Americans' love of all things tasty, fatty, and generally bad for them means doctors such as Daniel Cassavar aren't in danger of going out of business anytime soon.

Dr. Cassavar is a cardiologist, and he is in high demand. Heart disease is the No. 1 cause of death for men and women. It kills about 950,000 Americans annually, which is 40 percent of all deaths and more than the next six leading causes of death combined, including cancer.

“People continue to smoke, and their dietary habits have not improved. [Because of that] we don't see a decrease in the need [for heart care]; in fact, we see it rising as baby boomers age,” Dr. Cassavar said. “Despite all the warnings and recommendations, fast food is still a big part of our diet ... It's a matter of what we eat and how we eat it.”

Physicians and hospitals have long recognized there's money to be made in heart care, which is one of the most lucrative types of medical care. In some parts of the country hospitals have opened that are devoted exclusively to heart care. That hasn't happened in Toledo, but Dr. Cassavar and 25 other local physicians (most cardiologists, but a few surgeons as well) hope they have come up with a new way to tap into the growing market for heart care.

They have formed the Cardiovascular Diagnostic Group, which will begin seeing patients tomorrow in a facility on the St. Vincent Mercy Medical Center campus. A similar facility owned by the same group is planned for St. Charles Mercy Hospital in Oregon. Physicians in the company are not employed by St. Vincent's and come from several cardiology groups or solo practices. The new facility is on the main level of a building just to the west of the main St. Vincent entrance. The company is the first of its kind in Ohio because it's fully physician-owned.

Physicians in the group will do outpatient, low-risk heart catheterizations, which are the most common of today's heart procedures. In a catheterization, a cardiologist inserts a thin tube through a blood vessel in the arm or leg area and slides it into the heart. A dye is then injected to look for blockages. Low risk means a doctor doesn't suspect a patient is in immediate danger of a heart attack, while high risk generally means a physician expects the patient will need surgery or other more invasive treatment.

Catheterizations are done in several hospitals in the Toledo area, so what makes the venture unique is the potentially lucrative financial setup by the physicians.

By owning the company and not being in a hospital, the doctors will be able to reap all of the revenue. In most traditional catheterization programs, physicians share revenue with hospitals. For example, Medicare pays physicians about $350, while hospitals can pocket $2,500 or more, which is referred to as the “technical fee.”

Dr. Cassavar acknowledged the financial reward is potentially greater in the new lab, but said that's not the main motivation. “I want to do [catheterizations] where my patients are most comfortable,” he said. “What we do in the hospital is good, but this is more patient-focused. It's very convenient for patients.”

Some local cardiologists are skeptical of that rationale.

“It's being motivated more by financial issues than patient-care issues,” said Toledo cardiologist William Schafer, who was approached about the venture but decided not to invest. “The physicians are trying to capture not just the professional fee, but the technical component.”

Dr. Charles Gbur, another Toledo cardiologist who decided not to invest, said he doesn't fault the physicians for trying to make money, but “what I have a problem with is if you do something and it basically changes the way you practice. If I have a patient and I do a heart cath, and if they need an intervention, I do it right there ... I don't have to stick you [insert the catheter] twice.”

By law, the new venture can only do diagnostic, low-risk catheterizations because it doesn't have on-site surgical backup. So if a physician detects a problem and decides an angioplasty (inserting a small balloon to reopen clogged vessels) or other intervention is needed, the patient will have to make another trip to a hospital for that procedure. Dr. Schafer and Dr. Gbur said catheterizations done now in the Toledo area are in a hospital so usually patients can get everything done at once and not, as Dr. Gbur puts it, get stuck twice.

Dr. Schafer adds that while heart catheterizations have very low complication rates, increasing the times patients need a catheter inserted increases the chances for a complication.

Dr. Cassavar, who's co-medical director of the new company, disputes that there is any increased risk in the new lab. He said only 10 to 20 percent of patients need surgical intervention or angioplasty.

He added that because the center will focus solely on low-risk catheterizations, it will allow staff to become more efficient at doing the procedure.

St. Vincent's owns the building and leases it to the physicians, and provides nonphysician staff. Steve Mickus, president of Mercy Health Partners, said Mercy officials hope to get business from patients who need more invasive care.

“If a cath is done here and an angioplasty is to be done, that patient could go somewhere else. Do we hope it will be done here? Of course I do,” he said.

Dr. John Hirshfeld, director of the cath lab at the University of Pennsylvania Medical Center, said that arrangement makes sense financially because heart care, especially the more invasive care that is done in hospitals, is “one of the most lucrative sectors of hospital operations.”

Dr. Hirshfeld, who's also chairman of the cardiac catheterization committee for the American College of Cardiology, said the proximity of the lab to surgical facilities at St. Vincent's is important in terms of safety.

He said what troubles him about ventures such as the Cardiovascular Diagnostic Group is the financial involvement of cardiologists. He said there will be pressure on cardiologists to take cases because they make good money from them, possibly blurring the line between low-risk and high-risk patients.

Dr. Theodore Fraker, cardiologist and medical director for Medical College of Ohio Hospitals, agreed.

“I'm not an investor [in the company], and I don't see a problem with another low-risk lab in town, to be honest. The only question is an ethical one. If the investors in the lab are profiting from it, will they be more likely to do procedures,” he said.

The danger of complications in low-risk catheterization has been debated for years in Ohio and across the country. The American Heart Association recommends against cardiac catheterizations' being done outside a hospital because of concerns over complications.

Ohio has 31 low-risk catheterization labs, down from 40 in 1995 because some of the labs either converted to high-risk or were in hospitals that shut down. Even with the decline in facilities, there has been a 20 percent increase in the number of low-risk catheterizations performed in Ohio since 1995, according to the Ohio Department of Health.

Ohio law used to ban labs without surgical backup from doing any heart catheterizations. The ban was declared in the mid-1990s after some low-risk cath labs in Ohio improperly accepted high-risk patients and some patients died. The law was changed in 2000, but still bans labs located outside a hospital. Michigan also bans free-standing labs.

The lab on St. V's campus was granted a waiver by the Ohio Department of Health because it's connected to the hospital by a hallway. In fact, Dr. Cassavar said he's just as close to surgical backup in the new lab as he would be if he did a low-risk cath inside the main hospital.

Dr. Thomas Bashore, a cardiologist at Duke Medical Center, was the chairman of an American College of Cardiology committee that drew up guidelines on cardiac catheterization. He said as long as cardiac catheterization labs follow some key guidelines, he sees nothing wrong with new labs opening, even those outside hospitals. For example, he said Duke runs two mobile cath units.

But “if you build one, you need in writing a bail-out procedure so that if a complication occurs, there's a clear pathway you'd follow that would allow you to take care of the problem ... and it needs to be very clear you're doing the lowest-risk patient.” Dr. Cassavar said the lab meets all of the American College of Cardiology guidelines.

Another concern with catheterization labs is volume. Like any medical procedure, the phrase “practice makes perfect” applies here too, he said. Dr. Bashore said it's generally accepted that a facility should ideally do 400 to 600 catheterizations annually to ensure both patient safety and profitability. The new cath lab at St. Vincent's expects to perform about 1,450 procedures in its first year, officials there said, so the lab should have more than enough volume to ensure proficiency.

Dr. Bashore added that the issue raised by Dr. Schafer and Dr. Gbur about patients' needing to be stuck twice is “a very valid argument” but “the same thing happens in a lot of cath labs that have surgical backup.”

First Published December 9, 2001, 11:50 a.m.