Hospitals Oppose New Dept. Of Health Rules That Endanger Cardiac Patients

Cooper University Hospital, Deborah Heart and Lung Center and Our Lady of Lourdes Medical Center opposed new rules published today in the New Jersey Register that would continue the elective angioplasty experiment in which the New Jersey Department of Health and Senior Services has said four patients have died.

The rules would allow hospitals without the capability to perform open heart surgery to perform elective angioplasty as part of an experiment. Current state rules and national clinical guidelines require on-site open heart surgery be available for hospitals performing elective angioplasty. Statistics show 1 or 2 in 500 elective angioplasties develop complications that sometimes require immediate open heart surgery to correct.

The proposed rules also could increase the number of unqualified elective angioplasty hospitals in the study to 12, up from the current nine, although no study has shown New Jersey needs more elective angioplasty centers. Currently, 18 hospitals meet all state regulations for providing elective angioplasty safely and every potential heart patient in New Jersey is within a short drive of these hospitals.

“The study will dramatically increase the number of hospitals in New Jersey performing elective angioplasties though the need for the procedure has leveled off. This will increase the number of hospitals with poor volumes and lower the quality of elective angioplasty in New Jersey,” said Dr. Joseph Parrillo, Director Cooper Heart Institute and Chief Department of Medicine, Cooper University Hospital. “This experiment benefits a few hospitals but ultimately hurts cardiac care and the quality of care for cardiac patients.”

“Until now, the policy of New Jersey has been to create cardiac centers of excellence that provide high quality care in accessible areas to patients around the state. Now, we are allowing hospitals to perform elective angioplasty without required safety procedures, without a demonstrated need, and clustered among cardiac centers that already perform the procedure safely,” said Dr. Jan Weber, Chief, Division of Cardiology Our Lady of Lourdes Medical Center. “The ultimate result of this unscientific experiment will be to weaken the quality of our cardiac centers that we have worked so hard to create.”

New Jersey Commissioner of Health and Senior Services Fred M. Jacobs, MD., J.D., has told a meeting of cardiac advisors in June 2007 that four out of 1,100 patients in the angioplasty experiment had died.

The hospitals also condemned the experiment for not disclosing to patients that the study violates national clinical guidelines for safety. The study also violates New Jersey regulations that prevent charging fees to patients who receive medical treatment as part of scientific studies.

The proposed rules were published today in the New Jersey Register and, if adopted after a 60-day comment period, would allow the Atlantic C-PORT-E trial to continue in New Jersey. In a ruling May 31, 2007, a case brought by the three hospitals, the New Jersey Supreme Court said the study violated NJ Department of Health and Senior Services safety rules and regulatory procedures.

If the new rules are not approved, unqualified New Jersey hospitals will stop performing elective angioplasty on November 30, 2007.