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Comorbitities in CRT

Comorbitities in CRT. A.CURNIS. University of Brescia Iitaly Hheart Failure &Co. Napoli 2013. The birth of CRT … in Europe, 15 years ago. Since then … many major improvements … then Guidelines 30% nonresponders. ESC/EHRA guidelines. NYHA III-IV QRS > 120 ms LVEF < 35%

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Comorbitities in CRT

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  1. Comorbitities in CRT A.CURNIS University of Brescia Iitaly Hheart Failure &Co. Napoli 2013

  2. The birth of CRT … in Europe, 15 years ago

  3. Since then … many major improvements … then Guidelines 30% nonresponders ESC/EHRA guidelines • NYHA III-IV • QRS > 120 ms • LVEF < 35% • HF optimal medical therapy Class I/A • NYHA III-IV, LVEF<35% • Indicationtopermanent pacing Class IIa/C • NYHA III-IV, LVEF<35% • Permanent AF • Indicationto AVN ablation Class IIa/C Other potential candidates to CRT (ongoing trials) • NYHA I-II • QRS < 120 ms • HF & AF Soft End-Points (QOL, VO2, 6min WT) Hard End-Points (Mortality, Hospitalization reduction) • Upgrade fromantibrady-pacing *Commentary of “Current practice of CRT in the real world: insights from the European CRT survey”; EHJ August 2009

  4. Research programs in CRT today New pts groups? CRT to “prevent HF” Reductionof NON-responder rate Implant procedure Success Rate Reductionof NON-responders rate CRT Optimization Reductionof NON-responders rate Remote management of HF pts

  5. ESC HF Guidelines 2012: CRT Summary Sinus Rhythm Permanent AF Need for Pacing NYHA III/IV NYHA III/IV(amb.) NYHA II NYHA II NYHA III/IV(amb.) EF ≤ 35% EF ≤ 30% EF ≤ 35% EF ≤ 35% EF≤35% QRS ≥ 120ms any QRS any QRS LBBB Non-LBBB LBBB Non-LBBB Slow V rate orPost AVN ablation or60bpm at rest & 90bpm on ex. QRS ≥ 120ms QRS ≥ 150ms QRS ≥ 130ms QRS ≥ 150ms ClassIIb C CRT-P CRT-D Class IIa A CRT-P CRT-D ClassIIa C CRT-PCRT-D Class I A CRT-P CRT-D Class IIa A Preferably CRT-D Class I A Preferably CRT-D ClassIIb C CRT-PCRT-D EurHeart J. 2012 All patients under Optimal PharmacologicalTherapy & life expectancy > 1 year

  6. Most common reasons for Non-Response • 47% inadequate device programming • 32% suboptimal medical treatment • 32% arrhythmias • 21% inappropriate lead position • 9% lack of baseline dyssynchrony • CRT Delivery • Suboptimal Drug Therapy • Arrhythmias • Lead Position • Patient Selection Insights from a Cardiac Resynchronization Optimization Clinic as Part of a Heart Failure Disease Management Program; Mullens et. All. JACC Vol.53, No.9, 2009

  7. Echo in heart failure :What is mandatory in the report ? • LV size and systolic function (low dose dobutamine) • Mitral regurgitation • LV diastolic function • Pulmonary artery pressure • RV function • Inter- and Intra-ventricular asynchrony • Coro-angio

  8. LV Lead Position in CRT Higher response when pacing the latest site of contraction1 Lower response when pacing areas of scar2 1 Ypenburg et al J Am Coll Cardiol.2009;53(6):483-490 2Bleeker et al Circulation 2006;113(7):969-976.

  9. Progression of Heart Failure Stage A At high riskbut without structural disease or symptoms Stage B Structural heart diseasebut without HF symptoms Stage C Structural heart diseasewith prior or current HF symptoms Stage D Refractory HFrequiring specialized Interventions Refractory symptoms of HF at rest Structural heart disease • Patients with • previous MI • LV systolic dysfunction, • asymptomatic valve disease • Patients with • - known structural heart disease • shortness of breath, fatigue, reduced ex. tolerance Patients with marked symptoms at rest despite maximal medical therapy Development of symptoms of HF • Patients with • Hypertension • CAD • Diabetes • Obesity • Metabolic syndrome • OR • using cardiotoxins • with familial Hx of DCM ACC/AHA Guidelines, JACC 2001; 38:2092

  10. Use of neurohumoral antagonists • ↑ survival / ≈ symptoms The Cascade of Advanced Heart Failure • Ageing of the population • Better CV treatment • ↑ HF prevalence • ↑ Indication / Use of ICDs • ↓↓↓ Sudden death ↑ pts. With end-stage HF Severe symptoms / Poor QOL / high mortality

  11. Aims of treatment in Advanced HF Quality of life Prognosis End of life

  12. Haemodynamic support: Relief of congestion ↑peripheral perfusion ↓ arrhythmias ↓ myocardial damage ↑ renal function ↓ neurohormonal activation ↑ renal function ↓ myocardial damage Treatment of Advanced HF ↓Symptoms Ultrafiltration, devices, … Diuretics Vasodilators Inotropes… Failure ↑ short-term survival Neurohormonal antagonists, CRT … Patient stable ↑ Long-term survival

  13. Co-morbidities Causing Abnormalities of the Laboratory Exams in the Patients with Heart Failure • Ischemia  Necrosis • Diabetes • Anemia • Renal insufficiency • Hypercholesterolemia • Hyperuricemia

  14. Prevention of Heart Failure: The Next Target • Hypertension • Coronary artery disease • Hypercholesterolemia  Statins • Neurohumoral blockade (ACEi /  -blockade) • Revascularization / Antiplatelet agents • Diabetes • Glycemic control • BP control • Albuminuria • Renal disease • Obesity • Metabolic Syndrome

  15. Effect of the aging population on the prevalence of heart failure in the U.S. 9 8 7 6 5 Population (1.000.000s) 4 3 2 1 0 1950 1960 1970 1980 1990 2000 2010 2020 2030 2040 2050 (data from Phase I of the National Health and Nutrition Examination Survey III 1980 and US Bureau of the Census Data and Projections in Bristow MR Management of HF in Braunwald’s Heart Disease)

  16. Hypertensive Patients Are at Increased Risk for Cardiovascular Events. Framingham Study Heart failure Biennial Age-Adjusted Rate per 1000 Population attributable risk (%) Men 16 13.9 39% 14 12 10 8 6.3 6 Women 3.5 4 2.1 2 0 Men Women 59% Normotensive Hypertensive Kannel WB JAMA 1996;275(24):1571-1576 Levy et al., JAMA 1996; 275:1557 Hypertension Non HBP

  17. Risk of Death in the Patients with LVD with Recurrent Myocardial Infarction (MI) or Unstable Angina (SOLVD Trials) Myocardial infarction Unstable Angina 70 60 MI 30 50 40 20 Angina % Event % Event 30 No Angina 20 10 No MI 10 P<0.001 P<0.001 0 0 0 6 12 18 24 30 36 42 0 6 12 18 24 30 36 42 Months Months Yusuf et al., Lancet 1992;340:1173

  18. Severity of the Residual Stenosis of the Infarct-Related Artery and LV Dilatation After Acute MI End-Diastolic Volume (mL/m2) End-Systolic Volume (mL/m2) Ejection Fraction (%) 120 70 50 * * 110 * 45 60 * 100 † † 40 90 50 80 35 40 * 70 30 60 30 25 50 40 20 20 0 6 12 0 6 12 0 6 12 Months Months Months Total occlusion Lesion diameter < 1.5 mm Lesion diameter > 1.5 mm Leung et al. JACC 1992;20:307

  19. Prevention of Heart Failure: The Next Target • Hypertension • Coronary artery disease • Hypercholesterolemia  Statins • Neurohumoral blockade (ACEi /  -blockade) • Revascularization / Antiplatelet agents • Diabetes • Glycemic control • BP control • Albuminuria • Renal disease • Obesity • Metabolic Syndrome

  20. Diabetes as a Risk Factor for Heart Failure • Incidence • Risk of developing HF in diabetes (Framingham, JAMA 1979) • 4 fold increase in young diabetic males (< 65 years) • 8 fold increase in young diabetic females (< 65 years) • Prevalence Proportion of Patients with Diabetes 23% CONSENSUS SOLVD 25% 20% V-HeFT II ATLAS 20% 10% NETWORK RESOLVD 27% 0% 10% 20% 30% 40% 50% Proportion of diabetic patients (%)

  21. Glycemic Control and Heart Failure Among 48 858 Adult Patients with Diabetes Hb A 1c Each 1% increase in HbA1C is associated with a 8% increase in the risk of heart failure Iribarren et al., Circulation 2001; 103:2668

  22. Diabetes Mellitus as a Predictor of Mortality: SOLVD Trials All-cause mortality CV mortality Treatment trial 35 33 Placebo 30 29 30 Enalapril 27 25 23 Total 21 20 % of patients 20 18 Prevention trial 15 Placebo 10 Enalapril 5 Total 0 3 0 0,5 1,5 2,5 1 2 Placebo Enalapril Placebo Enalapril Relative risk (95% CI) Non diabetic Diabetic Schindler et al., Am J Cardiol 1996; 77:1017

  23. Prognostic Impact of Diabetes Mellitus According to the Etiology of Heart Failure SOLVD Treatment SOLVD Prevention P<0.0001 EVENT-FREE SURVIVAL P<0.0001 Ischemic nondiabetics (n=1392) Nonischemic (n=642) Ischemic diabetics (n=534) Ischemic nondiabetics (n=3086) Nonischemic (n=562) Ischemic diabetics (n=575) DAYS DAYS Dries et al., J Am Coll Cardiol 2001; 38:421

  24. Anemia is Associated with Increased Mortality in HF:Single-center study in 1061 patients Hb>14.8 Hb 13.7-14.8 Hb 12.3-13.6 Hb < 12.3 P=0.00001 Horwich, Fonarow, Hamilton et al., JACC 2002;39:1780

  25. Hemodilution Is Common in Patients With Advanced Heart Failure Dilutional Normal Hct True anemia Anemic P=0.08 P<0.05 Androne et al., Circulation. 2003;107:226

  26. Anemia is related with Maximal Functional Capacity and Rehospitalization rate in the Patients with Heart Failure Rehospitalization-free survival Peak VO2 1.2 35 Hb < 12.5 1.0 30 Hb > 12.5 25 0.8 20 Peak VO2, mL/kg/min 0.6 Fraction of patients, % 15 P < 0.05 0.4 10 R = 0.50 P < 0.01 0.2 5 0.0 0 9 10 11 12 13 14 15 16 17 18 0 200 400 Hemoglobin, Gm/dL Time, days L Dei Cas et al., 2003

  27. Impact of Comorbidities in Patients with Chronic Kidney Disease 5 years follow-up of 27 998 patients with estimated GFR < 60 mL/min per 1.73 m2 14 13.1 11.5 12 10.4 10 7.4 8 6.2 % of subjects 6 5.2 6 4 1.8 2 0 CAD baseline CAD Δ in prevalence CHF Baseline CHF Δ in prevalence Control Chronic Kidney Disease Keith et al., Arch Intern Med 2004; 164:659

  28. Impact of Proteinuria and Chronic Kidney Disease in the Incidence of Heart Failure 5 years follow-up of 27 998 patients with estimated GFR < 60 mL/min per 1.73 m2 25 19.4 20 15 12.6 12.5 % of subjects 10.7 10 5.8 5.4 3.9 5 1.4 0 GFR 60-89 No proteinuria Stage 2 Stage 3 Stage 4 Baseline Change Keith et al., Arch Intern Med 2004; 164:659

  29. Obesity and the Risk of Heart Failure:Framingham Study (5881 subjects; 14 ys FU) Men Obesity Class 2 (35-39.9) Obesity class 1 (30-34.9) Overweight Women Obesity class 3 (>40) Obesity Class 2 (35-39.9) Obesity class 1 (30-34.9) Overweight 0 5 10 15 Risk ratio (95% CI) Kenchaiah et al. New Engl J Med 2002; 347:305

  30. Continuous Relationship Between Total Cholesterol and 5-years Rates of Death or Urgent Transplantation Horwich, Hamilton, Maclellan, Fonarow. J Cardiac Fail 2002; 8:216

  31. Rate of In-Hospital Death Associated with Hyperkalemia among Patients Recently Hospitalized for Heart Failure Who Were Receiving ACE Inhibitors 2.5 – 2.0 – 1.5 – 1.0 – 0.5 – 0.0 – Online release Of RALES Rate of In-Hospital from Hyperkalemia(per 1000 patients) 1994 1995 1996 1997 1998 1999 2000 2001 Study Year Juurlink, D. N. et al. N Engl J Med 2004;351:543-551

  32. Outcome of patients hospitalized for HF In-hospital mortality: 4-9% 6-months mortality: 9-15% 6-months rehospitalizations, 30-45% Ms = months

  33. Diabetes SBP at discharge <115 mmHg Anemia at admission ∆ s-creatinine >0.30 Furosemide dose >50 mg/d Restrictive LV filling at discharge 0 1 2 3 4 Odds ratio (95% CI) Decreased ← → Increased Predictors of subsequent CV mortality or HF hospitalisations in patients with Acute HF: Results of multivariable analysis in 318 patients L Dei Cas, 2006

  34. The last six months of life for patients with congestive heart failure: data from SUPPORT: 539/1404 patients died < 1 year Levenson JW, et al. J Am Geriatr Soc 2000;48:S101-9.

  35. Towards new paradigms to better select patients? Auricchio A, Prinzen FW. Circulation Journal 2011;75:521-7

  36. Identify NON-Responders (and potential reasons) is relevant… n = 75 CRT-D pts referred to the HF lab due to NON-response to CRT … these are the reasons for a suboptimal response to CRT Mullens W & al, JACC 2009

  37. Conclusions • Better patient selection and better Non-responders management: the main clinical topics to be targeted (Comorbidity) • CRT optimization (device optimization, optimal lead position, new implant options..) to improve therapy efficacy: the technical improvements to be explored • Refine Diagnostic capacity of CRT devices: the clinical usefulness to be empowered • CRT patient follow-up (with remote monitoring) to early identify acute HF events: the new management challenge

  38. Comparison of Healthcare CostsICD Costs are Minimal Compared to Other Healthcare Spending in Europe 150.00 Annual Cost in € Billion 64.00 46.00 2.12 2.70 0.49 1.07 ICD Pacemakers CABG* PTCA* Healthcare Administration*1 Inefficiencies in hospital operations2 Cost of inappropriate care & adverse drug usage*1 * Includes only Fr, De, It, UK Source: 1Datamonitor report: E-healthcare opportunities The risks and rewards 1999, 2 Mckinsey Health Europe March 2004

  39. Comparison of Healthcare Costs 350.0 294 300.0 $11.6 B—estimated amount due to miscoding, insufficient documentation, etc. in Medicare (HCFA 2000 Financial Report) Healthcare Administration1 250.0 200.0 Annual Cost in Billions 150.0 100 100.0 30 50.0 9 9 8 2 0.0 ICD* PTCA† CABG+ Statins‡ Lost dollars from healthcare fraud, abuse and waste^^ *Medtronic estimations (total number of implants x $30,000). †Morgan Stanley Dean Witter Research Report, 2001 / CMS reimbursement data. +AHA 2002 / Cowper, et al; American Heart Journal. 143;(1):130–9. ‡ Pharmacy Times, “Top 200 drugs of 2000”; 2001. ^ National Institute of Health, Antimicrobial Resistance, NIAID Fact Sheet. ^^ U.S. General Accounting Office 2001. 1 Woolhandler S, et al. Costs of Healthcare Administration in the United States and Canada. N Engl J Med 344, 2003; 349: 768-75. Economic impact of over- prescribing antibiotics^

  40. Final Considarations Clinical Randomized Study exclusion Criteria Inclusion Criteria • Guidelines • Comorbiditys • Life perspective • Clinicalexperience

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