Cardiac Resynchronisation Therapy
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Cardiac Resynchronisation Therapy Presentation Transcript

  • 1. Cardiac Resynchronisation Therapy September 2008
  • 2. The Effect of Cardiac Resynchronization on Morbidity and Mortality in Heart Failure (CARE-HF) John G.F. Cleland, M.D., Jean-Claude Daubert, M.D., Erland Erdmann, M.D., Nick Freemantle, Ph.D., Daniel Gras, M.D., Lukas Kappenberger, M.D. and Luigi Tavazzi, M.D. N Engl J Med Volume 352;15:1539-1549 April 14, 2005
  • 3. Background
    • Despite pharmacological advances in treatment of HF, mortality & morbidity remain high
    • Cardiac dyssynchrony (regions of delayed myocardial activation & contraction) is common
    • Small studies (up to 6/12) cardiac resynchronisation therapy (CRT) improved quality of life, exercise capacity & ventricular function
    • Trials with CRT +/- ICD (COMPANION) showed that with CRT alone the decrease in risk of death was insignificant
    • Meta-analysis are inconclusive
    • This trial was designed to assess the effect of CRT on mortality in patients with severe HF
  • 4. Methods
    • Multicenter, randomised, non blinded, international trial comparing
    • “ the risk of complications & death of standard pharmacological therapy alone with that of combination of standard therapy and CRT (without ICD) in patients with LV systolic dysfunction, cardiac dyssynchrony and symptomatic heart failure”
    • 82 European centers between Jan 2001 & March 2003
    • Inclusion Criteria:
      • 18yrs+
      • HF for at least 6 weeks
      • NYHA III/IV
      • LVEF < 35%
      • QRS of at least 120ms
    • Exclusion Criteria:
      • Conventional indications for PPM/ICD
      • Major CV event in last 6/52
      • HF requiring IV therapy
      • Atrial arrhythymias
  • 5. Methods
    • End Points
      • Primary: Composite of death from any cause or an unplanned hospitalisation for major CV event (worsening HF, MI, USA, Stroke, Arrhythmia)
      • Secondary: Death from any cause, Quality of life assessment
    • Statistical Analysis
      • Intention to treat Principle
      • Statistical power of 80% to identify a 14% relative reduction given an α value of 0.025 & predicted number of events as 300
  • 6. Baseline Characteristics of the Patients Cleland, J. et al. N Engl J Med 2005;352:1539-1549
  • 7. Kaplan-Meier Estimates of the Time to the Primary End Point (Panel A) and the Principal Secondary Outcome (Panel B) Cleland, J. et al. N Engl J Med 2005;352:1539-1549
  • 8. Study Outcomes in Analyses Stratified According to NYHA Class Cleland, J. et al. N Engl J Med 2005;352:1539-1549
  • 9. Hemodynamic, Echocardiographic, and Biochemical Assessments Cleland, J. et al. N Engl J Med 2005;352:1539-1549
  • 10. Discussion
    • CRT substantially reduced risk of complications & death among patients with moderate/severe heart failure
    • Consistent with a reduction in cardiac dyssynchrony leading to improved physiological parameters and clinical outcome:
      • Quality of Life
      • Ventricular function
      • Blood pressure
      • Mortality
    • For every 9 devices implanted 1 death and 3 hospitalisations are prevented
  • 11. Cardiac Resynchronisation Therapy
  • 12. Background 1
    • Approx 25% of patients with CHF have intraventricular conduction delay; commonly LBBB
    • Electrical activation of lateral aspect of LV can be delayed in relation to that of RV and/or interventricular septum
    • This results in
      • Dyssynchronous electrical activation & contraction
      • Unequal distribution of myocardial workload
      • Altered myocardial blood flow & metabolism
    • Patients with conducting disease have worse prognosis from CHF
    • Patients with a paced RV end up having an artificially induced interventricular conducting delay and overall systolic function is poorer
  • 13. Procedure 2
    • Simultaneous pacing of RV & LV = Biventricular pacing
    • RA, RV & LV
    • LV paced via coronary sinus
  • 14. Physiological Effects
    • Doesn’t restore normal physiological conducting pattern
    • RA pacing with short AV delay ensures all beats are paced
    • RV & LV pacing reduces the delay in electrical activation of LV free wall
    • QRS duration tends to decrease
    • Haemodynamic response:
    • Increase in rate of rise of LV pressure
    • Increases pulse pressure, LV stroke volume
    • Improves myocardial function without increasing myocardial energy consumption
  • 15. Evidence
    • Early Trials : <500 patients, up to 1 year showed increases in functional capacity & improvements in quality of life
    • COMPANION 3 (ICD): mortality from all causes was reduced with CRT & ICD (p=0.003) but not from CRT alone (p=0.059)
    • CARE-HF 4 : mortality from all causes was reduced (p<0.002)
  • 16. Guidance for CRT 5
    • NICE May 2007 ; must fulfil ALL the below
    • NYHA III or IV
    • SR with QRS >150ms
    • SR with QRS 120-149ms & echo evidence of dyssynchrony
    • LVEF < 35%
    • Optimal pharmacological therapy
    • Cost: £3809
    • Number: 500/year
  • 17. Guidance for CRT-D 6
    • NICE May 2007 & January 2006
    • Criteria as before plus:
    • Primary Prevention
      • MI (>4/52) & either (LVEF <35% and NSVT on holter and inducible VT on EP studies) OR (LVEF <30% and QRS >120ms)
      • Familial Tendency (longQT, Brugada, HOCM, ARVD)
    • Secondary Prevention (in absence of treatable cause)
      • Post VT/VF arrest
      • Spontaneous sustained VT causing compromise
      • Sustained VT without compromise but LVEF >35%
    • Cost : £16000
    • Number : 500/year
  • 18. Adverse Effects
    • Unable to implant LV lead due to unfavourable anatomy (3-10%)
    • Diaphragmatic stimulation due to proximity of phrenic nerve
    • Coronary sinus dissection (0.3-4.0%)
    • Coronary sinus perforation & tamponade (0.8-2.0%)
    • Periprocedural death (0.4%)
    • Dislodgement of LV lead (10%)
    • Pneumothorax
    • Complete Heart Block
    • Asystole
    • Pacemaker pocket infection
    • External electromagnetic field
  • 19. Further Study
    • ? Benefit in NYHA I/II patients
      • REVERSE 7 : no significance at end point
      • MADIT-CRT: late 2009
    • Approx. 20-30% of patients with CRT are non-responders
      • Is the QRS duration a good predictor of CRT response?
      • Could echo evidence of ventricular dyssynchrony be more predictive? 8
      • “ Dyssynhcrony study” 9
    • Application in patients with AF?
  • 20. References
    • Jarcho JA. Biventricular Pacing. N Engl J Med 2006;355:288-294 http://content.nejm.org/cgi/content/full/355/3/288
    • Jarcho JA. Resynchronising Ventricular Contraction in Heart Failure. N Engl J Med 2005;352:1594-1597 http://content.nejm.org/cgi/content/full/352/15/1594
    • Bristow MR, Saxon LA, Boehmer J, et al. Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. (COMPANION) N Engl J Med 2004;350:2140-2150 http://content.nejm.org/cgi/content/full/352/15/1539
    • Cleland JGF, Daubert J-C, Erdmann E, et al. The effect of cardiac resynchronization on morbidity and mortality in heart failure (CARE-HF) N Engl J Med 2005;352:1539-1549 http://content.nejm.org/cgi/content/full/350/21/2140
    • NICE: Heart Failure – Cardiac Resynchronisation; May 2007 http://www.nice.org.uk/TA120
    • NICE: Arrhythmias – Implantable Cardioverter defibrillators: January 2006 http://www.nice.org.uk/TA95
    • Linde C, Abraham WT, Gold MR, Daubert J-C. Results of the REVERSE trial. Program and abstracts from the American College of Cardiology 2008 Scientific Sessions, March 29-April 1, 2008, Chicago, Illinois http://www.medscape.com/viewarticle/573311
    • Yu CM, Bax JJ, Monaghan M, Nihoyannopoulos. Echocardiographic evaluation of cardiac dyssynchrony for predicting a favourable response to cardiac resynchronisation therapy. Heart 2004;90:vi17-vi22 http://heart.bmj.com/cgi/content/full/90/suppl_6/vi17
    • Bax JJ, Ansalone G, Breithardt et al. Echocardiographic evaluation of CRT: ready for routine clinical use? J Am Coll Cardiol 2004;44:1-9 http://content.onlinejacc.org/cgi/content/full/44/1/1