Ann Otol Rhinal Laryngol99: 1990
TRANSCUTANEOUS INTRAFOLD INJECTION FOR UNILATERAL VOCAL FOLD PARALYSIS: FUNCTIONAL RESULTS MINORU HIRANO, MD
SHINZO TANAKA, MD
YASUMASA TANAKA, MD
SEISHI HIEI, PHD KURUME, JAPAN
This paper presents the technique of transcutaneous intrafold silicone injection and the functional results of 44 procedures in 42 patients. The injection is given under local anesthesia with the patient in a supine position. The needle is inserted through the cricothyroid space. The location of the needle as well as the effect of injection is monitored by means of a fiberscope connected to a television camera and screen. The preoperative and postoperative vocal function was multidimensionally evaluated with the use of a test battery consisting of the maximum phonation time (MPT), mean airflow rate (MFRc), fundamental frequency (FO) range and sound pressure level (SPL) range of phonation, pitch perturbation quotient (PPQ), amplitude perturbation quotient (APQ), and normalized noise energy (NNEa). In the majority of the patients, MPT, FO range, and SPL range increased and MFRc, PPQ, APQ, and NNE a decreased postoperatively. In the overall evaluation based on the test values of these parameters, the result was excellent for 16 procedures, good for 16, fair for 7, and poor for 5. The most frequent cause of failure was an insufficient amount injected. KEY WORDS -
functional results, intrafold injection, transcutaneous approach, vocal fold paralysis.
Many surgical techniques have been successfully employed worldwide in treating glottic incompetence caused by unilateral vocal fold paralysis. They can be classified into three major categories: medialization surgery, intrafold injection, and neuromuscular surgery. Techniques of medialization surgery can be further classified into three major groups: surgical augmentation, medial shift of the thyroid cartilage, and rotation of the arytenoid cartilage. Intrafold injection can be performed transorally by use of a direct laryngoscope or an indirect laryngeal mirror, or transcutaneously through the cricothyroid space. 1
con 6500 Additive, a viscosity of 100 centistokes. Prior to injection, they are mixed in the ratio of 1:2 to 1:3, and then a few drops of catalyzer are added for the purpose of solidification. It takes 10 to 15 minutes for Phycon to solidify following the addition of the catalyzer. Injection should be completed before Phycon is solidified. Following local anesthesia of the nasal, pharyngeal, and laryngeal mucosa, the patient assumes a supine position with the anterior neck stretched. A fiberscope is inserted into the larynx via the nose and the fiberscopic laryngeal image is viewed on a television screen throughout the procedure. The entire procedure is also documented on videotape.
The senior author (M.H.) of this paper was trained first with the surgical augmentation technique in 1959. Since then, we have employed several techniques, including surgical augmentation, medial shift of the thyroid cartilage, and transoral and transcutaneous intrafold injections. Since 1983, because of its technical simplicity, minimum surgical invasion, and wide applicability, transcutaneous injection has been the first choice in our institution for nearly all patients with unilateral vocal fold paralysis who require surgical treatment. A preliminary report of this procedure was given in 1985. 2 The purposes of this paper are to describe the technique in detail and to report objective functional results in a series of patients.
Injection is given with a 2-mL locking syringe and a dental needle. Hypodermic anesthesia is performed at the injection site. The location of the vocal fold is estimated as shown in Fig 1. The vocal fold edge is usually positioned horizontally at the midlevel of the anterior angle of the thyroid cartilage. The tip of the vocal process of the arytenoid cartilage is located approximately at the anteroposterior midpoint of the thyroid lamina. The membranous vocal fold is, therefore, located in the anteroinferior quadrant of the thyroid lamina. In order to facilitate a correct placement of the injection needle, it is advisable to mark the estimated location of the vocal fold edge and that of the vocal process on the cervical skin, as well as the location of the upper, lower, and posterior edges of the thyroid cartilage; the upper and lower edges of the cricoid arch; and the midline (Fig 2A). The depth of needle insertion is also estimated prior to insertion (Fig 2B).
METHODS AND SUBJECTS
Injection Technique. We employ Phycon 6500 and Phycon 6500 Additive medical silicone rubber (Fuji Industrial Co, Tokyo, Japan), which was first used for intrafold injection by Fukuda." Phycon 6500 has a viscosity of 10,000 centistokes and Phy-
From the Department of Otolaryngology-Head and Neck Surgery, Kurume University, Kurume, Japan. Presented at the meeting of the American Laryngological Association, Palm Beach, Florida, April 28-29, 1990. REPRINTS - Minoru Hirano, MD, Dept of Otolaryngology-Head and Neck Surgery, Kurume University, 67 Asahi-rnachi, Kurume, Japan 830.
598
Downloaded from aor.sagepub.com at UNIV OF PENNSYLVANIA on June 17, 2015
599
Hirano et al, Transcutaneous Intrajo1d Injection
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Fig 1. Estimation of location of tip of vocal process (VP) and vocal fold (dotted area).
The needle is inserted at the level of the upper edge of the cricoid arch, approximately 5 mm from the midline on the paralyzed side. It is directed posteriorly, superiorly, and laterally between the thyroid and cricoid cartilages. In order to monitor its location, the needle is gently shaken medially back and forth as it proceeds. When small movements are observed in the region lateral and slightly anterior to the tip of the vocal process, the injection is started. The bevel of the needle must be directed laterally so that the silicone rubber does not enter the mucosa. Once the silicone rubber enters the mucosa, the mucosa becomes stiff and, consequently, disturbances of vocal fold vibration and dysphonia may result. Injection is performed slowly and carefully with visual and auditory monitoring. Figure 3 shows laryngeal images of a patient before and after injection.
Subjects. During the period from July 1983 to April 1989, a total of 51 patients, 30 males and 21 females, underwent transcutaneous intrafold injec-
tion for unilateral vocal fold paralysis. Their ages ranged from 17 to 81 years, with a mean age of 56.7 years. The cause of paralysis was thyroid cancer or its surgical treatment in 11 cases, esophageal cancer or its surgical treatment in 10, lung cancer or its surgical treatment in 8, aortic aneurysm or its surgical treatment in 4, a heart operation in 1, vertebral operations in 2, operation on the neck in 1, neck trauma in 1, and neuritis in 13. Two patients underwent two procedures because the first was not very successful. The preoperative and postoperative vocal function was evaluated for 44 procedures in 42 patients. The other 9 patients did not come back for postoperative evaluation. This paper describes the functional results of the 44 procedures.
Evaluation of Vocal Function. The vocal function was evaluated by means of seven measures: maximum phonation time (MPT) , mean airflow rate during phonation over comfortable duration (MFRc), fundamental frequency (Fa) range of phonation, sound pressure level (SPL) range of phonation, pitch perturbation quotient (PPQ), amplitude perturbation quotient (APQ), and normalized noise energy for the frequency band 0 to 4 kHz (NNE a) . The first two reflect the degree of glottic incompetence, the following two roughly show the ability of Fa and SPL control, and the last three reflect some important aspects of voice quality. The postoperative evaluation was conducted 1 to 1,701 days following injection. Evaluation was repeated on different occasions in some patients. It was impossible to evaluate the vocal function at the same given interval after injection in all subjects. Figure 4 depicts temporal changes of MFRc and PPQ following injection. There were no consistent and systematic changes in MFRc and PPQ that depended on the interval following injection. This was also the case with the other five test items. Therefore, the most recent test values for each procedure were employed in the following data analyses. For each test, scores were assigned according to the following rules. When the postoperative value
Fig 2. Photographs of anterior neck. A) Estimated location of tip of vocal process (VP). T lage, ML - midline. B) Estimated depth (arrow) of needle insertion.
Downloaded from aor.sagepub.com at UNIV OF PENNSYLVANIA on June 17, 2015
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cricoid carti-
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Fig 3. Preoperative and postoperative laryngeal images. Note that bowing of vocal fold edge and glottic incompetence are eliminated postoperatively .
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was within normal range, a score of 2 was assigned. When the test value was improved postoperatively but remained out of normal range, a score of 1 was assigned. A score of 0 was assigned when injection caused no change, and a score of - 1 was assigned when the test value was worsened. An overall evaluation was made in the following way. When the sum of the scores for the seven tests was 11 to 14, the result was categorized as excellent. A sum of 6 to 10 was categorized good; 1 to 5, fair; and 0 or less, poor. For five injection procedures, data for Fo range and SPL range were not available, whereas data for all seven tests were obtained for the other 39 procedures. In the former five cases, a sum of the scores of 8 to 10 was categorized excellent; 4 to 7, good; 1 to 3, fair; and 0 or less, poor. Computed Tomography. In order to determine whether or not the injected silicone rubber had stayed in place, computed tomography was conducted on nine patients 63 to 2,156 days after injection. Review oj Injection Procedure. The entire injection procedure for each patient documented on videotape was repeatedly reviewed and the adequacy of each procedure was evaluated. RESULTS
Score jor Each Test. Figure 5 depicts scatterplots of the preoperative and postoperative values of each test, and the Table shows a summary of the results. The majority of the procedures resulted in an improvement for each test, ie, an increase in MPT, Fo
range, and SPL range and a decrease in MFRc, PPQ, APQ, and NNEa. The occurrence of scores of 2 and 1 was most frequent for MPT (89 %), second most frequent for MFRc (84 %), and least frequent for Fo range (69 %). In other words, the effect of intrafold injection was manifested most frequently in an improvement of glottic closure and least frequently in the ability of Fo control. The Fo range was reduced in 10, or 26 %, of the 39 procedures evaluated. Overall Evaluation. The result of the overall evaluation was excellent for 16 procedures, good for 16, fair for 7, and poor for 5. Analyses oj Failures. Among the five procedures with a poor result, the amount of injection was insufficient in three and too much in one procedure. One of the three patients in whom the amount of injection was insufficient underwent another injection later under a direct laryngoscope with an excellent result. The other two were not motivated to have an additional procedure. In the fifth case, the injection was conducted adequately. This patient, however, had a deep sulcus on the affected vocal fold and she developed strained phonation. Both MPT and MFRc were within normal range postoperatively, but PPQ, APQ, and NNEa were increased, reflecting an unfavorable voice quality. Among the seven procedures with a fair result, the amount of injection was not enough in five procedures. Two of the five patients received another transcutaneous injection later with a successful result. In the other three patients, the cause of paralysis had been lung cancer, an operation for lung can-
Downloaded from aor.sagepub.com at UNIV OF PENNSYLVANIA on June 17, 2015
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TRANSCUTANEOUS INTRAFOLD INJECTION FOR UNILATERAL VOCAL FOLD PARALYSIS: FUNCTIONAL RESULTS MINORU HIRANO, MD
SHINZO TANAKA, MD
YASUMASA TANAKA, MD
SEISHI HIEI, PHD KURUME, JAPAN
This paper presents the technique of transcutaneous intrafold silicone injection and the functional results of 44 procedures in 42 patients. The injection is given under local anesthesia with the patient in a supine position. The needle is inserted through the cricothyroid space. The location of the needle as well as the effect of injection is monitored by means of a fiberscope connected to a television camera and screen. The preoperative and postoperative vocal function was multidimensionally evaluated with the use of a test battery consisting of the maximum phonation time (MPT), mean airflow rate (MFRc), fundamental frequency (FO) range and sound pressure level (SPL) range of phonation, pitch perturbation quotient (PPQ), amplitude perturbation quotient (APQ), and normalized noise energy (NNEa). In the majority of the patients, MPT, FO range, and SPL range increased and MFRc, PPQ, APQ, and NNE a decreased postoperatively. In the overall evaluation based on the test values of these parameters, the result was excellent for 16 procedures, good for 16, fair for 7, and poor for 5. The most frequent cause of failure was an insufficient amount injected. KEY WORDS -
functional results, intrafold injection, transcutaneous approach, vocal fold paralysis.
Many surgical techniques have been successfully employed worldwide in treating glottic incompetence caused by unilateral vocal fold paralysis. They can be classified into three major categories: medialization surgery, intrafold injection, and neuromuscular surgery. Techniques of medialization surgery can be further classified into three major groups: surgical augmentation, medial shift of the thyroid cartilage, and rotation of the arytenoid cartilage. Intrafold injection can be performed transorally by use of a direct laryngoscope or an indirect laryngeal mirror, or transcutaneously through the cricothyroid space. 1
con 6500 Additive, a viscosity of 100 centistokes. Prior to injection, they are mixed in the ratio of 1:2 to 1:3, and then a few drops of catalyzer are added for the purpose of solidification. It takes 10 to 15 minutes for Phycon to solidify following the addition of the catalyzer. Injection should be completed before Phycon is solidified. Following local anesthesia of the nasal, pharyngeal, and laryngeal mucosa, the patient assumes a supine position with the anterior neck stretched. A fiberscope is inserted into the larynx via the nose and the fiberscopic laryngeal image is viewed on a television screen throughout the procedure. The entire procedure is also documented on videotape.
The senior author (M.H.) of this paper was trained first with the surgical augmentation technique in 1959. Since then, we have employed several techniques, including surgical augmentation, medial shift of the thyroid cartilage, and transoral and transcutaneous intrafold injections. Since 1983, because of its technical simplicity, minimum surgical invasion, and wide applicability, transcutaneous injection has been the first choice in our institution for nearly all patients with unilateral vocal fold paralysis who require surgical treatment. A preliminary report of this procedure was given in 1985. 2 The purposes of this paper are to describe the technique in detail and to report objective functional results in a series of patients.
Injection is given with a 2-mL locking syringe and a dental needle. Hypodermic anesthesia is performed at the injection site. The location of the vocal fold is estimated as shown in Fig 1. The vocal fold edge is usually positioned horizontally at the midlevel of the anterior angle of the thyroid cartilage. The tip of the vocal process of the arytenoid cartilage is located approximately at the anteroposterior midpoint of the thyroid lamina. The membranous vocal fold is, therefore, located in the anteroinferior quadrant of the thyroid lamina. In order to facilitate a correct placement of the injection needle, it is advisable to mark the estimated location of the vocal fold edge and that of the vocal process on the cervical skin, as well as the location of the upper, lower, and posterior edges of the thyroid cartilage; the upper and lower edges of the cricoid arch; and the midline (Fig 2A). The depth of needle insertion is also estimated prior to insertion (Fig 2B).
METHODS AND SUBJECTS
Injection Technique. We employ Phycon 6500 and Phycon 6500 Additive medical silicone rubber (Fuji Industrial Co, Tokyo, Japan), which was first used for intrafold injection by Fukuda." Phycon 6500 has a viscosity of 10,000 centistokes and Phy-
From the Department of Otolaryngology-Head and Neck Surgery, Kurume University, Kurume, Japan. Presented at the meeting of the American Laryngological Association, Palm Beach, Florida, April 28-29, 1990. REPRINTS - Minoru Hirano, MD, Dept of Otolaryngology-Head and Neck Surgery, Kurume University, 67 Asahi-rnachi, Kurume, Japan 830.
598
Downloaded from aor.sagepub.com at UNIV OF PENNSYLVANIA on June 17, 2015
599
Hirano et al, Transcutaneous Intrajo1d Injection
VP
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I
.
-.
, I
I I
, I
I I
,
..
'. ,,
III
..
III
Fig 1. Estimation of location of tip of vocal process (VP) and vocal fold (dotted area).
The needle is inserted at the level of the upper edge of the cricoid arch, approximately 5 mm from the midline on the paralyzed side. It is directed posteriorly, superiorly, and laterally between the thyroid and cricoid cartilages. In order to monitor its location, the needle is gently shaken medially back and forth as it proceeds. When small movements are observed in the region lateral and slightly anterior to the tip of the vocal process, the injection is started. The bevel of the needle must be directed laterally so that the silicone rubber does not enter the mucosa. Once the silicone rubber enters the mucosa, the mucosa becomes stiff and, consequently, disturbances of vocal fold vibration and dysphonia may result. Injection is performed slowly and carefully with visual and auditory monitoring. Figure 3 shows laryngeal images of a patient before and after injection.
Subjects. During the period from July 1983 to April 1989, a total of 51 patients, 30 males and 21 females, underwent transcutaneous intrafold injec-
tion for unilateral vocal fold paralysis. Their ages ranged from 17 to 81 years, with a mean age of 56.7 years. The cause of paralysis was thyroid cancer or its surgical treatment in 11 cases, esophageal cancer or its surgical treatment in 10, lung cancer or its surgical treatment in 8, aortic aneurysm or its surgical treatment in 4, a heart operation in 1, vertebral operations in 2, operation on the neck in 1, neck trauma in 1, and neuritis in 13. Two patients underwent two procedures because the first was not very successful. The preoperative and postoperative vocal function was evaluated for 44 procedures in 42 patients. The other 9 patients did not come back for postoperative evaluation. This paper describes the functional results of the 44 procedures.
Evaluation of Vocal Function. The vocal function was evaluated by means of seven measures: maximum phonation time (MPT) , mean airflow rate during phonation over comfortable duration (MFRc), fundamental frequency (Fa) range of phonation, sound pressure level (SPL) range of phonation, pitch perturbation quotient (PPQ), amplitude perturbation quotient (APQ), and normalized noise energy for the frequency band 0 to 4 kHz (NNE a) . The first two reflect the degree of glottic incompetence, the following two roughly show the ability of Fa and SPL control, and the last three reflect some important aspects of voice quality. The postoperative evaluation was conducted 1 to 1,701 days following injection. Evaluation was repeated on different occasions in some patients. It was impossible to evaluate the vocal function at the same given interval after injection in all subjects. Figure 4 depicts temporal changes of MFRc and PPQ following injection. There were no consistent and systematic changes in MFRc and PPQ that depended on the interval following injection. This was also the case with the other five test items. Therefore, the most recent test values for each procedure were employed in the following data analyses. For each test, scores were assigned according to the following rules. When the postoperative value
Fig 2. Photographs of anterior neck. A) Estimated location of tip of vocal process (VP). T lage, ML - midline. B) Estimated depth (arrow) of needle insertion.
Downloaded from aor.sagepub.com at UNIV OF PENNSYLVANIA on June 17, 2015
thyroid cartilage, C -
cricoid carti-
600
Hirano et al, Transcutaneous Intrajold lniection
., .e, .,oCI.
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c':
Fig 3. Preoperative and postoperative laryngeal images. Note that bowing of vocal fold edge and glottic incompetence are eliminated postoperatively .
., .e,
> .;;
CI.
o
l
Respiration
Phonation
was within normal range, a score of 2 was assigned. When the test value was improved postoperatively but remained out of normal range, a score of 1 was assigned. A score of 0 was assigned when injection caused no change, and a score of - 1 was assigned when the test value was worsened. An overall evaluation was made in the following way. When the sum of the scores for the seven tests was 11 to 14, the result was categorized as excellent. A sum of 6 to 10 was categorized good; 1 to 5, fair; and 0 or less, poor. For five injection procedures, data for Fo range and SPL range were not available, whereas data for all seven tests were obtained for the other 39 procedures. In the former five cases, a sum of the scores of 8 to 10 was categorized excellent; 4 to 7, good; 1 to 3, fair; and 0 or less, poor. Computed Tomography. In order to determine whether or not the injected silicone rubber had stayed in place, computed tomography was conducted on nine patients 63 to 2,156 days after injection. Review oj Injection Procedure. The entire injection procedure for each patient documented on videotape was repeatedly reviewed and the adequacy of each procedure was evaluated. RESULTS
Score jor Each Test. Figure 5 depicts scatterplots of the preoperative and postoperative values of each test, and the Table shows a summary of the results. The majority of the procedures resulted in an improvement for each test, ie, an increase in MPT, Fo
range, and SPL range and a decrease in MFRc, PPQ, APQ, and NNEa. The occurrence of scores of 2 and 1 was most frequent for MPT (89 %), second most frequent for MFRc (84 %), and least frequent for Fo range (69 %). In other words, the effect of intrafold injection was manifested most frequently in an improvement of glottic closure and least frequently in the ability of Fo control. The Fo range was reduced in 10, or 26 %, of the 39 procedures evaluated. Overall Evaluation. The result of the overall evaluation was excellent for 16 procedures, good for 16, fair for 7, and poor for 5. Analyses oj Failures. Among the five procedures with a poor result, the amount of injection was insufficient in three and too much in one procedure. One of the three patients in whom the amount of injection was insufficient underwent another injection later under a direct laryngoscope with an excellent result. The other two were not motivated to have an additional procedure. In the fifth case, the injection was conducted adequately. This patient, however, had a deep sulcus on the affected vocal fold and she developed strained phonation. Both MPT and MFRc were within normal range postoperatively, but PPQ, APQ, and NNEa were increased, reflecting an unfavorable voice quality. Among the seven procedures with a fair result, the amount of injection was not enough in five procedures. Two of the five patients received another transcutaneous injection later with a successful result. In the other three patients, the cause of paralysis had been lung cancer, an operation for lung can-
Downloaded from aor.sagepub.com at UNIV OF PENNSYLVANIA on June 17, 2015
601
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