Not Everyone Agrees Laser Holes Ease Chest Pain
The surgeon took aim at his patient’s naked beating heart with a bent plastic nozzle. The thing looked like something borrowed from a water faucet.
But it was a laser gun, the hot end of a 2,000-pound machine, and the surgeon was about to burn a hole clear through the woman’s left ventricle, the main pumping chamber of her heart.
“Arm laser!” he ordered.
A red dot of light showed exactly where the laser beam would hit. He held the gun against the fat-streaked heart, pulsing like a nervous animal inside the open chest.
The surgeon stepped on a foot pedal. Thud. Gray-white smoke puffed from an exquisitely round hole, followed by a little geyser of blood.
“Hit?” the surgeon asked. An anesthesiologist watched the result on an ultrasound screen. A dark cloud blossomed inside the heart. Vaporized blood. “Yes,” came the reply.
Until that moment, the operation had been an ordinary coronary bypass, much like 600,000 others done in the United States each year. Dr. Keith Horvath, the surgeon, had spent three hours stitching wormlike strands of vein and artery onto the woman’s heart, detouring blood around her clogged blood vessels.
The laser, however, was something new. Horvath moved the gun a fraction of an inch and fired again. Ten minutes and 17 holes later, he was done.
What the surgeon accomplished with this final flourish--so elegant, yet crude--is something no one can say beyond a doubt.
Horvath hoped that he improved his patients’ chances of escaping bad chest pain, that he increased the flow of blood to parts of the heart muscle that would not be helped by the bypass operation.
But did he? Or had he just added several thousand dollars to the patient’s hospital bill for no good reason?
The questions are the core of a debate over an unusual piece of medical technology. Those who believe in the laser say it can profoundly relieve otherwise unmanageable angina. But even if people feel better--and they clearly often do--some wonder if the laser is simply an expensive placebo, a surgical version of the sugar pill.
Two competing versions of the laser have been on the market for more than two years, and many thought it would be used more widely by now. But the technology has been held back in part by a public relations problem: Drilling holes through the heart is an odd thing to do, and no one can explain with certainty why it works. If, in fact, it does.
“The technology is not intuitive,” concedes Mark Tauscher, head of PLC Medical Systems, one of the two companies selling the lasers. “When you tell people that you burn a hole in people’s hearts and make them feel better, they don’t say, ‘Aha! I understand.’ ”
The idea of drilling holes through the heart has been around since the 1980s. Early advocates supposed the holes would act like new blood vessels, bringing blood directly from the pumping chambers into the oxygen-starved muscle that surrounds them.
But this theory has been largely refuted. It turns out the holes quickly fill up with clots and then heal. Within a few months, they disappear.
Nevertheless, drilling holes in the heart does something. Between half and three-quarters of patients studied have dramatic relief from chest pain.
“In 20 years of medicine, I have never seen anything that gives as much symptomatic benefit for patients,” says Dr. William O’Neill of William Beaumont Hospital in Royal Oak, Mich.
Testimonies of Recoveries
O’Neill is a cardiologist, a nonsurgical heart specialist, and he has tested a still-experimental form of heart laser that is delivered into the heart through a tube called a catheter. Instead of burning holes from the outside in, as the surgeons do, this technique burns notches into the walls of the heart from the inside.
Practically every doctor who has tried the laser--whether the surgical or catheter variety--tells stories of almost unbelievable recoveries. Among O’Neill’s patients is Frank Warren, 41, an auto worker from Sterling Heights, Mich.
Warren suffered with heart problems for almost 10 years. Sometimes it was a burning sensation, other times a pain that came on even while he was resting. He had no energy. The slightest exercise was exhausting. Over the years, he underwent eight angioplasties, but nothing helped.
“After the laser, I felt immediate results,” says Warren. “I felt a warmth in my face. My color seemed to change. I made a decision right there on the table that if this thing worked, I would begin to try to run.”
He started out in rehab. He walked and eventually took up running, first a half mile and then longer. Almost a year to the day after his laser, Warren ran a marathon and finished in a respectable 4 hours, 29 minutes.
Most laser patients are too old to run marathons, but substantial and even complete relief of angina is common. Often they are able to give up nitroglycerin, the medicine they take, often in large quantities, for chest pain.
“I had an 80-year-old man who could not even wash himself,” remembers Washington University cardiologist John Lasala. “Then I got calls from family members the next week saying, ‘Dad’s out gardening.’ ”
Putting Laser to the Test
Such anecdotes are impressive, but doctors prefer large-scale follow-up studies to make sure the successes are more than flukes. The longest of these was compiled by Horvath at Chicago’s Northwestern Memorial Hospital.
Doctors grade angina symptoms on a scale of 1 to 4, with 4 being the most severe. Horvath followed the progress of 78 patients whose scores averaged 3.7. Five years after their laser treatments, most were still considerably better. Eighty-one percent had scores of 2 or lower, and 17% had no angina at all. The average was 1.6.
These data convince many that laser’s benefits are real. Perhaps patients could will themselves to feel better for a few months, the thinking goes, but not five years.
“A placebo effect doesn’t work that long,” says Dr. David Faxon, cardiology chief at the University of Chicago. “If that’s a placebo effect, I want that placebo.”
However, Horvath’s data are not the kind of gold-standard research that settles all doubt. For that, doctors would have to randomly give people real laser operations or fake ones--without telling anyone who got what--and then compare the results. Such a study will not be done for the surgical laser because doctors cannot cut patients open for sham operations.
However, such a study can be done with the catheter laser, since the comparison group is exposed to nothing more dangerous than a routine heart checkup called an angiogram. Doctors tested an experimental catheter laser this way on 298 patients with severe, untreatable chest pain.
The volunteers--sedated but awake--were randomly assigned to get the laser or not. Doctors talked about lasers within earshot, leaving the impression that everyone was getting the real thing. The results, released in October, were a shock.
As expected, the laser patients did well, but the do-nothing group improved even more. More than 40% of them lowered their angina scores by at least two points, even though their treatments were make-believe.
‘We Don’t Know That It Works’
The study’s director, Dr. Martin B. Leon of Lenox Hill Hospital in New York City, called the results more than just a blow to catheter-based lasers. He said they mean that the surgical variety, which is already approved for routine use, is also probably nothing but a fancy placebo.
Surgeons were angry. They point out many technical differences between the two kinds of lasers that, in their minds, make the surgical kind much better. Still, the results have increased skepticism among heart specialists who send patients to surgeons.
“Personally, I wouldn’t do it now,” says Dr. Timothy Henry, a cardiologist at the Hennepin County Medical Center in Minneapolis. “You are subjecting people to a procedure that has inherent dangers, and we don’t know that it works.”
Skeptics argue that people with bad pain can talk themselves into feeling better. They have withstood a big operation, and they profoundly believe it will stop their misery. Hope itself can be a painkiller--at least for a while. So they feel better and turn over a new leaf. They exercise more, eat less, quit smoking and lower their cholesterol. In time, the new habits improve the condition of their hearts.
Unlikely, responds Horvath. “It assumes these people have a giant epiphany as a result of this procedure and turn their lives around. That just doesn’t happen.”
And the placebo theory strikes patients as ridiculous. “I definitely find it hard to believe it’s all in my head,” says Warren, the marathon runner. “If it’s a hoax, they got me good.”
But if laser’s benefits are not a placebo effect, then what? Doctors have two theories--nerve destruction and blood vessel growth.
Some say the laser cuts nerves in the heart. This blocks the distress signals that muscles send when deprived of blood. Nothing really changes except that people cannot feel their own chest pain.
Others argue the laser holes cause inflammation. This, in turn, triggers the heart to grow more tiny blood vessels, a process called angiogenesis, bringing in needed circulation.
Although the new-blood-vessel theory is the more popular of the two, some surgeons are skeptical. Often patients feel better the very next day--too soon for new blood vessels, which take a month or more to sprout.
“They come out of the operating room in pain, or they come out and say, ‘I feel great,’ ” says Dr. Wayne Richenbacher of the University of Iowa. “That makes absolutely no sense if you think angiogenesis is the effect.”
Many doctors say this uncertainty makes them uncomfortable about recommending lasers. Even some surgeons are uneasy.
“We’re trained to understand how things make patients better,” says Dr. Gary Marrone of Allegheny General Hospital in Pittsburgh. “Since we don’t understand this, it makes me a little leery about doing it.”
Laser Procedure as Part of Bypass
When first approved for general use in 1998, lasers were largely used as stand-alone therapy for patients who could not undergo bypass surgery. But last year, Medicare agreed to pay for lasers used during bypass, as was done on a recent morning in Horvath’s operating room in Chicago.
The patient, a 69-year-old diabetic recovering from a heart attack, had clogged arteries. Horvath could reroute blood around three of them. But two more were too skinny and diseased to fix. That left a 3-by-4-inch section of her heart with less than optimal blood flow.
Until recently, surgeons would have been satisfied to do what they could. But Horvath and other advocates say the laser gives them a chance to finish the job. Last year, U.S. surgeons did about 5,000 heart laser procedures. Manufacturers estimate there could be up to 90,000 if lasers became routine during bypass surgery.
Two weeks after her operation, Horvath’s patient was walking without chest pain. However, it is always possible she might have fared as well with bypass alone.
The laser adds about $8,000 to the price of a bypass, and some surgeons worry it would be an expensive mistake to burn holes in the hearts of large numbers of patients.
“It opens up a whole can of worms,” says Dr. Jai Lee, a surgeon at University Hospitals of Cleveland. “Do we really want to bankrupt the system to expand a therapy that is questionable?”
