Controversies in Heart Failure Management

M.Birhan YILMAZ, MD, FESCM.Birhan YILMAZ, MD, FESC

Cumhuriyet University School of Cumhuriyet University School of MedicineMedicine

Department of Cardiology, Sivas, Department of Cardiology, Sivas, TURKEYTURKEY

Heart FailureHeart Failure

-2% of the population, ->10% over 70 years

- no “healing”, irreversible -high mortality, -frequent rehospitalizations

- Extremely costly (in terms of hospitalization and currently device related)

Potential areas of controversyPotential areas of controversy

• Diagnosis• Life style• Device related• HR reduction• Anticoagulation• Revascularization• Inotrope• AHF

Increased sensitivity at a cost of compromised specificity

The diagnosis of HF-PEFHF-PEF remains a particular challenge, and the optimum approach incorporating symptoms, signs, imaging, biomarkers, and other investigations is uncertain.

*Different disease or a

different phase of the

same disease spectrum

*Diastolic stress test

Diagnostic Controversy

‘Artificial’ recommendations

ESC decided that the guidelines for HF probably had been artificially giving recommendations for lifestyle advice really on the basis of no good evidence.

The exceptions, both class IA recommendations: "Regular aerobic exercise is encouraged in patients with heart failure to improve functional capacity and symptoms," and patients are advised to enroll in a "multidisciplinary-care management program" to lower the risk of heart-failure hospitalization.

confessed

How much of salt?

ModerateCHF

SevereCHF

MildCHF

Post-MILV dysfunction

Heart Failure Therapy

SOLVD Treatment(enalapril)

CONSENSUS(enalapril)

AIRE/SAVE(ramipril/captopril)

US Carvedilol/MERIT/CIBIS(carvedilol/metoprolol/bisoprolol)

COPERNICUS(carvedilol)

CAPRICORN(carvedilol)

RALES(spironolactone)

EPHESUS(eplerenone)

CHARM/Val-HeFT(candesartan/valsartan)

MADIT, MUSTT(ICD)

SCD-HeFT, MADIT-II(ICD)

MIRACLE, COMPANION, MUSTIC (CRT +/- ICD)

CARE-HF

EMPHASIS-HF(eplerenone)

Solved Controversy

Device Related Controversies

Randomized Controlled Trials on Resynchronization therapy

• MIRACLE • MUSTIC SR • MUSTIC AF • PATH CHF • MIRACLE ICD • CONTAC CD

COMPANION • PATH CHF II • MIRACLE ICD II • CARE HF• RAFT

CRT Improves

NYHA Class,Quality of life score,

Exercise Capacity,LV function,

Reverse remodeling,Hospitalization,

Mortality

CRT in patient with Atrial fibrillation

• 1/3 of the patients with HF are in AF• 1/5 of the patients receiving CRT in

Europe• Older, more co-morbidities, worse

prognosis

5%10%

25%

50%

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

50%

Atrial fibrillation (%)

NYHA I

NYHA II

NYHA III

NYHA IV

HF and AFPrevalence by NYHA class

Why does AF matter when selecting for CRT?

• Loss of AF synchrony• AV optimization not possible

• Excessive intrinsic ventricular rate• High pacing rates needed to provide

biventricular capture, if possible at all!

How to improve CRT benefit on AF patients

• Complete ventricular capture Complete ventricular capture (>95% pacing)- is mandatory in (>95% pacing)- is mandatory in order to maximize clinical benefit order to maximize clinical benefit and improve the prognosisand improve the prognosis – Pharmacological therapy to slow

ventricular rate– Ablation of AVN– Pulmonary vein isolation

CRT-P versus CRT-D

• CRT-D is associated with more device-related complications (up to 10%)

Inappropriate shocks

CRT and reverse remodeling

Remodeling and arrhythmias REVERSE

CRT –ON doesn’t increase VT/VF

episodes

Remodeling is associated with

less VT/VF episodes

• The group of patients that benefit most is the one with QRS ≥ 150 ms

• Anyone who undergoes CRT for the most part is also indicated for an ICD if you look at the crossover.

• So, why use a CRT-P?So, why use a CRT-P?

CRT-P versus CRT-D

Why use a CRT-P?Why use a CRT-P?

• People may like, at least in Europe, to see or pursue a therapy that is less expensiveless expensive, compared with CRT-D, but that provided the same quality of life as CRT-D

• Choice of a patientChoice of a patient – “If I die suddenly, I die suddenly, but I really don't like the shortness of breath."

• Remember the 10% of complicationscomplications, inappropriate shocks

Electricity in HF -charged with sex discrimination

• CRT benefit favors women: MADIT-CRT

• Women with ICD get fewer shocks• Women have better heart-failure

survival than men

MADIT-CRTMADIT-CRT -CRT benefit favors women

• 69%69% plunge in rate of death or heart failure in women (p<0.001) far exceeded the 28%28% reduction (p<0.01) in men.

• associated with consistently greater echocardiographic evidence of reverse cardiac remodeling in women than in men

End point  Women, n=453  Men, n=1365 

Death or heart failure  0.31 (0.19-0.50), p<0.001 0.72 (0.57-0.92), p<0.01

Heart failure  0.30 (0.18-0.50), p<0.001 0.65 (0.50-0.84), p=0.001

Death  0.28 (0.10-0.79), p=0.02 1.05 (0.70-1.57), p=0.83

Women have better heart-failure survival than men MAGGIC study

Women with heart failure have better survival than man, irrespective of age, etiology and EF (patient data from 31 studies in 41 949 patients ).

CRT controversy

Patients with NYHA Class III or ambulatory IV

Patients with NYHA Class II

Device with Huge Controversy

Does lowering heart rate improve clinical outcomes in chronic HF?• Systematic reviews have demonstrated that a major contributor to the benefits of -blocker therapy may be their rate-lowering effect – but they are generally underused or underdosed!

• When ivabradine does become available, the results of SHIFT will likely support the use of ivabradine in patients with moderate to severe HF on optimum medical therapy including -blockade with LVEF 35% and resting heart rate 70 bpm.

HR reduction controversy

Anticoagulate in Heart Failure - Do We Have an Answer?

• Warfarin vs Aspirin in Reduced Cardiac Ejection Fraction (WARCEF trial)

Primary end point  Aspirin, n (%/y) 

Warfarin, n (%/y) 

Hazard ratio (95% CI) 

p 

Death, ischemic stroke or intracerebral hemorrhage 

320 (7.93) 302 (7.47) 0.93 (0.79-1.10)  0.40

No significant difference seen in the primary end point between groups

-no difference in death rates between groups, -intracerebral hemorrhage was very infrequent in both groups-highly significant reduction in ischemic stroke among those on warfarin vs aspirin.-Major hemorrhage was significantly higher with warfarin (GIT bleeding), -no significant differences in intracerebral or intracranial hemorrhage

Anticoagulation in HF

• ASPIRIN - safer to use, easier to use, patients tolerate it pretty well, there are no food interactions, and it's inexpensive

• Newer oral anticoagulants now becoming available—dabigatran and rivaroxaban, which are already approved, and apixaban, which is expected to be approved soon—might reopen this question.

• However, it is important to keep in mind that eGFR<30 ml/kg/min is a frequent exclusion (though it is common in HF)

• Thrombo-embolism prophylaxis in patients with HF and AF should be based on CHA2DS2-VAScCHA2DS2-VASc score Most patients with systolic HF will have a risk score consistent with a firm indication for (score ≥2), or preference for, an oral anticoagulant (score ≥ 1), although bleeding risk must also be considered

• Some new anticoagulant drugs such as the oral direct thrombin inhibitors and oral factor Xa inhibitors are contraindicated in severe renal impairment (creatinine clearance ,30 mL/min).

Rate or Rhythm Control in HF-AF

• In patients with chronic HF, a rhythm-control strategy including

• pharmacological or electrical cardioversion has not been demonstrated

• to be superior to a rate-control strategy in reducing mortality or morbidity.

Revascularization Controversy in HFRevascularization Controversy in HF

• STICH viability arm failed to show any benefit of viability testing (?)

Inotrope Controversy

• Dobutamine, Dopamine, Adrenaline, Levosimendan, Omecamtiv mecarbil (cardiac myosin activator) etc….

• Several studies with controversial or neutral results (even detrimental)

Controversies for VADsVADs and biventricular assist devices (bi-VADS) received a class I level B recommendation for use as a bridge to heart transplantation,

but a class IIa level B "should be considered" endorsement as destination therapy in 'highly-selected patients'

Acute HF

Land of Controversies