Heart Failure Moving Center Stage in Cardiology - A Tale of Drugs, Devices and Interventions
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1 Heart Failure Moving Center Stage in Cardiology - A Tale of Drugs, Devices and Interventions Prof. Dr. med. Dr. h.c. Frank Ruschitzka, FRCP (Edin.) Chairman, Dept. Cardiology University Heart Centre, Zurich /
2 Wonderful friend, family man and worldwide champion of cardiovascular research Henry Krum ( ) /
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6 Eur Heart J 2018
7 This is the unmet need in heart failure... /
8 Donald Trump`s Health Record /
9 Well, he promised us growth... /
10 ESC - SCORE Risk Charts 10 year risk (in %) of a fatal Myocardial Infarction or Stroke *July 6, 1946 *Jun 14, 1946 *Aug 4, 1961 *Aug 19, / 1946
11 Heart Failure The Disease of the Presidents MI, CHF MI, CHF RR, Stroke CAD, Stroke, CHF MI, CHF Stroke, MI, CHF Stroke, MI, CHF CHF MI, CHF MI, CHF, SCD CHF, Stroke MI, CHF AFib MI, CHF / CAD
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13 Ike`s Ischaemic Cardiomyopathy NTG / Morphine Bed Rest Acute MI Messerli FH et al. Am / J Cardiol. 2007
14 Ike Eisenhower From his first infarction in 1955 until his death in 1969, Eisenhower had at least 7 myocardial infarctions and 14 cardiac arrests. He died from heart failure on March 28, 1969, at the age of 78 years, nearly 14 years after his first heart attack. New England journal of Medicine 353: /
15 Advanced Heart Failure Therapy in 1994
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19 The Success of ACE Inhibition in Heart Failure CONSENSUS: NEJM 1987 SOLVD: NEJM 1991
20 Drugs in Systolic Heart Failure: From Mere Palliation to Saving Lifes McMurray EJHF 2011
21 PARADIGM-HF: Cardiovascular Death or Heart Failure Hospitalization (Primary Endpoint) Kaplan-Meier Estimate of Cumulative Rates (%) Enalapril (n=4212) LCZ696 (Entresto ) (n=4187) HR = 0.80 ( ) P = Number needed to treat = Days After Randomization McMurray NEJM 2014
22 Therapy of Heart Failure with reduced Ejection Fraction (HFrEF) / Heart Failure Guidelines EHJ / EJHF 2016
23 Dilative Cardiomyopathy: When drugs alone are not enough y., male, dilative cardiomyopathy referred for heart transplantation RR 98/64 mmhg HR 68/min/SR Resp. Rate 16/min 3/6 Syst. pm ERB (MR) HJR neg Lisinopril 30mg Carvedilol 25mg Eplerenone 50mg Toresamid 20mg /
24 Cardiomyopathies Understand the Enemy / Hershberger R et al. Nature Rev Cardiol 2013
25 Dilative Cardiomyopathy Non-Compaction Myocarditis Hypertrophic Cardiomyopathy Restrictive Cardiomyopathy Right Ventricular Dysfunction Mitral Regurgitation Left atrial Disease Amyloidosis /
26 When Cardiovascular Imaging Leads the Way Alkadhi, Distler, Ruschitzka 2017
27 A Tough Heart Team* Decision: Should We Accept this Donor Heart for Transplantation *The Mechanical Circulatory Support and Transplant Heart Team: Cardiac Surgery/Heart Failure, Anesthesiology/Intensive Care, Immunology, Infectious Disease, Transplant Coordinators et al.) /
28 Four Types of Takotsubo Cardiomyopathy Templin, Ghadri / NEJM 2015
29 Takotsubo Cardiomyopathy: 10-Year Outcomes Templin, Ghadri / NEJM 2015
30 Takotsubo Cardiomyopathy: ACE-Inhibitors Save Lives, Betablockers don`t Templin, Ghadri / NEJM 2015
31 (R)evolution of Heart Failure Treatment Palliative Drugs Neurohormonal Drugs Devices ARNI Pre s 1990s 2000s 2010s 2016 Digitalis Diuretics ACE-I ICDs β-blockers Transplantation CRT, CRT-D LVAD MR-Antagonists Ivabradine Sensing Devices ARNI Ruschitzka HFA 2016
32 When drugs alone are not enough... January months later
33 Cardiac Resynchronisation Therapy (CRT): Live Saving Therapy in Wide QRS CARE-HF EchoCRT Cleland J, et al. NEJM 2005 Ruschitzka F., et al. NEJM 2013 /
34 The Dos and Don`ts of CRT: Define the Sweet Spot for Benefit NO Yes LBBB Morphology NON-LBBB Morphology Ruschitzka HFA 2016 Ruschitzka NEJM 2013 Cleland EHJ 2013
35 Higher dosages of ACE-I and Betablockers, but lower doses of diuretics are associated with improved survival following CRT ACE-Inhibitors Betablockers Diuretics / Steffel EHJ 2014
36 Recommendations for implantable cardioverterdefibrillator in patients with heart failure
37 Danish: Primary outcome All-cause mortality Kober NEJM 2016
38 Danish: Secondary Outcome Sudden death Kober NEJM 2016
39 Danish: Subgroup Analysis of Primary Outcome Kober NEJM 2016
40 Recommendations for implantable cardioverterdefibrillator in patients with heart failure
41 Implant-based multiparameter telemonitoring of patients with heart failure (IN-TIME) Hindricks Lancet 2014
42 Implant-based multiparameter telemonitoring of patients with heart failure (IN-TIME) Hindricks Lancet 2014
43 The CardioMEMS implantable haemodynamic monitoring system Verdejo JACC 2007
44 Implantable haemodynamic monitoring system Reduces Heart Failure Hospitalizations Abraham Lancet 2011
45 Valvular Intervention: Crossfertilization of Interventional Cardiology, Cardiac Surgery, Cardiovascular Imaging and Heart Failure Severe Mitral Regurgitation Patient remains symptomatic (NYHA III) despite optimal drug and CRT therapy Result after successful percutaneous MitraClip Implantation courtesy Stämpfli, Tanner, Maisano
46 PERCUTANEOUS MITRAL TREATMENT Repair Replacement Anulus Leaflets Tendinous chords Ventricle Bioprosthesis /ring Native valve Anuloplasty Plication Ablation indirect direct Clip Suture Carillon (CS)* Mitralign (TF)* Monarc (CS) Accucinch GDS (TF) Viacor PTMA (CS) Quantum Cor (TS) Valtech Cardioband (TS)* MitraClip (TS)* MitraFlex (TA) Mobius (TS) Termocool (TF) Neochord (TA) Mardil-BACE (MT) Babic (TA-TS) icoapsys (TP) Mitraflex (TA) SAPIEN (TA)* CardiAQ (TS) Melody (TA)* Tiara (TA) Endovalve (MT) Lutter (TA) Edwards Fortis (TA) Tendyne (TA) *devices with CE mark approval devices with FDA approval devices withdrawn/on hold Figulla HR et al. Eur Heart J 2016;37:2226 L. Nombela-Franco et al. Rev Esp Cardiol. 2013;66:566 /
47 Mechanisms of Mitral Regurgitation /
48 FMR is Called Secondary MR for a Reason: It`s a Myocardial, not only a Leaflet Disease /
49 AF Ablation in Heart Failure: What do the ESC Guidelines Say? AFib Guidelines Heart Failure Guidelines Kirchhof P et al. EHJ 2016 Ponikowski et al., EHJ and EJHF 2016
50 More than 2 Million Ablations later..., and still no Outcome Trial Published? Gillinov NEJM 2016
51 Outcome Trials in Atrial Fibrillation and Heart Failure We are waiting and waiting... % Clinicaltrials.gov
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53 Study Design CASTLE-AF Investigator initiated, Prospective, Multicenter ( 31 sites, 9 countries), Randomized, Controlled 3013 pts Eligibility Assessment 21 pts excluded 179 pts Ablation 153 pts (26 cross-overs) Enrolled/ Randomized 397 pts 200 pts Run-in 5 weeks 197 pts 13 pts excluded Conventional Follow-up: 3, 6, 12, 24, 36, 48, 60 months ICD/CRT-D check Adverse event documentation Echocardiography 6-minute walk test Optimization of medication for HF Home Monitoring programming NYHA, weight, BP, QoL Patients diary 184 pts 165 pts (18 cross-overs)
54 Results-CASTLE AF All-Cause Mortality Survival Probability HR, 0.53 (95% CI, ); P=0.011 Log-rank test: P=0.009 Ablation Conventional Risk Reduction: 47% Follow-Up Time (Months) Patients at Risk Ablation Conventional
55 Results-CASTLE AF Worsening Heart Failure Admissions Survival Probability HR, 0.56 (95% CI, ); P=0.004 Log-rank test: P=0.004 Ablation Conventional Risk Reduction: 44% Follow-Up Time (Months) Patients at Risk Ablation Conventional
56 LA Size, not Afib per se predicts any cardiovascular or cerebrovascular event LAV over time for patients with events. Osranek EHJ 2006
57 Left Atrial Size, not AFib Predicts Outcome Kamel Stroke 2016
58 Phases of Left Atrial Function: Reservoir, Conduit, Contractile Chamber Rossi Circ HF 2014
59 Heart failure induces atrial substrate remodelling long before onset of AF De Jong CVR 2010
60 Atrial Fibrillation let`s call it what it is: LAD or Left Atrial Disease Kamel Stroke 2016
61 Axial-Flow and the Centrifugal-Flow Pumps Mehra NEJM 2016
62 Successful Weaning of a Ventricular Assist Device Delivery...5 months later...9 months later
63 MOMENTUM 3: A Fully Magnetically Levitated Circulatory Pump for Advanced Heart Failure Mehra NEJM 2016
64 MOMENTUM 3: Major Adverse Events Mehra NEJM 2016
65 VADs and Complications Mechanical wear Valve dysfunction Thrombembolic complications
66 VADs from Bridge to Transplant
67 Modern Management of Heart Failure The Heart Team Approach Palliative Care Medical therapy Heart Transplant ICD, CRT Mechanical Circulatory Support Acute Heart Failure Therapies Valvular Interventions Courtesy F. Maisano /
68 The New Heart Failure Doctor Acquired National Cardiologist Training or ESC Core Curriculum Start Specialist Heart Failure training (12 months for all) HFA Educational Modules online Additional Training in drugs, lifestyle and management 6-12 months Advanced Heart Failure Therapy Training 12 months Heart Failure Device Training 12 months Imaging Training Echo 6 months Echo 6 ms MR/alt 6 ms* 12 months 24 months Heart Failure Specialist Certification from HFA of ESC McDonagh et al, EJHF 2013
69 The Birth of a Specialty the New Heart Failure Specialist /
70 Certificate & Accreditation University of Zurich European Heart House / ESC Certificate of Advanced Studies Confirmation by HFA
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73 4 days of scientific exchange healthcare professionals abstracts and cases submitted 120+ scientific sessions 300+ expert faculty members 100+ countries represented 45+ industry sessions /workshops Call for abstracts: 3 November - 13 January /
74 Wonderful friend, family man and worldwide champion of cardiovascular research Henry Krum ( ) /
75 Merci
76 The SWISS Race to Develop Novel Acute Heart Failure Therapies Relaxin Ularitide Relaxin Ruschitzka HFA 2016
77 TRUE-AHF: Cardiovascular Mortality Proportion Free From Cardiovascular Death Placebo Ularitide 236 deaths HR = 1.03 (96% CI: ) P= deaths Months After Randomization TRUE-AHF Investigators NEJM 2017
78 RELAX-AHF-2 primary endpoint: CV mortality through Day 180 Variable Adjudicated CV death Serelaxin n/n (%) 285/3274 (8.7) Placebo n/n (%) 290/3271 (8.9) Total n/n (%) 575/6545 (8.8) Hazard ratio (95% CI) 0.98 (0.83, 1.15) p-value (adjusted alpha*) (0.0186) - Adjudicated CV deaths include adjudication-confirmed CV deaths plus deaths with unknown cause - Hazard ratio is obtained from Cox-regression model with treatment as a factor - one-sided p-value is based on log-rank test - * based on multiple testing procedure - A hazard ratio <1 favors serelaxin n/n: total number of events/total number of subjects in the analysis CV, cardiovascular Metra, Teerlink HFA 2017
79 TRUE-AHF: Study Organization Data Monitoring Committee K. Swedberg (SW), chair J. Borer (US) H. Wedel (SW) L. Tavazzi (IT) Executive Committee M. Packer (chair) W. Abraham, S. Anker, K. Dickstein, H. Krum, G. Filippatos, R. Holcomb, A. Maggioni, J. McMurray, A. Mebazaa, C. O Connor, F. Peacock, P. Ponikowski, D.J. van Veldhuisen F. Ruschitzka Clinical Events Committee J. McMurray, E. Connolly P. Jhund, M. MacDonald M. Petrie, M. Walters Medical Review Committee D. McGuire, J. de Lemos M. Packer Independent Statistical Analysis J. Wittes, L. Kowarski, M. Schactman National Leaders Investigative Sites Cardiorentis /Quintiles Operations Packer AHA 2016
80 TRUE-AHF: Baseline Characteristics Placebo (n=1069) Ularitide (n=1088) Age (years) 68.3 ± ± 11.4 Men/women 706/ /374 Non-black, n (%) 973 (91.0%) 989 (90.9%) LV ejection fraction < 40%, n (%) 449 (65.9%) 445 (64.5%) Time to treatment 6 hours, n (%) 528 (49.4%) 533 (49.0%) Coronary artery disease, n (%) 549 (51.4%) 556 (51.1%) Diabetes, n (%) 429 (40.1%) 414 (38.1%) Prior heart failure (n,%) 806 (75.6%) 825 (75.9%) Systolic blood pressure ± ± 17.8 Heart rate (beats/min) 85.6 ± ± 18.8 N-terminal probnp (pg/ml), median (25,75 percentiles) 7121 (3974,12599) 7156 (4230,13238) Cardiac troponin T (pg/ml), median, (25,75 percentiles) 33 (21, 54) 34 (22, 54) Intravenous nitrates at baseline 110 (10.3%) 101 (9.3%) TRUE-AHF Investigators NEJM 2017
81 Ularitide Improves Cardiac Distension and Intravascular Congestion Systolic blood pressure N-terminal pro BNP at 48 hours mm Hg Baseline Study drug infusion Placebo Ularitide Hours After Randomization Final Change from baseline Ularitide P < % greater decrease Placebo n=1088 n=1069 TRUE-AHF Investigators NEJM 2017
82 Effect of Ularitide on In-Hospital Heart Failure Events During First 120 Hours Number of In-Hospital Worsening Heart Failure Events Study drug infusion P=0.005 Placebo Ularitide 6 hr 24 hr 48 hr 72 hr 120 hr Time Since Randomization TRUE-AHF Investigators NEJM 2017
83 Serelaxin is a Relaxin Receptor Agonist that Triggers Multiple Pathways in Acute Heart Failure 154 Metra, Teerlink HFA 2017
84 Valvular Intervention: Crossfertilization of Interventional Cardiology, Cardiac Surgery, Cardiovascular Imaging and Heart Failure Severe Mitral Regurgitation Patient remains symptomatic (NYHA III) despite optimal drug and CRT therapy Result after successful percutaneous MitraClip Implantation courtesy Stämpfli, Tanner, Maisano
85 Successful Weaning of a Ventricular Assist Device Delivery...5 months later...9 months later
86 Modern Management of Heart Failure The Heart Team Approach Palliative Care Medical therapy Heart Transplant ICD, CRT Mechanical Circulatory Support Acute Heart Failure Therapies Valvular Interventions Courtesy F. Maisano
87 We need a new Heart Failure Doctor! Comprehensive Heart Failure Management Requires doctors with know-how in all areas Diagnosis and Therapy of Chronic, Acute and Advanced HF Devices (Implantation, Programming, CRM, MCS) Imaging (pre-/post implant CRT, valvular interventions)
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95 4 days of scientific exchange healthcare professionals abstracts and cases submitted 120+ scientific sessions 300+ expert faculty members 100+ countries represented 45+ industry sessions /workshops Call for abstracts: 3 November - 13 January
96 Merci Frank Ruschitzka, MD, FRCP, FESC Professor of Cardiology University Zürich
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