2016 REVIEW OF UNMET NEEDS IN THE TREATMENT

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2016 內科醫學會年會 心衰竭治療的最新進展 心衰竭治療的需求與重要性回顧 (REVIEW OF UNMET NEEDS IN THE TREATMENT OF HEART FAILURE)

2016 內科醫學會年會 心衰竭治療的最新進展 心衰竭治療的需求與重要性回顧 (REVIEW OF UNMET NEEDS IN THE TREATMENT OF HEART FAILURE) 殷偉賢 振興醫院 心臟內科 On behalf of the Study Group of the Registry of Heart Failure with Reduced Ejection Fraction, Taiwan Society of Cardiology

Ø The present guideline represents the commitment of the Taiwan Society of Cardiology to

Ø The present guideline represents the commitment of the Taiwan Society of Cardiology to recognize heart failure as a major health care challenge and to provide advices and resources for clinicians and related health care providers. ! a t a d e s Ø With guideline recommendations, we hope that the management of heart e n a w i failure can be improved. f Ta o k c La Ø Current recommendations from the guidelines on the diagnosis and treatment of chronic heart failure closely resemble those contained in guidelines in the western world.

Heart failure in Taiwan: Prevalence • Chin-Shan community cardiovascular cohort, 2660 subjects (1991 -1992)

Heart failure in Taiwan: Prevalence • Chin-Shan community cardiovascular cohort, 2660 subjects (1991 -1992) • The prevalence of HF was 5. 5% [HFp. EF 4. 6%; HFr. EF (LVEF<55%) 0. 9%] 70. 8% 51. 5% Huang et al. EJHF 2007; 9: 587 -593

Incidence of HF hospitalization, 2005 Incidence: 271. 2/100, 000 9. 7% 81. 1% Tseng

Incidence of HF hospitalization, 2005 Incidence: 271. 2/100, 000 9. 7% 81. 1% Tseng et al. JAGS 2010; 58

Heart failure in Taiwan: length of stay More than 20, 000 patients admitted due

Heart failure in Taiwan: length of stay More than 20, 000 patients admitted due to HF in 2014 Mean length of stay: 11. 9 days

Heart failure in Taiwan: outcomes Chronic decline Cardiac function Hospitalizations Disease progression Wang et

Heart failure in Taiwan: outcomes Chronic decline Cardiac function Hospitalizations Disease progression Wang et al. Acta Cardiol Sin 2012; 28: 161– 95

Taiwan Society of Cardiology Registry on Heart Failure with Reduced Ejection Fraction • Study

Taiwan Society of Cardiology Registry on Heart Failure with Reduced Ejection Fraction • Study population: – Patients with systolic HF (LVEF≦ 40%) and admitted for acute HF, pre-existed or new onset, during the enrollment period. • Follow-up: – Follow-up status was collected at the 6 th month and the 12 th month after enrollment.

Total patient numbers 1, 509 234 (15. 4%) 700 (46. 4%) 108 (7. 2%)

Total patient numbers 1, 509 234 (15. 4%) 700 (46. 4%) 108 (7. 2%) Total 21 hospitals 157 (10. 4%) 12 (0. 8%) 298 (19. 8%) Study period: 07/01/2013 to 12/31/2015

Characteristics at Admission LVEF (2 -D Echo) 29 ± 9 % N=1, 509 Age

Characteristics at Admission LVEF (2 -D Echo) 29 ± 9 % N=1, 509 Age 64 ± 16 years Male 1093 (72. 5 %) Day of hospitalization median 8 days (IQR= 5 -15 days) Stay in ICU 497 (33. 0 %) (median 4 days) Admission SBP 131 ± 28 mm. Hg Admission DBP 81 ± 20 mm. Hg Admission HR 93 ± 22 bpm Admission weight 67. 4 ± 17. 0 kg BMI 25. 4 ± 6. 5 Admission NYHA Fc I / III / IV 0. 7 / 11. 1 / 50. 3 / 37. 8 %

Precipitating Causes of Decompensated HF 診斷心衰病因 找尋誘發因素 I IIa IIb III ACS precipitating acute

Precipitating Causes of Decompensated HF 診斷心衰病因 找尋誘發因素 I IIa IIb III ACS precipitating acute HF decompensation should be 急性冠心病應及早診治 promptly identified by ECG and serum biomarkers including cardiac troponin testing, and treated optimally as appropriate to the overall condition and prognosis of the patient. I IIa IIb III Common precipitating factors for acute HF should be 急性心衰常見誘因應及早發現處理 considered during initial evaluation, as recognition of these conditions is critical to guide appropriate therapy.

Primary Etiology of HF 44. 1% Ischemic 32. 9% Dilated 7. 9% 7. 1%

Primary Etiology of HF 44. 1% Ischemic 32. 9% Dilated 7. 9% 7. 1% Hypertensive Valvular

Possible Precipitating Factors N=1, 509 Acute coronary syndrome / myocardial ischemia 31. 3 %

Possible Precipitating Factors N=1, 509 Acute coronary syndrome / myocardial ischemia 31. 3 % Non-compliance / behavioral / drugs 24. 6 % NSAID use 0. 1 % Rapid atrial fibrillation 16. 4 % Ventricular arrhythmia 5. 2 % Bradyarrhythmias 0. 9 % Uncontrolled hypertension 4. 8 % Infection 17. 0 % Renal dysfunction 14. 5 % Anemia 3. 3 % Asthma / COPD exacerbation 3. 3 %

Signs of hypoperfusion

Signs of hypoperfusion

Clinical presentations Hypotension Engorged jugular vein 23. 9% Pulmonary rales 9. 9% Confusion/Somnolence 5.

Clinical presentations Hypotension Engorged jugular vein 23. 9% Pulmonary rales 9. 9% Confusion/Somnolence 5. 1% 63. 5% Pleural effusion 28. 8% Peripheral edema 49. 3% S 3 Gallop 18. 2% Peripheral hypoperfusion 14. 1%

wet and warm Dry and cold WET & COLD

wet and warm Dry and cold WET & COLD

Specific Management during admission Duration (days) Dobutamine 307 (20. 4%) 8. 8 ± 10.

Specific Management during admission Duration (days) Dobutamine 307 (20. 4%) 8. 8 ± 10. 7 Dopamine 281 (18. 6%) 5. 9 ± 7. 6 Levosimendan 12 (0. 8%) Milrinone 17 (1. 1%) 9. 2 ± 13. 5 Nitroglycerin 408 (27. 1%) 3. 0 ± 2. 1 IV Diuretics 943 (62. 6%) 5. 8 ± 7. 6 New implant CIED 55 (3. 6%) 22 PPM, 15 ICD, 12 CRT-P, 6 CRT-D Ventilator support 195 (12. 9%) 6. 9 ± 11. 3 IABP 41 (2. 7%) 6. 3 ± 9. 2 ECMO 7 (0. 5%) 12. 9 ± 17. 4 CABG 35 (2. 3%) - Valvular surgery 17 (1. 1%) - SAVR surgery 9 (0. 6%) - 40. 9% 7. 3 ± 10. 4

 Patient numbers Timeframe Age (yrs) Male Ischemic etiology (%) Left Ventricular Systolic Dysfunction

Patient numbers Timeframe Age (yrs) Male Ischemic etiology (%) Left Ventricular Systolic Dysfunction Left Ventricular Ejection Fraction (%) Hypertension Hyperlipidemia Coronary Artery Disease Prior Myocardial Infarction Atrial Fibrillation Diabetes Mellitus Chronic Kidney Disease Chronic Obstructive Pulmonary Disease Heart rate (bpm) Systolic Blood Pressure (mm. Hg) Sodium (m. Eq/L) Creatinine (mg/d. L) BNP (pg/m. L) Hemoglobin (g/d. L) ADHERE EHFS II ATTEND TSOCHFr. EF 105, 388 2001 -2004 3, 580 2004 -2005 4, 842 2007 -2011 1, 509 2013 -2015 72 ± 14 70 ± 13 73 ± 14 64 ± 16 48 54 58 72 - 54 31 44 63 66 53 100 34 ± 16 38 ± 15 - 29 ± 9 73 63 69 35 37 - 37 34 57 54 - 42 31 - - 25 31 39 40 26 44 33 34 44 30 17 - 32 31 19 10 11 - 95 (77 -114) 99 ± 29 93 ± 22 144 ± 33 135 (110 -160) 145 ± 37 131 ± 28 - - 139 ± 4 138 ± 5 1. 8 ± 1. 6 - 1. 4 ± 1. 6 1. 9 ± 1. 8 840 (430 -1, 730) - 707 (362 -1, 284) 1250 (554 -2, 487) - - 12. 0 ± 2. 6 12. 9 ± 2. 4

Intravenous drugs and interventional procedures

Intravenous drugs and interventional procedures

Median Length of Stay 8 days (IQR 5~15) CO F S T Fr. E

Median Length of Stay 8 days (IQR 5~15) CO F S T Fr. E H

In-Hospital Mortality (%) * 2. 4% t D D P e E HF HF

In-Hospital Mortality (%) * 2. 4% t D D P e E HF HF II F HF -A lo om ICA HFS EA EN E R i S r E ZE E P tc G HF F T F M H A H T R I E OA AT AR E -HF Ou C AD TIM GW H R L D C O F A P S S A H T O E NI

GDMT at discharge 61. 6% 59. 7% 49. 0%

GDMT at discharge 61. 6% 59. 7% 49. 0%

Why NOT using RAAS inhibitors? ACEI/ARB yes ACEI/ARB no P value Patient numbers 900

Why NOT using RAAS inhibitors? ACEI/ARB yes ACEI/ARB no P value Patient numbers 900 (61. 6%) 560 (38. 4%) Age 61. 4 ± 16. 4 67. 3 ± 14. 9 <0. 001 Male 74. 2% 69. 5% 0. 048 Discharge SBP 120. 3 ± 18. 8 118. 5 ± 18. 0 0. 079 Discharge DBP 73. 0 ± 13. 5 70. 6 ± 12. 5 <0. 001 Discharge SBP ≤ 120 50. 8% 55. 7% <0. 001 Discharge HR 80. 4 ± 14. 9 80. 3 ± 15. 0 0. 844 Discharge BUN 28. 7 ± 19. 8 41. 0 ± 26. 8 <0. 001 Discharge Cr 1. 5 ± 1. 6 2. 2 ± 4. 3 <0. 001 Cr ≥ 2. 5 9. 2% 26. 3% <0. 001 K 4. 0 ± 0. 6 4. 1 ± 0. 7 0. 002 K ≥ 5. 5 5. 0% 10. 9% <0. 001

Why NOT using beta-blocker? Beta-blocker + Beta-blocker - P value Patient numbers 871 (59.

Why NOT using beta-blocker? Beta-blocker + Beta-blocker - P value Patient numbers 871 (59. 7%) 589 (40. 3%) Age 61. 4 ± 16. 3 67. 0 ± 15. 1 <0. 001 Male 72. 8% 71. 8% 0. 683 Admission SBP 134. 0 ± 28. 6 127. 6 ± 24. 8 <0. 001 Admission DBP 83. 0 ± 20. 2 78. 1 ± 17. 9 <0. 001 Admission HR 94. 0 ± 23. 1 91. 3 ± 20. 9 0. 022 Discharge SBP 120. 3 ± 18. 6 118. 6 ± 18. 3 0. 073 Discharge DBP 73. 1 ± 13. 5 70. 6 ± 12. 6 <0. 001 Discharge HR 79. 2 ± 14. 7 82. 1 ± 15. 2 <0. 001 Discharge BUN 33. 7 ± 24. 5 33. 6 ± 22. 2 0. 993 Discharge Cr 1. 9 ± 3. 7 1. 6 ± 1. 2 0. 082 Asthma/COPD 7. 3% 16. 0% <0. 001

Why NOT using aldosterone blockers? MRA + MRA- Patient numbers 716 (49. 0%) 745

Why NOT using aldosterone blockers? MRA + MRA- Patient numbers 716 (49. 0%) 745 (51. 0%) Age 60. 3 ± 17. 0 67. 0 ± 14. 5 <0. 001 Male 75. 1% 69. 8% 0. 022 Discharge SBP 116. 7 ± 18. 1 122. 4 ± 18. 5 <0. 001 Discharge DBP 72. 4 ± 13. 8 71. 8 ± 12. 6 0. 357 Discharge HR 81. 1 ± 15. 3 80. 0 ± 14. 6 0. 044 Discharge BUN 27. 2 ± 16. 0 39. 6 ± 27. 7 <0. 001 Discharge Cr 1. 3 ± 0. 7 2. 3 ± 4. 1 <0. 001 Cr ≥ 2. 5 6. 4% 24. 7% <0. 001 K 4. 0 ± 0. 6 Contra-indicated 4. 1 ± 0. 7 P value 0. 001 K ≥ 5. 5% 9. 0% 0. 055 LVEF 25. 8 ± 8. 5 30. 1 ± 8. 1 <0. 001 LVEF ≥ 35% and / or discharge NYHA Fc I 33. 9% 43. 3% <0. 001 Use of beta-blocker 59. 9% 59. 5% 0. 877 Use of ACEI/ARB 67. 1% 56. 4% <0. 001 Not-indicated

Taiwan Systolic Heart Failure Registry: follow-up at 1 year

Taiwan Systolic Heart Failure Registry: follow-up at 1 year

TSOC-HFr. EF outcomes 10. 5% 15. 9% Ø 1 -yr Re-hospitalization rates for HF:

TSOC-HFr. EF outcomes 10. 5% 15. 9% Ø 1 -yr Re-hospitalization rates for HF: 38. 5% (vs. 24. 8% in ESC-HF) Ø At 1 -yr, only 46. 4% were free from death, hospitalization for HF, LVAD or HTX (vs. 64. 2% in ESC-HF)

 OPTIMIZ EHFSE-HF 2 Baseline Characteristics IN-HF JCARECARD Kor. HF Hong Kong HF TSOCHFr.

OPTIMIZ EHFSE-HF 2 Baseline Characteristics IN-HF JCARECARD Kor. HF Hong Kong HF TSOCHFr. EF Year of enrollment 2003~04 ~2005 2007~09 2004~05 2004~09 2005~12 2013~15 Patient numbers, n 20, 118 2, 981 1, 292 847 1, 527 383 1, 509 Age, y/o 70. 4 71. 7 71 66. 6 69. 1 72. 2 63. 9 Male 62% 61. 6% 66. 4% 72. 2% 55. 9% 59. 8% 72. 4% BMI kg/m 2 NA 26. 8 27. 4 22. 7 23. 2 NA 25. 2 LVEF, % 24. 3 38. 4 31. 6 27 28. 7 NA 28. 5 Hypertension 66% 62. 1% 55. 6% 50. 4% 42. 0% 60. 3% 34. 5% Diabetes mellitus 39% 33. 1% 41. 0% 33. 3% 31. 4% 36. 0% 43. 6% NA 16. 5% 34. 0% 10. 4% 7. 3% 8. 9% 31. 5% Coronary artery dz 54% 53. 6% NA 39. 8% 40. 1% 34. 2% 41. 8% Atrial fibrillation 28% 38. 6% 32. 7% 24. 5% 20. 8% 31. 3% 26. 0% Comorbid Conditions Chronic renal failure Guideline-Directed Medication Therapy at Discharge ACEI or ARB NA 80. 2% NA 83. 5% 68. 0% 68. 6% 62. 1% ACEI 62% 71. 1% 57. 3% 44. 2% 45. 6% NA 27. 5% ARB 11% 10. 4% 20. 5% 45. 9% 24. 5% NA 34. 6% Beta-blocker 73% 61. 8% 67. 1% 65. 9% 40. 9% 48. 2% 59. 6% MRA 18% 47. 3% 60. 4% 45. 9% 37. 5% 12. 2% 49. 0% 60± 90 d 1 year 1 year All-cause mortality 9. 8% 21. 9% 24. 4% 8. 9% 9. 2% 19. 5% 15. 9% Re-hospitalization 29. 9% NA 30. 1% 23. 7% 9. 8% NA 38. 5% Outcomes after discharge Follow-up period

Trends in oral medication over time Discharge Medication 6 -months medication 12 -months medication

Trends in oral medication over time Discharge Medication 6 -months medication 12 -months medication ACEI 27. 5 % 17. 5% 16. 8% ARB 34. 6 % 39. 3% 40. 7% ACEI or ARB 62. 1 % 56. 8% 57. 5% Beta-blocker 59. 6 % 67. 3% 66. 3% MRA 49. 0% 43. 9% 40. 8% Diuretics 82. 2% 76. 5% 75. 9% Digoxin 25. 9 % 25. 5% 24. 0% Anti-platelet 59. 4 % 58. 0% 57. 3% Anti-coagulant 21. 3 % 21. 1% 23. 7% Nitrates 36. 4 % 32. 3% 32. 2% Hydralazine 4. 9 % 4. 6% 4. 2% Anti-arrhythmic agents 15. 7 % 16. 0% 14. 8%

GDMT: Prescription & Outcomes 64. 4% 35. 6% 20. 6% 10. 7% 18. 8%

GDMT: Prescription & Outcomes 64. 4% 35. 6% 20. 6% 10. 7% 18. 8% All 3 GDMTs 7. 4% 12. 3% 8. 7% 0 GDMTs 10. 0% 11. 6%

Multivariate analysis for all-cause morality Length of Stay Body Mass Index Fc III/IV Symptoms

Multivariate analysis for all-cause morality Length of Stay Body Mass Index Fc III/IV Symptoms at Discharge Hypothyroidism Hyponatremia GDMT usage≤ 1 Hazard ratio 1. 01 0. 95 95% CI P Value 1. 00 -1. 02 0. 91 -0. 99 0. 007 0. 023 1. 88 1. 28 -2. 77 0. 001 3. 97 1. 86 1. 59 1. 96 -8. 05 1. 27 -2. 72 1. 07 -2. 38 <0. 001 0. 023

Survival of HF patients according to the number of risk factors 2. 9% 13.

Survival of HF patients according to the number of risk factors 2. 9% 13. 1% 11. 2% LOS ≧ 8 days BMI ≤ 22. 4 kg/m 2 25. 2% Na ≤ 135 m. Eq/L NYHA Fc III/IV at discharge Hypothyroidism GDMT ≤ 1 type 41. 2%

2016 European HF guidelines

2016 European HF guidelines

Novel oral anti-HF medications Ivabradine: specific and selective inhibitor of the If ion Channel

Novel oral anti-HF medications Ivabradine: specific and selective inhibitor of the If ion Channel

Novel oral anti-HF medications Angiotensin Receptor Neprilysin Inhibitor (ARNI)

Novel oral anti-HF medications Angiotensin Receptor Neprilysin Inhibitor (ARNI)

New pharmaceutical targets in HF

New pharmaceutical targets in HF

Patient inertia Diuretics Inotropes, vasodilators ACEi/ARB, β-blockers, MRA, Neprilysin inhibitor CRT, CCM, MV repair

Patient inertia Diuretics Inotropes, vasodilators ACEi/ARB, β-blockers, MRA, Neprilysin inhibitor CRT, CCM, MV repair

Patient inertia Diuretics Inotropes, vasodilators ACEi/ARB, β-blockers, MRA, Neprilysin inhibitor CRT, CCM, MV repair

Patient inertia Diuretics Inotropes, vasodilators ACEi/ARB, β-blockers, MRA, Neprilysin inhibitor CRT, CCM, MV repair

Physician inertia

Physician inertia

Multi-disciplinary team approach for the management of HF patients 9. 1% 10. 9% 20.

Multi-disciplinary team approach for the management of HF patients 9. 1% 10. 9% 20. 6% 23. 4% Single center (Chang Gung Memorial Hospital, Keelung), 349 patients Multidisciplinary disease management program for HF improved outcomes Mao et al. J Cardiovasc Med 2015; 16: 616– 624

Post-acute care

Post-acute care

Conclusions • Although in-hospital mortality rate was low (2. 4%), mortality and readmission rates

Conclusions • Although in-hospital mortality rate was low (2. 4%), mortality and readmission rates were still high at 1 -yr follow-up in the HFr. EF Registry of TSOC, reflecting unmet needs in caring patients with HF. • Evidence-based guideline directed diagnosis, evaluation and therapy should be the mainstay for all patients with HF. • Effective implementation of guideline-directed best quality care reduces mortality, improves QOL and preserves health care resources. • How to overcome the possible underlying obstacles for the underperformance of HF treatment in Taiwan, including unwary about the impact of HF and exaggerated concerns over treatment risks and side-effects, etc. , are importance. • Multiple disciplinary team should be applied in order to improve the quality of heart failure care