MEDTRONIC CARELINK® 5242
TriageHF feature in the Heart Failure Management Report
Technical Manual
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
The following list includes trademarks or registered trademarks of Medtronic in the United
States and possibly in other countries. All other trademarks are the property of their respective
owners.
CareAlert, CareLink, CARELINK, Claria MRI, Medtronic, Medtronic CareLink, OptiVol,
SureScan, TriageHF
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MEDTRONIC CARELINK® 5242
Contents
1 Introduction ............................................................ 4
1.1 About this manual .................................................. 4
2 TriageHF feature description ............................................ 5
2.1 TriageHF overview ................................................. 5
2.2 Intended use ...................................................... 5
2.3 Important notes .................................................... 6
2.4 Contraindications .................................................. 6
2.5 TriageHF clinical data .............................................. 6
2.6 Operation of TriageHF ............................................. 11
2.7 Viewing and using TriageHF information ............................. 13
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MEDTRONIC CARELINK® 5242
1 Introduction
1.1 About this manual
This manual describes the intended use and operation of TriageHF, a feature that provides
an integrated heart failure risk assessment on the Medtronic CareLink Network. The
information provided in this manual applies to Medtronic CRT-D, CRT-P, and ICD devices
that have the OptiVol Fluid Status Monitoring feature.
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2 TriageHF feature description
2.1 TriageHF overview
The TriageHF feature helps clinicians identify patients who may have a higher risk of a heart
failure event in the near future, and, therefore, may need closer medical attention. The
TriageHF feature integrates the diagnostic data collected by the implanted device and
provides an overall heart failure risk assessment. The risk assessment analyzes the
diagnostic data from the previous 30 days to calculate the probability of a heart failure event
in the next 30 days.
The TriageHF feature has not been studied prospectively to verify how often the predictions
presented by the algorithm are followed by actual heart failure events in patients. A
post-market trial is planned to evaluate the relationship between the algorithm and heart
failure events.
Medtronic anticipates heart failure physicians may schedule CareLink transmissions once
per month to monitor a patient’s heart failure risk status.
The device manuals include information on the impact of monthly transmissions on the
projected service life of the implanted device. For example, for the Claria MRI CRT-D
SureScan devices, monthly transmissions over the life of the device reduce projected
service life by 46 days or 2%.
2.2 Intended use
The TriageHF feature can be used with commercially available Medtronic CRT-D, CRT-P, and
ICD devices that have the OptiVol Fluid Status Monitoring feature. The indications for use of
these devices do not change.
The TriageHF feature gives physicians another source of information to use in managing
their patients. It does not replace assessments that are part of standard clinical practice or
override recommended guidelines for treatment of heart failure patients. Clinicians should
not rely exclusively on the TriageHF information to assess a patient’s heart failure risk.
The TriageHF information is available to clinicians who monitor their device patients on the
Medtronic CareLink Network.
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2.3 Important notes
Review the following notes before using the TriageHF information:
• The TriageHF assessment does not replace heart failure assessments in standard
clinical practice. It is an additional and optional source of information for patient
management.
• The TriageHF feature has not been shown to reduce heart failure events.
• Medical treatment should not be modified remotely based solely on the TriageHF
assessment.
• Interpretation of the TriageHF assessment requires clinical judgment by a medical
professional.
• The TriageHF assessment should be used along with professional guidelines for patient
management decisions.
• Using the TriageHF assessment in a manner that is contrary to the intended use as
described in this manual may result in inappropriate patient management decisions.
• The TriageHF assessment alone is not to be used to identify imminent decompensation
from heart failure.
• The TriageHF feature is not a real-time alert. Going from a high status to a low status
does not necessarily indicate that a patient is no longer in heart failure.
2.4 Contraindications
There are no known contraindications for the use of the TriageHF information.
2.5 TriageHF clinical data
The TriageHF feature has not been prospectively studied to show how often predictions by
the algorithm are followed by heart failure events and whether heart failure events are
preceded by prediction by the algorithm.
A post market trial is planned to characterize these important performance characteristics.
The TriageHF feature was developed and validated using existing data sets from clinical
trials that Medtronic sponsored for CRT-D and ICD devices. The following sections contain
a summary of the clinical data.
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2.5.1 Methodology
The development data set included 921 heart failure subjects implanted with CRT-D devices
for a total of 9,790 follow-up months. A separate validation data set included 1,750 heart
failure subjects implanted with CRT-D and ICD devices for a total of 40,349 follow-up
months. Clinical trial data sets consisted of the following diagnostic data collected by the
device:
• OptiVol fluid index
• Patient activity
• AT/AF total hours
• Ventricular rate during AT/AF
• % Ventricular pacing
• Shocks
• Treated VT/VF
• Night ventricular rate
• Heart rate variability
A Bayesian approach, a probabilistic model that takes multiple parameters into account, was
used to calculate the patient’s risk of a heart failure event within the next 30 days. A baseline
or nominal risk of a heart failure event (hospitalization or emergency room visit with
intravenous diuretic administration) was set at Medium, based on the evidence in the patient
population in the clinical trials. The TriageHF feature calculates and adjusts the risk status to
either Low-risk or High-risk based on the device diagnostics data (see Section 2.6,
Operation of TriageHF, page 11).
During a simulated monthly follow-up session, clinicians evaluated the performance of the
TriageHF feature. They analyzed the maximum risk status during the previous 30 days and
evaluated the probability of a heart failure event during the following 30 days.
2.5.2 Results
In the validation data set, 2.8% of high-risk status months were followed by heart failure
events compared to 0.2% of low-risk status months and 0.7% of medium-risk status months,
as summarized in Table 1.
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100
90
80
70
60
50
40
30
20
10
0
0 1 2 3 4 5 6 7 8 9 10 11 12
False Alert Rate (per pt.-yr.)
Medium
High
Sensitivity (%)
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Table 1. Positive predictive value (months at low, medium, and high risk, followed by HFH)
Number of Subsequent
Risk Status Number of Months (%)
HFH Events (%)
Low 16,559 (41%) 40 (0.2%)
Medium 19,665 (49%) 144 (0.7%)
High 4,125 (10%) 116 (2.8%)
The performance of the TriageHF feature is summarized in Figure 1. Performance is
estimated based on retrospective evaluation of device data during sequential 30-day,
non-overlapping time windows. A more or less frequent evaluation of device data would yield
different performance estimates.
Figure 1. TriageHF performance
Pending validation by the planned post-market prospective study, the high-risk status may
yield a false alert rate of 1.2 per patient-year and a sensitivity of 38.7%.
Table 2. Sensitivity, FAR, and PPV in the main validation set
Sensitivity 38.7%
False alert rate 1.2 per patient-year
Positive predictive value 2.8%
Estimated TriageHF Clinical Performance is based on a Medtronic retrospective review
of 300 heart failure hospitalizations in 40,349 months of patient follow-ups.
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High vs. Medium + Low
Jan Feb Mar Apr May Jun
Jul Aug Sep Oct Nov Dec
In the same 100 patients, followed for one year, the TriageHF feature would predict that
120 heart failure hospitalizations would occur based on a high heart failure risk status.
Each black bordered box represents one predicted hospitalization.
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A series of graphics show the estimated performance for high-risk status, using the TriageHF
feature. The first graphic presents 100 boxes that represent 100 patients who were
monitored for one month. Green indicates that the patients were not hospitalized for heart
failure.
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The TriageHF feature
could correctly predict
3-4 of the 9 heart failure
hospitalizations
The TriageHF feature may
falsely predict 116-117
heart failure
hospitalizations that do not
occur
The TriageHF feature
may not predict
5-6 of the 9 heart failure
hospitalizations
Medtronic’s data that was used to validate the TriageHF feature suggests that 9 heart
failure hospitalizations are likely to occur over a duration of one year in 100 patients.
Red-shaded boxes represent individual patients hospitalized for heart failure. The
TriageHF feature would accurately predict 3-4 of the 9 heart failure hospitalizations based
on a High heart failure risk status.
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2.5.3 Conclusion
2.8% of patients identified as high risk by a TriageHF assessment may be hospitalized for
heart failure in the subsequent month. Approximately 1.2 false alerts may occur per
patient-year.
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24
20
16
12
4
8
0
>200
150
100
100
0
1
2
3
4
75
50
>200
160
120
80
<40
100
75
50
25
0
25
0
<50
Determine the
probability of a
heart failure event
Probabilistic model
Clinical trends
Risk status Risk factors
OptiVol
Patient activity
Night
ventricular rate
% Ventricular
pacing
AT/AF
Ventricular rate
during AT/AF
Heart rate
variability
Treated VT/VF
Shocks
Medium
High
Low
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2.6 Operation of TriageHF
Figure 2. Overview of TriageHF operation
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The TriageHF operation begins when the patient’s device transmits the data collected to the
Medtronic CareLink Network. For each day of the clinical trend data transmitted, the
TriageHF feature calculates a daily heart failure risk status for the patient.
When calculating the daily risk status, the TriageHF feature starts from the nominal risk level
of a heart failure event (Medium risk status) for the patient population (see Section 2.5,
TriageHF clinical data, page 6). The TriageHF feature then adjusts the daily risk status by
comparing the daily trend data values to the fixed threshold criteria for the risk factors (see
Table 3). For trend data values that exceed the fixed threshold criteria, the TriageHF feature
may adjust the daily risk status to a higher level. For trend data values that do not exceed the
fixed threshold criteria, the TriageHF feature may adjust the daily risk status to a lower level.
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Heart rate variability
Night ventricular rate
High
Risk of Heart Failure Event
in Next 30 days (based on
maximum daily
risk status in prior 30 days)
Low
Medium
Risk factors
OptiVol
Patient activity
AT/AF
Ventricular rate during AT/AF
% Ventricular pacing
Shocks
Treated VT/VF
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The TriageHF feature calculates the patient’s risk of a heart failure event occurring in the next
30 days by determining the maximum daily risk status from the previous 30 days (see
Figure 3).
Figure 3. TriageHF assessment for each day and next 30 days
1 The Medium risk status reported for the patient for the next 30 days is based on the maximum daily
risk status for the previous 30 days.
2 Boxes marked with an X indicate the risk factors that contributed to the Medium risk status.
Table 3. Heart failure risk factors and threshold criteria for CRT-D, ICD, and CRT-P devices
Heart failure
risk factors
OptiVol ≥ 60 x x x x
Patient activity ≤ 60 min per day or significant increase in
AT/AF ≥ 1 hour a day x x — x
Ventricular
rate during
AT/AF
% Ventricular
pacing
Shocks Delivered x x x —
Treated VT/VF ≥ 5 x x x —
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Risk factor applicability to device
Threshold criteria
type
CRT-D
a
DRICD
VRICD
CRT-P
x x x x
the accumulated daily difference from
expected normal activity
≥ 90 bpm during AF ≥ 6 hours a day x x — x
≤ 90% (for a patient with a CRT device) x — — x
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Table 3. Heart failure risk factors and threshold criteria for CRT-D, ICD, and CRT-P devices
(continued)
Heart failure
risk factors
Night ventricular rate
Heart rate variability
a
An x mark in the device type column indicates that the risk factor is a potential contributor
Threshold criteria
≥ 85 bpm or ≤ 55 bpm, or
significant increase in the accumulated
daily difference from expected normal value
for the patient
≤ 60 ms or significant increase in the accumulated daily difference from expected variability
Risk factor applicability to device
a
type
DR-
CRT-D
ICD
x x x x
x x x x
VRICD
CRT-P
to the TriageHF assessment. A dash indicates that the risk factor does not apply to the
device type.
2.7 Viewing and using TriageHF information
The TriageHF information is part of the Heart Failure Management Report available on the
Medtronic CareLink Network. The TriageHF assessment summary and the HFRS daily risk
status graph are specific to TriageHF in the Heart Failure Management Report. This report
continues to show clinical trend graphs of heart failure risk factors.
A patient’s risk status can also be viewed as one of the configurable columns in the
Medtronic CareLink Network Transmission List. Users can set up CareAlert notifications for
High Risk status transmissions through the Manage My Clinic or Manage My Patients tabs
in the Medtronic CareLink Network.
Note: The TriageHF assessment is first available in the Heart Failure Management Report
on day 65 after the device implant. This assessment is not available until this day because
the OptiVol Fluid Status Monitoring feature is unavailable for the first 34 days after the
implant. Thereafter, a 30-day data collection period is necessary for the TriageHF feature to
provide the heart failure risk assessment.
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2.7.1 How to access the Heart Failure Management Report
1. Navigate to the Transmissions page from the Medtronic CareLink Network home
page.
2. Find the patient and then tap the date under the Received column for the transmission.
The Heart Failure Management Report is displayed on the Transmissions Details
page.
Note: If your clinic is not enrolled in the Medtronic CareLink Network as a heart failure
clinic, select the Heart Failure Management Report from the More Reports drop-down
list.
2.7.2 High Risk Status CareAlerts
The user has two programmable options for the TriageHF High Risk Status CareAlerts: High
(New) and High (Ongoing).
• A High (New) CareAlert notifies the user when the first high-risk transmission is received.
A reset of the high-risk event is required to trigger this CareAlert in subsequent
transmissions.
• A High (Ongoing) CareAlert notifies the user of when subsequent transmissions
associated with an ongoing high-risk status are received. An initial high-risk
transmission is required before a subsequent transmission can be eligible to trigger this
CareAlert.
2.7.3 Using TriageHF information
The TriageHF feature is intended to be used by clinicians as an additional and optional
source of information to triage and manage their device patients with heart failure. The
TriageHF assessment provided in the Heart Failure Management Report should not be used
as a substitute for medical assessments that are part of standard clinical practices for patient
management.
2.7.3.1 TriageHF assessment summary
The summary of the TriageHF assessment in the Heart Failure Management Report
presents a picture of the patient’s risk for a heart failure event occurring within the next 30
days. This summary includes a list of potential heart failure risk factors and indicates those
risk factors that contributed to the risk status reported.
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Figure 4. Heart Failure Management Report, Page 1
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Useful notes for interpreting the summary in Figure 4.
• Low risk: Low risk indicates that the patient has an estimated risk of 0.2% for a heart
failure event in the next 30 days. To understand the patient’s risk status, review all the
information, including the clinical trend graphs, in the Heart Failure Management Report
on pages 1, 2, and 3.
• Medium risk: Medium risk indicates that the patient has an estimated risk of 0.7% for a
heart failure event in the next 30 days. To understand the patient’s risk status, review all
the information, including the clinical trend graphs, in the Heart Failure Management
Report on pages 1, 2, and 3. In addition, focus on trend graphs related to the risk factors
marked with an X in the TriageHF assessment summary.
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• High risk: High risk indicates that the patient has an estimated risk of 2.8% for a heart
failure event in the next 30 days. To understand the patient’s risk status, review all the
information, including the clinical trend graphs, in the Heart Failure Management Report
on pages 1, 2, and 3. In addition, focus on trend graphs related to the risk factors marked
with an X in the TriageHF assessment summary. Consider contacting the patient.
For information about probability estimates for TriageHF, see Table 1.
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2.7.3.2 Clinical trend graphs
The clinical trend graphs in the Heart Failure Management Report present an overview of the
device diagnostic information over time.
Clinical trend graphs – Clinical trend graphs show trends in various device parameters for
the reporting period. The trend data includes the following information:
• OptiVol fluid index
• Patient activity hours per day
• AT/AF total hours per day
• Ventricular rate during AT/AF
• Percent ventricular pacing per day
• Shocks per day
• Treated VT/VF episodes per day
• Average ventricular rate (day and night)
• Heart rate variability
As shown in Figure 5, the Heart Failure Management Report also provides the TriageHF daily
risk graph.
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Figure 5. Heart Failure Management Report, Page 2
1 The trend for AT/AF total hours per day shows that the time the patient spent in AT/AF exceeded
the risk threshold criterion of ≥ 1 hour a day or 60 minutes a day, thus contributing to the heart
failure risk status reported.
2 The trend for Ventricular rate during AT/AF indicates that this rate rose above the risk threshold
criterion of ≥ 90 bpm during AF ≥ 6 hours a day, thus contributing to the heart failure risk status
reported.
3 The trend for Percent pacing per day indicates that the percentage of ventricular pacing fell below
the threshold criterion of ≤ 90% (for a patient with a CRT device), thus contributing to the heart
failure risk status reported.
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Figure 6. Heart Failure Management Report, Page 3
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1 The trend for Average Ventricular Rate (bpm) shows that the patient’s night heart rate rose
above ≥ 85 bpm, therefore contributing to the heart failure risk status reported.
For information about heart failure risk factors, see Table 3, page 12.
An analysis of the diagnostic information shown in the trend graphs can be helpful in the
interpretation of changes in the risk factors that contributed to the TriageHF assessment.
For more information about the Heart Failure Management Report, refer to the clinician
manual specific to the device.
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