The aim of partial laryngeal surgery is to

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1 ORIGINAL ARTICLE REHABILITATION OF SWALLOWING WITH POLYDIMETHYLSILOXANE INJECTIONS IN PATIENTS WHO UNDERWENT PARTIAL LARYNGECTOMY Giuseppe Bergamini, MD, Matteo Alicandri-Ciufelli, MD, Gabriele Molteni, MD, Daniele Romolo De Siati, MD, Maria Pia Luppi, SLT, Daniele Marchioni, MD, Livio Presutti, MD Department of Otolaryngology Head and Neck Surgery, University of Modena and Reggio Emilia, Policlinico di Modena, Modena 41100, Italy. Accepted 14 October 2008 Published online 12 March 2009 in Wiley InterScience ( DOI: /hed Abstract: Background. We conducted this longitudinal prospective study to illustrate a surgical technique for swallowing rehabilitation of patients after partial laryngectomy. Methods. Nine patients with persistent swallowing impairment after partial laryngectomy were included in the study. Evaluation of swallowing was performed by fiberoptic endoscopic evaluation of swallowing (FEES), and was quantified using 2 scales: a dysphagia score and a modified penetrationaspiration scale. The site of bolus inhalation was identified. Polydimethylsiloxane (PDMS) was injected into the neoglottis to fill these passages, and to obtain a certain continence of the organ. Results. Mean follow-up was 25 months (range, 5 39). All patients showed an improvement both in the dysphagia score and in the modified penetration-aspiration scale. Average improvement was 2.6 points in the dysphagia score (p ¼.0042) and 2.1 points in the modified penetration-aspiration scale (p ¼.0043). Conclusion. PDMS injection can be considered as an option in surgical rehabilitation of swallowing in patients who underwent partial laryngectomy. VC 2009 Wiley Periodicals, Inc. Head Neck 31: , 2009 Correspondence to: M. Alicandri-Ciufelli VC 2009 Wiley Periodicals, Inc. Keywords: polydimethylsiloxane injections; swallowing rehabilitation; dysphagia; partial laryngectomy; fiberoptic endoscopic evaluation of swallowing The aim of partial laryngeal surgery is to perform a radical removal of the neoplasm, reconstructing the anatomical crossing of the respiratory and digestive tracts, with the recovery of laryngeal function. Postoperative functional problems that usually regress over time can last for a long period in some cases, although these are improved with speech therapy. Dysphagia is definitely the most important complication for a patient s quality of life. In the case of persistent and severe dysphagia, consequences can be dramatic and can lead to recurrent aspiration pneumonia, hyponutrition, and cachexia. The solutions to those critical situations can be gastrostomies or total laryngectomies. Total laryngectomy clearly nullifies all of the attempts for preservation of normal ways of deglutition, phonation, and breathing, and requires a permanent anterior tracheotomy, with all of the inflammatory, infective, aesthetic, and psychological problems that this condition 1022 Rehabilitation of Swallowing HEAD & NECK DOI /hed August 2009

2 gives rise to. 1 Also gastrostomy involves several problems for patients, such as loss of oral deglutition and aesthetic implications. 2 4 Nevertheless, swallowing problems after partial laryngectomy can be of a minor nature, and patients can obtain reasonable deglutition with adequate food intake in the absence of aspiration pneumonia. Minor problems, such as cough during deglutition, pharyngeal scraping, and forced swallowing positions, can however decrease patients quality of life. In fact, for those problems, patients might try to avoid all social situations that could embarrass them. The reasons for difficulties in swallowing recovery in partial laryngectomies can be varied: incorrect surgery (excessive resections, loose pexies, nerve lesions), worsening of general conditions, reduced patient compliance, and unfavorable local healing. In particular, unfavorable local healing can cause an inadequate functioning of the cricoarytenoideal unit, or the formation of grooves that facilitate the wrong passage of bolus during the pharyngeal deglutition phase in the upper respiratory tract. In some cases, regions with food accumulation can occur near the neoglottis: during deglutition, part of the bolus can accumulate in these regions, thereafter passing into the airways during the postswallowing respiratory phase (that follows the deglutition apnea). Attempts at surgical rehabilitation of that kind of problem have already been reported in the international literature: cricopharyngeal myotomies, 5,6 botulinum toxin injections, 7 collagen filling injections Polydimethylsiloxane (PDMS) already has many applications in medicine and surgery because of its well-known stability and tolerance in human tissues. In plastic surgery, PDMS injections have been used for aesthetic microimplants 11 ; other applications reported are in therapy of fecal incontinence 12 (with injections in the internal anal sphincter) or in cases of urinary incontinence 13 (with injections in the urethral sphincter). Vox-Implants (Bioplasty BV, Hofkamp 2, 6161 DC Geleen, The Netherlands) has been used in our study. It was used initially in otolaryngology for injection laryngoplasties in cases of phonatory prostheses leakage 14,15 and in cases of vocal cord paralyzes. 16,17 Vox-Implants is an injectable suspension of solid textured granules of an elastomer of PDMS, with a diameter of particles between 100 and 200 lm, suspended in a hydrogel of polyvinylpyrrolidone (PVP). The diameter of the particles avoids distant migration from the site of injection, while texturization facilitates mechanical bonds between particles and host tissues, favoring the formation of a fibrous envelope all round the particles, and making the tissue augmentation stable and long-lasting. From its first applications in laryngology, Vox-Implants was found to be an ideal filling material. Four years ago, our department started using PDMS, initially, for injection thyroplasties in vocal cord paralyzes and for therapy of phonatory prostheses leakage. The absence of side effects and the enduring nature of the results led us to use this material as a filler in persistent swallowing problems after partial laryngectomy, with the purpose of eliminating the passage of bolus toward the airways, and thus improving deglutition. PATIENTS AND METHODS From May 2003 until May 2007, 98 patients underwent partial laryngectomy for laryngeal cancer in the Otolaryngology Department of the University Hospital of Modena. Thirty-five patients underwent horizontal supraglottic laryngectomy with the Alonso technique (HSL). 18 Thirty-three patients underwent supracricoid laryngectomy with cricohyoidoepiglottopexy (CHEP). 19,20 Twenty-eight patients underwent supracricoid laryngectomy with cricohyoidopexy (CHP). 21 Two patients underwent horizontal glottic laryngectomy with the Calearo-Teatini technique (HGL). 22 From the seventh postoperative day, and in the case of normal postoperative course, patients started swallowing rehabilitation to recover an adequate food intake as soon as possible. Those therapies continued after patient discharge, with duration depending on quality of recovery, to optimize deglutition and to restore a compensation voice with a certain social utility. After adequate and prolonged swallowing rehabilitation, patients in whom dysphagia persisted, which provoked aspiration pneumonia, caused inadequate food intake, or conditioned patient s quality of life, were assigned for surgical rehabilitation by PDMS injections. Inclusion criteria were the following: patients who underwent horizontal partial laryngectomy or supracricoid laryngectomy; Rehabilitation of Swallowing HEAD & NECK DOI /hed August

3 Table 1. Clinical summary. Patient no. Age Sex Partial laryngectomy Site of injection Follow-up, mo 1 76 M HSL I. Left lateral portion of neoglottis 39 II. Lateral portion of neoglottis both sides 2 77 M CHEP Left lateral portion of neoglottis F HSL Right lateral portion of neoglottis M CHP with preservation of both arytenoids I. Anterior portion of neoglottis 33 II. Right lateral portion of neoglottis III. Right lateral portion of neoglottis IV. Anterior portion of neoglottis 5 74 M CHEP Left lateral portion of neoglottis M CHEP with partial resection of epiglottis Anterior portion of neoglottis M CHP Anterior portion of neoglottis M HSL with resection of right arytenoid and Right lateral portion of neoglottis 13 posterior vocal fold 9 65 M CHP with preservation of both arytenoid Right lateral portion of neoglottis 5 Abbreviations: HSL, horizontal supraglottic laryngectomy; CHEP, cricohyoidoepiglottopexy; CHP, cricohyoidopexy. persistent severe dysphagia that caused inadequate food intake or aspiration pneumonia after 3 months of swallowing rehabilitation by speech therapists; mild persistent dysphagia that caused decreased quality of life, after 6 months of swallowing rehabilitation. Exclusion criteria were the following: patients with signs of tumor recurrence documented by MRI, CT scan and/or fiberoptic evaluations; patients with poor general condition; patients with esophageal dysphagia documented by barium X-rays; patients with loose or incorrect pexies documented by cervical X-rays. Ten of 98 patients matched the inclusion criteria. One patient was excluded from our study because of poor general condition (advanced age, diabetes, multiple cardiovascular diseases), and underwent total laryngectomy. The final study group was of 9 patients: 8 men and 1 woman; average age was 73 (range, 65 77). Three patients underwent a HSL, 3 patients a CHEP, and the other 3 a CHP (Table 1). Every patient was evaluated in the phoniatric office by a surgeon (G.B.), 2 residents (M.A.C., G.M.), and a speech therapist (M.P.L.). Dysphagia symptoms were evaluated by a dysphagia score (Table 2), designed in advance and scored prospectively. Fiberoptic endoscopic evaluation of swallowing (FEES) was performed with boli of varied consistency, and results were quantified by a modified penetration-aspiration scale 23 to be suitable for partial laryngectomies (Table 3). The results for the penetration-aspiration scale were compiled by watching digital video recordings of patients, while the dysphagia score rates were obtained by interviewing the patients. The 4 examiners independently gave a score for each scale, and the final value was obtained from the average of those 4 scores (rounded to the nearest whole number). During the FEES, after the identification of incorrect routes for the passage of food or the presence of food accumulation regions, the exact site of injection was planned. All patients underwent maximum phonation time (MPT) measurements. Surgeries were all performed by the same surgeon (G.B.) in microlaryngoscopy, under general anesthesia. In each operation, quantities between 2 and 3 cc of PDMS (Vox-Implants) were injected into the site planned preoperatively. Injection was made with an appropriate syringe provided with a piston, whose advancement in steps allowed the surgeon to inject the correct quantity of PDMS. Preparations for intervention included a preventive lubrication of the needle to reduce sliding friction of the material during injection; only immediately before the injection was PDMS loaded into the needle to replace the lubricant. Table 2. Dysphagia score. Score Symptoms 1 No symptoms 2 Rare cough during liquid food deglutition 3 Frequent cough during liquid food deglutition. Rare cough during solid food deglutition 4 Frequent cough during solid and liquid food deglutition 5 Frequent cough not related to food introduction. Inadequate food intake 6 Recurrent aspiration pneumonia 1024 Rehabilitation of Swallowing HEAD & NECK DOI /hed August 2009

4 Table 3. Modified penetration-aspiration scale. Score Criteria 1 Material does not enter the airway 2 Material enters the airway, contacts the neoglottis, stimulates cough reflex and is ejected completely 3 Material enters the airway, contacts the neoglottis, stimulates cough reflex and is not completely ejected 4 Material enters the airway, passes below the neoglottis, stimulates cough reflex and is ejected completely 5 Material enters the airway, passes below the neoglottis, stimulates cough reflex and is not completely ejected 6 Material enters the airway, passes below the neoglottis and no effort is made to reject Two days after the operation, patients started swallowing rehabilitation exercises again, and this was continued in the outpatient setting to further improve the results of surgery. In the first postoperative period (generally within the first 3 days), patients were evaluated with the same methods as were used preoperatively, and new scores were given. In the case of persistence of deglutition problems, after 1 month of swallowing exercises, further operations were considered. Statistical analysis of postoperative results was performed by a Wilcoxon signed-rank test. A p value <.05 was considered statistically significant. An Internal Review Board (IRB) approval for this study and informed consent from each patient have been requested and obtained. RESULTS The average follow-up was 25 months (range, 5 39). All patients showed a statistically significant improvement both in the dysphagia score and in the modified penetration-aspiration scale. Average improvement was 2.6 points in the dysphagia score (p ¼.0042) (see Figure 1) and 2.1 points in the penetration-aspiration scale (p ¼.0043) (see Figure 2). Seven patients obtained good results after the first treatment while patients no. 1 and 4 required more than 1 operation (2 and 4, respectively) to obtain satisfactory swallowing. Results used for these 2 patients referred to evaluations made after the last operation. One patient (no. 6) immediately referred a severe dyspnea after the operation, which required an emergency tracheotomy reopening; at fiberoptic endoscopy, a moderate swelling of the neoglottis was noticed. Yet in the first postoperative day, edema disappeared, and the tracheotomy was closed. In every patient, MPT improved with a mean improvement of 5.1 seconds (range, 1 26 seconds) (p ¼.017) (see Figure 3). Even though 3 patients out of 9 did not initially succeed and required reoperation or FIGURE 1. Results of dysphagia score. [Color figure can be viewed in the online issue, which is available at wiley.com.] Rehabilitation of Swallowing HEAD & NECK DOI /hed August

5 FIGURE 2. Results of modified penetration-aspiration scale. [Color figure can be viewed in the online issue, which is available at invasive intervention, eventually, all patients treated achieved at least an adequate and, in many cases, a comfortable deglutition. DISCUSSION Partial laryngeal surgery causes important alterations of the normal anatomy of the upper digestive tract, particularly in its intersection with the airways. Postoperative sequelae on swallowing and phonation are always present, and recovery of adequate function can be difficult to achieve. Even though it is an infrequent condition nowadays, lack of swallowing recovery represents a severe condition that could require permanent gastrostomy or total laryngectomy. Surgical attempts to rehabilitate those patients have already been reported. These included cricopharyngeal myotomies, 5,6 botulinum injections, 7 and collagen filling injections 8 10 to reduce or eliminate neoglottic incontinence. Pharyngeal myotomy represents a questionable option, and many studies report the failure of this procedure, with even a worsening of gastroesophageal reflux. 5,6 FIGURE 3. Results of maximum phonation time (MPT). [Color figure can be viewed in the online issue, which is available at www. interscience.wiley.com.] 1026 Rehabilitation of Swallowing HEAD & NECK DOI /hed August 2009

6 Botulinum injections on cricopharyngeal muscle are based on the hypotheses of a lack of coordination of the modified organ during deglutition, and with a lack of relaxation of the upper esophageal sphincter. In the work of Marchese- Ragona et al, 7 very good results were reported in 5 patients, but injections were made very soon after the operation and the rationale for the absence of further injections (botulinum toxin has a well-known transitory persistence in human tissue) was not clarified. Collagen injections with filling intent have been reported in several studies in the international literature. In 1988, Bessede et al 9 carried out glutaraldehyde crosslinked (GAX) collagen injections in a case series of 9 patients: followup was only 5 months, and results were expressed with a very simplified subjective dysphagia scale (with only 3 scores). In 1990, Remacle et al 8 reported a case series of 3 patients in which postoperative swallowing problems were treated successfully with collagen injections. In 1992, Devars et al 10 reported a case of postoperative dysphagia (after partial laryngectomy) unsuccessfully injected with collagen. In 1997, Naudo et al 2 reported 3 cases treated with the same technique, without specifying the timing and sites of injections. In our opinion, it is also important to emphasize that in medialization thyroplasties, the use of collagen, fat, or other biological materials gave poor long-term results, because of their tendency to be reabsorbed. 17,24,25 PDMS had been reported to display stability and persistency in human tissues and in the laryngeal region, particularly when injected in medialization thyroplasties in the case of vocal fold paralyzes. 17,24,25 PDMS is considered a safe material, with few adverse effects or allergic reactions, even though in our case series, a patient suddenly showed postoperative edema of the neoglottis after the operation (patient no. 6). This could be due to an adverse reaction to silicon or to PVP, as supported by the recent literature. 26,27 The results in our case series are good according to both evaluation scales used. To quantify patients difficulties, 2 different scales have been used: one that measured clinical problems related to dysphagia (Table 2) and one that described FEES findings (Table 3). The scale that appeared more appropriate to evaluate FEES findings was the penetration-aspiration scale. 23 This scale was originally designed for videofluoroscopic evaluation of swallowing, but its reliability in FEES has already been demonstrated. 28 In our study, the penetrationaspiration scale required modification to adapt it to partial laryngectomy studies, as the original scale was based on the presence of an intact glottis. As stated previously, in 7 patients out of 9, only one operation sufficed to reach an acceptable or good deglutition score. Patients no. 1 and 4 required multiple injections (2 and 4 injections, respectively). Improvement in neoglottic continence was also confirmed by the improvement in MPT between the preoperative and postoperative period, demonstrating a reduced air consumption during phonation. A FEES study is fundamental for PDMS injection planning, because intraoperatively, it would be impossible to make any decision about the correct site of injection. In fact, preoperative FEES allows detailed analysis of the passage of bolus through the upper digestive tract, detecting the exact site of the incorrect routes; moreover, it allows the identification of food accumulation in the operated organ: these accumulations provoke the passage of material into the airways during breathing restart after deglutition apnea. For surgical and anatomic reasons, one of the most frequently used injection sites has been the superior aspect of the anterior portion of the cricoid cartilage (see Figure 4). The aim of injections in this site is to reduce the anterior-posterior gap due to incomplete contact of 1 or 2 arytenoids to the anterior surface (base of the tongue or epiglottis) during deglutition. The other frequently injected site has been the lateral portion of the neoglottis (see Figure 5), because, during the movement of the arytenoids toward the anterior surface, a lateral gap could be present between its base (that remains fixed to the cricoid cartilage and cannot slide anteriorly) and the lateral space of the pharynx; by filling this space, the lateral incorrect routes are closed to the passage of bolus. Other reasons for swallowing problems in patients undergoing partial laryngectomies are loose or incorrect pexies (particularly when the cricoid cartilage slides posterior to the hyoid bone). This has been excluded in our patients preoperatively by a cervical X-ray in the lateral position. As mentioned previously, speech therapy represents a very important tool in rehabilitation: in fact, the surgical route should only be Rehabilitation of Swallowing HEAD & NECK DOI /hed August

7 FIGURE 4. Example of PDMS injection into the superior aspect of the anterior portion of the cricoid cartilage (right panel) in a patient who underwent CHP. The aim of the injection was to reduce the anterior-posterior gap due to incomplete contact of 1 or 2 arytenoids to the anterior surface during deglutition (left panel). [Color figure can be viewed in the online issue, which is available at www. interscience.wiley.com.] considered after swallowing exercises over a long period. Also, after PDMS injections, speech therapy is vital for further improvement and to help patients to achieve normal or near-normal deglutition. The presence of neoplasm recurrence has been excluded preoperatively by radiological and endoscopic examinations. So far, no patients in our case series have had a recurrence. We believe that the risk of neoplastic recurrence does not represent a contraindication to laryngeal PDMS use, because mucosal appearance does not change after injections, and PDMS is clearly identifiable in MRI. In our study, preoperative or postoperative radiotherapy did not represent a contraindication to PDMS injections. None of the patients recruited had received preoperative radiotherapy, and only 3 (no. 1, 4, 7) had had postoperative radiotherapy on N. As emphasized by our study, PDMS injection is not without risk: the quantity of PDMS should be carefully administered in order to fill the neoglottic gap, avoiding an excessive FIGURE 5. Example of PDMS injection into the lateral portion of the neoglottis (in a CHEP): during the movement of the arytenoids toward the anterior surface, a lateral gap could be present between its base and the lateral space of the pharynx (left panel); by filling this space, the lateral incorrect routes were closed to the passage of bolus (right panel). [Color figure can be viewed in the online issue, which is available at Rehabilitation of Swallowing HEAD & NECK DOI /hed August 2009

8 reduction of airway lumen, and bearing in mind that PDMS is a nonreabsorbable material. Thus care should be taken in the amount of material injected, and in the case of insufficient correction of the gap, a further injection can be performed. Moreover, although rare, adverse reactions could occur, and the surgeon should be ready to perform emergency tracheotomy procedures in the immediate postoperative period. Our experience has to be considered as just an exploratory study, due to the small number of patients and the absence of long-term followup. It is important to emphasize the difficulties in obtaining a large case series, because functional results of partial laryngectomies are often satisfactory, particularly in centers having good experience with this kind of surgery. CONCLUSIONS Prolonged swallowing impairment after partial laryngectomy can be a challenging problem for both patients and surgeons. In some cases, total laryngectomy is considered the best solution to these problems, but in fact it represents a failure of all conservative attempts. PDMS is a well-known material in phoniatric surgery because of its safety and stability over time, as reported by other studies in the international literature. PDMS injections can be an option in surgical rehabilitation of swallowing in patients who underwent partial laryngectomies. FEES is an important tool for identifying anatomical alterations that can cause incorrect passage of bolus in the airways during deglutition, at the same time allowing the planning of the injection site. Filling these regions with PDMS can avoid the passage of food in the airways, thus improving deglutition. MPT can also be improved with this technique. 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