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February 2012MIAMI BEACH — Four pairs of experts squared off here on Jan. 26 at the Triological Society Combined Sections Meeting in a session of mini-debates over limits on training of residents, treatment of Zenker’s diverticulum, implantable hearing aids and the best approach to oropharyngeal cancer.
In the process, presenters offered important analyses of key subjects, often while finding some middle ground.
Work-Hour Limits
Bradley Marple, MD, professor and vice chair of otolaryngology-head and neck surgery at the University of Texas Southwestern Medical Center in Dallas, argued in favor of the changing paradigms in resident duty hours. He acknowledged that the limits seem to have had no effect on medical errors made. But the data regarding their effects on other areas, including surgical experience and exam scores, have been mixed.
“It’s hard to be completely pro in the argument about the duty hours, but one thing that we do have to acknowledge is that the duty hours are here,” he said. “They’re not driven by us, they’re driven by public perception. And they’re here to stay.”
He said that “one size doesn’t fit all,” that the standards should be matched with residents’ experience levels and that the ultimate goal should be to get residents ready to practice medicine outside the confines of the learning environment.
Paul Levine, MD, chair of otolaryngology-head and neck surgery at the University of Virginia Health System in Charlottesville, pointed out that handoffs play a bigger role in medical errors than fatigue. While “everybody has to accept” that there’s a point of fatigue when people don’t perform well, Dr. Levine said that the duty hour limits lead to fragmentation of care, missed educational opportunities and a shift of resident work to different personnel, among other problems.
He said working according to strict hour limits is not a mirror of reality in the medical world. It’s important, he said, to “instill in our residents that occasional self-sacrifice is, and has always been, a fundamental principle of being a physician.”
Open vs. Endoscopic Surgery
Albert Merati, MD, professor and chief of the laryngology service at the University of Washington in Seattle, argued for open procedures in cases of Zenker’s diverticulum, saying it puts patients in the best position for complete symptom relief after just one procedure.
In a 2002 study of 197 patients, open surgery was compared to endoscopic procedures, with the percentage of totally asymptomatic patients significantly higher after open procedures than after those treated endoscopically, no matter the size of the pouch (Ann Thorac Surg. 74:1677-1683). Eighty-five percent of patients with pouches smaller than 3 cm were asymptomatic when treated with open surgery, compared to 25 percent undergoing endoscopic treatment. For patients with pouches of 3 cm or greater, the numbers were 86 percent compared to 50 percent. Other studies have found similarly favorable results for open procedures.
Dr. Merati also pointed to a study that found that the size of the sac is related to the rate of recurrence: Of the 61 endoscopic procedures studied, 77 percent resulted in total symptom resolution, with pouches larger than 3 cm one of the most common risk factors for recurrence.
He said that for medium-sized sacs of 2 to 4 cm, an open or endoscopic procedure might be appropriate, but for all others, open procedure is preferred. He said the shorter procedure time for the endoscopic approach matters much more to the surgeons than to the patients. “I want to help predict, I believe, the swing of the pendulum back towards consideration of the open operation in our armamentarium,” Dr. Merati said.
But Richard Scher, MD, professor and associate chief of otolaryngology-head and neck surgery at Duke University, said an endoscopic procedure is usually the way to go. At Duke, from 2006 to 2011, just 2 percent of 259 endoscopic staple diverticulostomy patients had to have their procedure aborted, and there was a 4 percent recurrence rate, only nine patients out of 252, Dr. Scher said.
Dr. Scher acknowledged that pouches less than 1.5 centimeters in size are not good candidates for endoscopic treatment but said he could find no good data suggesting that endoscopic treatment should not be done on larger pouches. He also said that there was ultimate improvement in dysphagia symptoms in 85 to 92 percent of the patients at Duke over the last five years.
“For most patients, the endoscopic staple approach is the ideal way to deal with these patients initially,” he said, adding that the open approach should be applied “selectively, not in the majority of patients.”
New Hearing Devices
Moisés Arriaga, MD, MBA, FACS, director of otology-neurotology and professor of otolaryngology and neurosurgery at Louisiana State University Health Sciences Center in New Orleans, took the side of implantable hearing devices in the next mini-debate.
Dr. Arriaga, who has participated in clinical trials of several models of middle ear implants, said the approved devices, the Vibrant Soundbridge, the Maxum and the Esteem, have all resulted in better hearing improvement compared to traditional hearing aids. With the Esteem, for example, patients had an overall 21-point improvement in word recognition scores (WRS) compared to their scores with a hearing aid, according to results in the clinical trial leading to its approval.
One of the main reasons for their success is that the canal isn’t blocked with those devices as it is with hearing aids. They also involve direct vibration of the anatomy of the ear.
The Esteem is totally implantable, removing the social stigma of a visible device.
“The technology really has matured to the point where it’s a reasonable alternative,” Dr. Arriaga said. “The outcomes really are quite positive in the majority of patients,” he said. “It really does seem like a reasonable option for an unsatisfied hearing aid user.”
Peter Weisskopf, MD, FACS, head of the neurotology section at the Barrow Neurological Institute in Phoenix, Ariz., argued that what is left unsaid in marketing materials is that 44 percent of Esteem users had WRS scores worse than or equal to their hearing with a hearing aid, according to manufacturer Envoy Medical’s own published results, posted on envoymedical.com.
He called into question the ethics involved in the use of the devices, noting that companies spend up to $10 million a year on advertising, that patients’ first point of contact is the company itself and that implants are done on a cash basis.
“Can you get a second opinion? Is there a second opinion?” he said. “I don’t feel qualified to give one. I haven’t been trained by the Esteem company to tell what all the pros and cons are. So what is a patient to do?”
He also said there was an inherent bias at the centers that did the research leading to approvals, because the research was supported by the manufacturer. With little long-term data available, a cost that can reach $30,000 and the risk of a surgical procedure, he said, “Why take the risk?”
Managing Oropharyngeal Cancer
Randal Weber, MD, FACS, chair of head and neck surgery at the University of Texas M.D. Anderson Cancer Center in Houston, argued for a non-surgical approach to oropharyngeal cancer.
Among the data he cited were 102 patients at his own center who received unilateral irradiation for T1 and T2 tonsil cancer, with a five-year locoregional control rate of 100 percent, 95 percent overall survival and excellent functional outcome with no patients requiring a long-term G-tube or tracheostomy.
A 2006 study (N Engl J Med. 354;6) found that radiotherapy plus Cetuximab was superior to radiation alone for locoregionally advanced squamous cell carcinoma of the head and neck, resulting in 49 months of locoregional control among those with oropharyngeal cancer, he noted.
But he also said a non-surgical approach might not be best for those with high-risk oropharyngeal tumors, defined by T4 tumors and advanced neck disease, and for HPV-negative tumors, based on the RTOG 0129 trial recently published in the New England Journal of Medicine.
“Perhaps this is the group that we need to focus on for an alternative approach as opposed to chemoradiation,” he said.
Overall, though, Dr. Weber said, “non-surgical treatment is effective. We need more outcome and functional data than we have today.”
Wendell Yarbrough, MD, director of the Barry Baker Laboratory for Head and Neck Oncology at the Vanderbilt-Ingram Cancer Center in Nashville, lamented a lack of head-to-head studies comparing the two main approaches: surgery followed by radiation and chemoradiation and salvage surgery. He said it is HPV status, not treatment, that drives survival. “With two-year disease-free survival of less than 50 percent (in HPV-negative patients), why aren’t we treating these patients with surgery?”
Forgoing surgery could lead to bigger problems later, he said. “When we do get the failures (after chemoradiation) and are able to operate on them, obviously now the patients are having worse problems.”
But salvage surgery has been found to have a 21 percent rate of five-year overall survival. “Surgical salvage for oropharyngeal cancer,” Dr. Yarbrough said, “just doesn’t work.”
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