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Cardiac Resynchronisation Therapy. September 2008. The Effect of Cardiac Resynchronization on Morbidity and Mortality in Heart Failure (CARE-HF).

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Cardiac Resynchronisation Therapy


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slide2

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

background
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
methods
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
methods1
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
slide6

Baseline Characteristics of the Patients

Cleland, J. et al. N Engl J Med 2005;352:1539-1549

slide7

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

slide8

Study Outcomes in Analyses Stratified According to NYHA Class

Cleland, J. et al. N Engl J Med 2005;352:1539-1549

slide9

Hemodynamic, Echocardiographic, and Biochemical Assessments

Cleland, J. et al. N Engl J Med 2005;352:1539-1549

discussion
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
background 1
Background1
  • 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
procedure 2
Procedure2
  • Simultaneous pacing of RV & LV = Biventricular pacing
  • RA, RV & LV
  • LV paced via coronary sinus
physiological effects
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
evidence
Evidence
  • Early Trials: <500 patients, up to 1 year showed increases in functional capacity & improvements in quality of life
  • COMPANION3(ICD): mortality from all causes was reduced with CRT & ICD (p=0.003) but not from CRT alone (p=0.059)
  • CARE-HF4: mortality from all causes was reduced (p<0.002)
guidance for crt 5
Guidance for CRT5

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

guidance for crt d 6
Guidance for CRT-D6

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

adverse effects
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
further study
Further Study
  • ? Benefit in NYHA I/II patients
    • REVERSE7: 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?
references
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