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New Jersey Health Care Administration Board Votes for Continuation of Elective Angioplasty Demonstration Project

Posted on: Thursday, 15 November 2007, 15:00 CST

The state Health Care Administration Board (HCAB) today voted to approve for final adoption regulations proposed by the New Jersey Department of Health and Senior Services (NJDHSS) that will enable New Jersey's continued participation in a national demonstration project on elective angioplasty. The study, being conducted in six states by cardiologists at Johns Hopkins Medical Institutions, will 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. The board voted in favor of adopting the revised regulations, which were developed by NJDHSS in response to a Supreme Court ruling on May 31 of this year. The Commissioner of NJDHSS has until November 30 to enact the new regulations.

"Today's vote represents a major step forward for patients, hospitals and health care policy in general in the state of New Jersey," said Richard P. Miller, President and CEO of Virtua Health. "This is an extremely important study, the results of which will be integral to our ability to provide the highest quality cardiac care to residents of New Jersey -- now and in the future. The quality and integrity of the project are beyond reproach, and we are gratified that the board has recognized these facts and acted in favor of its continuation."

The Johns Hopkins-led study, conducted by the Cardiovascular Patient Outcomes Research Team, or C-PORT, 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.

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. 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 - 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. NJDHSS promptly developed revised regulations which were accepted by the HCAB on July 19. The new regulations were then published in the New Jersey Register and subject to a 60-day public comment period before being presented to the board for final adoption this morning.

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.

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. They 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 the study, 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.

The nine New Jersey C-PORT-E hospitals have come together to provide information and to act as an educational resource for the general public on this important public health issue. An informational Web site has been established at www.healthyheartnj.org.

Source: Business Wire

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