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Study: Angioplasty risk may be exaggerated

Sunday, March 30, 2008
Last Updated Sunday March 30, 2008, EDT 10:17 AM

[Image courtesy of know-heart-diseases.com]

Elective angioplasties at hospitals without emergency heart surgery resources may not be as risky as previously feared, according to a study released Saturday.

The study by the American College of Cardiology used a 300,000-patient database to determine that the success and complication rates are similar whether or not there is a backup surgery team.

If confirmed by other ongoing studies, the findings could influence policies in many states, including New Jersey.

The state is participating in a Johns Hopkins University study in which Teaneck's Holy Name Hospital and eight other hospitals without heart surgery capabilities are being allowed to perform elective angioplasty on an experimental basis.

Deaths and complications related to elective angioplasties are controversial in North Jersey.

The family of a North Bergen woman sued Holy Name Hospital and two cardiologists in February, arguing that her 2006 death was the result of a botched angioplasty.

Pearl Sullivan died after a heart artery ruptured during the procedure.

"What we don't want is a huge proliferation of hospitals" doing this without strict quality safeguards, or in places that already have many heart centers, said Dr. Ralph Brindis, a heart specialist at the California-based Kaiser Permanente health plan. Brindis supervised data collection for the study released Saturday.

Many states ban cardiac angioplasties at hospitals without heart-surgery units except in emergencies like heart attacks. Small hospitals, which can earn $15,000 or more on each angioplasty, have pressed for a reexamination of the rules. They say stents that have come on the market in recent years have made angioplasty safer by limiting how many times the balloon is inflated and the risk of puncturing an artery.

The procedure earns hospitals statewide $300 million to $400 million and could mean a significant amount of money for community hospitals without cardiac surgery ability.

Most elective angioplasties are for chest pain and non-urgent situations. The procedure helps relieve clogging in arteries, lowering risk of heart attack or other related problems. In an angioplasty, doctors push a tiny balloon into an artery, inflate it to flatten the clog and often place a stent to prop the vessel open.

The patient registry is not definitive science, but suggests that safety is pretty good at small hospitals doing angioplasties, as long as strict quality controls are in place.

Researchers compared results from January 2004 through March 2006 on 9,029 patients who had angioplasty at 61 centers without on-site cardiac surgery to 299,132 patients at 404 centers with heart surgeons. Only about half of the hospitals without surgical backup did more than three dozen angioplasties a year.

Yet complications and success rates were similar, said study leader Dr. Michael Kutcher of Wake Forest University in Winston-Salem, N.C.

Roughly four of every 1,000 patients needed emergency bypass surgery — far fewer than in the past. Nearly 2 percent died at hospitals without backup surgery versus just over 1 percent at larger hospitals. But there was no significant difference once researchers factored in age, severity of illness and other differences among patients.

Results did not differ for urgent or non-urgent angioplasties, though a greater portion of those at small hospitals were emergencies.

The issue has been most contentious in New Jersey. The nation's most densely populated state has 18 hospitals with heart surgery programs — one within a half-hour of virtually every resident — and they don't want more competition.

New Jersey's participation in a nine-state study comparing how patients fare at hospitals with and without heart surgeons has led to a lawsuit against the state. Some big hospitals have said patient safety was jeopardized, but a court allowed the state to remain in the study. The results aren't expected for at least two years.

Doctors will wait for more definitive studies to say the practice is safe, said Brindis, the Kaiser Permanente doctor.

Staff Writer Evelyn Shih contributed to this article, which also contains material from The Associated Press.