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

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

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

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 …

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%], …

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

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 …

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

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 …

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

No abstract provided.

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

No abstract provided.

Comparing Downstream Consequences Of Normal Exercise Stress Echocardiograms And Cardiac Computed Tomography Angiography Scans In Patients Suspected Of Having Of Obstructive Coronary Artery Disease: A Retrospective Cohort Study Of Tricare Beneficiaries., Cory G Madigan, Michael B Adams, Chu-Chiao Chu, Laith R Dinkha, Samuel J Farrell, Robert T Hoard, Andrea N Keithler, Kevin A Loudermilk, Jessica Rouse, Brandon L Walker, Susan G Williams, Andrew C Wyatt, Rosco S Gore, Dustin M. Thomas Md

Parkview Heart Institute

To compare overall number of downstream tests and total costs between negative exercise stress echocardiograms (ESE) or cardiac computed tomography angiography scans (CCTA) in symptomatic Tricare beneficiaries suspected of having coronary artery disease (CAD). This is a retrospective cohort study examining 651 propensity-matched patients who underwent ESE or CCTA with normal results between 2008 and 2014 at the United States' largest Department of Defense hospital. The total number of additional downstream tests over the next five years was determined. The total costs associated with each arm, inclusive of the initial test and all subsequent tests, were calculated using the 2018 …

The Role Of Cardiovascular Ct In Occupational Health Assessment For Coronary Heart Disease: An Expert Consensus Document From The Society Of Cardiovascular Computed Tomography (Scct)., Ahmad M Slim, Emilio Fentanes, Michael K Cheezum Md, Iain T Parsons, Christopher Maroules, Billy Chen, Suhny Abbara, Kelley Branch, Prashant Nagpal, Nishant R Shah, Dustin M Thomas, Todd C Villines, Ron Blankstein, Leslee J Shaw, Matthew Budoff, Ed Nicol

Parkview Heart Institute

No abstract provided.

First-In-Human Visone Heart Failure Study: Asymptomatic Diaphragmatic Stimulation For Chronic Heart Failure With Reduced Ejection Fraction: Case Report, Ana Jorbenadze, Nikoloz Shaburishvili, Michael Mirro Md, Facc, Fhrs, Faha, Michel Zuber, Paul Erne, Tamaz Shaburishvili

Parkview Heart Institute

Background

Asymptomatic Diaphragmatic Stimulation (ADS) is a novel device-based HF therapy under investigation. ADS gaited with the cardiac cycle transiently modulates intrathoracic pressure, thereby enhancing pre- and afterload, and stroke volume. It is hypothesized that ADS improves cardiac function and exercise tolerance in HFrEF patients.

Methods

HFrEF patients (15) underwent laparoscopic implantation of the VisONE ADS system (NCT03484780). Post-implant stimulation levels imperceptible to the patient are determined. At discharge, ADS therapy is turned on. Measures of cardiac function, HF status, QoL and adverse events are assessed every 3 months for 12 months.

Results

Results are presented from an initial patient …

A Comparison Of The Accuracy Of Watchman Device Sizing Between Ct, Tee And Patient Specific 3d Models, Luke Matthew Landrigan Md, John Lozo, T. Eric White Md, Emily Keltner Bs, Ma

Parkview Heart Institute

Poster Presented at Conference: Indiana University Student Education and Research Fellowship Program

Objective: Determine the accuracy and reliability of CT imaging and CT-based patient specific 3D models of the left atrial appendage for the preprocedural planning of WATCHMAN device implantation in comparison to TEE

Inferior Vena Cava Filter Clinic And Hospital Registry: One Year Review, Emily Keltner Bs, Ma, T. Eric White Md, Lisa Hollister

Parkview Heart Institute

Poster Presentation-

Background: Inferior vena cava (IVC) filters are small, cage-like devices placed percutaneously into the inferior vena cava to prevent propagation of thrombus into the pulmonary arteries. Currently, there are two available types of filters, permanent and temporary. Retrievable inferior vena cava (IVC) filter use has increased over 115% since the Food and Drug Administration (FDA) approval in 2009. Likewise, there has been a marked increase in complications related to their increased use. In 2014, the FDA initiated a comprehensive analysis of filter placement and issued the following recommendation: “The FDA recommends that implanting physicians and clinicians responsible for …

The Peripheral Vascular Intervention (Pvi)-Lower Extremity Structured Report: A Tool For Physician Reporting Data Elements For The National Cardiovascular Data Registry (Ncdr ® ) Pvi Registry ™, Emily Keltner Bs, Ma, Brenda Springer, T. Eric White Md

Parkview Heart Institute

Background

The American College of Cardiology (ACC)/ National Cardiovascular Data Registry (NCDR®) Peripheral Vascular Intervention (PVI) Registry™ relies on thorough data collection to give registry participants a way to measure and improve the quality of care they provide to their patients. The majority of the data being collected in the PVI lower extremity procedures comes directly from the Interventional Cardiologist’s procedural report. There were three different reports from five physicians. The Interventional Cardiologist Group meets monthly to discuss cases and other pertinent information to the group. The members of this group include the Interventional Cardiologists, Parkview Heart Institute’s Chief Operating …

Elective Direct Current Cardioversion For Patients With Atrial Fibrillation: A Registry Analysis Of Adverse Events And Recurrence, Emily Keltner Bs, Ma, Charles Wong, Christopher Davis, Aaron Baker Ba, William Wilson

Parkview Heart Institute

Background

Synchronized direct current cardioversion (CV) is a common treatment for atrial fibrillation (AF) if primary treatment with anti-arrhythmic drugs fails. However, direct current CV, without pretreatment precautions, is associated with an increased risk of embolic stroke, presumably due to dislodgement of intracardiac thrombi. In order to prevent such complications, patients are typically treated with systemic anticoagulants for at least 3 weeks prior to cardioversion. (1) Warfarin has historically been the standard for anticoagulant treatment in AF. Warfarin reduces the risk of embolic stroke by 66% in AF patients. In addition, warfarin is relatively inexpensive and unaffected by renal function, …

One Hospital's Path To Develop An Ivc Filter Registry, Emily Keltner Bs, Ma, T. Eric White Md, Lisa Hollister, Denise Milestone Rn

Parkview Heart Institute

Background- Inferior Vena Cava (IVC) filters are small cage like devices placed percutaneously into the inferior vena cava to prevent propagation of thrombus into the pulmonary arteries. Currently there are two available types of filters, permanent filters and retrievable filters. In 2014, the FDA initiated a comprehensive analysis of filter placement and issued a statement recommending implanting physicians and clinicians responsible for the ongoing care of patients with retrievable IVC filters consider removing the filter as soon as protection from pulmonary embolism is no longer needed. Prior to the hospital’s structured system, there was a low rate of follow-up. The …