Office-Based Injection Laryngoplasty for the Management of Unilateral Vocal Fold Paralysis *Sunil P. Verma and †Seth H. Dailey, *Irvine, California and yMadison, Wisconsin Summary: Objective. Office-based injection laryngoplasty (OBIL) is a common method of addressing glottal insufficiency. This retrospective chart review identifies the demongraphics, laterality, technique, success rate, injectates, and complications of OBIL performed over a 3-year period at a single institution. Study Design. Retrospective chart review. Methods. All OBILs performed for the management of UVFP by the senior author over 3 years (2007–2009) were identified from billing records. The age, gender, laterality, underlying disease process, augmentation material, route of injection, and complications were recorded. Results. Eighty-two OBILs were attempted on 57 patients. The most common route of access was transoral (85.6%). All OBILs were able to be completed. Injectates used were hyaluronic acid derivatives (57.3%), calcium hydroxyapatite (16%), and Cymmetra (16.5%). Three complications (3.7%) occurred. Thirty percent of patients ultimately elected for thyroplasty or ansa reinnervation, 22% found their condition to self-resolve, 14% died, and 25% were lost to follow-up. Conclusions. Using a variety of approaches, OBIL is possible in almost all patients. The single surgeon transoral route using a rigid angled telescope and curved injection needle was the most commonly used approach. Multiple injectates can be used and have good safety records. The final disposition of patients may be variable and warrants further investigation. Key Words: Laryngology–Laryngeal surgery–Office-based–Procedures–Surgery–Vocal fold paralysis–Hoarseness– Thyroplasty–Reinnervation. INTRODUCTION Injection laryngoplasty (IL) has been a cornerstone in the management of unilateral vocal fold paralysis (UVFP) since its first description.1 During the majority of the last century, IL was commonly performed in the operating room (OR). However, with the advent of ‘‘chip-tip’’ endoscopes, refinements in the ability to deliver anesthesia to the larynx2,3 and the development of numerous injectables,4,5 there has been a move toward IL performed in the office.6 Advantages of OBIL include markedly decreased cost, avoidance of the risks of general anesthesia, and the ability titrate injectate delivery for optimized voice outcomes, among others.7 As the population ages and grows and as some of the most common causes of UVFP increase,8 including the number of thyroid cancers,9 cervical spine surgeries,10 lung cancer resections, and aortic valve replacements,11 one may expect the incidence of UVFP to increase as well. As the paradigm of OBIL for UVFP continues to evolve, there are questions which remain to be answered. The first involves the safety profile of both OBIL and the numerous injectables which are being used for the treatment.
Accepted for publication October 10, 2013. Financial Disclosures: None. Conflicts of interest: None. Presented at the 2011 UCSF Fall Voice Conference/International Association of Phonosurgery; November 3, 2011; San Francisco, California. From the *University Voice and Swallowing Center, Department of OtolaryngologyHead and Neck Surgery, University of California, Irvine School of Medicine, California; and the yDivision of Otolaryngology-Head and Neck Surgery, Department of Surgery, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin. Address correspondence and reprint requests to Seth H. Dailey, Division of Otolaryngology-Head and Neck Surgery, Department of Surgery, University of Wisconsin School of Medicine and Public Health, K4/760 Clinical Science Center, Madison, WI, 53792-7395. E-mail: [email protected]
Journal of Voice, Vol. 28, No. 3, pp. 382-386 0892-1997/$36.00 Ó 2014 The Voice Foundation http://dx.doi.org/10.1016/j.jvoice.2013.10.006
UVFP often occurs secondary to malignancy, complications from surgery, or both. As such, patients with UVFP often possess multiple morbidities including general health concerns, cardiopulomonary compromise, need for anticoagulation, among other medical and psychosocial concerns. With this in mind, it is critical to evaluate the safety of OBIL as has been done for other office-based laryngeal surgeries.12,13 In an effort to avoid general anesthesia, another question to be answered is how often OBIL can actually be completed. Finally, there is an active discussion regarding the ultimate disposition of patients after injection.14–16 To answer these questions, a retrospective chart review was performed of all OBILs performed for UVFP over a 3-year period at an academic tertiary care institution.
MATERIALS AND METHODS After obtaining approval by the institutional review board, all OBILs attempted for UVFP by the senior author over 3 years (2007–2009) were identified from billing records. The age, gender, laterality, underlying disease process, route of injection, procedural success rate, amount and type of augmentation material used, complications, and patient disposition were recorded. All procedures were performed in the otolaryngology clinic examination suite containing a powered examination chair, video tower with photodocumentation capability. Informed consent was obtained and a procedural ‘‘time-out’’ was performed before each procedure. Patient vital signs were collected before the visit; however, no cardiopulomonary monitoring was performed during the procedure. All injectates were directed toward the paraglottic space musculature. Approaches used were transoral,17 transcricothyroid membrane,18 transthyrohyoid membrane,19 and transthyroid ala.
Sunil P. Verma and Seth H. Dailey
OBIL for the Management of UVFP
For the transoral approach, the oral cavity is first anesthetized with topical lidocaine spray applied with an atomizer. The tonsillar pillars, base of tongue, and posterior pharyngeal wall are sprayed with lidocaine. The patient is asked to assume the ‘‘sniffing’’ position and directed to hold his tongue with gauze. Visualization of the laryngopharynx is obtained with a transoral rigid 70 angled telescope held by the surgeon. The view from the scope is transmitted to a screen on the video tower (Figure 1). An Abraham cannula attached to a syringe with 4% lidocaine is placed along the patient’s lingual sulcus and directed over the larynx. A ‘‘laryngeal gargle’’ is performed with 4% lidocaine dripping lidocaine to the endolarynx during sustained phonation. The surgeon then advances a syringe with injectate attached to an orotracheal injector needle (model # 1650030 and 1650050; Medtronic, Minneapolis, MN) along the patient’s lingual sulcus and directs it to the larynx. The needle may be used to lateralize the patient’s false vocal fold. The needle is inserted through the superior surface of the vocal fold into its body. Injectate is applied within the paraglottic space with approximately 20% overinjection to account for reabsorption. The percutaneous techniques are performed with a surgeon and an assistant. The skin is anesthetized with 1% lidocaine. After the nasal cavity is anesthetized, a channeled flexible laryngoscope is advanced into laryngopharynx. A laryngeal gargle is performed by dripping 4% lidocaine to the endolarynx via the channel of the laryngoscope during sustained phonation. A 25 gauage 1.25-in needle is passed through the skin into the larynx by the surgeon and is directed into the vocal fold. RESULTS Eighty-two OBILs were attempted on 57 patients. Patients injected were aged between 16 and 83 years, with a mean age of 60 years. Thirty-five males and 22 females were treated. UVFP occurred on the left side in 40 patients and on the right side in 17. Tables 1 and 2 list the etiology of paralysis and approach used for injection, respectively. No procedure had to be terminated early and all procedures were able to be performed to the intended completion point. On average, 0.64 mL of injectate was used in each setting. The augmentation material used is listed in Table 3. Three complications (3.7%) were noted during or after OBIL. One patient had a hypersensitivity reaction to Restylane. One patient had calcium hydroxyapatite injected superficially
TABLE 1. Etiology of UVFP Etiology Thoracic Idiopathic Cervical Cerebral Intubation
Percentage of Patients 36 30 21 10 3
requiring microdirect laryngoscopy and removal at a later date. One patient experienced vocal fold edema after injection and was observed in the office without incident. Figure 2 details the disposition of patients after OBIL. DISCUSSION UVFP is an entity often encountered by otolaryngologists-head and neck surgeons. Management options include voice therapy, OBIL, and injection laryngoplasty performed under general anesthesia in the OR, reinnervation, thyroplasty, and arytenoid repositioning maneuvers. Definitive treatment typically is deferred for the first 9 months after onset and during that time, patients’ options are observation, voice therapy, or IL. IL has an important role in the management of glottal insufficiency. It provides immediate treatment of symptoms related to voice and cough. OBIL offers some advantages over IL performed in the OR. OBIL permits an unobstructed view of the vocal folds, allowing the surgeon to clearly visualize the change in configuration during injection.7 There is room for immediate analysis of results permitting simultaneous modification if necessary.20 Performing the procedure under local anesthesia not only reduces the risks associated with general anesthesia but also allows patients to return to normal activities immediately, preventing lost time from work. Another advantage of OBIL is cost savings. Grant et al estimated increased charges of $8250 for IL performed in the OR compared with the office.21 Similarly, other authors have noted significant financial savings associated with performance of IL in office as opposed to the OR.22,23 Surgeon preference for performance of IL in the OR versus the office for management of UVFP varies tremendously. A recent multi-institution analysis reported equal numbers of IL performed in the OR and in the office.6 Recent reports of UVFP management show IL performed entirely in the office24,25 and entirely in the OR.26 Rationale beyond surgeon preference drives the decision of where to perform IL, including TABLE 2. Approach Used for OBIL Approach
FIGURE 1. Surgeon and patient positioning for transoral vocal fold injection.
Transoral Transcricothyroid membrane Transthyrohyoid membrane Transthyroid ala
Number of Times (Percent of Total) 71 (86.6) 8 (9.8) 2 (2.4) 1 (1.2)
Journal of Voice, Vol. 28, No. 3, 2014
TABLE 3. Injectate Used During OBIL
Injectate Hyaluronic acid (Hylaform, AllerganInamed Crop, Irvine, CA) Calicium hydroxyapetite (Radiesse Voice, BioForm Medical, San Mateo, CA) Micronized dermis (Cymetra, LifeCell Corp, Branchburgh, NJ) Hyaluronic acid gel (Juvederm Ultra Plus, Allergan, Santa Barbara, CA) Hyaluronic acid (Restylane, Q Med, Uppsala, Sweden) Teflon
Number of Times Used (Percent of Total) 33 (40.2) 20 (24.4)
14 (17.1) 8 (9.8) 6 (7.3) 1 (1.2)
access to resources. In this series, all patients were treated in office. One reason for this is the fact that University of Wisconsin Clinics is a hospital-based practice in which injectables may be billed to the insurance. In a stand-alone clinic, patients are responsible for cost of the injectate, which causes many to elect for procedures in the OR. Additionally, the office laryngeal surgery suite is located within the hospital building, allowing both inpatients and outpatients to be examined and treated using the same setup. The average age of patients treated in this series was 60 years which is similar to other reports.25,27 The left vocal fold was affected more often, which is also consistent with large studies.8 The most common etiology of paralysis was thoracic which included injury to the recurrent laryngeal nerve (RLN) from mass effect of benign and malignant disease or complications after chest surgery. All patients in this series were able to
be injected to the intended completion point using a transoral, transcricothyroid membrane, transthyrohyoid membrane, or transthyroid ala approach. The transoral approach was preferred by the authors as it can be performed by one surgeon, without the need for an assistant. It also allows for the entirety of the needle to be visualized during the injection. The average amount of injectate applied in this population was 0.64 mL. Mau and Courey28 demonstrated that on average 0.62 and 0.41 mL of calcium hydroxyapatite were necessary to medialize a cadaveric vocal fold via a lateral injection. The increase may be a result of the overinejction necessary to account for reabsorption of injectate. Numerous injectates were used in this study, which were tolerated well by most patients. However, two complications noted in this study were related to the injectate used. The first was a hypersensitivity reaction to Restylane. A study of rabbit vocal folds injected with Restylane revealed that at 1 week and 3 months after injection, the vocal folds experienced ‘‘low fibrinogenesis,’’ ‘‘a slight inflammatory reaction and absence of necrosis,’’ and ‘‘granuloma formation and low fibrinogenesis.’’29 However, within the Dermatology literature, injection site inflammation resulting in transient redness and edema of the injected site immediately after injection has been noted in 0.02% of individuals who underwent injection of hyaluronic acid gel for soft tissue augmentation.30 Additionally, hypersensitivity and inflammatory reactions to hyaluronic acid gel have been noted after cutaneous injections for management of facial rhytids.30–32 It is very possible that the patient treated in this series experienced a similar reaction in the vocal fold after injection. The other complication resulted from an injection of calcium hydroxyapatite into the superficial lamina propria, requiring removal under general anesthesia during microlaryngoscopy. This was removed in a manner similar to techniques described by others.33 Ensuring placement of the injectate into the correct portion of the larynx is paramount in OBIL.
FIGURE 2. Disposition of patients after OBIL.
Sunil P. Verma and Seth H. Dailey
OBIL for the Management of UVFP
UVFP often results from malignancy, surgery, and sometimes both. As mentioned earlier, patients may also have general health concerns, cardiopulomonary compromise, anticoagulation needs, as well as psychosocial stressors. As such, the safety of any intervention for this patient population must critically be evaluated. These data, in combination with other data sets, confirm the notion that OBIL is a safe procedure for patients with UVFP.24,25 One patient had a complication in which vocal fold edema was noted and that the procedure was terminated without incident. There were no complications requiring hospital admission. Patients who were on aspirin prophylactically to prevent cardiac events were asked to stop taking medication 1 week before injection. However, those patients who were taking anticoagulants for therapeutic treatments did not stop taking medications for IL. No complications with hematoma or airway compromise occurred with this approach. For most patients who had injection performed transorally, IL was performed using a 27 gauge needle, in which little, if any, bleeding was noted even if patients were anticoagulated. For this reason, it was deemed safe to continue blood thinners for patients in whom it was medically necessary and do not report any complications with this approach. Others have also shown that procedures performed while a patient is taking anticoagulants are safe.3,34 There are risks associated with general anesthesia, which is one of the major motivators to performing office-based laryngeal surgery. Graboyes et al26 recently published their experience with IL performed under general anesthesia for patients with UVFP after thoracic surgery. Although the majority of their patients did quite well, one of the 20 patients did have intraoperative bile reflux on induction of anesthesia resulting in pneumonitis that may have been avoided with OBIL. The disposition of patients after injection is shown in Figure 1. Thirty percent of patients sought a definitive intervention in the form of thyroplasty or ansa cervicalis-RLN reinnervation. These results are similar to a study performed by Arviso et al,16 in which 29% of patients who underwent IL (in the OR or the office) for UVFP required further definitive intervention with medialization thryoplasty. Sixteen percent of the patients treated by Damrose25 for UVFP required thryoplasty and/or arytenoid adduction after OBIL. There are multiple reasons why this may have occurred. The concept of laryngeal synkinesis describes abnormal reinnervation of the laryngeal muscles after injury to the RLN.35–37 After deinnervation of the vocal fold, regeneration of RLN motor axons place the vocal fold in either a favorable or unfavorable position.37 It has been posited that early medialization of the vocal fold with IL places the vocal fold in a favorable position that is maintained by synkinetic reinnervation.15 Another consideration is that fibrosis and scarring secondary to IL assist in placing the vocal fold in a permanent medial position.14,38 Perhaps due to a combination of these reasons, only 30% of the patients in this study required definitive treatment. In the present study, 22% of individuals had a documented return of function and normal voice noted during stroboscopic examination of the larynx. Fourteen percent of the individuals died, and 9% returned to the office, were noted not to have
full recovery of vocal fold motion, and opted for no further intervention. One-quarter of patients did not follow-up. Although this is a sizable number, it is similar to the results of other retrospective studies.13–16,39 One reason for this is likely due to the large draw of the University of Wisconsin where patients may choose to follow-up with a local otolaryngologist or primary care physician. Some of these patients may have had return of normal or near normal voicing and not found a reason to follow-up. Sulica40 noted that in idiopathic vocal fold paralysis, which was the second most common reason for UVFP in this series, 52% ± 17% of individuals affected regained complete recovery of voice. There are limitations to this study which should be recognized. All patients were treated by a single-physician and the data were analyzed in a retrospective fashion. Outcome measures were not obtained in this study, so it is not possible to examine how effective OBIL is. However, other studies have demonstrated improvements in voice quality, swallowing ability, and voice-related quality-of-life after OBIL.13,25 From these data, further questions remain to be answered. Multiple injectates were used and it would be interesting to determine which of these is the most durable. The reasons for patients not opting for a more definitive surgery would also be helpful to know.
CONCLUSIONS OBIL is a safe procedure that is well tolerated in the management of UVFP. Multiple injectates may be used, and familiarity with multiple approaches is beneficial to be able to treat the most number of individuals in the office setting. As noted in this and other studies, a minority of patients who undergo IL require laryngeal framework surgery or a reinnervation procedure.
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