Closed loop stimulation and accelerometer-based rate adaptation: results of the PROVIDE study

Abstract

The arithmetic test was associated with a significantly higher heart rate for CLS than for AS, showing a greater sensitivity of CLS-based rate adaptation to mental stress. Performance during physical stress was comparable. Patients preferred CLS.

Influence of Patient’s Exercise Tolerance on Exercise Heart Rate in Closed Loop Stimulation vs. Accelerometer-based Rate Adaptive Pacing

“…Based on the insights from the PROVIDE study [5] with similar patient selection criteria, we made assumptions for the sample size calculation. Due to an "or" combination of the two alternative hypotheses, we used the union-intersection principle and thus a significance level of αCLS= αAS=2.5%.…”

“…As cardiac contractility is regulated by the autonomic nervous innervation, CLS is integrated into the natural cardiovascular control loop and responds to physical, mental, and emotional stress [5,[7][8][9][10]. …”

“…If the hypothesis turned to be true, it would imply that CLS is not only more sensitive to various kinds of stress [5,[7][8][9][10] but that it is also more specific than AS during physical exertion. The hypothesis was tested at 1 month, using symptom classification made at enrolment (NYHA I-like [higher exercise tolerance] vs. NYHA II-or III-like [lower exercise tolerance]) ( Table 1).…”

“…In an earlier, randomized, crossover study comparing accelerometer sensor (AS) and closed loop stimulation (CLS) driven by myocardial contraction dynamics, Coenen et al [5] observed that, during a 6-minute walk test, CLS resulted in higher heart rate in patients with symptomatic heart failure (NYHA class II or III) than in symptom-free patients (NYHA I).…”

“…This observation was interpreted as if CLS, unlike AS, might be able to differentiate between patients with higher exercise tolerance (NYHA I) and lower exercise tolerance (NYHA II-III), for whom walking represents a low-to-moderate exercise requiring a lower heart rate increase (NYHA I) or demanding exercise requiring a higher heart rate increase (NYHA II-III) [5]. As it was not a predefined study hypothesis, this observation required prospective validation.…”