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April 2015When to Use In-Office Balloon Sinuplasty
Subinoy Das, MD, a head and neck surgeon at Ohio ENT & Allergy in Columbus, said that technology has helped reduce morbidity in sinus surgery, once considered to be the “most dangerous” procedure in otolaryngology, with complication rates in the 30% to 40% range. “As people become comfortable with technology, the complication rate really goes down significantly,” he added. New technologies should be studied and vetted, but “when they are helpful to our patients, we should celebrate that.”
In patients for whom general anesthesia is risky, such as pregnant women or those with high bleeding risks, in-office balloon sinuplasty should be strongly considered, said Dr. Das, who disclosed that he has received speaking fees from Acclarent, which manufactures balloon sinuplasty devices.
He stressed that the procedure should not get a black eye simply because unscrupulous physicians might use it inappropriately. “There are immoral surgeons using in-office balloon for personal gain,” he said. It’s a case of “supplier-induced demand,” he said, presenting figures from a 2013
MarketScan report showing that 1.1% of surgeons perform 21% of all balloon sinuplasties. “My take home point is not to blame a piece of technology for the immoral actions of unethical surgeons,” he said.
Abtin Tabaee, MD, director of rhinology and endoscopic sinus surgery at Mount Sinai Beth Israel Medical Center in New York City, recommended a balanced, evidence-based approach to the use of in-office balloon sinuplasty. One of the primary concerns of overuse of the technology has to do with the very high reimbursement rate potentially leading to patients
undergoing the procedure when they either do not need any surgical procedure, or ultimately need a formal ESS in the operating room. “There has been a significant increase in the number of office balloon procedures being performed in the community without any associated increase in the incidence of chronic sinusitis,” said Dr. Tabaee.
“It’s neither right nor wrong, but we need to understand it better,” so that it can be applied in the correct situations, he said. He reviewed a number of well-performed research studies that support its safety and effectiveness, but cautioned that there has been “heavy industry involvement” in the current literature on the subject. Future, independent studies are necessary to determine its indications, safety and outcomes.
He added that while the procedure can be beneficial to certain patients, and can even be economical due to the savings on operating-room costs and a faster return to patient functionality, more studies on outcomes would be useful, and vigilance about abuse is needed.
Bilateral Cochlear Implants: When Are They Indicated?
Doug Backous, MD, medical director of the Center for Hearing and Skull Base Surgery at Swedish Medical Center in Seattle, said all patients who meet the criteria should get a bilateral cochlear implant.
The indications for a bilateral implant are the same as those for a unilateral implant: adults with bilateral severe to profound deafness with limited benefit from appropriate acoustic hearing aids and children with bilateral severe to profound deafness (for patients aged 12 to 18 months, it should be profound) and no progress with acoustic hearing aids.
“The problem is that in the United States, depending on which study that you read, our market penetration for cochlear implants for patients who are eligible is somewhere between 9% and 18%,” said Dr. Backous, who is a member of the Cochlear Corporation surgical advisory board.
A bilateral implant allows for better sound localization, not because of the time difference in sound reaching each ear, which isn’t registered well with cochlear implants, but because of the difference in the intensity of the sound for each ear.
Bilateral implants also help reduce the “head shadow effect,” in which the head blocks sound to the ear that isn’t facing the sound; they also help with binaural summation, in which potentially difficult-to-hear sounds have improved audibility when processed through both ears, and help differentiate speech from noise because each ear is able to process the sounds, a process called the “squelch effect.”
Dr. Backous suggested that bilateral implants are not used more often because of insurance considerations. Insurance coverage normally applies if a bilateral implant is received, but if the implants are done sequentially, another justification process is required. “So why don’t we do it for everyone? It costs too much,” he said. “If we could get this approved by insurance companies in the Pacific Northwest you would have a lot more bilateral users.”
John Niparko, MD, chair of otolaryngology-head and neck surgery in the Keck School of Medicine at the University of Southern California in Los Angeles, discussed some of the limitations of bilateral implants. “Bilateral cochlear implantation makes great sense if we appreciate that, currently, comparing a bilateral situation to binaural processing is comparing apples to oranges,” he said. “They are two fundamentally very different concepts, and this impacts, I think, the way we will go forward in advising our patients and assisting them in the management of their child’s deafness.”
In a multicenter study of 188 cochlear implant recipients from around the country, 96 children received bilateral implants, allowing for comparison of outcomes of those with bilateral implants to those with a unilateral implant (JAMA. 2010;303:1498-1506). Literature shows that children with early cochlear implantation develop language within one standard deviation of their hearing peers—good enough, typically, to allow them to sit in the same classroom.
The study found that, after eight years, 26% of the kids are performing at or above the norm, 16% are within one standard deviation, and 18% are on a trajectory in which it appears likely that they’ll get to within one standard deviation of their hearing peers. So the bottom line, he said, is that a child who received a cochlear implant 12 years ago has a 60% chance of being in an age-appropriate mainstream classroom with his or her hearing peers, without assists. This carries a tremendously positive societal imact generally, as well as expanded life opportunities for implanted children.
But, he said, while vocabulary and semantics developed at normal rates, grammar and the pragmatics of language were attained in this study consistently only when the implant was placed at less than 18 months of age and, even more importantly, when children were immersed in a language-rich environment.
When adjustments are made for a variety of factors to give each child an equal footing, Dr. Niparko said, “we see that bilateral implantation falls away—it’s not a predictor of strong language learning—whereas maternal sensitivity, age at implantation, baseline language comprehension, and the child’s IQ, in fact, are predictive.”
Also, he said, while there might be right-versus-left differentiation with bilateral implants, true effective spatial hearing is limited. Speech and noise are improved, but not likely with the same effect that could come with continued improvements in technology.
Cost is also an important consideration. The average implant costs $50,000. In a cost-effective analysis in which the cost-utility ratio of normal hearing is 0.9 to 1.0 and severe sensorineural hearing loss drops that ratio about 0.5 on average, the first cochlear implant brings much more benefit—an increase in 0.2—than the second implant, which brings an additional increase of approximately 0.05, Dr. Niparko said. “It is substantially unimpressive compared with the first implant’s impact,” he said, “and this suggests that, in fact, we have to look for better ways to provide a binaural benefit.”
Session moderator Paul Lambert, MD, chair of the depaertment of otolaryngology at the Medical University of South Carolina in Charleston, asked about the importance of timing with the second implant. “We don’t show good results with a second implant after five years in terms of language learning,” Dr. Niparko said. “In fact, there are some detriments in language performance over time.”
Dr. Lambert also asked how patients are counseled on the length of the array when they might still have some low-frequency hearing they want to preserve. “A lot of hearing preservation patients, in fact, go on to lose their acoustic hearing,” Dr. Niparko said. “And so many of them, if they had it during preservation procedure, are going to have a relatively short array. … We have to find that compromise between an adequate length of an array and one that is reasonably atraumatic in the cochlea and is likely to give a higher incidence of low-frequency preservation.”
Other broader factors, he said, can be crucial, such as looking at scholastic performance, the child’s language learning, and how the patient is doing socially and emotionally with respect to the goals of the family. “You can make a decision based on those broader goals [as to] whether this is a child who needs more assistance relative to what they’re getting with a hearing aid.”
Tom Collins is a freelance medical writer based in Florida.