GELFOAM PASTE INJECTION FOR VOCAL CORD PARALYSIS:
`TEMPORARY REHABILITATION OF
`GLOTTIC INCOMPETENCE.’~“"i‘
`
`VICTOR L. SCHRAMM, JR., M.D.,
`MARK MAY, M.D.,
`and
`
`ALFRED S. LAVORATO, Ph.D.,
`
`Pittsburgh, Pa.
`
`ABSTRACT.
`
`Vocal cord paralysis frequently results in open glottic incompetence with aspiration, an
`ineffective cough, and poor voice production. Glottic competence can be restored tempo-
`rarily by injecting the true vocal cord with Gelfoam paste. This clinical use of Gelfoam for
`temporary rehabilitation is indicated in: 1) situations in which paralysis may be temporary,
`2) patients for whom an open operative procedure must be delayed, and 3) circumstances
`in which it is desirable to determine the effect of vocal cord injection prior to placement of
`nonabsorbable material. The injection of Gelfoam paste results in minimal tissue reaction.
`Absorption is gradual over a period of six to ten weeks, allowing time for some glottic
`compensation. The injection may be repeated without adverse effects until the paralysis
`resolves or intervention of a permanent nature is indicated.
`
`.__..._:.O.___:
`
`Disturbances of the glottic sphincter which cause open incompetence of
`the glottis may produce major changes in swallowing, coughing, and pho-
`nation. Incomplete apposition of the true Vocal cords in these situations
`may be corrected temporarily by the injection of Ge1foam®i paste. The
`Gelfoam® paste injection technique, its clinical usefulness, and the histo-
`logic results of injection form the basis of this presentation.
`
`REVIEW OF LITERATURE.
`
`Laryngeal disability resulting from incomplete glottic closure may result
`from laryngeal paralysis or from congenital, surgical, or traumatic vocal
`cord volume deficiency. Injection of the vocal cord has been used for all
`of these situations. Briiningsf in 1911, injected paraffin into vocal cords
`and was the first to report the results of such a procedure. Arnold“ in-
`vestigated suitable substances for injection,
`including cartilage, bovine
`bone dust, tantalum powder, and Teflon®§ suspended in glycerine. He
`found that Teflon® is the most suitable material in that it is well-tolerated,
`is not absorbed and is easily injected through the long needle of the Brun-
`ings syringe? The efficacy of Teflon Vocal cord injection was established
`by Lewy in his review of the experiences (including his own) of 38 in-
`Vestigatorsfi
`
`*Presented at the Meeting of the Eastern Section of the American Laryngological, Rhinological
`and Otological Society, Inc., Pittsbur‘g'h, 1331., January 7, 1978.
`’rFrom the Department of Otolaryngology, University of Pitt.sburg'l1 School of Medicine, Eye and
`Ear Hospital, Pittsburgh, Pa.
`iThe Upjohn Company, Kalamazoo, Mich.
`§Codma.n and Shurtlcff, 1100., Randolph, Mass.
`Send Reprint Requests to Victor L. Schramm, .Ir., M.D., I)L-pi. of Otola1'yng.'olog'y, Eye and Ear
`Hospital, Pittsburgh, Pa. 15213.
`
`1268
`
`ETHICON EXHIBIT 1007
`
`ETHICON EXHIBIT 1007
`
`

`
`SCHRAMM, ET AL.: GELFOAM INJECTION.
`
`1269
`
`
`
`Fig. 1. Left: Gelfoam paste rolled and placed in 5 cc syringe. Right: Paste injected into Arnold-
`Briinings syringe reservoir.
`
`Incomplete glottic closure is the primary indication for Teflon injection.
`Complications of Teflon injection to date have primarily been related to
`mechanical misplacement of the material or over-injection and occur in
`approximately 10% of cases. Contraindications for Teflon injection include
`paralysis of less than six months duration, lack of attempted rehabilitation
`through voice therapy, and the possibility that the vocal disability is not
`entirely due to inadequate glottic closure?
`
`Three types of materials have been described for temporary vocal cord
`injection. LeWy7 used glycerine injected with a three—ring syringe via
`indirect laryngoscopv. Arnoldz used liouid gelatin. and Rubins reported on
`the use of sesame oil. Because all of these materials have low viscosities,
`the Briinings gun-type syringe cannot be used to inject them. More im-
`portantly,
`the duration of their effectiveness is less than 1 Week and
`usually only 2 or 3 days.
`
`Gelfoam® was developed as a hemostatic material. It is used widely in
`otologic surgery as a foam or film (the latter is marketed as Gelfilm). The
`foam, when filled with blood, may act as a scaffold for fibrous tissue
`ingrowth9 while Gelfilm” may provoke a temporary round cell infiltrate
`at the tissue interface but is not permeated by blood, and leaves only a
`thin fibrous scar after absorption. Gelfoam powder is used as a dressing
`material for open wounds and as a hemostatic material for bone bleeding‘.
`Tissue tolerance has been excellent for all forms of Gelfoam. When Gel-
`foam is placed in muscle, it remains for 2 to 5 weeks.“ The more dense
`Gelfilm remains in the middle ear about 6 weeks. Gelfilm dural or ocular
`implants are gradually absorbed over 8 to 12 weeks.” The rate of absorp-
`tion depends upon the density of the implanted material and the metabolic
`activity of the receptor tissue.
`
`MATERIALS AND METHODS.
`
`Sterile Gelfoam powder and physiologic saline are mixed immediately prior to vocal cord in-
`jection. One gram of Gelfoam powder is placed in a dish and 4.0 cc of saline is added slowly
`while mixing constantly. The viscosity of the mixture may be varied somewhat, but additional
`saline decreases the duration of Gelfoam retention in the vocal cord. The resulting 5 cc of thick
`paste is placed into the open barrel of a 5 cc syringe and then injected into the Arnold—Briinings
`injection system (Fig. 1). The viscosity of the Gelfoam aste is nearly the same as that of Teflon
`paste, and since the material is cohesive when injected? through a needle, the Teflon injection
`technique with the Arnold-Briinings system may be used (Figs. 2 and 3). It is recommended
`that the voice be rested completely for 24 hours following the injection to minimize postoperative
`edema and possible Gelfoam extrusion.
`We have injected Gelfoam paste into the true vocal cords of 25 patients. Vocal cord paralysis
`had followed craniotomy, thyroidcctomy. neck or thoracic surgery in 17 patients, and was of
`unknown etiology in 7 patients. One patient was injected to compensate for aspiration following
`supraglottic laryngectomy.
`
`INDICATIONS AND CONTRAINDICATIONS.
`
`Indications for Gelfoam paste injection complement the indications for
`
`

`
`
`
`Fig. 2. Cohesive Gelfoam paste extruded through 18 ga. side delivery dopth—eontrol needle.
`
`
`
`Fig. 3. Gelfoam paste injection of fresh cadaver hemilarynx. Vocal process transected vertical-
`ly following injection of Gelfoam (arrow) with side delivery needle. Dense Gelfoam paste re-
`mains well localized.
`
`permanent Teflon injection. Any laryngeal abnormality involving open
`glottic incompetence with excessive air escape, poor voice, inability to in-
`crease subglottic pressure with coughing, or a chronically open posterior
`commissure with aspiration may benefit from Gelfoam injection. Gelfoam
`should be used in cases of glottic incompetence which are thought to be
`temporary and as a diagnostic test if doubt exists as to the efficacy of
`permanent injection. It may be used at any time following the onset of
`vocal cord paralysis to decrease aspiration or improve Voice, and is partic-
`ularly useful in association with voice therapy to improve the assessment
`of probable results of a more permanent procedure.
`
`The only contraindication to vocal cord injection with a temporary ma-
`terial remains the possibility of bilateral vocal cord paralysis; a decrease
`in glottic airway without a mobile Vocal cord to compensate will not be
`tolerated. A relative contraindication to injection of a temporary sub-
`stance exists when the vocal paralysis is known to be permanent and
`immediate permanent rehabilitation is desired.
`
`

`
`SCHRAMM, ET AL.: GELFOAM INJECTION.
`
`1271
`
`RESULTS.
`
`In patients injected with Gelfoam paste because of aspiration, return
`of ability to cough effectively and to swallow without aspiration was
`immediate. In eight patients who had not had antecedent tracheostomy but
`who were injected for aspiration, this ability persisted because they were
`able to learn to compensate during the time when the Gelfoam was gradu-
`ally absorbed from the vocal cord. Tracheostomy for respiratory support
`and tracheal suction had been done in seven patients prior to vocal cord
`injection; three of these patients had multiple unilateral cranial nerve
`defects involving combinations of cranial nerves V through XII. The loss
`of pharyngwl and laryngeal sensation, along with cord paralysis, was the
`most difficult rehabilitation problem in these patients, but with instructions
`regarding the method of swallowing with a closed glottis all but one patient
`were extubated. Four of the tracheostomized patients had return of cord
`mobility, and compensation techniques learned during the slow absorption
`of Gelfoam allowed two others to function adequately and to avoid aspira-
`tion even with a permanently lateral cord position. The patient with aspi-
`ration following supraglottic laryngectomy ultimately required completion
`of the laryngectomy.
`
`Voice improvement was good to excellent in all patients following Gel-
`foam injection. Because of the relatively long period of cord stability fol-
`lowing Gelfoam injection, the patients were able to practice and to improve
`the quality of their voice with or without speech therapy. The vocal cord
`characteristics following Gelfoam injection were clinically identical
`to
`those heard following Teflon injection.
`
`in-
`The vocal cord reaction to Gelfoam injection was innocuous in all
`stances. Local mild mucosal edema at the injection sites resolved in 2 or
`3 days, and no further reactions developed. After mucosal edema had
`subsided, the vocal cord appeared to be normal except for the increase
`in its bulk and its near-midline position, both caused by the Gelfoam in-
`jection. During the first 3 or 4 weeks following injection, there was little
`change in the appearance of the vocal cords, but after one month a gradual
`decrease in cord bulk then occurred over the next 4 to 6 weeks. By 10 weeks
`after the injection the vocal cords had returned to their appearances be-
`fore the injection. Two patients had second Gelfoam injections prior to
`Teflon injections. Their reactions to the second Gelfoam injections were
`identical to those observed for the first injections.
`
`Histologic results of examination of a vocal cord removed at completion
`laryngectomy 8 weeks following Gelfoam paste injection are seen in Figure
`4. No inflammatory reaction or fibrosis is seen within the Gelfoam mass.
`A thin fibrous capsule is present around the Gelfoam and there is minimal
`inflammatory reaction in adjacent Vocal cord muscle.
`
`N o untoward result occurred from Gelfoam injection, although the Gel-
`foam paste was extruded 2 weeks after its injection in one instance. This
`was due to superficial injection with a standard injection needle, a prob-
`lem that has subsequently been overcome with the development of a side
`delivery depth-control needle system. One patient was injected 6 days fol-
`lowing mitral Valve replacement and 2 days following discontinuation of
`Coumadin anticoagulation therapy. She developed a hypopharyngeal hema-
`toma from glossopharyngeal and superior laryngeal nerve blocks but had
`no vocal cord ecchymosis. The hemostatic property of Gelfoam and the
`local tissue pressure resulting from the injection no doubt were beneficial
`
`

`
`Fig. 4. H and E section of Gelfoam paste in vocal cord 8 weeks following injection. Left: G -
`Gelfoam. F - Thin fibrous capsule. M — Vocal cord muscle (original magnification 24X). Right:
`G - Gelfoam paste with sparse round cell infiltrate. F - Gelfoam-muscle interface with no in-
`flammatory reaction. M - Normal muscle (original magnification 48X).
`
`in this situation. A trial injection was done for one patient who had an
`idiopathic left vocal cord para.lysis and a mild right paresis with poor
`voice quality and poor cough. He had marked improvement in his voice
`and cough but felt restricted during active exercise or participation in
`sports. Injection of a permanent material was not done in this case.
`SUMMARY.
`
`The advantages of Gelfoam for temporary injection make it a useful
`addition to compensatory therapy for vocal cord paralysis. Although it is
`a temporary treatment, the duration of the effects of Gelfoam injection
`is 8 to 10 Weeks. The effective duration may be decreased, to an extent, by
`increasing the amount of saline used to constitute the paste or decreasing
`the amount of material injected. During the several Weeks when the in-
`jected volume is relatively constant, speech and swallowing may be prac-
`ticed. The slow resorption of the injected material allows for gradual
`compensation in these functions. The injected material has the same con-
`sistency as Teflon, which permits use of the same techniques and equip-
`ment for injection of both materials. The lack of tissue reaction to Gelfoam
`paste is impressive and clinically is less than for Teflon paste.
`
`No disadvantages of Gelfoam injection have been noted. The use of
`Gelfoam paste as a temporary remedy for vocal cord incompetence has
`been found to be effective and safe in 25 patients.
`ACKNOWLEDGMENT.
`
`The authors thank Raimund G. Rueger, M.D. and David R. Rogerson,
`M.D. for allowing the histologic evaluation of the laryngeal specimen.
`
`

`
`SCHRAM M, ET AL.: GELFOAM INJECTION.
`
`1273
`
`BIBLIOGRAPHY.
`
`'1. BBi'ININGs, VV.: Uber eine neue behancllungsrnethode der recurrenslahrnung. Verh. Dcutche
`Laryngol, 18:151, 1911.
`
`Intra—
`
`IX. Technique of
`
`2. ARNOLD, G. E.: Vocal. Rehabilitation of Paralytic Dysphonia.
`chordal Injection. Arch. Otolaryngol, 76:358—368, 1962.
`3. ARNOLD, G. E.: Vocal Rehabilitation of Paralytic Dysphonia. X. Functional Results of In-
`traehordal Injection. Arch. Otolaryngol, 78:l79-186, 1963.
`4. ARNOLD, G. E.: Alleviafion of Aphonia or Dysphonia Through Intrachordal Injection of
`Teflon Paste. Ann. Otol. Rhlnol. Laryrigol, 72:384-395, 1963.
`5. KIRCHNER, F. R., TOLEDO, P. S. and SVOBODA, D. ].: Studies of the Larynx After Teflon In-
`jection. Arch. Otolaryngol, 83:350-354, 1966.
`6. LEWY, R. B.: Experience with Vocal Cord Injection. Ann. Otol., 85:440—450, 1976.
`7. LEWY, R. B.: Tracheotomy Avoidance: Glycerine Vocal Cord Injection. Arch. Otolaryngol.,
`922502-504, 71970.
`8. RUBIN, H. J.: Misadventures with Injectable Polytef (Teflon). Arch. Otolaryngol, 101:
`114-116, 1975.
`9.
`]osE1>H, R. B.: The Effect of Absorable Gelatin Sponge Preparations and Other Agents on
`Scar Formation in the Dog’s Middle Ear. THE LARYNGOSCOPE, 72:1528-1548, 1962.
`I0. HOLZER, F .: The Fate of Gelatin Film in the Middle Ear. Arch. Otolaryngol, 98:319-321,
`1973.
`
`11. JENKINS, H. P. and CLARKE, J. S.: Gelatin Sponge, a New Hemostatic Substance —
`Studies on Absorbability. Arch. Surg., 51:253-261, 1945.
`12. DANIELE, S., ET AL.: Gelatin as an Absorbable Implant in Scleral Buckling Procedures.
`Arch. Ophthalmol., 80:115-119, 1968.
`See Discussion on Page 1278.
`
`CALL FOR PAPERS.
`
`The 36th Annual Meeting of the American Cleft Palate Associa.tion, San
`Diego, California, will be held February 25-March 1, 1979.
`
`The Program Committee is soliciting from members and friends scien-
`tific papers, exhibits, motion pictures, videotapes, and poster sessions
`dealing with all aspects of crahlofacial malformation. Entries to be con-
`sidered for presentation at the annual meeting must be submitted on
`official forms, which can be obtained from the Program Chairman. The
`deadline for submission of abstracts is September 30, 1978. Acceptance
`letters will be mailed November 22, 1978.
`
`For more information contact: William S. Garrett, Jr., M.D., Program
`Chairman, 3600 Forbes Avenue, Pittsburgh, Pa. 15213,