President’s Message
During this holiday season, I would like to take time to reflect on our society and all that it has accomplished over the past year.
The annual meeting this past summer was a great success and was unique in that it brought a more diverse representation of practicing Otolaryngologists in the state, incorporating private and group practice physicians. This was very well received and we hope to continue to promote collaboration and networking between physicians in all practice settings and see a similar representation in our membership as we move forward. Planning for our next annual scientific meeting is well underway, with Drs. Sandra Stinnett from UPMC and Neerav Goyal from Penn State Health as course directors. This past year, Dr. Andy McCall, long time member and leader in the PAO-HNS moved out of state. Dr. Pam Roehm, St. Luke’s University Health System, was elected to the replace the PAO-HNS
Secretary/Treasurer position after Dr. McCall’s move and has been a welcomed addition to the leadership team along with President-elect, Colin Huntley. As you read through this issue of Soundings, you may note that it has had a “makeover” with changes to the format, style, and pieces that are published. A new section, highlighting different physicians in our state, has also been included to help us get to know our membership better and highlight some of the unique research, clinical services, or community or global outreach being performed in our state. As our website undergoes a similar makeover, these physician highlights will also be included on a member community page. Please send in photos and a brief highlight of yourself or your colleagues to info@otopa.org.
It has been a busy year for political advocacy for the PAO-HNS with issues such as examining and opposing the interstate compact for audiologists and speech language pathologists as written, addressing requests to expand the scope of practice for audiologists to perform cerumen removal, and evaluating the issue of select insurers in PA denying reimbursement for post-FESS debridements. In response to the numerous legislative issues being addressed, the PAO-HNS has also revamped the Political Action Committee, chaired by Dr. Rich Ferraro and open to additional society members and residents. I encourage those with interest to reach out and participate.
Additionally, with Dr. Andy McCall’s move, PAO-HNS representation on the State Board of Examiners in SpeechLanguage Pathology and Audiology was vacated. The PAO-HNS has offered
support for the nomination of Robert T. Sataloff, MD, DMA, FACS, FCPP to be appointed as a member of the State Board of Examiners in Speech-Language Pathology and Audiology. I encourage you to review the legislative update in this issue by the PAO-HNS lobbyist Phil Dunn for more details and stay tuned for additional updates on these topics that directly affect otolaryngologists in the commonwealth of PA.
Wishing you and your family the happiest of holiday seasons!
Jessyka G. Lighthall, MD FACS
President, Pennsylvania Academy of Otolaryngology-Head and Neck Surgery Chief, Division of Facial Plastic and Reconstructive Surgery Director, Facial Nerve Disorders Clinic Medical Director, Esteem Penn State Health Cosmetic Associates
Fellowship Director, Facial Plastic and Reconstructive Surgery
Associate Professor, Department of Otolaryngology-Head & Neck Surgery and Department of Surgery
Jessyka G. Lighthall, MD, FACS PAO-HNS President
President Jessyka G. Lighthall, MD, FACS
Penn State Health Milton S. Hershey Medical Center Otolaryngology—Head & Neck Surgery
President-Elect Colin T. Huntley, MD Jefferson University—Otolaryngology Head & Neck Surgery
Secretary-Treasurer
Pamela C. Roehm, MD, PhD
St. Luke’s University Health Network, Lehigh Valley, PA Division of Otolaryngology-Head and Neck Surgery
Administrative Office 400 Winding Creek Blvd. Mechanicsburg, PA 17050-1885 833-770-1544
855-918-3611 (fax)
at www.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. The opinions expressed in this newsletter do not necessarily reflect the opinion of PAO-HNS.
Effects of Supply Chain Shortages in Tympanostomy Tube Management
Tanner, Lyons DO1,2 Chi, Hye Rhee DO1,2; Roehm, Pamela MD, PhD1,3
1. Division of Otolaryngology, St. Christopher’s Hospital for Children, Philadelphia PA, USA
2. Department of Otolaryngology-Head and Neck Surgery, Philadelphia College of Osteopathic Medicine, Philadelphia, PA, USA
3. Division of Otolaryngology-Head and Neck Surgery, St. Luke’s University Health Network, Lehigh Valley, PA, USA
Introduction
Tympanostomy tube (TT) insertion is the most commonly performed operation on patients under 15 years of age.1
Approximately 667,000 pediatric patients undergo tympanostomy tube placement every year in the United States. The primary indications for the procedure include patients with recurrent otitis media, otitis media with effusion, and Eustachian tube dysfunction.2
The first TTs were made in the midnineteenth century of gold foil. Use of the gold foil ventilation tubes soon fell out of favor due to frequent occlusion.2 Various types of TTs were subsequently produced using a variety of materials including rubber, silver, Teflon, and aluminum. To minimize the rate of premature tube extrusion, tubes were designed with flanges or grooves. In the early 1900s, flanges were secured with silk sutures to prevent them from falling into the middle ear.3 Shapes of tubes included bobbin tubes and straight tubes.
In 1954, Beverly Armstrong introduced a TT composed of polypropylene plastic which is currently known as the 1.14mm diameter Armstrong myringotomy tube (Fig. 1).
The Armstrong grommets demonstrated lower extrusion rates and served as a model for many later myringotomy tube designs.3 The bevel of the Armstrong tube was intentionally sloped to simulate the curvature of the tympanic membrane in an attempt to improve the ease of tube insertion and to allow for use of a smaller myringotomy incision.4 The beveled flanges provided the added benefit of improved visibility of the TT lumen to quickly evaluate for myringotomy tube occlusion.3
Currently, there are over 50 commercially available myringotomy tube designs varying in shape, size, length, color, and composition that have been optimized for biocompatibility. Modern TTs are made from 3 types of materials: fluoroplastic, silicone elastomer, or metal such as stainless steel and titanium. Currently used TTs have 2 basic designs (t-tubes (Fig. 2) and grommet/bobbin tubes).6,11
The ability of TTs to maintain a stable, controlled perforation in the tympanic membrane depends on their biocompatibility with the middle ear and tympanic membrane. TTs can trigger a foreign body reaction.11 Decreasing the host’s foreign body reaction maximizes the duration of tube retention and reduces potential complications such as secondary infection.8 Fluoroplastics like Teflon, silicone elastomers, and titanium are some of the few biomaterials known to be biocompatible with the middle ear.
On a molecular level, fluoroplastics consist of carbon chains covalently bonded to fluorine atoms.9 The addition of fluorine atoms dramatically shifts the chemical properties of the material to have a high heat tolerance, increased resistance to degradation by chemicals and solvents, and increased biocompatibility. These properties are critical to TT optimization as they decrease tube-induced granulation tissue formation and the rate of infection.
Silicone is a flexible synthetic polymer made of silicon, oxygen, carbon, and hydrogen.10 The flexible polymer provides a greater degree of pliability, allowing folding and compression while inserting through a narrow external auditory canal. The hydrophobic surface of silicone TTs minimizes patients’ immune responses. The hydrophobicity of the silicone is also associated with a significantly longer time to first infection. 7
The current global shortage of materials used to manufacture common TTs, such as silicone, has forced Otolaryngologists to choose tympanostomy tubes that they have not previously used in their daily practice. Our children’s hospital primarily uses silicone tympanostomy tubes to ventilate the middle ear. The silicone tube is preferred compared with other bobbin and grommet tubes due to the pliability of the resin, which allows for easier tube placement
Figure 1. 1.02 mm silicone Paparella myringotomy tube
Figure 2. Silicone T-tube
Effects of Supply Chain Shortages in Tympanostomy Tube Management
through narrow external auditory canals, minimal canal trauma during insertion, and less ear canal damage during TT removal. Commonly used silicone tubes include Paparella (1.02 mm and 1.27 mm), butterfly tubes, and standard T-tubes that were selected based on the required duration of tube retention. Of the tubes listed above, butterfly tubes and T-tubes (Fig.2) are specifically utilized at our center for those requiring extended TT retention.
Several factors, such as shortages of raw materials, manufacturing disruptions, and altered global shipping, have led to recent silicone shortages. Consequently, the availability of Paparella (1.02 mm) myringotomy tubes has been decreased. These limitations in TT availability have forced many otolaryngologists to use unfamiliar TTs, further imposing technical challenges.11 At our institution, umbrella myringotomy tubes (1.02 mm, silicone, Fig. 3-4) have been used as an alternative for a Paparella ventilation tube of similar caliber for myringotomy and tube placement in smaller children.
The soft silicon of the umbrella tube offered a similar surgical experience to the Paparella myringotomy tube in terms of minimal canal trauma during insertion. The round, collapsible inner flange allowed insertion through an incision only slightly larger than that used for smaller Paparella tubes. With umbrella tubes, the inner flange can invert, further reducing the likelihood of tympanic membrane trauma and enlargement of tympanic membrane perforation during tube removal. Armstrong myringotomy tubes (fluoroplastic, 1.14 mm, Fig. 5) used for older children with larger external auditory canals during times in which Paparella tubes have been difficult to obtain.
in longer operative times, leading to prolonged anesthetic exposure for patients.
Each replacement TT has its own optimal methods for insertion. The novel round inner flange of the umbrella tube posed a formidable challenge during tube insertion. Frequently in our practice, bobbin and grommet tubes are inserted by first positioning the leading edge of the inner flange of the tube through the myringotomy incision and then applying steady pressure at the base of the inner flange to slide the rest of the inner flange beneath the tympanic membrane. For umbrella tubes, that method either leads to rapid intraoperative displacement of the TT into the external auditory canal or to nearcomplete insertion of the TT into the middle ear cavity when greater levels of force are used. When compared to the umbrella tubes, inserting the Armstrong myringotomy tube posed less of a technical challenge for residents because the angle of the beveled flange mirrored the curvature of the tympanic membrane.
Worsening the need to have unfamiliar replacement tubes is the shortages of the replacement TTs themselves, leading to further replacements and cycles of learning novel tube placements.
For trainees placing their initial 100-200 TTs, use of novel TTs feels like a completely different procedure, increasing the learning curve for attaining mastery of TT placement procedures.
The abrupt introduction of unfamiliar TTs imposed a technical challenge during the operation, particularly for trainees. As a result, the use of unfamiliar TTs resulted
Our general experience with these TTs does not indicate different outcomes or novel complications for either the umbrella or Armstrong tube compared to the Paparella tubes. Formal studies of the rates of infection, premature extrusion, and granulation tissue formation between umbrella, Paparella, and Armstrong have not yet been performed, mainly due to the (possibly mistaken) belief that these
Figure 3. 1.02 mm silicone umbrella myringotomy tube. Note the wide, curved inner flange, which can be tricky to place within a conventionally sized bobbin/grommet myringotomy incision.
Figure 5. 1.14 mm fluoroplastic Armstrong grommet myringotomy tube
Figure 4. Umbrella tube placed in anterior inferior quadrant of left tympanic membrane.
Effects of Supply Chain Shortages in Tympanostomy Tube Management
shortages will not continue, and our preferred myringotomy tubes will again be consistently available.
Ongoing global shortages will continue to challenge Otolaryngologists and force the use of unfamiliar devices. As fewer silicone TTs become available, alternative myringotomy tubes with less pliability, unfamiliar designs, or larger dimensions may continue to have to be used. These changes may lead to longer operating times and potentially avoidable postoperative complications. Trainees may also experience greater technical challenges influencing the length of surgery and development of intraoperative and postoperative complications. For example, larger ventilation tubes carry a higher risk of persistent perforation and implantation of canal skin into the middle ear space, leading to higher rates of cholesteatoma formation. Thus, the clinical outcomes of replacement myringotomy tubes warrant further investigation.
References
1. Bhattacharyya N, Shay SG. Epidemiology of pediatric tympanostomy tube placement in the United States. Otolaryngol Head Neck Surg. 2020; 163(3):600-602.
2. Simons JP, Baldassari CM. New clinical practice guideline on tympanostomy tubes in children. AAP Grand Rounds 2014; 31(6):72.
3. Rimmer J, Giddings CEB, Weir N. History of myringotomy and grommets. J Laryngol Otol 2007; 121(10):911-916.
4. Armstrong BW. Prolonged middle ear ventilation: The right tube in the right place. Ann Otol Rhinol Laryngol. 1983; 92(6 Pt 1):582-586.
5. Mudry A. The tympanostomy tube: an ingenious invention of the mid 19th century. Int J Pediatr Otorhinolaryngol. 2013;77(2):153-7.
6. Isaacson G. Tympanostomy tubes—A visual guide for the young Otolaryngologist. Ear Nose Throat J, 2020; 99(1_suppl):8S-14S.
7. Knutsson J, Priwin C, Hessén-Söderman AC, Rosenblad A, von Unge M. A randomized study of four different types of tympanostomy ventilation tubes: Full-term follow-up. Int J Pediatr Otorhinolaryngol, 2018;107:140-144.
8. Ho S, David K. Tympanostomy tube selection: A review of the evidence. Int J Head Neck Surg, 2016; 7:17-22.
9. Cardoso VF, Correia DM, Ribeiro C, Fernandes MM, Lanceros-Méndez S. Fluorinated polymers as smart materials for advanced biomedical applications. Polymers (Basel), 2018; 10(2):161.
10. Zare M, Ghomi ER, Venkatraman PD, Ramakrishna S. J Appl Polym Sci, 2021, 138( 38): e50969."
11. “Government of Canada.” Canada.ca, / Gouvernement Du Canada, https://www. canada.ca/en/health-canada/services/drugshealth-products/medical- devices/shortages/ list/covid19-silicone-ventilation-tubes.html, posted 1/18/2023, last modified 6/21/2023.
12. Nagar RR, Deshmukh PT. An overview of the tympanostomy tube. Cureus, 2022, 14(10):e30166.
BOG Update Fall 2024
Karen A. Rizzo, MD, FACS Chair BOG PA Governor/BOG
The BOG General Assembly was held on September 28 at the Miami Beach Convention Center. A dynamic agenda included a keynote address from Bruce Scott, MD, President of the American Medical Association, an otolaryngologist, who spoke on the importance of physician leadership in a changing America. He spoke about the many challenges physicians experience and the external threats to the health system that contribute to burnout, early retirements, workforce shortages, and the erosion of trust in medical institutions. Rahul Shah, MD, MBA also provided remarks regarding his excitement on becoming the new CEO & EVP of the AAO-HNS. The election of new officers occurred and Dr. Cristina Baldassari, a pediatric otolaryngologist from Virginia, became BOG chair for the 2024-2025 year. Changes to the BOG bylaws and a report on the new BOG strategic plan were presented to promote more engagement in advocacy, PAC donations, regional mentoring partnerships, and state society collaboration.
The BOG Practitioner of Excellence Award went to Michael L. Teixido, MD from Delaware who specializes in medical and surgical conditions impacting hearing and balance and has
substantially grown the cochlear implant program for children and adults in that state. The Model Society Award went to the Florida Otolaryngology Society.
A panel discussion was held between the Florida Otolaryngology Society and the Florida Medical Association regarding ways for both organizations to work together to benefit the patients of their state. The importance of building and sustaining collaborative partnerships with state societies and organizations to maximize advocacy efforts and results was examined.
The BOG has 3 podcasts on its website that tackle important challenges facing practitioners in various practice settings. They include: 1) Hiring in Healthcare today, 2) Otolaryngology Call Compensation: What is Fair? 3) Get in the Game! Tips for effective advocacy!
On July 30, Academy members went to Washington DC to participate in an advocacy conference that brought together different physicians from around the country to advocate for Medicare physician payment reform, prior authorization reform, and increased graduate medical education residency slots. Our Otolaryngology physician advocates held meetings with offices of their legislators discussing these critical issues. The importance of this type of advocacy cannot be overstated. Consider participating in the State Trackers
program that the AAO/BOG provides to keep updated on Pennsylvania legislation that can impact our health care delivery system.
In closing, the new AAO-HNS president is Dr. Troy Woodard, a rhinologist from the Cleveland Clinic. Dr. David Yen of Bethlehem was elected to the Academy’s Nominating Committee for Private Practice, Dr. Greg Farwell, Chair at the University of Pennsylvania’s Otolaryngology Department, is on the AAO Nominating Committee for Academics, and I was elected to the Director At Large for Private Practice position on the Board of Directors, AAO=HNS. I congratulate all elected physician leaders and encourage others to consider getting more involved with the BOG and our State specialty Society!!
Respectfully,
Karen A. Rizzo, MD, FACS
Founder Lancaster Ear, Nose, & Throat, LLC
BOG/ PA Governor
Immediate Past Chair BOG Director At Large Private Practice, Board of Directors/AAO Past President PAMED
Past President Pennsylvania Otolaryngology Head/Neck Society
A True Unicorn of a Case
Shriya Airen MD; Laura McDavid DO; MBA, Thanh Dinh DO; Sarita Ballakur MD; Sugosh Anur DO; David Zwillenberg MD, FACS,
Case Presentation:
A 4-year-old female presented to the emergency department with a chief complaint of dysphagia and odynophagia two hours after a suspected foreign body ingestion. She had no cyanosis, trismus, drooling, or respiratory distress. An antero-posterior and lateral x-rays were obtained by the emergency department that demonstrated a radio-opaque object consistent with a unicorn, located in the proximal esophagus (Figures 1-2). Per parent report, she wore a unicorn hairpin day of presentation, and she had been seen with it in her mouth. The decision was made to take the patient to the operating room for rigid esophagoscopy and foreign body removal.
Anesthesia was induced and direct laryngoscopy was performed using a Miller laryngoscope. With the application of cricoid pressure, the foreign body was visible in the proximal esophagus. A Magill forceps was used to retrieve this. Anesthesia was then reversed, and the patient was kept overnight for observation. She did not develop any fevers, tachycardia or pain overnight and her diet was advanced to regular food the next morning. She tolerated a diet and was discharged home on postoperative day 1.
Discussion
Esophageal foreign body ingestion is a common problem, with more than 110,000 cases reported in the American Association of Poison Control Centers’ National Poison Data System (NPDS) in 2011, and with more than 85% occurring in the pediatric population (1). The peak age for foreign body ingestion is between the ages of 6 months to 6 years, with an equal incidence among boys and girls (1). Coins are the most common foreign object that is retained in the esophagus, comprising up to 80% of ingested foreign bodies (1,2,3)
Establishing the diagnosis in children can be difficult if ingestion of the foreign body was not witnessed. The most common symptoms were drooling of saliva in 30 (60%) patients, followed by vomiting in 36 (51%) patients in a retrospective study of 70 patients by Tariq (et al.) (2). Six patients were asymptomatic but presented with witnessed foreign body ingestion. The physical examination includes airway and oropharyngeal evaluation, listening for stridor, palpation of the neck and upper thorax to assess for crepitus, and auscultation of the lungs. The imaging of choice would be a frontal and lateral radiograph of the neck and chest.
The three most common sites of foreign body impact are the upper esophageal sphincter, mid esophagus, and the lower esophageal sphincter. On a chest radiograph, the upper esophageal sphincter is located at the thoracic inlet, the area between the clavicles, as noted in our patient (Figure 1) (3)
The determination of when to go to the operating room is determined by the severity of symptoms at the time of patient evaluation and the object itself. Indications for urgent intervention include inability to manage secretions, signs of intestinal obstruction, types of foreign body such as sharp/long objects (>5 cm), a button battery or magnet, or presence of foreign body impaction for longer than 24 hours (3). Some esophageal coins spontaneously pass within 24 hours (3) Rigid esophagoscopy is performed under general anesthesia with placement of an endotracheal tube to reduce the risk of aspiration. Complications related to the procedure are usually related to the kind of foreign body ingested and can include esophageal perforation. A retained ingested esophageal foreign body can cause tracheal compression or lead to the formation of an aortoesophageal fistula (4)
References
1. Bronstein A.C., Spyker D.A., Cantilena Jr., L.R. et al. 2011 annual report of the American Association of Poison Control Centers' National Poison Data System (NPDS): 29th annual report, Clin Toxicol (Phila). 2012; 50: 911-1164
2. Tariq I. Altokhais, Alhanouf Al-Saleem, Abdulmonem Gado, Ayed Al-Qahtani, Abdulrahman Al-Bassam, Esophageal foreign bodies in children: Emphasis on complicated cases, Asian Journal of Surgery, Volume 40, Issue 5, 2017, Pages 362-366, ISSN 1015-9584, https://doi.org/10.1016/j. asjsur.2015.12.008.
3. Wright, Christian C. et al. Updates in Pediatric Gastrointestinal Foreign Bodies. Pediatric Clinics, Volume 60, Issue 5, 1221 - 1239
4. Berdan, E. A., & Sato, T. T. (2017). Pediatric airway and esophageal foreign bodies. Surgical Clinics of North America, 97(1), 85–91. https://doi. org/10.1016/j.suc.2016.08.006
Figure 1: An antero-posterior chest x-ray revealing a radiopaque object in the shape of a unicorn overlying the proximal esophagus.
Figure 2: radiopaque object in the proximal esophagus.
Figure 3. removed from the patient’s esophagus.
Sessions and Events
June 2024 PAO-HNS Annual Scientific Meeting, Hotel Hershey
The Keynote Address was presented by Dr. Doug Backous, President of the American Academy of Otolaryngology - Head and Neck Surgery.
Dr. Backous also joined the session panel on Private Practice: "What Can PAO and Academic Centers Do to Support Your Practice?" and the "Ask a Private Practice Clinician: Speed Mentoring" event for residents.
Thank you, Dr. Backous!
Women in Otolaryngology Event speaker Dr. Mary Mitskavich, Founder and Managing Partner, Coastal Ear Nose and Throat provided insights from her personal professional journey in her talk "Lessons Learned." Pictured here with Dr. Jessyka Lighthall, President PAO-HNS and Dr. Karen Rizzo, Lancaster Ear Nose and Throat/ AAO-HNS Board of Governors
PAO-HNS thanks Stryker for their generous support of this event.
PAO-HNS Committees Meetings, Welcoming standing and new members, PAO-HNS committees support the content of annual meeting sessions and submit articles in Soundings, the PAO-HNS newsletter.
Interested? Visit www.otopa.org!
State Senator Lynda Culver received the 2024 Community Service Citation.
Dr. Paul Swanson was presented with the 2024 Helen Krause, MD Distinguished Service Award.
Annual Awards
Annual Awards: Dr. Lighthall and Dr. Sataloff presented the 2024 PAO-HNS awards to distinguished colleagues and public servants.
Philip Doucette was awarded the 2024 Citation for Distinguished Service.
Dr. Cheng Ma was the honored recipient of the 2024 Ellie Goldenberg award.
Annual Abstract and Poster Competitions
First Place, Oral Presentation:
David Goldrich, MD: "Asthma and Comorbid Obstructive Sleep Apnea: Outcomes afterHypoglossal Nerve Stimulation and Other Sleep Surgery"
Dr. Goldrich’s presentation discussed the background and global impact of OSA, and the high overlap of asthma and OSA comorbidity. The project asked: “Can surgical treatment of OSA provide similar benefit in comorbid asthma?” It hypothesized that given previously demonstrated therapeutic benefit of OSA medical therapy (CPAP) upon comorbid asthma outcomes, HNS and other sleep surgery procedures treating OSA might also improve asthma outcomes. It aimed to measure this through reduction in asthma medication burden.
This study is the first demonstrating HNS may improve comorbid asthma outcomes as measured by prescription burden, and that sleep surgical intervention may offer similar benefit to CPAP for comorbid asthma.
Annual Abstract and Poster Competitions
Second Place, Oral Presentation: Kelly Daniels, MD: "A Novel Proof-Of-Concept Study of Mixed Reality Technology for Ideal Placement of Bone-Anchored Hearing Devices for Application in Complex Patient Populations"
Dr. Daniels’s presentation considered various forms of virtual reality and where augmented or mixed reality fits into the current research landscape. The study asked ‘Can mixed reality technology be used to help optimize implant location (skull thickness) and trajectory (90 degree angle) for bone conduction implants?’
The main take-aways were that the AR system can be learned and integrated, with exponentially decreasing “trial” times. Software improvements are needed to further correct for human error, currently software introduces further human error in places. Finally, AR has utility in complex cases with atypical anatomy, and part of its use is dependent on finding the right problem to solve.
Annual Abstract and Poster Competitions
First Place, Poster Presentation; Eric V. Mastrolonardo MD, et al, being accepted by team member Pablo Llerena, MD “Response-Adaptive Surgical Timing in neoadjuvant immunotherapy demonstrates enhanced pathologic treatment response in Head and Neck Squamous Cell Carcinoma”
The project utilized a novel trial design called response-adaptive surgical timing which maximizes treatment to responders (R) and limits treatment to non-responders (NR) using a combination of nivolumab + IDO1-inhibitor (BMS-986205) to address current neoadjuvant immunotherapy trial designs limited in their ability tailor treatment based on initial response.
It concluded that:
• Response-adaptive surgical timing reliably identifies R vs NR. and maximizes treatment to R while limiting treatment to NR
• Patients with elevated baseline IDO1 levels had improved. pathologic response to combination Nivo + IDO inhibitor. combination
• HPV-negative cohort: treatment response demonstrated. CD8+ T cell, Macrophage, and NK cell enrichment
• HPV-positive cohort: treatment response may be driven by Bcell. maturation mechanism while inflammatory CAF pathway. may be associated with nonresponse.
• The trial points to the need for identifying nodes of resistance to immunotherapy treatment and targeting those nodes with specific therapeutics.
Annual Abstract and Poster Competitions
Second Place, Poster Presentation:
Eric L. Wu, MD; Fendi Obuekwe, BS; Mario G. Solari, MD; Arturo A. Eguia, MD; Tonge Enoh, BS; Anthony Tang, BS; Marci L. Nilsen, PhD, RN, FAAN; Jonas T. Johnson, MD, FACS1; Seungwon Kim, MD; Kevin J. Contrera, MD, MPH; Shaum S. Sridharan, MD; Matthew E. Spector, MD: "Free Flap Neurotization and Radial Forearm Free Flap Reconstruction Improves Functional Outcomes in Hemiglossectomy Defects"
The oral cavity, and tongue specifically, remains one of the most common sites of head and neck cancer in both the developing and developed world.1 Although the management of tongue cancer is primarily surgical, the extent of ablation and subsequent reconstruction varies widely depending on the extent of disease. For larger tongue defects, free tissue transfer has become the mainstay of reconstruction. Because the tongue plays an important role in speech and swallowing, a range of approaches have been proposed, all with the goal of restoring tongue function postoperatively.2,3
Neurotization of free flaps to create sensate tissue has been studied as an adjunct to improve functional outcomes. Neurorrhaphy at the time of free flap reconstruction has been shown to
improve objective measures of sensation.4,5 Functional outcomes related to free flap neurotization, however, are equivocal.5,6 Recent studies with larger, more homogenous cohorts have showed evidence of improved speech intelligibility and swallowing function in neurotized flaps. 7 The aim of this study was to assess the effect of neurotization and free flap choice on functional outcomes for patients undergoing reconstruction of subtotal hemiglossectomy and total hemiglossectomy defects.
A cross-sectional retrospective cohort study was conducted of patients at least 18 years old, between December 2016 and December 2023 at the University of Pittsburgh Medical Center, diagnosed with oral cavity squamous cell carcinoma that underwent a subtotal hemiglossectomy or total hemiglossectomy with free flap reconstruction with or without neurotization. Subtotal hemiglossectomy was defined as ablation involving less than one-half of the oral tongue and not including the left or right tip of the tongue.8 Total hemiglossectomy was defined as ablation involving one-half of the tongue without involvement of the contralateral tongue.8 Patients that had at least 6 months of follow-up post-operatively were included. Objective measures of speech and swallowing were collected using the University of Washington Quality of Life (UW-QOL) questionnaire and Eating Assessment Tool (EAT-10) administered to patients at their post-operative visits.9,10 Bivariate analysis was performed using t-tests or chi-square tests.
Thirty-nine patients underwent a subtotal hemiglossectomy or total hemiglossectomy with free flap reconstruction and met criteria for study analysis; eight patients (21%) had neurotization of their free flap reconstruction. Neurotized patients were significantly more likely to swallow all or most solids than non-neurotized patients (100% vs 61%, p=0.03). They were also more likely to report no extra effort in swallowing liquids (88% vs 52%, p=0.07) and no extra effort in swallowing solids (37% vs 29%, p=0.64), but these differences did not reach statistical significance. There was no significant difference between neurotized patients and
non-neurotized patients in the ability to chew without restrictions (63% vs 32%, p=0.12). There was also no significant difference between neurotized patients and non-neurotized patients in reported speech understandability (25% vs 16%, p=0.56).
When examining functional outcomes between patients that underwent reconstruction with an anterolateral thigh free flap compared to a radial forearm free flap, swallowing and chewing outcomes were similar. Patients with subtotal hemiglossectomy defects that underwent anterolateral thigh free flap reconstruction were more likely to have difficulties in speech understandability than those that underwent radial forearm free flap reconstruction (100% vs 50%, p=0.04). However, patients with total hemiglossectomy defects that underwent anterolateral thigh free flap reconstruction had no significant difference in difficulties in speech understandability compared to those that underwent radial forearm free flap reconstruction (86% vs 100%, p=0.87).
In this study, we found that free flap neurotization for reconstruction of subtotal hemiglossectomy and total hemiglossectomy defects resulted in improved ranges of swallowing. We found that ranges of swallowing and chewing were comparable between patients that underwent anterolateral thigh free flap reconstruction and radial forearm free flap reconstruction. However, patients that underwent anterolateral thigh free flap reconstruction for subtotal hemiglossectomy defects had worse speech outcomes compared to those that underwent radial forearm free flap reconstruction.
While literature has shown improved objective measures of sensation with free flap neurotization, an arguably more important question is whether neurotization improves functional outcomes related to speech and swallowing. Chang (etal.) performed a retrospective review of 268 patients that underwent free flap reconstruction for a range of glossectomy
Continued on page 14
Annual Abstract and Poster Competitions
defects. 7 Subgroup analysis of neurotized and non-neurotized flaps stratified by defect size showed that neurotization provided improved speech function for hemiglossectomy defects. Neurotization also provided improved swallow function and diet tolerance for hemiglossectomy and subtotal glossectomy patients. Marchiano (et al.) examined a more homogenous cohort of patients that underwent hemiglossectomy and radial forearm free flap reconstruction.11 Neurotization improved speech understandability, improved range of liquids and solids, and decreased the likelihood of gastrostomy tube dependence.
Our study investigating a cohort of patients that underwent hemiglossectomy and free flap reconstruction supports the findings of the Chang (et al.) and Marchiano (et al.) studies. 7,11 Patients undergoing neurotization had improved swallowing function. Unlike the findings by Marchiano (et al.), our study did not find a statistically significant decreased effort in swallowing liquids or solids separately.11 Our cohort had heterogeneity in free flap type as well as a smaller cohort size, thereby potentially decreasing the power of our findings.
shown to improve speech and swallow outcomes.12 However, for smaller subtotal hemiglossectomy defects, increased tongue mobility, including protrusion and elevation, may play a more important role in speech than sensation.13,14 Thinner, more pliable, donor tissue like that from the radial forearm could provide more mobility. Further studies are needed to investigate the impact of flap type on speech and swallow.
There are several limitations of our study. The retrospective nature of our study limits data availability. Our small cohort size limits the power of our statistical analysis. Our measures of functional outcomes were extracted from patient-reported surveys. There was also heterogeneity of glossectomy defect size and location despite attempting to control for hemiglossectomy defect extent. The decision on whether to perform neurorrhaphy was also surgeon-dependent, introducing bias into our cohort. Choice of free flap type was also surgeon-dependent and likely dependent on patient body habitus.
Free flap neurotization for reconstruction of subtotal hemiglossectomy and total hemiglossectomy defects resulted in improved range of swallowing. In this small series, anterolateral thigh free flaps had worse speech outcomes compared to radial forearm free flaps for subtotal hemiglossectomy defects. More robust case-matched studies with defect size and flap type are needed to fully investigate differences.
References
1. Montero, P. H. & Patel, S. G. Cancer of the oral cavity. Surg. Oncol. Clin. N. Am. 24, 491–508 (2015).
14. Manrique, O. J. et al. Optimizing Outcomes following Total and Subtotal Tongue Reconstruction: A Systematic Review of the Contemporary Literature. J. Reconstr. Microsurg. 33, 103–111 (2017). Continued from page 13
When we stratified our cohort by flap type, patients that underwent anterolateral thigh free flap reconstruction had no significant difference in swallowing or chewing from those that underwent radial forearm free flap reconstruction. Patients that had smaller subtotal hemiglossectomy defects and underwent anterolateral thigh free flap reconstruction had worse understandability of speech compared to radial forearm free flap reconstruction. However, this difference in understandability of speech was not noted in patients with larger total hemiglossectomy defects. Increased free flap bulk, particularly in larger total hemiglossectomy, subtotal glossectomy, and composite defects, has been
2. Soutar, D. S., Scheker, L. R., Tanner, N. S. & McGregor, I. A. The radial forearm flap: a versatile method for intra-oral reconstruction. Br. J. Plast. Surg. 36, 1–8 (1983).
3. Urken, M. L., Weinberg, H., Vickery, C. & Biller, H. F. The neurofasciocutaneous radial forearm flap in head and neck reconstruction: a preliminary report. The Laryngoscope 100, 161–173 (1990).
4. Santamaria, E., Wei, F. C., Chen, I. H. & Chuang, D. C. Sensation recovery on innervated radial forearm flap for hemiglossectomy reconstruction by using different recipient nerves. Plast. Reconstr. Surg. 103, 450–457 (1999).
5. Namin, A. W. & Varvares, M. A. Functional outcomes of sensate versus insensate free flap reconstruction in oral and oropharyngeal reconstruction: A systematic review. Head Neck 38, 1717–1721 (2016).
6. Loewen, I. J., Boliek, C. A., Harris, J., Seikaly, H. & Rieger, J. M. Oral sensation and function: a comparison of patients with innervated radial forearm free flap reconstruction to healthy matched controls. Head Neck 32, 85–95 (2010).
7. Chang, E. I., Yu, P., Skoracki, R. J., Liu, J. & Hanasono, M. M. Comprehensive analysis of functional outcomes and survival after microvascular reconstruction of glossectomy defects. Ann. Surg. Oncol. 22, 3061–3069 (2015).
8. Chepeha, D. B. et al. Glossectomy for the treatment of oral cavity carcinoma: Quantitative, functional and patient-reported quality of life outcomes differ by four glossectomy defects. Oral Oncol. 142, 106431 (2023).
9. Hassan, S. J. & Weymuller, E. A. Assessment of quality of life in head and neck cancer patients. Head Neck 15, 485–496 (1993).
10. Belafsky, P. C. et al. Validity and reliability of the Eating Assessment Tool (EAT-10). Ann. Otol. Rhinol. Laryngol. 117, 919–924 (2008).
11. Marchiano, E. et al. Neurotization of the radial forearm free flap improves swallowing outcomes in hemiglossectomy defects. Head Neck 45, 798–805 (2023).
12. Vincent, A., Kohlert, S., Lee, T. S., Inman, J. & Ducic, Y. Free-Flap Reconstruction of the Tongue. Semin. Plast. Surg. 33, 38–45 (2019).
13. Chepeha, D. B. et al. Hemiglossectomy tongue reconstruction: Modeling of elevation, protrusion, and functional outcome using receiver operator characteristic curve. Head Neck 38, 1066–1073 (2016).
Annual Abstract and Poster Competitions
And the Concha Bowl goes to... Team Jefferson & PCOM!
Congratulations on the Jeopardy victory to Arianne Abreu, DO, Annie Moroco, MD, and Lauren Melley, DO !
A Dressed Up Friendship
Sarita Ballakur, MD; Laura McDavid, DO; Thanh Dinh, DO; Shriya Airen, MD; Sugosh Anur, DO; David Zwillenberg, MD, FACS, HSD; Pamela Roehm, MD, PhD
Robert Thayer Sataloff, MD, DMA, FACS, is a prominent member of the Pennsylvania otolaryngology community and an extraordinary physician, musician and individual. He has inspired many of us with his curiosity and wisdom. We would like to take the time to recount a story, shared by his friend and colleague, David Zwillenberg, MD, FACS, HSD.
It was summertime many years ago. Dr. Sataloff’s father, eminent otologist Joseph Sataloff, MD, DSc would close his downtown Philadelphia office each summer to spend two months in Maine where he taught a course on occupational hearing loss. The younger Dr. Sataloff continued this tradition when he joined his father in the practice. When he was away on these occasions, Dr. Zwillenberg would gladly cover his patients. At the end of each summer, Dr. Sataloff returned to Philadelphia with a gift as a gesture of appreciation despite Dr. Zwillenberg’s protestations.
Read this warm tribute to longtime advocate and supporter of the PAO-HNS
Dr. Robert T. Sataloff as he retires from full-time practice.
During the summer in question, Dr. Sataloff returned from Maine with a special gift. It was not salt water taffy or blueberry jam that most would bring back from New England in the summer. This gift box contained an elegant black tuxedo. Dr. Zwillenberg laughed. Earlier that year, Dr. Sataloff had held a 35th birthday party at an upscale venue with a black tie dress code. Ever the simple guy, Dr. Zwillenberg did not own a tuxedo. He attended the party in his only dark blue suit. Dr. Zwillenberg was pleased with himself - he had a wonderful time; and he thought he got away, unnoticed, with the blue suit. Dr. Sataloff, ever the keen observer, did notice and so thoughtfully sought to help his friend out.
Dr. Zwillenberg returned home and tried on the tuxedo. To his astonishment, the tuxedo fit him perfectly! Eventually the mystery was revealed. Unbeknownst to Dr. Zwillenberg, Dr. Sataloff had been planning this gift since his 35th birthday party six months previously. He secretly arranged for the OR staff at Jefferson to obtain Dr. Zwillenberg’s clothing from his locker and then had a tailor measure his clothing to get his right size. The lengths and coordination Dr. Sataloff went to help out his friend typified his commitment and loyalty to his friends!
The gifted tuxedo has been shared over the years by Dr. Zwillenberg, his brother, and a friend who have all gotten use from it. This story has been told fondly to many trainees who have rotated with Dr. Zwillenberg, including us. This story captures the extraordinary thoughtfulness, attention to detail, and resourcefulness of Dr. Sataloff. The Otolaryngology community is truly grateful to have a star like him among us.
Philip Dunn PAO-HNS Lobbyist
Leading to the close of the 2023-24 Legislative Session, the Pennsylvania General Assembly took up several pieces of legislation that had been on the radar of the Pennsylvania Academy of Otolaryngologists.
Noncompete Clauses/Restrictive Covenants
On July 17, 2024 Governor Shapiro signed HB1633 into law. The measure, known as Act 74 of 2024 places, for the first time in PA statutory restrictions on noncompete agreements in physician employment contracts. Act 74 will limit noncompete agreements in physician contracts to maximum duration of one year. In a related matter, on August 20, 2024, a Federal District Court judge in Texas struck down the Federal noncompete rule.
Senate Bill 25
A scope of practice measure that continues to be of interest to the physician community is SB25. This legislation is known as the Rural Certified Registered Nurse Practitioner Health Care Access Program. If passed into law, this program could be implemented in the 49 (our of 66) counties of the Commonwealth that are deemed rural.
This bill will allow an eligible rural Certified Registered Nurse Practitioner to practice as an independent primary healthcare practitioner without a written or collaborative agreement with a physician. The bill requires a CRNP to comply with the requirements of law and standard of advanced nursing care and recognize limitations in knowledge and experience. A CRNP must wear a name identification badge showing the professional title and must inform patients of the title before or during the initial patient encounter. Any signage or advertisements must contain a CRNP’s professional title. A CRNP is required
Fall Legislative Update
to plan for the management of situations beyond a CRNP’s expertise and consult with and refer patients to other health care providers as appropriate. Senate Bill 25 excludes a collaborating physician from having any legal responsibility for acts or omissions of a CRNP while practicing under the program when there is a written or collaborative agreement with the physician outside of the program. The bill specifically prohibits a CRNP from practicing under the Medical Practice Act of 1985 or the Osteopathic Medical Practice Act through the program. No physician-patient relationship is established when a CRNP consults with a physician or seeks clinical information or guidance.
SB25 has been reported out of the Senate Consumer Protection and Professional Licensure Committee as well as the Senate Appropriations Committee. It currently is on the legislative calendar for full Senate consideration this fall.
House Bill 1235
Lastly, SB 1235, which if passed, would authorize PA to join the Audiology and Speech Language Pathology Interstate Compact. Although 33 states have passed legislation to join the Compact as of this writing, PAO has taken the position of opposing the legislation as currently written.
Reasons for opposing the legislation are as follows;
• Despite assurances to the contrary, the proposed Interstate Compact for Audiology and Speech-language Pathology attempts to overtake the established licensure process and create a compact that puts the protection of the public in their own hands by creating a Commission that can override state laws,
• Unlike the medical licensure compact where a physician must already be licensed
to practice in a state (voluntary expedited licensure), this compact attempts to create and dictate initial universal licensure for
two very different professions without adequate quality standards. For example, an ASLP licensed in a state with lower standards of practice would be allowed to practice in a state with stronger practice standards.
• Telehealth: The current compact proposal would allow any compact member to practice telehealth in any other member’s state without documenting appropriate standards of care are being met.
• Exclusion of physician members: Physician members are appointed to the state ASLP licensing boards, but this is excluded in the Compact.
• This compact calls for an audiology or speech language pathology service provider to be in compliance with state practice laws outside of their home state yet, the compact negates states’ jurisdictional testing requirements.
• Oversight is missing from the compact including continuing education.
On August 29, 2024 members of the PAO had a meeting with the prime sponsor of the bill to relay their concerns with the legislation. From this discussion we found out that the legislation would most likely not advance this fall and will be reintroduced next year when the new legislative session begins. During the next 3 months, PAO will work with House staff to see if common ground can be found resulting in possible amendments to the measure.
Jennifer E. Douglas, MD
SPOTLIGHT: on Jennifer Douglas, MD
Assistant Professor, Division of Rhinology and Skull Base Surgery Associate Director, Rhinology and Skull Base Surgery Fellowship Department of Otorhinolaryngology - Head & Neck Surgery, Hospital of the University of Pennsylvania Affiliated Scientist, Monell Chemical Senses Center
Jennifer Douglas, MD specializes in rhinology and skull base surgery. She has a specific clinical interest in caring for patients with complex sinonasal inflammatory disease and skull base tumors, with a research focus on chemosensory disorders.
The Douglas Lab is a basic and translational laboratory in the Department of Otorhinolaryngology at the University of Pennsylvania focused on investigating the causes of olfactory dysfunction. Our work occurs at the intersection of epithelial biology, neuroscience, virology, and immunology. We utilize techniques such as three-dimensional organoid culture, immunofluorescence, and live cell imaging to characterize in vivo and in vitro alterations in the olfactory epithelium following insult (e.g., viral infection). Our goal is to better understand the causes of olfactory dysfunction and identify targets for therapeutic intervention. We work closely with collaborators at the Monell Chemical Senses Center and are fortunate to receive funding from the American Rhinologic Society and the McCabe Fund at the University of Pennsylvania Perelman School of Medicine.
400 Winding Creek Blvd.
Mechanicsburg, PA 17050-1885
BENEFITS OF MEMBERSHIP
Soundings Newsletter
Members receive hard copies of Soundings, the PAO-HNS member newsletter
Legislative Representation
Representation in the state legislature via our own lobbyist
Direct Input with Medicare
Representation on the Novitas Solutions Carrier Advisory Committee (CAC), which has input into local Medicare reimbursement policy
Specialty Events Listings
Members may post their specialty events at no cost
Priority Review for ENT Journals
Priority review for possible publication in ENT Journal, the official journal of the PAO-HNS
National Representation
Representation on the American Academy of Otolaryngology-Head Neck and Neck Surgery's Board of Governors
Discounted Registration forAnnual Science Meeting
Discounted registration to our annual Scientific Meeting featuring CME-approved educational seminars focused on current otolaryngology topics and family-oriented social functions