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  • Title: Heart rate changes during acute mental stress with closed loop stimulation: report on two single-blinded, pacemaker studies.
    Author: Chandiramani S, Cohorn LC, Chandiramani S.
    Journal: Pacing Clin Electrophysiol; 2007 Aug; 30(8):976-84. PubMed ID: 17669080.
    Abstract:
    BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
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