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

1、,The EP ShowCOMPANION and CARE-HF,Eric Prystowsky MD Director, Clinical Electrophysiology Laboratory St Vincent Hospital Indianapolis, IN Hugh Calkins MD Director, Electrophysiology Lab Johns Hopkins University Medical Center Baltimore, MD John Cleland MD Professor of Cardiology Hull University King

2、ston upon Hull, UK,Use of cardiac resynchronization therapy (CRT) in COMPANION and CARE-HF,Brief 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,Comparison of Medical Therapy, Pacing, and Defibrillati

3、on in Heart Failure,COMPANION,COMPANION,Design 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; op

4、timal drug therapy plus CRT; or optimal drug therapy plus CRT with an ICD (CRT-D),Results,Primary 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

5、40% in CRT-D group,Results,Secondary 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,Significant reductions,This study sh

6、owed in a large population of patients that resynchronization therapy improves survival and reduces hospitalization. Survival benefit limited to those with CRT and ICD,Calkins,CRT challenges,Implanting the coronary sinus lead Difficulty involves not getting the lead in, but getting it in the right p

7、lace To achieve effective resynchronization, the lead needs to be implanted in a lateral branch of the coronary sinus Requires experienced implanter,Cardiac Resynchronization Heart Failure,CARE-HF,CARE-HF,Rationale Cardiac dyssynchrony a problem in a large number of patients with HF and left ventric

8、ular 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,CARE-HF,Design Randomized, controlled, open-label, blinded-end-point study Randomized patients to conti

9、nue 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,CARE-HF,Patients with a QRS duration 150 ms were required to have echocardiographic confirmation of ventricular dyssynchrony Primary

10、 end point was all-cause mortality/unplanned hospitalization for CV event,Strengths of CARE-HF,Study 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 w

11、as 40 mg daily),Cleland JGF et al. N Engl J Med 2005; 352:1539-1549,Primary and secondary outcomes in CARE-HF,Other 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 imp

12、rovements at 18 months in levels of N-terminal pro-B-type natriuretic peptide (NT-proBNP),Problems encountered,Lead 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

13、procedure-related death in each group,Possible 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,What therapy?,No question to the value of CRT, but candidates for CRT are

14、 also candidates for ICD therapy The question then becomes, which treatment do they receive?,Treating patients,Its a fairly easy decision. Real difference comes down to cost, but the added protection of the ICD warrants the use of CRT with a defibrillator,Calkins,Other issues,Morbidity There is the

15、possibility of inappropriate shocks from the ICD in healthy patients who might not stand to benefit from its addition In studies using older devices, the morbidity from the defibrillator was unacceptable,If money were not an issue . . .,CRT with newer defibrillators does provide an additional benefi

16、t But cost in the UK remains an issue, and I would continue to be selective about which patients received CRT with defibrillator backup,Cleland,Patient selection,Have you learned anything from the studies that would help you select patients for a CRT-D implant? - Prystowsky The brief answer to that

17、is not yet. - Cleland,Inappropriate shocks,Not 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 school,Prystowsky,Inappropriate shocks,It irks me at times because people throw that up as

18、 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,Looking 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,Looking to the future,The fact that CARE-HF was so positive in a rather milder populati