A new procedure that could save millions of dollars annually in medical costs

Feb 7 2005

A new procedure that could save millions of dollars annually in medical costs – and result in much better patient outcomes and satisfaction – was performed for the first time in the world this week at Wake Forest University Baptist Medical Center.

The procedure removed growths from the airway of a patient using new technology that allows the surgery to be done in the doctor's office with the patient completely awake, and the patient to go home immediately afterward. In the past, this surgery required equipment that could be used only in the operating room with the patient under general anesthesia, and the patient was often required to spend the night in the hospital.

In the procedure this week, two different lasers were used: a carbon-dioxide (CO2) laser delivered by a newly developed hollow-core optical fiber, and a pulsed-dye laser delivered by standard solid optical fiber. Each is guided by a high-resolution video-endoscope, and the entire system is delivered to the patient through a tiny tube that is placed in the nose. It was the world's first use of both lasers in an office-based procedure.

The surgery was performed by Jamie Koufman, M.D., professor of surgery-otolaryngology at Wake Forest Baptist and director of the Center for Voice and Swallowing Disorders.

Koufman explained that the two lasers are complementary. The CO2 first removes the growths in the larynx (voice box) and trachea (airway to the lungs), and the pulsed-dye laser is then used to treat the base of the growths and help prevent recurrence.

This week Koufman removed recurrent respiratory papillomas, warts that cause severe hoarseness and obstruct the trachea; left untreated, the condition can be fatal.

She said that she chose a papilloma case for the trial of the new approach "because this is one of the worst growths to remove. If we can do the worst case, we can do almost everything else."

Koufman said that the same approach will work for 50 to 70 percent of all laryngeal surgeries, including removal of vocal nodules, polyps, cysts, granulomas, and even vascular lesions.

For her alone, Koufman said, that represents hundreds of patients a year. It may eventually be used to treat laryngeal cancer as well.

"We now have the right set of surgical tools to aggressively do unsedated, in-office, laser surgery," said Koufman. "This is the future of this specialty, and there are probably going to be many other applications in other endoscopic specialties. We're talking about potential cost and time savings in the billions of dollars nationally."

The new hollow-core optical fiber and CO2 laser combination was developed by OmniGuide Communications Inc. of Cambridge, Mass., and the pulsed-dye laser was developed by Cynosure Inc. of Chelmsford, Mass. The fiber-optic camera system used to view the surgical site was designed by Pentax Medical Corp. of Montvale, N.J.

The FDA approved the use of the new CO2 laser delivery system for "compassionate use" on this one patient, although general approval is anticipated by summer.

Steve Sheng, Ph.D., OmniGuide's president and CEO said, "We at OmniGuide are excited to see our technology being used for the first time on a human patient. The medical community has waited for a flexible fiber to deliver CO2 laser energy for many years, and we are delighted to offer a solution. We are excited to be working with Dr. Koufman, a creative thought leader who is developing the future standard of care in ENT."

Nick Tsaclas of ENT division manager Pentax Medical said, "This technology is going to revolutionize the field." Koufman added, "The combination of the CO2 laser optical fiber and the pulsed-dye laser is dynamite and dramatically extends our in-office surgical capabilities.

"For 25 years, the CO2 laser has been the 'workhorse' laser of our specialty, but until now it could be used only in the operating room. The difference between that experience and the new procedure," Koufman said, "is like the difference between a horse-drawn cart and a Cadillac.

"We're talking about a paradigm shift for laryngeal and airway surgery. It's easier, it's cheaper, we do a better job, there's less risk, and we do it here in the office. "It's the future of surgery."