a relação veterinário-cliente pela sobrecarga do cuidador. Esforços para reduzir a sobrecarga do cuidador utilizando planos terapêuticos mais simples podem beneficiar a relação veterinário-cliente.

Introducción- el aumento de la complejidad de los planes de tratamiento se asocia a mayores niveles de responsabilidad de los propietarios de perros con enfermedades de la piel. Es posible que esta mayor carga para el propietario resultante de la complejidad del tratamiento pueda, a su vez, afectar a la relación veterinario-cliente. Hipótesis/Objetivos- esperábamos que la complejidad del tratamiento, la mayor responsabilidad para cuidadores y la percepción de los propietarios de la relación veterinario-cliente estuvieran relacionadas entre sí. También esperábamos un efecto de mediación de la mayor carga del cuidador en la asociación transversal entre la complejidad del tratamiento y la relación veterinario-cliente, y que este efecto sería sólido para el ajuste del curso y la gravedad de la enfermedad de la piel del perro. Participantes- los participantes fueron 349 propietarios de perros con enfermedades de la piel reclutados a través de paneles de consumidores vía telemática. Materiales y métodos- se completaron evaluaciones transversales en línea sobre la carga del cuidador, la complejidad del plan de tratamiento, la relación veterinario-cliente y el curso y la gravedad de la enfermedad de la piel. También se recopiló información demográfica. Resultados - El efecto indirecto de la carga del cuidador sobre la relación entre la complejidad del tratamiento y la relación veterinario-cliente fue estadísticamente significativo, explicando el 42,76% de la varianza del modelo. Después de controlar la gravedad y el curso de la enfermedad, ese efecto siguió siendo estadísticamente significativo y representó el 37,76 % de la varianza. Conclusiones e importancia clínica- los hallazgos respaldan la noción de que una mayor complejidad del tratamiento está relacionada con la percepción del propietario de la relación veterinario-cliente mediante una mayor carga del cuidador. Esfuerzos para reducir la carga del cuidador mediante el uso de tratamientos efectivos más simples pueden beneficiar a la relación veterinario-cliente.

Owner quality of life, caregiver burden and anticipatory grief: How they differ, why it matters.

BACKGROUND: Understanding client perspective is important for veterinary communications, particularly during problem visits. Key client experiences of caregiver burden, anticipatory grief and quality of life (QoL) have been previously examined in this context, but never simultaneously considered. METHODS: A sample of 393 owners of an elderly or seriously ill companion animal was recruited online to complete cross-sectional measures of psychosocial function, companion animal presentation and demographics. RESULTS: Exploratory factor analysis demonstrated that owner caregiver burden, anticipatory grief and QoL reflect distinct constructs. Cluster analysis showed these experiences occur in four separate owner profiles: 'distressed', 'resilient', 'non-distressed' and owners experiencing strain due to 'other influences'. These groups appear to be differentially influenced by various factors, such as the companion animal's QoL, nature of the illness and the owner's attachment. They also show distinct differences in consideration of euthanasia and emotional functioning, including experience of stress and depressive symptoms. CONCLUSIONS: Constructs of caregiver burden, anticipatory grief and QoL are not interchangeable and may differentially impact owner decisions and behaviour. The veterinarian's understanding of owner profiles relevant to these issues and distinguishing underlying features may foster effective communication.

Treatment complexity and caregiver burden are linked in owners of dogs with allergic/atopic dermatitis.

BACKGROUND: Skin disease severity and treatment plan complexity are both related to owner experience of caregiver burden; however, to date they have not been examined simultaneously in owners of dogs with atopic or other chronic allergic dermatitis. HYPOTHESES/OBJECTIVES: We expected to replicate and extend previous work by showing that caregiver burden is linked to treatment complexity and disease severity in this population. Moreover, we hypothesized that a relationship between burden and treatment complexity would be present in both subjective (owner report of experience) and objective (number of weekly treatments) measures, and that these relationships would exist independent of skin disease severity. PARTICIPANTS: Eighty-six owners of dogs with atopic or other chronic allergic dermatitis recruited through social media dog allergy groups. METHODS AND MATERIALS: Cross-sectional online assessments were completed for caregiver burden, treatment plan complexity and skin disease severity. RESULTS: Caregiver burden was correlated with skin disease severity (r = 0.40) and both subjective (r = 0.37) and objective (r =0.30) measures of treatment complexity (P < 0.01 for all). Relationships between caregiver burden and treatment complexity remained significant after accounting for skin disease severity. CONCLUSIONS AND CLINICAL IMPORTANCE: Greater treatment plan complexity is associated with higher caregiver burden in owners of dogs with atopic or other chronic allergic dermatitis. The independence of this relationship highlights the importance of simplicity in effective treatment planning.

Euthanasia from the Veterinary Client's Perspective: Psychosocial Contributors to Euthanasia Decision Making .

End-of-life decision making for a companion animal relies on the veterinarian acting as educator and counselor. However, little research has been conducted to understand client variables in this context. The current study examined potential client-related contributors to steps taken toward a euthanasia decision. Caregiver burden, anticipatory grief, depression, stress, and income all correlated positively with this outcome. However, when client factors were examined in a regression model controlling for animal quality of life, only caregiver burden and income emerged as significant predictors. All 3 caregiver burden factors: general strain, affective/relational discomfort, and guilt/uncertainty were significantly related to consideration of euthanasia.

Validation of an abbreviated instrument to assess veterinary client caregiver burden.

BACKGROUND: Caregiver burden is present in many clients managing illness in a companion animal, but current assessment tools are time-consuming and lack normative reference values. OBJECTIVES: Statistical reduction of items in a measure of caregiver burden to create an abbreviated version, validation of the abbreviated version, and calculation of reference values. ANIMALS: None. METHODS: This study was conducted using observational methods. Owners of an ill cat or dog were recruited through social media (n = 429). Veterinary clients with an ill (n = 459) or healthy (n = 961) cat or dog were recruited through a general veterinary and an academic hospital with multiple specialties. The study was conducted in 3 stages: (a) reduction of the Zarit Burden Interview (ZBI) adapted for use in pets via factor and item analyses, (b) psychometric validation of the abbreviated instrument, and (c) standardization of the abbreviated (7 items) and full (18 items) measures. RESULTS: A 7-item measure showed high correlations with the full measure (r = 0.88-0.93) and good internal consistency (α = .71-.75) across samples of veterinary clients with an ill cat or dog. This abbreviated measure correlated significantly (P < .001) and positively with stress (r = 0.40-0.75) and negatively with quality of life (r = -0.32 to -0.56). Reference values derived from clients with a healthy companion animal suggest "normal" burden ranges of 0 to 17 on the full measure and 0 to 8 on the abbreviated version. CONCLUSIONS AND CLINICAL IMPORTANCE: For situations precluding full assessment of client caregiver burden, this brief 7-item version can be used with good internal consistency and validity. Reference values can help determine if a client's caregiver burden is increased.

Caregiver Burden and Veterinary Client Well-Being.

This article describes veterinary client caregiver burden, including how it differs from other key client experiences in the palliative care setting. Caregiver burden in human relationships is reviewed. Research examining veterinary client caregiver burden in the context of serious illness (or pet caregiver burden), including the link between pet caregiver burden and client psychosocial well-being, is summarized. Risk factors for development of pet caregiver burden are discussed in the context of beginning to address how it might be reduced or prevented. Finally, suggestions are provided for veterinarians working with clients facing these issues in a palliative care setting.

Assessment of caregiver burden and associations with psychosocial function, veterinary service use, and factors related to treatment plan adherence among owners of dogs and cats.

OBJECTIVE To investigate caregiver burden and its potential associations with psychosocial function and veterinary service use among dog and cat owners and with factors related to treatment plan adherence among owners of animals with chronic or terminal disease. DESIGN Cross-sectional, observational study. SAMPLE 124 clients of a small animal hospital. PROCEDURES Study participants were recruited by email. Owners of sick animals were blindly matched with owners of healthy animals (62/group) by age, gender, and companion animal species. Respondents completed electronic questionnaires related to demographics and previously described measures of caregiver burden, psychosocial function, and treatment plan adherence. Veterinary medical records were reviewed to verify animal health status and assess veterinary service use (billable and nonbillable contacts with veterinary staff) in the 12 months prior to study enrollment. Variables were tested for association by statistical methods. RESULTS Questionnaire scores reflected greater caregiver burden; greater symptoms of depression, anxiety, and stress; and poorer quality of life for respondents with sick animals than for respondents with healthy animals. Greater caregiver burden was associated with scores reflecting poorer psychosocial function and with greater veterinary service use. The number of nonbillable, but not billable, contacts was greater for respondents with high caregiver burden than for those without this finding. Treatment plan factors associated with greater caregiver burden included changes in routine because of the animal's condition and perception that following new rules and routines for management of the condition was challenging. CONCLUSIONS AND CLINICAL RELEVANCE Awareness of potential caregiver burden and psychosocial distress in clients with sick companion animals may help veterinarians identify opportunities for an empathic response. Future research should assess directionality of the relationship between these factors.

Development and validation of a Burden Transfer Inventory for predicting veterinarian stress related to client behavior.

OBJECTIVE To develop and validate a Burden Transfer Inventory (BTI) of stressful client behaviors and to evaluate whether those behaviors are associated with client caregiver burden and contribute to veterinarian stress and burnout. DESIGN 3-stage cross-sectional psychometric validation study. SAMPLE 1,151 small animal veterinarians and 372 dog and cat owners. PROCEDURES During stage 1, a pool of 34 items representing stressful client behaviors was created through open-ended surveys of practicing veterinarians and 3 phases of pilot testing. During stage 2, 1,151 veterinarians recruited through the Veterinary Information Network completed a survey including those behavior items and validated measures of stress and burnout. Completed surveys were randomly assigned to either a measure development or validation database for factor and item analyses. Data were then combined to determine whether the BTI was correlated with measures of stress and burnout. During stage 3, owners of dogs and cats with a serious illness completed an online survey to assess how frequently they engaged in each BTI item as well as a validated measure of caregiver burden. RESULTS For dog and cat owners, there was a significant positive correlation between caregiver burden and the frequency that those owners reported engaging in BTI items. The frequency that veterinarians reported encountering BTI items was positively correlated with measures of stress and burnout, which suggested burden transfer from owners to veterinarians. The extent to which veterinarians reported being bothered by BTI items was a more robust predictor of stress and burnout than the frequency with which those items occurred. CONCLUSIONS AND CLINICAL RELEVANCE Results indicated the BTI can be used to understand how client behaviors associated with caregiver burden affect veterinarian stress and burnout. The BTI may be useful to identify specific stressors affecting individual veterinarians and how they react to those stressors.

Caregiver burden in the veterinary dermatology client: comparison to healthy controls and relationship to quality of life.

BACKGROUND: Skin disease in companion animals often requires long-term management which may contribute to caregiver burden in the dermatology client. HYPOTHESES/OBJECTIVES: We expected greater caregiver burden in dermatology clients relative to healthy control veterinary clients and that no difference would be present between healthy controls and dermatology clients reporting good skin disease control. Within the dermatology sample, we hypothesized that greater caregiver burden would correlate with client perception of the animal's severity of disease (ASD), animal skin disease quality of life (ASD-QoL), and client general quality of life (CG-QoL) and skin disease-related quality of life (CSD-QoL). PARTICIPANTS: Participants were 358 dog owners, including veterinary dermatology clients (n = 152) and healthy general veterinary control clients (n = 206). METHODS AND MATERIALS: Cross-sectional online assessments were completed for client caregiver burden (both samples) and CG-QoL, CSD-QoL, ASD-QoL and ASD (dermatology sample only). RESULTS: Caregiver burden was greater in dermatology clients overall relative to healthy controls (P < 0.001); it was comparable for those reporting good skin disease control (P > 0.05). Within the dermatology group, correlations between caregiver burden and CSD-QoL were high (r = 0.58; P < 0.001). CG-QoL was predicted by caregiver burden (P < 0.001) but not significantly by CSD-QoL (P > 0.05). CONCLUSIONS AND CLINICAL IMPORTANCE: In the presence of good skin disease control, caregiver burden in dermatology clients is as low as general veterinary clients with a healthy dog. Understanding client experiences of companion animal skin disease may be optimized by assessing caregiver burden.

Caregiving for a Companion Animal Compared to a Family Member: Burden and Positive Experiences in Caregivers.

Introduction: Research in human caregiving shows burden is often present in the caregiver and can be reduced by interventions that increase positive perceptions of caregiving. Recent work suggests burden is also present in owners of a seriously ill companion animal. To help determine if findings from the human caregiving literature are likely to generalize to companion animal caregiving, we undertook a comparison of burden and positive aspects of caregiving in these groups. Material and Methods: Caregivers recruited through social media disease support and information groups completed self-report questionnaires of burden and positive aspects of caregiving in an online research protocol. Owners of a seriously ill companion animal (n = 117) and caregivers of a family member with dementia (n = 252) were cross-sectionally compared. Analyses in the full sample were repeated in a subset (n = 75 per group) of caregivers with blindly matched demographic profiles. Results: Burden was elevated in both dementia and companion animal caregiver groups, though higher overall for dementia caregivers (p < 0.001 for full and matched samples). In contrast, greater positive aspects of caregiving were reported by companion animal caregivers (p < 0.001 for full and matched samples). In both groups, positive aspects of caregiving were negatively associated with burden (full sample p < 0.001; matched sample p < 0.05). Exploratory item analyses suggested the two groups show comparable experiences of fearing the future, guilt, and financial strain (p = ns for full and matched sample). Discussion: Although both groups showed elevated burden, companion animal caregivers reported less burden and a more positive appraisal of caregiving. Elements of burden showing similarities across groups provide a foundation for understanding caregiver burden in the companion animal owner. The inverse correlation between positive aspects of caregiving and burden suggests the impact of positive caregiving experiences should be considered in burden interventions, but because companion animal owners already positively appraise caregiving, enhancing positive aspects of caregiving may not offset burden as it does in human caregiving samples.

Caregiver burden in owners of a sick companion animal: a cross-sectional observational study.

Much recent work has focused on occupational stress in veterinary medicine, although little is known about the possible contribution of client-based factors. Clients providing care for a companion animal with protracted illness are likely to experience 'caregiver burden' and reduced psychosocial functioning, which may ultimately lead to increased veterinarian stress. This cross-sectional observational study assessed caregiver burden and psychosocial function in 238 owners of a dog or cat, comparing owners of an animal with chronic or terminal diseases (n=119) with healthy controls blindly matched for owner age/sex and animal species (n=119). Results showed greater burden, stress and symptoms of depression/anxiety, as well as poorer quality of life, in owners of companion animals with chronic or terminal disease (p<0.001 for all). Higher burden was correlated with reduced psychosocial function (p<0.001 for all). Owners of a sick companion animal exhibit elevated caregiver burden, which is linked to poorer psychosocial functioning. This knowledge may help veterinarians understand and more effectively handle client distress in the context of managing the challenges of sick companion animal caregiving. Future work is needed to determine whether clients with this presentation impact veterinarian stress and how burden in this population might be reduced.

Quality of care for sudden cardiac arrest: Proposed steps to improve the translation of evidence into practice.

Sudden cardiac arrest (SCA) is the most common cause of death in the United States. Despite national guidelines, patients at risk for SCA often fail to receive evidence-based therapies. Racial and ethnic minorities and women are at particularly high risk for undertreatment. To address the persistent challenges in improving the quality of care for SCA, the Duke Center for the Prevention of Sudden Cardiac Death at the Duke Clinical Research Institute (Durham, NC) reconvened the Sudden Cardiac Arrest Thought Leadership Alliance. Experts from clinical cardiology, cardiac electrophysiology, health policy and economics, the US Food and Drug Administration, the Centers for Medicare and Medicaid Services, the Agency for Health Care Research and Quality, and device and pharmaceutical manufacturers discussed the development of SCA educational tools for patients and providers, mechanisms of implementing successful tools to help providers identify patients in their practice at risk for SCA, disparities in SCA prevention, and performance measures related to SCA care. This article summarizes the discussions held at this meeting.

A phase III randomized, double-blind, placebo-controlled study of pilocarpine for vaginal dryness: North Central Cancer Treatment group study N04CA.

Vaginal dryness is a common problem for which effective and safe nonestrogenic treatments are needed. Based on preliminary promising data that pilocarpine attenuated vaginal dryness, the current trial was conducted. A double-blind, placebo-controlled, randomized trial design was used to compare pilocarpine, at target doses of 5 mg twice daily and 5 mg four times daily, with a placebo. Vaginal dryness was recorded by patient-completed questionnaires at baseline and weekly for 6 weeks after study initiation. The primary endpoint for this study was the area under the curve summary statistic composed of the longitudinal responses obtained at baseline and through the 6 weeks of treatment to a numerical analogue scale asking patients to rate their perceived amount of vaginal dryness. The primary analysis was carried out by a single t test using a two-side alternative to compare the collective pilocarpine treatment arms with the collective placebo arms. A total of 201 patients enrolled in this trial. The primary analysis, comparing vaginal dryness symptoms in the collective pilocarpine arms against the placebo arm, did not reveal any benefit for the pilocarpine treatment. This finding was confirmed by other secondary analyses. Toxicity evaluation revealed more nausea, sweating, rigors, and urinary frequency with the pilocarpine arms compared with the placebo arm.

Addressing disparities in sudden cardiac arrest care and the underutilization of effective therapies.

Sudden cardiac arrest (SCA) is the most common cause of death in the Unites States. Despite its major impact on public health, significant challenges exist at the patient, provider, public, and policy levels with respect to raising more widespread awareness and understanding of SCA risks, identifying patients at risk for SCA, addressing barriers to SCA care, and eliminating disparities in SCA care and outcomes. To address many of these challenges, the Duke Center for the Prevention of Sudden Cardiac Death at the Duke Clinical Research Institute (Durham, NC) held a think tank meeting on December 7, 2009, convening experts on this issue from clinical cardiology, cardiac electrophysiology, health policy and economics, the US Food and Drug Administration, the Centers for Medicare and Medicaid Services, the Agency for Health Care Research and Quality, and device and pharmaceutical manufacturers. The specific goals of the meeting were to examine existing educational tools on SCA for patients, health care providers, and the public and explore ways to enhance and disseminate these tools; to propose a framework for improved identification of patients at risk of SCA; and to review the latest data on disparities in SCA care and explore ways to reduce these disparities. This article summarizes the discussions that occurred at the meeting.

Impact of implantable cardioverter-defibrillator, amiodarone, and placebo on the mode of death in stable patients with heart failure: analysis from the sudden cardiac death in heart failure trial.

BACKGROUND: The Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) demonstrated that implantable cardioverter-defibrillator (ICD) therapy reduces all-cause mortality in patients with New York Heart Association class II/III heart failure and a left ventricular ejection fraction < or =35% on optimal medical therapy. Whether ICD therapy reduced sudden death caused by ventricular tachyarrhythmias without affecting heart failure deaths in this population is unknown. METHODS AND RESULTS: SCD-HeFT randomized 2521 subjects to placebo, amiodarone, or shock-only, single-lead ICD therapy. Over a median follow-up of 45.5 months, a total of 666 deaths occurred, which were reviewed by an Events Committee and initially categorized as cardiac or noncardiac. Cardiac deaths were further adjudicated as resulting from sudden death presumed to be ventricular tachyarrhythmic, bradyarrhythmia, heart failure, or other cardiac causes. ICD therapy significantly reduced cardiac mortality compared with placebo (adjusted hazard ratio, 0.76; 95% confidence interval, 0.60 to 0.95) and tachyarrhythmia mortality (adjusted hazard ratio, 0.40; 95% confidence interval, 0.27 to 0.59) and had no impact on mortality resulting from heart failure or noncardiac causes. The cardiac and tachyarrhythmia mortality reductions were evident in subjects with New York Heart Association class II but not in subjects with class III heart failure. The reduction in tachyarrhythmia mortality with ICD therapy was similar in subjects with ischemic and nonischemic disease. Compared with placebo, amiodarone had no significant effect on any mode of death. CONCLUSIONS: ICD therapy reduced cardiac mortality and sudden death presumed to be ventricular tachyarrhythmic in SCD-HeFT and had no effect on heart failure mortality. Amiodarone had no effect on all-cause mortality or its cause-specific components, except an increase in non-cardiac mortality in class III patients. [corrected] CLINICAL TRIAL REGISTRATION INFORMATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00000609.