Before undergoing an experimental and perhaps lifesaving procedure, Aron Vayneberg’s heart was pumping inefficiently and beating on borrowed time.
“Everything in my heart was blocked,” said the 42-year-old Vayneberg of Buffalo Grove. “I couldn’t do anything. I couldn’t even walk.”
Vayneberg had suffered three previous heart attacks, though he said they were minor. Four angioplasties, in which a segment of narrowed coronary artery is expanded by the insertion of a balloon through a catheter, also were performed on Vayneberg through the years but were not helpful.
But today Vayneberg said he feels “100 percent better.”
Six months ago Vayneberg entered an ongoing clinical trial in which growth-stimulating genes were being tested against a placebo. A substance was injected into Vayneberg’s coronary arteries through a catheter inserted in his groin and fed into the heart area. As part of a double-blind study, however, neither the doctor nor the patient know what was injected into Vayneberg’s arteries–either the growth-stimulating genes or a placebo.
The dramatic improvement in Vayneberg’s cardio health may be attributable to new coronary blood vessels his body has grown; test results have yet to be evaluated. But if Vayneberg has indeed grown new blood vessels, they would detour around Vayneberg’s blocked arteries and keep the blood, with its life-sustaining oxygen and nutrients, flowing through his body.
The non-surgical procedure that apparently helped Vayneberg is called intracoronary gene therapy, or therapeutic angiogenesis, and was performed by Dr. Timothy Sanborn, head of cardiology at Evanston Northwestern Healthcare.
If successful, it could provide a way around surgery for a technique that in itself was already groundbreaking: growing new vessels around older, blocked ones. The standard surgical treatment for this is a bypass operation. But the idea of essentially creating a bypass without having to put the patient under the knife is tantalizing.
Vayneberg’s procedure took 20 minutes and was performed at Evanston Northwestern Healthcare. Local anesthesia was used, and the patient was sedated with Valium or a similar drug. After the procedure, Vayneberg was kept overnight in the hospital for observation. There were no significant side effects and he was sent home the following day, Sanborn said.
“Because the [genetic agent] is carried in a virus, side effects might include cold or flu symptoms for 24 to 48 hours,” he said.
Vayneberg continued to suffer symptoms caused by a heart stent narrowed with scar tissue, and he had to return to the hospital about two months later for additional treatment. A heart stent is a wire mesh tube inserted into a coronary artery to hold it open.
This time, Sanborn said, radiation seeds were implanted for three minutes inside Vayneberg’s stent in an FDA-approved procedure called vascular brachytherapy. After this brief, temporary exposure, the seeds were removed and Vayneberg’s symptoms disappeared.
The results of other preliminary studies, some of which were not double-blind tests, published in medical journals report that many patients such as Vayneberg who have undergone the angiogenesis procedure have experienced significant improvement of symptoms.
“Patients can walk longer on a treadmill [without pain or shortness of breath] than the control [group], which received a placebo,” Sanborn said. “Patients are followed at intervals of three, six, and 12 months for a physical examination and a treadmill test. Treadmill time is the way we assess this.”
Sanborn’s particular test is ongoing and results have not yet been evaluated. Each patient is followed for five years.
Whether Vayneberg received the growth-stimulating agent will remain unknown until his involvement in the study is concluded in 4 1/2 years.
Nevertheless, he seems to enjoy his improved cardio symptoms.
“I still don’t cut the grass and I never will, but at least I can walk again,” he said.
This type of therapy would be less invasive than another, proven type, which in itself is a major advance: angiogenesis heart therapy through a laser procedure developed by Dr. Keith Horvath, a cardiothoracic surgeon at Northwestern Memorial Hospital.
Describing the procedure, Horvath said, “We open the chest and use a high-powered carbon dioxide laser to create channels from outside the heart to the inside of the heart. I usually open one channel per square centimeter so it becomes 25 to 30 channels.”
The new channels are a “controlled injury,” he explained. And the body’s response to such an injury is to grow new blood vessels to promote healing. The new vessels provide an alternate route for blood to flow around the blocked vessels.
Sometimes when coronary vessels are blocked because of atherosclerosis, or hardening of the arteries, the heart will attempt its own bypass by trying to grow new blood vessels. Patients then may be getting reasonable amounts of blood when at rest, Horvath said. But when the heart is stressed, such as during exercise or while climbing stairs, blood flow in these vessels is not adequate.
Covered by insurance
Officially called transmyocardial laser revascularization, Horvath’s laser procedure is approved by the FDA, is covered by many insurance companies and also is covered by Medicare.
Horvath teaches the procedure to other surgeons and lectures on the subject around the country at meetings and seminars.
“This kind of laser surgery is relatively new but growing,” Horvath said. “There probably has been only about 200 [surgeries] worldwide done so far.
“I began doing this about 1989,” Horvath said of his laser heart surgery. “I developed the procedure as a result of research I was doing to monitor myocardial [heart muscle] metabolism. There’s some risk in the procedure, but with the laser there’s no side effects, and 75 percent of the patients report significant angina relief.”
Angina is chest pain that occurs when blood flow to the heart is inadequate, often due to the narrowing of blood vessels. This narrowing usually is caused by atherosclerosis.
Grading angina pain subjectively on a scale of 1 to 4, with 4 being the worst, these patients had pain measuring 3.7 prior to angiogenesis surgery, according to Horvath. One year later, pain was graded at 1.5 and five years later at 1.6.
“So far about 12,000 patients around the world have had the procedure, and most have done well postsurgically,” Horvath said.
A typical beneficiary of Horvath’s laser surgery is Robert O’Brien, 75, who underwent the procedure three years ago. O’Brien, who lives in South Bend, Ind., and works as an automotive consultant in Chicago, had quadruple bypass surgery about 15 years ago and until three years ago felt fine.
Two-pack-a-day habit
“I started feeling tired all the time,” O’Brien said. “I was also short of breath, but I’m a two-pack-a-day smoker. I was then and I still am.” He laughed and coughed simultaneously as he confessed his violation of a prime rule for good health.
“My symptoms persisted for probably a couple of months,” O’Brien said. “My cardiologist referred me to a surgeon. The surgeon told me I was not a good candidate for another bypass.”
With no conventional means of repairing O’Brien’s blocked coronary vessels, his surgeon referred him to Horvath, who was performing his experimental operation at Northwestern Memorial Hospital and suggested that it might be helpful.
O’Brien recalled that “Dr. Horvath told me the procedure was experimental. But he said I might have good results.” With no other alternatives available, O’Brien agreed to undergo the surgery.
“Dr. Horvath opened my chest on the left side,” said O’Brien, recounting clinical details of the procedure. “He spread my ribs right under my nipple. Then he used a laser to make 20 or so channels, actually holes, in my heart. I don’t know how long I was out.
“I was in the hospital three days postsurgically,” O’Brien said. “Recovery was easy. There were no unpleasant side effects. No pain, nothing. I was back to work in two weeks.”
Lots of energy
Today at 75, O’Brien works a 12- to 14-hour day four days a week as a car salesman. “I have lots of energy. I drive 200 miles every day from South Bend to Chicago and back. I don’t do any exercise, but I’m not short of breath. I never went on a special diet.”
O’Brien credits Horvath with saving his life. “I’m beholden to him as anyone in my position would be,” he said.
Another heart patient who has benefited from Horvath’s laser surgery is 79-year-old Malcolm Kravitz.
“I’d already had two triple bypasses, and my symptoms came back,” said Kravitz, a Highland Park plumbing contractor. “I couldn’t walk, I was short of breath. Then I had the [surgery]. Now I can walk again. I do it for exercise almost every day, and I’m not short of breath. I also work with my son, although an abbreviated week.”
Surgical recovery was easy, not too painful and without side effects, Kravitz said. “The only problem is I didn’t lose any weight. But Dr. Horvath gave me a new lease on life.”
Will Horvath’s laser surgery ever replace the bypass?
“I don’t think so,” Horvath said. “I think it’ll be used most often in combination with bypass surgery. Some arteries would be targeted for bypass surgery. But for other areas of the heart in which we can’t use the bypass, we’d use the laser process for angiogenesis.”
Horvath said new research is being conducted in which angiogenetic solutions are being injected into the channels he drills into the heart. If successful, this may be used to further stimulate the body’s angiogenetic process and provide additional help for heart patients.
For information on enrollment in the therapeutic angiogenesis study, phone the Cardiology Research Lab of Evanston Northwestern Healthcare at 847-570-2366.
The reverse side of angiogenesis
The reverse side of the angiogenesis coin also may offer medical benefits. Cancerous tumors need new blood vessels for oxygen and nutrition, elements essential for growth. Without blood vessels, tumors cannot spread, or metastasize, through the body and eventually cause death.
Clinical trials of 20 or more different anti-angiogenesis drugs, a group of compounds called angiogenesis inhibitors, are being conducted on humans and have been for several years. The drugs are being tested against a variety of cancerous tumors, including lung, colon, breast and skin, according to the National Cancer Institute. Additional angiogenesis-inhibitor drugs, not yet being tested, are being prepared for clinical trials.
Tests are designed to establish the effectiveness, side effects, safety and most effective dosage.
Clinical trials of angiogenesis inhibitors have been described by the National Cancer Institute as a promising avenue of cancer research.
— Marc Davis
