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Botulinum toxin injection to improve tracheoesophageal speech after total laryngectomy
Botulinum toxin injection to improve tracheoesophageal speech after total laryngectomy MICHELE M. ZORMEIER, MD, ROBERT J. MELECA, MD, MARK L. SIMPSON, PhD, JAMES P. DWORKIN, PhD, ROGER KLEIN, MD, MARTIN GROSS, MD, and ROBERT H. MATHOG, MD, Detroit, Michigan
Total laryngectomy patients, after undergoing a tracheoesophageal puncture (TEP), may have poor TEP speech because of hypertonicity or spasm of the pharyngoesophageal segment (PES). Conventional treatment options include speech therapy, PES dilation, pharyngeal neurectomy, and myotomy. Botulinum toxin injection into the PES has recently been reported to be effective for this disorder. However, data accumulated were based primarily on subjective analyses. This prospective investigation used both qualitative and quantitative measures to assess the effects of videofluoroscopyguided botulinum toxin injection on TEP voice quality in laryngectomees with PES dysfunction. Patients underwent voice analyses, tracheal air pressure measures, and barium swallows before and after botulinum toxin injection. Seven of 8 patients had significant voice quality improvement, and tracheal air pressures normalized in 6 of 8 patients after injection. Videofluoroscopic botulinum toxin injection into the PES is efficacious, safe, and cost-effective and should be considered as a first-line therapy for the treatment of laryngectomees with poor quality TEP speech caused by PES dysfunction. (Otolaryngol Head Neck Surg 1999;120:314-9.)
B
otulinum toxin (Botox) is produced by the bacterium Clostridia botulinum. When injected it acts as a potent neurotoxin that creates its effects at the neuromuscular junction by irreversibly blocking the presynaptic release of acetylcholine, thus resulting in a localized muscle paralysis. Botox was initially used to treat strabismus,
From the Departments of Otolaryngology (Drs Zormeier, Meleca, Simpson, Dworkin, and Mathog) and Radiology (Drs Klein and Gross), Wayne State University, Detroit Medical Center. Presented at the Annual Meeting of the American Academy of Otolaryngology–Head Neck Surgery, San Francisco, CA, September 7-10, 1997. Reprint requests: Robert J. Meleca, MD, Department of Otolaryngology, Wayne State University, 4201 St Antoine, 5E—University Health Center, Detroit, MI 48201. Copyright © 1999 by the American Academy of Otolaryngology– Head and Neck Surgery Foundation, Inc. 0194-5998/99/$8.00 + 0 23/1/90397 314
but its indications have been expanded to include treatment for other dystonic and/or spasmodic disorders of the head and neck, including cervical torticollis, hemifacial spasm, oromandibular dystonia, and spasmodic dysphonia.1-4 Complications have been minimal, the effects begin within 72 hours, and results typically last for an average of 3 months. Recent reports suggest that Botox is an effective treatment for pharyngoesophageal segment (PES) hypertonicity or spasm in laryngectomees with poor tracheoesophageal puncture (TEP) speech.5-8 Although results are encouraging the methodology used by previous investigators is subjective by design and fails to use quantitative measurements. Our investigation is a prospective study, using both qualitative and quantitative analyses, of the effect of Botox injection on TEP speech in laryngectomees with identified hypertonicity/spasm of the PES. PATIENTS AND METHODS Patients From June 1995 to July 1997, 8 laryngectomy patients (all male) with poor TEP speech were treated at the Detroit Medical Center with videofluoroscopy-guided Botox injections of the PES to reduce underlying spasms. Patients ranged in age from 42 to 78 years (mean 61 years). At the time of the laryngectomy procedure 5 patients underwent a 2-layer pharyngeal closure technique as described by Clevens et al,9,10 and 3 patients had a standard 3-layer pharyngeal closure.11,12 The TEP was performed as a secondary procedure in all patients studied. The average time from the TEP procedure to Botox injection was 4.3 months (range 5 days to 15 months). Seven patients received postoperative radiation therapy. Four of 8 patients had undergone a previous myotomy procedure with no symptom relief, and 3 patients were rated as having no TEP speech before treatment. Four of 8 patients had had previous Botox injections performed in the office with only partial resolution of symptoms. Because of failure to provide consistently good results in the voice clinic, we began performing injections using videofluoroscopic guidance. Diagnostic Evaluation of PES Hypertonicity/ spasm All patients were judged to have PES segment hypertonicity/spasm on the basis of clinical symptoms, pre-TEP insufflation pressures, tracheal back pressure measurements, and
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Fig 1. Fluoroscopic image of the area of pharyngoesophageal muscle spasm (curved arrow). Preliminary barium swallow will help differentiate spasm from stricture of the PES. In addition, the barium will highlight the PES and TE prosthesis (open arrow). With the patient attempting TE speech, note column of air dilating the PES (straight arrow) below area of spasm.
Fig 2. Needle placement (long straight arrow) directly into the area of pharyngoesophageal muscle spasm (curved arrow) under fluoroscopic visualization. Note column of air dilating the PES during tracheoesophageal speech (short straight arrow). Open arrow indicates tracheoesophageal prosthesis.
barium swallow evaluation. Before Botox injection, TEP voice characteristics were initially rated by a single speech pathologist (M.L.S.) with more than 15 years of experience working with this patient population. Despite post-TEP voice therapy, all patients had persistent poor voice quality and symptoms of PES dysfunction. These included (1) difficulties with onset of TEP speech, (2) phonatory breaks during speech, (3) a strangled or high-pressure voice, and/or (4) an inability to produce any phonation whatsoever. Those patients with elevated pre-TEP insufflation pressures (suggesting PES spasm) and poor TEP speech were treated with Botox injection at earlier time intervals from the TEP procedure because of generally poor speech outcomes after speech therapy alone for this patient population. No patient reported swallowing difficulties. Measurement of the air pressure required to produce TEP speech was obtained with a sphygmomanometer sealed at the tracheostome. These measures directly correlate with the amount of respiratory effort required to initiate airflow and sustain phonation.13,14 Pressure measurements were performed before injection and were repeated 1 week after injec-
tion. All measurements were performed during counting and open-vowel tasks. Multiple pressure recordings were taken for each patient, and an average measurement was calculated. A barium sulfate swallow with videofluoroscopy was used to evaluate the PES for hypertonicity/spasm before the Botox injection. The barium served to outline the PES and better delineate the characteristic “bulge” of the posterior pharyngeal wall, which partially relaxes during bolus transit, suggesting dysfunction of the PES (Fig 1). This finding is in contradistinction to a nonyielding PES, which is diagnostic of a stricture that will not respond to Botox therapy.13,14 The spasmodic segment was further defined by having the patient perform various TEP speech tasks. Injection Technique An initial barium sulfate swallow will help outline the PES, and the area of spasm is further illustrated by having the patient perform TEP speech tasks under videofluoroscopic visualization (Fig 1). A 25-gauge needle attached to a 5 mL syringe containing the Botox solution is inserted transcutaneously through the anterior neck skin in the midline, above
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Table 1. Seven-point equal-appearing interval scale 7 = Superb: Equal to the best TEP speech imaginable 6 = Excellent TEP speech 5 = Good TEP speech 4 = Fair TEP speech 3 = Poor TEP speech 2 = Very poor TEP speech 1 = No (or virtually no) discernible TEP speech
Fig 3. Typical Botox injection sites into the PES muscle complex. Injections can be performed with or without electromyographic guidance.
the stoma, and into the inferior portion of the bulging posterior pharyngeal wall (Fig 2). After proper needle tip placement into the muscle is verified with fluoroscopy, 20 to 30 units of Botox is injected. Two additional vertically aligned Botox injections (approximately 20 units each) are given into the middle and superior portions of the affected region for a total of 60 to 90 units (Fig 3). Outcome Measures All patient voices were recorded and analyzed acoustically before and after injection. Subjective ratings of voice quality were performed before and after Botox injection by the patient using a 7-point equal-appearing interval scale (Table 1). A score of 7 represented superb TEP speech, whereas 1 represented no TEP speech. Perceptual ratings of voice quality were performed by 3 judges (speech pathology graduate students) who were trained for the task and who listened to tape samples. All judges were blinded with regard to patient identity and whether the samples represented pretreatment or posttreatment recordings. Independent ratings were obtained on 2 separate occasions, spaced 72 hours apart, by use of the 7-point equal-appearing interval scale. RESULTS
Both intrajudge and interjudge reliability reached the 95% level of confidence; ratings never varied by more than 1 scale value on any of the measures. All patients reported improvement in their TEP speech quality after Botox injection, with ratings ranging from good to superb (Fig 4). The patients’ self-ratings before and after Botox injection were highly correlated with those
of the trained listeners. Discomfort from the injection procedure was considered mild, and no complications were reported. No patients reported dysphagia before injection. However, 2 of 8 patients reported improvement in swallowing ability after injection. A comparison of preinjection and postinjection perceptual TEP speech quality ratings by 3 trained listeners revealed that 7 of 8 patients experienced voice improvement after injection, with scores in the good-toexcellent range in 5 of 8 patients (Fig 5). Patients 1, 4, and 6 had no TEP speech before injection. They exhibited marked voice improvement after injection. One of 8 patients was rated by the listeners to have no improvement after injection. He was a 42-year-old man with bilateral hypoglossal nerve injuries at the time of his cancer resection, and it was thought that this impairment contributed to his poor TEP speech characteristics. Notwithstanding this limitation, he perceived that his speech quality improved after injection. Tracheal air pressure measurements obtained with the sphygmomanometer were used to assess back pressure within the trachea during TEP speech. Fluent tracheoesophageal voicing produces pressure readings approximating 20 to 30 cm H2O. Figures 6 and 7 show the preinjection and postinjection pressure measures obtained from the current patients during open-vowel and counting tasks, respectively. Note that the preinjection values are greater than those obtained after Botox injection and that 6 of 8 patients demonstrated normal pressures after injection, suggestive of fluent TEP speech and voice. Pressure measures are similar when open-vowel and counting tasks are compared. DISCUSSION
Total laryngectomy patients, after undergoing a TEP procedure, may exhibit strained-strangled, spasmodic TEP speech characteristics.13 All of our patients struggled with such difficulty before Botox injection. It has been speculated that these abnormalities are most commonly caused by interruption of airflow through an abnormally hypertonic or spasmodic PES muscle complex during speech efforts, which disrupts vibration of the underlying PES mucosa.15,16 Baugh et al17 reported
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Fig 4. Evaluation of tracheoesophageal speech as rated by each patient using the 7-point equalappearing interval scale. Ratings were scored before Botox injection and repeated 1 week after injection.
Fig 5. Evaluation of tracheoesophageal speech as rated by 3 trained judges using the 7-point equalappearing interval scale. Subjects underwent tape samples of voice recordings before Botox injection and 1 week after injection. All judges were blinded with regard to patient identity and whether samples represented pretreatment or posttreatment recordings. Independent ratings were obtained on 2 separate occasions. Intrajudge and interjudge reliability was greater than 95%.
that PES spasm accounted for 79% of TEP voice failures in their series, whereas stricture accounted for 26%. The diagnosis of PES spasm is based largely on clinical perceptions of the patient’s TEP speech characteristics. A poor-fitting tracheoesophageal prosthesis, or one that is occluded with secretions, may mimic symptoms of PES spasm. Therefore careful evaluation of the prosthesis is mandatory.18 Ancillary objective diagnostic tests include the modified barium swallow study, tracheal air pressure measures, lidocaine injection, and air insufflation testing.17 The barium sulfate swallow study may help to differentiate spasm from stricture of the PES. Failure of the segment to open or display relaxation during a swallowing attempt correlates significantly with stricture, a condition that likely will not respond to Botox.17,19 Tracheal air pressure measurements are thought to correlate significantly with the respiratory effort generated to produce TEP speech. In this study all 8 patients demonstrated improvement in tracheal air pressures after Botox injection, and 5 of 8 patients were rated as having good-to-excellent posttreatment TEP voice.
A lidocaine injection into the PES may be used to predict those patients who might benefit from Botox. However, in our experience several patients showed no improvement after a lidocaine injection but subsequently responded well to Botox. Recently, we have seen temporary improvement in spasmodic TEP speech symptoms after a viscous lidocaine swallow. The mechanism for improved symptoms may be partly attributed to the anesthetic effects of the lidocaine on the PES mucosa, causing blunting of reflex muscle contraction when the PES dilates during speech tasks. This procedure may prove to be an effective, innocuous, and costeffective diagnostic test, as well as a predictor of success after a Botox injection. Studies are currently being performed at our institute to further investigate this phenomenon. Insufflation testing is thought to predict those patients with spasticity of the PES before a TEP procedure is performed.20 However, the literature is ambiguous regarding how accurately this test predicts eventual TEP speech quality.13,21,22 More conventional treatment options for PES spasm include speech therapy, PES dilation, pharyngeal
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Fig 6. Air pressure measurements required to produce tracheoesophageal speech during open-vowel tasks. A sphygmomanometer sealed at the tracheostome was used, and measurements were obtained in centimeters of water. These measures directly correlated with the amount of respiratory effort required to initiate airflow and sustain phonation. Recordings were performed before Botox injection and repeated 1 week after injection.
Fig 7. Air pressure measurement required to produce tracheoesophageal speech during counting tasks. A sphygmomanometer sealed at the tracheostome was used, and measurements were obtained in centimeters of water. These measures directly correlated with the amount of respiratory effort required to initiate airflow and sustain phonation. Recordings were performed before Botox injection and repeated 1 week after injection.
neurectomy, and pharyngeal myotomy. These therapies are not always successful, and some are associated with significant complications: speech therapy may be ineffective or require months of treatment before the patient makes significant gains, PES dilations typically result in only short-term symptom relief, and open surgical procedures are associated with a significant complication rate.23 Scott et al24 reported a 17% complication rate for total laryngectomy patients undergoing a secondary myotomy procedure, with postoperative fistula accounting for 7% of the cases. Results of our investigation corroborate the findings of other clinical researchers.5-8 Botulinum toxin for treatment of PES spasm has been shown to provide relaxation of the PES muscle complex, thus allowing improved fluency of vibration of the underlying mucosa and improved TEP speech. These findings revealed improvements in both the subjective and quantitative measures of TEP speech quality and PES function after Botox injection. For those patients who will need repeat injections to
maintain fluent TEP speech, Botox can provide diagnostic and prognostic information with regard to the benefit of longer lasting therapeutic options. These data also demonstrated that Botox injection is an effective treatment for those patients whose TEP speech has not improved with a myotomy and who continue to struggle with poor TEP speech performance. Although we have conducted several in-office Botox injections without EMG or fluoroscopic guidance with good results, this technique failed in 4 patients in this study, necessitating the current injection methodology. We believe that the videofluoroscopy-guided approach to PES Botox injections provides more accurate localization of the area of hyperfunctional muscle activity, thus potentially lowering the dose of toxin necessary to provide maximum effects. Although we used a high dose of Botox in this investigation, further research is needed to determine the optimal dose while maintaining limited morbidity. The fluoroscopy-guided Botox injection procedure is quickly and easily performed in a radiology suite, the
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diagnostic barium swallow is performed immediately before the injection, no anesthesia is required, there is little or no morbidity, and results are seen within 72 hours. The average duration of effect from the neurotoxin is reported to be 3 months.3 However, for unknown reasons patients may have prolonged periods of symptom relief, sometimes greater than 1 year. An explanation for this phenomenon is lacking but is currently an ongoing topic of study at our institute. Interestingly, only 1 of 8 patients has subsequently reported recurrent speech difficulties. Six months after their injections, the remaining patients are presently symptom free. If only 1 or 2 injections are needed to provide permanent TEP speech fluency, it may be more cost-effective and may cause less morbidity to perform this procedure rather than alternative surgical approaches, such as pharyngeal myotomy. Crary and Glowasky7 report that the cost of 1 injection procedure is 25% less than that of a myotomy, not including additional costs of surgery and hospitalization for the latter procedure. CONCLUSION
Botox injection into the PES for the treatment of poor-quality TEP speech is a safe and effective procedure. Videofluoroscopy-guided botulinum toxin injections provide an accurate method of localization of the area of hyperfunctional muscle activity. In addition, the procedure can be performed at the same time as the diagnostic barium swallow. On the basis of our results, combined with the cost-effectiveness and lower morbidity rate when compared with pharyngeal myotomy, videofluoroscopy-guided Botox injection should be considered a potential initial treatment option for laryngectomees with poor-quality TEP speech caused by PES hypertonicity or spasm. REFERENCES 1. Dutton JJ, Buckley EG. Long-term results and complications of botulinum A toxin in the treatment of blepharospasm. Ophthalmology 1988;95:1529-34. 2. Schneider I, Thumfart WF, Pototschnig C, et al. Treatment of dysfunction of the cricopharyngeal muscle with botulinum A toxin: introduction of a new, noninvasive method. Ann Otol Rhinol Laryngol 1994;103:31-5.
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3. Blitzer A, Brin MF. Laryngeal dystonia: a series with botulinum toxin therapy. Ann Otol Rhinol Laryngol 1991;100:85-90. 4. Terrell JE, Lewin JS, Esclamado R. Botulinum toxin injection for postlaryngectomy tracheoesophageal speech failure. Otolaryngol Head Neck Surg 1995;113:788-91. 5. Blitzer A, Brin MF, Fahn S. Botulinum toxin injection for the treatment of oromandibular dystonia. Ann Otol Rhinol Laryngol 1989;98:93-7. 6. Blitzer A, Komisa A, Baredes S, et al. Voice failure after tracheoesophageal puncture: management with botulinum toxin. Otolaryngol Head Neck Surg 1995;113:668-70. 7. Crary MA, Glowasky AL. Using botulinum toxin A to improve speech and swallowing function following total laryngectomy. Arch Otolaryngol Head Neck Surg 1996;122:760-3. 8. Hoffman HT, Fischer H, VanDenmark D, et al. Botulinum neurotoxin injection after total laryngectomy. Head Neck Surg 1997;19:92-7. 9. Clevens RA, Esclamado RM, Lewin JS, et al. Voice rehabilitation after total laryngectomy and tracheoesophageal puncture using a non-muscle closure. Ann Otol Rhinol Laryngol 1993;102:792-6. 10. Olsen NR, Callaway E. Nonclosure of pharyngeal muscle after laryngectomy. Ann Otol Rhinol Laryngol 1990;99:507-9. 11. Stiernberg CM, Bailey BJ. Transglottic carcinoma and total laryngectomy. In: Bailey BJ, Biller HF, editors. Surgery of the larynx. Philadelphia: WB Saunders; 1985. p. 325-32. 12. Applebaum EL, Levine HL. Pharyngeal reconstruction after laryngectomy. Laryngoscope 1977;87:1884-90. 13. Singer MI, Blom ED. Selective myotomy for voice restoration after total laryngectomy. Arch Otolaryngol 1981;107:670-3. 14. Baugh RF, Lewin JS, Baker SR. Preoperative assessment of tracheoesophageal speech. Laryngoscope 1987;97:461-6. 15. Henley J, Souliere C. Tracheoesophageal speech failure in the laryngectomee: the role of constrictor myotomy. Laryngoscope 1986;96:1016-20. 16. Perry AL, Cheesman AD, McIvor J, et al. A British experience of surgical voice restoration techniques as a secondary procedure following total laryngectomy. J Laryngol Otol 1987;101:155-63. 17. Baugh RF, Lewis JS, Baker SR. Vocal rehabilitation of tracheoesophageal speech failures. Head Neck Surg 1990;12:69-73. 18. Izdebski K, Reed CG, Ross JC, et al. Problems with tracheoesophageal fistula voice restoration in totally laryngectomized patients. Arch Otolaryngol Head Neck Surg 1994;120:840-5. 19. Cheesman AD, Knight J, McIvor J, et al. Tracheo-oesophageal puncture speech: an assessment technique for failed oesophageal speakers. J Laryngol Otol 1986;100:191-9. 20. Lewin JS, Baugh BF, Baker SR. An objective method for prediction of tracheoesophageal speech production. J Speech Hearing Disorders 1987;52:212-7. 21. Singer MI, Blom ED. An endoscopic technique for restoration of voice after laryngectomy. Ann Otol Rhinol Laryngol 1980;89: 529-33. 22. Johns ME, Cantrell RW. Voice restoration of the total laryngectomy patient: the Singer-Blom technique. Otolaryngol Head Neck Surg 1981;89:82-6. 23. Singer MI. The upper esophageal sphincter: role in alaryngeal speech acquisition. Head Neck Surg 1988;(Suppl II);118-23. 24. Scott PMJ, Bleach NR, Perry AR, et al. Complications of pharyngeal myotomy for alaryngeal voice rehabilitation. J Laryngol Otol 1993;197:430-3.
Total laryngectomy patients, after undergoing a tracheoesophageal puncture (TEP), may have poor TEP speech because of hypertonicity or spasm of the pharyngoesophageal segment (PES). Conventional treatment options include speech therapy, PES dilation, pharyngeal neurectomy, and myotomy. Botulinum toxin injection into the PES has recently been reported to be effective for this disorder. However, data accumulated were based primarily on subjective analyses. This prospective investigation used both qualitative and quantitative measures to assess the effects of videofluoroscopyguided botulinum toxin injection on TEP voice quality in laryngectomees with PES dysfunction. Patients underwent voice analyses, tracheal air pressure measures, and barium swallows before and after botulinum toxin injection. Seven of 8 patients had significant voice quality improvement, and tracheal air pressures normalized in 6 of 8 patients after injection. Videofluoroscopic botulinum toxin injection into the PES is efficacious, safe, and cost-effective and should be considered as a first-line therapy for the treatment of laryngectomees with poor quality TEP speech caused by PES dysfunction. (Otolaryngol Head Neck Surg 1999;120:314-9.)
B
otulinum toxin (Botox) is produced by the bacterium Clostridia botulinum. When injected it acts as a potent neurotoxin that creates its effects at the neuromuscular junction by irreversibly blocking the presynaptic release of acetylcholine, thus resulting in a localized muscle paralysis. Botox was initially used to treat strabismus,
From the Departments of Otolaryngology (Drs Zormeier, Meleca, Simpson, Dworkin, and Mathog) and Radiology (Drs Klein and Gross), Wayne State University, Detroit Medical Center. Presented at the Annual Meeting of the American Academy of Otolaryngology–Head Neck Surgery, San Francisco, CA, September 7-10, 1997. Reprint requests: Robert J. Meleca, MD, Department of Otolaryngology, Wayne State University, 4201 St Antoine, 5E—University Health Center, Detroit, MI 48201. Copyright © 1999 by the American Academy of Otolaryngology– Head and Neck Surgery Foundation, Inc. 0194-5998/99/$8.00 + 0 23/1/90397 314
but its indications have been expanded to include treatment for other dystonic and/or spasmodic disorders of the head and neck, including cervical torticollis, hemifacial spasm, oromandibular dystonia, and spasmodic dysphonia.1-4 Complications have been minimal, the effects begin within 72 hours, and results typically last for an average of 3 months. Recent reports suggest that Botox is an effective treatment for pharyngoesophageal segment (PES) hypertonicity or spasm in laryngectomees with poor tracheoesophageal puncture (TEP) speech.5-8 Although results are encouraging the methodology used by previous investigators is subjective by design and fails to use quantitative measurements. Our investigation is a prospective study, using both qualitative and quantitative analyses, of the effect of Botox injection on TEP speech in laryngectomees with identified hypertonicity/spasm of the PES. PATIENTS AND METHODS Patients From June 1995 to July 1997, 8 laryngectomy patients (all male) with poor TEP speech were treated at the Detroit Medical Center with videofluoroscopy-guided Botox injections of the PES to reduce underlying spasms. Patients ranged in age from 42 to 78 years (mean 61 years). At the time of the laryngectomy procedure 5 patients underwent a 2-layer pharyngeal closure technique as described by Clevens et al,9,10 and 3 patients had a standard 3-layer pharyngeal closure.11,12 The TEP was performed as a secondary procedure in all patients studied. The average time from the TEP procedure to Botox injection was 4.3 months (range 5 days to 15 months). Seven patients received postoperative radiation therapy. Four of 8 patients had undergone a previous myotomy procedure with no symptom relief, and 3 patients were rated as having no TEP speech before treatment. Four of 8 patients had had previous Botox injections performed in the office with only partial resolution of symptoms. Because of failure to provide consistently good results in the voice clinic, we began performing injections using videofluoroscopic guidance. Diagnostic Evaluation of PES Hypertonicity/ spasm All patients were judged to have PES segment hypertonicity/spasm on the basis of clinical symptoms, pre-TEP insufflation pressures, tracheal back pressure measurements, and
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Fig 1. Fluoroscopic image of the area of pharyngoesophageal muscle spasm (curved arrow). Preliminary barium swallow will help differentiate spasm from stricture of the PES. In addition, the barium will highlight the PES and TE prosthesis (open arrow). With the patient attempting TE speech, note column of air dilating the PES (straight arrow) below area of spasm.
Fig 2. Needle placement (long straight arrow) directly into the area of pharyngoesophageal muscle spasm (curved arrow) under fluoroscopic visualization. Note column of air dilating the PES during tracheoesophageal speech (short straight arrow). Open arrow indicates tracheoesophageal prosthesis.
barium swallow evaluation. Before Botox injection, TEP voice characteristics were initially rated by a single speech pathologist (M.L.S.) with more than 15 years of experience working with this patient population. Despite post-TEP voice therapy, all patients had persistent poor voice quality and symptoms of PES dysfunction. These included (1) difficulties with onset of TEP speech, (2) phonatory breaks during speech, (3) a strangled or high-pressure voice, and/or (4) an inability to produce any phonation whatsoever. Those patients with elevated pre-TEP insufflation pressures (suggesting PES spasm) and poor TEP speech were treated with Botox injection at earlier time intervals from the TEP procedure because of generally poor speech outcomes after speech therapy alone for this patient population. No patient reported swallowing difficulties. Measurement of the air pressure required to produce TEP speech was obtained with a sphygmomanometer sealed at the tracheostome. These measures directly correlate with the amount of respiratory effort required to initiate airflow and sustain phonation.13,14 Pressure measurements were performed before injection and were repeated 1 week after injec-
tion. All measurements were performed during counting and open-vowel tasks. Multiple pressure recordings were taken for each patient, and an average measurement was calculated. A barium sulfate swallow with videofluoroscopy was used to evaluate the PES for hypertonicity/spasm before the Botox injection. The barium served to outline the PES and better delineate the characteristic “bulge” of the posterior pharyngeal wall, which partially relaxes during bolus transit, suggesting dysfunction of the PES (Fig 1). This finding is in contradistinction to a nonyielding PES, which is diagnostic of a stricture that will not respond to Botox therapy.13,14 The spasmodic segment was further defined by having the patient perform various TEP speech tasks. Injection Technique An initial barium sulfate swallow will help outline the PES, and the area of spasm is further illustrated by having the patient perform TEP speech tasks under videofluoroscopic visualization (Fig 1). A 25-gauge needle attached to a 5 mL syringe containing the Botox solution is inserted transcutaneously through the anterior neck skin in the midline, above
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Table 1. Seven-point equal-appearing interval scale 7 = Superb: Equal to the best TEP speech imaginable 6 = Excellent TEP speech 5 = Good TEP speech 4 = Fair TEP speech 3 = Poor TEP speech 2 = Very poor TEP speech 1 = No (or virtually no) discernible TEP speech
Fig 3. Typical Botox injection sites into the PES muscle complex. Injections can be performed with or without electromyographic guidance.
the stoma, and into the inferior portion of the bulging posterior pharyngeal wall (Fig 2). After proper needle tip placement into the muscle is verified with fluoroscopy, 20 to 30 units of Botox is injected. Two additional vertically aligned Botox injections (approximately 20 units each) are given into the middle and superior portions of the affected region for a total of 60 to 90 units (Fig 3). Outcome Measures All patient voices were recorded and analyzed acoustically before and after injection. Subjective ratings of voice quality were performed before and after Botox injection by the patient using a 7-point equal-appearing interval scale (Table 1). A score of 7 represented superb TEP speech, whereas 1 represented no TEP speech. Perceptual ratings of voice quality were performed by 3 judges (speech pathology graduate students) who were trained for the task and who listened to tape samples. All judges were blinded with regard to patient identity and whether the samples represented pretreatment or posttreatment recordings. Independent ratings were obtained on 2 separate occasions, spaced 72 hours apart, by use of the 7-point equal-appearing interval scale. RESULTS
Both intrajudge and interjudge reliability reached the 95% level of confidence; ratings never varied by more than 1 scale value on any of the measures. All patients reported improvement in their TEP speech quality after Botox injection, with ratings ranging from good to superb (Fig 4). The patients’ self-ratings before and after Botox injection were highly correlated with those
of the trained listeners. Discomfort from the injection procedure was considered mild, and no complications were reported. No patients reported dysphagia before injection. However, 2 of 8 patients reported improvement in swallowing ability after injection. A comparison of preinjection and postinjection perceptual TEP speech quality ratings by 3 trained listeners revealed that 7 of 8 patients experienced voice improvement after injection, with scores in the good-toexcellent range in 5 of 8 patients (Fig 5). Patients 1, 4, and 6 had no TEP speech before injection. They exhibited marked voice improvement after injection. One of 8 patients was rated by the listeners to have no improvement after injection. He was a 42-year-old man with bilateral hypoglossal nerve injuries at the time of his cancer resection, and it was thought that this impairment contributed to his poor TEP speech characteristics. Notwithstanding this limitation, he perceived that his speech quality improved after injection. Tracheal air pressure measurements obtained with the sphygmomanometer were used to assess back pressure within the trachea during TEP speech. Fluent tracheoesophageal voicing produces pressure readings approximating 20 to 30 cm H2O. Figures 6 and 7 show the preinjection and postinjection pressure measures obtained from the current patients during open-vowel and counting tasks, respectively. Note that the preinjection values are greater than those obtained after Botox injection and that 6 of 8 patients demonstrated normal pressures after injection, suggestive of fluent TEP speech and voice. Pressure measures are similar when open-vowel and counting tasks are compared. DISCUSSION
Total laryngectomy patients, after undergoing a TEP procedure, may exhibit strained-strangled, spasmodic TEP speech characteristics.13 All of our patients struggled with such difficulty before Botox injection. It has been speculated that these abnormalities are most commonly caused by interruption of airflow through an abnormally hypertonic or spasmodic PES muscle complex during speech efforts, which disrupts vibration of the underlying PES mucosa.15,16 Baugh et al17 reported
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Fig 4. Evaluation of tracheoesophageal speech as rated by each patient using the 7-point equalappearing interval scale. Ratings were scored before Botox injection and repeated 1 week after injection.
Fig 5. Evaluation of tracheoesophageal speech as rated by 3 trained judges using the 7-point equalappearing interval scale. Subjects underwent tape samples of voice recordings before Botox injection and 1 week after injection. All judges were blinded with regard to patient identity and whether samples represented pretreatment or posttreatment recordings. Independent ratings were obtained on 2 separate occasions. Intrajudge and interjudge reliability was greater than 95%.
that PES spasm accounted for 79% of TEP voice failures in their series, whereas stricture accounted for 26%. The diagnosis of PES spasm is based largely on clinical perceptions of the patient’s TEP speech characteristics. A poor-fitting tracheoesophageal prosthesis, or one that is occluded with secretions, may mimic symptoms of PES spasm. Therefore careful evaluation of the prosthesis is mandatory.18 Ancillary objective diagnostic tests include the modified barium swallow study, tracheal air pressure measures, lidocaine injection, and air insufflation testing.17 The barium sulfate swallow study may help to differentiate spasm from stricture of the PES. Failure of the segment to open or display relaxation during a swallowing attempt correlates significantly with stricture, a condition that likely will not respond to Botox.17,19 Tracheal air pressure measurements are thought to correlate significantly with the respiratory effort generated to produce TEP speech. In this study all 8 patients demonstrated improvement in tracheal air pressures after Botox injection, and 5 of 8 patients were rated as having good-to-excellent posttreatment TEP voice.
A lidocaine injection into the PES may be used to predict those patients who might benefit from Botox. However, in our experience several patients showed no improvement after a lidocaine injection but subsequently responded well to Botox. Recently, we have seen temporary improvement in spasmodic TEP speech symptoms after a viscous lidocaine swallow. The mechanism for improved symptoms may be partly attributed to the anesthetic effects of the lidocaine on the PES mucosa, causing blunting of reflex muscle contraction when the PES dilates during speech tasks. This procedure may prove to be an effective, innocuous, and costeffective diagnostic test, as well as a predictor of success after a Botox injection. Studies are currently being performed at our institute to further investigate this phenomenon. Insufflation testing is thought to predict those patients with spasticity of the PES before a TEP procedure is performed.20 However, the literature is ambiguous regarding how accurately this test predicts eventual TEP speech quality.13,21,22 More conventional treatment options for PES spasm include speech therapy, PES dilation, pharyngeal
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Fig 6. Air pressure measurements required to produce tracheoesophageal speech during open-vowel tasks. A sphygmomanometer sealed at the tracheostome was used, and measurements were obtained in centimeters of water. These measures directly correlated with the amount of respiratory effort required to initiate airflow and sustain phonation. Recordings were performed before Botox injection and repeated 1 week after injection.
Fig 7. Air pressure measurement required to produce tracheoesophageal speech during counting tasks. A sphygmomanometer sealed at the tracheostome was used, and measurements were obtained in centimeters of water. These measures directly correlated with the amount of respiratory effort required to initiate airflow and sustain phonation. Recordings were performed before Botox injection and repeated 1 week after injection.
neurectomy, and pharyngeal myotomy. These therapies are not always successful, and some are associated with significant complications: speech therapy may be ineffective or require months of treatment before the patient makes significant gains, PES dilations typically result in only short-term symptom relief, and open surgical procedures are associated with a significant complication rate.23 Scott et al24 reported a 17% complication rate for total laryngectomy patients undergoing a secondary myotomy procedure, with postoperative fistula accounting for 7% of the cases. Results of our investigation corroborate the findings of other clinical researchers.5-8 Botulinum toxin for treatment of PES spasm has been shown to provide relaxation of the PES muscle complex, thus allowing improved fluency of vibration of the underlying mucosa and improved TEP speech. These findings revealed improvements in both the subjective and quantitative measures of TEP speech quality and PES function after Botox injection. For those patients who will need repeat injections to
maintain fluent TEP speech, Botox can provide diagnostic and prognostic information with regard to the benefit of longer lasting therapeutic options. These data also demonstrated that Botox injection is an effective treatment for those patients whose TEP speech has not improved with a myotomy and who continue to struggle with poor TEP speech performance. Although we have conducted several in-office Botox injections without EMG or fluoroscopic guidance with good results, this technique failed in 4 patients in this study, necessitating the current injection methodology. We believe that the videofluoroscopy-guided approach to PES Botox injections provides more accurate localization of the area of hyperfunctional muscle activity, thus potentially lowering the dose of toxin necessary to provide maximum effects. Although we used a high dose of Botox in this investigation, further research is needed to determine the optimal dose while maintaining limited morbidity. The fluoroscopy-guided Botox injection procedure is quickly and easily performed in a radiology suite, the
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diagnostic barium swallow is performed immediately before the injection, no anesthesia is required, there is little or no morbidity, and results are seen within 72 hours. The average duration of effect from the neurotoxin is reported to be 3 months.3 However, for unknown reasons patients may have prolonged periods of symptom relief, sometimes greater than 1 year. An explanation for this phenomenon is lacking but is currently an ongoing topic of study at our institute. Interestingly, only 1 of 8 patients has subsequently reported recurrent speech difficulties. Six months after their injections, the remaining patients are presently symptom free. If only 1 or 2 injections are needed to provide permanent TEP speech fluency, it may be more cost-effective and may cause less morbidity to perform this procedure rather than alternative surgical approaches, such as pharyngeal myotomy. Crary and Glowasky7 report that the cost of 1 injection procedure is 25% less than that of a myotomy, not including additional costs of surgery and hospitalization for the latter procedure. CONCLUSION
Botox injection into the PES for the treatment of poor-quality TEP speech is a safe and effective procedure. Videofluoroscopy-guided botulinum toxin injections provide an accurate method of localization of the area of hyperfunctional muscle activity. In addition, the procedure can be performed at the same time as the diagnostic barium swallow. On the basis of our results, combined with the cost-effectiveness and lower morbidity rate when compared with pharyngeal myotomy, videofluoroscopy-guided Botox injection should be considered a potential initial treatment option for laryngectomees with poor-quality TEP speech caused by PES hypertonicity or spasm. REFERENCES 1. Dutton JJ, Buckley EG. Long-term results and complications of botulinum A toxin in the treatment of blepharospasm. Ophthalmology 1988;95:1529-34. 2. Schneider I, Thumfart WF, Pototschnig C, et al. Treatment of dysfunction of the cricopharyngeal muscle with botulinum A toxin: introduction of a new, noninvasive method. Ann Otol Rhinol Laryngol 1994;103:31-5.
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