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

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<ul><li><p> Cardiac Resynchronization Therapy </p><p>Stefano Nardi, MD AZIENDA OSPEDALIERA SANTA MARIA TERNIDIPARTIMENTO CARDIOTORACOVASCOLARE STRUTTURA COMPLESSA DI CARDIOLOGIA UNITA OPERATIVA DI ARITMOLOGIA CARDIACA LABORATORIO DI ELETTROFISIOLOGIA ED ELETTROSTIMOLAZIONE </p></li><li><p>NYHA CLASSAnnual survival (%)Hospitalizations / year1007550250IIIIIIIV110SurvivalHospitalization.1Hospitalization / NYHA-classCardiac Resynchronization Therapy</p></li><li><p>Quality of Life for HF patientsHobbs FDR, et al. Eur Heart J 2002Cardiac Resynchronization Therapy</p></li><li><p>Delayed Ventricular ActivationSinusnodeAVnodeBundlebranch ordiffuse blockDelayed conductionDelayed AV sequenceMitral regurgitationDecreased filling timeWhat is abnormal in the HF pts?</p><p>Cardiac Resynchronization Therapy</p></li><li><p>Dyssynchrony Ventricular ContractionSinusnodeAVnodeBundlebranch ordiffuse blockDelayed conductionAbnormal RV-LV sequenceAbnormal LV activation sequenceSegmentary dyskinesiaAggravation of mitral regurgitationDisynchrony of RV and LV filling flows</p><p>What is abnormal in the HF pts?</p><p>Cardiac Resynchronization Therapy</p></li><li><p>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</p><p>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.</p><p>Relationship of SCD and LV DysfunctionCardiac Resynchronization Therapy</p></li><li><p>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</p></li><li><p>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%)</p><p>Cardiac Resynchronization Therapy</p></li><li><p>WHO? Which criteria ?WHEN? Which NYHA class ?WHERE? RV+LV / LV ? WHY? Symptoms / Mortality ?KEY QUESTIONSCardiac Resynchronization Therapy</p></li><li><p>Optimizes AV contraction sequenceReduces pre-systolic mitral regurgitationImproves atrial preloading of the ventricleIncreases filling timeMechanism IAtrio-Ventricular SynchronyCardiac Resynchronization TherapyWhat does pacing change?</p></li><li><p>OAVD Restores AV SynchronyAuricchio et al, PACE 1998Cardiac Resynchronization Therapy</p></li><li><p> 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?</p></li><li><p>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</p></li><li><p>Acute studiesBlanc et al., Circulation 199723 pts mean SDCardiac Resynchronization Therapy</p></li><li><p>Acute studiesKass et al, Circulation 99IntrinsicCardiac Resynchronization Therapy</p></li><li><p>PATH-CHF: Inclusion Criteria (42 pts)Dilated cardiomyopathy of any etiologyNYHA Class III (&gt; 6 months) or NYHA IVOptimal individual drug therapy QRS duration &gt;120 msec PR Interval &gt;150 msecSinus rate &gt; 55 bpmNo conventional pacemaker indicationAuricchio et al., NASPE 99PATH CHFCardiac Resynchronization Therapy</p></li><li><p>PATH CHF:Study DesignPATH CHFCardiac Resynchronization Therapy</p></li><li>MUSTIC Inclusion Criteria (67 pts)Dilated cardiomyopathy of any etiologyNYHA Class III Optimal individual drug therapy LBBB and QRS duration &gt;150 msec LVEF60mm6-MWT</li><li><p>S.Cazeau et al NEJM 2001;344:873-80Cardiac Resynchronization TherapyMUSTIC Results (67 pts)</p><p>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</p></li><li><p>MR areaLVESV and LVEDVLV Reverse RemodelingPacingNo pacingN = 25Cardiac Resynchronization TherapyMUSTIC Results (67 pts)</p></li><li>MIRACLE Inclusion Criteria (571 pts)Moderate or severe HF (NYHA III-IV)Stable optimal HF medical therapy regimen for &gt;1mo Diuretics (93-94%) ACE-I or ARB (90-93%) if tollerated -blocker (55-62%) at stable regimen for&gt;3 months QRS duration 150 msec LVEF 35% or LVEDD 55mm (echo measure)Sinus rate &gt; 55 bpm 6 MWT </li><li>Cardiac Function and StructureChange in MR Jet Area-4-3-2-101Control(n=118)CRT(n=116)cm2P</li><li><p>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</p></li><li><p>Myocardial Oxidative MetabolismVO2 (ml/min/m2)DO2 (ml/min/m2)Cardiac Resynchronization TherapyO2ERCritical DO2 DISOXIACritical VO2VO2 = DO2 X O2ERNormal</p></li><li><p>Time to Death or Worsening HF requiring HospitalizationPatients At RiskCardiac Resynchronization TherapyMIRACLE</p><p>Control22521420419719117970CRT22821821320920420199</p></li><li><p>SurvivalW.T. Abraham for MIRACLE and MIRACLE ICD InvestigatorsCardiac Resynchronization TherapyMIRACLE and MIRACLE ICD Trials</p></li><li><p>QOL &amp; 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</p></li><li><p>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</p></li><li><p>Mortality/Morbidity from Published Randomized, Controlled Trials * P &lt; 0.05Cardiac Resynchronization Therapy</p></li><li><p>Effects on Cardiac Function and Oxidative StressNelson et al. Circulation 2000Ukkonen et al. Circulation 2003n=7Cardiac Resynchronization Therapy</p></li><li><p>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</p></li><li><p>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</p><p>CRT Long term follow up every 6 monthsCPXCardiac Resynchronization TherapyMIRACLE ICD II</p></li><li><p>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</p><p>2Death21Missed 6M FU1</p></li><li><p>Reverse Remodeling in Class II CHF Control (n=85) CRT (n=69)Cardiac Resynchronization TherapyMIRACLE ICD II</p></li><li><p>Related RisksCardiac Resynchronization Therapy 1. Greenberg, et al. PACE 2003;26(4p2): 952 (Abstract 93) 2. Unpublished data. Medtronic. Inc.</p><p>StudyPeriodAttemptsPrimary LV LeadMIRACLE11/98 12/00591Attain 2187Contak CD2/98 12/00517EasyTrakMIRACLE ICD10/99 8/01 636Attain 4189InSync III11/00 6/02 334Attain 4193</p></li><li><p>Cumulative Enrollment in C.R.T. Randomized Trials Actual ProjectedDOUG SMITHCardiac Resynchronization Therapy</p></li><li><p>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</p></li><li><p>Relative Cost of CRTDoug Smith:Cardiac Resynchronization Therapy</p></li><li><p>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</p></li><li><p>Reduced Mortality in Heart FailureFurther Reduction with CRT + ICD for Higher Risk PatientsCHFMortalitySuddenCardiac DeathCRTICDCardiac Resynchronization Therapy</p></li><li>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</li><li><p>Creating Realistic patients expectationsCardiac Resynchronization TherapyApproximately two-third of patients should experience improvement (responders vs. non-responders)1Some patients may not experience immediate improvement</p></li><li><p>Creating Realistic patients expectationsHave patients set their own goals of what they would like to do following CRT: Grocery shopping, Decreasing Lasix dose Walking to the mailbox without stopping, Lying flat to sleepEncourage them to be part of the group that responds to their therapyCardiac Resynchronization Therapy</p><p>HF is a progressive disease with no therapeutic option to cure the illness. This graph shows the correlation between the severity of HF expressed by the 4 NYHA functional classes and survival as well as hospitalization. You can see a very clear decrease of survival (or in other words: an tremendous increase of mortality) and an increase in the frequency of hospital admissions with increasing NYHA function class. Main purpose: Remind all of the poor quality of life that burdens heart failure patientsKey messages: Patients with heart failure have statistically significant impairment of all aspects of their quality of life when compared with other chronic disorders.Additional information:From a community screening study involving over 4,000 people in Birmingham, UK. The SF 36 is a standard quality of life instrument that should be familiar to most clinicians. The lower the score, the more significant is the perceived impairment.Bakker P, Meijburg H, de Jonge N, van Mechelen R, Wittkampf F, Mower M, Thomas A. Beneficial effects of biventricular pacing in congestive heart failure. PACE 1994;17:820 (abstract 318). CPI study of 5 NYHA Class III/IV pts with DCM, complete LBBB and prolonged PR interval. DDD pacemaker implanted with endocardial RV lead and epicardial LV lead. LV capture lost in 1 pt at 3 months, who had improved initially. 4 pts improved at least 1 NYHA Class at 3 months.Cazeau S, Ritter Ph, Lazarus A, Gras D, Backdach H, Mundler O, Mugica J. Multisite pacing for end-stage heart failure: early experience. PACE 1996;19[II]:1748-1757. Initial experience on 8 pts with wide QRS (mean 200 35 ms) and end-stage HF (NYHA Class IV) with biventricular pacing including 5 pts with transvenous LV system. Daubert JC, Ritter Ph, Gras D, Pavin D, Cazeau S, Mabo Ph. Use of specifically designed coronary sinus leads for permanent left ventricular pacing: preliminary experience. PACE 1997; 20[II]:? (NASPE abstract 17). 15 pts, mean follow-up 6 months (2-10) with either model 2188 or custom 2879 (2188 with different bend) implanted in the LV. Successful implant in 11 pts (73%). 1.30.7 V pacing threshold acutely vs. 1.91.0 V threshold chronically. No lead dislodgment or other lead-related complication was observed. In conclusion, this preliminary experience is encouraging in terms of feasibility, safety and long term results. Further improvement in lead configuration is needed to increase implantation success rate. Gras D, Mabo Ph, Tscheliessnigg KH, Pedersen AK, Tang T. Early results regarding implant procedures of a new biventricular atrial synchronized pacing system. PACE 1998; 21[II]:824 (NASPE Abstract). 18 DCM pts. 16 successful implants (89%), 14 in lateral vein, 2 in GCV. Total procedure duration: 101 35 min. Fluoroscopic time: 24 12 min. Lurie K, , Benditt D, Samiah N, Blanc JJ. A transvenous Long Guiding Sheath technique for permanent left ventricular pacing lead implantation in patients with heart failure. Circulation 1998; 98[17]: I-841 (abstract 4414). Report on use of a 45 cm radiopaque peel away introducer sheath by Daig for LV lead placement. The steps: 1) sheath is placed in SVC as introducer; 2) EP catheter (Daig CSL) is put through the sheath and introduced into the CS; 3) A venogram is obtained using the EP catheter; 4) sheath is advanced over the EP catheter into the CS; 5) EP catheter is removed; 6) LV lead (std RV leads used) is placed through the sheath into the CS. 80% success rate with no complications in 20 pts. Main purpose: Demonstrate evidence of left ventricular reverse remodeling.Key messages: Following 3 months of chronic cardiac resynchronization, LV volumes return slowly to baseline, pre-implant levels after the device is turned off indicating reverse remodeling. On the other hand, mitral regurgitation increases acutely, a finding corroborated by Breithardt and colleagues (J Am Coll Cardiol 2003;41:76570).Key Points: (Note a subset of the 453 patients provide the paired data) Measures of both cardiac function and cardiac structure showed improvement with cardiac resynchronization. A 4.6 percentage point improvement in LVEF within the CRT group of patients contrasted significantly with a reduction of 0.2 percentage points in the Control group. Likewise, patients receiving CRT showed a reduction in mitral regurgitation (-2.7 cm2)that was statistically significantly greater than the modest improvement (-0.5 cm2) observed within the Control group of patients. The reduction in left ventricular end diastolic diameter of 3.5 mm for CRT patients was significant compared with no change on average for Control group patients.Other Information: Echocardiographic results are from a single observer at a core laboratory (University of Pennsylvania). All data are paired; data for the same patients are shown for each time point. While ventricular pacing spikes were often observed on the simultaneously recorded ECG, each echo study was blinded with regard to identity and analyzed individually and without reference to echocardiographic images or knowledge of measurements from other studies of the same patient. Key Points: (Note a subset of the 453 patients provide the paired data) Peak...</p></li></ul>

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