Advances in - Cleveland Clinic · tary paraganglioma-pheochromocytoma syndrome. In a...

Advances in Otolaryngology & Dentistry

F a l l 2 0 1 3 – F E a T U R E D C O N T E N T I N C l U D E S :

a PhySICIaN’S NEwSlETTER

Game Changer in Nasal Reconstruction (p. 5)

Care Paths for laryngeal Cancer and Dizziness (pp. 8 and 26)

Maxillofacial Surgery: Facing the Future with Virtual Surgical Planning (p. 14)

Pearls, Pitfalls of TopicalDrug Delivery for Chronic Rhinosinusitis (p. 16)

FROM ThE hEaD & NECk INSTITUTE

Continued on page 3

Paragangliomas were long regarded as the “10 percent tumor” — 10 percent familial, 10 percent malignant and 10 percent extra-adrenal. However, it turns out that the familial component of that rule of thumb is greater than we once thought.

With the discovery of the succinate dehydrogenase genes (SDHB, SDHC and SDHD) in 2000 and 2001, we now know that at least 30 percent of patients with a paraganglioma and no other known risk factors (i.e., no family his-tory, a single tumor) harbor a genetic mutation that increases their risk for these tumors and for other neoplasia. Moreover, three other genes discovered within the past three years — SDHAF2, TMEM127 and SDHA — add to the genetic complexity of heredi-tary paraganglioma-pheochromocytoma syndrome.

In a multidisciplinary effort, otolaryngologists in Cleveland Clinic’s Head & Neck Institute are collaborating with oncologists and medical geneticists to identify and manage patients with genetic predispositions to paraganglioma.

Since a large proportion of patients with a paraganglioma have an underlying hereditary predisposition syndrome, all patients, including those with an apparently sporadic tumor, should be referred for a genetics consultation. Genetic counseling and testing are critical for guiding treatment and surveillance, not only for patients but for

Paraganglioma Management: How and Why Genomic Medicine Plays an Increasingly Vital RoleBy Jessica Moline, MS; Charis Eng, MD, PhD; Robert Lorenz, MD; and Erika Woodson, MD

their gene-positive relatives as well. First-degree relatives have a 50 percent chance of inheriting the familial gene mutation.

an Eye on Surveillance, Etiology

Hereditary paraganglioma-pheochromocytoma syndrome is a newly identified condition, so there are no consensus guidelines for surveillance. At Cleveland Clinic, we recommend that unaf-fected individuals with mutations in any of the aforementioned genes undergo annual biochemical surveillance for functional paraganglioma (plasma and/or 24-hour urine collection for cate-

Figure 1. Axial (left) and coronal (right) MRIs show a massive recurrent left glomus jugulare tumor (arrows) involving the petrous apex and the posterior fossa dura in a previously operated ear. During the patient’s previous surgery, the facial nerve was rerouted at the geniculate ganglion, and the ear canal was oversewn. Not shown is a labyrinthine fistula from the epidermoid cholesteatoma lateral to the glomus tumor and a synchronous intracanalicular vestibular schwannoma in the same ear.

2 Head & Neck Institute

Michael S. Benninger, MD

From the Chairman

DeaR ColleaGue:

Michael S. Benninger, MD Chairman, Head & Neck Institute [email protected]

On behalf of the professionals whose time and talent are devoted to Cleveland Clinic’s Head & Neck Institute, I invite you to enjoy this issue of Advances in Otolaryngology & Dentistry.

In these pages you’ll find news of the latest develop-ments in our disciplines. A few examples:

• In our cover story, a quartet of specialists explains how

otolaryngologists, oncologists and medical geneticists are collaborating to identify and manage patients with genetic predispositions to paraganglioma. Genetic counseling and testing are becoming increasingly important for affected patients and their first-degree relatives, and genomic medicine is an emerging area we will all be hearing much more about.

• Elsewhere, our head and neck surgeons remain on the cut- ting edge. Dr. Michael Fritz takes us step by step through a novel method of performing complex nasal reconstructions (p. 5). This new technique was developed by our staff and

promises to be a game changer. Similarly, Dr. Michael Horan describes the use of medical modeling and virtual surgical planning to create lifelike templates on which maxillofacial reconstruction is planned (p. 14).

• Laryngeal pathology occupies much of our attention, and two articles provide an update. First we share newly released results of our study of salvage laryngectomy for recurrent laryngeal cancer along with plans for a laryngeal cancer contribution to the new Cleveland Clinic Care Path initiative, which is designed to help make practice guidelines operational (p. 8). Later we describe our use of high-definition, high-speed, narrow- band technology to obtain precise images of laryngeal lesions (p. 12).

Other contributions profile our diverse clinical and research activi-ties in audiology and otology, sleep medicine, rhinology, speech-language pathology, vestibular and balance disorders, and voice care.

We hope you enjoy reviewing this publication as much as we’ve enjoyed preparing it. We welcome your comments as well as in-quiries about how we may collaborate to advance head and neck care moving forward.

Respectfully,

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cholamines and their metabolites). We also recommend imaging every two years for patients with both nonfunctional and functional tumors. Imaging typically comprises MRI or spiral high-resolution CT and either dihydroxyphenylalanine PET or a meta-iodobenzylguani-dine scan. It is important to note that the MRI or CT should also detect SDHB-associated thyroid and kidney cancers.

To further understand the genetic etiology of paraganglioma and pheochromocytoma, Charis Eng, MD, PhD, Chair of the Genomic Medicine Institute, and Jessica Moline, a certified genetic coun-selor-coordinator at Cleveland Clinic, are conducting a multicenter research study that involves germline testing of the SDH genes as well as tumor banking and genomic analysis of tumor DNA. The aims of their project are to learn more about known susceptibility genes, to investigate other potential genetic causes of paragangli-oma and to learn how each specific gene confers different risks of paraganglioma/pheochromocytoma and/or extraparaganglial neo-plasias. This type of research will enhance gene-specific clinical management.

Tailoring Treatment to Specific Genes

Knowledge of the distinct geno-type-phenotype correlations for the various predisposition genes can be useful when considering treatment and surveillance. For example:

• Individuals with mutations in SDHD and SDHAF2 have an extremely high risk of developing multiple head and neck paragan-gliomas and a lower risk of pheochromocytoma. Since their head and neck tumors are likely to be benign, observation or noninvasive treatment options can be considered.

• Approximately one-third of paragangliomas associated with SDHB mutations are malignant. Individuals with SDHB mutations are also more likely to develop extra-adrenal pheochromocytoma, and they have an increased risk of thyroid and kidney cancers.

• Head and neck paragangliomas and pheochromocytomas are seen in individuals with mutations in SDHA, SDHC and TMEM127. However, mutations in these genes are less common than muta-tions in SDHB and SDHD genes.

The specialists at Cleveland Clinic advocate for a balanced approach of surgery, observation and radiation to maximize func-tional outcomes. Our management is customized, with no single “right way” for all patients.

For many years, microsurgical resection was the only reliable treat-ment for patients with skull base paragangliomas. However, surgical resection is associated with a high rate of morbidity; specifically, lower cranial neuropathies can lead to voice dysfunction, swallow-ing dysfunction and occasionally the need for a tracheostomy.

There is also a likelihood of hearing loss and at least temporary facial paresis after surgical resection. Finally, the recurrence rate of these tumors is high, so long-term observation is strongly recom-mended, even after complete tumor removal. Recurrence rates as high as 1 in 3 among patients with germline mutations and 1 in 7 among patients without identifiable mutations have been reported.1

For paraganglioma patients without complications and without sig-nificant tumor growth on imaging over time, we are considering treatment algorithms that are more conservative than was the case in years past. This is especially true of glomus vagale tumors, for which surgical extirpation would require resection of the vagal nerve.

When serial imaging does show tumor growth, immediate reinner-vation of the recurrent laryngeal nerve — with potential cricothy-roid-to-cricothyroid grafting in patients with concurrent resection of the superior laryngeal nerve — has been demonstrated to lead to normal voices and swallowing resolution postoperatively.

Nonsurgical Treatment with the Gamma knife

Gamma Knife® radiosurgery (GKRS) has become an attractive alternative to surgical resection of glomus tumors, particularly when the functional status of the lower cranial nerves is good. The key advantage of GKRS is that it allows for a single administration

of highly conformed low-dose radiation to the tumor, which mini-mizes the dose to critical structures such as the cochlea, carotid artery and brain stem, as well as to the cranial nerves. Another advantage is that GKRS is typically an outpatient procedure, so there is no real downtime for the patient. Control rates in the litera-ture have been excellent thus far — greater than 95 percent in one meta-analysis.2

There are several considerations in selecting patients for GKRS:

• First, GKRS cannot be delivered to any tumor situated lower than the stereotactic frame, which is roughly at the level of the angle of the mandible.

• Second, very large tumor burdens are beyond the capabilities of radiosurgery. Tumor board discussion of these candidates is critical, as the radiation oncologist may favor traditional fractionated radia-tion therapy for very large tumors or for tumors with extensive extracranial extension.

• Although control rates are very good, one must consider the long-term expectations for the patient. For patients who are young and have a hereditary syndrome that predisposes to multifocal, recurrent or histologically aggressive tumors, judicious surgical resection and radiosurgery will both play a role in their future.

Paraganglioma Management (continued from p. 1)

Genetic counseling and testing are critical for guiding paraganglioma therapy and surveillance for patients and for their gene-positive relatives.

Continued on page 4


Partial Resections to Preserve Function

Many centers, including Cleveland Clinic, are offering patients partial tumor resections to reduce symptoms and to improve functional out-comes. The images that accompany this article are from a patient who was diagnosed with a massive recurrence of a previously resected tumor. The tumor was too large to allow for radiosurgery, and the patient had synchronous lesions, including an ipsilateral ves-tibular schwannoma and a cholesteatoma in the closed-off ear and mastoid cavity (Figure 1). The patient underwent resection of most of the tumor bulk, but some residual tumor was left in the pars nervosa so that the integrity of the lower cranial nerves was not compromised (Figure 2). Radiosurgery can be performed at a later date to control the growth of the much smaller tumor remnant if the need arises.

References

1. Amar L, Fassnacht M, Gimenez-Roqueplo AP, et al. Long-term postopera-tive follow-up in patients with apparently benign pheochromocytoma and paraganglioma. Horm Metab Res. 2012;44(5):385-389.

2. Guss ZD, Batra S, Limb CJ, et al. Radiosurgery of glomus jugulare tumors: a meta-analysis. Int J Radiat Oncol Biol Phys. 2011;81(4):e497-e502.

Ms. Moline is a certified genetic counselor-coordinator in the Genomic Medicine Institute and Taussig Cancer Institute. She can be reached at [email protected] or 216.445.6798.

Dr. Eng is Chair of the Genomic Medicine Institute and a staff physician in the Taussig Cancer Institute. She is also an American Cancer Society Clinical Research Professor and Hardis Endowed Chair in Cancer Genomic Medicine. She can be reached at 216.444.3440 or [email protected].

Dr. Lorenz is a staff physician in the Head & Neck Institute and the Taussig Cancer Institute. He can be reached at 216.444.3006 or [email protected].

Dr. Woodson is a staff physician in the Head & Neck Institute and the Gamma Knife Center. She can be reached at 216.444.6696 or [email protected].

Figure 2. Postoperative imaging in the patient from Figure 1 con-firms the near-total resection of the glomus jugulare tumor and total removal of the vestibular schwannoma and cholesteatoma. The tumor remnant (circle) in the petrous apex was left in order to preserve the pars nervosa. An anterolateral free-tissue transfer from the thigh was used to reconstruct the dura and soft tissue.

Jessica Moline, MS Charis Eng, MD, PhD Robert Lorenz, MD Erika Woodson, MD

Paraganglioma Management (continued from p. 3)


A novel method of complex nasal recon-struction has been developed by facial plastic surgeons in Cleveland Clinic’s Head & Neck Institute, and it promises to reshape the way these reconstructions are performed. Our patients have achieved excellent functional and cosmetic out-comes with less surgery and less morbidity than we see with the traditional surgical

approach. The key to this technique is the use of free vascular-ized fascia lata to reconstruct the nasal lining.

Reconstruction of total or near-total nasal defects is among the most challenging procedures in facial plastic surgery. To achieve a satisfactory result, the nasal lining, framework and external skin must be individually recreated. Moreover, this must be accomplished in a way that reproduces the delicate external nasal form while maintaining nasal patency.

a Simpler way of Recreating Mucosal lining

The replacement of vascularized nasal lining is the most difficult component of reconstructing a large defect. Traditional methods have involved the use of fasciocutaneous free flaps, particularly radial forearm free flaps. These have proved effective for internal nasal coverage and vascularized support for structural grafts. However, this approach requires several stages that involve sequential placement of the free flap, cartilage grafts and para-median forehead flap. Furthermore, flap redundancy and thick-ness typically mandate additional debulking procedures to achieve an aesthetic appearance and patent nasal airway. Given tissue bulk, the latter goal in particular is often elusive.

The use of the anterolateral thigh (ALT) free flap for head and neck reconstruction has increased greatly over the past decade,

and many surgeons now prefer this flap for cutaneous and mucosal replacement. Cutaneous perforators within this flap pass through and vascularize the fascia lata, thus allowing for development of a free vascularized fascia flap. We have employed vascularized fascia lata as a thin, pliable tissue for oral mucosal reconstruction, and our success with it spurred us to adopt it for large nasal lining defects.

Remarkable Success in Early Cases

We have now used free vascularized fascia lata in seven patients who had massive and complex nasal defects. All patients under-went a total or subtotal rhinectomy for cutaneous or mucosal malignancy. Following revascularization of the fascia lata via a microvascular technique, the flap is inset and altered to replace the lining of the nose and septum as required. In contrast to the established staged reconstructive approach, the bony and carti-laginous nasal structure and external skin coverage are then applied over the free flap in the same operative setting. Structure is recreated with harvested septal cartilage, conchal cartilage and/or rib in a manner similar to previously described techniques, and a paramedian forehead flap is used to provide cutaneous color and texture match (Figure 1A-C). A representative case is detailed in the sidebar on page 7 (Figures 2 and 3) and was ini-tially reported by our team in JAMA Facial Plastic Surgery earlier this year (see Suggested Reading).

Our experience has shown that using free vascularized ALT fascia lata to recreate the nasal lining has several advantages over the standard radial forearm free flap. Our flap provides more quantity and versatility of tissue with less donor-site morbidity. The very thin and well-vascularized flap enables simultaneous replace-ment of the nasal structure and external skin, thus allowing for

Free anterolateral Thigh Fascia lata Flaps:a Game Changer in Nasal Reconstruction By Michael A. Fritz, MD

Michael A. Fritz, MD

Our success using vascularized fascia lata as a thin, pliable tissue for oral mucosal reconstruction spurred us to adopt it for large nasal lining defects.

The thin and well-vascularized flap enables simultaneous replacement of the nasal structure and external skin, allowing for faster recovery and fewer large revision surgeries.

Continued on page 6


more rapid recovery and requiring fewer large revision surgeries. In addition, functional nasal airways can be achieved without further debulking procedures.

Thanks to this significant innovation, our patients have achieved adequate nasal patency with minimal revisions. Given all its advantages, vascularized fascia lata appears to hold great prom-ise for complex nasal reconstructions.

Suggested Reading

Burget GC, Walton RL. Optimal use of microvascular free flaps, cartilage grafts, and a paramedian forehead flap for aesthetic recon-struction of the nose and adjacent facial units. Plast Reconstr Surg. 2007;120(5):1171-1207.

Menick FJ. Facial reconstruction with local and distant tissue: the interface of aesthetic and reconstructive surgery. Plast Reconstr Surg. 1998;102(5):1424-1433.

Seth R, Revenaugh PC, Scharpf J, Shipchandler TZ, Fritz MA. Free anterolateral thigh fascia lata flap for complex nasal lining defects. JAMA Facial Plast Surg. 2013;15(1):21-28.

Seth R, Revenaugh PC, Vidimos AT, Scharpf J, Somani AK, Fritz MA. Simultaneous intraoperative Mohs clearance and reconstruction for advanced cutaneous malignancies. Arch Facial Plast Surg. 2011;13(6):404-410.

Tollefson TT, Kriet JD. Complex nasal defects: structure and internal lining. Facial Plast Surg Clin North Am. 2005;13(2):333-343, vii.

Walton RL, Burget GC, Beahm EK. Microsurgical reconstruction of the nasal lining. Plast Reconstr Surg. 2005;115(7):1813-1829.

Dr. Fritz is a specialist in facial plastic and reconstructive surgery in the Head & Neck Institute. He can be reached at 216.444.2792 or [email protected].

Figure 1A. Illustration depicts the skeletal framework for reconstruction of a total or near-total defect. Septal, costal and/or auricular cartilage is harvested and used to recreate the nasal ala and sidewalls, and a rib graft is used for dor-sal and caudal supports. Vascularized anterolateral thigh fascia lata is secured to these grafts, and the vascular pedicle is tunneled subcutaneously to the distal facial or angular artery and vein for microvascular anastomosis.

Figure 1B. A harvested rib is carved so that it articulates distally to form an L-shaped strut. The vascularized fascia lata is woven into and suspended around the rib graft to create an underlying nasal lining. Surrounding the grafts with vascularized tissue promotes cartilage and bone graft survival.

Figure 1C. In a multiple-layer reconstruction, a paramedian forehead flap (red) is used to reconstruct the outer skin cover. Cartilage and bone grafts are placed below the cover (blue and white) to establish the nasal framework. The vascularized fascia lata recreates the nasal lining, and a split-thickness skin graft is often used to cover the fascia at the reconstructed nasal vestibule.

Figure 1B

Figure 1C

Figure 1A

Nasal Reconstruction (continued from p. 5)


Case StudyOne of our patients was a 54-year-old man with persistent desmoplastic melanoma who had previously undergone nasal resection and reconstruction at another hospital. We performed a subtotal rhinectomy and partial septectomy, sparing only the columella and alar rim (Figure 2A). One week postoperatively, pathology revealed complete margin clearance. The patient then underwent reconstruction of the external defect and nasal septum with ear and costal cartilage (Figure 2B), vascularized anterolateral thigh fascia lata (Figure 2C) and a paramedian forehead flap (Figure 2D).

The patient’s postoperative course was uneventful, and three weeks after the initial reconstruction he underwent a forehead

flap takedown. A nasal sidewall debulking was performed two months later, and a minor left nostril revision was done three months after debulking. Each of these secondary procedures was performed on an outpatient basis.

At 19 months of follow-up, the patient’s nasal airway function was excellent bilaterally, and he was pleased with the aesthetic outcome (Figure 3A-C). Endoscopic evaluation demonstrated an intact septum and widely patent and mucosalized nasal cavities (Figure 3D). At two years postoperatively, he remains satisfied with the results.

Figure 3. (A-C) Follow-up at 19 months postoperatively shows an excellent cosmetic result. (D) Endoscopic exam-ination at the same follow-up visit reveals a patent nasal passageway lined with mucosa. No crusting is present.

Figure 2. (A) Intraoperative photo shows the subtotal rhinectomy and partial sep-tectomy. (B) The nasal framework is constructed with autogenous ear and costal cartilage. (C) Vascularized anterolateral thigh fascia lata is placed to reconstruct the septum and create the nasal lining. (D) A paramedian forehead flap is used to form the skin envelope. Local cheek advancement flaps provide coverage lateral to the nasofacial sulcus bilaterally (not shown).

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Treatment of laryngeal cancers is an area of great interest — and expertise — among the surgeons in the Section of Head and Neck Surgery and Oncology in Cleveland Clinic’s Head & Neck Institute. Much of our recent activity has centered on two particular areas: salvage laryngectomy for recurrent laryngeal cancer and the devel-opment of a Cleveland Clinic Care Path for laryngeal cancer. The latter effort should make the treatment of laryngeal cancer more effective and efficient, both at our institution and at other sites nationally, and fits well with the emphasis on patient safety that is now a pre-eminent issue in the United States.

What We Learned About Salvage Surgery

Laryngeal squamous cell carcinoma is highly radiosensitive, with reported postirradiation locoregional control rates in the range of 73 to 95 percent in patients with early-stage disease. For recurrent disease, however, the focus of treatment shifts to salvage surgical procedures, which are capable of achieving ultimate tumor control in most cases. Our Head & Neck Institute group has comprehen-sively evaluated our experience with salvage laryngeal surgery. We presented our findings at the 2012 annual meeting of the American Academy of Otolaryngology – Head and Neck Surgery (AAO-HNS) and published the entire study in the AAO-HNS journal.1

The goal of our study was to determine the effectiveness of salvage surgery for recurrent laryngeal cancer after initial nonsurgical treat-ment of both early and advanced laryngeal carcinomas. Among our main endpoints were locoregional control, long-term (five years)


Taking a leadership Role to Help Patients with laryngeal CancerTwo Recent Endeavors Highlight Commitment to Consistency and Quality of Care

By Eric Lamarre, MD, FACS; Joseph Scharpf, MD, FACS; and Brian B. Burkey, MD, FACS

Eric Lamarre, MD, FACS Joseph Scharpf, MD, FACS Brian B. Burkey, MD, FACS

disease-specific survival (DSS) and time to initial recurrence. We also sought to identify any additional factors that might influence long-term survival because such prognostic factors are not well established. Finally, we looked at outcomes in patients who under-went neck dissection.

Time to recurrence. We found that the median time to recurrence from initial diagnosis was 11 months in advanced-stage cancers and 15 months in early-stage tumors. This emphasizes the impor-tance of frequent follow-up for at least two years after initial treat-ment and extended long-term follow-up thereafter.

locoregional control and survival. The overall locoregional control rate after salvage laryngectomy was 70 percent, and overall five-year DSS ranged from 55 to 70 percent, depending on the initial staging. Both these findings are similar to what has been previ-ously reported in the literature. In cases of treatment failure, there was no significant correlation between long-term survival and the staging of either the initial tumor or the recurrent tumor.

We found no significant difference in five-year DSS between patients with early-stage cancer, who had been initially treated with radiotherapy alone, and those with advanced-stage cancer, who had been initially treated with both radio- and chemotherapy. Therefore, we conclude that once tumors recur, the type of initial treatment plays little or no role in long-term prognosis.

Cleveland Clinic Care Paths are more than just guidelines; they show how to implement guidelines and make them operational.


Neck dissection. Currently, the criteria for neck dissection in the treatment of recurrent laryngeal cancer are not well established. In our series, 82 percent of patients underwent neck dissection to treat their recurrence. The group that did not undergo neck dissec-tion consisted of only a small portion of the overall series (21 percent of the early-stage group). They were highly selected patients whose treatment was discussed in a multidisciplinary review of physical exam findings and radiologic imaging. In our series, a surprisingly high rate of occult nodal disease (30.5 percent) was found among patients undergoing neck dissection, and this may argue for stron-ger consideration of neck dissection in all patients undergoing sal-vage surgery.

a Care Path to Guide Our Patients’ Journey

Management of laryngeal cancer is complex, as it spans multiple disciplines in both outpatient and inpatient settings. It involves substantial utilization of resources and has a significant impact on the patient’s overall daily function and quality of life. In general, the coordination between ancillary services and resource utilization during a patient’s treatment journey is variable.

Clinical care pathways for head and neck cancer in general have proved valuable in reducing resource utilization while improving quality of care. Yet despite these documented improvements, until now no care pathways have been developed specifically for laryn-geal cancer. In view of the elaborate surgical procedures involved, the high degree of postoperative morbidity, the prolonged hospital stays, the ancillary services required and the complexity of post-discharge care, laryngeal cancer is an ideal subject for a care pathway.

We in the Head & Neck Institute have created a Cleveland Clinic Care Path to standardize the complete course of management for patients with laryngeal cancer. It is our goal to establish a Disease-

Specific Care Certification Program for The Joint Commission, as no nationally accredited program for laryngeal cancer currently exists.

Our collaboration will feature evidence-based guidelines that span all the involved disciplines. This care path will not only standardize management and decrease variability among providers, it will iden-tify and eliminate redundancies, resulting in a more effective use of resources. It is important to point out that Cleveland Clinic Care Paths are more than just guidelines; they show how to implement guidelines and make them operational, drawing on a highly inte-grated model of care (Figure 1).

Our Laryngeal Cancer Care Path begins with the diagnosis and extends to oncologic surveillance five years after completion of treatment. It will be fully integrated within our electronic medical record system. With continuous direct feedback from patients, our intention is to enhance patients’ overall experience. Our goal is to have this care path finalized and in effect by the end of 2013.

Reference

1. Li M, Lorenz RR, Khan MJ, et al. Salvage laryngectomy in patients with recurrent laryngeal cancer in the setting of nonoperative treatment failure. Otolaryngol Head Neck Surg. 2013;149(2):245-251.

Dr. Lamarre is a staff physician in the Head & Neck Institute’s Section of Head and Neck Surgery and Oncology. He can be reached at 216.444.8552 or [email protected].

Dr. Scharpf is a staff physician in the Section of Head and Neck Surgery and Oncology. He can be reached at 216.445.8252 or [email protected].

Dr. Burkey is Head of the Section of Head and Neck Surgery and Oncology and Vice Chairman of the Head & Neck Institute. He can be reached at 216.445.8837 or [email protected].

Figure 1. Schematic depicts the multifaceted nature of integrated care that serves as the model for Cleveland Clinic Care Paths.

Community-based organizations

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PATIENTS FIRST M

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CC clinic

Emergency facilities

Ambulatory diagnostic and treatment centers

Hospitals

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Cleveland Clinic’s Integrated Care Model


While continuous positive airway pressure (CPAP) is widely recognized as the first-line treatment for obstructive sleep apnea (OSA), several studies have revealed that noncompliance rates range from 35 per-cent to as high as 85 percent.1 According to a review by the National Commission on Sleep Disorders Research, approximately 50 percent of patients discontinue CPAP

therapy within the first year.2 What’s more, it is still unclear what level of compliance with CPAP therapy is necessary to achieve a long-term benefit.3,4

With the substantial lack of adherence to CPAP protocols, a sig-nificant number of patients with OSA remain untreated or incom-pletely treated. As a result, they continue to experience the attendant morbidity of a poorly controlled chronic medical condi-tion, particularly the common and potentially dangerous sequela of daytime sleepiness.

Fortunately, sleep apnea surgery is available as a more definitive alternative to CPAP for selected patients. The primary goal of surgery for OSA is to prevent obstruction by increasing the potential volume of airspace in the upper airway. A new study of uvulopalatopharyngoplasty (UPPP) at Cleveland Clinic has shown how effective surgery can be. This work was presented at the annual meeting of the Trio-logical Society in April.5

Beyond the apnea-hypopnea Index

Although surgical success rates have traditionally been based on the postoperative apnea-hypopnea index (AHI), we chose to look at additional outcomes measures. The objectives of our study were to determine any postoperative changes from baseline not only in AHI but in quality-of-life and sleepiness/fatigue measures

as well. We also sought to determine if there were any baseline differences between patients who did and did not improve signif-icantly with surgery.

We searched our electronic medical record (EMR) system to identify all patients who had undergone UPPP over the prior 10 years. We compiled preoperative data from the EMR and obtained postoperative follow-up and outcomes data either from the EMR itself or from answers to surveys we sent by mail. Our final study population was made up of 55 evaluable patients.

We first looked at the median AHI and found that it dropped from 41.5 preoperatively to 19.5 postoperatively, which was a statistically significant difference (Figure 1).

In terms of daytime sleepiness, a score of 10 or greater on the validated Epworth Sleepiness Scale (ESS) indicates excessive sleepiness during the day. Our study found that 40 of the 55 patients (73 percent) experienced a reduction in ESS score after surgery. Overall, the median ESS score dropped from 10.0 to

7.0, which also represented a statistically significant improve-ment (Figure 2).

We also noted some improve-ment in the Fatigue Severity Scale score, although this change did not reach the level of statistical significance. Of interest, we found no significant differences in preoperative

baseline parameters between patients who did and did not receive some benefit from surgery.

Patients Benefit Even Without Traditional “Cure”

Quality-of-life data about the potential benefits of UPPP will help us counsel patients in a more thorough way. Thanks to our EMR system, we now have an ever-increasing amount of data that will enable us to answer our patients’ questions and provide them with appropriate expectations after surgery.

Sweeter Dreams for Patients with Sleep apneaUvulopalatopharyngoplasty Can Play an Important Role for Those Who Cannot Tolerate CPAP

By Alan Kominsky, MD, FACS

Alan Kominsky, MD

We demonstrated that improvements in the apnea-hypopnea index do not necessarily predict improvements in quality of life or alertness.


Our results support a growing body of evidence suggesting that it is not necessary for OSA to be completely cured in order for patients to experience an improvement in quality of life or day-time alertness.6,7 We also demonstrated that improvements in AHI are not necessarily predictive of improvements in quality of life or alertness. This suggests that benefits of surgery are signifi-cant, even if apnea is not “cured” in the traditional sense.

References

1. Weaver TE, Grunstein RR. Adherence to continuous positive airway pressure therapy: the challenge to effective treatment. Proc Am Thorac Soc. 2008;5(2):173-178.

2. Wake Up America: A National Sleep Alert. Report of the National Commission on Sleep Disorders Research. Bethesda, MD: National Heart, Lung, and Blood Institute; 1993.

3. Weaver TE, Maislin G, Dinges DF, et al. Relationship between hours of CPAP use and achieving normal levels of sleepiness and daily func-tioning. Sleep. 2007;30(6):711-719.

4. Weaver EM, Maynard C, Yueh B. Survival of veterans with sleep apnea: continuous positive airway pressure versus surgery. Otolaryngol Head Neck Surg. 2004;130(6):659-665.

5. Russell JO, Bae CJ, Kominsky AH. Pre and postoperative quality of life in uvulopalatopharyngoplasty. Paper presented at: 116th Annual Meeting of The Triological Society; April 13, 2013; Orlando, Fla.

6. Yaremchuk K, Tacia B, Peterson E, Roth T. Change in Epworth Sleepi-ness Scale after surgical treatment of obstructive sleep apnea. Laryngo-scope. 2011;121(7):1590-1593.

7. Weaver EM, Woodson BT, Yueh B, et al. Studying Life Effects & Effec-tiveness of Palatopharyngoplasty (SLEEP) study: subjective outcomes of isolated uvulopalatopharyngoplasty. Otolaryngol Head Neck Surg. 2011;144(4):623-631.

Dr. Kominsky is a staff physician in the Head & Neck Institute with board certifications in both otolaryngology and sleep medicine. He can be reached at 216.444.1948 or [email protected].

Figure 2. Graph shows the statistically significant reduction in median Epworth Sleepiness Scale (ESS) score from 10.0 preoperatively to 7.0 postoperatively (P < .001).

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Preoperative(N = 55)

Postoperative(N = 55)

Figure 1. Graph shows the statistically significant improvement in median apnea-hypopnea index (AHI) from a preoperative level of 41.5 to a postoperative level of 19.5 (P < .001).


Laryngeal dysplasia is a premalignant condition of the true vocal folds that is often challenging to treat. Its spectrum of severity ranges from epithelial hyperplasia to severe dysplasia

and carcinoma in situ. Complicating the management of laryn-geal dysplasia is the variable reliability of tumor grading among pathologists.

Cleveland Clinic’s Voice Center and Section of Laryngology offer state-of-the-art diagnosis and management of these lesions. Diagnostically, high-definition videostroboscopy (Figure 1), high-speed video and narrow-band imaging (Figure 2) demonstrate excellent anatomic detail and provide clinicians with the ability to compare lesions over time.

Natural Course Is Variable

According to traditional teaching on the natural progression of laryngeal dysplasia, it worsens gradually until it becomes a car-cinoma. Many clinicians will employ watchful waiting for these lesions, even in patients with a significant voice handicap. The timing and rate of malignant transformation is variable and depends on the severity of disease. Indeed, a large number of patients in Cleveland Clinic’s Head & Neck Institute have what appears to be recurrent but indolent and nonprogressive dyspla-sia or carcinoma in situ.

Clinically, patients can present with signs and symptoms of vary-ing severity, ranging from minimal voice complaints to severe hoarseness. Endoscopically, laryngeal dysplasia typically appears as patch-like white or red lesions (leukoplakia or eryth-roplakia) on the surface of the vocal folds. The lesions can

dampen mucosal pliability and negatively impact voice. Most patients who develop vocal fold dysplasia have a history of tobacco use, but others have never used tobacco.

Microsurgery with high Precision

The mainstay of treatment has traditionally been microsurgical excision, with or without use of the CO2 laser. Microsurgical exci-sion continues to be the standard with regard to diagnosis, and several advances in laser technology and surgical technique have enhanced our treatment of these lesions in the operating room and the office.

The pulsed potassium titanyl phosphate (KTP) laser has improved the treatment of premalignant vocal fold lesions. The light’s 532-nm wavelength is preferentially absorbed by the sub-epithelial microcirculation, allowing for the lesion and its surround-ing blood supply to be photoangiolysed with high precision. The KTP laser’s fiber-based delivery system also allows patients to be treated comfortably and without sedation in an office-based set-ting (Figure 3).

Given the propensity of dysplastic lesions to recur, this is a rea-sonable treatment option for most patients once their disease has been characterized and staged via microsurgical excision, and it may allow them to avoid recurrent general anesthesia. It also allows the laryngeal surgeon to actively treat premalignant disease rather than wait for malignant degeneration.

Paul C. Bryson, MD Michael S. Benninger, MD

Contemporary Management of laryngeal Dysplasia Starts with High-Tech ImagingTreatment Options Also Continue to Evolve

By Paul C. Bryson, MD, and Michael S. Benninger, MD

Given these lesions’ propensity to recur, the pulsed KTP laser is a reasonable treatment option for most patients once their disease has been characterized and staged via microsurgical excision.


Monitoring for Malignant Transformation

Malignant transformation is more common in severe dysplasia and carcinoma in situ than in less serious dysplasias, and it can take many years to occur. Therefore, routine surveillance and treatment is our standard of care at the Voice Center. With our state-of-the-art imaging and laser technology, we are able to closely monitor and treat premalignant disease to maintain opti-mal voice and to survey for possible development of invasive carcinoma.

Dr. Bryson is Director of the Voice Center and Section Head of Laryngol-ogy in the Head & Neck Institute. He can be reached at 216.445.6468 or [email protected].

Dr. Benninger is Chairman of the Head & Neck Institute. He can be reached at 216.444.6686 or [email protected].

Figure 1. High-definition videostroboscopic images demonstrate the improved ability to see and charac-terize the appearance of this lesion on the antero-superior aspect of the left true vocal fold. The papil-lary appearance of this lesion is distinct from the surrounding epithelium.

Figure 1

Figure 2

Figure 3

Figure 2. These images demonstrate the utility of narrow-band imaging in further clarifying the topo-graphic and angiogenic footprint of a laryngeal neoplasm.

Figure 3. Office-based KTP laser photoangiolysis is performed on the severe dysplasia shown in Figure 1. It is performed with the assistance of narrow-band imaging and high-definition endoscopy.


Of all the patients who present with maxillo-facial trauma, those with panfacial fractures are among the most challenging. While it is almost always best to repair facial frac-tures quickly, this is not always possible. Due to injury severity or involvement of multiple organ systems, some patients must undergo delayed repair or repair in stages. Outcomes of delayed reconstruction are not always ideal.

In Cleveland Clinic’s Section of Oral and Maxillofacial Surgery, we are using advanced technology, including medical modeling and virtual surgical planning, to aid in the surgical correction of acquired dentofacial deformities secondary to trauma. Medical modeling is a method of using medical imaging to construct three-dimensional (3-D) models of selected anatomic sites. The models are then used for virtual surgical planning, which is a process of computer-guided planning for making surgical splints.

a Case of Malocclusion Following an assault

A 42-year-old man with insulin-dependent diabetes mellitus pre-sented to the Oral and Maxillofacial Surgery Clinic with a signifi-cant dental malocclusion secondary to a traumatic facial injury. The patient said that he had been assaulted approximately five months earlier during a dispute at a pub. He sustained a blunt-force trauma to the midface, which resulted in bilateral orbital fractures, bilateral nasal bone fractures and a Le Fort I/II fracture.

The patient underwent primary treatment of his facial fractures. Due to the extent of the injuries, the lack of bony support in the midface and limited dentition, the trauma team was unable to place the maxilla in a stable position. As a result, the patient developed a significant malocclusion, and he was referred to us.

Examination in our clinic revealed that only two of the patient’s teeth on the left side of his mouth were able to come into contact. He had developed a significant left-sided crossbite, a right poste-rior open bite and an Angle class III malocclusion. Masticatory insufficiency secondary to the malocclusion made it difficult for him to maintain his weight and manage his diabetes.

assembling the 3-D Model

We performed a complete orthognathic surgical workup to obtain the necessary clinical data for medical modeling, including extra- and intraoral clinical photographs, maxillary and mandibu-lar impressions, a facebow transfer, bite registration and CT of the facial bones without contrast.

In addition to severe malocclusion, the patient had a significant midface concavity and a gross nasal deformity. The facebow and bite registration were used to mount the patient’s dental casts on a semiadjustable dental articulator for reference. A sec-ond set of casts were mounted on a Galetti articulator, and the final desired occlusion was set. Once preliminary assessment of the dental records was completed, the patient’s 3-D CT (Figure 1) and dental casts were marked with the final desired occlusion and sent to Medical Modeling Inc., a Colorado company that specializes in constructing 3-D medical models.

After the materials were studied by one of the vendor’s engineers, a web conference was held with the oral and maxillofacial sur-geon to complete the virtual surgical planning (Figures 2 and 3). (These consultations typically take less than 30 minutes.) The vendor fabricated a custom surgical splint to guide surgical repo-sitioning of the maxilla intraoperatively. Soft-tissue rests were incorporated into the final splint to provide stability and counter-act the effects of the patient’s multiple edentulous areas (Figure 4).

The patient was seen before surgery to check the fit of the splint. The splint fit perfectly when placed on the patient’s maxillary and mandibular dentition and when placed in the models mounted on the Galetti articulator in the final desired occlusion.

The Day of Surgery

After administration of general anesthesia, arch bars were placed on both the maxillary and mandibular arches so the patient could be placed into maxillomandibular fixation. A traditional arch bar was wired to the maxillary dentition, but because of the limited dentition on the mandibular arch, a Stryker Hybrid MMF bar was used there. The patient was then prepped and draped in standard fashion for orthognathic surgery.

Medical Modeling and Virtual Surgical Planning for Maxillofacial Reconstruction: Facing the FutureBy Michael Horan, MD, DDS, PhD

Michael Horan, MD, DDS, PhD


A circumvestibular incision was created, and the anterior and lat-eral maxilla was fully exposed. Retained hardware in the maxilla from the previous surgery was removed. The patient had several fenestrations along the anterior wall of the maxilla, and he was missing a significant portion of the left lateral piriform rim. A standard Le Fort I osteotomy was created, and the maxilla was downfractured and completely mobilized. The prefabricated splint was inserted, and the patient was placed into maxilloman-dibular fixation. Standard titanium midface plates were used to secure the right maxilla. A larger reconstruction plate was used to stabilize the left maxilla due to poor bone quality and lack of bony support in the left piriform rim. Finally, bone from the ante-rior iliac crest was grafted to the anterior maxilla.

The patient was taken out of maxillomandibular fixation, and the surgical splint was removed. The occlusion was noted to be stable and reproducible, and the patient was placed back into maxillomandibular fixation. Due to airway edema, he was kept intubated in the surgical ICU overnight and extubated the next morning. His postoperative course was uneventful, and he was discharged on postoperative day 2.

The patient remained in maxillomandibular fixation with wire for five weeks, after which the inter-arch wires were removed and he was placed in heavy elastics. The occlusion remained stable and reproducible (Figure 5). The patient returned to his primary surgeon for definitive nasal reconstruction approximately 10 weeks after his maxillary reconstruction. Overall, he was pleased with the outcome of his surgery.

This Is the Future of Maxillofacial Surgery

While our patient had a complex maxillary dental malocclusion, similar planning techniques can be used for trauma patients with malocclusions secondary to either mandibular or maxillary-man-dibular trauma. In addition to surgical splints, pre- and postsurgi-cal 3-D models and resection guides can be fabricated if needed.

This case is just one example of how oral and maxillofacial sur-geons at Cleveland Clinic are using medical modeling and virtual surgical planning to improve outcomes for maxillofacial trauma patients. These techniques have proven to be very accurate, and they most certainly represent the future of maxillofacial surgery.

Dr. Horan is Section Head of Oral and Maxillofacial Surgery in the Head & Neck Institute. He can be reached at 216.636.4329 or [email protected].

Figure 1. Three-dimensional reconstruction of the preoperative CT is obtained for virtual surgical planning. Figure 2. Three- dimensional reconstruction of the preoperative CT is seen following virtual surgical planning for the Le Fort I osteotomy. Note that the dental casts have been scanned and superimposed on the reconstruction to provide accuracy when setting the patient’s occlusion. Figure 3. Virtual surgical planning of the Le Fort I osteotomy can show the exact movements of the maxilla. Figure 4. Soft-tissue rests (light red) are incorporated into the splint (dark red) to provide stability. Figure 5. Postoperative panoramic radiograph shows the alignment of the maxillary and mandibular arches.

Figures 1 to 3 (left to right)

Figures 4 and 5


Although surgery for chronic rhinosi-nusitis (CRS) has been shown to improve quality of life, it is not cura-tive, and patients routinely require ongoing postopera-

tive medical therapy. There is a growing trend in postoperative care toward the use of topical drugs delivered directly to the dis-eased sinus mucosa via nebulization and irrigation. Topical treat-ments have two primary advantages over oral medications:

• With topical delivery, a higher concentration of drug can be administered directly to the site of the infection or inflammation within the sinuses themselves.

• Patients treated topically are not exposed to the systemic effects and complications of oral medications.

Green Lights, Yellow Flags

The literature in support of the use of topical antimicrobials for CRS and topical steroids for nasal polyps is mounting. The high-est levels of evidence exist for studies of culture-directed antibi-otic therapy in postsurgical patients, and it appears that both stable and acute exacerbations of CRS may respond to topical therapy. For example, use of adjunctive mupirocin irrigations to treat exacerbations of staphylococcal infections or to help eradi-cate methicillin-resistant Staphylococcus aureus from the nose is gaining favor. High-dose topical steroids are also now widely used by rhinologists as maintenance therapy for patients with refractory nasal polyps.

Nasal irrigations are easy to perform, they provide mechanical debridement and they can deliver medications into sinuses that have been surgically opened. Among the drugs being used as nasal irrigants are steroids, antibiotics and antifungals. However, although the popularity of this type of drug delivery is growing, there is actually little information in the literature on possible complications or concerns regarding its use. Some recent evi-

dence suggests that there are indeed caveats associated with nasal irrigations that practitioners need to be aware of (see “What to Watch For” sidebar).

a New Type of Sinus lesion

One such caveat about topical delivery pertains to the emergence of paranasal sinus exostoses (PSE), a new diagnostic entity that was recently characterized by Cleveland Clinic rhinologists.1 PSE appears to be a complication of cold nasal irrigations affecting postoperative sinus cavities. These exostoses are analogous to exostoses of the external auditory canal that are related to cold-water surfing. Once formed, the sinus exostoses appear to be permanent, but they do not progress further after discontinuation of cold irrigations.

On endoscopy, these exostoses characteristically appear as “multiple cysts” (Figure 1), but they are actually hard to palpa-tion with an instrument. On CT, they appear as multiple small bony growths on the luminal surfaces of the involved sinuses (Figure 2).

PSE does not require surgical intervention unless the lesions progress to the point of being obstructive. A history of nasal irri-gations with cold solutions in a postoperative patient, combined with the characteristic endoscopic findings of this condition, is sufficient for diagnosis. Of note, PSE can mimic Gardner syn-drome, an autosomal dominant disease characterized by multiple polyps within the colon, tumors (including skull base osteomas and thyroid cancer), fibromas and a variety of cysts. We suspect that the incidence of PSE will increase, given the rising popularity of nasal irrigations.

Raj Sindwani, MD Troy Woodard, MD

Topical Drug Delivery: The New Trend in Maintenance Therapy for Chronic RhinosinusitisBy Raj Sindwani, MD, and Troy Woodard, MD

The incidence of paranasal sinus exostoses will likely increase, given the rising popularity of nasal irrigations.


Irrigants are Commonly Cold

Many of the medicated irrigations currently in vogue are com-pounded by local pharmacists or mixed by patients themselves. Notably, many of these solutions or their components do in fact require refrigeration. We recently analyzed several standard for-mulations of medicated nasal solutions and found that it took more than two hours for these solutions to reach room tempera-ture after being removed from the refrigerator. The rate of pas-sive warming for medicated solutions containing budesonide, mupirocin, amphotericin and tobramycin was not significantly different from the rate for saline. Although the critical tempera-ture associated with PSE formation is unknown, it seems pru-dent to advise patients to remove irrigation solutions from the refrigerator at least 45 minutes before use to bring them closer to room temperature.

However, busy patients may not want to wait for their medica-tion to warm up naturally, and they may attempt to help the pro-cess along with active warming in a microwave oven or by some other means. Unfortunately, this might compromise the effec-tiveness of their medication. The good news is that newer meth-ods of formulating medicated solutions by mixing a dry-powder form of the drug (using materials such as Loxasperse®, for exam-ple) with room-temperature saline should mitigate some of these concerns. This is a growing area of interest for clinicians and pharmacies.

what to Tell your Patients

When patients are prescribed a topical nasal therapy for CRS, they should be informed of the planned duration of treatment as well as the risks, benefits and alternatives. With the evolving trend toward treating postoperative sinus disease topically, clini-cians should be aware of the complications of nasal irrigations, and patients should be advised to use a clean irrigation device with clean water and to irrigate with solutions at or close to room temperature.

Reference

1. Haffey T, Woodard T, Sindwani R. Paranasal sinus exostoses: an unusual complication of topical drug delivery using cold nasal irrigations. Laryngoscope. 2012;122(9):1893-1897.

Dr. Sindwani is Head of the Section of Rhinology, Sinus and Skull Base Surgery in the Head & Neck Institute. He can be reached at 216.445.2845 or [email protected].

Dr. Woodard is a staff physician in the Section of Rhinology, Sinus and Skull Base Surgery. He can be reached at 216.445.7157 or [email protected].

What to Watch For: Limitations and Complications of Nasal Irrigations

• Drug-related side effects/systemic absorption (e.g., hearing loss with aminoglycosides)

• Potential salt absorption with prolonged use of saline irrigations

• Infections related to the cleanliness of the water used to mix solutions or contamination from improperly maintained devices

• Local trauma to the anterior nose

• Cost for compounded medications

• Patient dissatisfaction with issues such as tolerability, inconvenience and compliance

• Development of paranasal sinus exostoses from cold irrigation solutions

Figure 1 (A-B). Endoscopic views show two postoperative sinus cavities with the hard paranasal sinus exostoses.

Figure 2. CT imaging shows paranasal sinus exostoses as bony irregular-ities on the luminal surfaces of the affected sinuses.

1a 1B

2


Innovations that improve the assessment and management of patients with hear-ing loss, tinnitus and other otologic impairments are the focus of activ-

ity in Cleveland Clinic’s Audiology Research Laboratory. Our mis-sion includes investigating and/or developing practical clinical tools and technologies that can have an immediate application in everyday clinical practice. Below are synopses of investiga-tions currently underway in the Audiology Research Laboratory.

Putting a New SPIN on Cochlear Implant Evaluations Cochlear implant technology, which has improved significantly in recent years, requires outcomes measures that are ecologically valid and sufficiently difficult to avoid ceiling effects. The Audiol-ogy Research Laboratory team has selected an existing test — the Speech Perception in Noise (SPIN) test — and modified it to increase the level of listening difficulty. The standard SPIN test is based on sentence-length materials that contain high- and low-predictability contextual cues, which makes this test highly eco-logically valid.

We modified the SPIN test by applying four different reverbera-tion conditions that increase listening difficulty while simulating different environmental situations. The reverberation conditions progress from easy to very difficult:

• Easy (no reverberation)

• Somewhat difficult (e.g., reverberation in a living room)

• Slightly more difficult (e.g., an empty classroom or college lecture hall)

• Very difficult (e.g., a hard-walled hall such as an auditorium)

Our new test, which we call the SPIN-Reverberation test, is designed to be administered to cochlear implant patients across all listening skill levels. The availability of multiple lists that have been shown to be equivalent allows for pre- and post-testing to assess patient benefit. This investigation is being carried out in conjunction with the Columbia University College of Physicians and Surgeons.

Better Digital Signal Processing in hearing Devices Digital signal-processing algorithms in today’s hearing devices are designed not only to provide audibility for speech and non-speech signals but to increase the clarity of sounds in complex environments. We undertook a study to compare various engi-neered signal-processing strategies in patients with sensorineu-ral hearing loss. For this investigation, we are using a series of laboratory tests of speech understanding in quiet and noise, as well as subjective measures (i.e., questionnaires).

Our intent is to identify specific signal-processing algorithms that provide the greatest benefit with the least amount of listening effort. These benefits include achieving a natural sound quality and improving comprehension in background noise and rever-berant environments.

Soothing New Sounds for Tinnitus Relief

Sound therapy coupled with ongoing counseling and patient educa-tion is at the heart of audiologic management for patients with tinni-tus. We are currently evaluating the efficacy of a new ear-level device that combines state-of-the-art digital signal processing and

Craig W. Newman, PhD Sharon A. Sandridge, PhD

audiology Research lab Is Humming with activityBy Craig W. Newman, PhD, and Sharon A. Sandridge, PhD

Our laboratory’s mission is to conduct ecologically valid research that can be implemented into the practice of clinical audiologists who treat hearing loss, tinnitus or balance issues.


proprietary therapeutic sounds. The set of therapeutic sounds includes natural environmental soundscapes such as waterfalls, ocean waves and “night sounds.” These therapeutic sounds have been developed as an alternative to the traditional white noise used for tinnitus masking and/or habituation regimens.

We are evaluating these new devices by quantifying changes in our patients’ perceived tinnitus handicap and distress over a six-month period. Our assessment tools include a series of standard-ized tinnitus disease-specific questionnaires, generic measures of health-related quality of life (HRQoL) and user listening prefer-ence tools.

helping Spouses Understand Tinnitus handicap

The social support network of patients with clinically significant tinnitus is likely to play an important role in these patients’ ability to cope with and manage the disabling consequences of tinnitus. In this context, the quality and structure of a spousal relationship can influence how patients with chronic conditions manage their circumstances. It can also affect how patients perceive their bio-psychosocial health status.

In Cleveland Clinic’s multispecialty Tinnitus Management Clinic, we are using the Tinnitus Handicap Inventory (THI) and its com-panion form for spouses (THI-SP) to compare our patients’ per-ceptions of their tinnitus with their spouses’ perceptions before we undertake any extensive counseling and management. A spouse’s empathy regarding the handicapping nature of tinnitus may be critical to the well-being of the relationship and to the mental health of each partner. Our determination of the degree of spousal comprehension will ultimately influence counseling strategies, tinnitus management options and treatment outcome.

a New Screen for Otologic Impairments Hearing loss, tinnitus and falls are among the most common problems that older adults face. The underdetection and under-treatment of these manageable (medically and/or rehabilitatively) otologic impairments can have a negative impact on HRQoL and quality of care.

We are in the first phase of a study to evaluate the psychometric characteristics of a newly developed screening tool called the Screening for Otologic Functional Impairments in the Elderly (SOFIE) instrument. The 10-item SOFIE was developed by selecting items from the Hearing Handicap Inventory for the Elderly, the Dizziness Handicap Inventory and the THI.

In the second phase of our study, we will evaluate the efficacy and utility of SOFIE for use by primary care physicians and nurses so they can identify and refer older adults at risk for oto-logic functional impairments.

Our Goal: Relevance to Daily Practice Our mission in the Audiology Research Laboratory is to conduct research that is ecologically valid and can be implemented into the daily practice of clinical audiologists who treat hearing loss, tinnitus or balance issues.

Dr. Newman is Section Head of Audiology and Co-Director of the Audiology Research Laboratory in the Head & Neck Institute. He can be reached at 216.445.8520 or [email protected].

Dr. Sandridge is Director of Clinical Audiology Services and Co-Director of the Audiology Research Laboratory. She can be reached at 216.445.8517 or [email protected].

what we’re working On

The audiology Research laboratory’s current investigations are focusing on:

• The effectiveness of hearing technology signal-processing algorithms

• Objective and subjective audiologic outcomes measures

• Digitally generated environmental sounds used to provide tinnitus relief

• The psychosocial consequences of tinnitus as perceived by patients and their spouses

• A new screening tool for older adults to identify otologic functional impairments associated with hearing loss, tinnitus and dizziness

Hyperacusis Research: The Noise Is Too loud!By James Kaltenbach, PhD


James Kaltenbach, PhD

The causes of hyperacusis are much the same as the causes of tinnitus.

Hyperacusis is a condition characterized by a heightened sensitivity to sound that can result in patients having difficulty tolerating many sounds. Those with hyperacusis per-ceive environmental sounds as being louder and/or more annoying than what normal-hearing people perceive. Sounds that are particularly bothersome include automobile traffic, sirens and other back-

ground noise, but even the sounds of other people’s voices or music can create much discomfort. Patients with severe hyper-acusis can have such a low tolerance for sound that they confine themselves to quiet rooms.

Our Study of hyperacusis in a Rodent Model

As is the case with other hearing disorders, the development of effective therapies for hyperacusis will require a better under-standing of its mechanisms. To achieve this, it is necessary to establish an animal model of the chronic form of hyperacusis. Recently, researchers in Cleveland Clinic’s Auditory Neurobiology Laboratory discovered that animals exposed to intense sound develop long-lasting hyperacusis-like “enhancements” in their responses to noise.1 These enhancements occurred in two ways:

• First, animals that had been exposed to intense sound were still hypersensitive to noise a few weeks later. This hypersensitiv-ity manifested as a heightened startle response when brief bursts of noise were presented. When we compared measures of the startle amplitude of the sound-exposed animals with those of unexposed control animals, we found a large increase in the amplitude of the startle in the exposed group when the sound pressure level exceeded 105 dB (Figure 1).

• Second, the exposed animals exhibited an enhanced sensitivity to background noise. The addition of background noise resulted in a suppression of the startle response, as though the animals had become sensitized to background noise. In the normal-hear-ing animals, the addition of background noise to the startle stim-ulus had no significant effect on the startle response.

Both types of enhancements were observed over several months of testing, so it appears that the sensitization to noise in the exposed animals represents a chronic condition. Therefore, the question of whether these enhancements do indeed represent a chronic form of hyperacusis is of central importance. The answer may lie in some recent studies of hyperacusis and tinnitus in humans.

a link to Tinnitus

The causes of hyperacusis are much the same as the causes of tinnitus, with which it is often associated. They include exposure to excessive noise or ototoxic drugs, in addition to other insults that induce injury to the inner ear. Two recent studies are of interest:

• Dauman and Bouscau-Faure2 found that the incidence of hyperacusis in patients with tinnitus was almost 80 percent. Based on the strong association, it is likely that these two disor-ders are interrelated.


Figure 1. Graph shows the significant differences (asterisks) in startle amplitudes between the control animals and those exposed to intense sound.

• Fournier and Hébert3 studied acoustic startle responses in tin-nitus patients and found that most of them displayed enhanced startle responses, which were analogous to what we found in our study of sound-exposed animals.

Continued Quest for an animal Model

Further work will be necessary to verify that an enhanced startle response is a characteristic of humans with hyperacusis, but for now, the parallel is quite striking and gives us reason to perse-vere with studies of startle in animals. Establishment of an ani-mal model of chronic hyperacusis would move us a step closer to understanding its underlying mechanisms, which is ultimately the key to developing appropriate treatments.

References

1. Chen G, Lee C, Sandridge SA, Butler HM, Manzoor NF, Kaltenbach JA. Behavioral evidence for possible simultaneous induction of hyperacu-sis and tinnitus following intense sound exposure. J Assoc Res Otolaryn-gol. 2013;14(3):413-424.

2. Dauman R, Bouscau-Faure F. Assessment and amelioration of hyper-acusis in tinnitus patients. Acta Otolaryngol. 2005;125(5):503-509.

3. Fournier P, Hébert S. Gap detection deficits in humans with tinnitus as assessed with the acoustic startle paradigm: does tinnitus fill in the gap? Hear Res. 2013;295:16-23.

Dr. Kaltenbach is Director of Otology Research and Head of the Auditory Neurobiology Laboratory in the Head & Neck Institute. He can be reached at 216.444.5171 or [email protected].

Further work is needed to verify that an enhanced startle response is a characteristic of hyperacusis in humans, but the parallel is striking.

Current FDA indications for cochlear implantation in adults include moderate to profound bilateral sensorineural hearing loss with poor speech recognition in the best-aided condition. Although the candi-dacy criteria vary by implant manufacturer, even the most liberal criteria do not include patients with a score higher than 60 percent on sentences in quiet in the best-aided (typically bilaterally aided) condition. However, patients with asymmetric hearing loss (AHL) often present with a very poor hearing ear (one that meets FDA cri-teria when assessed individually) and a better hearing ear (one that falls outside these criteria). These patients report significant hear-ing challenges and a lack of benefit from hearing aids alone.

The staff of Cleveland Clinic’s Hearing Implant Program recognize that AHL poses significant difficulties for these patients, and we are actively developing ways to accurately assess their communica-tion challenges and identify management options that will help them achieve the best hearing possible.

The Special Challenges of Asymmetry

Research has indicated that patients with significant AHL have dif-ficulty understanding speech, particularly speech in noise, even if their better hearing ear exhibits normal hearing thresholds.1 Fur-thermore, speech perception scores in the best-aided condition often reflect the abilities of the better hearing ear only.2 As a result, a traditional bilaterally aided assessment is not generally represen-tative of a patient’s real-world hearing abilities.

In many cases of AHL, the poorer ear cannot benefit from amplifi-cation because its speech recognition ability is reduced. Therefore, patients cannot take advantage of the binaural benefits that are critical for speech understanding, even if they pursue amplification


Treating asymmetric Hearing loss with Bimodal Devices: a Successful Balancing actBy Sarah A. Sydlowski, AuD, PhD; Rachel Vovos, AuD; and Erika Woodson, MD

Sarah A. Sydlowski, AuD, PhD Rachel Vovos, AuD Erika Woodson, MD

of the poorer ear or use a BiCROS system. The only option for true binaural hearing for patients with AHL may be cochlear implanta-tion in the poorer hearing ear and a hearing aid in the contralateral ear (bimodal hearing).

what Our Research Shows

Members of our Hearing Implant Program team recently conducted an IRB-approved retrospective analysis of the pre- and postopera-tive speech perception abilities in six bimodal recipients with AHL. All six patients had received their cochlear implant in our program under off-label indications, and the chart review was conducted to determine if bimodal stimulation would benefit patients who have only one ear that meets cochlear implant candidacy criteria. Our hypothesis was that in nontraditional cochlear implantation candi-dates, the use of both a cochlear implant and a hearing aid (which together provide adequate binaural stimulation) would result in bet-ter understanding of speech in both quiet and noise than the use of bilateral hearing aids.

The hearing aids were programmed on the basis of each patient’s most recent audiogram (Figure 1). The settings were verified with an Audioscan Verifit® system using simulated real-ear measures and NAL-NL1 targets prior to testing in the right-aided, left-aided and bilaterally aided conditions. Speech materials were presented at 60 dB(A) in the soundfield at 0 degrees azimuth.

We then compared individual preoperative aided scores with post-operative scores in the cochlear implant-only and bimodal conditions, referencing published confidence intervals to determine clinically significant differences. Paired t tests were used to compare the group’s mean scores for each speech parameter measured (Figure 2):

Patients with asymmetric hearing loss benefit from bimodal stimulation even when hearing in the better ear does not meet FDA implantation criteria.


• AzBio sentences in quiet3

• CNC words in quiet4

• BKB-SIN™ (Bamford-Kowal-Bench Speech-in-Noise test)5

Compared with baseline, we found that all six patients performed significantly better in quiet and in noise when listening with their poorer hearing ear alone. Most of these improvements were observed within one month of activation. Notably, three patients performed significantly better on at least one measure with their cochlear implant alone than they had preoperatively with two hear-ing aids. Moreover, all but one patient (P4) performed significantly better in the bimodal condition than with the bilateral hearing aids preoperatively (the one outlier was an inconsistent cochlear implant user whose intermittent use likely affected her outcomes).

The Proven advantages of Bimodal hearing

The advantages of bimodal hearing for traditional cochlear implan-tation candidates are well documented. Postimplant hearing in patients who had substantial preoperative hearing in the contralat-eral ear has been shown to surpass preoperative levels.6-8 Ching et al showed that associated binaural benefits ultimately led to better speech understanding in the bimodal condition than with either a cochlear implant or a monaural hearing aid alone.9 Firszt et al investigated patients with AHL and concluded that they can indeed benefit from use of a cochlear implant in the poorer hearing ear; recipients demonstrated improvement in sound detection, word and sentence recognition, and localization.2

In light of these findings as well as our own, we conclude that patients with AHL receive significant benefit from bimodal stimula-tion, even when the hearing in the better ear does not meet FDA

Figure 1. Graphs show hearing thresholds in each patient as a function of frequency. Preoperative unaided thresholds are represented by the green lines (better ear) and turquoise lines (poorer ear). Blue lines represent preoperative thresh-olds obtained for the poorer hearing ear with use of a hearing aid. Orange lines represent the postoperative cochlear implant-assisted thresholds in the same ear. Aided and implant-assisted thresholds were obtained in the soundfield using FM-warbled tones. Note that the responses marked at 120 dBHL represent no response at equipment limits.

Figure 2. Bar graphs show the entire group’s mean scores in the implanted ear and the bilaterally aided (candidacy evalu-ation) or bimodal (one month and most recent) conditions pre- and postoperatively for each test. CI = implanted ear only; AU = bilaterally aided/bimodal.

Continued on page 24

BkB-SIN

azBio Sentences in Quiet CNC words in QuietCandidacy Evaluation One Month Post-activation Most Recent Evaluation

Candidacy Evaluation One Month Post-activation Most Recent Evaluation

Patient and Device Condition Patient and Device Condition

Patient and Device Condition

BkB-SIN

Candidacy Evaluation One Month Post-activation Most Recent Evaluation

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implantation criteria. Intervention through cochlear implantation may provide important binaural stimulation that cannot be ade-quately achieved with either bilateral hearing aids or the use of a BiCROS system. Moreover, treatment of individual ears is impor-tant in order to avoid the negative effects of auditory deprivation in an ear that cannot be adequately aided.2 To adequately assess and identify these potential cochlear implant recipients, we must evaluate each ear independently. Our current assessment protocol has been updated accordingly, and we are diligent in considering the abilities of each individual ear when evaluating a patient for cochlear implant candidacy, particularly in challenging situations such as background noise.

References

1. Wie OB, Pripp AH, Tvete O. Unilateral deafness in adults: effects on communication and social interaction. Ann Otol Rhinol Laryngol. 2010;119(11):772-781.

2. Firszt JB, Holden LK, Reeder RM, et al. Cochlear implantation in adults with asymmetric hearing loss. Ear Hear. 2012;33(4):521-533.

3. Spahr AJ, Dorman MF, Litvak LM, et al. Development and validation of the AzBio sentence lists. Ear Hear. 2012;33(1):112-117.

4. Thornton AR, Raffin MJ. Speech-discrimination scores modeled as a binomial variable. J Speech Hear Res. 1978;21(3):507-518.

5. BKB-SIN Speech-in-Noise test, v. 1.03. Etymotic Research Inc. web-site. etymotic.com/pdf/bkbsin-user-manual.pdf. Accessed June 24, 2013.

6. Cullen RD, Higgins C, Buss E, et al. Cochlear implantation in patients with substantial residual hearing. Laryngoscope. 2004;114(12):2218-2223.

7. Dowell RC, Hollow R, Winton E. Outcomes for cochlear implant users with significant residual hearing: implications for selection criteria in chil-dren. Arch Otolaryngol Head Neck Surg. 2004;130(5):575-581.

8. Gifford RH, Dorman MF, Shallop JK, Sydlowski SA. Evidence for the ex-pansion of adult cochlear implant candidacy. Ear Hear. 2010;31(2):186-194.

9. Ching TY, Incerti P, Hill M. Binaural benefits for adults who use hearing aids and cochlear implants in opposite ears. Ear Hear. 2004;25(1):9-21.

Dr. Sydlowski is Audiology Director of the Head & Neck Institute’s Hearing Implant Program. She can be reached at 216.444-0354 or sydlows@ ccf.org.

Dr. Vovos is a clinical audiologist in the Head & Neck Institute’s Section of Audiology. She can be reached at 216.444.0354 or [email protected].

Dr. Woodson is Medical Director of the Hearing Implant Program. She can be reached at 216.444.0354 or [email protected].

Modified Barium Swallow Studies: We’ve Got the RemoteBy Brian J. Hedman, MA, CCC-SLP, and Lauren R. Miller, MA, CCC-SLP

Brian J. Hedman, MA, CCC-SLP

Lauren R. Miller, MA, CCC-SLP

A significant equip-ment and software upgrade has enhanced the way in which speech-language patholo-gists (SLPs) at Cleveland Clinic can view and inter-pret recordings of

their patients’ modified barium swallow (MBS) studies. With these improvements, the referring service can receive and review results more quickly and efficiently.

In the past, MBS studies were recorded onto a DVD or VHS tape with basic video recording software. The SLP and/or a licensed independent practitioner (LIP) would then review the recorded study in the radiology department. Today, SLPs and LIPs can view these studies remotely, which frees them from the physical restrictions of having to view the studies at a particular time in a particular place.

More Platforms, Sharper Images

The remote access has been made possible by installation of the TIMS DICOM® System. This integrated hardware and software pro-gram captures data and images from analog medical devices and converts them to digital forms on DICOM-compliant picture archiving and communication system (PACS) servers. Once stored in the PACS servers, the MBS videos and other images can be transferred throughout Cleveland Clinic’s vast hospital system. With instant access, SLPs and LIPs can view these dynamic stud-ies more conveniently at their desktop computer or on a portable computer at the bedside with the patient and family. MBS studies completed at any Cleveland Clinic GI radiology department can be accessed and viewed at other Cleveland Clinic facilities.

The new system records MBS and other studies at high resolution (1024 × 1024) for superior image quality. Audio can be synchro-nized with the video and recorded on a DVD, CD or USB memory stick equipped with a DICOM viewer. In this way, specific images can be viewed without waiting for rewinding or fast-forwarding. Images can also be emailed, printed and burned on a CD or DVD.


Asymmetric Hearing Loss (continued from p. 23)

Our Testing Protocol

The MBS study, also called the videofluoroscopic swallow study, is the gold standard for objective evaluation of oropharyngeal swallow function. The MBS procedure performed in the GI radiology suite at Cleveland Clinic’s main campus is novel in that the radiology techni-cian remotely controls the X-ray tower from outside the suite, thereby reducing the technician’s radiation exposure. Meanwhile, the SLP runs the study unassisted from within the suite.

The fluoroscopy suite itself is also novel in that the distance between the X-ray tower and the fluoroscopy table can be modified to accommodate patients brought in by wheelchair or stretcher, reducing the need for unnecessary transfers and improving patient comfort. Our ability to modify positioning also improves the experi-ence for patients with a large body habitus or atypical posture.

Greater Access, More Efficiency

Our equipment upgrades allow us to achieve greater access to a wider patient population while increasing patient comfort and improving the quality of imaging. Our staff is now able to access MBS studies remotely from the convenience of their personal com-puter within minutes of the evaluation, thus improving the efficiency of patient care.

Photo (above): A speech-language pathologist independently completes a modified barium swallow study in the fluoroscopy suite while a radiology tech-nician remotely controls the imaging equipment. Remote access reduces the technician’s exposure to radiation.

Photo (left): Clear fluoroscopic evidence of contrast aspiration (arrow) below the level of the vocal cords during a modified barium swallow study using high- resolution imaging equipment.

Mr. Hedman and Ms. Miller are speech-language pathologists in the Head & Neck Institute’s Section of Speech-Language Pathology. They can be reached, respectively, at 216.445.9177 or [email protected] and at 216.636.5584 or [email protected].



Dizziness and Vertigo: a New Way to Manage Them and a New Place to Do So Two Significant Developments Underscore Our Commitment to Being the Best

By Judith White, MD, PhD

Dizziness and vertigo pose challenges to healthcare systems because of the large number of patients who are affected. Indeed, dizziness is the most common presenting complaint in adults seeking medical evaluation. Meanwhile, the preva-lence of self-reported vertigo among com-munity-based adults has been reported to range from 21 to 29 percent.1 The burden

is further magnified by the changing demographics of the aging American population.

One of the serious sequelae of dizziness is falling. Patients who complain of dizziness experience an eightfold increase in falls. Falls are a major contributor to not only functional decline but healthcare utilization as well, with an estimated cost to the healthcare system of more than $20 billion annually.2,3 Approxi-mately 10 percent of falls result in major injuries such as frac-

tures, serious soft-tissue injuries and traumatic brain injuries, all of which lead to a tenfold increase in the need for skilled nursing facility care. Studies have shown that even falls that do not result in serious injury increase skilled nursing facility placement three-fold when cognitive status, psychological assessment, social functioning and medication factors are controlled for.

In view of the prevalence of dizziness and vertigo, the Head & Neck Institute has undertaken two significant projects to maxi-mize their treatment: our soon-to-be-published Cleveland Clinic Dizziness and Vertigo Care Path and our new multidisciplinary treatment center.

Care Paths: More than Just Guidelines

To ensure access to consistently top-quality care across a wide range of disorders, clinicians throughout Cleveland Clinic are cre-ating a series of evidence-based Cleveland Clinic Care Paths. These care paths are comprehensive manuals to guide clinicians through the complete management of a given disease process, from initial presentation (Figure 1) through long-term follow-up.

Our care paths are more than just sets of practice guidelines, which is significant because there is scarce evidence to suggest that practice guidelines enhance care or improve outcomes. The purpose of care paths is to make guidelines work. Care paths are actually built on top of guidelines as a means of showing clini-cians how to implement guidelines in the most effective way possible. The care paths will be embedded in Cleveland Clinic’s electronic medical record (EMR) system so that multidisciplinary care can be rendered without unnecessary delay.

highlights from the New Care Path

Dizziness and vertigo were chosen as the focus of one of the first care paths issued by the Head & Neck Institute. We plan to have our Dizziness and Vertigo Care Path available in our EMR system soon. Here is a sampling of some of its contents:

• All care is coordinated by the patient’s primary care provider.

• Benign paroxysmal positional vertigo (BPPV), which is the most common form of vertigo, can be readily identified in the office by a careful history and with the easy-to-perform Dix- Hallpike test.

• Once BPPV has been diagnosed, repositioning maneuvers and referral for vestibular physical therapy are recommended. Medi-cations are not effective for the treatment of BPPV.

Judith White, MD, PhD

The purpose of care paths is to make guidelines work. Our Dizziness and Vertigo Care Path is built on top of guidelines to show how to implement guidelines in the most effective way.


• CT scans are of limited benefit in the diagnostic evaluation of dizziness when focal neurologic deficits are absent.

• Severe instability and focal neurologic deficits — e.g., sensory changes, abnormal reflexes, cranial nerve signs, dysmetria and/or motor weakness — represent red flags for stroke.

• Referral to ENT is suggested when unilateral hearing loss is present.

• Only a small fraction of patients with dizziness and vertigo will be surgical candidates.

• Referral to neurology should be considered when headache is a prominent concomitant symptom.

Our New Center Is One of a kind

To better accommodate our large volume of dizziness/vertigo patients, we recently opened a new multidisciplinary Dizziness, Balance and Fall Prevention Center. This center is the only multi-specialty facility of its kind in the nation. It is staffed by more than 20 physical therapists with specialized expertise and certifi-cation in vestibular assessment and treatment. These therapists use infrared videonystagmography to evaluate patients and then work hand in hand with otolaryngologists, otologists, neurolo-

gists, geriatricians and audiologists as needed. Our comprehen-sive assessments also include analyses of fall risk and outcomes data, such as the Clinical Global Impression scale (clinician-rated), the Dynamic Gait Index (an objective assessment), the Dizziness Handicap Inventory (self-reported) and patient satis-faction assessments.

References

1. Agrawal Y, Carey JP, Della Santina CC, Schubert MC, Minor LB. Disorders of balance and vestibular function in US adults: data from the National Health and Nutrition Examination Survey, 2001-2004. Arch Intern Med. 2009;169(10):938-944.

2. Tinetti M, Kumar C. The patient who falls: “It’s always a trade-off.” JAMA. 2010;303(3):258-266.

3. Stevens JA, Corso PS, Finkelstein EA, Miller TR. The costs of fatal and non-fatal falls among older adults. Inj Prev. 2006;12(5):290-295.

Dr. White is Section Head of Vestibular and Balance Disorders in the Head & Neck Institute and Director of the Dizziness, Balance and Fall Prevention Center. She can be reached at 216.839.3000 or [email protected].

Figure 1. This excerpt from a preliminary flowchart in the Dizziness and Vertigo Care Path guides the early-assessment phase of care.

Presenting symptom of

dizziness/vertigo

History andphysical

Generalmedicine

Dehydrationtreatment

Stroke evaluation

Cardiacevaluation

Stroke treatment

Cardiactreatment

Riskfactors

Patient hasdehydration

Patient had stroke

Patient has CV

diagnosis

Dix-Hallpiketest

Neurological orcardiovascular

Care path continues based on fi ndings of Dix-Hallpike test

Red fl ags

Yellow fl ags

None

No

Yes

NegativePositive

NoNo

Yes Yes


Patients with laryn-geal hyper-respon-siveness (LHR) who come to Cleveland Clinic for care are the beneficiaries of a fruitful clinical alli-ance between the Voice Center in the

Head & Neck Institute and the Asthma Center in the Respiratory Institute.

Specialists in these two areas have joined forces to provide more effective care for LHR patients, whose constellation of symptoms can defy easy diagnosis. These symptoms can include, among others:

• Episodes of severe shortness of breath

• Chronic refractory cough

• A prominent sensation of chest and throat constriction

• Dramatic stridor

• Hypersensitivity to fumes and strong smells

In some patients with LHR, relentless symptoms persist for years, even decades, and frequent hospitalizations are common.

LHR’s impact on daily life is significant, and in some instances it leads to substantial disability.

Shortening the Time to Diagnosis

The collaboration between the Voice Center and the Asthma Center seemed to be a natural response to the fact that LHR patients have been referred to both centers for evaluation. These patients often have been misdiagnosed as having asthma or recurrent anaphylaxis, but treatments for these conditions are ineffective and often result in unnecessary medical interven-tions. The ineffectiveness of care is reflected in a reported mean time to proper diagnosis of 4.5 years.

Among the factors that contribute to the difficulties in establish-ing a timely diagnosis are a poor understanding of the underlying pathophysiology, the involvement of numerous specialties and a lack of unifying terminology. Fortunately, clinician interest in and understanding of LHR have increased over the past decade, and effective clinical care is reducing the time from symptom onset to proper diagnosis and effective treatment.

Etiology: Evidence Mounts for CNS Involvement

There are two keys to managing LHR:

• Viewing these patients and their symptoms from a different theoretical construct

• Relying on a multidisciplinary approach to care

We believe in thinking outside the usual algorithms when a patient’s signs and symptoms do not easily fit a traditional diag-nosis. In what is called the “umbrella construct,” LHR encom-passes several entities, including irritable larynx syndrome, chronic refractory cough and paradoxical vocal fold dysfunction. A growing body of literature supports the notion that peripheral sensory and motor neuropathies are the cause of the aberrant laryngeal activity in these conditions. New research suggests the central nervous system (CNS) may play a key role as well.

Claudio F. Milstein, PhD Douglas M. Hicks, PhD

a Joint Response to laryngeal Hyper-ResponsivenessLHR Is Difficult to Diagnose, but Our Collaboration with the Asthma Center Is Helping Patients Breathe Easier

By Claudio F. Milstein, PhD, and Douglas M. Hicks, PhD

Laryngeal hyper-responsiveness can have significant impact on patients’ daily lives, sometimes leading to substantial disability.


Recent reports of encouraging progress with various neuromodu-lators (e.g., gabapentin, amitriptyline, tramadol and pregabalin) in some patients further support the idea of CNS involvement.

Once the patient is correctly diagnosed, our prescriptive care goes beyond drug therapy. The efficacy of behavioral therapy has been demonstrated in several randomized trials. Respiratory and laryngeal control therapy, as provided by our expert speech-language pathologists, is an essential component of our treat-ment algorithm.

It all Comes Back to Teamwork

Because patients who are referred to our centers often travel long dis-tances to be here, efficiency in pro-viding combined care is paramount to offering them the best overall experience. For example, regardless of where patients with possible LHR enter our system, they are sched-uled to be seen at both the Voice Center and the Asthma Center. The degree of cooperation between our centers is uncommon at many other major healthcare facilities, and we encourage voice specialists at all levels to reach out to colleagues in pulmonary and allergy medicine to develop a similar collaboration.

Establishing a professional network with other specialists, with fluid communication among providers, and providing easy access for patients are the keys to providing state-of-the-art care for patients with respiratory disorders of laryn-geal etiology.

Dr. Milstein is Director of the Voice Center. He can be reached at 216.444.8677 or [email protected].

Dr. Hicks is Section Head of Speech-Language Pathology. He can be reached at 216.444.6691 or [email protected].

keys to Diagnosing laryngeal hyper-Responsiveness

• Identify atypical diagnostic profiles for patients with suspected “asthma,” “anaphylaxis” or “cough-induced asthma,” e.g.:

– Rapid onset and transient duration of severe dyspnea

– Inconsistent benefit from asthma medications

– Prominent sensation of throat constriction

– Dramatic stridor

• Expand the diagnostic filter for alternate etiologies

• Think outside the diagnostic “box”

• Establish a collaborative relationship among the ENT, speech-language pathology, pulmonary medicine and allergy services

• Maintain fluid communication among all involved providers

We encourage voice specialists at all levels to establish a collaborative relationship with their pulmonary and allergy medicine colleagues.


Advances in Otolaryngology & Dentistry Fall 2013

Advances in Otolaryngology & Dentistry offers information from

Cleveland Clinic otolaryngologists, speech pathologists, audiologists

and dentists about new and emerging medical, surgical and

rehabilitative techniques. It is written for physicians and should be

relied on for medical education purposes only. It does not provide a

complete overview of topics covered and should not replace the

independent judgment of a physician about the appropriateness or risks

of a procedure for a given patient.

© The Cleveland Clinic Foundation 2013

Michael S. Benninger, MDChairman, Head & Neck Institute

Erika Woodson, MD Michael P. Horan, MD, DDS, PhD Medical Co-Editors

Glenn Campbell Managing Editor

Barbara Ludwig Coleman Art Director

Martha Makar, Melissa MasonMarketing PleaSe DIReCT CoRReSPoNDeNCe To:

Head & Neck Institute The Cleveland Clinic Foundation 9500 Euclid Ave./AC311 Cleveland, OH [email protected]

Katie Geelan-Hansen, MD

New StaffThe Head & Neck Institute welcomes the following new specialists:

katie Geelan-hansen, MD, is an adult and pediatric otolaryngologist with inter-ests in sinus disorders, ear infections, thyroid conditions and hearing loss. She completed her residency at Cleveland Clinic after graduating from the Univer-sity of Iowa College of Medicine.

Michael P. horan, MD, DDS, PhD, joins the Head & Neck Institute as Section Head of Oral and Maxillofacial Surgery. He is a graduate of the Com-prehensive Training in Oral and Cranio-facial Sciences Program at The Ohio State University, where he received his DDS and PhD degrees. Dr. Horan completed his residency in oral and

maxillofacial surgery at Case Western Reserve University (CWRU) and University Hospitals of Cleveland. He is also a graduate of the CWRU School of Medicine. He is actively involved in academic medicine and dentistry, holding an appointment at the CWRU School of Dental Medicine as an assistant professor of oral and maxillofacial surgery and teaching predoctoral students and residents. His interests include dentoalveolar surgery, implant dentistry, orthognathic surgery, maxillofacial reconstructive surgery and TMJ surgery.

New appointments in the Head & Neck InstitutePaul Bryson, MD, has been named Section Head of Laryngology.

Paul Bryson, MD, and Claudio Milstein, PhD, have been named Directors of the Voice Center — Dr. Bryson as Medical Director and Dr. Milstein as Clinical Director.

Staff awards and achievementsBrian Burkey, MD, received a Presidential Citation from the American Head and Neck Society in recognition of achievements in education and microvascular reconstruction that have advanced the field of head and neck surgery in the past two decades.

Todd Coy, DMD, was awarded fellowship in the Pierre Fauchard Academy, an international dental honor society that recognizes contributions to the dental literature and service to both the pro-fession and the general community.

Douglas hicks, PhD, was elected Chairman, Board of Ethics, for the American Speech-Language-Hearing Association effective January 1, 2014.

Robert lorenz, MD, MBa, was selected to serve on two national working groups to guide surgical society payment reform efforts: the Health Policy and Advocacy Group for the American College of Surgeons and the American Academy of Otolaryngology – Head and Neck Surgery Payment Reform Subcommittee.

Craig w. Newman, PhD, and Sharon a. Sandridge, PhD, were among a team of authors who received the 2012 Ear and Hear-ing Editor’s Award for Outstanding Research Publication for the article “The Tinnitus Functional Index: development of a new clinical measure for chronic, intrusive tinnitus” (Ear Hear. 2012; 33[2]:153-176).

Michael P. Horan, MD, DDS, PhD


Resources for Physicians

24/7 Referrals

Referring Physician Hotline

855.ReFeR.123 (855.733.3712)

clevelandclinic.org/refer123

Live help connecting with our specialists, scheduling and confirming appointments, and resolving service- related issues.

Hospital Transfers

800.553.5056

PhySICIaN DIRECTORyView our staff online at clevelandclinic.org/staff.

SaME-Day aPPOINTMENTSCleveland Clinic offers same-day appointments to help your patients get the care they need, right away. Have your patients call our same-day appointment line, 216.444.CaRE (2273) or 800.223.CaRE (2273).

TRaCk yOUR PaTIENTS’ CaRE ONlINEEstablish a secure online DrConnect account for real-time information about your patients’ treatment at Cleveland Clinic at clevelandclinic.org/drconnect.

CRITICal CaRE TRaNSPORT wORlDwIDE

To arrange for a critical care transfer, call 216.448.7000 or 866.547.1467. Learn more at clevelandclinic.org/criticalcaretransport.

CME OPPORTUNITIES: lIVE aND ONlINEVisit ccfcme.org to learn about the Cleveland Clinic Center for Continuing Education’s convenient, complimentary learning opportunities.

OUTCOMES DaTaView Outcomes books at clevelandclinic.org/outcomes.

ClINICal TRIalSWe offer thousands of clinical trials for qualifying patients. Visit clevelandclinic.org/clinicaltrials.

ExECUTIVE EDUCaTIONLearn about our Executive Visitors’ Program and two-week Samson Global Leadership Academy immersion program at clevelandclinic.org/executiveeducation.

DOwNlOaD OUR NEw PhySICIaN REFERRal aPP!Contacting us is now easier than ever before. With our new free Physician Referral App, you can view all of our specialists and get in touch immediately with one click of your iPhone® or iPad®. (Coming soon to Android™ phones and tablets.) Download today at the App Store.

GET ThE laTEST ON ClEVElaND ClINIC CaNCER TRIalS wITh OUR NEw MOBIlE aPPDownload from the App Store or Google Play, or go to clevelandclinic.org/cancertrialapp.

aBOUT ClEVElaND ClINIC

Cleveland Clinic is an integrated healthcare delivery system with local, national and

international reach. At Cleveland Clinic, more than 3,000 physicians and researchers

represent 120 medical specialties and subspecialties. We are a nonprofit academic

medical center with a main campus, eight community hospitals, more than 75

northern Ohio outpatient locations (including 16 full-service family health centers),

Cleveland Clinic Florida, Cleveland Clinic Lou Ruvo Center for Brain Health in Las

Vegas, Cleveland Clinic Canada, Sheikh Khalifa Medical City and Cleveland Clinic

Abu Dhabi.

In 2013, Cleveland Clinic was ranked one of America’s top 4 hospitals in U.S. News

& World Report’s annual “America’s Best Hospitals” survey. The survey ranks Cleve-

land Clinic among the nation’s top 10 hospitals in 14 specialty areas, and the top in

heart care for the 19th consecutive year.

Erika woodson, MD, was named Governor to the Ameri-can Academy of Otolaryngology – Head and Neck Surgery, representing the Northeastern Ohio Otolaryngology Head and Neck Surgery Society.

The following Head & Neck Institute physicians have been recognized in Cleveland Magazine’s “Best Doctors 2013,” produced in partnership with national physician peer-rating organization Best Doctors Inc.®:

Tom abelson, MD

Daniel alam, MD

Michael S. Benninger, MD

Brian Burkey, MD

Edward Fine, MD, PhD

alan kominsky, MD

Robert lorenz, MD

Joseph Scharpf, MD

Raj Sindwani, MD

Benjamin wood, MD

13-E

NT-

00

4

Stay connected to Cleveland Clinic

Advances in Otolaryngology & DentistryF a l l 2 0 1 3

a PhySICIaN’S NEwSlETTERFROM ThE hEaD & NECk INSTITUTE

The Cleveland Clinic Foundation9500 Euclid Avenue/AC311Cleveland, OH 44195

CMe from the Head & Neck InstituteFriday, Nov. 8, 2013

Contemporary Multidisciplinary Care of the Head and Neck Cancer Patient: Focus on oral Malignancy

7:30 a.m. to 5 p.m. (reception follows)

Cleveland Clinic lerner Research Institute (Na5-08 auditorium), Cleveland, Ohio

• Fourth annual course offering, with focus this year on oral cancer

• Expert faculty from Cleveland Clinic and other leading medical centers

• Mix of lectures, case presentations, panel discussions

Register today at ccfcme.org/headneck13.

For registration questions, call 216.448.0777 or email [email protected].

Friday-Saturday, Feb. 14-15, 2014

2014 Multidisciplinary Head and Neck Cancer update

Sanibel harbour Marriott Resort, Fort Myers, Fla.

• Second annual course offering, with focus on innovation, controversies and multidisciplinary care

• Expert faculty from Cleveland Clinic and other leading medical centers

• Mix of lectures, case presentations, poster discussions, panel discussions

Visit ccfcme.org/headandneck14 for program and registration.

For registration questions, call 216.448.0777 or email [email protected].

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