PMID- 33559358
OWN - NLM
STAT- MEDLINE
DCOM- 20210701
LR  - 20231111
IS  - 2055-5822 (Electronic)
IS  - 2055-5822 (Linking)
VI  - 8
IP  - 2
DP  - 2021 Apr
TI  - Cardio-microcurrent device for chronic heart failure: first-in-human clinical 
      study.
PG  - 962-970
LID - 10.1002/ehf2.13242 [doi]
AB  - AIMS: Most devices for treating ambulatory Class II and III heart failure are 
      linked to electrical pulses. However, a steady electric potential gradient is 
      also necessary for appropriate myocardial performance and may be disturbed by 
      structural heart diseases. We investigated whether chronic application of 
      electrical microcurrent to the heart is feasible and safe and improves cardiac 
      performance. The results of this study should provide guidance for the design of 
      a two-arm, randomized, controlled Phase II trial. METHODS AND RESULTS: This 
      single-arm, non-randomized pilot study involved 10 patients (9 men; mean age, 
      62 +/- 12 years) at two sites with 6 month follow-up. All patients had New York 
      Heart Association (NYHA) Class III heart failure and non-ischaemic dilated 
      cardiomyopathy, with left ventricular ejection fraction (LVEF) <35%. A device was 
      surgically placed to deliver a constant microcurrent to the heart. The following 
      tests were performed at baseline, at hospital discharge, and at six time points 
      during follow-up: determination of LVEF and left ventricular 
      end-diastolic/end-systolic diameter by echocardiography; the 6 min walk test; and 
      assessment of NYHA classification and quality of life (36-Item Short-Form Health 
      Survey questionnaire). Microcurrent application was feasible and safe; no 
      device-related or treatment-related adverse events occurred. During follow-up, 
      rapid and significant signal of efficacy (P < 0.005) was present with 
      improvements in LVEF, left ventricular end-diastolic diameter, left ventricular 
      end-systolic diameter, and distance walked. For eight patients, NYHA 
      classification improved from Class III to Class I (for seven, as early as 14 days 
      post-operatively); for one, to Class II; and for one, to Class II/III. 36-Item 
      Short-Form Health Survey questionnaire scores also improved highly significantly. 
      CONCLUSIONS: Chronic application of microcurrent to the heart is feasible and 
      safe and leads to a rapid and lasting improvement in heart function and a near 
      normalization of heart size within days. The NYHA classification and quality of 
      life improve just as rapidly.
CI  - (c) 2021 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on 
      behalf of European Society of Cardiology.
FAU - Kosevic, Dragana
AU  - Kosevic D
AD  - Cardiovascular Institute Dedinje Belgrade, Belgrade, Serbia.
FAU - Wiedemann, Dominik
AU  - Wiedemann D
AUID- ORCID: 0000-0002-2055-8293
AD  - Medical University Vienna, Vienna, Austria.
FAU - Vukovic, Petar
AU  - Vukovic P
AUID- ORCID: 0000-0002-9202-213X
AD  - Cardiovascular Institute Dedinje Belgrade, Belgrade, Serbia.
FAU - Ristic, Velibor
AU  - Ristic V
AD  - Cardiovascular Institute Dedinje Belgrade, Belgrade, Serbia.
FAU - Riebandt, Julia
AU  - Riebandt J
AUID- ORCID: 0000-0002-8601-9989
AD  - Medical University Vienna, Vienna, Austria.
FAU - Radak, Una
AU  - Radak U
AD  - Cardiovascular Institute Dedinje Belgrade, Belgrade, Serbia.
FAU - Brandes, Kersten
AU  - Brandes K
AD  - Berlin Heals, Berlin, Germany.
FAU - Goettel, Peter
AU  - Goettel P
AUID- ORCID: 0000-0003-3553-390X
AD  - Berlin Heals, Berlin, Germany.
FAU - Duengen, Hans-Dirk
AU  - Duengen HD
AD  - Charite - Universitatsmedizin Berlin, Berlin, Germany.
FAU - Tahirovic, Elvis
AU  - Tahirovic E
AD  - SciRent Clinical Research and Science, Belgrade, Serbia.
FAU - Kottmann, Tatjana
AU  - Kottmann T
AD  - Clinical Research Organization Kottmann, Hamm, Germany.
FAU - Voss, Hans Werner
AU  - Voss HW
AD  - Clinical Research Organization Kottmann, Hamm, Germany.
FAU - Zdravkovic, Marija
AU  - Zdravkovic M
AUID- ORCID: 0000-0003-4059-0263
AD  - University Hospital Medical Center Bezanijska Kosa Belgrade, Belgrade, Serbia.
FAU - Putnik, Svetozar
AU  - Putnik S
AD  - School of Medicine, University of Belgrade, Belgrade, Serbia.
FAU - Schmitto, Jan D
AU  - Schmitto JD
AD  - Hannover Medical School, Hannover, Germany.
FAU - Mueller, Johannes
AU  - Mueller J
AD  - Berlin Heals, Berlin, Germany.
FAU - Rame, Jesus Eduardo
AU  - Rame JE
AD  - Advanced Cardiac and Pulmonary Vascular Disease Programs, Jefferson Heart 
      Institute, Philadelphia, PA, USA.
FAU - Peric, Miodrag
AU  - Peric M
AD  - Cardiovascular Institute Dedinje Belgrade, Belgrade, Serbia.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20210209
PL  - England
TA  - ESC Heart Fail
JT  - ESC heart failure
JID - 101669191
SB  - IM
MH  - Aged
MH  - *Heart Failure/therapy
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Pilot Projects
MH  - *Quality of Life
MH  - Stroke Volume
MH  - Treatment Outcome
MH  - Ventricular Function, Left
PMC - PMC8006737
OTO - NOTNLM
OT  - Electric potential gradient
OT  - Electrical microcurrent
OT  - Electro-osmosis
OT  - Heart failure
COIS- The authors P. Goettel, K. Brandes and J. Mueller are employees of Berlin Heals, 
      the company that developed the device.
EDAT- 2021/02/10 06:00
MHDA- 2021/07/02 06:00
PMCR- 2021/02/09
CRDT- 2021/02/09 06:41
PHST- 2021/01/05 00:00 [revised]
PHST- 2020/11/06 00:00 [received]
PHST- 2021/01/19 00:00 [accepted]
PHST- 2021/02/10 06:00 [pubmed]
PHST- 2021/07/02 06:00 [medline]
PHST- 2021/02/09 06:41 [entrez]
PHST- 2021/02/09 00:00 [pmc-release]
AID - EHF213242 [pii]
AID - 10.1002/ehf2.13242 [doi]
PST - ppublish
SO  - ESC Heart Fail. 2021 Apr;8(2):962-970. doi: 10.1002/ehf2.13242. Epub 2021 Feb 9.