Improvement of cardiac function with device-based diaphragmatic stimulation in chronic heart failure patients: the randomized, open-label, crossover Epiphrenic II Pilot Trial.

Beeler, Remo; Schoenenberger, Andreas; Bauerfeind, Peter Georg Karl-Heinz; Kobza, Richard; Bergner, Michael; Mueller, Xavier; Schlaepfer, Reinhard; Zuberbühler, Michel; Erne, Susanne; Erne, Paul (2014). Improvement of cardiac function with device-based diaphragmatic stimulation in chronic heart failure patients: the randomized, open-label, crossover Epiphrenic II Pilot Trial. European journal of heart failure, 16(3), pp. 342-349. Oxford University Press 10.1002/ejhf.20

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AIMS

Device-based pacing-induced diaphragmatic stimulation (PIDS) may have therapeutic potential for chronic heart failure (HF) patients. We studied the effects of PIDS on cardiac function and functional outcomes.

METHODS AND RESULTS

In 24 chronic HF patients with CRT, an additional electrode was attached to the left diaphragm. Randomized into two groups, patients received the following PIDS modes for 3 weeks in a different sequence: (i) PIDS off (control group); (ii) PIDS 0 ms mode (PIDS simultaneously with ventricular CRT pulse); or (iii) PIDS optimized mode (PIDS with optimized delay to ventricular CRT pulse). For PIDS optimization, acoustic cardiography was used. Effects of each PIDS mode on dyspnoea, power during exercise testing, and LVEF were assessed. Dyspnoea improved with the PIDS 0 ms mode (P = 0.057) and the PIDS optimized mode (P = 0.034) as compared with the control group. Maximal power increased from median 100.5 W in the control group to 104.0 W in the PIDS 0 ms mode (P = 0.092) and 109.5 W in the PIDS optimized mode (P = 0.022). Median LVEF was 33.5% in the control group, 33.0% in the PIDS 0 ms mode, and 37.0% in the PIDS optimized mode (P = 0.763 and P = 0.009 as compared with the control group, respectively). PIDS was asymptomatic in all patients.

CONCLUSION

PIDS improves dyspnoea, working capacity, and LVEF in chronic HF patients over a 3 week period in addition to CRT. This pilot study demonstrates proof of principle of an innovative technology which should be confirmed in a larger sample.

TRIAL REGISTRATION

NCT00769678.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of General Internal Medicine (DAIM) > Geriatric Clinic
04 Faculty of Medicine > Department of Gastro-intestinal, Liver and Lung Disorders (DMLL) > Clinic of Visceral Surgery and Medicine

UniBE Contributor:

Schoenenberger, Andreas, Bauerfeind, Peter Georg Karl-Heinz

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1388-9842

Publisher:

Oxford University Press

Language:

English

Submitter:

Rebecca Rufer

Date Deposited:

29 Apr 2015 12:25

Last Modified:

05 Dec 2022 14:31

Publisher DOI:

10.1002/ejhf.20

PubMed ID:

24464736

Uncontrolled Keywords:

Acoustic cardiography, Cardiac pacing, Diaphragm stimulation, Heart failure

BORIS DOI:

10.7892/boris.46436

URI:

https://boris.unibe.ch/id/eprint/46436

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