Author Interviews, Brigham & Women's - Harvard, Cost of Health Care, Heart Disease, Medicare / 15.03.2018

MedicalResearch.com Interview with: Dr. Rishi K. Wadhera MD Clinical Fellow in Medicine Brigham and Women's Hospital  MedicalResearch.com: What is the background for this study?   Response: The Hospital Value Based Purchasing program, in which over 3,000 hospitals participate, is a Centers for Medicare and Medicaid Services (CMS) pay-for-performance program that links hospital fee per service reimbursement to performance, through measures like 30-day mortality rates after an acute myocardial infarction (a heart attack), and other measures such as average spending for an episode of care for Medicare beneficiaries. Hospitals that perform poorly on these measures are financially penalized by CMS. (more…)
Author Interviews, Diabetes, Duke, Heart Disease / 14.03.2018

MedicalResearch.com Interview with: Stephen J. Greene, MD Division of Cardiology Duke University Medical Center Durham, NC MedicalResearch.com: What is the background for this study? What are the main findings? Response: In 2008, the United States FDA issued an industry guidance specifying that diabetes drugs should routinely be tested in large cardiovascular outcome trials to confirm cardiovascular safety. The guidance specifically mentioned cardiovascular safety in terms of MACE, or major adverse cardiac events, including cardiovascular death, myocardial infarction, and stroke.  Largely because of this, these trials have traditionally had a focus on cardiovascular disease in terms of atherosclerotic events. Heart failure was not mentioned in the FDA document and these trials have had a lesser focus on it. As the years have gone by, we have learned more and more about the connection between diabetes and heart failure. There is tremendous overlap between the two patient populations. Also, as more and more of the large cardiovascular outcome trials have been completed, we have seen multiple examples of various glucose lowering therapies either increasing or decreasing risk of heart failure events. Given all these data on heart failure/ diabetes interactions, the goal of our research was to carefully examine all of the completed large cardiovascular outcome trials of diabetes therapies to systematically describe the type of heart failure-related data they capture. As an initial step in improving heart failure characterization in these trials, we wanted to first describe what trials have already been doing and where the gaps in understanding heart failure in these trials exist. Overall, we found major gaps in the amount and quality of the heart failure data capture in these trials. We looked at 21 large trials, including over 150,000 patients. Rates of patients with baseline heart failure were inconsistently provided, and among those trials that did provide it, heart failure patients tended to be underrepresented compared to the general population. Patients with baseline heart failure were also poorly characterized, with minimal data on functional status, ejection fraction, or heart failure medications. Only 6 trials reported rates of new-onset heart failure and the definitions used were non-specific. Most trials tended to report rates of heart failure hospitalization, but did not include data on fatal or other types of heart failure events. Only 2 trials included heart failure events within the primary study endpoint. More details are included in our full manuscript, which was published in the Journal of the American College of Cardiology to coincide with our presentation at the ACC conference. (more…)
Author Interviews, Brigham & Women's - Harvard, Diabetes, Heart Disease / 12.03.2018

MedicalResearch.com Interview with: Muthiah Vaduganathan, MD MPH Heart and Vascular Center Brigham and Women's Hospital  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The prevalence of heart failure with preserved ejection fraction (HFpEF) is rising globally, yet no medical therapies are currently available to alter its natural history and its progression remains incompletely understood. Sudden death may represent a target for therapy in this disease entity. In 1,767 patients with HFpEF enrolled in the Americas region of the TOPCAT trial, we found that sudden death accounts for ~20% of all deaths. Male sex and insulin-treated diabetes mellitus identify patients at higher risk for sudden death. Sudden death was numerically lower but not statistically reduced in those randomized to spironolactone. (more…)
Author Interviews, Heart Disease, Psychological Science / 11.03.2018

MedicalResearch.com Interview with: Dr. Alexander Fanaroff MD Duke University School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Response: Among patients with chronic angina, there are strong associations between depression and clinical outcomes, which illustrates the important interplay between psychosocial symptoms and physical symptoms in this condition. But depressive symptoms are distinct from expectations and optimism regarding recovery and returning to a one’s normal lifestyle. Patients with chronic angina may not be optimistic about their outlook for a number of reasons, including uncertainty about their prognosis or lack of medical knowledge, but for many patients with chronic angina, the outlook is actually quite good. We examined data from RIVER-PCI, a clinical trial that randomized patients with chronic angina and incomplete revascularization to ranolazine or placebo, and were followed for the primary outcome of ischemia-driven hospitalization or revascularization. Patients were asked at baseline, 1 month, 6 months, and 12 months how much they agreed with the phrase, “I am optimistic about my future and returning to a normal lifestyle.” We categorized patients by their responses at baseline – we coded “strongly agree” as very optimistic, “agree” as optimistic, “neutral” as neutral, and “disagree” and “strongly disagree” as not optimistic – and evaluated the association between baseline optimism and the primary outcome over long-term follow-up. We found that most patients were optimistic at baseline – 33% were very optimistic, 42% were optimistic, 19% were neutral, and 5% were not optimistic – and the majority remained optimistic over long-term follow-up. The most optimistic patients had a lower prevalence of prior myocardial infarction, heart failure, diabetes, and chronic kidney disease and less severe angina at baseline than less optimistic patients. The rate of the ischemia-driven hospitalization or revascularization was higher in neutral (32.8%) and not optimistic (35.0%) patients compared with the most optimistic patients (24.4%). Even after adjusting for baseline comorbidities and angina frequency, the most optimistic patients had a 30% lower risk of ischemia-driven hospitalization or revascularization compared with neutral or not optimistic patients. (more…)