1. RightRate™ Minute Ventilation Programming
Welcome to the RightRate Minute Ventilation Programming Course.
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2. Overview of Chronotropic Incompetence
RightRate™ Respiration-based Sensor
Heart Rate Score / Rate Adaptive Pacing
How to Program the RightRate™ Sensor
After completing this module, you should be able to understand:
The clinical significance of Chronotropic Incompetence
How the RightRate™ Respiration-Based Sensor works
How to Determine the Patient’s Heart Rate Score
How to Program the RightRate™ Sensor
Completing the entire course will result in 1 CEU credit.
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3. RightRate™: Background
RightRate is the only sensor clinically proven to restore CI3, and the VISIONIST X4 battery technology is labeled for up to 13.1 years projected longevity, even with RightRate turned on*.
*Assumes: 2.0V RA/RV/LV, RA 500Ω, RV/LV 700Ω, No LATITUDE, 0.4ms pulse width, 100% BiV pacing, 15% atrial pacing, 70 ppm LRL
Heart Failure patients need to perform activity, but many people may not feel strong enough to participate.
Chronotropic Incompetence (CI) impacts approximately 70% of the CRT population.1,2
Restoring chronotropic competence may improve exercise capacity for Heart Failure patients.
Traditional motion-based accelerometer sensors are available in most cardiac devices, but the motion-based sensors may not work for every type of activity. The RightRate minute ventilation sensor adjusts the rate response based on the patient’s breathing, which is a more physiologic method.
VISIONIST™ X4 CRT-P features Boston Scientific’s RightRate™ MV Sensor, which is:
The only sensor clinically proven to restore chronotropic competence.3
Projected longevity of up to 13.1 years even when RightRate™ is turned on*.
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4. RightRate™: Chronotropic Incompetence (CI)
Typically, patients need to achieve a heart rate of approximately 100 beats per minute for a slow walk, 120 bpm for a brisk walk, and 135 bpm for walking up stairs.
Background
Chronotropic Incompetence (CI) is defined as the failure to achieve optimal heart rate during activity.
Prevalence
Approximately 70% of CRT patients have CI.¹ʼ²
Clinical Impact
Patients with CI have greater risk of mortality.⁴ʼ⁵Patients may not achieve an adequate heart rate for normal, everyday activities.
If CRT patients can’t get their heart rate to increase proportional to workload, it makes it difficult to exercise, in addition to everyday activities like walking to the mailbox, mowing the lawn, or playing with their grandkids. Rate response may provide a quality of life improvement by allowing patients to return to their every day activities.
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5. 4 Types of Chronotropic Incompetence
RightRate™: Chronotropic Incompetence Definition
CI is the inability of the heart to regulate its rate appropriately.
There are 4 types of CI:
Delay in achieving maximum heart rate
Failure to achieve maximum heart rate
Inadequate sub-maximal and recovering heart rate
Rate instability during exercise
Chronotropic Incompetence
The inability of the heart to regulate its rate appropriately in response to physiologic stress.8
Symptoms may include:
Delay in achieving maximum heart rate.
Failure to achieve maximum heart rate.
Inadequate sub-maximal and recovering heart rate.
Rate instability during exercise.
4 Types of Chronotropic Incompetence
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6. RightRate™: Chronotropic Incompetence Clinical Data
Approximately 70% of CRT patients have CI ¹ʼ²
CI is very common in the heart failure patient popultion, and even more common in the CRT population. Numerous studies have shown the prevalence of CI is rougly 45% for heart failure patients, and approximately 70% for CRT patients.
The causes of CI may include medication, not exercising, or compromised heart function.
Since CI impacts the ability of the heart to achieve proper heart rate, a majority of CRT patients may not be able to acheive a heart rate that is high enough to perform daily activities.
*Substantial variability likely influenced by the criteria employed to determine CI and differing patient characteristics (age, disease severity, type/dose of medications).
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7. RightRate™: Chronotropic Incompetence Clinical Data
Numerous benefits are associated with exercise, including reduced mortality and hospitalization, improved quality of live, and improved CRT response measures.
Benefits of Exercise with CRT
Reduced Mortality⁴
Reduced Hospitalization⁴
Improved Exercise Tolerance⁴ʼ¹³
Improved Quality of Life⁴ʼ¹³
Improved NYHA Class¹³
Improved Hemodynamic Measures¹³
It is difficult for patients to exercise if their heart rate does not get high enough.
ACC / AHA / ESC Guidelines recommend exercise training in HF patients as part of treatment, Class 1A.4,13
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8. RightRate™: Rate Adaptive Pacing Sensor Types
The RightRate minute ventilation sensor doesn’t require motion of the accelerometer, and therefore may provide a more physiologic rate response.
A motion-based sensor may not always detect when the patient is exercising or being active, potentially resulting in inadequate rate response for activities such as:
Riding a bicycle
Holding a grandchild
Carrying groceries
Working in the garden
Using a walker
Swimming
Lifting weights
There are typically 2 types of rate adaptive pacing sensors: accelerometer-based sensors and respiration-based sensors. Additionally, blended sensors combine both sensor types.
Accelerometer-Based Sensors
Most devices have a motion-based accelerometer sensor.
Rate response is proportional to motion.
Respiration-Based Sensors
Boston Scientific’s RightRate™ is a physiologic minute ventilation sensor.
Rate response is highly correlated with breathing.
RightRate™ Respiration-Based Sensor paces at a rate based on the physiological
Minute ventilation sensor and is not dependent on motion.
Ask your patients if their heart rate increases appropriately when they perform daily activities such as walking the dog, getting the mail, or light housework?
If not, then RightRate Respiration- based pacing may be right for them.
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9. RightRate™: Minute Ventilation Sensor Details
The device calculates the Minute Ventilation by multiplying the derived respiratory rate by the tidal volume.
To explain how MV works, let’s start with the fundamental equation V=IR.
First, the device delivers a fixed 320 micro amp pulse every 50ms from Ring to Can*.
Second, the device measures the sensed voltage from the tip to the can.
Finally, using the equation V=IR, the device calculates the trans-thoracic impedance. As the patient inhales and exhales, the impedance cycles up and down, and this can be used to derive the tidal volume and respiration period.
The minute ventilation, in volume of air per minute, is calculated by multiplying the respiration rate by the tidal volume.
* The current can also be programmed down to 80 micro amps
How the MV Sensor Works
Minute Ventilation = Respiration Rate x Tidal Volume
(volume of air/minute) (breaths/minute) (volume of air/breath)
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10. Sensor Indicate Rate = LRL + [Response Factor X ΔMV]
RightRate™: Sensor Baseline
The sensor indicated pacing rate is determined taking the lower rate limit and adding the Programmable Response Factor multiplied by the change in MV.
Long-term Baseline
Calibration automatically begins 2 hours after the lead is attached and then takes 6 hours.
Alternatively, a manual sensor calibration can be completed in 2−5 minutes.
The baseline is typically adjusted every 4 minutes.
Short-term Average
Average of the last 30 seconds.
Adjusted every 7.5 seconds.
Programmable Response Factor
If the short-term average is greater than the long-term baseline, the sensor-driven rate will increase to meet the metabolic needs of the patient.
How MV Response Factor is Determined
Sensor Indicate Rate = LRL + [Response Factor X ΔMV]
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11. Using Atrial Histogram to Determine Heart Rate Score
RightRate™: Heart Rate Score – Example 1
In this example, the patient’s HR Score is 73. Since most of the pacing and sensing is near the lower rate limit, this patient could potentially benefit from rate adaptive pacing.
In order to identify which patients may benefit from rate adaptive pacing, we will introduce a concept called Heart Rate Score. The Heart Rate Score is a simple metric to help identify if a patient is getting proper rate response by assessing the patient’s histograms. If a patient has most of their paced and sensed beats occurring near the lower rate limit, this patient likely isn’t getting proper rate response and may benefit from rate adaptive pacing.
Heart Rate Score
A simple metric to help identify if a patient is getting proper rate response.
Heart Rate Score is defined as the height of the tallest atrial histogram bin.
Patient Example 1
Patient’s Heart Rate is at bpm 73% of the time; therefore, the Heart Rate Score is 73.
Most of the pacing / sensing is at the lower rate limit; since the Heart Rate Score is high, this patient could potentially benefit from rate adaptive pacing.
A broader range of heart rate is typically better for the patient; therefore, a lower heart rate score is preferred.
Using Atrial Histogram to Determine Heart Rate Score
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12. Using Atrial Histogram to Determine Heart Rate Score
RightRate™: Heart Rate Score – Example 2
In this example, the patient’s HR Score is 38. Since the pacing/ sensing rate varies significantly, this patient is likely achieving proper rate response.
Example 2 shows another patient who is achieving good heart rate range. In this example, the patient’s heart rate is at beats per minute 38% of the time. Therefore, the HR Score is 38.
Since the pacing/sensing rate varies, this patient is likely achieving proper heart rate range. Generally speaking a lower Heart Rate Score is preferred because it means the patient is able to increase the heart rate to support daily activities.
A broader range of heart rate is typically better for the patient; therefore, a lower heart rate score is preferred.
Using Atrial Histogram to Determine Heart Rate Score
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13. RightRate™: Heart Rate Score – Predictor of Survival
Patients with a lower Heart Rate Score were shown to have an improved 5-year survival rate⁵. 5
In an analysis of 67,929 CRT-D patients enrolled in LATITUDE™ Remote Patient Management System, the Heart Rate Score was shown to be an independent predictor of survival. ⁵
At 5 years:
Patients with a Heart Rate Score ≥ 70 had a 43% survival rate⁵.
Patients with a Heart Rate Score < 30 had a 68% survival rate⁵.
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14. RightRate™: Heart Rate Score – Rate Adaptive Pacing
Patients with a high baseline Heart Rate Score were more likely to improve with DDDR than with DDD¹⁴.
In another LATITUDE analysis of 6,164 patients, it was shown that patients with a baseline HR Score greater than 70% benefited from rate adaptive pacing.
In addition, patients with a baseline Heart Rate Score > 70% significantly improved their Heart Rate Score with DDDR (from 88±9% to 78±15%; P<0.001). ¹⁴
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15. RightRate™: Heart Rate Score – MV+XL
A blended sensor with RightRate MV improved the Heart Rate Score more than XL only, indicating that Respiration Based Pacing was helpful in achieving the optimal rate response for these patients¹⁵.
501 patients from the LIFE Study were analyzed and Blended Sensor (RightRate-MV+ Accelerometer- XL) programming reduced the Heart Rate Score substantially more than Accelerometer sensor alone.¹⁵
Using a blended sensor (MV + XL) resulted in a Heart Rate Score reduction of 18% and converted almost twice as many patients to Heart Rate Score < 70% when compared to Accelerometer only.¹⁵
Lower is Heart Rate Score is better. Patients with a lower Heart Rate Score were shown to have an improved 5-year survival.⁵
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16. RightRate™: Chronotropic Incompetence Clinical Data
The patients who were programmed to DDDR MV during this prospective study were able to increase their heart rate by 7 beats per minute and walk an additional 38 feet on average¹⁶. ¹⁶
In the RALLY CRT-P study, CI patients with MV ON prospectively demonstrated an improvement in Hall Walk Heart Rate, Hall Walk Distance and Heart Rate Score. ¹⁶
Study Design: 35 CRT-P patients with CI were
Programmed to DDD at implant and assessed for 6-minute Hall Walk at 1 month.
Patients were then reprogrammed to DDDR MV and re-assessed for 6-minute Hall Walk at 3 months.
From 1 to 3 months, there was a significant improvement in Hall Walk Heart Rate, Hall Walk Distance and Heart Rate Score after programming DDDR MV¹⁶.
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17. Programming RightRate: 3-Step Process
RightRate™: Programming Overview
Programming RightRate is a 3 step process.
First, Assess sinus node function using the histograms or patient indications. If the Heart Rate Score is high (> 50), the patient may benefit from rate adaptive pacing.
Second, review the past 24 hours of data and determine if the patients heart rate was appropriate for the activity performed. If necessary, consider asking the patient to engage in physical activity if there isn’t sufficient data in the past 24 hours. In most cases, the sensor will be calibrated, unless the device is a new implant.
Third, optimize the sensor using the Sensor Replay function, which shows what the heart rate would have been over the past 24 hours if DDDR was programmed. Click “More MV Pacing” or “Less MV Pacing” until the Sensor Replay achieves the desired heart rate.
Programming RightRate: 3-Step Process
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18. RightRate™: Programming Example Patient
Let’s look at an example patient who is in for 6 month scheduled follow-up and complains of feeling tired and a lack of energy.
As shown on the previous page, the 3-step process is:
Step 1: Assess Chronotropic Competence
Step 2: Prepare Calibration and Sensor Baseline
Step 3: Optimize Sensor Trending Data
Example Patient
6-month scheduled follow-up.
Complains of feeling tired and a lack of energy.
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19. RightRate™: Programming Example Patient
Events
Step 1 is to Assess CI. Begin by clicking the Events tab.
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20. 80% of beats are at LRL; Heart Rate Score = 80
RightRate™: Programming Example Patient
This patient has a Heart Rate Score of 80. Since the Heart Rate Score is high, this patient may benefit from rate adaptive pacing.
Patient Diagnostics
80% of beats are at LRL; Heart Rate Score = 80
Next click Patient Diagnostics and review the patient’s Histograms.
For this patient, 80% of beats are at the LRL bin. Therefore, the Heart Rate Score is 80. Since Heart Rate Score is high, this patient may benefit from rate adaptive pacing.
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21. RightRate™: Programming Example Patient
Ask what activities the patient has performed in the past 24 hours. If the patient has not been active in the past 24 hours, consider asking the patient to engage in light to moderate physical activity, such as a Hall Walk or stairs.
Next, prepare the patient by calibrating the sensor and reviewing the sensor trending data for the past 24 hours.
Calibration:
For this patient, the sensor was automatically calibrated, since the device was implanted 6 months ago. Automatic calibration is complete approximately 8 hours after implant.
Sensor Baseline:
Assume this patient walked the dog this morning before coming to the clinic. Therefore, the physician decided not to perform a hall walk at the clinic and will assess data from earlier today.
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22. RightRate™: Programming Example Patient
Settings
Brady Settings
To access the Sensor Trending Screen, click Settings, then Brady settings.
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23. RightRate™: Programming Example Patient
Next, click Rate Adaptive Pacing.
Rate Adaptive Pacing
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24. Walked into Clinic Desired HR: 100 BPM Actual HR: 81 BPM
RightRate™: Programming Example Patient
The desired heart rate would have been 100 BPM for walking into the clinic, but this patient only achieved 81 BPM. Since this patient did not achieve proper heart rate response, he may benefit from rate adaptive pacing.
Discuss patient’s activity for the past 24 hours while reviewing the Sensor Trending. In this case, the patients actual heart rate was 81 beats per minute (BPM) while walking into the clinic. The desired heart rate for this activity would have been 100 BPM.
Walked into Clinic Desired HR: 100 BPM Actual HR: 81 BPM
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25. RightRate™: Programming Example Patient
The desired heart rate would have been 100 BPM for walking the dog, but this patient only achieved 75 BPM. Since this patient did not achieve proper heart rate response, he may benefit from rate adaptive pacing.
Scroll to view 1-hour segment within past 24 hours
You can then move the cursor and scroll to view a 1 hour segment within the past 24 hours. Earlier today, the patient walked the dog and achieved an actual heart rate of 75 BPM. The desired heart rate for this activity would have been 100 BPM.
You can use the scroll bar at the top to view the patient's data from the past 24 hours.
Walked into Clinic Desired HR: 100 BPM Actual HR: 81 BPM
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26. RightRate™: Programming Example Patient
Program Mode to DDR
The final step is to optimize the sensor. Program the pacing mode to DDDR, and then click Rate Adaptive Pacing.
Rate Adaptive Pacing
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27. RightRate™: Programming Example Patient
The sensor replay adjusts when you change the response factor. Incrementally press More MV pacing so that the sensor replay (orange line) matches the desired heart rate for this activity.
The Sensor Replay (orange line) indicates the rate at which the pacemaker would have paced this patient for this exact same activity.
On this screen, the Sensor Replay (orange line) indicates the rate at which the pacemaker would have paced this patient for this exact same activity.
For this patient, the desired heart rate was 100 BPM for walking the dog. Incrementally press More MV pacing to achieve the optimal heart rate.
More MV Pacing
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28. Sensor Replay = 83 BPM at response factor of 9
RightRate™: Programming Example Patient
Sensor Replay = 83 BPM at response factor of 9
Example Patient
6-month scheduled follow up.
Complains of feeling tired and a lack of energy.
For this patient, the desired heart rate was 100 BPM for walking the dog. Incrementally increase MV pacing to achieve the optimal heart rate.
After increasing the MV Response Factor to 9, the sensor replay was 83 beats per minute. Since we are targeting 100 beats per minute, click more MV pacing again.
More MV Pacing
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29. Sensor Replay = 95 BPM at response factor of 10
RightRate™: Programming Example Patient
For this patient, the desired heart rate was 100 BPM for walking the dog. By turning on DDDR-MV and increasing the MV Response Factor to 10, we were able to achieve a sensor replay of 95 beats per minute.
Sensor Replay = 95 BPM at response factor of 10
After increasing the response factor to 10, the sensor replay was 95 beats per minute
It is recommended to gradually increase the Response Factor over time. Increasing the Response Factor too fast for a particular patient may result in inappropriate pacing at Maximum Sensor Rate.
Therefore, for this patient it is suggested to stop at a response factor of 10 and reassess the patient at the next follow up visit if needed.
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30. Program the Fitness Level
RightRate™: Programming Example Patient
The Fitness Level is used to automatically determine the appropriate Ventilatory Threshold and Ventilatory Threshold Response Factor. Ventilatory Threshold and Ventilatory Threshold Response Factor are applied at higher heart rates to mimic the anerobic threshold.
Program the Fitness Level
Next, program the Fitness Level to sedentary, active, athletic, or endurance sports. The settings you choose here will automatically determine the appropriate Ventilatory Threshold and Ventilatory Threshold Response Factor.
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31. Program Accelerometer if a blended sensor is desired
RightRate™: Programming Example Patient
A blended sensor using both MV and Accelerometer may help athletes who need a quick uptake in heart rate for sprint activities.
Program Accelerometer if a blended sensor is desired
Next, turn on the Motion-Based Accelerometer if a blended sensor is desired.
A blended sensor using both MV and Accelerometer may help any patient who needs a quick uptake in heart rate (for example, athletes who participate in sprint activities such as rowing or running).
For this patient, assume the Accelerometer is not needed. Therefore, the Accelerometer can be left as Passive.
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32. RightRate™: Programming Example Patient
Adjusting the Maximum Sensor Rate or Lower Rate Limit can impact the Response Factor.
If you adjust the Maximum Sensor Rate or Lower Rate Limit, reassess the Response Factor
If you adjust the Maximum Sensor Rate or Lower Rate Limit, this can impact the Response Factor, so make sure to reassess the settings.
In this example, assume that a clinical decision was made to keep the previously programmed settings of 130 ppm Maximum Sensor Rate and 60 ppm Lower Rate Limit.
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33. When finished, press Program
RightRate™: Programming Example Patient
Finally, when you are finished, press Program.
When finished, press Program
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34. RightRate™: Conclusion
Remember that RightRate is the only sensor proven to restore chronotropic competence3, and Boston Scientific’s VISIONIST battery technology is labeled for up to 13.1 years projected longevity* even when RightRate is turned on.
* Assumes 70 ppm LRL, DDDR mode; 100% biventricular pacing; 15% atrium pacing and 0.4 ms pacing Pulse Width (RA, RV, LV); RA Impedance 500 Ω; sensors On, 2.0V RA/RV/LV, RV/LV Impedance 700 Ohms.
In Conclusion:
CI is common and problematic in HF patients.1,2,4,5
Heart Rate Score is a simple measure to help identify which patients have CI and may benefit from rate adaptive pacing.14,15,16
Patients with Heart Rate Score > 70 had significantly higher mortality rates.5
Using a blended sensor (XL + MV) was associated with a significant reduction in Heart Rate Score versus accelerometer alone.15
Ask your patients if their heart rate increases appropriately when they perform daily activities such as walking the dog, getting the mail, or light housework?
If not, then RightRate Respiration- based pacing may be right for them.
RightRate™ is the only sensor proven to restore chronotropic competence3, and Boston Scientific’s VISIONISTTM battery technology is labeled for up to years projected longevity* even when RightRate™ is turned on.
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35. Section 2: Hands On Training
Using your own internet connected device:
Proceed to
Complete the interactive element and earn 1 CE credit
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36. References
Samara MA, et al. Chronotropic impairment improves in patients responding to cardiac resynchronization defibrillator therapy (CRT-D). Data from the DECREASE HF Trial. Poster at HRS 2012.
Ujeyl A, Stevenson LW, West EK, et al., Impaired heart rate responses and exercise capacity in heart failure patients with paced baseline rhythms. J Cardiac Fail Mar;17(3):
Chronotropic competence is defined by the Model of the Cardiac Chronotropic Response to Exercise. Wilkoff B, Corey J, Blackburn G. A mathematical model of the cardiac chronotropic response to exercise. J Electrophysiol June;3(3): Refer to the Physician’s System Guide for more information on adaptive-rate therapy. Additional clinical performance was assessed using INSIGNIA® Ultra clinical data with the AutoLifestyle® feature programmed On. Data on file with Boston Scientific. ALTRUA® Pacemaker System Guide. 2008;1:20-5.
Swedberg K, et al. Guidelines for the diagnosis and treatment of chronic heart failure. The taskforce for the diagnosis and treatment of CHF of the ESC. EHJ 2005.
Wilkoff BL, Richards M, Sharma A, et al. A device histogram-based simple predictor of mortality risk in ICD and CRT-D patients: The Heart Rate Score. Pacing Clin Electrophysiol Apr;40(4):
Shaber JD, Fisher JD, Ramachandra I, et al. Rate responsive pacemakers: A rapid assessment protocol. Pacing Clin Electrophysiol Feb;31(2):192-7.
Mianulli M, Birchfield D, Yakimow K, et al. Do elderly pacemaker patients need rate adaptation – implications of daily heart rate behavior in normal adults. Pacing Clin Electrophysiol. 1996;19(ptII):681(abstract).
Chronotropic incompetence as defined by H. Weston Moses, in A Practical Guide to Cardiac Pacing, Lippincott Williams & Wilkins, 2007.
Brubaker PH, Kitzman DW. Chronotropic incompetence: Causes, consequences, and management. Circulation Mar 8;123(9);
Witte KKA, Cleland JGF, Clark AL. Chronic heart failure, chronotropic incompetence, and the effects of beta blockers. Heart Apr;92(4):481-6.
Al-Najjar Y, Witte KK, Clark AL. Chronotropic incompetence and survival in chronic heart failure. Int J Cardiol. 2012; May 17;157(1):48-52.
Jorde UP, Vittorio TJ, Kasper ME, et al. Chronotropic incompetence, beta-blockers, and functional capacity in advanced congestive heart failure: Time to pace? Eur J Heart Fail Jan;10(1):
Patwala AY, Woods PR, Sharp L, et al. Maximizing patient benefit from cardiac resynchronization therapy with the addition of structured exercise training. A randomized controlled study. J Am Coll Cardiol Jun 23;53(25):
Olshansky B, Richards M, Sharma A, et al. Survival after rate-responsive programming in patients with cardiac resynchronization therapy-defibrillator implants is associated with a novel parameter: The Heart Rate Score. Circ Arrhythm Electrophysiol Aug;9(8). pie:e
Richards M, Olshansky B, Sharma AD, et al. The addition of minute ventilation to rate responsive pacing improves Heart Rate Score more than accelerometer alone. Heart Rhythm
Pakarinen S, Richards M, Olshansky B, et al. First demonstration of improved Heart Rate Score with DDDR pacing in a prospective trial. HRS 2018 Poster. B-PO
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