1. What is the C-PORT-E demonstration project?
C-PORT-E is a nationwide study of more than 16,000 patients designed to compare the outcomes of patients treated with a life-saving procedure called elective angioplasty at hospitals with cardiac surgery on-site versus hospitals that have off-site cardiac surgery back-up. Expanding sites allowed to perform elective angioplasty lets patients remain in the continuous care of their trusted primary care physician and cardiologist.

2. Who is conducting the C-PORT-E demonstration project?
C-PORT-E is being led by Johns Hopkins Medicine and conducted by the Cardiovascular Patient Outcomes Research Team (or C-PORT). Dr. Thomas Aversano, M.D., an interventional cardiologist and associate professor at The Johns Hopkins University School of Medicine, is the senior investigator and Director of Atlantic C-PORT.

3. What is angioplasty?
Angioplasty is a procedure in which a tiny balloon is inflated and used to widen a blocked artery narrowed from the buildup of cholesterol-laden plaque. After the obstruction is relieved by the balloon dilation, most patients then immediately receive a stent. Stents are small, metal mesh cylinders that are delivered to the site of obstruction and expanded in the artery. Stents act as scaffolds to hold the artery open so it can heal with a normal diameter to allow blood to flow freely. Primary (or emergency) angioplasty is performed on a patient who is in the throes of an acute myocardial infarction (heart attack). Elective angioplasty is performed on patients who are not experiencing a heart attack, but have blockages significant enough to require an interventional procedure.

4. Is angioplasty a commonly performed procedure?
Yes, the number of angioplasties performed annually continues to rise as the number of heart surgeries performed falls. According to the American Heart Association, in 2002 an estimated 650,000 angioplasty procedures were performed on 640,000 Americans. This amounts to a 324 percent increase in volume since 1987. As the baby boom generation ages, the incidence of heart disease and the need for angioplasty is expected to grow even more.

5. Where are angioplasty procedures performed?
Both primary and elective angioplasty procedures are performed by interventional cardiologists in cardiac catheterization laboratories (or cath labs). While many hospitals operate cath labs and perform numerous diagnostic angiograms every year, most states have historically limited delivery of angioplasty procedures to hospitals with on-site, specialized heart surgery back-up. This has changed in recent years, as research has shown that qualified hospitals with off-site cardiac surgery back-up can perform angioplasty procedures as safely and effectively as hospitals with on-site back-up. As a result, many states, including New Jersey, now allow qualified, licensed facilities with off-site back-up to perform emergency angioplasty procedures. There are 23 such hospitals in New Jersey today, including the nine participants of the C-PORT-E demonstration project.

6. Which nine New Jersey hospitals are providing elective angioplasty as part of the project?
The nine hospitals selected by the New Jersey Department of Health and Senior Services to participate in the C-PORT-E (Cardiovascular Patient Outcomes Research Team) demonstration project are: Bayonne Medical Center, Holy Name Hospital, Monmouth Medical Center, Muhlenberg Regional Medical Center, Raritan Bay Medical Center, Robert Wood Johnson University Hospital Hamilton, Somerset Medical Center, Trinitas Hospital and Virtua West Jersey Hospital Marlton.

7. How were these nine hospitals chosen to participate?
The nine participating hospitals were selected based on their satisfaction of rigorous clinical and safety criteria as defined by both the C-PORT-E protocol and the New Jersey Department of Health and Senior Services. To participate, hospitals must demonstrate an ability to meet a combined emergency and elective angioplasty volume of at least 100 cases in the first year and 200 cases per year thereafter. They must also have a staff whose training meets national standards set by the American Heart Association and American College of Cardiology. All nine participating institutions have successfully performed cardiac catheterization and emergency angioplasty for several years, and clearly meet the rigorous requirements for participation in the demonstration project.

8. Why is New Jersey’s participation in the project
so important?
New Jersey’s participation in the project is important for several reasons. New Jersey accounts for over 30% of patient volume and data collected and analyzed in the CPORT-E project, as a result of our dense population and the high demand for angioplasty among state residents. The continued participation of New Jersey’s nine participating hospitals is essential to the timely completion of the project and development of conclusive evidence-based data on this important national public health issue. The outcomes of this study will also help New Jersey’s policymakers plan for the future needs of heart patients.

9. What if a patient does not want to have elective angioplasty at one of the nine participating hospitals?
Patients requiring elective angioplasty may choose to have the procedure performed at one of the 18 cardiac surgery centers in the state if they do not want to participate in the elective angioplasty demonstration project. The C-PORT-E study does not interfere with the patients’ right to choose from among the licensed facilities available to perform elective angioplasty.

10. What happens if a patient experiences complications during an angioplasty procedure at one of the nine participating hospitals?
In order to participate in the project, every non-cardiac surgery hospital must have a transfer agreement with a licensed cardiac surgery center.  These transfer agreements ensure that cardiac surgery centers will receive and treat any patients that require surgery as a result of complications arising from an angioplasty procedure. In addition, a number of New Jersey’s 18 cardiac surgery centers are participating in the project themselves. As required by the study protocols, 25% of the patients are randomly selected to receive their elective angioplasty at a cardiac surgery center and a number of such centers have elected to participate in this project. This enables C-PORT-E researchers to effectively compare outcomes between patients treated at facilities without cardiac surgery back-up and those with cardiac surgery capabilities in the safest possible manner.

11. Who pays for the C-PORT-E project in New Jersey?
The project is funded by the participating institutions. Each participating hospital is responsible for funding to support its Clinical Coordinating Center, data collection and management infrastructure, angiographic core laboratory and other study-related costs. Hospitals are also responsible for personnel costs associated with data collection.

12. What other states are involved in the C-PORT-E study?
In addition to New Jersey, the following states are participating in this study: Pennsylvania, Alabama, Georgia, Illinois and Ohio.