2018 ASSEMBLY...113th Congress (2013 – 2015) From 2013‐2015 there were 21 physicians in U.S.Congress, 20 of whom were male and 17 were members of the Republican party. 114th Congress

This continuing medical education activity is jointly provided by the North Carolina Society of Otolaryngology and Head & Neck Surgery and

Southern Regional Area Health Education Center.

July 20-22, 2018 | Omni Grove Park Inn Resort | Asheville, NC

2018 ASSEMBLY

SATURDAY HANDOUTS

North Carolina/South CarolinaOtolaryngology and Head & Neck Surgery

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Advocacy for Patient Care

Representative Gregory F. Murphy, MD, FACS

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NC House NC Senate

NC Governor

Overview of Political Structure

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Legislative Executive

Judicial4

The Political Process• NC Bicameral Legislature—Senate (50) and House of

Representatives (120) with Gov as Executive Branch• Many types of Individuals Represented (retirees, lawyers,

businessmen, bail bondsmen, educators, one Nurse Practitioner and one Physician)--paid $13,900/year, $104 per diem

• Each w own district—elected/appointed by Gov• Each serve 2 year terms• 1st year—”Long Session” / 2nd Yr “Short session”• Committee Assignments (Health (Chair), Health

Appropriations (Chair), Ethics, Insurance, Appropriations, Education (Universities), Alcoholic Beverage Commission

• Typical Day 7am-8pm when in session…

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How are laws made?

• Issue brought up by constituent, business group, society (NCMS), environmental group, state gov agency, anyone

• Bill drafted with assistance of Staff Attorneys and then submitted to the Speaker of the House

• Assignment of Bills…Very Important…o If viewed favorably by leadership, good assignmento If not viewed favorably, often sent to the Rules Committee where

bills usually die

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Historical Political Involvement by Physicians

*In 1776, 11 percent of signers of the Declaration of Independence were physicians.

*In 1787 5 percent of the individuals crafting the US Constitution were physicians.

113th Congress (2013 – 2015)From 2013‐2015 there were 21 physicians in U.S.Congress, 20 of whom were male and 17 were members of the Republican party.

114th Congress (2015 – 2017)From 2015‐2017, there were 18 physicians in U.S. Congress. All were male and 15 were members of the Republican party. (38% Lawyers)

115th Congress (2017 – 2019)From 2017‐2019 there were 15 physicians in U.S. Congress, all were male and 13 were members of the Republican party. (3% Physicians)

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Physicians Vote less than 1/3rd

of the time

Less than Attorneys, Farmers or the General Public

How physicians are viewed

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It is ALL about Relationships….

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What is an Advocate?

A person who speaks, writes or intercedes on behalf of a particular person, cause, policy or institution

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Population 10,600,000 (9th most populous state, 5th fastest growth rate)

15 Electoral Votes (2010)

Swing State

Voted Republican 9 out of last 10 Presidential Elections

Legislature Republican (Both Chambers), Governor‐‐Democratic

North Carolina

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The Political Process• NC Bicameral Legislature—Senate (50) and House of

Representatives (120) with Gov as Executive Branch• Many types of Individuals Represented (retirees,

lawyers, businessmen, bail bondsmen, educators, one Nurse Practitioner and one Physician)--paid $13,900/year, $104 per diem

• Each w own district—elected/appointed by Gov• Each serve 2 year terms• 1st year—”Long Session” / 2nd Yr “Short session”• Committee Assignments (Health (Chair), Health

Appropriations (Chair), Ethics, Insurance, Appropriations, Education (Universities), Alcoholic Beverage Commission

• Typical Day 7am-8pm when in session…

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CAMPAIGNING

Raising Money….

Knocking Doors…not easy…

Away from Practice and Family…

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The Work begins:

Still practice full time

*See patients/OR from 7a‐2p Monday*Raleigh Monday night til Thursday at 2pm*Thursday Evening clinic, All day Friday, Saturday Am Clinics

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Average Day in the General Assembly…..Very busy…..

Committee Meetings/Caucus

Session

Constituents

Lobbyists

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Rules…lots of them….Political Life MUCH different than Medical Life

• Campaign Contributions

• Campaign Expenditures

• Personal Involvements• Financial• Relationships

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North Carolina Senate Bill 332011

Caps on noneconomic damageSB 33 caps compensation for noneconomic damages at $500,000. “Noneconomic damages” refers to compensation for pain, suffering, personal loss, professional loss or anything else that cannot be defined monetarily.

Immunity for emergency personnelIn addition to the cap, SB 33 gave extra protection to emergency personnel by putting tougher standards to prove medical malpractice in an emergency situation. Plaintiffs must prove “gross negligence” when pursuing a malpractice case classified as an emergency. 23

North Carolina Senate Bill 332011

Almost didn’t happen:Although passed in Senate and then in House BUT—Vetoed by Governor Bev Perdue

NCMS and other Stakeholders went into actionurging physicians to visit their legislators and made their voices heard one on one

Veto Overridden!!! 74‐42

Physician Advocacy Works!!!!!

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How did we get here?

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Gender: n % Age: n %

Male 330 66% <15 8 2%

Female 170 34% 15‐24 80 16%

25‐34 205 41%

35‐44 99 20%

Race: n % 45‐54 45 9%

White 435 87% 55‐64 38 8%

Black 39 8% 65+ 25 5%

Other 21 4%

Missing 5 1%

Note: Counts based on diagnosis (ICD‐9/10‐CM code) of an opioid overdose of any intent (accidental, intentional, assault, and undetermined) for North Carolina residents. Opioid overdose cases include poisonings with opium, heroin, opioids, methadone, and other synthetic narcotics.

Opioid Overdose Emergency Department Visits: North Carolina, July 2017

NORTH CAROLINA INJURY AND VIOLENCE PREVENTION www.injuryfreenc.ncdhhs.gov 8/17/2017

Source: NC DETECT: ED; Syndrome: Overdose: Opioid Overdose (ICD-9/10-CM)

500 Compared to

Opioid overdose ED visits: July 2017

July 2016410

The heat map shows the highest concentration of cases in

Mecklenburg, Guilford, Cabarrus, Cumberland, and

Buncombe counties. With the highest rates occurring in

Cabarrus (72.3 per 100,000 person) and Vance (20.3 per

100,000 person) counties.

Cases were predominantly male (66%), white (87%), and

between 25‐34 years of age (41%).

Gender: n % Age: n %

Male 330 66% <15 8 2%

Female 170 34% 15‐24 80 16%

25‐34 205 41%

35‐44 99 20%

Race: n % 45‐54 45 9%

White 435 87% 55‐64 38 8%

Black 39 8% 65+ 25 5%

Other 21 4%

Missing 5 1%

Note: Counts based on diagnosis (ICD‐9/10‐CM code) of an opioid overdose of any intent (accidental, intentional, assault, and undetermined) for North Carolina residents. Opioid overdose cases include poisonings with opium, heroin, opioids, methadone, and other synthetic narcotics.

Opioid Overdose Emergency Department Visits: North Carolina, July 2017

NORTH CAROLINA INJURY AND VIOLENCE PREVENTION www.injuryfreenc.ncdhhs.gov 8/17/2017

Source: NC DETECT: ED; Syndrome: Overdose: Opioid Overdose (ICD-9/10-CM)

500 Compared to

Opioid overdose ED visits: July 2017

July 2016410

The heat map shows the highest concentration of cases in

Mecklenburg, Guilford, Cabarrus, Cumberland, and

Buncombe counties. With the highest rates occurring in

Cabarrus (72.3 per 100,000 person) and Vance (20.3 per

100,000 person) counties.

Cases were predominantly male (66%), white (87%), and

between 25‐34 years of age (41%).

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Physician Leadership in Legislation

House Bill 243

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NC House Bill 243 “STOP ACT” Initial Draft

Initial restriction of 3 day script for Opioids*Would have been exceedingly bothersome for MD’s*Subsequently changed to 5 day restriction for Acute Pain*Post Op pain to 7 days

Required Queries of Controlled Substance Reporting System (CSRS) with each Narcotic prescription to check patients history

*Must document in EHR*Had to explain what limitations EHR’s have*Allow paper script to be used at times

Attorney General wanted to fine MD’s $250 for each instance *CSRS not queried*Changed language to reporting to NCMB—no fine

Initially a yearly fee of $50 per doc to keep CSRS going*Negotiated that down to $0

Written by Attorney General and his staff‐‐‐Very Unfavorable to Doctors

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Initial prescription limits for ACUTE PAINCSRS Queries with each prescriptionE‐scribing of OpioidsCloser consultation with NP’s/PA’s/MD’s at Pain ClinicsBetter defined disposal of Prescribed Opioids (Hospice)Standing Order for NaloxonePharmacy Reporting with CSRS and regulationsMandatory yearly review of CSRS$10M State/$20M Fed monies for Community BasedTreatment

‘STOP ACT’ SUMMARY

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HB 243 Signed into Law

Politics the way it is supposed to work…

First step in many ahead to combat the Opioid Crisis…

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The HOPE ACT

2nd Chapter

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Playing Defense…

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Bill to allow Optometrists to perform Laser Surgery in their Offices

Optometrists hired $750K worth of Lobbyists

Would have had profound implications if passed

As a Chair able to get it blocked completely and turned into a ‘study bill’, then died in Senate….

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Scope of Practice IssuesHB 88

HB 88 seeks to allow NP’s, CRNA’s and Midwives to practice without supervision.

Would fundamentally change the way Health Care is delivered in NC

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Defense: Motor Cycle Helmet Law

Would have allowed persons 21 years and older to no longer be required to wear helmets

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Chiropractors vs Physical Therapists

Acupuncturists vs Physical Therapists

Dentists vs Dental Hygenists

Anesthesiologists vs Nurse Anesthetists

OB’s vs Midwives

Family Practitioner’s vs Nurse Practitioners

Professional Land Grabs

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Chiropractors file to be able to performSports Physicals

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Future Legislative Issuesfor North Carolina

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Carolina Cares HB 662

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Key ComponentsAlternative to Medicaid ExpansionHealth Insurance for the State’s Working PoorParticipant’s required to do health maintenance

activities AND a Work RequirementPaid for by Fed return of monies to state and tax

on Hospitals (2:1 return)Participant Contributions2% of household’s income

Carolina Cares HB 662

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Certificate of Need Laws

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What does the future of Medicine look like?

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Get to know your Legislator…

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We are all busy

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• Be Respectful‐‐‐of their position, their time• Know your issue‐‐‐be prepared for Questions• Introduce yourself and your issue• Know your opposition• Succinct literature• Do not be argumentative or try to back them into a corner• Do not interrupt, take notes or be arrogant• Be kind to their staff….

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The Bottom Line…..

#1 Comment when Controversial Medical issue comes up

“I never hear from doctors unless they want something”

You have to get to know your Legislator and you MUST Contribute to their campaigns.

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1

The Role of Sinus Cultures in Children with Blood or Bone Marrow

Transplants

Anatoli F. Karas MD, Marisa A. Ryan MD MPH, Vaibhav H. Ramprasad MD, C. Scott Brown MD, Rose J. Eapen MD, Eileen M. Raynor MD

Duke University Medical Center, Durham, NC

HNSCS Alumni/Graduation WeekendJune 23rd, 2017

Disclosures

• None

Case Presentation

• 18 mo with SCID, preparing for 2nd bone marrow transplantation

• Referred to Otolaryngology for “opacification of sinuses noted on CT”

• Symptoms: nasal congestion, clear rhinorrhea

• Nasal endoscopy: “there were clear secretions noted. A culture was taken of left middle meatus thick clear secretions and sent for cultures.”

• Remainder of physical exam unremarkable

Case Background Methods Results Conclusions

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Case Imaging


Case Presentation

• Started on nasal saline, Flonase• Empirically started on Moxifloxacin and Voriconazole per transplant team

• Cultures:– Bacterial – mixed gram positive organisms– Viral – H1N1– AFB/Fungal not obtained

• Underwent successful bone marrow transplantation at 20 months of age

• No sinus surgery performed


https://www.bmtinfonet.org/transplantcenter/duke‐university‐medical‐center‐pediatric‐bone‐marrow‐transplant‐program

Background

• Over the past 5 years, Duke has performed between 60‐70 pediatric BMT per year

• Sinus imaging frequently obtained– pre‐transplant workup– fever of unknown origin

• Non‐specific findings on imaging is common and create significant concern in this immunocompromised population

• Otolaryngology consult for evaluation and cultures often requested


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Specific Aims

• Primary aim

– Collect sinonasal culture data in the pediatric bone marrow transplant population

• Secondary aims

– Determine if positive sinonasal cultures are associated with physical exam and imaging findings, surgical intervention, success of transplant, overall patient outcome


Methods

• Retrospective review of 25 patients:–< 18 years old

–undergone bone marrow or cord blood transplant

–had an otolaryngology consultation for evaluation of sinusitis either pre‐transplant or post‐transplant.

–1/1/2010 – 6/1/2016


Methods

• Chart review included: – Type of and indication for transplant– Symptoms

– Physical exam findings by otolaryngology

– Imaging findings by radiology vs senior author

– Lab, culture and pathology data– Surgical interventions–Complications/death


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Statistical Methods• The associations between categorical variables were

assessed with the Fisher’s exact test

• Continuous variables were evaluated with a t‐test to assess the differences between group means

• The significance level was set to ⍺=0.05


Characteristics of Included Patients


Culture Results

0% 10% 20% 30% 40% 50% 60% 70% 80% 90%

AFB

Viral

Fungal

Bacteria

Positive Cultures


44% (4/9) with invasive fungal sinusitis

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Bacterial Culture Results

8 mixed/non‐speciated

5 streptococcus viridans

4 nega7ve

3 coagulase nega7ve staphylococcus

2 haemophilus influenza

1 stenotrophomonas maltophilia

1 pseudomonas aeruginosa

1 MRSA

1 moraxella catarrhalis

1 lactobacillus

1 enterobacter aerogenes


Predictors of positive cultures or IFS

Statistically significant associations:

• IFS with:– Facial edema

– Sinus tenderness

– Transplant failure

– Mortality

• Cough and positive fungal cultures







– Mortality


No association with positive cultures or IFS with:

• Indication for transplant

• Type of transplant

• Any symptom, physical or endoscopic finding

• WBC or ANC


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– Mortality


No association with positive cultures or IFS with:

• Indication for transplant

• Type of transplant

• Any symptom, physical or endoscopic finding

• WBC or ANCNo association with positive cultures with:

• Subsequent sinus surgery

• Transplant failure

• Mortality


Conclusions

• Cultures may be helpful when speciation occurs, but they are frequently negative or non‐speciated.

• Bacteria speciated in this population were similar to non‐transplanted pediatric patients

• Culture results did not predict subsequent sinus surgery or all‐cause mortality.

• Viral and AFB cultures, unless specific clinical concern, may not add helpful clinical evaluation

• Suspicion should remain high for IFS, especially when facial edema and sinus tenderness are present.


References1. Arulrajah S, Symons H, Cahoon EK, Tekes A, Huisman TA, Izbudak I. Relationship

between clinical sinusitis symptoms and sinus CT severity in pediatric post bone marrow transplant and immunocompetent patients. Eur J Pediatr. 2012;171(2), 375‐381.

2. Billings KR, Lowe LH, Aquino VM, et al. Screening sinus CT scans in pediatric bone marrow transplant patients. Int J Pediatr Otorhinolaryngol. 2000;52(3), 253‐260.

3. Zamora CA, Oppenheimer AG, Dave H, Symons H, Huisman TA, Izbudak I. The role of screening sinus computed tomography in pediatric hematopoietic stem cell transplant patients. J Comput Assist Tomogr. 2015;39(2), 228‐231.

4. Tomazic P, Neuschitzer A, Koele W, Lang‐Loidolt D. Feasibility of routine paranasalsinus CT‐scans in preoperative transplant patients. Ann Transplant. 2001;16(2), 31‐35.

5. Savage DG, Taylor P, Blackwell J, et al. Paranasal sinusitis following allogeneic bone marrow transplant. Bone Marrow Transplant. 1997;19(1), 55‐59.

6. Brook I. Acute sinusitis in children. Pediatr Clin North Am 2013;60(2):409‐424.7. Hsin CH, Su MC, T CH, et al. Bacteriology and antimicrobial susceptibility of

pediatric chronic rhinosinusitis – a 6‐year result of maxillary sinus punctures. Am J Otolaryngol Head Neck Med Surg 2010;31(3):145‐149.

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National Databases for Pediatric ENT Research:Pitfalls and Possibilities

Joshua Dean Horton, MD

18th Annual Charleston Magnolia Conference

Medical University of South Carolina Dept. of Otolaryngology-HNS

Mentors: Clarice Clemmens, MD and David White, MD

Disclosures: No financial ties, IRB exempt

Presented at: 2018 SC/NC Otolaryngology Meeting, Asheville, NC

1. Temporal Trends of Pediatric Dysphagia- Poster at ASPO 2017 and Dysphagia 2018

2. Pharyngeal flap vs sphincter pharyngoplasty for velopharyngeal insufficiency

- Oral presentation at Academy 2017

3. Comparative outcomes of VPI surgery in patients with and without 22q11.2 deletion syndrome

- Poster at Academy 2017

“Quality” Healthcare in the United States

Per capita healthcare expenditure, 2015Deaths/100,000 from preventable

diseases or complications

Source: Organization for Economic Co-operation and Development. Not all OECD members shown. (L.A. Times Graphics)

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National Response

Patient Protection and Affordable Care Act (PPACA) of 2010- Broad goal of increasing the VALUE of US healthcare

Agency for Healthcare Research and Quality (AHRQ):

Quality = “doing the right thing, at the right time, in the right way, for the right person—and having the best possible results.”

Image Credit: HealthcareITNews.com

Role of National Databases

• Identify disease trends and establish benchmarks for quality and cost

• In rarer conditions and in at-risk populations (children, pregnant women) where randomized blinded studies are challenging to carry out

• Determine the “cost” of a particular disease process and identify potential areas of unnecessary or avoidable resource expenditure

McCormick, M.E. & Shah, R.K. Curr Otorhinolaryngol Rep (2014)

KID and NSQIP-P

• Kids’ Inpatient Database (KID) from the Healthcare Cost and Utilization Project (HCUP)

• National Surgical Quality Improvement Program – Pediatric (NSQIP-P) from the American College of Surgeons (ACS)

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Kids’ Inpatient Database (KID)

• Only all-payer pediatric inpatient care database in the US

• Released every three years (1997-2015)

• 80% of pediatric admissions, 20% of in-hospital births from hospitals in participating states

• Weighted hospitalizations allows for national population-scale estimates of incidence

ICD9/10 and CPT codesDischarge statusPatient demographics (e.g., sex, age, race, median income)Hospital characteristics (e.g., ownership, size, teaching status)Expected payment sourceTotal chargesLength of stayComorbidity measures

Examples from the Oto Literature

Preterm infants surviving at increasing rates

Stoll et al, JAMA 2015

Hypothesis: with improvements in neonatal care and increased survival of premature infants and those with congenital/neurodevelopmental abnormalities, the incidence of dysphagia diagnoses are also increasing

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• Kids’ Inpatient Database (KID) weighted hospitalizations 1997‐2012• ICD‐9 diagnosis of dysphagia (787.2 cluster)• Demographic data (including gestational age and birthweight) retrieved• Statistical Package for the Social Sciences (SPSS) for analysis• Shapiro‐Wilk for normality. Chi‐squared contingency tables to compare

frequencies. Values were considered significant at the level of p<0.05.

KID Data Publication Year, No. (%)

1997 2000 2003 2006 2009 2012 p

Total Weighted Hospitalizations

6607653 7291039 7409162 7558812 7370203 6675222 <0.001a

Dysphagia Coded 5107 (0.08) 7484 (0.10) 9551 (0.13) 13646 (0.18) 20459 (0.28) 27464 (0.41)

95% CI 4452-5761 6361-8607 8406-10696 11895-15397 17654-23264 23462-31467

Increasing pediatric dysphagia

Overall trend p< 0.001

y = 0.0523e0.331x

R² = 0.9849

Age and prematurity in dysphagia patients

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Limitations of KID (in our data)

• Each data point is a hospitalization, not a patient

• The definition of dysphagia is ambiguous and reliant on accurate ICD• 787.2 cluster used: “Dysphagia” categorized by phase

• 779.3 cluster omitted: “Feeding problems in newborn”

• 783.3 cluster omitted: “Feeding difficulties and mismanagement”

• Dysphagia of esophageal origin omitted

• Paucity of long-term follow up, therefore clinical significance unclear

Velopharyngeal Insufficiency

The velopharyngeal port closes when producing oral sound

Failure allows nasal escape of oral sound

(/s/, /sh/, /z/, and /f/)

Cleft palate is most common cause

VPI after 1/1500 adenoidectomies1,2

1. Donnelly MJ, Ir J Med Sci 19942. Fraulin FO et al, Plast Reconstr Surg 1998

Surgical Correction of VPI

Pharyngeal Flap (PF)

- sagittal defects

- ? airway obstruction

- proven outcomes

Sphincter Pharyngoplasty (SP)

- most defects

- ? less airway obstruction

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National Surgical Quality Improvement Program - Pediatric (NSQIP-P)

• Prospectively validated 30-day risk-adjusted surgical outcomes

• More than 50 pediatric hospitals in the US• Community hospitals Tertiary referral centers

• CPT and ICD-9/10

• ~300 data points: demographics, pre-op comorbidities, operative and post-op characteristics, length of stay, complications, reoperation, and readmissions

• 30 days follow up that is not institution specific

Methods

• National Surgical Quality Improvement Project – Pediatric• Retrospective review of 2014 and 2015 data releases

• CPT 42225 + 42226 = pharyngeal flap (+/- palatal lengthening)• CPT 42950 = sphincter pharyngoplasty

• ICD-9 478.29, 528.9, 750.29 = velopharyngeal insufficiency

• Extract demographics, OR times, LOS, complications, readmissions, reoperations

• Chi squared, Mann-Whitney U Test, Grubb’s Test

PF vs SP: Patients

PF SP

n 250 196

Male 52% 54%

Mean Age 8.053.8 8.654.0

Premature 14% 22%

Hispanic 14% 16%

White 79% 77%

Asian 17% 15%

Black 12% 8%

Unknown 22% 18%

PF SP

Cardiac RFs

Minor 12% 8.7%

Major 4% 8.2%

Severe 2% 2%

Cardiac Surgery 8.8% 10.7%

ASA - 1 18% 26%

ASA - 2 61% 58%

ASA - 3 22% 32%

ASA - 4 0% 0.5%

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PF vs SP: OR Utilization

72min

70.5min

**p=0.004

**

PF vs SP: Complications

PF SP p

TotalComplications

10 (4%) 3 (1.5%) 0.12

Respiratory 2 (0.8%) 0 (0%) 0.21

Dehiscence 7 (2.8%) 1 (0.5%) 0.071

UnplannedReadmission

3 (1.2%) 1 (0.5%) 0.44

Unplanned RelatedReoperation

3 (1.2%) 0 (0%) 0.12

PF vs SP: Hospital Bed Utilization

Inpatient/Outpatient Length of Stay

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• Reliant on manually entered case tracking statistics (ICD, CPT, OR start/stop time)

• No knowledge of procedural success

• No long-term follow up• Outcome of most interest in comparing these two procedures is

development of OSA, not tracked in NSQIP (> 30 days)

Limitations of NSQIP-P (in our data)

Conclusions

Dysphagia increasing in pediatric patients, especially premature

- KID limited by reliance on coding, lack of follow up

Longer length of stay for PF compared to SP for VPI

Longer OR times for PF compared to SP (clinical significance)

- NSQIP limited by reliance of accurate case tracking, lack of outcomes data, short follow up

National databases will play a role in improving quality of care

Must be diligent at acknowledging limitations of database research

Thank you

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What Otolaryngologists Should Know about Facial Dysmorphic DisorderWesley Stepp, MS4Department of Otolaryngology/HNS21 July 2018NC/SC Oto/HNS 2018 Assembly

Major Contributors

Madison Clark, MDAssociate Professor

UNC Otolaryngology/HNS

Amelia Drake, MDProfessor

UNC Otolaryngology/HNS

Eva SteinMS4

UNC School of Medicine

We have no disclosures

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What is facial dysmorphic disorder (FDD)?

Understanding FDD as a sequala of body dysmorphism

Required symptoms

Severity of disease“I look deformed,” or “I look ugly.”

Why does an otolaryngology meeting merit discussion about a psychological disorder?

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Why does an otolaryngology meeting merit discussion about a psychological disorder?

Patients with facial deformities (trauma, burns, surgical, congenital, etc) often experience low self esteem with respect to

their appearance

Hypothesis: Patients with orofacial clefts will exhibit higher BDD symptom severity scores than non‐cleft counterparts.

Study design and methods

• Performed semi‐structured, qualitative interviews with patients to assess adult cleft needs and determine barriers to accessing cleft care as adults.

• Calculated a BDD symptom score using a validated scoring tool: BBD‐YBOCS (Yale‐Brown Obsession and Compulsion Scale)

• Compared cleft results to non‐cleft patients using a convenience sample from an adult facial plastics and rhinology clinic at UNC.

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Qualitative interview—sample questions

The BDD‐YBOCS assessment for symptom severity

Pre‐occupation

Interference w/ ADLs

Distress

Remainder of questions cover two areas: obsessions and compulsions

How much does patient think about appearance

Obsession sub‐score Compulsion sub‐score

Drive to act on obsession

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Appearance is not limited to outward physical projection in orofacial cleft patients

22y female with unilateral CP, seen regularly by craniofacial team at UNC until 18y. Continued problems with speech perception, intermittent dysphagia, chronic dental issues.

BDD screening score: 8 (>5 requires further evaluation)Total symptom severity score: 20Obsession sub‐score: 10Compulsion sub‐score: 6

Demographic data of enrolled patients stratified by cleft status

Control Cleft p‐Value (CI95)

N 20 18

Age in years (SD) 40.3 (12.4) 40.5 (18.8) 0.9647 (‐10.1‐10.5)*

Gender (% Female) 15/20 (75.0%) 13/19 (63.2%) 0.4365 (‐0.4235‐0.1866)*

Ethnicity (% non‐white) 4/20 (20.0%) 5/19 (33.3%) 0.6503 (‐0.2168‐0.3432)*

Cleft Status 0/20 (0.0%) 100.0%

Cleft lip 0/19 (0.0%)

Cleft palate 4/19 (21.1)

Cleft lip and palate 15/18 (78.9%)

Age (yrs) at 1st repair (SD) N/A 2.0 (3.7)*two‐tailed, unpaired student’s t‐test

Cleft patients screen positive for FDD at a higher proportion than non‐cleft patients

Control Patients CL/P Patients0

2

4

6

8

10

12

Patient Classification

BD

D-Y

BO

CS

Sco

re (

Mo

dif

ied

Scr

een

er)

Control Patients

CL/P Patients

**

• BDD‐YBOCs three question screening tool

• N=20 non‐cleft controls and N=19 cleft patients

• Control patients are non‐cosmetic surgery seeking or non‐rhinoplasty patients from facial plastics ENT or rhinology clinics at UNC.

• p<0.01; error bars= SEM

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Cleft patients have elevated FDD severity scores compared to controls

Control Patients CL/P Patients0

10

20

30

40

Patient Classification

BD

D-Y

BO

CS

Sev

erit

y S

core

** • Full BDD‐YBOCs questionnaire

• N=20 non‐cleft controls and N=13 cleft patients

• Control patients are non‐cosmetic surgery seeking or non‐rhinoplasty patients from facial plastics ENT or rhinology clinics at UNC.

• p<0.01; error bars= SEM

Both obsession and compulsion sub‐scores are higher in patients with orofacial clefts

Control CL/P Control CL/P0

5

10

15

20

Sev

erit

y S

ub

-sco

re

Obessions Compulsions

** **

Back to our case…22yo woman with continued issues pertaining to her CP

22y female with unilateral CP, seen regularly by craniofacial team at UNC until 18y. Continued problems with speech perception, intermittent dysphagia, chronic dental issues.

BDD screening score: 8 further workupTotal symptom severity score: 20 (Moderate)Obsession sub‐score: 10 (Elevated risk)Compulsion sub‐score: 6 (Elevated risk)

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Summary and Future Plans

• Patients with repaired orofacial clefts have lasting psychological effects, including some aspects of facial dysmorphic disorder

• Compared to non‐cleft controls, there is increased BDD symptom scoring for patients with clefts

• Degree of obsession and compulsion symptoms is higher in patients with clefts.

• Patients should not only be treated for their physical appearance, but treatment should include a psychological aspect as well.

Summary and Future Plans

• Continue expanding enrollment in study. Goal is 30/30.

• Use both qualitative and quantitative data to develop an adult cleft care arm to the UNC Craniofacial Center (already in pilot stages)

• Compare cleft patients with patients seeking cosmetic alterations to compare BDD symptomatology between these two groups.

Acknowledgments• Madison Clark, MD

• Amelia Drake, MD

• Eva Stein (MS4)

• UNC Craniofacial Center team/staff

• UNC‐CH Department of Otolaryngology

• Funding sources:

– Newton D. Fischer Research Scholar Award (WS)

– AOA Carolyn L. Kuckein Student Research Fellowship (ES)

– NIH/NIAID‐UNC PhD to MD Training Grant (WS)

8

Questions?

1

Primary Surgery Versus Radiotherapy for Early Stage Oral Cavity Cancer

Mark A. Ellis, MD

Mentor: Terry A. Day, MD

1

Background

SEER, Cancer Statistics, Oral Cavity Cancer

• Oral cavity squamous cell carcinoma is the 2nd most common malignancy of the upper aerodigestive tract

2

Background

• Primary surgery considered “standard of care”

• High risk of osteoradionecrosis with primary radiotherapy

• However, unclear survival difference between surgery and radiotherapy

3

2

NCCN Guidelines, Head and Neck Cancers, 2018

4

Objectives/Questions

1. Is there a survival difference between primary surgery versus radiotherapy for early staged oral cavity cancer?

2. How frequently is primary radiotherapy used?

3. What are risk factors for receiving primary radiotherapy?

5

Subjects and Methods

• Retrospective cohort study

• Data Source: National Cancer Database– 70% of cancer diagnoses in the United States

• Study Cohort: Inclusion Criteria– SCC of the OC

– cT1‐T2N0M0

– 2004‐2014

– Primary surgery or primary radiotherapy

• Primary Outcome: Overall survival

• Secondary Outcome: Risk factors for receiving primary radiotherapy

6

3

Statistical Methods

• Kaplan Meier estimates of survival

• Univariable and multivariable Cox proportional hazards regression analyses

• Propensity score matching

• Univariable and multivariable logistic regression analyses

• Statistical significance set at a P value of < 0.01

7

Demographic, Clinicopathologic, and Treatment Characteristics

Total Patients (n=20,779)

Primary Surgery (n=19,823)

Primary Radiotherapy

(n=956)

OR (99% CI)

Variable # (%) # (%) # (%)

Age (years) <50 4,104 (19.8) 4,014 (20.2) 90 (9.4) ref

50-59 5,111 (24.6) 4,946 (25.0) 165 (17.3) 1.49 (1.06-2.09) 60-69 5,124 (24.7) 4,942 (24.9) 182 (19.0) 1.64 (1.17-2.30) > 70 6,440 (31.0) 5,921 (29.9) 519 (54.3) 3.91 (2.90-5.27) Gender Male 12,326 (59.3) 11,759 (59.3) 567 (59.3) ref Female 8,453 (40.7) 8,064 (40.7) 389 (40.7) 1.00 (0.84-1.19) Race White 19,077 (91.8) 18,213 (91.9) 864 (90.4) ref Black 662 (3.2) 605 (3.1) 57 (6.0) 1.99 (1.38-2.87) Other 1,040 (4.0) 1,005 (5.1) 35 (3.7) 0.73 (0.47-1.15) Insurance Type

Private 9,253 (44.5) 9,023 (45.5) 230 (24.1) ref Medicaid 1,044 (5.0) 988 (5.0) 56 (5.9) 2.22 (1.50-3.30) Medicare 8,959 (43.1) 8,367 (42.2) 592 (61.9) 2.78 (2.26-3.40) No Insurance 1,008 (4.9) 965 (4.9) 43 (4.5) 1.75 (1.13-2.71) Other/Unknown 515 (2.5) 480 (2.4) 35 (3.7) 2.86 (1.77-4.64)

Charlson/Deyo Comorbidity Score 0 16,375 (78.8) 15,600 (78.7) 775 (81.1) ref 1 3,455 (16.6) 3,331 (16.8) 124 (13.0) 0.75 (0.58-0.97) >2 949 (4.6) 892 (4.5) 57 (6.0) 1.29 (0.89-1.85) Oral Cavity Subsite Tongue 10,420 (50.1) 10,185 (51.4) 235 (24.6) ref Lip 3,365 (16.2) 3,189 (16.1) 176 (18.4) 2.39 (1.84-3.11) Floor of Mouth 2,984 (14.4) 2,815 (14.2) 169 (17.7) 2.60 (2.00-3.39) Gum 1,565 (7.5) 1,470 (7.4) 95 (9.9) 2.80 (2.03-3.86) Buccal Mucosa 1,068 (5.1) 988 (5.0) 80 (8.4) 3.51 (2.49-4.95) Retromolar Trigone 723 (3.5) 587 (3.0) 136 (14.2) 10.04 (7.45-13.53) Other 654 (3.1) 589 (3.0) 65 (6.8) 4.78 (3.28-6.97) AJCC Clinical Stage Grouping I 13,398 (64.5) 13,057 (65.9) 341 (35.7) ref II 7,381 (35.5) 6,766 (34.1) 615 (64.3) 3.48 (2.91-4.16) Treatment Facility Annual Case Volume <2 6,161 (29.7) 5,629 (28.4) 532 (55.6) ref 2-4 4,421 (21.3) 4,198 (21.2) 223 (23.3) 0.56 (0.46-0.70) >4-10 4,860 (23.4) 4,728 (23.9) 132 (13.8) 0.30 (0.23-0.38) >10 5,337 (25.7) 5,268 (26.6) 69 (7.2) 0.14 (0.10-0.19)

Ellis et al, OHNS, 2018

8

Kaplan‐Meier estimates of overall survival comparing surgery versus radiotherapy

5 year overall survival:

71% vs 36%


9

4

HR: 2.96 (2.65‐3.32)aHR: 1.97 (1.74‐2.22)

Univariable Analysis Multivariable Analysis Variable Hazard Ratio (99% CI) Adjusted Hazard Ratio (99% CI)

Primary Treatment Modality

Surgery ref ref

Radiotherapy 2.96 (2.65-3.32) 1.97 (1.74-2.22)

Year of Diagnosis 2004-2005 ref ref 2006-2007 0.97 (0.87-1.07) 0.97 (0.87-1.07) 2008-2009 0.89 (0.80-0.98) 0.94 (0.85-1.04) 2010-2011 0.86 (0.77-0.96) 0.91 (0.82-1.02) 2012-2013 0.84 (0.74-0.95) 0.87 (0.77-0.98) Age (years) <50 ref ref 50-59 1.32 (1.16-1.51) 1.26 (1.10-1.44) 60-69 1.74 (1.53-1.97) 1.43 (1.25-1.64) > 70 3.81 (3.40-4.26) 2.94 (2.56-3.38)

Gender Male ref ref Female 1.06 (0.99-1.13) 0.92 (0.86-0.99) Insurance Type Private ref ref Medicaid 2.27 (1.94-2.65) 1.89 (1.62-2.21) Medicare 2.78 (2.56-3.00) 1.50 (1.36-1.67) No Insurance 1.45 (1.20-1.74) 1.44 (1.19-1.73) Other 2.02 (1.64-2.5) 1.62 (1.30-2.01)

Charlson/Deyo Comorbidity Score 0 ref ref 1 1.54 (1.42-1.68) 1.36 (1.25-1.48) >2 2.57 (2.26-2.91) 2.00 (1.76-2.27) Oral Cavity Subsite Tongue ref ref Lip 0.85 (0.77-0.94) 0.68 (0.61-0.76) Floor of Mouth 1.28 (1.17-1.41) 1.13 (1.23-1.24) Gum 1.32 (1.16-1.41) 0.87 (0.77-0.99) Buccal Mucosa 1.40 (1.21-1.61) 1.02 (0.88-1.18) Retromolar Trigone 1.65 (1.41-1.93) 1.10 (0.94-1.29) Other 1.57 (1.32-1.86) 1.08 (0.90-1.28) AJCC Clinical Stage Grouping I ref ref II 1.95 (1.82-2.09) 1.73 (1.62-1.86) Treatment Facility Annual Case Volume <2 ref ref 2-4 0.89 (0.81-0.97) 0.94 (0.86-1.03) >4-10 0.70 (0.64-0.77) 0.77 (0.70-0.84) >10 0.71 (0.65-0.78) 0.79 (0.72-0.86)

Multivariable Cox Proportional Hazards Model


10

Kaplan‐Meier estimates of overall survival in the propensity score matched subset analysis comparing surgery versus radiotherapy


5 year overall survival:

62% vs 36%

11

Multivariable Analysis of Risk Factors Associated with Receiving Primary Radiotherapy.

Variable Adjusted Odds Ratio (99% CI) Year of Diagnosis 2004-2005 ref 2006-2007 0.73 (0.55-0.95) 2008-2009 0.53 (0.40-0.70) 2010-2011 0.46 (0.35-0.60) 2012-2013 0.35 (0.27-0.47) Age (years) <50 ref 50-59 1.34 (0.94-1.91) 60-69 1.36 (0.93-1.97) > 70 2.82 (1.93-4.11) Race White ref Black 1.82 (1.21-2.73) Other 0.66 (0.31-1.43) Insurance Type Private ref Medicaid 1.65 (1.01-2.51) Medicare 1.36 (1.03-1.79) No Insurance 1.58 (0.99-2.50) Other 1.99 (1.18-3.35)

Variable Adjusted Odds Ratio (99% CI) Charlson/Deyo Comorbidity Score 0 ref 1 0.62 (0.48-0.82) >2 0.92 (0.62-1.37 Oral Cavity Subsite Tongue ref Lip 2.16 (1.64-2.90) Floor of Mouth 2.36 (1.79-3.12) Gum 2.46 (1.75-3.47) Buccal Mucosa 2.62 (1.82-3.77) Retromolar Trigone 8.59 (6.20-11.89) Other 3.46 (2.67-3.91) AJCC Clinical Stage Grouping I ref II 3.23 (2.67-3.91 Treatment Facility Annual Case Volume <2 ref 2-4 0.55 (0.44-0.69) >4-10 0.29 (0.22-0.38) >10 0.13 (0.09-0.18)


12

5

Conclusions

• Primary RT for early stage OC SCC is associated with significantly increased mortality

• Unfortunately, 5% of patients with early stage OC SCC receive primary RT

• Risk factors for receiving primary RT include: elderly age, black race, public insurance and treatment at low volume hospitals.

13

Acknowledgements

• Evan M. Graboyes, MD

• Amy E. Wahlquist, MS

• David M. Neskey, MD

• John M. Kaczmar, MD

• Heather K. Schopper

• Anand K. Sharma, MD

• Patrick F. Morgan, MD

• Shaun A. Nguyen, MD

• Terry A. Day MD

14

1

Sex Bias in Research: Where Do We Stand in Otolaryngology?

ZainabFarzal,MD,1 ElizabethD.Stephenson,BA,1 LaurenA.Kilpatrick,MD,1BrentA.Senior,MD, 1 AdamM.Zanation,MD1,3

1Department of Otolaryngology/HNS, University of North Carolina at Chapel Hill2Department of Surgery, University of North Carolina at Chapel Hill

3Department of Neurosurgery, University of North Carolina at Chapel Hill

1

Disclosures

• No pertinent disclosures

Outline

• Historical Perspective

• Sex Bias in Clinical Research

• Sex Bias in Basic Science/Translational Research

• Best Practices for Researchers

2

Historical Perspective

Sex vs. Gender

Sex individual’s biological sex– Two sexes

Gender personal identification– Multiple genders

Medical literature primarily reports sex as a demographic

Background

Women and men experience many diseases differently• Prevalence, symptoms, metabolism, and variable therapeutic

outcomes

Women were excluded from clinical trials in 1970s for concern of adverse effects on childbearing potential

• NIH Office of Research on Women’s Health (ORWH) created in 1990

• NIH Revitalization Act passed in 1993 • INCLUSION OF WOMEN AND MINORITIES IN

CLINICAL TRIALS

3

Circulation; 2012.

NEJM; 2000.

Background

Background

Historically, preclinical studies have included only animals of a single sex, more commonly male Desire for homogeneity:

• Concern for confounding in biological processes from estrous cycle

Availability:• Easier access to male animals or a single sex animal group

Simple obliviousness to the importance of sex

Increased awareness in the 1990s and 2000s on sex bias in clinical research, but….

Nature; 2010.

Background

4

Why was this problematic?

Example: Ambien (Zolpidem tartrate)• Multiple women were in fatal motor vehicle accidents in the

morning post-administration

• Pre-clinical data abstracted only from male animals

• Pre-market: women took 2x longer to metabolize

• Initial market dosage identical for both sexes

Background

Background

2016: NIH requires all funding proposals to account for sex as a biological variable in all human and

animal research

Background

5

2016: NIH requires all funding proposals to account for sex as a biological variable in all human and

animal research

2016

Background

Sex Bias in Clinical Research

Determine:

1) Whether sex bias is prevalent in the otolaryngology literature

2) Sex is appropriately analyzed as an independent variable in

otolaryngology clinical research

Objective

6

Review of all articles published in 2016 in 3 major Oto-HNS journals:

• The Laryngoscope

• JAMA Otolaryngology-Head & Neck Surgery (HNS)

• Otolaryngology/Head and Neck Surgery (Oto-HNS)

Exclusion Criteria: • Editorials/commentary/“How I

Do It” reports

• Best practices

• Non-patient related studies (cost or practice analyses, education-based or cadaver studies)

• Meta-analyses or systematic reviews

• Methods development or feasibility papers

• Case reports or cases series <10 patients

Methods

Analysis of: • Number/sex of subjects

• Subspecialty

• ≥50% sex matching, SM≥50

• Sex-based statistical analysis

Sub-Analysis of randomized controlled trials (RCTs)

Statistical Analysis: –Chi-squared test using STATATM 15

–Significance set at p-value < 0.05

Methods

Example of study meeting SM≥50 criteria:100 males, 50 females100 50100

100 50%

600 of 1209 articles comprised original patient-centered clinical research

–9 billion subjects • Males: 3.9 billion (43.3%)

• Females: 5.1 billion (56.7%)

• Unknown: 3.2 million (0.04%)

Study Features# of Articles

(%)JournalOto-HNS 199 (33.2%)Laryngoscope 298 (49.7%)JAMA Oto-HNS 103 (17.1%)Study LocationDomestic 392 (65.3%)International 208 (34.7%)Study OriginSingle Institution 425 (70.8%)Multi-Institutional 83 (13.8%)Database 92 (15.3%)

Results: Overall

7

Sex reported: 90.7% (544) studies

Sex unknown in 9.3% (56) studies

Statistical Analysis by sex: 46.7% (280) of studies

SM≥50 criteria met: 60.7% (330) studies

Results: Overall

JOURNAL

Oto-HNS LaryngoscopeJAMA Oto-

HNSTOTAL

P-value

Manuscripts

Sex Reported173/199 (86.9%)

273/298 (91.6%)

98/103 (95.1%)

544/600 (90.7%)

0.050

Unknown Sex 26 25 5 56

Single Sex 1 10 2 13Male Only 1 4 0 5Female Only 0 6 2 8

Sex-based Analysis96/199 (54.3%)

128/298 (43.0%)

56/103 (48.2%)

280/600 (46.7%)

0.116

SM≥50102/173 (59.0%)

166/273 (60.8%)

62/98 (63.3%)

330/544 (60.7%)

0.782

No significant difference in sex reporting, sex-based analysis, or sex matching amongst the 3 journals

Results: By Journal

Results: Randomized Controlled Trials (N=30)

Randomized Controlled Trials Study LocationDomestic 11 (36.7%)International 19 (63.3%)Study Institution(s)Single Institution 21 (70%)Multi-Institutional 10 (30%)Studies by Participant SexBoth Sexes 28 (93.3%)Sex Not Reported 2 (6.7%)Participants (N=3990)Males 2026 (50.8%)Females 1856 (46.5%)Sex Not Reported 108 (2.7%)Statistical Analysis by Sex 12 (40%)SM≥50* 19 (67.9%)

**6.7% of RCTs did not report participant sex

**60% of RCTs did not perform outcomes analysis by sex

**67.9% had equal or greater than 50% sex matching

8

Results: Study Origin

Discussion and Conclusions

Sex bias is prevalent in clinical ENT research Highest impact ENT journals

Persistent in RCTs

Higher standard of sex reporting and analysis better evidence-based patient recommendations

Sex Bias in Basic Science/Translational

Research

9

Determine if sex bias exists in the current otolaryngology basic science

and translational research by analyzing the prevalence of sex

reporting and sex-based statistical analysis

Objective

Review of all articles with animal subjects, human subject cells, or commercial cell lines published in 2016 in 3 major Oto-HNS journals:

• The Laryngoscope

• JAMA Otolaryngology-Head & Neck Surgery (HNS)

• Otolaryngology/Head and Neck Surgery (Oto-HNS)

Data collected included number and sex of cells and animals, sex-based data analysis, and study location

Statistical Analysis:

–Chi-squared tests using STATATM 15; significance set at p-value < 0.05

Methods

73 of 1209 articles comprised animal or cell research • 51 studies (69.9%) with animal subjects only

• 11 studies (15.1%) used cell or commercial cell line subjects only

• 11 studies (15.1%) used both animal and cell subjects

Total animals or cells:• Males: 30.33% (449)

• Females: 35.5% (525)

• Unknown: 34.2% (506)

Results: Overall

10

9.6% (7/73) studies lacked total number of subjects

50.7% (37/73) studies did not report sex

Of 36 studies reporting sex, 16.7% (6/36) included both sexes

Results: Overall

83% (30/36) studies reporting sex were single sex studies• 13 studies had males only, and 17 had females only

5.5% (4/73) performed sex-based statistical analysis of outcomes

Results: Overall

Lack of sex reporting and use of single sex animals are common practices in ENT basic science research

Preclinical studies form the foundation for clinical trials and sex must be taken into account from the beginning

Discussion and Conclusions

11

Best Practices for Researchers

What Researchers Can do

1) Use the right descriptor in reporting demographics• Typically participant sex data more widely available than gender

2) Report participant sex

3) Sex matching of participants when feasible

4) Perform statistical analysis by sex

5) Animal and cell research: assess availability of both male and female animals/cells

6) If utilize single sex model in research, provide justification

Acknowledgements• UNC Department of Otolaryngology/Head & Neck Surgery

–Dr. Adam Zanation

–Dr. Brent Senior

–Dr. Lauren Kilpatrick

–Dr. Amelia F. Drake

• Dr. Melina R. Kibbe

–Chairwoman of General Surgery at UNC

• Dr. Sujana Chandrasekhar

• Women in Rhinology

12

Thank you for your attention.

1

TheEvolutionofCochlearImplantationCandidacyCriteria

Harold C. Pillsbury, MD

Lifechangingtechnology

“I can hear my grandchildren’s little voices! It is the sweetest sound!”

“I did not realize what I was missing!”

“I have my independence back. And that means everything to me.”

Lifechangingtechnology

2

InnovationBuiltonHistory

Mission: To preserve and/or restore the hearing of all individuals through high‐quality patient care, research, teaching, and service.

InnovationBuiltonHistory

First Cochlear Implantation Procedure

Helpingmorepeoplewithhearingloss

020406080

100120140160

Number of Cases

UNC Cochlear Implantation Procedures

Adults Pediatrics

3

Whowecanhelpisevolving

Research has taught us who can benefit from cochlear implantation, and raises the question of:

Who else can benefit from cochlear implantation?

ResearchSupportingInnovation

Candidacy Criteria:

Early 1990’s: Children with bilateral profound SNHL

ResearchSupportingInnovation:Early1990’s

Question:

What are parents expectations who are seeking cochlear implants for their children?

4


Question:

What are parents expectations who are seeking cochlear implants for their children?

Conducted a study investigating the expectations and needs of the parents and families of children with profound SNHL

Kampfe CM, Harrison M, Oettinger T, Ludington J, McDonald‐Bell C, Pillsbury HC 3rd (1993)


Findings (3):1. Cochlear implants in children were relatively

new and rare, therefore, parents may have unrealistically high expectations about how they function and the potential benefits;

2. Expectations influence feelings about outcomes, therefore, counseling on realistic expectations is important;

3. And, it is important to give parents the tools they need in decision‐making.

Kampfe CM, Harrison M, Oettinger T, Ludington J, McDonald‐Bell C, Pillsbury HC 3rd (1993)


The success of cochlear implantation in children requires support for the patient and the family. A dedicated team of physicians,

audiologists, speech‐language pathologists, and researchers is needed to provide the best treatment for children with cochlear implants.

5

ResearchSupportingInnovation:1992

Established the Cochlear Implant Center at UNC

Originally: W. Paul Biggers, MD Carolina Children’s Communicative Disorders Program (CCCDP)

Grant from North Carolina General Assembly


Adult and pediatric cochlear implant recipients with bilateral profound SNHL demonstrated a benefit with the cochlear implant as compared to preoperative

performance.

What about patients with severe‐to‐profound SNHL?


Candidacy Criteria:


Early 2000’s: Adults with bilateral severe‐to‐profound SNHL

6


Question:

What are the outcomes of adult patients with severe‐to‐profound sensorineural hearing loss who are implanted with the Combi 40+ electrode array (31‐mm)?

Bassim et al. (2005)


Question:

What are the outcomes of adult patients with severe‐to‐profound sensorineural hearing loss who are implanted with the Combi 40+ electrode array (31‐mm)?

Conducted a study investigating outcomes in adults implanted with the Combi 40+ electrode array (31‐mm)



Findings (2):

1. Results supported the safety and effectiveness of cochlear implantation with the MED‐EL Combi40+ cochlear implant system;

2. And, cochlear implant recipients experienced improved speech perception over time.


7


Patients with more residual hearing experience a benefit from cochlear implant use as compared to preoperative performance.

What about patients with auditory neuropathy or abnormal anatomy?


Candidacy Criteria:



2002: Children with auditory neuropathy


Question:

Auditory neuropathy is associated with a particularly poor response to amplification. Would these children benefit from cochlear implantation?

Conducted a study investigating outcomes of cochlear implantation in children with AN

Buss et al. (2002)

8


Findings (2):

1. Children with auditory neuropathy experienced similar outcomes as other children with cochlear implants;

2. And, the cochlear implant was able to overcome the desynchronization hypothesized to underlie auditory neuropathy.

Buss et al. (2002)


Candidacy Criteria:




2004: Children with inner ear malformations


Question:

What are the audiologic and surgical considerations and outcomes for pediatric cochlear implant patients with inner ear malformations?

Conducted a study reviewing HRCT scans, intraoperative findings, postoperative complications, and performance on speech perception measures.

Buchman et al. (2004)

9


Findings (3):

1. Children with inner ear malformations can achieve significant benefits from cochlear implant use;

2. Surgical complications were limited;

3. and, specific types of inner ear malformations may influence the prognosis.

Buchman et al. (2004)

ResearchSupportingInnovation:2006‐2018

Patients with normal‐to‐moderate low‐frequency hearing yet severe‐to‐profound high‐frequency hearing experience poor speech

understanding with conventional amplification.

Would a cochlear implant provide better speech understanding?


Candidacy Criteria:





2006‐2018: Bilateral normal‐to‐moderate low‐frequency hearing

10


Questions:

Can hearing be preserved after cochlear implantation?

If so, can CI recipients incorporate acoustic and electric information in the same ear for improved speech understanding?


Questions:

2006: Initiated clinical trial investigating cochlear implantation with a shorter, more flexible electrode array in patients with normal‐to‐moderate low‐frequency hearing loss.


Findings (2):

1. Hearing preservation is possible;

11


Findings (2):

1. Hearing preservation is possible;

2. And, cochlear implant recipients experience a significant benefit for speech understanding in noise when listening with combined hearing aid and CI stimulation.


Cochlear implant recipients can combine acoustic and electric technology in the same ear for significantly improved speech understanding…

What about patients with poor hearing in one ear and normal hearing in the contralateral ear?


Candidacy Criteria:





2006‐2018: Bilateral normal‐to‐moderate low‐frequency hearing

2014‐present: Moderate‐to‐profound SNHL in one ear

12

ResearchSupportingInnovation:2014‐present

Questions:

Can patients with moderate‐to‐profound hearing loss in one ear, and normal hearing in the contralateral ear benefit from cochlear implant use?

CAUTION: Not FDA approved. Investigational Device Exemption.


Questions:

2014: Initiated a clinical trial investigating cochlear implantation in patients with unilateral and asymmetric hearing loss.



Findings (4):

1. Improved speech perception in spatially‐separated noise

Subjects experienced a significant improvement in speech perception, even when the noise was presented to the normal hearing ear


Better

Buss et al. (2018)

13


Findings (4):

1. Improved speech perception in spatially‐separated noise,

2. Improved localization abilities,

Identification of the sound source significantly improved with only one month of listening experience.


Buss et al. (2018)


Findings (4):



3. Reduction in tinnitus with device use,

Perceived tinnitus severity significantly reduced when the CI is on.


Dillon et al. (2017)

Better


Findings (4):



3. Reduction in tinnitus with device use,

4. And, improved quality of life

Subjective report follows same pattern observed on speech perception and localization measures at 1‐month. CAUTION: Not FDA approved. Investigational Device Exemption.

Dillon et al. (2018)

Better

14


Where do we go from here?

ResearchSupportingInnovation:Today

Question:

Is cochlear implantation effective in children with unilateral hearing loss and asymmetric hearing loss?



Question:

Is cochlear implantation effective in children with unilateral hearing loss and asymmetric hearing loss?

Conducting a study on the speech perception, localization, and quality of life of pediatric CI recipients with UHL.


15


Question:

What are the performance outcomes for children listening with Electric‐Acoustic Stimulation (EAS) as compared to the cochlear implant alone?

Conducting a study investigating EAS in pediatric CI recipients


EvolutionofCICandidacyCriteria

Bilateral, Profound HL

Bilateral, Steeply Sloping

UnilateralBilateral,

Moderate-to-Profound HL

Who we can help is evolving.

UNCCochlearImplantTeam

Physicians• Harold Pillsbury, MD• Kevin Brown, MD, PhD• Lauren Kilpatrick, MD• Brendan O’Connell, MD• Carlton Zdanski, MD

Research• Emily Buss, PhD• Margaret Dillon, AuD• Douglas Fitzpatrick, PhD• John Grose, PhD• Lisa Park, AuD• Meredith Rooth, AuD

Adult Audiologists• English King, AuD• Shelley Anderson, AuD• Andrea Bucker, AuD• Sarah McCarthy, AuD

Pediatric Audiologists• Melissa Auchter, AuD• Erika Gagnon, AuD• Jennifer Woodard, AuD

Speech‐Language Pathologists• Hannah Eskridge, MSP• Maegan Evans, PhD• Sandra Hancock, MS• Lillian Henderson, MSP• Christine Kramer, MS• Erin Thompson, MS

16

Thankyou

1

Pyridostigmine for the Reversal of Severe Adverse Reactions to Botulinum Toxin in ChildrenMentors: Lucinda Halstead, MD and David White, MD

• Therapeutic botulinum toxin (BTX) injections are commonly performed within the realm of pediatric otolaryngology and generally tolerated with few adverse effects.

• Botulinum toxin acts at the presynaptic cleft by preventing the release of acetylcholine. Common uses include treatment of muscular spasticity and sialorrhea.

• Pyridostigmine inhibits acetylcholinesterase in the synaptic cleft and is frequently used to treat Myasthenia Gravis.

• We report two cases of aerodigestive complications arising from injection of BTX that were successfully treated with pyridostigmine.

Background

Mechanism of Botulinum Toxin (BTX)

Various botulinum neurotoxin serotypes are capable of disruption of Synaptobrevin, Syntaxin, or SNAP-25 preventing the fusion of synaptic vesicles on the neuronal membrane and subsequent release of acetylcholine into the synaptic cleft.

Barr et al

2

Potential Complications of BTX Injection

BOTOX package insert

Clinical Case 1: Immediate Adverse Effect

• A one year old female infant weighing 9 kg had a cricopharyngeal BTX injection for cricopharyngeal spasticity and recurrent aspiration pneumonia after a modified barium swallow study (MBSS) showed a poorly relaxing cricopharyngeus muscle.

• One day post-operatively, she presented with choking, profuse oropharyngeal secretions, and difficulty breathing with mild stridor.

• Initial modified barium swallow study (MBSS) showed profound global swallowing dysfunction.

Clinical Case 1: Immediate Adverse Effect

• On post-operative day 5 given limited improvement, she was started on low-dose pyridostigmine at 4mg/kg/day enterically; however, MBSS the following day was essentially unchanged from her initial presentation.

• On post-operative day 7, her dose of oral pyridostigmine was increased to 6mg/kg/day enterically resulting in almost immediate and dramatic clinical improvement.

• A MBSS two days later showed substantial improvement in swallowing function, and the patient was subsequently discharged home on six weeks of oral pyridostigmine.

• MBSS one month later showed no aspiration and continued improvement in swallowing function.

3

Clinical Case 2: Spatially Distant Adverse Effect

• An 8 year-old-female weighing 25 kg underwent BTX injection into bilateral submandibular and parotid glands for treatment of chronic sialorrhea.

• On post-operative day 7, the patient returned to clinic with poor oral intake, dysphagia, and choking with feeds.

• An MBSS was performed showing poor clearance of pharyngeal residue and laryngeal penetration, neither of which were present previously.

• The patient was admitted on post-operative day 11 due to poor oral intake and dehydration.

Clinical Case 2: Spatially Distant Adverse Effect

• She was started on pyridostigmine with dose titration up to 6.4mg/kg/day.

• Upon reaching the maintenance dose, there was noted rapid and complete resolution of symptoms and return to baseline oral intake.

• Follow-up MBSS showed no aspiration and continued improvement in swallow function.

Mechanism of Pyridostigmine

• Acetylcholinesterase near the endplate membrane cleaves acetylcholine preventing further depolarization of the motor endplate.

• Pyridostigmine inhibits acetylcholinesterase in the synaptic cleft allowing further depolarization of the motor endplate and generation of an action potential.

Kumar et al

4

Possible Delayed and Distant Adverse Effects from BTX Injection

• Research by Restani et al elucidates the mechanism of action of temporally delayed and spatially distant side effects from BTX injection as seen in Case 2.

• BTX injection has been reported to show measurable weakness at both adjacent and distant sites after injection both by systemic spread and by retrograde axonal transport.

• Such retrograde transynaptic transport has been shown to release active BTX up to two synapses away from the injection site days to weeks after injection.

Treatment of Adverse Effects from BTX Injection in Adults

Halstead et al

Adverse Effects of Pyridostigmine

• Adverse effects of pyridostigmine are mostly due to the cholinergic properties of the medication.

• These include abdominal cramping, diarrhea, increased salivation, nausea, increased bronchial secretions, and bradycardia.

• Medications to treat adverse effects of pyridostigmine can be considered and include glycopyrrolate (reduce salivary, tracheobronchial, and pharyngeal secretions), propantheline (sweating, abdominal cramping), and hyoscyamine (abdominal cramping).

• Muscarinic side effects can be controlled in many patients with the use of anticholinergic drugs that have little or no effect at the nicotinic receptors.

5

Conclusions

• Aerodigestive complications from BTX injection in children are rare but may be serious resulting in severe dysphagia, dehydration, potential airway compromise, and prolonged hospital admissions.

• Our experience shows that oral pyridostigmine may be effective in symptomatic treatment of complications related to BTX injection with few adverse effects.

• Pyridostigmine dosing for pediatric patients with Myasthenia Gravis is 0.5-1mg/kg every 4-6 hours titrated up to a total daily dose of 7mg/kg/day.

• The upper range of 6-7mg/kg/day appears to be appropriate to treat adverse effects of BTX injection.

• Treatment duration was six weeks for both patients.

References

Barr JR, Moura H, Boyer AE, Woolfig AR, Ashley DL, et al, “Botulinum neurotoxin detection and differentiation by mass spectrometry,” Emerg Infect Dis. 2005 Oct; 11(10): 1578–1583. doi:10.3201/eid1110.041279.

Bakheit AM, Ward CD, McLellan DL. Generalized botulism-like syndrome after intramuscular injections of botulinum toxin type A: a report of two cases. J Neurol Neurosurg Psychiatry. 1997;62(2):198.

Botox (R) [package insert]. 2013.

Chiang LM, Darras BT, Kang PB, “Juvenile myasthenia gravis,” Muscle Nerve. 2009; 39:423.

Coté TR, Mohan AK, Polder JA, Walton MK, Braun MM. Botulinum toxin type A injections: Adverse events reported to the US Food and Drug Administration in therapeutic and cosmetic cases. J Am Acad Dermatol. 2005;53(3):407-415. doi:10.1016/j.jaad.2005.06.011.

Druschel C, Althuizes HC, Funk JF, Placzek R. Off Label Use of Botulinum Toxin in Children under Two Years of Age: A Systematic Review. Toxins. 2013;5(1):60-72. doi:10.3390/toxins5010060.

Ionita CM, Acsadi G, “Management of juvenile myasthenia gravis,” Pediatr Neurol. 2013. 48-95.

Karami M, Taheri A, Mansoori P. Treatment of Botulinum Toxin–Induced Eyelid Ptosis with Anticholinesterases. Dermatol Surg. 2007;33(11): 1392–1395. doi:10.1111/j.1524-4725.2007.33299.x.

Klein AW. Complications and adverse reactions with the use of botulinum toxin. Dis Mon. 2002;48(5):336-356. doi:10.1053/mda.2001.25964.

Kumar K, “Cholinergic system and drugs,” hgps://www.slideshare.net/karunkumar/cholinergic-system-and-drugs-46682039.

Restani, L., et al (2012). Botulinum neurotoxins A and E undergo retrograde axonal transport in primary motor neurons. PLoS Pathog. 8, e1003087.

Restani, L. et al. Botulinum neurotoxin A impairs neurotransmission following retrograde transynaptic transport. Traffic 13, 1083–1089 (2012).Torpy JM, Glass TJ, Glass RM, “Myasthenia Gravis,” JAMA. 2005. 293 (15). doi: 10.1001/jama.293.15.1940.

Young DL, Halstead LA, “Pyridostigmine for reversal of severe sequelae from botulinum toxin injection,” J Voice Off J Voice Found. 2014. doi: 10.1016/j.jvoice.2014.04.010.

1

Parth V. Shah1, MD, Maheer M. Masood1, BA, Gregory Capra1, MD, Charles S. Ebert Jr.1,2, MD MPH, Brian D. Thorp1,2, MD, Adam M. Zanation1,2, MD

1Department of Otolaryngology – Head and Neck Surgery, University of North Carolina, Chapel Hill, NC2Department of Neurosurgery, University of North Carolina, Chapel Hill, NC

NC/SC Otolaryngology Assembly

July 21, 2018

Outcomes of Transorbital NeuroendoscopicSurgery Using the Superior Eyelid

Approach

1

Disclosures

• None

2

Background

• Approaches to the anterior skull base have evolved from open craniofacial resections to minimally invasive endoscopic techniques.

• These endoscopic techniques have reduced morbidity associate with the traditional open approaches.

• However, a significant amount of the ventral portion of the anterior skull base is occupied by the orbit. Thus, access to these regions via the endonasal approach requires crossing important neurovascular structures.

3

2

Background

• Limitations of Endonasal Surgery» Technical complexity

» Limited ability for proximal control of major vasculature

» Narrow surgical corridor

» Lack of 3-D visualization with standard 0-degree and angled endoscopes

4

Background

• Transorbital neuroendoscopic surgery (TONES) was developed to decrease these risks and provide a novel way to reach the anterior skull base.

• TONES has previously been reported in cadaveric and clinical studies. It has been used for a wide variety of orbital and intracranial pathology.

• It allows for a multi-angled approach to skull base lesions. Two surgeons can work simultaneously in a coplanar manner.

5

Background

• Common Indications for TONES» Cerebrospinal fluid leaks

» Trauma of the anterior skull base

» Benign masses/lesions

» Encephaloceles

» Infectious/inflammatory processes

» Malignancy

6

3

Background

• Four approaches have been described:» Precaruncular

• Allows for medial access to the cavernous sinus, cavernous carotid artery, optic nerve, and structures of the central corridor

» Preseptal lower eyelid• Useful for access to pathology of the orbital

floor or maxillary sinus

» Lateral retrocanthal• Access to the deep lateral orbit, lateral portion

of the frontal fossa, infratemporal fossa, middle cranial fossa

7

Background

» Superior eyelid crease (SLC)• Can be used for orbital roof fractures, pathology

of the frontal sinus, and for access to the anterior cranial fossa

• At our institution, the SLC approach is the primary technique used during TONES

8

Objectives

• Delineate the SLC approach of TONES used at our institution.

• Describe the outcomes of TONES using the SLC approach at our institution.

9

4

Methods

• IRB approved retrospective study of all patients who underwent TONES at our institution from May 2017 through May 2018.

• Collected data included: » Demographics

» Outcomes• Intraoperative details

• Intraoperative/Postoperative complications

• Length of follow-up

• Pathologic diagnoses

10

The SLC Approach

• This coronal CT shows an encephalocele within the right frontal sinus

• The superior eyelid crease incision was marked out. The incision was made and carried through the orbicularis oculi. The dissection proceeded in a strictly preseptal plane to avoid orbital fat and to preserve the levator aponeurosis. A subperiosteal plane was developed and the orbital roof was drilled out until the frontal sinus was visualized.

11

The SLC Approach

• The encephalocele was identified and decompressed. This image shows a transorbital view of the decompressed encephalocele.

• The remaining defect was repaired with Alloderm in underlay fashion, followed by a middle turbinate free mucosal graft, and then again with Alloderm in overlay fashion.

12

5

Results

N 11

Age 45.3 +/- 19.2 y

Gender 36.4% female

Follow-up 87.6 +/- 77.3 d

Approach SLC approach (n=11)

ComplicationsV1 numbness (n=1)

Temporary diplopia (n=2)

Mortality None

Recurrence None

13

Results

• Biopsy was the goal in 5 patients.

• Gross total resection was the goal in 6 patients.

• Successful in 5 patients.

• 2 out of 5 required extension of SLC incision medially to Lynch incision.

• Failure in 1 patient with intradural abscess.• Required separate frontal craniotomy.

14

Results

Pathologic Diagnosis N (%)

Encephalocele 3 (27.3%)

Mucocele 1 (9.1%)

Inverted Papilloma 2 (18.2%)

Ossifying Fibroma 1 (9.1%)

Metastatic Prostate Adenocarcinoma 1 (9.1%)

Langerhans Cell Histiocytosis 1 (9.1%)

Intradural Abscess 1 (9.1%)

Fungal Infection 1 (9.1%)

15

6

Discussion

• TONES via the SLC approach has been increasingly used at our institution to treat a large variety of pathology, showing its wide applicability.

• There have been no major complications, recurrences, or incidences of mortality.

• Thus, TONES can be successfully utilized for both biopsy and gross total resection of anterior skull base lesions.

16

Discussion

• Limitations

» Small subject population

» Lack of a formal statistical analysis of outcomes and comparison to more conventional techniques

» Retrospective nature of study

17

Conclusions and Future Directions

• TONES via the SLC approach has proven to be a reliable technique with a high success rate at our institution.

• Future studies will have larger patient populations, thus providing greater statistical power.

• Eventually, the outcomes of this approach will be compared to those of the traditional endoscopic endonasal approach.

18

7

References1. Krischek B, Carvalho FG, Godoy BL, et al. From craniofacial resection to endonasal endoscopic removal of malignant tumors of the anterior skull base. World Neurosurg 2014;82:S59-65.

2. Lee JT, Kingdom TT, Smith TL, Setzen M, Brown S, Batra PS. Practice patterns in endoscopic skull base surgery: survey of the American Rhinologic Society. Int Forum Allergy Rhinol. 2014;4:124–131.

3. Verillaud B, Bresson D, Sauvaget E, et al. Endoscopic endonasal skull base surgery. Eur Ann Otorhinolaryngol Head Neck Dis 2012;129:190-6.

4. Zanation AM, Thorp BD, Parmar P, et al. Reconstructive options for endoscopic skull base surgery. Otolaryngologic clinics of North America 2011;44:1201-22.

5. Kasemsiri P, Carrau RL, Ditzel Filho LF, et al. Advantages and limitations of endoscopic endonasal approaches to the skull base. World Neurosurg 2014;82:S12-21.

6. Moe KS, Bergeron CM, Ellenbogen RG. Transorbital neuroendoscopic surgery. Neurosurgery 2010;67:ons16-28.

7. Balakrishnan K, Moe KS. Applications and outcomes of orbital and transorbital endoscopic surgery. Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery 2011;144:815-20.

8. Ramakrishna R, Kim LJ, Bly RA, et al. Transorbital neuroendoscopic surgery for the treatment of skull base lesions. J Clin Neurosci 2016;24:99-104.

9. Moe KS, Kim LJ, Bergeron CM. Transorbital endoscopic repair of cerebrospinal fluid leaks. Laryngoscope 2011;121:13-30.

10. Lim JH, Sardesai MG, Ferreira M, Jr., et al. Transorbital neuroendoscopic management of sinogenic complications involving the frontal sinus, orbit, and anterior cranial fossa. J Neurol Surg B Skull Base 2012;73:394-400.

11. Bly RA, Ramakrishna R, Ferreira M, et al. Lateral transorbital neuroendoscopic approach to the lateral cavernous sinus. J Neurol Surg B Skull Base 2014;75:11-7.

12. Rivkin MA, Turtz AR, Morgenstern KE. Transorbital endoscopic removal of posterior lateral orbital mass. Laryngoscope 2013;123:3001-4.

13. Gardner PA, Kassam AB, Rothfus WE, et al. Preoperative and intraoperative imaging for endoscopic endonasal approaches to the skull base. Otolaryngologic clinics of North America 2008;41:215-30, vii.

14. Haerle SK, Daly MJ, Chan HH, et al. Virtual surgical planning in endoscopic skull base surgery. Laryngoscope 2013;123:2935-9.

19

Thank you for your attention.

20

1

TAWF IQ KHOURY MD

MAR ISA A . RYAN MD, MPH

MATTHEW G . CROWSON MD

CL I F FORD BROWN MD

JAY MCLENNEN AOCA , CCA , CFM

DAVID KAYL I E MD

E I LEEN M. RAYNOR MD

Osseointegrated implants for ear prostheses: A cost‐effective alternative to autologous repair

1

NONE

Disclosures

2

Outline

• Patients

• Autologous repair

• Osseointegratedimplants

• Cost comparison

• Summary

3

2

Children are born with ear defects

Patients Autologous Repair Implants Cost Comparison Summary

Affects 1/3000 live births

90% are associated with hearing loss

Hispanic, Asian, and Native American ancestry increases the risk for these disorders by 2‐3 fold

4

We remove ears to cure cancer


5

Accidents happen


6

3

Autologous repair requires multiple surgical stages


7

Autologous repairs can fail


8

Extreme Ear Anatomy

Beauty is subjective

9

4

Anaplastologists create life‐like prostheses out of silicone


10

Patients Autologous Repair Implants Cost Comparison Summary11

Adhesive retained prostheses have downsides

Inconsistent bonding

Removal for water and contact sports

Difficult positioning

Skin damage

Decreased lifetime of prosthesis


12

5

Osseointegrated implants simplify prosthesis retention


13

Hearing rehabilitation is often necessary


14

BAHA can be placed at the same surgery


15

6

Good cosmetic and functional outcome


16

Good cosmetic and functional outcome


17

Autologous Autologous Osseointegrated implantOsseointegrated implant

11.6 years – Mean Age

5/9 female, 4/9 male

40.7 years – Mean Age

7/16 female, 9/16 male

Demographics


18

7

Autologous Autologous Osseointegrated implantOsseointegrated implant

8/9 Anotia/microtia

0/16 Cancer

1/9 Trauma

6/16 Anotia/microtia

8/16 Cancer

2/16 Trauma

Indications


19

AutologousAutologous Osseointegrated implantOsseointegrated implant

$3,229 each surgery $7,302 each surgery

Implants can be more cost‐effective


20


$3,229 each surgery

$10,047 each ear

$7,302 each surgery

$6,491 each ear



21

8


$3,229 each surgery

$10,047 each ear

$7,302 each surgery

$6,491 each ear


Mean cost savings of $3556 per ear


22


$3,229 for each surgery

$10,047 for each ear

$7,302 for each surgery

$6,491 for each ear


After excluding bilateral cases, the cost per implanted ear increases to $7304 and the cost savings is $2743.

Mean cost savings of $3556 per ear


23


$6385 OR Costs

$1832 Room Fees

$5,141 Prosthesis

$1,676 OR Costs

What goes into the cost?

OR Costs64%

Room Fees18%

Other18%

Prosthesis70%

OR Costs23%

Other7%


24

9


3.1 surgeries per patient 1 per patient

Implants require fewer surgeries

About 2 fewer surgeries per patient


25

CostCost ChargeCharge

Surgical Template: $2,948

3mm Drill Burr: $5

OR time: $361

Cost vs Charge – a caveat in interpreting the data

Patients Autologous Repair Prosthetic Implants Cost Comparison Summary

26



3mm Drill Burr: $5

OR time: $361

Cost vs Charge


3mm Drill Burr: $946

OR time: $1,826


27

10



3mm Drill Burr: $5

OR time: $361

Cost vs Charge


3mm Drill Burr: $946

OR time: $1,826

The two metrics are not comparable.Costs also exclude all services not billed by the hospital.


28


Unilateral

Lower half of ear intact

Poor manual dexterity

Inability to follow‐up

Bilateral

Need for hearing aid

Failed autologous reconstruction

Elderly

Radiation of the area

High operative risk

Patients should have a choice


29

Summary

Autologous repair and osseointegrated implants are both good options for ear reconstruction.

Osseointegrated implants can be more cost‐effective and require fewer surgeries.

Patients should be able to choose the option that is best for them.

Surgeons should guide patients to understand the relative benefits of each.

Future studies can compare patient perception of cosmetic outcomes with these procedures.


30

1

Alexander W. Murphey, MDWilliam Clinkscales, MD

Samuel L. Oyer, MD Department of Otolaryngology- Head and Neck Surgery

Masseteric Nerve Transfer for Facial Nerve Paralysis

Systematic Review and Meta Analysis

Presenter Disclosure Information

Alex Murphey

No relationships to disclose

2

Masseteric Nerve Transfer• Described by Spira in 1978, used to power neuromuscular flap• ‘Babysitter’ nerve due to rapid innervation time

• Increasing popularity as primary procedure• Rapid recovery• Proximity to facial nerve • Limited morbidity • Ease of activation

• Role: Restores dynamic movement

in short term paralysis

3

2

Masseteric Nerve Transfer

4

Objectives

• Systematically review available literature on isolated masseteric to facial nerve transfer in the treatment of facial paralysis.

• Evaluate pooled results across studies to measure quantitative and qualitative changes in facial paralysis following surgery

5

MethodsData Sources: PubMed‐NCBI and SCOPUS

Inclusion Criteria:1. Masseter nerve transfer to facial nerve without muscle flap or

other cranial nerve transposition

2. Facial paresis and paralysis in human subjects regardless of the cause or severity

3. Study included 4 or more total patients.

Exclusions:

‐ Masseter nerve transfer with additional cranial nerve transposition

‐ Masseter nerve transfer as part of free muscle flap6

3

Outcome measures

Qualitative• Facial analysis scoring systems• Complication rates• Spontaneous smile

Quantitative• Time from surgery to first facial movement• Oral Commissure excursion• Smile Asymmetry

7

PRISMA Flow

DiagramRecords identified through

PubMED/SCOPUS database search(n = 1096)

Records screened for titles and abstracts/duplicates removed

(n = 1096)

Full text articles assessed for eligibility (n=27)

Articles excluded(n=1069)

Articles excluded(n=14)

Identification

Screening

Eligibility

Studies included in quantitative synthesis (meta‐analysis) (n=13)

Included

8

Search Results

• 13 studies met inclusion criteria

• Type of Paralysis: Complete vs. Incomplete

• Outcomes Measures: Qualitative vs Quantitative

• Interposition Graft

• Facial nerve branch target: ‐Main trunk vs. Zygomatic/Buccal

9

4

Author (Year) NFacial Nerve

TargetInterposition

GraftLevel of Evidence

Pavese 11 Main Yes 4

Albathi 14 Main No 3b

Biglioli 20 Main Yes 4

Sforza (2014) 14 Main Yes 4

Bianchi 4 Main No 4

Sforza (2012) 7 Main Yes 4

Wang 16 Z/B No 4

Hontanilla (2013) 23 Z/B No 4

Klebuc 10 Z/B No 4

Faria 10 Z/B No 4


Socolovsky 15 Z/B No 4


Demographics

• Total Population: 183 patients (53.5% Female)

• Mean age: 43 (± 12.2) years

• Duration of paralysis: 14 (± 6) months

• Follow up exam after surgery: 22 (± 7.6) months

• Etiology of paralysis: CPA Tumors (81%)

– trauma, cholesteatoma, infection, parotid cancer, AVM11

Results1. Qualitative:

• Facial analysis scoring systems• Spontaneous smile

2. Quantitative:• Oral Commissure excursion• Time from surgery to first facial movement

3. Intergroup Analysis• Facial nerve branch targets• Use of interposition nerve graft

12

5

Study Qualitative Scale Scoring System Results (SD/R)

Albathi Smile Recovery Score 1 (Poor) to 5 (Excellent) 3.2 (0.6)

House Brackmann 1 to 6 (Complete Paralysis) 2.9 (0.7)

Wang Terzis Smile Function

1 (No contraction) to 5 (Full

contraction, symmetric smile) 3.8 (1.1)

Sforza

(2014)

Modified House

Brackmann

1 to 6 (No movement/disfiguring

synkinesis) 2.4 (1.5)

Bianchi Terzis Smile Function

1 (No contraction) to 5 (Full

contraction, symmetric smile) 3 (1)

Biglioli

Modified House

Brackmann

1 to 6 (no movement/disfiguring

synkinesis) 2.5 (1.1)

Socolovsky

House Brackmann 1 to 6 (Complete Paralysis) 3.9

POFRA

0 to 12 (Normal movement/no

synkinesis) 6.55

Pavese Facial Disability Index

0 to 100 (Complete physical function

or social well being) P ‐70, S ‐76

Sunnybrook Facial 0 to 100 (Normal Facial Function) 54 (46‐59)13

Spontaneous Smile• 7 studies reported spontaneous smile

• Present in 23% (25/108 pts)

• Definition of spontaneity:• Home video recording of patient watching funny video (n=1): 56%

• Self report of smile during laugh (n=2)• Ability to smile without effortful jaw clench (n=4)

• Quicker onset and higher rate of spontaneous smiles seen among females in one study

14



2. Quantitative:• Oral Commissure excursion• Time from surgery to first facial movement


15

6

Oral Commissure Excursion

Author N Measurement ScaleImprovement

(mm), [SD]

Sforza

(2012)7

Intensity of 3D vector of max

displacement for specific facial markers

for smile7.2

Sforza

(2014)14

Intensity of 3D vector of max

displacement for specific facial markers

for smile (clenching)8.5

Hontanilla 23Difference between max and minimum

commissure displacement 7.9 [3.8]

Klebuc 10Difference between max and minimum

commissure displacement 12.4 [2.2]

16

Time to Nerve RecoveryStudies N MD ci‐ ci+ z p w

Pavese 11 7.5 5.25 9.75 6.55 <0.01 8.27%

Albathi 14 5.6 4.4 6.8 9.11 <0.01 10.07%

Biglioli 20 6.2 5.27 7.13 13.08 <0.01 10.44%

Sforza (2014) 14 6 4.43 7.57 7.48 <0.01 9.48%

Bianchi 4 3.8 2.33 5.27 5.07 <0.01 9.65%

Sforza (2012) 7 6 4.52 7.48 7.94 <0.01 9.63%

Wang 16 3.4 2.47 4.33 7.16 <0.01 10.44%

Hontanilla (2013) 23 2.2 2.04 2.36 26.38 <0.01 11.02%

Klebuc 10 5.3 4.25 6.35 9.86 <0.01 10.28%

Faria 10 4.3 3.62 4.98 12.36 <0.01 10.71%

129 4.95 3.66 6.24 7.52 <0.01 100%

Q I2

CI‐ CI+

214.90 95.8% 93.9% 97.1%17



2. Quantitative:• Time from surgery to first facial movement• Oral Commissure excursion


18

7

Time to Nerve RecoveryN Time (mos) MD Significant

Distal 59 3.76Main 70 5.76

Interposition graftYes 52 6.24No 77 4.06

Yes 52 6.24No 18 4.75

Facial nerve branch

1.99 No

2.18 Yes

Main trunk interposition graft

1.49 No19

Complications• Incidence was low 6.5% (12/183 pts)

• Most were minor and transient• Sialocele (n=1)• Hematoma/bleed (n=2)• Surgical site infection (n=2)• Masseter atrophy (n=4)

• Discomfort with mastication (n=2)• Otitis externa (n=1)

• Overall, no significant jaw/chewing weakness reported20

Limitations• Included studies involved small case series without control arms

•Lack of standardized scales and consistent outcomes

•Post‐operative facial rehabilitation was not standardized

21

8

Discussion• Growing patient experience supporting masseteric nerve transfer as dynamic reanimation option in short term paralysis

• Faster recovery and less morbidity than hypoglossal transfer

• Interposition graft not routinely needed• Standardization of outcomes would aid understanding

• Future Questions ?• Optimal time frame for transfer (incomplete paralysis)• Predictors of sub‐optimal results (when to utilize neuromuscular flap)

• Definition of spontaneous smile (what matters to patients and observers)

• Optimal rehabilitation protocols

22

Take home points…•Masseter nerve transfer improves quantitative smile production and qualitative patient and physician scores of facial function

• Onset of motion occurs on average 5 mos post op

• Smiles may be spontaneous or without conscious clench in 23%

• Functional deficits are minimal and side effects are uncommon (6.5%)

23

Special Thanks!Dr. Sam Oyer

Dr. William Clinkscales

24

9

References1. Sforza, C., et al., Facial reanimation with masseteric to facial nerve transfer: a three-dimensional longitudinal

quantitative evaluation. J Plast Reconstr Aesthet Surg, 2014. 67(10): p. 1378-86.

2. Faria, J.C., G.P. Scopel, and M.C. Ferreira, Facial reanimation with masseteric nerve: babysitter or permanent procedure? Preliminary results. Ann Plast Surg, 2010. 64(1): p. 31-4.

3. Biglioli, F., et al., Masseteric-facial nerve neurorrhaphy: results of a case series. J Neurosurg, 2017. 126(1): p. 312-318.

4. Albathi, M., et al., Early Nerve Grafting for Facial Paralysis After Cerebellopontine Angle Tumor Resection With Preserved Facial Nerve Continuity. JAMA Facial Plast Surg, 2016. 18(1): p. 54-60.5

5. Bianchi, B., et al., The masseteric nerve: a versatile power source in facial animation techniques. Br J Oral Maxillofac Surg, 2014. 52(3): p. 264-9.

6. Hontanilla, B. and A. Cabello, Spontaneity of smile after facial paralysis rehabilitation when using a non-facial donor nerve. J Craniomaxillofac Surg, 2016. 44(9): p. 1305-9.

7. Hontanilla, B. and D. Marre, Masseteric-facial nerve transposition for reanimation of the smile in incomplete facial paralysis. Br J Oral Maxillofac Surg, 2015. 53(10): p. 943-8.

8. Hontanilla, B., D. Marre, and A. Cabello, Masseteric nerve for reanimation of the smile in short-term facial paralysis. Br J Oral Maxillofac Surg, 2014. 52(2): p. 118-23.

9. Klebuc, M.J., Facial reanimation using the masseter-to-facial nerve transfer. Plast Reconstr Surg, 2011. 127(5): p. 1909-15.

10. Pavese, C., et al., Rehabilitation and functional recovery after masseteric-facial nerve anastomosis. Eur J PhysRehabil Med, 2016. 52(3): p. 379-88.

11. Sforza, C., et al., Facial movement before and after masseteric-facial nerves anastomosis: a three-dimensional optoelectronic pilot study. J Craniomaxillofac Surg, 2012. 40(5): p. 473-9.

12. Socolovsky, M., et al., Treatment of complete facial palsy in adults: comparative study between direct hemihypoglossal-facial neurorrhaphy, hemihipoglossal-facial neurorrhaphy with grafts, and masseter to facial nerve transfer. Acta Neurochir (Wien), 2016. 158(5): p. 945-57

13. Wang, W., et al., Masseter-to-facial nerve transfer: a highly effective technique for facial reanimation after acoustic neuroma resection. Ann Plast Surg, 2014. 73 Suppl 1: p. S63-9.

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Documents

2018 ASSEMBLY...113th Congress (2013 – 2015) From 2013‐2015 there were 21 physicians in U.S.Congress, 20 of whom were male and 17 were members of the Republican party. 114th Congress