心脏再同步化治疗临床应用companion研究和carehf研究课件.ppt

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 Kingston upon Hull, UKMay 2005EP ShowUse of cardiac resynchronization therapy (CRT) in COMPANION and CARE-HFMay 2005EP ShowBrief history •Large group of patients in need of ICDs for primary prevention•New era of biventricular pacing to improve HF symptoms•COMPANION and CARE-HFMay 2005EP ShowComparison of Medical Therapy, Pacing, and Defibrillation in Heart FailureCOMPANIONMay 2005EP ShowCOMPANIONDesign•Parallel, 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 1:2:2 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 point•Combination of all-cause death and all-cause hospitalizations reduced 19% in the CRT study arm and 20% in the CRT-D study arm•Death from or hospitalization for HF reduced 34% in CRT group and 40% in CRT-D groupMay 2005EP ShowResultsSecondary end point•CRT alone associated with a nonsignificant trend toward a 24% reduction in all-cause mortality, a secondary end point of the study•CRT with a defibrillator reduced all-cause mortality 36%, a highly significant resultMay 2005EP ShowSignificant reductions"This study showed in a large population of patients that resynchronization therapy improves survival and reduces hospitalization."•Survival benefit limited to those with CRT and ICDCalkinsMay 2005EP ShowCRT challengesImplanting the coronary sinus lead•Difficulty involves not getting the lead in, but getting it in the right place•To achieve effective resynchronization, the lead needs to be implanted in a lateral branch of the coronary sinus•Requires experienced implanterMay 2005EP ShowCardiac Resynchronization Heart Failure CARE-HFMay 2005EP ShowCARE-HFRationale•Cardiac dyssynchrony a problem in a large number of patients with HF and left ventricular systolic dysfunction•Previous studies have suggested that CRT can improve symptoms, quality of life, and exercise capacity•No conclusive evidence of an effect on hospitalizations or mortality May 2005EP ShowCARE-HFDesign•Randomized, controlled, open-label, blinded-end-point study•Randomized patients to continue with medical therapy or to receive CRT•Included 813 patients with NYHA class 3-4 HF despite standard drug therapy, an LVEF <35%, and QRS duration of at least 120 msMay 2005EP ShowCARE-HF•Patients with a QRS duration <150 ms were required to have echocardiographic confirmation of ventricular dyssynchrony•Primary end point was all-cause mortality/unplanned hospitalization for CV eventMay 2005EP ShowStrengths of CARE-HFStudy details•Large control group•Implant success rate 96%•Long-term follow-up, with an average of 2.5 years•Average age of patient 67 years•Only 40% of patients taking >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 mortality0.64(0.48-0.85)0.0019All-cause mortality/HF hospitalization0.54(0.43-0.68)<0.0001May 2005EP ShowOther improvements•CRT group also benefited significantly with improved LVEF, NYHA class, end-systolic volume, mitral-valve function, blood pressure, and quality-of-life indices•Dramatic improvements at 18 months in levels of N-terminal pro-B-type natriuretic peptide (NT-proBNP)May 2005EP ShowProblems encounteredLead problems•27 lead-related problems, such as fracture or displacement, in the 409 patients randomized to CRT•Number of cases of coronary sinus dissection, none of which caused death•One procedure-related death in each groupMay 2005EP ShowPossible remission"I think we see a substantial proportion of patients who become asymptomatic and whose cardiac function is normalized by this therapy."•Possibility of HF "remission" ClelandMay 2005EP ShowWhat therapy?No question to the value of CRT, but candidates for CRT are also candidates for ICD therapyThe question then becomes, which treatment do they receive?May 2005EP ShowTreating patients"It's a fairly easy decision."•Real difference comes down to cost, but the added protection of the ICD warrants the use of CRT with a defibrillatorCalkinsMay 2005EP ShowOther issuesMorbidity 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 unacceptableMay 2005EP ShowIf money were not an issue . . .•CRT with newer defibrillators does provide an additional benefit•But cost in the UK remains an issue, and I would continue to be selective about which patients received CRT with defibrillator backup ClelandMay 2005EP ShowPatient selectionHave you learned anything from the studies that would help you select patients for a CRT-D implant?- PrystowskyThe brief answer to that is not yet.- Cleland May 2005EP ShowInappropriate shocksNot a case of inappropriate shocks but inappropriate programmers•EPs programming devices that deliver inappropriate shocks more than 5% of the time need to go back to schoolPrystowskyMay 2005EP ShowInappropriate shocks"It 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."- Prystowsky"But not everybody can come to your center and benefit from your expertise."- ClelandMay 2005EP ShowLooking to the future•Interesting issue as not everybody with a wide QRS benefits, and even some with a narrow QRS benefit from CRT•Pathophysiology suggests applying therapy earlier, to patients in NYHA class 2, to prevent progression of HFMay 2005EP ShowLooking to the future"The fact that CARE-HF was so positive in a rather milder population than COMPANION supports the drift to using these devices at an earlier stage." ClelandMay 2005EP ShowPatient selection•Some patients have such dramatic improvements with CRT that they may no longer be candidates for an ICD•Need more research on the benefit of the defibrillator in CRT-D therapy May 2005EP ShowConclusionsSummaryPatient who meets criteria for resynchronization should be treated accordingly•Defibrillator component remains to be debated, mainly due to the issue of economicsMay 2005EP ShowConclusionsCARE-HF showed major reductions in mortality with pacing alone"The world is better off for the fact that we've had these two studies."- Prystowsky。