Laser heart surgery gets closer to FDA approval
The most recent study of transmyocardial laser revascularization (TMR) showed the developing technology remains a promising treatment for patients with serious angina. The six-month study of 100 patients at 12 clinical sites showed dramatic improvement of TMR patients. Nearly three-quarters of TMR patients improved by two angina classes.
Class one angina is considered stable with pain occurring during strenuous exercise. Class four angina is considered unstable with pain occurring with only slight exertion or even at rest. Patients in the study had an average angina class of 3.7. Six months after the procedure, the group registered an average angina class of 1.7.
TMR patients had a mortality rate of 6%. In the control group of angina patients treated medically, the mortality rate was 16%.
"The patients in this study were not re-do [angioplasty] candidates or CABG candidates, [TMR] was their only option. It not only helped with the pain, but it seems it also improved their quality of life," says Penelope Carlson, RN, BSN, CCRN, cardiovascular research coordinator at Florida Hospital in Orlando.
In January, the Florida Heart Institute of Florida Hospital in Orlando became the 13th cardiac center to offer TMR as part of a clinical trial and has since performed the procedure nine times. Through the end of 1995, 350 patients in the United States and 900 patients outside the United States had been treated with TMR.
Milford, MA-based PLC Systems has been granted an expedited review of its pre-market approval application from the Food and Drug Administration and expect FDA authorization in 1997.
(Editor’s note: July’s Cost Management in Cardiac Care, p. 84, described Florida Hospital’s participation in TMR studies.)
Nathan R. Every, MD, MPH, a cardiologist at the Seattle Veterans Affairs Medical Center and assistant professor at the University of Washington in Seattle. Telephone: (206) 762-1010.
J. Tift Mann III, MD, FACC, Wake Heart Associates, 3020 New Bern Ave., Suite 520, Raleigh, NC 27610. Telephone: (919) 231-8253. Fax: (919) 231-9546.
Barbara J. McNeil, MD, PhD, Ridley Watts professor of health care policy at Harvard Medical School in Boston. Telephone: (617) 432-1909.
Chris Thomson, executive director of the Heart Institute at St. Joseph’s Medical Center, Towson, MD. Telephone: (410) 337-3939.
Deborah Hare, RN, CPHQ, director of quality management and risk management at White County Medical Center, Searcy, AR. Telephone: (501) 268-6121.
Leo M. Henikoff, MD, President and CEO of Rush-Presbyterian-St. Luke’s Medical Center, Chicago. Telephone: (312) 942-5000.
Patti Higginbotham, RN, CPHQ, director of quality improvement at Arkansas Children’s Hospital in Little Rock. Telephone: (501) 320-1100.
Robert W. Stewart, MD, a cardiac surgeon and head of Cardiac Transplantation at The Cleveland Clinic Heart Center. Telephone: (216) 444-1000.
Jeanne Sandecki, RN, Promina-Gwinnett Health System in Lawrenceville, GA. Telephone: (770) 995-4667.
Penelope Carlson, RN, BSN, cardiovascular research coordinator at Florida Hospital in Orlando, FL. Telephone: (407) 896-6611.
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