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Journal review. Trials on cardiac resynchronization therapy. Early trials Randomised controlled trials Specific issues NYHA I/II AF Narrow QRS Upgradation of pacemaker Echo assessment of dyssynchrony Role of CMR. Cazeau et al ,1994 54yr,NYHA IV,LBBB,QRS dur200 ms

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journal review

Journal review

Trials on cardiac resynchronization therapy

slide2

Early trials

  • Randomised controlled trials
  • Specific issues
    • NYHA I/II
    • AF
    • Narrow QRS
    • Upgradation of pacemaker
    • Echo assessment of dyssynchrony
    • Role of CMR
slide3

Cazeau et al ,1994

    • 54yr,NYHA IV,LBBB,QRS dur200 ms
    • Temp. 4 chamber pacing-improved hemodynamics
    • Permanent 4 chamber pacing-6 wks-marked clinical imprvt
  • Observational studies
  • Epicardial leads to transvenous leads
  • Various pacing sites
path chf
PATH-CHF
  • First randomised controlled trial,2001
  • 42 pts,NYHA III/IV,ischemic or non ischemic,SR,QRS 120ms,PR 150ms
  • Univentricular Vs biventricular pacing
  • Primary endpoints-Oxygen consumption at peak exercise and at anerobic threshold,6-minute walk distance
  • Secondary endpoints-changes in New York Heart Association functional class, hospitalization frequency and quality of life
  • Trend towards improvement in all primary &sec endpts with biventricular pacing
mustic sr
MUSTIC-SR
  • Single blind,randomised,crossover study
  • NYHAIII,SR,EF<35%,LVEDD>60,QRS>150ms,6min walk<450m
  • 47pts completed
  • Randomised to resynchronization or to no pacing for 3 mth,crossed over to alternative group for 3 mths,followed up for 12 mths
  • Primary endpt-6-min walked distance
  • Sec-peak Vo2, quality of life, NYHA class,worseningHF,total mortality
  • Significant improvement
mustic af
MUSTIC-AF
  • Same study design,41 pts
  • Significant imprvt,magnitude less than SR grp
miracle
MIRACLE
  • first prospective, randomized,doubleblind,parallel-controlled clinical trial
  • Idiopathic or ischemic dilated cardiomyopathy, NYHA class III/IV , LVEF<35 %,LVEDD> 55 mm,QRS>130 ms,6min.walk<450 m
  • CRT(n=228) Vs control(n=225) for 6 mths
miracle icd
MIRACLE ICD
  • Trial design similar to MIRACLE
  • CRT+ICD Vs CRT
  • Included NYHA II also,all pts had class I indication for ICD
contak cd
CONTAK-CD
  • randomized controlled, double-blind study
  • 6-month parallel control study design
  • NYHA II–IV ,LVEF< 35%, QRS>120 ms,indication for an ICD.
  • 581 patients were randomized, 248 into 3 mth crossover study and 333 into the 6-month parallel controlled trial.
  • Primary endpnt was a composite of mortality, hospitalizations for HF &VT/VF-insignificant trend favoring CRT grp
  • Sec endpts-peak Vo2, 6-min.walk distance, quality of life, and NYHA class-significant imprvnt in CRT grp
  • Imprvmnt NYHA class III–IV subgroup
companion
COMPANION
  • 1520 patients,NYHA III or IV ,ischemic or nonischemiccardiomyopathy,LVEF<35%, QRS ≥120 msec,PRint>150 ms, sinus rhythm, no clinical indication for pacemaker or ICD
  • Randomly assigned in a 1:2:2 ratio to receive OMT,OMT+CRT,OMT+CRT-D
  • Primary composite endpt-death from or hospitalization for any cause
  • Sec endpt-death from any cause
  • Death from or hospitalization for cardiovascular causes and death from or hospitalization for heart failure also noted
slide20

Implantation successful in 87% in CRT,91% in CRT-D

  • Follow-up 11.9 months OMT,16.2 months in CRT,15.7 months in CRT-D
  • CRT&CRT-D reduced the risk of the primary end point by 20 %
slide23

Death from or hospitalization for heart failure

    • reduced by 34 percent in the pacemaker group(P<0.002)
    • 40 percent in the pacemaker–defibrillator group (P<0.001)
  • Death from any cause reduced by
    • 24 percent (P=0.059) in CRT
    • 36 percent (P=0.003) in CRT-D
care hf
CARE-HF
  • Mortality benefit with CRT alone not significant in COMPANION
  • NYHA class III or IV,LVEF<35%,LVEDD>30 mm (indexed to height),QRS≥150 ms/>120 ms +echo evidence of dyssynchrony,SR,no indication for pacing
  • Primary end point-composite of death from any cause or an unplanned hospitalization for a major cardiovascular event
  • Secondary outcome-death from any cause,composite of death from any cause and hospitalization with heart failure,NYHA class and quality of life
  • OMT-404 patients Vs OMT+CRT-409,mean follow-up 29.4 mths
slide28

McAlister et al,2004-meta-analysis of several CRT trials- HF hospitalizations were reduced by 32% and all-cause mortality by 25%

ahascience advisory 2005 guidelines 2008 update 2009
AHAscience advisory-2005,guidelines 2008,update 2009
  • Sinus rhythm
  • LVEF <35%
  • Ischemic or nonischemiccardiomyopathy
  • QRS complexduration 120 ms
  • NYHA functional class III or IV
  • Maximal pharmacological therapy for heart failure
crt in nyha i ii
CRT in NYHA I/II
  • MIRACLE ICD,CONTAK CD-earlier trials
  • MADIT CRT,REVERSE-reduced morbidity
  • MADIT CRT
    • 1820 patients
    • Ischemic I/II or nonischemiccardiomyopathy II
    • EF 30% or less
    • QRS duration of ≥130msec
    • NYHA I/II
  • 3:2 ratio,CRT+ICD(n=1089) Vs ICD alone (n=731)
  • Follow-up of 2.4 years
slide32

Primary end point:death or heart failure

    • CRT–ICD group (17.2%)Vs ICD-only group (25.3%) (hazard ratio=0.66; P = 0.001)
  • 34% reduction in the risk of death or heart failure
  • Superiority of CRT was driven by a 41% reduction in the risk of heart-failure events,primarily in subgroup with a QRS >150 ms
reverse
REVERSE
  • NYHA Class II or I (previously symptomatic),QRS  120 ms; LVEF  40%; LVEDD  55 mm ,SR,Optimal medical therapy (OMT)
  • 610 pts,12 mth follow up
slide38

Primary Composite endpoint : all-cause mortality, HF hospitalizations, crossover due to worsening HF, NYHA class, and the patient global assessment assessed in double blind manner

  • Secondary: Left Ventricular End Systolic Volume Index
slide39

No significant difference primary end point

  • Significant degree of reverse LV remodelling was observed in CRT, manifested by decreases in the LVESV&LVEDV and increase in LVEF
  • LV end-systolic volume index was significantly smaller in CRT grp
slide40

MADIT-CRT and REVERSE enrolled a small proportion of asymptomatic patients, only 15% and 18%, respectively

  • NYHA class I, MADIT-CRT did not show significant reduction in the all-cause mortality or HF by CRT over ICD
  • REVERSE-trend toward less clinical efficacy conferred by CRT among class I compared to class II
crt in af
CRT in AF
  • Prevalence of AF in patients with HF-5% in NYHA I as compared with 25–50% in NYHA III/IV
  • Intrinsic AF rhythm reduces the percentage of effectively biventricular paced captured beats (BVP%).
  • Effective ‘CRT-dose’ may be reduced compared to atrial-synchronous rhythm with a short AV interval (as in SR)
slide44

MUSTIC AF first randomized trial demonstrating possible benefits of CRT in HF in pts with permanent AF

  • Two trials comparing CRT in SR Vs AF-comparable but benefit more in SR-Leclercq et al (AJC 2000),Molhoek et al (AJC 2004)
  • OPSITE trial- ‘rate control’ by AVJ ablation significantly improved symptoms &functional status
  • PAVE trial-‘ablate and pace’ approach-greater benefit of the BVP mode in patients with depressed LVEF (45%) and/or in NYHA functional class III
slide46

5 studies followig a total of 1,164 patients

  • Mortality was not significantly different at 1 year
  • NYHA class improved similarly both groups
  • SR patients showed greater relative improvement in 6-min walk&Minnesota score
  • AF patients-statistically significant greater change in ejection fraction
upgradation to biventricular pacing
Upgradation to biventricular pacing
  • small prospective studies
  • Clinical benefit of upgrading to biventricular pacing with long-standing right ventricular pacing, severe ventricular dysfunction, NYHA class III symptoms, regardless of QRS duration- Vatankulu MA et al(AJC 2009),Paparella G(Pacing clinele 2010)
  • Detrimental effects of RV pacing on symptoms and LV function in patients with HF of ischaemic origin and preserved LVEF (Kindermann M et al ,HOBIPACE-JACC 2006)
slide49

In patients with a conventional indication for pacing, NYHA III/IV symptoms, an LVEF of ≤35%, and a QRS width of ≥120 ms,CRT-P/CRT-D is indicated.

  • RV pacing will induce dyssynchrony
  • Chronic RV pacing in patients with LV dysfunction should be avoided
  • CRT may permit adequate up-titration of B-blocker
crt in narrow qrs
CRT in narrow QRS
  • RethinQ study
  • Patients with a indication for ICD,LVEF<35%, NHYA class III heart failure,QRS<130 ms,echo evidence of dyssynchrony
  • 172 patients,6 months follow up
  • Primary end point was the proportion of patients with an increase in peak oxygen consumption
  • CRT group and the control group did not differ significantly in proportion of patients with the primary end point (46% Vs 41%)
  • No significant difference in HF events
prospect
PROSPECT
  • 498 patients with standard CRT indications
  • Twelve echocardiographic parameters of dyssynchrony
  • Positive CRT response were improved clinical composite score and 15% reduction in LVESV at 6 months
  • Ability of the 12 echo parameters to predict clinical composite score response-
    • sensitivity ranging from 6% to 74%
    • specificity ranging from 35% to 91%
  • No single echocardiographic measure of dyssynchrony may be recommended to improve patient selection for CRT beyond current guidelines
role of cmr in crt
Role of CMR in CRT
  • Venous anatomy
    • assessed noninvasively to determine whether a transvenous approach is feasible or surgical approach should be used for LV lead placement
  • Assessment of dyssynchrony:
    • 77 patients undergoing CRT, those with a CMR-TSI ≥ 110 ms were more likely to meet the endpoints of death or adverse cardiac events
    • Leyva F et al:JACC 2007
slide63

Internal flow fraction fraction (IFF) is defined as the total internal flow as a percentage of stroke volume

  • IFF of 10 ± 5% in typical CRT patients (NYHA class III or IV,LVEF < 35%, QRS > 150 ms) and of 1 ± 1% in the healthy controls (p < 0.001)
  • IFF cut-off of 4% discriminated b/w patients and controls with 90% sensitivity and 100% specificity.
  • Fornwalt et al (JMRI,2008)
slide64

Assessment of scar

    • White et al-scar burden < 15% as the best cut-off for predicting a clinical response to CRT
  • LV lead placement
    • pacing outside the LV free wall scar is associated with a better response than pacing over thescar (86% vs 33%, p = 0.004)
conclusion
Conclusion
  • CRT is an accepted modality of treatment with mortality benefit in NYHA III/IV HF
  • Reduce morbidity in NYHA II
  • No evidence of benefit in HF with narrow QRS
  • In AF with III/IV HF reduces morbidity&AV nodal ablation may be necessary
  • Echo parameters of dyssynchrony not proven to be useful
  • CMR may prove to be useful to assess dyssynchrony and feasibility of CRT