News Release

Cedars-Sinai part of study published in Sept. 30 New England Journal of Medicine on laser procedure to relieve severe angina in cardiac patients

Peer-Reviewed Publication

Cedars-Sinai Medical Center

LOS ANGELES (Sept. 29, 1999) -- Cedars-Sinai Medical Center was one of 12 U.S. medical centers participating in a study on Transmyocardial Revascularization (TMR) -- a procedure designed to reduce severe angina in cardiac patients unsuitable for angioplasty or coronary bypass surgery -- published in the New England Journal of Medicine's Sept. 30 issue. Study results indicated significant declines in angina, reduced hospital stays, improved blood flow to the heart and increased survival rates for patients who underwent TMR. Approved by Medicare this summer, the procedure is now more readily accessible for an estimated 10 to 15 percent of patients with significant heart disease and few options.

Cedars-Sinai cardiothoracic surgeon Gregory Fontana, M.D., was co-investigator for the Transmyocardial CO2 Laser Revascularization Study Group and principal investigator for the medical center and the southwestern U.S. The article, submitted on behalf of the group by three participating physicians, is entitled "Transmyocardial Revascularization with a Carbon Dioxide Laser in Patients with End-Stage Coronary Artery Disease." Other sites for the research, conducted July 1995 through September 1997, included Cleveland Clinic, Columbia-Presbyterian Medical Center, Duke University Hospital, Texas Heart Institute and Northwestern University Medical School.

"This important study confirms the efficacy of transmyocardial laser revascularization in patients who are not candidates for bypass surgery or angioplasty," explained Dr. Fontana. "In many patients, the results have been dramatic."

In addition, TMR is being integrated into treatment strategies for patients who are not fully treated with angioplasty or bypass surgery, Dr. Fontana added. "Combining TMR with these procedures may lead to even greater blood supply to the heart."

In the study, investigators randomly assigned 91 patients to undergo TMR and 101 patients to continue medical treatment. The severity of angina was documented at the study's onset as well as at three, six and 12 months. At 12 months, angina had significantly improved in 72 percent of the patients who had the TMR procedure; in contrast, only 13 percent of those assigned to medical treatment reported a decrease in their symptoms.

The TMR group also reported improved quality of life, and 20 percent improvement in blood flow to the heart. In comparison, patients receiving medical treatment had a 27 percent decrease in blood flow. Only two percent of the TMR patients were hospitalized for unstable angina as compared to 69 percent of the other study group. At 12 months, the survival rate for the TMR group was 85 percent, and the medical treatment group had a 79 percent survival rate.

Effective July 1, 1999, Medicare began reimbursement for TMR -- an innovative procedure performed at Cedars-Sinai utilizing lasers to create small channels in the heart muscle wall, stimulating the formation of new blood vessels and improving blood flow.

"This technique holds new hope for patients with severe chest pain who have no other options," said Dr Fontana, who has performed approximately 50 TMR procedures. Cedars-Sinai, the first medical center in the southwest to provide TMR, has the longest and largest surgical experience in the region and has participated in three major, national clinical trials.

According to Dr. Fontana, TMR is used extensively in Europe and Asia to relieve extreme angina, which is characterized by pain in the chest, arms, neck or back due to insufficient blood flow in the heart. Since approval by the Federal Drug Administration, the procedure has been provided at Cedars-Sinai for patients who desperately needed intervention despite the fact that Medicare or private insurance did not cover TMR. It's anticipated that other insurers will follow Medicare's lead, making the procedure more feasible for the estimated 100,000 to 200,000 patients in the U.S. who could benefit from its effects.

Retired dentist Edwin Frischling of West Covina knows first hand the relief TMR can provide. A nearly life-long diabetic, Dr. Frischling, 74, had suffered a mild heart attack in 1990 and subsequently underwent a five-way bypass and two angioplasties. Despite these procedures, he continued to experience chest pain. "I'm a big UCLA football fan, and when I watched the games and the action got exciting, I'd get terrific angina," he explained. "I'd have the same pain when I was under stress, trying to get somewhere on time or dealing with other pressures."

While undergoing his second angioplasty, Dr. Frischling asked his cardiologist about the possibility of TMR, which he'd read about in a medical journal. His doctor agreed that he might be a good candidate for the procedure, since other avenues to relieving his angina had been exhausted. Most TMR patients, like Dr. Frischling, are in their 60s and 70s, and many suffer from conditions that preclude conventional treatments. These may include very small or deteriorated blood vessels, and fragile health due to other illnesses or disease. In the past, patients deemed unsuitable for angioplasty or bypass surgery had little choice but to rely on medications and learn to live with their pain.

Dr. Frischling's query about TMR led to a referral to Dr. Fontana, who ultimately performed the procedure in October 1997. "I knew it was experimental at the time, but I decided to go for it," said Dr. Frischling, who was growing frustrated with the constraints angina was placing on his active lifestyle.

The operation involves making a small incision - three to four inches - in the left front side of the chest to allow insertion of a small laser wand. The laser's beam is directed to create small, one-millimeter channels in the heart muscle wall. The heart responds by creating tiny blood vessels that provide additional blood flow. The procedure typically requires a four- to five-day hospital stay.

Choosing TMR is a decision Dr. Frischling doesn't regret. On a scale of 1 to 10, he estimates his level of angina has dropped from 10 ("as bad as it gets") to 2 or 3 and often even a 1, despite an occasional bout. Dr. Frischling is back to enjoying his football games, he said, "I've been through two seasons and they were pretty hectic, but I did well." He also pursues a myriad of other physical activities, including regular workouts at the gym, yoga and stream fishing.

"For most patients, there's improvement right away and this continues over the next few months," Dr. Fontana explained. "By three to six months, the results are typically as good as they will get. Most patients can assume a higher level of function and become more active."

Dr. Frischling whole-heartedly concurs. "I went on a fishing trip with two 30-year-olds and held my own. I can't believe how much the TMR has helped - I was in the hot sun, on my feet six or seven hours and climbing over rocks, but it really didn't bother me. I feel like I'm getting better all the time."

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