PAO Annual Meeting

Fluorescence-guided Surgery: an overview and an institutional experience

Emma De Ravin, BS Karthik Rajasekaran, MD Jason G Newman, MD

Despite improvements in other surgical subspecialties, positive margin rates on final pathology in head and neck oncologic procedures remain high (up to 30%).1 Negative margin status is associated with improved survival and progression-free survival, and is the single most important prognosticator in head and neck cancer.2 As a result, head and neck oncologic surgeons are beginning to explore novel fluorescence-guided surgery (FGS) techniques to improve margin clearance rates and reduce iatrogenic neurovascular injury. FGS is the process of injecting patients with fluorescent contrast agents that target and highlight a tissue of interest, i.e., a tumor, blood vessel, or nerve bundle.

When struck with a specific excitation wavelength, these probes emit near-infrared (NIR) light visible using specialized imaging systems, enabling realtime intraoperative nerve visualization, tumor localization, and tumor margin delineation.

The last 10 years have seen remarkable progress in optical imaging techniques via novel fluorophore development, NIR camera advancement, and clinical trials. Currently, as far as we know, four NIR contrast agents are being studied in head and neck cancer: indocyanine green (ICG), Cyanine 5.5 (Cy5.5), IRDye800CW, and zw800-1.3 ICG is a non-targeted fluorophore that is widely used for multiple non margin-enhancing procedures and has been applied to intraoperative angiography, oncologic procedures, sentinel lymph node resection, and hepatic function testing.4 Unlike ICG, both IRDye800CW and zw800 are conjugated with other molecules to increase their specificity and improve tumor targeting: while IRDye800 is often conjugated with chemotherapeutic agents such as anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (panitumumab, cetuximab), zw800 has been conjugated to cyclo-[Arg-GlyAsp], a drug that binds to tumor surface antigens.3,5

There are multiple ongoing clinical trials at our institution working to advance intraoperative molecular imaging techniques across numerous specialties.6 However, these techniques are still in their infancy—as of yet, of the above fluorescent contrast agents, only ICG is FDA-approved for biomedical purposes and thus remains the most widely used fluorophore in head and neck surgery. Our group previously demonstrated that NIR imaging of high-dose ICG injected 24 hours preoperatively, a novel technique called Second Window ICG (SWIG), could be used for intraoperative identification of head and neck lesions and regional metastasis: ICG has an 86% and 100% sensitivity in primary head and neck cancers and metastatic lymph nodes, respectively.7 In a small proof of concept case series of six patients, we recently demonstrated the efficacy of ICG imaging during transoral robotic surgery. Furthermore, in two of the six cases, NIR imaging was able to identify occult neoplasm that was not otherwise visible under white light, indicating that intraoperative NIR imaging may be useful in the surgical management of head and neck carcinoma of an unknown primary (unpublished data, August 2021). We are currently performing immunohistochemistry studies on fixed surgical tissue specimens to further understand the localization of ICG on the tissue and cellular level. Though SWIG has demonstrated some promise in head and neck squamous cell carcinoma (HNSCC), one limitation of ICG is that it has no molecular targeting abilities, and instead relies on the enhanced permeability and retention effect, which stipulates that ICG accumulates within neoplasms due to disrupted intratumoral vasculature and lymphatic drainage.8

We are currently also participating in a clinical trial for HNSCC investigating ONM-100 (OncoNano Medicine, Southlake, TX), a drug that applies ICG in a novel configuration, in which ICG is encased in a pH-sensitive micelle that dissociates within the acidic tumor microenvironment. This enables more targeted localization of the ICG fluorophore, as it is only released intratumorally. ONM-100 demonstrated clear demarcation of fluorescence at all doses tested in Phase 1a of the trial.9 Now in Phase 2a, we are currently evaluating ONM-100 administered 24 hours preoperatively in the imaging of Stage II-IV HNSCC

Figure 1. NIR imaging system setup during TORS. In this photo, a patient (left, below blue drapes) is undergoing transoral robotic surgery (TORS) for squamous cell carcinoma of the tonsil. Dr. Karthik Rajasekaran is viewing the fluorescent imaging of ONM-100 on the screen to help define the extent of the tumor.

Figure 2. Fluorescence-guided assessment of tumor boundaries. Representative intraoperative images of a head and neck squamous cell carcinoma of the tongue demonstrating in vivo ONM-100 fluorescence in the tumor without fluorescence of the surrounding normal parenchyma .

The head and neck are an area of highrisk real estate, containing vital structures that can be life-threatening if injured. With its ability to enhance intraoperative tumor, nerve, and vascular visualization, optical imaging holds tremendous promise to revolutionize the landscape of otolaryngology, both by improving rates of tumor margin clearance, minimizing the need to remove normal tissue, and thus decreasing rates of iatrogenic neurovascular injury. However, larger scale clinical trials and more preclinical basic science studies dedicated to the investigation of additional fluorophore targets and development of new contrast agents are essential to the continued advancement of the field. Through the development of these emerging technologies, surgeons will be able to offer their patients better oncologic and surgical outcomes. References 1. van Keulen, S. et al. The Clinical

Application of Fluorescence-Guided

Surgery in Head and Neck Cancer. J.

Nucl. Med. 60, 758–763 (2019). 2. Eldeeb, H., Macmillan, C., Elwell, C. &

Hammod, A. The Effect of the Surgical

Margins on the Outcome of Patients with Head and Neck Squamous Cell

Carcinoma: Single Institution Experience.

Cancer Biol Med 9, 29–33 (2012). 3. Wu, C., Gleysteen, J., Teraphongphom,

N. T., Li, Y. & Rosenthal, E. In-vivo optical imaging in head and neck oncology: basic principles, clinical applications and future directions. Int. J. Oral Sci. 10, 10 (2018). 4. Alander, J. T. et al. A Review of

Indocyanine Green Fluorescent

Imaging in Surgery. International

Journal of Biomedical Imaging vol. 2012 1–26 (2012). 5. de Valk, K. S. et al. First-in-Human

Assessment of cRGD-ZW800-1, a

Zwitterionic, Integrin-Targeted, Near-

Infrared Fluorescent Peptide in Colon

Carcinoma. Clin. Cancer Res. 26, 3990–3998 (2020). 6. Azari, F. et al. Intraoperative molecular imaging clinical trials: a review of 2020 conference proceedings. JBO 26, 050901 (2021). 7. Stubbs, V. C. et al. Intraoperative

Imaging with Second Window

Indocyanine Green for Head and

Neck Lesions and Regional Metastasis.

Otolaryngol. Head Neck Surg. 161, 539–542 (2019). 8. Teng, C. W. et al. Applications of indocyanine green in brain tumor surgery: review of clinical evidence and emerging technologies.

Neurosurg. Focus 50, E4 (2021). 9. Voskuil, F. J. et al. Exploiting metabolic acidosis in solid cancers using a tumoragnostic pH-activatable nanoprobe for fluorescence-guided surgery. Nat.

Commun. 11, 3257 (2020).

Tympanostomy Tubes for RAOM: What the Data Really Show

Emily Savoca, MD Jeffrey P. Simons, MD, MMM

Myringotomy with tympanostomy tube placement is one of the most common pediatric surgical procedures. The broad indications include chronic middle ear effusion with hearing concerns and recurrent acute otitis media (RAOM), defined as at least four episodes over a one-year period or three episodes over six months. [1]

The widely held dogma that tympanostomy tubes decrease the incidence of acute otitis media is actually quite controversial in the literature and was again challenged in a New England Journal of Medicine publication earlier this year. [2] The study by Hoberman et al. has led to a wave of questions from parents, pediatricians, and otolaryngologists alike regarding the role for tympanostomy tubes. In light of these issues, it is timely to review the data behind tympanostomy tubes for RAOM and to take a deeper look into the Hoberman et al. study design and results.

Acute otitis media (AOM) is very common in young children due to Eustachian tube dysfunction and a high incidence of upper respiratory infections. It is one of the most common reasons for non-well-child visits to pediatricians, and the leading diagnosis prompting antibiotic prescriptions for children. [1] The approach to AOM has traditionally relied on a combination of tympanostomy tube placement, episodic antibiotic therapy, and prophylactic antibiotics, the latter of which has fallen out of favor due to lack of data supporting the risk-benefit ratio.

The benefits of tympanostomy tubes should be considered depending on indication for placement. Tubes for chronic otitis media with effusion (OME) treat the effusion and can lead to improvement in hearing. Conductive hearing loss from OME can range from minimal to moderate, with average loss around 28 dB.[3] Given concern for longstanding effects on speech and language development, tubes are recommended for chronic OME persistent beyond three months with hearing concerns or in children unlikely to spontaneously resolve the effusion. Furthermore, “at-risk” children are tympanostomy tube candidates for an even shorter duration chronic OME. The indications for tympanostomy tubes in patients with chronic OME are only briefly covered in this article, as the focus of the present discussion is on RAOM. In the management of RAOM, tympanostomy tubes provide a port of entry for ototopical medications and, controversially, may decrease the incidence of infections. The official guidelines per the American Academy of Otolaryngology-Head and Neck Surgery recommend tympanostomy tube consideration for patients with uncomplicated RAOM with the presence of middle ear effusion at the time of assessment. [1] The rationale for consideration of the middle ear status is that a cleared effusion is indicative of adequate Eustachian tube function. Following an episode of AOM, effusion persists in 40% of children after one month and drops to 10% at three months. [4] The likelihood of resolution after three months is lower, tying back to hearing concerns. In practice, however, many children undergo tympanostomy tube placement despite falling short of these guideline criteria, which has prompted concern about overuse. [5]

Indeed, the natural history of AOM may favor expectant management. The incidence of AOM peaks between the ages of six and 12 months. [6] In a systemic review of 15 trials, Rosenfeld et al. reported that children with RAOM averaging 5.5 episodes per year prior to study enrollment subsequently developed infections at a mean rate of only 2.8 episodes per year on placebo alone over the study period. [4] This finding supports the concept that child growth and development is the main driver to reduce incidence of infections as opposed to medical intervention. Two other systematic reviews, both published in 2011, concluded that tympanostomy tubes either marginally reduced risk of AOM, or that data to support this benefit was inconclusive. [7,8] The marginal data, from Lous et al., demonstrated a numberneeded-to-treat of two to five children. In other words, a single prevented episode of AOM over a six-month period required tympanostomy tube placement in two to five children with RAOM. [8]

In a large, matched cohort study using a national insurance claims database, Raol et al. reported that tympanostomy tubes did decrease infection rate and number of oral antibiotic prescriptions compared

Tympanostomy Tubes for RAOM: What the Data Really Show

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to medical management over the first year after surgery. [9] That said, the absolute difference between groups was low (1.96 episodes per year in the tube group versus 2.18 episodes per year in the medical group). Because the sample population was over 13,000 patients, this difference did reach statistical significance. However, this small difference is unlikely to be of clinical significance. Of note, healthcare utilization was higher in the tube group based on number of visits to primary care or otolaryngology. Also of note, the benefit with tubes at one year study did not persist into the second year. Similarly, the 2018 Cochrane review on tympanostomy tubes for RAOM found a benefit with tympanostomy tubes over active monitoring. The calculated number-needed-to-treat at six- and twelve-months post-tubes, respectively, was three and eight children, showing fatigue of the benefit with time. This review concluded that tubes were superior to active monitoring, but with the contingency that evidence in support of tubes was of low- to very-low quality. [10] In May of 2021, Hoberman et al. published their study on this topic in the New England Journal of Medicine. In a multicenter prospective trial, children between the ages of six and 35 months with a history of RAOM were enrolled and randomized to tympanostomy tube placement or medical management, meaning antibiotic treatment for AOM episodes. Based on the final intention-to-treat analysis of 250 children, the researchers concluded that tympanostomy tubes did not reduce the rate of AOM compared to expectant medical management. [2] To better interpret the results, a few salient study features deserve attention. 1. First of all, the criteria to define an episode of AOM differed between groups. For the medical group, an episode of AOM was defined by a score of two or higher on the AOM

Severity of Symptom (AOM-SOS) scale with a middle ear effusion during event and either otalgia, tympanic membrane bulging, erythema, or purulent otorrhea.

In patients with tubes, AOM was defined by otorrhea with one or more positive items of the AOM-SOS scale.

This excluded symptoms immediately following surgery, which could be attributed to post-operative and postanesthesia effects. The AOM-SOS scale inquires about symptoms of increased ear tugging/rubbing, crying, irritability, difficulty sleeping, decreased activity/ appetite, and fevers over the preceding 12-hour period. While AOM does manifest differently in patients with and without tubes, differing diagnostic criteria between groups raises concern for discrepant rates of over- or underdiagnosis. For example, otorrhea is likely far less susceptible to diagnostic error than tympanic membrane erythema and middle ear effusion.

2. The study’s crossover rate was high and largely unilateral. Two hundred and fifty children were enrolled, with 129 assigned to tympanostomy tubes and 121 to medical management. Of the 129 children assigned to the tube group, 116 underwent tube placement.

In the medical group, 54 of 121 children (45%) also ultimately underwent tube placement. This crossover to receiving tympanostomy tubes was either for persistent AOM meeting initial enrollment criteria (35 children) or per parental request (19 children). These cases were defined as “treatment failures.” 3. Results were reported based on an intention-to-treat analysis. This means that the 54 patients in the medical group that did undergo tubes were counted in the medical group. The intention-totreat analysis did not show a significant difference in incidence of AOM between group (1.48 vs 1.56 infections per child per year in the tube vs medical group, respectively, p= 0.66). There were also no significant differences between groups regarding percentage of severe AOM episodes, antimicrobialrelated diarrhea or diaper dermatitis, antimicrobial resistance, quality of life measures, and parent satisfaction.

Given the high rate of deviation for study protocol, a per-protocol analysis was also completed. This excluded the 13 tubegroup children that did not receive tubes and the 54 children in the medical group that did undergo tympanostomy tube insertion. The per-protocol results were reported for the primary outcome only, incidence of AOM, for which there was a significant difference between groups (tubes 1.47 vs medical 1.71, RR 0.82, 95% CI 0.69-0.97). Granted, the sample size was much smaller for this analysis. While not presented, the per-protocol analysis of secondary outcomes reportedly mirrored the intention-to-treat results.

The author’s decision to stay with the intention-to-treat analysis despite the high cross-over rate drew criticism. To the authors’ defense, per-protocol analyses do tend to overestimate treatment effects. Furthermore, a per-protocol analysis in this study would be underpowered given loss of participants to crossover. In an editorial response, the authors also argued that the modest difference between groups in the per-protocol analysis suggested that any

Continued on page 14

Tympanostomy Tubes for RAOM: What the Data Really Show

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difference is likely clinically insignificant. [11] Lastly, the either marginal or lack of difference between groups (depending on analysis) is in fact consistent with historic data, as reviewed above.

4. A final note on the Hoberman et al. study: there were a few underemphasized findings in favor of tympanostomy tubes. The days per year on systemic antibiotics was lower in the tube group (8.3 days/year vs 12.9 days/year in medical group), the time to first episode of AOM was longer, and the rate of treatment failure was lower. Per trial protocol, patients with

AOM in the medical-management group were treated with Augmentin.

Those in the tube group were treated initially with twice daily ofloxacin, and only received systemic oral antibiotics when otorrhea lasted more than seven days.

A primary benefit of tympanostomy tubes for RAOM is access for direct topical delivery of antibiotics, thus decreasing the need for systemic antibiotics. Ototopical therapy allows for a higher concentration of drug delivery, which improves treatment response. [1] The Hoberman results do support this benefit. Interestingly, the results did not support any benefit from tubes in terms of decreasing the risks from systemic antibiotics, including diarrhea and antibiotic resistance.

It is also important to remember that the Hoberman et al. study specifically applied to tympanostomy tubes for RAOM. Patients referred for or undergoing tympanostomy tube placement for hearing concerns were excluded. Ultimately, the Hoberman et al. study confirmed what the data has historically suggested. Tympanostomy tubes may slightly decrease the incidence of episodes in children with RAOM, but if so, the effect is likely small. Tympanostomy tubes do allow for more effective treatment using ototopical antibiotics, and fewer days per year on systemic antibiotics. Concerns for adverse and downstream effects from systemic antibiotics are warranted, though a causal effect is not well-established in the medical literature. With tubes, parents should expect occasional otorrhea, which can be a quality of life issue. Parents should also understand that the natural history of RAOM is favorable, and that time alone will coincide with disease resolution in most children. Based on this, younger children are more likely to benefit from tympanostomy tubes. Lastly, the possible benefits must always be weighed against the risks of surgery. For tympanostomy tubes specifically, the relevant risks include general anesthesia, tympanostomy tube dysfunction, and persistent tympanic membrane perforation. It is valuable to take a critical look at this recent study by Hoberman et al. in the context of other evidence regarding the potential benefits of tympanostomy tubes and to incorporate clinical judgment, clinical practice guidelines, and shared decision making with caregivers into the clinical care decisions for each patient.

1. Rosenfeld RM, Schwartz SR, Pynnonen MA,

Tunkel DE, Hussey HM, Fichera JS, Grimes AM,

Hackell JM, Harrison MF, Haskell H, Haynes

DS, Kim TW, Lafreniere DC, LeBlanc K, Mackey

WL, Netterville JL, Pipan ME, Raol NP, Schellhase

KG. Clinical practice guideline: Tympanostomy tubes in children. Otolaryngol Head Neck

Surg. 2013 Jul;149(1 Suppl):S1-35. doi: 10.1177/0194599813487302. PMID: 23818543.

2. Hoberman A, Preciado D, Paradise JL, Chi DH,

Haralam M, Block SL, Kearney DH, Bhatnagar S,

Muñiz Pujalt GB, Shope TR, Martin JM, Felten DE,

Kurs-Lasky M, Liu H, Yahner K, Jeong JH, Cohen

NL, Czervionke B, Nagg JP, Dohar JE, Shaikh N.

Tympanostomy Tubes or Medical Management for Recurrent Acute Otitis Media. N Engl J

Med. 2021 May 13;384(19):1789-1799. doi: 10.1056/NEJMoa2027278. PMID: 33979487. 3. Fria TJ, Cantekin EI, Eichler JA. Hearing acuity of children with otitis media with effusion. Arch

Otolaryngol. 1985 Jan;111(1):10-6. doi: 10.1001/ archotol.1985.00800030044003. PMID: 4038450.

4. Rosenfeld RM, Kay D. Natural history of untreated otitis media. Laryngoscope. 2003

Oct;113(10):1645-57. doi: 10.1097/00005537200310000-00004. PMID: 14520089.

5. The Joint Commission. Proceedings from the

National Summit on Overuse. September 24, 2012. http://www.jointcommission.org/ assets/1/6/National_Summit_Overuse.pdf.

Accessed April 1, 2016.

6. Kaur R, Morris M, Pichichero ME. Epidemiology of Acute Otitis Media in the Postpneumococcal

Conjugate Vaccine Era. Pediatrics. 2017

Sep;140(3):e20170181. doi: 10.1542/peds.20170181. Epub 2017 Aug 7. Erratum in: Pediatrics. 2018 Feb 28;: PMID: 28784702; PMCID:

PMC5574724.

7. Hellström S, Groth A, Jörgensen F,

Pettersson A, Ryding M, Uhlén I, Boström

KB. Ventilation tube treatment: a systematic review of the literature. Otolaryngol Head

Neck Surg. 2011 Sep;145(3):383-95. doi: 10.1177/0194599811409862. Epub 2011 Jun 1.

PMID: 21632976.

8. Lous J, Ryborg CT, Thomsen JL. A systematic review of the effect of tympanostomy tubes in children with recurrent acute otitis media. Int J Pediatr

Otorhinolaryngol. 2011 Sep;75(9):1058-61. doi: 10.1016/j.ijporl.2011.05.009. Epub 2011 Jun 2.

PMID: 21636136.

9. Raol N, Sharma M, Boss EF, Jiang W, Scott

JW, Learn P, Weissman JS. Tympanostomy

Tube Placement vs Medical Management for Recurrent Acute Otitis Media in TRICARE-

Insured Children. Otolaryngol Head Neck

Surg. 2017 Nov;157(5):867-873. doi: 10.1177/0194599817707718. Epub 2017 May 23. PMID: 28535362.

10. Venekamp RP, Mick P, Schilder AG, Nunez DA.

Grommets (ventilation tubes) for recurrent acute otitis media in children. Cochrane Database

Syst Rev. 2018 May 9;5(5):CD012017. doi: 10.1002/14651858.CD012017.pub2. PMID: 29741289; PMCID: PMC6494623.

11. Paradise JL, Hoberman A, Preciado D.

Tympanostomy Tubes or Medical Management for Recurrent Acute Otitis Media. Reply. N Engl

J Med. 2021 Aug 26;385(9):861-862. doi: 10.1056/NEJMc2109725. PMID: 34437793.

The Impact of Positive Margin on Survival in Oral Cavity Squamous Cell Carcinoma

Vishaal Patel, MD; Thomas J. Galloway, MD; Jeffrey C. Liu, MD

Oral cavity squamous cell carcinoma (OCSCC) is a common cancer globally with more than 200,000 cases per year. The mainstay of therapy for early stage OCSCC is primarily surgical resection with positive margin rates varying from 2.7% to 15%. National Comprehensive Cancer Network (NCCN) guidelines recommend re-resection, radiation, or radiation with systemic therapy as possible options in the event of a positive margin, however radiation and systemic therapy are associated with severe toxicity making counseling and treatment decisions difficult. While many studies have shown that positive margins negatively impact survival by up to 8%, others have suggested that positive margins may have a limited impact. Other studies have shown that radiation can limit the impact of positive margins however they are generally smaller, single-institution patient cohorts.

To better examine the impact of positive margins OCSCC outcomes, we obtained data from the National Cancer Database, a national, multi-institution oncology dataset that captures treatment and survival outcomes for more than 80% of head and neck cancers. The aim of our study was to measure the effect of positive margins on survival in early stage OCSCC and evaluate the relationship of co-factors, such as radiation, with survival following a positive margin.

We included a total of 26,049 patients with 2,093 positive margins and 3,642 patients receiving adjuvant radiation. These patients were then separated into one of eight cohorts based on their history of positive or negative margin, positive or negative history of radiation, and positive or negative history of neck dissection. By separating the analysis into specific cohorts, patients in whom upfront neck dissection was performed were only compared to other patients with neck dissection and non-dissected patients were only compared with non-dissected patients as a measure to control for neck dissection as a co-variate impacting survival.

When comparing non-irradiated negative margin patients with non-irradiated positive margin patients, overall survival fell by 11.4% and 12.8%, depending on history of neck dissection. Five year survival fell by 13.2% and 15.5%. After univariate analysis was performed, positive margins continued to convey a hazard ratio of 1.47 and 1.62 (p<0.001) on multivariate analysis. Other factors that correlated with survival in multivariate analysis were age, T-stage, and comorbidity index.

To determine if radiation improved survival, we compared survival outcomes in irradiated positive margin patients to nonirradiated positive margin patients. We found no significant difference in survival in these comparisons: overall survival varied by only 0.5 and 2.8% with 5-year survival varying by 0.9% and 1.6%, depending on history of neck dissection. Radiation did not correlate with survival outcomes on univariate analyses in these patient cohorts.

Using the NCDB database, we found that positive margins resulted in a 11-15% reduction in overall survival. We found no difference in survival in irradiated and non-irradiated positive margin patients. This study adds a high powered analysis to the literature regarding management of positive margins in OCSCC and questions the utility of radiation alone in this setting. Re-resection should be performed when possible and adjuvant treatment thereafter be discussed in a multi-disciplinary tumor board.

Keith R. Conti MD1, Ronak Modi MD2, and Aaron Jaworek MD1,3,*

Karen A. Rizzo, MD, FACS Governor

The 125th Annual Meeting of the AAO/HNS was recently held in Los Angeles. Dr. Ken Yanagisawa started his President's term and Dr. Carol Bradford completed hers. The meeting was attended by over 2000 physicians. Both live presentations and on demand sessions were available. The Board of Governors also elected its new leadership. Dr. Karen Rizzo was elected Chair Elect and Dr. Christina Baldasarri was elected Secretary. Dr Troy Woodard is the new Chair. Dr Lance Manning is now past chair. Dr Denneny discussed strategic goals of the academy to include a new Business of Medicine Program focusing on helping physicians maintain and promote practice viability and sustainability. A Private Practice Study Group has been formulated to study and evaluate various ways for the academy to utilize its resources to aid physicians in managing their practices to sustain growth and financial stability. Promoting inclusivity and diversity encouraged. From a legislative perspective, physicians are potentially facing a 9.75% Medicare reimbursement reduction on January 1, 2022. Representatives Ami Bera MD from California and Larry Bushon MD from Indiana through their letter are urging passage of legislation to avert these legislative cuts. By using the Academy's advocacy website, otolaryngologists are urged to contact their US representative to ask asking them to sign the Beri Bera-Bushon letter and support fair reimbursement for practicing otolaryngologists. The AAO continues to lead efforts to oppose the audiology direct access legislation. It has sent several letters to House and Senate leadership expressing strong opposition to the Medicare Audiologist Access and Services Act

Save the Date!

HR 1587. Over 110 national, state, and local organizations have expressed patient safety concerns for Medicare beneficiaries as well.

The Academy has demonstrated strong endorsement for HR 3173 which improves Seniors Timely Access to Care Act. This legislation which currently has 195 cosponsors would help protect Medicare patients from delays in care by streamlining and standardizing the use of prior authorization in the Medicare Advantage Program. Toolkits are now available on the Board of Governors website to help physicians in the handling of reimbursement problems with insurers. Toolkits are also present to assist state societies with developing, organizing, and managing their society. Slide sets are available for several clinical practice guidelines. Appeal letters and advocacy statements are available when payers deny claims. Using the BOG as a conduit for the sharing of information which impacts patient, practice, and legislative advocacy is recommended. Members are encouraged to visit the website to see the vast amount of information now available.

Karen A. Rizzo, MD FACS Chair Elect BOG/ PA Governor

Abhinav R. Ettyreddy MD, Philip Perez MD, & Barry E. Hirsch MD, Andrew A. McCall MD

Cochlear implantation (CI) remains the primary tool to restore auditory perception in patients with severeto-profound sensorineural hearing loss. Traditionally, CI was reserved for patients with bilateral profound hearing loss who failed an appropriate trial of hearing aid amplification. The benefits of CI in this population are well established including improvements in multiple quality-of-life metrics.1 Cochlear implantation CI candidacy criteria have expanded over time as advances in technology have resulted in improved outcomes and decreased surgical morbidity. Most recently, the U.S. Food and Drug Administration (FDA) approved the MED-EL Cochlear Implant System for individuals five years of age or older with single-sided deafness (SSD) or asymmetric hearing loss (AHL). The goal of the current article is to provide an overview of the benefits of binaural hearing that led to the expansion of CI candidacy criteria and to review the current guidelines for CI in SSD/AHL. Single-sided deafness is defined as a hearing loss with normal or nearly normal hearing in one ear and severe to profound hearing loss in the contralateral ear.2 The definition of AHL, on the other hand, is subject to some variability but generally accepted to be an interaural asymmetry of >20 dB hearing level (HL) in at least two contiguous frequencies. 3 Traditionally, patients with SSD or AHL were managed with contralateral routing of signal (CROS) hearing aids or bone conduction hearing devices which would route sound to the functional/ better hearing ear. Since these methods do not recreate binaural hearing, there have been limited benefits noted on subjective reports and on spatial hearing tests.4 The key advantages of binaural hearing include head shadow effects, binaural squelch, and binaural summation. These binaural benefits are important for understanding speech in noise, especially in complex listening environments.4 In a cross-sectional study comparing adults with unilateral deafness to those with normal hearing, individuals with unilateral deafness demonstrated significant challenges in environments with background noise.5 Given the benefits of binaural hearing in complex listening environments, there has been increased interest in the role of CI in patients with SSD. Several studies have assessed the long-term audiologic outcomes after CI for SSD and demonstrated significant improvements in key metrics including sound localization, hearing in noise, and quality-of-life metrics.6 These benefits were rarely seen with the traditional CROS and bone conduction hearing systems. In 2019, the FDA approved the MED-EL cochlear implant system for SSD/AHL to improve speech understanding in noise, sound localization, and self-perceived quality of hearing. On-label use indicates that the implanted ear has profound sensorineural hearing loss, which is defined as a pure tone average of 90 dB HL or greater at 500, 1000, 2000, and 4000 Hz. There are no defined restrictions on hearing level for the contralateral ear. For sentence testing, patients must score <5% on consonant-nucleus-consonant (CNC) words in quiet under the best aided conditions when tested in the ear to be implanted. On-label use indicates that profound hearing loss should not be present for more than 10 years. Unlike traditional CI criteria, there is limited role for binaural sentence testing in this population. Finally, before implantation, individuals with SSD and AHL must complete a one-month trial with a CROS hearing aid system or similar device without subjective benefit. The management of patients with SSD/ AHL requires a thoughtful and nuanced approach. The traditional CROS hearing aid system remains the initial treatment option and may in fact be the ideal choice for patients who are hesitant to undergo a surgical procedure or are poor surgical candidates. However, patients who find themselves in complex listening environments may be unsatisfied with the CROS hearing aid system and report minimal subjective improvements. In this population, CI is now a viable hearing rehabilitation strategy that can restore binaural hearing and provide significant benefit in multiple hearing domains.

References

1. Carlson ML. Cochlear implantation in adults. NEJM 2020; 382: 1531-1542. 2. Yu JW. Understanding patient perspectives on single-sided deafness.

JAMA Otolaryngol Head Neck Surg 2020; 146(10): 8875-886. 3. Durakovic N, Valente M, Goebel

JA, & Wick CC. What defines asymmetric sensorineural hearing loss?

Laryngoscope 2018; 129(5): 10231024.

4. Thompson NJ, Dillon MT, Buss E, Rooth

MA, King ER, Bucker AL, McCarthy

SA, Deres EJ, O’Connell BP, Pillsbury

JC, Brown KD. Subjective benefits of bimodal listening in cochlear implant recipients with asymmetric hearing loss.

Otolaryngol Head Neck Surg 2020; 162(6): 933-941. 5. Wie OB, Pripp AH, & Tvete O.

Unilateral deafness in adults: effects on communication and social interaction.

Ann Otol Rhinol Laryngol 2010; 119(11): 772-781.

6. Sullivan CB, Al-Qurayshi Z, Zhu V, Liu

A, Dunn C, Gantz BJ, & Hansen MR.

Long-term audiologic outcomes after cochlear implantation for single-sided deafness. Laryngoscope 2020; 130(7): 1805-1811.

Pallavi Kulkarni, BS; Jacqueline Tucker, BS; Jessyka G. Lighthall, MD FACS, Karen Y. Choi, MD

Mental health disorders are surrounded by biases and stigma that can strongly impact patients’ quality of life. Head and neck cancer (HNC) patients are known to be at high risk for mental health disorders, such as anxiety and depression, in part due to the disfigurement of the disease and functional impact on daily activities such as eating, talking, and breathing. HNC patients are treated with surgery, radiation, or chemotherapy, and often a combination of these modalities are employed. Often, for large and advanced HNCs, reconstructive surgery is required to restore function and image, and these surgical changes are often highly visible. While reconstructive measures aim to establish a “new normal” that allow patients to regain function, they often have lasting effects from surgery that impact their appearance, and cause them to be socially isolated, crippling their quality of life.

It is important to focus on patients' mental health and quality of life so they can holistically heal. This is an important and pertinent topic of research in HNC patients. The most common surveys used in the HNC population to assess quality of life include the Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module, the University of Washington Quality of Life Questionnaire, and the Functional Assessment of Cancer Therapy Head and Neck scale.[1] Often, these questionnaires group image disorders in with questions that assess quality of life, but it is important to note image disorders are a singular part of the bigger picture. Body Image Disturbance (BID) is a complex and multidimensional mental health concern and includes selfperceptions, attitudes, and satisfaction of one’s physical appearance and ability to function. BID can be extremely common with HNC patients who undergo treatment. Patients often feel embarrassed or concerned about changes they have endured.[2] However, there is a lack of consensus on how best to evaluate body image perceptions. Most studies have used quantitative surveys, but these surveys vary in questions and focus. In fact, when conducting a systematic review, Kling et al. found more than 150 different body image measures had been used in recent years. [3] As such, there is a need to improve cohesiveness in this field in order for studies to be comparable and improve our management of this issue. Some popular survey studies for image disorders used in HNC research include the Body Image Scale (BIS) and the Body Image Quality of Life Inventory. [2,4,5] One study using the BIS found 13-20% of HNC patients were experiencing body image distress. Additionally, patients reported feelings of shame, feeling bad/ugly, depression, and negative reactions by individuals around them in the qualitative part of the same study.[2] Prior research has shown that patients with HNC undergoing a surgical procedure have a greater likelihood of having an issue with their appearance. [5] Additionally, factors such as female sex, low level of education, smoking, and prior history of feelings of shame/ stigma and depression have been linked to increased risk of development of a body image disorder.[6,7] Understanding which patients are at increased risk for body image disturbances can help guide physicians’ expectant management. When assessing how perceptions of body image change over time, Rhoten et al. found that while body image scores decrease from baseline to after treatment, by 12 weeks post-treatment there is significant body image improvement. [5] Additionally, a systematic review found two longitudinal studies reporting improvement in body image disturbance over time as patients get further from treatment.[8] This could represent the time needed for appropriate healing, and resolution of complications, or time for patients to adjust to their “new normal.” Since body image is a broad term that refers to the entire body, it may not adequately assess how patients feel specifically about the head and neck area that underwent treatment.

The face is the initial way people recognize us. It directly affects how we interact with our surroundings and helps form our identity to the world. Since HNC often affects facial appearance, it is important to specifically assess patient perceptions of the face. In patients undergoing microsurgery as part of their treatment for HNC, a body area satisfaction survey (BASS) showed lowest scores of satisfaction for the face. [9] This data suggests that the face is an emotionally sensitive area for individuals that have undergone surgical intervention. There have been very few patient-reported outcome measurement (PROM) studies in HNC, and no specific PROM surveys that focus on head and neck-specific measures of body image disturbance.[8] Recently, the Medical University of South Carolina developed and validated the first PROM for use in HNC.[10] The survey consists of items assessing patients’ perceptions of their bodies following HNC treatment. However, this survey has not yet been widely distributed, and future studies should consider implementing this survey in different clinics and patient populations. To aid in coping with and prevention of facial image disturbances, there is a critical need to understand the prevalence in HNC patients. As more data is gathered on head and neck specific image disturbance and head and neck specific measures become available, this will assist in early identification of changes in mental health that would benefit from further evaluation and treatment. An understanding of how post-treatment facial image disorders specifically impact patients’ mental health, outcomes, and satisfaction will allow for optimization of patient care and the patient experience.

Continued from page 18

References:

[1] Ojo, B., Genden, E. M., Teng, M.

S., Milbury, K., Misiukiewicz, K. J., &

Badr, H. (2012). A systematic review of head and neck cancer quality of life assessment instruments. Oral oncology, 48(10), 923-937. [2] Melissant, H. C., Jansen, F.,

Eerenstein, S. E., Cuijpers, P., Laan,

E., Lissenberg-Witte, B. I., ... &

Verdonck-de Leeuw, I. M. (2021).

Body image distress in head and neck cancer patients: what are we looking at? Supportive Care in

Cancer, 29(4), 2161-2169. [3] Kling, J., Kwakkenbos, L., Diedrichs, P.

C., Rumsey, N., Frisen, A., Brandao,

M. P., ... & Fitzgerald, A. (2019).

Systematic review of body image measures. Body Image, 30, 170-211. [4] Hung, T. M., Lin, C. R., Chi, Y. C., Lin,

C. Y., Chen, E. Y. C., Kang, C. J., ... &

Chang, J. T. C. (2017). Body image in head and neck cancer patients treated with radiotherapy: the impact of surgical procedures. Health and

Quality of Life Outcomes, 15 (1), 1-7 [5] Rhoten, B. A., Deng, J., Dietrich, M. S.,

Murphy, B., & Ridner, S. H. (2014).

Body image and depressive symptoms in patients with head and neck cancer: an important relationship. Supportive

Care in Cancer, 22(11), 3053-3060 [6] Graboyes, E. M., Hill, E. G., Marsh,

C. H., Maurer, S., Day, T. A., &

Sterba, K. R. (2019). Body Image

Disturbance in Surgically Treated

Head and Neck Cancer Patients:

A Prospective Cohort Pilot Study.

Otolaryngology–Head and Neck

Surgery, 161(1), 105–110. https://doi. org/10.1177/0194599819835534 [7] Nogueira, T. E., Adorno, M.,

Mendonca, E., & Leles, C. (2018).

Factors associated with the quality of life of subjects with facial disfigurement due to surgical treatment of head and neck cancer. Medicina Oral Patología

Oral y Cirugia Bucal. https://doi. org/10.4317/medoral.22072 [8] Ellis, M. A., Sterba, K. R., Brennan, E.

A., Maurer, S., Hill, E. G., Day, T. A., &

Graboyes, E. M. (2019). A systematic review of patient-reported outcome measures assessing body image disturbance in patients with head and neck cancer. Otolaryngology–Head and Neck Surgery, 160(6), 941-954. [9] Liu, H.-E. (2008). Changes of satisfaction with appearance and working status for head and neck tumour patients. Journal of Clinical

Nursing, 17(14), 1930–1938. https://doi.org/10.1111/j.13652702.2008.02291.x

[10] Graboyes EM, Hand BN, Ellis

MA, Huang AT, Nilsen ML, Pipkorn

P, Marsh CH, Maurer S, Day TA,

Sterba KR. Validation of a Novel,

Multidomain Head and Neck

Cancer Appearance- and Function-

Distress Patient-Reported Outcome

Measure. Otolaryngol Head Neck

Surg. 2020 Nov;163(5):979-985. doi: 10.1177/0194599820927364.

Epub 2020 Jun 2. PMID: 32482151.

David Goldenberg MD, FACS

Conservative estimates show that 100,000 to 150,000 thyroidectomies are performed in the United States annually. An estimated 53,000 patients will develop cancer in 2020, indicating that most thyroidectomies are for benign thyroid disease. Thyroid nodules are prevalent in the United States. The risk of developing a palpable thyroid nodule is about 10%; however, due to the use of high-resolution ultrasound, some 19-70% of randomly selected individuals will be shown to have a thyroid nodule. Nodular disease of the thyroid is common, but malignancy of the thyroid occurring in a nodule is not. The risk of malignancy in a solitary nodule is between 7–15 %. The incidence of thyroid nodules has increased rapidly in recent years. This increase is thought to be primarily driven by early detection and the increased use of highresolution imaging techniques. Benign thyroid nodules may represent various conditions, including colloid nodules, degenerative cysts, hyperplasia, thyroiditis, or benign neoplasms. The diagnostic workup of a thyroid nodule includes laboratory evaluation, utilizing a sensitive thyroid-stimulating hormone assay, which is used to screen for hyperthyroidism or hypothyroidism. The routine initial diagnostic evaluation of a solitary thyroid nodule no longer includes nuclear imaging studies. Because of technological advances, ultrasonography is highly sensitive in determining the size and number of thyroid nodules and may even hint towards a malignancy versus a benign nodule. By itself, ultrasonography cannot reliably be used to distinguish between a benign nodule or a malignant one. However, a combination of high-resolution sonography and fineneedle aspiration biopsy is both sensitive and specific. CT scanning or MRI is generally not cost-effective in the initial evaluation of a solitary thyroid nodule. Up until recently, the management of a solitary benign thyroid nodule included observation versus surgical excision. Ultrasound-guided radio-frequency ablation (RFA) for thyroid lesions is a minimally invasive treatment modality that may be an alternative to surgery in patients with benign thyroid nodules which are symptomatic. It may also have an effective complementary role in the management of small or recurrent thyroid cancers. RFA is typically efficacious and safe in managing thyroid nodules that cause compressive symptoms or cosmetic problems. Radio-frequency ablation utilizes an electrode carrying a high-frequency alternating current to cause thermal injury in the nodule tissue. This leads to cell death and shrinkage of the affected nodule. The procedure is performed under local anesthesia with the option of mild sedation if necessary. After a local anesthetic is instilled, a thin needle is introduced into the thyroid nodule through the skin. This is done under continuous ultrasound visualization. The needle is connected to a generator that uses electricity to generate heat around the tip of the needle only. The needle is then moved back and forth inside the nodule, ablating it from the inside. Normal thyroid tissue is typically not affected since this is done under ultrasonic guidance with direct visualization of both the nodule and the surrounding thyroid. Thyroid ablation, using RFA, is effective and successful when the nodules are reduced by 50% or more. On average, a solid thyroid nodule will shrink by 80% and, in some cases, totally disappear. In most cases, this nonsurgical option results in an improvement in compressive symptoms and cosmetic concerns.

Complications of RFA are rare and may include hoarseness, which in most cases is temporary. Complications can be avoided by the physician using caution in the danger triangle towards the posterior portion of the thyroid gland near the recurrent laryngeal nerve. Skin burns have been reported, and nausea and vomiting may occur after the procedure. Rarely, a nodule may rupture. RFA procedure costs vary depending on the state and location of the procedure. As with any medical procedure conducted in the hospital setting, it may be costly. However, the RFA treatment costs are significantly less than a thyroid lobectomy. Pre-ablation assessment: All patients are to be evaluated clinically and undergo a neck ultrasound and a fine needle aspiration biopsy showing that the nodule in question is indeed benign. Patients who have metallic hardware or pacemakers, bleeding tendencies, pregnancy, or nodules that appear very suspicious on ultrasound, are not considered candidates for RFA. Informed consent should be obtained from the patient before performing the RFA.

Lobbyist Message: Are you ready to fall into a busy legislative season?

by Deborah Ann Shoemaker, PAO-HNS Lobbyist

It is hard to believe that October is upon us. When I wrote my first article to our members this past spring, I expressed optimism that we could move past much of the political name calling and divisiveness. Well, wishful thinking I guess in some respects.

The rest of the year will keep us busy, but in a good way.

Here is an update on grassroots advocacy activities that have occurred since our last newsletter article and a strategy moving ahead.

FALLING INTO ACTION: COVID-19 AND RELATED LEGISLATIVE ISSUES

We are now into year two of the COVID-19 pandemic. Although Pennsylvania continues to experience more individuals either partially or fully vaccinated, we still have a long way to go. Debate continues as to if a booster shot is needed; if kids under the age of 11 should get vaccinated; and if a mandated mask mandate (especially in schools) is necessary or just a violation of personal freedoms. Regardless of your personal convictions on all the above topics, one thing is certain: access to care cannot be compromised for your patients- regardless of a pandemic.

On the federal level, the Biden Administration continues to extend the Public Health Emergency Declaration. If it is in place, any federal rulemaking or policies that were relaxed or initiated during the pandemic remain in effect. We will continue to advocate for those policies that have assisted in providing patient care (such as Medicare coverage of telemedicine) to continue throughout the duration of the declaration is over and/or beyond if applicable.

However, at the state level, there is much work to do in this regard. The state legislature enacted legislation that required a constitutional amendment change to limit any governor’s authority to declare a Public Health Emergency (PHE) to 21 days- regardless of the issue. All state regulatory and policy relaxations and/or changes would have to be vacated after the PHE. For sake of education, a Pennsylvania constitutional change must be voted on by voting citizens of the commonwealth prior to being enacted. This past spring, the referendum was on the state primary ballot and got a majority vote.

So, what does that mean for

PAO-HNS? The end of our state’s PHE was September 30th. Prior to that deadline, I reviewed the significant impact of these changes to our members and provided an analysis. At that time, some of the biggest concerns involved the use of telemedicine, relaxed hospital practice privileges for those not on hospital staff, relaxed collaboration between CRNPs, PAs and other non-MD providers, and delayed state medical license renewals.

After much consumer/healthcare provider outrage and public pressure, House Republican leadership introduced House Bill 1861 to extend those policies initiated during COVID from September 30th for another 6 months. The governor signed the bill into law this week and its provisions immediately went into effect. NOTE: this victory buys us some time, but we will have to revisit this issue next year.

FALL INTO ACTION: PRIOR AUTHORIZATION

House Bill 225 and Senate Bill 225 were introduced early this legislative session related to prior authorization. PAO-HNS sent out a solicitation in late June, targeting members residing and/or laboring in senatorial districts of Senate Banking and Insurance Committee members to request an affirmative vote in committee. As a result of medical specialty collective grassroots advocacy efforts, Senate Bill 225 was voted out of the committee on June 25th with significant amendments. For a copy of the amended version of the bill, feel free to ask me or get a copy on our website.

FALLING INTO ACTION: ASSISTING OUR COLLEAGUES WITHIN PAMED AND THEM WITH US!

Our friends at PAMED have taken the lead on crucial legislative and regulatory initiatives, such as scope of practice expansion, medical malpractice, change of venue for liability actions, non-disclosure agreements, and payer relations.

Phillips Recall Issue- Our Collective Work: It was brought to our attention that Phillip Respironics device recall of 3-4 million devices (and their recommendation to cease using devices immediately) is impeding patient care and has the potential of adverse outcomes.

After invaluable input from PAO-HNS sleep member experts, we sent our draft letter to PAMED’s practice support department for input. PAO-HNS is finalizing our recipient list. After that is completed, we will forward our comment letter to the appropriate stakeholders for review and comment.

Continued from page 15

House of Delegates:

Although we do not have a dedicated representative this year at HOD, our voice can still be heard. Our colleagues at the Pennsylvania Academy of Dermatology have introduced a House of Delegate Resolution on non-medical switching. After careful review by Drs. Cognetti and McGinn, we wholeheartedly endorsed their resolution.

Prior to the virtual HOD later this month, I will review all HOD resolutions and provide a comprehensive overview.

Last, but not least, one of the best ways to get politically active is to educate our members about grassroots advocacy, our issues, and how to get engaged. I was excited to meet many of you (albeit in a virtual format) at our annual scientific meeting in June. Although my virtual booth did not do justice to meeting you in person, it was an opportunity for our members to review legislation or be reminded to check out our website.

To tackle our aggressive grassroots advocacy efforts on the state and national level, we can use all your help. Please do not hesitate to reach out to me via email (dshoemaker@pamedsoc.org) if you have any questions, need more information, or want to get involved. A copy of our most recent legislative watch list and legislative update is enclosed for your review and can be viewed on our website.

Congratulations UPMC!

Happy Fall!

Congratulations to UPMC for their success winning the Resident Jeopardy Bowl

Elliott Jody Bilofsky, DO, FAOCO,

an otolaryngologist at UPMC Altoona Ear Nose & Throat and chief of UPMC Altoona ENT Service, has been named a Pennsylvania Medical Society (PAMED) Everyday Hero. He received the award on July 28, 2021.

Dr. Bilofsky was nominated for this award by a colleague, who said that he is not only an outstanding otolaryngologist, but also a humanitarian and leader.

“Until last July, he was the solo otolaryngologist for UPMC Altoona,” said his nominator. “During the pandemic, Dr. Bilofsky has worked tirelessly to fight COVID-19. He has singlehandedly performed at least 70 tracheotomies in critically ill ICU COVID-19 patients. He has worked nights and weekends, even when not "on call,” to care for the sickest of sick COVID-19 patients.”

She went on to say, “We are lucky and blessed to have Doctor Bilofsky at UPMC Altoona; he is absolutely phenomenal!”

Colleagues and others share the accolades, describing Dr. Bilofsky as a physician who provides phenomenal care to patients and is all around amazing and a true leader of the profession. They call him a humanitarian at its finest, and refer to him as a modest and true physician who never stops and is ever giving of his expertise.

PAMED’s Everyday Hero Award program, launched in 2018, honors member physicians who go above and beyond in their profession and in providing patient care. It’s designed to showcase exemplary physicians who probably don’t view themselves as heroes, but to patients and colleagues they are.

Patients and medical colleagues can nominate PAMED member physicians for this award at www.pamedsoc.org/EverydayHero.

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