1 / 69

Journal review

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

happy
Download Presentation

Journal review

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Journal review Trials on cardiac resynchronization therapy

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

  3. 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

  4. 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

  5. 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

  6. MUSTIC-SR results

  7. MUSTIC-AF • Same study design,41 pts • Significant imprvt,magnitude less than SR grp

  8. MUSTIC-AF results

  9. 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

  10. MIRACLE ICD • Trial design similar to MIRACLE • CRT+ICD Vs CRT • Included NYHA II also,all pts had class I indication for ICD

  11. NYHA II subgroup(MIRACLE-ICD)

  12. 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

  13. 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

  14. 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 %

  15. 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

  16. 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

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

  18. 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

  19. ESC guidelines

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. ESC guidelines

  27. 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)

  28. 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

  29. 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

  30. ESC guidelines

  31. 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)

  32. 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

  33. ESC guidelines

More Related