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Published on: December 11, 2017
Recruitment and blocking properties of the CardioFit stimulation lead
Tamar Ahilea Anholt1, Shai Ayal, Joshua A Goldberg
1BioControl Medical Ltd, Yehud 56100, Israel.
Insights
The CardioFit system shows promise for treating congestive heart failure by selectively stimulating vagal nerve fibers. This therapy demonstrated significant unidirectional attenuation of A-fiber action potentials in preclinical tests.
Area of Science:
- Biomedical Engineering
- Neuroscience
- Cardiovascular Research
Background:
- Congestive heart failure (CHF) is a serious condition with limited therapeutic options.
- Vagal nerve stimulation is being explored as a novel treatment for CHF.
- The CardioFit system aims to selectively target cardiac vagal fibers.
Purpose of the Study:
- To characterize the recruiting and blocking properties of the CardioFit stimulation lead (CSL).
- To evaluate the CSL's ability to selectively stimulate efferent cardiac vagal fibers while minimizing off-target activation.
- To inform optimal parameter settings for the CardioFit system in clinical trials.
Main Methods:
- The CardioFit stimulation lead (CSL) was tested on isolated porcine vagus nerves.
- Nerves were maintained at elevated temperature in artificial cerebrospinal fluid.
- Charge-balanced, quasi-trapezoidal pulses were used to measure nerve activation and blocking thresholds.
Main Results:
- A 63% ± 13% mean unidirectional attenuation of A-fiber compound action potentials was achieved.
- This effect was observed in 8 out of 9 tested nerves at 3.0 ± 0.8 mA.
- The activation thresholds for A- and B-fibers were determined to be 0.3 ± 0.17 mA and 2.5 ± 1.1 mA, respectively.
Conclusions:
- The CardioFit stimulation lead demonstrates effective selective vagal nerve fiber recruitment and blocking.
- These findings support the potential of the CardioFit system as a therapy for congestive heart failure.
- The study provides crucial data for optimizing CardioFit system parameters in the INOVATE-HF clinical trial.
Abstract:
The CardioFit vagal stimulation system has been developed as a proposed therapy for congestive heart failure (CHF). CardioFit is to be implanted in several hundred CHF patients enrolled in the INOVATE-HF clinical trial, an FDA approved study. The CardioFit stimulation lead (CSL), which is a cuff electrode that delivers stimulation pulses to the right cervical vagus, was designed to recruit efferent cardiac vagal fibers while minimizing unwanted recruitment of other fibers. This paper presents the CSL and measurements of its recruiting and blocking properties when placed on isolated porcine vagus nerves maintained at an elevated temperature in oxygenated artificial cerebrospinal fluid. Using charge balanced quasi-trapezoidal pulses driven through the CSL, we show in eight out of nine nerves a 63% ± 13% (mean ± SD) unidirectional attenuation of the A-fiber compound action potential attained at a current of 3.0 ± 0.8 mA. The threshold for the activation of A- and B-fibers was found to be 0.3 ± 0.17 mA and 2.5 ± 1.1 mA, respectively. The results presented here should help to guide the optimal parameters used in the upcoming deployment of the CardioFit system.
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