Medtronic D314VRM Technical Manual

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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MEDTRONIC CARELINK® 5242

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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MEDTRONIC CARELINK® 5242

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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