Soundings PUBLISHED IN THE INTEREST OF OUR MEMBERS AND THEIR PATIENTS
President’s Message Ahmed M.S. Soliman, MD
sustained efforts, the PAO-HNS has also secured the support of the AAO-HNS leadership in this battle. The AAO-HNS has just sent a letter directly to IBC also demanding repeal of the policy and are awaiting their response. To view a copy of the letter online, please visit www.otopa. org/ibcletters.html. The fight is ongoing, but we are hopeful given Anthem’s recent revocation of a similar policy.
I would like to thank the entire PAO-HNS council for all their hard work this year. Our promise to you is that we will all continue our efforts on behalf of Pennsylvania Otolaryngologists and our patients. It has indeed been a very busy year for the PAO-HNS so far, and I have certainly hit the ground running. On the advocacy front, much effort has been focused on IBC’s recently implemented policy to reimburse an Evaluation and Management (E/M) service appended with Modifier 25 at 50 percent when it is performed with a procedure having a 0- or 10-day post-operative period. Our strategy has been multipronged: 1. We have drafted and sent a letter directly to IBC explaining our position and demanding the immediate revocation of this ill-advised policy. To view a copy of the letter online, please visit www.otopa. org/ibcletters.html. 2. We have partnered with PAMED who has also sent multiple communications and is currently vetting practices for face to face meetings with the IBC leadership; several of our members will be meeting with IBC to explain how the policy has negatively affected their practice. 3. Through
Legislatively, the PAO has been actively engaged with the Pennsylvania Academy of Audiology in drafting new legislation to govern hearing aid dispensing in the state. Talks have started and are ongoing; Drs. John McGinn and Brian McKinnon’s efforts and expertise have been invaluable in these negotiations. We have also been working closely with the Pennsylvania Association of Physician Assistants and PAMED to revise the current legislation governing supervisory guidelines. The PAO-HNS has joined multiple state societies in signing an Amicus Brief to the Pennsylvania Supreme Court that opposes their recent decision to not allow known complications as stated in the informed consent to be included as evidence in medical malpractice cases. We will keep you abreast of developments in these issues as they unfold.
Planning for our annual meeting is in full swing under the leadership of Jessyka Lighthall, MD. Sessions on Clinical Practice Guidelines and Patient Safety are on the schedule, as well as the ever-popular Resident Bowl. Dr. James Denneny, the Executive Director of the AAO-HNS will be joining us again this year to discuss the new CMS reporting guidelines. A hands-on session will include ultrasound guided biopsies, sialoendoscopy, endoscopic eustachian tube dilation, and minimally invasive nasal valve surgery. There will also be an inaugural Women in Otolaryngology Pennsylvania Section reception and networking event on Friday before dinner. This year’s venue, Kalahari Resort & Conventions, is a new one for the PAO-HNS and promises to be a great location for education and fun as well. Please register ASAP to join us for this fantastic event. Our website has been updated, and under the leadership of Michael Ondik, MD, clinical content for patients is under development, and will be ready for unveiling at the Annual Meeting. Visit www.otopa.org to see the new design and features. Finally, I would like to thank the entire PAO-HNS council, our executive director Jen Keeler and her dedicated team, as well as our Government Relations firm, Milliron & Goodman, for all their hard work this year. Our promise to you is that we will all continue our efforts on behalf of Pennsylvania Otolaryngologists and our patients. See you at Kalahari! Sincerely, Ahmed M.S. Soliman
BOARD OF GOVERNOR’S UPDATE
content Spring 2018
Karen Rizzo, MD, FACS, Board of Governor Representative, PAO-HNS
The Annual Leadership Forum and Board of Governor’s Spring Meeting recently took place in Alexandria, VA. It included a weekend of discussions, BOG meetings, informative speakers, advocacy updates, and mentoring/ networking opportunities. Our PAO President, Dr. Soliman, and PAO Executive Director, Jen Keeler, also attended the Interactive State OTO Society Roundtable meeting representing our State Society on Friday, March 9. A new email process has been approved to facilitate enhanced communication between the AAO-HNS and state and local Societies. Other 2018 state trends the AAO-HNS continues to monitor include scope of practice issues with audiologists/ SLP’s, hearing aid dispensers, dentists, advance practice nurses, physician assistants, and pharmacists. AAO-HNS federal legislative accomplishments include: 1. Increased visibility of World Hearing Day on March 3. 2. Repeal of the IPAB (Independent Payment Advisory Board) effective February 2018. 3. Defeat of proposed cuts to Medicare physician payments. 4. Secured funding for Early Hearing and Detection Intervention (EHDI) programs effective October 2017. 5. Urging Congress to promulgate rules to implement information blocking protections included in the 21st Century Cures Act to facilitate the transfer of patient data to clinical registries such as Reg-ent. 6. The AAO-HNS strongly opposed the “Audiology Patient Choice Act” (H.R.2276/S.2575) which inappropriately expands audiologist’s scope of practice, granting direct access to Medicare patients by removing current physician referral requirements and reclassifies audiologists as “limited license physicians” under Medicare.
Certification/MOC. Dr. Nussenbaum from the American Board of Otolaryngology discussed possible new changes impacting our specialty and the potential for Cert/Link a new process that will serve as an alternative to the “high stakes” exam. This new process will not involve extra cost, will be quick and convenient, and involve practice relevant questions. Medical Liability Reform, Balanced Billing, and Telemedicine all continue to be followed by the State Trackers system. Discussion on Unconscious/Implicit Bias and how it influences recruitment, interviewing, selection, and hiring was done. The importance of enhancing diversity and promoting meritocracy was discussed. Sessions regarding improving patient communication, resolving workplace conflict, and complications in clinical practice also occurred. The AAO continues to support Private Payer Advocacy through its 3P’s committee. Recent input into United Health Care’s policies for Balloon Sinus Dilation, Hearing Aids, and Implantable Devices was done. Additional input was also provided for Blue Cross/Blue Shield’s policy on Vocal Cord Injectable Agents and Eustachian Tube Balloon Dilation. The AAO impacted the reversal of Anthem’s policy on Balloon Sinus Dilation and the Modifier 25 Payment Reduction. It provided input on Flexible Laryngoscopy Policy, Sex Reassignment, and Eustachian Tube Balloon Dilation. Additional information on these topics and more can be found on the Academy website www.entnet.org. The next Leadership Spring Forum will be April 26-28, 2019 in Alexandria, Va. The potential to send an interested resident to this meeting is currently being considered and more information is forthcoming.
Broader medicine issues followed by the AAO-HNS include Board
Soundings accepts classified advertisements, however, there is no guarantee that they will be published. All submissions are subject to review. The advertisement should be of interest/pertain to otolaryngologists, their practice, and health care in Pennsylvania. Submissions that are self-promotional or commercial in nature will not be accepted. Publication of advertising does not imply endorsement of the products advertised or the statements contained in such advertising by Soundings or the PAO-HNS. The opinions expressed in this newsletter do not necessarily reflect the opinion of PAO-HNS.
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SOUNDINGS | Spring 2018
1 President’s Message 2 Board of Governor’s Update 3 Update on Imaging in the Diagnosis and Management of Necrotizing Otitis Externa 4 Pediatric Deep Space Neck Infections 6 Ocular Management in Facial Paralysis 8 HPV-Associated Oropharynx Cancer Prevention: Trends in HPV Vaccination Recommendations by Primary Care Practitioners 10 AJCC-8ed Staging System Better Prognosticates Surgically Managed HPV-Positive Oropharyngeal Cancer 12 Legislative Update 13 A Low-Cost, High Fidelity Stapedotomy Simulator for the Training of Otolaryngologists 14 What Can We Learn from Analysis of Pennsylvania Patient Safety Reporting System (PA-PSRS) Data?
President Ahmed M.S. Soliman, MD Temple Otorhinology Associates Kresge West Building 3440 N Broad St Fl 1 Philadelphia, PA 19140-5104 President-Elect Johnathan D. McGinn, MD Division of Otolaryngology – Head & Neck Surgery Penn State College of Medicine-Hershey 500 University Drive, MC H091 Hershey, PA 17033-2360 Secretary-Treasurer David M. Cognetti, MD FACS Otolaryngology-Head & Neck Surgery 925 Chestnut St Fl 6 Philadelphia PA 19107-4204 Administrative Office 777 East Park Drive, PO Box 8820 Harrisburg, PA 17105-8820 717-558-7750 ext. 1519 717-558-7841 (fax) Visit our website at www.otopa.org
Update on Imaging in the Diagnosis and Management of Necrotizing Otitis Externa Timothy Cooper, MD, FRCSC; Andrew A. McCall, MD; Barton F. Branstetter, IV, MD; Barry E. Hirsch, MD
Necrotizing otitis externa (NOE) describes an invasive infectious process and osteomyelitis of the temporal bone.1 Patients present with chronic severe otalgia and otorrhea and in advanced cases may have cranial nerve deficits.2 Similar to otitis externa, Pseudomonas aeruginosa is the most common pathogen cultured in cases of NOE.3 However, an increasing number of non-Pseudomonal NOE cases are being reported.4 The diagnosis of NOE relies on sound clinical judgement combined with laboratory studies and imaging. Physical exam may demonstrate granulation tissue at the bony-cartilaginous junction of the external auditory canal and pain out of proportion to the objective findings.1 Elevated inflammatory markers such as erythrocyte sedimentation rate (ESR) may further support a diagnosis of NOE.2 Imaging studies are routinely ordered both to support the diagnosis of NOE as well as to assess for clinical response to therapy. Treatment consists of 6-8 weeks of systemic antibiotic therapy.2 Antibiotics should be culture directed and often ciprofloxacin is the treatment of choice in sensitive Pseudomonas species.5 In patients with persistent granulation tissue despite an appropriate course of antibiotics, a biopsy is required to rule out malignancy.1 Commonly used imaging modalities in the diagnosis and management of NOE are computed tomography (CT), contrast enhanced magnetic resonance imaging (MRI), and nuclear medicine studies
including technetium-99 and gallium-67 scans. Selection of imaging studies depends on several factors including clinical judgement, the inherent strengths of the imaging modality considered, and availability of the studies. CT scans are sensitive for detecting bony erosion, decreased skull-base density and soft tissue abscesses.1,6 MRI is useful in evaluating soft tissue in detail including early medullary bone changes, dural involvement, and intracranial extension.6 Technetium-99 scans are highly sensitive in the diagnosis of temporal bone osteomyelitis but remain positive after resolution of infection.2,7 Gallium concentrates in areas of active infection by binding to leukocytes and forming a gallium-lactoferrin complex.8 As such, gallium-67 scans demonstrate areas of active infection and can be used to assess for resolution of NOE.7 Historically, nuclear medicine studies including technetium-99 and gallium-67 scans have been described as key studies in the diagnosis of NOE and in determining resolution of infection. However, with improvement in crosssectional imaging modalities, CT and MRI have become more heavily relied upon in the management of patients with NOE. A recent survey of 136 neurotologists and head and neck radiologists distributed through the American Neurotology Society and the American Society of Head and Neck Radiology characterizes the current use of imaging in the diagnosis and management of NOE.9
The results of the survey suggest heterogeneity in clinical practice. CT was identified as the imaging modality of choice for establishing a diagnosis of NEO by 37.5% of respondents followed by technetium scintigraphy (21.3%) and CT and MRI in combination (16.9%). MRI was selected by 41.9% of participants in the survey as the imaging modality of choice for determining the extent of disease. Gallium scanning was the most commonly used imaging modality to assess response to therapy (30.9%) followed closely by MRI (28.7%). When asked regarding the imaging modality used to determine when to cease medical therapy, gallium scanning was the most common choice (32.4%), although an almost equal number of respondents (29.4%) indicated that they did not use imaging for this purpose. Many of the participants indicated that they did not use technetium scintigraphy (39.5%) or gallium scans (42%) in the
diagnosis and management of NOE. In comparison, CT and MRI were always or frequently used by 95.5% and 72.9% of respondents, respectively. The institutional practice at University of Pittsburgh uses CT and MRI as the primary imaging modalities in NOE. A high-resolution CT scan of the temporal bones is used to confirm the diagnosis when NOE is clinically suspected. MRI is also frequently obtained at the time of initial presentation in order to determine the extent of disease and softtissue involvement. Symptom resolution including decreased pain, improvement of clinical examination, and normalization of laboratory values such as ESR, c-reactive protein (CRP), and leukocytosis are the main indicators used to assess response to treatment. MRI is the imaging modality utilized when the clinical picture is unclear regarding response to therapy and resolution of infection. Nuclear www.otopa.org | PAO-HNS
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medicine scans are not regularly used in either the diagnosis or management of patients with NOE in our clinical practice. The diagnosis and management of NOE requires sound clinical judgement and appropriate use of adjunctive laboratory and imaging studies. There is significant variation in the use of imaging in patients with NOE, although recent survey data suggests that many clinicians are relying on CT and MRI in place of nuclear medicine studies. For a list of references, visit www.otopa.org/references.html
INTERVENTIONAL SIALENDOSCOPY
Pediatric Deep Space Neck Infections Jillian Mattioni, DO; Sri Kiran Chennupati, MD, FAAP
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The clinical presentation of DSNI widely overlaps with other diseases commonly encountered in children such as tonsillitis, viral pharyngitis, and lymphadenitis, which may confuse physicians and lead them to make incorrect diagnoses.3 Additionally, physical examination and communication of symptoms may be difficult in the pediatric population. As a result, a concise history and physical examination are both vital in identifying the presence, source and any complications of infection.4 DSNIs often present with a prodromal illness with upper respiratory tract symptoms, with or without fever, which progresses to include decreased oral intake, neck pain, swelling of the cervical lymph nodes, and limitation in neck range of motion with or without trismus, which may be associated with either a deep neck space cellulitis or abscess formation.5
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Deep space neck infections (DSNIs) are of particular interest in the pediatric population. Epidemiological studies from the United States estimated the national incidence of DSNI to be 4.6 per 100,000 children, and most cases are reported to occur in children under 6 years of age.1 DSNIs can have a rapid onset and cause serious complications such as airway obstruction, jugular vein thrombosis, and mediastinal involvement, leading to potential mortality and morbidity.2 As such, the priority should be identification and management of possible airway compromise followed immediately by medical and/or surgical management.
SOUNDINGS | Spring 2018
OHNS-D41669-EN-F
DSNIs occur along defined fascial planes and can spread through potential spaces created by these planes. Infection in one space can spread to another space as well as to connecting regions, such as the mediastinum and along the vertebral spine. Because of the complex anatomy of the head and neck and the subtle symptoms of the children, a high index of suspicion is necessary to prevent failures in diagnosis.6 Multiple deep neck spaces lie within the layers of cervical fascia and as long as their natural points of resistance along communicating fascial boundaries are not overcome, they serve to contain DSNIs.7 Of particular interest in the pediatric
Epidemiological studies from the United States estimated the national incidence of DSNI to be 4.6 per 100,000 children, and most cases are reported to occur in children under 6 years of age.
population, the parapharyngeal space is just lateral to the peritonsillar region and extends from the skull base to the hyoid. The space is divided into prestyloid and poststyloid compartments with the poststyloid containing cranial nerves 9-12, the carotid, sympathetic chain and internal jugular vein. Posteromedial spread of infection from here can go into the retropharyngeal space. Inferolateral spread from the parapharyngeal space can go into the masticator and submandibular spaces. The retropharyngeal space spreads from the skull base to the tracheal bifurcation. Lymph nodes in this area are much more common in children, which is why retropharyngeal space infections are more prevalent. The danger space lies just posterior to the retropharyngeal space, which extends from the skull base to the diaphragm.
imaging is reported to have an accuracy of 89% of differentiating a drainable abscess from cellulitis.11 Ultrasound is a useful tool especially in the pediatric population as there is no radiation exposure. Ultrasound has a reportedly more accurate role than CT imaging in differentiating a drainable abscess from cellulitis.4 However, ultrasound does not easily delineate the spaces of the neck or allow diagnosis of deeper neck space infections. Although magnetic resonance imaging (MRI) yields better soft tissue definition and also does not require radiation, in the pediatric population, a general anesthetic is often necessary and therefore MRI is not ideal. If necessary, magnetic resonance angiography (MRA) is used to evaluate potential vascular complications, such as internal jugular vein thrombosis and carotid artery aneurysm or rupture.4
Sources of DSNI in pediatric cases include tonsillitis, pharyngitis, hematogenous, and suppurative cervical adenitis compared with adult DSNI, which often have an odontogenic origin.4 The organisms commonly isolated in DSNIs are Staphylococcus aureus and group A Streptococcus.4 Anaerobic species include Fusobacterium, Peptostreptococcus, and Porphyromonas.8 However, cultures of aspirated fluid are usually polymicrobial, reflecting the wide spectrum of organisms in the oral cavity.8 Laboratory work up traditionally includes a complete blood count with differential and cultures when available. Although an elevated white blood cell count is helpful in suggesting an infectious process, it is not significantly associated with the success of medical versus surgical management.9 In addition to aerobic and anaerobic cultures, fungal and acid-fast cultures are required in immunocompromised patients.4 Cultures for atypical causes such as mycobacteria should be considered where there is clinical suspicion.4 The management of a DSNI is highly dependent on the location and extent of deep neck involvement, and it is argued that diagnostic imaging is essential in nearly every case (Veira). Lateral neck radiographs have been used historically to screen for retropharyngeal and parapharyngeal abscesses.4 However, after Nagy and Backstrom reported a 83% sensitivity compared with a 100% sensitivity of contrast enhanced computed tomography (CT) imaging, the use of lateral neck radiographs was advised against.10 When combined with thorough clinical examination, CT
for optimal empiric coverage.7 Rates of MRSA infections are higher in younger children and therefore initial empiric antibiotic therapy with clindamycin should be considered.12 Surgical management is advised when patients have clinical deterioration even under intravenous antibiotics in the first 24 to 48 hours.6 An abscess size greater than 20 mm is associated with a tendency to fail exclusive medical treatment.6 Also, younger children, especially those less than 15 months of age, tend to require surgical drainage.9 Furthermore, the presence of airway obstruction and multiple abscess sites have been reported in association with severe infections and complicated clinical courses, which may lead to an undesired outcome if early surgical intervention does not occur.6 When surgical intervention is necessary, the DSNI can be approached from a transoral or lateral direction. A transoral approach is often effective in treating most parapharyngeal and retro-pharyngeal abscesses (93% and 92%, respectively).6 Only if the abscess collection is lateral to the great vessels, should an external approach be considered.6 In conclusion, it is necessary to have a high index of suspicion for DSNIs in the pediatric population. Once the airway is secured, appropriate imaging studies should take precedence to classify the location, size and number of abscesses in order to direct clinical management. Patients less than 15 months of age, abscesses greater than 2cm in size, multiple abscesses and airway compromise should all direct towards earlier surgical management rather than an initial observation period of 24-48 hours of exclusive intravenous antibiotic therapy. For a list of references, visit www.otopa.org/ references.html
It is advocated that all patients with a DSNI should be given initial empiric antibiotic therapy (even if the patient is also being managed surgically) until culture and sensitivity results are available and advised that therapy should be effectively targeted against aerobic and anaerobic bacteria.7 Either penicillin in combination with a Ă&#x;-lactamase inhibitor (such as amoxicillin with clavulanic acid) or a Ă&#x;-lactamase–resistant antibiotic (such as cefoxitin, cefuroxime, imipenem, or meropenem) in combination with a drug that is highly effective against most anaerobes (such as clindamycin or metronidazole) is recommended www.otopa.org | PAO-HNS
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Ocular Management in Facial Paralysis Tom Shokri MD, Division of Otolaryngology-Head and Neck Surgery, Penn State Hershey Medical Center, Hershey, Pennsylvania Christopher Weller MD, Penn State Hershey Eye Center, Hershey, Pennsylvania, Assistant Professor, Oculofacial Plastic and Reconstructive Surgery Jessyka G. Lighthall MD, Director, Section of Facial Plastic and Reconstructive Surgery, Assistant Professor, Division of Otolaryngology-Head and Neck Surgery, Penn State Hershey Medical Center, Hershey, Pennsylvania
Facial paralysis may result in devastating ocular sequelae. Therefore, assessment of the eye in facial paralysis is a critical component of patient management. Although the management of facial paralysis should be individualized to the patient, initially the primary objective in all patients with orbicularis oculi weakness should include ophthalmologic evaluation and implementation of measures to protect the ocular surface and preserve visual acuity. The degree of facial paralysis, lacrimal secretion, corneal sensation, and position of the lower lid should be assessed thoroughly. Patients with anticipated recovery of facial nerve function may respond to more conservative temporizing measures to protect the ocular surface. Conversely, patients with expected prolonged or unlikely recovery should be appropriately identified as they will benefit from surgical reconstruction and rehabilitation of the periorbital complex. The majority of reconstructive measures within a facial surgeon’s armamentarium augments coverage of the eye, but is unable to restore blink. Eyelid reanimation restores the aesthetic proportionality of the eye with blinking and reestablishes protective functions necessary for ocular preservation and function. This article will review the current management paradigm of the eye in patients with facial paralysis. Paralysis of the facial nerve has devastating psychosocial and physiologic sequelae. Preservation of ocular function should be the initial priority in the management of the patient with facial paralysis. Proper assessment of the underlying etiology and degree of facial paralysis is an essential component of management.1,2 Detailed ocular history, including prior to and following the onset of facial paralysis, is an important part of the initial evaluation. Physical examination should include visual acuity, extraocular muscle motility, visual fields, lacrimal function, pupillary response, upper and lower eyelid position, palpebral fissure height, marginal reflex distances (MRDs), and presence of intact Bell’s phenomenon. Corneal sensation should be evaluated in comparison to the unaffected side. All patients should initially be evaluated by an ophthalmologist in order to establish a baseline ophthalmologic examination and facilitate future care.3,4 The primary aim in periocular management with facial paralysis is protection of the ocular surface and preservation of baseline visual function. Secondarily, the goal is to restore facial form and symmetry. A variety of short and long-term measures are available. These interventions can be further subdivided into static and dynamic reanimation procedures. The facial surgeon should be familiar with the majority of these procedures. An individualized approach to management will need to be employed based upon the duration of paralysis, prognosis of recovery, integrity of functional corneal protective mechanisms, current state of the ocular surface, and finally the extent of both dynamic and static dysfunction. This article presents advancements in the care of paralytic lagophthalmos.
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Non-operative Management of Temporary Paralysis In cases where spontaneous recovery is expected, aggressive ocular surface lubrication is the first line of management. Patients should be instructed to use preservative-free artificial tears frequently during the day and lubricating ointment prior to sleep. For patients with mild exposure of the ocular surface and expected recovery of facial nerve function, such as in the setting of neuropraxia following parotidectomy, these measures alone may be sufficient. If moderate ocular surface exposure exacerbated by lagophthalmos is present, a moisture chamber should be used to mitigate damage secondary to desiccation or mechanical trauma. More recently, scleral lenses, such as the prosthetic replacement of the ocular surface ecosystem (PROSE) device, have been implemented in ocular care of patients suffering from facial paralysis and have shown to be effective in facilitating continued hydration of the cornea and preventing injury to the surface of the eye.5,6 These devices have shown to be equally effective in providing corneal protection, and more aesthetically appeasing to patients, in comparison to temporary tarsorrphaphy.6-9 In patients with low tear film production, confirmed on Schirmer test, punctal occlusion with use of silicone plugs or cauterization may also provide benefit.10-11 If conservative medical interventions, to increase lubrication or provide a corrective microenvironment along the ocular surface, prove to be insufficient in maintaining visual function and ocular health then temporary procedural interventions should be implemented. These methods are most suitable for patients in whom facial nerve recovery is expected, such as in Bell’s palsy, or for patients that are poor surgical candidates for more aggressive reconstructive procedures due to high comorbidity indices. Chemodenervation of the levator palpebrae superioris (LPS), utilizing botulinum toxin-A, may be used to induce ptosis for approximately 8-12 weeks thereby decreasing upper lid retraction and counteracting paralytic lagophthalmos.12-16 Alternatively, ptosis may be induced using injectable hyaluronic acid filler, injected in the pre-levator aponeurosis plane, as a temporary upper lid weight, effectively reducing lagophthalmos and ocular surface exposure.17-18 Hyaluronic acid filler may be similarly placed along the lower eyelid, in the area surrounding the orbitomalar ligament and the orbital septum, to reduce malposition and ocular exposure.19 While the above measures have proven useful in prevention of ocular damage, patients with significant ocular surface exposure and impaired protective mechanisms, including decreased corneal sensation or Bell’s phenomenon, are more suitable candidates for a temporary tarsorrhaphy to reduce exposed ocular surface area, particularly if the patient is a poor surgical candidate for more intensive reconstructive procedures or has inadequate follow-up care. A permanent tarsorrhaphy may be considered if the anticipated recovery of facial nerve function is poor. These patients should be counseled regarding restriction of peripheral visual field prior
to intervention. These procedures should be employed sparingly in patients with expected recovery as reversal will result in irregularity of the eyelashes and lid margin.9,11
Surgical Management Although long term facial paralysis is debilitating and has been associated with depression and psychosocial distress, surgical rehabilitation, particularly of the periocular complex, has been shown to improve quality of life measures.20-21 The majority of procedures are intended to improve ocular surface coverage but do not address the blink reflex or natural eyelid closure. The clinician should keep in mind that as facial aging progresses, the persistent effects of gravity and increased skin laxity will lead to soft tissue descent. Periorbital reconstruction will consequently be a continually evolving process.
Upper Eyelid Reconstruction Upper eyelid loading continues to be one of the most common techniques employed in the management of lid retraction and lagophthalmos in patients with facial paralysis. This technique utilizes the gravitational pull on the upper lid and induces a mechanical ptosis. Upper eyelid loading may be performed under local or general anesthesia, and is therefore a practical alternative for poor surgical candidates. The implant is attached to tarsal plate, between the mid-pupillary line and the medial limbus, and may be sutured to the levator aponeurosis or superior to the tarsus to prevent migration. While gold was the most common material originally used, platinum is now preferred due to its higher density and thinner profile allowing for decreased visibility and improved contour.22 Platinum induces less of an inflammatory response resulting in lower rates of capsule formation, extrusion, and uncomplicated removal.22-25 A less commonly implemented method of addressing upper eyelid retraction is Müller’s muscle extirpation.26 Müller’s muscle is a sympathetically innervated upper lid retractor that accounts for 2-3mm of lid elevation. The procedure is performed through a conjunctival incision along the superior tarsal border while everting the upper lid. The muscle is identified at its insertion along the superior margin of the tarsal plate and dissected free from underlying conjunctiva, overlying levator aponeurosis, and subsequently transected. Therefore, although this procedure provides preservation of upper
lid contour, it may not provide sufficient reduction in lagophthalmos. Lastly, use of the palpebral spring has been well documented in the literature. This is more suitable in younger patients as a strong levator function is necessary to overcome recoil tension of the spring. Moreover, results of this procedure are highly dependent on the experience of the operating surgeon and risks of poor outcomes including wire extrusion are well documented throughout the primary literature.29,30
Lower eyelid Reconstruction Lateral canthal suspension is a commonly performed procedure in lower eyelid reconstruction in facial paralysis. Although several modifications of this procedure exist, the general principle is equivalent. Any component of horizontal lengthening of the lower lid will exacerbate lid laxity and ectropion. Therefore, shortening of the lower lid, in combination with resuspension, will counteract this laxity. A lateral tarsal strip, or canthoplasty, consists of a lateral canthotomy incision followed by creation of a tarsal tongue via separation of the anterior and posterior lamellae. The tarsal plate is then shortened and resuspended via suture ligature to the inner orbital rim periosteum at or slightly above Whitnall’s tubercle. If laxity of the lower lid is present without evidence of lengthening a lateral canthopexy may be performed in which the tendon is reattached to the lateral orbital rim without shortening of the eyelid.31-33 Severe paralytic ectropion and lower lid retraction may not be amenable to correction with a horizontal tightening procedure alone. The vertical height and stability of the lower eyelid can be augmented in these cases with recession of the lower eyelid retractors in conjunction with placement of spacer grafts. A transconjunctival approach can be used to visualize the lower eyelid retractors and release them from the inferior tarsal border.34-35 Spacer grafts can then be placed along the inferior border of the tarsus using autograft (hard palate mucosa or ear cartilage), allograft (acelluar dermal matrix), or xenograft (acellular porcine dermis) material.34-39 Patients with significant eyelid retraction and midface ptosis, with an associated negative vector, benefit most from suspension of the suborbicularis oculi fat (SOOF) or a midface lift to further support the lower eyelid and offset the effects of gravitation pull.30-45
Neurotization In patients with unilateral facial palsy with an insensate cornea, direct neurotization of the cornea using the contralateral supraorbital or supratrocheal branches of the ophthalmic division of the trigeminal nerve have been shown to be an effective method of restoring corneal sensation and preventing neurotrophic keratopathy.46-48 Minimally invasive approaches employing a short transverse upper lid incision and superior dissection deep to the orbicularis oculi, with isolation of the nerve as it exits the orbit through the supraorbital notch, have been employed. Preservation of the supraorbital nerve is made in an attempt to preserve forehead sensation. A sural nerve graft is then tunneled subcutaneously along the nasal dorsum to the globe and placed within a subconjunctival plane along the perilimbal areas of the cornea. The epineurium from the graft is then dissected and nerve fascicles are separated, distributed around the cornea, and secured subconjunctivally with 10-0 nylon. After creating an epineural window an end-to-side coaptation, endto-end if the nerve is small, is performed proximally.47 Ocular preservation is the primary priority in the initial management of the patient with facial paralysis. The surgeon must therefore be familiar with the diversity of techniques that may be implemented in the care of this patient population. Coordination of care between the clinician, ophthalmologist, oculoplastic surgeon, and facial plastic surgeon managing the facial paralysis patient is critical. For a list of references, visit www.otopa.org/ references.html
www.otopa.org | PAO-HNS
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HPV-Associated Oropharynx Cancer Prevention: Trends in HPV Vaccination Recommendations by Primary Care Practitioners Gloria Hwang, The Pennsylvania State University, College of Medicine Genevieve Ann Andrews, The Pennsylvania State Health Milton S. Hershey Medical Center
The human papilloma virus (HPV) infection is the most common sexually transmitted disease in humans1 According to the most recent statistics from the National Health and Nutrition Examination Survey (NHNES), the period prevalence of HPV on penile and vaginal mucosa is 45.2% and 39.9% respectively, whereas on the oral mucosa, the prevalence is 11.5% and 3.3% in men and women respectively.2 HPV can also be transmitted through nonsexual occurrences through contaminated objects, direct contact with skin or mucosa, or transplacental transmission in rare cases.29 HPV infection usually is asymptomatic and clears spontaneously. However, acute HPV infections can cause benign growths such as genital and cutaneous warts, respiratory papillomatosis, and nasal or oral papilloma. Chronic infections of the high-risk 8
SOUNDINGS | Spring 2018
HPV types (most commonly 16 and 18) can cause malignancies of the cervix, anus, penis, vulva, vagina, and oropharynx.3 HPV-induced oropharynx squamous cell carcinoma has been dramatically increasing over the last few decades and has recently surpassed cervix cancer as the most common HPV-induced malignancy.3,4,29 Out of the 39,844 HPVassociated cancers per year on average between 20082013, 16,479 were from HPV-positive oropharyngeal cancer (HPVOPC), surpassing the 11,693 cervical cancers per year.31 Of those with HPVOPC, about 19.4% are female and 80.6% are males.29 Of all oropharynx cancer cases in the United States, those that were HPV-positive increased from 16.3% during the 1984–1989 time period to greater than 70% in the 2000–2004 time period.4 The population with
the largest increase in HPVinduced oropharynx cancer is 40-59 year old white men.5 HPV-positive oropharynx cancer patients are less likely to have a history of tobacco or alcohol exposure compared to HPV-negative oropharynx cancer patients.6 There is evidence that HPV infection likely precedes the development of OPSCC by many years if not decades.7 The treatments for this cancer includes surgical resection, radiotherapy with or without chemotherapy, or a combination of these modalities, which has proven a more effective treatment of radiosensitive HPV-positive oropharyngeal cancer (HPVOPC) than of HPV-negative oropharyngeal cancer.5 Though innovative improvements in surgical approaches and nonsurgical treatments continue to develop, patients continue to suffer acute and chronic
morbidity, with some suffering mortality despite appropriate treatment. Although cervical precancer and cancer screening including Pap smears, conventional cytology, and high-risk HPV testing, and have lowered HPVinduced cervical cancers, current oropharyngeal cancer screening is lacking.30 In fact, most HPVOPC presents after it has already metastasized to regional lymph nodes. As such, HPV vaccination is theorized to be the most effective HPVOPC prevention strategy. Thus, efforts to increase HPV vaccination rates are extremely important.29 The first quadrivalent vaccine developed for the prevention HPV infection was approved for widespread use in the United States in 2006, and was primarily recommended for girls age 11 or 12 years old.8 Three years later in
2009, the HPV vaccine was certified for use in boys.12 The HPV vaccine Gardasil 9 covers nine subtypes of HPV (high and low risk). Since 2011, the Centers for Disease Control and Prevention (CDC) has recommended HPV vaccination of both girls and boys. Specifically, the HPV vaccine is FDA-approved for the prevention of genital and anal cancers, precancers, and benign tumors in females and males age 9-26 years.9 Despite the etiologic link of HPV infection in the majority of oropharynx cancers, the effect of the vaccine on oropharynx cancer has not been able to be studied due to the long lag time between HPV infection and oropharynx diagnosis. The prevalence of oral HPV infection has been shown to decrease in those who completed HPV vaccination as recommended.10 Recently, the largest professional society of head and neck oncologic surgeons, the American Head and Neck Society, published a statement that endorses HPV vaccination of boys and girls for the likely impact it will have on decreasing HPV-induced oropharynx cancer.11
Despite the availability of these potentially life-saving vaccines, the rate of HPV vaccination in the United States is relatively low. Despite the availability of these potentially life-saving vaccines, the rate of HPV vaccination in the United States is relatively low. In the first 5 years the HPV vaccine was FDA-approved, only 25-30% of 16-year old females received the recommended vaccine doses.12 The CDC more recently reported national HPV vaccination rates amongst boys ages 13-17 years old as 50% and amongst girls ages 13-17 years as 63%.32 A number of studies have been performed over the last several years to assess the reasons for this low participation in HPV vaccination. A systematic review of the literature by Holman et al., summarized these barriers to vaccination.13 Differences in uptake of HPV vaccination have been found across ethnic and socioeconomic groups. Specifically, black and Hispanic girls are less likely than whites to receive a recommendation,14 and complete the vaccination series 15,16,17 compared to their white counterparts.13,18 Some of the reasons for low uptake of the HPV vaccination as given by parents, usually
in the form of surveys, have been lack of education about the vaccine, young age, concern of the effect of the vaccine on their child’s sexual behavior, and lack of primary health care provider endorsement of the vaccine.13 Barriers to vaccinating patients from the perspective of health care professionals have also been studied.13 Some studies identified knowledge gaps in providers about HPV infection and its relation to non-cervical cancers.19,20 Other reasons providers gave for not offering HPV vaccination were that providers preferred to vaccinate older patients and patients with perceived higher rates of sexual activities, which put them at higher risk. Some providers stated other reasons for not vaccinating such as HPV not being an important health threat, and time constraints. Concerns about safety and efficacy were rarely identified by providers as barriers.13 One study examined physician’s impressions of barriers to HPV vaccination, citing financial reasons, including vaccine costs and insurance coverage as the most frequently reported barrier. Factors associated with not strongly recommending HPV vaccine to 11- to 12-year-old female patients included considering it necessary to discuss sexuality before recommending HPV vaccine and reporting more vaccine refusals among parents of younger versus older adolescents as barriers to HPV vaccination.21 Reasons for not strongly recommending adolescent male patients included considering male patients at lower risk of developing HPVrelated illnesses. As opposed to patient/parent or physician resistance, hospital or office systems issues have been also been identified as barriers to HPV vaccination in the literature.23,28 For example, the institution of electronic alerts and reminders to physicians during eligible patient visits have been shown to increase HPV vaccination rates.23,28 A systematic review by Walling et al. summarized intervention studies in the US and other countries. The various approaches these studies used to increase HPV vaccination included environmental intervention (e.g. school-based vaccination programs), community-wide media campaigns, patient directed decision support programs, patient-targeted reminders, provider-targeted reminders and incentive programs, and policy enactment and governmental involvement.22
Several publications have used surveys to gather physician perspectives on HPV vaccination for the purposes of designing interventional strategies to improve HPV vaccination rates.24,25,26,27 In order to gather physician perspectives on HPV vaccination at Penn State Health, we recently anonymously surveyed primary care practitioners (PCP) in the fields of Pediatrics and Family Medicine (FM).33 The 21-question survey assessed practitioner characteristics (gender, years in practice, volume of patients, practice demographics), practitioner preferences regarding HPV vaccination discussion initiation, recommendation, and administration. Questions were also asked that were meant to reveal how PCPs were presenting the vaccine to patients/parents, for example if they are presenting it as a routine vaccine for a certain age group, as a cancerpreventing vaccine, or as a sexually transmitted disease-preventing vaccine. Additionally, PCP-perceived barriers to HPV-vaccination was assessed in the survey. Lastly, a few questions in the survey assessed PCP’s knowledge on HPV vaccination and HPV-induced cancers. Overall, we had a response rate of 25% (60 of 243) with the majority of respondents being FM practitioners. The majority of PCP respondents were medical doctors (81% in the Family and Community Medicine Department and 94% in the Pediatrics Department) PCP recommendations varied by specialty and years in practice. For example, Pediatric practitioners were significantly more likely than FM practitioners to recommend HPV vaccination to 1112 year-old boys (p=0.045). Most respondents (68%) reported strongly recommending the HPV vaccine to candidates for the vaccine who are ≥11 years old rather than to the 9-10 year old age group. Pediatricians were significantly more likely to strongly recommend the HPV vaccine to patients and their parents in the 11-12 yearold age group compared to Family Practitioners. More FM compared to Pediatric practitioners provided strong recommendations to their older eligible patients within 13- to 26- years of age. Additionally, practitioners who have been in practice for over 11 years were significantly more likely to strongly recommend the HPV vaccine. From our data, there appears to be an opportunity for PCP education about HPV vaccination and HPV-induced cancers. When asked how confident PCPs feel about their own understanding of the relevant issues related to HPV vaccination, 61% of FM practitioners www.otopa.org | PAO-HNS
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rated themselves as “Somewhat confident,” whereas 56% of Pediatricians rated themselves as “Very confident”. Upon assessment of PCPs knowledge, most PCPs underestimated current national HPV vaccination rates. 84% of total PCPs were found to be aware of the most common side effect of the HPV vaccination, but only 37% of total respondents were knowledgeable about the side effects of oropharynx cancer treatment. PCP responses to “which HPV-related cancer is currently the most common” included 84% of FM and 81% of Pediatricians indicating cervical cancer, compared to 9% of FM and 6% of Pediatricians stating oropharyngeal cancer. When asked how PCPs advocate for HPV vaccination with their patients, 90% of PCPs stated they promote the vaccine as potentially cervix cancer-preventing, compared to only 42% who promote it as potentially HPV-OPCpreventing. In summary, HPV-OPC is a growing problem with an incidence rivaling that of cervix cancer which is also HPVassociated. Because of the lack of an adequate screening method, and the subtly of symptoms of localized oropharynx cancer, HPV-OPC usually presents after it has already metastasized to the cervical lymph nodes. Thankfully, when properly treated, these patients achieve a very good survival rate. However, the side effects of treatment are frequently chronic and can be severe. HPV vaccination holds immense promise for patients in the prevention of HPVassociated oropharynx cancer, though the data proving this result is forthcoming, largely due to the long latency between infection and cancer presentation. PCPs have a pivotal opportunity to prevent HPV-associated oropharynx cancer in eligible patients by strongly advocating for the vaccine. Our data show that though most PCPs strongly recommend HPV vaccination in patients ≥11 years old, they are largely unaware of increased incidence of HPV-OPC compared to cervix cancer. Most PCPs are also not discussing the potential of the vaccine to prevent HPVOPC specifically. Further studies on the effect of HPV vaccination on HPV-OPC incidence are needed to help guide practitioners in discussions with patients. Further education of both practitioners and the general public about HPV-OPC is also needed to increase vaccine uptake, and thus utilize the HPV vaccine to its full potential. For a list of references, visit www.otopa.org/references. html
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AJCC-8ed Staging System Better Prognosticates Surgically Managed HPV-Positive Oropharyngeal Cancer Michael C. Topf, MD1; Kealan C. Hobelmann, MD1; David M. Cognetti, MD Department of Otolaryngology—Head and Neck Surgery, Thomas Jefferson University, 925 Chestnut Street, 6th Floor, Philadelphia, Pennsylvania, 19107
The TNM system provides an anatomic-based classification to depict cancer prognosis. Accurate cancer staging is important for outcome prediction, treatment selection, and patients’ perception of their own disease. Updates to the TNM staging system are periodically required as cancer demographics change and clinical outcomes improve. A shortcoming of the American Joint Committee on Cancer (AJCC-7ed) staging system1 is its handling of nodal metastases. The presence of nodal metastases in AJCC-7ed results in a minimum of Stage III and typically Stage IV classification. For many other cancers, Stage IV is synonymous with incurable, and this designation causes much anxiety in patients with newly diagnosed head and neck cancer. This is particularly problematic for HPVpositive oropharyngeal squamous cell carcinoma (OPSCC).2,3 HPV-positive OPSCC occurs more often in younger, healthier individuals with limited to no tobacco exposure4 and is typically highly responsive to treatment and carries an excellent prognosis.5,6 To address this inconsistency, the recently released eighth edition of the American Joint Committee on Cancer (AJCC8ed) staging system7 incorporates a new stage classification to distinguish HPV-positive OPSCC from its HPV-negative counterpart. This is especially important given that the incidence of HPV-positive OPSCC in the United States and elsewhere has risen 5% per year since 1990.4,8 In the new AJCC-8ed, the pathologic N category for HPV-positive OPSCC defines pN1 disease as metastasis in 4 or fewer lymph nodes and pN2 disease as metastasis in greater than 4 lymph nodes (Table I). The AJCC8ed places no emphasis on lymph node size, presence of positive nodes in the contralateral neck, or extranodal extension (ENE) for HPV-positive OPSCC. The stage groupings for HPV-positive OPSCC were also significantly changed to better reflect the markedly improved overall survival seen in HPV-OPSCC (Table II). Stage IV disease is now reserved for patients with distant metastatic disease, a subset of patients known to have clinically more aggressive disease and a much poorer survival. Early evaluation of the new AJCC-8ed with independent datasets appears to show improved discrimination between stages compared to the previous AJCC-7ed.9,10 We chose to assess the pathological outcomes of OPSCC treated with primary transoral robotic surgery (TORS) with attention to nodal status as a means to evaluate the prognostic impact of the new AJCC-8ed staging system relative to the previous AJCC-7ed system. We reviewed clinical data for all patients undergoing TORS for OPSCC at our institution between March 2010 and February 2015. Patients were included in the cohort if they had no previous history of head and neck cancer and were treated with curative intent using a primary surgical approach including adjuvant radiation (RT) or chemoradiation therapy (CRT) as appropriate based on pathologic findings. Sufficient follow-up was defined as 2 years of clinical records beyond treatment completion or a documented recurrence within 2 years. Pathological staging was determined using both the AJCC-7ed1 and AJCC-8ed7 staging systems. Of the 156 patients who were reviewed, 116 met all criteria for inclusion.
Under the AJCC-7ed staging system, the vast majority of the tumors were stage T1 or T2, including 50 patients (43%) and 60 patients (52%) respectively. Tumors most often involved N2a or N2b neck metastases, including 24 patients (21%) and 64 patients (55%) respectively. Cancer stage primarily included stage IVA disease, as was the case for 92 patients (79%), driven largely by the extent of nodal disease. While the pathologic T-stage of the study population was unchanged under the AJCC-8ed staging system, the pathologic N-stage changed significantly. The majority (89 patients; 77%) were stage N1 with 9 (8%) stage N0 and 18 (16%) stage N2 under the new system. As expected by definition, all 10 patients with N1 metastases and all 24 patients with N2a metastases under the AJCC-7ed system were staged as N1 under the AJCC-8ed system. Of the 64 patients with previous N2b disease, 49 (77%) were down-staged to N1 and 15 (23%) remained as N2 under the new system. Of the 4 patients with previously N2c disease, 1 (25%) was down-staged to N1 and 3 (75%) remained at N2 under AJCC-8ed. All 5 patients with previously N3 disease were downstaged to N. There were 92 patients (79%) with stage I disease, 24 patients (21%) with stage II disease, and no patients with stage III disease using the AJCC-8ed staging system. All 6 of the patients with previous stage II disease and 10 (91%) of the patients with previous stage III disease were down-staged to stage I under AJCC-8ed. Another 69 patients (75%) with previous stage IVA disease and all 5 patients with previous stage IVB disease were down-staged to stage I under the new system. One patient (9%) with previous stage III disease and 23 patients (25%) with previous stage IVA disease were down-staged to stage II under AJCC-8ed (Table III). Of the 116 total patients, 10 (8.6%) developed recurrent disease. Among these were 1 local recurrence, 2 regional recurrences, and 8 distant metastases, with 1 patient having both regional and distant recurrences (99.2% local control, 97.4% locoregional control). Interestingly, initial treatment for patients who later experienced recurrence included adjuvant CRT for 9 of 10 patients (90%). Our TORS population reflects the sentiment of the AJCC that HPV-positive OPSCC staging under the AJCC-7ed staging system did not adequately reflect prognosis. Within our TORS population, 83% were stage IVA or IVB under the AJCC-7ed system, but disease-free survival was 91.4%. The AJCC-8ed changes had a significant impact on the staging of our HPVpositive OPSCC patients, with many being down-staged. Of interest, a large majority (67%) of previously N2b, N2c, and N3 patients were down-staged to N1. This change alone shifted the majority (75%) of stage IVA patients to stage I. Where 83% of HPV-positive patients were stage IV under the old system, restaging resulted in 79% stage I and 21% stage II.
TABLE I Pathologic N Category Human Papillomavirus-Associated (p16-Positive) Oropharyngeal Cancer, 8th Edition Staging Manual N Category
N Criteria
Nx pN0 pN1 pN2
Regional lymph nodes cannot be assessed No regional lymph node metastasis Metastasis in 4 or fewer lymph nodes Metastasis in more than 4 lymph nodes
Table I is used with the permission of the American Joint Committee on Cancer (AJCC), Chicago, Illinois. The original source for this material is the AJCC Cancer Staging Manual, Eighth Edition (2017) published by Springer Science and Business Media LLC (springer.com) (Amin MB, Edge SB, Greene FL, et al, eds. AJCC Cancer Staging Manual. 8th ed. New York: Springer; 2017, with permission).
TABLE II Anatomic Stage and Prognostic Groups for Pathologic TNM Grouping of Human Papillomavirus-Associated (p16-Positive) Oropharyngeal Cancer, 8th Edition Staging Manuala N Category T Category
N0
N1
N2
T0 T1 T2 T3 T4
NA I I II II
I I I II II
II II II III III
Any M1 is stage IV.
a
Table II is used with the permission of the American Joint Committee on Cancer (AJCC), Chicago, Illinois. The original source for this material is the AJCC Cancer Staging Manual, Eighth Edition (2017) published by Springer Science and Business Media LLC (springer.com) (Amin MB, Edge SB, Greene FL, et al, eds. AJCC Cancer Staging Manual. 8th ed. New York: Springer; 2017, with permission).
TABLE III Cancer stage changes from AJCC-7ed (2010) staging to AJCC-8ed (2017) staging system (stage changes in bold) AJCC-8ed AJCC-7ed I II III IVA IVB Total
I
II
III
Total
2 6 10 69 5 92 (79%)
0 0 1 23 0 24 (21%)
0 0 0 0 0 0 (0%)
2 (2%) 6 (5%) 11 (9%) 92 (79%) 5 (4%) 116
Send correspondence to Michael C. Topf, MD, Department of Otolaryngology— Head and Neck Surgery, Thomas Jefferson University, 925 Chestnut Street, 6th Floor, Philadelphia, PA 19107. michael.topf@jefferson.edu. Telephone: (585) 2784883. Fax: (215) 923-4532.
In conclusion, the AJCC-8ed pathologic staging system represents a significant improvement in prognostication for patients with HPV-positive OPSCC. This should facilitate discussions with patients and their families and improve patients’ perception and anxiety g their cancer stage. For a list of references, visit www.otopa.org/references.html
www.otopa.org | PAO-HNS
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Legislative Update Milliron & Goodman, LLC
BUDGET UPDATE
HEARING AID DISPENSERS LAW
Democratic Governor Tom Wolf’s election-year budget plan will renew battles with the Republican-controlled Legislature over imposing a tax on Marcellus Shale natural gas and increasing the minimum wage. Wolf, who is seeking re-election to a second term this year, wants to spend about $33 billion in the 2018-19 fiscal year, about a $1 billion, or 3.1 percent increase. He’d steer more toward schools, with an emphasis on workforce development. His budget plan would rely on about $250 million from a new Marcellus Shale tax — Wolf’s fourth straight attempt to impose one — and $100 million in savings on human services programs. Administration officials say the savings would come from reduced demand for the services because of an increase in the minimum wage to $12 an hour, up from the federal minimum of $7.25. Wolf is also renewing his call for municipalities who use state police to pay extra and is proposing funding to put body cameras on troopers. During his budget address, Wolf was in campaign mode and touted his successes over three-plus years. He highlighted increased funding for schools, pension reform, liquor reform, medical marijuana legalization, prison reform, and the opioid fight as accomplishments. His budget plan does not increase broad-based taxes on Pennsylvanians (i.e. sales or income taxes), and while Republicans were pleased to hear it, they are worried that the proposed spending could lead to tax hikes in the future. Republicans say they will have to look at where they can try to cut spending in the proposal. Lawmakers have until midnight on June 30 to pass the state budget.
The PAO-HNS and PA Academy of Audiology have recently discussed the Hearing Aid Dispensers Law. Our meeting had fruitful discussion and a mutual agreement that the law should be reviewed and potentially updated. The two organizations have many mutual points that would help ensure the safety of the patient, while hopefully increasing access to the latest technologies on the market. While nothing is concrete, the two organizations agreed to continue the discussion throughout 2018.
ASF TAX Pennsylvania Governor Tom Wolf’s 2018-19 state budget proposes a new provider tax on Pennsylvania Ambulatory Surgery Centers (ASCs) to generate an additional $25 Million dollars. The new tax will impact the state’s ambulatory surgery centers, and the tens of thousands of patients they serve annually, by driving up health care costs and putting surgery centers at risk of closing. Surgery centers that remain open will likely cut back on the services they provide – as investment dollars needed for new equipment and advanced technologies would be redirected to the state. It is estimated that more than 25 percent of Pennsylvania’s surgery centers will operate at a loss if the tax is enacted. Pennsylvania lawmakers need to hear from you. The new tax on affordable and convenient community-based surgical care would be detrimental on your practice and patients. Please take the time to call or email your local state House and Senate legislators and ask them to oppose Governor Wolf’s tax on surgery centers.
ELECTION 2018 The list of state lawmakers who have announced they won’t be seeking re-election is growing. Not running for re-election in 2018 are: Rep. William Keller (D-Philadelphia), Rep. Mike Hanna (D-Clinton), Rep. John Maher (R-Allegheny), Rep. Joe Markosek (D-Allegheny), Rep. Matthew Baker (R-Tioga/Resigned 2/19/18), Rep. Mark Mustio (R-Allegheny), Rep. Flo Fabrizio (D-Erie), Rep. Kevin Haggerty (D-Lackawanna), Rep. Adam Harris (R-Juniata), Sen. Stewart Greenleaf (R-Montgomery), Sen. Charles McIlhinney (R-Bucks), Rep. Ron Marsico (R-Dauphin), Rep. Bob Godshall (R-Montgomery), Rep. Kathy Watson (R-Bucks), Rep. Will Tallman (R-Adams), Rep. Harry Lewis (R-Chester), Rep. John Taylor (R-Philadelphia), Rep. Eli Evankovich (R-Westmoreland), and Rep. John McGinnis (R-Blair). Running for a different seat and not seeking reelection are: Rep. Marguerite Quinn (R-Bucks) – Running for state Senate, Rep. Dave Reed (R-Indiana) – Running for US House, Sen. Scott Wagner (R-York) – Running for Governor, Rep. Kristin Phillips-Hill (R-York) – Running for state Senate, Rep. Stephen Bloom (R-Cumberland) – Running for US House, Sen. John Eichelberger (R-Blair) – Running for US House, Rep. Judith Ward (R-Blair) – Running for state Senate, Rep. Jim Christiana (R-Beaver) – Running for US Senate, and Rep. Rick Saccone (R-Allegheny) – Running for US House. SENATE SPRING SESSION SCHEDULE March 19, 20, 21, 26, 27, 28 April
16, 17, 18, 23, 24, 25, 30
May
1, 2, 21, 22, 23
June 4, 5, 6, 11, 12, 13, 18, 19, 20, 25, 26, 27, 28, 29 HOUSE SPRING SESSION SCHEDULE March 12, 13, 14 April
9, 10, 11, 16, 17, 18, 30
May
1, 2, 22, 23
June 4, 5, 6, 11, 12, 13, 18, 19, 20, 21, 25, 26, 27, 28, 29, 30 continued on page 13
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SOUNDINGS | Spring 2018
A Low-Cost, High Fidelity Stapedotomy Simulator for the Training of Otolaryngologists Brandon Kamrava BS, Steven Zuniga MD, Ruth S. Ochia PhD, Pamela C. Roehm MD PhD Department of Otolaryngology-Head & Neck Surgery, Lewis Katz School of Medicine at Temple University
data regarding performance of the procedure, making it difficult to track surgical training milestones. Furthermore they, fail to adequately simulate the biophysical properties of otosclerosis.15-18 Recent advances in computer aided design and 3D printing offer new training avenues. Additionally, the cost of electronic supplies has greatly decreased. We have employed these technological advancements to create a low-cost and accurate stapedotomy simulator for otolaryngologist training. Clinically apparent otosclerosis affects approximately 0.4% of the population1-4, causing 1 – 5% of all cases of hearing loss.5-7 When performed correctly, stapedotomy can close the air-bone gap within 10 dB for approximately 90% of patients.8 This surgery is considered “one of the most technically challenging procedures performed by an otologist”9, and audiologic outcomes are directly related to surgeon experience.10-12 Unfortunately, residents today are exposed to few cases, possibly due to the steady decline in annual cases and increase in otolaryngologists.13 Outside of the operating room, resident training in stapedotomy is limited to modified human temporal bones and middle ear simulators. Human cadaveric temporal bones can be used as a stapedotomy training tool. However, they have limitations, which include high cost, issues of storage, risks of pathogen transfer, toxic/carcinogenic risks of tissue preservatives, difficulties with recreation and repetition of similar surgical pathology from specimen to specimen, and the potential for conflict with religious beliefs.14 Changes in postmortem tissues alter their similarity to the surgery on live patients, even with appropriate fixation or freezing. Most temporal bones do not have pathological footplate thickening and fixation found in otosclerosis, and thus not providing users with an accurate recreation of intraoperative findings. Current middle ear simulators described as alternatives to human temporal bones have limited ability to measure quantitative
A proper simulator requires accurate recreation of the middle ear. MicroCT scans offer 25-micron resolution and facilitate production of 3D computerbased models. From a microCT scan of a cadaveric temporal bone, a high-fidelity computer model of the middle ear anatomy was produced. To accompany this model, a housing structure was developed to allow for multiple trial use. All parts may be manufactured with a 3D printer and easily assembled. This allows institutions in any region with access to an adequate 3D printer to produce this simulator and incorporate it into their training program at minimal costs. In addition to fine detail reproduction, electronic sensors were incorporated into the system to monitor user performance. Forces applied at the footplate during the operation are detected in real-time and displayed. A dehiscent fallopian canal with an exposed facial nerve is present and contains a conductive wire. Upon contact with the wire, a speaker is triggered to beep, notifying the user. With these components, users can objectively judge and compare their performance. A pilot study on model utility for resident training has been conducted, and the initial results have been very promising. 14 subjects in total were enrolled, including 4 medical students, 7 junior residents, and 3 senior residents. All users worked with the model and were provided the opportunity to perform the following steps in stapedotomy: disarticulation, superstructure down
fracture, microdrill fenestration of the footplate, and prosthesis placement and crimping. Survey of the users after model use demonstrated that 100% of subjects believed the simulator is a useful tool for training and provided a better understanding of middle ear anatomy. 71% users experienced an increase in comfort level with stapedotomy procedures after simulator use, as well. General feedback from many users was enthusiasm towards the model and interest in performing repeat. In summary, our team has developed a 3D printed simulator for stapedotomy procedures which includes electronic sensors that provide real time feedback. Initial studies of the simulator indicate the potential benefits this model may have in otolaryngology training programs. For a list of references, visit www.otopa.org/ references.html
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GRASSROOTS ADVOCACY At Milliron & Goodman, we spend a lot of time emphasizing the importance of getting to know your legislators and more importantly, making sure they know you. Your involvement in the legislative process is crucial to the future success and stability of Pennsylvania’s showmen. Please get engaged.
CONTACT If you have any questions regarding this legislative update or would like to get involved, please do not hesitate to contact us at 717-232-5322. We have an open-door policy. www.otopa.org | PAO-HNS
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What Can We Learn from Analysis of Pennsylvania Patient Safety Reporting System (PA-PSRS) Data? Abstract: After the topic of latex allergies surfaced in the 1980s, awareness grew and risk reduction strategies were created; however, a review of events reported through the Pennsylvania Patient Safety Reporting System (PA-PSRS) questions the persistence of latex exposure protections. Pennsylvania healthcare facilities reported 616 latex-related events through PA-PSRS that occurred from 2014 through 2016, including 72 near miss events. Analysis revealed that latex indwelling urinary catheters were the most common source of inadvertent exposure in patients with documented latex allergies (75.0%, n = 408 of 544). The perioperative care area accounted for the
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SOUNDINGS | Spring 2018
highest number of both exposures and near misses (57.1%, n = 352 of 616). Event narratives highlight contributing factors such as deficits in communication, documentation, supply management, and staff awareness. Strategies to address these contributing factors may include screening, thoughtful handoffs, evaluation of product alternatives, assessment of staff awareness, and observation of practice patterns. The full article can be found in the Pennsylvania Patient Safety Advisory: http://patientsafety.pa.gov/ADVISORIES/ Pages/201803_LatexUpdate.aspx
Abstract: Near-miss event reporting and analysis is an essential part of a robust patient safety program. Pennsylvania has seen an increase of more than 2,700% in reports of near-miss barcode medication administration (BCMA) events over twelve years, from January 2005 through December 2016. During the same period, events that reached the patient and caused harm (Serious Events) accounted for only 0.5% of reported BCMArelated events. Reporting, but more importantly, the analysis of near-miss events can lead to improvements in processes and reduce the potential for patient harm. Through a case study, the Pennsylvania Patient Safety Authority shares the story of how
Blue Mountain Health System reduced its barcode-workflow events by 53% between 2014 and 2016. Through a collaborative effort with the Authority’s analysts and patient safety liaison, the health system used near-miss event review and analysis to improve its BCMA process. The Authority shares best practice strategies for BCMA use in the context of near-miss event analysis. The full article can be found in the Pennsylvania Patient Safety Advisory: http://patientsafety.pa.gov/ADVISORIES/ Pages/201712_BCMA.aspx
For more information about the Authority, patient safety topics, Advisory articles, and safety tips for patients, please visit patientsafety.pa.gov.
www.otopa.org | PAO-HNS
15
2018 ANNUAL
SC IENTI FI C MEETI NG JU N E 22-23, 20 18 KALAHARI RESORTS & CONVENTIONS | POCONO MOUNTAINS, PA
EDUCATIONAL TOPICS: • Establishing Best Practice: Clinical Practice Guidelines in Otolaryngology • Advances and Technology in Otolaryngology Practice: Hands-On Introductory Sessions • Patient Safety and Quality in Pennsylvania: How does it help my patients? • Resident Research and Education
REGISTRATION FEES: PAO-HNS Physician Nurse/Affiliate Resident/Student Non-member Physician
until May 31 $130 $80 $40 $305
after May 31 $180 $80 $40 $355
NEW MEMBER Physician: Join for $95 and register for the meeting at the member rate!
Approved for 8.75 AMA PRA Category 1 Credit™ ACCREDITATION: This activity has been planned and implemented in accordance with the accreditation requirements and polices of the Accreditation Council for Continuing Medical Education through the joint providership of the Pennsylvania Medical Society and the Pennsylvania Academy of Otolaryngology - Head and Neck Surgery. The Pennsylvania Medical Society is accredited by the ACCME to provide continuing medical education for physicians. The Pennsylvania Medical Society designates this live activity for a maximum of 8.75 AMA PRA Category 1 Credits™. Physician should claim only the credit commensurate with the extent of their participation in the activity.
ONLINE REGISTRATION AVAILABLE AT www.otopa.org