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HeartLogicTM Heart Failure Diagnostic:Allied Healthcare Professional Training Workbook

HeartLogicTM

Heart Failure Diagnostic

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This module introduces you to a novel heart failure diagnostic, Boston Scientific’s (BSC) HeartLogic™ Heart Failure Diagnostic (HeartLogic), available in the Resonate™ family of Cardiac Resynchronization Therapy Defibrillator (CRT-D) and Implantable Cardioverter Defibrillator (ICD) devices. HeartLogic provides you and your clinic with summary information collected by the CRT-D or ICD concerning your patient’s heart failure status. The benefit of HeartLogic is it provides a HeartLogic Alert via LATITUDE™ NXT if the diagnostic indicates that the patient may have an episode of worsening heart failure approaching. The alert enables your team at the clinic to take proactive and timely measures to mitigate worsening heart failure.

This HeartLogic training should take approximately 1 hour to complete. After completing, you should be able to proactively manage worsening signs and symptoms of heart failure on the basis of HeartLogic Alerts by:

1. Reading and interpreting them effectively.

2. Reconstructing likely reasons for each alert to corroborate during patient examination or interview.

Using this information, you and your team may be able to develop best practices or protocols for preventing debilitating heart failure episodes.

Outcome: Receive a certificate of completion and 1 CEU credit at the end of the HeartLogic training.

LATITUDE™ NXT Report Disclaimer:

This workbook contains reports that show data created for education and demonstration purposes only; the patient data displayed in this report is not actual patient data nor does it interact with any device or clinic.

This information is an example of what a Heart Failure Management Report may look like for a healthcare provider.

Implant Management Introduction and Objectives

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Table of Contents

Introduction

Highlighting HeartLogic and its Benefits

Managing Alerts, The 3A Process: Alert, Assessment and Action

Alert

Clinician’s Assessment of the Alert Context

The Heart Failure Management Report

Patient Discussion

Clinical Action

Enabling HeartLogic on the Resonate CRT-D or ICD

Navigating LATITUDE NXT

Indications, Safety, and Warnings

Implant Management Table of Contents

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Using this Workbook

KEY CONCEPTThis workbook offers insight into:• How to interpret and use Heart Failure Management reports--diagnostic reports detailing the risk of worsening heart failure in patients with Resonate CRT-D or ICD devices.• The emphasis on what is new: the HeartLogic Index, the HeartLogic Alert and the algorithm that aggregates information from the following physiologic measurements;

• Heart Sounds--S3 and S1• Thoracic Impedance• Respiration (Rate and Tidal Volume)• Night Heart Rate• Activity Level

Each page is centered on one concept and begins with an illustration offering the focus for the page.

This column explains the informational content, as needed, in the shortest possible form.

A separate study guide helps ensure that you havelearned the content within this workbook.

This box describes the key takeaway that we have in mind for this page.

If there are cautions to recommend concerning use of a feature or perhaps limitations of the feature, they appear here.

NOTES

Figure A. The graphic focuses on the main topic. The caption offers a concise explanation. Callouts appear occasionally in the graphic to explain key points but are not part of the Heart Failure Management Report itself.

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What is HeartLogic and What are its Benefits?

Figure 1. A device-based algorithm offers a single indicator to predict possible heart failure events: the HeartLogic Heart Failure Index--a high performing composite indicator for detecting worsening heart failure using multiple physiologic measurements.

HeartLogic offers a single composite indicator for detecting worsening heart failure.

NOTES

KEY CONCEPTHeartLogic uses multiple sensors and an alert algorithm in implanted Resonate CRT-D or ICD devices to provide a patient specific composite index for detecting worsening heart failure.

When the HeartLogic Index crosses a clinician configurable threshold (HeartLogic Alert threshold), HeartLogic may be configured to send a yellow alert to the clinic via LATITUDE NXT. The alert allows the clinic to corroborate the risk of worsening heart failure and to prevent it through proactive patient management.

The HeartLogic Index is derived from a diverse set of heart failure sensors. HeartLogic is exclusively available in the Resonate family of ICD and CRT-D devices.

NOTESNOTESNOTES

LATITUDE NXT sends the clinic a yellow alert if the patient is at an increased risk for worsening heart failure.

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What Clinical Study Validated HeartLogic?

HeartLogic is highly sensitive to the early warning signs for worsening heart failure events and offers the clinic time to help risk stratify the patient to the right therapy for mitigating.

In the MultiSENSE Study, data from multiple sensors were combined by the HeartLogic algorithm to predict worsening heart failure.

Key results from the MultiSENSE Study demonstrated that HeartLogic had:+

• 70% sensitivity in detecting heart failure events1

• Weeks of advanced notice to a potential heart failure event - median 34 days1

• Low burden of less than 2 total alerts per patient per year1

• Heart failure event rate was 10 times higher when HeartLogic was in alert state versus when it was not in alert state2

• HeartLogic augmented the prognosis of a baseline NT-proBNP assessment, stratifying patients with up to 50 times higher rate for heart failure events between the lowest risk and the highest risk patient groups.3

+Using the nominal threshold of 16.

KEY CONCEPT

HeartLogic offers the clinic plenty of time to help risk stratify the patient to the right therapy for mitigating.

KEY CONCEPT

NOTES

Results from the MultiSENSE Study demonstrated HeartLogic had:• 70% sensitivity• Weeks of advance notice to a

potential heart failure event• Alert rate of less than 2.0 per

patient year• 10X heart failure event rate

when HeartLogic alerting• 50X heart failure event rate

when HeartLogic augmenting baseline NT-proBnP assessment

Figure 2. The MultiSENSE Study data demonstrated that HeartLogic met the displayed primary endpoints

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Managing Alerts, The 3A Process: Alert, Assessment and Action

This section explains the 3A Process, a clinical workflow where a HeartLogic alert triggers a data review of the Heart Failure Management Report and prompts patient discussions to motivate clinical action. When using this process, practice standard of care4 for all patients, regardless of their HeartLogic alert status. The 3A Process suggests steps and information to consider when choosing the course of clinical action.

Once the HeartLogic diagnostic is enabled on a patient’s device, follow the 3A Process of ALERT, ASSESSMENT and ACTION.

Step 1: Alert The transmission of the HeartLogic Alert and additional heart failure diagnostics, combined into a Heart Failure Management Report and delivered via the LATITUDE NXT system.Step 2: Assessment A. The review of trends from the Heart Failure Managment Report. B. The assessment of the patient to corroborate the trends.Step 3: Action The steps that you and your team decide are warranted for maintaining or adjusting therapy.

Continue to monitor the patient and consider repeating the 3A Process per standard of care.

KEY CONCEPT

The easiest way to ensure quality outcomes is by using a consistent set of steps for HeartLogic Alert workflow.

KEY CONCEPT

NOTES

The heart of the 3A Process is assessment.

Figure 3. The 3A Process: A useful blueprint for HeartLogic workflow.

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Managing Alerts, The 3A Process: Alert, Assessment and ActionStep 1: HeartLogic Alert

A HeartLogic Alert is a part of the HeartLogic Heart Failure Diagnostic comprised of a composite trend called the HeartLogic Index, a configurable yellow alert and threshold. These are all delivered via LATITUDE NXT.

The HeartLogic Index is computed daily and combines measurements from multiple device-based sensors, looking for changes from a historical baseline in a worsening direction and weighting those changes based on a patient’s current risk level. Baselines are assessed on data spanning up to three recent months.

When the HeartLogic Index crosses the threshold, a HeartLogic Alert is issued. Additional alerts will be delivered every 7 days as long as the HeartLogic Index remains above the threshold.*

* HeartLogic provides additive, optional information for clinicians to use in context with standard-of-care patient treatment and should not replace standard-of-care treatment. Due to the long-term averaging involved, the Index may not be sensitive to faster changes in sensor data over shorter time frame. As such, sensor changes due to acute interventions may not be immediately reflected in the Index. It is not recommended to use the Index values for day-to-day patient management.

KEY CONCEPT

When the HeartLogic Index crosses the threshold, a HeartLogic Alert is issued.

KEY CONCEPT

NOTES

The HeartLogic Index is computed daily and combines measurements from multiple

Figure 4. The 3A Process: HeartLogic Alert

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Managing Alerts, The 3A Process: Alert, Assessment and ActionStep 2: Assessment of the Alert Context, Heart Failure Management Report

Review the Heart Failure Management Report and talk with the patient to assess the context of the alert and identify potential causes. Note that HeartLogic is a sensitive diagnostic tool that may issue an alert before signs and symptoms.

The Heart Failure Management Report is a comprehensive summary of diagnostic trends tailored to the management of heart failure. The trends covered in this guide are S3 heart sound, S1 heart sound, thoracic impedance, respiratory rate, night heart rate, sleep incline, activity level, AT/AF burden, V therapy, % LV paced and weight.

The device collects and reports the data daily, and the LATITUDE NXT System delivers the data to the clinician. Even though not all of the diagnostic trends included in the Heart Failure Management Report are a part of HeartLogic, all the data together can help you understand the context of the HeartLogic Alert.

The details of each of the trends will be explained in the next section of this workbook. An overall summary of trend direction and how it correlates to worsening heart failure can be seen in Figure 5.

KEY CONCEPT

HeartLogic is a sensitive diagnostic that may issue an alert before signs and symptoms.

KEY CONCEPT

NOTES

The Heart Failure Management Report is a comprehensive summary of diagnostic trends.

Figure 5. The Heart Failure Management Report and Table 1 provides a brief summary of directional changes in trends that may be associated with worsening heart failure.

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The Heart Failure Management Report: Sample Patient

To make you familiar with the Heart Failure Management Report available in LATITUDE NXT and to help practice reading these reports, a sample report begins on the next page.

Note that the clinic first received an alert on this patient on March 18th, when sensor findings included in HeartLogic caused the HeartLogic Index to cross the alert threshold.

Let’s use the report of that event and the sequence of the reported trends to familiarize you with the sensor data that are included in the Heart Failure Management Report. Trends include:• Heart Sounds S3 and S1• Thoracic Impedance• Respiratory Rate• Night Heart Rate• Sleep Incline• Activity Level• AT/AF Burden• Ventricular Therapy• RV Rate during AT/AF• Mean Heart Rate• % LV Paced (CRT-D devices only)• Heart Rate Variability (SDANN)

Figure 6. Sample Heart Failure Management Report showing a patient with an alert and contributing trends.

To receive HeartLogic Alerts the patient’s Resonate CRT-D or ICD must be properly enabled and the patient set up in LATITUDE NXT as described in the next section.

KEY CONCEPT

NOTES

A HeartLogic Alert is issued when the index crosses the alert threshold.

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The Heart Failure Management Report--Page 1

Results from the case studies are not necessarily predictive of results in other cases. Results in other cases may vary.

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The Heart Failure Management Report--Page 2

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The HeartLogic Heart Failure Index: How Do You Read It?

KEY CONCEPTThe HeartLogic Index appears in bold black, available whenever HeartLogic is enabled for the CRT-D or ICD and in LATITUDE NXT. Daily index measures are derived from multiple sensors in the CRT-D or ICD.

An index line in the white area of the graph indicates low risk of approaching heart failure.An index line in the gray area indicates that measurements of the sensors have crossed the higher dotted, configurable threshold line (nominally at a value of 16 and configurable in steps of 2 from10-40). When this occurs, the patient may be at an increased risk of a heart failure event.

The alert is considered cleared when the alert state transitions from Alert to No Alert. Sucha transition is indicative of current sensor values no longer being different enough from the moving baseline to be in the alert status at the configured threshold. Changing from a state of Alert to No Alert does not necessarily indicate that a patient is no longer in worsening heart failure; instead, the patient may be improving, staying the same, or worsening at a slower rate. Additionally, abrupt unavailability of individual sensor data may result in a sudden decrease in the HeartLogic Index.

When the index initially crosses the threshold it signals that the patient may be at an increased risk of a heart failure event.

NOTESNOTESNOTESNOTES

Figure 7. The HeartLogic Index rises from the baseline and crosses the threshold (dotted line), indicating a potential worsening heart failure event. The rising index in the gray portion of the graph describes a patient at continuing risk.

X-axis shows timeY-axis shows the value of the HeartLogic Index, which can range from 0 to 100

Changing from a state of Alert to No Alert does not necessarily indicate that a patient is no longer in worsening heart failure; instead, the patient may be improving, staying the same, or worsening at a slower rate.

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The HeartLogic Heart Failure Index: How Do You Read It?

KEY CONCEPTWhen HeartLogic is enabled, the Resonate CRT-D or ICD is programmed and LATITUDE NXT is configured appropriately, the clinic may receive alerts for threshold crossings. When such an alert occurs, it signals that the patient is at an increased risk of a heart failure event, providing the clinic an opportunity to proactively corroborate with the patient the reasons for the alert.

First, it may be appropriate to use the Heart Failure Management Report to verify what the CRT-D or ICD is reporting. Telephone follow-up or physical examination (or both) of the patient could confirm the patient’s condition and need for therapy.

To receive a HeartLogic Alert for a patient threshold crossing:• Enable HeartLogic by calling

LATITUDE Customer Support at 1.800.CARDIAC.

• Enroll and configure the patient in LATITUDE NXT.

NOTES

Figure 8. When the HeartLogic Index crosses the HeartLogic threshold (here at 16), the clinic will receive a remote alert of this event via LATITUDE NXT.

An alert indicates that the patient is at an increased risk of worsening heart failure. In the MultiSENSE Study, true positive alerts preceded a hospitalization or therapeutic intervention by a median 34 days.

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The HeartLogic Heart Failure Index: How Do You Read It? Contributing trends

HeartLogic Contributing Trends present only after the index value has crossed the configured threshold. The trends displayed here are: S3 (third heart sound), S3/S1 (the ratio of the third and the first heart sound), Thoracic Impedance, Respiratory Rate and Night Heart Rate.

The shaded portion of each bar for a given trend indicates the degree of worsening in that trend from its respective baseline for that specific point in time. Such changes are weighted based on patient risk. A simple summation of the changes may not correctly represent the HeartLogic Index.

The report may enable you to determine quickly how/why HeartLogic sent an alert and may help you isolate likely physiologic symptoms to ask about or examine.

In the pages that follow we will look at each of the individual sensors used by the CRT-D or ICD and the characteristic display of trend information for each on the Heart Failure Management Report.

KEY CONCEPTKEY CONCEPT

After a HeartLogic Alert, contributing trends help the user determine the degree of change in each of the individual trends. They save time in getting to the potential root causes of the alert so that you can corroborate by examination or interview.

NOTES

Note that there are no contributing trends provided if the patient’s HeartLogic Index has NOT crossed the threshold and generated an alert.

Figure 9. When a threshold crossing occurs, a summary of the contributing trends is displayed underneath the HeartLogic Index.

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The Heart Failure Management Report: How Do You Read It? Contributing Trend Graphs: S3 Heart Sounds

A unique measure of heart failure symptoms in HeartLogic are S3 and S1 Heart Sounds.

The S3 heart sound uses the accelerometer embedded in the pulse generator to detect cardiac vibrations of the third heart sound during periods of patient inactivity. The vibrations are then used to measure the intensity of the S3 heart sound, reported in milligravities(mG). An S3 heart sound cannot be obtained when the patient’s heart rate is too high or the heart rate is too variable.

Auscultated S3 is known as an early sign of heart failure and elevated filling pressure.5-8 Device-measured S3 occurs during early diastolic filling, consistent with its known physiologic genesis9; is correlated with echo parameters consistent with impaired left ventricular functions,10,11 and correlates with hemodynamic parameters, such as left atrial pressure.12

Device-measured S3 includes sub-audible components that were better able to distinguish heart failure patients from non-heart failure patients.13 A 30-day average S3 of larger than 1 mG predicted the risk of future heart failure events better than the baseline auscultated S3.14 Worsening heart failure may be associated with an increase in S3.15-17

In the patient above, the rising trend occurring between March and May shows that the S3 sound is louder, and may signal worsening heart failure.

KEY CONCEPT

NOTES

KEY CONCEPT

A 30-day average S3 of larger than 1 mG at baseline predicted the risk of future heart failure events better than the baseline auscultated S3.14 Worsening heart failure may be associated with an increase in S3.

Missing S3 values may occur when heart rate is high, too variable or the patient is active.

Figure 10. Auscultated S3 is known as an early sign of heart failure and elevated filling pressure.5-8

Daily measurements appear in gray; the three-day average appears as bold and black.

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The Heart Failure Management Report: How Do You Read It? Contributing Trend Graphs: S1 Heart Sounds

NOTES

KEY CONCEPTThe S1 Heart Sound uses the accelerometer embedded in the pulse generator to detect cardiac vibrations of the first heart sound during periods of patient inactivity. The vibrations are then used to measure the intensity of the S1 heart sound, reported in milligravities(mG). An S1 heart sound cannot be obtained when the patient’s heart rate is too high or the heart rate is too variable.

Auscultated S1, which is related to the closure of the mitral and tricuspid valves, identifies the onset of ventricular systole and the end of mechanical diastole.18 Acutely, S1 amplitude has been shown to be closely related to cardiac contractility.12,19,20 A decrease in the intensity of S1 may be associated with myocardial depression, mitral regurgitation, ventricular septal defect and acute aortic regurgitation.21 Worsening heart failure may be associated with a decrease in S1.15-17

S3 to S1 Ratio: Note also that as the S1 becomes softer and the S3 rises, the “ratio” between the measured values amplifies the signal. The greater the changing ratio the more marked the changes in S3, S1, or both.

A falling S1 trend line suggests worsening heart failure. A contributing trend, the S3 toS1 Ratio, refers us to the heart sounds for indicators of worsening heart failure.

Diminished S1 sounds may indicate diminished ventricular filling, a sign of worsening heart failure.

Figure 11. Worsening heart failure may be associated with a decrease in S1.15-17

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The Heart Failure Management Report: How Do You Read It? Contributing Trend Graphs: Thoracic Impedance

KEY CONCEPT

NOTES

Thoracic Impedance is a measure of thoracic resistance between the coil electrode on the right ventricular lead and the pulse generator. Lower thoracic impedance may be associated with pulmonary congestion,22,23 pocket infection,23 pleural/pericardial effusion24 and respiratory infection.23 Worsening heart failure may be associated with a decrease in thoracic impedance.15-17,25

Note on the graphic above that the thoracic impedance has trended progressively lower since February. On May 6, the report, thoracic impedance has reached a new low, suggestive of possible increased fluid accumulation.

Low thoracic impedance measures may also accompany fluid accumulation from bronchitis or pneumonia. Thoracic impedance measurements may be influenced by right ventricular lead integrity issues, pocket infection, pleural/pericardial effusion and respiratory infection.

Thoracic impedance measurements are indicators of fluid status in the patient’s thorax: Higher measurements represent less accumulation (high is dry); lower measurements represent more accumulation.

Figure 12. Thoracic impedance measures fluid in the thorax: high is dry; low is wet.

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The Heart Failure Management Report: How Do You Read It? Contributing Trend Graphs: Respiration (Rate and Tidal Volume)

KEY CONCEPT

NOTES

Respiratory Rate is a daily median rate of all valid breaths within 24 hours. Nearly 90% of patients admitted to hospitals for acute decompensated heart failure had shortness of breath (dyspnea) upon admission according to the ADHERE Registry.26 When patients experience dyspnea they often have a rapid shallowing breathing pattern with an elevated respiratory rate (tachypnea) and a reduced tidal volume.

Respiratory rate may increase prior to a heart failure event.15-17,27 A 30-day average respiratory rate above 20 breaths per minute had a 3.5-fold increased risk of heart failure events within the following 30 days.28 Respiratory rate with a higher day-to-day variation over 30 days had a 4.9-fold increased risk of heart failure events within the following 30 days.29

To obtain respiration information the CRT-D or ICD uses transthoracic impedance measurement to learn the patient’s respiratory rate and tidal volume.

Our patient here is experiencing a rising respiratory rate up to a peak value of 24 respirations per minute on May 6. As we have seen, the increase coincides with a rising S3 trend, a falling S1 trend and falling thoracic impedance. All are indicators of approaching worsening heart failure.

One of the signs of worsening heart failure is an increase in respiratory rate.

Figure 13. Rising respiratory rate in an inactive patient is a marker of worsening heart failure.

To obtain respiration information the CRT-D or ICD uses transthoracic impedance measurement to learn the patient’s respiratory rate and tidal volume.

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The Heart Failure Management Report: How Do You Read It? Contributing Trend Graphs: Night Heart Rate

The Night Heart Rate sensor measures sensed and paced right ventricular heart rate each day between midnight and 6a.m. This patient was likely to be paced from the steady night heart rate during March and April. However, during the latter part of April, you see that night heart rate is on the rise.

Resting heart rates may have prognostic value in patients with chronic heart failure.30 An increase in night heart rate may be associated with worsening heart failure15-17,31 or autonomic dysfunction.31 An increase in heart rate may also be associated with conducting atrial arrhythmias and may be a sign of an insufficient rate control.

Note: A period of rising night heartrate may also be associated with ventricular arrhythmias, as detected and treated in this patient at the same time period as the increased nocturnal ventricular instability. The Heart Failure Management report separately lists treated ventricular arrhythmias, signifying ATP treatments as dots and shocks as mini-lightning bolts.

KEY CONCEPT

NOTES

KEY CONCEPT

Note that when the patient is sleeping or inactive the activity sensor does not vary the pacing rate in this CRT-D patient.

Rising night heart rate is a strongpredictor of cardio-vascular events. Rising night heart rate is frequently associated with increased frequency of PVCs and/or with rapid ventricular response to conducted atrial tachy arrhythmias.

Figure 14. Increasing night heart rate occurs during worsening heart failure and predicts cardiovascular events.

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Sleep incline is the angle between the patient’s torso and the horizontal plane measured during the sleep time period specified by the patient. Orthopnea is a symptom where the patient has shortness of breath (dyspnea) when assuming a horizontal posture. Paroxysmal nocturnal dyspnea (PND) is a sudden awakening due to an acute shortness of breath that generally occurs at night. Orthopnea and PND are common posture-related symptoms in heart failure patients, and their importance for heart failure assessment is well supported in current heart failure management guidelines, heart failure clinical assessment scores and clinical research.1,32-38 Both symptoms are due to fluid redistribution from the periphery to the thoracic region upon lying down. Since these symptoms are unpleasant, patients will often prop themselves up to varying degrees in order to get restful sleep at night. Elevated sleep incline angle was indicative of orthopnea or PND.39,40 If you are not seeing the sleep incline trend on the Heart Failure Management Report but would like to, work with your BSC Rhythm Management Representative to enable this trend

The following trends are also available on the Heart Failure Management Report.

The Heart Failure Management Report: How Do You Read It? Additional Trend Graphs

AT/AF Burden trend displays the total amount of time spent in an atrial tachy response (ATR) mode switch, in hours per day. The trend is generally representative of the duration of atrial tachycardia (AT) or atrial fibrillation (AF) episodes. AT and AF epsodes in heart failure are associated with poor prognosis and mortality and are often asymptomatic. AF can exacerbate heart failure and worsening heart failure may result in the new onset or exacerbation of AF.

Activity level shows the number of hours per day a patient is active. Changes in device-measured activity have been correlated with a 6-minute walk test.41,42 A reduced level of physical activity had a 4-fold increased risk of heart failure hospitalization within the next 30 days.43 Worsening heart failure may be associated with a decrease in activity.15-17

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% LV Paced trend is the percent of cardiac beats paced with a left ventricular (LV) lead per day.* The goal of CRT is to maximize resynchronization through a high rate of biventricular pacing with the preferred percentage of pacing as close to 100% as possible.50 A high percentage of biventricular pacing in patients with a CRT device is associated with improved prognosis.50

Mean Heart Rate trend displays a 24-hour average of ventricular beats including both paced and sensed.

RV Rate during AT/AF trend displays mean and maximum RV rate during ART mode switch events.

*The trend is only available on CRT devices

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Weight and Blood Pressure trends show data collected by external devices assigned by clinicians managing LATITUDE NXT. LATITUDE NXT provides the ability to configure alerting parameters for these trends. Guidelines recommend weight monitoring as part of the heart failure management routine.1 Sudden or steady gain in daily weight may be associated with fluid retention and worsening heart failure.51, 52 If you are not seeing the weight and blood pressure trends on the Heart Failure Management Report but would like to, work with your BSC Rhythm Management Representative to order this equipment.


Heart Rate Variability trend indicates the standard deviation of 5-minute average intrinsic normal beats.

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Managing Alerts, The 3A Process: Alert, Assessment and ActionStep 2: Assessment of the Alert Context, Patient Discussion

Talk with your patient to obtain additional context for the HeartLogic Alert and identify a possible course of action. Conduct the patient discussion by phone or in person, following your standard approach to patient assessment or published guidelines.1 Seek answers to the following questions:

1. Are there any specific precipitating factors that can be immediately addressed, such as:

• Medication nonadherence • Dietary indiscretion • Use of harmful medications such as NSAIDs • Arrhythmia and device therapy (ATP, shocks) • Reduction or loss of CRT (CRT devices only) • Recent medication changes • Recent clinical events especially those requiring infusion of fluids (e.g., a surgery)

• Active ischemia • Non-optimal medical therapy

2. Are there other signs or symptoms of worsening heart failure, such as:

• Shortness of breath with exertion and/or at rest • Shortness of breath when lying flat (orthopnea or paroxysmal nocturnal dyspnea) • Sleeping regularly in a chair or on multiple pillows in bed • Dry cough or frothy sputum • Weight gain • Swelling of abdomen, feet or ankles • Changes in the frequency of urination • Fatigue

KEY CONCEPT

Follow your standard approach to patient assessment or published guidelines.1

KEY CONCEPT

NOTES

Talk with your patient to obtain additional context for the HeartLogic Alert and identify a possible course of action.

Figure 15. The 3A Process: Patient Discussion

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Managing Alerts, The 3A Process: Alert, Assessment and ActionStep 3: Clinical Action

Upon completing your assessment of the Heart Failure Management Report and patient discussion(s), consider modifying your patient’s treatment and monitoring your patient’s condition to ensure safety per standard of care.1

Depending on the factors you believe may have accompanied the HeartLogic Alert (Step 2), consider one or more of the following actions:

• Reinforce medication compliance • Repeat patient education on dietary sodium and fluid restriction, remind of daily activity/exercise plan and keeping regular follow-up appointments with his/her healthcare provider • Address patient therapy related issues, such as worsening atrial burden, loss of CRT pacing, ventricular arrhythmias, etc. • Treat fluid overload • Further optimize current ACCF/AHA guideline- directed medical therapies

Continue to monitor your patient by following standard of care guidelines.1

KEY CONCEPT

Continue to monitor your patient by following standard of care guidelines.1

KEY CONCEPT

NOTES

Consider modifying your patient’s treatment and monitoring your patient’s condition to ensure safety per standard of care.1

Figure 16. The 3A Process: Clinical Action

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Configuring and Navigating HeartLogicPreparing the Resonate CRT-D or ICD and LATITUDE NXT

NOTES

KEY CONCEPT

It will take up to 37 days from the time of enabling the HeartLogic yellow alert to the point where it provides a HeartLogic Index number, assuming that the nominal “ON” Heart Failure Sensor Suite data collection was not changed.

The CRT-D or ICD should already be programmed to collect the Heart Failure Sensor Suite data; this is nominally enabled ON.

KEY CONCEPTThere are three elements needed in order for you to see the HeartLogic Index and receive a HeartLogic Alert from LATITUDE NXT:

• The CRT-D or ICD should already be programmed to collect the Heart Failure Sensor Suite data; this is nominally enabled ON. If you are currently not receiving Heart Failure Sensor Suite data you may reach out to your BSC Rhythm Management Representative for assistance in turning this feature ON.

• Ensure that the patient is enrolled in LATITUDE NXT, has setup their communicator at home, and that the LATITUDE NXT system is configured appropriately.

• The HeartLogic yellow alert is enabled within the LATITUDE NXT patient profile.

Contact your Rhythm Management Representative for further discussion on how to enable HeartLogic.

Verify the Heart Failure Sensor Suite is ON

If you have access to a programmer and would like to ensure the Heart Failure Sensor Suite is ON in the Resonate CRT-D or ICD:

1. Interrogate the CRT-D or ICD and navigate to the area under the heading SUMMARY-HEART FAILURE MANAGEMENT.

2. Under this heading, select the Setup tab. Under Sensor Activation the Heart Failure Sensor Suite should be listed as ON (see Figure 17).

Figure 17. Contact your Rhythm Management Representative for further discussion on how to enable HeartLogic.

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Configuring and Navigating HeartLogicEnabling HeartLogic Alerts in LATITUDE NXT

NOTESIn the event that you DO NOT program the Perform daily interrogations until alert condition is resolved ON and the episode of worsening heart failure continues (i.e., there is no alert recovery), the sensor trends will be updated automatically in seven days, assuming that the patient remains in alert according to HeartLogic.

Configuring LATITUDE NXT as described here ensures that LATITUDE NXT is “ready” to receive HeartLogic Alerts.

KEY CONCEPTEnabling HeartLogic Alert:

1. In LATITUDE NXT hover over Manage Clinic then select Manage Clinic Settings.

2. Select Edit/View Schedule and Alert Defaults.

3. Under HeartLogic, confirm the checkbox to the left of HeartLogic heart failure index at or above is checked.

4. The threshold is nominally set to 16. If you would like to change the threshold, use the dropdown to configure between 10 and 40, in steps of 2.

NOTE: When the threshold value is set, a recovery threshold value is also automatically configured. The recovery threshold is the value below which the HeartLogic Index must fall in order to determine that the episode of worsening heart failure has been averted or has ended.

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Configuring and Navigating HeartLogicConfiguring LATITUDE NXT to Send Daily Follow-Up Alerts

NOTESChanges made to the alert configuration (threshold) will not take place until the communicator (at the patient’s home/bedside) calls LATITUDE NXT to obtain the new configuration, which may take up to seven days. Once again, after you enable HeartLogic in the CRT-D or ICD it may take up to 45 days before HeartLogic information can be transmitted.

When you program LATITUDE NXT as described here, any HeartLogic Alert is followed by daily interrogations for a period of seven days, as long as the Index value remains higher than the threshold.

KEY CONCEPTPatients followed in LATITUDE NXT with HeartLogic enabled nominally upload data every seven days. If a patient triggers a HeartLogic Alert, LATITUDE NXT will re-alert you in seven days (as long as the index remains higher than the threshold). If you would like data to upload daily until the alert condition is resolved, follow the steps below to configure this feature ON.

To enable daily interrogation and transmission following a HeartLogic alert:

1. Go to the prompt Perform daily interrogations...

2. Click the down arrow in the checkbox to select On.

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Configuring and Navigating HeartLogicTurning OFF Patient Group Defaults for a Particular Patient

NOTESIn the event that you deselect patient group defaults, you may configure the patient’s parameters as you deem appropriate.

You may wish to set up special parameters for a particular patient. To do so you must deselect Use Patient Group Defaults for the patient.

KEY CONCEPTTo turn OFF Patient Group Defaults for a particular patient:

1. Select a particular patient from your clinic group.

2. Select

Edit/View Schedule and Alert Defaults.

3. Under the heading Alert Configuration, deselect Use Patient Group Defaults...

4. Once Use Patient Group Defaults... is deselected, you may configure the patient’s parameters as you deem appropriate.

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Configuring and Navigating HeartLogic: LATITUDE NXT

With HeartLogic and a LATITUDE NXT account, you have the opportunity to navigate your HeartLogic Alerts interactively online. Below we offer you a look at several screens you can anticipate seeing in LATITUDE NXT.

To access the LATITUDE NXT website:

Login as usual.

You will then see the screen at the top of the following page, associated in the following examples with the clinic of Dr. Betty Hamilton:

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You have arrived at the Patient List for the fictitious Dr. Hamilton’s clinic. Note the following:

• All patients displayed are in the HeartLogic group.

• All have been interrogated.

• Two patients show a HeartLogic Alert and have been reviewed.

To access the report for the patient with the HeartLogic Alert click on their name.

You will then see the screen at the top of the next page:

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While observing the screen above, note the following:

• Latest Device Transmission is March 02.

• LATITUDE NXT draws specific attention to the HeartLogic Alert under the My Alerts.

To look further, click on the tab marked Health in the middle of the screen to see the Heart Failure Sensor Suite data.

You will then see the screen at the top of the next page:

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While observing the screen above, note the following:

• The individual data points from the interrogation are at the top of the Heart Failure Management Report, offering a quick thumbnail overview of the patient status.

• You are able to select under View the resolution that you want: 1m(onth), 3m(onths), 6m(onths) or 1y(ear).

• You are able to scroll down the report freely to additional trend graphs.

• You can left mouse click once on the black HeartLogic Index trendline to get to an individual date and read the measured value associated with that day. Clicking a second time will create a reference bar for that day. The reference bar appears on all the trend graphs and allows you to easily see all data points for that selected date.

You will then see a Heart Failure Management Report with blue reference line, as on the next page:

View offers selectable graphic resolution for Index and Trend graph.

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Figure 18. The reference line refers you to what was happening on a particular day in the patient’s history, from the HeartLogic Index through each of the trends contained in the Heart Failure Management Report. Place your mouse anywhere in the patient’s index to access and double click to place the reference line.

This concludes the HeartLogic Heart Failure Diagnostics Allied Healthcare Professional Training workbook. Included within this training is a separate study guide that helps ensure you have learned the content contained within this workbook in addition to the interactive CE training program.

Please contact your Boston Scientific Rhythm Management Representative to further discussions on how HeartLogic can assist your clinic in the management of Heart Failure patients.

Reference Line

Reference Line

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PrecautionsNote that a HeartLogic™ Index reading below the configured Threshold value simply means that the ICD remains in an ongoing monitor mode, “watching” and documenting the patient’s heart failure. Seeing a reading below the threshold does not indicate by itself that the patient no longer needs to be treated for heart failure.

A reading indicating that the HeartLogic™ Index has crossed the configured Threshold is not, by itself, sufficient reason to modify therapeutic treatment for heart failure; the threshold crossing must be evaluated and compared to the “Trend Graphs” that come with the HeartLogic™ diagnostic and especially to informed physical examination of the patient and informed assessment of patient interview data in order to provide adequate basis for revising the patient’s treatment pattern.

General Disclaimer Results from case studies are not necessarily predictive of results in other cases. Results in other cases may vary.

To the extent you make any external use of any information in these materials, your use must be consistent with the approved labeling of our device(s).

BSC does not promote or encourage the use of its devices outside their approved labeling.

NOTE: It is always the physician, in the exercise of his/her professional medical judgement and in collaboration with the patient, who decides how, when and where to diagnose/treat the patient’s particular condition.

IMPORTANT INFORMATION: These materials are intended to describe common clinical considerations and procedural steps for the on-label use of referenced technologies as well as current standards of care for certain considerations.

Of course, patients and their medical circumstances vary, so the clinical considerations and procedural steps described may not be appropriate for every patient or case.

As always, decisions surrounding patient care depend on the physician’s professional judgment in light of all available information for the case at hand.

BSC does not promote or encourage the use of its devices outside their approved labeling.

The presenter’s [or author’s] experience with BSC products may not be interpreted or relied upon to support clinical claims about BSC devices or product comparison claims regarding BSC and competitive devices.

The experiences of other users may vary.

CRT-D Systems –RESONATE™HF, RESONATE™, RESONATE™X4, VIGILANT™, VIGILANT™X4, MOMENTUM™, MOMENTUM™ X4

INDICATIONS AND USAGE

These Boston Scientific Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications: Moderate to severe heart failure (NYHA Class III-IV) with EF ≤ 35% and QRS duration ≥ 120 ms; left bundle branch block (LBBB) with QRS duration ≥ 130 ms, EF ≤ 30%, and mild (NYHA Class II) ischemic or nonischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure

CONTRAINDICATIONS

There are no contraindications for this device.

WARNINGS

Read this manual thoroughly before implantation to avoid damage to the pulse generator and/or lead. For single patient use only. Do not reuse, reprocess, or resterilize. Always have external defibrillation equipment available during implant and electrophysiologic testing. Ensure that an external defibrillator and medical personnel skilled in CPR are present during post-implant device testing should the patient require external rescue. Do not use defibrillation patch leads with the pulse generator system. Do not use this pulse generator with another pulse generator. Program the pulse generator Tachy Mode(s) to Off during implant, explant, or postmortem procedures. Do not kink, twist, or braid the lead with other leads. For leads that require the use of a Connector Tool, use caution handling the lead terminal when the Connector Tool is not present on the lead. Do not directly contact the lead terminal with any surgical instruments or electrical connections such as PSA (alligator) clips, ECG connections, forceps, hemostats, and clamps. Do not contact any other portion of the DF4–LLHH or DF4–LLHO lead terminal, other than the terminal pin, even when the lead cap is in place. Do not contact any other portion of the IS4–LLLL lead terminal, other than the terminal pin, even when the lead cap is in place. When implant a system that uses both a DF4–LLHH or DF4–LLHO and IS4–LLLL lead, ensure that the leads are inserted and secured in the appropriate ports. Do not use atrial tracking modes in patients with chronic refractory atrial tachyarrhythmias. Do not use atrial-only modes in patients with heart failure. Left ventricular lead dislodgement to a position near the atria can result in atrial oversensing and left ventricular pacing inhibition. Physicians should use medical discretion when implanting this device in patients who present with slow VT. Advise patients to seek medical guidance before entering environments that could adversely affect the operation of the active implantable medical device, including areas protected by a warning notice that prevents entry by patients who have a pulse generator. RESONATE HF, RESONATE, and VIGILANT devices with an IS-1/DF4/IS4 lead connection are considered MR Conditional. For these devices, unless all of the MRI Conditions of Use are met, MRI

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scanning of the patient does not meet MR Conditional requirements for the implanted system, and significant harm to or death of the patient and/or damage to the implanted system may result. For potential adverse events applicable when the Conditions of Use are met or not met, refer to the MRI Technical Guide.. Do not subject a patient with an implanted pulse generator and/or lead to diathermy. If desired, ensure that Patient Triggered Monitor (PTM) is enabled prior to sending the patient home by confirming the magnet response is programmed to Store EGM. Once the PTM feature has been triggered and the magnet response set to Inhibit therapy the patient should not reapply the magnet.

PRECAUTIONS

For specific information on precautions, refer to the following sections of the product labeling: clinical considerations, sterilization and storage, implantation, device programming, environmental and medical therapy hazards, hospital and medical environments, home and occupational environments, follow-up testing, explant and disposal, supplemental precautionary information. Advise patients to avoid sources of EMI because EMI may cause the pulse generator to deliver inappropriate therapy or inhibit appropriate therapy.

POTENTIAL ADVERSE EVENTS

Potential adverse events include, but are not limited to, the following: allergic/physical/physiologic reaction, death, erosion/migration, fibrillation or other arrhythmias, lead or accessory breakage (fracture/insulation/lead tip), hematoma/seroma, inappropriate or inability to provide therapy (shocks /pacing/sensing), infection, procedure related, and component failure. Patients may develop psychological intolerance to a pulse generator system and may experience fear of shocking, fear of device failure, or imagined shocking. In rare cases severe complications or device failures can occur.

Refer to the product labeling for specific indications, contraindications, warnings/precautions and adverse events. Rx only.(Rev B)

ICD Systems – RESONATE™ HF, RESONATE™ EL, PERCIVA™ HF, PERCIVA™, VIGILANT™ EL, MOMENTUM™ EL

INDICATIONS AND USAGE

Boston Scientific implantable cardioverter defibrillators (ICDs) are intended to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.

CONTRAINDICATIONS

Use of these Boston Scientific pulse generators are contraindicated for the following: patients whose ventricular tachyarrhythmias may have reversible cause, such as: digitalis intoxication, electrolyte imbalance, hypoxia, sepsis; or patients whose ventricular tachyarrhythmias have a transient cause, such as: acute myocardial infarction (MI), electrocution, drowning; or patients who have a unipolar pacemaker.

WARNINGS

Read this manual thoroughly before implantation to avoid damage to the pulse generator and/or lead. For single patient use only. Do not reuse, reprocess, or resterilize. Always have external defibrillation equipment available during implant and electrophysiologic testing. Ensure that an external defibrillator and medical personnel skilled in CPR are present during post-implant device testing should the patient require external rescue. Do not use this pulse generator with another pulse generator. Program the pulse generator Tachy Mode(s) to Off during implant, explant, or postmortem procedures to avoid inadvertent high voltage shocks. Do not kink, twist, or braid the lead with other leads as doing so could cause lead insulation abrasion damage or conductor damage. For leads that require the use of a Connector Tool, use caution handling the lead terminal when the Connector Tool is not present on the lead. Do not directly contact the lead terminal with any surgical instruments or electrical connections such as PSA (alligator) clips, ECG connections, forceps, hemostats, and clamps. Do not contact any other portion of the DF4–LLHH or DF4–LLHO lead terminal, other than the terminal pin, even when the lead cap is in place. Do not use atrial tracking modes in patients with chronic refractory atrial tachyarrhythmias. Tracking of atrial arrhythmias could result in ventricular tachyarrhythmias. Advise patients to seek medical guidance before entering environments that could adversely affect the operation of the active implantable medical device, including areas protected by a warning notice that prevents entry by patients who have a pulse generator. RESONATE HF, RESONATE, PERCIVA HF, PERCIVA, and VIGILANT devices with a DF4 right ventricular lead connection are considered MR Conditional. For these devices, unless all of the MRI Conditions of Use are met, MRI scanning of the patient does not meet MR Conditional requirements for the implanted system, and significant harm to or death of the patient and/or damage to the implanted system may result. For potential adverse events applicable when the Conditions of Use are met or not met, refer to the MRI Technical Guide. Do not subject a patient with an implanted pulse generator and/or lead to diathermy. If desired, ensure that Patient Triggered Monitor is enabled prior to sending the patient home. Once the Patient Triggered Monitor feature has been triggered by the magnet and an EGM has been stored, or after 60 days have elapsed from the day that Store EGM was enabled, the patient should not apply the magnet.

PRECAUTIONS

For specific information on precautions, refer to the following sections of the product labeling: clinical considerations, sterilization and storage, implantation, device programming, environmental and medical therapy hazards, hospital and medical environments, home and occupational environments, follow-up testing, explant and disposal, and supplemental precautionary information.

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POTENTIAL ADVERSE EVENTS

Potential adverse events include, but are not limited to, the following: allergic/physical/physiologic reaction, death, erosion/migration, fibrillation or other arrhythmias, lead or accessory breakage (fracture/insulation/lead tip), hematoma/seroma, inappropriate or inability to provide therapy (shocks /pacing/sensing), infection, procedure related, and component failure. Patients may develop psychological intolerance to a pulse generator system and may experience fear of shocking, fear of device failure, or imagined shocking. In rare cases severe complications or device failures can occur.

Refer to the product labeling for specific indications, contraindications, warnings/precautions and adverse events. Rx only.(Rev B)

LATITUDE™ NXT Patient Management System

Important Safety Information

Intended Use

The LATITUDE™ NXT Patient Management System is intended for use to remotely communicate with a compatible pulse generator from Boston Scientific CRM and transfer data to a central database. The LATITUDE NXT System provides patient data that can be used as part of the clinical evaluation of the patient.

Contraindications

The LATITUDE NXT Patient Management System is contraindicated for use with any implanted device other than a compatible Boston Scientific implanted device. Not all Boston Scientific implanted devices are compatible with the LATITUDE NXT System. For contraindications for use related to the implanted device, refer to the System Guide for the Boston Scientific implanted device being interrogated.

Precautions

Alerts may appear on the LATITUDE NXT website on a daily basis. Primary notification of alert conditions is through the View Patient List page on the LATITUDE NXT website. The clinician needs to log onto the LATITUDE NXT website in order to receive alerts. Although secondary notification through email and SMS text messages is available, these reminders are dependent on external systems and may be delayed or not occur. The secondary notification feature does not eliminate or reduce the need to check the website. Implanted device data and alerts are typically available for review on the LATITUDE NXT website within 15 minutes of a successful interrogation. However, data uploads may take significantly longer (up to 14 days). If the Communicator is unable to interrogate the implanted device or if the Communicator is unable to contact the LATITUDE NXT server to upload data, up to 14 days may elapse before the LATITUDE NXT server detects these conditions and informs the clinic user that monitoring is not occurring. If both of these conditions occur at the same time, this notification could take up to 28 days. Implanted device data and alert notification may be delayed or not occur at all under various conditions, which include but are not limited to the following: System limitations; the Communicator is unplugged; the Communicator is not able to connect to the LATITUDE NXT server through the configured phone system; the implanted device and the Communicator cannot establish and complete a telemetry session; the Communicator is damaged or malfunctions; the patient is not compliant with prescribed use or is not using the LATITUDE NXT System as described in the patient manual; if subscribed to the LATITUDE Cellular Data Plan, missing two or more payments discontinues the subscription; the clinic user can identify any patients that are not being monitored as described above by using the Not Monitored filter on the View Patient List.

Adverse Effects: None known.

System Limitations:

The LATITUDE NXT System does not provide continuous real-time monitoring. As a remote monitoring system, the LATITUDE NXT System provides periodic patient monitoring based on clinician configured settings. There are many internal and external factors that can hinder, delay, or prevent acquisition and delivery of implanted device, sensor, and patient information as intended by the clinician. These factors include: implanted device clock; patient environment; cellular data service; telephone system; communicator memory capacity; clinic environment; schedule/configuration changes; or data processing.

Refer to the product labeling for specific instructions for use. Rx only. (Rev. D)

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2. Gardner R, et al. The HeartLogic multi-sensor algorithm as an automatic predictor of heart failure events: Results from the Multisensor Chronic Evaluation in Ambulatory Heart Failure Patients (MultiSENSE) Study. Presented as a late breaking clinical trial at ESC Heart Failure Congress, 2017.

3. Boehmer JP, et al. The HeartLogic Multi-Sensor Algorithm Significantly Augments the Prognosis of a Baseline NT-proBNP Assessment for Heart Failure Events. J Card Fail 2017;23(11):831.

4. Yancy CW, et al. 2013 ACCF/AHA guideline for the management of heart failure. Circ 2013:128:240-327. 5. Shah SJ, et al. Hemodynamic correlates of the third heart sound and systolic time intervals. Congest Heart Fail 2006;12(1):S8-S13. 6. Marcus GM, et al. Association between phonocardiographic third and fourth heart sounds and objective measures of left ventricular function. JAMA

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diastolic filling. J Card Fail 2017;23(8):S68. 10. Gardner R, et al. Ambulatory S3 measured by an implanted device changes consistently with echocardiography in stable and acute decompensated heart

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