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Synchronized Diaphragmatic Stimulation For Heart Failure Using The Visone System: A First-In-Patient Study., Ana Jorbendaze, Robin Young, Tamaz Shaburishvili, Vitaly Demyanchuk, Roman Buriak, Borys Todurov, Kostyantyn Rudenko, Michel Zuber, Simon F Stämpfli, Felix C Tanner, Paul Erne, Michael Mirro Md, Facc, Fhrs, Faha, Marat Fudim, Lee R Goldberg, John G F Cleland
Synchronized Diaphragmatic Stimulation For Heart Failure Using The Visone System: A First-In-Patient Study., Ana Jorbendaze, Robin Young, Tamaz Shaburishvili, Vitaly Demyanchuk, Roman Buriak, Borys Todurov, Kostyantyn Rudenko, Michel Zuber, Simon F Stämpfli, Felix C Tanner, Paul Erne, Michael Mirro Md, Facc, Fhrs, Faha, Marat Fudim, Lee R Goldberg, John G F Cleland
Parkview Heart Institute
AIMS: Synchronized diaphragmatic stimulation (SDS) modulates intrathoracic and intra-abdominal pressures with favourable effects on cardiac function for patients with a reduced left ventricular ejection fraction (LVEF) and heart failure (HFrEF). VisONE-HF is a first-in-patient, observational study assessing the feasibility and 1 year effects of a novel, minimally invasive SDS device.
METHODS AND RESULTS: The SDS system comprises a pulse generator and two laparoscopically delivered, bipolar, active-fixation leads on the inferior diaphragmatic surface. Fifteen symptomatic men with HFrEF and ischaemic heart disease receiving guideline-recommended therapy were enrolled (age 60 [56, 67] years, New York Heart Association class II [53%] /III [47%], …