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Congenital heart disease (CHD) comprises a range of structural anomalies, each with a unique natural history, evolving treatment strategies, and distinct long-term consequences. Current prediction models are challenged by generalizability, limited validation, and questionable application to extended follow-up periods. In this JACC Scientific Statement, we tackle the difficulty of risk measurement across the lifespan. We appraise current and future risk measurement frameworks and describe domains of risk specific to CHD. Risk of adverse outcomes varies with age, sex, genetics, era, socioeconomic status, behavior, and comorbidities as they evolve through the lifespan and across care settings. Emerging technologies and approaches promise to improve risk assessment, but there is also need for large, longitudinal, representative, prospective CHD cohorts with multidimensional data and consensus-driven methodologies to provide insight into time-varying risk. Communication of risk, particularly with patients and their families, poses a separate and equally important challenge, and best practices are reviewed.
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Cardiopatias Congênitas , Humanos , Cardiopatias Congênitas/epidemiologia , Medição de Risco/métodos , Fatores de RiscoRESUMO
Background: The identification of low-voltage proarrhythmic areas for catheter ablation of scar-mediated ventricular tachycardia (VT) remains challenging. Integration of myocardial perfusion imaging (single-photon emission computed tomography/computed tomography; SPECT/CT) and electroanatomical mapping (EAM) may improve delineation of the arrhythmogenic substrate. Objective: To assess the feasibility of SPECT/CT image integration with voltage maps using the EnSite Precision system (Abbott) in patients undergoing scar-mediated VT ablation. Methods: Patients underwent SPECT/CT imaging prior to left ventricular (LV) EAM with the EnSite Precision mapping system. The SPECT/CT, EAM data, and ablation lesions were retrospectively co-registered in the EnSite Precision system and exported for analysis. Segmental tissue viability scores were calculated based on SPECT/CT perfusion and electrogram bipolar voltage amplitude. Concordance, specificity, and sensitivity between the 2 modalities as well as the impact of SPECT/CT spatial resolution were evaluated. Results: Twenty subjects (95% male, 67 ± 7 years old, left ventricular ejection fraction 36% ± 11%) underwent EAM and SPECT/CT integration. A concordance of 70% was found between EAM and SPECT/CT for identification of cardiac segments as scar vs viable, with EAM showing a 68.5% sensitivity and 76.4% specificity when using SPECT/CT as a gold standard. Projection on low-resolution 3D geometries led to an average decrease of 38% ± 22% of the voltage points used. Conclusion: The study demonstrated the feasibility of integrating SPECT/CT with EAM performed retrospectively for characterization of anatomical substrates during VT ablation procedures.
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BACKGROUND: Various noninvasive intermittent rhythm monitoring strategies have been used to assess arrhythmia recurrences in trials evaluating pharmacological and invasive therapeutic interventions for atrial fibrillation (AF). We determined whether a frequency and duration of noninvasive rhythm monitoring could be identified that accurately detects arrhythmia recurrences and approximates the AF burden derived from continuous monitoring using an implantable cardiac monitor (ICM). METHODS: The rhythm history of 346 patients enrolled in the CIRCA-DOSE trial (Cryoballoon Versus Contact-Force Irrigated Radiofrequency Catheter Ablation) was reconstructed. Using computer simulations, we evaluated event-free survival, sensitivity, negative predictive value, and AF burden of a range of noninvasive monitoring strategies, including those used in contemporary AF ablation trials. RESULTS: A total of 126 290 monitoring days were included in the analysis. At 12 months, 164 patients experienced atrial arrhythmia recurrence as documented by the ICM (1-year event-free survival, 52.6%). Most noninvasive monitoring strategies used in AF ablation trials had poor sensitivity for detecting arrhythmia recurrence. Sensitivity increased with the intensity of monitoring, with serial (3) short-duration monitors (24-/48-hour ECG monitors) missing a substantial proportion of recurrences (sensitivity, 15.8% [95% CI, 8.9%-20.7%] and 24.5% [95% CI, 16.2%-30.6%], respectively). Serial (3) longer-term monitors (14-day ECG monitors) more closely approximated the gold standard ICM (sensitivity, 64.6% [95% CI, 53.6%-74.3%]). AF burden derived from short-duration monitors significantly overestimated the true AF burden in patients with recurrences. Increasing monitoring duration resulted in improved correlation and concordance between noninvasive estimates of the invasive AF burden (R2 = 0.85 and interclass correlation coefficient = 0.91 for serial [3] 14-day ECG monitors versus ICM). CONCLUSIONS: The observed rate of postablation atrial tachyarrhythmia recurrence is highly dependent on the arrhythmia monitoring strategy employed. Between-trial discrepancies in outcomes may reflect different monitoring protocols. On the basis of measures of agreement, serial long-term (7-14 day) intermittent monitors accumulating at least 28 days of annual monitoring provide estimates of AF burden comparable with ICM. However, ICMs outperform intermittent monitoring for arrhythmia detection, and should be considered the gold standard for clinical trials. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01913522.
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Fibrilação Atrial/radioterapia , Ablação por Cateter/métodos , Fibrilação Atrial/mortalidade , Ensaios Clínicos como Assunto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Intervalo Livre de ProgressãoRESUMO
A nation's health and economic development are inextricably and synergistically connected. Stark differences exist between wealthy and developing nations in the use of cardiac implantable electronic devices (CIEDs). Cardiovascular disease is now the leading cause of death in low- and middle-income countries (LMIC), with a significant burden from rhythm-related diseases. As science, technology, education, and regulatory frameworks have improved, CIED recycling for exportation and reuse in LMIC has become possible and primed for widespread adoption. In our manuscript, we outline the science and regulatory pathways regarding CIED reuse. We propose a pathway to advance this technology that includes creating a task force to establish standards for CIED reuse, leveraging professional organizations in areas of need to foster the professional skills for CIED reuse, collaborating with regulatory agencies to create more efficient regulatory expectations and bring the concept to scale, and establishing a global CIED reuse registry for quality assurance and future science.
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BACKGROUND: We compared physical functioning, mental health, and quality of life (QoL) of patients with different subtypes of congenital heart disease (CHD) in a large international sample and investigated the role of functional class in explaining the variance in outcomes across heart defects. METHODS: In the cross-sectional Assessment of Patterns of Patient-Reported Outcome in Adults with Congenital Heart Disease-International Study (APPROACH-IS), we enrolled 4028 adult patients with CHD from 15 countries. Diagnostic groups with at least 50 patients were included in these analyses, yielding a sample of 3538 patients (median age: 32 years; 52% women). Physical functioning, mental health, and QoL were measured with the SF-12 health status survey, Hospital Anxiety and Depression Scale (HADS), linear analog scale (LAS) and Satisfaction with Life Scale, respectively. Functional class was assessed using the patient-reported New York Heart Association (NYHA) class. Multivariable general linear mixed models were applied to assess the relationship between the type of CHD and patient-reported outcomes, adjusted for patient characteristics, and with country as random effect. RESULTS: Patients with coarctation of the aorta and those with isolated aortic valve disease reported the best physical functioning, mental health, and QoL. Patients with cyanotic heart disease or Eisenmenger syndrome had worst outcomes. The differences were statistically significant, above and beyond other patient characteristics. However, the explained variances were small (0.6% to 4.1%) and decreased further when functional status was added to the models (0.4% to 0.9%). CONCLUSIONS: Some types of CHD predict worse patient-reported outcomes. However, it appears that it is the functional status associated with the heart defect rather than the heart defect itself that shapes the outcomes.
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Estado Funcional , Saúde Global/estatística & dados numéricos , Cardiopatias Congênitas , Saúde Mental , Medidas de Resultados Relatados pelo Paciente , Qualidade de Vida , Adulto , Assistência ao Convalescente/estatística & dados numéricos , Correlação de Dados , Estudos Transversais , Feminino , Disparidades nos Níveis de Saúde , Cardiopatias Congênitas/classificação , Cardiopatias Congênitas/epidemiologia , Cardiopatias Congênitas/psicologia , Cardiopatias Congênitas/terapia , Humanos , Masculino , Desempenho Físico FuncionalRESUMO
AIMS: In the randomized, placebo-controlled Colchicine Cardiovascular Outcomes Trial (COLCOT) of 4745 patients enrolled within 30 days after myocardial infarction (MI), low-dose colchicine (0.5 mg once daily) reduced the incidence of the primary composite endpoint of cardiovascular death, resuscitated cardiac arrest, MI, stroke, or urgent hospitalization for angina leading to coronary revascularization. To assess the in-trial period and lifetime cost-effectiveness of low-dose colchicine therapy compared to placebo in post-MI patients on standard-of-care therapy. METHODS AND RESULTS: A multistate Markov model was developed incorporating the primary efficacy and safety results from COLCOT, as well as healthcare costs and utilities from the Canadian healthcare system perspective. All components of the primary outcome, non-cardiovascular deaths, and pneumonia were included as health states in the model as both primary and recurrent events. In the main analysis, a deterministic approach was used to estimate the incremental cost-effectiveness ratio (ICER) for the trial period (24 months) and lifetime (20 years). Over the in-trial period, the addition of colchicine to post-MI standard-of-care treatment decreased the mean overall per-patient costs by 47%, from $502 to $265 Canadian dollar (CAD), and increased the quality-adjusted life years (QALYs) from 1.30 to 1.34. The lifetime per-patient costs were further reduced (69%) and QALYs increased with colchicine therapy (from 8.82 to 11.68). As a result, both in-trial and lifetime ICERs indicated colchicine therapy was a dominant strategy. CONCLUSION: Cost-effectiveness analyses indicate that the addition of colchicine to standard-of-care therapy after MI is economically dominant and therefore generates cost savings.
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Colchicina , Infarto do Miocárdio , Canadá/epidemiologia , Colchicina/uso terapêutico , Análise Custo-Benefício , Humanos , Infarto do Miocárdio/complicações , Infarto do Miocárdio/tratamento farmacológico , Anos de Vida Ajustados por Qualidade de VidaRESUMO
BACKGROUND: Contemporary guidelines recommend that atrial fibrillation (AF) be classified into paroxysmal and persistent AF based on clinical assessment, with these categorizations forming the basis of therapeutic recommendations. While pragmatic, clinical assessment may introduce misclassification errors, which may impact treatment decisions. We sought to determine the relationship between AF classification, baseline AF burden, and post-ablation arrhythmia outcomes. DESIGN: The current study is a sub-analysis of a prospective, parallel-group, multicenter, single-blinded randomized clinical trial. All 346 patients enrolled in CIRCA-DOSE received an implantable cardiac monitor a median of 72 days prior to ablation. AF was classified as low burden paroxysmal, high burden paroxysmal, or persistent based on clinical assessment prior to device implantation. Prior to ablation patients were re-classified using the same definitions based on device monitoring data. Correlation between classifications, AF burden, and post-ablation arrhythmia outcomes were assessed. RESULTS: There was poor agreement between clinical and device-based AF classification (Cohen's kappa: 0.192). AF classification derived from pre-ablation continuous monitoring reflected baseline and post-ablation AF burden with greater accuracy and with less overlap between the AF classes (P < 0.01 for all categorical comparisons). Patients objectively classified as "Low Burden" paroxysmal by continuous monitoring data had significantly greater freedom from recurrent AF/AT/AFL compared to those classified as "High Burden" paroxysmal (hazard ratio [HR] 0.57 for AF/AT/AFL recurrence) or persistent AF (HR 0.19 for AF/AT/AFL recurrence). CONCLUSIONS: Classification of AF pattern based on pre-ablation continuous cardiac rhythm monitoring better predicted AF burden and freedom from recurrent AF post ablation. Despite the use of standardized definitions, classification of AF based on clinical assessment did not predict baseline AF burden, post ablation AF burden, or freedom from recurrent AF post ablation. TRIAL REGISTRATION: ClinicalTrials.govNCT01913522.
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Fibrilação Atrial , Ablação por Cateter , Veias Pulmonares , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/cirurgia , Eletrocardiografia , Humanos , Estudos Prospectivos , Veias Pulmonares/cirurgia , Recidiva , Resultado do TratamentoRESUMO
Arrhythmias are a leading cause of morbidity in adults with congenital heart disease. Numerous challenges to managing arrhythmias include vascular access issues, intracardiac shunts, unconventional locations of the conduction system, and anatomical complexities. Technological advances are improving our ability to diagnose and treat arrhythmias. Implantable loop recorders and various technologies developed for consumers to record electrocardiographic tracings using smartphone applications, watches, and dedicated portable devices are expanding our armamentarium of diagnostic tools. Remote magnetic-guided catheter ablation is enhancing access to otherwise difficult to reach arrhythmia substrates. Cryoablation allows perinodal arrhythmias to be safely treated in patients with displaced or difficult to predict locations of the atrioventricular conduction system. Interventions that minimize radiation exposure to near 0 levels are gaining interest and pulmonary vein isolation procedures to treat atrial fibrillation are increasingly performed. Cardiac implantable electronic devices compatible with magnetic resonance imaging have become the norm. Subcutaneous defibrillators and leadless pacemakers are providing effective solutions to patients in whom transvenous leads are contraindicated or not desired. His-bundle pacing is emerging as a viable option to provide more physiological pacing. Progressive advances in multicomponent communicating leadless devices carry the promise of providing leadless dual chamber pacing and cardiac resynchronization therapy in the near future. The safety of transvenous lead extraction procedures is likely to improve with advances such as the low-pressure balloon to manage superior vena cava lacerations. Awareness of these developments and referral to sites with dedicated expertise could contribute to further improving outcomes in adults with congenital heart disease.
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Arritmias Cardíacas/epidemiologia , Arritmias Cardíacas/terapia , Tecnologia Biomédica/tendências , Terapia de Ressincronização Cardíaca/métodos , Cardiopatias Congênitas/epidemiologia , Tecnologia de Sensoriamento Remoto/métodos , Adulto , Arritmias Cardíacas/diagnóstico por imagem , Procedimentos Cirúrgicos Cardíacos/métodos , Comorbidade , Gerenciamento Clínico , Feminino , Previsões , Cardiopatias Congênitas/diagnóstico por imagem , Cardiopatias Congênitas/cirurgia , Humanos , Masculino , Melhoria de Qualidade , Medição de Risco , Análise de SobrevidaRESUMO
BACKGROUND: Conflicting results have been reported regarding employment status and work ability in adults with congenital heart disease (CHD). Since this is an important determinant for quality of life, we assessed this in a large international adult CHD cohort. METHODS: Data from 4028 adults with CHD (53% women) from 15 different countries were collected by a uniform survey in the cross-sectional APPROACH International Study. Predictors for employment and work limitations were studied using general linear mixed models. RESULTS: Median age was 32 years (IQR 25-42) and 94% of patients had at least a high school degree. Overall employment rate was 69%, but varied substantially among countries. Higher education (OR 1.99-3.69) and having a partner (OR 1.72) were associated with more employment; female sex (OR 0.66, worse NYHA functional class (OR 0.67-0.13), and a history of congestive heart failure (OR 0.74) were associated with less employment. Limitations at work were reported in 34% and were associated with female sex (OR 1.36), increasing age (OR 1.03 per year), more severe CHD (OR 1.31-2.10), and a history of congestive heart failure (OR 1.57) or mental disorders (OR 2.26). Only a university degree was associated with fewer limitations at work (OR 0.62). CONCLUSIONS: There are genuine differences in the impact of CHD on employment status in different countries. Although the majority of adult CHD patients are employed, limitations at work are common. Education appears to be the main predictor for successful employment and should therefore be encouraged in patients with CHD.
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Efeitos Psicossociais da Doença , Escolaridade , Emprego , Cardiopatias Congênitas/epidemiologia , Qualidade de Vida , Adulto , Estudos Transversais , Avaliação da Deficiência , Feminino , Nível de Saúde , Inquéritos Epidemiológicos , Cardiopatias Congênitas/diagnóstico , Cardiopatias Congênitas/terapia , Humanos , Descrição de Cargo , Masculino , Prognóstico , Fatores de Risco , Avaliação da Capacidade de Trabalho , Adulto JovemRESUMO
AIMS: Geographical differences in patient-reported outcomes (PROs) of adults with congenital heart disease (ConHD) have been observed, but are poorly understood. We aimed to: (1) investigate inter-country variation in PROs in adults with ConHD; (2) identify patient-related predictors of PROs; and (3) explore standard of living and healthcare system characteristics as predictors of PROs. METHODS AND RESULTS: Assessment of Patterns of Patient-Reported Outcomes in Adults with Congenital Heart disease - International Study (APPROACH-IS) was a cross-sectional, observational study, in which 4028 patients from 15 countries in 5 continents were enrolled. Self-report questionnaires were administered: patient-reported health (12-item Short Form Health Survey; EuroQOL-5D Visual Analog Scale); psychological functioning (Hospital Anxiety and Depression Scale); health behaviors (Health Behavior Scale-Congenital Heart Disease) and quality of life (Linear Analog Scale for quality of life; Satisfaction With Life Scale). A composite PRO score was calculated. Standard of living was expressed as Gross Domestic Product per capita and Human Development Index. Healthcare systems were operationalized as the total health expenditure per capita and the overall health system performance. Substantial inter-country variation in PROs was observed, with Switzerland having the highest composite PRO score (81.0) and India the lowest (71.3). Functional class, age, and unemployment status were patient-related factors that independently and consistently predicted PROs. Standard of living and healthcare system characteristics predicted PROs above and beyond patient characteristics. CONCLUSIONS: This international collaboration allowed us to determine that PROs in ConHD vary as a function of patient-related factors as well as the countries in which patients live.
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Atenção à Saúde/normas , Cardiopatias Congênitas/epidemiologia , Internacionalidade , Medidas de Resultados Relatados pelo Paciente , Fatores Socioeconômicos , Adulto , Estudos Transversais , Atenção à Saúde/métodos , Feminino , Cardiopatias Congênitas/diagnóstico , Cardiopatias Congênitas/terapia , Humanos , Masculino , Autorrelato/normasRESUMO
BACKGROUND: The effect of frailty on outcomes after transcatheter aortic valve replacement (TAVR) remains incompletely understood. The objective of this study was to evaluate the performance of four commonly used frailty markers as predictors of early and late outcomes among patients undergoing TAVR. METHODS: A review was performed of 361 high- and extreme-risk patients undergoing TAVR from 2011 to 2015. Four frailty variables were assessed: serum albumin (g/dL), 5-m walk (seconds), grip strength (kg), and Katz index of independence in activities of daily living. Logistic regression was used to examine the association between the frailty indicators and 30-day composite of mortality, stroke, new heart block requiring permanent pacemaker, major or life-threatening bleeding, acute renal failure, major vascular complication, and 30-day readmission rate. Minimum distance to the perfect point (0, 1) was performed to delineate a cutoff point for each frailty indicator, and risk models were compared using receiver-operating characteristics curves. RESULTS: The composite of outcomes occurred in 28% of patients. Serum albumin, activities of daily living, and 5-m walk were independent predictors for 30-day composite outcomes, but only albumin was predictive of 30-day mortality. A new frailty model (four frailty indicators, age, and sex) to predict 30-day mortality was created and compared with The Society of Thoracic Surgeons predicted risk of mortality. Better discrimination was found with the new frailty model (area under the curve 0.74 versus 0.58). New individual frailty variable cutoff values were found to predict our composite of events. CONCLUSIONS: Among high- and extreme-risk patients undergoing TAVR, our new frailty model was more discriminative of 30-day mortality than The Society of Thoracic Surgeons predicted risk of mortality. New cutoff values for frailty indicators were identified and will require further validation.
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Estenose da Valva Aórtica/cirurgia , Fragilidade , Seleção de Pacientes , Substituição da Valva Aórtica Transcateter , Atividades Cotidianas , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/mortalidade , Tolerância ao Exercício , Feminino , Força da Mão , Humanos , Modelos Logísticos , Masculino , Estudos Retrospectivos , Medição de Risco , Albumina Sérica/metabolismo , Resultado do TratamentoRESUMO
BACKGROUND: Mitral regurgitation (MR) is a common valvular heart disorder requiring intervention once it becomes severe. Transcatheter mitral repair with the MitraClip device is a safe and effective therapy for selected patients denied surgery. The authors sought to evaluate the clinical outcomes and economic impact of this therapy compared to medical management in heart-failure patients with symptomatic mitral regurgitation. METHODS AND RESULTS: The study was comprised of two phases; an observational study of patients with heart failure and mitral regurgitation treated with either medical therapy or the MitraClip, and an economic model. Results of the observational study were used to estimate parameters for the decision model, which estimated costs, and benefits in a hypothetical cohort of patients with heart failure and moderate-to-severe mitral regurgitation treated with either standard medical therapy or MitraClip. The cohort of patients treated with the MitraClip was propensity matched to a population of heart failure patients, and their outcomes compared. At a mean follow-up of 22 months, all-cause mortality was 21% in the MitraClip cohort and 42% in the medical management cohort (p = .007). The decision model demonstrated that MitraClip increased life expectancy from 1.87-3.60 years and quality-adjusted life years (QALY) from 1.13-2.76 years. The incremental cost was $52,500 Canadian dollars, corresponding to an incremental cost-effectiveness ratio (ICER) of $32,300.00 per QALY gained. Results were sensitive to the survival benefit. CONCLUSION: In heart failure patients with symptomatic moderate-severe mitral regurgitation, therapy with the MitraClip is associated with superior survival and is cost-effective compared to medical therapy.
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Custos de Cuidados de Saúde , Insuficiência Cardíaca/cirurgia , Implante de Prótese de Valva Cardíaca/economia , Valva Mitral/cirurgia , Resultado do Tratamento , Idoso , Canadá , Análise Custo-Benefício , Feminino , Custos de Cuidados de Saúde/estatística & dados numéricos , Recursos em Saúde/economia , Recursos em Saúde/estatística & dados numéricos , Insuficiência Cardíaca/economia , Humanos , Masculino , Pessoa de Meia-Idade , Modelos Econômicos , Estudos Prospectivos , Anos de Vida Ajustados por Qualidade de VidaRESUMO
The number of adults with congenital heart disease (CHD) has increased markedly over the past few decades as a result of astounding successes in pediatric cardiac care. Nevertheless, it is now well understood that CHD is not cured but palliated, such that life-long expert care is required to optimize outcomes. All countries in the world that experience improved survival in CHD must face new challenges inherent to the emergence of a growing and aging CHD population with changing needs and medical and psychosocial issues. Founded in 1992, the International Society for Adult Congenital Heart Disease (ISACHD) is the leading global organization of professionals dedicated to pursuing excellence in the care of adults with CHD worldwide. Recognizing the unique and varied issues involved in caring for adults with CHD, ISACHD established a task force to assess the current status of care for adults with CHD across the globe, highlight major challenges and priorities, and provide future direction. The writing committee consisted of experts from North America, South America, Europe, South Asia, East Asia, and Oceania. The committee was divided into subgroups to review key aspects of adult CHD (ACHD) care. Regional representatives were tasked with investigating and reporting on relevant local issues as accurately as possible, within the constraints of available data. The resulting ISACHD position statement addresses changing patterns of worldwide epidemiology, models of care and organization of care, education and training, and the global research landscape in ACHD.
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Saúde Global , Cardiopatias Congênitas , Administração dos Cuidados ao Paciente , Sociedades Médicas , Adulto , Criança , Saúde Global/estatística & dados numéricos , Saúde Global/tendências , Cardiopatias Congênitas/epidemiologia , Cardiopatias Congênitas/terapia , Humanos , Administração dos Cuidados ao Paciente/métodos , Administração dos Cuidados ao Paciente/organização & administração , Administração dos Cuidados ao Paciente/tendênciasRESUMO
BACKGROUND: Data on patient-reported outcomes (PROs) in adults with congenital heart disease (CHD) are inconsistent and vary across the world. Better understanding of PROs and their differences across cultural and geographic barriers can best be accomplished via international studies using uniform research methods. The APPROACH-IS consortium (Assessment of Patterns of Patient-Reported Outcomes in Adults with Congenital Heart disease - International Study) was created for this purpose and investigates PROs in adults with CHD worldwide. This paper outlines the project rationale, design, and methods. METHODS/DESIGN: APPROACH-IS is a cross-sectional study. The goal is to recruit 3500-4000 adults with CHD from 15 countries in five major regions of the world (Asia, Australia, Europe, North and South America). Self-report questionnaires are administered to capture information on PRO domains: (i) perceived health status (12-item Short-form Health Survey & EuroQOL-5D); (ii) psychological functioning (Hospital Anxiety and Depression Scale); (iii) health behaviors (Health-Behavior Scale-Congenital Heart Disease); and (iv) quality of life (Linear Analog Scale & Satisfaction With Life Scale). Additionally, potential explanatory variables are assessed: (i) socio-demographic variables; (ii) medical history (chart review); (iii) sense of coherence (Orientation to Life Questionnaire); and (iv) illness perceptions (Brief Illness Perception Questionnaire). Descriptive analyses and multilevel models will examine differences in PROs and investigate potential explanatory variables. DISCUSSION: APPROACH-IS represents a global effort to increase research understanding and capacity in the field of CHD, and will have major implications for patient care. Results will generate valuable information for developing interventions to optimize patients' health and well-being. REGISTRATION: ClinicalTrials.gov: NCT02150603.
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Cardiopatias Congênitas/diagnóstico , Cardiopatias Congênitas/epidemiologia , Internacionalidade , Autorrelato , Adulto , Estudos Transversais , Feminino , Cardiopatias Congênitas/terapia , Humanos , Masculino , Projetos de Pesquisa/normas , Autorrelato/normas , Resultado do TratamentoAssuntos
Arritmias Cardíacas/epidemiologia , Arritmias Cardíacas/terapia , Cardiopatias Congênitas/epidemiologia , Arritmias Cardíacas/diagnóstico , Arritmias Cardíacas/prevenção & controle , Terapia de Ressincronização Cardíaca , Ablação por Cateter , Comorbidade , Desfibriladores Implantáveis , Técnicas Eletrofisiológicas Cardíacas , Acessibilidade aos Serviços de Saúde , Cardiopatias Congênitas/diagnóstico , Cardiopatias Congênitas/cirurgia , Humanos , Marca-Passo ArtificialRESUMO
Pharmacological treatment of atrial fibrillation in the context of heart failure poses numerous challenges. Management decisions are limited by contraindications to several drugs and the paucity of robust clinical trials that provide evidence-based guidance. This review proposes a structured action plan for managing atrial fibrillation coexisting with heart failure that considers published clinical guidelines and integrates recent data derived from substudies of randomized trials, including the atrial fibrillation and congestive heart failure (AF-CHF) trial. Areas of uncertainty, such as target heart rates in atrial fibrillation and upstream therapies, are also discussed.
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Antiarrítmicos , Fibrilação Atrial/tratamento farmacológico , Insuficiência Cardíaca/tratamento farmacológico , Antiarrítmicos/classificação , Antiarrítmicos/farmacologia , Fibrilação Atrial/complicações , Fibrilação Atrial/fisiopatologia , Contraindicações , Insuficiência Cardíaca/complicações , Insuficiência Cardíaca/fisiopatologia , Frequência Cardíaca/efeitos dos fármacos , Humanos , Conduta do Tratamento Medicamentoso , Avaliação de Resultados em Cuidados de Saúde , Guias de Prática Clínica como Assunto , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
BACKGROUND: Atrial fibrillation (AF) is common in patients with heart failure. Rhythm- and rate-control strategies are associated with similar efficacy outcomes. We compared the economic impact of the 2 treatment strategies in patients with AF and heart failure from the province of Québec, Canada. METHODS: In a substudy of the Atrial Fibrillation and Congestive Heart Failure trial, health care expenditures of patients from Québec randomized to rhythm and rate-control treatment strategies were compared from a single-payer perspective using a cost-minimization approach. In-trial resource utilization and unit costs were estimated from Québec Health Insurance Board databases supplemented by disease-specific costs from the Ontario Case Costing Initiative. RESULTS: In all, 304 patients were included, aged 68 ± 9 years; 86% male; ejection fraction, 26% ± 6%. Baseline characteristics were similar in rhythm-control (n = 149) and rate-control (n = 155) groups. Arrhythmia-related costs accounted for 45% of total expenditures. Rate-control patients had fewer cardiac procedures (146 vs. 238, P < 0.001), driven by fewer cardioversions, and lower costs related to antiarrhythmic drugs (CAD $48 per patient [95% confidence interval {CI}, $21-$96] vs. $1319 per patient [95% CI, $1124-$1522]). However, these differences were offset by higher expenditures due to hospitalizations for noncardiovascular diagnoses, implantable cardiac arrhythmia devices, and noncardiovascular drugs in the rate-control group. The total cost per patient was not significantly different between rhythm-control ($72,764 [95% CI, $61,575-$85,145]) and rate-control ($78,767 [95% CI, $67,101-$92,139]) strategies. CONCLUSION: In the study population, the therapeutic strategy used to manage AF in patients with severe heart failure appears to have little influence on the overall financial burden, which remains substantial.
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Fibrilação Atrial/terapia , Fármacos Cardiovasculares/economia , Cardioversão Elétrica/economia , Insuficiência Cardíaca/terapia , Custos Hospitalares/estatística & dados numéricos , Guias de Prática Clínica como Assunto , Idoso , Fibrilação Atrial/complicações , Fibrilação Atrial/economia , Fármacos Cardiovasculares/uso terapêutico , Análise Custo-Benefício , Feminino , Insuficiência Cardíaca/complicações , Insuficiência Cardíaca/economia , Humanos , Masculino , QuebequeRESUMO
OBJECTIVES: Efforts to improve care for adult congenital heart disease (ACHD) patients necessitates collection of accurate, detailed, longitudinal data. We sought to document what electronic health record systems are currently available at ACHD centers and to assess national interest in a uniform ACHD-focused system. DESIGN: Directors of ACHD centers in the United States were invited to complete an online questionnaire regarding current health information systems at their institution both for general cardiology and for ACHD. Topics that were surveyed included utility and perceived limitations of currently available systems. The survey also assessed the level of interest in an ACHD-specific system, and its optimal functions. RESULTS: Thirty-four centers responded, representing both pediatric and adult institutions that care for patients with ACHD. Of these, 80% reported using a variety of commercially supported electronic medical record products, whereas only 50% employed an ACHD-specific noncommercial database to supplement their institutional system. Comparison of the two systems revealed that most clinical activities are pursued through the institutional electronic medical record system. Research and tracking of clinical activities were the primary uses of ACHD-specific systems, which have several noted limitations. Strong interest in an integrated ACHD-specific system was found among responders. CONCLUSIONS: There is both an unmet need and a strong interest in an ACHD-oriented electronic health record that could facilitate research, outcome tracking, quality assurance, and inter-institutional collaboration, all functions that are lacking in electronic health systems currently in use.
Assuntos
Registros Eletrônicos de Saúde , Pesquisa sobre Serviços de Saúde , Cardiopatias Congênitas/terapia , Sistemas de Informação , Academias e Institutos , Adulto , Criança , Comportamento Cooperativo , Mineração de Dados , Bases de Dados Factuais , Registros Eletrônicos de Saúde/normas , Cardiopatias Congênitas/diagnóstico , Humanos , Sistemas de Informação/normas , Relações Interinstitucionais , Internet , Avaliação de Processos e Resultados em Cuidados de Saúde , Garantia da Qualidade dos Cuidados de Saúde , Inquéritos e Questionários , Estados UnidosRESUMO
BACKGROUND: In 2003, a satellite cardiac surgery program (SAT) was implemented at an affiliated community hospital located in an area historically served by an academic medical center (AMC). This study assessed the financial consequences and the changes in case-mix that occurred at the AMC after SAT implementation. METHODS: From June 2002 through December 2005, 4593 adult patients underwent cardiac operations at the AMC. Excluded were 400 patients operated on during the 4-month transition period after SAT implementation and 1210 patients living more than 35 miles from the AMC. Multivariable regression was used to compare changes in case-mix and propensity-score adjusted costs for AMC patients referred from SAT area (N(before/after =) 328/291) vs other patients (N(before/after =) 897/1467). RESULTS: The SAT area referral rate decreased by 55%. Compared with other patients, AMC patients referred from the SAT area showed a greater increase in age in the second period (p = 0.013). The nursing workload and adjusted mean costs increased more for patients from the SAT area (p = 0.015 and 0.014, respectively). The hospital margin decreased in the second period for both referral areas (p < 0.001). For the patient subgroup undergoing coronary artery bypass grafting, this hospital margin decrease was greater for SAT area patients (p = 0.017). CONCLUSIONS: After implementation of SAT program, fewer patients of lower complexity came to the AMC from the SAT area, and there was a significant increase in nursing workload and costs. During this interval, hospital margin for cardiac operations decreased from both referral areas but decreased significantly more for coronary artery bypass graft patients from the SAT area.