South Shore Hospital is among seven community hospitals the Senate has voted to let perform artery-clearing angioplasty treatments even though a safety study into the treatment is years from completion.
When seven community hospitals joined a clinical trial two years ago and began performing routine angioplasties, the goal was clear: to determine if patient-safety is compromised without heart surgeons on-hand.
The trial is far from finished and no findings have been released. But on Beacon Hill, the Senate has approved a measure that would allow the hospitals to perform the life-saving and lucrative procedures permanently – regardless of the study’s eventual outcome.
At issue is whether more hospitals should be allowed to offer the artery-clearing procedure, which has long been restricted to academic medical centers with open-heart surgery programs.
Across the country, a debate has unfolded among cardiologists and policymakers on whether that remains essential for rare instances when an angioplasty fails and surgery becomes necessary.
Hospitals in the study – South Shore Hospital in Weymouth, Caritas Norwood Hospital and Brockton Hospital among them – insist patients are safe in their hands.
“This means patients could be treated at home, in their communities, by doctors they’re comfortable with,” Dr. Mark Furman, chief of cardiovascular medicine at South Shore Hospital, said.
In recent years, the number of angioplasties – where a tiny balloon is inflated in a clogged artery and, often, a metal stent is inserted to keep the passage open – has soared. And community hospitals have pressed for the right to perform them, arguing patients deserve close-to-home care and hospitals deserve a chance to profit from the growing market.
Since 1998, state regulations have permitted several community hospitals to perform angioplasties in an emergency. In non-emergencies, community hospital doctors must send their patients to Boston for the procedure.
To ensure safety, it should remain that way, according to the American Heart Association and the American College of Cardiology, which have jointly recommended against angioplasties at hospitals without heart surgery programs.
Dr. Burton Polansky, emeritus chief of cardiology at Brockton Hospital, said cardiologists there are skilled at angioplasty after years of emergency procedures.
“How is it we can do that, but we can’t do it at nine o’clock in the morning when everything is thought out and planned,” he said.
The five-year clinical study began with approval from the state Department of Public Health. It is overseen by the Harvard School of Public Health, which tracks the procedures to see if more patients die than at hospitals with open-heart surgery units.
The study calls for a sample of 6,000 patients. As of last Thursday, 968 had enrolled, said Donna Rheaume, spokeswoman for the health department. There have been no findings, she said.
But during Senate debate last week on a major health-care bill, Sen. Steven A. Baddour, D- Methuen, tacked on an amendment that would let the hospitals do the procedures without concluding the study, “in recognition of the successful comparative outcomes” so far. There was no floor debate and it passed unanimously. Baddour did not return calls for comment on his reasons for the amendment.
Approval from House lawmakers and Gov. Deval Patrick are still needed.
The hospitals, two of which border Baddour’s district, have each paid $200,000 so far to fund the study, Rheaume said.
Hospitals are hesitant to reveal how much they charge for angioplasty, but the price-tag can be high.
The Centers for Medicare and Medicaid Services reports hospital charges at $15,000 to $18,000.
Dr. Furman of South Shore Hospital, among the most active in the study, said money is not behind hospitals’ push to offer nonemergency angioplasty.
“This would mean patients can be treated at home, in their communities, by doctors they’re comfortable with,” Furman said. “I’m convinced it’s safe.”
Twenty-eight states allow hospitals without surgical units to do the procedures, he added, and research shows it is safe.
In Massachusetts, 12,921 non-emergency angioplasties were performed from October 2005 to October 2006 – 82 of the patients died.
John P. Kelly may be reached at email@example.com.