Download T AL REPOR ANNU

Surgical Hearing
Implant Program
ANNUAL REPORT
2012-2013
Otolaryngology
Department Name
Title
Executive Summary
Vision
To enrich communication and quality of life for Manitobans by delivering safe, accessible and
innovative hearing solutions.
Mission
To establish a nationally recognized surgical hearing implant centre through collaborative
research, evidence-based practice and state-of-the-art technology.
Summary
This report will outline the current status of the Surgical Hearing Implant Program (SHIP) of the
department of Otolaryngology – Head & Neck Surgery at Health Sciences Centre (HSC) as of
March 31st, 2013. The report will provide information on the status of the bone anchored
hearing aid (BAHA) program and the cochlear implant (CI) program, including patient
demographics, audiometric/candidacy information, financial statements and the projected plan
for program development in the upcoming fiscal year.
The BAHA program achieved 78% (11/14) of its annual implant quota
for the 2012-2013 fiscal year. Eleven adult patients (average age: 60
years) were implanted unilaterally and fit with an external processor.
There are currently 9 patients awaiting implant surgery and 60
patients awaiting trial for candidacy. Assuming approximately 40 of
those patients will meet candidacy criteria, the waiting list for BAHA implantation will exceed 3
years at current quota levels of 14 per year. The BAHA program exceeded its annual budget the
past fiscal year, despite not meeting quota. However, these costs were offset by savings
achieved through the CI program and did not affect patients.
The Cochlear Implant program achieved 97% (34/25) of its annual implant quota for the 20122013 fiscal year. The program completed 29 surgical procedures on 21 adult and 8 pediatric
patients, including 4 pediatric patients who were implanted bilaterally. There are currently 8
patients preparing for CI surgery and approximately 52 patients
who have passed audiological candidacy criteria and are
awaiting consultation with physicians, resulting in an
approximate 2-year waiting list for implantation. The cochlear
implant program achieved 95% of its annual budget and saw a
reduction in the average implant cost of approximately $2,500
due to completion of primary and secondary vendor contracts in the 3rd quarter.
Entering the third fiscal year and first full year with a dedicated coordinator on staff, both BAHA
and CI programs require more work to streamline patient flow and maintain consistent levels of
ancillary support. However the work of many dedicated individuals has allowed the Surgical
Hearing Implant Program to come very close to meeting annual quotas while still operating
within budget in order to provide Manitobans with state-of-the art hearing implant technology
in an evidenced-based delivery model. It is the goal of the program to continue improving
processes in order to create a consistent and manageable surgical schedule that will decrease
stress on the entire system while still maximizing beneficial outcomes for patients. This will be
accomplished through inter-disciplinary research, dedicated personnel and collective teamwork
to ensure patients in Manitoba receive the quality of care they expect and deserve.
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Title
Contents
Executive Summary ........................................................ 1
Contents ......................................................................... 2
1. BAHA Program Summary............................................ 3
2. Cochlear Implant Program Summary ......................... 7
3. Future Program Development.................................. 11
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Title
1. BAHA Program Summary
1.1 Current BAHA Program Status
The BAHA program has a current caseload of approximately 167 participants with 30 of those
patients using some form of osseointegrated device. 32% of these patients were implanted outof-province prior to program initiation (or were simply absorbed into the program by migrating
permanently to Manitoba from other regions) while 59% were implanted in-province since
2010. Finally, 9% of patients use the processor in conjunction with a soft-band and did not
undergo surgery for implantation.
Since the inception of the program, a total of 10 patients have been implanted in Manitoba
between 2010 and 2011 and 8 patients have been implanted in the current fiscal year
(01/04/2012 – 31/03/2013). There are currently 11 patients awaiting surgery for implantation
and 58 awaiting a consultation/trial with audiology. Approximately 33 patients have undergone
a trial period and declined to proceed with surgery. Table 1 (below) specifies the number and
designation of each patient category.
Total number of patients involved in the program
162
Number of patients implanted in province (prior to current fiscal year)
10
Number of patients implanted out of province (prior to 2010)
11
Number of patients implanted in the current fiscal year (1-4-2012 / 31-03-2013)
11
Number of patients using devices with soft band (non-implanted)
3
Total number of patients currently fit with implanted devices:
30
Number of patients awaiting implantation surgery for current fiscal year
12
Number of patients awaiting trial/consultation with audiologist
52
Number of patients seen for consultation who did not meet candidacy requirements
33
Table 1. Overview of current BAHA patient status.
1.2 Patient Demographics: Mixed-Conductive Hearing Loss
Individuals with Mixed-Conductive hearing loss comprise 93% of all implanted patients in the
program. Patients range in age from 33 to 78 years with a mean age of 54. Figure 1 (below)
represents the average audiogram for this patient group. On average, patients in the MixedConductive hearing loss group present with flat, moderate to moderately-severe air conduction
thresholds and slightly sloping, normal-to-mild bone conduction thresholds. The average airbone gap, per frequency (Figure 1) is consistent with BAHA candidacy for this type of hearing
loss.
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Title
Figure 1. Average audiogram for Mixed-Conductive hearing loss group.
1.3 Patient Demographics: Unilateral Sensorineural Hearing Loss (Single Sided Deafness)
At this point in the program, individuals with unilateral sensorineural hearing loss (“Single Sided
Deafness”) comprise 17% of all implanted patients. Patients in this category range in age from
64 to 76 years with a mean age of 70. Figure 2 (below) represents the average audiogram for
this patient group. On average, patients with unilateral sensorineural hearing loss present with
flat, profound air conduction thresholds in the poorer ear and mild-to-moderate air/bone
conduction thresholds in the better ear. Bone conduction thresholds for the poorer ear in this
group exceeded the maximum output limits of the testing equipment.
Figure 2. Average audiogram for Unilateral Sensorineural hearing loss group.
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Title
1.4 BAHA Program - Financials for 2012-2013 Fiscal Year
A total of 11 patients were unilaterally implanted this fiscal year, enabling the program to come
close to reaching the annual quota of 14 implants. See Table 2 (below) for all implanted patients
in the BAHA program from this fiscal year as well as patients who have successfully completed
the BAHA trial and are awaiting the procedure.
Table 2. Cost per BAHA surgery for current fiscal year.
The cost structure for all osseointegrated devices are listed in Table 3 below. The funding for
BAHA type instruments are separated into 2 categories: (1) implant with abutment and (2)
external processor. With an annual quota of 14 BAHA implants, the estimated cost for
implantation and external device was originally $5,500, for a total of approximately $77,000.
However, the original estimate was low as the actual cost per implant is approximately $6,500
(Table 3). Part of the reason for this discrepancy was the absence of finalized vendor contracts
prior to the launch of the program. As a result, the cost of the implant and external processor
exceeded expectations for both primary and secondary vendors.
In addition, despite not reaching its’ annual quota of implants, the BAHA program exceeded its
budget for this fiscal year by approximately $22,604. The reason for this overrun was that the
funding estimate also neglected to account for needed inventory for each procedure as the
length and diameter of the implant may vary per patient based on factors present during
surgery. However, due to savings achieved on the cochlear implant budget, the program was
able to absorb this added cost without reducing services for patients. Looking forward to the
upcoming fiscal year, negotiations will take place with vendors to arrange consignment for
necessary inventory in order to avoid this same impact on the next budget.
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Title
Fiscal Year:
2012 - 2013
Month
Number of Surgeries/Implants
Funding for BAHA Surgery
April
June
August
September
October
November
1
1
1
1
1
1
$6,384
$6,865
$6,175
$6,715
$6,715
$6,115
January
February
March
Inventory
1
1
3
-
$6,327
$6,327
$18,981
$19,000
Total:
Projected:
Variance:
Average Cost Per Surgery:
$99,604
$77,000
($22,604)
$6,453
Table 3. BAHA patients, current fiscal year.
1.5 BAHA Waiting List Management
The program receives approximately 8 physician referrals per month, resulting in 60 patients
currently on the waiting list for a BAHA trial. A fully operational BAHA program should be able
to facilitate 4 new BAHA trials per week using a week-long trial structure. Under this system
(accounting for the new referrals each month), the BAHA program should be able to eliminate
the waiting list for new trials within approximately 16 weeks to facilitate wait times of no longer
than one month per patient.
Figure 3. Projected time frame for reducing BAHA waiting list.
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Title
2. Cochlear Implant Program Summary
2.1 Cochlear Implant Program Status
The Cochlear Implant program has a current caseload of approximately 42 active participants
currently implanted and approximately 50 patients awaiting surgery. In the first year of the
program (2011-2012), there were 12 surgeries completed using a total of 12 implants. The
current fiscal year (2012-2013) has seen 29 surgeries completed using 34 implants. 86% of
active patients were implanted with a unilateral implant while 14% of patients utilize bilateral
implants (all bilateral implants were pediatric patients). Patients from across Manitoba have
undergone surgery for implantation; however the majority of recipients reside within 100
kilometers of Winnipeg (Figure 4).
Figure 4. Geographical location of all Manitoban cochlear implant recipients.
2.2 CI Patient Demographics: Adults
Adult patients range in age from 33 to 85 years with a mean age of 60.2. On average, patients
present with flat, severe-to-profound audiometric configurations, although there are a few
exceptions where some usable hearing in the low frequencies is demonstrated. Figure 5 (below)
represents the average audiogram for this patient group as well as the average “aided” hearing
thresholds as measured in sound field through the cochlear implant.
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Title
Figure 5. Average unaided/aided audiogram for the adult patient group.
2.3 CI Patient Demographics: Pediatrics
Pediatric patients range in age from 18 months to 6 years with a mean age of 3.5. On average,
patients present with flat, severe-to-profound audiometric configurations. Figure 6 (below)
represents the average audiogram for this patient group as well as the average “aided” hearing
thresholds as measured in sound field through the cochlear implant.
Figure 6. Average unaided/aided audiogram for the pediatric patient group.
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Title
2.4 CI Outcome Measures
Aided benefit with the cochlear implant is evaluated by testing the patient’s ability to correctly
identify speech in the form of phonemes, words and entire phrases in both quiet and with
competing noise. The entire test battery for cochlear implant users can be referenced here, but
the tests presented for this report include:
Consonant-Nucleus-Consonant (CNC) Test
Hearing in Noise Test (HINT)
AzBio Test (Arizona State University)
Standardized speech recognition testing is used to measure the objective benefit each patient
receives from their implanted device. Patients are placed in a sound-treated booth and asked to
repeat consonant sounds, word and phrases at threshold and supra-threshold levels with and
without competing broadband noise.
Patients are typically tested in a number of conditions which include unaided (without the use of
either cochlear implant or conventional hearing aid), and aided with cochlear implant only. The
ability of the patient to accurately identify and repeat speech stimuli is expressed as a percent
correct score in Table 4 (below). The average results indicate a net increase in the ability to
correctly identify speech using the cochlear implant ranging from 32% to 57%, depending on the
test.
Table 4. Average speech reception test results: unaided (gray columns) and aided (green columns).
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Title
2.5 CI Program - Financials for 2012-2013 Fiscal Year
The monthly cochlear implant surgeries for the past fiscal year are illustrated in Figure 7 (below)
in order to examine trends in surgical procedures and to help improve efficiencies within the
process. Figure 7 demonstrates where periods of activity existed during the last fiscal year,
followed by brief periods of higher levels of activity weighted towards the end of the year. This
creates stress on the system and affects all parties involved with regard to finding available OR
time for surgeons, prepping and booking patients for surgery, maintaining appropriate surgical
supplies on short notice, tracking patient flow and creating consistent budgeting expectations.
Looking forward to the next fiscal year, one of the goals of the surgical hearing implant program
will be to create a consistent patient flow that results in approximately 3 cochlear implant
surgeries per month. This will help reduce variability in the process, eliminate uncertainty and
ease burden on surgeons and OR resources, while still meeting the annual quotas for implants.
Figure 7. Number of Cochlear Implant procedures/implants per month during 2012-2013 fiscal year.
Budget
The funding for cochlear implants is separated into 2 categories: (1) internal implant with
electrode array and (2) external speech processor. With an annual quota of 35 cochlear
implants, the estimated cost for implantation and external device is $30,000, for a total of
approximately $1,050,000 allotted for the cochlear implant portion of the surgical hearing
implant program. The program has a working relationship with 3 individual cochlear implant
manufacturers which results in a different surgical and equipment cost for each procedure. Due
to primary and secondary vendor contract deductions, the actual average cost per cochlear
implant surgery is approximately $30,705 and the average cost per implant was $26,190. The
cost structure for internal implant and external processor for each vendor is listed in table 5
below.
Vendor
Med-El
Cochlear
Advanced Bionics
Internal Implant
$16,973
$25,358
$13,781
External Processor
$8,487
$5,699
$8,978
Total
$25,460
$31,057
$22,759
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Title
Fiscal
Year:
2012 2013
Month
April
June
August
September
October
November
December
January
February
March
Total:
Projected:
Variance:
Average Cost per Surgery:
Average Cost per Implant:
Surgeries
2
3
3
3
1
4
4
4
4
1
29
35
(6)
Implants Ordered
2
3
4
4
1
4
4
4
6
2
34
35
(1)
Funding
$56,052
$79,276
$114,423
$109,538
$22,759
$107,632
$93,737
$91,036
$170,482
$45,518
$890,453
$1,050,000
$172,407
$30,705
$26,190
Table 5. Cost per cochlear implant procedure for current fiscal year.
Vendors
The surgical hearing implant program has cultivated partnerships with three different cochlear
implant vendors, including Med-El, Cochlear Corporation and Advanced Bionics. The primary
vendor contract was awarded to Advanced Bionics and was finalized in October 2012 while the
secondary contract was awarded to Cochlear in November 2012. To meet the contract
obligations, the program must dispense approximately 60% Advanced Bionics product and
approximately 30% Cochlear product per year. These contracts allowed the program to reduce
the average cost of each cochlear implant by approximately $2,500. Since these contracts were
ratified towards the end of the fiscal year,
3. Future Program Development
3.1 Program Plan for Next Fiscal Year
It is the goal of the surgical implant coordinator to provide a detailed protocol around the CI
program in order to streamline existing hospital processes, create a national evidenced-based
centre for excellence and to offer patients a consistent and positive experience throughout their
relationship with HSC. In order to achieve these goals, the CI program will begin to implement
the following over the next 12 months:
Create a consistent system that facilitates 3 CI surgeries per month, every month.
Determine a streamlined system for patient referral, device ordering and tracking costs.
Create a comprehensive patient information packet – detailing all the steps from
diagnosis to device activation.
Establish consistent clinic schedules for cochlear implant patient fittings and follow up
Create a consistent set of measurable outcomes to assess benefit for the patient and
justify funding for the program
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Title
Create an informative and interactive internet presence for patients and professionals
Collaborate with other implant programs across the country in order to ensure best
practices are in place
Collaborate with local professionals to ensure transparency and open communication
for patient benefit
Reduce patient waiting lists for surgery and cochlear implant consultation
Apply for provincial and federal grants for additional funding for research
Justyn Pisa AuD, Coordinator – Surgical Hearing Implant Program
Department of Otolaryngology – Head & Neck Surgery
31/03/2013
[email protected]
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