Cardiac Resynchronization Therapy (CRT) Follow-Up. Allied Healthcare Professional Training WORKBOOK

Allied Healthcare Professional Training

WORKBOOK

Cardiac Resynchronization Therapy (CRT)

Follow-Up

This module introduces you to fundamentals of cardiac resynchronization follow-up with Boston Scientific systems. The simplest statement concerning the goal of cardiac resynchronization therapy (CRT) follow-up:

• Maintain as close to 100% biventricular pacing as possible1

Achieving this goal ensures that the patient enjoys the well known best clinical benefits of cardiac resynchronization:

• Improved mortality2

• Improved NYHA Heart Failure Class (improvement by one or more classes) • Reverse (heart failure) remodeling

• Improved exercise tolerance (as measured by hallwalk distance) • Improved quality of life (measured by Quality of Life questionnaires)

• CRT-D offers a 98% likelihood of rescuing a patient from Sudden Cardiac Death3 This training:

• Describes the mechanisms by which patients most benefit from CRT

• Offers a protocol for approaching in-person or remote patient follow-up with a Boston Scientific CRT system.

• Builds on the general knowledge of pacing that you have acquired by offering you a limited additional set of knowledge and tools for achieving best CRT results during patient follow-up.

The training should take approximately 1 hour to complete. When you have completed it, you will receive a certificate of completion and 1 CEU credit.

After completing this training you should be able to:

• Obtain the information you need to conduct comprehensive CRT follow-up.

• Differentiate presenting rhythms from underlying rhythms, captured RV, LV, and biventricular QRS complexes.

• Interpret and evaluate a combined follow-up report and suggest possible reprogramming for discussion with the physician and team.

Implant Management

After completing this training you should be able to (continued): • Document follow-up to physician/team satisfaction.

• Seek more detailed training on HeartLogic™, the Heart Failure Management Report™, and SmartCRT™ for assessing the patient’s heart failure status and determining how best to use the device to optimize CRT for the patient.*

• Complete the companion CRT AHP Follow-Up Workbook Study Guide, also at this site for download.

*This training is available at two sites, depending on your needs: heartlogictraining.com and also smartcrttraining.com. CEUs are also available for completing training at each.

Please refer to the specific product manual for the full instructions for use including the contraindications, warnings, precautions, and adverse events.

Implant Management

Table of Contents

How to Use this Workbook

Logistics: Reimbursable CRT Follow-Up Intervals

The Patient Indication for CRT and the Goals of Cardiac Resynchronization Therapy The CRT System and Hemodynamic Benefit

Tasks Associated With CRT-P and CRT-D Follow-Up Patient Disease and Therapy History

Facilitating Hemodyamic Benefit at Follow-Up

CRT: Presenting Rhythm--Effect at Present Programmed Settings CRT: Underlying Rhythm--Native Interventricular Conduction CRT: RV Threshold Testing

CRT: LV Threshold Testing

Steps for Providing Continuous Biventricular Capture: LV Outputs

Considerations for Optimizing Cardiac Output and Biventricular Pacing: AV and VV Timing Implications

Device Settings: Brady/CRT Programming

Device Settings: Tachy Detection and Therapy Programming Assess Counters/Trends: Biventricular Pacing and VT

Assess Histograms Assess Recorded Events Assess Battery/Charge Time Assess Lead System

Assess Lead Trends

Improving Patient Response to CRT Therapy

Improving Patient Response to CRT Therapy: SmartCRT

Ensuring Patient Safety in an ICD Patient Before Ending Session CRT Follow-Up Process Checklist

Endnotes

Implant Management

Using this Workbook

KEY CONCEPT

cardiac resynchronization follow-up. It has three parts:

1. A process for CRT follow-up

2. Resources for understanding CRT basics 3. A study guide with which you can check your

mastery of CRT follow-up.

Included in this workbook is a combined follow-up report that offers you experience in reading and interpreting follow-up detail.

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 study guide helps ensure that you have learned what we want to teach.

This box describes the takeaway that we have in mind for this page. It is the most important thing on the page. It can also be used to help you assess if you need to read the material or if it is known to you.

For the latest Boston Scientific instructions on any device feature or issue:

www.bostonscientific.com/IFU. Technical Service:1-800-CARDIAC. Notable clinician quotes may also appear here.

NOTES

The graphic focuses on the main topic. The caption offers a concise explanation. Callouts appear occasionally in the graphic to explain key points.

• In-person programming device evaluation includes evaluation of all device functions and iterative adjustments to the CIED. Frequency is determined by Medical Necessity &

Guidelines.

• Remote device interrogation includes evaluation of device parameters. Report only once every 90 days.

• Remote device interrogation of ICM includes analysis of 1 or more longitudinal physiologic cardiovascular data elements. Report only once every 30 days.

KEY CONCEPT

in-person device and remote device interrogation.

Difference Between In-Person and Remote Monitoring Codes

In-Person CPT codes for in-person device checks are differentiated by:

• Type of device (ICD, PM, ICM)

• Number of leads (single, dual, or multi-lead) • Include both technical and professional

components

• Frequency is determined by Medical Necessity & Guidelines

• A complete summary report must be included in the medical record

• Payment for In-Person and Remote device interrogations are not allowed during the same period

Remote CPT codes for remote monitoring: • Differentiated by the type of device only • Provide separate codes for professional and

technical components • Billing frequency is defined

• A complete summary report must be included in the medical record

NOTES

See important notes on the uses and limitations of this information on page 33.

Logistics: Reimbursable Follow-Up Intervals for CRT

In-person and Remote Monitoring

* Novitas Solutions Local Coverage Determination (LCD): Cardiac Rhythm Device Evaluation (L30529), Novitas Solutions. Jurisdiction: Texas, Page 7-Utilization Guidelines

** Current Procedural Terminology (CPT) 2018. Professional Edition. Copyright 2017 American Medical As-sociation. Chicago, IL. All rights reserved. CPT is a registered trademark of the American Medical Associa-tion. CPT Global codes include a technical and professional component. Technical and professional compo-nents are indicated by use of a modifier appended to the device monitoring code. Note: Modifiers may apply in some instances. Check the CPT Manual for further guidance.

• In-person programming device evaluation includes evaluation of all device functions and iterative adjustments to the CIED. Frequency is determined by Medical Necessity &

Guidelines.

• Remote device interrogation includes evaluation of device parameters. Report only once every 90 days.

• Remote device interrogation of ICM includes analysis of 1 or more longitudinal physiologic cardiovascular data elements. Report only once every 30 days.

KEY CONCEPT

used to assist the physician in the management of non-rhythm-related cardiac conditions, such as heart failure. The device collects longitudinal physiologic cardiovascular data elements from one or more internal (e.g. HeartLogic, respiratory rate trend, left atrial pressure) or external sensors (e.g. blood pressure and weight). ICM device services are always separately reported from implantable defibrillator or pacemaker evaluation services. **

In-person programming device evaluation includes evaluation of all device functions, including battery, programmable setting and lead(s). To capture thresholds, iterative adjustments (e.g. progressive changes in pacing output of a pacing lead) of the programmable parameters are evaluated. The final program parameters may or may not change after the evaluation. **

Remote interrogation includes evaluation of

programmed parameters, lead(s), battery, capture and sensing function, presence or absence of therapy for ventricular tachyarrhythmias, and underlying heart rhythm. **

NOTES

See important notes on the uses and limitations of this information on page 33.

Logistics: Reimbursable Follow-Up Intervals for CRT

In-person and Remote Monitoring

* Novitas Solutions Local Coverage Determination (LCD): Cardiac Rhythm Device Evaluation (L30529), Novitas Solutions. Jurisdiction: Texas, Page 7-Utilization Guidelines

** Current Procedural Terminology (CPT) 2018. Professional Edition. Copyright 2017 American Medical As-sociation. Chicago, IL. All rights reserved. CPT is a registered trademark of the American Medical Associa-tion. CPT Global codes include a technical and professional component. Technical and professional compo-nents are indicated by use of a modifier appended to the device monitoring code. Note: Modifiers may apply in some instances. Check the CPT Manual for further guidance.

The Patient Indication for CRT

KEY CONCEPT

NOTES

characteristics:

• NYHA Class II, III or ambulatory Class IV systolic heart failure with left ventricular dysfunction

• a reduced LV ejection fraction ≤ 35%) • electro-mechanical conduction delay (QRS

duration ≥ 150 ms.) resulting from Left Bundle Branch Block and possible 1st degree AV block Patients must already be receiving optimal medical therapy before CRT is administered. Medical

therapy continues after CRT implant. (Class I indication.)4

A typical patient symptom profile includes: • shortness of breath

• exercise intolerance/exhaustion and inability to perform Activities of Daily Living

• decreased quality of life

• co-morbidities, such as atrial fibrillation, which further diminishes cardiac output

• ventricular dyssynchrony, which also diminishes cardiac output.

Systolic heart failure is the inability of the heart to be able to pump adequately to satisfy patient metabolic demand.

CRT patients have the following characteristics:

• systolic heart failure, • left ventricular systolic

dysfunction,

• electro-mechanical conduction delay.

They are also on optimal medical therapy for heart failure.

The heart failure classifications and LVEF ≤ 35% are also part of the SCD-HeFT indication for an ICD.

Normal LVEF is closer to 60%. The primary indication for CRT is heart failure. Above find a representation

KEY CONCEPT

NOTES

cardiac pump function through:

1. pacing to change the timing and amount of atrio-ventricular filling prior to ventricular contraction (the advantage of Frank-Starling). 2. resynchronizing the contractions of the right

and left ventricles to increase cardiac output. To do this, the system relies on a conventional right-sided endocardial pacing system plus the left ventricular lead, which is epicardial, placed in a coronary vein at the extreme left lateral or left posterior aspect of the coronary venous system. The electrodes of this lead lie against the left ventricular wall. We can pace selectively using one or more of them to gain greatest contractile benefit for the patient.

Typical system pacing function:

• the atrial lead monitors (“sees” or “senses”) patient rhythms to ensure that therapy is delivered as needed, on time;

• each atrial event starts a flexible AV timer; • when the AV timer elapses ventricular pulses are

triggered;

• the ventricular pulses elicit mechanical ventricular contractions, enhancing cardiac output.

Successful CRT is provided when biventricular pacing is as close to 100% as possible.

CRT patients often differ from pacemaker patients in two regards:

1. They have normal sinus nodes, no chronotropic incompetence, and do not require atrial

pacing.

2. They have normal A-V conduction.

Sensing is therefore the most important function to monitor on the atrial lead.

The CRT System and Hemodynamic Benefit

The CRT System--an epicardial left ventricular lead and conventional RA and RV leads with a pacemaker or ICD pulse generator (PG).

1. Pace as close to 100% of the time as possible in both ventricles.

2. Ensure optimal AV filling. 3. Track the patient’s atrium

whenever there is sinus rhythm present.

Tasks Associated with CRT-P/CRT-D Follow-Up

KEY CONCEPT

See the detailed step-by-step follow-up protocol at the end of this module.

KEY CONCEPT

NOTES

• achieve as close as possible to 100% CRT pacing

• identify an upcoming heart failure exacerbation and take measures to avert it

• (for CRT-D) ensure prompt detection and treatment of true ventricular tachyarrhythmias.

1. Review patient indication/history, check patient status.

2. Interrogate and/or printout SUMMARY. Interpret:

• Rhythm strip and device status

• Heart Failure Management Diagnostics and HeartLogic Report

3. Review data and confirm normal operation/exceptions.

4. If exception, test to confirm and document system function (e.g.,

SmartCRT).

5. Reprogram, as needed, verifying programmed parameters.

6. Confirm/document final pacing and tachyarrhythmia settings/ECG.

Follow-up of current devices needs to include all of the above. With recent progress in the ability of devices to perform automatized patient testing daily, the initial SUMMARY contains much of the information that the follow-up clinician would earlier have had to generate through testing. For example, a LATITUDE NXT SUMMARY contains: • a rhythm strip showing device operation and an

example of what Bi-V pacing looks like • time to battery change/explant

• lead impedances

• intrinsic sensing amplitudes • pacing thresholds

• arrhythmia monitoring/counters/observations This data is up-to-date and may be used to

determine that the system is functioning normally. It also points up exceptions--where we are

uncertain if that operation is normal. Only then do we need to test manually.

This frees us up to assess patient ability to perform activities of daily living, evaluate device reports on key measures of heart failure status, and discern if the patient is facing an imminent heart failure exacerbation.

For thorough follow-up, explore: • Patient indication

• Patient system and symptoms • What programming changes

would make a difference? A detailed step-by-step how-to guide is available at the end of this module.

KEY CONCEPT

present, and future of the patient to determine the nature of what you can do for them.

• Patient indication

• Implanted system: Which PG and lead are implanted? Number of LV pacing vectors available?

• Implanter practice/preferences: How does this implanter program?

• Co-morbidities: Atrial fibrillation (RVR)? Frequent ventricular ectopy?

• Medication compliance

• NYHA Class: Compare symptoms--this time vs. last time

• Diagnostic information: HeartLogic and Heart Failure Management Rep • Exercise tolerance

• Left ventricular lead: Stable?

• Non-magnet strip: 100% biventricular pacing?

• Pacing mode and settings

Consider the role that SmartCRT might play in helping optimize the patient’s therapy:

• Vector selection

• Pacing to site of latest activation

• SmartDelay

NOTES

Patient’s Disease/Therapy History

KEY CONCEPT

NOTES

biventricular pacing and patient hemodynamic benefit requires vigilant attention to many of the factors normally involved in pacing system follow-up plus:

• The pacing percentage on the device counters and histograms. Is the device achieving close to 100% atrial synchronous biventricular pacing? • Are the pacing pulses eliciting captured

beats? The device does not “know”--even if PaceSafe is ON. (PaceSafe measures thresholds automatically in RA, RV, and LV.)

• Pacing thresholds must be tested to ensure safety margins.

• Impedances give evidence of electrical integrity. They are measured with each pacing stimulus. • Sensing is essential. The device must be able

to see and respond to the patient’s cardiac rhythms: p-waves; r-waves; and fibrillatory waves.

• Device settings: Any new setting must be explicitly approved by the doctor.

• HeartLogic and Heart Failure Management Report diagnostics are also important.5

• AV delays are provided by Boston Scientific’s SmartDelay™.6

• LV pacing vector management is provided by Boston Scientific’s VectorGuide™.7

CRT achieves effectiveness by: • pacing to resynchronize the

ventricles as close to 100% of the time as possible, improving cardiac output.

• forcing ventricular pacing but allowing time during the A-V interval for as much diastolic filling as possible.

We are interested primarily in “tracking” sinus atrial rates into the ventricle.

Facilitating Hemodyamic Benefit at Follow-Up

On the left, the effect of resynchronizing the ventricles and on the right, a reminder of the important role of atrio-ventricular filling.

KEY CONCEPT

NOTES

involves connecting the patient to the five-lead ECG and printing out a presenting ECG, documenting how the presently programmed values are contributing to expected CRT pacing function. Examples of presenting strips appear above.*

Let’s review the presenting strips.

Notice the decided positivity of the QRS

morphology in Lead I and the negativity in Lead III (at right). What is the QRS duration? About 160 ms.

We want to know if the programmed settings and implanted system are eliciting captured beats, as CRT calls for, in the Left and Right Ventricles. Is it capturing both ventricles? The best patient response comes from biventricular capture.

*A LATITUDE NXT combined follow-up report also contains a presenting rhythm report at the end of the report.

To be effective, RV and LV pacing pulses need to elicit captured beats or cause each ventricle to contract at timed intervals. What indicates biventricular pacing and capture here? What would you say?

Markers? ______________ Morphologies? __________

The markers spell out RVP and LVP so pacing is occurring. The pacing spikes are followed by QRS morphologies that are consistent and uniform.

Using the information here we know “what pacing looks like.” There are no “stray” or

uncontrolled events occurring. What we mean becomes more evident as we review threshold testing, below.

CRT: Presenting Rhythm--Effect at Present Programmed Settings

A typical presenting rhythm strip for a patient programmed DDD. A careful review shows whether the present settings are providing the expected benefit of CRT.

KEY CONCEPT

NOTES

sense markers throughout the strip: AS, RVS, LVS. What are the characteristic morphologies?

The QRS morphology Lead I is characteristic of Left Bundle Branch Block, the notch following the R-wave showing a characteristic conduction with mechanical delay in the ventricles.

The QRS duration in Lead I and Lead III is about 180 ms. Recall that the QRS duration specified for the CRT indication is presently > 150 ms. and more.

On the Shock EGM, the QRS morphology looks different but the QRS duration is very similar to what we see from the surface electrodes and is also about 180 ms. It measures signal from the PG to the RV coil.

The PR interval appears to be about 160-170 ms. giving us an idea of how long the AV delay could be.

In presenting and underlying strips atrial events are exclusively sensed at a rate of roughly 62 bpm. This is typical of most CRT: we track the patient’s sinus rhythm into the ventricle.

The comparison of the paced and sensed (underlying) Lead I and Lead III inscriptions will help us determine when we are successfully delivering therapy and when we are not.

What are key differences between paced biventricular QRSs and sensed QRSs?

________________________

Sensed QRSs are accompanied by sense markers.

Paced QRSs are somewhat

narrower than sensed/underlying QRSs. (Biventricular pacing is intended to bridge/shorten interventricular conduction somewhat.) Sensed/underlying QRSs typically show Left Bundle Branch morphology, very visible here on the left (Lead I).

The Shock EGM also portrays the difference in QRS width between paced and sensed.

CRT: Underlying Rhythm--Native Interventricular Conduction

A underlying rhythm strip. Reference the underlying QRS morphologies and widths; these help us see when we have lost capture.

KEY CONCEPT

NOTES

Our underlying rhythm check in the preceding pages paid off as the RV threshold was evaluated. On what beat do we have Loss of Capture (LOC)?__________ How can we distinguish LOC on this strip?______________ What is the pacing threshold? ________________________

LOC occurs on beat 9. The indicator of LOC is the presence of the intrinsic QRS with pronounced LBBB showing through at beat 9.

The QRS showing up here is labeled LVS--a sensed event. This is true for the other non-captured beats also.

The pacing threshold on the RV lead is 1 Volt @ 0.4 ms. This is the lowest voltage at which we have consistent capture.

KEY CONCEPT

pacing; note the markers--AS RVP/LVP and the morphology

On the third beat we begin pacing DDD at 90 ppm with AV delay of 60 ms for the RV threshold test. Notice the characteristic RV pace morphology in Lead I in beats 3-8 and the change at beat 9. What happens with beat 9? Which familiar

morphology is visible from our underlying rhythm tests? It is the underlying LBBB morphology. It is also visible in beat 12. Note that in each of these events, the markers show LV sensing--a sign that the energy of our pace stimuli did not capture and that the ventricle “escaped”--an intrinsic beat occurred.

Also note the distance between the pacing spike and the QRS in each of the captured beats (biventricular and RV only). The pacing spike is followed immediately by the QRS in the Lead I capture beats. However, the pacing spike occurs well before the QRS in the events in which capture is lost.

The RV pacing threshold is 1 V @ 0.4 ms.

RV threshold testing, Lead I. When do we lose RV capture?

CRT: RV Threshold Testing

KEY CONCEPT

NOTES

conducted in DDD 90 ppm, AV delay of 60 ms. The first beat on the upper left shows the familiar morphology of biventricular pacing that was seen in earlier strips.

As soon as the LV only pacing begins, a brief lag between the pacing spike and the LV capture event becomes evident. It appears that the time distance to LV capture is about 40-60 ms. This is an

indicator of the difference in LV pace stimulation. Here the pace is delivered through an electrode lying alongside the patient’s cardiac tissue (vs. in the tissue as with the RV active fixation electrode) and takes slightly longer to propagate a heartbeat (latency). Consider also the degree to which the patient’s cardiac tissue may be scarred at the site where the LV electrode is placed.

Is the LV capturing? Yes in the left and middle panels. Each LVP is followed by a QRS and the morphologies of the events are consistent. In the right panel, a morphology change occurs with the shift to 0.5 V. The LBB Lead I morphology shows up, as does an LVS marker, indicating

sensing.

To determine if we are delivering biventricular therapy we check: • underlying LV and RV QRS morphology • presenting biventricular morphology • paced LV and RV QRS morphologies.

Strips in patient file helps! What is the LV pacing

threshold?________________

LV pacing threshold is 0.6 V @ 0.4 ms.

KEY CONCEPT

NOTES

Verify that capture is occurring consistently for optimal ventricular pacing therapy. The SafePace™ auto threshold feature may be used to monitor thresholds on all leads automatically in Resonate and Valitude.

SmartCRT helps ensure that we LV pace at:

• the latest site of LV activation, • at a site that offers a good

threshold

• at a site that offers least likelihood of phrenic nerve stimulation.

It is up to the AHP to determine the pacing outputs that meet safety standards.

KEY CONCEPT

prepared to provide the patient with the outputs needed for continuous biventricular pacing therapy. Typically, the RV output threshold is the basis for setting a back-up pacing safety margin in a CRT pacing system. Once again, this will be a two times voltage safety margin or, with a pulse width threshold of 0.3 ms or less, a three times pulse width safety margin.

The LV lead output is not programmed with a traditional pacing safety margin. Local physician practice is the guideline. Often physicians choose to set outputs to threshold setting + 1 Volt. This has to do with the fact that LV thresholds are often higher than RV thresholds. As such, the LV is not chosen as the chamber for back-up pacing. For example, it is acceptable to have an LV threshold of 3 Volts at implant. If a patient with this threshold were programmed with a conventional safety margin, the chronic setting would rapidly drain an implantable device battery.

With multiple LV pacing electrodes to choose from, SmartCRT can help make an informed choice of the best LV electrode for pacing, taking into account RV-LV timing, absence of phrenic nerve stimulation, and best threshold. See smartcrttraining.com

Steps for Providing Continuous Biventricular Capture: LV Outputs

An LV output safety margin is a matter of physician preference. Many physicians use the voltage threshold + 1 V.

Considerations for Optimizing Cardiac Output and Biventricular

Pacing: AV and VV Timing Implications

Evaluating AV and VV timing components is important for biventricular pacing with optimal outcomes.

Smart CRT includes SmartDelay, a feature that helps tailor the AV delay and VV delay to ensure: • Adequate AV filling time with

appropriate AV delays

• Biventricular pacing just before intrinsic ventricular contraction • LV pace just before RV pace to

ensure mechanical ventricular resynchronization.

KEY CONCEPT

has a PR interval of about 120-130 ms at rest. We also determined that there is a slight lag between an LV pace and an LV contraction. Also, it is well known that the results of biventricular pacing are best when:

1. there is time for adequate atrio-ventricular filling to occur

2. the biventricular paces occur just before the intrinsic ventricular contraction occurs

3. the time to mechanical contraction of RV and LV is resynchronized; identifying the LV vector with greatest RV-LV distance is the best way to accomplish this.

SmartCRT, a Boston Scientific feature, takes each of these into account. See the separate site smartcrttraining.com to learn more.

NOTES

At left a strip to use in measuring AV delay. At right, the outcome of SmartDelay testing for capturing the ventricles for optimal cardiac output. Test results unrelated to this patient.

Brady/CRT parameters here are intended for CRT patients.

Typically the Lower Rate gets set slower than the patient’s sinus rate to avoid unnecessary atrial pacing. Typically the MTR gets set to the same rate as the patient’s sinus exercise rate.

Here the patient’s AV delay is programmed rate adaptively (e.g., PAV 140-230 ms). 230 ms is used at the slower rates and 140 ms at MTR.

KEY CONCEPT

NOTES

Device Settings: Brady/CRT Programming

The next key activity in evaluating a CRT patient is to check settings of the implanted system. The settings show expected device operation. Reviewing them at follow-up ensures optimal device behavior.

Reference the Brady/CRT parameters first: • Lower Rate (LR) 60 ppm.

• Maximum Tracking Rate (MTR) 140 ppm. The preference is to be able to track the patient’s maximum sinus rate.

• The Total Atrial Refractory Period (Paced AV delay + PVARP) is set to allow the patient to see and track 1:1 up to the patient’s maximum sinus rate.

• The LV offset is set to pace the LV before the RV (here 70 ms) to help coordinate the mechanical response of the RV and LV. Pacing outputs programmed based on pacing thresholds and safety margins.

Sensitivity

ICD: set for arrhythmia sensing. The AGC (Automatic Gain Control) feature is designed to help avoid T-wave or Far-Field R-wave oversensing. Pacemakers: the rule is to set sensitivity at about 50% of R-wave (ventricle) or P-wave (atrium).

KEY CONCEPT

Many arrhythmias detected in the VT and VF zones are ventricular tachycardias.

The VF Zone is the arrhythmia zone for _______ (benign/

malignant) arrhythmias which are 200 bpm and higher.

The VT Zone is used for _______ (slower/faster) arrhythmias.

Therapies for the VF zone include ______ and _______.

The VF Zone is the arrhythmia zone for malignant arrhythmias. 200 bpm and higher.

The VT Zone is used for slower arrhythmias.

Therapies for the VF zone include QuickConvert™ and Shocks.

KEY CONCEPT

ANSWERS

Device Settings: Tachy Detection and Therapy Programmings

Reference arrhythmia detection and therapy settings:

Atrial Tachy

• ATR (Atrial Tachy Response) detects atrial rates > 170 bpm and then switches to a non-tracking mode (DDIR). The algorithm monitors for the patient’s return to sinus rhythm. When this occurs it mode switches back to DDD(R). Ventricular Tachy

• VT zone detects arrhythmia at 180-199 bpm and offers one anti-tachycardia pacing (ATP) therapy and six 41 Joule shocks.

• VF zone detects arrhythmia at > 200 bpm and offers QuickConvert™ (ATP) first (rates ≤ 250 bpm), then six shocks.

• ATP (Anti-Tachycardia Pacing) is a series of pacing pulses delivered at maximum output (7.5 Volts @ 1.5 ms.). The primary advantage of this therapy is that the patient remains unaware of it and that it has been shown to terminate monomorphic ventricular arrhythmias in repeated clinical trials.

How would you assess this patient’s biventricular pacing %?

__________________________ How would you assess their atrial arrhythmia %?

__________________________ What about ventricular

arrhythmias?

__________________________

The patient’s biventricular pacing percentage is nearly 99% and very close to the goal of 100%. They have had atrial arrhythmia < 1% of the time. There have been few incidents of rapid ventricular response to AF to interfere with biventricular pacing. They have had only 1

non-sustained ventricular arrhythmia and very few PVCs to interfere with pacing.

KEY CONCEPT

ANSWERS

Assess Counters/Trends: Biventricular Pacing and VT

Our presenting rhythm shows biventricular

capture. The next most important result we have to look at is the biventricular pacing percentage. This information is available under Brady/CRT Counters in the combined follow-up report. It is reported as % RV Paced, which we can compare to % LV Paced--here 99% and 98%, respectively. Recent clinical research shows that the % of

biventricular pacing should be as close to 100% as possible to provide the patient the beneficial results we hope for. We are doing well with this patient.

Particularly if the pacing percentages were 90% or below, we would need to identify ways to increase biventricular pacing.

With regard to atrial arrhythmia, it appears that there has been almost none. Atrial arrhythmias often interfere with CRT and drop the percentage of successful pacing. When one sees so little atrial arrhythmia one wonders if the detected atrial arrhythmia could be “noise oversensing.” We can seek to verify that elsewhere with this patient. With regard to ventricular tachycardia, it

appears there has been one non-sustained episode with no treatment.

Assess Histograms

What does the Atrial Activity histogram show concerning the patient?

______________________ What does the Ventricular Activity histogram show? ________________________

Atrial Activity shows atrial sensing exclusively in this patient;

elsewhere, we read of 15% atrial pacing.

The Ventricular histogram shows some sensing (solid areas at bottom of histogram bars) but predominantly ventricular pacing on both the LV and RV leads.

KEY CONCEPT

ANSWERS

KEY CONCEPT

for assessing performance.

• Atrial activity offers a full picture of the rates of the patient’s sinus node--entirely sensed as we see here.

• Ventricular activity offers a picture of biventricular pacing, indicating the same

performance as reflected in the numbers above. The rate distribution is clearly driven by a good sinus node and the patient is receiving atrial synchronous biventricular support throughout the programmed rate range (60-140 bpm).

The events summary offers a thumbnail of important events since the last time we looked at the patient. It prompts us to assess whether there is anything we need to address as we complete follow-up with the patient. If it is a remote follow-up it may also prompt us to invite the patient into the office for a more detailed check.

When atrial and ventricular events overlap, they may be related. For example, it could be that during an Atrial Tachy Response episode there is a non-sustained or sustained VT. In this instance the ATR episode and associated rapid ventricular response may actually be causing the rapid rate detected by the device in the VT zone. Here, however, the ATR and VT occurred at different times and were separate.

KEY CONCEPT

NOTES

Assess Recorded Events

Here at the end of the combined follow-up report is a summary of the events that the device has seen. The predominating event is pacemaker mediated tachycardia (PMT) occurring at a rate just above the Maximum Tracking Rate of 140. AV synchrony may be lost for many reasons, including atrial fibrillation, PVCs, PACs, atrial oversensing, or loss of atrial capture. If the patient has an intact retrograde conduction pathway when AV synchrony is lost, the unsynchronized beat may conduct retrograde to the atrium, resulting in premature atrial depolarization. In DDD(R) and VDD(R) pacing modes, the device may detect and track retrograde conducted P-waves that fall outside of PVARP. The repeated cycle of sensing and tracking retrograde conduction is known as PMT, which can result in triggered ventricular pacing rates as high as the MTR.

The untreated VT is also documented. It is just on the border of VT and VF zones (rate: 199 bpm) but was not sustained long enough to receive therapy. We also receive a bit more information about the Atrial Tachy Response episode. It was less than a minute long. The average ventricular rate during the episode was 127 bpm.

Assess Battery/Charge Time

Battery management is a critical function of device follow-up. The battery status indicator (somewhat like a gas gauge) makes this very easy.

You may also consider manually charging the capacitors at in-person follow-up.

KEY CONCEPT

NOTES

follow-up is monitoring battery performance and the potential need for changing out/replacement/ upgrade of a device. A second critical dimension, particularly for ICDs, is managing charge-time performance. This is the length of time it takes the device to charge the capacitors for a full energy shock of 41 Joules.

The gas gauge on the report helps visualize device longevity: eight years in this case. Also, the

most recent charge time, dated about six months prior to the recent interrogation, is good at 10.3 seconds.

Begin paying close attention to battery issues when the device says: approximate time to explant one year. At that time, assess how frequently the patient is using the device:

• Is the patient pacemaker dependent? • Frequency of tachyarrhythmia episodes

associated with therapies?

Patients who are dependent and who are receiving frequent therapies will need more intense scrutiny per local Elective Replacement practice guidelines.

If measured values deviate by more than 30% from time to time it is helpful to test sensing and pacing thresholds.

Serial impedance testing may be done to verify out-of range measurements--also on the shocking circuit (painlessly, without shock testing).

Identify your clinic’s protocol for handling out-of-range lead measurements, both on the pacing and shock circuits.

For LV leads, identify the protocol for handling phrenic nerve

stimulation, should it come up.

KEY CONCEPT

NOTES

Assess Lead System/P- and R-waves and Impedance

Lead Integrity

Critical for pacing and ICD systems because the device uses the lead/shock coil to

• sense the patient’s cardiac activity • deliver pacing stimuli

• deliver tachyarrhythmia therapy

Above find the measures the device records to help assess lead integrity:

• intrinsic amplitude for each sensing bipole

• impedance for each circuit (pace/sense or shock) • threshold values (for all but shock).

Time stamps indicate when measures were recorded. Expected Values

• Intrinsic amplitudes, measured in millivolts, are uniform and relatively consistent.

• Pace impedance measures on the RA, RV, and LV leads, should be between 200 and 2000 ohms. • Pace thresholds on RA, RV, and LV leads should

also differ from each other by no more than 30%. • Shock impedance measures on the shocking

circuit, should be between 20-125 ohms and relatively consistent.

Deviations of up to 30% in the measured values are considered acceptable.

Lead trend information offers up to 12 months of measured data for you to use in comparing today’s measurements

to the larger picture. The opportunity to compare different measures (R-wave, impedance) from the same lead may help you determine the status of the lead overall.

In lead placements where the lead continues to move, such as, for example, septal placements, the vector may change slightly, offering variable measurements from time to time.

KEY CONCEPT

NOTES

Assess Lead Trends

If you are seeing deviations in lead measurements, the trend information contained in the CRT devices offers an opportunity to compare individual

measurements to a larger picture.

The trend information offers up to 12 months of data and displays one data point for each 24 hour period. Daily values, portrayed as “dots” may be compared to three-day running averages, portrayed as darker lines.

In Resonate and Valitude, PaceSafe displays pacing threshold trending information also on RA, RV, and LV leads.

NOTE:

There is other trend information contained in combined follow-up reports from Boston Scientific CRT devices. This information is addressed in other training materials, such as heartlogictraining.com on the EDUCARE site. Please visit us there.

Some patients are non-responders to CRT. How can we improve their likelihood of responding at follow-up?

• Maximize biventricular pacing • Optimize LV pacing vector • Change AV delays

• Change LV offset

• Eliminate phrenic nerve stim

An important part of improving patient response is knowing the PG and leads that the patient has implanted. For example, an Acuity X4 LV lead offers 17 different pacing vectors for optimizing resynchronization. Even earlier bipolar LV leads have up to 6 possible pacing vectors. Recent PGs also have features for helping optimize AV delay

KEY CONCEPT

NOTES

Improving Patient Response to CRT Therapy

About one-third of the patients receiving CRT therapy do not respond to/benefit in expected ways. They continue to experience symptoms associated with their heart failure.

What tools do we have at our disposal that we could use to help them improve?

The following is a limited list:

• Maximize biventricular pacing percentage • Optimize the biventricular pacing vector

• On a bipolar LV lead • On a quadripolar LV lead

• Change AV delays to maximize ventricular filling • Change LV Offset to resynchronize

• Eliminate phrenic nerve stimulation

Before you begin to put this plan into practice, be sure to determine what CRT system the patient has in place, including:

• PG model

• LV lead model and associated pacing vectors • Automatic features available to help, such as

• VectorGuide • SmartDelay • SmartCRT

To determine features, check PG/lead model number. www.bostonscientific.com.IFU

A sample of the information that may be contained in the patient’s device. It is particularly helpful to know whether the LV lead is bipolar or quadripolar.

KEY CONCEPT

NOTES

KEY CONCEPT

KEY CONCEPT

available in the Resonate™ family of CRT-D, has means for automatically optimizing CRT patients. At smartcrttraining.com you will find a workbook and hands-on programming guide that will guide you through the process of doing each of these. Enjoy it. You can receive credit for taking that training, too. Next, go to the Study Guide to try your hand at reading and interpreting a combined follow-up report.

Improving Patient Response to CRT Therapy: SmartCRT™

The VectorGuide™ helps select the best electrode to use in pacing the LV.

SmartDelay™ helps select the best SAV and PAV for diastolic filling and optimal cardiac output. With Acuity™ X4 leads, Valitude and Resonate have 17 vectors.

The VectorGuide™ helps in three ways:

• Finding the pacing vector with the best RV-LV timing for the patient

• Calculating the best Sensed and Paced AV delays for optimizing ventricular filling • Helping optimize

multisite timing to use for resynchronizing the patient’s ventricles

Ensuring Patient Safety in an ICD Patient Before Ending Session:

Monitor + Therapy

KEY CONCEPT

KEY CONCEPT

NOTES

do two things before you end session:

1. clear the counters. Clearing the counters refreshes system memory for storage of information concerning device-patient interaction, making it possible to get a more complete accounting of patient-device interaction for the next several months.

2. re-initiate arrhythmia monitoring and therapy before you leave the patient. It is quite

possible to unintentionally leave detection or therapy OFF during an in-person follow-up. This can have lethal consequences.

The Boston Scientific Model 3300 programmer is well designed to combat user programming errors. It prompts you to take both of the steps above. Be sure and follow its advice.

The screen above indicates just which box you check in order to take the proper steps.

When you are following ICD patients, make sure that you turn ON Monitor + Therapy when ending session.

The Boston Scientific Model 3300 programmer is oriented to ensuring patient safety by prompting you to execute important final steps when you end session with an ICD patient. These include:

• ensuring that Monitor + Therapy is ON

• ensuring that you clear the counters.

CRT Follow-up Process Checklist (In-Person) Page 1 __ 1. Apply surface electrodes.

__ 2. Place the interrogation wand over the implanted device. __ 3. Press the “Quick Start” icon on the programmer.

Remove the wand when indicated if an RF device is implanted.

__ 4. Print a presenting strip by pressing the “25” button on the top of the programmer

__ 5. Locate the “Temporary Brady” screen

__ 6. Select pacing mode: VVI, rate: 40 ppm or the rate that will result in sensed events

__ 7. Press the “25” button on the top of the programmer to run paper __ 8. Press “Start” to initiate Temporary Parameters. Stop after

documenting underlying rhythm

__ 9. Evaluate the System summary screen. Check battery status.

__ 10. Review the Patient Information screen (lead model numbers, notes). Review the patient’s implant indication

__ 11. Print the programmed parameters, histograms and counters, and HF diagnostic data

12. Review the brady and tachy parameters:

__ LRL, AV Delay, MTR, features (i.e., BiV Trigger, VRR, etc.) __ Post-therapy brady settings

__ Tachy zones and their rates

__ Rhythm discriminators (initial and post-shock) __ Program therapy in each detection zone

__ Programmed LV pacing vector, shock polarity and shock vector (Continued)

CRT Follow-up Process Checklist (In-Person) Page 2 13. Events

a. Arrhythmia Logbook (evaluate new EGMs recorded since previous follow-up) __ i. Appropriate tachy therapy

__ ii. Drop out

__ iii. VF amplitude measurements __ iv. Conversion with first therapy

b. Evaluate Counters

__ i. Atrial and ventricular pacing percentages __ ii. Atrial Burden

__ iii. Ventricular Tachy Counters (treated and non-sustained events) __ c. Evaluate histograms for heart rate distribution

__ d. Evaluate heart failure diagnostic trends (HeartLogic, Heart Failure Management Diagnostics,HRV footprint, SDANN, Mean HR, Activity)

__ 14. Perform basic lead testing __ a. Intrinsic amplitudes __ b. Lead impedances __ c. Shock impedance

__ d. Threshold testing in three chambers (consider 2:1 safety margin for RA and RV; LV safety margin per physician order).

__ 15. Assess above numbers for abnormal measurements

__ 16. Observe for diaphragmatic stimulation while performing LV threshold testing

__ 17. Select the LV pacing vector with the lowest threshold and no diaphragmatic stimulation __ 18. If utilizing Quadripolar lead, use Smart CRT to determine optimal pacing vector.

Confirm findings with physician.

__ 19. Make any programming changes as appropriate and with physician’s order. For example: a. Decrease outputs to chronic settings

b. Enable rate response based on histogram/counter data __ 20. Review Trends

__ 21. Evaluate any troubleshooting issue __ 22. Print results or save data

__ 23. Clear counters and histograms after ensuring that they have been printed __ 24. Ensure that tachy mode is programmed to “Monitor + Therapy”

CRT Follow-up Process Checklist (In-Person) Page 3 __ 26. Document your finding on clinic flowsheet.

__ 27. Give print out or saved data to appropriate clinic personnel.

__ 28. Alert the physician of ANY issues that may compromise patient safety. __ 29. Report any product experience issues as appropriate.

Endnotes

1. David Hayes, et al.”Cardiac Resynchronization Therapy and the Relationship of Percent Biventricular Therapy to Symptoms and Survival,” Heart Rhythm (2011), 8, No. 9, 1469-1475.

2. Woods, B, N Hawkins et al. Individual patient data network meta-analysis of mortality ef-fects of implantable cardiac devices. Heart. 2015 Nov;101(22):1800-6

3. Himmrich E, Liebrich A, Michel U, et al. [Is ICD-programming for double intraoperative defibrillation threshold energy safe and effective during long-time follow-up? Results of a prospective randomized multicenter study (Low-Energy Endotak Trial--LEET)]. Z Kardiol. February 1999;88(2):103- 112. (Article in German).

4. Jean-Claude Daubert et al. 2012 EHRA/HRS expert consensus statement on cardiac resynchronization therapy in heart failure: implant and follow-up recommendations and management, http://resources.hrsonline.org/provider.html

5. HeartLogicTraining.com 6. SmartCRTTraining.com 7. ImageReadyTraining.com

Health economic and reimbursement information provided by Boston Scientific Corpora-tion is gathered from third-party sources and is subject to change without notice as a result of complex and frequently changing laws, regulations, rules and policies. This information is presented for illustrative purposes only and does not constitute reimbursement or legal advice. Boston Scientific encourages providers to submit accurate and appropriate claims for services. It is always the provider’s responsibility to determine medical necessity, the proper site for delivery of any services and to submit appropriate codes, charges, and modifiers for services that are rendered. Boston Scientific recommends that you consult with your pay-ers, reimbursement specialists and/or legal counsel regarding coding, coverage and reim-bursement matters. Boston Scientific does not promote the use of its products outside their FDA-approved label. It is always the provider’s responsibility to understand and comply with national coverage determinations (NCD), local coverage decisions (LCD) and any other cov-erage requirements established by relevant payers which can be updated frequently.

Payer policies will vary and should be verified prior to treatment for limitations on diagnosis, coding or site of service requirements. The coding options listed within this guide are com-monly used codes and are not intended to be an all-inclusive list. We recommend consulting your relevant manuals for appropriate coding options.

CPT Copyright 2017 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Restrictions Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related com-ponents are not assigned by the AMA, are not part of CPT, and the AMA is not recommend-ing their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

CRT-D Systems –AUTOGEN™, AUTOGEN™X4, DYNAGEN™, DYNAGEN™X4,

INOGEN™, INOGEN™ X4, ORIGEN™, ORIGEN™X4, INCEPTA™, ENERGEN™,

PUNCTUA™. COGNIS™ 100-D CRT-D

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; or 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 implanting 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. DYNAGEN, INOGEN, and ORIGEN devices with an IS-1/DF4/IS4 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. Significant harm to or death of the patient and/ or damage to the implanted system may result. All other devices covered by this statement are not MR conditional. Do not expose a patient with non-MR Conditional devices to MRI scanning. For potential adverse events applicable when the Conditions of Use are met or not met, refer to the ImageReady MR Conditional Defibrillation System 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 D) 046774_AF

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 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)

Left Ventricular Pace/Sense Leads– ACUITY X4™

Indications

This Boston Scientific lead is indicated for use as follows: Intended for chronic, left-ventricular pacing and sensing via the coronary venous system when used in conjunction with a compatible pulse generator. The Boston Scientific ACUITY X4 lead is a steroid-eluting (dexamethasone acetate) IS4 quadripolar lead.

Contraindications

Use of this Boston Scientific lead is contraindicated for the following patients: Patients with a hypersensitivity to a maximum single dose of 0.54 mg dexamethasone acetate.

Warnings

Read the manual thoroughly before implantation to avoid damage to the pulse generator and/or lead. Such damage can result in patient injury or death. 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. When using a right ventricular (RV) pace/sense lead in conjunction with this left coronary venous pace/sense lead, it is recommended that a polyurethane- insulated lead be used. Lead fracture, dislodgment, abrasion, or an incomplete connection can cause a periodic or continual loss of pacing or sensing or both. Although pliable, the lead is not designed to tolerate excessive flexing, bending or tension. Do not kink, twist, or braid the lead with other leads as doing so could cause lead insulation abrasion damage or conductor damage. 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 lead terminal, other than the terminal pin, even when the lead cap is in place. When implanting a system which uses both a DF4-LLHH/LLHO and IS4-LLLL lead, ensure that the leads are inserted and secured in the appropriate ports. Implant of the system cannot be performed in an MRI site zone III (and higher). Only use the Connector Tool for electrical connections to pacing system analyzers or similar monitors. Take care to obtain appropriate electrode position.. When connecting the lead to the pulse generator, it is very important that proper connetions are made. 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 since diathermy may cause fibrillation, burning of the myocardium, and irreversible damage to the pulse generator because of induced currents.

Precautions

Refer to the lead product labeling for cautions specific to clinical considerations, sterilization and storage, handling, implantation, hospital and medical environments, and follow-up testing. Failure to observe these cautions could result in incorrect lead implantation, lead damage and/or harm to the patient.

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 (pacing/sensing), infection, procedure-related, and component failure. 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.

LATITUDE™ Patient Management System

Intended Use

The LATITUDE™ 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 System provides patient data than can be used as part of the clinical evaluation of the patient.

Contraindications

The LATITUDE System is contraindicated for use with any pulse generator other than a compatible pulse generator from Boston Scientific CRM. Not all Boston Scientific pulse generators are compatible with the LATITUDE System. For contraindications for use related to the pulse generator, refer to the System Guide for the pulse generator being interrogated.

Precautions

The LATITUDE System is designed to notify clinicians within 24 hours if new red alert conditions are detected by the Communicator. Alert notifications are based on clinician configured alert settings. Pulse generator data is typically available for review on the LATITUDE System within 15 minutes of a successful interrogation. However, data

availability and alert notification can take up to 24 hours or the next business day. Note that pulse generator data will not be available and alert notification cannot occur if:

• The Communicator is unplugged or is not able to connect to the LATITUDE System through an active phone line. • The pulse generator and the Communicator cannot complete a telemetry session. This session must be initiated by the patient if he or she has a pulse generator that uses inductive telemetry.

• The Communicator is damaged or malfunctions.

• The patient is not compliant with prescribed use or is not using the LATITUDE System as described in the patient manual.

Up to two weeks may elapse before LATITUDE System first detects the conditions mentioned above. Additional time may be required for clinic notification and resolution of the condition. During this time, no new patient data, device data, or alert notifications since the last successful data transmission are available.

Adverse Effects

None known.