Angioplasty without on-site surgery prompts lawsuit

A New Jersey hospital is suing to stop the first randomized trial that will compare outcomes in hospitals with and without surgical backup.

Controversy over whether nonprimary angioplasty should be performed with or without surgical on-site backup has sparked a lawsuit by one New Jersey hospital over an upcoming randomized clinical trial.

The trial, led by Thomas Aversano, MD, Johns Hopkins University, will enroll patients undergoing nonprimary angioplasty and will compare patient outcomes, primarily mortality, between those who are treated at hospitals with on-site cardiac surgery to those without on-site cardiac surgery.

“Currently, most states and all the national organizations such as the American College of Cardiology and the American Heart Association require or recommend that angioplasty be performed only at hospitals with a cardiac surgery program,” Aversano told Cardiology Today.

Aversano said the reasons for this requirement are historical; when angioplasty was developed in the late 1970s, the complication rate requiring emergency surgery was as high as 15%. “Over the past 20 to 25 years, the need for cardiac surgery has decreased 100-fold, which inspired the idea that we do not need cardiac surgery anymore,” he said.

Lynn B. McGrath

Lynn B. McGrath, MD, chief of the medical staff at Deborah Heart & Lung Hospital, in Browns Mills, N.J. the institution that has filed the lawsuit, did not dispute that the need for cardiac surgery during angioplasty is very low.

“But if it happens to you, it’s 100%,” McGrath told Cardiology Today. “I don’t believe that I would want to send my family member, my loved one, my patient, to have an angioplasty and a stent in an institution where there is no cardiac surgery available.”

Underutilization

Aversano said the trial was scheduled to begin enrollment this summer, and state health departments in Massachusetts, Connecticut, Ohio, Georgia and Maryland are actively considering enrolling patients.

New Jersey has already agreed to participate, Aversano said. The lawsuit filed by Deborah Heart & Lung Hospital seeks to stop the New Jersey Department of Health from participating, according to local news reports.

“Our goal is to halt the institution of an unneeded, unwanted, unnecessary program,” McGrath said.

A spokesman for the American Hospital Association said he knows of no other similar lawsuit in the country. Aversano said he has encountered no other hospital that has used this tactic. “I expected this sort of reaction, however, because this is a study that is going to change health care policy for literally hundreds of thousands of patients. That’s not an exaggeration,” he said.

Aversano said that the change would be positive. “Access to this form of therapy is, in fact, being denied and there is an underutilization of this procedure. Patients with acute coronary syndrome who are admitted to hospitals that do not have this capability are not being transferred to hospitals that have angioplasty with surgical backup. As a result the mortality rates are much higher,” he said.

“We have this idea about regionalization of health care, especially with procedures like angioplasty, and it’s a nice idea when you are sitting around a table, but in the real world of health care it’s a failure.”

Deborah Heart & Lung Hospital is one of 17 hospitals in New Jersey that can perform angioplasty. “Obviously we have a vested interest because we have a busy cath lab and we have heart surgery here. We know from experience, however, that the quicker you get a bypass made if your artery becomes obstructed, the better your chances are for a full recovery,” McGrath said.

Patient care

Case report studies about whether patients fare better in hospitals with or without access to cardiac surgery have yielded mixed results. Aversano said there are now about 80,000 patients reported in the literature that have undergone angioplasty at hospitals without on-site cardiac surgery. The ACC in March reported on about 2,500 patients undergoing angioplasty without on-site surgery — and outcomes were essentially identical to those at hospitals with on-site surgery. However, a review of about 625,000 Medicare case reports reported in the JAMA found higher adverse outcomes in patients treated at hospitals without surgical capability that performed very low volumes of angioplasty.

George W. Vetrovec, MD, chairman of the division of cardiology at the Virginia Commonwealth University Medical Center, and editorial board member of Today in Cardiology’s Interventional Cardiology section, said the reason for the disparity in outcomes might be subtler than whether the surgery is available.

“Surgery is a marker for the commitment of a hospital to do on-site angioplasty,” Vetrovec told Cardiology Today. “Hospitals that are really committed to a huge cardiac program have well-staffed cath labs with well-trained staffs. In some of the smaller programs that may not be the case.” – by Jeremy Moore