The CARD PORT project is funded by the Agency for Health Care Policy and Research, Grant HSO8362. The principal investigator is Dr. Mark Hlatky, Chair of the Health Research and Policy Department at Stanford University.

General Information

The Cardiac Arrhythmia and Risk of Death Patient Outcomes Research Team (CARD PORT) is a five year project with the overall goal of improving the outcomes of patients with heart disease at risk for sudden cardiac death. Sudden cardiac death due to arrhythmia accounts for half of the more than 700,000 cardiac deaths each year in the U.S. alone. The CARD PORT has been designed to provide insights into the management of patients at risk for sudden cardiac death. While ongoing clinical trials will provide the best efficacy estimates for mortality on promising treatments such as amiodarone and the implantable cardioverter defibrillator (ICD) in specific populations, the CARD PORT study will compare the medical effectiveness of alternative strategies for disease by assessing the effect of these clinical strategies on mortality, morbidity, functional status, quality of life, and cost. By building a solid scientific foundation for the development of recommendations for the prevention of sudden cardiac death, the PORT will contribute to this difficult clinical problem of widespread importance in medical and economic terms.

The PORT consists of six inter-related projects:

1. Determining costs and practice patterns using Medicare claims analysis.
2. Evaluating risk-stratification methods through a case cohort analysis of patients admitted to a coronary care unit in the Seattle area.
3. Using meta-analysis to assess the effect of interventions aimed at cardiac arrhythmia on total mortality and mechanism of death.
4. Assessing the effectiveness of pharmacologic and device therapy on functional status and quality of life through a prospective, longitudinal cohort study.
5. Eliciting patient preferences for treatments and outcomes using survey methods.
6. Constructing screening and treatment decision and cost-effectiveness models synthesizing evidence found through the other projects.

Project 1: Costs and Practice Patterns

The goals of Project 1 are to 1) measure costs over time associated with treatment of patients with cardiac arrhythmias, and 2) characterize practice patterns and outcomes for these patients. The clinically detailed and statistically rigorous analyses of data sets in Project 1 will be particularly important for practice recommendations by documenting costs of alternative management strategies and suggesting the effectiveness of interventions at the population level. Our documentation of variations in management practices across geographic regions or demographic groups should also highlight the areas in which evidence based recommendations could affect arrhythmia management.

Project 2: Clinical Predictors of Sudden Cardiac Death

The specific aim of Project 2 is to identify clinical factors that predict sudden and non-sudden cardiac death in a large cohort of Seattle patients admitted to a coronary care unit (the MITI Registry). The information developed by Project 2 will be of particular value in suggesting methods to identify patients at particular risk of sudden cardiac death in whom interventions such as antiarrhythmic drug therapy (e.g. amiodarone) or ICD implantation might be beneficial.

Project 3: Meta-analysis of the Literature

The goal of project 3 is to use quantitative methods, especially meta-analysis, to summarize information about: 1) the value of risk factors for prediction of SCD in patients with recognized heart disease, and 2) the effectiveness of therapies for the prevention of sudden death. In our initial application, Project 3 proposed to build on previous meta-analyses in this field in two ways: 1) updating analyses of specific anti-arrhythmic therapies as new data became available, and 2) analyzing whether interventions specifically reduce SCD to a greater extent than non-SCD. The information developed by Project 3 will inform policy recommendations by identifying those therapies and testing strategies for which solid evidence indicates clinical value.

Project 4: A Cohort Study of Outcomes

The overall goal of Project 4 is to document a broad array of outcome measures in patients at high risk for sudden cardiac death. To achieve this overall goal, we plan: 1) to follow a cohort of patients with life-threatening ventricular arrhythmias for one to three years, 2) to assess functional status (physical, work-role, emotional, and perceived general health status) depression and anxiety, arrhythmia-related symptoms at six month intervals from the time of identifications and enrollment into the study cohort, 3) to measure and study the determinants of these outcomes, including underlying disease and its severity, comorbid conditions, therapies, diagnostic practices, and patient preferences/values, and 4) to understand selection of treatment and maintenance of treatment as a function of patient role in decision-making, elements of functional status and their "importance" to the patient, and treatment-related symptoms.

Project 4 will provide considerable information about outcome measures that have been either largely neglected in research about patients with cardiac arrhythmias or only examined in patients with ICDs. Data on functional status, quality of life, and cost will provide a broader basis for informed choices among management strategies.

Project 5: Patient Preferences

The broad goal of Project 5 is to collect data in a population of patients at risk for sudden cardiac death on 1) the outcomes patients consider important, and 2) the values and preferences patients hold towards these outcomes. Project 5 will provide information about patients' concerns and values to bear on clinical recommendations about arrhythmia treatment.

Project 6: Decision Modeling

The specific aim of Project 6 is to construct a comprehensive decision model that incorporates evidence about risk assessment, the medical effectiveness of treatment, and data about patient preferences to assist physicians and patients in decisions about prevention and treatment of sudden cardiac death. The decision modeling project has three stages. In Stage I (Years 1 and 2) we are using preliminary decision models to help identify crucial epidemiologic and outcome data needed for the subsequent development of clinical recommendations. In Stage II (Years 3, 4, and 5) we will develop final decision models needed to synthesize the data from Projects 1 through 5, and to develop clinical recommendations. In Stage III (Year 5), we will use decision models to examine how clinical recommendations should be modified to account for variations among patients and providers. The decision modeling project provides an internal review which ensures that evidence and analyses are directed toward clinical and policy decision-making.