FDA Hot Topics: Two Novel Drug Approvals, User Fee Act Reauthorization and Off-Label Marketing

Kovacs headshotThis post was authored by Richard J. Kovacs, MD, FACC, member of ACC’s Board of Trustees.

It’s been a busy summer for U.S. Food and Drug Administration (FDA) news. Several key decisions made by the Agency and the courts in recent months are sure to impact medicine in the months and years to come.

Of course the big FDA headline in July was the Agency’s approval of the first proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor – Regeneron Pharmaceuticals’ Praluent (alirocumab) – for the treatment of patients with familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease in conjunction with maximally tolerated statin therapy and diet modification. The FDA is expected to make a decision about a second PCSK9 inhibitor – Amgen’s Repatha (evolocumab) – later this summer. This new class of lipid-lowering drugs has the potential to offer millions of patients with high LDL-C an alternative treatment option to statins, which have been associated with numerous side effects for decades. Continue reading

ACTION Registry-GWTG Exceeds 1,000 Participating Sites

Bhatt_HeadshotjollisThis post was authored by Deepak L. Bhatt, MD, MPH, FACC, and James G. Jollis, MD, FACC, co-chairs of the ACC’s ACTION Registry-GWTG steering committee.

ACC’s ACTION Registry-GWTG recently welcomed its 1,000th participating hospital – Florida Hospital Celebration Health. This marks an important milestone for the registry and for the larger cardiovascular community because it serves as evidence that the registry is and will continue to contribute to improved care and outcomes for ST-segment elevation myocardial infarction (STEMI) and non-STEMI patients. With a history of evolving to meet the demands of changing science and definitions of quality care, the registry has brought real, life-saving changes for this patient population. Continue reading

PINNACLE Registry QI Program in India: A Model For Other Resource-Limited Countries?

This post was authored by Nathan Glusenkamp, MA, director of the PINNACLE Program and William J. Oetgen, MD, MBA, FACC, executive vice president of the ACC’s Publication, Education, Science & Quality.

Today marks a seminal event in the evolution of the PINNACLE Registry with the publication of an article in the Journal of the American Heart Association. “Cardiovascular Disease Performance Measures in the Outpatient Setting in India: Insights from the American College of Cardiology’s PINNACLE India Quality Improvement Program (PIQIP)” is the first published report from PIQIP, an international project within the PINNACLE Registry program that has been ongoing for the past three years. Continue reading

NCDR.15 Kicks Off With Focus on Physician Engagement

This post was authored by John S. Rumsfeld, MD, PhD, FACC, chief science officer of the ACC’s NCDR.

Today, more than 1,200 registry professionals, quality experts, cardiovascular administrators and physicians have come together in San Diego for two days of registry-focused learning and best practice sharing. Over the years, the ACC’s NCDR Annual Conference has grown in size, reflecting the expansion of the NCDR registries and conference offerings.

Originally developed to educate data managers and abstractors on data accuracy, registry advances and the application of registry data for quality improvement, the curriculum has expanded in recent years to cover the role registries play in health care, engaging physician and administrators in ownership and use of data, and applying data to meet growing regulatory and educational requirements. Continue reading

Striving to Improve Quality Cardiovascular Care

BRINDIS_BOT_2010This post was authored by Ralph G. Brindis, MD, MPH, MACC, senior medical officer of external affairs for the NCDR.

An article published today in U.S. News and World Report asks the question, “Are Doctors Exposing Heart Patients to Unnecessary Cardiac Procedures?” The article strongly implies that many doctors who are performing unnecessary procedures are doing so in order to “reap the benefits in Medicare payments.” The ACC acknowledges that there is a marked variation in percutaneous coronary intervention (PCI) rates and there are indeed nationwide opportunities to improve appropriate patient case selection for PCI. This assessment is not the same of the authors’ implications of “reaping the benefits of Medicare payments.” Continue reading

New NCDR-Derived Risk Model For AKI Patients Undergoing PCI

This post was authored by Thomas T. Tsai, MD, MSc, FACC, member of the NCDR Science and Quality Oversight Committee and steering committee chair of the PVI Registry.

A paper detailing the development of a new risk model of acute kidney injury (AKI) in patients undergoing percutaneous coronary intervention (PCI) was recently published in the Journal of the American Heart Association. The study, conducted by myself and several colleagues, applied data from the ACC’s NCDR CathPCI Registry to develop this viable tool, which will potentially aid clinicians in counseling patients undergoing PCI regarding the risk of acute kidney injury, identify patients for preventative strategies, and support local quality improvement efforts. Continue reading

PINNACLE Registry Wraps Up Successful Year of Research

This post was authored by William J. Oetgen, MD, MBA, FACC, executive vice president of Science, Education, & Quality of the ACC.

I recently had the opportunity, along with other members of the ACC staff, to serve on the research team for a project that analyzed data from the PINNACLE Registry India database. The database now includes well over 100,000 patient records collected from Indian hospital outpatient clinics. Using this database, Yashashwi  Pokharel, MD, MSCR, and a team of his colleagues recently submitted an abstract entitled “Guideline Recommended Medication Use Among Systolic Heart Failure (HF) Patients in India: Insights from the American College of Cardiology Practice Innovation and Clinical Excellence (PINNACLE) India Registry,” to the 66th Annual Conference of the Cardiological Society of India. The abstract was selected for a prestigious oral presentation at the conference this past December, which was delivered by Prafulla Kerkar, MD, FACC, the Mumbai-based chair of the PINNACLE India research group. Not only does this study inform us on guideline-recommended medication use among patients in India, but it also marks the first time data from ACC’s outpatient registry in India have been presented at a conference outside of the U.S. Continue reading

The Need to Improve Evidence-Base Use of Prasugrel

This post was authored by Ravi S. Hira, MD, and members of the PINNACLE Registry Research and Publications Subcommittee: Paul S. Chan, MD, MSc and Salim S. Virani, MD, PhD, FACC.

Approved for use in patients with acute coronary syndrome undergoing percutaneous coronary intervention in July 2009, prasugrel is a relatively new antiplatelet agent that was shown to decrease cardiovascular death, myocardial infarction (MI) and stroke when compared to clopidogrel in the TRITON-TIMI 38 trial. Despite the proven efficacy, prasugrel has been associated with increased major bleeding in patients with prior stroke or transient ischemic attack, and therefore is contraindicated in these patients. It is also not recommended in patients 75 years of age or older without a history of diabetes or prior MI. Continue reading

Using PINNACLE to Demonstrate Excellence

This post was authored by Barbara Watkins, administrator at the Heart & Vascular Center of Arizona.

Barbara Watkins, administrator at the Heart & Vascular Center of Arizona, used the PINNACLE Registry to demonstrate her practice is striving toward excellence.

Barbara Watkins, administrator at the Heart & Vascular Center of Arizona, used the PINNACLE Registry to demonstrate her practice is striving toward excellence.

In April, the Heart & Vascular Center of Arizona (HVCA) received the “2014 Gold ArizonaQuality Improvement Recognition Award.” Health Services Advisory Group, Inc., the Medicare Quality Improvement organization of Arizona presented this award to HVCA for making strides in improving patient care by applying best practices and reporting on process and outcomes measures using health information technology (IT).  Continue reading

What Are You Doing With Your Registry Data?

This post was authored by Robert N. Vincent, MD, CM, FACC, chair of the IMPACT Registry Steering Committee

The ACC’s IMPACT Registry is a vehicle to collect data on all pediatric patients and adult patients with congenital heart disease undergoing diagnostic and interventional catheterization procedures.  First and foremost, its key objective is to collect data to identify variability in procedures amongst institutions and operators, link variability to outcomes, assess performance, provide benchmarks and implement quality improvement initiatives.  Specifically, the intent is to improve the care and outcome of patients with congenital heart disease undergoing cardiac catheterization.  It is meant to be used internally to help institutions and operators identify areas for improvement and institute practices to improve outcomes.  Continue reading