Hospitals to keep performing elective angioplasties in non-emergency cases until December 2012
Laure Rosales RT prepares for an angioplasty procedure at Cardiac Catheterization Laboratory in Raritan Bay Medical Center located in Perth Amboy on 03/26/10. The center is one of the 11 hospitals allowed to participate in performing angioplasty.TRENTON — A state health board recommended today 11 community hospitals should continue participating in a national study that allows them to perform the artery-clearing procedure known as angioplasty, despite not being licensed to provide heart surgery.
The state Health Care Administration Board's 7-2 vote with one abstention allows these hospitals to keep performing elective angioplasties in non-emergency cases until December 2012 — a year after a Johns Hopkins University researcher says he expects the study data to be collected and analyzed.
Cardiologist and researcher Thomas Aversano had asked for an extension from April until the end of this year, so more patients could be added and analyzed. But at the Department of Health and Senior Services' request, the board gave him another year, when his research is expected to be published in a medical journal, so not to "disrupt" patient care, a department official said.
Aversano is conducting the study to determine whether patients would benefit if non-emergency angioplasties were more widely available at hospitals that are not permitted to perform heart surgery.
Since its inception about five years ago, the study has stirred up controversy in New Jersey, where community hospitals — many of which struggle financially — are eager to offer the lucrative service.
Doctors, nurses and executives from many of the participating hospitals told the board today their patients are grateful they can get this non-emergency service safely without having to change doctors or drive to a unfamiliar medical facility.
Ray Fredericks, President & CEO of Solaris Health System said after the vote he was pleased JFK Medical Center in Edison would continue participating. "It is about more than just good science – it is about providing access to good care. Everyone in the communities we serve deserves access to this important and potentially life-saving procedure,'' Fredericks said.
The board's decision however, disappointed a prominent health care think tank, as well as executives from heart surgery hospitals. They have long argued the procedure is too risky to perform without a cardiac team on-site. And with 18 licensed cardiac hospitals in the state, these hospital executives have argued, patients should have no trouble finding one close to home.
Catherine Angrisani-Purnell of the New Jersey Health Care Quality Institute questioned why the board would allow the 11 hospitals to continue performing angioplasties about a year after the researchers stop monitoring patients and collecting data. That "scheme. . .will carry the project into perpetuity,'' she said.
The study "has never been done in an open or transparent way,'' Angrisani-Purnell said, noting the institute has repeatedly asked for the number of deaths associated with these procedures. "We were told to wait until the study was completed, yet that date keeps being pushed forward.''
Devon Graf, director of legal and regulatory compliance for the health department, acknowledged there have been criticisms of the study but they "have not come true.''
"There were discussions of putting hospitals out of business,'' Graf said. "Some predicted a lot of people have been dying on the operating table. We have just not seen that.''
Bayonne Medical Center in this 2007 photo. The center is one of the 11 hospitals allowed to participate in performing angioplasty.Graf said there is a data and safety monitoring board at Hopkins that reviews data. "They would advise us if they determine if there is a problem,'' he said. "It has not indicated to us anything we should be concerned about.''
Angioplasty involves inserting a catheter and a balloon through the patient's groin to clear a coronary artery clogged with plaque. These hospitals, however, must have an arrangement with one of the 18 cardiac surgery hospitals to accept patients should something go wrong during the procedure.
Participating in the study are Bayonne Medical Center; Raritan Bay Medical Center, Perth Amboy; Somerset Medical Center, Somerville; Trinitas Hospital, Elizabeth; Virtua West Jersey Hospital, Marlton; Holy Name Hospital, Teaneck; JFK Medical Center in Edison; Clara Maass Medical Center, Belleville; Community Medical Center, Toms River; Overlook Hospital, Summit; and Riverview Medical Center, Red Bank.
Robert Wood Johnson University Hospital in Hamilton was dropped from the study in 2009 for performing too few elective angioplasties, according to state health records.
The board's vote is not the last word on the matter. The health department expects to publish new rules in the April 4 New Jersey Register, a biweekly magazine that lists proposals to change government procedures, extending the length of the study, Graf said.
The public will have 60 days to respond in writing to extending the study.