By J.M. Copeland
For Hometown News
Dr. Dinesh Arab, the director of cardiology and the carotid stenting at Florida Hospital Memorial Medical Center, was one of the lead investigators for a cardiac clinical trial.
The trial tested the atherectomy procedure with the Diamond device, to clear hard plaque out of coronary arteries in a less invasive procedure.
An impressive feat for the doctor, following his long path to Daytona Beach.
Dr. Arab's road to Florida began when he was a medical student at Gulbarga, Karnataka, India. After a year in England, he began his residency at the University of Buffalo and accepted a fellowship in cardiology in Chicago, teaching at Loyola.
A chance meeting at an American College of Cardiology meeting in Orlando resulted in his being asked to move to Florida to open a practice and join the staff at Florida Hospital Memorial.
Because of his experience and expertise, Dr. Arab and three other physicians at the hospital were asked to participate in the trial, the first major study in the world to examine the safety of CSI's Diamondback device and its application to arteries in the heart.
The cardiac clinical trial included 443 patients in 49 locations throughout the nation. Florida Hospital Memorial joined the clinical trial after it had been going on for about eight months and continued for about 12 to 18 months before it was completed.
According to Dr. Arab, Florida Hospital Memorial was one of the top 10 locations for the clinical trial and performed more procedures (10) than any of the other 40 locations in the nation. Because of the number of procedures performed, Dr. Arab was one of the lead investigators for the clinical trial.
The 14 participants in the local trial were unusual, they were older, had ailments, including diabetes and kidney disease, and hard plaque -- patients not usually selected.
"Most medical device makers haven't wanted to use this group in trials before," Dr. Arab said. "Hard plaque is very common, especially in Florida with the older population. Patients with hard plaque tend to be older and sicker, with diabetes or kidney disease. These sicker patients tend to be excluded from other trials."
Traditionally, artery blockage is treated by going through an artery in the groin or the wrist, to open the blockage with a balloon and then place a stent to keep the blockage open. This is most successful when the blockages are soft and fibrous plaque. When the plaque is hard and calcified, the balloon can't move the hard plaque and by-pass surgery was often the only option.
"The benefit was already proven, this was determining the safety," Dr. Arab said. "You don't have to send these patients to by-pass surgery anymore. The stent already works, this helps facilitate the placement of the stent."
Patients are anesthetized but conscious during the procedure that takes about 20 minutes.
"Think of it like shaving," Dr. Arab said. "When you shave, you cut the hair, but not the skin. With this device, it is so sensitive it can cut the plaque, but not the healthy artery tissue. The first demonstration was with an egg; it would cut the shell, but not the membrane."
The results of the clinical trial demonstrated the Diamondback device by CSI is safe to use in patients with hard plaque in the arteries in their hearts; the risk was the same as a traditional procedure and it was approved by the FDA.
"We are making things possible that before were not," Dr. Arab said. "Volusia County is surrounded by Orlando and Shands and Miami to the south and we are in the top 10 in the U.S."
Now that the clinical trial has received FDA approval and will be published in the Journal American College of Cardiology, Florida Hospital Memorial will become a teaching facility, training other physicians around the country on the Diamondback device and its use in patients with hard plaque in the heart.
"This device is now the only FDA approved device for hard plaque," Dr. Arab said. "There are a lot of things we do in medicine -- and this applies even outside of medicine -- that we do because it makes sense. We were using the rotablator because it was the only thing we could do for patients, but we never scientifically knew that what we were doing was the right thing. None of the companies wanted to perform the research because if the research proves it doesn't offer good outcomes, there goes the device. This is the first time a company said they would try this and see if it would work. The study showed that the mortality rate was .02 percent, which is that of a normal procedure. This proves the technique is safe and feasible."
"We are part of technology, we are contributing with the best in the nation," he said.