Intracordal auricular cartilage injection for unilateral vocal fold paralysis Yun-Sung Lim,1,2 Yoon Se Lee,2,3 Jin-Choon Lee,2 Byung-Joo Lee,2 Soo-Geun Wang,2 Hee-June Park,2 Su-Bong Nam,4 Yong-Chan Bae4 1
Department of Otorhinolaryngology—Head and Neck Surgery, Ilsan Hospital, Dongguk University, Goyang, Gyeonggi, Korea Department of Otorhinolaryngology—Head and Neck Surgery, Pusan National University School of Medicine and Medical Research Institute, Busan, Korea 3 Department of Otorhinolaryngology—Head and Neck Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea 4 Department of Plastic Surgery, Pusan National University School of Medicine and Medical Research Institute, Busan, Korea 2
Received 17 December 2013; revised 3 April 2014; accepted 12 April 2014 Published online 25 April 2014 in Wiley Online Library (wileyonlinelibrary.com). DOI: 10.1002/jbm.b.33189 Abstract: We evaluated the efficacy and outcome of intracordal auricular cartilage injection in patients with unilateral vocal fold paralysis. Our interest developed from findings of a canine model study that reported that histologic characteristics of cartilage were preserved 2 and 3 years after intracordal autologous cartilage injection. Between May 2002 and July 2010, 29 patients with breathy dysphonia caused by unilateral vocal fold paralysis underwent intracordal auricular cartilage injection. Each subject underwent preoperative and postoperative perceptual assessments, acoustical voice analysis, and videostroboscopy. Fourteen patients were male, and the mean age was 52-years old. Patients were tracked for a mean duration of 257 days. Injections were performed through a transoral approach under general anesthesia. Per-
ceptual assessments by GRBAS scale, acoustic parameters of jitter, shimmer, noise-to-harmonic ratio, and maximum phonation time significantly improved at 3, 6, and 12 months after cartilage injection (p < 0.005). No major complications were observed after injection. Initial clinical results with intracordal auricular cartilage injection are promising for patients with unilateral vocal fold paralysis. Autologous auricular cartilage can be a safe, effective, and alternative material for vocal fold medialization, and can be a long lasting one. C 2014 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl BioV
mater, 103B: 47–51, 2015.
Key Words: cartilage, vocal cord paralysis, medialization laryngoplasty, voice quality
How to cite this article: Lim Y-S, Lee Y-S, Lee J-C, Lee B-J, Wang S-G, Park H-J, Nam S-B, Bae Y-C. 2015. Intracordal auricular cartilage injection for unilateral vocal fold paralysis. J Biomed Mater Res Part B 2015:103B:47–51.
INTRODUCTION
With glottic incompetence due to unilateral vocal fold paralysis (UVFP), patients complain about breathy voice and sometimes aspiration problem. Treatments for glottic incompetence include thyroplasty type I, arytenoid adduction, and intracordal injection using various materials. The thyroplasty type I and arytenoid adduction require relatively long surgical time and scar formation due to anterior neck skin incision.1 The intracordal injection is simple and does not require neck skin incision, and is widely used for vocal fold augmentation. Over the years, many different materials, such as, paraffin,2 bone paste,3 bovine collagen,4 and Teflon,5 have been used for augmentation of vocal cord. The substances that are most commonly injected today include collagen,6 fat,7 fascia,8 cymetra,9 hyalurononic acid,10 and hydroxylapatite.11 All have drawbacks, including resorption (collagen, fat, fascia), immunological consequences (bovine collagen), a lack of long-term results beyond 2 years (collagen, fascia,
cymetra, hyalurononic acid, and hydroxylapatite), no US Food and Drug administration approval (hyaluronic acid, bovine collagen, and polydimethylsiloxane12), and foreign body reaction (hydroxylapatite).13 Grafted cartilage has a high survival rate, a low absorption rate and small voluminous change. Therefore, it is widely used for otologic surgery and rhinoplasty. In our animal studies, we demonstrated that the autologous auricular cartilage graft is well tolerated and may be very effective material for long-term volumetric augmentation on paralyzed vocal fold.14,15 The purpose of this study was to report the efficacy of intracordal auricular cartilage injection (IACI) for medialization of the vocal fold in patients with UVFP by objective and subjective preoperative and postoperative criteria. MATERIAL AND METHODS
We reviewed the charts and videostroboscopic records of patients diagnosed with UVFP from January 2002 to July,
Correspondence to: B.-J. Lee (e-mail: [email protected]) Contract grant sponsor: Pusan National University Research Institute; contract grant number: 2012-16
C 2014 WILEY PERIODICALS, INC. V
47
FIGURE 1. Auricular cartilage. (A) The cartilage was harvested from the auricle. (B) The cartilage was minced into small pieces using sharp scissors and scalpel. [Color figure can be viewed in the online issue, which is available at wileyonlinelibrary.com.]
2010 at Pusan National University Hospital. In this period, 274 patients were diagnosed with UVFP, and intracordal auricular cartilage injection (IACI) was performed in 29 patients who agreed to IACI procedure with informed consent. We also obtained approval from the ethical committee. All subjects gave a standard history and underwent physical examination with diagnostic workup for vocal fold paralysis. All 29 patients were observed for at least 3 months after last injection. The mean patient age was 52 years (range, 27–72 years), and 14 (48.3%) patients were male. Before performing the surgical procedures, we evaluated the state of laryngeal exposure. Cartilage and fat were harvested from auricle and abdomen under general anesthesia [Figure 1(A)]. Cartilage was obtained by posterior auricular vertical incision and it was minced with a scalpel and #15 blade into small pieces for passage of needle [Figure 1(B)]. For loading and vehicle of cartilage, 2 g of abdominal fat was obtained by a small periumbrical incision and cut into pieces. The minced cartilage was put into a 1-mL syringe that was then filled with fat (Figure 2). The 1-mL syringe filled with the minced cartilage and fat was connected to a
Bruning injector and connected to a 19-gauge needle. The needle was filled and prepared with the cartilage up to its tip with several clicks (Figure 3). The rigid laryngoscope was introduced and cartilage was injected into the vocalis muscle at the junction of the middle and posterior third of the vocal fold under laryngeal microscope with the slope of the Bruning injector needle made to face outside. Great care was taken not to inject material superficial to the vocal ligament, which can result in permanent dysphonia, and not to let the implanted material leak out of the injection point for a little bit of over-correction. The amount of injected cartilage was about 0.5 mL, but it varied and depended on the individual for optimal consequences. Antibiotic and mucolytic drugs were prescribed for the postoperative recuperation period. Pretreatment and post-treatment examinations and tests were collected from patient who were followed up at 3-, 6-, and 12-months postinjection. Video laryngostroboscopy, grade, roughness, breathiness, asthenia, strain scale (GRBAS) perceptual evaluation; and maximum phonation time (MPT) measurements were
FIGURE 2. Filling the syringe with cartilage (arrow head). Additional fat (arrow) was used as a vehicle of filling and emptying the needle. [Color figure can be viewed in the online issue, which is available at wileyonlinelibrary.com.]
FIGURE 3. Injection of autologous cartilage through Bruning injector. Cartilage was easily injected without resistance. [Color figure can be viewed in the online issue, which is available at wileyonlinelibrary.com.]
48
LIM ET AL.
CARTILAGE INJECTION FOR VOCAL FOLD PARALYSIS
ORIGINAL RESEARCH REPORT
FIGURE 4. Vocal fold vibratory patterns during phonation by serial stroboscopic images of patient who underwent IACI to left vocal fold more than 2-years ago. The mucosal waves and complete glottal closure can be noticed. [Color figure can be viewed in the online issue, which is available at wileyonlinelibrary.com.]
obtained. GRBAS and MPT were measured by a single speech language pathologist at the time of patients’ visits in a blinded fashion. The patients were instructed to sustain the vowel sound /a/. A 2-s data sample was used for analysis by the Kay Elemetrics Compterized Speech Lab (CSL model No. 4300). From the sustained vowel /a/, fundamental frequency, jitter, shimmer, and noise-to-harmonic ratio (NHR) values were tabulated. Maximum phonation time (MPT) was measured by asking the subject to take a deep breath and prolong the vowel /a/ for as long as and as steadily as possible. A stopwatch was used to measure the duration of this prolonged phonatory effort in seconds. Laryngeal stroboscopic images were obtained during constant vowel /i/ phonation with the Kay Elemetrics Laryngovideostroboscopy system (model No. 9100) and a 70 rigid endoscope (model No. 9105). Paired nonparametric comparison (Wilcoxon signed rank test) was used to compare parameters in pre- and postinjection, and the Friedman test was used to assess differences between follow-up parameters. All analyses were carried out using SPSS (release 15; Chicago, IL). RESULTS
The majority of patients with UVFP had a history of previous operation (23 cases: 79.3%) including thyroidectomy (15 cases), thoracic surgery (7 cases), and a surgery for parapharyngeal tumor (1 case). There were also unknown origin (5 cases: 17.3%) and pulmonary tuberculosis (1 case: 3.4%) for the cause of UVFP. All patients tolerated the injection and its related procedure. The mean operation time for preparing and mincing auricular cartilage with harvesting abdominal fat was 0.05) in MPT, jitter, shimmer, and NHR. There was no one who needed and performed the additional intervention for UVFP. DISCUSSION
Although the vocal fold augmentation using various material, such as collagen, fat, fascia, hydroxylapatite, dextranomeres in hyaluronan and hyaluronic acid, have been used, the ideal material has not yet been found. An ideal material of injection laryngoplasty should posses the following characteristics as stated by Karpenko et al.9: (1) little or no resorption, (2) high tissue biocompatibility to maintain fluency of vibration of the vocal fold mucosa, (3) no tissue reactivity at the injection site, (4) reversibility or potential for later modification, (5) easy handling and administration in either the operating room or office setting, (6) no migration of the injected material. Although calcium hydroxylapatite is FDA approved for vocal fold medialization and appears extremely promising for the treatment of glottal insufficiency, it can produce a minor inflammation response (chronic inflammation with foreign body giant cells).13,16 In some patients, calcium hydroxylapatite can cause an intense inflammatory reaction, potentially migrate, and compromise vocal fold function. It should be used with full understanding of the potential serious adverse reactions and risk of at least minor impairment of vibratory function.17 In animal studies, we demonstrated that injected cartilage had little or no resorption in the vocal fold at 3 years after injection.14,15 There was no disturbance of mucosal vibration because the autologous cartilage was injected into the vocalis muscle. There was no foreign body reaction or granuloma in the injection site because autologous cartilage has superior histocompatibility compared to alloplastic
JOURNAL OF BIOMEDICAL MATERIALS RESEARCH B: APPLIED BIOMATERIALS | JAN 2015 VOL 103B, ISSUE 1
49
TABLE I. Summary of Pre- and Postinjection Voice Measurements
Parameters G (SD); p valuea R (SD); p valuea B (SD); p valuea MPT, s (SD); p valuea Jitter, (SD); p valuea Shimmer, (SD); p valuea NHR, (SD); p valuea
Preinjection; N 5 29 2.6 0.4 2.3 8.7 4.8 6.0 0.3
(0.5) (0.5) (0.5) (2.9) (2.3) (3.7) (0.1)
3 Months Postinjection; N57
6 Months Postinjection, N54
12 Months Postinjection, N 5 18
0.8 (0.7); 0.05 0.7 (0.6);
Department of Otorhinolaryngology—Head and Neck Surgery, Ilsan Hospital, Dongguk University, Goyang, Gyeonggi, Korea Department of Otorhinolaryngology—Head and Neck Surgery, Pusan National University School of Medicine and Medical Research Institute, Busan, Korea 3 Department of Otorhinolaryngology—Head and Neck Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea 4 Department of Plastic Surgery, Pusan National University School of Medicine and Medical Research Institute, Busan, Korea 2
Received 17 December 2013; revised 3 April 2014; accepted 12 April 2014 Published online 25 April 2014 in Wiley Online Library (wileyonlinelibrary.com). DOI: 10.1002/jbm.b.33189 Abstract: We evaluated the efficacy and outcome of intracordal auricular cartilage injection in patients with unilateral vocal fold paralysis. Our interest developed from findings of a canine model study that reported that histologic characteristics of cartilage were preserved 2 and 3 years after intracordal autologous cartilage injection. Between May 2002 and July 2010, 29 patients with breathy dysphonia caused by unilateral vocal fold paralysis underwent intracordal auricular cartilage injection. Each subject underwent preoperative and postoperative perceptual assessments, acoustical voice analysis, and videostroboscopy. Fourteen patients were male, and the mean age was 52-years old. Patients were tracked for a mean duration of 257 days. Injections were performed through a transoral approach under general anesthesia. Per-
ceptual assessments by GRBAS scale, acoustic parameters of jitter, shimmer, noise-to-harmonic ratio, and maximum phonation time significantly improved at 3, 6, and 12 months after cartilage injection (p < 0.005). No major complications were observed after injection. Initial clinical results with intracordal auricular cartilage injection are promising for patients with unilateral vocal fold paralysis. Autologous auricular cartilage can be a safe, effective, and alternative material for vocal fold medialization, and can be a long lasting one. C 2014 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl BioV
mater, 103B: 47–51, 2015.
Key Words: cartilage, vocal cord paralysis, medialization laryngoplasty, voice quality
How to cite this article: Lim Y-S, Lee Y-S, Lee J-C, Lee B-J, Wang S-G, Park H-J, Nam S-B, Bae Y-C. 2015. Intracordal auricular cartilage injection for unilateral vocal fold paralysis. J Biomed Mater Res Part B 2015:103B:47–51.
INTRODUCTION
With glottic incompetence due to unilateral vocal fold paralysis (UVFP), patients complain about breathy voice and sometimes aspiration problem. Treatments for glottic incompetence include thyroplasty type I, arytenoid adduction, and intracordal injection using various materials. The thyroplasty type I and arytenoid adduction require relatively long surgical time and scar formation due to anterior neck skin incision.1 The intracordal injection is simple and does not require neck skin incision, and is widely used for vocal fold augmentation. Over the years, many different materials, such as, paraffin,2 bone paste,3 bovine collagen,4 and Teflon,5 have been used for augmentation of vocal cord. The substances that are most commonly injected today include collagen,6 fat,7 fascia,8 cymetra,9 hyalurononic acid,10 and hydroxylapatite.11 All have drawbacks, including resorption (collagen, fat, fascia), immunological consequences (bovine collagen), a lack of long-term results beyond 2 years (collagen, fascia,
cymetra, hyalurononic acid, and hydroxylapatite), no US Food and Drug administration approval (hyaluronic acid, bovine collagen, and polydimethylsiloxane12), and foreign body reaction (hydroxylapatite).13 Grafted cartilage has a high survival rate, a low absorption rate and small voluminous change. Therefore, it is widely used for otologic surgery and rhinoplasty. In our animal studies, we demonstrated that the autologous auricular cartilage graft is well tolerated and may be very effective material for long-term volumetric augmentation on paralyzed vocal fold.14,15 The purpose of this study was to report the efficacy of intracordal auricular cartilage injection (IACI) for medialization of the vocal fold in patients with UVFP by objective and subjective preoperative and postoperative criteria. MATERIAL AND METHODS
We reviewed the charts and videostroboscopic records of patients diagnosed with UVFP from January 2002 to July,
Correspondence to: B.-J. Lee (e-mail: [email protected]) Contract grant sponsor: Pusan National University Research Institute; contract grant number: 2012-16
C 2014 WILEY PERIODICALS, INC. V
47
FIGURE 1. Auricular cartilage. (A) The cartilage was harvested from the auricle. (B) The cartilage was minced into small pieces using sharp scissors and scalpel. [Color figure can be viewed in the online issue, which is available at wileyonlinelibrary.com.]
2010 at Pusan National University Hospital. In this period, 274 patients were diagnosed with UVFP, and intracordal auricular cartilage injection (IACI) was performed in 29 patients who agreed to IACI procedure with informed consent. We also obtained approval from the ethical committee. All subjects gave a standard history and underwent physical examination with diagnostic workup for vocal fold paralysis. All 29 patients were observed for at least 3 months after last injection. The mean patient age was 52 years (range, 27–72 years), and 14 (48.3%) patients were male. Before performing the surgical procedures, we evaluated the state of laryngeal exposure. Cartilage and fat were harvested from auricle and abdomen under general anesthesia [Figure 1(A)]. Cartilage was obtained by posterior auricular vertical incision and it was minced with a scalpel and #15 blade into small pieces for passage of needle [Figure 1(B)]. For loading and vehicle of cartilage, 2 g of abdominal fat was obtained by a small periumbrical incision and cut into pieces. The minced cartilage was put into a 1-mL syringe that was then filled with fat (Figure 2). The 1-mL syringe filled with the minced cartilage and fat was connected to a
Bruning injector and connected to a 19-gauge needle. The needle was filled and prepared with the cartilage up to its tip with several clicks (Figure 3). The rigid laryngoscope was introduced and cartilage was injected into the vocalis muscle at the junction of the middle and posterior third of the vocal fold under laryngeal microscope with the slope of the Bruning injector needle made to face outside. Great care was taken not to inject material superficial to the vocal ligament, which can result in permanent dysphonia, and not to let the implanted material leak out of the injection point for a little bit of over-correction. The amount of injected cartilage was about 0.5 mL, but it varied and depended on the individual for optimal consequences. Antibiotic and mucolytic drugs were prescribed for the postoperative recuperation period. Pretreatment and post-treatment examinations and tests were collected from patient who were followed up at 3-, 6-, and 12-months postinjection. Video laryngostroboscopy, grade, roughness, breathiness, asthenia, strain scale (GRBAS) perceptual evaluation; and maximum phonation time (MPT) measurements were
FIGURE 2. Filling the syringe with cartilage (arrow head). Additional fat (arrow) was used as a vehicle of filling and emptying the needle. [Color figure can be viewed in the online issue, which is available at wileyonlinelibrary.com.]
FIGURE 3. Injection of autologous cartilage through Bruning injector. Cartilage was easily injected without resistance. [Color figure can be viewed in the online issue, which is available at wileyonlinelibrary.com.]
48
LIM ET AL.
CARTILAGE INJECTION FOR VOCAL FOLD PARALYSIS
ORIGINAL RESEARCH REPORT
FIGURE 4. Vocal fold vibratory patterns during phonation by serial stroboscopic images of patient who underwent IACI to left vocal fold more than 2-years ago. The mucosal waves and complete glottal closure can be noticed. [Color figure can be viewed in the online issue, which is available at wileyonlinelibrary.com.]
obtained. GRBAS and MPT were measured by a single speech language pathologist at the time of patients’ visits in a blinded fashion. The patients were instructed to sustain the vowel sound /a/. A 2-s data sample was used for analysis by the Kay Elemetrics Compterized Speech Lab (CSL model No. 4300). From the sustained vowel /a/, fundamental frequency, jitter, shimmer, and noise-to-harmonic ratio (NHR) values were tabulated. Maximum phonation time (MPT) was measured by asking the subject to take a deep breath and prolong the vowel /a/ for as long as and as steadily as possible. A stopwatch was used to measure the duration of this prolonged phonatory effort in seconds. Laryngeal stroboscopic images were obtained during constant vowel /i/ phonation with the Kay Elemetrics Laryngovideostroboscopy system (model No. 9100) and a 70 rigid endoscope (model No. 9105). Paired nonparametric comparison (Wilcoxon signed rank test) was used to compare parameters in pre- and postinjection, and the Friedman test was used to assess differences between follow-up parameters. All analyses were carried out using SPSS (release 15; Chicago, IL). RESULTS
The majority of patients with UVFP had a history of previous operation (23 cases: 79.3%) including thyroidectomy (15 cases), thoracic surgery (7 cases), and a surgery for parapharyngeal tumor (1 case). There were also unknown origin (5 cases: 17.3%) and pulmonary tuberculosis (1 case: 3.4%) for the cause of UVFP. All patients tolerated the injection and its related procedure. The mean operation time for preparing and mincing auricular cartilage with harvesting abdominal fat was 0.05) in MPT, jitter, shimmer, and NHR. There was no one who needed and performed the additional intervention for UVFP. DISCUSSION
Although the vocal fold augmentation using various material, such as collagen, fat, fascia, hydroxylapatite, dextranomeres in hyaluronan and hyaluronic acid, have been used, the ideal material has not yet been found. An ideal material of injection laryngoplasty should posses the following characteristics as stated by Karpenko et al.9: (1) little or no resorption, (2) high tissue biocompatibility to maintain fluency of vibration of the vocal fold mucosa, (3) no tissue reactivity at the injection site, (4) reversibility or potential for later modification, (5) easy handling and administration in either the operating room or office setting, (6) no migration of the injected material. Although calcium hydroxylapatite is FDA approved for vocal fold medialization and appears extremely promising for the treatment of glottal insufficiency, it can produce a minor inflammation response (chronic inflammation with foreign body giant cells).13,16 In some patients, calcium hydroxylapatite can cause an intense inflammatory reaction, potentially migrate, and compromise vocal fold function. It should be used with full understanding of the potential serious adverse reactions and risk of at least minor impairment of vibratory function.17 In animal studies, we demonstrated that injected cartilage had little or no resorption in the vocal fold at 3 years after injection.14,15 There was no disturbance of mucosal vibration because the autologous cartilage was injected into the vocalis muscle. There was no foreign body reaction or granuloma in the injection site because autologous cartilage has superior histocompatibility compared to alloplastic
JOURNAL OF BIOMEDICAL MATERIALS RESEARCH B: APPLIED BIOMATERIALS | JAN 2015 VOL 103B, ISSUE 1
49
TABLE I. Summary of Pre- and Postinjection Voice Measurements
Parameters G (SD); p valuea R (SD); p valuea B (SD); p valuea MPT, s (SD); p valuea Jitter, (SD); p valuea Shimmer, (SD); p valuea NHR, (SD); p valuea
Preinjection; N 5 29 2.6 0.4 2.3 8.7 4.8 6.0 0.3
(0.5) (0.5) (0.5) (2.9) (2.3) (3.7) (0.1)
3 Months Postinjection; N57
6 Months Postinjection, N54
12 Months Postinjection, N 5 18
0.8 (0.7); 0.05 0.7 (0.6);
