9 NJ HOSPITALS URGE CONTINUATION OF ANGIOPLASTY DEMONSTRATION PROJECT
Nine New Jersey hospitals - including Trinitas Hospital - that are participating in an important demonstration project that will help determine national healthcare policy today launched a public education effort to highlight the facts supporting continuation of this ongoing project by the New Jersey State Department of Health and Senior Services (NJDHSS).
The study, launched in six states by cardiologists at Johns Hopkins Medical Institutions, is set 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. The hospitals without cardiac surgery back-up on-site already perform diagnostic and emergency angioplasty, treating the sickest of patients experiencing acute heart attack.
Three South Jersey hospitals – Cooper University Hospital, Deborah Heart and Lung Center, and Our Lady of Lourdes Medical Center - have filed suit against the NJDHSS and Virtua Health, one of the demonstration project participants, to stop the study based on procedural issues. The New Jersey Supreme Court ruled that the Commissioner of the NJDHSS did have the right to approve the study, but that the state would have to re-write the regulations for the project to continue beyond November 30, 2007. The three hospitals had also requested that the Superior Court Appellate Division and later the Supreme Court stop the study while the case was being considered. Both courts refused to do so.
Angioplasty is a procedure in which a catheter is inserted into the coronary artery, and a tiny balloon is inflated and used to widen an artery that has been narrowed or blocked 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.
Each of the nine hospitals participating in the demonstration project has a proven history of safely and effectively performing cardiac catheterizations for the diagnosis of coronary artery disease and angioplasty for the emergency treatment of patients suffering an acute heart attack. In 2004, NJDHSS invited hospitals to apply to participate in the demonstration project. Nine hospitals were approved to do so in 2005, and each commenced their participation in the project last year.
This project is designed to evaluate patient outcomes when an interventional cardiologist who diagnoses a blockage during a diagnostic catheterization at a hospital without on-site surgical back-up immediately moves on to clearing the blockage via a balloon angioplasty rather than having to stop the procedure and transfer the patient to another hospital. Rather than undergo two separate procedures for diagnosis and treatment, patients could have both done during one procedure at the same hospital.
The nine New Jersey hospitals participating in this demonstration project have all met a stringent set of safety and clinical requirements, and have been approved for participation by NJDHSS. To participate, hospitals must have a combined emergency and elective angioplasty volume of at least 200 cases per year after the first year and a staff whose training meets national standards set by the American Heart Association and American College of Cardiology.
In addition, the project is under continuous review by an independent Data and Safety Monitoring Board comprised of scientists, medical experts and ethicists from around the country to ensure that the protocols are safe and that the data collected is accurate and appropriate. As recently as May 2007, this independent board recommended the continuation of enrollment in the project and did not recommend any modifications to the project protocol.
"The aim of our study is to determine what is best for the patient and what kind of hospitals should provide angioplasty services and under what conditions," said interventional cardiologist and study senior investigator Thomas Aversano, M.D., an associate professor at The Johns Hopkins University School of Medicine and its Heart Institute. "The results will allow physicians and health policymakers to develop evidenced-based policies about who will have access to angioplasty services, and the results, we believe, will significantly influence the overall quality of cardiovascular care in community hospitals."
In the Johns Hopkins-led study, conducted by the Cardiovascular Patient Outcomes Research Team, or C-PORT, participating patients who require angioplasty are randomly assigned to have angioplasty at either the hospital without on-site cardiac surgery where they undergo diagnostic catheterization or at a center with on-site cardiac surgery for angioplasty. Each participant's progress is followed by the researchers for a period of nine months to determine their health status and whether they have any subsequent problems related to their heart. At the end of the project the researchers will compare outcomes, or well-being, of patients treated in the two groups. Patients are fully informed of the study protocols, and, along with counsel from their primary physician and/or cardiologist, can choose whether or not to participate.
So far, six states have approved hospitals to participate in the Johns Hopkins demonstration project: New Jersey, Georgia, Illinois, Ohio, Pennsylvania and Alabama. Several other states are considering participating. The nine hospitals selected by the New Jersey Department of Health and Senior Services to participate in the C-PORT-E demonstration project are: Bayonne Medical Center, Holy Name Hospital, Monmouth Medical Center, Muhlenberg Hospital, Raritan Bay Medical Center, Robert Wood Johnson University Hospital – Hamilton, Somerset Medical Center, Trinitas Hospital and Virtua West Jersey Hospital Marlton.
The nine New Jersey C-PORT-E hospitals support the regulations proposed this summer by the NJDHSS that will enable New Jersey’s continued participation in this important demonstration project.
These nine institutions have come together to provide information and to act as an educational resource for the general public throughout the public comment and re-authorization process. An informational web site has been established and can be visited at www.HealthyHeartNJ.org.
Posted: October 12, 2007