Abstract 3512: Increased Heart Rate during Acute Mental Stress with Closed Loop Stimulation: The Emotional Response 2 Study
Background: The Emotional Response (ER) 2 study was performed to confirm that Closed Loop Stimulation (CLS) provides appropriate heart rate response to acute mental stress. The objective of the study was to compare heart rates during an emotional and mental stress test, while the patient’s pacemaker (PM) was programmed with CLS, compared to an accelerometer (R) mode. CLS is a novel sensor that translates right ventricular contractility into patient specific pacing rates, resulting from myocardial contraction dynamics designed to allow patients a wider and more physiologic range of heart rates.
Methods: Patients (PTS) were implanted with a BIOTRONIK Protos/CLS PM. The computer directed test consisted of relaxation slides followed by a color-word test and an arithmetic test. The ER 2 study was blinded, randomized, and utilized a crossover design with the PTS serving as their own control.
Results: Analysis included PTS that exhibited at least 80% sensor driven heart rates during the test. Results of 138 PTS (male = 58%, age = 76.24 ± 7.84 years) over age 60 and 11 PTS (male = 64%, age = 51.09 ± 6.52) ages 40–60 are shown in the table⇓. A total of 83 patients completed testing in the CLS mode first. An evaluation of an historical control, published by Braune et al (1996), is also presented in the table⇓. The article examined the effects of different non-invasive procedures on blood pressure and heart rate in 137 healthy volunteers. One procedure utilized was the Mental Arithmetic Challenge, which closely relates to the testing in the ER 2 study.
Conclusion: The ER 2 study demonstrates that the CLS algorithm responds with an appropriate heart rate increase to acute mental stress in PTS exhibiting a high percentage of sensor-driven pacing. The study also demonstrates that the rate response provided by CLS is consistent with historical controls for age-matched healthy subjects.