March 31, 2008 (Chicago) -- Angioplasty procedures to open clogged heart arteries can be performed safely and successfully at medical centers that don't have a heart surgery team on site in case of an emergency, a large study suggests.
But the findings should not be interpreted as an endorsement of that practice, says researcher Michael A. Kutcher, MD, director of interventional cardiology at Wake Forest University Health Sciences Center in Winston-Salem, N.C.
"Given a choice, I would still suggest going to a hospital with surgical backup," he tells WebMD. "But it does offer some reassurance that angioplasty can be safe [at centers without backup] -- if they have a very structured process and a strong commitment to quality."
Kutcher and colleagues analyzed data on 9,029 patients who had angioplasty at 61 centers without heart surgery backup and 299,132 patients at 404 centers that had a heart surgery team on site. It's the largest study to look at the issue.
The findings were presented at a meeting sponsored by the Society for Cardiovascular Angiography and Interventions (SCAI), which was held in conjunction with the American College of Cardiology (ACC) summit.
Angioplasty is a common treatment for coronary artery disease, in which plaque builds up in the heart's arteries, making it harder for blood to get through and depriving the heart muscle of oxygen. Untreated, it can lead to heart attacks and chronic chest pain that worsens when you exercise.
During angioplasty, a balloon at the end of a long tube is threaded through an artery in the groin. An interventional cardiologist carefully guides the probe up through the patient's leg and into the arteries of the heart, where the balloon is inflated to open the vessel. An expandable wire mesh tube called a stent is often inserted to keep the vessel open.
If you're in the throes of a , guidelines call for getting treatment at the closest medical center -- and the new study doesn't change that.
But most angioplasties are scheduled, when the procedure is less urgent. In these cases, it's recommended that heart surgeons be available to perform bypass surgery in the rare -- but potentially fatal -- chance that an artery is punctured.
Some small hospitals argue that the guidelines are outdated, pointing out that emergency bypass surgery is needed in only about 0.3% of angioplasty patients. They say they need to include elective procedures in their mix in order to survive economically and to keep staff skills high.
Kutcher says that despite a lack of studies showing it is safe, more and more U.S. hospitals are performing angioplasty without surgical backup.
Well-Run Centers Studied
For the new study, the researchers looked at information from the National Cardiovascular Data Registry, to which hospitals voluntarily submit data.
Results showed that the angioplasty procedure was a success at 94% of hospitals that didn't have surgical backup and 93% of centers that did -- a difference so small it could have been due to chance.
Fewer than four of every 1,000 patients in both groups needed emergency bypass surgery. There were also similar rates of complications (6.4% vs. 6.3%, respectively) and deaths (1.8% vs. 1.2%).
Kutcher says that the hospitals with off-site programs studied probably represent the cream of the crop. A total of 92% were prepared to do angioplasty 24/7. In 75% of cases, the hospital where patients were taken in case of an emergency was less than 30 minutes away.
Plus, the fact that they voluntarily submitted data to the national database shows a commitment to quality, Kutcher says.
"These medical centers are very accomplished and represent the premier programs offering PCI with off-site cardiac surgical backup," he says. "And they are doing angioplasty for the right reasons: to improve outcomes for heart attack patients and to better serve patients in remote geographic areas."
A Change in Angioplasty Guidelines?
SCAI President Bonnie Wiener, MD, director of interventional research at Saint Vincent Hospital in Worcester, Mass., says the findings could lead to a re-examination of the guidelines.
"In the right circumstances, with the right quality and systems in place, angioplasty without onsite surgery can be safe and effective," she tells WebMD.
But what the researchers do not want is a "wild expansion of offsite [angioplasty] programs" in urban areas that already have a lot of hospitals with surgical backup, Kutcher says.
So what should you do if you or a family member has an elective angioplasty coming up and there's no center with surgical backup nearby?
First, ask how long it will take to get to the closest center that offers bypass surgery, Kutcher says. If it's more than 90 minutes away, explore other options, he advises.
Regardless of whether backup is available, ACC guidelines recommend that you go to a hospital that does at least 200 procedures a year. The cardiac interventionalist should do 75 or more procedures annually, Kutcher says.
In the study, only 30% of programs without surgical backup performed more than 200 procedures annually.
Also, ask if the interventionalist is board certified and if the hospital reports its success rates to the National Cardiovascular Data Registry or is otherwise reviewed by independent doctors, Kutcher advises. Both are signs of well-run, quality programs, he says.