By MARY JO LAYTON and BOB GROVES

Reports of patients dying after elective angioplasty have heated up debate over the safety of the procedure without a cardiac surgery team to handle complications.

At least four patients have died, said the chiefs of cardiology from two hospitals that contend surgical backup teams are essential. A report published this week puts the number of deaths at seven.

"Pure and simple, it's a safety issue," said Dr. Jay R. Weber, chief of cardiology at Our Lady of Lourdes Medical Center in Camden. Weber said he recently learned from state health officials that four of 1,000 patients have died.
Our Lady of Lourdes is one of three hospitals with cardiac surgery teams that had sued to stop the state from allowing hospitals without surgical backup to offer the procedure to clear blocked arteries.

The disclosure of the deaths comes as state Health Commissioner Fred M. Jacobs prepares to appear before a state board to discuss rule changes that will allow as many as 12 hospitals without surgical backup teams to perform the procedure. Nine hospitals, including Holy Name Hospital in Teaneck, are currently performing the procedure without such backup. Holy Name spokeswoman Jane Ellis could not be reached for comment.

Jacobs would not comment on any fatalities, said Tom Slater, a Health Department spokesman.

But Dr. Augustine Agocha, chief of cardiology at Deborah Heart and Lung Center in Browns Mills, said he "heard of at least four deaths." His hospital had joined Our Lady of Lourdes and Cooper University Hospital in Camden in the suit against the state.

It not known where the patients were having their angioplasties -- and whether they would have had the same complications at hospitals with surgical backup. The patients were transferred to hospitals with cardiac surgery teams, though Agocha said he did not know whether some died en route or at the hospital where they were transferred.

Adding to the debate over safety, NJBIZ, a business publication, reported seven deaths without citing the source of the information.

New Jersey is allowing the nine hospitals to offer elective angioplasty as part of a nine-state study sponsored by Johns Hopkins University that will compare the results of angioplasty performed in hospitals with and without the ability to perform surgery on-site.

Dr. Thomas Aversano, who is directing the three-year study of 16,000 patients, also declined to comment on any deaths. "It is unethical for me to discuss any interim results," he said.

A national "data and safety monitoring board" meets semiannually -- most recently on May 17 -- to review the data from the study. If the study were unsafe for patients, he said, the board would end it.

He added that he couldn't believe the level of acrimony on the issue in New Jersey. "It's reached a level of insanity that I haven't seen elsewhere," he said.

The battle has pitted New Jersey's hospitals against each other because the procedure brings in $300 million to $400 million annually. The debate over money and safety resulted in a flood of editorials in several newspapers this week, an ad campaign warning patients of potential dangers and a flurry of e-mails and phone calls in anticipation of Jacobs' proposal.

The three hospitals that sued the state after it allowed hospitals to offer elective angioplasty won a Supreme Court ruling in May. The court ruled that without the new rules that Jacobs is presenting today to the Health Care Administration Board, the nine hospitals now performing angioplasty would have to stop.

Advocates for limiting the procedure to hospitals with on-site backup surgery say patients are at greater risk without such backup. In about 1 out of 500 cases, something goes wrong that requires intervention by a cardiac surgical team, said Gary S. Young, executive vice president of Cooper University Hospital.

The American Heart Association, American College of Cardiology and the Society for Cardiovascular Angiography and Intervention all say elective angioplasty should only be done at a hospital with on-site cardiac surgery.

Proponents of allowing more hospitals to offer elective angioplasty say it will increase availability for a much-needed procedure. Advances in angioplasty -- improvements in catheter design, the advent of stents, metal meshes to prop open arteries, and better monitoring -- have made it safer. Emergency bypass surgery is performed in 2 percent to less than 0.4 percent of cases, state health officials said.

But Young said that patients are at 38 percent greater risk of death if the elective angioplasty is done at a hospital without cardiac surgery. And nowhere in the patient consent form are patients told of the greater risk of death in the event of complications, he said.

Before the rules can be enacted, they must be published in the state register. The public comment period lasts for 60 days.

The hearings will no doubt generate substantial debate.

"There is always controversy that attends this kind of thing, but it hasn't reached the vitriol of New Jersey," Aversano said.

Source:www.northjersey.com