Cardiologists at Johns Hopkins have launched a nationwide study of more than 16,000 patients to see if a potentially life-saving procedure called angioplasty can be safely performed in smaller, community hospitals, easing access to the therapy for patients. Researchers expect to enroll the first study patients in early fall 2005.
Angioplasty is a procedure in which a tiny balloon is inflated and used to widen a blocked artery narrowed from the buildup of cholesterol-laden plaque. Most states' health care regulations limit the availability of angioplasty in community hospitals to emergency situations, such as during a heart attack. In all other cases, patients must be transferred to another hospital that has on-site, specialized heart surgery backup.
This kind of surgical backup has been required for nonemergency angioplasty because, in rare instances, the procedure has led to a tear in a vessel or closing of an artery rather than opening it. The risk that angioplasty patients will need emergency heart bypass surgery is less than 1 to 2 in every 1,000 cases. Indeed, medical advances in the last two decades have provided nonsurgical means of treating many of these complications, including the use of stents to keep arteries open. For these reasons, the researchers say, the need for on-site cardiac surgery backup is questionable. However, they point out, national guidelines from the American Heart Association and the American College of Cardiology have for the past 20 years maintained a requirement for on-site cardiac surgery to back up angioplasty.
"There is a large and growing number of people who could benefit from angioplasty, and the procedure is being applied to more types of heart conditions," says interventional cardiologist and study senior investigator Thomas Aversano, M.D., an associate professor at The Johns Hopkins University School of Medicine and its Heart Institute.
"Many patients with coronary artery disease admitted to hospitals that do not have angioplasty available would benefit from transfer to a hospital where they can have angioplasty performed.
"The ability to perform angioplasty at hospitals without on-site cardiac surgery will significantly improve access and outcomes for the more than one-half of patients who would benefit from such a transfer but in fact are not transferred and consequently have a higher mortality," Aversano says.
According to the American Heart Association, in 2002 an estimated 650,000 angioplasty procedures were performed on 640,000 Americans. This amounts to a 324 percent increase in volume since 1987.