Tracheoesophageal Puncture

Prior to the 1970s, rehabilitation of aphonia following a total laryngectomy (TL) was accomplished using esophageal speech or through the use of mechanical or electrical devices.

Esophageal speech requires the patient to volitionally swallow air via the neopharynx and emit the air while articulating, as with normal speech. This produces a belchlike understandable speech.[1] Instead of using the vocal fold vibration as the sound source, this is replaced by the vibration of the pharyngeal walls. Many patients are able to teach themselves to speak to a degree in this manner, but fluency remains a challenge. Working with a speech pathologist can increase the fluency and clarity of their speech. The major advantage of this technique is the lack of any necessary prostheses or external devices.

In contrast, the mechanical larynx has been a mainstay in voice restoration. The early pneumatic devices were supplanted by electrical vibratory electrolarynges in the 1940s. Using these devices, speech is generated via an external vibration of the air column within the upper aerodigestive tract, combined with speech articulations, as in esophageal speech. The early learning period for this technique is short, and a reproducibly understandable voice can be quickly accomplished. The downsides to using an electrolarynx include an unnatural, mechanical, and often monotonal quality to the voice, as well as the necessity of a device itself. The device relies on battery power, may break, and may not be covered by the patient’s insurance.

First described in 1980 by Singer and Blom,[2] tracheoesophageal puncture (TEP) with prosthesis placement affords the clarity of esophageal speech without the volitional need to ingest and expel air. Their simple technique involves the surgical placement of a one-way valve between the tracheostoma and neopharynx, which allows air to be shunted on demand through the neopharynx and produce speech similar to esophageal speech. The one-way valve prevents retrograde flow from neopharynx to the trachea and prevents aspiration. Multiple advances have been made in prosthesis design and construction (including the advent of hands-free adjuvant devices), surgical technique, as well as in the timing of the procedure over the past 3 decades.

Patients undergoing total laryngectomy (TL) or those that are status post TL are candidates for tracheoesophageal puncture (TEP) with prosthesis placement.[3, 4, 5]

Contraindications to tracheoesophageal puncture (TEP) are few, and most are relative. Absolute contraindications include a subtotal laryngectomy, such as a cordectomy, hemilaryngectomy, supraglottic laryngectomy, or near-total laryngectomy. Additionally, separation of the space between the esophagus and tracheostoma (party wall), or a total laryngopharyngoesophagectomy with gastric pull-up[4] are contraindications for a primary tracheoesophageal puncture because this necessarily creates a potential space for infection or abscess.

Relative contraindications include poor pulmonary function,[4, 5] which decreases the ability to use the prosthesis due to the need for relatively higher positive pressures in the trachea; a strong alcohol drinking habit,[5] which increases the possibility of aspiration and complications; and an inability to maintain the prosthesis,[4, 5] either due to a lack of manual dexterity or impaired mental status. Concerns for maintenance of the prosthesis may also be noted for the uninsured, poorly-insured, or those with financial limitations, due to the ongoing costs of caring for and replacing the prosthesis.

Best practices

Both primary (time of TL) and secondary (another procedure after TL) tracheoesophageal puncture (TEP) are viable options, and each has its positive and negative aspects.[6] The main advantage to primary TEP is that it does not require an additional procedure that may produce associated comorbidities (including possibly a second general anesthetic). Negative aspects are mostly stoma-related problems, including possible difficulties due to delayed stenosis of the stoma and interference with the use or cleaning of the TEP prosthesis. Other issues may include difficulty with wound healing of the fistula in light of preoperative or postoperative radiation, risk of leakage and aspiration in the early postoperative period, and the inability to try pure esophageal speech (although prelaryngectomy esophageal speech may be practiced).[1]

Secondary TEP allows for the ability to attempt esophageal speech if desired, as well as maturation of the stoma after radiation and other adjuvant therapies before placement of the TEP.

The prosthesis can also be placed in a primary (at the time of puncture placement) or secondary (after puncture placement) fashion. The major manufacturers of TEP prostheses now have "kits" that facilitate primary prosthesis placement. In cases where the prosthesis is placed in a delayed fashion (secondarily), a red rubber catheter is often used to stent the puncture site and the prosthesis is placed in-office in a delayed fashion.

Procedure planning

Patient selection is important in planning for TEP. To minimize complications, patients should be motivated, have enough dexterity to clean their prosthesis, and be counseled on the complications and therapy involved to use their prosthesis safely and correctly. The patient must be appropriately counseled regarding the care and maintenance required, along with incumbent costs, prior to the procedure.[1, 5, 7] Consideration should be given to the relative contraindications as previously described.

The esophageal insufflation test was developed to preoperatively predict tracheoesophageal voice outcomes,[8] in order to determine those patients who were more likely to experience difficulty passing air through the neopharynx due to hypertonicity or spasm. Subsequent studies have shown that these tests are more predictive of short-term outcomes, but that long-term outcomes are not well predicted by insufflation testing.[9]

Complication prevention

Prevention of complications largely relies on good patient counseling and training. Maintenance of the prosthesis is the most important aspect of preventing complications. This includes cleaning the prosthesis to remove mucous, food, and prevent microbial growth, especially yeast.[1, 10] Monitoring of the prosthesis through close follow-up for damage to the valve and leakage around the prosthesis is also important. Prosthesis life can be increased by medical management, such as reducing reflux by antireflux medications and elevating the head of the bed at night.[10]

The prophylactic use of antifungal medications may also be indicated. Studies have shown that prosthesis life can be nearly doubled when antifungals such as miconazole or fluconazole are prescribed either prophylactically or after colonization by fungal organisms.[11, 12] Ameye et al studied the effects of a daily buccal slow release nystatin tablet compared to routine prosthesis cleaning with a nystatin solution with a control group and found a significant increase in the lifetime of the prosthesis using the daily tablets.[13] Additionally, prostheses have been designed with silver oxide within the lumen and have been shown to extend the life of the prosthesis and possibly prevent fungal growth.[14]

Multiple studies since the development of tracheoesophageal puncture (TEP) have shown that the speech produced by TEP alaryngeal speech is superior to that of both electrolarynx and esophageal speech[4, 15, 16] in both understandability and acceptability to the speaker. TEP speech has been rated the closest to laryngeal speech of all the available options.[16] The ability to learn and use the prosthesis successfully occurs in 50–90% of patients,[3, 4] whereas as few as 23% of patients are able to learn esophageal speech.[4]

When comparing primary TEP to secondary TEP, the literature shows no significant difference in outcomes initially or at later follow-up, with success rates in the 75–90% range after 2 years.[17, 18, 19] Although Chone et al have shown a possibly decreased failure rate in primary versus secondary TEP, the sample size in the study was small.[17] The similarity in outcomes is even true in those patients who underwent free flap reconstruction or postoperative radiation, which are often reasons stated for forgoing a primary TEP.

Reasons for poor speech outcomes with TEP include increased pharyngeal spasm, pressure, hypertonicity, or presence of a stricture in the pharyngoesophageal segment. Some of these issues can be managed by pharyngeal myotomy or pharyngeal neurectomy.

However, early complications are related to the procedure itself, and include bleeding, pain, stricture, and abscess formation or infection of nearby structures.[20] Late complications include enlargement of the puncture site, with displacement of or leakage around the prosthesis (approximately 19% of patients).[21, 22, 23] Conversely, stenosis or granulation and polyp formation around the stoma and puncture site can block the prosthesis or make it nonusable and can happen in approximately 20% of patients.[20] Migration of the prosthesis is reported to occur in 2% of patients.[20] Careful planning and monitoring of the site can help to prevent these complications. In particular, correct sizing of the prosthesis, in order to prevent pistoning of the prosthesis during use, decreases the amount of enlargement of the TEP.[4, 16] A feeling of fullness in the neopharyngeal segment or esophagus may also be present and is a common complication of TEP, typically attributed to thepresence of the prosthesis or either stenosis or hypertonicity of the region.[1]

The valve must be monitored for wear and replace it as it begins to leak. This can happen anywhere from 3 weeks to years after placement. The life of the valve can be extended, as described above, by careful cleaning and monitoring. Valves have also been developed that use magnets to aid in valve closure even in the presence of secretions. Leakage through or around the valve presents opportunity for aspiration of secretions, food, or both. In addition, a loose valve itself may be aspirated.

Patient instructions

Educating the patient on expectations of voice following tracheoesophageal puncture (TEP), as well as the need for speech therapy and long-term maintenance of the valve, is important. Speech therapy to develop coherent and understandable speech is necessary and should be planned prior to the procedure.[4, 7]  As described, maintenance of the valve, and methods for improving the life of the valve and the puncture site are also important parts of education and patient selection. The patient must also be counseled on what to do if the prosthesis comes out for an extended period of time, to prevent closure of the TEP.

Elements of informed consent

The informed consent for this procedure varies by physician but should make mention of the risk of infection, valve incompetence or leakage around the valve, poor speech outcome, need for further procedures including revision of the puncture site, stenosis or closure of the TEP site, and migration of the valve.

Depending on whether a primary or secondary tracheoesophageal puncture (TEP) is being performed, different equipment is necessary.

For a primary TEP, the instruments required for the total laryngectomy also suffice for the TEP. Specifically this includes the following:

• Right-angle clamp

• No. 15 blade

If the prosthesis is going to be placed at the time of puncture (primary placement), the prosthesis itself and any prosthesis-specific equipment is also necessary. Otherwise a catheter (red rubber or Foley) is used to stent the puncture until prosthesis placement at a later time in the office setting (secondary placement).

For a secondary TEP, the equipment necessary depends on the specific prosthesis device used.

Under general anesthesia the following equipment is used:

• Cervical esophagoscope

• No. 18 gauge needle

• Dilating catheter with guidewire

If this is performed under local anesthesia, various kits are available to assist with placement. Generally speaking, the items needed include the following:

• Inserting needle/trochar

• Dilating catheters/tubes

Again, whether in the office or the operating room, if the prosthesis is not going to be placed at the time of puncture, a catheter should be used to stent the puncture site until prosthesis placement.

Patient-maintained prostheses

Patient-maintained prostheses come in two types, duckbill and low-pressure, both based on the original Blom-Singer valve. These valves are designed to be removed and cleaned or replaced by the patient every 3-4 days. The duckbill prosthesis has the advantage of being a longer-lasting valve than the low-pressure prosthesis but requires more respiratory effort due to increased airway resistance.

Indwelling prostheses

Indwelling prostheses are placed by the clinician at the time of tracheoesophageal puncture (TEP) or in-office replacement, and can stay in place for years if properly maintained. They allow for patients with less manual dexterity to have prostheses, so long as they are able to clean the prosthesis with flushing.

Management of complications

Complication management in TEP requires good and prompt communication between the laryngectomy patient and the clinician, either a physician or speech pathologist. Aspiration of the prosthesis is a medical emergency, and should be treated as such, with prompt presentation to the emergency department and management to include retrieval of the foreign body in the airway.

Displacement of the prosthesis without aspiration is also a time sensitive complication, as the puncture site has the ability to close quickly. Prompt presentation to the clinician is important. If already narrowed, a smaller soft catheter may be able to be placed through puncture to prevent complete stenosis, with immediate or delayed dilation back to appropriate size for TEP prosthesis placement. The largest sized catheter that can fit comfortably through the puncture should be used. Additionally, the external portion of the catheter should be secured to the patient's neck to prevent the patient from aspirating the catheter. The catheter can also be used for feeding without worrying about aspiration.

Placement of a new prosthesis is then indicated if desired, with resizing. A prosthesis may also need to be resized if leakage occurs due to an improperly sized prosthesis or enlargement of the TEP.[21] Mechanical failure of the valve due to blockage from secretions or fungal growth, or simple wear from use, may require placement of a new valve.[20]

Closure of the TEP, either primarily through ligation of the tract, or secondarily, through removal of the prosthesis with subsequent stenosis, is an option. This usually occurs when a patient is unhappy with the TEP or when there are complications best managed by allowing the TEP to close and be performed again at a later date. Chone et al describes that some patients in their study elected for removal of the voice prosthesis after establishing esophageal speech.[17]

Stenosis of the TEP may be treated with dilation or surgical opening, including repuncture. Stenosis of the neopharynx or esophagus may also be treated with dilation, as well as cricopharyngeal myotomy, if the stenosis is due to muscular spasm or hypertrophy. Granulation around the site should be treated with resection of the granulation tissue, which can be performed with silver nitrate cautery. Additionally, pathologic evaluation of this tissue may be necessary to rule out recurrence of the primary tumor.

Patients should be educated on how a TEP prosthesis works as well as associated costs. In the United States, most insurers do not cover the complete cost of a TEP prosthesis and as such, patients should be aware of the potential for out-of-pocket costs prior to the procedure. Given the need for routine replacement of these devices, patients should understand the potential annual "maintainence" cost associated with a TEP prosthesis.

No specific physician monitoring or follow-up is necessary, however, it is important that the patient is sufficiently educated regarding the care and maintainence of the TEP prosthesis (including daily cleaning).

The patient should follow up with a speech-language pathologist (SLP) who has specific experience and training with TEP prostheses and TEP speech. Their expertise is important to rehabilitating these patients and optimizing speech outcomes with TEP speech. This may involve discussing breathing and relaxation exercises to avoid excess tension with speech.

Additional follow up with the physician or SLP may be necessary to manage prosthesis replacement and troubleshooting if there are concerns for leak or fungal colonization.

Deciding between a primary or secondary tracheoesophageal puncture (TEP) can depend on multiple factors. Pou describes that a primary TEP is absolutely contraindicated if the party wall between the trachea and esophagus have been separated, either as a consequence of surgeon technique or secondary to the degree of oncologic resection. Relative contraindications include conditions precluding adequate use of the prosthesis such as poor pulmonary function, poor manual dexterity, or bilateral hearing loss. She notes that preoperative or the need for postoperative radiation are not contraindications to primary TEP.[4]

The primary tracheoesophageal puncture (TEP) is performed at the same time as the total laryngectomy. For the purposes of this approach, we are using a technique similar to that used for a Blom-Singer prosthesis. The prosthesis portion of the procedure is performed after the laryngeal specimen has been removed from the patient, leaving an exposed distal trachea with an endotracheal tube in place, posterior pharyngeal mucosa, and an exposed cervical esophagus.

For this portion of the procedure utmost care must be taken to avoid separating the party wall between the esophagus and the trachea. Some describe using absorbable suture to further approximate the posterolateral aspect of the trachea to the anterolateral wall of the esophagus.[4, 24] When performing the puncture, make the hole sufficiently below the superior aspect of the remaining posterior tracheal wall. This edge makes the superior portion of the stoma, and making a puncture to close to the edge results in the prosthesis angling downwards.

Some device sets, such as the Hermann set, come with a hook that is placed in the esophagus and pierces the esophageal and tracheal wall. This puncture needle is guided over the finger into the esophagus and should be placed between 12 mm and 15 mm below the resected margin of the posterior tracheal wall.[5] Other surgeons describe using a blunt instrument such as a right angle clamp to enter the esophagus, and then again making a puncture more than 1 cm below the resected tracheal margin. A stab or horizontal incision should be made over the tips of the right angle.[4, 24] After creating the puncture, a red rubber catheter or Foley catheter can be placed through the puncture site and fed into the esophagus. This can provide a method of feeding during the initial postoperative period. Alternatively, the prosthesis can be placed immediately and a nasogastric tube can be used for feeding access.

The secondary tracheoesophageal puncture (TEP) is performed after the TL has had time to heal, and some advocate performing the procedure after a radiation course, if prescribed, has been completed. Several techniques are described, both under general or local anesthesia.

Under general anesthesia, the classic method of performing a secondary puncture involves the use of a cervical rigid esophagoscope. The esophagoscope is inserted into the neopharynx and advanced to the level of the party wall and positioned with the bevel facing anteriorly, thus protecting the posterior esophageal wall. Under direct visualization, a needle or trochar can be inserted through the party wall, approximately 8-10 mm below the superior edge of the posterior tracheal wall into the bevel of the esophagoscope.

A catheter or wire is then fed through the puncture site or trochar until it is visualized out of the oral end of the esophagoscope. Deschler et al describe a Teflon catheter that is fed over the puncturing needle. The tract can then be dilated either via a Seldinger technique or via serially larger red-rubber catheters. The final catheter can be then reduced back into the esophagus for future TEP prosthesis placement or the prosthesis itself can be placed. To place the prosthesis, it is secured to the catheter emerging from the mouth, and the catheter is pulled from the stoma, pulling the prosthesis in a retrograde fashion back through the mouth and out the TEP into proper position.[25]

Under local anesthesia and after topical anesthesia of the neopharynx, Rabanal and Herranz describe having the patient swallow a hollow tube (such as a No. 8 Portex tube) until it can be seen bulging through the visible posterior tracheal wall. Then a needle is placed approximately 1 cm below the superior edge of the posterior tracheal wall into the hollow tube and a catheter (Drum-Cartridge catheter) is advanced over the needle into the tube until it comes out the mouth. Then the tube and needle are withdrawn, and the hole is consecutively dilated using serially larger catheters. Once a 12 Fr catheter is placed, these authors describe the prosthesis being inserted into the puncture site.[26]

Bach et al describe the use of the transnasal esophagoscope to place the puncture under local anesthesia in a clinic setting. The patient's nose is sprayed with oxymetazoline and lidocaine and the patient is asked to dissolve benzonatate capsules in the mouth and then ingest viscous lidocaine (5 mL of 2% lidocaine). Local anesthetic is also injected into the posterior tracheal wall at the site of the puncture. The scope is then passed through the nose into the esophagus. The authors also describe dilating the patient's neopharynx in the office if stenosis is evident.

Under fiberoptic visualization with insufflation of the esophagus, the proposed puncture site is identified using a blunt instrument, and then an 18-gauge needle is advanced through the posterior tracheal wall into the esophageal lumen. Afterwards a cruciate incision is made at the site and dilating catheters are passed through the puncture site into the esophagus. Bach then describes the speech pathologist placing the prosthesis and using the esophagoscope to ensure adequate placement.[27]

Generally speaking, in-office placement requires the use of either a trochar or needle to puncture through the party wall into the esophagus, while protecting the posterior esophageal wall. After creating the puncture, the puncture site should be dilated until it is the appropriate size for the prosthesis. The prosthesis can then be placed at the same time as the puncture or can be placed in a delayed fashion. If the prosthesis is going to be delayed, then a red rubber catheter should be left in place to stent the puncture and the visible portion of the catheter should be secured to the neck.

If the voice prosthesis needs to be replaced or if it is being placed for the first time after the puncture, it is often placed in the office by either a speech language pathologist or by an otolaryngologist. Each device manufacturer has a different system for placement of the prosthesis; this chapter will discuss the procedure in generalities.

The systems for replacing the prosthesis involve stenting the puncture site open, placing the new prosthesis into the puncture site with the phalanges bent, and the phalanges then opening into place thus securing the prosthesis across the puncture site. Use an appropriately sized prosthesis to avoid problems with leaking around the puncture site and issues with poor voice production. Many kits come with the phalanges of the prosthesis bent and either secured within the prosthesis applier or by a dissolvable gel cap. By either twisting the prosthesis once it is in position or allowing the gel cap to dissolve, the intraesophageal phalanges open up, thus securing the prosthesis across the puncture site.

After placing the prosthesis, it should be evaluated for a leak. The patient can be asked to sip some water, and the site should be examined by the provider to ensure that the water does not leak around or through the prosthesis. Food coloring in the water can ease detection of a leak.

Although no specific testing is indicated after tracheoesophageal puncture (TEP), visualization of the neopharynx, esophagus and trachea may help in determining the cause of problems, such as during leakage or stenosis. Tests include esophagoscopy (with or without insufflation to determine the quality of seal), bronchoscopy, or swallow study.[4] However, a swallow study may be contraindicated in the presence of a suspected TEP leak, due to the likelihood of aspiration of contrast.