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


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.


CONCLUSIONS
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.


BACKGROUND
NCT00769678.
FESC, Department of Cardiology, St Anna Klinik, St Anna Strasse 32, CH-6006 Luzern, Switzerland.
Remo
R
Beeler
Andreas W
AW
Schoenenberger
Peter
P
Bauer
Richard
R
Kobza
Michael
M
Bergner
Xavier
X
Mueller
Reinhard
R
Schlaepfer
Michel
M
Zuber
Susanne
S
Erne
Paul
P
Erne
D000368:Aged; D002304:Cardiac Pacing, Artificial / Q000379:methods*; D002908:Chronic Disease; D018592:Cross-Over Studies; D003964:Diaphragm / Q000502:physiology*; D022062:Electrophysiologic Techniques, Cardiac; D005260:Female; D006333:Heart Failure / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D016896:Treatment Outcome
Acoustic cardiography; Cardiac pacing; Diaphragm stimulation; Heart failure