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Announcement
Posted on 07.02.02
Update on Laser Treatment for Patients with Heart Disease
By Judith M. Kramer, MD, MS and Nancy M. Allen LaPointe, PharmD
In a previous article, we described a study being conducted by the Society for Thoracic Surgeons (STS), Duke CERTs researchers, and the U.S. Food and Drug Administration (FDA) that is evaluating the safety of a new laser treatment for patients with severe chest pain: transmyocardial revascularization (TMR). This article covers the progress of this study.
The treatment uses a laser to "drill" tiny holes in the parts of the heart muscle that are not getting enough blood. These areas are said to be ischemic. The FDA approved two laser devices in 1998 for patients with ischemic chest pain who do not get relief from either coronary artery bypass grafting (CABG, or "bypass surgery"), in which another blood vessel is used to bypass a blocked artery in the heart, or angioplasty, in which a balloon threaded into the blocked artery is used to compress the obstructive material against the inner walls of the vessel.
Over 500 hospitals around the U.S. are collecting information about the heart surgeries they perform, and they are putting the information into one large common database. The STS, Duke CERTs, and FDA researchers have used the information in this database to examine the use and outcomes of TMR over time.
From January 1998 through December 2001, 3136 patients had received TMR. Of note, about 80% of these patients had the laser treatment combined with CABG. The bypass grafts were placed in ischemic areas of heart muscle that could be reached by these connecting blood vessels, and TMR was performed in ischemic areas that could not be reached by the bypass grafts.
During this time, the number of hospitals in the database performing TMR increased from 5% to 32%. The results of this study are being developed for publication and will include why patients received TMR and how well they did after the procedure.
Recent articles have described the use of TMR with CABG in patients with ischemic heart muscle that could not be reached by bypass grafts. We hope that our study will add important information to what is already known about this treatment, to better understand its benefits and risks.