A large study finds that it is OK to have a non-emergency procedure to open clogged heart arteries in a hospital that doesn't have surgeons ready to operate if something goes wrong. The results could help make this much more available in rural areas and at smaller community hospitals.
The procedure, called balloon angioplasty, has become so safe that surgical backup is no longer needed when treating low-risk, simple cases, doctors say. Only about 20 states allow this now, and hospitals in some areas have sued so they can offer it.
"The intent of this project was not to expand the number of centers doing angioplasty" but to give policymakers an idea whether it is safe, said study leader Dr. Thomas Aversano of Johns Hopkins University. He presented results Monday at an American Heart Association conference in Florida.
Nearly a million angioplasties are done each year in the United States. Most are non-emergency cases for people having chest pain because clogged arteries are keeping enough blood from reaching the heart.
The treatment involves pushing a tube into an artery and inflating a tiny balloon to flatten a clog. A mesh scaffold called a stent often is placed to keep the artery open. In rare cases, a tear in an artery or other complication will require emergency surgery, but these problems have become less frequent as the procedure has grown more common in recent years.
The study was the first large experiment to see if doing it without surgical backup was safe. About 4,500 were given angioplasty at hospitals that had heart surgeons available, and 14,000 others had it at facilities without one. Hospitals without heart surgeons on duty had to complete special training to make sure experienced doctors were doing the angioplasty procedures. And patients were carefully selected to avoid especially troublesome types of blockages.
Six weeks after angioplasties were done, success rates, complications and deaths did not differ between the two groups of patients. Emergency surgery was needed in only 30 cases _ patients were transferred to hospitals with that capacity if the one treating them lacked it.
"The risk was small and there was no signal of harm" from having the procedure in a hospital without heart surgeons on duty, said Dr. Elliott Antman of Brigham and Women's Hospital in Boston, leader of the heart association conference.
"You could have it done in your community suburban hospital. The advantage is you don't have to travel terribly far from where you live," Antman said.
Guidelines from major heart groups long advised against angioplasty where heart surgeons were not available, but they were changed just last week to say it's not unreasonable to consider it, said Dr. Ralph Brindis, a cardiologist for Northern California Kaiser Permanente and past president of the American College of Cardiology.
Brindis and Antman, though, said they personally wouldn't take the risk.
"I would prefer to have my own angioplasty at a center that has surgical backup," although many people in rural areas may find travel to such a hospital burdensome, Brindis said.
Heart Association: http://www.americanheart.org
Marilynn Marchione can be followed at http://twitter.com/MMarchioneAP