2005 roma, convegno regionale, la terapia di resincronizzazione cardiaca nello scompenso cardiaco

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  • Cardiac Resynchronization Therapy

    Stefano Nardi, MD AZIENDA OSPEDALIERA SANTA MARIA TERNIDIPARTIMENTO CARDIOTORACOVASCOLARE STRUTTURA COMPLESSA DI CARDIOLOGIA UNITA OPERATIVA DI ARITMOLOGIA CARDIACA LABORATORIO DI ELETTROFISIOLOGIA ED ELETTROSTIMOLAZIONE

  • NYHA CLASSAnnual survival (%)Hospitalizations / year1007550250IIIIIIIV110SurvivalHospitalization.1Hospitalization / NYHA-classCardiac Resynchronization Therapy

  • Quality of Life for HF patientsHobbs FDR, et al. Eur Heart J 2002Cardiac Resynchronization Therapy

  • Delayed Ventricular ActivationSinusnodeAVnodeBundlebranch ordiffuse blockDelayed conductionDelayed AV sequenceMitral regurgitationDecreased filling timeWhat is abnormal in the HF pts?

    Cardiac Resynchronization Therapy

  • Dyssynchrony Ventricular ContractionSinusnodeAVnodeBundlebranch ordiffuse blockDelayed conductionAbnormal RV-LV sequenceAbnormal LV activation sequenceSegmentary dyskinesiaAggravation of mitral regurgitationDisynchrony of RV and LV filling flows

    What is abnormal in the HF pts?

    Cardiac Resynchronization Therapy

  • Reduced LVEF remains the single most important risk factor for overall mortality and SCD.1Increased risk is measurable at EF above 30%, but an EF 30% is the single most powerful independent predictor for SCD.2

    1Prior SG, Aliot E, Blonstrom-Lundqvist C, et al. Task Force on Sudden Cardiac Death of the European Society of Cardiology. Eur Heart J, Vol. 22; 16; August 2001.2 Myerburg RJ, Castellanos A. Cardiac Arrest and Sudden Cardiac Death, in Braunwald E, Zipes DP, Libby P, Heart Disease, A textbook of Cardiovascular Medicine. 6th ed. 2001. W.B. Saunders, Co., p. 895.

    Relationship of SCD and LV DysfunctionCardiac Resynchronization Therapy

  • Which is the prognostic value of QRS width ?VEST study analysisNYHA Class II IV pz3,654 ECGs digitally scannedAge, creatinine, LVEF, heart rate, and QRS duration found to be independent predictors of mortalityRelative risk of widest QRS group 5x greater than narrowestQRS Duration (msec)220Adapted from Gottipaty et al. JACC 1999; 33(2):145A (abstract 847-4)Cardiac Resynchronization Therapy

  • CHF Population in EuropeCHF Population6.5 MioNYHA III + IV (30 - 35%)1.95 MioWide QRS (10 - 30%)Resynchronization Rx Target Population: 195000650000Incidence = 580000 (9.0%)Mortality = 300000 (4.6%)

    Cardiac Resynchronization Therapy

  • WHO? Which criteria ?WHEN? Which NYHA class ?WHERE? RV+LV / LV ? WHY? Symptoms / Mortality ?KEY QUESTIONSCardiac Resynchronization Therapy

  • Optimizes AV contraction sequenceReduces pre-systolic mitral regurgitationImproves atrial preloading of the ventricleIncreases filling timeMechanism IAtrio-Ventricular SynchronyCardiac Resynchronization TherapyWhat does pacing change?

  • OAVD Restores AV SynchronyAuricchio et al, PACE 1998Cardiac Resynchronization Therapy

  • Optimizes ventricular activation Increases pumping effectiveness Reduces regional wall stress (WMSI) Decreases mitral regurgitation Resynchronizes ventricular filling flows Decreases filling pressuresCardiac Resynchronization TherapyMechanism IIVentricular CoordinationWhat does pacing change?

  • LV Lead Implant Historical EvolutionThoracic epicardial LV lead - 1994 1RV lead adapted for transvenous LV implant - 1996 2CS lead adapted for transvenous LV implant -1997 3Special designed transvenous LV lead - 1998 4Guiding catheter sheath for LV lead delivery -1998 5 1. Bakker et al. PACE 1994;2. Cazeau et al. PACE 1996; 3.Daubert et al. PACE 1997; 4. Gras et al. PACE 1998 5. Lurie et al. Circulation 1998Cardiac Resynchronization Therapy

  • Acute studiesBlanc et al., Circulation 199723 pts mean SDCardiac Resynchronization Therapy

  • Acute studiesKass et al, Circulation 99IntrinsicCardiac Resynchronization Therapy

  • PATH-CHF: Inclusion Criteria (42 pts)Dilated cardiomyopathy of any etiologyNYHA Class III (> 6 months) or NYHA IVOptimal individual drug therapy QRS duration >120 msec PR Interval >150 msecSinus rate > 55 bpmNo conventional pacemaker indicationAuricchio et al., NASPE 99PATH CHFCardiac Resynchronization Therapy

  • PATH CHF:Study DesignPATH CHFCardiac Resynchronization Therapy

  • MUSTIC Inclusion Criteria (67 pts)Dilated cardiomyopathy of any etiologyNYHA Class III Optimal individual drug therapy LBBB and QRS duration >150 msec LVEF60mm6-MWT
  • S.Cazeau et al NEJM 2001;344:873-80Cardiac Resynchronization TherapyMUSTIC Results (67 pts)

    ResultsActive pacingInactivepacingp6-min w (m)399 100326 134.0001QOL score29.6 21.343.2 22.8.0002VO2 (ml/min/Kg)16.2 4.715 4.90.02

  • MR areaLVESV and LVEDVLV Reverse RemodelingPacingNo pacingN = 25Cardiac Resynchronization TherapyMUSTIC Results (67 pts)

  • MIRACLE Inclusion Criteria (571 pts)Moderate or severe HF (NYHA III-IV)Stable optimal HF medical therapy regimen for >1mo Diuretics (93-94%) ACE-I or ARB (90-93%) if tollerated -blocker (55-62%) at stable regimen for>3 months QRS duration 150 msec LVEF 35% or LVEDD 55mm (echo measure)Sinus rate > 55 bpm 6 MWT
  • Cardiac Function and StructureChange in MR Jet Area-4-3-2-101Control(n=118)CRT(n=116)cm2P
  • Metabolic ExerciseBaseline (ml/kg/min)13.7 3.814.0 3.5Baseline (seconds)462 217484 209Cardiac Resynchronization TherapyMIRACLE Abraham WT, Fisher WG, Smith AL, et al. N Engl J Med 2002;346:1845-1853

  • Myocardial Oxidative MetabolismVO2 (ml/min/m2)DO2 (ml/min/m2)Cardiac Resynchronization TherapyO2ERCritical DO2 DISOXIACritical VO2VO2 = DO2 X O2ERNormal

  • Time to Death or Worsening HF requiring HospitalizationPatients At RiskCardiac Resynchronization TherapyMIRACLE

    Control22521420419719117970CRT22821821320920420199

  • SurvivalW.T. Abraham for MIRACLE and MIRACLE ICD InvestigatorsCardiac Resynchronization TherapyMIRACLE and MIRACLE ICD Trials

  • QOL & Functional Capacity 6 Months in Moderate to Severe HFQoL Score(MLWHF)Avg. ChangeData sources:MIRACLE: Circulation 2003;107:1985-90MUSTIC SR: NEJM 2001;344:873-80MIRACLE ICD:JAMA 2003;289:2685-94Contak CD: JACC 2003;2003;42:1454-59 Control CRTNYHA ClassProportionChanging 1 or more Classes Improve. Not ReportedCardiac Resynchronization Therapy

  • Exercise Capacity 6 Months in Moderate to Severe HF6 Min WalkAvg. Change(m)Data sources:MIRACLE: Circulation 2003;107:1985-90MUSTIC SR: NEJM 2001;344:873-80MIRACLE ICD:JAMA 2003;289:2685-94Contak CD: JACC 2003;2003;42:1454-59 Control CRTPeak VO2Avg. Change (mL/kg/min)Cardiac Resynchronization Therapy

  • Mortality/Morbidity from Published Randomized, Controlled Trials * P < 0.05Cardiac Resynchronization Therapy

  • Effects on Cardiac Function and Oxidative StressNelson et al. Circulation 2000Ukkonen et al. Circulation 2003n=7Cardiac Resynchronization Therapy

  • CRT Does Not Promote Ventricular ArrhythmiasAnalyzed 1,044 patients with ICDs from 2 trials:CONTAK CDMIRACLE ICD Odds ratio (CI):0.92 (0.67 1.27)Bradley DJ, et al. JAMA 2003Cardiac Resynchronization Therapy

  • Baseline ex CPXImplantAttemptSuccessfulImplantControlICDCRTCRT + ICD Pre-dischargeRandomization6 Month Follow-up6 Month Follow-upCRT DoubleBlindedStableMedicalTherapy 1weekClass NYHA IIIntent to treat analysesComparison between groupsCore labs: metabolic exercise, echocardiography, and neurohormone data

    CRT Long term follow up every 6 monthsCPXCardiac Resynchronization TherapyMIRACLE ICD II

  • 210 Class II429 Class III/IV98 Completed 6M FU82 Completed 6M FU101 Control (ICD+OPT)85 CRT (CRT+ICD+OPT)639 Enrolled and Implant Attempted19 Unsuccessful191 (91%) Successful186 Randomized5 not randomized 1 death 4 LV lead dislodge.Cardiac Resynchronization TherapyMIRACLE ICD II

    2Death21Missed 6M FU1

  • Reverse Remodeling in Class II CHF Control (n=85) CRT (n=69)Cardiac Resynchronization TherapyMIRACLE ICD II

  • Related RisksCardiac Resynchronization Therapy 1. Greenberg, et al. PACE 2003;26(4p2): 952 (Abstract 93) 2. Unpublished data. Medtronic. Inc.

    StudyPeriodAttemptsPrimary LV LeadMIRACLE11/98 12/00591Attain 2187Contak CD2/98 12/00517EasyTrakMIRACLE ICD10/99 8/01 636Attain 4189InSync III11/00 6/02 334Attain 4193

  • Cumulative Enrollment in C.R.T. Randomized Trials Actual ProjectedDOUG SMITHCardiac Resynchronization Therapy

  • BaselinePost-implantPatient Cost Baseline: 12,784 Euro Patient Cost (Implant included): 12,362 EuroPatient Cost Post-implant: 1,680 EuroHospital costs per patientCost EffectivenessAnalysis of Biventricular Pacing in HFCurnis A 2001Cardiac Resynchronization Therapy

  • Relative Cost of CRTDoug Smith:Cardiac Resynchronization Therapy

  • Weight of Evidence: CRTMore than 4000 patients evaluated in randomized controlled trialsConsistent improvement in QOL, functional status, and exercise capacityStrong evidence for reverse remodeling LV volumes and dimensions LV ejection fraction Mitral regurgitation Courtesy of Dr. Bill AbrahamCardiac Resynchronization Therapy

  • Reduced Mortality in Heart FailureFurther Reduction with CRT + ICD for Higher Risk PatientsCHFMortalitySuddenCardiac DeathCRTICDCardiac Resynchronization Therapy

  • Cardiac Resynchronization Therapy CRT in NYHA class II ? Which implication in pts with unstable Haemodinamic profile ? CRT in chronic Atrial Fibrillation ? CRT in Right Bundle Branch Block ? QRS
  • Creating Realistic patients expectationsCardiac Resynchronization TherapyApproximately two-thi

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