The latest cure for broken hearts is to turn them into Swiss cheese.
A crop of high-tech lasers that drill tiny holes through the heart is on the way, with the first of the lot approved by the Food and Drug Administration late last month.
Although doctors can't say exactly how the lasers work their magic, the dozens of pinholes burned through the left ventricle-the workhorse pumping chamber of the heart-effectively relieve the crushing pain of angina in patients without other treatment options. Somehow the tiny holes spur the flow of oxygen-rich blood to heart muscle starved by clogged coronary arteries.
Called transmyocardial revascularization, or TMR, the laser procedure is a new option for the approximately 80,000 patients each year whose heart conditions no longer respond to drugs, such as nitroglycerin, and who can't tolerate bypass surgery, angioplasty or stents.
If clinical studies by several devicemakers pan out, the lasers may be used as supplemental therapies to those cardiological standbys.
The recent FDA approval thrusts on hospitals the question of whether it's worth the considerable expense to be the first on the clinical block to have one of the sexy, high-tech gadgets whose long-term effects and ultimate clinical role are unknown.
One thing's for sure: Lasers aren't cheap.
For now, the laser pack is represented by Franklin, Mass.-based PLC Systems, which began working on the technology in 1988. Other laser makers with products in the pipeline include Eclipse Surgical Technologies and CardioGenesis Corp., both of Sunnyvale, Calif.
The PLC laser sells for about $400,000 and also is available under a pay-per-use plan for $25,000 down and about $3,500 per procedure, says Michele Fasano, a PLC spokeswoman. A leasing plan is in the works.
Other lasers are expected to cost at least $200,000.
Notwithstanding the lasers' hefty price tags and some lingering scientific questions about their mechanism of action, the lasers work, according to the FDA.
"Although this is not a life-saving procedure, (the PLC laser) can provide significant relief of severe angina and improve the quality of life for a select group of patients for whom there is currently no effective treatment," says FDA Acting Commissioner Michael Friedman, M.D.
During clinical studies of the PLC device, almost three-quarters of about 750 patients treated with the laser experienced significantly less angina pain, an improvement that remained at least one year after treatment, the FDA says. Patients were not studied beyond a year. By comparison, only 13% of patients treated with drugs alone reported the same relief.
Like most medical treatments, the heart laser has risks. About 10% of patients in the PLC study had serious irregular heartbeats, and about 3% of patients died within a month of treatment, the FDA said. After one year, however, the overall mortality was similar for patients who received the laser treatment and those who did not.
Payment for the laser procedure raises perhaps the biggest question for purchasers.
"FDA approval is only the first step for a technology to be used more generally," says Karl Matuszewski, director of technology assessment at the University HealthSystem Consortium, Oak Brook, Ill.
In May 1997, HCFA instituted a noncoverage policy for TMR performed on Medicare patients in the U.S., reversing its course of paying during the early part of clinical trials for the PLC laser.
PLC hopes HCFA will soon pay again, although there is no guarantee. But HCFA proposed procedure codes that could be active as early as this fall, the company says. HCFA could ultimately reimburse hospitals about $25,000 each.
Other payers haven't started weighing the clinical and economic factors. The technology assessment machine of the Blue Cross and Blue Shield Association in Chicago is about to begin crunching the data on the new laser treatment. FDA approval is a precondition for the Blues to begin its evaluation, says spokesman Chris Martin. The national Blues isn't expected to make a recommendation on the laser's clinical merits or guidance for payment until late this year or early 1999, Martin says.
Meanwhile, hospitals across the country are trying to figure out whether to sign on or take a pass on the laser breakthrough.
"It's wonderful that it's been approved for a very difficult group of patients," says Wayne Richenbacher, a cardiothoracic surgeon at the University of Iowa Hospitals and Clinics, who has used an Eclipse laser in clinical trials. However, Richenbacher counsels that hospitals and doctors should be cautious in adopting the new technology so that its appropriate use and long-term effects can be better understood.
For some, though, there's no time to waste in bringing the lasers into the competition for local dominance in cardiac care.
"We're one of the largest heart programs in the state, and I believe we'll be in for the long haul," says Michael Uribe, director of materials management and purchasing at Loyola University Health System in Maywood, Ill. So last year Uribe worked with Loyola's heart doctors to secure a laser from Eclipse as part of a clinical investigation of the device.
Having a laser "gets our name out there," Uribe says, and careful negotiations with the manufacturer have protected the hospital financially.
"From a reimbursement perspective, we're not taking any type of loss," he says.