Soundings: Fall 2018

Soundings PUBLISHED IN THE INTEREST OF OUR MEMBERS AND THEIR PATIENTS

President’s Message Ahmed M.S. Soliman, MD

new addition to the program, and one that will continue. We look forward to next year’s meeting in Hershey with Colin Huntley, MD and Jessyka Lighthall, MD as Program Chairs.

This year’s meeting was also bittersweet; we wished Jennifer Keeler well as she departed, after 12 years at the PAO, for her new role as Executive Director of the World Surgical Foundation. However,

I am pleased to announce that a new Executive Director has been named and is already hard at work.

Barbara Husic comes to us most recently from the prestigious K&L Gates in Washington DC. With the long hot summer at an end, and fall underway, I want to both reflect on the past few months as well as look forward to the coming year. The Annual Scientific Meeting was a great success and attended by a record number once again. I am indebted to the Program Committee, faculty, and fantastic PAO staff which made it all happen. We were once again very pleased to have the Executive Vice President of the American Academy of Otolaryngology-Head & Neck Surgery Foundation, James Denneny, MD, in attendance. We had several innovative sessions including an interactive patient safety symposium and the ever-popular Resident Bowl.

This year, for the first time, a combined team from PCOM and UPMC clinched the top prize so the “Conchal Bowl” will spend six months at each institution. This year’s meeting also featured the inaugural “Women in Otolaryngology” session headed by Karen Rizzo; this was a great

I am pleased to announce that a new Executive Director has been named and is already hard at work. Barbara Husic comes to us most recently from the prestigious K&L Gates in Washington DC. She has previously worked as personal assistant to Eunice Kennedy Shriver and US Senator Harris Wofford and served on the personal staff of Governor Robert P. Casey. Along with Kevin Shivers, the new Director for Specialty Society Management Services at PAMED, our Assistant Executive Director, Kimberly Whetsell; Member Service Specialist, Melanie Dupont; and Meeting Manager, Jessica Winger, we have a great team that will take the PAO into the coming years.

On the advocacy front, we continue to work with PAMED, the AAO-HNSF, and other specialty societies in our fight against IBC’s ill-advised Modifier 25 policy. The process is gaining momentum

as the Polsinelli Firm has been retained and an analysis of the financial repercussion of the policy on physicians is underway. We thank PAO members, Pinnacle ENT Associates and Philadelphia ENT Associates for volunteering to represent our society in the ongoing process.

There are many other potential threats on the horizon that we continue to closely monitor. New CMS coding guidelines which combine levels 2-5 are moving forward and are in the public comment period. Otolaryngology is predicted to have a net gain in reimbursement although this will likely vary based upon individual billing patterns. Look for more on this soon.

Legislatively, we continue to work with our government relations firm, Milliron & Goodman, and the Pennsylvania Academy of Audiology on the Hearing Aid Dispenser Certification bill. We have also met with the Pennsylvania Society of Physician Assistant’s leadership regarding changes proposed to the Medical Practice Act. We thank all those who participated in our online survey which has helped us gauge the opinion of our members.

Finally, the patient content on our website continues to grow under the guidance of Michael Ondik, MD, and we expect it to be finalized shortly. I will end by promising you that the Pennsylvania Academy of Otolaryngology will not waiver in its mission to advocate for Pennsylvania Otolaryngologists and their patients.

Sincerely, Ahmed M.S. Soliman

AAO-HNS BOARD OF GOVERNOR’S UPDATE

content Fall 2018

Karen A. Rizzo, MD PA Governor, BOG

On July 12, the Centers for Medicare and Medicaid Service (CMS) issued a proposed rule that includes 2019 updates to payment policies, payment rates and quality provisions for services furnished under the Medicare Physician Fee Schedule (PFS) and the Quality Payment Program (QPP). The AAO-HNS is analyzing the 1500-page proposed rule and will submit comments by the September 10 deadline. To help answer questions regarding the proposed rule and its impact on patients and one’s practice, a new panel presentation has been added to the AAO-HNSF 2018 Annual Meeting program. A final rule from CMS is expected to be released in November.

CMS proposes applying a single payment rate for new and established patient E/M code levels II through V. It also proposes a modifier 25 payment reduction of 50% for any procedure done on the same day as an E/M visit. Significant reductions in reimbursement from both of these proposals can significantly impact the financial viability of both private practice and academic practices.

The Pennsylvania Medical Society has

submitted a letter on behalf of the state’s physicians expressing their concerns and lack of support regarding devaluing E/M codes and the modifier 25 reduction.

ENT PAC made the academy’s voice heard at political events in support of US Representative Vern Buchanan (R-FL), Buddy Carter (R-GA), Leonard Larue (RNJ), Bill Pascrell (D-NJ) and US Senator Lamar Alexander (R-TN).

In Insurance news, Aetna expanded coverage for hypoglossal nerve stimulation for the treatment of OSA. Under the new policy, FDA approved hypoglossal nerve neurostimulation devices are considered medically necessary to treat OSA when certain clinical criteria are met.

3 What Can We Learn from Analysis of Pennsylvania Patient Safety Reporting System (PA-PSRS) Data?

3 Identifying Patient Harm from Direct Oral Anticoagulants 4 Hot Topic: Non-surgical, Healthcare-Associated Burn Injuries 5 Update on Wrong-Site Surgery: More Data Provides More Insight 5 Aspirin Exacerbated Respiratory Disease: an Often-missed Diagnosis in Patients with Nasal Polyposis 6 Idiopathic Sudden Sunsorineural Hearing Loss: A Review of Management and Limitations of Current Evidence

For more information on any of these topics, visit info@otopa.org.

12 Legislative Update

The opinions expressed in this newsletter do not necessarily reflect the opinion of PAO-HNS.

SOUNDINGS | Fall 2018

2 Board of Governor’s Update

Lastly, the AAO-HNSF is spearheading a medical supplies and instrument donation drive in collaboration with Medshare by sourcing and directly delivering surplus medical supplies and equipment to communities in need around the world.

Anyone wishing to donate supplies should contact info@otopa.org.

Soundings accepts classified advertisements, however, there is no guarantee that they will be published. All submissions are subject to review. The advertisement should be of interest/pertain to otolaryngologists, their practice, and health care in Pennsylvania.

Submissions that are self-promotional or commercial in nature will not be accepted. Publication of advertising does not imply endorsement of the products advertised or the statements contained in such advertising by Soundings or the PAO-HNS.

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1 President’s Message

10 Translating Tumor Microenvironment to Clinical Trials 11 Unilateral Hearing Loss in Children

14 Pennsylvania Women in Otolaryngology Update

President Ahmed M.S. Soliman, MD Temple Head & Neck Institute Kresge West Building 3440 N Broad St Fl 1 Philadelphia, PA 19140-5104 President-Elect Johnathan D. McGinn, MD Division of Otolaryngology – Head & Neck Surgery Penn State College of Medicine-Hershey 500 University Drive, MC H091 Hershey, PA 17033-2360 Secretary-Treasurer David M. Cognetti, MD FACS Otolaryngology-Head & Neck Surgery 925 Chestnut St Fl 6 Philadelphia PA 19107-4204 Administrative Office 777 East Park Drive, PO Box 8820 Harrisburg, PA 17105-8820 717-558-7750 ext. 1519 717-558-7841 (fax) Visit our website at www.otopa.org

Surgical Fires: Decreasing Incidence Relies on Continued Prevention Efforts T

Abstract: Fires on the operating field, although preventable and declining in number, continue to be a hazard to patients and providers. The Pennsylvania Patient Safety Authority has updated its 2012 analysis of surgical fires reported through the Pennsylvania Patient Safety Reporting System.

Using the same analytical criteria, analysts identified reports of fires submitted over the subsequent five years that occurred in the operating room (OR) on the sterile operating field and involved flaming combustion resulting from a combination of heat, oxygen, and fuel. Twenty-eight events that met the analysts’ definition of fires on the operating field were reported from July 2011 through June 2016, equating to 5.6 fires per year in Pennsylvania.

That incidence is down from the 10 fires per year found in the 2012 analysis and represents a 44.0% reduction since

2011. Since 2004, the rate of surgical fires varied from 0.83 per 100,000 OR procedures in the academic year 2005 (AY2005; July 2004 through June 2005) to 0.24 per 100,000 OR procedures in AY2016. This represents a statistically significant (p < 0.001) reduction in the patient risk of surgical fires of 71% since 2004. In this updated analysis, one-

half of the reported events indicated some degree of harm to the patient; the operative sites of the head, neck, and upper chest constituted about two-thirds of the locations that were mentioned. Oxygen-enriched atmospheres continue to be a major contributing factor to these incidents.

Surgical fires with devastating consequences remain a significant risk.

Facilities should consider using the Fire Risk Assessment Score and adhere to the recommendations of the American Society of Anesthesiologists Task Force on Operating Room Fires, the Anesthesia Patient Safety Foundation, and those of ECRI Institute.

The full article can be found in the Pennsylvania Patient Safety Advisory: http://patientsafety.pa.gov/ADVISORIES/ Pages/201806_SurgicalFires.aspx Pa Patient Saf Advis 2018 Jun;15(2)

Identifying Patient Harm from Direct Oral Anticoagulants T

Abstract: Direct oral anticoagulants (DOACs), a newer class of oral anticoagulants, have been promoted as a safer and more effective option than warfarin. A query of the Pennsylvania Patient Safety Reporting System (PA-PSRS) database for events involving DOACs that occurred from January 2011 through August 2017 revealed 1,811 reported events, including 265 that resulted in patient harm. The data from these reports were categorized into two groups: harmful events (i.e., adverse drug events) (14.6%, n = 265) and medication errors without harm (85.4%, n = 1,546). Hemorrhage was the most frequently reported adverse event (70.2%, n = 186 of 265). Almost 40% (38.5%, n = 102 of 265) of harmful events occurred in patients who were 80 years or older. Duplicate therapy (33.3%, n = 515 of 1,546) was the most frequently reported type of error without harm. Employing standard protocols to guide therapy, reviewing baseline patient information, including patient weight (in metric units) and laboratory test results, such as renal and liver function, and considering the therapeutic indication can aid selection of an appropriate anticoagulant medication for patients.

The full article can be found in the Pennsylvania Patient Safety Advisory: http://patientsafety.pa.gov/ADVISORIES/Pages/201806_DOACs. aspx Pa Patient Saf Advis 2018 Jun;15(2)

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Hot Topic: Nonsurgical, HealthcareAssociated Burn Injuries

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Burns are preventable injuries. Although most burns occur in the home, a recent review of events reported through the Pennsylvania Patient Safety Reporting System (PA-PSRS) found reports of patient burns occurring in the healthcare environment. These healthcare-associated burns may be related to the patient’s medical treatments or to components of the healthcare environment. In addition, the risk of burns may be increased in patients with certain underlying medical conditions.

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Abstract:

SOUNDINGS | Fall 2018

OHNS-D41669-EN-F

An analysis of reports submitted in 2016 through PA-PSRS identified 230 events of burns, of which 61.3% (n = 141) occurred in nonsurgical healthcare settings. Of the 141 nonsurgical burns 75.9% (n = 107) were considered thermal in nature (caused by direct contact with heat sources such as hot metals, scalding liquids, steam, and flames). The most frequent thermal burns involved dietary spills of heated drinks or food (49.5%; n = 53 of 107) and heating devices (30.8%; n = 33), including powered devices such as circulating water or air blankets, warm compresses, and instant hot packs.

Implementing processes to assess and identify patients at risk for burns and developing risk reduction strategies are key to decreasing nonsurgical, healthcare-associated burns. Highlighting the relationship of temperature and time to development of a serious burn is essential in burn risk education; an object that feels only warm to the touch can cause serious injury if left on the skin over time.

The full article can be found in the Pennsylvania Patient Safety Advisory: http://patientsafety.pa.gov/ADVISORIES/Pages/201803_ BurnInjuries.aspx Pa Patient Saf Advis 2018 Mar;15(1)

Update on Wrong-Site Surgery: More Data Provides More Insight Introduction: From July 2004 through September 2017, there were 779 wrong-site perioperative events, including wrong-site nerve blocks, reported through the Pennsylvania Patient Safety Reporting System (PA-PSRS) and analyzed by the Pennsylvania Patient Safety Authority. This update provides an overview of the wrong-site events over time, as well as a focused analysis of the events reported between October 2016 and September 2017.

The full article can be found in the Pennsylvania Patient Safety Advisory: http://patientsafety.pa.gov/ADVISORIES/Pages/201803_ WSSUpdate.aspx Pa Patient Saf Advis 2018 Mar;15(1) For more information about the Pennsylvania Patient Safety Authority, patient safety topics, Advisory articles, and safety tips for patients, please visit patientsafety.pa.gov.

Aspirin Exacerbated Respiratory Disease: an often-missed diagnosis in patients with nasal polyposis By: Nithin D. Adappa, MD, Heather N. Ungerer, BA, John V. Bosso, MD â&#x20AC;&#x201C; Hospital of the University of Pennsylvania

Background: Aspirin exacerbated respiratory disease (AERD), formerly known as Samterâ&#x20AC;&#x2122;s Triad, is a chronic inflammatory condition characterized by a triad of symptoms including chronic eosinophilic rhinosinusitis, asthma and a respiratory hypersensitivity to cyclooxygenase-1 inhibitors. AERD patients experience acute reactions that mimic an asthma attack when exposed to aspirin or other non-steroid anti-inflammatory drugs (NSAIDs). AERD patients often present with aggressive nasal polyps that do not respond well to conventional treatments and have an extremely fast and high rate of polyp regrowth after sinus surgery, often necessitating multiple surgeries.

AERD is an acquired condition commonly starting in patients in the third or fourth decade of life and the triad of symptoms can present in any order. According to the Center for Disease Control, approximately 25 million people have asthma. The 2012 Pennsylvania Asthma Burden Report estimated the annual prevalence of asthma among adults in Pennsylvania increased by approximately 35% between 2001 and 2010.1 Given the rising number of asthmatics, proper identification of AERD is critical as the morbidity rate continues to climb. Overall, AERD may affect as many as 10% of all asthmatics and up to 40% of asthmatics with nasal polyps, or 1.25-2.5 million people nationwide.

However, the condition becomes hard to diagnose when a patient has either not been exposed to cyclooxygenase inhibitors

since developing AERD or does not recognize the association between NSAID consumption and their resulting reaction.2 These reactions are generally not IgE-mediated. In fact, while the immunologic basis for AERD is not fully understood, patients with AERD typically display mast cell and ILC2 cell activation, a robust overproduction of inflammatory cysteinyl leukotrienes, enhanced peripheral blood and tissue eosinophils as well as increased expression of IL4, IL5 and interferon gamma, epithelial alarmins like TSLP, IL25 and IL33, all of which may contribute to the inflammatory characteristics of the disease.

Diagnosis: Diagnosis of AERD is based upon the combination of patient history with the distinct symptomatology of nasal polyps, asthma and NSAID sensitivity. In cases where the history is unclear, a positive response to aspirin challenge can clinch the diagnosis.

Up to 15% of patients are unaware that they have a NSAID sensitivity, further complicating the ability to conclusively diagnose the disease.3 In patients with documented nasal polyps, asthma and a suspected hypersensitivity to aspirin, a physician-observed aspirin challenge is necessary.

Treatment of AERD is a multifaceted process that almost always involves surgical intervention, ASA desensitization and long-term aspirin therapy. AERD represents the most severe endotype of chronic rhinosinusitis with nasal polyps. In the absence of aspirin desensitization, a high rate of re-growth is continued on page 7

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Idiopathic Sudden Sensorineural Hearing Loss: A review of management and limitations of current evidence Timothy Cooper MD FRCSC, Barry E. Hirsch MD, Andrew A. McCall MD

Sudden sensorineural hearing loss is a presentation that is likely to be encountered in the clinical practice of any otolaryngologist managing patients with otologic complaints.

Although there is a wide differential for causes of sudden sensorineural hearing loss including infectious disease, vascular compromise, autoimmune disease, trauma, ototoxicity, and central and inner ear pathologies, a discrete etiology is often not identified in individual cases.1 The diagnosis of idiopathic sudden sensorineural hearing loss (ISSNHL) is assigned as a diagnosis of exclusion when no other etiology is identified. A recent population based cross sectional analysis calculated the annual incidence of sudden sensorineural hearing loss to be 27 per 100,000 in the United States.2 This means that an estimated 66,594 new diagnoses of sudden sensorineural hearing loss will be made each year throughout the country.2 Most patients present with unilateral hearing loss although approximately 5% present with bilateral ISSNHL.3 The incidence of ISSNHL has been shown to increase with age, with patients over 65 years of age having the highest risk.2 Risk factors that have been described for ISSNHL include diabetes mellitus, hypertension, history of cardiovascular disease and stroke, smoking, and numerous genetic factors.4 However, there is mixed evidence to support these various risk factors.4 The evaluation of patients presenting with sudden hearing loss begins with a complete history and physical examination to rule out conductive hearing loss or an identifiable underlying cause for sensorineural hearing loss. Complete diagnostic audiologic evaluation is necessary to confirm the diagnosis and serves as a baseline in evaluating response to therapy.

The American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) clinical practice guideline defines sudden sensorineural hearing loss as a decrease in â&#x2030;Ľ30 decibels (dB) affecting 3 or more consecutive frequencies occurring acutely in less than 72 hours.5 Although this definition is helpful for the purposes of research, patients experiencing sudden hearing loss that does not strictly meet these criteria may still benefit from management using the same principles.

The AAO-HNS guidelines do not support the use of routine laboratory investigations in patients with sudden sensorineural hearing loss unless concern is raised for another etiology based on their history or examination.5 Systemic disease should be given stronger consideration in patients with bilateral sudden sensorineural hearing loss.6 It is important to rule out a retrocochlear pathology as a cause for the sudden sensorineural hearing loss. The gold standard remains gadolinium enhanced magnetic resonance imaging (MRI) with attention to the internal auditory canal, cerebellopontine angle, and brainstem.5 It is estimated that 5% of patients with sudden sensorineural hearing loss are found to have a vestibular schwannoma after undergoing MRI to investigate their hearing loss.7 The treatment of ISSNHL generally consists of oral steroids, intratympanic steroids, or a combination of the two.3,6 The dose and duration of systemic steroids and frequency, steroid

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SOUNDINGS | Fall 2018

concentration, and number of intratympanic injections varies from clinician to clinician. A large multicentered randomized controlled trial (RCT) showed non-inferiority of intratympanic methylprednisolone to oral prednisone.8 Ideally, treatment should be initiated as soon as possible with efficacy declining after 4 to 6 weeks.6 Although the use of steroids to treat ISSNHL has widespread agreement amongst otolaryngologists, the body of evidence that supports this practice is not overwhelming. Due to variations in study methodology, definition of treatment success, and a limited number of high quality RCTs, there is mixed evidence on the benefit of oral and intratympanic steroids in treating ISSNHL.5,9 However, the use of salvage intratympanic steroid injections in patients who do not respond to systemic steroids is supported by meta-analysis.10 Other less conventional treatments for ISSHNL including antivirals, vasoactive medications, and thrombolytics are not supported by evidence.5 The use of hyperbaric oxygen in ISSNHL is supported by some evidence but is neither approved by the Food and Drug Administration nor commonly used in the United States for this indication.5 The diagnosis of ISSNHL can be particularly distressing to patients.11 It is important to support patients through this difficult period and thoroughly discuss the available treatment options, prognosis for recovery, and potential rehabilitative options for single sided deafness if hearing does not recover.

There is wide variation in the rate of spontaneous hearing recovery in the literature ranging from approximately one third to two thirds of patients.3,6 Recovery is most common early, within the first 2 weeks of presentation.3,6 Despite significant research efforts and a published clinical practice guideline, the optimal management of ISSHNL is not clearly defined. However, the importance of timely patient evaluation, treatment with steroids (systemic, intratympanic, or both), and appropriate imaging to rule out retrocochlear pathology are widely agreed upon by otolaryngologists.

References 1. Chau JK, Lin JRJ, Atashband S, Irvine RA, Westerberg BD. Systematic review of the evidence for the etiology of adult sudden sensorineural hearing loss.

Laryngoscope. 2010;120(5):1011-21.

2. Alexander TH, Harris JP. Incidence of sudden sensorineural hearing loss. Otol Neurotol. 2013;34(9):1586-1589.

3. Schreiber BE, Agrup C, Haskard DO, Luxon LM. Sudden sensorineural hearing loss. Lancet. 2010;375(9721):1203-1211.

4. Lin RJ, Krall R, Westerberg BD, Chadha NK, Chau JK. Systematic review and meta-analysis of the risk factors for sudden sensorineural hearing loss in adults. Laryngoscope. 2012;122(3):624-635.

5. Stachler RJ, Chandrasekhar SS, Archer SM, et al. Clinical Practice Guideline: Sudden hearing loss. Otolaryngol Neck Surg. 2012;146(3_suppl):S1-S35.

6. Metrailer AM, Babu SC. Management of sudden sensorineural hearing loss.

Curr Opin Otolaryngol Head Neck Surg. 2016;24(5):403-406.

7. Aarnisalo AA, Suoranta H, Ylikoski J. Magnetic resonance imaging findings in the auditory pathway of patients with sudden deafness. Otol Neurotol.

2004;25(3):245-249.

8. Rauch SD, Halpin CF, Antonelli PJ, et al. Oral vs intratympanic corticosteroid therapy for idiopathic sudden sensorineural hearing loss: a randomized trial.

JAMA. 2011;305(20):2071-2079.

9. Wei BP, Stathopoulos D, O’Leary S. Steroids for idiopathic sudden sensorineural hearing loss. Cochrane Database Syst Rev. 2013;(7):CD003998.

10. Ng JH, Ho RC, Cheong CS, Ng A, Yuen HW, Ngo RY. Intratympanic steroids as a salvage treatment for sudden sensorineural hearing loss? A meta-analysis.

Eur Arch Otorhinolaryngol. 2015;272(10):2777-2782.

11. Härkönen K, Kivekäs I, Rautiainen M, Kotti V, Vasama J-P. Quality of Life and Hearing Eight Years After Sudden Sensorineural Hearing Loss. Laryngoscope.

2017;127(4):927-931.

continued from page 5

expected after initial surgery even with traditional oral and topical corticosteroid therapy. A study comparing AERD patients who underwent both sinus surgery and aspirin desensitization with patients who underwent only sinus surgery found that none of the desensitized patients needed a second surgery while 80% of patients who were not desensitized and only had surgery needed a revision surgery within two years.1 Thus, in order to enhance the efficacy of ASA desensitization, approximately four to six weeks prior to desensitization patients undergo thorough and aggressive functional endoscopic sinus surgery to clean out all sinuses including skull base ethmoid disease as well as frontal disease. After desensitization, patients are expected to continue with long-term, daily aspirin consumption and nasal steroid lavage. Aspirin desensitization can be undone in as little as two or three days without the maintenance dose of aspirin, resulting in a relapse of aspirin sensitivity and nasal polyp growth. While AERD presents as a challenging onset of symptoms, aggressive sinus surgery, aspirin desensitization, and daily aspirin ingestion provides a comprehensive approach to reduce polyp regrowth and related AERD symptoms. Ultimately, it is critical to inquire about NSAID/Aspirin intolerance in any patients with aggressive nasal polyposis and asthma, and those patients without recent NSAID ingestion should be referred to an experienced allergist for an aspirin challenge.

References 1. Pennsylvania Asthma Partnership. (2012). 2012 Asthma Burden Report. Retrieved from: https://www.pennmedicine.org/for-health-care-professionals/forphysicians/physician-education-and-resources/clinical-briefings/2016/september/ desensitization-therapy-for-aspirin-exacerbated-respiratory-disease 2. Teran, L. M., Holgate, S. T., Park, H., & Sampson, A. P. (2012). Aspirin Exacerbated Respiratory Disease. Journal of Allergy,2012, 1-2. doi:10.1155/2012/473863 3. Khan, D. A., & Banerji, A. (2018). Drug Allergy Testing. St. Louis: Elsevier.

4. McMains KC, Kountakis SE. Medical and surgical considerations in patients with Samter’s triad. Am J Rhinol. 2006;20:573–576.

www.otopa.org | PAO-HNS

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Advances in our Understanding of Angioedema Suraj Kedarisetty MD, Derrick Tint MD, and Ahmed M.S. Soliman MD

The modern understanding of angioedema can be traced back to the work of Quincke in the late 19th century. In 1882, he presented a case series of patients with lip and face swelling, which was referred to as “Quinke’s edema.”1,2 A few years later in 1888, Osler described a family with laryngeal edema and asphyxiation and then coined the term hereditary angioedema.3 The term combines two ancient Greek terms, angion meaning vessel, and oedema, referring to swelling. More than a 100 years later, Osler’s terminology continues to be relevant. Today we understand this condition as swelling in subepithelial or submucosal tissues due to fluid leakage from blood vessels, mainly effecting the head and neck.

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SOUNDINGS | Fall 2018

We understand this condition as swelling in subepithelial or submucosal tissues due to fluid leakage from blood vessels, mainly effecting the head and neck.

One characteristic that makes angioedema unique is the several subtypes that can lead to the same presentation.

While many familial patterns exist, the two most well recognized deficiencies are the C1 esterase inhibitor and Factor XII deficiencies.

Acquired angioedema is a distinct entity that lacks a familial pattern. In the United States, most cases are attributed to angiotensin converting enzyme inhibiter use (ACE-I).4,5 A minority of angioedema whether acquired or hereditary is

idiopathic. Most significant research is available on hereditary angioedema and is mainly from large European cohorts.6 However, most of the angioedema in the United States is acquired, with up to 30% related to ACE-I.7 While these definitions are essential in differentiating subtypes of angioedema, the acute management of patients without a distinct prior diagnosis can be challenging. At our institution, we have come to recognize an unexpectedly

large group of patients who present with recurrent episodes of angioedema, most of whom fall under the acquired idiopathic primary angioedema category. Our investigation of this group has demonstrated that recurrent angioedema is generally more benign than the subtype attributed to ACE inhibitor use. In fact, recurrent idiopathic angioedema is less likely to progress after initial presentation compared to ACE-I angioedema.8 Thus, patients with recurrent idiopathic angioedema and a benign initial presentation are less likely to need airway interventions compared to their ACE-I angioedema counterparts. In addition, patients with idiopathic recurrent angioedema have a similar pattern of anatomic subsite involvement on recurrent episodes compared

to the first episode. This is a curious finding, as the current understanding of the pathophysiology of angioedema does not adequately explain why some episodes recur in the same region while others recur elsewhere.

Despite our growing understanding of the pathways and patterns that are involved in various subtypes of angioedema, the factors which precipitate an episode are still poorly understood. There is some evidence that certain trigger factors exist such as physical exertion, mental stress, or mechanical trauma.9,10 Others have suggested environmental factors, such as pollen counts, may be associated with angioedema.11 Yet the current evidence available provides no

Patients with recurrent idiopathic angioedema and a benign initial presentation are less likely to need airway interventions compared to their ACE-I angioedema counterparts. definitive explanation as to why patients develop symptoms on any particular day. Similarly, there is also a paucity of information regarding the timing of an episode of acquired angioedema. It has been well documented that patients who take ACE-I may develop angioedema anytime during their treatment course.

Although many patients present within their first week of initiating treatment, a substantial number of cases occur more than 6 weeks afterwards, with some documented episodes occurring up to 20 years later.12 At our institution, we have demonstrated an association between air pollution and increased episodes of angioedema.

Specifically, days with multiple presentations of angioedema were associated with higher levels of ground level ozone and poor air quality.

Ground level ozone has been previously implicated to contribute to various respiratory conditions including asthma, COPD, and ARDS, but this is the first time a link has been made between angioedema and ozone.13,14 Ozone is a particle formed by the interaction between air pollutants, such as volatile organic compounds, with nitrogen

Despite our growing understanding of the pathways and patterns that are involved in various subtypes of angioedema, the factors which precipitate an episode are still poorly understood. oxide in the presence of sunlight.15 Peak ozone months range from May through September. While an exact mechanism of action is not known at this time, a suggested pathway may be through vasodilation and inflammation due to reactive oxygen species created by the ozone molecule. However, this association between angioedema and ozone levels may be confounded by other co-present environmental particles such as pollen. As such, further studies are underway to elucidate this relationship.

At our institution, we have demonstrated an association between air pollution and increased episodes of angioedema.

Specifically, days with multiple presentations of angioedema were associated with higher levels of ground level ozone and poor air quality.

References 1. Quincke H. About acute circumscribed edema of the skin. Mschr Prakt Dermatol. 1882;1:160-169.

2. Reshef A, Kidon M, Leibovich I. The Story of Angioedema: from Quincke to Bradykinin.

Clin Rev Allergy Immunol. 2016;51(2):121-139. doi:10.1007/s12016-016-8553-8 3. Osler W. Hereditary Angio-neurotic Œdema. Am J Med Sci. 1888;95(4):362-367.

4. Grant NN, Deeb ZE, Chia SH. Clinical experience with angiotensin-converting enzyme inhibitorinduced angioedema. Otolaryngol Head Neck Surg. 2007;137(6):931-935. doi:10.1016/j. otohns.2007.08.012 5. Loftus PA, Tan M, Patel G, et al. Risk factors associated with severe and recurrent angioedema: An epidemic linked to ACE-inhibitors.

Laryngoscope. 2014;124(11):2502-2507. doi:10.1002/lary.24777 6. Mansi M, Zanichelli A, Coerezza A, et al.

Presentation, diagnosis and treatment of angioedema without wheals: a retrospective analysis of a cohort of 1058 patients. J Intern Med. 2015;277(5):585-593. doi:10.1111/joim.12304 7. Smith A, Ray M, Jain N, Zhang H, Sebelik M. The burden of angioedema on United States emergency departments: 2006–2010.

Laryngoscope. 2017;127(4):828-834. doi:10.1002/ lary.26336 8. Kedarisetty S, Tint D, Michael A, Soliman AMS. Recurrent Angioedema: Experience at a Tertiary Care Urban Medical Center. Laryngoscope. 2019; Accepted for Publication.

9. Steiner UC, Kölliker L, Weber-Chrysochoou C, et al. Food as a trigger for abdominal angioedema attacks in patients with hereditary angioedema. doi:10.1186/s13023-018-0832-4 10. Zotter Z, Csuka D, Szabó E, et al. The influence of trigger factors on hereditary angioedema due to C1-inhibitor deficiency. Orphanet J Rare Dis. 2014. doi:10.1186/1750-1172-9-44 11. Straka B, Nian H, Sloan C, et al. Pollen count and presentation of angiotensin-converting enzyme inhibitor-associated angioedema. J allergy Clin Immunol Pract. 2013;1(5):468-73.e1-4. doi:10.1016/j.jaip.2013.05.003 12. Chan NJ, Soliman AMS. Angiotensin Converting Enzyme Inhibitor-Related Angioedema: Onset, Presentation, and Management. Ann Otol Rhinol Laryngol. 2015;124(2):89-96. doi:10.1177/0003489414543069 13. Khatri SB, Holguin FC, Ryan PB, Mannino D, Erzurum SC, Teague WG. Association of ambient ozone exposure with airway inflammation and allergy in adults with asthma. J Asthma.

2009;46(8):777-785.

14. Reilly JP, Zhao Z, Shashaty MGS, et al. Low to Moderate Air Pollutant Exposure and Acute Respiratory Distress Syndrome after Severe Trauma. Am J Respir Crit Care Med. August 2018:rccm.201803-0435OC. doi:10.1164/ rccm.201803-0435OC 15. US EPA O. Ozone Pollution. https://www.epa. gov/ozone-pollution. Accessed August 19, 2018.

Angioedema is a complex multifactorial disease resulting in potentially lifethreatening complications. There is significant research and understanding of the most common subtypes though there is still work to be done to determine what exactly induces an episode of angioedema.

www.otopa.org | PAO-HNS

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Translating Tumor Microenvironment to Clinical Trials Swar Vimawala, Adam Luginbuhl MD, Joseph Curry MD (Affiliations: TJU - Department of Otolaryngology; Squamous Cell Carcinoma Tumor Ecology & Microenvironment; Sidney Kimmel Cancer Center)

With the introduction of immunotherapy for treatment of head and neck cancer, additional therapeutic options have become available to the head and neck surgeon alongside the traditional mainstays of surgery, chemotherapy, and radiation.

Furthermore, existing pharmaceuticals are being explored as immune microenvironment modulators in the field of cancer research, including metformin, tadalafil, and antibiotics. While these new treatments offer means to reduce morbidity and elicit better responses from definitive treatment, the ability to determine patient responsiveness to particular therapies and patient outcomes on new regimens is unclear. The role of the head and neck surgeon lies in researching the appropriateness of new regimens of therapy to offer patients, ensuring the safety of these treatments, and determining clinically significant outcomes.

The Thomas Jefferson University (TJU) Sidney Kimmel Cancer Center (SKCC) Squamous Cell Carcinoma Tumor Ecology & Microenvironment (STEM) Working Group is a multidisciplinary team consisting of researchers, head and neck surgeons, medical oncologists, radiation oncologists, psychiatrists, and public health personnel focused on a multimodal approach to battling head and neck cancer.

Fundamentally, the research group is focused on two aspects of cancer treatment, the tumor microenvironment and tumor ecology. The former is defined as the entire group of cells within a tumor mass, and the latter is defined as factors that impact the tumor on a “macro” scale. The combined expertise of the TJU SKCC STEM research group will allow us to utilize multiple strategies to increase the anti-tumor activity of a number of aspects of the immune system, including innate and adaptive responses. While combating the tumor, the group will focus on modulating factors that impact the patients’ response to immunotherapy such as stress by investigating interventions such as psychosocial support, cannabis therapy, and psychotropic medications. Due to the broad expertise of the group, we are able to focus on understanding the role of the tumor microenvironment, metabolism, and immunology on tumor behavior and growth. This research informs the novel therapies we offer to patients. Clinical trials developed and orchestrated by our team offer patients access to PD-1 inhibitors in combination with immune microenvironment modulators such as tadalafil as well as metabolic modifiers in the form of metformin. Additional investigator initiated trials include combinations of check point inhibitors as well as innovative use of monoclonal antibodies with photodynamic activation.

The Window of Opportunity Trial, led by Adam Luginbuhl MD, is a phase I study that aims to determine the effect of adding tadalafil, a phosodiesterase-5 (PDE5) inhibitor, to Nivolumab therapy, a biologic, on intratumoral and systemic anti-tumor immunity. Furthermore, the study aims to determine the effect of this combination of therapy on safety, exosome composition

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and function, intratumoral immune cell population composition, wound healing, and tumor radiographic response. The study completion is estimated for end of year 2019. All patients are treatment naïve and after just 4 weeks of treatment prior to surgical resection 60% are demonstrating treatment response and immune activation. Current data analysis reveals that imaging accurately stratified patients into response categories.

These results were validated by histopathologic assessment of HNSCC specimens obtained after two doses of nivolumab and will be presented at the upcoming SITC meeting.

Another ongoing trial, led by Joseph Curry, MD, studies the effects of Durvalumab, given with or without metformin, a drug typically used to treat diabetes, in treating patients with head and neck squamous cell carcinoma. Previous studies have shown the effect of metformin in altering the tumor microenvironment by changing the metabolic activity of cancer cells and other cells in the microenvironment. Our group previously performed a clinical trial of metformin in head and neck cancer and demonstrated increased tumor cell apoptosis and alteration of the phenotype of cancer associated fibroblasts. We also recently reported preliminary data suggesting that metformin may alter immune cell composition of the tumor as well. The current study focuses on the effect of Durvalumab, a PD-L1 inhibitor that improves T cell anticancer functions and metformin on the tumor immune microenvironment. Patients will undergo preoperative treatment with the Durvalumab or the combination, followed by surgical resection. There will be an estimated 38 patients enrolled in this study with completion estimated for 2021.

Additionally, a third trial offered to our patients, led by Ralph Zinner, MD; David Cognetti, MD; and Jessica Bauman, MD, studies the effects of the addition of Nivolumab, a PD-1 inhibitor, to an induction regimen of weekly carboplatin paclitaxel on pathologically determined tumor response. Previous studies have shown that induction chemotherapy elicits higher response rates, and patients with a pathological complete response had a better progression free survival and overall survival. Additionally, studies have established single agent efficacy of Nivolumab in squamous cell carcinoma in the head and neck (SCCHN). A combination of these therapies as an induction regimen may increase the rate of pathologic complete response. The target population is patients with newly diagnosed and untreated Stage III-IVA SCCHN of the oral cavity, oropharynx, larynx, and hypopharynx. There will be an estimated 37 patients enrolled in this study with completion estimated for 2020.

As we look to the future, our group will further the understanding of the tumor microenvironment and tumor ecology on response to immunotherapeutics while striving to mitigate the adverse effects of cancer therapy.

Unilateral Hearing Loss in Children Nandini Govil, MD, MPH, Dennis J. Kitsko, DO, and Jeffrey P. Simons, MD

Unilateral hearing loss (UHL) is estimated to affect 1/1000 children at birth.1 The prevalence may be even higher when different definitions of UHL are used.2 In the US, about 3-6% of school aged children have UHL.1 Some of these cases are associated with progressive hearing loss.2 UHL can also be missed by regular newborn hearing screenings, and diagnosis may be delayed until school age in some children.2 The etiology of UHL differs from that of bilateral hearing loss (BHL). Children with UHL are more likely to have temporal bone abnormalities compared to children with BHL.1,2 Some common temporal bone abnormalities in UHL include enlarged vestibular aqueduct, common cavity malformation, Mondini deformity, and cochlear and vestibular malformations.1,3 Children with severe UHL are more likely to have temporal bone abnormalities, with up to 50% having cochlear nerve aplasia or hypoplasia.1 Syndromic causes of UHL include Goldenhar syndrome, branchiootorenal syndrome, and Waardenburg syndrome.1,2 Perinatal infections such as CMV or meningitis may also cause UHL.1 Additionally, head trauma is a common cause of acquired UHL.2 Bilateral hearing loss has been shown to negatively impact speech and academic achievement in children.3 There is a strong push to identify children with bilateral hearing loss prior to the age of 1 month, and intervene with hearing amplification prior to 6 months to minimize impact of hearing loss on speech and auditory development.2 However, guidelines on management of children with unilateral hearing loss are less clear. Until recently, the traditional teaching for most otolaryngologists and audiologists was that children with unilateral hearing loss did not require hearing amplification due to ability to compensate with the normal hearing ear.

However, recent research has brought this into question.

Children with UHL have lower scores on expressive and receptive language tests compared to their normal hearing counterparts.1â&#x20AC;&#x201C;3 Speech understanding in noise and the ability to localize sound are particularly affected.4 Lieu et al

compared school age children with unilateral hearing loss to their normal hearing siblings and found worse scores on language comprehension and oral expression.3 Up to one third of children with UHL need to repeat a grade in school.4 UHL has also been linked to greater amounts of behavioral issues.2 Whether these differences last until adulthood is unclear. However, even normal hearing children require a higher signal to noise ratio than adults to comprehend speech in the presence of background noise.1,2 Therefore, children with UHL may have even more difficulty picking up speech in noisy environments, such as school, and experience a higher cognitive load with

Untreated unilateral hearing loss may negatively affect overall brain development. auditory tasks.1 Furthermore, unilateral auditory stimulation of the brain has been shown to affect central auditory processing, indicating that untreated UHL may negatively affect overall brain development.1 In terms of quality of life (QOL), children and adolescents with UHL rate their hearing related QOL similar to children with BHL, but with worse scores on the social interactions domain.1 Hearing rehabilitation options for children with UHL include lifestyle interventions such as preferential seating in school and frequency modulated (FM) systems; amplification by conventional hearing aids or Contralateral Routing of Sound (CROS) hearing aids; and surgical management with osseointegrated bone conducting implants, or cochlear implants.1,5 The option chosen is case dependent and a clinician should consider the patientâ&#x20AC;&#x2122;s individual level of functional handicap, and ability to withstand surgery when developing a treatment plan.

A CROS hearing aid takes the incoming signal to the ear with hearing loss, and routes it to the normal hearing ear via

a microphone. A significant downside of CROS is having to wear a device on the normal hearing ear. However, an advantage of CROS is that it does not require surgery.5 Data on benefits of CROS hearing aids in UHL children is lacking, but studies do show a trend towards improved speech perception.6 One study showed improvement in QOL scores and subjective hearing in children with mild to moderately severe UHL who were fit with conventional hearing aids.7 However, no study has shown a significant objective hearing benefit in children with CROS hearing aids.

Furthermore, there is some concern that fitting an older, previously unaided, child with hearing aids could cause cognitive confusion due to prior neural plasticity which has already rerouted auditory processing networks to other functions.1 Therefore, there may be an upper limit on when children with UHL benefit from hearing amplification.

Osseointegrated bone conducting implants such as the BAHA system, Ponto or Sophono system use a surgically implanted device which takes sound and converts it to vibrations which are then transmitted through bone conduction directly to the cochlear nerve.8 These can be excellent hearing amplification options for children who have outer or middle ear pathology, such as microtia or aural atresia, impacting air conduction of sound.3 Two different types of BAHA implant are currently available: BAHA Connect has a transcutaneous abutment physically connecting the external processor with the implanted magnet, whereas the BAHA Attract relies on passive magnetic connection between the external processor and the implant without an abutment.9 The advantage of the Attract is that there are less postoperative skin complications. However, some studies have shown a decrease in speech reception threshold of about 5-10 dB for the BAHA Attract when compared to BAHA Connect due to skin attenuation between the magnet and external processor.10 This difference has not been replicated in other studies.9 In children with UHL, BAHAs are related to consistent gains in speech reception thresholds and improvement in QOL measures continued from page 15 www.otopa.org | PAO-HNS

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Legislative Update Milliron & Goodman, LLC

OVERVIEW

ELECTIONS 2018

After three years of protracted budget fights, Pennsylvania’s election year budget plan was wrapped-up more than a week ahead of its June 30th deadline. And, for the first time in Democratic Governor Tom Wolf’s tenure, he has signed a budget. His signature came hours after the Republicancontrolled Legislature sent a $32.7 billion spending plan to his desk, barely three days after the first details of the no-new-taxes package were unveiled. The budget invests in education with an emphasis on workforce development and school safety initiatives.

Nearly 30 state lawmakers are not seeking reelection and/ or are running for a different seat in 2018. Four incumbent lawmakers – Sen. Randy Vulakovich (R-Allegheny), Rep. Paul Costa (D-Allegheny), Rep. Emilio Vazquez (D-Philadelphia), and Rep. Dom Costa (D-Allegheny) – and Lt. Governor Mike Stack lost their Primary Elections and will not be on the November ballot. State Senator Scott Wagner secured the GOP nomination for governor, setting up an Election Day matchup between him and a fellow millionaire and York Countian Democratic Governor Tom Wolf. In June, Wagner resigned from his Senate Seat to focus on his campaign.

With the state budget complete, Lawmakers spent the summer break back home in the districts gearing up for the looming general election. All 203 state House members and half of the state Senate (25 seats – even numbered district seats) are on the November ballot along with Democratic Governor Tom Wolf. The House and Senate will return to Harrisburg the week of September 24. With the election stakes high, there will be limited voting session days this fall – 9 days in the Senate and 8 days in the House. Although the 2-year Legislative Session constitutionally ends on November 30, lawmakers have refrained from coming back to session to vote on bills after the November Election.

Among the bills that stalled before lawmakers left for the summer include measures to expand the state’s response to the opioid crisis; amend the state constitution to shrink the size of the legislature; create a citizens’ commission to draw legislative and congressional district boundaries; combat sex trafficking; increase criminal penalties for hazing; and force people with a domestic violence conviction or restraining order against them to forfeit their firearms more quickly. After the August release of a grand jury report on clergy sex abuse in the state, many expect the Legislature to spend the bulk of its remaining session days on addressing the grand jury recommendations in some form. All bills die when the two-year legislative session ends November 30.

2018 SENATE FALL SESSION SCHEDULE September 24, 25, 26 October

1, 2, 3, 15, 16, 17

November 14

Lawmakers who are not running for reelection in 2018 are: Rep. Bernie O’Neill (R-Bucks); Rep. Mike O’Brien (D-Philadelphia); Rep. Hal English (R-Allegheny); Rep. Michael Corr (R-Montgomery); Rep. Stephen Bloom (R-Cumberland); Sen. John Eichelberger (R-Blair); Rep. Jim Christiana (R-Beaver); Rep. Rick Saccone (R-Allegheny); Rep. Nick Miccarelli (R-Delaware); Rep. Dave Reed (R-Indiana); Rep. John McGinnis (R-Blair); Rep. Curtis Thomas (D-Philadelphia); Rep. William Keller (D-Philadelphia); Rep. Mike Hanna (D-Clinton); Rep. John Maher (R-Allegheny); Rep. Joe Markosek (D-Allegheny); Rep. Mark Mustio (R-Allegheny); Rep. Flo Fabrizio (D-Erie); Rep. Kevin Haggerty (D-Lackawanna); Rep. C. Adam Harris (R-Juniata); Sen. Stewart Greenleaf (R-Montgomery); Sen. Charles McIlhinney (R-Bucks); Rep. Ron Marsico (R-Dauphin); Rep. Bob Godshall (R-Montgomery); Rep. Katharine Watson (R-Bucks); Rep. Will Tallman (R-Adams); Rep. Harry Lewis (R-Chester); Rep. John Taylor (R-Philadelphia); and Rep. Eli Evankovich (R-Westmoreland).

Lawmakers who are running for a different seat in 2018 are: Sen. Guy Reschenthaler (R-Allegheny) - running for US House (not up for reelection to State Senate); Rep. Marguerite Quinn (R-Bucks) - running for State Senate; Rep. Kristin Phillips-Hill (R-York) - running for State Senate; Rep. Judith Ward (R-Blair) - running for State Senate; and Rep. Madeleine Dean (D-Montgomery) - running for US House.

Rep. Tina Davis (D-Bucks) is running for reelection in her current seat and running for the state Senate seat held by incumbent Republican Senator Tommy Tomlinson.

Stay tuned for Milliron Goodman’s 2018 General Election update.

2018 HOUSE FALL SESSION SCHEDULE September 24, 25, 26

SMOKING LEGISLATION

April

9, 10, 11, 16, 17, 18, 30

October

1 (non-voting), 2 (non-voting), 9, 10, 15, 16, 17

The House and Senate have different bills introduced that would ban smoking throughout the Commonwealth. Both bills would remove any remaining exemptions from the Clean Indoor Air Act. We continue to monitor the legislation closely, but the clock has run out for 2018 legislative votes.

We certainly expect to see more action on these bills in the coming session. Also, we expect to see a lot of discussion and legislative activity related to E-Cigarettes.

November 13

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AMBULATORY SURGERY CENTERS We are pleased the 2018-2019 State Budget does not include a tax on Ambulatory Surgery Centers (ASCs). The Administration was seeking to impose a 3 percent tax on ASC Net Patient Revenue as part of the State Budget. Net Patient Revenue is what an ASC is paid for patient care services.

This is a tax before expenses are taken out and it would come at a significant cost – dramatically decreasing patient access to quality, affordable community-based healthcare in Pennsylvania. We want to thank Lawmakers for recognizing taxing efficient, cost-effective health care is counterproductive and will have unintended, undesirable consequences.

OPIOID LEGISLATION E-Prescribing (HB 353 – Rep. Tedd Nesbit, R-Mercer): This bill amends the Controlled Substance, Drug, Device and Cosmetic Act to require electronic prescriptions of a Schedule II, III, IV and V controlled substance.

Milliron Goodman worked with various stakeholders to clarify exceptions in the bill. As amended, the electronic prescription requirement shall not apply if the prescription is issued: by a veterinarian; under circumstances when an electronic prescription is not available to be issued or received due to a temporary technological or electrical failure, and in the instance of a temporary technological failure, a practitioner shall, within seventy-two hours, seek to correct any cause for the failure that is reasonably within his or her control; by a practitioner and dispensed by a pharmacy located outside this Commonwealth; by a practitioner who or health care facility that does not have either of the following: (i) internet access; or (ii) an electronic health record system; by a practitioner treating a patient in an emergency department or a health care facility under circumstances when the practitioner reasonably determines that electronically prescribing a controlled substance would be impractical for the patient to obtain the controlled substance prescribed by electronic prescription or would cause an untimely delay resulting in an adverse impact on the patient’s medical condition; for a patient enrolled in a hospice program or for a patient residing in a nursing home or residential health care facility; for controlled substance compounded prescriptions and prescriptions containing certain elements required by the Food and Drug Administration or any other governmental agency that are not able to be accomplished with electronic prescribing; for a prescription issued pursuant to an established and valid collaborative practice agreement between a practitioner and a pharmacist, a standing order or a drug research protocol; for a prescription issued in an emergency situation pursuant to Federal or State law and regulations of the board; under circumstances where the pharmacy that receives the prescription is not set up to process electronic prescriptions; or for controlled substances that are not required to be reported to the Prescription Drug Monitoring Program system administered by the department. The bill passed the state House by a

vote of 194-0. The bill was unanimously voted out of the Senate Health and Human Services Committee and is now before the full Senate. It is currently in the Senate Appropriations Committee.

Prescribing Opioids to Patients (SB 472 – Sen. Gene Yaw, R-Lycoming): This bill limits prescriptions for a controlled substance containing an opioid to seven days unless there is a medical emergency that puts the patient’s health or safety at risk. The bill, among other things, also requires prescribers to discuss the risks of addiction and dangers of overdoses associated with the opioid medication with the patient or family. Currently, state law (changed last session by Act 125 of 2016) limits prescriptions designated for minors to a seven-day duration, unless there is a medical emergency that puts the child’s health or safety at risk. SB 472 would expand that limit to all individuals. Exceptions include cases involving acute pain, chronic pain, cancer treatment, or for palliative care or hospice care. In cases of acute pain, the medical professional would be required to document the acute medical condition in the minor’s record with the prescriber and indicate the reason why a non-opioid alternative is not appropriate to address the acute medical condition. Milliron Goodman worked with various stakeholders to clarify exceptions in the bill. The bill unanimously passed the state Senate 49-0 and is now in the House Health Committee. Further amendments to the bill are expected in the House. Governor Wolf has long said he would sign SB 472.

Opioid Prescribing Guidelines (SB 655 – Sen. Gene Yaw, R-Lycoming): This legislation would establish the Pennsylvania Safe and Effective Opioid Prescribing Advisory Council within the Department of Health. The advisory council shall examine and make recommendations regarding opioid prescribing and dispensing practices. It would require the Secretary of Health to promulgate regulations relating to the prescription of opioids consistent with guidelines issued by the advisory council. The intent of the bill is to give the prescribing guidelines “teeth”. The regulations would give the guidelines the force of law. Among the regulations to be issued are emergency department pain treatment guidelines. SB 655 unanimously passed the state Senate and is currently in the House Health Committee.

GRASSROOTS ADVOCACY At Milliron Goodman, we spend a lot of time emphasizing the importance of getting to know your legislators and more importantly, making sure they know you. Your involvement in the legislative process is crucial to the future success of your profession and your patients. We encourage you to get engaged.

CONTACT If you have any questions regarding this legislative update or would like to get engaged in grassroots, please do not hesitate to contact us at 717.232.5322. We have an open door policy.

www.otopa.org | PAO-HNS

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Pennsylvania Women in Otolaryngology Update Karen A. Rizzo, MD

The inaugural meeting of Pennsylvania’s “Women in Otolaryngology” session took place at this year’s Annual PAO Scientific Meeting on June 22 at the Kalahari Resort. Several female Otolaryngologists participated from various Pennsylvania residency programs along with female academic attendings and female Otolaryngologists in private practice. It was a great opportunity to network and participate in lively discussions regarding common concerns and challenges encountered in our professional lives, as well as talk about social and family interests.

An informative presentation was made by Rosemary Dempsey, a financial advisor with 1847 Financial, who presented “Worth for Women, planning for a life you can depend on.” Options regarding debt management, loan repayment, practice buy in, and saving money in early careers were all addressed. The importance of having disability insurance, life insurance, and saving for your children’s college funds were also discussed. Prioritizing methods to help with financial management were reviewed.

Also in the session, the importance of developing referral networks and marketing yourself in whatever practice arrangement you are in was discussed. This new PAOHNS session will strive to offer women Otolaryngologists opportunities to strengthen their professional support system and skills. Understanding the importance of contract negotiation,

formulas for reimbursement and salary, including productivity compensation, will be future topics for inclusion.

The PAO-HNS “Women in Otolaryngology” (WIO) session will be a catalyst for ideas and topics to bring to the AAO “Women in Otolaryngology” meeting held annually at our academy meeting in October.

The ability to promote mutual support and respect for issues unique to female physicians and address the importance of work-life balance to optimize the growth and enrichment of the female Otolaryngology experience will be fostered.

The PAO-HNS session will serve as a conduit for information to be disseminated in our state from topics discussed at the Academy’s WIO meeting. The potential to be awarded financial support from the WIO Endowment to support projects or research on issues relevant to female Otolaryngologists, and are authored by Pennsylvania physicians in Otolaryngology, is possible as well.

There was genuine enthusiasm and support for this session at its inaugural meeting. All female Otolaryngologists in Pennsylvania are encouraged to join and participate in its growth and evolution. The goal is to optimize its function and value and to be collectively supportive of female Otolaryngology endeavors. Our male colleagues are invited to attend as well to better understand issues that are important to female Otolaryngologists.

Looking for a new career or the right candidate for an open position?

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SOUNDINGS | Fall 2018

continued from page 11

and speech discrimination, especially in noisy environments.8 The data on impact of BAHA on sound localization in UHL children is more inconsistent.8 BAHA can be attached to a soft fabric headband prior to surgical implantation, so that patients can have a trial period prior to undergoing surgery.

Cochlear implantation (CI) in children with UHL is a controversial subject. One pilot study in the US by Friedmann et al examined 12 adult and 4 pediatric UHL implants, and demonstrated improvements in consonant-vowelconsonant (CNC) and sentence in noise scores.11 However, most of these improvements were noted in the adult UHL implants, and results in the pediatric implants were more scattered.11 Additionally, this study did not have long term follow up of these patients.11 Another retrospective study of 21 German UHL children undergoing CI found an improvement in sound lateralization ability and subjective benefit in QOL measures.4 However, there was no change in hearing measures between children implanted prior to age 6 and those implanted after.4 Additionally, 3/5 children in this study with a follow up of 3 years or greater were limited users, or non-users of their CI.4 Therefore, the utility of cochlear implantation in UHL children remains unknown.

UHL is a prevalent issue in children, and has been linked to difficulty with

speech understanding in noise and speech localization.1–3 Children with UHL are also more likely to have lower academic achievement and behavioral issues compared to their normal hearing counterparts.2–4 Intervention with hearing amplification may positively impact objective and subjective hearing measures.5,6,8 These children should be followed closely by an otolaryngologist, particularly since a large proportion of UHL may be progressive.2 Unlike BHL, there are no clear guidelines on the management of UHL in children.

Developing a treatment plan for a child with UHL should be done on a case by case basis and employ a multidisciplinary approach with the active involvement of parents, teachers, and audiologists. More research is needed on the optimal age of intervention in children with UHL, and the impact of various treatment options on objective hearing measures.

References 1. Lieu JEC. Management of Children with Unilateral Hearing Loss. Otolaryngol Clin North Am. 2015;48(6):1011-1026. doi:10.1016/j. otc.2015.07.006 2. Rohlfs A-K, Friedhoff J, Bohnert A, et al. Unilateral hearing loss in children: a retrospective study and a review of the current literature. Eur J Pediatr.

2017;176(4):475-486. doi:10.1007/s00431-0162827-2 3. Lieu JEC, Tye-Murray N, Karzon RK, Piccirillo JF. Unilateral hearing loss is associated with worse speech-language scores in children.

Pediatrics. 2010;125(6):e1348-e1355. doi:10.1542/ peds.2009-2448

Congenital Single-Sided Deafness. Otol Neurotol Off Publ Am Otol Soc Am Neurotol Soc Eur Acad Otol Neurotol. 2017;38(4):496-503. doi:10.1097/ MAO.0000000000001343 5. Heubi C, Choo D. Updated optimal management of single-sided deafness. The Laryngoscope.

2017;127(8):1731-1732. doi:10.1002/lary.26553 6. Appachi S, Specht JL, Raol N, et al. Auditory Outcomes with Hearing Rehabilitation in Children with Unilateral Hearing Loss: A Systematic Review.

Otolaryngol--Head Neck Surg Off J Am Acad Otolaryngol-Head Neck Surg. 2017;157(4):565571. doi:10.1177/0194599817726757 7. Briggs L, Davidson L, Lieu JEC. Outcomes of conventional amplification for pediatric unilateral hearing loss. Ann Otol Rhinol Laryngol. 2011;120(7):448-454. doi:10.1177/000348941112000705 8. Liu CC, Livingstone D, Yunker WK. The role of bone conduction hearing aids in congenital unilateral hearing loss: A systematic review.

Int J Pediatr Otorhinolaryngol. 2017;94:45-51. doi:10.1016/j.ijporl.2017.01.003 9. Dimitriadis PA, Carrick S, Ray J. Intermediate outcomes of a transcutaneous bone conduction hearing device in a paediatric population. Int J Pediatr Otorhinolaryngol. 2017;94:59-63. doi:10.1016/j.ijporl.2017.01.018 10. Hol MKS, Nelissen RC, Agterberg MJH, Cremers CWRJ, Snik AFM. Comparison between a new implantable transcutaneous bone conductor and percutaneous bone-conduction hearing implant.

Otol Neurotol Off Publ Am Otol Soc Am Neurotol Soc Eur Acad Otol Neurotol. 2013;34(6):10711075. doi:10.1097/MAO.0b013e3182868608 11. Friedmann DR, Ahmed OH, McMenomey SO, Shapiro WH, Waltzman SB, Roland JTJ. Single-sided Deafness Cochlear Implantation: Candidacy, Evaluation, and Outcomes in Children and Adults. Otol Neurotol Off Publ Am Otol Soc Am Neurotol Soc Eur Acad Otol Neurotol. 2016;37(2):e154-e160. doi:10.1097/ MAO.0000000000000951

4. Thomas JP, Neumann K, Dazert S, Voelter C. Cochlear Implantation in Children With

Check out PAO-HNS’s complimentary Job Board at web.otopa.org/jobbank

www.otopa.org | PAO-HNS

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