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  • Main purpose: Remind all of the poor quality of life that burdens heart failure patients Key messages: Patients with heart failure have statistically significant impairment of all aspects of their quality of life when compared with other chronic disorders. Additional information: From a community screening study involving over 4,000 people in Birmingham, UK. The SF 36 is a standard quality of life instrument that should be familiar to most clinicians. The lower the score, the more significant is the perceived impairment.
  • Masoudi and colleagues used retrospective medical chart data of 19,710 pts Medicare beneficiaries hospitalized w/ HF and for whom LV systolic function was confirmed. LBBB present in 8% of those with preserved LV systolic function (diastolic HF) and in 24% of those with EF < 50% (p<0.001). Aaronson developed and validated a multivariable survival model for ambulatory advanced heart failure patients wait listed for a heart transplant. IVCD (QRS > 120 ms) present in 27% of the 268 pts in derivation sample, and in 53% of the 199 pts in validation sample. IVCD identified as contributing risk factor. Other studies have shown that fro the entire HF population about 15% have a wide QRS.
  • Key message: A wide QRS is associated with a poor prognosis. Additional information: Baldasseroni: Study to determine whether LBBB associated w/ AF had independent, cumulative effect on mortality for CHF. Analysed 1-yr follow-up data for 5517 pts ( 63 + 12 yrs) from Italian Network on CHF (IN-CHF; 150 cardiology centers). Of these, 3328 (60.3%) had neither LBBB nor AF (group A), 1206 (2.9%) had isolated complete LBBB (group B), 798 (14.5%) had isolated chronic AF (group C), and 185 (3.3%) had complete LBBB associated w/ chronic AF (group D). Group D presented greater reduction in functional capacity (NYHA) and more significant clinical impairment (higher rate of pts w/ third heart sound, previous hospitalization for CHF, hypotension and cardiac enlargement). In Group D, cause of CHF was dilated cardiomyopathy (38.4%), ischaemic heart disease (35.1%), hypertensive heart disease (17.3%), and other aetiologies (9.2%). LBBB w/ AF (Group D) was associated w/ increased 1-yr mortality from any cause and sudden death and 1-yr hospitalization rate. Synergistic effect remained significant after adjusting for advanced HF clinical variables. LBBB w/ AF identifies CHF specific population w/ high risk of mortality. Iuliano: 669 HF pts (ischemic or nonischemic cardiomyopathy, NYHA II-IV heart failure. Median followup of 45 mo. Prolonged QRS was associated w/ increase in mortality (49.3% vs 34.0%) and sudden death (24.8% vs 17.4%). LBBB was associated w/ worse survival but not sudden death.
  • Main purpose: Illustrate for referral clinicians how the leads are placed to achieve cardiac resynchronization. Many outside the implant world may not be entirely aware of how the device is placed. Key messages: The implant procedure, while typically of longer duration, is similar to that of a standard pacemaker or implantable defibrillator implantation. A key difference is the placement of a left ventricular lead via the coronary sinus opening. Coronary venous anatomy varies significantly between patients. In a small percentage of cases it may not be possible to place the left ventricular lead transvenously. Some centers are opting for an epicardial approach if the transvenous approach is unsuccessful. Additional information: Standard pacing leads are placed in the right atrium and right ventricle. The LV lead is placed via the coronary sinus in a cardiac vein, preferably a lateral or postero-lateral vein in the mid part of the LV. The successful deployment of this lead to physician-guided development of left-heart delivery systems, and new LV leads to meet varying patient
  • Main purpose: Explain the risks of a CRT system implant to referral clinicians. Based on Medtronic’s MIRACLE study program and on Guidant’s Contak CD trial. Source of complications is abstract presented at NASPE 2003. Key messages: Each clinical trial utilized a clinical events review committee to evaluate complications, including defined procedure-related mortality. Chiefly due to challenging venous anatomy, implants have been unsuccessful in approximately 10% of patients attempted. Complication rates by category appeared to be reduced with the Medtronic Attain 4193, with an over-the-wire delivery system, used in the InSync III trial. Coronary sinus dissection or perforation generally were resolved without further complication. For comparison, the 30-day mortality in the CABG-PATCH and the AVID trials were 5.4% and 2.4% respectively. Left ventricular lead complications, primarily dislodgements, occurred in 9% of all cases (4% in the InSync II study). There is a learning curve. Implant times came down with increased center-based experience.
  • Main purpose: Show concordance of proof from randomized controlled trials that CRT improves quality of life and functional status. Key messages: Results from blinded studies that randomized 1,000 NYHA Class III/IV heart failure patients with a wide QRS show that CRT dramatically improves patients’ perceived quality of life and the clinicians’ assessment of functional status. The so-called placebo effect was expected. These studies were designed to assess whether there was a treatment effect, and all consistently demonstrated a positive effect.
  • University Medical Center Utrecht - Division heart & lungs Cardiostim 2008, 20-06-08 M. Meine
  • University Medical Center Utrecht - Division heart & lungs Cardiostim 2008, 20-06-08 M. Meine
  • University Medical Center Utrecht - Division heart & lungs Cardiostim 2008, 20-06-08 M. Meine
  • Approximately 300,000 Americans die from Sudden Cardiac Arrest every year. Data from 1996 shows that other major causes of death affected fewer people: SCA ~300,000 Stroke 160,500 Lung Cancer 153,000 Breast Cancer 44,100 AIDS 37,000 Fire 5,000
  • The majority (83%) of arrhythmias leading to SCA are tachyarrhythmias.
  • EF = left ventricular ejection fraction VT/VF = ventricular tachycardia – ventricular fibrillation Estimates of the incidence and total number of SCDs per year are shown for the overall adult population and for higher risk subgroups. The overall estimated incidence is 0.1 – 0.2% per year, totaling more than 300,000 deaths per year in the U.S.
  • Today’s dual-chamber devices can detect and treat bradyarrhythmias, as well as VT and VF. In addition, they can discriminate SVTs and other atrial tachyarrhythmias to reduce the incidence of inappropriate ventricular therapies, including inappropriate shocks. Treatment in the ventricle includes antitachycardia pacing (ATP), low-energy cardioversion and defibrillation for ventricular tachyarrhythmias (VT/VF). Treatment in the atrium AND the ventricle also includes brady sensing and pacing for bradyarrhythmias. Before the development of dual-chamber ICDs, VT/VF patients with symptomatic bradyarrhythmias would also receive a pacemaker implant. Dual-chamber devices were developed for use in patients with VT/VF who also have a bradyarrhythmia or pacing indication.

Transcript

  • 1. Modern Solutions to Heart Failure – role of devices Dr. P. Clarkson Consultant Cardiologist Raigmore Hospital Inverness
  • 2. Heart Failure - Demography
    • UK prevalence of 1.5%
    • Highland Population 3500 patients
    • Natural history - 5 year survival (male-Framingham) 25%
    • Modern drugs – 20% mortality at 2.5 yrs
    • 5% of medical admissions
    • Prevalence increasing with ageing population and greater survival of IHD patients
  • 3. Poor Quality of Life for HF patients Hobbs FDR, et al. Eur Heart J 2002;23:1867-1876
  • 4. Aetiology of heart failure
    • Valves?
    • Rhythm?
    • Pump (LV) function?
    • Also secondary causes e.g cor pulmonale with right heart failure
  • 5. Dilated Cardiomyopathy
  • 6. Mitral Stenosis
  • 7. NSF - Aim of treating cardiac failure
    • Improve symptoms / slow deterioration
    • Reduce mortality
    • Reduce cardiac events / admissions to hospital
    • Avoid adverse treatment effects
    • Improve end of life experience for both patients and carers
  • 8. Drugs
    • Diuretics – aim for lowest dose to control symptoms
    • ACE Inhibitors – start before b-blockers, start at low dose, titrate every few weeks, checking biochem at each increment
    • Spironolactone – if symptoms persist can add this in, but specialist advice recommended
    • Digoxin – if atrial fibrillation or severe heart failure despite ACE, b-blockers and diuretics
    • Aspirin – if combination of heart failure and atherosclerotic arterial disease
    • Statins if known atherosclerotic vascular disease
  • 9. Non medical treatment of heart failure
    • Transplantation
    • Biventricular pacing (resynchronisation)
    • Implantable defibrillators (ICD)
  • 10. Cardiac Transplantation
    • Final approach for advanced heart failure
    • In UK < 300 donor hearts per year and decreasing
    • Will never help more than a small percentage of heart failure patients
    • Xenotransplantation from GM pigs poses complex ethical dilemmas / clinical problems
  • 11. Cardiac Resynchronisation (CRT) – electrical timing
    • Disordered electrical timing frequent in damaged ventricles esp in LBBB
    • Normal ventricular activation is rapid with minimal time delay throughout ventricular wall
    • Intra LV delay causes dys-synchronous contraction
    • Mechanically inefficient.
    • Also redistributes mechanical load in LV reducing wall thickness at site of early activation
    • Delayed sequential activation of papillary muscles can aggravate MR
  • 12. Prevalence of Ventricular Dyssynchrony in Heart Failure 1. Masoudi, et al. JACC 2003;41:217-23 2. Aaronson, et al. Circ 1997;95:2660-7
  • 13. Prognosis with Ventricular Dyssynchrony Baldasseroni S, et al. Eur Heart J 2002;23:1692-98 N=5,517
  • 14. How to detect dys-synchrony
    • ECG – broad QRS complex
    • ECHO – often very obvious on ‘eyeball’
    • Other indices e.g. speckle tracking
  • 15. Ventricular Resynchronisation - CRT
    • Recently developed pacing strategy for severe heart failure
    • For patients with asynchronous LV contraction
    • Correction of intra LV conduction delay
    • Pacing leads in RA/RV/Cardiac veins
  • 16. Achieving Cardiac Resynchronization Goal: Atrial synchronous biventricular pacing Transvenous approach for left ventricular lead via coronary sinus Doug Smith: Right Atrial Lead Right Ventricular Lead Left Ventricular Lead
  • 17. CRT Procedure and Device Related Risks Venous anatomy highly variable 20% no vein in optimal site Phrenic nerve stimulation No stimulation in scar tissue Veins either too small or too large
  • 18. CRT Improves Quality of Life & Functional Capacity in Moderate to Severe Heart Failure QoL Score (MLWHF) Avg. Change Data sources: MIRACLE: Circulation 2003;107:1985-90 MUSTIC SR: NEJM 2001;344:873-80 MIRACLE ICD: JAMA 2003;289:2685-94 Contak CD: J Am Coll Cardiol 2003;2003;42:1454-59  Control  CRT NYHA Class Proportion Changing 1 or more Classes Improve.  Not Reported
  • 19. CRT Symptom benefit
    • All RCT’s have shown alleviation of symptoms and increased exercise capacity
    • On average NYHA decreased by 0.5-0.8
    • 6 min walk distance increased by 20%
    • VO2 max increased by 10-15%
    • Lowers hospitalisation by 39-76%
    • With current selection only 70% respond
  • 20. Pre Device 1 Day post CRT 2 Months post CRT 1 Year post CRT
  • 21. Mortality effects of CRT
  • 22. Cardiac Resynchronisation- NICE guidance -2007
    • LVEF < 35%
    • NYHA 3 – 4 recently experienced
    • Sinus Rhythm
    • QRS > 150ms or >120ms plus echo dys-synchrony
    • Optimal Medical Therapy
    • SIGN 2007 – very similar QRS>120ms
  • 23. MADIT-CRT (III) N Engl J Med 2009;361
  • 24. Methods – MADIT-CRT
    • enrollment: N = 1820, 12/2004 – 04/2008
    • inclusion:
      • ICMP NYHA I,II (N = 265, 734)
      • NICMP NYHA II (N = 821)
      • EF ≤ 30% (mean EF = 24 %)
      • QRS ≥ 130 ms (65 % had QRS ≥ 150 ms, 70 % LBBB)
      • stable CHF, optimal medication, SR at least 1 m before enrollment
    • randomization CRT-D (3) : ICD (2)
    Moss et al., N Engl J Med 2009;361
  • 25.  
  • 26. Sub-analysis MADIT-CRT Moss et al., N Engl J Med 2009;361
  • 27. 2010 European Guidelines
    • All for LVEF <35%
    • NYHA III-IV, QRS>120ms, SR, optimal med
    • NYHA II, QRS>150ms, SR, optimal med
    • NYHA III-IV, QRS>130ms, AF but slow enough to pace 95%, optimal meds
    • Needs an anti bradycardia PPM with NYHA III-IV and QRS>120ms
  • 28. Current challenges in CRT
    • Patient selection – only 70% respond
    • Lack of perfect screening/selection tool
    • Limitations of anatomy
    • Mechanistic research still required
  • 29. TriVentricular CRT
    • 2 CS and RV lead
    2 RV and CS lead
  • 30. 6 minute walk p = 0.008
  • 31. Responders
    • BiV:
    • TriV:
    70% 81%
  • 32. How are we doing with CRT?
  • 33. Implantable Defibrillators in heart failure
  • 34.  
  • 35. Sudden Cardiac Arrest is one of the Leading Causes of Death in the U.S. In UK 50,000 – 70,000 sudden cardiac arrests per annum 0 5 0 , 0 0 0 1 0 0 , 0 0 0 1 5 0 , 0 0 0 2 0 0 , 0 0 0 2 5 0 , 0 0 0 3 0 0 , 0 0 0 A I D S B r e a s t C a n c e r L u n g C a n c e r S t r o k e S C A
  • 36. Underlying Arrhythmia of Sudden Cardiac Arrest Survival rate for OOHCA is <5% Primary VF 8% Torsades de Pointes 13% Bradycardia 17% VT 62%
  • 37. Rhythm Strip During Episode of Sudden Death Josephson, ME 6:02 AM 6:05 AM 6:07 AM 6:11 AM
  • 38. Sudden Cardiac Death Incidence and Total Events
    • Overall Incidence in Adult Population
    Source: Myerburg RJ. Circulation. 1992;85(suppl I):I-2 – I-10. High Coronary Risk Sub-Group Any Prior Coronary Event EF < 30% Heart Failure Out-of-Hospital Cardiac Arrest Survivors 30 20 10 5 2 1 0 (%) Incidence (%/Year) 300 200 100 0 (x 1000) Total Events (#/Year)
  • 39. Severity of Heart Failure . Modes of Death NYHA II 12% 64% 24% CHF Other Sudden Death Deaths = 103 NYHA IV 56% 11% 33% CHF Other Sudden Death Deaths = 27 NYHA III 26% 15% 59% CHF Other Sudden Death Deaths = 232
  • 40. Therapies Provided by Today’s Dual-Chamber ICDs Atrium & Ventricle Ventricle
    • Antitachycardia pacing
    • Cardioversion
    • Defibrillation
    • Bradycardia sensing
    • Bradycardia pacing
  • 41. Defibrillators –Primary Prevention Guidance post MI
    • NICE guidance - 2006
    • Post MI > 4 weeks NYHA I-III and either
    • LVEF < 30% and QRS > 120ms or
    • LVEF < 35% and non sustained VT on Holter monitoring and inducible VT on EP Testing
    • SIGN guidance – 2007 and ESC 2010
    • 1/12 post MI NYHA I-III and LVEF <35%
  • 42. Number of ICD implants
    • NICE – 5.8% of post MI should get an ICD
    • ESC - 37% of post MI should get an ICD
    • Approx cost £10,000
  • 43. Non-ischaemic cardiomyopathy - guidance
    • NICE/SIGN – None!
    • ESC – LVEF<35% NYHA II-III good functional status
  • 44. How are we doing with ICD’s
  • 45. Biventricular ICD’s
    • Essentially a combination of ICD and CRT devices
    • Current indication - those who fulfil criteria for both ICD and CRT
  • 46. Heart Failure and Devices – Summary
    • Common Condition
    • Complex Therapeutics
    • Expanding and changing treatment strategies
    • Expanding role for devices
    • ICD’s – consider if LVEF < 35% and not NYHA IV
    • CRT – consider if LVEF < 35%, QRS > 120ms and has symptoms