PAO-HNS Fall 2020 Soundings Newsletter, PUBLISHED IN THE INTEREST OF OUR MEMBERS AND THEIR PATIENTS

Soundings FALL 2020

PUBLISHED IN THE INTEREST OF OUR MEMBERS AND THEIR PATIENTS

President’s Message

Johnathan D. McGinn, MD, FACS PAO-HNS President I very much hope this Fall Newsletter finds you and yours to be well. I know these are stressful times for many of us. We are dealing with new challenges in our return to practice during the COVID era and establishing some form of a normalcy in the care of our patients, all while our nation struggles with issues far beyond the current pandemic. While we realize that many hurdles exist in healing our nation medically and socially, we also should realize we have novel opportunities for substantive changes. PAOHNS will remain vigilant in seeking opportunities to support all our members and our patients.

Despite all the recent challenges faced, celebration and praise are in order for the Program Committee and Chairs of the PAOHNS Annual Scientific Meeting.

As you know, the Annual Meeting was converted quite swiftly from the planned event at Nemacolin resort to a virtual format. Because of the hard work and tireless preparation of Drs. Huntley and Roehm, along with our PAMED staff of Ms. Jessica Winger and Ms. Ariel Jones, the meeting was a great success. I received a lot of unsolicited positive feedback on

how smooth the meeting flowed, and the content provided despite the challenges of not being in-person. While I hope we all get to see one another in Hershey next summer, I also feel confident we can provide high-quality, impactful CME in the virtual format, if necessary. A lot of great information was shared by our presenters and panel members. We even had a little bit of fun - Drs. Purdy and Gniady, along with the help of Dr. Cognetti, created an engaging virtual resident trivia event. The PENNedy Twins team (Dr. Will Kennedy and Dr. Ravi Shah) from University of Pennsylvania triumphed over their peers to take home the coveted Conchal Bowl along with a monetary award. The scientific abstracts and posters were strong again this year, with awardees from Thomas Jefferson University, Penn State, and University of Pittsburgh.

Congratulations to all.

I also feel confident we can provide high-quality, impactful CME in the virtual format While COVID pandemic has dominated the landscape in the legislature, the important issues of preauthorization, surprise patient billing, and other important issues have not gone away, but may have been delayed. However, other topics like telemedicine, scope of practice, and access to PPE remain very important to our membership. PAOHNS continues to support efforts to direct these topics in a direction that is best for our patients and our membership.

As I prepare my President’s Message, I typically look back through prior Soundings to gain some ideas of how to best convey our society’s successes and future goals. While reviewing the Fall 2017 issue, I found an article by our

incoming President, Dr. David Cognetti, discussing telemedicine in otolaryngology.

In the piece, he discusses his institution’s successes and challenges at that time in creating a telehealth program. In 2017, I had viewed telemedicine as a tool to provide care to those in remote locations without access to a specialist. In retrospect, I applaud this team’s prescient insights into the value of telemedicine for care of those far less remote. Recently, we have been separated from our patients not necessarily by the issues of hundreds of miles in distance, but instead by the needs for social distancing, protection of the vulnerable, and even the protection of our staff and ourselves. Yet patients need our help, and telemedicine may serve a role in providing that care in many circumstances. That is why PAOHNS continues to support, along with PAMED, the extension of telemedicine options, along with fair reimbursement, beyond the limits of Governor Wolf’s emergency declaration. Challenges do exist however, as the recently submitted bills supporting continued telemedicine efforts were passed in both the House and Senate, but vetoed by the Governor related to prohibitions in the bill related to telemedicine and abortion. While new legislation is not expected this year, we will support efforts to reintroduce such in next session.

PPE availability has been a challenge for many otolaryngologists in recent months, especially given our uniquely vulnerable practice based on personal proximity to patients’ mucosal surfaces and instrumentation of the airway. While some hospitals have fared reasonably well through PPE conservation, PPE reprocessing, and broader COVID testing capacity, community practices have sometimes struggled. Governor Wolf had asked the PEMA to prioritize PPE stockpiles for hospitals and health systems.

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President’s Message Continued from page 1

We have supported PAMED’s ongoing efforts to request the Governor release needed PPE to independent practices, especially given a potential second wave of COVID occurs this fall.

During the state of emergency, many practice restrictions were temporarily lifted to maintain Pennsylvanians’ access to care, reduce burdens on first-line providers, and permit alternative models of care delivery. Unfortunately, some groups have made efforts to use these wellintended efforts to erode the scope of practice, established to insure a safe physician-led health care team. HB2779 has been introduced to extend the supervision waiver for advanced practice clinicians for one year beyond the end of Governor’s Wolf’s state of emergency. While I understand no PA hospital needed to waive this requirement even at the peak of the pandemic, the suspension of written agreements, record review by physicians, and prescribing outside of formulary for APC’s represents an unnecessary and potentially dangerous change for our patients. This bill is currently being opposed by PAMED and members of the Specialty Leadership Cabinet, and we will continue to monitor any concerning trends in support.

While we have weathered the first wave of COVID and successful held our first virtual meeting, we know that challenges will continue to arise and PAOHNS will be there to assist our membership and their patients in meeting those issues. In that light, you should expect to receive an invitation to a membership survey as we enter the fall to gauge satisfaction with what we are doing and seeking input from members as to what we may do to further support our specialty in the state. We look forward to hearing your perspectives and suggestions for the future.

Thank you for the honor to serve as your Society’s President and please reach out with concerns and issues.

Contents | Fall 2020 1 President’s Message 3 Dysphonia & Vocal Fold Necrosis 4 BOG Update 7 Tongue Ties 9 Standardization Pro and Con

President Johnathan D. McGinn, MD, FACS Penn State Hershey Otolaryngology-Head & Neck Surgery 500 University Dr., Ste. 400 UPC, H091 Hershey, PA 17033-2360 President-Elect David M. Cognetti, MD, FACS Otolaryngology-Head & Neck Surgery 925 Chestnut St Fl 6 Philadelphia PA 19107-4204 Secretary-Treasurer Jessyka G. Lighthall, MD Penn State Hershey Otolaryngology-Head & Neck Surgery 500 University Dr., Ste. 400 UPC, H091 Hershey, PA 17033-2360 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

Sincerely, Johnathan D. McGinn, MD 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 selfpromotional 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.

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Dysphonia & Vocal Fold Necrosis in Patients Treated with Anti-VEGF Chemotherapeutic Agents Anita Sulibhavi, MD Senthuran Tharmalingam, MD, MSc Liane McCarroll, MS, CCC-SLP/L Ahmed M.S. Soliman, MD First purified and cloned in 1989, vascular endothelial growth factor (VEGF) is an important signaling molecule critical for vascular survival, angiogenesis, endothelial migration, and permeability.1,2 It is part of the system which restores oxygen supplies to tissues when blood circulation is inadequate by promoting new blood vessel formation.

Tumors need oxygen to survive and at first, they are able to obtain enough oxygen by co-opting the surrounding vasculature. However, when a tumor becomes too large to be sufficiently supplied by the existing vasculature, an “angiogenic switch” is turned on, VEGF is produced in the tumor cells thereby creating its own vasculature for an oxygen supply. These properties make it a convenient target for anti-tumor medications which work by blocking the process of tumor angiogenesis.

Several anti VEGF medications are currently available for the treatment of advanced gastrointestinal, lung, renal, brain, thyroid and gynecological malignancies. They include bevacizumab, apatinib, cabozantinib, pazopanib, ramucirumab, Sorafenib, sunitinib, vandetanib, and ziv-aflibercept Unfortunately, it is impossible to direct the effects of these agents to specific sites when they are administered systemically.1,2 The larynx contains a high concentration of VEGF receptors making its microvasculature

particularly sensitive to the action of VEGF inhibitors.3,4 Although, the effect of VEGF inhibition has not been directly studied in the larynx, Baffert et al, demonstrated a 19% decrease in tracheal capillaries at 7 days and a 30% decrease at 21 days after VEGF inhibition using a murine model. Subsequent regrowth of capillaries was noted following cessation of treatment.5 Common side effects of VEGF inhibitors are primarily gastrointestinal and include dry mouth, loss of appetite, nausea, vomiting and diarrhea. Vocal fold necrosis is a rare side effect of VEGF inhibitors with only 2 reported cases in the literature.3,4 We have seen two additional cases of vocal cord necrosis after bevacizumab use at our institution. Although, it is difficult to predict which patients will develop dysphonia, women may be at greater risk due to their thinner lamina propria.3 Both previously reported patients of vocal fold necrosis following bevacizumab and our two patients have been women.

The onset of symptoms after initiation of bevacizumab is variable. Both previously reported cases had symptom onset approximately 3 weeks after starting therapy. Our patients however developed symptoms at one and two years after starting bevacizumab. The fact that both previously reported cases were on a combination regimen of bevacizumab plus another chemotherapeutic agent, may have enhanced the anti-VEGF effect and resulted in earlier injury to the vocal folds.3,4 This demonstrates the broad range of time within which this side effects can manifest and that many additional factors may influence this timing.

Treatment for the vocal fold necrosis has thus far consisted of cessation of bevacizumab. Voice symptoms may be reversible as early as one to two weeks after discontinuation.3 Of the two previously reported cases; only one patient had recovery of their voice at the time of the report. The other patient did not discontinue the bevacizumab and remained dysphonic 6 weeks after initial evaluation.3,4 Both of our patients had improvement of their stroboscopic exam and voice quality after bevacizumab cessation, although one had a slow improvement while the other had nearcomplete resolution of symptoms at two months. As dysphonia is not life threatening, it is important to weigh the risks of treatment cessation. As anti-VEGF medications are being more widely use, it is important for otolaryngologists to be aware of this potential complication.

References: 1. Dvorak H, F, Detmar M, Claffey K, P, Nagy J, A, van de Water L, Senger D, R: Vascular Permeability Factor/ Vascular Endothelial Growth Factor: An Important Mediator of Angiogenesis in Malignancy and Inflammation. Int Arch Allergy Immunol 1995;107:233235. doi: 10.1159/000236988 2. Kazazi-Hyseni F, Beijnen JH, Schellens JH. Bevacizumab. Oncologist. 2010;15(8):819–825. doi:10.1634/theoncologist.2009-0317 3. Caruso AM, Meyer TK, Allen CT. Hoarseness After Metastatic Colon Cancer Treatment. JAMA Otolaryngol Head Neck Surg. 2014;140(9):881–882. doi:10.1001/ jamaoto.2014.1766 4. Hartl DM, Bahleda R, Hollebecque A, Bosq J, Massard C, Soria JC. Bevacizumab-induced laryngeal necrosis. Annals of Oncology. 2011;23(1):276-278. doi:10.1093/annonc/mdr515 5. F. Baffert, T. Le, B. Sennino, et al. Cellular changes in normal blood capillaries undergoing regression after inhibition of VEGF signaling. Am J Physiol Heart Circ Physiol. 2006;290:H547-H559.

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AAO/HNS Board of Governors UPDATE almost 11% decrease from 2020. Due to budget neutrality requirements set by law, proposed increases to office payments are being offset by payment reductions in surgery and anesthesia. For Otolaryngology it appears a 7% increase is estimated.

Karen A. Rizzo, MD, FACS Governor On August 3,2020 the Centers for Medicare and Medicaid Services released the 2021 proposed rule for the Medicare Fee Schedule and proposed changes for the Quality Payment Program.

The physician fee schedule release came hours after the President signed an Executive Order for the Department of Health and Human Services to promote telehealth use and access. CMS has proposed to retain certain codes for Telehealth services that were temporarily added during the COVID-19 public health emergency and the compensation for them. The 2021 physician fee schedule includes a significant decrease in the conversion factor representing an

The AAO-HNS urged CMS to sunset temporary waivers involving scope of practice and licensure when the COVID-19 crisis concludes. It reaffirmed its support for the physician led team- based care and opposed efforts to undermine the physician-patient relationship during and after the pandemic. It continues to advocate for Congress to pass legislation that would increase Medicare funded residency positions to help alleviate physician shortages.

Regulatory advances include the BCBS Federal Employee Program now considering Balloon Ostial Dilation as medically necessary for the treatment of chronic sinusitis. The AAO-HNS submitted a position statement to Anthem on hypoglossal nerve stimulation providing extensive literature supporting it as an effective 2nd line treatment for moderate to severe OSA in select patients. A new Academy position statement on Recurrent Respiratory Papillomatosis and Gardasil vaccination was approved as well.

The AAO-HNS promotes use of its Coronavirus Disease Resource website where a comprehensive list of resources for members on Covid-19 issues impacting the specialty are addressed.

Lastly, this year’s Academy meeting was Virtual and encompassed 6 weeks of on demand presentations and sessions that participants could access at their convenience. Dr. Carol Bradford became the new President of the AAO-HNS and Dr. Ken Yanagisawa President elect. Dr. Troy Woodard was elected Chair elect of the BOG and Dr. Lance Manning the new BOG Chair. I continue to serve as the BOG Secretary and on the AAO Nominating Committee. Any member interested in running for an AAO position including Nominating Committee, Audit committee, At Large Director (Academic or Private Practice), and President elect (Academic) please contact me.

Karen A. Rizzo, MD FACS / BOG Governor and Secretary Lancaster Ear, Nose, & Throat

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Development of a Formal Dysphagia Program for Head and Neck Cancer Patients Melissa Montano, MS, CCC-SLP, Erin Kelly, MS, CCC-SLP, Karen Y. Choi, MD Dysphagia, or difficulty swallowing, is one of the top priorities for functional outcome measurements in patients treated for head and neck cancer, both by patients themselves and by many national and international trials for head and neck cancer (HNC) (such as Eastern Cooperative Oncology Group 3311, PATHOS, and ORATOR). It is also one of the main components of quality of life after cancer treatment and can significantly contribute to development of pneumonias or severe malnutrition, which can potentially be life-threatening if not addressed properly. Furthermore, with the rising incidence of HPV-associated oropharyngeal cancer, the HNC patient population is becoming increasingly younger with improved survival after treatment. As such, there is a growing population of younger, relatively healthy, cancer survivors who are now faced with the devastating and often longterm consequences of treatment, such as pharyngeal dysphagia. In a recent SEER database review from 2002-2011, prevalence of dysphagia was found to be as high as 45% at 2 years after treatment, and was highest in patients treated with chemoradiation and multimodal therapy.

Data has shown that there is a significant effect on quality of life for patients who are feeding-tube dependent or even have only mild dysphagia; furthermore, patients who remain NPO for greater than 2 weeks have severe negative impact on long-term swallowing outcomes. In line with these findings, many survivors report dysphagia as the primary reason for decisional regret.

Many large-volume head and neck cancer institutions have implemented a formal dysphagia program in coordination with head and neck surgeons and speech language pathologists (SLP). These programs are comprised of pre- and posttreatment assessments of patient’s functional swallowing, with standardized swallowing exercises and therapy implemented at the start of treatment. Paramount to these assessments include patient-reported outcomes, collected via validated surveys such as the MD Anderson Dysphagia

Inventory (MDADI) and the Performance Status Scale – Head and Neck Cancer (PSS-HNC), and outcome measures based on modified barium swallow study results such as the DIGEST (Dynamic Imaging Grade of Swallowing Toxicity).

Using these clinical measures, patients at risk for significant dysphagia can then be targeted for an intensive dysphagia therapy program, performed by a certified and trained SLP.

The goal of the program is to allow for a proactive dysphagia intervention strategy by tracking their swallowing function prior to, during, and following radiation treatment.

There is strong data from larger institutions that show a regimented formal dysphagia program results in improved long-term swallowing and quality of life measures for patients who participate in formal dysphagia pathway program. These patients have a higher probability of eating a regular oral diet long-term, shorter duration of feeding tube dependence, and superior functional status when compared to patients who were not participating in swallow exercises. Chemoradiation induces mucosal inflammation and pain, as well as fibrosis of the pharyngeal musculature.

Thus, the importance of continued swallowing during treatment is essential to optimizing long-term quality of life outcomes for these patients.

The HNC disease team at PennState Health Milton S. Hershey Medical Center (PSHMC) launched a formal dysphagia pathway program in 2019 for patients undergoing nonsurgical treatment for HNC. The goal of the program is to allow for a proactive dysphagia intervention strategy by tracking their swallowing function prior to, during, and following radiation treatment. The initial referral to a Speech-Language Pathologist (SLP) prior

to treatment initiation is critical in educating patients on the benefits of maintaining nutrition by mouth and exercising the swallowing musculature throughout their course of treatment. Approximately 92% of patients who maintain full oral intake and a swallowing exercise regimen during treatment return to a regular diet following radiation, while only 65% of non-compliant patients may return to their baseline diet.

Patients who do not receive pre-radiation swallowing education may be unaware of these risks and often downgrade their diets due to side effects from treatment, including odynophagia, mucositis, dysgeusia, trismus, and xerostomia, all of which contributes to significant negative impact on longterm swallowing outcomes. Furthermore, following completion of HNC treatment, progress with swallowing therapy for these patients may still be limited due to anatomic changes secondary to surgical reconstruction, radiation-induced fibrosis, weakness of pharyngeal muscles, and general fatigue, making it imperative to provide proactive intervention and counseling.

To prevent this, PSHMC patients meet with an SLP prior to beginning radiation to discuss side effects of treatment that may impact swallowing and to emphasize the importance of adhering to a swallowing regimen while also maintaining PO intake to the best of their abilities. Patients are taught pharyngeal swallowing exercises targeting hyolaryngeal elevation, pharyngeal constriction, tongue base retraction, soft palate elevation, and airway protection to prevent dysphagia. Jaw flexibility exercises are also included to prevent trismus and jaw opening measurements are taken regularly to assess progress. Subjective questionnaires are completed to assess how swallowing and side effects of treatment impact patient quality of life. Patients meet regularly with SLP during radiation treatment, and at regular intervals following treatment. A modified barium swallow study is obtained at 3 months post-treatment and based on results of this test, patients at high-risk of Continued on page 6

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Development of a Formal Dysphagia Program for Head and Neck Cancer Patients Continued from page 5

enrolled in intensive swallowing therapy in an effort to minimize and prevent further swallowing dysfunction. This frequent observation and counseling by SLP following radiation increases compliance with recommendations, aims to prevent long-term dysphagia, and allows for swift intervention to target worsening dysphagia, with the ultimate goal to improve long-term quality of life measures and functional outcomes for our head and neck cancer survivors.

References 1. Mcclelland, S., Andrews, J. Z., Chaudhry, H., Teckie, S., & Goenka, A. Prophylactic versus reactive gastrostomy tube placement in advanced head and neck cancer treated with definitive chemoradiotherapy: A systematic review.

Oral Oncology 2018; 87: 77-81.

2. Hutcheson, K. A., Bhayani, M. K., Beadle, B. M., Gold, K. A., Shinn, E. H., Lai, S. Y., & Lewin, J. Eat and Exercise During Radiotherapy or Chemoradiotherapy for Pharyngeal Cancers. JAMA Otolaryngology–Head & Neck Surgery 2013; 139(11): 1127.

3. C audell, J. J., Schaner, P. E., Meredith, R. F., Locher, J. L., Nabell, L. M., Carroll, W. R., et al. Factors Associated With Long-Term Dysphagia After Definitive Radiotherapy for Locally Advanced Head-andNeck Cancer. International Journal of Radiation Oncology*Biology*Physics 2009; 73(2): 410-415.

4. Bhayani, M. K., Hutcheson, K. A., Barringer, D. A., Lisec, A., Alvarez, C. P., Roberts, D. B., et.al. Gastrostomy tube placement in patients with oropharyngeal carcinoma treated with radiotherapy or chemoradiotherapy: Factors affecting placement and dependence. Head & Neck 2013; 35(11): 1634-1640.

5. O rlandi, E., Miceli, R., Infante, G., Mirabile, A., Alterio, D., Rocca, M. C., . et. al. Predictors of Patient-Reported Dysphagia Following IMRT Plus Chemotherapy in Oropharyngeal Cancer. Dysphagia 2018; 34(1): 52-62.

6. Kulbersh, B. D., Rosenthal, E. L., Mcgrew, B. M., Duncan, R. D., Mccolloch, N. L., Carroll, W. R., & Magnuson, J. S. Pretreatment, Preoperative Swallowing Exercises May Improve Dysphagia Quality of Life. The Laryngoscope 2006; 116, 883-886.

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WELCOME! New Members Sharon Tomaski MD Mark E Whitaker MD, FACS

Penn State Hershey Medical Center

Tongue Ties Grace Kim, MS1, Timothy Koo, BA1, Sri Chennupati, MD1,2 1. Morsani College of Medicine, University of South Florida 2. Lehigh Valley Health Network Ankyloglossia, or tongue tie, involves the tongue attaching to the floor of the mouth in such a way that tongue movement is restricted. The incidence of ankyloglossia has been rising overall, with an estimated 834% increase in diagnoses in the US from 1997 to 2012.1 While the cause is unclear, the increasing incidence of ankyloglossia does not seem to be due to environmental or developmental factors but rather a result of the social push promoting breastfeeding in recent years.1,2,3 Untreated ankyloglossia can lead to impaired breastfeeding and speech impediments, which can have psychosocial effects later in life. However, the treatments for ankyloglossia are not without risk, bringing up the question of when and if to correct the tongue-tie.

In most infants, the lingual frenulum, the thin tissue connecting the tongue to the floor of the mouth, attaches posteriorly.

Ankyloglossia occurs when the lingual frenulum attaches near the tip of the tongue and/or is short, thick, or rigid, thereby preventing movement of the tongue. Its prevalence is estimated to affect 4-11% of infants.4 Although the exact cause is unknown, it is believed that genetics play a role, as ankyloglossia has been found to run in families.3 The methods employed to correct ankyloglossia range from a simple in-office procedure to a surgical procedure under general anesthesia.

Lingual frenotomy is the cutting of the frenulum close to the base of the tongue to separate the tongue from the floor of the mouth. It is a straightforward procedure that can be done with sterile scissors, although some clinicians prefer using a laser, and does not require anesthesia.5 Due to its simplicity, these

types of frenotomies are often done in the office and are performed by various healthcare providers, including midwives, surgeons, and dentists. For severe cases, more invasive surgical techniques can be implemented, such as frenectomy and frenuloplasty. While frenotomy does not require local or general anesthesia, a frenectomy with myotomy and frenuloplasty do require local anesthesia and possibly intravenous sedation, especially for young children. Frenectomy with myotomy involves not only cutting the lingual frenulum, but also dividing some of the underlying mucosa and muscle layers to provide a better release of the tongue. Frenuloplasty is a surgical method that lengthens the frenulum by creating flaps, repositioning them, and suturing them together in a manner that provides greater length. Studies have shown that frenuloplasty has decreased risk of recurrence and hypertrophy compared to frenectomy with myotomy and frenotomy, along with better outcomes for feeding, maternal pain, and speech.6,7 Despite this, lingual frenotomy remains the treatment of choice for uncomplicated ankyloglossia in infants due to its less invasive nature, efficiency, and lower cost.

Early correction of ankyloglossia is important as it can impact infant health and development, as well as maternal psychological health. Infants usually present to the physicians’ office with difficulty breastfeeding, which manifests as irritability, difficulty latching or maintaining suction on the nipple, longer feeding times, and poor weight gain. The restricted tongue movement can affect speech later in life, create difficulties with eating, and can even alter the structure of the

jaw and teeth, which can have lasting social and psychological impacts as the child becomes older.8,9 Furthermore, mothers of children with ankyloglossia who breastfeed report higher rates of breast pain and mastitis. Difficulty in breastfeeding can significantly impact maternal psychological health. Negative breastfeeding experiences have been linked to postpartum depression and the increased societal pressure to breastfeed has exacerbated feelings of anxiety and depression.10,11 Thus, the inability to breastfeed due to ankyloglossia can negatively impact maternal bonding with the child and cause stress and depression in new mothers.4 Despite the benefits of correcting ankyloglossia, risks from surgical interventions include bleeding, infection, scarring, damage to adjacent structures, adhesion formation, and recurrence, as well as risks associated with anesthesia.12 The procedure should be performed by a trained clinician, in order to minimize complications and adverse outcomes.

Furthermore, the cost must be taken into account. A basic frenotomy can cost $850, and more complex procedures requiring general anesthesia can add on at least another $500, in addition to hospital charges which can be as high as $8000.

The expense is further complicated by varying insurance coverage.2 The decision to intervene has been complicated by the lack of a formal definition of ankyloglossia and what is considered pathologic. This has resulted in a lack of consensus regarding the treatment Continued on page 8

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Tongue Ties Continued from page 7

indications for less severe cases of ankyloglossia.5,13 The current indications for frenotomy are symptom dependent and are largely determined by subjective maternal reports. Furthermore, the reports of the actual benefit, particularly in the long-term, provided by frenotomies have been mixed. The reliability of the results of studies has been called into question due to their limitations, which included small sample sizes and short follow-up periods.1,4,5,13,14,15 In the past, there have been attempts at a grading system based on anatomy (Coryllos system), which did not necessarily predict trouble with breastfeeding. However, the Hazelbaker Assessment Tool for Lingual Frenulum Function and the Bristol Tongue-tie Assessment Tool have provided a way to categorize ankyloglossia based on function.13,15 More recently, a consensus statement was released by the American Academy of Otolaryngology--Head and Neck Surgery.16 It included statements regarding the definition of ankyloglossia, its contribution to difficulty in breastfeeding, the indications for surgical correction, and the procedure itself. The development of grading tools and the consensus statements will standardize the guidelines for both research and clinical practice.

Frenotomies should be performed after other causes of difficulty breastfeeding have been ruled out and conservative interventions have failed.16 These include support from lactation specialists, feeding evaluations, and speech therapists.

Studies have shown that it is possible to decrease frenotomy rates through targeted interventions, education of healthcare professionals, patients and parents, and a standardized step-bystep program. With the implementation of these methods, a study showed that 62.7% of surgical referrals for frenotomy did not undergo surgical procedures

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and another showed a 7.8% decrease in frenotomy rates from 2015 to 2017.2,15 Ankyloglossia can have many detrimental effects on both the mother and child.

However, with the surge of public interest in breastfeeding, ankyloglossia has made its way into the mainstream consciousness as the culprit for infant feeding difficulty; as a result, diagnoses of ankyloglossia and frenotomies have risen. Frenotomy is a relatively simple procedure, but a more conservative approach with a thorough evaluation should be taken when confronted with a probable ankyloglossia diagnosis. To this end, there have been strides in recent years to standardize definitions and guidelines for ankyloglossia, and in the near future, frenotomy rates may begin to decrease.

References

1. Walsh J, Links A, Boss E, Tunkel D. (2017). Ankyloglossia and lingual frenotomy: national trends in diagnosis and management in the United States, 1997-2012.

Otolaryngol Head Neck Surg, 156(4): 735-740.

6. Dusara K, Mohammed A, Nasser NA (2014) Z-frenuloplasty: a better way to 'untangle' lip and tongue ties. J Dent Oral Disord Ther 2(1): 4.

7. Yousefi J, Namini FT, Raisolsadat SMA, Gillies R, Ashkezari A, Meara JG. (2015). Tongue-tie repair: Z-plasty vs simple release. Iran J Otorhinolaryngol 27(79): 127-135.

8. Ferres-Amat E, Pastor-Vera T, Ferres-Amat E, MarequeBueno J, Prats-Armengol J, Ferres-Padro E. (2016).

Multidisciplinary management of ankyloglossia in childhood: treatment of 101 cases. Med Oral Patol Oral Cir Bucal 21(1): e39-47.

9. Francis DO, Chinnadurai S, Morad A, Epstein RA, Kohanim S, Krishnaswami S, Sathe NA, McPheeters ML. (2015). Treatments for ankyloglossia and ankyloglossia with concomitant lip-tie. Comparative Effectiveness Review 149.

10. Watkins S, Meltzer-Brody S, Zolnoun D, Stuebe A. (2011). Early breastfeeding experiences and postpartum depression. Obstet Gynecol 118(2): 214-221.

11. Pope CJ, Mazmanian D. (2016). Breastfeeding and postpartum depression: an overview and methodological recommendations for future research.

Depress Res Treat.

12. Opara PI, Gabriel-Job N, Opara KO. (2012).

Neonates presenting with severe complications of frenotomy: a case series. J Med Case Reports 6(77).

2. C aloway C, Hersh CJ, Baars R, Sally S, Diercks G, Hartnick CJ. 2019. Association of feeding evaluation with frenotomy rates in infants with breastfeeding difficulties.

JAMA Otolaryngol Head Neck Surg 145(9): 817-822.

13. Walsh J, Tunkel D. 2017. Diagnosis and treatment of ankyloglossia in newborns and infants: A review. JAMA Otolaryngol Head Neck Surg 143(10): 1032-1039.

3. S egal LM, Stephenson R, Dawes M, Feldman P. (2007).

Prevalence, diagnosis, and treatment of ankyloglossia.

Can Fam Physician 53(6): 1027-1033.

14. Chinnadurai S, Francis DO, Epstein RA, Morad A, Kohanim S, McPheeters M. (2015). Treatment of ankyloglossia for reasons other than breastfeeding: a systematic review. Pediatr 135(6): e1467-1474.

4. H ill R. 2019. Implications of ankyloglossia on breastfeeding. MCN Am J Matern Child Nurs. 44(2): 73-79.

5. O ’Shea JE, Foster JP, O’Donnell CP, Breathnach D, Jacobs SE, Todd DA, Davis PG. 2017. Frenotomy for tongue-tie in newborn infants. Cochrane Database Syst Rev 3(3).

15. Dixon B, Gray J, Elliot N, Shand B, Lynn A. (2018). A multifaceted programme to reduce the rate of tonguetie release surgery in newborn infants: observational study. Int J Pediatr Otorhinolaryngol 113: 156-163.

16. Messner AH, Walsh J, Rosenfeld RM, Schwartz SR, Ishman SL, Baldassari C, Brietzke SE, Darrow DH, Goldstein N, Levi J, Meyer AK, Parikh S, Simons JP, Wohl DL, Lambie E, Satterfield L. (2020). Clinical consensus statement: Ankyloglossia in children.

Otolaryngol Head Neck Surg 162(5): 597-611.

Standardization: Pro and Con Neerav Goyal, MD, MPH, and Ellen S Deutsch, MD, MS PAO-HNS Patient Safety Committee Patient care is complex and often involves managing conflicting goals, such as balancing potential risks vs benefits of a treatment or providing the best care for an individual patient vs conserving resources for society. The PAO-HNS Patient Safety Committee has decided to tackle specific patient safety principles with the same appreciation for nuanced understanding that you face in making clinical recommendations.

We present a “point-counterpoint” discussion about a patient safety / healthcare quality principle, and conclude with areas of agreement, which we hope will provide the foundation for the optimal application of safety and quality principles.

PRO: STANDARDIZATION IS GOOD

Standardization has its roots in eliminating variation with a goal of simplifying processes and making them more efficient and safer. The concept is employed in industries that require high reliability such as manufacturing, aviation, and healthcare.

We rely on many standardized processes, some of which are so embedded in our culture that we may not even recognize their power.

Standardization informs our expectations;1 when information about a patient is presented to us, we know that first we’ll hear a high-level summary (e.g., this is a 5 year old boy who underwent tonsillectomy 7 days ago) and then relevant details in a predictable sequence that allows us to understand the patient’s condition.

However, it is also important to understand that standardized algorithms in healthcare often come from administrators and managers and not clinicians,2 and represent “work as imagined” rather than “work as done.”3 This disconnect can lead to well-intended processes contributing to worse patient outcomes. For example, to reduce the rate of catheter associated urinary tract infections (CAUTI), many hospitals have implemented algorithms for earlier catheter removal as a triggered nursing task. The result is an increased number of catheter removals on post-operative day 0 or 1. Interestingly, in select populations the policy has been associated with increases in urinary retention and re-catheterization without decreasing the rate of CAUTIs.4,5

Similarly, the documentation of patient care starts with history, proceeds through examination, incorporates an assessment, and concludes with a plan. While the details may vary, the familiar structure helps us find the information we seek.

Standardized processes underpin handoffs, often based on an SBAR format (situation, background, assessment, recommendation), operative reports and other informational resources.

Standardization allows us to generate evaluation and treatment processes that ensure completeness and consistency; indeed, creating an informed algorithm requires review and integration of current knowledge. These processes provide stable guidance to improve the care of individual patients by providing direction for technical processes such as surgical procedures as well as non-technical processes such as obtaining a complete patient history.

Standardization can oversimplify complex processes, especially when applied to a heterogenous population. In contrast to industries like manufacturing or aviation, healthcare must accommodate the significant variations introduced by different comorbidities, diagnoses, necessary management, and preferences of each individual patient.

In chasing efficiency and standardization, we can lose sight of the individual and collective expertise that clinicians can bring, and instead suggest that all members of a discipline have equivalent skills. For example, considering all floor level beds to be equivalent can lead to an increased availability of beds for admitted patients and improve hospital efficiency and available capacity.

However, it negates the unique expertise specialized hospital units could bring when taking care of patients with tracheotomies, nasogastric tubes, or free flap reconstructions. Having less experienced teams care for complex patients can lead to more patient safety events. For otolaryngologists this can be especially concerning for patients such as laryngectomees, who have undergone relatively low volume procedures that result in complex, critical airway needs and require allied clinicians with specific expertise.

Standardization also supports our efforts to move beyond analysis based on anecdotal information to evidence-based medicine. Some knowledge may only be revealed through analyzing collective experiences over many patient encounters. Effective treatment algorithms should be based on meaningful data; to accomplish this, data must be aggregated in a standardized manner. This knowledge is then disseminated in a standardized format: healthcare publications use an “IMRAD” (introduction, methods, results, analysis, discussion) structure, again to make it easier for readers to find the information we seek.

Standardization helps us in the direct provision of care. Standardized roles help us distribute responsibilities during routine patient care and enhance our responses during crises; we know what capabilities to expect from the different personnel in our healthcare teams.

Standardization can lead to diffusion of responsibility, and complacency; we have all witnessed recitations of pre-operative site verifications that are conducted in a perfunctory thoughtless manner.

Standardization allows predictability, which decreases anxiety, and anticipation, which improves planning and responses. When managing a patient in the operating room, shared expectations of responsibilities and understanding of each healthcare provider’s skill set allow us to respond effectively to, for example, an airway crisis.

As we have seen with responses to COVID-19, variations such as resource limitations, technologic advances and disease evolution require flexibility and adaptability. Standardization, even when based on proven principles and processes, is inherently fixed in the past; rigid adherence can create a brittle system that prevents innovation.

Studies of standardization have demonstrated decreased costs, increased compliance with guidance, decreased hospital length of stay, and improved timeliness of healthcare delivery, among other benefits.2 In summary, standardization contributes to efficient, thorough care processes.

CON: STANDARDIZATION IS BAD

In summary, standardization can be detrimental to patients with unique needs and limit a system’s ability to adapt.

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Standardization: Pro and Con Continued from page 9

AREAS OF AGREEMENT ABOUT STANDARDIZATION Standardization can be helpful but must be thoughtfully applied to optimize patient outcomes while reducing unnecessary variation in care. Implementing standardized protocols, such as with “evidence-based medicine,� helps to provide a floor, a minimum standard, for care, but not necessarily a ceiling for optimal care. Standardization may be most useful in stable activities with predictable resources; and may provide a starting point for novices or newly formed teams, or for participation in infrequently performed processes.

The development and implementation of standards should include and incorporate the expertise of front-line clinicians as well as other stakeholders.

Healthcare delivery is a complex adaptive system, and the consequences of many patient care processes in this dynamic environment are not completely predictable. Creating standards that are goal- rather than process-oriented supports customization and optimization for specific applications.

Decisions about when standardization is a help or a hindrance requires balancing potential shortcomings and benefits, based on a combination of objective data and expertise-based judgment.

References 1. Bilmes J. Charles R. Berger and James J. Bradac, Language and Social Knowledge: Uncertainty in interpersonal relations. london: Edward arnold, 1982. pp. viii + 151.

Language in Society. 1984;13(1):87-90. doi: 10.1017/S004740450001592X. 2. What is the impact of standardisation on hospital efficiency. Standardisation in healthcare. https://static.healthcare.siemens.com/siemens_hwem-hwem_ssxa_websites-contextroot/wcm/idc/groups/public/@global/documents/download/mda4/nzy0/~edisp/standardization_in_healthcare-05852743.pdf. Accessed 14Sep, 2020.

3. Hollnagel E, Wears R, Braithwaite J. From safety-I to safety-II: A white paper. 2015.

4. Tam V, Lutfi W, Morgan K, et al. Impact of enhanced recovery pathways and early urinary catheter removal on post-operative urinary retention.

The American journal of surgery. 2020. doi: 10.1016/j.amjsurg.2020.06.057.

5. Chai J, Pun T. A prospective randomized trial to compare immediate and 24-hour delayed catheter removal following total abdominal hysterectomy. Acta obstetricia et gynecologica Scandinavica. 2011;90(5):478-482. doi: 10.1111/j.1600-0412.2011.01104.x.

Announcing the upcoming addition of MEDSTRO!

SOUNDINGS | Fall 2020

During the new membership year, members will be able to interact via our virtual message boards.

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Outcomes data for the new fluticasone exhalation delivery system Ishita Srivastava, BS Jasmine Miravitlles, BS George R. Gardner, BS Nithin D. Adappa, MD Introduction Chronic rhinosinusitis (CRS) is a complex inflammatory disease that is caused by a combination of factors, and leads to local inflammation in the paranasal sinuses and a significant decrease in quality of life. This disease presents as one of two phenotypes: chronic rhinosinusitis with nasal polyps (CRSwNP) and without nasal polyps (CRSsNP). Both types are currently managed by medical and surgical treatments. The surgical treatment, namely endoscopic sinus surgery (ESS), is highly effective in decreasing inflammatory burden and improving the efficacy of long-term medical therapy. One such method of long-term control is the steroid nasal spray.

Topical steroids are effective due to their ability to reach a higher concentration of local tissue without increased bioavailability and subsequent reduction of side effects characteristic of systemic steroids. Typical spray delivery systems tend to be both low pressure and low volume. This results in a majority of the medication being delivered to the anterior nasal cavity and inferior turbinates, as opposed to the paranasal sinuses1,2. This has been proven to be the case regardless of whether surgery was performed. This poor delivery to the paranasal sinuses is worsened with the presence of common CRS symptoms, such as large polyps or stenosed sinuses. Another method of long-term therapy is irrigating with steroids. As opposed to steroid sprays, steroid irrigations have a high volume and high pressure delivery system3. When performed correctly, such irrigations allow for effective treatment of all of the mucosal surfaces, especially following ESS in which the sinus cavities have been opened.

Despite the effectiveness of this method, this treatment poses its own disadvantages as a significant amount of the steroid medication is quickly evacuated from the

sinuses along with the rinse.

An alternative steroid delivery system that can be used as a medical therapy for longterm control of CRS is the novel exhalation delivery system-fluticasone (EDS-FLU). This FDA-approved treatment for nasal polyps is the OptiNoseÂŽ exhalation delivery system that has been on the market since 2018. This nasal spray combines a patient-initiated exhalation through a mouthpiece which is connected to a steroid reservoir. This allows for the elevation of the soft palate against the posterior nasopharyngeal wall, which separates the nasal cavity from the oropharynx. Thus, the steroid is confined to the nasal cavities and paranasal sinuses, as opposed to being wasted in untargeted areas4. We examined the evidence for the use of EDS-FLU, particularly in the management of chronic rhinosinusitis with and without nasal polyps.

Data During the FDA-approval process, four large-scale studies were performed to assess the efficacy of EDS-FLU as an adjunctive treatment for sinonasal inflammation: Navigate I5, Navigate II6, Exhance-37, and Exhance-128. The first two studies were part of a prospective, double-blind, randomized controlled phase 3 trail. The strongest level of evidence is shown in the CRSwNP patient population in both of the Navigate studies.

Each had four treatment arms: placebo, 93, 186, and 372 mcg delivered twice daily through EDS-FLU for a total of 16 weeks. By the end of the study, all of the patients transitioned to 372 mcg twice daily. Compared to the placebo group, patients showed statistically significant improvements in nasal congestion/ obstruction, facial pain/pressure, rhinorrhea, and hyposmia/anosmia.

There was a notable lack of improvement in facial pain/pressure at 93 mcg and anosmia at 186 mcg. In regard to the Sino-Nasal Outcome Test-22 (SNOT-22), there was a significant 7-9 point increase compared to the placebo group5.

Both Navigate I and II also observed nasal polyp grade improvement as determined

via endoscopic examination. In Navigate I, there was greater than one point polyp grade improvement in 66% of patients receiving 186mcg EDS-FLU and 72% of those receiving 372 mcg EDS-FLU5. In Navigate II, there was greater than one point polyp improvement in 68% of patients receiving 93 mcg EDS-FLU, 63% of patients receiving 186 mcg EDS-FLU, and 69% of patients receiving 372 mcg EDSFLU. Navigate II also showed significantly different polyp elimination in at least one nostril in 16% more patients as compared to the placebo cohort6.

Smaller scale studies that have utilized the data from the Navigate I and II studies have found significant improvements in quality of life. One such study found that EDS-FLU patients missed significantly fewer days of work due to CRS as compared to the placebo group9. Another study used the Standard Form-36 survey and found that EDS-FLU patients had a three-fold improvement in general quality of life and health status after 16 weeks of treatment, as compared to the placebo group10.

The other two studies mentioned earlier, Exhance-3 and Exhance-12, examined the effects of 372 mcg EDS-FLU7,8.

Exhance-3 enrolled 705 patients (603 with CRSsNP) and lasted for 3 months7, while Exhance-12 enrolled 224 patients (189 with CRSsNP) and lasted for 12 months8. Both studies found that the mean SNOT-22 scores improved regardless of CRS phenotype, with Exhance-3 patients showing a 24 point increase7 and Exhance-12 patients showing a 21 point increase8. Upon examination of nasal polyps, polyp elimination in at least one nostril was observed in 48% of Exhance-3 patients7 and 54% of the Exhance-12 group8. Notably, 83% of the Exhance-12 cohort also showed greater than one point polyp grade improvement8. Additional evidence of effectiveness was also found in subjective measures such as patient reports of symptomatic improvement.

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PRSRT STD US POSTAGE PAID HARRISBURG PA PERMIT NO 922 777 East Park Drive PO Box 8820 Harrisburg, PA 17105

Outcomes data for the new fluticasone exhalation delivery system Continued from page 11

Conclusion EDS-FLU has been shown to be an effective alternative steroid delivery system, as demonstrated by the results of the multiple double-blinded and randomized controlled trials in patients with CRS. The novel combination of a patient-initiated exhalation mouthpiece and steroid reservoir allows for more effective medication delivery to the nasal cavities and paranasal sinuses, especially when considering the drawbacks of traditional topical steroid methods. The data shown in Navigate I, Navigate II, Exhance-3, and Exhance-12 demonstrate how EDS-FLU can lead to significant improvement for patients in numerous areas, from sinonasal symptoms to enhanced quality of life.

Conflicts of Interest Dr. Nithin Adappa is a consultant for OptiNoseÂŽ.

References 1. Harvey RJ, Goddard JC, Wise SK, Schlosser RJ. Effects of endoscopic sinus surgery and delivery device on cadaver sinus irrigation. Otolaryngol Neck Surg 2008; 139: 137 - 142 2. Djupesland PG, Skretting A. Nasal deposition and clearance in man: comparison of a bidirectional powder device and a traditional liquid spray pump. J Aerosol Med Pulm Drug Deliv 2012; 25: 280 - 289.

3. Harvey RJ, Schlosser RJ. Local drug delivery. Otolaryngol Clin North Am 2009; 42: 829 - 845 4. Kovacs AJ, Goshtasbi K, Kuan, EC. What is the evidence for fluticasone exhalation delivery system in chronic rhinosinusitis?. Current Op in Otolaryngol & Head and Neck Surg 2020; 28: 14-17 5. Sindwani R, Han JK, Soteres DF, et al. NAVIGATE I: randomized, placebo-controlled, double-blind trial of the exhalation delivery system with fluticasone for chronic rhinosinusitis with nasal polyps. Am J Rhinol Allergy 2018; 33: 69 - 82 6. Leopold DA, Elkayam D , Messina JC, et al. NAVIGATE II: randomized, double-blind trial of the exhalation delivery system with fluticasone (EDS-FLU) for nasal polyposis. J Allergy Clin Immunol 2018; 143: 126 - 134.e5.

7. Sher MR, Mair EA, Messina J, et al. EXHANCE-3: a Phase 3, three-month study of safety and efficacy of fluticasone propionate exhalation delivery system (FLU-EDS) in patients with chronic rhinosinusitis with (CRSwNP) and without nasal polyps (CRSsNP). J Allergy Clin Immunol 2017; 139: AB66.

8. Palmer JN, Jacobson KW, Messina JC, et al.

EXHANCE-12: 1-year study of the exhalation delivery system with fluticasone (EDS-FLU) in chronic rhinosinusitis.

Int Forum Allergy Rhinol 2018; 8:869 - 876.

9. Velez FF, Sacks H, Messina JC, et al. Impact of EDS-FLU on work productivity: results from two phase III trials, Navigate 1 and 2. Poster presentation at American Rhinologic Society Spring Meeting, April 19 - 20, 2018, National Harbor, MD. 10. Velez FF, Mahlis EM, Messina JC, et al. EDS-FLU improves quality of life and health status: pooled analysis of phase 3 trials Navigate I and II. J Allergy Clin Immunol 2018; 141: AB163.