MUSCULAR COUNTER PULSATION IN ACUTELY DECOMPENSATED HEART FAILURE

Heart failure (HF) is a frequent disorder with acute decompensations leading to
a relevant number of hospitalisations and a worsening in prognosis. Still,
there are only few therapeutic options (e.g. diuretics, nitrates or positive
inotropic agents) none of which has shown to improve prognosis in acute
decompensated heart failure (ADHF). Additionally, HF leads to muscle wasting
which is accentuated in phases of immobilisation as during hospitalisation.
Besides medication, other support systems such e.g. intra-aortic balloon pumps
have been used with the disadvantage of being invasive. Muscular
counterpulsation (MCP) is a new treatment option which seems to improve
hemodynamics but might also have positive effects on muscular and vascular
function. Additionally, it is non-invasive and does not seem to have relevant
side effects. So far, it has been tested in different setting including stable,
chronic HF or coronary artery disease.

The aim of the study is to evaluate the effect of MCP in acutely decompensated
HF with the primary objective being its effect on the cumulative amount of
diuretics needed and the length of the hospital stay due to decompenstaed heart
failure . Secondary objectives are changes in renal function, quality of life,
use of positive inotropic agents or support systems, mortality and muscular
function.

All patients will receive standard HF therapy as applied in all our patients
being hospitalized with ADHF. Additionally, patients in the treatment group
will be provided with an MCP device (m.pulse, Cardiola AG, Winterthur,
Switzerland) which consists of a pulse generator with electrocardiogram (ECG)
sensors, stimulation pads, and a patient-operated control unit. Via external
electrodes, peripheral muscles are stimulated at early diastole using an
ECG-triggered control unit and pulse generator. The electric stimuli consist of
biphasic square wave pulses with a duration of 1 ms. The product of stimulation
frequency (default about 200 Hz) and the voltage amplitude (max. 45 V)
determines the intensity of skeletal muscle activation. It is aimed at
generating a visible muscle contraction without causing discomfort to the
patients. Thus, patients may adjust the applied intensity for each stimulation
site separately. Each application will be three times 120 minutes per day.

All patients will receive standard HF therapy as applied in all our patients
being hospitalized with ADHF. Additionally, patients in the treatment group
will be provided with an MCP device (m.pulse, Cardiola AG, Winterthur,
Switzerland) which consists of a pulse generator with electrocardiogram (ECG)
sensors, stimulation pads, and a patient-operated control unit. Via external
electrodes, peripheral muscles are stimulated at early diastole using an
ECG-triggered control unit and pulse generator. The electric stimuli consist of
biphasic square wave pulses with a duration of 1 ms. The product of stimulation
frequency (default about 200 Hz) and the voltage amplitude (max. 45 V)
determines the intensity of skeletal muscle activation. It is aimed at
generating a visible muscle contraction without causing discomfort to the
patients. Thus, patients may adjust the applied intensity for each stimulation
site separately. Each application will be three times 120 minutes per day.

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