心脏再同步化治疗临床应用：COMPANION研究和CARE-HF研究课件.ppt

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1、May 2005EP ShowThe EP ShowCOMPANION and CARE-HFEric Prystowsky MDDirector,Clinical Electrophysiology Laboratory St Vincent HospitalIndianapolis,INHugh Calkins MDDirector,Electrophysiology LabJohns Hopkins University Medical CenterBaltimore,MDJohn Cleland MDProfessor of CardiologyHull University King

2、ston upon Hull,UKMay 2005EP ShowUse of cardiac resynchronization therapy(CRT)in COMPANION and CARE-HFMay 2005EP ShowBrief history Large group of patients in need of ICDs for primary preventionNew era of biventricular pacing to improve HF symptomsCOMPANION and CARE-HFMay 2005EP ShowComparison of Medi

3、cal Therapy,Pacing,and Defibrillation in Heart FailureCOMPANIONMay 2005EP ShowCOMPANIONDesignParallel,randomized clinical trial in 1600 patients with moderate or severe heart failure with QRS 120 ms and PR interval 150 ms(Bristow MR et al.N Engl J Med 2004;350:2140-2150)Patients randomized in a 1:2:

4、2 fashion to optimal medical therapy;optimal drug therapy plus CRT;or optimal drug therapy plus CRT with an ICD(CRT-D)May 2005EP ShowResultsPrimary end pointCombination of all-cause death and all-cause hospitalizations reduced 19%in the CRT study arm and 20%in the CRT-D study armDeath from or hospit

5、alization for HF reduced 34%in CRT group and 40%in CRT-D groupMay 2005EP ShowResultsSecondary end pointCRT alone associated with a nonsignificant trend toward a 24%reduction in all-cause mortality,a secondary end point of the studyCRT with a defibrillator reduced all-cause mortality 36%,a highly sig

6、nificant resultMay 2005EP ShowSignificant reductionsThis study showed in a large population of patients that resynchronization therapy improves survival and reduces hospitalization.Survival benefit limited to those with CRT and ICDCalkinsMay 2005EP ShowCRT challengesImplanting the coronary sinus lea

7、dDifficulty involves not getting the lead in,but getting it in the right placeTo achieve effective resynchronization,the lead needs to be implanted in a lateral branch of the coronary sinusRequires experienced implanterMay 2005EP ShowCardiac Resynchronization Heart Failure CARE-HFMay 2005EP ShowCARE

8、-HFRationaleCardiac dyssynchrony a problem in a large number of patients with HF and left ventricular systolic dysfunctionPrevious studies have suggested that CRT can improve symptoms,quality of life,and exercise capacityNo conclusive evidence of an effect on hospitalizations or mortality May 2005EP

9、 ShowCARE-HFDesignRandomized,controlled,open-label,blinded-end-point studyRandomized patients to continue with medical therapy or to receive CRTIncluded 813 patients with NYHA class 3-4 HF despite standard drug therapy,an LVEF 35%,and QRS duration of at least 120 msMay 2005EP ShowCARE-HFPatients wit

10、h a QRS duration 80 mg furosemide(most common dose was 40 mg daily)May 2005EP ShowCleland JGF et al.N Engl J Med 2005;352:1539-1549 Primary and secondary outcomes in CARE-HFOutcomesHazard ratio(95%CI)pAll-cause mortality/unplanned hospitalization for CV event0.63(0.51-0.77)0.0001All-cause mortality0

11、.64(0.48-0.85)0.0019All-cause mortality/HF hospitalization0.54(0.43-0.68)0.0001May 2005EP ShowOther improvementsCRT group also benefited significantly with improved LVEF,NYHA class,end-systolic volume,mitral-valve function,blood pressure,and quality-of-life indicesDramatic improvements at 18 months

12、in levels of N-terminal pro-B-type natriuretic peptide(NT-proBNP)May 2005EP ShowProblems encounteredLead problems27 lead-related problems,such as fracture or displacement,in the 409 patients randomized to CRTNumber of cases of coronary sinus dissection,none of which caused deathOne procedure-related

13、 death in each groupMay 2005EP ShowPossible remissionI think we see a substantial proportion of patients who become asymptomatic and whose cardiac function is normalized by this therapy.Possibility of HF remission ClelandMay 2005EP ShowWhat therapy?No question to the value of CRT,but candidates for

14、CRT are also candidates for ICD therapyThe question then becomes,which treatment do they receive?May 2005EP ShowTreating patientsIts a fairly easy decision.Real difference comes down to cost,but the added protection of the ICD warrants the use of CRT with a defibrillatorCalkinsMay 2005EP ShowOther i

15、ssuesMorbidity There is the possibility of inappropriate shocks from the ICD in healthy patients who might not stand to benefit from its additionIn studies using older devices,the morbidity from the defibrillator was unacceptableMay 2005EP ShowIf money were not an issue.CRT with newer defibrillators

16、 does provide an additional benefitBut cost in the UK remains an issue,and I would continue to be selective about which patients received CRT with defibrillator backup ClelandMay 2005EP ShowPatient selectionHave you learned anything from the studies that would help you select patients for a CRT-D im

17、plant?-PrystowskyThe brief answer to that is not yet.-Cleland May 2005EP ShowInappropriate shocksNot a case of inappropriate shocks but inappropriate programmersEPs programming devices that deliver inappropriate shocks more than 5%of the time need to go back to schoolPrystowskyMay 2005EP ShowInappro

18、priate shocksIt irks me at times because people throw that up as a reason not to get a defibrillator,but I say get a better implanter,get a smarter doctor.-PrystowskyBut not everybody can come to your center and benefit from your expertise.-ClelandMay 2005EP ShowLooking to the futureInteresting issu

19、e as not everybody with a wide QRS benefits,and even some with a narrow QRS benefit from CRTPathophysiology suggests applying therapy earlier,to patients in NYHA class 2,to prevent progression of HFMay 2005EP ShowLooking to the futureThe fact that CARE-HF was so positive in a rather milder populatio

20、n than COMPANION supports the drift to using these devices at an earlier stage.ClelandMay 2005EP ShowPatient selectionSome patients have such dramatic improvements with CRT that they may no longer be candidates for an ICDNeed more research on the benefit of the defibrillator in CRT-D therapy May 200

21、5EP ShowConclusionsSummaryPatient who meets criteria for resynchronization should be treated accordinglyDefibrillator component remains to be debated,mainly due to the issue of economicsMay 2005EP ShowConclusionsCARE-HF showed major reductions in mortality with pacing aloneThe world is better off for the fact that weve had these two studies.-Prystowsky