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New concepts in prosthetic voice rehabilitation in the laryngectomized patient

Erenstein, S.E.J.

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Citation for published version (APA):Erenstein, S. E. J. (2003). New concepts in prosthetic voice rehabilitation in the laryngectomized patient. s.n.

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Download date: 11 Mar 2021

Chapterr 4:

Locall factors influencing voice prosthetic function

Microbiall colonization of silicone voice prostheses in

laryngectomizedd patients

Simonee E.J. Eerenstein, MD

Wilkoo Grolman, MD

Paull F. Schouwenburg, MD PhD

ClinicalClinical Otolaryngology

1999;24:398-403. 1999;24:398-403.

CHAPTERR 4.1

Abstract t

Thee aim of this study was to identify the microbial colonization or dvsfunctjoning yoice

prosthesess in larvngectomized patients and determine the influence of patient radiation

therapyy on prosthesis life span. In a 40 months period, 25" outpatient voice prosthesis

replacementss were carried our in a laryngectomized group or 31 patients. The voice

prosthesess were all removed from the tracheo-oesophageal fistula atter dxsfunctioning

off the prosthesis. Of the replaced prostheses 183 were cultured. The microbial cultures

showedd a predominant colonization with Candida albicans and commensal oral

microflora.. Radiation therapy induced xerostomia shortened the lifetime ot the first

insertedd prosthesis in particular.

KeyKey words: Mai laryngectomy, voice prosthesis, biofilnt, Candida, silicone deterioration, ///icrobiai

colonisation. colonisation.

120 0

MICROBIALL COLONIZATION OF SILICONE VOICE PROSTHESES

Introductio n n

Followingg total laryngectomy, the restoration ot voice is an important issue. This can be

achievedd by oesophageal speech, an artificial larynx or a voice prosthesis with a valve

mechanism. .

Sincee the introduction of the Blom-Singer duckbill silicone prosthesis in 1979 and the

descriptionn of the tracheo-oesophageai (TE) puncture technique, voice prostheses have

widelyy come into use.1"4 The success rate is high: ~ 90% ot larvngectormzed patients

achievee good, intelligible speech. Also, the objective characteristics of prosthetic voice

havee been shown to be superior to oesophageal speech or voice with an artificial larynx.^

'''' In the Netherlands, the most common prostheses are indwelling, semi-permanent

devices.. These require only a certain amount of manual dexterity for daily prosthesis

care.. Non-indwelling prostheses, which require more manual dexterity and insight into

thee de novo anatomy and motivation from the patient, are not seldom used in regions

withh large distances separating patients and their treating physicians (e.g. the USA).

Basically,, voice prostheses are one-wax valves, made of medical grade silicone rubber

andd are inserted into the TK-fistula. They have some important features: on occlusion of

thee tracheostoma, air passes through the prosthesis into the oesophagus and the shunted

airr generates voice in the pharvngo-oesophageal segment.' The one-way valve inhibits

transportt from oesophagus to trachea, preventing oesophageal contents from entering

thee trachea and lungs.

Thee oesophagus is a non-sterile environment and multiple micro-organisms come into

closee contact with the inserted prosthesis, leading to rapid colonization ot the prosthesis

surfacee with a mixed biofiim of bacteria and yeasts. -8

Biofilmss are defined as a variety' of microbial strains and species, embedded in a mixture

off moisture (saliva) and microbial components.'! Thev are formed at a solid-liquid

interfacee and the microbial components cling to each other and to the surface on which

thee biofiim is formed.1" Due to the biofiim formation degradation of the silicone occurs,

causingg prosthesis dysfunction which determines the prosthesis life span."

Dvsfunctioningg voice prostheses cause leakage of oesophageal contents into the trachea

orr an increased resistance to airflow. Passing fluids into the trachea tnggers coughing and

mayy cause pulmonary infection. Any dvsfunctioning voice prosthesis should be replaced

promptly. .

121 1

CHAPTERR 4.1

Otherr studies have shown that the biofllm covering the prosthesis surface consists

mainlyy or bacteria and veasts. I electron microscopy of the silicone prosthesis surface

revealss degradation of the silicone due to filamentous and vegetative veast cell invasion.1'-

]] 2. 13

Commonlyy identified bacteria present in the analysed biofilms are of oral origin (such as

StreptococcusStreptococcus sp.) and skin bacteria (such as , : Yeasts isolated from the

colonisingg biofllm were mainly Candida albicans and Candida tmpicalis.

Wee analysed the lire span and microbial colonization of 183 voice prostheses from 2S

larvngectomizedd patients in a 40-month period. To date, no other series in literature

comprisess as many cultured prostheses.

Material ss and methods

Alll silicone voice prostheses were removed from TH-fistulas or larvngectomized

patients.. All prostheses were removed when dysfunction of the prosthesis, such as

leakagee or fluids through the prosthesis or an increase in phonanon pressure, occurred.

Immediatelyy after removal of the dvstunctioning prosthesis, a new prosthesis was

insertedd into the TH-fistula of each patient. Cultures were taken directly after

replacement,, trom the oesophageal side of the removed prostheses.

Twoo hundred fittv-seven dvstunctioning silicone prostheses were removed trom 31

larvngectomizedd patients in a 40-month period. In three patients no prostheses at all

weree ever cultured. ( )ne hundred and eighty-three '1~3 Provox valves, 10 other types) ot

thesee prostheses were cultured. Seventy-tour prostheses were not cultured because ot

varyingg reasons, i.e. replacement during weekends, prostheses thrown awav after

replacement.. After removal, the prostheses were examined macroscopicallv for visible

depositss or other abnormalities and cultures were obtained to determine the microbial

floraa present.

Dirccdvv after removal ot the prosthesis, a culture from the oesophageal side ot the

devicee was obtained bv swabbing. The samples were cultured on agar plates using the

standardd tour-quadrant method. The veast colonization was defined as few, many or

profusee colonies.

122 2

MICROBIALL COLONIZATION OF SILICONE VOICE PROSTHESES

Results s

Thee culture results show presence of yeast strains in 94.54" <> of the dvsfunctioning

valvess (Table 1). A combination of veast strains and bacteria was seen in 86.6" n.

Presencee of solitary- yeast without co-existing bacteria was seen in " . 1" u of the cultures.

Thee type of yeast in the culture (Table 2) was determined and the following results were

obtained:: C. a/biotas was the solitarv colonizing veast in 35" n of the cultures; C tivpicalisxw

20"" n; other yeasts such as ('.. Kefir, (.. Kr/iset or (V. paraps'ilosis accounted for 4.5"o. In 8" n

moree than one type of yeast was present in the cultures. In 2~7"-.. the veast was not

specified. .

Amongstt the cultured bacteria were species like Staph, annus, l:nterocom, Pseiidon/onas sp.,

I:srf>erirf>/aI:srf>erirf>/a coli, S'tnptococci and Klebsiella.

Tli ee patient group constituted of 24 men and 7 women. The mean age of the men was

64.55 years (range 35-85), the mean age of the women was 63 (range 56-AT), and group

meann age was 64.6 (range 35 - 85).

Thee life span of a prosthesis varied from 1 dav to a maximum of 1430 davs. Of those

patientss with complete records since laryngectomy, the prosthesis life times for the

patient'ss first prosthesis after laryngectomy and his/her average prosthesis lifetime were

compared. .

Alll but one of the patients with a primary Tl>puncture (i.e. insertion of prosthesis

duringg laryngectomy) and post-operative irradiation had a shorter lifetime for the first

insertedd prosthesis when compared to their average prosthesis life span. The first

prosthesiss life span was shorter for the preoperativelv irradiated patient group (9"\4 davs)

whenn compared to the postoperatively irradiated patient group (14".1 days). Also, the

hrstt prosthesis lite span was shorter in the irradiated group than in the non-irradiated

groupp (124.8 versus 166.2 days). Furthermore, the average prosthesis life span was shorter

inn the irradiated group when compared to the non-irradiated group (96.9 itrsns 128.3

davs;; Table 3).

AA detailed survey of the cultured prostheses per patient and individual patient

characteristicss are to be found in tables 4 and 5.

Almostt all of our patients wear dentures: some of the patients with dentures have a

longerr prosthesis life span than those who do not wear dentures. However, we did not

findd a statistical correlation between the presence of dentures and prosthesis life span.

123 3

CHAPTERR 4.1

Tabl ee 1. Distribution of cultured micro-organisms of dvstunctioning, replaced voice prostheses.

11 veast + 1 vcast + >1 vcast >1 vcast *

Solitaryy oral comm. 1 vcast — oral comm. + oral > 1 vcast — oral cimini. + No

vcastt Mora bacteria + bacteria a in ini bacteria bacteria vcast

S9 9

4K.6" "

31 1

H O " "

42 2

1.0",. .

9 9

4.9" "

Solitan"" veast (no bacteria) = only one tvpe ot veast and no bacteria present in the culture.

11 vcast + oral conini. flora = one U)pe ot veast and oral commensal microflora

11 vcast + bacteria = one rvpe ot veast and bacteria, no commensal microflora

11 vcast + oral comm. + bacteria = one t\pe ot vcast, oral commensal microflora and bacteria

>> 1 veast... — more than one type ot vcast...

Noo vcast = no vcast present.

iiii = number of cultures

Tabl ee 2. Distribution ot vcast species found in the cultured voice prostheses spc c L £ £

Totall C albicans (single) )

C.. tropicalis Other veast Non-specified Yeast species (single)) (single) vcast >1

nn = 1 S3 64

34.9" "

36 6

19.6" "

8 8

4.3" "

30 0

2".30 0 8.20 0

(,.(,. ti/biaiiis (single) = onh' veast species present in culture was Candida n/bhwis.

C.C. Smpiailis (single) = onh" \'east species present in culture was Candida tmpicalis.

Otherr veast (single) = one type ot veast present in culture (i.e. C. Kr/isci, (.. Ktpii, C. panipsi/osis), not (..

albicansalbicans or (.. tivtiiuilis.

Non-specitiedd vcast — veast species in culture, not specified what tvpe ot vcast.

\eastt species > 1 = more than one tvpe of vcast present in the same culture.

Tablee 3. Prosthesis life span per patient group

hirstt prosth. lifespan P-value Averagee lite span P-valuc c

Preoperat ivee RT

POM-operativee RT

RTT +

RT T

9~.44 davs

14".. I davs

124."" clays

166.22 davs

0.0356 6

0.0219 9

1!.(III >4<)

0.0190 0

89.55 days

115."" davs

96.99 days

128.33 davs

0.0591 1

().(HH )45

().ll M ).56

0.000 r

RT—— Radiotherapy, RT + - patient group that received radiotherapy, either pre- or post-operauvclv, RT-

== patient group that did not receive radiotherapy

124 4

MICROBIALL COLONIZATION OF SILICONE VOICE PROSTHESES

Discussion n

Whenn inserted into a TK-fistula, the voice prosthesis is brought into a non-sterile

environment.. The close contact of the prosthesis surface with multiple micro-organisms,

presentt in the orai cavitv and upper respiratory tract, leads to rapid colonization of the

device. .

Thee colonization (occurs through bio film formation, by an as vet not fully understood

mechanism.. The colonization induces deterioration of the silicone material. It is thought

thatt the deposition of a conditioning film on the silicone surface is the first step in the

biofilmm formation. Next, adhesion of micro-organisms to the conditioning film followed

byy attachment and growth into the material inducing deterioration of the material. The

formationn of the biofilm and the consequent material deterioration is one of the most

commonn reasons for prosthesis replacements (Figures 1 and 2).1'- '3

Thee deposition of a salivary film on the prosthesis surface is thought to protect the

device.. Saliva exerts a negative influence on the adhesion of micro-organisms and thus

slowss the biofilm formation. It has been demonstrated that micro-organisms attached to

aa salivary conditioning film are less firmly attached to the silicone surface and can quite

easilyy be dislocated from the surface bv passing air bubbles, food bolus or liquids. Micro-

organisms,, in the absence of or in a thinner salivary conditioning film, are more strongly

bondedd to the silicone surface and thus more difficult to detach.13 Larvngectomized

patientss who have had radiotherapy, have a lower secretion of saliva and are known to

bee oropharyngeal earners of Candida sp.14 These factors mav ven' well influence the rate

off biofilm formation and the consequent degradation of the silicone, thus influencing

thee prosthesis life span. In our irradiated patient group we found a shorter prosthesis life

spann than in those who were not irradiated: this is in accordance with the known lower

salivan'' secretion in irradiated subjects, leading to a thinner salivan' film and enabling

strongerr bonding of the micro-organisms to the silicone surface, a higher micro-

organismm count in the biofilm and consequently an earlier deterioration of the silicone.

Also,, the first prosthesis lifetime was shorter in those patients who had been irradiated

priorr to the lanngectomw In the latter, the salivan' production decreases in the course of

thee irradiation whilst the preoperativelv irradiated patient group alreadv has less saliva

priorr to the insertion of the first prosthesis.

125 5

CHAPTERR 4.1

Figuree 1: Voice prosthesis (Provox') with characteristic Candida colonization of the oesophageal surface (a)) and relatively clean tracheal surface (b). Note: deformation of the circular valve due to Candida growth.

Figuree 2. Close-up of Candida colonised voice prosthesis. Note: due to colonization of the silicone surfacee the valve can not close properly and causes dysfunction.

MICROBIALL COLONIZATION OF SILICONE VOICE PROSTHESES

Itt is not only salivary production which influences the micro-organism load and biofilm

formation:: the micro-organism count in the environment surrounding the prosthesis

mayy increase due to the ingestion of certain foods such as vogurt, cheese, spices and

applee juice. The hypothesis of food being a potential source of specific veast npes in the

biofilmm microflora has been demonstrated.11 ]" Not all food-related microflora leads to

siliconee degeneration: it is known that products such as buttermilk, vogurt and pickled

foodss may prolong prosthesis life span by decreasing the Candida load.

Microbiall analyses ot biofilms in previously published culture series have shown a

diversityy of micro-organisms present: predominance of (.. albicans and C. tmpicalis, skin

Staphylococci,Staphylococci, hntcrococci'and oral Streptococci.' ]1- '3

Ourr 183 cultures revealed a predominance of C. albicans; this corresponds with

previouslyy published culture series. No previously published series comprised as manv

culturedd prostheses as the series wc present in this paper: the largest series until today

comprisedd one of 55 culrured Groningen16 and one of 55 cultured Provox prostheses.1"

Somee studies found a predominance of C. tropica/is in the more mature biofilms.'' ls We

didd not find such a predominance; specially not in our "patient L" who had an average

prosthesiss life-time of only 36 days and had C. tropicalis present as a single yeast in 21 of

thee cultured prostheses.

CandidaCandida sp. in the biofilm are held responsible for the deterioration of the silicone.

However,, it has been postulated that bacteria plav a role.1'* / intemcocci and stivptococci are

saidd to be implicated in valve failure, however, it is as vet unknown how these micro-

organismss interact with the Candida sp.u'

Ass Candida is considered to be the main cause of silicone deterioration, several strategies

too eliminate Candida from the vicinity of the prosthesis have been described, such as the

eliminationn of certain types of food to dimmish the Candida intake, the use of

antimycoticss such as Amfotericin B lozenges or Nystatin.r We have not applied either

off these measures, as their effect is limited and their possible benefits do not seem to

outweighh the disadvantages such measures have for the patient.

Thee solution must be sought in the use of other known materials, previously

impregnatedd silicone or new materials. Furthermore, blocking the transport of Candida

towardss the prosthesis area or to eliminate Candida from the prosthesis area. Recently,

surfacee modification of the silicone by chemisorption of perfluoro-alkvlsiJoxane polymer

127 7

CHAPTERR 4.1

chainss was propagated as an effective solution to the problem. The chemisoiption of the

longg tluorocarbon chains modifies the silicone surface tree energy and decreases the

adherencee of microorganisms.-" Those micro-organisms that do adhere to the surface

formm weaker bonds and are more easilv detached bv passing food bolus, liquids or air

bubbles.. The use of other materials tor the production of a new generation of

prosthesess is also being investigated and a definite solution mav be found in the near

future. .

Acknowledgments s

Wee would like to thank Wies 1 .angenberg for her critical and constructive comments

regardingg the biotllm cultures and this paper. Also, we thank the other colleagues at the

Departmentt of Medical Microbiology at the Academic Medical Centre Amsterdam who

eachh time patient.lv analysed the biotilms of vet another voice prosthesis.

128 8

MICROBIALL COLONIZATION OF SILICONE VOICE PROSTHESES

Tabi cc 4. Distribution of prostheses and culture results per patient.

Pit.. 1'r- C albicans Camp. ( Ither yeast \ on spec. Yeast sp. Bacteria Comm.

\ r .. Mn l̂e single, '̂ inirle.- > ( > 1 j (non- Bact.

cii >mm. i

—— - ^—~Z [71 72 j I j =

bb S 2 + - + 3 + * + 3' \ ' , T 4-4-4- 4

CC 13 5 + + + 4 f + 1< \-( kr + + + () 8

DD I 1< i^ -u + + I j

r:: I I - r ++ i

I-- - 5 - + ~ I . i ' \ - . K ̂ + 3 3

33 4 c, , H H

1 1

.1 1

K K

1. .

M M

N N

O O

P P

O O

R R

s s

4 4

4 4

13 3

f i i

2') )

!4 4

.i i

i n n

4 4

3 3

--

44 + + +

inn 4-4-4-

11 - -

100 - -

22 + +

33 + +

44 - + +

33 - + +

ss - -

4 4

1 1

4 4

21 1

+ +

--

+ +

--

* *

--

+ +

--

+ +

--

2'' Kr'

1'' '̂

p kr r

p kr r

pr. .

- t - - r -

++ + ^

++ ̂ +

+ +

4--i--

"> >

3 3

3 3

3 3

1 1

3 3

~> ~> i i

++ +

++ +

4-4--

—— +

++ +

4-4--

++ +

++ +

+ +

++ 1< \-<'lr + + -

A - < T rr + -

111 1

6 6

SS " 2 — r + 1 4 -- + 3 4-+~ IMr-.s:, + + + 3 3

'II 1 1' 1- f + +

[[ 4 1 + 4 4 2 4-4-4- 1 3

YY 3 1 - 2 4- -4- I

\YY i l < \ - ' i - + ~ + 1

XX 3 3 — - 2 4-+ 1 2

YY 3 .} * — 2 I

// 3 3 ~ 4

Aaa 3 1 4-4- 2' v , ' I r 4-+ 1 2

A hh I p..\-<k + + 4- ]

CAA = (.. ,///i/t\ws; C Tr - C. hiipiitilir, C Pa = C ptmipsilosis; ( . K r = C. X-w.fr/'/CK. - C /w/y/rCSp = C spn'it-s;

CAA + CTr = C albicans and C, twpiuilis present in same culture; Bacteria (non comm.) = non-commensal

bacteria;; Comm. bactena = commensal oral & throat bacteria present in the culture.

- - ++ - profuse Candida colonies in cultures; 4-4- = manv Candida colonics; + = few Candida colonies

Pal.. = patients, named in alphabetical order; Pr. nr. = number of cultured prostheses per patient

129 9

CHAPTERR 4.1

Tabl ee 5. Prosthesis lifetime per patient

Pat. .

]] .itenme first

Civv Prosth.Mavs;

Preoperat ivee Radii 'thcrapv

I--

i i l . .

() ) R R

s s Vi' ' Ah h Aa a

68 8 68 8

66 6 68 8

66 6 56 6

6S S

66 6 ~( i i

04 4

T --

H>5 5 IDS S

45 5

I6l> >

LSI I 5~0 0

65 5

II 15

Averagee lifetime prosth.ulavs. .

126,2 2

111,5 5

68,6 6

56,1 1

~2,o o

111 >5,( i

15(( i,( I

08.5 5

65,(i i

TNM M II .< >catn m P u n a.. Dentun

T l \ < > \ |n n

T 2 \ o Mn n

T IMiMi i i

' I ' INnMi i i

l '2MMi i i

T l b \ o \ I < i i

T 5 \ o \ [ d d

T 2 M ) \ I 0 0

Radiii Jiiecr. T2\oM<> >

' l '2a\0.\ l (i i

( l lotnc c

SupraCilott t

SupraCilott t

Glottic c Glottic c

CC ilotnc

Citottic c

CC ill uric

Glottic c

GlottlC C

prim m

prim m

prim m

prim m

prim m

prim m

prim m

prim m

pnm m

prim m

sec. .

Pii ist-i >pcrati\ e Radi< >thcrap\

A A

(,) ) T T Y Y

Ac c

H H N N

P P

X X

Y Y

7. 7.

N o o

c; ; Is s

M M

I T T

40 0 "( I I

60 0

60 0

62 2

60 0

60 0

66 6

66 6

51) )

Radiotl l 0 0

1) )

1) )

110 0

5() )

281 1

142 2

14 4

145 5

212 2

188 8

596 6

45 5 5" "

crapv v

154 4

558 8 ii~> ii~>

156,4 4 158.8 8

15~,() )

185,5 5

II 11,6

188,4 4

62," "

611,4 4

111 »5,8

11 66,4

64,2 2

56,6 6

215.6 6

T2N0M0 0 ' I '5 \2MO O

'I"5\i)M 0 0

T4N2c.\IO O T4N0M0 0

T4\2b.MO O T4N0MII I T 4 \ 2 h \ I0 0

T2N0MO O

T5N0MO O

SupraCilott t

Glottic c

SupraGlott t

Cilott t

SupraCilott t

11 Ivpoph.

SupraCilott t

SupraCilott t

SupraCilott t

b.sophauus s

prim. .

prim. .

prim. .

prim. .

prim. .

sec. .

sec. .

sec. .

sec. .

sec. .

sec. .

++ +

++ +

44 +

+ +

4-- +

++ +

--++ +

44 +

++ + ++ +

T 5 \ o . \mm SupraCilott pnm.

Chondromaa Cricoid pnm.

T5 \0 . \100 C ilortic pnm.

sec. .

Traumaa Larynx sec.

Pat.== patients. Ci\ - Radiotherapy doses in d raw Location - site of tumour. Puna. = puncture ot

tracheoesophageall fisrula tor prosthesis, pr im.- primary puncture 'during laryngectomy., sec. -

secondaryy puncture (after laryngectomy;. SupraCilott - supra.ulott.ic tumour. Glome = glottic tumour.

Hypoph.. = hvpopharvngcal tumour, not further specified. - - incomplete surgical history, operation not

performedd in our clinic. " = second prosthesis still in situ, no average calculated, + + = upper and lower

dentures.. + = either upper or lower dentures. - = no dentures

Thee records of patients D & I ' who were operated elsewhere, were too incomplete: these patients are

thereforee not mentioned in this table.

130 0

MICROBIALL COLONIZATION OF SILICONE VOICE PROSTHESES

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131 1

CHAPTERR 4.1

1".. van Wcissenbruch R, Bouckacrt S, Remon | i \ \ e l is l[\, Aeris R, Alhers I \ \ |. Chcmopmrvlaxis of

fungall deterioration of the Provox silicone tracheoesophageal prosthesis in postlan ngcciomy

patients.. Ann O/oJ'K/vW 'I j/iviy>/1 t>tJ_;l()6:32l>-3_.

18.. Neu TR, de Boer CP, \ 'erkerke GJ, Schutte I l k , Rakhorst G. van tier Mei HG, B u t c h er i l|. Film

developmentt in time on a silicone rubber voice prosthesis - a case study. \\/<rob \:a>! I lïiil/h D/s

1994f:2"-33. .

19.. Busscher l l | , Gcerrscma-Doornbusch G l, I .vcracrt HPJ.M, Verkerk c G|, van de Belt Grirter B,

Kalicharann R, van der Mei H G Biohlm formation on silicone rubber surface modification in the

developmentt of a total artificial larvnx. Surfen and prosthetic voice restoration after total and

subtotall laryngectomy Aloiibti / (I u/j, lUser/erSIVI-IIÏC. Amstmlow, 1996;4~-.32.

20.. b.veraert I .P|M, van der Mei HG, Busscher l l | . Adhesion of \easts and bacteria to tluoro-

alk\isiloxanee Livers chemisorbed on silicone rubber. Winfil»/ /orw,///',// on milMt w<>difhtl sihcith mDi/tr r<>ia-

f»wt/.«;<,:t.f»wt/.«;<,:t. Okiphr -. PhD /A-..-/> / -.ivnifit I.PJM. IVT.

132 2

Thee role of gastroesophageal reflux in

post-laryngectomyy voice prosthesis dysfunction

Simonee E.J. Eerenstein, MD

Paull F. Schouwenburg. MD PhD

Submitted. Submitted.

CHAPTERR 4.2

Abstract t

Objectives:Objectives: Determine the possible role of gastro-esophageal reflux in Candida yeast

inducedd dysfunction of silicone voice prostheses.

StudyStudy design: Pilot study in a select group of larvngectomized patients with a high

prosthesiss replacement rate in which Candida species present on prosthesis surface and

inn the gastric contents were compared.

MaterialsMaterials and methods: Dysfunctioning prostheses were replaced in the out-patient clinic

andd a sample of gastric contents was obtained at the same time. The samples were

culturedd and Candida presence was determined. Also, if patients had reflux-related

complaintss anti-reflux medication was prescribed.

Results:Results: In all of the patients Candida was present in the gastric contents. Also, the

Candidaa species present in the stomach matched those cultured from the prosthesis

surface.. Prosthesis lifetime was markedly increased when patients with reflux complaints

weree started on anti-reflux medication.

Conclusions:Conclusions: The role of gastro-esophageal reflux should be seriously taken into

considerationn when a high prosthesis replacement rate is seen in laryngectomycd

patients. .

Keywords:Keywords: voice prosthesis, Candida, gastro-esophageal reflux, laryngectomy, biofilm.

134 4

GASTRO-ESOPHAGEALL REFLUX AND PROSTHESIS DYSFUNCTION

Introductio n n

Thee use ot silicone voice prostheses lias become the leading rehabilitation method after

totall laryngectomy. These prostheses —basically consisting of a one-wav vah'e- are

insertedd into a surgically created tracheoesophageal (TH) fistula. The prostheses

functionn as a shunt for expiratory air from the lungs into the pharvngo-esophageal

Segmentt where the air is used to generate voice. The one-way valve prevents leakage of

esophageall contents into the trachea and aspiration into the lungs.1

Thee non-sterile environment at the TK-fistula site leads to rapid formation of a bio film

off microorganisms on the surface of the prosthesis when it is inserted into the fistula.

Thiss biofilm mainly consists of Candida yeasts and bacteria. Owing to this biofilm

formationn - specifically the Candida yeasts the silicone prosthetic material gradually

deteriorates,, and this eventually causes dysfunction of the device.2"4

Inn the individual case, the rate in which the prosthesis dysfunction occurs is higher than

averagee and therapies to reduce Candida concentration at the prosthesis site arc applied.

Thesee therapies can consist of the local administration of antt-mveotic drugs or dietary

6 6

Althoughh the prosthesis life span can be prolonged with the above mentioned measures,

theyy focus on decreasing Candida specifically at the fistula site and other possible

mechanismss are not considered.

Inn our view, gastroesophageal reflux disease (GKRD) is one of such mechanisms. In

orderr to analyze the possible role of (ilvRD-induced auto-contamination of the fistula

sitee through reflux of Candida present in the stomach, we conducted a pilot study in

whichh matched samples of the microflora present at the TI>fistula site and in the gastric

contentss were obtained. Also, reflux-related complaints were analyzed if a patient was

enteredd into the study.

Material ss and methods

Thee average prosthesis life span of each laryngectomized patient coming in for voice

prosthesiss replacement in our outpatient clinic was determined. Patients were entered in

thee study if the individual prosthesis life span of their three previously replaced

135 5

CHAPTERR 4.2

prosthesess was at least a full month shorter than the minimal average lifespan of 2.5

monthss as cited in literature. "

()ff each entered patient the dvsfuncttoning prosthesis was replaced and a sample of

gastricc contents was obtained. The gastric contents were aspirated with the aid of a

gastricc tube inserted through the tracheo-esophageal fistula alter removal or the

prosthesis.. The first few ml of aspirated gastric juices were discarded and the next tew

mll were kept for analvsis. Both the prosthesis and the sample or gastric juice were sent

inn for cultunng with the specific question if the Candida species present on the

prosthesiss were also present in the gastric contents.

Orr the patients entered into the studv, the presence of and frequency or reflux-related

complaintss as well as the use of anti-reflux medication was registered. If patients were

nott using anv anti-reflux medication this type of medication was prescribed and the lite

spann of the first prosthesis with the newlv started anti-reflux therapy was determined.

Results s

Whenn a margin of at least one full month below the minimum cited literaaire lifespan of

2.55 months was considered, 6 out of our 27 larvngcctomi/.ed patients had an individual

prosthesiss lifespan that was markedlv shorter. In these 6 patients the prosthetic lifespans

rangedd from 14.3 to 41.3 davs (0.4 to 1.3 months).

Off the six patients entered, 6/6 samples of gastric contents contained morphologically

identicall Candida veasts to those found on the prosthesis surface.

5/66 patients claimed to have daily reflux-related complaints such as heartburn. 3/5 of

thesee reflux-patients were on anti-reflux medication (()meprazol, 4(1 mg lddj. (Table \)

Thee 3 non-medication users (2 with and 1 without reflux-related complaints) were

startedd on anti-reflux medication (Omeprazol, 40 mg ldd) and the prosthesis lifetime of

thee first prosthesis under this anti-reflux regime was determined. ()f these three patients,

thee patients with reflux-related complaints attained a prosthesis lifetime with anti-reflux

medicationn of respectively 78 and 32 days versus their previous average prosthesis

lifetimee of 41.3 and 18.7 without anti-reflux therapy. No noteworthy prosthesis lifetime

136 6

GASTRO-ESOPHAGEALL REFLUX AND PROSTHESIS DYSFUNCTION

increasee was seen in the non-reflux patient when anti-reflux medication was

administeredd (2~ days with medication versus average ot 22,6;,

Tabi cc 1.

Refluxx Anu-rcflux Prosthesis

Patientt Average prosth. Samples match complaints at medication at litetime with new

lifetimee start of study start of study medication

1 1

-> -> 3 3

4 4 n n

f> >

Id d 14.3 3 2D D

IK." " 41.3 3 22.6 6

Vl'S, ,

Yes, , Yes, , Ye<, ,

Yes, , No o

mild d severe e mild d mild d mild d

Ye e Ye e Ye e N( ( X. .

\( (

.. Ircrt/'^i'pros/l>. li(rfitin = average prosthesis lifetime determined over the last 3 prostheses per patient at the

momentt of prosthesis dysfunction. Siwijik-s matei' = + if Candida species .ire moqihologically identical in

bothh the gastric contents samples as well as on the prosthesis surface. liifh/x annphiints tit shirt oj study -

patientt experiences regular daily periods of reflux-related complaints such as heartburn,

ithdiuitioiiithdiuitioii at shirt of stud] - ves / no patient is using /not using anti-reflux medication at the start ot the

studvv and was therefore taking anti-reflux medication during the time period over winch the average

prosthesiss lifetime was determined. Pivsthrs/s Ihrttim- irith nor wdiuitioii = period of time before dysfunction

off the inserted prosthesis when non-medication using patients started anti-reflux medication.

Althoughh voice prostheses are of great importance for the post-laryngectomv

rehabilitationn process, their frequent dvstunction is a major patient discomfort. Through

yearss of research, the causative role of biofilm formation -specifically Candida

colonizationn and deterioration of the prosthetic material- in prosthesis dvstunction has

beenn established, - 4

Thee average prosthesis lifetimes cited in literature van- from 2.5 to 6,5 months. n As in

anvv calculation of average values, there are many patients in whom dysfunction of their

prosthesiss occurs at much shorter intervals. These intervals -in the extreme individual

case-- can be as short as a few days. In order to allow tor a fair -unbiased- selection ot the

patientss entered into the study, we determined the minimum average prosthesis lifespan

hadd to lie well below the minimum averaged lifespan of 2.5 months as cited in literature.

Wee therefore determined a cut-off point around 5<'"<i of this minimum average lifespan

137 7

CHAPTERR 4.2

off 2.5 months. As the minimum average lifespan was used, this also ensured a true

selectionn of patients with a very low prosthesis lifespan when compared to the higher

generallyy cited average prosthesis lifespans in literature.

II wen though voice prosthesis replacement is a simple outpatient procedure taking onlv a

feww minutes, patients often experience prosthesis dvsfunction and the necessary

replacementt as cumbersome. This patient-burden not onlv lies in the prosthesis

replacementt itself but also in the necessary visits to the outpatient clinic and the more

frequentt than necessary confrontation with their disability. Given all these factors, as

welll as a —not often mentioned- substantial financial motivation, methods influencing

prosthesiss life span enjov a considerable interest.

Thesee methods mainly focus on the currently generally accepted reason of dvsfunction:

thee susceptibility of the silicone prosthetic material to biofilm -specifically Candida-

inducedd deterioration. Therefore, the local environment at the prosthesis site has been

extensivelyy studied and the factors involved in biofilm formation, such as saliva as well

ass the present micro-organisms have been determined.24-I 2

Salivaa forms a protective, adhesion-repellent film on the prosthetic surface and therefore

slowss the formation of a biofilm. It is thought that in larvngectomized patients, who

havee often had radiotherapy and therefore have a lower salivary production as a

consequence,, are more prone to biofilm formation. Also, larvngectomized patients are

knownn oropharyngeal Candida-carriers, and this further influences the micro-flora

concentrationn at the prosthesis site. .Another possible reason for higher concentrations

off Candida can be found in the patient's dietary habits, specifically if the patient regularly

ingestss certain types of food such as yogurt and cheese.4 14

Severall strategies aiming to reduce the local Candida concentration have been applied

overr the years. These strategies include the popular local application of anti-mveotics

(Nystatin,, Amphotencin-B or fluconazole) and the reduction of Candida intake through

dietaryy measures. Although often applied, convincing scientific evidence of the effect of

anti-mycoticc therapy has yet to be demonstrated. Furthermore these strategies are

limitedd to influencing the environment at the prosthesis site. Given this relative success

rate—expressedd in a slightly higher prosthesis life time- other environment influencing

factorss should be taken into consideration. Should the boundaries of the environment at

thee prosthesis site be expanded from the current pharvngo-esophageal segment to the

138 8

GASTROESOPHAGEALL REFLUX AND PROSTHESIS DYSFUNCTION

wholee pharvngo-gastroesophageal segment and could gastroesophageal reflux disease

possiblyy be one such influencing factor.-'

Inn recent years, GKRD has been established as an often present entity in patients with

headd and neck cancer. Also, due to the surgical techniejues used in laryngectomy, a high

incidencee of GHRD is seen in larvngectomi/ed patients.15 Given this tendency for a high

refluxx incidence, it seems a logical step to extend the boundaries of die local

environmentt to include the gastric region, also because Candida is known to survive and

rhriyee within the stomach.u>> '" Attempts to reduce the Candida load at the prosthesis site

mightt therefore not be as effective as one would hope as gastroesophageal reflux might

ven-- well re-introduce the Candida yeasts at the previously decontaminated site.

Focussingg on the aspects of gastroesophageal reflux, it is a striking factor that 5/6 of

thee patients entered in our study have reflux-related complaints. Of these 5, 2 patients

hadd no previous anti-reflux medication, but achieved an increase in prosthesis lifetime

whenn then' started taking the prescribed medication. Furthermore, the only patient in our

pilot-studyy without any reflux complaints showed no lengthening of prosthesis lifetime

iff anti-reflux medication was given as a trial.

.Anotherr factor strengthening our belief in the possible role of gastro-esophageal reflux is

thee positive Candida-match found in the obtained samples of the prosthesis site and of

thee gastric contents. The risk of possible auto-contamination of gastric contents with

locall oro-pharvngeal microorganisms was reduced bv introducing the gastric tube

throughh the tracheoesophageal fistula (after removal of the prosthesis), thus bypassing

thee oropharynx. Furthermore, the first milliliter s of gastric aspirate were not sent in for

analysiss as these first milliliter s might contain possible micro-organisms accumulated on

thee tip of the gastric tube during its passage through the tracheoesophageal fistula and

esophagus. .

Thee performed analysis focused on the morphological aspects of the Candida yeasts

presentt in the obtained samples and given the pilot-aspect of our study no expansive or

expensivee research techniejues such as PCR were performed.

Althoughh the number of patients entered into our study group is small, we believe our

findingss merit publication as they shed such a new light on Candida-related issues within

thee field of prosthesis dysfunction. Further research is being carried out and these data

willl be presented for publication at a later date.

139 9

CHAPTERR 4.2

Conclusion n

GKRDD an often-present en tin- in head and neck cancer patients, spccificalh after

larvngcctomv,, might ven wet! be a contributing factor to Candida induced voice

prosthesiss dvstunction. The positive matches of Candida species present in the obtained

sampless at the prosthesis site and in the gastric contents render credibility to the possible-

rolee ot reflux in the individual patient. Also, the reflux-related complaints in patients with

aa high trequencv ot prosthesis failure and the positive lifetime lengthening effects of

administeredd anti-reflux medication as seen in 2 of our patients further add belief to this

assumption.. The results as presented in this paper are those ot a small pilot-studv and

currentlvv further research is being carried out of which the results will be published in

thee tutu re.

140 0

GASTROESOPHAGEALL REFLUX AND PROSTHESIS DYSFUNCTION

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CHAPTERR 4.2

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142 2