Clinicians Practical Guide for Using OptiVol® and Other Trends for Managing Heart Failure Patients

How to Use This Guide This guide summarizes two years of experience using OptiVol® Fluid Status Monitoring in the clinical setting. It intends to be a practical tool to help clinicians understand, interpret, and use the monitoring trends captured in Medtronic’s implantable cardiac defibrillator (ICD) and resynchronization therapy (CRT-D) devices. This information provides additional insight into the patient’s status, it does not replace current assessment tools but it may aid in the proactive monitoring and management of these patients.

Table of Contents Overview ................................................................................................................3 OptiVol ....................................................................................................................7 Other Device Trends.........................................................................................12 AF Management .................................................................................................19 Process – 3 Easy Steps to Use the Data ......................................................21 Common OptiVol Cases ..................................................................................27 Algorithms and Tools ........................................................................................ 31

Considerations in this Clinicians Practical Guide are courtesy of Lisa Rathman, MSN, CRNP; Roy Small, MD, FACC; and Jill Repoley, MSN, CRNP. The Heart Group and Lancaster General Hospital, Lancaster, PA.

2

OptiVol Fluid Status Monitoring

Overview

Heart Failure, Congestion, and Hospitalizations Heart failure affects 5 million Americans and 550,000 new diagnoses are made every year. Further, heart failure is the primary reason for over 1 million hospital admissions each year.1 For patients, the prognosis is poor once he or she has been hospitalized. For clinicians, the challenge is identifying and managing those patients at risk for clinical decompensation and the resulting hospitalization. Fluid congestion is the major reason for heart failure hospital admissions. Typically, clinicians use signs and symptoms to evaluate patients for fluid buildup but these signs and symptoms may occur relatively late in the process of developing congestion. Some patients may develop sub-clinical congestion days or even weeks before the onset of clinical symptoms and signs.2 Other cardiac physiologic parameters may also change in advance of the presentation of signs and symptoms.3 By monitoring changes in these physiologic parameters clinicians may be able to improve clinical outcomes.2 The ability of implantable devices to continuously monitor cardiac trends and intrathoracic fluid may provide early warning of changes in cardiac status, including impending fluid overload, and subsequently may help clinicians identify patients at risk for decompensation.

3

Key Concepts • Congestion is the primary cause of heart failure hospital admissions and predicts readmissions • Congestion is often difficult to recognize, delaying appropriate interventions • Clinical congestion often lags behind rising filling pressures • Congestion contributes to progression of heart failure

OptiVol Fluid Status Monitoring

Overview

There are three different ways to access the data that is provided on the Heart Failure Management Report or the Cardiac Compass® Reports. They are listed below.

Medtronic CareLink® Network Medtronic CareLink Network is the nation’s leading remote monitoring service. Patients can connect to their clinic from home or away, providing peace of mind and freedom to LIVE LIFE. Clinicians have 24/7 access to device data on a secure Internet website. Conexus® Wireless Telemetry for Medtronic’s newest devices takes remote monitoring to the next level, paving the way to true cardiac disease management. The Medtronic CareLink Network with Conexus Wireless Telemetry offers automatic data transmissions of 14 months of data and customizable alert notifications, new features to enable improved patient care. With wireless device interrogation, routine follow-ups occur automatically while the patient sleeps, alleviating patient compliance issues. Using the Medtronic CareLink Clinician website, clinic staff can pre-schedule up to six automatic device checks for each patient, minimizing time spent rescheduling missed appointments and playing phone tag.

CardioSight® CardioSight provides referring cardiologists easy access to device information tailored to the management of heart failure, helping clinicians identify problems before symptoms occur. It enables clinicians treating heart failure to better understand, appreciate, and communicate with electrophysiologists about cardiac device therapy. Access to the reports provides 90-day trended information from the Heart Failure Management Report or the Cardiac Compass Trends Report. Temporal alignment of trended information allows clinicians to easily assess changes across multiple dimensions. The CardioSight Reader – based on proven Medtronic CareLink technology – is quick and easy to use, providing flexibility in clinic workflow. Much like existing tools for measuring patients’ vital signs, the CardioSight Reader can be used to conveniently obtain important details on patient status. Within minutes of downloading device information using the reader, a Heart Failure Management Report or Cardiac Compass Trends Report is faxed to the clinic and can be added to the patient chart before the physician consults with the patient. The CardioSight Reader gives insight into a patient’s condition without using a device programmer. It provides simple, one-touch operation, enabling access to read-only information without the possibility of changing device parameters.

Medtronic CareLink Programmer Medtronic CareLink Programmer is used in the clinic or operating room to manage device therapies and parameters. Enabled with Conexus Wireless Telemetry, the new generation programmer provides follow-up and implant efficiencies for Medtronic’s latest CRT-Ds and ICDs. Additionally, a version of the trended reports is available via the programmer.

4

OptiVol Fluid Status Monitoring

Overview

AT/AF P

I

V rate during AF Fluid Index

Patient Activity Resting Night HR

Thoracic Impedance

HR Variability % Pacing

Heart Failure Trend Data4 Clinicians can review device trends via the Cardiac Compass or Heart Failure Management Reports. Both provide up to 14 months of temporally aligned information on potential fluid status and other heart failure parameters, including: • OptiVol Trends* • AT/AF • Ventricular Rate during AT/AF • Patient Activity • Resting Night Rate • Heart Rate Variability • Percentage Pacing In addition, the reports also provide programming and interrogation annotations as follows: • Evaluation during an office visit: “I” • Evaluation during a home monitor session: “I” • Device parameters change: “P” The OptiVol Trends and the Heart Failure Management Report (HFMR) as a whole should be used with the clinical assessment of the patient to provide the diagnostic picture.5-8 If “I” and “P” values are recorded for a day, only the “P” is displayed on the report. Reports from CardioSight do not provide these values.

* OptiVol Fluid Management is a feature in Concerto® and InSync Sentry® CRT-Ds and Virtuoso® DR/VR ICDs.

5

Key Concept • The trend data reports provide clinicians with a multi-dimensional perspective of the patient

OptiVol Fluid Status Monitoring

Overview

Clinical Utility5-14 Thoracic impedance and OptiVol can be a useful tool. Some of the utility includes: • An assessment tool that provides essential insight into the patient’s clinical status • Better disease management by assisting therapy titration and disease stabilization through continuous monitoring of patient status • An educational tool for patients on medication and dietary adherence The results of MID-HeFT, a feasibility study, indicated that intrathoracic impedance5: • Correlates with physiologic measures of heart failure such as pulmonary capillary wedge pressures (PCWP) • Precedes patient’s symptoms and weight gains by two weeks Clinicians using OptiVol trends have indicated the following: • Detection of clinically relevant events including: – Pulmonary congestion/heart failure decompensation5,7,8 – Onset of atrial fibrillation6 – Pneumonia7 – Lead dislodgement9,10 • OptiVol trends have shown clinical utility in association with other device data such as heart rate variability, night heart rate, activity level, and tachycardias.5-14

6

Key Concepts • OptiVol is adjunctive to existing evaluation and assessment tools • It is not subjective to patient compliance • It can serve as an educational tool to improve patient adherence to a prescribed treatment plan

OptiVol Fluid Status Monitoring

OptiVol Many times during the day, electrical impulses travel from the lead in the right side of the heart to the implanted device. Using this electrical impulse vector, OptiVol Fluid Status Monitoring measures impedance across the thoracic cavity.

With less fluid in the thoracic cavity, patient’s intrathoracic impedance increases. Electrical Impedance Increases

As fluid accumulates in the patient’s lungs, intrathoracic impedance decreases. Electrical Impedance Decreases

Continuous and Automatic Fluid Status Monitoring with OptiVol4,5 OptiVol is a monitoring tool that objectively tracks fluid changes in heart failure patients using intrathoracic impedance.15 Thoracic impedance, a technology originally developed by NASA in the 1960s, is based on the principle that water is a relatively good conductor of electrical current. Thus, electric conductance through body tissues varies according to the water content of the tissue. When a very low electric current is passed through the thorax, water content should be directly related to electric conductance and inversely related to impedance.

7

Key Concepts • Thoracic impedance tracking with fluid is a proven concept5-14 • OptiVol continuously tracks fluid changes4 • If fluid retention goes up, impedance goes down; if fluid retention goes down, impedance goes up4

OptiVol Fluid Status Monitoring

OptiVol

OptiVol fluid index is an accumulation of the difference between the daily and reference impedance.

P = Program I = Interrogate OptiVol fluid index OptiVol Threshold

P

I

> 200 160 120 80 40

Daily Impedance Fluid

0 Jul 2003

Thoracic impedance (ohms) Daily Reference

Sep 2003

Nov 2003

Jan 2004

Mar 2004

May 2004

Jul 2004

> 100 90

Reference Impedance

80 70 60 50 40 Jul 2003

Sep 2003

Nov 2003

Jan 2004

OptiVol Trends4,5

Mar 2004

May 2004

Jul 2004

Key Concepts

The OptiVol Trends are displayed in two separate graphs: The thoracic impedance graph plots the raw data measured from the right ventricular coil to the device can pathway. It is best to review this graph first as it represents the status of the patient’s impedance. The OptiVol fluid index indicates that an event* may occur or has occurred. It is only a graphical representation of the data captured and plotted by the thoracic impedance algorithm and should not be used in isolation. The next few pages will go into more detail regarding OptiVol Trends.

* An Event is defined in the MID-HeFT study as the OptiVol fluid index crossing 60 ohms which may be related to a relevant clinical occurrence.

8

• Thoracic impedance is a representation of the patient’s impedance status. It should always be reviewed first. • The OptiVol fluid index should be interpreted within the context of the Daily impedance and Reference impedance

OptiVol Fluid Status Monitoring

OptiVol

As fluid accumulates in the patient’s lungs, intrathoracic impedance decreases and the OptiVol fluid index increases.

How OptiVol Is Measured4,5 • Impedance is measured from RV coil to device can • Average Daily impedance is an average of measures taken several times a day (12 noon to 5 pm every 20 minutes) • Reference impedance trend starts 34 days post-implant – It is a moving standard that works as the patient’s own control • Programmable parameter – OptiVol Threshold (nominal at 60 Ω) Any thoracic fluid can result in impedance decline regardless of pathology.5,7-12,15-17 Non-thoracic fluid is excluded. Thoracic fluid may include: Vascular, Interstitial, Alveolar.15

9

Key Concepts • OptiVol is sensitive to multiple etiologies of fluid accumulation in the thoracic cavity5,7-12,15-17 • The OptiVol algorithm starts 34 days after implant to allow time for pocket and lead maturation15 • The Reference impedance works as the patient’s own control4,5

OptiVol Fluid Status Monitoring

OptiVol Daily Fluid Changes

Thoracic impedance (ohms)

Severity of Fluid Accumulation

> 100

Daily Reference

90 80 70

Magnitude of impedance reduction

60 50 40 Jul 2003

Sep 2003

Nov 2003

Jan 2004

Mar 2004

Daily line track below Reference line may indicate fluid build-up

Reference impedance initializes 34 days post-implant. It adapts slowly to changes in the Daily impedance and acts as the patient’s own control.

When Evaluating the OptiVol Data, Follow These Two Steps4,5,7,*: 1A. Review Thoracic Impedance Review the thoracic impedance graph first. It shows the raw impedance and indicates the severity of an event. It is an accurate representation of the patient’s impedance status. Observe on the image above how the Daily impedance and Reference impedance track over time. Fluid may be accumulating in the thoracic cavity if the Daily impedance consistently tracks below the Reference impedance. Reference impedance initializes 34 days post-implant. It adapts slowly to changes in Daily impedance and acts as the patient’s own control.15 Magnitude and duration of impedance reduction below the Daily impedance represent the severity of fluid accumulation.7 Changes in Intrathoracic Impedance Rising impedance†

Declining impedance may be the result of:

may be the result of: 5,8,15

• HF congestion (with or without symptoms) • Appropriate reduction of diuretics in the dehydrated patient16 • Pneumonia7 • Pleural effusion17 • Wound fluid from pocket revision or infection17 • Pocket/lead revision7,9,10,17 • Lead dislodgement9,10 • IV fluids/blood transfusion15 • Blood volume15

Duration of impedance reduction

• Volume depletion5 – Diuretics (increases)16 – Dehydration5 – Dialysis/ultrafiltration18 • Positive pressure ventilation15 • Pneumothorax17

† Note: It is normal for the Daily impedance to generally increase after implant. This is likely due to maturation of the device pocket and the resolution of the pocket fluid accumulation post-implant. * Courtesy of The Heart Group and Lancaster General Hospital, Lancaster, PA.

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Key Concept Thoracic impedance4,5: • Plots the raw impedance from the RV coil to the device can • It is an accurate representation of the patient’s impedance status15 • It may indicate the severity of an event7

OptiVol Fluid Status Monitoring

OptiVol

P = Program I = Interrogate OptiVol fluid index OptiVol Threshold

P

I

> 200 160 120

An Event is defined in the MID-HeFT study as the OptiVol fluid index crossing 60 ohm-days

Upward trend may indicate the beginning of an Event

80 40 Fluid

0 Jul 2003

Sept 2003

Nov 2003

Jan 2004

1B. Review OptiVol Fluid Index4,5,7,* Review the OptiVol fluid index graph. It is a graphical representation of the accumulation of consecutive day-to-day differences between the Daily and Reference impedance reviewed on step 1. When the OptiVol crosses the physician programmable threshold it may signal an EVENT of clinical relevance. The severity of this EVENT can only be assessed by reviewing the thoracic impedance graph and other device diagnostics and clinical assessment. The fluid index is reset when the Daily impedance increases above the Reference impedance for a sustained period of three days. A common misconception is that the height of the fluid index indicates the severity. However, the fluid index is a better gauge of a possible event occurring. Indicates an Event

May Indicate Severity

* Courtesy of The Heart Group and Lancaster General Hospital, Lancaster, PA.

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Mar 2004

Key Concepts • A threshold crossing indicates only that a clinical event may have occurred4,5 • Upward trend indicates the beginning of fluid build-up4,5

OptiVol Fluid Status Monitoring

Other Device Trends

Evaluate Other Device Trend Data4,15

Evaluate trend for:

• New onset AF • Increasing/decreasing AF frequency • Total burden

• Effectiveness of rate control during AF episodes

• Trended data of patient’s activity level

• Day/night HR trends • Separation between day/night HR

• Trended data of HR variability

• Percentage A. pacing • Percentage V. pacing

2. Evaluate Other Device Trend Data Evaluate all trends for changes over time; typically interrelationships can be seen across multiple trends as the patient’s condition changes. The lists on the next page reflect some of the more common trend changes that may be observed as a patient’s status changes.

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OptiVol Fluid Status Monitoring

Other Device Trends

Cardiac Compass Report

Note: Available on Cardiac Compass Report only

VT/VF Episodes/Day4,19,*

V. Rate During VT/VF4,19,*

Clinical Use • Changes in number of episodes may indicate effects of medication changes or compliance • Patterns or clusters of episodes may correlate to the patient’s medical condition

Clinical Use • Information about rate during VT/VF may be useful in evaluating effects of medication and identifying new arrhythmias Details • This graph shows the median ventricular rate during each episode, displayed as a point. Multiple points on the Y-axis may indicate different ventricular arrhythmia episodes with different rates that occurred on the same day. The dotted, dashed, and solid horizontal lines indicate the programmed detection rates for VT, FVT, and VF (i.e., VTDI, VFTI, and VFDI respectively). • The median ventricular rate is calculated from 12 beat RR Median at the time of detection (same as is stored in the Episode Log)

Details • This graph provides daily information about the number of spontaneous VT/VF episodes (treated or aborted) • VT monitored episodes are not counted. Induced episodes are not counted (episodes that are detected within 120 seconds of the end of a manual temporary operation are termed as induced). • VT and VF episodes are combined

Non-Sustained VT Episodes/Day4,19,* One or More Shocks/Day

4,19,*

Clinical Use • May be useful to correlate patient symptoms to NSVT • May trigger further investigation (for example, an increasing trend in NST may prompt a clinician to check patient’s electrolytes)

Clinical Use • Changes in number of episodes and patterns of shocks (clustering) may provide information about changes in patient’s medical condition Details • This graph uses a vertical line to represent a day where at least one shock therapy (Defib or CV) was being delivered during a spontaneous episode

Details • This graph is similar to the VT/VF episodes/day graph. Non-sustained episodes are those in which five consecutive beats are less than the TDI (or FDI, if VT is OFF or Monitor), but detection is not satisfied • Induced episodes are not included (using same criteria as VT/VF episodes)

Patient results may vary; not every response is the same. *

Courtesy of The Heart Group and Lancaster General Hospital, Lancaster, PA.

Considerations in this document do not replace a physician’s expert judgment. The physician’s knowledge of the patient’s medical condition should be considered, and clinical and device intervention considerations may be tailored to fit the patient.

13

OptiVol Fluid Status Monitoring

Other Device Trends

Evaluate trend for:

• New onset AF • Increasing/decreasing AF frequency • Total burden

• Effectiveness of rate control during AF episodes

AT/AF Total Hours/Day4,20 Provides information about the patient’s AT/AF burden. Information may be useful in: • Rhythm control: identifying new arrhythmias • Rhythm control: evaluating efficacy of antiarrhythmic drugs • Risk control: assessing potential risk for stroke and need to anticoagulate

V. Rate During AT/AF4,20 Provides average and maximum ventricular rate during AT/AF. The maximum V. rate is the fastest sensed RR median during AT/AF. Information may be useful in: • Rate control: correlating ventricular rate to patient symptoms • Rate control: assessing potential risk for stroke and need to anticoagulate

Intervention Considerations20,* If AT/AF is observed, consider: • Reviewing stored episodes, if not available, reprogram the device to store episodes • AT therapies especially if atrial flutter is identified • Adjusting rhythm control therapy • Adjusting anticoagulation therapy • Cardioversion • Referral for surgery If higher V. rates during AT/AF are observed, consider20,*: • Changes in rate control therapy (surgical procedure) • Program Mode Switch “ON,” if not already4 • Program Conducted AF Response “ON” in CRT-D devices (Concerto), if not already4

Patient results may vary; not every response is the same. *

Courtesy of The Heart Group and Lancaster General Hospital, Lancaster, PA.

Considerations in this document do not replace a physician’s expert judgment. The physician’s knowledge of the patient’s medical condition should be considered, and clinical and device intervention considerations may be tailored to fit the patient.

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OptiVol Fluid Status Monitoring

Patient activity hours/day

Other Device Trends

4 3 2 1 0

Patient Activity4,6,7 Provides trends of patient activity determined using the accelerometer sensor. Information may be useful in: • Monitoring heart failure (decreased activity may be an indicator of progression of heart failure symptoms) • Monitoring patient’s exercise regimen • Monitoring changes in activity following changes in therapy

Intervention Considerations* If decrease in patient activity is observed6-8,11-15,17,21: • Assess for etiology of decreased activity • Assess for association with OptiVol fluid index • Further assess for volume overload/ depletion to determine if heart failure symptoms changed • Promote exercise as stated in AHA Guidelines • Assess rate response programming

Patient results may vary; not every response is the same. *

Courtesy of The Heart Group and Lancaster General Hospital, Lancaster, PA.

Considerations in this document do not replace a physician’s expert judgment. The physician’s knowledge of the patient’s medical condition should be considered, and clinical and device intervention considerations may be tailored to fit the patient.

15

OptiVol Fluid Status Monitoring

Avg V. rate (bpm) Day Night

Other Device Trends

>120 100 80 60 200 160 120 80 40

Fluid

0 Mar 2005

Thoracic impedance (ohms) Daily Reference

May 2005

Jul 2005

Sep 2005

Nov 2005

Jan 2006

> 100 90

Impedance trending down

80 Impedance trending upward; fluid index reset when Reference line is met

70 60 50 40 Mar 2005

May 2005

Jul 2005

Sep 2005

Nov 2005

Jan 2006

A Practical Case5 Background 85-year-old male with past medical history of CHF with ICM EF 20%. He has CAD, Hyperlipidemia, Type 2 Diabetes Mellitus, Atrial Flutter ablation in September 2003. He had an InSync Sentry device implant in February 2005. Medications Amiodarone, Bumetanide, Warfarin, Lisinopril, and Metoprolol.

STEP 1: Review Impedance and OptiVol Trend Data Look for: • Impedance trends up/down • Fluid index reset Patient results may vary; not every response is the same.

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OptiVol Fluid Status Monitoring

3 Easy Steps to Use the Data

Atrial Fibrillation

High Ventricular Rate

CRT Reduced

OptiVol Fluid Trends (Feb 2005 to Jul 2005) OptiVol fluid index is an accumulation of the difference between the daily and reference impedance.

P = Program I = Interrogate OptiVol fluid index OptiVol Threshold

P

P P

I

> 200 160 120 80 40

Fluid

Thoracic impedance (ohms) Daily Reference

0 Mar 2005

May 2005

Jul 2005

Sep 2005

Nov 2005

Jan 2006

Mar 2005

May 2005

Jul 2005

Sep 2005

Nov 2005

Jan 2006

> 100 90 80 70 60 50 40

STEP 2: Evaluate Other Device Trend Data5 • Note the correlation between the declining impedance and onset of AFib, reduced CRT pacing, and fast ventricular response • April 26: AF begins, impedance starts declining • Patient activity is stable • No HRV data due to AFib Patient results may vary; not every response is the same.

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OptiVol Fluid Status Monitoring

3 Easy Steps to Use the Data

2a. Check for Trend Changes Over Time*

Condition improving:

Condition worsening:

Patient activity increasing7,12,13

Atrial fibrillation burden increasing21

HR variability increasing13,38

Average day/night HR increasing3,39

Separation between day/night HR increased39

High RV pacing in ICD patient23,24

CRT pacing maximized22,25

Ventricular rate with AF uncontrolled31,32

Ventricular rate with AF controlled40

CRT pacing below 100%22,25

Average day/night HR decreasing3,39

Patient activity declining7,12,13

Atrial fibrillation burden decreasing

HR variability decreasing6,13,38,39

Increasing

*

Neutral

Courtesy of The Heart Group and Lancaster General Hospital, Lancaster, PA.

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Decreasing

OptiVol Fluid Status Monitoring

3 Easy Steps to Use the Data

2b. Clinical and Device Intervention Considerations4-10* Daily impedance is changed, consider possible cause: Although the most common cause, thoracic fluid accumulation is not the only reason thoracic impedance might change. Nevertheless, a thoracic impedance change may indicate a clinically relevant event that may require medical attention.5,8-12,15,16 Heart failure-related event: • Pulmonary edema5,8 • Volume retention5,8 • Pulmonary Congestion5,8 • Pocket or lead revision8-11

Clinically relevant event: • Pocket infection5 • Anemia11 15 • Pleural/pericardial effusion • Dialysis18 • Diuretic therapy changes5,16 • Respiratory infection5

Consider the following actions: • Corroborate with other diagnostic trend findings4 • Educate patient, i.e., dietary and/or fluid, medication compliance6,14,21 • Adjust HF medications to achieve optimal management21 • Titrate diuretics and appropriately monitor electrolytes21 • Refer to electrophysiology for system-related issue21,22 AT/AF observed, consider20: • Corroborating with other diagnostic trend findings4 • Cardioversion • Adjusting rhythm control therapy • Instituting of anticoagulation therapy • Surgical procedures AF with rapid ventricular response observed, consider20: • Corroborating with other diagnostic trend findings4 • Cardioversion • Adjusting rate control therapy • Program Conducted AF Response “ON” in CRT-D devices (Concerto)4 • Program Mode Switch “ON” – to a nontracking pacing mode4 Decrease in patient activity, consider: • Corroborating with other diagnostic trend findings4 • Promoting regular exercise as indicated6,14,21 Increasing day/night HR with poor separation, consider3,21,39: • Corroborating with other diagnostic trend findings4 • Adjusting HF medications • Atrial fibrillation • Sleep apnea or nocturnal dyspnea Persistently low HRV (< 50 ms) or declining values, consider3,21,39: • Corroborating with other diagnostic trend findings4 • Adjusting HF medications21 • Not measured if patient is in AF4 • Consider if patient is in AF or atrially paced Percent ventricular pacing below 100% in CRT patient, consider21,22,25: • Corroborating with other diagnostic trend findings4 • Atrial fibrillation with rapid ventricular response31,32 • Evaluating device settings, may necessitate electrophysiology consult22 • AV optimization • Lead dislodgement9 Percent pacing higher than desired in dual chamber ICD patient, consider23,24: • Corroborating with other diagnostic trend findings4 • AV delay • Atrial fibrillation • Program MVP Mode “ON”4 • Reprogram rate response settings4 *

Courtesy of The Heart Group and Lancaster General Hospital, Lancaster, PA.

Considerations in this document do not replace a physician’s expert judgment. The physician’s knowledge of the patient’s medical condition should be considered, and clinical and device intervention considerations may be tailored to fit the patient.

25

OptiVol Fluid Status Monitoring

3 Easy Steps to Use the Data

STEP 3: Evaluate Patient and Correlate Findings to Make Clinical Decision*

*

Courtesy of The Heart Group and Lancaster General Hospital, Lancaster, PA.

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OptiVol Fluid Status Monitoring P = Program I = Interrogate OptiVol fluid index OptiVol Threshold

Common OptiVol Cases

P P

P

P

> 200 160 120 80 40

Fluid

0 Dec 2005

Thoracic impedance (ohms) Daily Reference

Feb 2006

Apr 2006

Jun 2006

Aug 2006

Oct 2006

Dec 2006

> 100 90 80

Stable Impedance

70 60 50 40 Dec 2005

Feb 2006

Apr 2006

Jun 2006

Aug 2006

The following cases are examples of common trends you will see while evaluating patients’ OptiVol Trends. Over time, it will become easier to understand what you are seeing the more OptiVol Trends you read and patients you talk to regarding their trends.

Oct 2006

Dec 2006

Key Concept Stable, well-managed patient after implant. Impedance has stabilized.

Stable, Well-Managed Patient5 This OptiVol data resembles the profile of a stable heart failure patient. Note the steady increase in Daily impedance post-implant. This is indicative of pocket maturation.15

Patient results may vary; not every response is the same.

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OptiVol Fluid Status Monitoring OptiVol fluid index OptiVol Threshold

Common OptiVol Cases > 200 160 120 80 40

Fluid

Thoracic impedance (ohms) Daily Reference

0 Mar 2005

May 2005

Jul 2005

Sep 2005

Nov 2005

Jan 2006

Mar 2005

May 2005

Jul 2005

Sep 2005

Nov 2005

Jan 2006

> 100 90 80 70 60 50 40

Medication Nonadherence Patient5 The intrathoracic impedance decline led to OptiVol Threshold crossing which was associated with a worsening heart failure due to medication nonadherence. Note the cyclical changes in impedance. Commonly, elapses in the medications regimen happen monthly. The root cause could be associated with financial inability to fill out prescriptions. These events are shown in the report as monthly impedance decline and fluid index rise (peaks). This is a good opportunity to probe the patient, educate on medication adherence, and find alternatives for medication access.

Patient results may vary; not every response is the same.

28

Key Concept Medication nonadherence is often characterized by monthly changes in impedance.

OptiVol Fluid Status Monitoring OptiVol fluid index

OptiVol threshold

Common OptiVol Cases >200 160 120 80 40

Fluid

Thoracic impedance (ohms) Daily Reference

0 Feb 2005

Apr 2005

Jun 2005

Feb 2005

Apr 2005

Jun 2005

>100 90 80 70 60 50 40

Dietary Nonadherence Patient5 Commonly, events such as dietary nonadherence due to vacation, holidays, and special occasions lead to a decrease in impedance and rise in the fluid index that resembles a trend like this. This is a good opportunity to probe the patient and educate on diet adherence.6,12,*

Patient results may vary; not every response is the same. *

Courtesy of The Heart Group and Lancaster General Hospital, Lancaster, PA.

29

Key Concept Isolated changes in impedance are commonly associated with dietary nonadherence. Look for these changes especially during the holiday season and summer.6,12,*

OptiVol Fluid Status Monitoring

Common OptiVol Cases

P = Program I = Interrogate OptiVol fluid index OptiVol Threshold

P

P

P

P

> 200 160 120 80 40

Fluid

Thoracic impedance (ohms) Daily Reference

0 Mar 2005

May 2006

Jul 2006

Mar 2005

May 2006

Jul 2006

> 100 90 80 70 60 50 40

Dehydrated Patient5 This patient was dehydrated when the Reference line was initialized. When patient’s status improved, the Daily impedance dropped below the Reference line and the fluid index began to rise even though the patient was not congested. Dehydration will cause a rise in Daily impedance. Appropriate reductions in diuretic therapy will cause the Daily impedance to decline which may result in OptiVol Threshold crossing.

Patient results may vary; not every response is the same. *

Courtesy of The Heart Group and Lancaster General Hospital, Lancaster, PA.

30

Key Concept Fluid status of the patient at time of implant may impact the Reference impedance.15,*

OptiVol Fluid Status Monitoring

Algorithms and Tools

Heart Failure Patient Care Using OptiVol Courtesy of The Heart Group and Lancaster General Hospital, Lancaster, PA

Heart Failure Clinic Visit No OptiVol

OptiVol

Clinical Evaluation

Clinical Evaluation

Stable

Decompensated

Routine Follow-Up

Frequent Follow-Up

Stable Normal OptiVol

Decompensated

Routine Follow-Up

Stable

Clinically Stable Abnormal OptiVol

Frequent Follow-Up

Stable

This guideline is meant to assist in the management of heart failure patients using monitoring data from certain implanted Medtronic devices. It is not designed to replace clinical judgment or individual patient needs. It does not provide the full scope of heart failure services.

31

References 1

American Heart Association. Heart Disease and Stroke Statistics – 2007 Update.

2

Fonarow GC. Proactive monitoring and management of the chronic heart failure patient. Rev Cardiovasc Med. 2006;7(Suppl 1):S1-S2.

3

Adamson PB, Smith AL, Abraham WT, et al. Continuous autonomic assessment in patients with symptomatic heart failure: prognostic value of heart rate variability measured by an implanted cardiac resynchronization device. Circulation. October 19, 2004;110(16):2389-2394.

4

Medtronic Virtuoso® DR/VR ICD and Concerto® and InSync Sentry® CRT-D System Reference Guides.

5

Yu CM, Wang L, Chau E, et al. Intrathoracic impedance monitoring in patients with heart failure: correlation with fluid status and feasibility of early warning preceding hospitalization. Circulation. August 9, 2005;112(6):841-848.

6

Germany R, Murray C. Use of device diagnostics in the outpatient management of heart failure. Am J Cardiol. May 21, 2007;99(10A):11G-16G.

7

Small RS. Integrating device-based monitoring into clinical practice: insights from a large heart failure clinic. Am J Cardiol. May 21, 2007;99(10A):17G–22G.

8

Vollmann D, Nägele H, Schauerte P, et al. Clinical utility of intrathoracic impedance monitoring to alert patients with an implanted device of deteriorating chronic heart failure. Eur Heart J. August 2007;28(15):1835-1840.

9

Repoley J, Dukes-Graves D, Kiser C. Surgical revision of implantable device “pocket” or lead can alter thoracic impedance-based indices of worsening heart failure. J Card Fail. 2006;12(6)(suppl): S66.

10

Patient Case: LV Lead Dislodgement and Pocket Revision. Courtesy of R. Ward Pulliam and Jill Repoley, NP. The Heart Group and Lancaster General Hospital, Lancaster, PA. 2006 Medtronic Inc., data on file, UC200602091 EN.

11

Small R, Tang W, Wickemeyer R, et al. Managing heart failure patients with intra-thoracic impedance monitoring: a multi-center US evaluation. J Card Fail. 2007;13(6)(suppl):S113-S114.

12

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13

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Brief Statement InSync Sentry® Models 7297/7299, Concerto® Model C154DWK, and Virtuoso® Models D154AWG/D154VWC (DR/VR) Indications for InSync Sentry and Concerto The InSync Sentry and Concerto are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias, and for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction less than or equal to 35% and a prolonged QRS duration. Indications for Virtuoso Virtuoso DR/VR devices are indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias in patients with NYHA Functional Class II/III heart failure. The Virtuoso DR device is also indicated for use in the above patients with atrial tachyarrhythmias, or those patients who are at significant risk of developing atrial tachyarrhythmias. Atrial rhythm management features, available on the Virtuoso DR, such as Atrial Rate Stabilization (ARS), Atrial Preference Pacing (APP), and Post Mode Switch Overdrive Pacing (PMOP) are indicated for the suppression of atrial tachyarrhythmias in ICD-indicated patients with atrial septal lead placement and an ICD indication. Due to the addition of the OptiVol® diagnostic feature, the Virtuoso indication is limited to NYHA Functional Class II/III heart failure patients who are indicated for an ICD. The clinical value of the OptiVol fluid monitoring diagnostic feature has not been assessed in those patients who do not have fluid retention related symptoms due to heart failure. Contraindications The InSync Sentry and Concerto are contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes; patients with incessant VT or VF; and patients who have a unipolar pacemaker. Virtuoso DR/VR devices are contraindicated for patients experiencing any of the following conditions: tachyarrhythmias with transient or reversible causes, incessant ventricular tachycardia or ventricular fibrillation, present implant of a unipolar implantable pulse generator, and primary disorder or bradyarrhythmia. Virtuoso DR is also contraindicated for patients who have a primary disorder of chronic atrial tachyarrhythmia with no concomitant VT or VF. Additionally, Virtuoso VR is contraindicated for patients who have a primary disorder of atrial arrhythmia. Warnings and Precautions Changes in a patient’s disease and/or medications may alter the efficacy of the device’s programmed parameters. Patients should avoid sources of magnetic and electromagnetic radiation to avoid possible underdetection, inappropriate sensing and/or therapy delivery, tissue damage, induction of an arrhythmia, device electrical reset, or device damage. Do not place transthoracic defibrillation paddles directly over the device. Certain programming and device operations may not provide cardiac resynchronization. Potential Complications Potential complications include, but are not limited to, rejection phenomena, erosion through the skin, muscle or nerve stimulation, oversensing, failure to detect and/or terminate tachyarrhythmia episodes, acceleration of ventricular tachycardia, and surgical complications such as hematoma, infection, inflammation, and thrombosis. See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1 (800) 328-2518 and/or consult Medtronic’s website at www.medtronic.com. CardioSight® Reader The 2020A CardioSight Reader is intended for use in a clinical setting and is indicated for the transfer of patient and device data from compatible Medtronic implantable devices to a clinician. There are no contraindications for the 2020A CardioSight Reader. The CardioSight Reader must only be used for interrogating compatible Medtronic implantable devices. Do not use a cellular phone while the antenna is positioned over the implanted device. The CardioSight Reader is designed for use in the continental United States, Alaska, and Hawaii. For further information, please call Medtronic at 1 (800) 328-2518 and/or consult Medtronic’s website at www.medtronic.com. Medtronic CareLink® Monitor/Medtronic CareLink Network The Medtronic CareLink Monitor and the Medtronic CareLink Network are indicated for use in the transfer of patient data from some Medtronic implantable cardiac devices based on physician instructions and as described in the product manual. These products are not a substitute for appropriate medical attention in the event of an emergency and should only be used as directed by a physician. Do not use a cellular phone while the antenna is positioned over the implanted device. The Medtronic CareLink Network is currently available in the continental United States, Alaska, and Hawaii. For further information, please call Medtronic at 1 (800) 328-2518 and/or consult Medtronic’s website at www.medtronic.com. 2090 Programmer The Medtronic/Vitatron CareLink Programmer system is comprised of prescription devices indicated for use in the interrogation and programming of implantable medical devices. Prior to use, refer to the Programmer Reference Guide as well as the appropriate programmer software and implantable device technical manuals for more information related to specific implantable device models. Programming should be attempted only by appropriately trained personnel after careful study of the technical manual for the implantable device and after careful determination of appropriate parameter values based on the patient’s condition and pacing system used. The Medtronic/Vitatron CareLink programmer must be used only for programming implantable devices manufactured by Medtronic or Vitatron. See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. For further information, please call Medtronic at 1 (800) 328-2518 and/or consult Medtronic’s website at www.medtronic.com. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

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UC200703479a EN © Medtronic, Inc. 2008 All Rights Reserved Printed in USA April 2008