Bypass, Angioplasty Appear Safe for High-Risk Patients with Heart Failure
NEW ORLEANS, LA -- Many heart failure patients with additional heart problems who are routinely considered too sick for bypass surgery or angioplasty may benefit from these procedures after all, according to a study conducted by cardiologists at Duke University Medical Center.
While their study involved only 125 patients, the researchers said they believe the results are strong enough to suggest that physicians should not automatically rule out revascularization procedures in these patients. The researchers said a larger prospective study should be conducted to further define which of heart failure patients would best benefit and how many more years of life they may gain.
This follow-up study, led by Duke cardiologist Dr. Eric Velazquez, found that 38.5 percent of these high-risk patients who received revascularization procedures were alive after five years, compared to 28.8 percent who did not have a procedure performed. Of the group that received a procedure, 41.7 percent of the bypass patients and 32.1 percent of the angioplasty patients were alive after five years.
Velazquez prepared the results of his study for presentation Sunday at the annual scientific sessions of the American College of Cardiology.
"Most physicians in the community do not even consider referring these patients for bypass surgery or angioplasty, and their decisions are not based on any concrete data, but on the assumption that the procedures would be too risky," Velazquez said. "But in our practice here at Duke we know that we can help some of these people, so we examined detailed data which we had collected on the sickest heart failure patients."
The trial, known as HIRMIT (High Risk Myocardial Ischemia Trial), enrolled patients with heart failure, a condition marked by an enlarged and weakened heart. These patients also had coronary artery disease and reduced strength of the left ventricle, which pumps blood throughout the body and whose pumping power is measured by ejection fractions.
All patients had been turned down for bypass, angioplasty and heart transplantation as a routine way of controlling their heart disease.
About one-fifth (23) of the patients agreed to be randomized to one of three arms: coronary bypass grafting, angioplasty or continued medical treatment. Of the other group, 37 ended up receiving one of the revascularization procedures as a last-ditch measure to save their lives.
"This was considered a 'last chance' type of trial," Velazquez said. "These patients were the sickest of the sick."
Patients were enrolled at Duke from 1989 through 1992. As an indication of how sick these patients were, only 20 of the original 125 patients are still alive today.
"While our results are not statistically significant, for a group of patients where no prospectively gathered data are available, it seems that revascularization can benefit these patients," Velazquez said. "This trial shows the feasibility and necessity of a larger trial of revascularization versus medical therapy in patients with low ejection fractions, coronary artery disease, and clinical heart failure.