Evaluation of the Health Economic Impact of Adopting SHERLOCK 3CG™ Tip
Confirmation System for Peripherally Inserted Central Catheter Placement:
U.S. and U.K Healthcare Systems Perspective
Pswarayi C1, Kara R2, Hollmann S3, Ferko N3, Dawson D1, Delatore P2
Bard Inc., Crawley, Sussex, UK, 2CR Bard Inc., Murray Hill, NJ, USA, 3Cornerstone Research Group Inc., Burlington, ON, Canada
INTRODUCTION
METHODS CONTINUED
• Peripherally inserted central catheter (PICC) placement may be achieved through
various methods:
 “Blind” bedside PICC placement using nurse-driven teams has been associated with
decreased costs and wait times compared with placement in interventional radiology
suites.1-8 However, limitations with “blind” catheter placement remain, such as risk of
PICC tip malposition and the need for confirmatory chest X-rays (CXRs).5-9
 Other PICC placement methods include the use of fluoroscopy and other tip location
systems (e.g., SHERLOCK™ Tip Location System (TLS); see disclaimer for full
indication).6; 7
 Successful PICC placement may be achieved through an integrated, bedside-driven
system that facilitates venous access, catheter navigation, and catheter tip
confirmation.2; 5; 10
– The SHERLOCK 3CG™ Tip Confirmation System (TCS) is indicated for guidance and
positioning of Peripherally Inserted Central Catheters (PICCs). The SHERLOCK 3CG™
TCS provides real-time PICC tip location information by using passive magnet
tracking and the patient’s cardiac electrical activity (ECG). When relying on the
patient’s ECG signal, the SHERLOCK 3CG™ TCS is indicated for use as an alternative
method to CXR and fluoroscopy for PICC tip placement confirmation in adult
patients.
– Limiting but not contraindicated situations for this technique are in patients where
alterations of cardiac rhythm change the presentation of the P-wave as in atrial
fibrillation, atrial flutter, severe tachycardia, and pacemaker driven rhythm. In such
patients, who are easily identifiable prior to PICC insertion, the use of an additional
method is required to confirm PICC tip location.
• Recently, the National Institute for Health and Care Excellence (NICE) recommended
the adoption of SHERLOCK 3CG™ TCS in the United Kingdom (U.K.) based on clinical
evidence and U.K. modelled health economic benefits.11
OBJECTIVE
• The objective of this study was to estimate the health economic impact of adopting
SHERLOCK 3CG™ TCS as an option for PICC placement from a United States (U.S.)
healthcare systems perspective and compare these results to the SHERLOCK 3CG™
TCS analyses performed by NICE from a U.K. healthcare systems perspective.
Table 1. Summary of NICE/EAC U.K. analysis parameters and assumptions.
83.5%
Patients with successful initial placements
Patients with malposition+
Proportion of malpositions successfully treated
“Blind” Bedside
Patients with successful initial placement
Patients with malposition+
Proportion of malpositions successfully treated
Fluoroscopy
Patients with successful initial placement
Patients with malposition+
Proportion of malpositions successfully treated
Cost Inputs
100%
0%
NA
93.1%
6.9%
100%
100%
0%
NA
Value
Assume 93% patients are eligible, as 7% meet exclusion criteria (i.e. patients with nondiscernable P-wave) and would require CXR; note costs were attributed to all patients5
93%
Patients with successful initial placement
Patients with malposition+
Proportion of malpositions successfully treated
“Blind” Bedside
Patients with successful initial placements
Patients with malposition+
Proportion of malpositions successfully treated
SHERLOCK™ Tip Location System
Patients with successful initial placement
Patients with malposition+
Proportion of malpositions successfully treated
Cost Inputs
Chest x-ray
Nurse time
Notes
Assumption for annual number of PICCs for a single hospital.
Based on the conservative lifespan of SHERLOCK 3CG™ TCS11
Notes
99.1%
0.9%
100%
Research study evidence from Pittiruti 201015
Assumption.11
86%
14%
100%
Research study evidence from Naylor 2007 and Lobo 2009 suggest malposition rate of
approximately 14%7; 9
Assumption.11
97.5%
2.5%
100%
Value
$61.26
$0
Research study evidence from Naylor 20077
Assumption.11
Notes
The Medicare cost of CXR and professional fee as reported by Ziegler et al. 201316
Conservatively assumed no difference in nurse time between insertion methods, no
nursing costs for initial insertion. Costs only attributed to reposition with cost of CXR
SHERLOCK 3CG™ Tip Confirmation System
Device capital
$4.58
Consumables
$240.62
Maintenance
$0.27
Training
$0.45
Total
“Blind” Bedside
$245.92
Device capital
$3.50
Consumables
$158.67
Total
SHERLOCK™ Tip Location System
$223.43
Device capital
$4.00
Consumables
$203.01
Total
$268.27
Based on capital cost of ultrasound and SHERLOCK 3CG™ TCS ($14,000 and $4,300),
amortized over 4 years, and 1,000 patients annually14
Includes PICC trays, maximal barrier, the cost of SHERLOCK 3CG™ TCS catheter and
other insertion components14
Annual maintenance cost is 5.96% of total capital cost, over 1,000 patients annually14
Assume 3 nurses trained for 4.5 hours annually, with a wage of $33.50/hr, over 1,000
patients annually14; 17
Includes device capital, consumables, maintenance, and training14
Table 3. Summary of parameters varied in the U.S. one-way sensitivity analyses.
Parameter
Base Case Value Lower Value Upper Value
8 years
Lifespan of SHERLOCK 3CG™ TCS device‡
4 years
2 years
1,200
Number of PICCs placed annually§
1,000
800
9%
Proportion of patients ineligible for SHERLOCK 3CG™ TCS*
7%
2.8%
1.08%
Proportion of SHERLOCK 3CG™ TCS patients with malposition requiring another CXR§
0.9%
0.72%
93.1%
Proportion of “blind” bedside patients with successful initial placement+
86%
70%
16.8%
Proportion of “blind” bedside patients with malposition requiring another CXR§
14%
11.2%
5 hours
Annual nurse training time required per nurse‡
4.5 hours
4 hours
8
Number of nurses trained on SHERLOCK 3CG™ TCS‡
3
2
$5,160
Total cost of SHERLOCK 3CG™ TCS capital device§
$4,300
$3,440
$288.74
Consumable cost for SHERLOCK 3CG™ TCS§
$240.62
$192.50
$190.40
Consumable cost for “blind” bedside§
$158.67
$126.94
$73.51
Cost of CXR§
$61.26
$48.74
Assumptions and Sources:
§ Assumption: +/- 20%, ‡ Analysis performed for NICE submission.14 * Based on clinical evidence from Pittiruti 2012 and Corsten
1994.18; 19 + Based on clinical evidence from Trerotola 2007 (assuming all unsuccessful insertions were re-attempted) and Walker
2013.13; 20
Based on capital cost of ultrasound ($14,000), amortized over 4 years, and 1,000
patients annually14
Includes cost of PICC trays, maximal barrier, and other insertion components relevant
to bedside placement14
Includes consumables and cost of x-ray14
Based on capital cost of ultrasound and SHERLOCK™ TLS ($14,000 and $2,000),
amortized over 4 years, and 1,000 patients annually14
Includes cost of PICC trays, maximal barrier, and other insertion components relevant
to TLS placement14
Includes consumables and cost of x-ray14
Notes
Based on Bard questionnaire of health professionals11
Based on the conservative lifespan of SHERLOCK 3CG™ TCS11
Notes
Based on publication by Adams 2013, remaining 16.5% of patients treated
with blind bedside (using appropriate clinical and cost inputs)12
Based on NICE/EAC assumption that there would no way to know if there is a
malposition without x-ray11
Assumption.11
Research study evidence from Walker 201313
Assumption.11
Research study evidence from Walker 201313
Primary Results:
• The incremental cost per patient was similar in the U.S. and U.K. analyses (Figure 1).
–
When comparing SHERLOCK 3CG™ TCS with “blind” bedside, NICE/EAC reported £9.37 per patient.
–
Similarly, in the U.S. analyses, SHERLOCK 3CG™ TCS compared with “blind” bedside was associated with $18.73 (£12.17) per patient.
Secondary Results:
• For the alternate U.K. analysis, when the use of SHERLOCK 3CG™ TCS was compared with fluoroscopy, the analysis predicted cost savings of £106.12 (Figure 2).
• For the alternate U.S. analysis, when the use of SHERLOCK 3CG™ TCS was compared with SHERLOCK™ TLS, the analysis predicted cost savings of $19.06 (£12.39) (Figure 3).
–
For ease of comparison, U.S. results presented in Figure 1 and Figure 3 were converted to Pounds Sterling using an exchange rate of: 1 USD: 0.65 GBP.
Fluoroscopy vs. SHERLOCK 3CG™ TCS (U.K.)
£350
£300
£293
£500
£303
£200
£151
£150
£163
£100
£9
£50
£12
£0
£303
£300
£200
£100
£0
-£100
Cost of SHERLOCK 3CG™ TCS
U.S.
Incremental Cost
Figure 1. Incremental cost-impact of PICC insertion with SHERLOCK 3CG™
TCS vs. “Blind” Bedside from U.K. and U.S. perspectives.
Note: U.S. results converted to Pounds Sterling by a conversion of 1 USD: 0.65 GBP. The values in the figure have been rounded for presentation
purposes.
Cost of Fluoroscopy
Cost of SHERLOCK 3CG™ TCS
£163
£100
£50
£0
-£12
-£50
Incremental Cost
Cost of SHERLOCK™ TLS
Cost of SHERLOCK 3CG™ TCS
Incremental Cost
Figure 2. Incremental cost impact of PICC Figure 3. Incremental cost impact of PICC
placement with SHERLOCK 3CG™ TCS
placement with SHERLOCK 3CG™ TCS
compared to Fluoroscopy (U.K. Analysis). compared to SHERLOCK™ TLS (U.S. Analysis).
Note: U.S. results converted to Pounds Sterling by a conversion of 1 USD: 0.65 GBP.
The values in the figure have been rounded for presentation purposes.
Note: The values in the figure have been rounded for presentation purposes.
Sensitivity Analysis Results:
• NICE/EAC indicated the uncertainly in the U.K. model was sufficiently tested in
the sensitivity analyses; the range of values tested were aligned with clinical
opinion and literature.
– Results of the U.K. analyses were robust to a wide range of inputs and
assumptions.
– One-way sensitivity analysis results demonstrated the primary drivers of the
U.K. analyses were the cost of a PICC insertion and the success rate of the
initial insertion methods.11
– Threshold analyses identified situations where SHERLOCK 3CG™ TCS would be
cost-incurring (e.g., lower insertion success with SHERLOCK 3CG™ TCS or
higher insertion success with “blind” bedside).11
– NICE/EAC scenario analyses based on data from Johnston and colleagues in
2013 and 2014 also indicated that SHERLOCK 3CG™ TCS was particularly costsavings (-£41.35) in a subgroup of ICU patients due to significant reduction in
the proportion of malpositioned catheters that needed to be repositioned.11
• The results of the U.S. sensitivity analyses were aligned with those of the U.K.
as the results were robust to changes in key parameters.
• The use of SHERLOCK 3CG™ TCS for PICC insertion is estimated to be cost
neutral for the majority of scenarios (Figure 4).
• The parameters with the largest impact on results for the U.S. analysis included
the cost of consumables for both insertion methods, the cost of a CXR, and
the proportion of successful insertions with “blind” bedside.
£175
£150
-£106
-£200
U.K.
Cost of "Blind" Bedside
£200
£409
£400
£250
SHERLOCK™ TLS vs. SHERLOCK 3CG™ TCS (U.S.)
Cost per Patient
• In both the U.S. and U.K. primary analyses, SHERLOCK 3CG™ TCS was compared with
“blind” bedside PICC placement.
• SHERLOCK 3CG™ TCS was also compared with other methods of PICC placement in
secondary analyses:
–In the U.K. analyses, SHERLOCK 3CG™ TCS was compared with fluoroscopy.
–In the U.S. analyses, SHERLOCK 3CG™ TCS was compared with SHERLOCK™ TLS.
• Clinical and economic outcomes were assessed per patient over the duration of a
successful PICC insertion procedure.
• In the primary analyses, all eligible patients with an identifiable P-wave in their ECG
rhythm were assumed to switch to SHERLOCK 3CG™ TCS and did not require
confirmatory CXR.
• PICC placement success rates, as well as region-specific costs for capital,
maintenance, nurse training, consumable materials, and CXRs were included.
• Parameters and assumptions were based on the NICE/External Assessment Centre
(EAC) report and published literature when possible.
–The summary of U.K. parameters and assumptions are presented in Table 1.
• Note that these inputs are based on the NICE/EAC recommendations.
–The summary of U.S. parameters and assumptions are presented Table 2.
• Note that these inputs were aligned with the NICE/EAC recommendations
where possible and supplemented with U.S.-specific assumptions and
published literature.
• The results of the U.S. analyses were compared with the results of the U.K. analyses.
• Discounting was not applied in either analysis.
Proportion of eligible patients
Value
1,000
4 years
Value
Proportion of eligible patients
Cost per Patient
Analyses:
Value
468
4 years
Value
General Inputs
Number of PICCs placed annually
Time horizon
Clinical Inputs
SHERLOCK 3CG™ Tip Confirmation System
RESULTS
METHODS
General Inputs
Number of PICCs placed annually
Time horizon
Clinical Inputs
SHERLOCK 3CG™ Tip Confirmation System
Sensitivity Analyses:
 NICE/EAC reported that the uncertainty in the U.K. analyses were sufficiently
tested using a variety of sensitivity analyses (e.g., one-way, two-way, and
scenario analyses).
 The sensitivity analyses of the comparison of SHERLOCK 3CG™ TCS versus
“blind” beside were used to acknowledge some of the limitations available with
the current data.
 For example, parameters evaluated in the U.K. sensitivity analyses included:
– Proportion of successful placements for both methods, proportion of
successful adjustments or replacements after initial misplacement, cost of
insertion, cost of reinsertion after initial failure for both insertion methods
 Similarly, to test the robustness of the U.S. model, sensitivity analyses were
performed by varying all base case inputs (Table 3).
– These sensitivity analyses were aligned, where possible, with the U.K. analyses.
– Results are presented in a tornado diagram which is meant to report the
most impactful parameters, and demonstrate the economic impact of
changing these parameters through a range of plausible values.
Table 2. Summary of U.S. analysis parameters and assumptions.
Cost per Patient
1CR
Incremental Cost Impact
-$40
-$20
$0
$20
$40
$60
$80
Consumable cost for SHERLOCK 3CG™ TCS ($192.50, $288.74)
Consumable cost for “blind” bedside ($126, $190.40)
Cost of CXR ($49.01, $73.51)
Proportion of successful “blind” bedside placements (70%, 93.1%)
Proportion of patients ineligible for SHERLOCK 3CG™ TCS (2.8%, 9%)
Proportion of malpositions requiring CXR with “blind” bedside (11.2%, 16.8%)
Lifespan of SHERLOCK 3CG™ TCS device (2yrs, 8yrs)
Lower Value
Number of PICCs placed annually (800, 1,200)
Upper Value
Number of nurses trained on SHERLOCK 3CG™ TCS (2, 8)
Total cost of SHERLOCK 3CG™ TCS capital device ($3,440, $5,160)
Proportion of malpositions requiring CXR with SHERLOCK 3CG™ TCS (0.72%, 1.08%)
Annual nurse training time required per nurse (4hrs, 5hrs)
Figure 4. U.S. one-way sensitivity analyses varying base case in put parameters for
SHERLOCK 3CG™ TCS compared to “blind” bedside.
Note: The vertical access represents the U.S. base case results ($18.73 per patient).
Assumption.11
Notes
Chest x-ray
£5.67
Cost of x-ray captured through radiographer time and associated unit cost14
Nurse time
£87.49
Insertion and malpositions with SHERLOCK 3CG™ TCS and blind bedside each
received nurse time cost14
Device capital
£6.39
Total capital cost of £9,900, amortized over 4 years*, and 391 eligible patients
annually11
Consumables
£189.91
Maintenance
£1.52
Bard data on file14
Training
£1.17
Assume 3 nurses trained for 4.5 hours annually, with a wage of £34/hr, over
391 patients annually14
SHERLOCK 3CG™ Tip Confirmation System
Includes PICC, sterile maximum barrier, procedure tray, ECG leads, printer
paper, gloves, etc.14
Total
£304.48 Includes device capital, consumables, maintenance, training, and nurse time14
“Blind” Bedside
Cost
Total
Fluoroscopy
£181.18 Includes equipment costs, ultrasound, consumables, etc14
£274.33 Includes consumables, nurse time, and CXR cost14
Cost
£408.75
Includes equipment cost, ultrasound, radiologist time, nurse time, and theatre
cost14
Assumptions and Sources:
* The capital cost of SHERLOCK 3CG™ TCS was amortized over a 4-year time horizon which is a conservative assumption on the lifespan of
SHERLOCK 3CG™ TCS. Bard, data on file14
DISCUSSION
DISCUSSION & CONCLUSIONS
CONCLUSIONS
• Results of the U.S. analyses for placement of PICCs with SHERLOCK 3CG™ TCS
• SHERLOCK 3CG™ TCS is predicted to be an economically favorable PICC
compared with “blind” bedside were found to be consistent with the U.K. analysis
insertion option from both the U.K. and U.S. health systems perspectives.
reported by NICE/EAC.
– Additional analyses in other regions may help to further substantiate
– The health economic impact of adopting SHERLOCK 3CG™ TCS when compared
to “blind” bedside is estimated to be cost neutral.
these results.
– A key benefit of SHERLOCK 3CG™ TCS is the reduced need for confirmatory
• Future analyses using real-world time and motion data would also help to
CXRs, potentially limiting patients and health care practitioners from being
further elucidate these findings.
exposed
to unnecessary radiation. The estimated cost savings were also due to reduced
staff time requirements.
• Similar to the use of fluoroscopy in the U.K., comparison to an alternative method
1. Robinson MK, et al. (2005). JPEN. 29 (5): 374-379.
12. Adams T (2013) The Clinical Efficacy of PICC Tip Confirmation using ECG Tip
of PICC placement (SHERLOCK™ TLS), the use of SHERLOCK 3CG™ TCS results in
Locator Technology. Poster Presentation at the Association of Vascular Access
2. Sainathan S, et al. (2014). J Vasc Access. 15 (6): 498-502.
Annual Scientific Meeting.
cost savings.
3. Lelkes V, et al. (2013). Clin Imaging. 37 (5): 917-921.
13. Walker G, Todd A (2013). Br J Nurs. 22 (19): S9-15.
• The sensitivity analyses demonstrated that the base case results were robust, with the 4. Meyer BM (2010). J Infus Nurs. 33 (5): 292-303.
14. Bard Access Systems Inc. Data on file. Salt Lake City, UT.
5. Pittiruti M, et al. (2011). J Vasc Access. 12 (4): 280-291.
15. Pittiruti M (2010) evGuide-SapiensTM TLS Post-market Clinical Study Report.
majority of different assumptions having little to no impact on the overall conclusions. 6. Hockley SJ, et al. (2007). Crit Care Resusc. 9 (3): 251-255.
Catholic University Hospital. n = 332.
• The key limitation of this study was that results were not based on head-to-head
16. Ziegler K, et al. (2013). J Trauma Manag Outcomes. 7 (1): 2.
7. Naylor CL (2007). JAVA. 12 (1): 33-35.
17. Bureau of Labor Statistics (Web Page) Occupational Employment and Wages,
8. Smith B, et al. (2010). J Electrocardiol. 43 (3): 274-278.
clinical study comparisons.
May 2014: 29-1141 Updated March 25, 2015. Available online at:
9. Lobo BL, et al. (2009). J Hosp Med. 4 (7): 417-422.
http://www.bls.gov/oes/current/oes291141.htm. Accessed: July 3, 2015.
• In addition, these results must be interpreted with caution, as these estimates were
10.Hostetter R, et al. (2010). JAVA. 15 (3): 112-125.
18. Pittiruti M, et al. (2012). J Vasc Access. 13 (3): 357-365.
based on specific inputs and assumptions that may not be generalizable to all users. 11.National Institute for Health and Care Excellence (2015). The Sherlock 3CG
19. Corsten SA, et al. (1994). J Clin Anesth. 6 (6): 469-472.
REFERENCES
Tip Confirmation System for placement of peripherally inserted central
catheters. Available online at: guidance.nice.org.uk/mtg24.
DISCLAIMERS
• Please consult labels and inserts for any indications, contraindications, hazards, warnings, precautions, and instructions for use.
• The SHERLOCK 3CG™ Tip Confirmation System (TCS) is indicated for guidance and positioning of Peripherally Inserted Central Catheters (PICCs). The SHERLCOK 3CG™ TCS provides realtime PICC tip location information by using passive magnet tracking and the patient’s cardiac electrical activity (ECG). When relying on the patient’s ECG signal, the SHERLOCK 3CG™
TCS is indicated for use as an alternative method to chest X-ray and fluoroscopy for PICC tip placement confirmation in adult patients. Limiting but not contraindicated situations for
this technique are in patients where alterations of cardiac rhythm change the presentation of the P wave as in atrial fibrillation, atrial flutter, severe tachycardia, and pacemaker driven
rhythm. In such patients, who are easily identifiable prior to PICC insertion, the use of an additional method is required to confirm PICC tip location.
• The SHERLOCK™ Tip Location System (TLS) detector quickly locates the position of specially designed magnet-tipped Peripherally Inserted Central Catheters (PICCs) and Central Venous
Catheters (CVCs) during initial placement. This device may be used by appropriate caregivers in hospitals, long-term care facilities or home-care settings. The SHERLOCK™ Tip Location
System (TLS) detector provides rapid feedback to the caregiver but was not designed to replace conventional methods of placement verification. Users are urged to confirm correct
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20. Trerotola SO, et al. (2007). J Vasc Interv Radiol. 18 (4): 513-518.
placement according to their established institutional protocol and clinical judgment.
These results are based on a predictive model only and are not indicative of actual clinical results.
This model is not intended to produce exact estimates of the financial consequences but to provide a valid computing framework (a “model”) that allows users to understand the
relationships and sensitivities between the characteristics of their setting and the possible financial consequences of purchasing product(s), choosing a care pathway, implementing a
service/program, or entering into a business relationship.
Thus, the model reflects scenarios that consist of a set of specific assumptions and data inputs of interest to the decision maker.
This model is intended as an aid to current decision making, and outputs from the model should always be reported as conditional upon the input and assumptions. Furthermore, the
output should never be represented as a guarantee of results or a certainty in outcomes.
Bard, SHERLOCK, and SHERLOCK 3CG are trademarks and/or registered trademarks of C. R. Bard, Inc. © 2015 C. R. Bard, Inc. All rights reserved.
ISPOR 18th Annual European Congress. 7-11 November 2015; Milan, Italy.