Some community hospitals by January will be able to offer patients routine angioplasty, the popular artery-clearing procedure that long has been restricted primarily to the state's academic medical centers.
The Department of Public Health will allow community hospitals that meet certain criteria to offer angioplasty if they agree to participate in a five-year study to track patient mortality rates and complications. Paul Dreyer, director of the Division of Health Care Quality, said officials will establish criteria in the coming months.
The number of angioplasties -- a procedure in which a cardiologist inflates a tiny balloon inside an artery and often inserts a wire stent to prop it open -- is soaring. They are now more common than cardiac bypass surgery, which a decade ago was the favored way to treat diseased arteries. But the growth in angioplasty also has sparked disputes in many states, including Massachusetts, over who should perform them and where.
In about a dozen states, including Massachusetts, nonemergency angioplasties are allowed only at hospitals with open-heart surgery programs, usually teaching hospitals. As a result, community hospitals are trying to persuade legislatures and state regulatory boards to allow them to perform the procedure. Community hospital executives argue that a change will increase patient convenience and generate thousands of dollars in revenue for smaller hospitals.
In Massachusetts, doctors performed 17,608 angioplasties last year, a 50 percent jump since 1998. Fourteen Massachusetts hospitals with heart surgery programs are allowed to offer nonemergency angioplasties, which make up the bulk of the total procedures.
In December, a committee advising the health department, made up of teaching and community hospital cardiologists, voted down a proposal to allow community hospitals to offer angioplasties as part of a study run by a Johns Hopkins Medical Center physician. But this week, the group voted 12 to 1 to set up a clinical trial just in Massachusetts overseen by the Harvard School of Public Health, Dreyer said.
Dreyer said he's not sure which community hospitals will offer angioplasty, because hospitals have to apply. But he said some already have expressed interest, including South Shore Hospital in Weymouth, Brockton Hospital, Caritas Norwood Hospital, and MetroWest Medical Center in Framingham. Only hospitals that already perform emergency angioplasty can apply, Dreyer said.
Dr. Richard Zelman, a cardiologist at Cape Cod Hospital in Hyannis, was the only advisory committee member to dissent.
Zelman said he objects to the study design because the trial will take five years to complete and has not secured outside funding -- hospitals that participate must pay for the data collection and analysis, about $1 million a year. He said that's too long to find out whether the procedure is as safe at community hospitals as at academic medical centers.
Instead, Zelman said, Massachusetts should push for a multistate trial that can enroll a larger number of patients and produce results faster. He said he's concerned that the study is just a way to give community hospitals approval to offer angioplasties. Cape Cod Hospital already offers routine angioplasty because its doctors received special approval to perform open heart surgery.
''If we're just giving hospitals a vehicle to start performing these, we shouldn't be fooling ourselves," he said.
Dreyer said officials hope to recruit 4,800 patients to take part in the five-year trial. Patients diagnosed with clogged arteries at participating community hospitals and need an angioplasty will be given a choice: They can be transferred to a teaching hospital for the procedure, or enroll in the clinical trial. Patients who enroll in the trial will be randomly assigned to either a community or teaching hospital, with a 75 percent chance they will stay at the community hospital.
If health officials discover safety problems, they can stop the trial at any point, Dreyer said.
Liz Kowalczyk can be reached at kowalczyk@globe.com. ![]()