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Success and Predictability of Provox Prosthesis Voice Rehabilitation
Michel A. Hotz, MD;
Ariane Baumann, MD;
Isabelle Schaller, MA;
Peter Zbären, MD
Arch Otolaryngol Head Neck Surg. 2002;128:687-691.
ABSTRACT
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Objectives To determine the success rate and relating clinical factors of voice
prosthesis rehabilitation and to analyze the discrimination ability of the
multidimensional Harrison–Robillard-Shultz Tracheoesophageal Puncture
Rating Scale (HRS Rating Scale).
Design Prospective clinical study.
Setting University Department of Otorhinolaryngology, Head and Neck Surgery,
University Hospital Inselspital, Bern, Switzerland.
Subjects And Methods From 1992 through 1998, 87 patients with advanced squamous cell carcinoma
of the larynx and/or hypopharynx underwent primary tracheoesophageal puncture
after total laryngectomy. Clinician otolaryngologists and speech/language
pathologists independently used the HRS Rating Scale for success assessment
of voice prosthesis rehabilitation.
Results Age, sex, tumor localization, tumor stage, and radiation therapy had
no influence on the success of voice prosthesis rehabilitation. Overall, voice
rehabilitation success rates between 40% and 62% were achieved. Speech/language
pathologists and clinician otolaryngologists evaluated the same patient group
without significant statistical differences. The HRS Rating Scale analysis
showed an equal distribution of the subscale parameter care in functional and nonfunctional speakers and a strong correlation
between the subscale parameters quality and use.
Conclusions Because of its safety and simplicity, tracheoesophageal puncture has
become a state of the art method for voice rehabilitation after total laryngectomy.
The short-term superiority of voice prosthesis in voice rehabilitation over
esophageal speech rehabilitation must be seen in light of comparable long-term
success rates of the 2 methods.
INTRODUCTION
THE LOSS of vocal function is generally considered the most disabling
consequence of total laryngectomy. Many innovative surgical and nonsurgical
procedures aim to restore the patient's verbal communication. Since the introduction
of the first real tracheoesophageal valve prosthesis by Mozolewski in 1972,
tracheoesophageal shunt techniques gained increasing acceptance because of
the relative simplicity of the operation, the acquisition of speech, and better
voice quality.1 Maves and Lingeman2 first described performing the primary tracheoesophageal
puncture (TEP) at the time of laryngectomy. More than a dozen shunt valve
prostheses were developed in the last 30 years.
With reported success rates ranging from 50% to 90%, the results of
surgical rehabilitation by means of voice prostheses are, on the average,
better than rehabilitation by esophageal speech, with a success rate of 33%.1 The wide variability of reported success rates of
the TEP procedure may be explained by the lack of controlled success criteria.
Almost every published study used its own success criteria. In 1992, Harrison
and Robillard-Shultz introduced the Harrison–Robillard-Shultz Tracheoesophageal
Puncture Rating Scale (HRS Rating Scale), a 15-point rating scale incorporating
key elements of the definitions of use and quality of speech as well as ability
to care for the fistula and the prosthesis from 15 reviewed studies.3 Between 1992 and 1998, we consequently applied the
HRS Rating Scale to our laryngectomized and voice prostheses–implanted
patients. The purposes of the present study are to determine the success rate
and relating clinical factors of voice prosthesis rehabilitation and to analyze
the discrimination ability of the multidimensional HRS Rating Scale.
PATIENTS AND METHODS
PATIENTS
Between 1992 and 1998, 87 consecutive patients were primarily implanted
with a Provox or Provox 2 (Atos Medical AB, Hörby, Sweden) voice prosthesis
directly after total laryngectomy.4-5
This group consisted of 82 men and 5 women who ranged in age from 44 to 81
years, with a mean age of 62 years.
Before total laryngectomy, patients underwent psychological evaluation
and had the opportunity to speak to voice-rehabilitated patients. Patients
with anticoagulation and diseases or anomalies prone to putative prosthesis
handling problems, such as Parkinson disease, were not considered for voice
prosthesis implantation. Each patient received voice prosthesis rehabilitation
training by speech/language pathologists 14 days after laryngectomy. The speech/language
pathologists observed the patients for about 18 months and during this time
assessed their condition using the HRS Rating Scale after 2, 6, 12, and 18
months. The otolaryngologist checked the patients when the voice prosthesis
had to be changed, mostly owing to leakage. Before the prosthesis was removed,
the patient's condition was scored using the HRS Rating Scale. All patients
were independently seen by the speech/language pathologist and otolaryngologist.
Three rehabilitation times of voice prosthesis follow-up were arbitrarily
defined: phase I covered months 0 through 9 after implantation; phase II,
months 10 through 30; and phase III, months 31 through 72. Speech/language
pathologists saw patients only in phases I and II, otolaryngologists in phases
I, II, and III. According to the above-mentioned voice prosthesis follow-up
procedure, speech/language pathologists saw the patients most often in phase
I, while otolaryngologists compiled the most data in phase II. Moreover, all
patients were seen in a tumor follow-up program every 1 to 3 months after
the end of the surgical treatment and/or radiotherapy.
For statistical analysis, the Mantel-Haenszel  2 test
was used. For every patient, all ratings were summarized in a 2 x 2
cross-classification table, rater by ratings. The Mantel-Haenszel 2 test was used in all these tables to analyze the relation between rater
and ratings. An unequal number of ratings from the speech/language pathologists
and from the otolarnygologists were allowed.
THE HRS RATING SCALE
The HRS Rating Scale3 (Figure 1) defined success by the following 3 parameters: (1) use (degree to which tracheoesophageal speech is used as
the main means of communication), (2) quality (the
ease of voice production and its effect on intelligibility), and (3) care (the patients' independence from professional aid
for maintenance of the fistula and the prosthesis). Each parameter was scored
on a 1- to 5-point scale. The score of 1 or 2 was considered nonfunctional;
a score of 3, marginally functional; and a score of 4 or 5, functional. The
3 scores for the subscale parameters use, quality, and care were then tallied for an
overall score that ranged from 3 to 15. A total overall score of 12 or higher
was established as the cutoff level for successful voice prosthesis rehabilitation.3 Because the Provox voice prosthesis was not to be
self-removed and inserted by most patients, the maximum reachable score of
the subscale parameter care in these patients was
only 4 instead of 5 points. Either way, the cutoff level of 12 or more points
for a functional speaker was maintained.
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Figure 1. The Harrison–Robillard-Shultz
Tracheoesophageal Puncture (TEP) Rating Scale.3
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The study used 2 approaches for success assessment: (1) patient independent,
ie, every prosthesis was scored according to the above-mentioned criteria
and cutoff level and (2) all prostheses used in every single patient were
scored according to the above-mentioned criteria and cutoff level. A successful
patient voice rehabilitation was defined as successful voice prosthesis rehabilitation
in more than 50% of the assessed prostheses.
RESULTS
CLINICAL RESULTS
Total laryngectomy was indicated in 30 (34%) cases due to hypopharynx
carcinoma and in 57 (66%) cases due to carcinoma of the larynx. Of the 87
patients in the sample, 8 (9%) had relapsing T2 tumors, 32 (37%) had T3, and
47 (54%) had T4. The N stage distribution included 49 patients (56%) with
N0 lymph node status, 11 (13%) with N1, 25 (29%) with N2, and 2 (2%) with
N3. While larynx carcinomas had N0 lymph node status in 64 patients (74%),
hypopharynx carcinomas had N2 lymph node status in 59 patients (68%). Sixty-six
patients (76%) received radiotherapy treatment. The Kaplan-Meier survival
curve is shown in Figure 2. The
2-year survival rate of all patients was 70%, and the 5-year survival rate
was 48%. Patients with hypopharynx carcinoma with N2 or N3 lymph node metastasis
showed the worst prognoses.
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Figure 2. Kaplan-Meier proportion of survival
curve with confidence intervals of 87 patients with advanced larynx and/or
hypopharyx squamous cell carcinoma after laryngectomy.
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VOICE PROSTHESIS REHABILITATION RESULTS
Based on the independent evaluation of speech/language pathologists
and otolaryngologists, age, sex, tumor localization, tumor stage, and radiotherapy
had no significant influence on the success of voice prosthesis rehabilitation.
In phase I, the mean voice prosthesis life cycle was 4.2 months (2.14 prostheses
in 9 months; 95% confidence interval, 1.55-2.74 prostheses) for successfully
rehabilitated patients and 3.6 months (2.5 voice prostheses in 9 months; 95%
confidence interval, 1.09-3.91 prostheses) for unsuccessfully rehabilitated
patients. In phase II, successfully rehabilitated patients had significantly
shorter voice prosthesis life cycles than unsuccessfully rehabilitated patients.
The cost to the patient per year after successful voice rehabilitation is
estimated to be about $600 (Euro $640). Medical complications of voice prosthesis
rehabilitation were scarce and showed no correlation with voice rehabilitation
success: 1 patient experienced aspiration, 2 patients ingested the Provox
prosthesis, 3 patients had aspiration pneumonias due to periprosthetic leakage,
and peristomal infections occurred in 4 patients and fistula granulomas in
2 patients. No patient died from a complication or resulting treatment. Inner
prosthesis seepage was not considered to be a complication but a normal wear
effect. Periprosthetic leakage was observed mostly in the old Provox prosthesis.
Spontaneous closure of the tracheoesophageal fistula with prosthesis in place
occurred in 14 patients (8 functional and 6 nonfunctional speakers). Five
functional and 1 nonfunctional speakers asked for insertion of a new prosthesis.
Of the other 8 patients, 5 were nonfunctional speakers; the 3 functional speakers
had learned esophageal speech in parallel and did not want a new voice prosthesis
inserted.
EVALUATION BY SPEECH/LANGUAGE PATHOLOGIST
The 87 patients were seen 218 times by speech/language pathologists;
38 patients were seen only in phase I and 49 patients in phases I and II.
Phase I includes 160 HRS Rating Scale assessments and phase II includes 58.
The results of voice prosthesis assessments are given
in Table 1. Speech/language pathologists
observed a successful voice prosthesis rehabilitation for 34% of all voice
prosthesis assessments in phase I, 64% in phase II, and 42% in both phases.
The overall and corresponding phase I-II results of speech/language pathologist patient assessments are given in Table 2. Speech/language pathologists found that 29% of the individual
patients showed a successful voice prosthesis rehabilitation in phase I, 65%
in phase II, and 40% in phases I and II.
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Table 1. Voice Prosthesis Success Rates*
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Table 2. Patient Success Rates*
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EVALUATION BY OTOLARYNGOLOGIST
The 87 patients were seen 425 times by otolaryngologists; 50 patients
were seen only in phase I, 22 patients in phases I and II, and 15 patients
in phase I, II, and III. Phase I includes 176 HRS Rating Scale assessments;
phase II, 177; and phase III, 72. The overall and corresponding phase I-II
results of otolaryngologist voice prosthesis assessments
are given in Table 1. Otolaryngologists
observed a successful voice prosthesis rehabilitation for 39% of all voice
prosthesis assessments in phase I, 77% in phase II, 81% in phase III, and
62% in all phases. The overall and corresponding phase I-II results of otolaryngologist patient assessments are given in Table 2. A successful voice prosthesis rehabilitation was seen for
34% of the individual patients in phase I, 68% in phase II, 73% in phase III
(not given in Table 2), and 54%
in all phases,.
The Mantel-Haenszel 2 tests comparing all data for each
patient independently revealed no significant difference in HRS Rating Scale
success assessments by speech/language pathologists and otolaryngologists
(phase I, P = .29; phase II, P = .81). The P values are far from significant,
so there is no hint of a difference in ratings between speech/language pathologists
and otolaryngologists for phase I, with ratings of 87 patients, and even for
phase II, with ratings of only 37 patients. According to their higher voice
prosthesis replacement frequency, patients with successful voice rehabilitation
were seen more often by otolaryngologists. The success rate of phase II was
statistically significantly higher than phase I in speech/language pathologist
and otolaryngologist assessments (P = .003), and
the success rate of phase III (assessed only by otolaryngologists) was statistically
significantly higher than phase II (P = .02).
HRS RATING SCALE
Table 3 gives the rating
scale distribution for the 3 HRS Rating Scale criteria use, quality, and care
for speech/language pathologists and otolaryngologists. The criterion care shows a much narrower distribution for both assessors,
resulting in a much lower standard deviation than the criteria quality and use.
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Table 3. Rating Scale Distribution for the HRS Rating Scale Criteria Use, Quality, and Care*
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Table 4 correlates the successful
and nonsuccessful event status based on the 3 criteria quality, use, and care
to the rating scale sum distribution of 2 criteria: choosing a cutoff line
between 7 and 8 points for an evaluation of success seemed to be the most
appropriate approach. The contribution of the criterion care to an evaluation of success is minimal owing to the uniform rating
scale distribution. Eliminating the subscale parameter care would have changed the success status in 0 of 425 prostheses assessed
by otolaryngologists and in 1 of 217 prostheses assessed by speech/language
pathologists.
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Table 4. Correlation of Voice Prosthesis Rehabilitation Success Status
Based on 3 Criteria to the Rating Scale Subscore Distribution of 2 HRS Criteria*
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The criteria use and quality correlate strongly. For both otolaryngologists and speech/language
pathologists, the Spearman rank correlation between use and quality is higher
(correlation factor, 0.8 [otolaryngologists] and 0.87 [speech/language pathologists])
than between use and care (correlation factor, 0.66 and 0.43, respectively)
and between quality and care (correlation factor, 0.64 and 0.42, respectively).
Lacking either one of the criteria use and quality does not significantly change the evaluation of
a successful voice prosthesis rehabilitation.
COMMENT
Over the past 2 decades, TEP has grown to become a state of-the-art
method for voice rehabilitation after total laryngectomy. In contrast to esophagus
speech rehabilitation, TEP allowed patients speech and clear communication
already by the fifth postoperative week after laryngectomy.6
The safety and simplicity of the surgical and follow-up procedure are confirmed
by our data. Handling of the fistula and prosthesis can be learned well and
often turns the motivated patient into a voice prosthesis expert. A prosthesis
life cycle of about 4 months can be expected in successfully rehabilitated
long-term patients. In our population, an in situ longevity of 10 or more
months as described by Laccourreye et al7 was
exceptional and mostly observed in unsuccessfully rehabilitated patients.8 As in other mechanical valves, use-induced wear may
shorten voice prosthesis longevity. In several patients, a suddenly decreasing
voice quality in functional speakers was correlated with local or metastatic
tumor relapse.
The HRS Rating Scale was applied without problems by the 2 independent
tester groups. No differences were observed in the results. The cutoff level
proposed by Harrison and Robillard-Shultz is observed to be correct. Due to
a narrow distribution in our patient group, the subscale parameter care did not really contribute to the evaluation of success of voice
prosthesis rehabilitation. The excellent prosthesis handling and care attitude
in our population could be a local geographical phenomenon. Also, the almost
identical distribution of the subscale parameters use
and quality may be attributed to our study group.
More data are needed to evaluate the validity of the individual subscale parameters.
Success rates for voice prosthesis rehabilitation vary from 50% to 90%
in the literature. The success variety may be explained by a bonus factor
for the new method, a heterogeneous patient population, and a different and
deficient evaluation system.9-18
The present study is the first to have applied the published multiparametric
voice prosthesis HRS Rating Scale to TEP evaluation.19-20
The same approach is used by 2 independent tester groups. Moreover, the rated
success is correlated with the individual patient and with the single prosthesis.
Speech/language pathologists and otolaryngologists evaluated the same patient
group without statistically significant differences. The overall patient success rates of our assessment groups are 40% (speech/language
pathologists) and 54% (otolaryngologists), and the overall voice prosthesis success rates are 42% (speech/language pathologists)
and 62% (otolaryngologists). Short-term success reports dominated the studies
of the 1980s. Interestingly, in the literature, the long-term success is slightly
lower than the short-term success. We observed no such decrease but instead
found a learning curve with an increase of success over time. This complies
with a shorter voice prosthesis longevity in the advanced functional speaker
compared with the beginner. The 50% overall success rate of voice prosthesis
rehabilitation is not far removed from the 33% success rate of esophageal
speech rehabilitation, the classic long-term approach for voice rehabilitation.1 However, 24% of functional speakers with spontaneous
closure of the fistula renounced a new prosthesis implant and preferred esophageal
speech rehabilitation of "less hassle." Their esophageal speech abilities
developed in parallel to voice prosthesis rehabilitation.
In our estimation, voice prosthesis rehabilitation is the essential
first step in voice rehabilitation after total laryngectomy. A functionally
rehabilitated voice prosthesis speaker may more easily switch to esophageal
speech. A special effort is required on the part of the speech/language pathologist
to perform both the TEP as well as the esophageal speech rehabilitation.
AUTHOR INFORMATION
Accepted for publication November 2, 2001.
This article was presented in part at the 107th Congrès Français
d'Otorhinolaryngologie et de Pathologie Cervico-faciale, Paris, France, October
1-3, 2000.
Corresponding author and reprints: Michel A. Hotz, MD, Department
of Otorhinolaryngology, Head and Neck Surgery, University Hospital Inselspital,
3010 Bern, Switzerland (e-mail: michael.hotz{at}insel.ch).
From the Department of Otorhinolaryngology, Head and Neck Surgery,
University Hospital Inselspital, Bern, Switzerland.
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