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.
In the Hopkins-led study, conducted by the Cardiovascular Patient Outcomes Research Team, or C-PORT, participating patients who require angioplasty will be randomly assigned to have angioplasty at either the community hospital without on-site cardiac surgery where they underwent diagnostic catheterization or at a center with on-site cardiac surgery for angioplasty, which is the usual treatment. Each participant's progress will be followed by the researchers for a period of six months to determine their health status and whether they have any subsequent problems related to their heart. At the end of the study, expected in 2008, the researchers will compare outcomes, or well-being, of patients treated in the two groups.
About 40 community hospitals are expected to participate in the study. Special waivers from state authorities are required for participating community hospitals.
So far, six states have confirmed waivers for community hospitals to participate in the study: New Jersey, Georgia, Illinois, Ohio, Pennsylvania and Alabama. Several other states are considering granting waivers.
In addition to the waiver from their state government, participating community hospitals must also have a combined emergency and elective angioplasty volume of at least 200 cases per year and a staff whose training meets national standards set by the American Heart Association and American College of Cardiology.
Aversano has a long track record of studying best practices in medicine. His previous research, published in the Journal of the American Medical Association in 2002, showed that heart attack patients who received emergency angioplasty at hospitals without cardiac surgery as backup did better than patients initially treated with a clot-busting drug to open up the artery.
"The aim of our study is to determine what is best for the patient and what kind of hospitals should provide angioplasty services and under what conditions," says Aversano. "The results will allow physicians and health policymakers to develop evidenced-based policies about who will have access to angioplasty services, and the results, we believe, will significantly influence the overall quality of cardiovascular care in community hospitals."