Medicine and Health Sciences Commons^™

Synchronized Diaphragmatic Stimulation For Heart Failure With A Reduced Left Ventricular Ejection Fraction Using The Visone System: A First-In-Patient Study With Extended Population, Ana Jorbenadze Md, Lee R. Goldberg Md, Tamaz Shaburishvili Md, Michel Zuber Md, Michael Mirro Md, Facc, Fhrs, Faha, Marat Fudim Md,Mh

Parkview Heart Institute

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Highlights

• Synchronized diaphragmatic stimulation (SDS) is a new extra-cardiac HFrEF therapy
• SDS impacts intrathoracic pressure and pericardial restraint•
• SDS exhibits a favorable safety profile over 1 year of chronic use
• Exercise tolerance and QOL improved with SDS over 1 year
• Early results will soon be validated in a randomized control trial

Abstract

Background

Synchronized diaphragmatic stimulation (SDS) produces localized contractions of the diaphragm gated to the cardiac cycle to transiently modulate intrathoracic pressures, thereby impacting cardiac function for heart failure patients with reduced ejection fraction (HFrEF). This study prospectively evaluated the safety and 1-year effectiveness of SDS in an expanded …

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Diaphragmatic Function In Cardiovascular Disease: Jacc Review Topic Of The Week., Husam M Salah, Lee R Goldberg, Jeroen Molinger, G Michael Felker, Willard Applefeld, Tienush Rassaf, Ryan J Tedford, Michael Mirro Md, Facc, Fhrs, Faha, John G F Cleland, Marat Fudim

Parkview Heart Institute

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In addition to the diaphragm's role as the primary respiratory muscle, it also plays an under-recognized role in cardiac function. It serves as a pump facilitating venous and lymph return, modulating left ventricular afterload hemodynamics and pericardial pressures, as well as regulating autonomic tone. Heart failure (HF) is associated with diaphragmatic changes (ie, muscle fiber atrophy and weakness, increased ratio of type I to type II muscle fibers, and altered muscle metaboreflex) that lead to diaphragmatic dysfunction with subsequent symptomatic manifestations of HF. Herein, it is proposed that targeting the diaphragm in patients with HF via inspiratory muscle training or …

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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

Parkview Heart Institute

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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%], …

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Synchronized Diaphragmatic Stimulation: A Case Report Of A Novel Extra-Cardiac Intervention For Chronic Heart Failure., Lee R Goldberg, Ana Jorbenadze, Tamaz Shaburishvilli, Michael Mirro Md, Marat Fudim, Michel Zuber, Simon F Stämpfli, Felix C Tanner, Paul Erne, John G Cleland

Parkview Heart Institute

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Synchronized diaphragmatic stimulation (SDS) is a novel extra-cardiac device-based therapy for symptomatic heart failure with reduced ejection fraction. SDS provides imperceptible chronic stimulation of the diaphragm through a laparoscopically implanted system consisting of an implantable pulse generator and two sensing/stimulating leads affixed to the inferior surface of the diaphragm delivering imperceptible R-wave gaited pulses that alter intrathoracic pressure improving ventricular filling and cardiac output. We describe, in a man with a history of myocardial infarctions resulting in heart failure and persistent New York Heart Association Class III symptoms despite standard therapies, the successful implantation of SDS resulting in improved quality …

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Audicor Remote Patient Monitoring: Fda Breakthrough Device And Technology For Heart Failure Management, Marat Fudim Md, Mhs, Michael Mirro Md, Facc, Fhrs, Faha, Hao-Ming Cheng Md

Parkview Heart Institute

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Research Letter: The impact of heart failure (HF) on patients, physicians, and hospital systems remains despite recent successes in pharmacologic and device-based treatments. Chronic HF represents one of the nation’s top health issues, leading to reduced patient quality of life, increased risks of hospitalization, increased health care utilization, and high incidence of patient morbidity and mortality. Titration of guideline directed medical therapy and prevention of HF hospitalizations have been identified as key targets in the management of HF. Remote monitoring provides the opportunity to address both issues and has gained significant momentum during the COVID-19 pandemic. Device-based solutions to manage …

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Synchronized Diaphragmatic Stimulation For The Treatment Of Symptomatic Heart Failure: A Novel Implantable Therapy Concept, Marat Fudim Md, Mhs, Michael Mirro Md, Lee R. Goldberg Md, Mph

Parkview Heart Institute

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No abstract provided.

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Audicor Remote Patient Monitoring: Fda Breakthrough Device And Technology For Heart Failure Management, Marat Fudim Md, Mhs, Michael Mirro Md, Hao-Ming Cheng Md

Parkview Heart Institute

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No abstract provided.

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