- Email: [email protected]
The development of successful tracheoesophageal voice restoration
Otolaryngol Clin N Am 37 (2004) 507–517
The development of successful tracheoesophageal voice restoration Mark I. Singer, MD, FACS* Department of Otolaryngology–Head and Neck Surgery, University of California, San Francisco, 400 Parnassus Avenue, 7th Floor, San Francisco, CA 94143, USA
Since the first reports of laryngectomy surgery, voice preservation has been an important consideration in planning treatment and developing improved methods. General acceptance of laryngectomy for the management of laryngeal cancer demands a realistic chance of voice preservation. The most frequently quoted paper describing the first successful laryngectomy reported Billroth’s operation and proposed a fistula technique for voice restoration [1]. The procedure used a pharyngostoma to manage secretions and an external device to direct exhaled air into the pharynx for voice production. By the late 19th century, the pharyngostoma was no longer part of the laryngectomy procedure, making it more acceptable, but voice rehabilitation required the development of esophageal speech or an external device to provide vibrating air for phonation. A number of pneumatic or electrical devices became available for voice. The most effective was esophageal speech, which freed the laryngectomee from devices and provided an ‘‘internal’’ voice from the patient’s natural pharyngoesophageal tissues, often called the pseudoglottis. The acquisition of esophageal speech requires dedicated training, and depends on the development of the pseudoglottis after laryngectomy, which is never a planned part of the procedure. For these reasons, less than one third of laryngectomees acquire esophageal speech, and only a few are considered exceptional speakers. Thus, many patients are relegated to unnaturalsounding external devices, writing pads, or silence. Alternatively, with the development of clinical radiation therapy techniques, treatment of many laryngeal cancers by a nonsurgical method is more acceptable to patients and medical colleagues. This preference for nonsurgical management of laryngeal cancer is the basis for today’s organ-preservation protocols. The recurring and * 2380 Sutter Street, San Francisco, CA 94143-1703 E-mail address: [email protected] 0030-6665/04/$ - see front matter Ó 2004 Elsevier Inc. All rights reserved. doi:10.1016/j.otc.2004.01.001
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important issue is voice loss, making nonsurgical alternatives always more desirable. Another primary consideration is adequate swallowing function, which often takes precedence over voice. Deglutition must be weighed equally with voice preservation in treatment planning by surgeons and oncologists and critically evaluated when ‘‘improved’’ results are reported. After World War II, there were new reports of fistula speech using either tracheal devices or imaginative surgical techniques [2]. These surgeons attempted to restore voice and manage the laryngeal cancer more effectively. Most cases were complicated by the need for customized airway devices or by the inevitable development of fistula stenosis or tracheal aspiration. Exceptional cases were reported frequently, but large numbers of durable results were not achieved. Different geographic regions developed and use various treatment methods for laryngeal cancer. The United Kingdom favors radiation therapy; the Mediterranean countries frequently use surgical options, but stop short of total laryngectomy. North Amercan treatment mixes radiation and total laryngectomy procedures. There has never been a worldwide consensus on the management of laryngeal cancer. Different regions are also affected by the availability and cost of providing radiation therapy, which bears particularly on treatment planning in developing countries. Contemporary otolaryngology practice was affected greatly by the development and popularization of conservation laryngectomy procedures [3], which can maintain vocal function, swallowing function, and avoid a permanent tracheostomy in selected patients. The results are dramatic and more acceptable to patients and medical colleagues. On the other hand, the techniques are more demanding surgically, and the recovery periods are more extended compared to conventional total laryngectomy. The use of conservation laryngectomy after radiation therapy, although not controversial, is difficult, with unpredictable results. In the 1960s, a number of research efforts investigated prosthetic rehabilitation of the voice after laryngectomy with limited results [4]. Most prosthetic materials failed in the unique environment of head and neck cancer surgery, where contaminated secretions, proximity to the airway, and radiated tissues differ from those found in cardiovascular or orthopedic surgery, where progress was made with different implantable prosthethic devices. This problem remains and must be accepted before grants are awarded for research efforts, as in the recent case of the ‘‘implantable larynx’’ with the European Community’s Eureka Project. In 1974, the World Centennial Conference on Laryngeal Cancer was held in Toronto to commemorate the centennial of the Billroth procedure and to bring scholars together to make progress against laryngeal cancer. At this meeting, Italian and Spanish surgeons introduced less-than-total laryngectomy or neoglottic procedures as alternatives to total laryngectomy, radiation therapy, or partial laryngectomy [5]. The initial results were impressive and a number of North American surgeons attempted to apply them. The success
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rates were poor, hospitalizations were prolonged, and few of the procedures tolerated radiation therapy as part of accepted adjunctive treatment. More intense review of the neoglottic procedures decreased their relevance to North American patients and to acceptable treatment conventions. With this history in mind, the author used the tracheoesophageal shunt procedure of Amatsu in 1978 [6,7]. The results were limited and wound healing was complicated. Adjunctive radiation therapy also complicated the recovery of patients. One persistent result of direct tracheoesophageal shunt, however, was voice production. Although shunt stenosis and aspiration into the trachea were frequent problems that limited the use of this procedure in the United States, it served as a window into the mechanism of alaryngeal speech by clarifying the role of the pseudoglottis and revealing its simplicity. Surgeons had tried for a century to fabricate a better voicing source through shunts, nerve preservation, flaps, tendon transfers, and implants. The simple tracheoesophageal shunt, introducing air inferior to the cricopharyngeus muscle, permitted high-quality voice acquisition without sacrificing accepted oncologic procedures for voice. It does not preserve remnants of the epiglottis or arytenoids, as proposed in less-than-total laryngectomy procedures, which can jeopardize cancer treatment. Additionally, radiation therapy can be used successfully. Patients can acquire alaryngeal speech without tedious therapy, and the voice assessments exceed the quality of esophageal speech and external voicing devices. The procedure was applied easily by any surgeon trained in laryngectomy surgery and could be applied across cultures and various patient populations. Additionally, swallowing function is not different from a conventional laryngectomy, and the need for aspiration precautions, time-consuming deglutition therapy, or prolonged gastric-tube feeding is eliminated. Two problems remained, however. The voicing shunt often closed from stenosis, or deglutition was affected by esophageal contents leaking into the trachea through a patent shunt. The observations from the Amatsu experience led to the establishment of criteria for surgical voice restoration after laryngectomy, which are summarized as follows:
No compromise of oncologic principles for the goal of voice restoration Applicable in the irradiated field No complex reconstruction Limited role for speech therapy Rapid recovery No alteration of swallowing function Easily understood by patients Limited cost Superior speech production
In collaboration with Eric D. Blom, PhD, a multipurpose voice prosthesis was developed and modified over time [8,9]. Careful review of previous prosthetic approaches highlighted problems that others had experienced.
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Most of the devices shared the airway and required adaptors to fit the tracheostoma, complicating use because of the need for additional patient fittings. The devices were cumbersome in some cases, expensive, and hygiene was often difficult. Many earlier devices were placed in a pharyngostoma, and achieving a proper fit was difficult over time because of dilatation of the fistula. In many successful case reports, customization of the device or fittings was needed [10]. Most surgeons and many speech clinicians eventually abandoned these approaches because of the impracticalities. Fistula speech became an interesting footnote in laryngeal cancer treatment, but failed to gain acceptance. In addition, this area was overshadowed by the publicized death of a well-known actor from carotid hemorrhage attributed to a prosthetic voicing device. The first need of tracheoesophageal-speech patients is maintenance of the tract between the trachea and the esophagus. Most of the fistula procedures that maintained patency were mucosal-lined but vulnerable to uncontrolled dilation. The tracheoesophageal shunt in our patient group was not mucosal-lined and required a stenting tube to maintain patency for voice production. Therefore, a tube or catheter was used to provide the stenting effect. A rubber urethral catheter (14 French) provided satisfactory stenting for the tract, and was easy for patients to remove, replace, clean, and maintain. The inconvenience of loss of voice with stenting required the development of a one-way valve to permit exhaled tracheal air to enter the esophagus for voice production, but to remain closed at other times to prevent tracheal aspiration of the contents of the esophagus. The earliest valved stent tube the author used was a ‘‘snorkel’’ or ball valve mounted in a urethral catheter. This permitted one-way airflow without reflux, and maintained the patency of the tracheoesophageal tract. Initial experiences with this valve were unsuccessful. Although tracheoesophageal speech was possible, the moveable ball valve would remain closed when food particles entered its housing. The second valve the author investigated was a ‘‘slit valve’’ made by cutting 8 mm through the tip of the catheter. The resulting ‘‘valve’’ allowed easy air entry into the esophagus and the elastic recoil of the rubber protected against oropharyngeal secretions. The housing for the voice prosthesis remained the catheter. The slit valve functioned well in the esophageal environment and became the first voice prosthesis (Fig. 1). It was named the duckbill voice prosthesis to describe its method of action. The red rubber catheter was replaced by medical-grade silicone and a commercial product became available in 1980. (The development, US Food and Drug Administration clearance, intellectual property rights, and trademark processes for such a device are complex issues requiring advice from counsel. For example, the patent-protected Blom-Singer devices have seen at least two prolonged court actions in their short existence.) The duckbill voice prosthesis served many laryngectomy patients with a low incidence of problems. Eventually, a device that was less resistive than
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Fig. 1. Slit-valve (duckbill) voice prosthesis.
the duckbill design was needed. Thus, a flap valve design was introduced that permitted easier voicing and allowed for the introduction of a stoma valve, so that the user would not need to cover the tracheostoma manually and could maintain better hygiene (Fig. 2). The indwelling voice prosthesis represents a further design change for the voice prosthesis. This device is designed to remain in situ for several weeks to months, easing the patient’s burden of device maintenance (Fig. 3). A speech pathologist must replace the device, however, which is difficult if the
Fig. 2. Tracheostoma valve with adhesive stoma housings.
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Fig. 3. Indwelling voice prosthesis.
patient must travel long distances. Furthermore, the device is more prone to yeast colonization of the valve leaflet, destroying its function. There are a few other voice prosthetic devices available, all of which are of the same basic design. Some are preferable for certain patients and should be offered as a trial for them to maximize their vocal efficiency and intelligibility. After a successful voice prosthesis was developed, a simple operative technique for establishing the tracheoesophageal tract was needed that could be applied primarily for laryngectomy patients and secondarily for esophageal speech failure patients. Based on the simple tracheoesophageal tract procedure observed in the Amatsu experience, it was apparent that a horizontal tract from the tracheostoma to the esophagus could be established endoscopically. A rigid esophagoscope was selected and modified to place a target on the instrument, which was then used to place a needle from the trachea to the esophagus. The needle was used to guide a wire and then a catheter from the trachea to the esophagus as a stent. After 2 days, the catheter was exchanged for a voice prosthesis and speech acquisition could proceed. This simple procedure requires a few minutes in the operating room under direct vision, and is safe, midline, and easily repeated. The patients need no perioperative antibiotics, resume oral intake, and leave the hospital on an ambulatory basis. The procedure requires no additional skills other than placing a rigid esophagoscope in the laryngectomized pharynx. The author experienced no major complications using the procedure and patients were satisfied with their vocal rehabilitation. There have been many reported techniques, ranging from the use of modified transoral devices to flexible endoscopic procedures. The initial placement of the tracheoesophageal tract at laryngectomy requires no special techniques or instrumentation. The overall results of tracheoesophageal speech exceed those of any form of alaryngeal speech, and its improved intelligibility has made it the method
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of choice for surgical voice rehabilitation after laryngectomy. As a result, voice production no longer drives treatment planning for laryngeal cancer because total laryngectomy will result in effective and socially acceptable voice and appropriate cancer treatment without compromise. Nonoperative treatments for laryngeal cancer that commit patients to permanent tracheotomies and feeding tubes are not alternative but inferior treatments of this disease. Complete laryngectomy for functional failure after laryngeal preservation protocols has been difficult, costly, and time-consuming. If organ preservation fails, surgical salvage is possible, but is more complicated than in the patient who has never received chemotherapy or radiation therapy. It is easy to place indwelling devices at the time of endoscopy, decreasing the need for outpatient fitting and measurements and permitting the use of the voice prosthesis as early as the recovery room, which is a clinical experience similar to placement of a stapes prosthesis with immediately improved hearing. The indwelling voice prosthesis maintains the tracheoesophageal tract and eliminates inadvertent loss of the tract if the catheter or stent is dislodged. If tract placement is done primarily at the initial laryngectomy, the stenting catheter is preferred while the tracheostoma is healing, and can be used as an effective feeding tube during convalescence. In this case, the voice prosthesis can be placed 2 weeks after laryngectomy when oral nutrition is resumed. The prosthesis can be used throughout the course of postoperative radiation therapy, although the voice result may deteriorate at the fourth week until completion of the treatment course. A frustrating problem with voice acquisition after prosthesis placement was identified early. Some alaryngeal speakers (20%–40%) were incapable of fluent or effortless speech because of what initially seemed to be spasm. These patients were unable to speak easily with or without the prosthesis. It was reasoned that the problem was not with the prosthesis but with the outflow of air through the pharyngoesophageal tract. Most of these patients were complete esophageal speech failures or poor speakers, and some could be detected preoperatively by catheter insufflation of the esophagus. When speech was attempted, only a few syllables were produced, great effort was required, and the Valsalva effect was evident. The challenge was to characterize this problem further, and to correct it. It was initially unclear that pharyngeal constrictor spasm could occur in the laryngectomized pharynx. According to much of the relevant literature, the laryngectomized pharynx was myotomized thoroughly and incapable of generating a pressure head that would prevent air egress through the vocal tract [11]. Some surgeons stated that they did not close the constrictors during pharyngeal reconstruction, but the problem still resulted. The author infiltrated the retropharyngeal plane with lidocaine 2% as a presumptive nerve block in failed tracheoesophageal speakers, which immediately resolved the spasm problem and allowed fluent speech production. This experience was supported further by radiographic studies
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pre- and postblock showing a significant change in the appearance of the region of the cricopharyngeus muscle [12]. It was reasoned that the constrictors remain active after laryngectomy, and when the esophagus is distended with air, a spasm state develops that blocks air egress and voice production. A key report from an early esophageal manometry study supported this idea [13]. For patients with an intact larynx, measuring esophageal pressures at the gastroesophageal junction, midesophagus, and the upper-esophageal sphincter during esophageal distension documented a simultaneous rise in resting tone at the upper-esophageal sphincter. This study supported the author’s observations in the laryngectomized patients whose esophagi were distended by air entering the tracheoesophageal tract, resulting in upperesophageal–tonicity alterations that could be eliminated by field block of the pharyngeal plexus. It was simple to perform a myotomy of the upper-esophageal sphincter in failed patients with release of the tonicity and acquisition of voice, a step supported by the patient series of the author and others. The tracheoesophageal speech method then became a two-phase technique. If placement of the tracheoesophageal tract and adequate voice prosthesis resulted in effective speech, then nothing more was required; alternatively, voice failure required relaxation of the pharyngeal constrictors. The initial method for relaxation was pharyngeal constrictor myotomy, which was effective but occasionally complicated by pharyngocutaneous salivary drainage and, in some cases, fistula development. Botox injection is now an alternative, effective, nonsurgical method. (This topic is discussed in detail elsewhere in this issue). During the development of a theory for voice failure, it was demonstrated that pharyngeal plexus neurectomy would achieve the same result of tonicity reduction in the pharyngeal constrictors. This was applied more easily during laryngectomy, but was also possible in some secondary cases. The advantages of pharyngeal plexus neurectomy are less trauma to the pharyngeal wall and its blood supply, and less flaccidity of the pharyngeal wall with a higher quality of voice [14]. Thus, it is the author’s preferred pharyngeal relaxation technique during laryngectomy. Deschler [15] has proposed a simpler procedure, however. Taking advantage of modifying the upper-esophageal constrictor reconstruction, a ‘‘half muscle’’ closure is used, which avoids reconstituting the entire circumference of the sphincter and eliminates the problem of pharyngeal constrictor hypertonicity. To manage this problem in the secondary cases, The author prefers to inject Botox during the endoscopic procedure, which eliminates the constrictor tonicity and allows for rapid voice acquisition. Few patients need secondary injections or myotomies today. As the operative management changes and evolves, prosthetic devices are also changing. The most frequently used devices are called indwelling because they are changed only after a few months of wear, or if they leak
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with resulting tracheal contamination. Their long wearability reduces the need for patients to take care of their prosthetic devices, which is difficult because of their size and proximity to the tracheostoma. There are domestic and imported devices that meet this criterion; all are flapper valve–based designs. They are particularly popular in European treatment centers where patients avoid manipulating the devices. The indwelling devices need to be changed by a speech pathologist, nurse, or otolaryngologist, making them inconvenient for patients who live far from a treatment center. Also, the continuous exposure to esophageal contents in radiated patients results in Candida sp colonization causing valve deterioration over time (6–12 weeks). Attempts to alleviate the fungal problem include the use of topically ingested antifungals and systemic antifungals; devices in development will either resist fungal colonization or be impregnated with antifungal agents. Focal Candida colonization of the prosthesis is harmless, but troublesome. It is impossible to eliminate the fungus in radiated patients and it will attach ubiquitously to silicone, Teflon, metal alloys, and glass. This problem remains a challenge to manufacturers and device designers. Extrusion or poorly fit prostheses are frequent problems because the currently popular design incorporates the blunt esophageal end, which can extrude or imbed in the esophageal or tracheal wall with subsequent loss of vocal function. For some patients, replacement or revision of the tracheoesophageal tract may be needed because of this problem. A new design for the voice prosthesis may alleviate the problems of fit and fungal colonization. Most manufacturers have introduced heat moisture exchangers that cover the tracheostoma or are incorporated in tracheal tubes or devices. These inserts trap exhaled moisture and heat and allow the patient to inspire the remaining moisture, thereby maintaining a more natural tracheal environment. There are reports of decreased mucus production and decreased coughing with improved tracheal humidity. Innovative surgeons have introduced reconstructive or extended laryngectomies over the past 40 years with various success [16]. The problems of aspiration, failures to achieve local disease control, intolerance to radiation therapy, uncontrolled fistulizations, and the need for frequent revision procedures remain, however. The permanence of the tracheotomy is the strongest criticism. In the author’s view, dependence on the tracheotomy obviates most of the advantages of these procedures, because the goals can be achieved more easily by the tracheoesophageal voice prosthesis than by complex surgical reconstructions. When the patient’s airway can be restored, however, the author believes a significant advance in laryngeal surgery has been made. Achieving this goal accepts no aspiration, maintains an adequate and patent airway, returns normal humidification and hygiene of the trachea, requires no valves, risks no contamination, restores voice, maintains swallowing function, and finally, makes no compromise in the management of the cancer. Consistent restoration of the airway after
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laryngeal cancer surgery should be the primary consideration in new treatment and technique planning. Some investigators have proposed microsurgical reconstructions for voice rehabilitation. These approaches have included radial forearm flaps and free jejunal transfers to shunt air from the trachea to the pharyngoesophagus in a circuitous manner similar to the voice prosthesis in function. If microvascular surgical transfer of the trachea is accomplished, then the above goals may be realized, justifying the cost and effort of microsurgery. Recently, transplantation of a larynx in a case of laryngeal trauma was successfully reported [17]. This required a marathon effort, complex surgery, immunosuppression, and raises serious ethical questions. The larynx is not a vital organ, and chronic immunosuppresion does not seem justified to restore voice in a trauma victim when simple alternatives are readily available. In a case of laryngeal cancer, the issue is even of greater concern. Long-term immunosuppression of cancer patients is contraindicated in the author’s view. Chronic, intermittent aspiration in an immunocompromised patient seems unwise and possibly fatal with development of a second malignancy. From the earliest considerations of surgery for laryngeal cancers, the crucial human quality of speech has been a foremost concern. It has affected the development of treatments and has affected patient choice profoundly. The loss of voice has motivated surgeons to try innovative approaches to laryngeal surgery. Speech clinicians and scientists, surgeons, and oncologists have offered many solutions and will continue to do so as better cure rates and rehabilitation are achieved. Until then, tracheoesophageal speech is an important bridge that improves the quality of life for many laryngeal cancer patients.
References [1] Singer M. Tracheoesophageal speech: vocal rehabilitation after total laryngectomy. Laryngoscope 1983;93(11):1454–65. [2] Staffieri M, Serafini I. Lariabilitzaione chirurgica della respirazione dopo laringectomia totale. Presented at the 29th National Congress of Associazione Otologi Ospedalieri Italiana. 1976. [3] Ogura JH. Supraglottic subtotal laryngectomy and radical neck dissection for carcinoma of the epiglottis. Laryngoscope 1958;68:983–1003. [4] Taub S, Spiro RH. Vocal rehabilitation of laryngectomees: preliminary report of a new technique. Am J Surg 1972;124:87–90. [5] Holinger PH. A century of progress of laryngectomies in the northern hemisphere. Laryngoscope 1975;85:322–32. [6] Amatsu M. A one stage surgical technique for postlaryngectomy voice rehabilitation. Laryngoscope 1980;90:1378–86. [7] Blom ED, Singer MI. Surgical prosthetic approaches for postlaryngectomy voice restoration. In: Keith RL, Darley FL, editors. Laryngectomy rehabilitation. Houston (Texas): College Hill Press; 1979. p. 251–76.
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[8] Singer MI, Blom ED. An endoscopic technique for voice restoration of voice after laryngectomy. Ann Otol Rhinol Laryngol 1980;89:529–33. [9] Singer MI, Blom ED, Hamaker RC. Further experience with voice restoration after total laryngectomy. Ann Otol Rhinol Laryngol 1981;90:498–502. [10] Conley JJ, DeAmesti F, Pierce MK. A new surgical technique for the vocal rehabilitation of the laryngectomized patient. Ann Otol Rhinol Laryngol 1958;67:655–64. [11] Kirchner JA, Dey FL, Shedd DP. The pharynx after laryngectomy. Laryngoscope 1963;73: 18–33. [12] Creamer B, Schlagel JF. Motor responses of the esophagus to distension. J Appl Physiol 1857;10:498–504. [13] Singer MI, Blom ED. Selective myotomy for voice restoration after total laryngectomy. Arch Otolaryngol 1981;107:670–3. [14] Singer MI, Blom ED, Hamaker RC. Pharyngeal plexus neurectomy for alaryngeal speech rehabilitation. Laryngoscope 1986;96:50–3. [15] Deschler DG, Doherty ET, Reed CG, Hayden RE, Singer MI. Prevention of pharyngoesophageal spasm after laryngectomy with a half-muscle closure technique. Ann Otol Rhinol Laryngol 2000;109:514–8. [16] Pearson BW. Subtotal laryngectomy. Laryngoscope 1981;91:1904–12. [17] Strome M, Stein J, Esclamado R, Hicks D, Lorenz RR, Braun W, et al. Laryngeal transplantation and 40-month follow-up. N Engl J Med 2001;344:1676–9.
The development of successful tracheoesophageal voice restoration Mark I. Singer, MD, FACS* Department of Otolaryngology–Head and Neck Surgery, University of California, San Francisco, 400 Parnassus Avenue, 7th Floor, San Francisco, CA 94143, USA
Since the first reports of laryngectomy surgery, voice preservation has been an important consideration in planning treatment and developing improved methods. General acceptance of laryngectomy for the management of laryngeal cancer demands a realistic chance of voice preservation. The most frequently quoted paper describing the first successful laryngectomy reported Billroth’s operation and proposed a fistula technique for voice restoration [1]. The procedure used a pharyngostoma to manage secretions and an external device to direct exhaled air into the pharynx for voice production. By the late 19th century, the pharyngostoma was no longer part of the laryngectomy procedure, making it more acceptable, but voice rehabilitation required the development of esophageal speech or an external device to provide vibrating air for phonation. A number of pneumatic or electrical devices became available for voice. The most effective was esophageal speech, which freed the laryngectomee from devices and provided an ‘‘internal’’ voice from the patient’s natural pharyngoesophageal tissues, often called the pseudoglottis. The acquisition of esophageal speech requires dedicated training, and depends on the development of the pseudoglottis after laryngectomy, which is never a planned part of the procedure. For these reasons, less than one third of laryngectomees acquire esophageal speech, and only a few are considered exceptional speakers. Thus, many patients are relegated to unnaturalsounding external devices, writing pads, or silence. Alternatively, with the development of clinical radiation therapy techniques, treatment of many laryngeal cancers by a nonsurgical method is more acceptable to patients and medical colleagues. This preference for nonsurgical management of laryngeal cancer is the basis for today’s organ-preservation protocols. The recurring and * 2380 Sutter Street, San Francisco, CA 94143-1703 E-mail address: [email protected] 0030-6665/04/$ - see front matter Ó 2004 Elsevier Inc. All rights reserved. doi:10.1016/j.otc.2004.01.001
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important issue is voice loss, making nonsurgical alternatives always more desirable. Another primary consideration is adequate swallowing function, which often takes precedence over voice. Deglutition must be weighed equally with voice preservation in treatment planning by surgeons and oncologists and critically evaluated when ‘‘improved’’ results are reported. After World War II, there were new reports of fistula speech using either tracheal devices or imaginative surgical techniques [2]. These surgeons attempted to restore voice and manage the laryngeal cancer more effectively. Most cases were complicated by the need for customized airway devices or by the inevitable development of fistula stenosis or tracheal aspiration. Exceptional cases were reported frequently, but large numbers of durable results were not achieved. Different geographic regions developed and use various treatment methods for laryngeal cancer. The United Kingdom favors radiation therapy; the Mediterranean countries frequently use surgical options, but stop short of total laryngectomy. North Amercan treatment mixes radiation and total laryngectomy procedures. There has never been a worldwide consensus on the management of laryngeal cancer. Different regions are also affected by the availability and cost of providing radiation therapy, which bears particularly on treatment planning in developing countries. Contemporary otolaryngology practice was affected greatly by the development and popularization of conservation laryngectomy procedures [3], which can maintain vocal function, swallowing function, and avoid a permanent tracheostomy in selected patients. The results are dramatic and more acceptable to patients and medical colleagues. On the other hand, the techniques are more demanding surgically, and the recovery periods are more extended compared to conventional total laryngectomy. The use of conservation laryngectomy after radiation therapy, although not controversial, is difficult, with unpredictable results. In the 1960s, a number of research efforts investigated prosthetic rehabilitation of the voice after laryngectomy with limited results [4]. Most prosthetic materials failed in the unique environment of head and neck cancer surgery, where contaminated secretions, proximity to the airway, and radiated tissues differ from those found in cardiovascular or orthopedic surgery, where progress was made with different implantable prosthethic devices. This problem remains and must be accepted before grants are awarded for research efforts, as in the recent case of the ‘‘implantable larynx’’ with the European Community’s Eureka Project. In 1974, the World Centennial Conference on Laryngeal Cancer was held in Toronto to commemorate the centennial of the Billroth procedure and to bring scholars together to make progress against laryngeal cancer. At this meeting, Italian and Spanish surgeons introduced less-than-total laryngectomy or neoglottic procedures as alternatives to total laryngectomy, radiation therapy, or partial laryngectomy [5]. The initial results were impressive and a number of North American surgeons attempted to apply them. The success
M.I. Singer / Otolaryngol Clin N Am 37 (2004) 507–517
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rates were poor, hospitalizations were prolonged, and few of the procedures tolerated radiation therapy as part of accepted adjunctive treatment. More intense review of the neoglottic procedures decreased their relevance to North American patients and to acceptable treatment conventions. With this history in mind, the author used the tracheoesophageal shunt procedure of Amatsu in 1978 [6,7]. The results were limited and wound healing was complicated. Adjunctive radiation therapy also complicated the recovery of patients. One persistent result of direct tracheoesophageal shunt, however, was voice production. Although shunt stenosis and aspiration into the trachea were frequent problems that limited the use of this procedure in the United States, it served as a window into the mechanism of alaryngeal speech by clarifying the role of the pseudoglottis and revealing its simplicity. Surgeons had tried for a century to fabricate a better voicing source through shunts, nerve preservation, flaps, tendon transfers, and implants. The simple tracheoesophageal shunt, introducing air inferior to the cricopharyngeus muscle, permitted high-quality voice acquisition without sacrificing accepted oncologic procedures for voice. It does not preserve remnants of the epiglottis or arytenoids, as proposed in less-than-total laryngectomy procedures, which can jeopardize cancer treatment. Additionally, radiation therapy can be used successfully. Patients can acquire alaryngeal speech without tedious therapy, and the voice assessments exceed the quality of esophageal speech and external voicing devices. The procedure was applied easily by any surgeon trained in laryngectomy surgery and could be applied across cultures and various patient populations. Additionally, swallowing function is not different from a conventional laryngectomy, and the need for aspiration precautions, time-consuming deglutition therapy, or prolonged gastric-tube feeding is eliminated. Two problems remained, however. The voicing shunt often closed from stenosis, or deglutition was affected by esophageal contents leaking into the trachea through a patent shunt. The observations from the Amatsu experience led to the establishment of criteria for surgical voice restoration after laryngectomy, which are summarized as follows:
No compromise of oncologic principles for the goal of voice restoration Applicable in the irradiated field No complex reconstruction Limited role for speech therapy Rapid recovery No alteration of swallowing function Easily understood by patients Limited cost Superior speech production
In collaboration with Eric D. Blom, PhD, a multipurpose voice prosthesis was developed and modified over time [8,9]. Careful review of previous prosthetic approaches highlighted problems that others had experienced.
510
M.I. Singer / Otolaryngol Clin N Am 37 (2004) 507–517
Most of the devices shared the airway and required adaptors to fit the tracheostoma, complicating use because of the need for additional patient fittings. The devices were cumbersome in some cases, expensive, and hygiene was often difficult. Many earlier devices were placed in a pharyngostoma, and achieving a proper fit was difficult over time because of dilatation of the fistula. In many successful case reports, customization of the device or fittings was needed [10]. Most surgeons and many speech clinicians eventually abandoned these approaches because of the impracticalities. Fistula speech became an interesting footnote in laryngeal cancer treatment, but failed to gain acceptance. In addition, this area was overshadowed by the publicized death of a well-known actor from carotid hemorrhage attributed to a prosthetic voicing device. The first need of tracheoesophageal-speech patients is maintenance of the tract between the trachea and the esophagus. Most of the fistula procedures that maintained patency were mucosal-lined but vulnerable to uncontrolled dilation. The tracheoesophageal shunt in our patient group was not mucosal-lined and required a stenting tube to maintain patency for voice production. Therefore, a tube or catheter was used to provide the stenting effect. A rubber urethral catheter (14 French) provided satisfactory stenting for the tract, and was easy for patients to remove, replace, clean, and maintain. The inconvenience of loss of voice with stenting required the development of a one-way valve to permit exhaled tracheal air to enter the esophagus for voice production, but to remain closed at other times to prevent tracheal aspiration of the contents of the esophagus. The earliest valved stent tube the author used was a ‘‘snorkel’’ or ball valve mounted in a urethral catheter. This permitted one-way airflow without reflux, and maintained the patency of the tracheoesophageal tract. Initial experiences with this valve were unsuccessful. Although tracheoesophageal speech was possible, the moveable ball valve would remain closed when food particles entered its housing. The second valve the author investigated was a ‘‘slit valve’’ made by cutting 8 mm through the tip of the catheter. The resulting ‘‘valve’’ allowed easy air entry into the esophagus and the elastic recoil of the rubber protected against oropharyngeal secretions. The housing for the voice prosthesis remained the catheter. The slit valve functioned well in the esophageal environment and became the first voice prosthesis (Fig. 1). It was named the duckbill voice prosthesis to describe its method of action. The red rubber catheter was replaced by medical-grade silicone and a commercial product became available in 1980. (The development, US Food and Drug Administration clearance, intellectual property rights, and trademark processes for such a device are complex issues requiring advice from counsel. For example, the patent-protected Blom-Singer devices have seen at least two prolonged court actions in their short existence.) The duckbill voice prosthesis served many laryngectomy patients with a low incidence of problems. Eventually, a device that was less resistive than
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Fig. 1. Slit-valve (duckbill) voice prosthesis.
the duckbill design was needed. Thus, a flap valve design was introduced that permitted easier voicing and allowed for the introduction of a stoma valve, so that the user would not need to cover the tracheostoma manually and could maintain better hygiene (Fig. 2). The indwelling voice prosthesis represents a further design change for the voice prosthesis. This device is designed to remain in situ for several weeks to months, easing the patient’s burden of device maintenance (Fig. 3). A speech pathologist must replace the device, however, which is difficult if the
Fig. 2. Tracheostoma valve with adhesive stoma housings.
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Fig. 3. Indwelling voice prosthesis.
patient must travel long distances. Furthermore, the device is more prone to yeast colonization of the valve leaflet, destroying its function. There are a few other voice prosthetic devices available, all of which are of the same basic design. Some are preferable for certain patients and should be offered as a trial for them to maximize their vocal efficiency and intelligibility. After a successful voice prosthesis was developed, a simple operative technique for establishing the tracheoesophageal tract was needed that could be applied primarily for laryngectomy patients and secondarily for esophageal speech failure patients. Based on the simple tracheoesophageal tract procedure observed in the Amatsu experience, it was apparent that a horizontal tract from the tracheostoma to the esophagus could be established endoscopically. A rigid esophagoscope was selected and modified to place a target on the instrument, which was then used to place a needle from the trachea to the esophagus. The needle was used to guide a wire and then a catheter from the trachea to the esophagus as a stent. After 2 days, the catheter was exchanged for a voice prosthesis and speech acquisition could proceed. This simple procedure requires a few minutes in the operating room under direct vision, and is safe, midline, and easily repeated. The patients need no perioperative antibiotics, resume oral intake, and leave the hospital on an ambulatory basis. The procedure requires no additional skills other than placing a rigid esophagoscope in the laryngectomized pharynx. The author experienced no major complications using the procedure and patients were satisfied with their vocal rehabilitation. There have been many reported techniques, ranging from the use of modified transoral devices to flexible endoscopic procedures. The initial placement of the tracheoesophageal tract at laryngectomy requires no special techniques or instrumentation. The overall results of tracheoesophageal speech exceed those of any form of alaryngeal speech, and its improved intelligibility has made it the method
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of choice for surgical voice rehabilitation after laryngectomy. As a result, voice production no longer drives treatment planning for laryngeal cancer because total laryngectomy will result in effective and socially acceptable voice and appropriate cancer treatment without compromise. Nonoperative treatments for laryngeal cancer that commit patients to permanent tracheotomies and feeding tubes are not alternative but inferior treatments of this disease. Complete laryngectomy for functional failure after laryngeal preservation protocols has been difficult, costly, and time-consuming. If organ preservation fails, surgical salvage is possible, but is more complicated than in the patient who has never received chemotherapy or radiation therapy. It is easy to place indwelling devices at the time of endoscopy, decreasing the need for outpatient fitting and measurements and permitting the use of the voice prosthesis as early as the recovery room, which is a clinical experience similar to placement of a stapes prosthesis with immediately improved hearing. The indwelling voice prosthesis maintains the tracheoesophageal tract and eliminates inadvertent loss of the tract if the catheter or stent is dislodged. If tract placement is done primarily at the initial laryngectomy, the stenting catheter is preferred while the tracheostoma is healing, and can be used as an effective feeding tube during convalescence. In this case, the voice prosthesis can be placed 2 weeks after laryngectomy when oral nutrition is resumed. The prosthesis can be used throughout the course of postoperative radiation therapy, although the voice result may deteriorate at the fourth week until completion of the treatment course. A frustrating problem with voice acquisition after prosthesis placement was identified early. Some alaryngeal speakers (20%–40%) were incapable of fluent or effortless speech because of what initially seemed to be spasm. These patients were unable to speak easily with or without the prosthesis. It was reasoned that the problem was not with the prosthesis but with the outflow of air through the pharyngoesophageal tract. Most of these patients were complete esophageal speech failures or poor speakers, and some could be detected preoperatively by catheter insufflation of the esophagus. When speech was attempted, only a few syllables were produced, great effort was required, and the Valsalva effect was evident. The challenge was to characterize this problem further, and to correct it. It was initially unclear that pharyngeal constrictor spasm could occur in the laryngectomized pharynx. According to much of the relevant literature, the laryngectomized pharynx was myotomized thoroughly and incapable of generating a pressure head that would prevent air egress through the vocal tract [11]. Some surgeons stated that they did not close the constrictors during pharyngeal reconstruction, but the problem still resulted. The author infiltrated the retropharyngeal plane with lidocaine 2% as a presumptive nerve block in failed tracheoesophageal speakers, which immediately resolved the spasm problem and allowed fluent speech production. This experience was supported further by radiographic studies
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pre- and postblock showing a significant change in the appearance of the region of the cricopharyngeus muscle [12]. It was reasoned that the constrictors remain active after laryngectomy, and when the esophagus is distended with air, a spasm state develops that blocks air egress and voice production. A key report from an early esophageal manometry study supported this idea [13]. For patients with an intact larynx, measuring esophageal pressures at the gastroesophageal junction, midesophagus, and the upper-esophageal sphincter during esophageal distension documented a simultaneous rise in resting tone at the upper-esophageal sphincter. This study supported the author’s observations in the laryngectomized patients whose esophagi were distended by air entering the tracheoesophageal tract, resulting in upperesophageal–tonicity alterations that could be eliminated by field block of the pharyngeal plexus. It was simple to perform a myotomy of the upper-esophageal sphincter in failed patients with release of the tonicity and acquisition of voice, a step supported by the patient series of the author and others. The tracheoesophageal speech method then became a two-phase technique. If placement of the tracheoesophageal tract and adequate voice prosthesis resulted in effective speech, then nothing more was required; alternatively, voice failure required relaxation of the pharyngeal constrictors. The initial method for relaxation was pharyngeal constrictor myotomy, which was effective but occasionally complicated by pharyngocutaneous salivary drainage and, in some cases, fistula development. Botox injection is now an alternative, effective, nonsurgical method. (This topic is discussed in detail elsewhere in this issue). During the development of a theory for voice failure, it was demonstrated that pharyngeal plexus neurectomy would achieve the same result of tonicity reduction in the pharyngeal constrictors. This was applied more easily during laryngectomy, but was also possible in some secondary cases. The advantages of pharyngeal plexus neurectomy are less trauma to the pharyngeal wall and its blood supply, and less flaccidity of the pharyngeal wall with a higher quality of voice [14]. Thus, it is the author’s preferred pharyngeal relaxation technique during laryngectomy. Deschler [15] has proposed a simpler procedure, however. Taking advantage of modifying the upper-esophageal constrictor reconstruction, a ‘‘half muscle’’ closure is used, which avoids reconstituting the entire circumference of the sphincter and eliminates the problem of pharyngeal constrictor hypertonicity. To manage this problem in the secondary cases, The author prefers to inject Botox during the endoscopic procedure, which eliminates the constrictor tonicity and allows for rapid voice acquisition. Few patients need secondary injections or myotomies today. As the operative management changes and evolves, prosthetic devices are also changing. The most frequently used devices are called indwelling because they are changed only after a few months of wear, or if they leak
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with resulting tracheal contamination. Their long wearability reduces the need for patients to take care of their prosthetic devices, which is difficult because of their size and proximity to the tracheostoma. There are domestic and imported devices that meet this criterion; all are flapper valve–based designs. They are particularly popular in European treatment centers where patients avoid manipulating the devices. The indwelling devices need to be changed by a speech pathologist, nurse, or otolaryngologist, making them inconvenient for patients who live far from a treatment center. Also, the continuous exposure to esophageal contents in radiated patients results in Candida sp colonization causing valve deterioration over time (6–12 weeks). Attempts to alleviate the fungal problem include the use of topically ingested antifungals and systemic antifungals; devices in development will either resist fungal colonization or be impregnated with antifungal agents. Focal Candida colonization of the prosthesis is harmless, but troublesome. It is impossible to eliminate the fungus in radiated patients and it will attach ubiquitously to silicone, Teflon, metal alloys, and glass. This problem remains a challenge to manufacturers and device designers. Extrusion or poorly fit prostheses are frequent problems because the currently popular design incorporates the blunt esophageal end, which can extrude or imbed in the esophageal or tracheal wall with subsequent loss of vocal function. For some patients, replacement or revision of the tracheoesophageal tract may be needed because of this problem. A new design for the voice prosthesis may alleviate the problems of fit and fungal colonization. Most manufacturers have introduced heat moisture exchangers that cover the tracheostoma or are incorporated in tracheal tubes or devices. These inserts trap exhaled moisture and heat and allow the patient to inspire the remaining moisture, thereby maintaining a more natural tracheal environment. There are reports of decreased mucus production and decreased coughing with improved tracheal humidity. Innovative surgeons have introduced reconstructive or extended laryngectomies over the past 40 years with various success [16]. The problems of aspiration, failures to achieve local disease control, intolerance to radiation therapy, uncontrolled fistulizations, and the need for frequent revision procedures remain, however. The permanence of the tracheotomy is the strongest criticism. In the author’s view, dependence on the tracheotomy obviates most of the advantages of these procedures, because the goals can be achieved more easily by the tracheoesophageal voice prosthesis than by complex surgical reconstructions. When the patient’s airway can be restored, however, the author believes a significant advance in laryngeal surgery has been made. Achieving this goal accepts no aspiration, maintains an adequate and patent airway, returns normal humidification and hygiene of the trachea, requires no valves, risks no contamination, restores voice, maintains swallowing function, and finally, makes no compromise in the management of the cancer. Consistent restoration of the airway after
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laryngeal cancer surgery should be the primary consideration in new treatment and technique planning. Some investigators have proposed microsurgical reconstructions for voice rehabilitation. These approaches have included radial forearm flaps and free jejunal transfers to shunt air from the trachea to the pharyngoesophagus in a circuitous manner similar to the voice prosthesis in function. If microvascular surgical transfer of the trachea is accomplished, then the above goals may be realized, justifying the cost and effort of microsurgery. Recently, transplantation of a larynx in a case of laryngeal trauma was successfully reported [17]. This required a marathon effort, complex surgery, immunosuppression, and raises serious ethical questions. The larynx is not a vital organ, and chronic immunosuppresion does not seem justified to restore voice in a trauma victim when simple alternatives are readily available. In a case of laryngeal cancer, the issue is even of greater concern. Long-term immunosuppression of cancer patients is contraindicated in the author’s view. Chronic, intermittent aspiration in an immunocompromised patient seems unwise and possibly fatal with development of a second malignancy. From the earliest considerations of surgery for laryngeal cancers, the crucial human quality of speech has been a foremost concern. It has affected the development of treatments and has affected patient choice profoundly. The loss of voice has motivated surgeons to try innovative approaches to laryngeal surgery. Speech clinicians and scientists, surgeons, and oncologists have offered many solutions and will continue to do so as better cure rates and rehabilitation are achieved. Until then, tracheoesophageal speech is an important bridge that improves the quality of life for many laryngeal cancer patients.
References [1] Singer M. Tracheoesophageal speech: vocal rehabilitation after total laryngectomy. Laryngoscope 1983;93(11):1454–65. [2] Staffieri M, Serafini I. Lariabilitzaione chirurgica della respirazione dopo laringectomia totale. Presented at the 29th National Congress of Associazione Otologi Ospedalieri Italiana. 1976. [3] Ogura JH. Supraglottic subtotal laryngectomy and radical neck dissection for carcinoma of the epiglottis. Laryngoscope 1958;68:983–1003. [4] Taub S, Spiro RH. Vocal rehabilitation of laryngectomees: preliminary report of a new technique. Am J Surg 1972;124:87–90. [5] Holinger PH. A century of progress of laryngectomies in the northern hemisphere. Laryngoscope 1975;85:322–32. [6] Amatsu M. A one stage surgical technique for postlaryngectomy voice rehabilitation. Laryngoscope 1980;90:1378–86. [7] Blom ED, Singer MI. Surgical prosthetic approaches for postlaryngectomy voice restoration. In: Keith RL, Darley FL, editors. Laryngectomy rehabilitation. Houston (Texas): College Hill Press; 1979. p. 251–76.
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[8] Singer MI, Blom ED. An endoscopic technique for voice restoration of voice after laryngectomy. Ann Otol Rhinol Laryngol 1980;89:529–33. [9] Singer MI, Blom ED, Hamaker RC. Further experience with voice restoration after total laryngectomy. Ann Otol Rhinol Laryngol 1981;90:498–502. [10] Conley JJ, DeAmesti F, Pierce MK. A new surgical technique for the vocal rehabilitation of the laryngectomized patient. Ann Otol Rhinol Laryngol 1958;67:655–64. [11] Kirchner JA, Dey FL, Shedd DP. The pharynx after laryngectomy. Laryngoscope 1963;73: 18–33. [12] Creamer B, Schlagel JF. Motor responses of the esophagus to distension. J Appl Physiol 1857;10:498–504. [13] Singer MI, Blom ED. Selective myotomy for voice restoration after total laryngectomy. Arch Otolaryngol 1981;107:670–3. [14] Singer MI, Blom ED, Hamaker RC. Pharyngeal plexus neurectomy for alaryngeal speech rehabilitation. Laryngoscope 1986;96:50–3. [15] Deschler DG, Doherty ET, Reed CG, Hayden RE, Singer MI. Prevention of pharyngoesophageal spasm after laryngectomy with a half-muscle closure technique. Ann Otol Rhinol Laryngol 2000;109:514–8. [16] Pearson BW. Subtotal laryngectomy. Laryngoscope 1981;91:1904–12. [17] Strome M, Stein J, Esclamado R, Hicks D, Lorenz RR, Braun W, et al. Laryngeal transplantation and 40-month follow-up. N Engl J Med 2001;344:1676–9.