Get the facts about elective angioplasty
What is the elective angioplasty project?
In 2005, cardiologists at Johns Hopkins launched a nationwide demonstration project to compare the outcomes of 16,000 patients treated with "elective" angioplasty at hospitals with cardiac surgery on-site to outcomes at hospitals that have off-site cardiac surgery back-up. The project is known as the Atlantic C-PORT-E Demonstration Project. Ten states, including New Jersey, Pennsylvania and Maryland are participating in the project and two additional states are conducting their own independent studies. Twenty other states have already approved regulations that allow hospitals without on-site cardiac surgery backup to perform elective angioplasties.
Why was this project started?
The Atlantic C-PORT-E Demonstration Project was undertaken to compare quality, outcomes and cost among hospitals with and without on-site cardiac surgery backup. This project was undertaken based on previous studies that retrospectively looked at hundreds of thousands of angioplasty records that demonstrated that there was no significant difference in patient outcomes between non-cardiac surgery centers with off-site back-up to centers that had on-site cardiac surgery back-up. A national organization - the American College of Cardiology - determined that a study like the C-PORT-E Demonstration Project should be done on a prospective basis with a model such as the one that Dr. Thomas Aversano from Johns Hopkins has designed to answer that question conclusively.
This demonstration project was based on the original C-PORT study, also led by Dr. Thomas Aversano and John Hopkins in the late 1990s. That study showed that primary angioplasty (emergency angioplasty) could safely be performed at hospitals without cardiac surgery on-site. As a result, NJ changed its policy and regulations and now 24 hospitals perform emergency angioplasty with off-site cardiac surgery - saving hundreds of lives in the process.
The results of the current project will help shape future health care policy on the availability of elective angioplasty in New Jersey and in the nation.
What is elective angioplasty?
The term "elective" in this case means that the procedure is needed, but not on an emergent basis. When a person is having a heart attack, he or she requires an emergency or "primary" angioplasty. This procedure is performed regularly at Virtua Marlton to save patients' lives as they are experiencing a heart attack.
An "elective" angioplasty is also a life-saving procedure, but the patient is not in an immediate emergency situation and the angioplasty is performed on a scheduled or "elective" basis. In both instances, a patient's blockage is cleared by a balloon inserted into an artery and the artery may be propped open with a stent, a tiny mesh device that enables blood to flow to the heart. Both procedures are performed in Marlton's Cardiac Catheterization Laboratory using highly sophisticated digital equipment.
Why does Virtua want to participate in the project?
Virtua is principally concerned with providing a complete spectrum of services to the communities it serves. Virtua's physicians and staff have saved more than 100 lives to date through the emergency angioplasty program. Having the ability to provide elective angioplasty complements and supports the emergency angioplasty program. In addition, there is no reason not to perform the procedure electively if a hospital can successfully perform emergency cases. The aging of the enormous Baby Boom generation dictates that this service needs to be more widely available.
How does the aging of the Baby Boom generation impact angioplasty services?
Over the long term, the incidence of heart disease and the need for angioplasty is expected to grow. This is anticipated due to the aging of Baby Boom generation, the largest population increase in the nation's history, and the increase in the incidence of obesity and other health factors.
However, in the seven southern counties of New Jersey, there are fewer primary and elective angioplasty providers per capita than in the northern and central counties of the state. It stands to reason that with increased patient need, there is a strong reason for expanding the region's capacity for angioplasty.
Why has there been so much controversy around this issue?
We believe that Cooper and Lourdes, the only opponents of this project in the state, fear a loss of revenue. But the statistics do not support this fear nor justify their efforts at trying to derail this project. They have aggressively misrepresented the facts and misinformed the media and the public in order to bring the project to a halt. Their case to the public has been that the project is not safe and they claim there have been deaths at Virtua Marlton among angioplasty patients. Their claims are false. The demonstration project has a high degree of patient safety and protections, and there have been no deaths at Virtua Marlton as a result of this project.
In December 2007, 24 New Jersey hospitals applied to participate in the C-PORT-E demonstration project and every one of these hospitals had to have a signed agreement with a cardiac surgery center as a study partner. Out of 18 cardiac surgery centers in the state, the only cardiac surgery centers that objected to the study were Cooper and Lourdes. None of the others considered this a public safety issue and most signed on as a study partner with one or more of the applicant hospitals. In fact, Deborah, which was previously opposed to C-PORT-E, signed on to be the study partner with Capital Health System in Mercer County in its certificate of need application.
What measures are taken to ensure this project is safe?
This project has been more closely scrutinized by regulators and the public than any other healthcare issue in recent years. Hospitals participating in the Demonstration Project have more layers of oversight to protect patients than any of the cardiac surgery centers in the state.
This project is overseen by the following:
- Johns Hopkins cardiologists, the study director who is a cardiologist, and his staff;
- The Johns Hopkins Institutional Review Board (IRB)
- An Independent Data Safety and Monitoring Board which has the authority to stop the study at any time if they determine there is a safety issue
- The New Jersey Department of Health and Senior Services
- Virtua's own IRB
In fact, three successive Commissioners of the Department of Health and Senior Services, two of whom are physicians, have all supported this project.
The angioplasty procedure itself is a tested and proven procedure that is being performed in hospitals in all 50 states, and the complication rates are very low. Angioplasty is not what is being examined in the demonstration project. What is being determined by this project is whether it can be demonstrated that the outcomes are any different at hospitals without on-site cardiac surgery programs than they are at cardiac surgery centers. It is not a clinical trial.
Virtua believes that patient safety is paramount and that safety issues must be transparent and understood by the public.
What about patient outcomes?
There have been no deaths related to either emergency or elective angioplasty at Virtua Marlton.
How do patients make an informed decision about participating in the project?
At Virtua Marlton, an eight-page consent form is reviewed and explained to patients. The form describes every aspect of the project. It meets the requirements of the Food and Drug Administration and the New Jersey Department of Health. It has also been reviewed and approved by the Institutional Review Boards of Johns Hopkins and Virtua which are made up of clinicians and representatives from the community, and by the Independent Data Safety and Monitoring Board.
How will Virtua Marlton meet the state's volume targets?
The state Department of Health and Senior Services requires that participating hospitals perform 200 angioplasties in its second year of the project. This requirement applies to Virtua Marlton in 2009 and beyond. To help meet the requirement, more interventional cardiologists have agreed to participate in the project.
It is also important to get the facts about the demonstration project out to the community so they understand that the procedure is safe, that Virtua's physicians (who perform the same procedure at cardiac surgery hospitals) are highly skilled, and that there have been no mortalities at Marlton related to the project.
What has been the position of the courts and other regulating bodies?
In 2005, the New Jersey Department of Health and Senior Services approved nine hospitals to participate in the project. Virtua Marlton was the only hospital in the southern part of the state to be approved.
Cooper, Lourdes and Deborah immediately moved through legal means to challenge the Department of Health's decision and stop the project by filing an appeal in the Appellate Division of the Superior Court and finally taking their case to the NJ Supreme Court. The courts refused to stop the project. However, because of a technicality, the New Jersey Supreme Court required the state health department to develop new regulations governing the project which resulted in hospitals having to reapply for approval to participate in the C-PORT-E project.
In 2007, after two lengthy public hearings, the Health Care Administration Board approved the new regulations. In 2008, the State Health Planning Board recommended that the Commissioner approve the applications of 12 hospitals, including Virtua Marlton. The Commissioner subsequently granted certificates of need to those 12 hospitals to participate in the project.
What can I do?
It is important that you understand the issues so that you can speak knowledgeably to your family, friends and neighbors about Virtua's angioplasty services. In fact, doing just that could help save a life.
As one of New Jersey’s largest health systems, Virtua helps people be well, get well and stay well through a comprehensive range of health care services. Services are delivered through three health and wellness centers, three fitness centers, three acute care hospitals, primary and specialty physician practices with more than 240 physicians, urgent care centers, nine ambulatory surgery centers, home health services, two long-term care and rehabilitation centers, 12 paramedic units and a wide range of outpatient services. A leader in maternal and child health services, Virtua delivers more than 8,000 babies a year. Virtua also provides employment and wellness services to 1,700 businesses and corporations. An innovator in clinical and information technology such as electronic medical records, Virtua is recognized for its ground-breaking partnerships with GE Healthcare
, Children's Hospital of Philadelphia (CHOP)
and the Fox Chase Cancer Center
. Virtua employs more than 8,700 people and has been honored as the #1 Best Place to Work in the Delaware Valley every year since 2007. It is the recipient of the Consumer Choice Award from the National Research Corporation. For more information, visit www.virtua.org