FDA panel rejects heart laser surgery

Web posted July 29, 1997

Associated Press

A panel of government scientists Monday voted against approving an unusual operation intended for the sickest coronary patients, who would get up to 40 holes burned into their hearts with a fast-pulsing laser.

Experts on heart disease and laser surgery were assembled from throughout the United States and met near Washington, to decide the fate of a carbon-dioxide laser manufactured by PLC Medical Systems Inc. of Milford, Mass.

The heart-blasting laser was touted by its makers as having the potential to revolutionize heart surgery by providing a treatment option for patients with angina who had been all but written off by their doctors.

``The panel recommended against approving the device because of questions both about safety and effectiveness,'' said Food and Drug Administration spokeswoman Sharon Snider.

Columbia-Presbyterian Medical Center in New York City, Harvard University's Brigham and Women's Hospital in Boston and the Texas Heart Center in Houston were among the centers around the country where the device was tested.

``I am a little surprised,'' said Dr. Craig Smith, chief of cardiac surgery at Columbia-Presbyterian. ``The finding is that 75 percent of patients have significant relief of angina.''

Angina pectoris means ``strangling in the chest.'' It is the most common form of heart disease and is characterized by crushing pain. It occurs when the flow of blood into the heart is insufficient to meet the body's demands because fatty debris obstructs vascular pathways.

Seven of the heart-piercing operations had been performed with the PLC laser at Columbia-Presbyterian; another seven have been performed in a clinical trial of a YAG laser, which uses a metallic element instead of a gas as its power. The second laser was not under consideration by the FDA Monday.

The controversial treatment, in which laser pulses are fired between heartbeats, is called transmyocardial revascularization. Patients who got the laser treatment generally had been turned down as candidates for bypass surgery or balloon angioplasty because their vessels were too badly damaged. The procedure creates a perfusion of blood into the damaged muscle by producing anywhere from 19 to 40 tiny holes.