Latest Conference Articles

In this session, data were presented from 3 separate trials that focused on potential ways to reduce the risk for bleeding in patients who require anticoagulation therapy, including the use of genetic tests to optimize warfarin dosing and the use of the factor Xa inhibitor edoxaban. Munir Pirmohamed, MD, PhD, from the University of Liverpool, discussed results from the EU-PACT trial; Stephen Kimmel, MD, from the University of Pennsylvania School of Medicine discussed results from the COAG trial; and Robert P. Giugliano, MD, SM, FAHA, FACC, from Brigham and Women's Hospital, discussed results from the ENGAGE TIMI-AF 48 trial.

In this session, the efficacy and safety profiles of novel alternatives to warfarin were discussed by Jeffrey Weitz, MD, FACP, from McMaster University. Also discussed was the selection of the right anticoagulant for the right patient.

In this session, Denise Bonds, MD, MPH, from the National Heart, Lung, and Blood Institute, discussed the limitations of outcomes research conducted using claims or registry data. According to Dr Bonds, the trend is to use new data, big data, and patient-powered data. In another presentation, Catarina Kiefe, PhD, MD, from the University of Massachusetts Medical School, provided preliminary findings from her research in patients with acute coronary syndrome as an example of how outcomes research is evolving.

Patients spend far more time in the home than with their healthcare providers, making the home an ideal and perhaps essential place to improve adherence and outcomes. In this session, Kathryn Donofrio, DNP, MBA, RN, from Swedish Covenant Hospital, and Debra Moser, DNSc, MN, RN, from the University of Kentucky, discussed home-based strategies for care improvements in patients with heart failure.

Accountable Care Organizations (ACOs) are designed to improve the quality and continuity of care, but it remains unclear how stakeholders can be successful in this new model and also how the shift in incentives will truly impact care. In this session, W. Douglas Weaver, MD, from the Henry Ford Heart and Vascular Institute and Henry Ford Hospital, and Karen E. Joynt, MD, MPH, from Brigham and Women's Hospital and Harvard Medical School, discussed the potential impact of ACOs on specialty care and the potential for ACOs to limit access to care.

Recently released guidelines from the American College of Cardiology and American Heart Association base treatment on a 10-year risk for atherosclerotic cardiovascular disease, a shift from the previous guidelines' overall emphasis on treat to target. In this session, C. Noel Bairey Mertz, MD, FACC, from the Cedars-Sinai Heart Institute; Jennifer G. Robinson, MD, MPH, from the University of Iowa; and Karol Watson, MD, PhD, FACC, from the University of Southern California, Los Angeles, discussed the evidence supporting cholesterol lowering in women, the elderly, and minorities.

The participants in this session noted that the medical record of the future will likely include a prognostic genetic component that will have short- and long-term implications. Panelists included Jennifer Hall, PhD, FACC, FAHA, from the University of Minnesota; Dan Roden, MD, from Vanderbilt University; Gary H. Gibbons, MD, from the National Heart, Lung, and Blood Institute; and Christopher Cannon, MD, from Brigham and Women's Hospital.

The fourth session of the FDA Town Hall Meeting at the Transcatheter Cardiovascular Therapeutics (TCT) conference was titled Regulation and Reimbursement: Global Imperatives and Trends. It began with the keynote address, The Intersection of Innovation, Payment and Regulatory Approval in the Future of Interventional Cardiology, delivered by Jack L. Lewin, MD, CEO of the Cardiovascular Research Foundation. He discussed 5 critical trends affecting innovation: progression of science, information technology and big data, changing politics and public scrutiny of healthcare quality and costs, regulatory expansion, and healthcare payment reform.

FDA Town Hall Meeting is a multi-part session held yearly at the Transcatheter Cardiovascular Therapeutics (TCT) conference. At this year's conference, the first portion, titled The Year in Review: A Year in Transition, was introduced by Martin B. Leon, MD, and Bram D. Zuckerman, MD. The Town Hall Meeting is meant to be dynamic and inclusive of key forces from the regulatory environment, clinical scientists, and representatives from industry.

A multi-part session titled Stroke in Atrial Fibrillation: A Preventable Condition was begun by Michael D. Ezekowitz, MB, ChB, DPhil, of the Lankenau Institute for Medical Research. In his presentation titled All Novel Agents are Preferred to Warfarin, he discussed the benefits of novel anticoagulant agents.

Atrial Fibrillation, the Epidemic of Our Time was the first portion of a multi-part session titled Pharmacological and Interventional Options for Stroke Prevention in Atrial Fibrillation. The introduction, titled Multifaceted Approaches to Atrial Fibrillation: From Drugs to Ablation to Left Atrial Appendage Closure, was delivered by Vivek Y. Reddy, MD, professor of medicine in cardiology at Mount Sinai Medical Center.

The first part of the session titled Innovation in Transition: Models, Global Trends, Regulatory Challenges, and Funding Opportunities started with a presentation from John B. Simpson, MD, PhD, chief executive officer at Avinger, Inc, called Individual-Based Innovation. Dr Simpson briefly described the lumivascular approach to treatment of cardiovascular disease, which is image-guided atherectomy.

This multi-part presentation was begun with Then and Now: The Evolution of Translational Science, Clinical Evidence-Based Medicine, and Socioeconomic Considerations, delivered by Elazer R. Edelman, MD, PhD, physician at Brigham and Women's Hospital and professor at Harvard Medical School and MIT. He began by discussing the history of innovation in biomedical research and then outlining a current problem in US innovation.

The first presentation in this multi-part session, Current Status of Lipid Lowering Therapy in CAD, PAD, and CKD, was delivered by Rita Redberg, MD, professor of medicine and director women's cardiovascular services, University of California, San Francisco. According to Dr Redberg, a heart-healthy diet, regular physical activity, weight management, medications, and smoking cessation are mainstays of prevention.

The multi-part session at the Transcatheter Cardiovascular Therapeutics (TCT) conference was moderated by Roxana Mehran, MD, professor of medicine at Icahn School of Medicine at Mount Sinai in New York, NY. Dr Mehran began by emphasizing the importance of clinical research in interventional cardiology. She then described the session's speakers as premier investigators.

For Douglas Long, MBA, vice president, industry relations, IMS Health, Inc, keeping up-to-date on the trends and forecasts of the evolving managed care arena is crucial to remaining competitive.

Michael Fischer, MD, associate professor of medicine, Harvard Medical School, associate physician, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, said that the complexity of the healthcare system is part of the challenge of managing adherence.

Dual eligibles-the class of Americans that qualify for both Medicaid and Medicare coverage-are mostly older adults with low incomes and tend to be the sickest beneficiaries covered by either Medicaid or Medicare.

Almost all pharmacy and therapeutic committees have a unique process for evidence-based formulary decision making, said Steven Pearson, MD, founder & president, Institute for Clinical and Economic Review.

The dynamic landscape of healthcare and managed care pharmacy will be deeply impacted by new and emerging specialty medications. The ever-spiraling costs of specialty medications have led many experts to question whether these treatments translate into true improvements in health outcomes or patients' quality of life.

Not surprisingly, Thomas Merrill, lead researcher, Center for Accountable Care Intelligence, Leavitt Partners, LLC, said that cost is a major work flow challenge associated with Accountable Care Organizations.

In this interview, Curtis Triplitt, PharmD, associate professor and assistant dean of research, Texas Tech University Health Sciences Center, Permian Basin, explains why diabetes should be treated with a patient-centered approach.

Jeff Goldsmith, PhD, healthcare futurist and analyst, says that the Affordable Care Act (ACA) has significantly impacted healthcare policy, in both negative and positive ways.

The patient-centered medical home (PCMH) has many key goals and components. When paneled, the majority of AMCP 2013 Nexus attendees agreed that the PCMH is best described as a practice model that organizes primary care practice operations and incentives to deliver patient-centered, coordinated, comprehensive care with the goal of improved quality and efficiency.

Since 2010, the growth and proliferation of accountable care organizations (ACOs) has increased, and the rise of this collaborative care model is not without reason. Lack of consumer engagement, lack of competition, and misaligned incentives have made care less affordable.

Richard Stefanacci, DO, chief medical officer, The Access Group, said that it is necessary for retail pharmacists to break out of their silo. Dr Stefanacci noted that retail pharmacists are being utilized within practices and stepping out of their normal roles.

Suzanne Tschida, PharmD, vice president, specialty benefits & outcomes, OptumRx, said that at UnitedHealth Group a tiering system is used for the management of specialty medications with a cost-share or copay structure.

The gold standard for measuring treatment outcomes in multiple sclerosis (MS) is the randomized clinical trial (RCT). However, RCTs are often short-sighted and biased in their execution. Dr Maria Sormani, PhD, Biostatistics Unit, Department of Health Sciences, University of Genoa, Genoa, Italy, addressed this problem in a lecture on immunomodulatory treatment of MS.