525591
research-article2014
AORXXX10.1177/0003489414525591Annals of Otology, Rhinology & LaryngologyDamrose et al
Article
The Hybrid Tracheoesophageal Puncture Procedure: Indications and Outcomes
Annals of Otology, Rhinology & Laryngology 2014, Vol. 123(8) 584–590 © The Author(s) 2014 Reprints and permissions: sagepub.com/journalsPermissions.nav DOI: 10.1177/0003489414525591 aor.sagepub.com
Edward J. Damrose, MD, FACS1, Do-Yeon Cho, MD1, and Richard L. Goode, MD, FACS1
Abstract Objectives: This report aimed to describe a novel and efficient method of tracheoesophageal puncture using a hybrid device assembled from 2 commercially available puncture kits; to demonstrate the utility of this technique in the performance of primary and secondary procedures, under general and local anesthesia, with and without flap reconstruction; and to evaluate the efficacy of concurrent puncture and valve placement. Methods: Thirty-four patients who underwent either primary or secondary tracheoesophageal puncture for voice restoration. Charts were reviewed retrospectively for complications, time to first valve change, operative time, and blood loss. Results: Using this novel hybrid device, simultaneous puncture and valve placement was achieved in 34 consecutive patients. There was 1 major complication; blood loss was negligible; and the procedure could be accomplished in all cases. There were no cases of prosthesis failure as a result of the insertion technique. Conclusion: Concurrent tracheoesophageal puncture and voice prosthesis placement is a simple and efficient method of voice restoration in the laryngectomized patient and can be more easily accomplished with a hybrid device assembled from the components of 2 commercially available puncture kits. It can be performed under local as well as general anesthesia. The procedure is adaptable to a variety of clinical situations. Keywords cancer, dilation, esophageal stenosis, laryngectomy, tracheoesophageal puncture, voice prosthesis
Introduction Tracheoesophageal puncture (TEP) with voice prosthesis placement is an important part of voice rehabilitation for the total laryngectomy patient. It was initially described as a secondary procedure by Singer and Blom in 1980.1 There are a variety of ways to accomplish TEP placement, with variations in puncture technique, timing, type of anesthesia, and type of valve placed.2-5 The introduction of staplerassisted total laryngectomy represents a unique situation that can create a challenge for placement of a primary TEP.6 Recognition of the benefits of tracheoesophageal speech, coupled with improvements in endoscopic techniques and pressure to optimize the efficiency of valve placement, have all driven the development of new TEP techniques. Over the years, experience at our institution showed us that creating the TEP with a needle as opposed to a knife created a more stable tract that was less inclined toward leakage or dilation, or migration of the prosthesis. As our comfort with the technique grew, it became apparent that a voice prosthesis could be placed concurrently, eliminating the delay
between TEP and voicing. It also became apparent that we needed to create a technique that was readily teachable to our trainees. In an effort to simplify TEP, 2 commercially available kits designed to facilitate TEP—the Provox Guidewire (ATOS Medical, Horby, Sweden) and the Blom-Singer Tracheoesophageal Puncture Set (InHealth Technologies, Carpinteria, California, USA)—were combined to form a hybrid device. With this hybrid device, we are able to adapt the technique of TEP for broad application across a variety of surgical situations: primary and secondary procedures; stapler-assisted and conventional laryngectomy; and 1
Division of Laryngology, Department of Otolaryngology–Head and Neck Surgery, Stanford University School of Medicine, Stanford, California, USA Corresponding Author: Edward J. Damrose, MD, FACS, Division of Laryngology, Department of Otolaryngology–Head and Neck Surgery, Stanford University Medical Center, 801 Welch Road, Stanford, CA 94305, USA. Email: [email protected]
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Figure 1. ATOS Medical guidewire (left) and InHealth Technologies dilator (right).
Figure 3. Tracheoesophageal puncture made into esophageal lumen using 16-gauge curved introducer needle and 14-gauge Teflon sheath.
Figure 2. ATOS Medical guidewire coapted to InHealth Technologies dilator to create hybrid device. Friction keeps the 2 pieces together.
general and local anesthesia. Both the ATOS Medical and InHealth Technologies in-dwelling voice prostheses can be used. The aim of this report is to describe this simple technique of TEP and to assess its clinical outcomes.
Methods/Technique This study was conducted with the approval of the Stanford University Medical Center Institutional Review Board (IRB). Charts were reviewed for blood loss, length of operation, postoperative complications, time to first prosthesis change, and need for concurrent adjunctive procedures such as esophageal dilation or stomaplasty. The Blom-Singer Tracheoesophageal Puncture Set includes a Teflon-coated 16-guage needle and a feeding tube composed of a leader cable and dilator at 1 end and a
feeding port at the other. For descriptive purposes, the Blom-Singer Tracheoesophageal Puncture Set will be delineated as BSTPS, the leader cable and dilator from the BSTPS will be designated as the dilator, and the ATOS Medical guidewire will be delineated as the guidewire (Figure 1). The feeding port from the dilator is removed and the guidewire coapted firmly to the dilator and leader cable to create the hybrid device (Figure 2). The fit is quite secure and does not readily separate. An endotracheal tube (in the case of primary TEP either with traditional or stapler-assisted total laryngectomy), a rigid esophagoscope or gastroscope (in the case of traditional secondary TEP), or a transnasal esophagoscope (in the case of TEP under local/topical anesthesia) is passed into the esophagus. Palpation and/or transillumination allows external verification of the position of the tube or scope through the membranous trachea. Under direct visualization to confirm entry into the esophageal lumen and minimize the risk of inadvertent posterior esophageal wall injury, the 16-gauge introducer needle taken from the BSTPS is used to create the puncture (Figure 3). The puncture is typically made about 5 mm inferior to the 12 o’clock position of the stoma. However, the position should be individually tailored to ensure that a valve is seated well into the stoma but not too far inferiorly that access for cleaning and
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Figure 4. Hybrid device inserted; retrograde advancement. Figure 6. Valve seated into puncture site.
Figure 5. Dilator component removed and valve placed; anterograde withdrawal.
changing is compromised. The needle is withdrawn, leaving the Teflon sheath in place in the puncture site. The hybrid device (leader cable, dilator, and guidewire) is passed in a retrograde fashion and delivered through the mouth (Figure 4). As the dilator passes, controlled dilation of the tract occurs. When a flexible scope is used, a snare can be passed through the working channel of the scope to help grasp the leader cable, if needed. The guidewire is detached from the dilator and a voice prosthesis is then snapped onto the guidewire (Figure 5). The use of the guidewire ensures that the valve will not be dislodged during transit through the fistula. In addition, the guidewire
allows the prosthesis to be advanced by its tail, avoiding trauma to the delicate internal valve mechanism. The prosthesis is then passed in an anterograde fashion and inserted into the puncture site (Figure 6). The procedure itself, including assembly of the hybrid device and concurrent puncture and valve placement, will be referred to as the Hybrid Tracheoesophageal Puncture Procedure (HTEPP). Following prosthesis placement, the valve is flushed and brushed cleanto ensure that no debris is trapped within the valve mechanism. Immediately postoperatively, patients are allowed to resume liquids and a soft mechanical diet, with advancement of diet as tolerated by the patient. Voicing is also permitted immediately postoperatively. Patients are given 5 days of either amoxicillin/clavulanic acid 800 mg orally twice daily or clindamycin 600 mg orally 3 times daily. Protocol prior to placement includes preoperative speech pathology consultation with instruction on the use and care of a voice prosthesis, which is reinforced with follow-up speech therapy within 7 days postoperatively.
Results From January 2009 to July 2013, a total of 34 laryngectomized patients (27 male, 7 female) underwent 38 HTEPPs. The mean (SD) age was 65.9 years (range, 18-87 years). Indications for laryngectomy or laryngopharyngectomy were primary laryngeal and pharyngeal squamous cell carcinoma, laryngeal chondrosarcoma, esophageal carcinoma, laryngeal radionecrosis, and chronic aspiration. One patient in this study underwent HTEPP following jejunal free flap reconstruction for complete pharyngeal and cervical
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Damrose et al Table 3. Procedure Summary.
Table 1. Clinical Characteristics. Characteristic Gender Male Female Age, y < 70 ≥ 70 Tumor site Larynx Hypopharynx Oropharynx Esophageal
No. of Patients
No. of Patients
%
27 7
79.4 20.6
14 20
41.2 58.8
28 4 1 1
82.4 11.8 2.9 2.9
Scope Rigid esophagoscopy Flexible esophagoscopy Adjunctive procedures None Dilation Stomaplasty Dilation and stomaplasty Anesthesia General Local Prosthesis type Provox 2 InHealth indwelling
Table 2. Prior Treatment. Procedure
No. of Patients
Primary procedure Total laryngectomy Total pharyngolaryngectomy Total laryngectomy/partial pharyngectomy Neck dissection Bilateral Unilateral None Radiotherapy None Radiotherapy alone Radiotherapy and chemotherapy Reconstruction Primary closure Pectoralis major myocutaneous flap Jejunum free flap Anterolateral thigh free flap
29 3 2 15 11 8 5 19 10 26 5 2 1
26 8 19 10 4 1 32 2 31 3
% 76.5 23.5 55.9 29.4 11.8 2.9 94.1 5.9 91.2 8.8
% 85.3 8.8 5.9
44.1 32.4 23.5 14.7 55.9 29.4 76.5 14.7 5.9 2.9
esophageal stenosis complicating prior laryngectomy. Tumor histology included chondrosarcoma in 2 patients, adenosquamous carcinoma in 1 patient, and squamous cell carcinoma of the larynx or pharynx in the 30 remaining patients. Thirty patients (88%) had received radiation therapy prior to HTEPP—18 (53%) received radiation alone and 12 (35%) received concurrent radiation and chemotherapy. The American Joint Committee on Cancer stage was not available in 4 patients who underwent total laryngectomy at outside institutions. Of those 34 patients, 3 patients required multiple procedures for extrusion of the prosthesis and loss of the tract. Of these 3, 2 patients required 1 subsequent procedure, and 1 patient required 2 subsequent procedures. Therefore, a total of 38 HTEPPs was performed. Prosthesis placement was successful in all cases. The main clinical and treatment characteristics of the patients are summarized in Tables 1 and 2.
Nine procedures were performed in the setting of prior stapler-assisted laryngectomy and 8 in the setting of prior complex pharyngeal reconstruction (pectoralis myocutaneous flap, jejunal free flap, or anterolateral thigh free flap reconstruction) (Table 3). Two patients underwent HTEPP under local anesthesia and the remainder under general anesthesia. In 8 patients (24%), rigid esophagoscopy was not possible secondary to trismus or the inability to extend the neck adequately, and these patients underwent valve placement using flexible esophagoscopy. An InHealth Technologies indwelling voice prosthesis was placed in 3 patients, and an ATOS Medical Provox 2 indwelling voice prosthesis in the remainder. Primary HTEPP was performed in 8 cases and secondary HTEPP in 30 cases. Ten patients required concurrent esophageal dilation, 4 patients required concurrent stomaplasty, and 1 patient required concurrent stomaplasty and esophageal dilation. Therefore, 44% of patients underwent adjunctive procedures in addition to valve placement. Surgical time to create the puncture and place the prosthesis averaged 5.5 minutes (± 1.5 minutes). Blood loss was less than 20 mL in all cases. All patients achieved tracheoesophageal voicing. There was 1 major complication of a retropharyngeal abscess occurring 5 days following prosthesis placement. The patient required incision and drainage as well as intravenous antibiotic therapy. At the time of treatment, a small linear tear was noted in the posterior aspect of the esophageal wall where the rigid esophagoscope had been placed at the time of puncture. It was therefore felt that the abscess was more of a complication of the esophagoscopy rather than the creation of the puncture. The patient made a full recovery and no explantation of the valve was required. The mean (SD) time to first valve change was 126.8 (96.6) days (range, 14-367 days). This is comparable to similar reports evaluating valve life expectancy. The most common reason for valve change was leakage through the
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prosthesis, followed by downsizing of the length of the prosthesis, and occlusion. Three patients required repeat puncture and valve placement for extrusion. This appeared to be a consequence of inflammation of the puncture site, with resultant edema and granulation tissue formation that forces the prosthesis out and can cause the tract to spontaneously close. The patients involved presented too late in their clinical course to salvage the tract. Further education on the need for meticulous care and prompt attention to possible complications has prevented this situation from recurring in these individuals.
transnasal esophagoscope, the working channel of the device limits the size of the grasper or snare that can be passed. When passed either through the working channel or alongside the scope, a small grasper or snare can easily grip the leader cable of the device, helping to guide this along the esophagus and pharynx. Most important, the leader cable is fused to a dilator, which, when advanced in a retrograde fashion, atraumatically dilates the fistula for acceptance of the valve. On the other hand, the ATOS Medical guidewire has a slit on the tip that readily grips the voice prosthesis and prevents accidental dislodgement of the prosthesis as it transits the fistula. We have found that this slit readily accommoDiscussion dates both ATOS Medical and InHealth Technologies Tracheoesophageal puncture with valve placement is a indwelling voice prostheses. common and successful method of voice rehabilitation folSimultaneous fistula creation with valve placement, parlowing total laryngectomy.7 There have been numerous ticularly in the secondary setting, can obviate the need for technical modifications since originally described by Singer tube feeding, eliminates the delay between creation of the and Blom in 1980, with variations in puncture technique, fistula and time to phonation, and by eliminating the subsetiming, anesthesia, and type of valve placed.2-6,8 quent postoperative visit for initial placement of the valve, Tracheoesophageal puncture with concomitant valve placemay result in cost and time savings for patients and insurers. ment is not a new concept and has been successfully demConcurrent puncture and valve placement may have addionstrated in prior studies.3-5,8 Both ATOS Medical and tional advantages: the prosthesis itself may rest in a more InHealth Technologies, among others, manufacture indwellnatural horizontal position within the puncture tract and ing voice prostheses and supply the supporting equipment may better represent its eventual position within the stoma, to facilitate the care and use of voice prostheses. Each has and primary placement at the time of TEP avoids potential unique advantages. By hybridizing components of both of complications such as loss or aspiration of the catheter and these products, it has been possible to simplify the techpotential loss of the puncture tract.5 nique for broad application across a variety of surgical situThe procedure we describe as HTEPP has been in pracations in which TEP and concomitant valve placement are tice at our institution since 2009. In 2011, Deschler et al5 desired. published their experience with a similar technique wherein There is a vast array of TEP techniques currently the dilator is inserted through the center of the voice prosdescribed in the literature, a review of which is beyond the thesis valving mechanism and tied to the shaft of the dilator. scope of this article. This technique has allowed us to distill Although the authors reported good results with their techthe advantages of many techniques into 1, which simplifies nique, our concerns about potential shearing forces that teaching. It has been employed in a variety of clinical probcould disrupt the delicate internal valving mechanism as lems and scenarios: trismus; poor neck flexion; local versus well as concerns that the valve may dislodge from the dilageneral anesthesia; pharyngoesophageal reconstruction vertor when transiting the fistula have caused us to remain with sus no reconstruction; primary versus secondary placement; our current technique. In our institution, the cost of the and different voice prostheses. The universality of the proInHealth Technologies and ATOS Medical products is $245 cedure is an attractive feature: 1 technique, employed and $66, respectively. We feel that the addition of the guidethroughout a variety of clinic scenarios, is easy to teach and wire to the procedure is offset by the operative time saved easy to learn. and the potential for decreased risk of damage to the more Both components of the hybrid bring advantages to the expensive valve itself. procedure. With the InHealth Technologies components, a The procedure can be performed under local anesthesia, clean puncture is created, as opposed to a slit or a tear crewhich may make this technique readily applicable to the ated with a scalpel and/or hemostat clamp. This theoretioutpatient clinic setting. Approximately 45% of our patients, cally affords better tissue approximation against and however, required adjunctive procedures such as esophadecreased leakage around the device, while decreasing the geal dilation and stomaplasty. For those patients who risk of enlargement of the fistula. The use of the puncture require multiple concurrent procedures, then, the use of needle with the introduction of a leader cable—essentially general anesthesia may be more appropriate. Patients should an adaptation of the classic Seldinger9 technique— be triaged appropriately based on their needs. Three patients had undergone prior primary TEP and minimizes the risk of false passage or inadvertent injury to valve placement, which were lost secondary to extrusion. the posterior esophageal wall. When using a gastroscope or
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Damrose et al These individuals had used and enjoyed the InHealth Technologies indwelling voice prostheses, and it was their desire to return to this same device that prompted us to use this line of voice prosthesis with HTEPP. We found that the tail of this line of voice prosthesis fit securely into the slotted end of the ATOS Medical guidewire, allowing easy placement. Two of these patients had been rejected for TEP under general anesthesia by their original surgeons owing to the interim development of advanced cardiac disease. These patients were offered TEP under local anesthesia. The overall procedure length was considerably shorter in these patients since anesthesia was not required, and the patients tolerated the procedure without complication. In patients who undergo the procedure secondarily, office-based puncture and valve placement can also be done successfully with simple topical anesthesia using the transnasal esophagoscope.10 Office-based transnasal esophagoscopy is a relatively new procedure and there are few studies that have addressed this technique.10-12 Sidell et al13 reported in 2010 that voice prosthesis sizing was better in patients who had office-based TEP than in patients who had operating room-based TEP. However, in their study, voice prostheses were placed several days following the puncture, which may have afforded time for postsurgical edema to resolve. Transnasal esophagoscopy-assisted TEP with local anesthetic may represent the simplest, most cost-effective method of secondary TEP and is currently being evaluated. In this study, 2 commercially available devices were used in an off-label manner with 1 device requiring alteration. Surgeons must understand their responsibilities and liabilities in these situations. Although the term off-label use is sometimes used in a pejorative manner or used to imply a sense of risk or impropriety, it is important to understand that manufacturers do not have the resources to explore all indications of a device prior to marketing. Indeed, the discovery and subsequent publication of new applications for medical devices “can serve as a useful catalyst to expand the conceptual and technical horizon for how devices and other tools may be used.”14 It is interesting to note that the use of the red rubber catheter for the creation of a tracheoesophageal puncture, originally described by Singer and Blom in 1980 and still used for this purpose today, was an off-label use of the device that helped to usher in the era of modern postlaryngectomy voice rehabilitation.1,15 Surgical innovation is key to the advancement of knowledge and the development of technologies that can benefit humankind, but surgeons must also understand that this path of discovery carries certain responsibilities. When a device is modified, liability is transferred from the manufacturer to the practitioner.16 Therefore, it is incumbent upon the surgeon to ensure that risk is minimized compared to the potential benefits that may accrue to the patient. A thorough discussion of risks and benefits with the patient
prior to surgery with the acquisition of informed consent is clearly important. Oversight and guidance from the local IRB is highly advisable. If the intervention proposed is of high enough risk, then an application to the US Food and Drug Administration for a formal investigational device exemption should always be considered.17
Conclusion Combining the components of 2 commercially available TEP kits has allowed the construction of a hybrid device that has proved adaptable to TEP in numerous situations: primary versus secondary; traditional versus stapler-assisted laryngectomy; and local versus general anesthesia. This hybrid device simplifies the technique of TEP. Outcomes and complications have proven favorable. For patients who require multiple concurrent procedures such as stomaplasty or esophageal dilation, general anesthesia remains the treatment of choice. For candidates who require puncture exclusively, the procedure can be performed under local anesthesia with flexible esophagoscopy, rendering concurrent puncture and prosthesis placement in the clinic setting feasible. Acknowledgment The lead author would like to acknowledge Dr Mark Singer for the technological innovations that were the inspiration for this article, and for his vision to improve the lives of all laryngectomy patients.
Declaration of Conflicting Interests The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding The author(s) received no financial support for the research, authorship, and/or publication of this article.
References 1. Singer MI, Blom ED. An endoscopic technique for restoration of voice after laryngectomy. Ann Otol Rhinol Laryngol. 1980;89:529-533. 2. Emerick KS, Tomycz L, Bradford CR, et al. Primary versus secondary tracheoesophageal puncture in salvage total laryngectomy following chemoradiation. Otolaryngol Head Neck Surg. 2009;140:386-390. 3. Makitie AA, Niemensivu R, Juvas A, Aaltonen LM, Back L, Lehtonen H. Postlaryngectomy voice restoration using a voice prosthesis: a single institution’s ten-year experience. Ann Otol Rhinol Laryngol. 2003;112:1007-1010. 4. Op de Coul BM, Hilgers FJ, Balm AJ, Tan IB, van den Hoogen FJ, van TH. A decade of postlaryngectomy vocal rehabilitation in 318 patients: a single institution’s experience with
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c onsistent application of Provox indwelling voice prostheses. Arch Otolaryngol Head Neck Surg. 2000;126:1320-1328. 5. Deschler DG, Emerick KS, Lin DT, Bunting GW. Simplified technique of tracheoesophageal prosthesis placement at the time of secondary tracheoesophageal puncture (TEP). Laryngoscope. 2011;121:1855-1859. 6. Leahy KP, Tufano RP. Primary tracheoesophageal puncture in stapler-assisted total laryngectomy. ORL J Otorhinolaryngol Relat Spec. 2010;72:124-126. 7. Bozec A, Poissonnet G, Chamorey E, et al. Results of vocal rehabilitation using tracheoesophageal voice prosthesis after total laryngectomy and their predictive factors. Eur Arch Otorhinolaryngol. 2010;267:751-758. 8. Deschler DG, Bunting GW, Lin DT, Emerick K, Rocco J. Evaluation of voice prosthesis placement at the time of primary tracheoesophageal puncture with total laryngectomy. Laryngoscope. 2009;119:1353-1357. 9. Seldinger SI. Catheter replacement of the needle in percutaneous arteriography; a new technique. Acta Radiol. 1953;39:368-376. 10. LeBert B, McWhorter AJ, Kunduk M, et al. Secondary tracheoesophageal puncture with in-office transnasal esophagoscopy. Arch Otolaryngol Head Neck Surg. 2009;135:1190-1194.
11. Doctor VS. In-office unsedated tracheoesophageal puncture. Curr Opin Otolaryngol Head Neck Surg. 2007;15: 405-408. 12. Doctor VS, Enepekides DJ, Farwell DG, Belafsky PC. Transnasal oesophagoscopy-guided in-office secondary tracheoesophageal puncture. J Laryngol Otol. 2008;122: 303-306. 13. Sidell D, Shamouelian D, Erman A, Gerratt BR, Chhetri D. Improved tracheoesophageal prosthesis sizing in office-based tracheoesophageal puncture. Ann Otol Rhinol Laryngol. 2010;119:37-41. 14. McElhinney DB. Beyond indications: postmarket surveil lance and the importance of expanded and off-label use of transcatheter devices in structural and congenital interventions. Circ Cardiovasc Interv. 2012;5:739-740. 15. Rusch Red Rubber Robinson Catheter [package insert]. Research Triangle Park, NC: Teleflex Medical; 2014. 16. Lenhard N, Coutinho M, Campbell B. The surgeon and medical devices: adverse incident reporting and off-label use. Ann R Coll Surg Engl. 2013;95:309-310. 17. Starnes BW. A surgeon’s perspective regarding the regulatory, compliance, and legal issues involved with physicianmodified devices. J Vasc Surg. 2013;57:829-831.
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research-article2014
AORXXX10.1177/0003489414525591Annals of Otology, Rhinology & LaryngologyDamrose et al
Article
The Hybrid Tracheoesophageal Puncture Procedure: Indications and Outcomes
Annals of Otology, Rhinology & Laryngology 2014, Vol. 123(8) 584–590 © The Author(s) 2014 Reprints and permissions: sagepub.com/journalsPermissions.nav DOI: 10.1177/0003489414525591 aor.sagepub.com
Edward J. Damrose, MD, FACS1, Do-Yeon Cho, MD1, and Richard L. Goode, MD, FACS1
Abstract Objectives: This report aimed to describe a novel and efficient method of tracheoesophageal puncture using a hybrid device assembled from 2 commercially available puncture kits; to demonstrate the utility of this technique in the performance of primary and secondary procedures, under general and local anesthesia, with and without flap reconstruction; and to evaluate the efficacy of concurrent puncture and valve placement. Methods: Thirty-four patients who underwent either primary or secondary tracheoesophageal puncture for voice restoration. Charts were reviewed retrospectively for complications, time to first valve change, operative time, and blood loss. Results: Using this novel hybrid device, simultaneous puncture and valve placement was achieved in 34 consecutive patients. There was 1 major complication; blood loss was negligible; and the procedure could be accomplished in all cases. There were no cases of prosthesis failure as a result of the insertion technique. Conclusion: Concurrent tracheoesophageal puncture and voice prosthesis placement is a simple and efficient method of voice restoration in the laryngectomized patient and can be more easily accomplished with a hybrid device assembled from the components of 2 commercially available puncture kits. It can be performed under local as well as general anesthesia. The procedure is adaptable to a variety of clinical situations. Keywords cancer, dilation, esophageal stenosis, laryngectomy, tracheoesophageal puncture, voice prosthesis
Introduction Tracheoesophageal puncture (TEP) with voice prosthesis placement is an important part of voice rehabilitation for the total laryngectomy patient. It was initially described as a secondary procedure by Singer and Blom in 1980.1 There are a variety of ways to accomplish TEP placement, with variations in puncture technique, timing, type of anesthesia, and type of valve placed.2-5 The introduction of staplerassisted total laryngectomy represents a unique situation that can create a challenge for placement of a primary TEP.6 Recognition of the benefits of tracheoesophageal speech, coupled with improvements in endoscopic techniques and pressure to optimize the efficiency of valve placement, have all driven the development of new TEP techniques. Over the years, experience at our institution showed us that creating the TEP with a needle as opposed to a knife created a more stable tract that was less inclined toward leakage or dilation, or migration of the prosthesis. As our comfort with the technique grew, it became apparent that a voice prosthesis could be placed concurrently, eliminating the delay
between TEP and voicing. It also became apparent that we needed to create a technique that was readily teachable to our trainees. In an effort to simplify TEP, 2 commercially available kits designed to facilitate TEP—the Provox Guidewire (ATOS Medical, Horby, Sweden) and the Blom-Singer Tracheoesophageal Puncture Set (InHealth Technologies, Carpinteria, California, USA)—were combined to form a hybrid device. With this hybrid device, we are able to adapt the technique of TEP for broad application across a variety of surgical situations: primary and secondary procedures; stapler-assisted and conventional laryngectomy; and 1
Division of Laryngology, Department of Otolaryngology–Head and Neck Surgery, Stanford University School of Medicine, Stanford, California, USA Corresponding Author: Edward J. Damrose, MD, FACS, Division of Laryngology, Department of Otolaryngology–Head and Neck Surgery, Stanford University Medical Center, 801 Welch Road, Stanford, CA 94305, USA. Email: [email protected]
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Figure 1. ATOS Medical guidewire (left) and InHealth Technologies dilator (right).
Figure 3. Tracheoesophageal puncture made into esophageal lumen using 16-gauge curved introducer needle and 14-gauge Teflon sheath.
Figure 2. ATOS Medical guidewire coapted to InHealth Technologies dilator to create hybrid device. Friction keeps the 2 pieces together.
general and local anesthesia. Both the ATOS Medical and InHealth Technologies in-dwelling voice prostheses can be used. The aim of this report is to describe this simple technique of TEP and to assess its clinical outcomes.
Methods/Technique This study was conducted with the approval of the Stanford University Medical Center Institutional Review Board (IRB). Charts were reviewed for blood loss, length of operation, postoperative complications, time to first prosthesis change, and need for concurrent adjunctive procedures such as esophageal dilation or stomaplasty. The Blom-Singer Tracheoesophageal Puncture Set includes a Teflon-coated 16-guage needle and a feeding tube composed of a leader cable and dilator at 1 end and a
feeding port at the other. For descriptive purposes, the Blom-Singer Tracheoesophageal Puncture Set will be delineated as BSTPS, the leader cable and dilator from the BSTPS will be designated as the dilator, and the ATOS Medical guidewire will be delineated as the guidewire (Figure 1). The feeding port from the dilator is removed and the guidewire coapted firmly to the dilator and leader cable to create the hybrid device (Figure 2). The fit is quite secure and does not readily separate. An endotracheal tube (in the case of primary TEP either with traditional or stapler-assisted total laryngectomy), a rigid esophagoscope or gastroscope (in the case of traditional secondary TEP), or a transnasal esophagoscope (in the case of TEP under local/topical anesthesia) is passed into the esophagus. Palpation and/or transillumination allows external verification of the position of the tube or scope through the membranous trachea. Under direct visualization to confirm entry into the esophageal lumen and minimize the risk of inadvertent posterior esophageal wall injury, the 16-gauge introducer needle taken from the BSTPS is used to create the puncture (Figure 3). The puncture is typically made about 5 mm inferior to the 12 o’clock position of the stoma. However, the position should be individually tailored to ensure that a valve is seated well into the stoma but not too far inferiorly that access for cleaning and
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Figure 4. Hybrid device inserted; retrograde advancement. Figure 6. Valve seated into puncture site.
Figure 5. Dilator component removed and valve placed; anterograde withdrawal.
changing is compromised. The needle is withdrawn, leaving the Teflon sheath in place in the puncture site. The hybrid device (leader cable, dilator, and guidewire) is passed in a retrograde fashion and delivered through the mouth (Figure 4). As the dilator passes, controlled dilation of the tract occurs. When a flexible scope is used, a snare can be passed through the working channel of the scope to help grasp the leader cable, if needed. The guidewire is detached from the dilator and a voice prosthesis is then snapped onto the guidewire (Figure 5). The use of the guidewire ensures that the valve will not be dislodged during transit through the fistula. In addition, the guidewire
allows the prosthesis to be advanced by its tail, avoiding trauma to the delicate internal valve mechanism. The prosthesis is then passed in an anterograde fashion and inserted into the puncture site (Figure 6). The procedure itself, including assembly of the hybrid device and concurrent puncture and valve placement, will be referred to as the Hybrid Tracheoesophageal Puncture Procedure (HTEPP). Following prosthesis placement, the valve is flushed and brushed cleanto ensure that no debris is trapped within the valve mechanism. Immediately postoperatively, patients are allowed to resume liquids and a soft mechanical diet, with advancement of diet as tolerated by the patient. Voicing is also permitted immediately postoperatively. Patients are given 5 days of either amoxicillin/clavulanic acid 800 mg orally twice daily or clindamycin 600 mg orally 3 times daily. Protocol prior to placement includes preoperative speech pathology consultation with instruction on the use and care of a voice prosthesis, which is reinforced with follow-up speech therapy within 7 days postoperatively.
Results From January 2009 to July 2013, a total of 34 laryngectomized patients (27 male, 7 female) underwent 38 HTEPPs. The mean (SD) age was 65.9 years (range, 18-87 years). Indications for laryngectomy or laryngopharyngectomy were primary laryngeal and pharyngeal squamous cell carcinoma, laryngeal chondrosarcoma, esophageal carcinoma, laryngeal radionecrosis, and chronic aspiration. One patient in this study underwent HTEPP following jejunal free flap reconstruction for complete pharyngeal and cervical
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Damrose et al Table 3. Procedure Summary.
Table 1. Clinical Characteristics. Characteristic Gender Male Female Age, y < 70 ≥ 70 Tumor site Larynx Hypopharynx Oropharynx Esophageal
No. of Patients
No. of Patients
%
27 7
79.4 20.6
14 20
41.2 58.8
28 4 1 1
82.4 11.8 2.9 2.9
Scope Rigid esophagoscopy Flexible esophagoscopy Adjunctive procedures None Dilation Stomaplasty Dilation and stomaplasty Anesthesia General Local Prosthesis type Provox 2 InHealth indwelling
Table 2. Prior Treatment. Procedure
No. of Patients
Primary procedure Total laryngectomy Total pharyngolaryngectomy Total laryngectomy/partial pharyngectomy Neck dissection Bilateral Unilateral None Radiotherapy None Radiotherapy alone Radiotherapy and chemotherapy Reconstruction Primary closure Pectoralis major myocutaneous flap Jejunum free flap Anterolateral thigh free flap
29 3 2 15 11 8 5 19 10 26 5 2 1
26 8 19 10 4 1 32 2 31 3
% 76.5 23.5 55.9 29.4 11.8 2.9 94.1 5.9 91.2 8.8
% 85.3 8.8 5.9
44.1 32.4 23.5 14.7 55.9 29.4 76.5 14.7 5.9 2.9
esophageal stenosis complicating prior laryngectomy. Tumor histology included chondrosarcoma in 2 patients, adenosquamous carcinoma in 1 patient, and squamous cell carcinoma of the larynx or pharynx in the 30 remaining patients. Thirty patients (88%) had received radiation therapy prior to HTEPP—18 (53%) received radiation alone and 12 (35%) received concurrent radiation and chemotherapy. The American Joint Committee on Cancer stage was not available in 4 patients who underwent total laryngectomy at outside institutions. Of those 34 patients, 3 patients required multiple procedures for extrusion of the prosthesis and loss of the tract. Of these 3, 2 patients required 1 subsequent procedure, and 1 patient required 2 subsequent procedures. Therefore, a total of 38 HTEPPs was performed. Prosthesis placement was successful in all cases. The main clinical and treatment characteristics of the patients are summarized in Tables 1 and 2.
Nine procedures were performed in the setting of prior stapler-assisted laryngectomy and 8 in the setting of prior complex pharyngeal reconstruction (pectoralis myocutaneous flap, jejunal free flap, or anterolateral thigh free flap reconstruction) (Table 3). Two patients underwent HTEPP under local anesthesia and the remainder under general anesthesia. In 8 patients (24%), rigid esophagoscopy was not possible secondary to trismus or the inability to extend the neck adequately, and these patients underwent valve placement using flexible esophagoscopy. An InHealth Technologies indwelling voice prosthesis was placed in 3 patients, and an ATOS Medical Provox 2 indwelling voice prosthesis in the remainder. Primary HTEPP was performed in 8 cases and secondary HTEPP in 30 cases. Ten patients required concurrent esophageal dilation, 4 patients required concurrent stomaplasty, and 1 patient required concurrent stomaplasty and esophageal dilation. Therefore, 44% of patients underwent adjunctive procedures in addition to valve placement. Surgical time to create the puncture and place the prosthesis averaged 5.5 minutes (± 1.5 minutes). Blood loss was less than 20 mL in all cases. All patients achieved tracheoesophageal voicing. There was 1 major complication of a retropharyngeal abscess occurring 5 days following prosthesis placement. The patient required incision and drainage as well as intravenous antibiotic therapy. At the time of treatment, a small linear tear was noted in the posterior aspect of the esophageal wall where the rigid esophagoscope had been placed at the time of puncture. It was therefore felt that the abscess was more of a complication of the esophagoscopy rather than the creation of the puncture. The patient made a full recovery and no explantation of the valve was required. The mean (SD) time to first valve change was 126.8 (96.6) days (range, 14-367 days). This is comparable to similar reports evaluating valve life expectancy. The most common reason for valve change was leakage through the
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prosthesis, followed by downsizing of the length of the prosthesis, and occlusion. Three patients required repeat puncture and valve placement for extrusion. This appeared to be a consequence of inflammation of the puncture site, with resultant edema and granulation tissue formation that forces the prosthesis out and can cause the tract to spontaneously close. The patients involved presented too late in their clinical course to salvage the tract. Further education on the need for meticulous care and prompt attention to possible complications has prevented this situation from recurring in these individuals.
transnasal esophagoscope, the working channel of the device limits the size of the grasper or snare that can be passed. When passed either through the working channel or alongside the scope, a small grasper or snare can easily grip the leader cable of the device, helping to guide this along the esophagus and pharynx. Most important, the leader cable is fused to a dilator, which, when advanced in a retrograde fashion, atraumatically dilates the fistula for acceptance of the valve. On the other hand, the ATOS Medical guidewire has a slit on the tip that readily grips the voice prosthesis and prevents accidental dislodgement of the prosthesis as it transits the fistula. We have found that this slit readily accommoDiscussion dates both ATOS Medical and InHealth Technologies Tracheoesophageal puncture with valve placement is a indwelling voice prostheses. common and successful method of voice rehabilitation folSimultaneous fistula creation with valve placement, parlowing total laryngectomy.7 There have been numerous ticularly in the secondary setting, can obviate the need for technical modifications since originally described by Singer tube feeding, eliminates the delay between creation of the and Blom in 1980, with variations in puncture technique, fistula and time to phonation, and by eliminating the subsetiming, anesthesia, and type of valve placed.2-6,8 quent postoperative visit for initial placement of the valve, Tracheoesophageal puncture with concomitant valve placemay result in cost and time savings for patients and insurers. ment is not a new concept and has been successfully demConcurrent puncture and valve placement may have addionstrated in prior studies.3-5,8 Both ATOS Medical and tional advantages: the prosthesis itself may rest in a more InHealth Technologies, among others, manufacture indwellnatural horizontal position within the puncture tract and ing voice prostheses and supply the supporting equipment may better represent its eventual position within the stoma, to facilitate the care and use of voice prostheses. Each has and primary placement at the time of TEP avoids potential unique advantages. By hybridizing components of both of complications such as loss or aspiration of the catheter and these products, it has been possible to simplify the techpotential loss of the puncture tract.5 nique for broad application across a variety of surgical situThe procedure we describe as HTEPP has been in pracations in which TEP and concomitant valve placement are tice at our institution since 2009. In 2011, Deschler et al5 desired. published their experience with a similar technique wherein There is a vast array of TEP techniques currently the dilator is inserted through the center of the voice prosdescribed in the literature, a review of which is beyond the thesis valving mechanism and tied to the shaft of the dilator. scope of this article. This technique has allowed us to distill Although the authors reported good results with their techthe advantages of many techniques into 1, which simplifies nique, our concerns about potential shearing forces that teaching. It has been employed in a variety of clinical probcould disrupt the delicate internal valving mechanism as lems and scenarios: trismus; poor neck flexion; local versus well as concerns that the valve may dislodge from the dilageneral anesthesia; pharyngoesophageal reconstruction vertor when transiting the fistula have caused us to remain with sus no reconstruction; primary versus secondary placement; our current technique. In our institution, the cost of the and different voice prostheses. The universality of the proInHealth Technologies and ATOS Medical products is $245 cedure is an attractive feature: 1 technique, employed and $66, respectively. We feel that the addition of the guidethroughout a variety of clinic scenarios, is easy to teach and wire to the procedure is offset by the operative time saved easy to learn. and the potential for decreased risk of damage to the more Both components of the hybrid bring advantages to the expensive valve itself. procedure. With the InHealth Technologies components, a The procedure can be performed under local anesthesia, clean puncture is created, as opposed to a slit or a tear crewhich may make this technique readily applicable to the ated with a scalpel and/or hemostat clamp. This theoretioutpatient clinic setting. Approximately 45% of our patients, cally affords better tissue approximation against and however, required adjunctive procedures such as esophadecreased leakage around the device, while decreasing the geal dilation and stomaplasty. For those patients who risk of enlargement of the fistula. The use of the puncture require multiple concurrent procedures, then, the use of needle with the introduction of a leader cable—essentially general anesthesia may be more appropriate. Patients should an adaptation of the classic Seldinger9 technique— be triaged appropriately based on their needs. Three patients had undergone prior primary TEP and minimizes the risk of false passage or inadvertent injury to valve placement, which were lost secondary to extrusion. the posterior esophageal wall. When using a gastroscope or
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Damrose et al These individuals had used and enjoyed the InHealth Technologies indwelling voice prostheses, and it was their desire to return to this same device that prompted us to use this line of voice prosthesis with HTEPP. We found that the tail of this line of voice prosthesis fit securely into the slotted end of the ATOS Medical guidewire, allowing easy placement. Two of these patients had been rejected for TEP under general anesthesia by their original surgeons owing to the interim development of advanced cardiac disease. These patients were offered TEP under local anesthesia. The overall procedure length was considerably shorter in these patients since anesthesia was not required, and the patients tolerated the procedure without complication. In patients who undergo the procedure secondarily, office-based puncture and valve placement can also be done successfully with simple topical anesthesia using the transnasal esophagoscope.10 Office-based transnasal esophagoscopy is a relatively new procedure and there are few studies that have addressed this technique.10-12 Sidell et al13 reported in 2010 that voice prosthesis sizing was better in patients who had office-based TEP than in patients who had operating room-based TEP. However, in their study, voice prostheses were placed several days following the puncture, which may have afforded time for postsurgical edema to resolve. Transnasal esophagoscopy-assisted TEP with local anesthetic may represent the simplest, most cost-effective method of secondary TEP and is currently being evaluated. In this study, 2 commercially available devices were used in an off-label manner with 1 device requiring alteration. Surgeons must understand their responsibilities and liabilities in these situations. Although the term off-label use is sometimes used in a pejorative manner or used to imply a sense of risk or impropriety, it is important to understand that manufacturers do not have the resources to explore all indications of a device prior to marketing. Indeed, the discovery and subsequent publication of new applications for medical devices “can serve as a useful catalyst to expand the conceptual and technical horizon for how devices and other tools may be used.”14 It is interesting to note that the use of the red rubber catheter for the creation of a tracheoesophageal puncture, originally described by Singer and Blom in 1980 and still used for this purpose today, was an off-label use of the device that helped to usher in the era of modern postlaryngectomy voice rehabilitation.1,15 Surgical innovation is key to the advancement of knowledge and the development of technologies that can benefit humankind, but surgeons must also understand that this path of discovery carries certain responsibilities. When a device is modified, liability is transferred from the manufacturer to the practitioner.16 Therefore, it is incumbent upon the surgeon to ensure that risk is minimized compared to the potential benefits that may accrue to the patient. A thorough discussion of risks and benefits with the patient
prior to surgery with the acquisition of informed consent is clearly important. Oversight and guidance from the local IRB is highly advisable. If the intervention proposed is of high enough risk, then an application to the US Food and Drug Administration for a formal investigational device exemption should always be considered.17
Conclusion Combining the components of 2 commercially available TEP kits has allowed the construction of a hybrid device that has proved adaptable to TEP in numerous situations: primary versus secondary; traditional versus stapler-assisted laryngectomy; and local versus general anesthesia. This hybrid device simplifies the technique of TEP. Outcomes and complications have proven favorable. For patients who require multiple concurrent procedures such as stomaplasty or esophageal dilation, general anesthesia remains the treatment of choice. For candidates who require puncture exclusively, the procedure can be performed under local anesthesia with flexible esophagoscopy, rendering concurrent puncture and prosthesis placement in the clinic setting feasible. Acknowledgment The lead author would like to acknowledge Dr Mark Singer for the technological innovations that were the inspiration for this article, and for his vision to improve the lives of all laryngectomy patients.
Declaration of Conflicting Interests The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding The author(s) received no financial support for the research, authorship, and/or publication of this article.
References 1. Singer MI, Blom ED. An endoscopic technique for restoration of voice after laryngectomy. Ann Otol Rhinol Laryngol. 1980;89:529-533. 2. Emerick KS, Tomycz L, Bradford CR, et al. Primary versus secondary tracheoesophageal puncture in salvage total laryngectomy following chemoradiation. Otolaryngol Head Neck Surg. 2009;140:386-390. 3. Makitie AA, Niemensivu R, Juvas A, Aaltonen LM, Back L, Lehtonen H. Postlaryngectomy voice restoration using a voice prosthesis: a single institution’s ten-year experience. Ann Otol Rhinol Laryngol. 2003;112:1007-1010. 4. Op de Coul BM, Hilgers FJ, Balm AJ, Tan IB, van den Hoogen FJ, van TH. A decade of postlaryngectomy vocal rehabilitation in 318 patients: a single institution’s experience with
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c onsistent application of Provox indwelling voice prostheses. Arch Otolaryngol Head Neck Surg. 2000;126:1320-1328. 5. Deschler DG, Emerick KS, Lin DT, Bunting GW. Simplified technique of tracheoesophageal prosthesis placement at the time of secondary tracheoesophageal puncture (TEP). Laryngoscope. 2011;121:1855-1859. 6. Leahy KP, Tufano RP. Primary tracheoesophageal puncture in stapler-assisted total laryngectomy. ORL J Otorhinolaryngol Relat Spec. 2010;72:124-126. 7. Bozec A, Poissonnet G, Chamorey E, et al. Results of vocal rehabilitation using tracheoesophageal voice prosthesis after total laryngectomy and their predictive factors. Eur Arch Otorhinolaryngol. 2010;267:751-758. 8. Deschler DG, Bunting GW, Lin DT, Emerick K, Rocco J. Evaluation of voice prosthesis placement at the time of primary tracheoesophageal puncture with total laryngectomy. Laryngoscope. 2009;119:1353-1357. 9. Seldinger SI. Catheter replacement of the needle in percutaneous arteriography; a new technique. Acta Radiol. 1953;39:368-376. 10. LeBert B, McWhorter AJ, Kunduk M, et al. Secondary tracheoesophageal puncture with in-office transnasal esophagoscopy. Arch Otolaryngol Head Neck Surg. 2009;135:1190-1194.
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