Heart Rate Changes during Acute Mental Stress with Closed Loop Stimulation: Report on Two Single-Blinded, Pacemaker Studies

Abstract

Mental stress affects hemodynamic properties of the heart in patients indicated for a pacemaker, therefore highlighting the need for a rate-adaptive sensor that responds to mental loads. One such sensor utilizes Closed Loop Stimulation (CLS), which translates right ventricular contractility into patient specific pacing rates. Clinical studies utilizing CLS [Emotional Response (ER) and Emotional Response 2 (ER2) studies] have been performed to confirm CLS provides appropriate heart rate response to acute mental stress. The objective of these studies was to compare heart rates during a mental stress test, with the patient's pacemaker programmed to a CLS pacing mode and an accelerometer pacing mode.Patients were implanted with a BIOTRONIK Protos/CLS pacemaker (Berlin, Germany) and subjected to mental stress testing. The stress test consisted of a relaxation period followed by a color-word test and an arithmetic challenge test. The ER2 study utilized a randomized study design, in which pacing mode testing order was randomized.Analysis included patients who exhibited at least 80% sensor-driven heart rates during stress testing. Results for both studies demonstrated that CLS provided a statistically significant higher increase in heart rate during testing compared with an accelerometer pacing mode. The studies also showed that CLS provided a statistically significant higher peak heart rate during testing compared with an accelerometer pacing mode.The ER and ER2 studies demonstrate that the CLS algorithm responds with an appropriate heart rate response to acute mental stress in patients exhibiting a high percentage of sensor-driven pacing.