2018 ENT JOURNAL - JULY ISSUE

JULY 2018 • VOL. 97, NO. 7

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Stapes surgery in patients with a small air-bone gap

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Intraoperative ultrasound-guided retrieval of an extraluminal pharyngoesophageal foreign body

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Analyzing Medicare payments to otologists

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Late free flap failure in head and neck reconstruction: A systematic review

www.entjournal.com A Vendome Publication

ARS 64th ANNUAL MEETING October 5-6, 2018

Westin Peachtree Plaza Hotel Atlanta, GA

MEETING HIGHLIGHTS: The 14th Annual Kennedy Lecture: Guest Speaker: Noam Cohen, MD, FARS •

Film FESStival A contest for the most interesting video case of sinus or skull base surgery

•

Women in Rhinology, Mentorship Program and Resident’s & Fellows Combined Educational Session

•

Resident’s Cadaveric Lab (Limited Space)

•

Poster Hall

•

Exhibit Hall

•

Welcome, Poster and DWK Lecturer Cocktail Reception

•

Guest Countries: Colombia, Japan, Portugal, South Africa, Turkey

Details at http://www.american-rhinologic.org/annual_meeting Contact: Wendi Perez, Executive Administrator, ARS, PO Box 269, Oak Ridge, NJ 07438 | Tel: 973-545-2735 | Fax: 973-545-2736 | wendi@amrhso.com

www.american-rhinologic.org

EDITORIAL BOARD

Editor-in-Chief

Robert T. Sataloff, MD, DMA, FACS

Professor and Chairman, Department of Otolaryngology–Head and Neck Surgery, and Senior Associate Dean for Clinical Academic Specialties, Drexel University College of Medicine Philadelphia, PA

EDITORIAL BOARD MEMBERS Jean Abitbol, MD Jason L. Acevedo, MD, MAJ, MC, USA Jack B. Anon, MD Gregorio Babighian, MD Peter C. Belafsky, MD, PhD Bruce Benjamin, MD Gerald S. Berke, MD Michael J. Brenner, MD Kenneth H. Brookler, MD Karen H. Calhoun, MD Steven B. Cannady, MD Ricardo Carrau, MD Swapna Chandran, MD Chien Chen, MD Dewey A. Christmas, MD Nicolle T. Clements, MS Daniel H. Coelho, MD, FACS David M. Cognetti, MD James V. Crawford, MD David H. Darrow, MD, DDS Rima Abraham DeFatta, MD Robert J. DeFatta, MD, PhD Hamilton Dixon, MD Paul J. Donald, MD, FRCS Mainak Dutta, MS, FACS Russell A. Faust, PhD, MD Ramón E. Figueroa, MD, FACR Charles N. Ford, MD Paul Frake, MD Marvin P. Fried, MD Richard R. Gacek, MD Andrea Gallo, MD Frank Gannon, MD Emilio Garcia-Ibanez, MD Soha Ghossani, MD William P. R. Gibson, MD David Goldenberg, MD Jerome C. Goldstein, MD Richard L. Goode, MD Samuel Gubbels, MD Reena Gupta, MD Joseph Haddad Jr., MD Missak Haigentz, MD Christopher J. Hartnick, MD Mary Hawkshaw, RN, BSN, CORLN Garett D. Herzon, MD Thomas Higgins, MD, MSPH Jun Steve Hou, MD John W. House, MD Glenn Isaacson, MD Steven F. Isenberg, MD Stephanie A. Joe, MD

Shruti S. Joglekar, MBBS Raleigh O. Jones, Jr., MD Petros D. Karkos, MD, AFRCS, PhD, MPhil David Kennedy, MD Seungwon Kim, MD Robert Koenigsberg, DO Karen M. Kost, MD, FRCSC Jamie A. Koufman, MD Stilianos E. Kountakis, MD, PhD John Krouse, MD Ronald B. Kuppersmith, MD, MBA, FACS Rande H. Lazar, MD Robert S. Lebovics, MD, FACS Keat-Jin Lee, MD Donald A. Leopold, MD Steve K. Lewis, BSc, MBBS, MRCS Daqing Li, MD Robert R. Lorenz, MD John M. Luckhurst, MS, CCC-A Valerie Lund, FRCS Karen Lyons, MD A.A.S. Rifat Mannan, MD Richard Mattes, PhD Brian McGovern, ScD William A. McIntosh, MD Brian J. McKinnon, MD Oleg A. Melnikov, MD Albert L. Merati, MD, FACS Joseph P. Mirante, MD, MBA, FACS Ron B. Mitchell, MD Steven Ross Mobley, MD Jaime Eaglin Moore, MD Thomas Murry, PhD Ashli K. O’Rourke, MD Ryan F. Osborne, MD, FACS J. David Osguthorpe, MD Robert H. Ossoff, DMD, MD Enrique Palacios, MD, FACR Michael M. Paparella, MD Kourosh Parham, MD, PhD Arthur S. Patchefsky, MD Meghan Pavlick, AuD Spencer C. Payne, MD Kevin D. Pereira, MD, MS (ORL) Nicolay Popnikolov, MD, PhD Didier Portmann, MD Gregory N. Postma, MD Matthew J. Provenzano, MD Hassan H. Ramadan, MD, FACS Richard T. Ramsden, FRCS

178 www.entjournal.com

Gabor Repassy, MD, PhD Dale H. Rice, MD Ernesto Ried, MD Alessandra Rinaldo, MD, FRSM Joshua D. Rosenberg, MD Allan Maier Rubin, MD, PhD, FACS John S. Rubin, MD, FACS, FRCS Amy L. Rutt, DO Anthony Sclafani, MD, FACS Raja R. Seethala, MD Jamie Segel, MD Moncef Sellami, MD Michael Setzen, MD, FACS, FAAP Stanley Shapshay, MD Douglas M. Sidle, MD Herbert Silverstein, MD Jeffrey P. Simons, MD Raj Sindwani, MD, FACS, FRCS Aristides Sismanis, MD, FACS William H. Slattery III, MD Libby Smith, DO Jessica Somerville, MD Thomas C. Spalla, MD Matthew Spector, MD Paul M. Spring, MD Brendan C. Stack, Jr., MD, FACS James A. Stankiewicz, MD Jun-Ichi Suzuki, MD David Thompson, MD Lester D.R. Thompson, MD, FASCP Helga Toriello, PhD, FACMG Ozlem E. Tulunay-Ugur, MD Galdino Valvassori, MD Emre Vural, MD Donald T. Weed, MD, FACS Neil Weir, FRCS Kenneth R. Whittemore, MD David F. Wilson, MD Ian M. Windmill, PhD Ian J. Witterick, MD,MSc, FRCSC Richard J. Wong, MD Naoaki Yanagihara, MD Eiji Yanagisawa, MD, FACS Ken Yanagisawa, MD, FACS Anthony Yonkers, MD Mark Zacharek, MD Joseph Zenga, MD Liang Zhou, MD

CLINIC EDITORS Dysphagia Peter C. Belafsky, MD, PhD Gregory N. Postma, MD Facial Plastic Surgery Anthony P. Sclafani, MD, FACS Geriatric Otolaryngology Kourosh Parham, MD, PhD, FACS Karen M. Kost, MD, FRCSC Head and Neck Ryan F. Osborne, MD, FACS Paul J. Donald, MD, FRCS Reena Gupta, MD Imaging Enrique Palacios, MD, FACR Ramón E. Figueroa, MD, FACR Laryngoscopic Robert T. Sataloff, MD, DMA, FACS Otoscopic John W. House, MD Brian J. McKinnon, MD Pathology Lester D.R. Thompson, MD, FASCP Pediatric Otolaryngology Rande H. Lazar, MD Rhinoscopic Eiji Yanagisawa, MD, FACS Dewey A. Christmas, MD Joseph P. Mirante, MD, MBA, FACS Ken Yanagisawa, MD, FACS Special Topics Robert T. Sataloff, MD, DMA, FACS Thyroid and Parathyroid David Goldenberg, MD

ENT-Ear, Nose & Throat Journal July 2018

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1. San Nicoló, et. al. 2017. Absorbable Implant to Treat Nasal Valve Collapse. Facial Plast Surg, 32:233-240.

2. Stolovitzky, P. , Sidle, D. M., Ow, R. A., Nachlas, N. E. and Most, S. P. (2018), A prospective study for treatment of nasal valve collapse due to lateral wall insufficiency: Outcomes using a bioabsorbable implant. The Laryngoscope. doi:10.1002/lary.27242 INDICATIONS FOR USE: The Latera Absorbable Nasal Implant is indicated for supporting upper and lower lateral nasal cartilage.

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Editor-in-Chief Robert T. Sataloff, MD, DMA, FACS 219 N. Broad St., 10th Fl., Philadelphia, PA 19107 entjournal@phillyent.com Ph: 215-732-6100 Managing Editor Linda Zinn Manuscript Editors Martin Stevenson and Wayne Kuznar Associate Editor, Reader Engagement Megan Combs Creative Director Eric Collander National Sales Manager Mark C. Horn mhorn@vendomegrp.com Ph: 480-895-3663 Traffic Manager Eric Collander Please send IOs to adtraffic@vendomegrp.com All ad materials should be sent electronically to: https://vendome.sendmyad.com Customer Service/Subscriptions www.entjournal.com/subscribe Ph: 888-244-5310 email: VendomeHM@emailpsa.com Reuse Permissions Copyright Clearance Center info@copyright.com Ph: 978-750-8400 Fax: 978-646-8600 Chief Executive Officer Jane Butler Chief Marketing Officer Dan Melore Vice President, Finance Bill Newberry Vice President, Custom Media Jennifer Turney Director, Circulation Rachel Beneventi

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ENT-Ear, Nose & Throat Journal July 2018

R E S TO R E PAT I E N T T I SSU E 1

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1. Ambro BT, Zimmerman J, Rosenthal M, Pribitkin EA, Nasal septal perforation repair with porcine small intestinal submucosa. Arch Facial Plast Surg. 2003;5(6):528-529.

2. Nayak JV, Rathor A, Grayson JW, et al. Porcine small intestine submucosal grafts improve remucosalization and progenitor cell recruitment to sites of upper airway tissue remodeling. Int Forum Allergy Rhinol. 2018;00:1–7.

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OHNS-D42808-EN-F

CONTENTS

JULY 2018 • VOL. 97, NO. 7

ORIGINAL ARTICLES 198

Stapes surgery in patients with a small air-bone gap

E17

Jeremy Lavy, FRCS(ORL-HNS); Fiona McClenaghan, MRCS

202

Intraoperative ultrasound-guided retrieval of an extraluminal pharyngoesophageal foreign body

Shin Hye Kim, MD, PhD; Hyun Sook Hong, MD, PhD; Jong Dae Lee, MD, PhD; Moo Kyun Park, MD, PhD

E21

Janet W. Lee, MD; Derrick R. Randall, MD, MSc; Maggie A. Kuhn, MD

208 213

Late free flap failure in head and neck reconstruction: A systematic review David Forner, MD; Blair A. Williams, MSc, MD, FRCS(C); Fawaz M. Makki, MSc, MD, FRCS(C); Jonathan R.B. Trites, MD, FRCS(C); S. Mark Taylor, MD, FRCS(C); Robert D. Hart, MD, FRCS(C)

Ocular vestibular evoked myogenic potentials and intravestibular intralabyrinthine schwannomas Massimo Ralli, MD, PhD; Giuseppe Nola, MD; Massimo Fusconi, MD; Luca Sparvoli, MD; Giovanni Ralli, MD

Analyzing Medicare payments to otologists T. Edward Imbery, MD; Brian D. Nicholas, MD; Parul Goyal, MD, MBA

Tympanometric volume as a useful tool for the evaluation of middle ear status in chronic otitis media

E26

Ameloblastomas of the mandible and maxilla Ivana D. Petrovic, DMD; Jocelyn Migliacci, MA; Ian Ganly, MD; Snehal Patel, MD; Bin Xu, MD; Ronald Ghossein, MD; Joseph Huryn, DDS; Jatin Shah, MD

E33

Accessory submandibular duct sialolithiasis identified during sialendoscopy Andrew J. Thomas, MD; Kevin F. Wilson, MD

ONLINE EXCLUSIVES E1

Esophageal perforation as a complication of the Heimlich maneuver in a pediatric patient: A case report Shira L. Koss, MD; William E. Karle, MD; Gregory Dibelius, MD; Ameet Kamat, MD; Craig Berzofsky, MD

E4

E8

Analysis of the audiogram shape in patients with idiopathic sudden sensorineural hearing loss using a cluster analysis Tetsuo Watanabe, MD, PhD; Masashi Suzuki, MD, PhD

DEPARTMENTS

Cochlear implantation using posterior suprameatal approach

184

ENT Journal Online

Gábor Répássy, MD, PhD; Marianna Küstel, MD, PhD; Magdolna Sz nyi, MD, PhD; Ádám Enreiter, MSc; Ede Birtalan, MD, PhD; László Tamás, MD, PhD

186

Editorial

188

Rhinoscopic Clinic

190

Laryngoscopic Clinic

191

Pathology Clinic

193

Dysphagia Clinic

196

Thyroid and Parathyroid Clinic

216

Advertiser Index

E41

Otoscopic Clinic

Warthin tumor of the larynx: A case report and review of the literature Irit Duek, MD; Miki Paker, MD; Ziv Gil, MD, PhD; Jacob T. Cohen, MD

E12

E36

Efficacy of montelukast as prophylactic treatment for seasonal allergic rhinitis Lisha Li, MD; Ruiqi Wang, MS; Le Cui, MD; Kai Guan, MD

EDITORIAL OFFICE

Robert T. Sataloff, MD, DMA, FACS, Editor-in-Chief • 219 N. Broad St., 10th Fl. • Philadelphia, PA 19107

182 www.entjournal.com

ENT-Ear, Nose & Throat Journal July 2018

ARE YOU MISSING HUNTER SYNDROME?

Silas, 1.5

Silas, 5

ACT EARLY*

HUNTER SYNDROME IS A PROGRESSIVE GENETIC DISEASE Consider the importance of early assessment, diagnosis, and follow-up by a specialist *

A rare combination of common childhood complaints could indicate Hunter syndrome1,2

Age 1-2 years

Age 3-4 years

78% of HOS patients developed an abdominal hernia1

68% of HOS patients were diagnosed with enlarged tonsils or adenoids1

72% of HOS patients had otitis media2

REFER TO A SPECIALIST TODAY For more information, visit:

MPS2Syndrome.com intended for audiences outside the U.S. hunterpatients.com intended for audiences within the U.S. Median age of onset and prevalence data from HOS (Hunter Outcome Survey). 1. Wraith JE et al. Genet Med 2008; 10(7): 508–516. 2. Keilmann A et al. J Inherit Metab Dis 2012; 35(2): 343–353.

© Shire 2017 C-ANPROM/INT//0074 March 2017 © 2017 Shire S30749 03/17

JOURNAL ONLINE

www.entjournal.com

Ear, Nose & Throat Journal's website is easy to navigate and provides readers with more editorial content each month than ever before. Access to everything on the site is free of charge to physicians and allied ENT professionals. To take advantage of all our site has to offer, go to www.entjournal. com and click on the “Registration” link. Once you have filled out the brief registration form, you will have full access. Explore and enjoy!

ONLINE EXCLUSIVES Esophageal perforation as a complication of the Heimlich maneuver in a pediatric patient: A case report

Efficacy of montelukast as prophylactic treatment for seasonal allergic rhinitis

We report a case of cervical esophageal perforation caused by the Heimlich maneuver in a healthy 16-yearold boy. The patient reported a short coughing episode while eating rice, and his mother performed the Heimlich maneuver on him. Five days later, he presented to the emergency department with throat pain, odynophagia, secretion intolerance, muffled voice, and neck stiffness.

He was admitted to the pediatric intensive care unit for conservative management. The next day he underwent....

The evidence supporting the prophylactic treatment of seasonal allergic rhinitis before the start of pollen dispersal is still lacking. We conducted a study to investigate the efficacy of prophylaxis with montelukast for seasonal allergic rhinitis and to evaluate its influence on the inflammatory condition of the lower airway. Our final study population was made up of 57 adults who were randomized to a prophylactic treatment group and a control group. The prophylaxis group was made up of 31 patients—10 men and 21 women, aged 18 to 54 years (mean: 36.9)—who were administered....

Cochlear implantation using posterior suprameatal approach

Tympanometric volume as a useful tool for the evaluation of middle ear status in chronic otitis media

When cochlear implantation was first introduced, the mastoidectomy and posterior tympanotomy approach was the most frequently used technique to gain access to the middle ear and the cochlea. Since 2000, several authors have routinely used a non-mastoidectomy nonposterior tympanotomy technique, which has undergone several modifications.

Alternative surgical techniques for cochlear implantation have recently been introduced, such as endomeatal-alone or suprameatal-alone and combined posterior tympanotomy/endomeatal approaches. The goal of this study was to describe another modification of this less invasive technique to perform cochlear implantation. Cochlear implantations....

Tympanometric volume is a useful tool for evaluating middle ear status in otitis media. However, its usefulness in chronic otitis media (COM) has not been well evaluated.

This study aimed to investigate whether tympanometric volume reflects the status of the middle ear and mastoid or can provide clinical information about patients with COM and subsequent tympanic membrane perforation. A prospective cohort study including 50 adult patients with COM and subsequent tympanic membrane perforation was performed.

The volumes of the middle ear and mastoid were preoperatively calculated using tympanometry and three-dimensional computed tomography (CT) reconstruction of the temporal bone, respectively. During surgery for COM, the patency....

Warthin tumor of the larynx: A case report and review of the literature

Ocular vestibular evoked myogenic potentials and intravestibular intralabyrinthine schwannomas

Shira L. Koss, MD; William E. Karle, MD; Gregory Dibelius, MD; Ameet Kamat, MD; Craig Berzofsky, MD

Gábor Répássy, MD, PhD; Marianna Küstel, MD, PhD; Magdolna Szőnyi, MD, PhD; Ádám Enreiter, MSc; Ede Birtalan, MD, PhD; László Tamás, MD, PhD

Irit Duek, MD; Miki Paker, MD; Ziv Gil, MD, PhD; Jacob T. Cohen, MD

Warthin tumor (papillary cystadenoma lymphomatosum) is a benign salivary gland tumor that occurs almost exclusively in the parotid gland. As far as we know, only 15 cases of laryngeal Warthin tumor have been previously reported worldwide. We describe the case of a 75-year-old woman with a supraglottic tumor that mimicked a mucoepidermoid carcinoma. The tumor was completely excised via a transcervical approach. Pathology identified it as a Warthin tumor. At follow-up, the patient maintained good oral intake. Computed tomography 3 months postoperatively....

184 www.entjournal.com

Lisha Li, MD; Ruiqi Wang, MS; Le Cui, MD; Kai Guan, MD

Shin Hye Kim, MD, PhD; Hyun Sook Hong, MD, PhD; Jong Dae Lee, MD, PhD; Moo Kyun Park, MD, PhD

Massimo Ralli, MD, PhD; Giuseppe Nola, MD; Massimo Fusconi, MD; Luca Sparvoli, MD; Giovanni Ralli, MD

Intravestibular intralabyrinthine schwannomas (ILSs) are uncommon benign tumors that arise from the saccular, utricular, and lateral and superior ampullary nerves.

According to the literature, there is an average delay of 8 years between the onset of symptoms and diagnosis. The diagnosis is based on an audiovestibular examination and magnetic resonance imaging (MRI). We describe a case of intravestibular ILS in which we included the ocular vestibular evoked myogenic potentials (oVEMPs) test in the....

ENT-Ear, Nose & Throat Journal July 2018

ENT JOURNAL ONLINE

Ameloblastomas of the mandible and maxilla

Ivana D. Petrovic, DMD; Jocelyn Migliacci, MA; Ian Ganly, MD; Snehal Patel, MD; Bin Xu, MD; Ronald Ghossein, MD; Joseph Huryn, DDS; Jatin Shah, MD

Ameloblastoma is a histologically benign but locally aggressive tumor of the jaws. We conducted a retrospective cohort study to review the clinical, radiologic, and pathologic features of patients with ameloblastoma of the mandible and maxilla and to report the outcomes of treatment.

Our study population was made up of a series of 30 consecutively presenting patients—15 men and 15 women....

Accessory submandibular duct sialolithiasis identified during sialendoscopy

Andrew J. Thomas, MD; Kevin F. Wilson, MD

We describe a unique case of a 62-year-old patient with recurrent right submandibular sialadenitis. He initially appeared to have extensive sialolithiasis of the right submandibular duct on computed tomography imaging and examination, but sialendoscopy demonstrated a normal-appearing right submandibular duct. An accessory duct posterior and parallel to the normal duct was identified at the time of sialendoscopy and was found to have extensive sialolithiasis, which required removal by both....

Analysis of the audiogram shape in patients with idiopathic sudden sensorineural hearing loss using a cluster analysis

Tetsuo Watanabe, MD, PhD; Masashi Suzuki, MD, PhD

We performed a cluster analysis to classify the audiogram shape in patients with idiopathic sudden sensorineural hearing loss (ISSNHL). We also investigated whether the audiogram shape is a prognostic indicator in the management of ISSNHL. A total of 115 inpatients with ISSNHL treated between 2001 and 2010 were analyzed. The data collected included age, sex, duration of hearing loss at the time of treatment, and the presence or absence of tinnitus, vertigo, diabetes, nystagmus, and canal paresis. A hierarchical cluster analysis was performed using the hearing threshold for each frequency on audiograms as variables. A logistic regression model was used for the prognostic analysis. The audiogram shape was classified into four clusters: (1) crossing....

ONLINE DEPARTMENTS Otoscopic Clinic: Iatrogenic skull base cholesteatoma

Renuka K. Reddy, BS; Kristen A. Echanique, BS; Robert W. Jyung, MD

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www.entjournal.com 185

EDITORIAL

Telemedicine: Part I

[Note: This is Part I of a two-part Editorial. Part II will be published in the August 2018 issue. It has been adapted with permission from Rubin J, Sataloff RT, Korovin G. Telemedicine. In: Rubin J, Sataloff RT, Korovin, G (eds). Diagnosis and Treatment of Voice Disorders. 4th Ed. San Diego: Plural Publishing, Inc.; 2014:781-4.]

The concept of remote medicine has generated increasing interest in recent years. Telemedicine is the provision of healthcare, consultation, and/or information using electronic communications technology.

Broad categories of telemedicine include (1) “store and forward,” (2) remote monitoring, and (3) real-time interactive services. It is useful for otolaryngologists to understand all three options.

“Store and forward” involves acquisition and review of medical data. This might include materials such as medical images or biosignals. It allows for the transmission of medical data off site, thereby permitting review at the convenience of the expert. There is no requirement for the two parties (patient and provider) to be present synchronously. For example, radiologists use this approach routinely. Images are acquired at point A, sent to point B, reported on by the radiologist at point B, and the results are returned to the initiating provider of services at point A or elsewhere, or simply stored for later interpretation or use. Histopathology is another service that uses this approach. There are potential applications for numerous other noninvasive bioimage acquisitions and interpretations.

Remote monitoring implies off-site monitoring of medical problems. It is particularly apt for chronic disease review that does not require face-to-face assessment. It has been used to monitor conditions such as diabetes, emphysema and chronic obstructive pulmonary disease, asthma, and congestive heart failure. A few reports have suggested that under carefully controlled circumstances, this type of remote monitoring has health outcomes comparable to face-to-face monitoring.1–5 Real-time interactive services can theoretically exist between patient and provider via phone, online, and in “kiosks.” One suggested approach is a “health spot,” perhaps located in a pharmacy or large department store, where a patient could enter and interact remotely with a physician. This examination booth or kiosk would be supplied with a variety of medical devices that could be monitored remotely. The physician could also be 186 www.entjournal.com

available on a “real-time” basis via a video-televised link for direct face-to-face history taking and discussion.

American Well Online Care is an online care delivery service that offers such a service via chat, voice, and video. Physicians can sign up for the service and thereby provide the patient and/or another physician with immediate consultation.6 American Well has launched a “direct-to-consumer” service with live video consultations available in 44 U.S. states and the District of Columbia.7 Early systematic reviews 4,5 found the strongest evidence for the efficacy of telemedicine in clinical outcomes from home-based care and monitoring applications in the areas of chronic disease management, hypertension, and AIDS (although Hersh et al noted that evidence of value of home glucose monitoring in diabetes mellitus was conflicting).4 They also found what they described as “reasonable evidence” that telemedicine is comparable to face-to-face care in emergency medicine and is beneficial in surgical and neonatal intensive care units, as well as patient transfer in neurosurgery.

Hersh et al cautioned that there is only a small amount of evidence that interventions provided by telemedicine result in clinical outcomes comparable to or better than face-to-face care and recommended larger randomized, controlled trials.4 It has been argued that telemedicine is cost-effective and may be associated with greater patient satisfaction.

In 2012, the Ontario Telemedicine Network summarized self-reported data from 813 enrolled patients with congestive heart disease and chronic obstructive pulmonary disease, noting a 64 to 66% decrease in hospital admissions, a 72 to 74% reduction in emergency department visits, a 16 to 33% decrease in primary care physician visits, and a 95 to 97% decrease in walk-in clinic visits.2 Others are less convinced. De Jongh et al performed a Cochrane review of mobile phone messaging for facilitating self-management of long-term illnesses.8 They concluded that there were some, albeit limited, indications that mobile phone messaging interventions may provide benefit in supporting the self-management of long-term illnesses. However, they noted significant information gaps regarding the long-term effects, acceptability, costs, and risks of such interventions.

Baron et al, looking at mobile management technologies on glycosylated hemoglobin of patients with diabetes, summarized in their abstract that the evidence on the effectiveness of mhealth (mobile health technolENT-Ear, Nose & Throat Journal July 2018

EDITORIAL

ogies) interventions for diabetes “was inconsistent for both types of diabetes and remains weak” in the studies that they reviewed.9 Smith et al performed a cost-benefit analysis for a telepediatric service in Queensland.10 They demonstrated the service to be financially viable over a 5-year program but found start-up costs to be considerable and to represent 40% of the entire 5-year costs. Stensland et al, in contrast, found a cost excess in a telemedical outpatient program in Minnesota.11 This was primarily due to cost of personnel and an increase in the volume of specialty care and in the use of specialty services by the patients.

Henderson et al, in the recent Whole Systems Demonstrator program, found total costs associated with the telehealth intervention side to be higher than those associated with traditional face-to-face contact.12 Davalos et al pointed out that economic evaluations of telemedicine remain rare, and few of those conducted have accounted for the wide range of economic costs and benefits.13 Benefits that have been suggested from telemedicine include an increase in productivity, increase in speed of processes and referrals, and increased ease in interaction among patients, medical, and paramedical personnel.

It has also been argued that such services allow for lower costs of health care. Arguments made by service providers include the benefits for remote environs and elimination of the need to travel long distances.

As one example, Massachusetts General Hospital and Brigham and Women’s Hospital offer a “Partner Telestroke Center.” This center offers collaboration via brain imaging review, remote examination via video conferencing, and a Web portal for synchronized storeand-forward requirements.14 References

1. Department of Health. Whole system demonstrator programme: Headline findings. December 2011. https://www.gov.uk/ government/publications/whole-system-demonstratorprogramme-headline-findings-december-2011. Accessed June 11, 2018.

2. OTN Telemedicine’s Leader. 2013. http://www.otn.ca 3. Rendina MC, Downs SM, Carasco N, et al. Effect of telemedicine on health outcomes in 87 infants requiring neonatal intensive care. Telemed J 1998;4(4):345–51.

4. Hersh WR, Helfand M, Wallace J, et al. Clinical outcomes resulting from telemedicine interventions: A systematic review.

BMC Med Inform Decis Mak 2001;1:5.

5. Hailey D, Roine R, Ohinmaa A. Systematic review of evidence for the benefits of telemedicine. J Telemed Telecare 2002;8(Suppl 1):1–30.

6. American Well Online Care. https://www.Americanwell.com.

Accessed June 11, 2018.

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7. Terry K. American Well: The doctor will see you online.

Information Week. October 8, 2013. www.informationweek. com/mobile/american-well-the-doctor-will-see-you-online/d/did/1111870. Accessed June 8, 2018.

8. de Jongh T, Gurol-Urganci I, Vodopivec-Jamsek V, et al. Mobile phone messaging for facilitating self-management of long-term illnesses. Cochrane Database Syst Rev 2012;12:CD007459.

9. Baron J, McBain H, Newman S. The impact of mobile monitoring technologies on glycosylated hemoglobin in diabetes: A systematic review. J Diabetes Sci Technol 2012;6(5):1185–96.

10. Smith AC, Scuffham P, Wootton R. The costs and potential savings of a novel telepaediatric service in Queensland. BMC Health Serv Res 2007;7:35.

11. Stensland J, Speedie SM, Ideker M, et al. The relative cost of outpatient telemedicine services. Telemed J 1999;5(3):245–56.

12. Henderson C, Knapp M, Fernández JL, et al. Cost effectiveness of telehealth for patients with long term conditions (Whole Systems Demonstrator telehealth questionnaire study): Nested economic evaluation in a pragmatic, cluster randomised controlled trial.

BMJ 2013;346:f1035.

13. Dávalos ME, French MT, Burdick AE, Simmons SC. Economic evaluation of telemedicine: Review of the literature and research guidelines for benefit-cost analysis. Telemed J E Health 2009;15(10):933–48.

14. Massachusetts General Hospital Stroke Service. 2013. https:// telestroke.massgeneral.org/default.asp. Accessed June 11, 2018.

John S. Rubin, MD, FACS, FRCS Consultant Otolaryngologist Royal National Throat Nose and Ear Hospital Honorary Consultant Otolaryngologist National Hospital for Neurology and Neurosurgery University College London Hospitals NHS Trust Honorary Visiting Professor School of Health Sciences City, University of London Honorary Senior Lecturer Department of Surgery University College of London London, United Kingdom Robert T. Sataloff, MD, DMA, FACS Editor-in-Chief Ear, Nose & Throat Journal Professor and Chairman Department of Otolaryngology–Head and Neck Surgery Senior Associate Dean for Clinical Academic Specialties Drexel University College of Medicine Philadelphia

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RHINOSCOPIC CLINIC

Endoscopic view of a sinonasal osteoma Dewey A. Christmas, MD; Joseph P. Mirante, MD, MBA, FACS; Eiji Yanagisawa, MD, FACS

Figure. Endoscopic view reveals a large, left intranasal mass arising from the ethmoid sinus (A). CT scans show an extensive left osteoma (B), orbital extension of the lesion (C), and extension of the mass into the orbit and the maxillary sinus (D).

An 88-year-old man was referred with a complaint of nasal obstruction. A nasal endoscopic exam revealed a large mucosa-covered mass obstructing the left nasal cavity (figure, A). Computed tomography (CT) of the paranasal sinuses revealed an extensive osteoma of the left ethmoid sinus and left nasal passage (figure, B). The lesion extended into the left orbit (figure, C) and left maxillary sinus (figure, D).

Because of extensive medical problems and his age, the patient and his family elected not to have any surgical intervention.

Osteomas generally present as slowly growing lesions of bone and are among the most common lesions of the nose and paranasal sinuses.1 They most often arise in the ethmoid sinus, with an overall prevalence of 3%.2 Surgical intervention is indicated only in the event of

symptoms or complications caused by the lesion. In the presented patient, the lack of significant complications in view of the patient’s general risk factors obviated the need for surgery.

Acknowledgement

The authors thank Grayson Bertaina for his assistance in preparing this article.

References 1. Atallah N, Jay MM. Osteomas of the paranasal sinuses. J Laryngol Otol 1981;95(3):291-304.

2. Erdogan N, Demir U, Songu M, et al. A prospective study of paranasal sinus osteomas in 1,889 cases: Changing patterns of localization. Laryngoscope 2009;119(12):2355-9.

From the Department of Otolaryngology, the Halifax Medical Center, Daytona Beach, Fla. (Dr. Christmas and Dr. Mirante); Florida State University School of Medicine, Daytona Beach (Dr. Mirante); and the Section of Otolaryngology, Yale New Haven Hospital–St. Raphael Campus and the Yale University School of Medicine, New Haven, Ct. (Dr. Yanagisawa).

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LARYNGOSCOPIC CLINIC

Inflammatory myofibroblastic tumor of the larynx Yu-Hsuan Wang, MD; Yi-Shing Leu, MD; Wei-Chin Chang, MD

A

B

Figure 1. Sagittal (A) and coronal (B) contrast-enhanced, T1-weighted MRI images reveal the enhancing soft-tissue tumor.

A 74-year-old man with congestive heart failure, hypertension, hyperlipidemia, diabetes mellitus, and a history of stroke was brought to our emergency room in August 2014 with pneumonia and acute respiratory failure. During emergent intubation, a supraglottic mass with subtotal upper airway obstruction was found. Magnetic resonance imaging (MRI) showed an enhancing soft-tissue tumor measuring approximately 1.27 × 1.72 × 3.56 cm (figure 1) in the supraglottic, glottic and subglottic area without destruction of the adjacent thyroid cartilage.

We performed tracheotomy and microlaryngeal surgery biopsy on September 1, 2014. Pathologic examination revealed atypical cells (final diagnosis deferred). We performed debulking excision of the supraglottic tumor on September 22, 2014. Pathologic examination revealed an inflammatory myofibroblastic tumor (IMT). However, tumor regrowth was

discovered by flexible laryngoscopy (figure 2). The patient subsequently received total laryngectomy and free radial forearm flap reconstruction on January 14, 2015. Final pathology was reported as an IMT with sarcomatous transformation.

Radiotherapy (2Gy/28 Fr) was suggested by the oncologist. However, after receiving 1 fraction of radiotherapy, total necrosis of the forearm flap with pus-like discharge developed. The plastic surgeon performed debridement and rotational pectoralis major flap and spilt thickness skin graft reconstruction. The patient was then lost to follow-up.

IMT usually involves the lungs, bronchopulmonary tree, and abdominal viscera. It represents less than 1% of all soft-tissue sarcomas.1 Patients with IMT in the head and neck area account for 14 to 18% of extrapulmonary IMTs.1 Currently, IMT is considered an intermediate, locally recurring neoplasm that rarely metastasizes, Continued on page 197

From the Department of Otolaryngology (Dr. Wang and Dr. Leu) and the Department of Pathology (Dr. Chang), MacKay Memorial Hospital, Taipei Taiwan.

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ENT-Ear, Nose & Throat Journal July 2018

PATHOLOGY CLINIC

HPV-related sinonasal carcinoma with adenoid cystic-like features with intracranial invasion Yuntsung Hung, MD; Yu-Yen Chung, MD; Mei-Ling Chen, MD; Jyun-Ying Guo, MD

A 60-year-old man was referred to the Department of Otolaryngology for evaluation of a right nasal tumor. He had a 3-month history of intermittent right epistaxis. One week before admission, he had noticed a sudden loss of vision in his right eye while watching television. At that time, he attended the outpatient clinic of the Department of Ophthalmology. Ophthalmologic examination showed limited bilateral eye motion in all directions, right ptosis, and a loss of vision in the right eye. No other neurologic signs were observed. Magnetic resonance imaging demonstrated a sinonasal tumor with orbital and intracranial extension (figure 1). He was referred to the Department of Otolaryngology for further management.

Anterior rhinoscopy showed a huge mass over the right nasal cavity, and nasopharyngoscopy revealed a smooth nasopharynx surface. All other otolaryngologic examinations were normal. A nasal biopsy was performed, revealing a sinonasal teratocarcinosarcoma. After discussions with the patient, debulking surgery combined with radiotherapy was suggested and performed on the second day after admission.

Histology of the sinonasal tumor retrieved after endoscopic debulking surgery revealed infiltration of solid sheets of basaloid cells with vesicular nuclei, nucleoli, and mitoses separated by fibrous bands of collagenized stroma. Focal microcystic spaces with basophilic material resembling adenoid cystic carcinoma were noted (figure 2, A). Immunohistochemistry staining was positive for p16 (a marker for human papillomavirus [HPV] infection) (figure 2, B); the genotyping was HPV-14D. Based on these findings, a diagnosis of HPV-related sinonasal carcinoma with adenoid cystic-like features

Figure 1. Coronal MRI of the nasal cavity shows a sinonasal tumor with orbital and intracranial extension.

was provided by the pathologist. No obvious complications, such as bleeding, meningitis, or sepsis, were noted postsurgically. Nevertheless, the patient did not recover the vision in his right eye.

The patient was discharged on the ninth day after admission. A radiotherapy plan of 7,000 cGy/35 fx was followed. To date, the patient continues follow-up at the outpatient clinic. Radiotherapy decreased the size of the tumor, but the patient’s vision in his right eye did not return. Intermittent epistaxis was noted during follow-up, and the patient died 11 months postsurgically.

Sinonasal tumors are rare, with an annual incidence of approximately 1 case per 100,000 inhabitants worldwide.¹ However, with the development of endoscopic sinus surgery and improvements in histologic detection, new sinonasal lesions are being diagnosed more

From the Department of Otorhinolaryngology–Head and Neck Surgery (Dr. Hung, Dr. Chung, and Dr. Guo) and the Department of Pathology (Dr. Chen), Changhua Christian Hospital, Changhua City, Taiwan.

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A

B

Figure 2. A: Focal microcystic spaces with basophilic material resembling adenoid cystic carcinoma are noted. B: The specimen is positive for p16 immunohistochemistry staining.

often. When Bishop et al researched the incidence and clinicopathologic profile of HPV-related carcinomas of the sinonasal tract, a variant resembling adenoid cystic carcinoma was found.2,3 HPV-related sinonasal carcinoma with adenoid cystic-like features is a recently described tumor with less than 10 cases reported in the literature to date.2–4 In rare instances, a sudden onset of visual loss has been reported in patients with pituitary adenoma, craniopharyngioma, mucoceles, and pyoceles of the paranasal sinuses, as well as in sphenoid sinus esthesioneuroblastoma.5 The case reported herein emphasizes that HPV-related sinonasal carcinoma with adenoid cystic-like features is one cause of sinonasal tumors, and that it may lead to sudden blindness and intermittent epistaxis.

References 1. Llorente JL, López F, Suárez C, Hermsen MA. Sinonasal carcinoma: Clinical, pathological, genetic and therapeutic advances. Nat Rev Clin Oncol 2014;11(8):460-72.

2. Bishop JA, Ogawa T, Stelow EB, et al. Human papillomavirusrelated carcinoma with adenoid cystic-like features: A peculiar variant of head and neck cancer restricted to the sinonasal tract.

Am J Surg Pathol 2013;37(6):836–44.

3. Bishop JA, Guo TW, Smith DF, et al. Human papillomavirusrelated carcinomas of the sinonasal tract. Am J Surg Pathol 2013;37(2):185-92.

4. Wenig BM. Recently described sinonasal tract lesions/neoplasms: Considerations for the new World Health Organization book.

Head Neck Pathol 2014;8(1):33–41.

5. Tamhankar MA, Volpe NJ, Loevner LA, et al. Primary sinonasal undifferentiated carcinoma presenting with bilateral retrobulbar optic neuropathy. J Neuroophthalmol 2007;27(3):189-92.

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DYSPHAGIA CLINIC

Pseudolymphoma of the palate: A rare cause of dysphagia and odynophagia C. Claire Melancon, MD; Oluwakemi Onajin, MD; Lyndsay L. Madden, DO

Figure 1. Endoscopic image depicts the patient’s soft and hard palate lesions, consistent with pseudolymphoma.

A 51-year-old woman with a history significant for systemic lupus erythematosis presented to clinic for evaluation of a lesion of the palate. She reported that the lesion had been present for more than 1 year and described symptoms of odynophagia, dysphagia, and globus sensation. Her physical examination revealed a lesion of the soft palate that was erythematous and papular in nature (figure 1).

Because we suspected malignancy, she was taken to the operating room for further examination and biopsy of the lesion. The lesion was friable, exophytic in nature, spanning the soft palate, and approximately 1.5 × 0.5 cm in size. An additional small (0.5 cm) ulceration on the hard palate was also noted. The lesion was biopsied and sent for pathologic analysis.

From the Department of Otolaryngology–Head and Neck Surgery (Dr. Melancon and Dr. Madden) and the Department of Pathology (Dr. Onajin), Wake Forest Baptist Medical Center, Winston Salem, N.C. Volume 97, Number 7

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Figure 2. A: Histopathology reveals a diffuse, mixed infiltrate composed predominantly of lymphocytes with scattered plasma cells, neutrophils, and eosinophils (hematoxylin and eosin, original magnification ×40). B: CD79a immunostain highlights the B cells within the infiltrate (original magnification ×40).

Histopathologic examination revealed a diffuse infiltrate composed of lymphocytes, plasma cells, neutrophils, and a few eosinophils (figure 2, A). Immunohistochemistry studies demonstrated B cells that were positive for CD79a and CD20 (figure 2, B). A few scattered T cells were positive for CD3, CD5, and Bcl-2. Kappa and lambda light chains were expressed in the infiltrate, with no restriction and no monoclonality. These results were consistent with pseudolymphoma of the palate.

Pseudolymphoma, also known as benign lymphoid hyperplasia, of the palate is a rare, benign process encountered in clinical practice that results in a distinct-appearing lesion of the palate. There are fewer than 30 published cases describing this pathology in available literature, and it is most commonly described in women and the elderly.1 The disease is characterized by its slow growth, its usually painless nature, and the lack of ulceration seen on examination. It is typically located in the hard palate and, less commonly, the soft palate.1,2 Important in diagnosis is differentiating pseudolymphoma from malignant lymphoid entities that appear similar in clinical and morphologic presentation.

Pseudolymphoma also has been shown to transform into malignant lymphoid entities in rare instances, requiring close and frequent follow-up. These two entities are primarily distinguished with immunologic and genetic analysis.1 Histopathology can reveal only subtle distinctions, making discerning the correct diagnosis challenging, and it alone is many times insufficient for making an accurate diagnosis.2,3 In summary, pseudolymphoma is a rare, benign lesion that must be carefully distinguished from sim-

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ilar appearing malignant entities. It is characterized pathologically by prominent lymphoid infiltrate that appears reactive in nature and lacks clonality on immunogenic analysis.3-5 Clinically, it is virtually impossible to appreciate differences between pseudolymphoma and various low-grade lymphomas. Its similarities on histopathology also pose a diagnostic challenge, and one must rely on immunohistochemistry to distinguish the two lesions. Differentiation is crucial in management planning. Pseudolymphoma has almost universally resolved with surgical excision alone or, in some cases, observation.

References 1. Jham BC, Binmadi NO, Scheper MA, et al. Follicular lymphoid hyperplasia of the palate: Case report and literature review. J Craniomaxillofac Surg 2009;37(2):79-82.

2. Menasce LP, Shanks JH, Banerjee SS, Harris M. Follicular lymphoid hyperplasia of the hard palate and oral mucosa: Report of three cases and a review of the literature. Histopathology 2001;39(4):353-8.

3. Manveen JK, Subramanyam R, Harshaminder G, et al. Primary B-cell MALT lymphoma of the palate: A case report and distinction from benign lymphoid hyperplasia (pseudolymphoma). J Oral Maxillofac Pathol 2012;16(1):97-102.

4. Kolokotronis A, Dimitrakopoulos I, Asimaki A. Follicular lymphoid hyperplasia of the palate: Report of a case and review of the literature. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2003;96(2):172-5.

5. Napier SS, Newlands C. Benign lymphoid hyperplasia of the palate: Report of two cases and immunohistochemical profile. J Oral Pathol Med 1990;19(5):221-5.

ENT-Ear, Nose & Throat Journal July 2018

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THYROID AND PARATHYROID CLINIC

Burkitt lymphoma of the thyroid gland Ashley P. O’Connell Ferster, MD; Guy Slonimsky, MD; Einat Slonimsky, MD; Henry Crist, MD; David Goldenberg, MD, FACS

A 53-year-old woman with a personal and family history of hypothyroidism presented with rapid growth of a neck mass for several weeks. A contrast-enhanced computed tomography (CT) scan of her neck obtained from an outside facility demonstrated a diffusely enlarged thyroid gland with substernal extension and bilateral lateral neck reactive-appearing lymphadenopathy. The trachea was compressed and slightly deviated to the right by a larger left thyroidal lobe (figure 1).

Fine-needle aspiration cytology, also obtained from an outside facility, demonstrated Hashimoto thyroiditis with no malignancy noted. She was prescribed steroids and referred for further evaluation and management.

Physical examination revealed firm thyromegaly with no palpable lymphadenopathy. The patient had dyspnea on exertion but not at rest, and she had dysphagia but no hoarseness. Flexible fiberoptic laryngoscopy revealed normal vocal fold mobility. The rapid growth of her thyroid on a background of Hashimoto thyroiditis raised the concern of a lymphoproliferative process of the thyroid. She gave consent for a partial thyroidectomy to pursue tissue diagnosis and possibly secure a surgical airway.

Intraoperative findings revealed diffusely enlarged, friable, white, fish-flesh-appearing thyroid tissue. A partial thyroidectomy and isthmectomy was performed, resecting the thyroid tissue overlying the trachea in case the patient would require an emergent tracheotomy in the future. A frozen section of the thyroid sent to pathology demonstrated atypical lymphocytes with no thyroid tissue. Permanent pathology and flow cytometry immunophenotyping analysis identified the tumor as a high-grade B-cell lymphoma with Burkitt morphology composed of intermediate-size malignant cells in a diffuse pattern with numerous tingible bodies creating a “starry sky” appearance (figure 2).

A

B

Figure 1. A: Axial contrast-enhanced CT scan obtained at the level of the thyroid shows a large, hypodense intrathyroid mass with central hypodensity suggesting an area of necrosis, externally compressing and narrowing the trachea. B: Coronal contrastenhanced CT scan at the same level demonstrates that the mass extends caudally to the mediastinum.

Oncology was consulted to begin workup and to prepare for further treatment. A left suprarenal mass, bilateral renal masses, and multiple small pancreatic masses were found on imaging and thought to represent lymphomatous involvement. Laboratory workup revealed elevated lactate dehydrogenase and low uric acid; all other laboratory values were unremarkable.

The patient was admitted to the oncology service to start chemotherapy and for further monitoring.

From the Department of Surgery, Division of Otolaryngology–Head and Neck Surgery (Dr. Ferster, Dr. G. Slonimsky, and Dr. Goldenberg), the Department of Diagnostic Radiology (Dr. E. Slonimsky), and the Department of Pathology, Division of Anatomic Pathology (Dr. Crist), The Pennsylvania State University, College of Medicine, Hershey, Penn.

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LARYNGOSCOPIC CLINIC

Continued from page 190

Figure 2. Shown are intermediate-size malignant cells in a diffuse pattern, with numerous tingible bodies creating a “starry sky” appearance (hematoxylin and eosin, original magnification ×250).

Chemotherapy was ultimately started on postoperative day 4. She is currently on her second round of chemotherapy and doing well.

Primary thyroid lymphoma (PTL) is extremely rare, with an annual incidence of 2 per 1 million individuals.1 Only 1 to 2% of all thyroid malignancies are PTL.2 Patients with Hashimoto thyroiditis have a higher incidence of developing lymphoma, with the two diagnoses coexisting in 40 to 80% of patients.3 Such patients present with rapidly enlarging thyroid masses and nonspecific compression symptoms, including hoarseness, dysphagia, dyspnea, and a sense of neck pressure.3 Burkitt lymphoma is among the rare types of lymphoma, accounting for less than 1% of all cases of PTL.4 It commonly presents at extranodal sites and is a highly aggressive lymphoma derived from the germinal center B cells. It is characterized histologically by a diffuse proliferation of intermediate-size neoplastic cells, a high mitotic rate, and numerous large macrophages with clear cytoplasm and phagocytized cellular debris (tingible bodies).

Burkitt lymphoma is sensitive to chemotherapy. Its early diagnosis and treatment, as well as airway considerations, are critical, as chemotherapy may provide a complete response and be life-saving, especially with rapidly progressing neck masses.

References 1. Green LD, Mack L, Pasieka JL. Anaplastic thyroid cancer and primary thyroid lymphoma: A review of these rare thyroid malignancies. J Surg Onc 2006;94(8):725-36.

2. Thieblemont C, Mayer A, Dumontet C, et al. Primary thyroid lymphoma is a heterogeneous disease. J Clin Endocrinol Metab 2002;87(1):105-11.

3. Yildiz I, Sen F, Toz B, et al. Primary Burkitt’s lymphoma presenting as a rapidly growing thyroid mass. Case Rep Oncol 2012;5(2):388-93.

4. Graff-Baker A, Sosa JA, Roman SA. Primary thyroid lymphoma: A review of recent developments in diagnosis and histologydriven treatment. Curr Opin Oncol 2010;22(1):17-22.

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Figure 2. The tumor is seen on laryngoscopy.

usually follows a benign course, and has a distinct histologic appearance.

The origin of this tumor is still unclear. Several theories have been proposed, including infectious, reactive (postsurgical or foreign body) immunologic factors and neoplastic theories. Complete surgical resection remains the mainstay of treatment.

The recurrence rate of laryngeal IMT has been reported to be 8 to 18%.2 Recurrence occurs mostly 2 to 12 months after surgery.3 The factors that may lead to recurrence include partial excision, incomplete excision, or steroid therapy alone. Surgical margin is the most significant and independent predictor for local relapses. Current studies report a 7.1% sarcomatous transformation rate without mention about the time from diagnosis to the transformation.4 References 1. Brooks JK, Nikitakis NG, Frankel BF, et al. Oral inflammatory myofibroblastic tumor demonstrating ALK, P53, MDM2, CDK4, pRb, and Ki-67 immunoreactivity in an elderly patient. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2005;99(6):716–26.

2. Alhumaid H, Bukhari M, Rikabi A, et al. Laryngeal myofibroblastic tumor: Case series and literature review. Int J Health Sci (Qassim) 2011;5(2):187-95.

3. Coffin CM, Watterson J, Priest JR, Dehner LP. Extrapulmonary inflammatory myofibroblastic tumor (inflammatory pseudotumor). A clinicopathologic and immunohistochemical study of 84 cases. Am J Surg Pathol 1995;19(8):859-72.

4. Ong HS, Ji T, Zhang LZ, et al. Head and neck inflammatory myofibroblastic tumor (IMT): Evaluation of clinicopathologic and prognostic features. Oral Oncol 2012;48(2):141–8.

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ORIGINAL ARTICLE

Stapes surgery in patients with a small air-bone gap Jeremy Lavy, FRCS(ORL-HNS); Fiona McClenaghan, MRCS

Abstract

The objective of this study was to determine hearing outcomes in patients undergoing stapes surgery with a preoperative air-bone gap (ABG) <21.25 dB. Patients with a unilateral or bilateral preoperative ABG <21.25 dB undergoing primary stapes surgery were identified from a database of all stapes surgeries performed in a tertiary center over 15 years. A total of 254 ears met the inclusion criteria. The primary outcome measure was the degree of closure of the preoperative ABG. A secondary outcome measure was improvement in bone-conduction thresholds at 4 kHz. All patients underwent stapes surgery under local anesthesia. Ossicular reconstruction was achieved using a SMart 360 nitinol fluoroplastic piston (Gyrus ACMI, Inc.; Southborough, Mass.), and complete posterior crurotomy was performed with a KTP laser. Hearing was assessed with clinical voice testing immediately postoperatively and with pure-tone audiometry at 6 weeks postoperatively. A total of 248 ears (97.6%) demonstrated ABG closure to <10 dB. Bone-conduction thresholds showed an increase in 114 (44.9%), no change 74 (29.1%), and a decrease in 66 (26.0%). There is a slight increase in the risk of stapes mobilization in ears with a small ABG when compared to those with larger ABGs; however, this can be overcome by using a laser-assisted technique in combination with good surgical experience.

The benefit in terms of hearing aid avoidance and the restoration of symmetrical hearing is both achievable and significant for the patient.

Introduction

Otosclerosis is a process of bone remodeling that occurs only in the otic capsule.1 It is characterized by progressive focal dysplasia with destruction, remodel-

From the Department of Otology, The Royal National Throat Nose and Ear Hospital, London, U.K. Corresponding author: Fiona McClenaghan, The Royal National Throat Nose and Ear Hospital, 330 Gray’s Inn Rd., London, WC1X8DA, UK. Email: fiona.mcclenaghan@gmail.com Previous presentation: This article has been edited for publication and updated from its presentation at The Royal Society of Medicine Otology Section Meeting; 6 May 2016; London, U.K. 198 www.entjournal.com

ing and, finally, sclerosis of the endochondral bone of the labyrinthine capsule.2 Any part of the otic capsule can be involved, with a predilection for a number of different sites, 3 most commonly anterior to the oval window, at the margins of the round window, and the apical-medial wall of the cochlea.4 When the anterior part of the oval window, the fissula ante fenestram, is involved there can be extension to the annular ligament and the stapes, causing bony ankylosis of the stapes and increased stiffness of the ossicular chain and resulting in conductive hearing loss.2 Stapes surgery (stapedectomy and stapedotomy) is one type of treatment that can be offered to patients experiencing such a loss.

The degree of hearing loss that is required as an indication for surgery varies among authors. Some authors advocate surgery only for patients with an air-bone gap (ABG) >30 dB, 5 while others accept 25 dB 6 or 15 dB, 2 with current guidelines advocating surgery for an ABG >20 dB.7 The debate over the minimum ABG centers on the risk-to-benefit ratio of stapes surgery in patients with small ABGs. However, good results in patients with smaller ABGs have been reported.8-10 A key surgical step in stapes surgery is the removal of the superstructure of the stapes bone. This involves either mechanical down-fracture of the superstructure or some degree of crurotomy (division of the posterior and anterior crura of the stapes). With early disease and partial fixation of the footplate, this step can become difficult, resulting in mobilization of the stapes and the potential need to abandon the procedure. Some might consider stapes mobilization a reasonable outcome for limited otosclerosis; however, the likelihood of refixation is high and therefore definitive surgery is more likely to give a better long-term result.

This study looks at the surgical results of 293 patients undergoing stapes surgery with relatively small (<21.25 dB) preoperative ABGs and represents, to our knowledge, the largest series in the literature.

ENT-Ear, Nose & Throat Journal July 2018

Stapes surgery in patients with a small air-bone gap

Patients and methods

The senior author (J.L.) used his stapes surgery database to identify those patients with a preoperative ABG of <21.25 dB (as defined by American Academy of Otolaryngology–Head and Neck Surgery [AAO– HNS] guidelines).7 This precise figure was decided upon as it was a common result when averaging across four frequencies (500, 1,000, 2,000, and 4,000 Hz) and translates to just a 5-dB difference at one frequency in a 20-dB gap.

A total of 293 of 1,087 ears met the criteria and were analyzed. Audiometry was performed a minimum of 6 months before surgery and at 6 weeks after. Most patients were then followed on an annual basis. The database was started in 2000 and is ongoing.

Stapes surgery was routinely performed under local anesthesia.11 All ears in this study had their ossicular chain reconstructed with a SMart 360 nitinol fluoroplastic piston (Gyrus ACMI, Inc.; Southborough, Mass.). Complete posterior crurotomy was achieved with a KTP laser. This a crucial step in the procedure as the anterior crus is only visible in approximately 5% of cases, meaning that in most, removal of the stapes superstructure is only possible by mechanical down-fracture of the anterior crus. At the end of the procedure, hearing was assessed in each patient with clinical voice testing.

Results

Thirty-nine of the 293 (13.3%) ears identified were revision cases and so were excluded from analysis. The

mean preoperative ABG of the remaining 254 ears was 16.81 dB, with a mean postoperative ABG of 4.24 dB. The number of ears in which the ABG was closed to <10 dB was 248 (97.6%). Bone-conduction thresholds at 4 kHz showed an increase in 114 ears (44.9%), no change in 74 (29.1%), and a decrease in 66 (26.0%).

Discussion

There is some disagreement among surgeons as to what degree of ABG is seen as an indication for stapes surgery.2,5,6,8-10 Smaller gaps are likely to be associated with less fixation of the stapes at the oval window and are potentially more at risk of inadvertent stapes mobilization during the procedure. This is borne out by a stapes mobilization rate of 4% in this group in the present study compared to 1% in patients with larger ABGs. Intraoperative stapes mobilization is often cited as a potential indication for abandoning the procedure and closing the ear. However, with the availability of laser and increased surgical experience in our series, it was possible in almost every case of mobilization to complete the original planned procedure. Surgical tips as to how to achieve this include fracturing the superstructure anteriorly rather than inferiorly and, in an already- mobilized stapes, manipulating the angle of the superstructure to allow access to the anterior crus for laser crurotomy.

Some surgeons will only consider stapes surgery when there is a reversal of the normal relationship

Figure. The most extreme Carhart effect in our series is shown here: Preoperative bone conduction (A) and postoperative bone conduction (B) are plotted.

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between air and bone conduction when tested with a tuning fork (Rinne test).2,10 However, a Rinne test has limited diagnostic utility; when the ABG is <17 dB or >30 dB, the Rinne test is often normal regardless of the underlying pathology.12 This would exclude many of the patients in our series from the benefits provided by surgery. However, a more detailed technique using both the 256- and 512-Hz tuning forks as described by Gordon et al may be more accurate in detecting small ABGs in otosclerosis.13 Another difficulty in assessing the preoperative ABG is the Carhart effect. First described by Carhart in 1950, it relates to a false elevation in bone conduction with a peak at 2 kHz ranging in frequency from 500 to 4,000 Hz associated with a conductive hearing loss.14 In our series, the Carhart effect at 2 kHz was an average of 6.9 dB with a range of –10 to +25 dB. The most extreme Carhart effect is shown in the figure, where the pre- and postoperative bone-conduction thresholds are plotted.

Interpretation of the preoperative audiogram, particularly in bilateral disease, therefore requires some degree of flexibility with the AAO–HNS guidelines, allowing for a 10-dB addition in review of the preoperative ABG at 2 kHz to allow for the Carhart effect.7 This raises the question as to whether preoperative bone conduction can be accurately measured in otosclerosis.15 Our results, to the best of our knowledge representing the largest series reported in the literature to date, show that excellent hearing outcomes are possible in patients who have a relatively small (<21.25 dB) preoperative ABG. Positive results with stapes surgery in patients with small ABGs also have been reported in the literature.

Salmon et al, in a retrospective comparative study, found that patients with a preoperative ABG <25 dB had significantly smaller postoperative ABGs and lower air-conduction thresholds when compared with those with a preoperative ABG >25dB.8 Similarly, Salvinelli et al found that surgery in patients with an ABG <20 dB can result in complete auditory recovery and postulated that surgery may be of further benefit by arresting the progression of otosclerosis and thus preserving inner ear structures.9 Lippy at al published a series of 136 patients with ABGs <10 dB, showing that a pure-tone audiogram overclosure of ≥0 dB can be consistently achieved in cases in which a Robinson stainless steel stapes prosthesis with vein graft is used.10 All cases in our series had a SMart 360 nitinol fluoroplastic piston placed for ossicular reconstruction. The prosthesis consists of a Teflon “vestibular” end and a heat-activated, self-crimping loop made of nitinol (alloy of nickel and titanium). Nitinol is a “smart” material with shape memory and super-elastic properties. The

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advantage of this prosthesis is the tight and uniform grip around the process of the incus or handle of the malleus.16 It has been shown in several small, retrospective series to produce comparable postoperative air-bone closure to that of traditional prostheses.16-19 However, because of its relatively recent introduction, systematic meta-analyses have been unable to achieve sample sizes sufficient to demonstrate a statistically significant difference in hearing outcomes.10 Nevertheless, temporal bone studies have demonstrated that the SMart piston improves the quality of the interface between the piston loop and the incus, and the decreased dead space theoretically should improve hearing outcomes in comparison to those achieved with manual crimping.16) There is a slight increase in the risk of stapes mobilization in ears with a small ABG when compared to those with larger ABGs (4 vs. 1%); however, this can be overcome by using a laser-assisted technique combined with good surgical experience. Most of the recent reports use a laser-assisted technique, with a recent systematic review reporting a decreased frequency of footplate fractures and sensorineural hearing loss when the procedure is compared with conventional fenestration stapedotomy.20 There is little consensus regarding the optimal type of laser, with some evidence suggesting superiority of the KTP and CO2 lasers over the thulium laser.21 All patients in our series underwent a complete posterior crurotomy with the KTP laser.

Surgeon experience is crucial in stapes surgery, especially in patients with small ABGs. The large series

by Lippy et al was performed in a tertiary center with experience of 14,000 stapedectomies performed over 35 years.10 At our center, the senior author (J.L.) routinely performs more than 200 stapes operations per year. In a recent survey of otologists in the United Kingdom, 73% perform stapes surgery, with the average number of operations per surgeon lying between 6 and 10 per year.22 This serves to highlight the importance of experience in stapes surgery, especially in view of the higher risk-to-benefit ratio in patients with a small ABG. However, the hearing benefit in terms of hearing aid avoidance and the restoration of symmetrical hearing, as our results have shown, is both achievable and significant for the patient.

References

1. Cureoglu S, Baylan MY, Paparella MM. Cochlear otosclerosis.

Curr Opin Otolaryngol Head Neck Surg 2010;18(5):357-62.

2. Somers TH, Declau F, Kuhweide R, Robillard TH. Otosclerosis.

B-ENT 2007;3(Suppl 6):3-10.

3. Rudic M, Keogh I, Wagner R, et al. The pathophysiology of otosclerosis: Review of current research. Hear Res 2015;330(Pt A):51-6.

Continued on page 212

ENT-Ear, Nose & Throat Journal July 2018

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ORIGINAL ARTICLE

Intraoperative ultrasound-guided retrieval of an extraluminal pharyngoesophageal foreign body Janet W. Lee, MD; Derrick R. Randall, MD, MSc; Maggie A. Kuhn, MD

Abstract

Pharyngoesophageal foreign bodies (FBs) are common otolaryngologic problems, but challenging cases cause significant patient and surgeon frustration. Extraluminal migration of an FB from the pharynx or esophagus is rare and usually necessitates external neck exploration. Approaching these complicated FBs endoscopically may avoid undue surgical morbidity. We present a case using real-time, intraoperative ultrasound (US) guidance for safe retrieval of a migrated submucosal FB. Intraoperative US is a widely available, powerful technology that can aid in the retrieval of difficult pharyngoesophageal FBs. In appropriate cases, this strategy may circumvent transcervical approaches and their associated risks.

Introduction

Pharyngoesophageal foreign bodies (FBs) are a common otolaryngologic problem.1-3 Most are managed endoscopically, but when not easily retrieved, they pose a significant challenge. We present such a case, involving a man with an extraluminal esophageal FB that migrated through the pharyngoesophageal segment. The use of intraoperative, real-time ultrasound (US) to guide endoscopic extraction of the FB allowed quick, safe treatment and prevented the need for a transcervical approach and its potential morbidities.

Existing literature on intraoperative ultrasound for FB retrieval describes its value in localizing a submucosal fish bone, enabling the creation of a well-positioned mucosal incision to afford direct endoscopic visualization of the FB.4 To the best of our knowledge, this is From the Department of Otolaryngology, University of California Davis Medical Center, Sacramento.

Corresponding author: Janet W. Lee, MD, UC Davis Department of Otolaryngology, 2521 Stockton Blvd., Suite 7200, Sacramento, CA 95817. Email: jwalee@ucdavis.edu Previous presentation: This article has been edited and updated from its previous presentation at the Combined Otolaryngology Spring Meeting, American Broncho-Esophagological Association section; May 19, 2016; Chicago.

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the first report of a case of submucosal chicken bone removal under US visualization without traditional endoscopic visualization of the FB. Case report

A 59-year-old man presented to the Emergency Department with 1 day of left-sided throat pain after inadvertently swallowing a presumed chicken bone. He sought medical attention after developing increasing pain and fever over the next day.

On examination, the patient was not in acute distress, nor did he have stridor or voice change.

He had a low-grade fever but was hemodynamically stable. The neck was without erythema, edema, or subcutaneous emphysema. The remainder of the head and neck examination was unremarkable. Flexible nasopharyngoscopy revealed a small abrasion of the left tongue base and mild edema of the left arytenoid, but no FB was identified within the oropharynx or hypopharynx. There was no appreciable submucosal fullness or abnormality.

Contrast-enhanced computed tomography (CT) of the neck demonstrated a 3-cm linear, radio-opaque FB in the postcricoid region abutting the left cricothyroid joint (figure 1). Consent was obtained for operative removal under general anesthesia. During rigid direct laryngoscopy and esophagoscopy, mild mucosal injury was appreciated in the postcricoid region, although no intraluminal FB was seen. A nasogastric tube was inserted under direct vision; the patient was kept nil per os (NPO) and started on antibiotics. A repeat neck CT confirmed an unchanged position of the FB. The next day, the patient was taken for repeat operative esophagoscopy and possible transcervical retrieval of the FB. Again, the FB was not encountered endoscopically despite attempts with both the rigid cervical esophagoscope and the Dedo-Pilling laryngoscope.

Before resorting to an open approach, we used intraoperative US to locate the FB. With the use of a standard US probe, the relationship of the FB to the ENT-Ear, Nose & Throat Journal July 2018

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Lee, Randall, Kuhn

minimal trauma to the intraluminal mucosal and submucosal site of FB removal. The patient remained NPO over the next 2 days to promote closure of the intraluminal defect and had resolution of his pain. A videofluoroscopic swallow study performed on the third postoperative day demonstrated no extravasation. The patient’s diet Figure 1. Axial, coronal, and sagittal soft-tissue neck CTs show the radio-opaque foreign body was advanced without difficulty, and he experienced full recovery in the postcricoid region (arrows). after discharge. rigid endoscope was evident (figure 2). It was oriented longitudinally in the cervical soft tissue, outside and Discussion anterior to the pharyngoesophageal lumen. Continuous Pharyngoesophageal FB is a common problem in both US imaging with a SonoSite HFL38 transducer with a children and adults. Up to 80% of adult FBs are fish frequency of 6 to 13 MHz (Fujifilm SonoSite; Bothell, bones, which have a dangerous predilection given Wash.) was performed by the US technician in real time, their potential to penetrate tissue and cause additional allowing the laryngologist to view the relationship of injury to underlying structures.1,3 While in this case, the cupped forceps to the FB. The Dedo-Pilling laryn- the FB was presumed to be a chicken bone and not a goscope was used instead of the rigid esophagoscope fish bone, the same penetrating tendency applies.

In a case series of more than 2,000 esophageal because the larger working channel allowed a better FBs by Hsu et al, 2 patients developed esophageal angle of approach for the endoscopic forceps.

No measurements were made, and no separate in- perforations requiring removal of the FB through an cision was created because the angle of the endoscope external approach.3 In another series, Loh et al found allowed US visualization of the FB just distal to the that of patients with major complications (including tip of the laryngoscope. The endoscopic forceps were esophageal perforation), 90% had a fish bone FB as advanced until US showed that only a thin layer of compared to 70% of those with minor complications.5 Perforation of the esophagus by an FB may predispose a soft tissue separated them from the tip of the FB. This layer of intervening tissue was then opened with the patient to further, more catastrophic complications. Pang endoscopic forceps, which was then advanced into et al reported a case in which an ingested FB migrated the submucosal tissue to grasp the tip of the FB under out of the esophageal lumen and punctured the common carotid artery, causing a retropharyngeal hematoma.6 real-time US visualization.

Expeditious treatment of FB is key to minimizing The linear FB was retrieved in one piece (figure 3) with no fragments visible on repeat US. There was secondary injuries, as there is evidence that increased

Figure 2. Intraoperative US demonstrates the ability to locate and remove the foreign body with endoscopic forceps (FB = foreign body; EF = endoscopic forceps; LS = laryngoscope; NGT = nasogastric tube).

204 www.entjournal.com

Figure 3: Extracted foreign body measures approximately 3 cm in length.

ENT-Ear, Nose & Throat Journal July 2018

For the treatment of AOMT in pediatric patients due to S. aureus, S. pneumoniae, H. influenzae, M. catarrhalis, and P. aeruginosa.

The difference is in the delivery.

OTOVEL® (ciprofloxacin and fluocinolone acetonide) is a sterile solution—not a suspension1 • Blow-fill-seal (BFS) technology provides sterile manufacturing and packaging2 • Containers are formed, filled, and sealed in a continuous, automated operation3 • BFS technology reduces human intervention in the fill/finish process3 • Every dose is sterile, precise, and preservative free1

Delivered in simple, single-dose vials1

• The first and only antibiotic/steroid combination ear drop in single-dose vials4

• No drop counting. No mixing or shaking required1

• Single-use vials contain 1 premeasured dose each—dose BID/7 days1

• Demonstrated efficacy and safety in 2 clinical trials1,5

We’d like to deliver Starter Packs to your practice.

Order yours at otovel.com/hcp/resources AOMT=acute otitis media with tympanostomy tubes; BID=twice daily.

INDICATIONS OTOVEL® (ciprofloxacin and fluocinolone acetonide) is indicated for the treatment of acute otitis media with tympanostomy tubes (AOMT) in pediatric patients (aged 6 months and older) due to S. aureus, S. pneumoniae, H. influenzae, M. catarrhalis, and P. aeruginosa.

IMPORTANT SAFETY INFORMATION Contraindications OTOVEL is contraindicated in: • Patients with known hypersensitivity to fluocinolone acetonide or other corticosteroids, ciprofloxacin or other quinolones, or to any other component of OTOVEL. • Viral infections of the external ear canal, including varicella and herpes simplex infections and fungal otic infections.

The following Warnings and Precautions have been associated with OTOVEL: hypersensitivity reactions, potential for microbial overgrowth with prolonged use, and continued or recurrent otorrhea.

The most common adverse reactions are otorrhea, excessive granulation tissue, ear infection, ear pruritis, tympanic membrane disorder, auricular swelling, and balance disorder.

For additional Important Safety Information, please see Brief Summary of Prescribing Information on adjacent page, and full Prescribing Information available at www.otovel.com.

References: 1. Otovel [package insert]. Atlanta, GA: Arbor Pharmaceuticals, LLC. 2016. 2. Data on file. Arbor Pharmaceuticals, LLC. 3. Guidance for industry: sterile drug products produced by aseptic processing—current good manufacturing practice. Food and Drug Administration. https://www.fda.gov/downloads/Drugs/Guidances/ucm070342.pdf. Published September 2004. Accessed March 15, 2018. 4. Orange Book: Approved drug products with therapeutic equivalence evaluations. US Food and Drug Administration. https://www.accessdata.fda.gov/scripts/ cder/ob/default.cfm. Updated May 17, 2013. Accessed July 15, 2016. 5. Spektor Z, Pumarola P, Ismail K, et al. Efficacy and safety of ciprofloxacin plus fluocinolone in otitis media with tympanostomy tubes in pediatric patients: a randomized clinical trial. JAMA Otolaryngol Head Neck Surg.

2017;143(4):341-349.

Otovel is a registered trademark of Laboratorios Salvat, S.A. with the US Patent and Trademark Office and under license by Arbor Pharmaceuticals, LLC. Trademarks are the property of their respective owners. © 2018 Arbor Pharmaceuticals, LLC. All rights reserved. Printed in USA. PP-OTO-US-0268

OTOVEL® (ciprofloxacin and fluocinolone acetonide) otic solution Brief Summary of Prescribing Information 1 INDICATIONS AND USAGE OTOVEL is indicated for the treatment of acute otitis media with tympanostomy tubes (AOMT) in pediatric patients (aged 6 months and older) due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa.

Table 1: Selected Adverse Reactions that Occurred in 1 or more Patients in the OTOVEL Group Number (%) of Patients Adverse Reactions1

OTOVEL N=224

CIPRO N=220

FLUO N=213

2 DOSAGE AND ADMINISTRATION

Otorrhea

12 (5.4%)

9 (4.1%)

12 (5.6%)

• OTOVEL is for otic use only. It is not for ophthalmic use, or for injection.

Excessive granulation tissue

3 (1.3%)

0 (0.0%)

2 (0.9%)

Ear infection

2 (0.9%)

3 (1.4%)

1 (0.5%)

Ear pruritus

2 (0.9%)

1 (0.5%)

1 (0.5%)

Tympanic membrane disorder

2 (0.9%)

0 (0.0%)

0 (0.0%)

Auricular swelling

1 (0.4%)

1 (0.5%)

0 (0.0%)

Balance disorder

1 (0.4%)

0 (0.0%)

0 (0.0%)

The recommended dosage regimen is as follows: • Instill the contents of one single-dose vial 0.25 mL into the affected ear canal twice daily (approximately every 12 hours) for 7 days. Use this dosing for patients aged 6 months of age and older.

• Warm the solution by holding the vial in the hand for 1 to 2 minutes. This is to avoid dizziness, which may result from the instillation of a cold solution into the ear canal.

• The patient should lie with the affected ear upward, and then instill the medication.

• Pump the tragus 4 times by pushing inward to facilitate penetration of the medication into the middle ear.

• Maintain this position for 1 minute. Repeat, if necessary, for the opposite ear [see Instructions for Use].

3 DOSAGE FORMS AND STRENGTHS Otic Solution: Each single-dose vial of OTOVEL (ciprofloxacin 0.3 % and fluocinolone acetonide 0.025 %) delivers 0.25 mL of solution equivalent to ciprofloxacin 0.75 mg and fluocinolone acetonide 0.0625 mg.

Selected adverse reactions that occurred in ≥ 1 patient in the OTOVEL group derived from all reported adverse events that could be related to the study drug or the drug class.

1

6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of ciprofloxacin and fluocinolone acetonide otic solution, 0.3% / 0.025% outside the US. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

4 CONTRAINDICATIONS OTOVEL is contraindicated in:

• Immune system disorders: allergic reaction.

• Patients with known hypersensitivity to fluocinolone acetonide or other corticosteroids, ciprofloxacin or other quinolones, or to any other components of OTOVEL.

• Nervous system disorders: dysgeusia, paresthesia (tingling in ears), dizziness, headache.

• Infections and infestations: candidiasis.

• Viral infections of the external ear canal, including varicella and herpes simplex infections and fungal otic infections.

• Ear and labyrinth disorders: ear discomfort, hypoacusis, tinnitus, ear congestion.

5 WARNINGS AND PRECAUTIONS 5.1 Hypersensitivity Reactions OTOVEL should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolones. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria and itching. Serious acute hypersensitivity reactions may require immediate emergency treatment.

• Skin and subcutaneous tissue disorders: skin exfoliation.

5.2 Potential for Microbial Overgrowth with Prolonged Use Prolonged use of OTOVEL may result in overgrowth of non-susceptible bacteria and fungi. If the infection is not improved after one week of treatment, cultures should be obtained to guide further treatment. If such infections occur, discontinue use and institute alternative therapy.

5.3 Continued or Recurrent Otorrhea If otorrhea persists after a full course of therapy, or if two or more episodes of otorrhea occur within 6 months, further evaluation is recommended to exclude an underlying condition such as cholesteatoma, foreign body, or a tumor.

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1)] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In clinical trials, 224 patients with AOMT were treated with OTOVEL for a median duration of 7 days. All the patients received at least one dose of OTOVEL. There were 220 patients who received at least one dose of ciprofloxacin (CIPRO) and 213 patients received at least one dose of fluocinolone acetonide (FLUO). The most common adverse reactions that occurred in 1 or more patients are as follows:

• Vascular disorders: flushing.

• Injury, poisoning and procedural complications: device occlusion (tympanostomy tube obstruction).

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary OTOVEL is negligibly absorbed following otic administration and maternal use is not expected to result in fetal exposure to ciprofloxacin and fluocinolone acetonide (12.3)].

8.2 Lactation Risk Summary OTOVEL is negligibly absorbed by the mother following otic administration and breastfeeding is not expected to result in exposure of the infant to ciprofloxacin and fluocinolone acetonide.

8.4 Pediatric Use OTOVEL has been studied in patients as young as 6 months in adequate and wellcontrolled clinical trials. No major differences in safety and effectiveness have been observed between adult and pediatric patients.

8.5 Geriatric Use Clinical studies of OTOVEL did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects.

Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

10 OVERDOSAGE Due to the characteristics of this preparation, no toxic effects are to be expected with an otic overdose of OTOVEL. Distributed by: Arbor Pharmaceuticals, LLC Atlanta, GA 30328 Under license of Laboratorios SALVAT, S.A. OTOVEL is a registered trademark of Laboratorios SALVAT, S.A. U.S. Patent No: 8,932,610 You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For more detailed information, see the full prescribing information for Otovel at www.otovel.com or contact Arbor Pharmaceuticals, LLC at 1-866-516-4950.

Intraoperative ultrasound-guided retrieval of an extraluminal pharyngoesophageal foreign body

time of impaction of FBs is related to increased risk of complications, including esophageal perforation, extraluminal migration, mediastinitis, abscess, and vascular injury.5-10 Patients have been found to have a greater than ten-fold chance of developing major complications from an esophageal FB if the FB had been impacted for more than 24 hours.5 Such was the case in multiple reports of complicated FBs, including a case of a fish bone that had migrated to the subcutaneous tissues causing tenting of the skin, several cases of thyroid abscess related to FB, and a case of a single fish bone FB that caused injury to both the carotid artery and jugular vein.6-10 Migrated or complex FBs often require a transcervical approach for retrieval.6-10 Intraoperative, real-time US is a minimally invasive and readily available adjunct to rigid endoscopy that may obviate the need for an open approach to access extraluminal FBs or other pathology.4 While use of US in esophageal FB localization before endoscopic retrieval has been described, to the best of our knowledge, this is the first report of real-time intraoperative US used to retrieve an extraluminal FB. Intraoperative US was used by Baba et al to locate a 2.4-cm fish bone in the upper esophageal submucosa.4 They were able to measure the distance from the endoscopic forceps to the fish bone, which guided the placement of a mucosal incision. Without the assistance of US, the FB was exposed and removed endoscopically through the mucosal incision.

In our case, the FB was a chicken bone rather than a fish bone, as determined by history, and was retrieved using US guidance only without the creation of a mucosal incision or traditional endoscopic visualization of the FB at any time. The use of US enabled localization of an entirely extraluminal FB and guided uncomplicated endoscopic retrieval, thereby circumventing the risks associated with neck exploration.

Limitations of this method include patient factors, equipment and personnel availability, and surgeon preference. Endoscopic FB retrieval in a patient with a FB located more distally may be complicated by a more difficult angle of approach and the inability to use a laryngoscope with a larger working channel.

Obese patients may present a greater challenge for US, given the increased depth of the field and potentially increased noise in the image. If there is concern for complications such as vascular injury, the endoscopic approach does not provide the opportunity to address and control these potential problems.

This method also depends on the availability of an appropriate ultrasound machine with the proper transducer, although these tend to be widely available.

Volume 97, Number 7

Depending on the operator’s familiarity with the equipment, the use of real-time US may require the presence of a radiologist or, as in our case, a skilled US technician. The quality of visualization is user-dependent, so the abilities of a radiologist or technician are a great advantage.

US also allows guidance in only one dimension at a time, so adjusting one’s position in three-dimensional space using US can be challenging. Lastly, because the surgeon is essentially performing an endoscopic surgery while relying solely on US for visualization, he or she must be quite skilled at endoscopy and comfortable interpreting US to use it to efficiently guide the procedure.

US could also be used intraoperatively to define the relationship between the FB and other anatomic obstacles, including vascular structures, hematoma, or abscess cavities, as well as to confirm complete removal of fragmented FBs. Because it can be difficult to determine the relationship of a migrated FB to the esophageal lumen on imaging when the esophagus is collapsed, intraoperative US performed while the esophagus is distended with an endoscope can provide information regarding the position of an FB that cannot be obtained otherwise. Therefore, we suggest consideration of real-time US-assisted endoscopy in appropriately selected cases of CT-confirmed, complicated FBS. References

1. Akazawa Y, Watanabe S, Nobukiyo S, et al. The management of possible fishbone ingestion. Auris Nasus Larynx 2004;31(4):413-16.

2. Digoy GP. Diagnosis and management of upper aerodigestive tract foreign bodies. Otolaryngol Clin North Am 2008;41(3):485-96.

3. Hsu WC, Sheen TS, Lin CD, et al. Clinical experiences of removing foreign bodies in the airway and esophagus with a rigid endoscope: A series of 3217 cases from 1970 to 1996. Otolaryngol Head Neck Surg 2000;122(3):450-4.

4. Baba S, Takizawa K, Yamada C, Monobe H. A submucosal esophageal fish bone foreign body surgically removed using intraoperative ultrasonography. Am J Otolaryngol 2014;35(2):268-70.

5. Loh KS, Tan LK, Smith JD, et al. Complications of foreign bodies in the esophagus. Otolaryngol Head Neck Surg 2000;123(5):613-16.

6. Pang KP, Tan NG, Chia KH, et al. Migrating foreign body into the common carotid artery. Otolaryngol Head Neck Surg 2005;132(4):667-8.

7. Sreetharan S, Prepageran N, Singh S. Migratory foreign body in the neck. Asian J Surg 2005;28(2):136-8.

8. Watanabe K, Amano M, Nakanome A, et al. The prolonged presence of a fish bone in the neck. Tohoku J Exper Med 2012;227(1):49-52.

9. Chen CY, Peng JP. Esophageal fish bone migration induced thyroid abscess: Case report and review of the literature. Am J Otolaryngol 2011;32(3):253-5.

10. DePietro J, Devaiah A. Endoscopic removal of esophageal foreign body and drainage of thyroid abscess. Am J Otolaryngol 2013;34(2):151-3.

www.entjournal.com 207

ORIGINAL ARTICLE

Analyzing Medicare payments to otologists T. Edward Imbery, MD; Brian D. Nicholas, MD; Parul Goyal, MD, MBA

Abstract

The study objective was to analyze Medicare payment data to otologists compared to otolaryngologists, using the publicly released Centers for Medicare and Medicaid Services dataset. Charges, payments, and common Current Procedural Terminology codes were obtained.

Otology providers were selected from the roster of the American Otological Society. Descriptive statistics and unequal variance two-tailed t tests were used for comparisons between otologists (n = 147) and otolaryngologists (n = 8,318). The mean overall submitted charge was $204,851 per otology provider and was $211,209 per other otolaryngology providers (non-otologists) (p = 0.92). The mean payment to otologists was $56,191 (range: $297 to $555,274, standard deviation [SD] ±$68,540) and significantly lower (p = 0.005) than $77,275 to otolaryngologists (range: $94 to $2,123,900, SD ±$86,423). The mean submitted charge-to-payment ratio (fee multiplier) per otology provider was 3.87 (range 1.50 to 9.10, SD ±1.70), which was significantly higher (p < 0.0001) than the ratio for otolaryngologists (mean 2.91; range: 1.25 to 17.51, SD ±1.22).

Office visit evaluation and management (E&M) codes made up the majority in terms of use and payments.

Interestingly, allergy-based services comprised a substantial amount of repeat use among a small subset of otologists. Audiology services were billed by a similar percentage of otologists and other otolaryngologists (52%), but otologists received a significantly higher overall payment for these services.

Introduction

In April 2014, the Centers for Medicare and Medicaid Services (CMS) made available its Medicare payment From the Department of Otolaryngology and Communication Sciences, SUNY Upstate Medical University, Syracuse, N.Y. (Dr. Imbery and Dr. Nicholas); and Syracuse Otolaryngology, Syracuse, N.Y. (Dr. Goyal).

Corresponding aut hor: Paru l Goya l, MD, MBA, Sy racuse Otolaryngology, 101 Richmond Ave., Ste. 320, Syracuse, NY 13204.

Email: syracuseoto@gmail.com Previous presentation: This article has been edited and updated from its previous presentation at the American Academy of Otolaryngology–Head and Neck Surgery Annual Meeting; Sept.

21-30, 2015; Dallas, Texas.

208 www.entjournal.com

data for the calendar year of 2012. This unprecedented release gave the public a wealth of previously restricted information on physician payments and services. This trend of transparency continued with the release of prescriber level Medicare Part D data in April 2015. Providers should be cognizant of this transparency and appreciate how their practice may relate to other providers in their field.

Preliminary analysis within our specialty provided interesting summary statistics, motivating further analysis and investigation.1 There has been a recent subspecialty analysis of rhinologists, providing an indepth comparison to general otolaryngologists.2 The goal of the present study was to similarly understand variations that exist within the subspecialty of otology.

By understanding the variations in the payment data, subspecialists may make meaningful comparisons of their practice with colleagues and may investigate factors contributing to these variations. Ultimately, this may lead to more efficient utilization of services.

Materials and methods

Charges, payments, and common Current Procedural Terminology (CPT) codes were extracted from the CMS dataset (www.cms.gov/Research-Statistics-Data -and-Systems/Statistics-Trends-and-Reports/Medicare-Provider-Charge-Data/Physician-and-OtherSupplier2012.html). This dataset is available for public download and contains only final-action (all claim adjustments had been resolved) physician/supplier Part B noninstitutional line items for the Medicare fee-for-service population. Other claims such as those for durable medical equipment, prosthetics, orthotics, etc., were not included. All obtained physician data are based on CMS administrative claims data for enrolled Medicare beneficiaries.

Data for all other otolaryngology providers (n = 8,318) had been obtained from previously published material.2 Otology providers were selected from the complete roster of the American Otological Society (AOS). In total, 147 unique, active otology providers were included for analysis. Providers were excluded if they did not make any Medicare claims or were research ENT-Ear, Nose & Throat Journal July 2018

Analyzing Medicare payments to otologists

members of the AOS (who do not have active clinical practices and therefore made no claims).

Extracted variables of interest included: submitted charges, payments, the ratio of submitted charges to payments (termed the fee multiplier), and the number of services performed.

Subgroup analysis was also done, investigating audiology services. Specific audiology service CPT codes (including audio and vestibular testing) were pulled from a comprehensive list made available through the American Speech-Language-Hearing Association (ASHA) model superbill for audiology practice (available at www.asha.org/uploadedFiles/ModelSuperbillAud.pdf).

Providers who submitted any one or more of these codes were included in the analysis.

Descriptive statistics were calculated and statistical analyses were performed using unequal variance twotailed t tests for non-overlapping samples with Excel software. P values <0.05 were considered significant.

Submitted charges, payments, number of services performed, and fee multipliers were compared between otologists and all otolaryngology providers.

This study was classified as having exempt status

by SUNY Upstate Medical University’s Institutional Review Board (IRB).

Results

Descriptive statistics and analyses are summarized in tables 1 through 6. Table 1 highlights the top five utilized CPT codes broken down between evaluation and management (E&M; 99XXX) and procedure-based codes;

we excluded allergy service, rehabilitation, and J codes, given their limited provider use. The top five in terms of overall payments to otologists are listed in table 2.

Table 3 highlights charge and payment statistics for otology providers. Again, overall data for otolaryngology providers (n = 8,318) had been obtained from a prior study2 and were used for comparisons. The mean submitted charge was $204,851 per otology provider compared to a mean of $211,209 for all otolaryngologists (p = 0.92). The mean payment to otologists was $56,191 (SD ±$68,540, range $297 to $555,274) compared to $77,275 for all otolaryngologists, which was significantly different (p = 0.005).

The top five codes in terms of average number of services per unique patient were 95027, 95004, 95165, 95117, and 95115, which reflected a high repeated use of allergy services, although they were used by a small number of providers. Table 4, excluding E&M, allergy service, rehabilitation, audiology, and J codes, lists the top five repeat otologic use codes per unique patient.

Table 5 lists statistics for services and fee multipliers for otology and otolaryngology providers. The mean number of services submitted by otology providers was 1,256 (SD ±2,492, range: 12 to 23,563) compared to 1,592 for otolaryngologists (SD ±2,349, range: 11 to 41,817) and this difference was not statistically significant (p = 0.09). The mean fee multiplier was 3.87 for otology providers (SD ±1.7, range: 1.5 to 9.1) compared to 2.91 for all otolaryngologists (SD ±1.22, range: 1.3 to 17.5), and this difference was significant (p < 0.0001).

Table 6 shows descriptive statistics and percentages for audiology services among otology providers and all

Table 1. Top CPT codes by overall service number* Description

Service no.

No. of providers

Avg. services per provider

Overall rank of use

E&M CPT code 99213

Office/outpatient visit, established pt.

35,057

140

250

1

99203

Office/outpatient visit, new pt.

11,612

126

92

3

99212

Office/outpatient visit, established pt.

10,842

86

126

4

99214

Office/outpatient visit, established pt.

8,843

102

87

6

99204

Office/outpatient visit, new pt.

6,183

110

56

11

69210

Remove impacted ear wax

9,108

92

99

5

92504

Ear microscopy examination

7,905

64

124

9

CPT Code

69220

Clean out mastoid cavity, simple

2,063

52

40

15

31575

Diagnostic laryngoscopy

1,517

23

66

19

31231

Diagnostic nasal endoscopy

1,074

14

77

24

*Average values rounded to nearest whole number. The CPT codes in the bottom half of the table exclude allergy service, rehabilitation, audiology, and J codes.

Key: E&M = evaluation and management; pt. = patient..

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www.entjournal.com 209

Imbery, Nicholas, Goyal

Table 2. Top five CPT codes by overall payments CPT code

Description

Total Medicare payment

99213

Office/outpatient visit, established pt.

$1,699,723

99203

Office/outpatient visit, new pt.

$826,200

99204

Office/outpatient visit, new pt.

$682,889

99214

Office/outpatient visit, established pt.

$634,390

69930

Implant cochlear device

$521,381

Table 3. Descriptive statistic summary of charges and payments* Number of providers

Average charge ± SD

Minimum charge

Maximum charge

Average payment ± SD

Minimum payment

Maximum payment

Otology

147

$204,851 ± $261,652

$648

$2,168,251

$56,190 ± $68,539

$297

$555,274

Otolaryngology

8,318

$211,209 ± $754,422

$590

$4,526,452

$77,275 ± $86,423

$94

$2,123,900

* Indicates a significant difference in average payments (p < 0.05) between otologists and otolaryngologists.

other otolaryngologists. Seventy-six otology providers (52%) billed for audiology services, with total payments ranging from $147.48 to $131,390.87 (mean: $12,216.87; median: $2,782.85, SD ±$20,749.59). This comprised a range of 0.33 to 56.10% of their overall received payments (mean: 13.02%, SD ±13.09%).

For all other otolaryngology providers, there were 4,329 providers (52%) who billed for audiology services. Total payments ranged $36.38 to $129,362.10 (mean: $5,560.51; median: $2,844.64, SD ±$8,956.98). This comprised a range of 0.02 to 100% of their overall payments received (mean: 6.02%, SD ±4.63%). Removing the three outliers who had 100% of their payments consisting of audiology services, the next highest was 80.61%, and their exclusion did not affect the overall mean or SD. The difference between mean total payment and percentage of received payments between the two groups were both significant (p < 0.0001).

Discussion

We have analyzed the CMS data for a subset of otology providers and provided comparisons with data for all otolaryngologists. Prior analysis of this dataset has been done for rhinologists,2 but to our knowledge, this was the first in-depth analysis for otologists.

With the CMS data widely available, providers who are outliers are coming under more scrutiny. Having data available for subspecialty groups allows providers to make comparisons with their colleagues and accurately assess their relation to the national averages. In other surgical specialties, similar research has been published.3 210 www.entjournal.com

Some interesting trends were noted in our study.

While average charge and services performed were similar between otologists and all otolaryngologists, average payments to otologists were statistically lower compared to all otolaryngologists.

A study analyzing Medicare payments to otolaryngologists within one geographic area may provide some insight into this difference.4 In that study, there were large differences in total Medicare payments to practitioners within three area academic groups. Those with the highest revenues performed a greater number of endoscopic office procedures which, among our otology providers, was not reflected highly in overall numbers of use, ranking 24th. The authors did point out, however, that payment differences were not directly related to provider subspecialty. Our noted difference may reflect the larger provider sample included in this study.

As expected, E&M codes made up the majority in terms of use and overall charges and payments. Interestingly, allergy-based services comprised a substantial amount of overall as well as repeat use among a small subset of 9 otologists, and code 95165 (antigen therapy services) ranked in the top five in terms of overall service count. Further analysis revealed these providers to be predominantly within one private group, which would argue against a growing trend of expanding allergy practices among subspecialty providers.

Analysis of audiology services revealed notable differences. While a similar percentage of providers were submitting audiology codes (52%), the otologists had significantly higher mean total payments ENT-Ear, Nose & Throat Journal July 2018

Analyzing Medicare payments to otologists

Table 4. The top five repeated otologic procedure codes per unique patient* CPT code Description

Average no. services

No. providers

Overall rank

69801

Incise inner ear

1.72

20

22

69220

Clean out mastoid cavity, simple

1.62

52

23

92504

Ear microscopy exam

1.37

62

29

69222

Clean out mastoid cavity, complex

1.35

2

30

69210

Remove impacted ear wax

1.20

92

39

*E&M, allergy service, rehabilitation, audiology, and J codes excluded.

Table 5. Summary of fee multipliers by provider for all otolaryngology providers and otologists Otolaryngology

Otology

Fee multiplier

Services

Fee multiplier

Services

Mean

2.91

1,592

3.87*

1,256

Minimum

1.25

11

1.50

12

Maximum

17.51

41,817

9.10

21,563

SD

1.22

2,349

1.70

2,492

*Indicates a significant difference in the fee multiplier (p < 0.05) between otologists and otolaryngologists.

Key: SD = standard deviation.

Table 6. Summary of audiology code payments and percentages between otologists and otolaryngologists (payments rounded to nearest dollar) Otolaryngology

Otology

Audiology payment

% Overall payment

Audiology payment

% Overall payment

Mean

$5,561

6.02

$12,217*

13.02*

Minimum

$36

0.02

$147

0.33

Maximum

$129,362

100

†

$131.391

56.10

SD

$8,957

4.63

$20,750

13.09

*Indicates a significant difference in mean payment and overall percentage of payments between otologists and otolaryngologists (p < 0.001). †Indicates there were 3 providers who had audiology payments that comprised their total payments.

Key: SD = standard deviation.

for these services, and these payments represented a significantly higher overall percentage of their total Medicare payments. It was determined that the higher payments were a result of more frequent use of these codes, as opposed to higher payments per code for otologists.

These findings are not surprising given the higher expected volume of associated audiology visits in an otology practice. It might be expected that a larger percentage of otology providers would submit audiology codes, but this is likely a reflection of various billing systems and different methods of practice organization among providers. For audiologists to bill Medicare claims independently, they must have an enrolled National Provider Identifier (NPI) number.

Volume 97, Number 7

The large CMS dataset allows for statistically meaningful and well-powered analysis, although this is not without limitation. The data are limited to Medicare payments, which will represent varying proportions of a provider’s practice model, and we are unable to further determine what these proportions might be from the dataset.

Using the AOS roster to extract our otology group did result in a bias of academic practitioners compared to private ones. The society membership requirements also will inherently lean toward more established otologists, thus leaving out more junior practicing otologists from analysis. Using other tools for defining a provider within the subspecialty of otology (e.g., the AAO–HNS roster) would have resulted in a far less specific, if more inclusive, cohort. Given the large number of otologists www.entjournal.com 211

Imbery, Nicholas, Goyal

STAPES SURGERY IN PATIENTS WITH A SMALL AIR-BONE GAP

Continued from page 200

ultimately included in our study, we believe that this allows for meaningful analysis.

Another potential limitation to the study was the inability to analyze differences in patient characteristics and disease complexity among different physicians’ practices.

These factors may certainly impact the frequency with which relevant services are performed.

Medicare payments to physicians are just one part of healthcare spending, and the results here should not be overstated. There are ultimately many factors that affect the services rendered and the fee schedules that providers set. There is a push to help stimulate discussion about changes in our healthcare delivery and move to a more value-based system. Variation within a specific specialty and within the field of otolaryngology has been the topic of significant study.5-9 With the release of these payment data, there has been a significant amount of media attention with respect to providers found to be outliers. The Medicare dataset does not account for subspecialty variation in practice, billing, and reimbursement patterns because all otolaryngologists are reported under the same specialty category. The goal of this type of analysis is to contextualize the data for subspecialty physicians.

In summary, this study highlights that Medicare charges for otologists are comparable to those for otolaryngologists as a whole, while payments to otologists are slightly lower than to all otolaryngologists. Office-based E&M codes account for the highest service count and aggregate payments to otologists.

References

1. Bhattacharyya N, Lin HW. Characteristics of otolaryngology claims to Medicare in 2012. Otolaryngol Head Neck Surg 2014;151(5):802-4.

2. Clair B, Goyal P. What does Medicare pay rhinologists? An analysis of Medicare payment data. Int Forum Allergy Rhinol 2015;5(6):481-6.

3. Ko JS, Chalfin H, Trock BJ, et al. Variability in Medicare utilization and payment among urologists. Urology 2015;85(5):1045-50.

4. Cracchiolo J, Ridge JA, Egleston B, Lango M. Practice arrangement and Medicare physician payment in otolaryngology. Otolaryngol Head Neck Surg 2015;152(6):979-87.

5. Krouse JH. Variation, cost, and the quality of care. Otolaryngol Head Neck Surg 2015;152(6):975-6.

6. Gawande A. “Overkill.” The New Yorker. www.newyorker.com/ magazine/2015/05/11/overkill-atul-gawande. Lat accessed April 6, 2018.

7. Gourin CG. Do geographic variations signify overuse?

Otolaryngol Head Neck Surg 2015;152(6):991-2.

8. Sun GH. From tonsils to scopes: 80 years of variation in the practice of otolaryngology. Otolaryngol Head Neck Surg 2015;152(6):988-90.

9. Venkatraman G, Likosky DS, Morrison D, et al. Small area variation in endoscopic sinus surgery rates among the Medicare population. Arch Otolaryngol Head Neck Surg 2011;137(3):253-7.

212 www.entjournal.com

4. Schuknecht HF, Barber W. Histologic variants in otosclerosis.

Laryngoscope 1985;95(11):1307-17.

5. De Seta E, Rispoli G, Balsamo G, et al. Indication for surgery in otosclerotic patients with unilateral hearing loss. Otol Neurotol 2009;30(8):1116-21.

6. Wiet RJ, Raslan W, Shambaugh GE Jr. Otosclerosis 1981 to 1985: Our four-year review and current perspective. Am J Otol 1986;7(3):221-8.

7. The American Academy of Otolaryngology–Head and Neck Surgery Foundation Position statement: Management of Otosclerosis 2014. www.entnet.org/content/management-oto-sclerosis. Accessed May 6, 2018.

8. Salmon C, Barriat S, Demanez L, et al. Audiometric results after stapedotomy operations in patients with otosclerosis and preoperative small air-bone gaps. Audiol Neurotol 2015;20(5):330-6.

9. Salvinelli F, Casale M, Peco VD, et al. Stapedoplasty in patients with small air-bone gap: Why not? Med Hypotheses 2003;60(4):535-7.

10. Lippy WH, Burkey JM, Schuring AG, Rizer FM. Stapedectomy in patients with small air-bone gaps. Laryngoscope 1997;107(7):919-22.

11. Lavy JA, Powell HR. Stapes surgery under local anaesthesia. Ann R Coll Surg Engl 2013;95(1):37-9.

12. Jacob V, Alexander P, Nalinesha KM, Nayar RC. Can Rinne’s test quantify hearing loss? Ear Nose Throat J 1993;72(2):152-3.

13. Gordon MA, Silverstein H, Willcox TO, Rosenberg SI. A reevaluation of the 512-Hz Rhinne tuning fork test as a patient selection criterion for laser stapedotomy. Am J Otol 1998;19(6):712-17.

14. Carhart R. The clinical application of bone conduction audiometry. Trans Am Acad Ophthalmol Otolaryngol 1950;54:699-707.

15. Wegner I, Bittermann AJ, Hentschel MA, et al. Pure-tone audiometry in otosclerosis: Insufficient evidence for the diagnostic value of the Carhart notch. Otolaryngol Head Neck Surg 2013;149(4):528-32.

16. Babighian G, Fontana M, Caltran S, et al. The heat-activated stapes prosthesis ‘SMart’ Piston: Technique and preliminary results. Adv Otorhinolaryngol 2007;65:190-96.

17. Harris JP, Gong S. Comparison of hearing results of nitinol SMART stapes piston prosthesis with conventional piston prostheses: Postoperative results of nitinol stapes prosthesis. Otol Neurotol 2007;28(5):692-5.

18. Hornung JA, Brase C, Bozzato A, et al. Retrospective analysis of the results of implanting Nitinol pistons with heat-crimping piston loops in stapes surgery. Eur Arch Otorhinolaryngol 2010;267(1):27-34.

19. Van Rompaey V, Claes G, Potvin J, et al. Systematic review of the literature on nitinol prosthesis in surgery for otosclerosis: Assessment of the adequacy of statistical power. Otol Neurotol 2011;32(3):357-66.

20. Wegner I, Kamalski DM, Tange RA, et al. Laser versus conventional fenestration in stapedotomy for otosclerosis: A systematic review. Laryngoscope 2014;124(7):1687-93.

21. Kamalski DM, Wegner I, Tange RA, et al. Outcomes of different laser types in laser-assisted stapedotomy: A systematic review.

Otol Neurotol 2014;35(6):1046-51/ 22. Lancer H, Manickavasagam J, Zaman A, Lancer J. Stapes surgery: A national survey of British otologists. Eur Arch Otorhinolaryngol 2016;273(2):371-9.

ENT-Ear, Nose & Throat Journal July 2018

ORIGINAL ARTICLE

Late free flap failure in head and neck reconstruction: A systematic review David Forner, MD; Blair A. Williams, MSc, MD, FRCS(C); Fawaz M. Makki, MSc, MD, FRCS(C); Jonathan R.B. Trites, MD, FRCS(C); S. Mark Taylor, MD, FRCS(C); Robert D. Hart, MD, FRCS(C) Abstract

Our objectives were to review all reported cases of late flap failure in head and neck surgery and describe any relevant patterns. We conducted a systematic review of all published cases of free flap failure after postoperative day 7 in head and neck surgery from January 1990 to January 2018. Data were collected with respect to flap type, site of reconstruction, reason for failure, and time to failure. A total of 45 cases of late free flap failure in the head and neck were identified. Among the 34 cases in which the necessary data were available for analysis, 50% of late failures occurred between postoperative day 7 and 14. Common reasons for failure were abscess and vascular compromise. We conclude that most late flap failures occur in the second postoperative week. In patients with risk factors for flap failure, close monitoring for up to 14 days after surgery could detect flap compromise before the flap is lost.

Introduction

Free flap reconstruction is a cornerstone in the management of many head and neck cancers. Free flaps were first described in head and neck reconstruction in 1959, but flaps were not a standard of care until the 1980s.1,2 One of the major postoperative complications in these surgeries is total flap necrosis, which leads to an unfavorable functional and cosmetic outcome and may require revision surgery.

Most flap failures occur within the first 48 hours postoperatively.3 The primary cause of flap loss is thrombosis in the vascular pedicle, with venous being more common than arterial thrombosis. Failure is uncommon, however, and the success rates of free flaps range from 94 to 99% in most large series.4,5 In the time immediately after free tissue transfer, the flap depends solely on microvascular anastomosis of the pedicle vessels to the recipient vessels for its From the Department of Surgery, Division of Otolaryngology–Head and Neck Surgery, Dalhousie University, Halifax, NS, Canada.

Corresponding author: Robert Hart, MD, FRCS(C), ENT Clinic, 3rd Floor Dickson Building, 5820 University Ave., Halifax, NS B3H 1V7 Canada. Email: drrobhart@gmail.com Volume 97, Number 7

blood supply. Over time, neovascularization from the recipient bed becomes sufficient to provide the flap with its blood supply. The period of time at which it is safe to divide the primary vascular pedicle ranges from postoperative day (POD) 7 to 21, depending on the type of flap and site of reconstruction.6,7 First signs of neovascularization between the flap and the recipient bed occur as early as POD 4, with a visible vascular channel present at POD 7.8,9 Loss of a flap after POD 7 is rare because of the decreased reliance of the flap on the pedicle vessels. There are few reported cases of late flap failure, and even fewer studies that have focused exclusively on the etiology of flap failure after POD 7 in head and neck surgery.

Materials and methods

A review of all published cases of late flap failures in head and neck reconstruction with free flap was conducted using the PubMed MeSH terms “head and neck neoplasms”[MeSH] AND “surgical flaps”[MeSH] AND “postoperative complications”[MeSH]). The limits used were “English” and “humans.” This study reviewed all articles published from January 1990 to January 2018. All included articles had their citations reviewed for any additional relevant cases.

All reports that described a free flap failure in head and neck reconstruction after POD 7 were included.

Exclusion criteria were reports of flaps that failed on or before POD 7, free flaps used in the reconstruction of areas other than the head and neck, subtotal flap failure, pedicle flaps, and visceral free flaps. Data collected included type of flap used, cause of failure, and at which POD the failure was noted. All cases matching the inclusion criteria were reported, regardless of whether all data were available.

Results

The literature review yielded 1,083 articles, in which 45 cases of flap failure after POD 7 were published (table 1). Most of these articles discussed the failures as part of larger studies of complications. Only two www.entjournal.com 213

Forner, Williams, Makki, Trites, Taylor, Hart

Table 1. A summary of all reported cases of late (after POD 7) free flap failure in head and neck reconstruction between 1990 and 2018 No. Cases Flap type

Author

2

Yoshimoto et al15

Site of reconstruction

Suspected cause of failure

POD

History of XRT

Scapula

Floor of mouth

Rectus abdominis

External ear

Infection

8

No

Arterial thrombosis

9

No

Nuara et al16

1

Fibula

Mandible and tongue

Embolic phenomenon

28

Yes

Yu et al12

6

NA

NA

Infection, unrecognized vascular event

>7

NA

Lim et al17

1

Lateral arm

Oral cavity

Venous thrombosis

13

NA

Yu et al18

1

Anterolateral thigh

Hypopharynx

NA

21

Yes

Dhawan et al19

1

Radial forearm

Tongue

Infection

10

No

Poeschl et al

20

1

Radial forearm

Oral cavity

Arterial thrombosis

10

Yes

Salgado et al10

1

Fibula

Floor of mouth, mandible Arterial thrombosis

42

Yes

Stark and Nathanson

1

Radial forearm

Laryngohypopharynx

NA

21

Yes

21

Miller et al

1

Fibula

Mandible

Infection

10

NA

Coleman and Wooden23

1

Fibula

Mandible

Fistula, abscess

14

No

Fig et al

1

Scapula

Mandible

Fistula, thrombosis

10

NA

13

Radial forearm (6)*

NA

Unknown, pressure

7-14

NA

Abscess/infection

14-30

NA

Tumor recurrence

>30

NA

ORN

11

Yes

22

24

Wax and Rosenthal

11

Rectus abdominis (2)* Fibula(4)* Latissimus dorsi (1)* 4

Klosterman et al25

Fibula (3)*

NA NA

ORN

18

Yes

NA

Venous thrombosis

28

NA

Scapula (1)*

NA

Venous thrombosis

11

NA

Jeremić and Nikolić

1

Radial forearm

Oral cavity

NA

10

NA

Revenaugh et al27

1

Anterolateral thigh

Mandible

Thrombosis

14

Yes

Zender et al28

2

Fibula

Mandible

NA

>7

NA

Weaver et al29

3

Osteocutaneous NOS

NA

NA

>8

NA

Clohessy et al30

1

Radial forearm

Floor of mouth

NA

10 mo

Yes

Mendoza et al

1

Anterolateral thigh

Oral cavity

Fistula

29

No

1

Anterolateral thigh

Mandible

NA

14

Yes

26

31

Devine et al32

*Numbers in parentheses represent specific flap numbers.

Key: POD = postoperative day; NA = information not available in original study for accurate analysis; XRT = radiation therapy; ORN = osteoradionecrosis; NOS = not otherwise specified.

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ENT-Ear, Nose & Throat Journal July 2018

Late free flap failure in head and neck reconstruction: A systematic review

articles focused on free flap failure after POD 7;10,11 only one of these two solely discussed free flap failure in head and neck reconstruction.11 This article contained inconsistency in categories of time to flap failure between the results and discussion sections of the report. For review, the numbers from the results section were assumed to be correct.

A total of 34 cases were reported that had sufficient data for analysis of time to failure (table 2). Of these cases, 50% of failures occurred between POD 7 and 14, 29% between POD 15 and 30, and 21% after POD 30.

Discussion

Late free flap failure is uncommon, due in part to the risk of pedicle compromise being offset by neovascularization of the flap after POD 7. As evidence, only 45 cases of free flaps failing after POD 7 in the head and neck have been reported (table 1). As stated earlier, most of these failures are mentioned as part of larger studies of complications, and only one article,

by Wax and Rosenthal, specifically discusses late flap failure in the head and neck.11 Wax and Rosenthal examined 1,530 free flap cases to determine the incidence and etiology of late flap failure.11 Thirteen cases of flap necrosis after POD 7 were identified, with a median time to failure of 20 days and with the latest flap failure occurring at POD 90. In the “Results” section of the published study, documented late flap failures were divided into three general categories: failure between POD 7 and 14, between POD 14 and 30, and after POD 30. The authors report that pressure-related causes are more common in the first category, infection and abscess in the second, and tumor recurrence in the third.

As mentioned above, there was inconsistency in the reported times to failure, as the categories outlined in the discussion were different from those in the results: within the first 2 weeks, after 1 month, and after 3 months.11 Wax and Rosenthal also describe the lack of studies that focused on late flap failure but do not provide a review of the available literature. The timing of failure for individual cases was not included in their report.

Table 2. Summary of the time frame of flap failures using the intervals defined by Wax and Rosenthal11* Days to flap failure

No. of cases

7 to 14

17 (50%)

15 to 30

10 (29%)

>30

7 (21%)

Total

34

were excluded from this summary because *Three studies the exact timing of flap failure was not reported.

12,28,29

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The remaining studies outlined in table 1 are cases that, for the most part, are listed complications in large retrospective studies of free flaps, or are individual case reports. The six cases documented by Yu et al did not include the exact time of flap necrosis, but simply that it was after POD 7.12 In analyzing the remaining cases, 50% of cases of late flap failure occurred between POD 7 and 14, with the remaining flaps split almost equally between failure at 15 to 30 days after surgery and failure later than POD 30 (table 2). No pattern in the type of flap or in the site of reconstruction was observable.

The timing of failure 7 to 14 days postoperatively may be attributable to delayed neovascularization. If the new vessels from the recipient bed are delayed in formation and insufficient to fully meet the requirements of the flap, then a vascular thrombosis will lead to flap necrosis. Neovascularization is believed to be impaired by previous irradiation to the recipient site, which has been demonstrated in animal models.13,14 As is shown in table 1, a number of late flap failures occurred in patients who had a history of radiation therapy. Although this information was not always available in the reviewed articles, it is interesting that nearly all failures occurring beyond 2 weeks postoperatively had received prior radiation. This discovery supports the assertion that blood supply to the flap may remain tenuous long after surgery with a history of radiation therapy. Flap viability can also be affected by such factors as hypertension, diabetes mellitus, and peripheral vascular disease.10 Unfortunately, information on comorbidities was generally unavailable in the reviewed reports.

Conclusion

Late free flap failure represents an uncommon and seemingly unpredictable complication in head and neck reconstruction. To the best of our knowledge, this report is the first comprehensive literature review of the reported cases of late flap failure in the head and neck. Given the paucity of reported cases of late free flap failure in the literature, generalization about the phenomenon is difficult. One pattern that emerges from the limited cases reported in larger studies is that the largest number of late failures occurs in the second postoperative week.

An inexpensive approach to early recognition of these cases could involve aggressive patient education regarding signs of flap failure. Monitoring patients with earlier and more frequent follow-up in the postoperative period when they have a history of radiation to the recipient bed may be reasonable. The role of preoperative radiation and significant comorbidities such as hypertension, diabetes, and peripheral vascular disease warrant further study in late flap failure. www.entjournal.com 215

Forner, Williams, Makki, Trites, Taylor, Hart

References

1. Seidenberg B, Rosenak SS, Hurwitt ES, Som ML. Immediate reconstruction of the cervical esophagus by a revascularized isolated jejunal segment. Ann Surg 1959;149(2):162-71.

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7. McGregor IA, Jackson IT. The groin flap. Br J Plast Surg 1972;25(1):3-16.

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12. Yu P, Chang DW, Miller MJ, et al. Analysis of 49 cases of flap compromise in 1310 free flaps for head and neck reconstruction.

Head Neck 2009;31(1):45-51.

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14. Schultze-Mosgau S, Rödel F, Radespiel-Tröger M, et al.

Vascularization of the area between free grafts and irradiated graft beds in the neck in rats. Br J Oral Maxillofac Surg 2002;40(1):37-44.

15. Yoshimoto S, Kawabata K, Mitani H. Analysis of 59 cases with free flap thrombosis after reconstructive surgery for head and neck cancer. Auris Nasus Larynx 2010;37(2):205-11.

16. Nuara MJ, Sauder CL, Alam DS. Prospective analysis of outcomes and complications of 300 consecutive microvascular reconstructions. Arch Facial Plast Surg 2009;11(4):235-9.

17. Lim CM, Lim J, Loh KS, Tan LK. Early experience in free tissue transfer in the reconstruction of head and neck defects. Singapore Med J 2007;48(7):652-5.

18. Yu P, Lewin JS, Reece GP, Robb GL. Comparison of clinical and functional outcomes and hospital costs following pharyngoesophageal reconstruction with the anterolateral thigh free flap versus the jejunal flap. Plast Reconstr Surg 2006;117(3):968-74.

19. Dhawan B, Bonnet R, Shukla NK, et al. Infection with an extended-spectrum beta-lactamase-producing strain of Serratia marcescens following tongue reconstruction. J Clin Microbiol 2003;41(5):2233-4.

20. Poeschl PW, Kermer C, Wagner A, et al. The radial free forearm flap—prelaminated versus non-prelaminated: A comparison of two methods. Int J Oral Maxillofac Surg 2003;32(2):159-66.

21. Stark B, Nathanson A. The free radical forearm flap: A reliable method for reconstruction of the laryngohypopharynx after incontinuity resection. Acta Otolaryngol 1998;118(3):419-22.

22. Miller MJ, Schusterman MA, Reece GP, Kroll SS. Interposition vein grafting in head and neck reconstructive microsurgery. J Reconstr Microsurg 1993;9(3):245-51; discussion 251-2.

23. Coleman JJ 3rd, Wooden WA. Mandibular reconstruction with composite microvascular tissue transfer. Am J Surg 1990;160(4):390-5.

24. Fig LM, Shulkin BL, Sullivan MJ, et al. Utility of emission tomography in evaluation of mandibular bone grafts. Arch Otolaryngol Head Neck Surg 1990;116(2):191-6.

25. Klosterman T, Siu E, Tatum S. Free flap reconstruction experience and outcomes at a low-volume institution over 20 years.

Otolaryngol Head Neck Surg 2015;152(5):832-7.

26. Jeremić JV, Nikolić ŽS. Versatility of radial forearm free flap for intraoral reconstruction. Srp Arh Celok Lek 2015;143(56):256-60.

27. Revenaugh PC, Haffey TM, Seth R, Fritz MA. Anterolateral thigh adipofascial flap in mucosal reconstruction. JAMA Facial Plast Surg 2014;16(6):395-9.

28. Zender CA, Mehta V, Pittman AL, Feustel PJ, Jaber JJ. Etiologic causes of late osteocutaneous free flap failures in oral cavity cancer reconstruction. Laryngoscope 2012;122(7):1474-9.

29. Weaver TS, Wester JL, Gleysteen JP, Peck JJ, Wax MK. Surgical outcomes in the elderly patient after osteocutaneous free flap transfer. Laryngoscope 2014;124(11):2484-8.

30. Clohessy J, Harding B, Shah D, Mehanna P. Delayed free flap failure: A case presentation and discussion. Oral and Maxillofacial Surgery 2017;46(Suppl. 1):177-8.

31. Mendoza DJC, Nieves CS, Castaneda SS. Late-onset anterolateral thigh free flap failure in buccal carcinoma reconstruction.

Philippine Journal of Otolaryngology Head and Neck Surgery 2017;32(2):47-50.

32. Devine CM, Haffey TM, Trosman S, Fritz MA. Short-stay hospital admission after free tissue transfer for head and neck reconstruction. Laryngoscope 2016;126(12):2679-83.

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