Non-invasive Lung IMPEDANCE-Guided Preemptive Treatment in Chronic Heart Failure Patients: a Randomized Controlled Trial (IMPEDANCE-HF trial) Michael Kleiner.

Slides:



Advertisements
Similar presentations
The prevalence of use of beta- blockers in secondary prevention of myocardial infarctions in patients hospitalized 1 Institute of Epidemiology and biostatistics,
Advertisements

Cardiac Insufficiency Bisoprolol Study (CIBIS III) Trial
Cardiac Resynchronization Heart Failure Study Cardiac Resynchronization Heart Failure Study Presented at American College of Cardiology Scientific Sessions.
Diuretic Strategies in Patients with Acute Decompensated Heart Failure Diuretic Optimization Strategies Evaluation (DOSE) trial.
The Importance of Beta-Blockers in Patients with Heart Failure: A Resynchronization-Defibrillation for Ambulatory Heart Failure Trial (RAFT) Analysis.
MADIT Randomized Trial to Reduce Inappropriate Therapy (MADIT-RIT) Arthur J. Moss, MD for the MADIT-RIT Executive Committee AHA Late Breaking Trials November.
Chronicle Offers Management to Patients with Advanced Signs and Symptoms of Heart Failure Presented at American College of Cardiology Scientific Sessions.
Effects of losartan compared with captopril on mortality in patients with symptomatic heart failure: randomized trial -- the Losartan Heart Failure Survival.
Losartan Heart Failure Survival Study ELITE II Losartan Heart Failure Survival Study ELITE II A Multicenter, Double-Blind, Randomized, Parallel, Captopril-Controlled.
CONSENSUS: Cooperative North Scandinavian Enalapril Survival Study Purpose To determine whether the ACE inhibitor enalapril reduces mortality in patients.
Purpose To determine whether metoprolol controlled/extended release
MIRACL, Val-HeFT, Cheney Clinical Trial Commentary Dr Eric Topol Chairman and Professor, Department of Cardiology Director of the Joseph J Jacobs Center.
Welcome Ask The Experts March 24-27, 2007 New Orleans, LA.
analysis from the SHIFT study
Loop diuretics VS venous ultrafiltration in cardio-renal syndrome Radek Debiec SHO Renal Medicine LGH Sept 2013.
Sudden Cardiac Death in Heart Failure Trial Presented at American College of Cardiology Scientific Sessions 2004 Presented by Dr. Gust H. Bardy SCD-HeFTSCD-HeFT.
Alon Barsheshet, MD1, Paul J. Wang, MD2, Arthur J. Moss, MD1, Scott D
May 23rd, 2012 Hot topics from the Heart Failure Congress in Belgrade.
Clinical Effectiveness of Implantable Cardioverter-Defibrillators Among Medicare Beneficiaries With Heart Failure Adrian F. Hernandez, MD, MHS; Gregg.
ATLAS Clinical Trial Commentary Dr Eric Topol Chairman and Professor, Department of Cardiology Director of the Joseph J Jacobs Center for Thrombosis and.
CHARM-Alternative: Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity - Alternative Purpose To determine whether the angiotensin.
CHARM-Preserved: Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity - Preserved Purpose To determine whether the angiotensin.
Clinical Impact of Adherence to Pharmacotherapeutic Guidelines on the Outcome in Patients with Chronic Heart Failure Suntheep Batra, M.Pharm Department.
L References Application to Clinical Practice The American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA) have cooperatively.
Value of Endothelin Receptor Inhibition with Tezosentan in Acute Heart Failure Studies VERITAS Trial Presented at The American College of Cardiology Scientific.
Specialized Atrial Fibrillation Clinic reduces cardiovascular morbidity and mortality in patients with atrial fibrillation Jeroen ML Hendriks, MSc Robert.
Thomas S. Rector, PhD, Inder S. Anand, MD, David Nelson, PhD, Kristine Ensrud, MD and Ann Bangerter, MS CHF QUERI NETWORK November 8, 2007 VA Medical Center,
Effect of ivabradine on recurrent hospitalization for worsening heart failure: findings from SHIFT S ystolic H eart failure treatment with the I f inhibitor.
RALES: Randomized Aldactone Evaluation Study Purpose To determine whether the aldosterone antagonist spironolactone reduces mortality in patients with.
HOPE: Heart Outcomes Prevention Evaluation study Purpose To evaluate whether the long-acting ACE inhibitor ramipril and/or vitamin E reduce the incidence.
CIBIS II Cardiac Insufficiency Bisoprolol Study
The Studies of Oral Enoximone Therapy in Advanced Heart Failure ESSENTIALESSENTIAL Presented at The European Society of Cardiology Congress 2005 Presented.
CI-1 ATACAND ® (candesartan cilexetil) Cardiovascular and Renal Drugs Advisory Committee Rockville, Maryland February 24, 2005 C.
COMET: Carvedilol Or Metoprolol European Trial Purpose To compare the effects of carvedilol (a β 1 -, β 2 - and α 1 -receptor blocker) and short-acting.
EP show – June 2004 EP show The EP show: Risk stratification for sudden death Eric Prystowsky MD Director, Clinical Electrophysiology Laboratory St Vincent.
ELITE - II Study Design  60 yrs; NYHA II - IV; EF  40 % ACEI naive or  7 days in 3 months prior to entry Standard Rx ( ± Dig / Diuretics ), ß - blocker.
Relationship of background ACEI dose to benefits of candesartan in the CHARM-Added trial.
Anne L. Taylor, M. D. , Susan Ziesche, R. N. , Clyde Yancy, M. D
Late Open Artery Hypothesis Jason S. Finkelstein, M.D. Tulane University Medical Center 2/24/03.
OVERTURE FDA Cardiovascular and Renal Drugs Advisory Committee Meeting July 19, 2002 Milton Packer, M.D., FACC Columbia University College of Physicians.
Candesartan in Heart Failure Presented at European Society of Cardiology 2003 CHARM Trial.
Interim Chair, Medicine Brigham and Women’s Hospital Boston, MA
CR-1 Candesartan in HF Benefit/Risk James B. Young, MD Cleveland Clinic Foundation.
COPERNICUS: Carvedilol Prospective Randomized Cumulative Survival trial Purpose To assess the effect of carvedilol, a β 1 -, β 2 - and α 1 -receptor blocker,
The Case for Rate Control: In the Management of Atrial Fibrillation Charles W. Clogston, M.D. Cardiologist CHI St. Vincent Heart Clinic Arkansas April.
Eric J Robinson, M.D. Cardiologist April 25, 2015
Response to Antiretroviral Treatment In an Ethiopian Hospital Samuel Hailemariam, MD, MPH; J Allen McCutchan, MD, MSc Meaza Demissie, MD, PMH, PHD; Alemayehu.
Ten Year Outcome of Coronary Artery Bypass Graft Surgery Versus Medical Therapy in Patients with Ischemic Cardiomyopathy Results of the Surgical Treatment.
Angela Aziz Donnelly April 5, 2016
Non-invasive Lung IMPEDANCE-Guided Preemptive Treatment in Chronic Heart Failure Patients: a Randomized Controlled Trial (IMPEDANCE-HF trial) Michael Kleiner.
Date of download: 9/19/2016 Copyright © The American College of Cardiology. All rights reserved. From: What resting heart rate should one aim for when.
Clinical Trial Commentary
These slides highlight a presentation at the Late Breaking Trial Session of the American College of Cardiology 52nd Annual Scientific Sessions in Chicago,
JOURNAL REVIEW HEART FAILURE MANAGEMENT – BETA BLOCKERS
Ivabradine – A new option for Heart Failure Patients
CLINICAL DILEMMAS IN HEART FAILURE:
O’Connor Efficacy and Safety of Exercise Training as a Treatment Modality in Patients With Chronic Heart Failure: Results of A Randomized Controlled.
EMPHASIS-HF Extended Follow-up
The following slides highlight a presentation at the Late-Breaking Clinical Trials session of the American Heart Association Scientific Sessions, November.
The American Heart Association
Section III: Neurohormonal strategies in heart failure
Biomarker-Guided HF Therapy: Is It Cost-Effective?
G. Michael Felker et al. JCHF 2014;2:
CIBIS II: Cardiac Insufficiency Bisoprolol Study II
Section III: Neurohormonal strategies in heart failure
Challenging the Myths in Heart Failure With Reduced Ejection Fraction
Impedence-guided management
Systolic Heart failure treatment with the If inhibitor ivabradine Trial Effect of ivabradine on recurrent hospitalization for worsening heart failure:
Presentation transcript:

Non-invasive Lung IMPEDANCE-Guided Preemptive Treatment in Chronic Heart Failure Patients: a Randomized Controlled Trial (IMPEDANCE-HF trial) Michael Kleiner Shochat, MD, BSc, PhD a, Avraham Shotan, MD a, David S Blondheim, MD a, Mark Kazatsker, MD a, Iris Dahan, MSIT a, Aya Asif, MD a, Yoseph Rozenman, MD b, Ilia Kleiner, MD c, Jean Marc Weinstein, MBBS, FRCP c, Aaron Frimerman, MD a, Lubov Vasilenko, MD a, Simcha R Meisel, MD, MSc a a Heart Institute, Hillel Yaffe Medical Center, Hadera, Rappaport School of Medicine, Technion, Haifa, Israel; b Cardiovascular Institute, Wolfson Medical Center, Holon, Sackler Faculty of Medicine, Tel-Aviv University, Israel, c Cardiology Department, Soroka University Medical Center, Beer Sheva. American College of Cardiology. Chicago. Late Braking Clinical Trial Session. Apr Conflict of interest: Michael Kleiner Shochat is a co-founder and member of the board of directors of the RSMM Company that manufactured and supplied the devices for the study. Presenter - Michael Kleiner Shochat

Our trial was performed to evaluate the hypothesis that- Lung impedance-guided treatment reduces hospitalizations for Acute Heart Failure. Inclusion criteria - Chronic Heart Failure patients Left Ventricle Ejection Fraction ≤35% New York Heart Association class II-IV Aim:

Process Of Lung Fluid Accumulation 3 STAGES OF HEART FAILURE: Stable stage - There is no fluid accumulation in lung Lung fluid accumulation - without clinical signs Ideal point to start treatment Current point where treatment starts Dramatic deterioration in patient’s condition & urgent hospitalization

The Objective: Accurately Identifying the Lung Impedance (LI) Value CWI 1 Ω X700~ CWI 2 Ω X700~ LI Ω X60~ A Transthoracic Impedance A-B (TTI AB ) = Target Organ B + Lung Impedance + Chest Wall Impedance 2 Chest Wall Impedance 1 The Challenge The Challenge : Identifying milled/critical changes in the LI from the total TTI The Solution The Solution : Obtaining accurate TTI score by Excluding CWI 1 and CWI 2 Leaving only the LI result >60< Can we detect changes when the total result is ~1460 ? >60<Changes easily detected~60

Traditional Impedance Technique TTI Traditional Technologies VS RSMM Technology EGM TTI

Monitoring Group (N=128). Mean = 48 m. FU Control Group (N=128). Mean = 39 m. FU One year before randomization HF hospitalizations = 1.2/patients year HF hospitalizations = 1.1/patients year Randomization Mean age in both groups 67 y. Men – 80%. Both groups were well adjusted by baseline patient characteristics, baseline medications and parameters of physical examination. Primary efficacy endpoints: 1. Acute heart failure hospitalizations up to 12 months. 2. Acute heart failure hospitalizations during entire follow up 1 y 2 y3 y 4 y 5 y7 y6 y8 y Study design: Randomized, single blinded, two centers. Study population. Efficacy endpoints. Run in period (3m) for adjustment maximally possible guidelines recommended drug doses for CHF treatment. Future Monitoring Group Future Control Group Secondary efficacy endpoints: 1. All –cause, Cardiac hospitalizations during entire follow up. 2. All-cause, Cardiac and Heart Failure mortality during entire follow up.

(ΔLIR) = [current LI/BLI)-1] 0% -10% -15% -20% -25% -30% -35% -40% -45% -50% -55% -24% ∆LIR Hospitalizations for Heart Failure Patient’s status is very stable. No or very small interstitial congestion. NYHA class I – II. No need in additional treatment. -18% -5% Baseline (dry) lung impedance (BLI). As if patient is healthy. Beginning Heart Failure hospitalizations Increasing in congestions Increased risk of Heart Failure hospitalizations Target zone for adjustment treatment Patients became more congested but still no more complains Strategy of drug adjustment

Lung Impedance-guided treatment group Control group treated by clinical assessment 1 year 2 year 3 year 4 year 5 year 6 year 7 year 8 year Follow up period P < Results Rate of Heart Failure hospitalizations (per patient*year)

All-cause Hospitalizations 39% reduction in all-cause hospitalizations during entire period of follow up P < Cardiac Hospitalizations 52% reduction in cardiac hospitalizations during entire period of follow up P < Heart Failure Hospitalizations 56% reduction in cardiac hospitalizations during entire period of follow up P < Follow Up period Number of hospitalizations Follow Up period Method of statistics: Cox regression analyses Results Hospitalizations

All-cause Death Follow Up period 43% reduction in all-cause deaths during entire period of follow up P < % reduction in cardiac deaths during entire period of follow up P < Cardiac Death Follow Up period 62% reduction in Heart Failure deaths during entire period of follow up P < Heart Failure death Method of statistics: Kaplan Meyer analyses Results Mortality

Difference in pulmonary congestion between groups during follow up period ∆LIR Follow Up period Linear mixed effects regression model was used to evaluate differences between ∆LIR into and between groups. P < Monitored Group Control Group Results

T A B L E Drug modifications during entire follow up MedicationsMonitored GroupControl Groupp Monitoring /Control group. Ratio of drug adjustment Beta Blockers0.74* NS ACE inh/ARB0.79*0.83*NS Rate of changes in medical therapy Total 3166 (6.2)†1244 (3.0)†< times Diuretics 1530 (48%)‡ 515 (42%)‡<0.05 Diuretics 1530 (3.0)† 515 (1.3)†< times Beta Blockers 792 (25%)‡ 303 (24%)‡<0.05 Beta Blockers 792 (1.6)† 303 (0.7)†< times ACE inh /ARB 410 (13%)‡ 142 (11%)‡<0.05 ACE inh /ARB 410 (0.8)† 142 (0.3)†< times Nitrates 166 (5%)‡ 78 (6%)‡<0.05 Nitrates 166 (0.3)† 78 (0.2)†< times MRA 154 (5%)‡ 144 (12%)‡NS MRA 154 (0.3)† 144 (0.4)†NS0.9 times Digoxin 114 (4%)‡ 62 (5%)‡<0.05 Digoxin 114 (0.2)† 62 (0.15)†< times

Data of “IMPEDANCE-HF” trial shows that Lung Impedance guided treatment in compare with treatment based on clinical assessment of HFrEF patients: 1. Reduces rate of HF hospitalizations during first year by 58%. 2. Reduces rate of HF hospitalizations during 4 years by 56%. 3. Reduces rate of all-cause hospitalizations during 4 years by 39%. 4. Reduces rate of cardiac hospitalization during 4 years by 52%. 5. Reduces rate of Non-cardiac hospitalization during 4 years by 9%, (p=0.6). 7. Reduces rate of All-cause mortality during 4 years by 43%. 8. Reduces rate of Cardiac mortality during 4 years by 55%. 9. Reduces rate of Heart Failure mortality during 4 years by 62%. 10. No changes in Non-cardiac mortality during 4 years. Hospitalizations (Primary endpoint) Hospitalizations (Secondary endpoint) Deaths (Secondary endpoint) Conclusions

Non-invasive Lung Impedance technology is enough sensitive to detect a very early stage of evolving pulmonary congestion and Lung Impedance-guided treatment is reliable for improving hospitalization and survival of Heart Failure patients. Thank you very much for attention! These results support