Mild heart failure (nyha i and ii) patients should not receive crt
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Mild heart failure (NYHA I and II) patients should not receive CRT
Dr. Yash LokhandwalaArrhythmia Associates
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Acknowledgement
Dr. Parag Barwad, DM: Electrophysiology Fellow, Holy Family Heart Institute
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CRT in NYHA I and II
Stretching our limits
Overdoing in false hope
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Benefit of CRT in NYHA III and IV (ambulatory)
• Companion trial – By one year CRT-P / CRT-D reduces death or hospitalization
for HF by 12% (ARR) – NNT: 9 patients for 1 year to prevent 1 death or
hospitalization for HF
• CARE - HF– Total follow up 30 months– CRT-P / CRT-D reduces death or hospitalization for HF by
16% (ARR) – NNT: 6 patient for 1 year to prevent 1 death or
hospitalization for HF
N Engl J Med 2004;350:2140-50.
N Engl J Med 2005;352:1539-49.
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Recommendations ACC/AHA/ESC/EHRA/HRS
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The NYHA class fallacy
• What many consider– NYHA class I: Asymptomatic – NYHA class II: mildly symptomatic
• But what guidelines says– NYHA class I: Initially any class but now Class I, after
medication as necessary– Similar for Class II
Adherence to BB, ACEI, ARB and diuretics: 97% in trial patients
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Trials (in NYHA I and II) which were the basis for the guidelines
• REVERSE
• RAFT
• MADIT – CRT
J Am Coll Cardiol 2008; 52:1834–43
N Engl J Med 2009;361:1329-38.
N Engl J Med 2010;363:2385-95.
Randomized trial of cardiac resynchronization in mildly symptomatic heart failure patients and in asymptomatic patients with left ventricular dysfunction and previous heart failure symptoms.
Cardiac- resynchronization therapy for mild-to-moderate heart failure.
Cardiac- resynchronization therapy for the prevention of heart- failure events
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Selection bias in trials
• Patients supposed to be included (Intention to treat) vs patients actually included
• Guidelines based on Intention to treat parameters
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REVERSE
• 610 patients (2:1) CRT on vs off– NYHA I & II– QRS >120 ms, LVEF < 0.4, LVEDD > 55 mm
• Overall – Mean LVEF 0.26, Mean QRS duration 153 ms, – NYHA II: 83%
Funded by Medtronic
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REVERSE (contd)
• At 12 months– 16% worsened on CRT on and 21% in CRT off– Absolute risk reduction 5%– 20 patients will have to be treated for 1 year to
prevent one death or hospitalization (NNT)• Non responders in CRT- ON
– 30%• Complications
– 16%
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Cost calculation – my assessment for India
• Average CRT implantation cost @ Rs. 4 lakhs
• Average device life 5 years (@ 35% required replacement at the end of 4 years)
• Average re-implant cost @ Rs. 3 lakhs
• 10% need lead replacement/repositioning- average cost Rs. 50000
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REVERSE (contd) • At 12 months
– 16% worsened on CRT on and 21% in CRT off– Absolute risk reduction 5%– 20 patients will have to be treated for 1 year to
prevent one death or hospitalization (NNT): Cost @ Rs. 10,000,000 (only 1 crore)
• Non responders in CRT- ON – 30%
• Complications– 16%
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REVERSE TRIAL
• NYHA I: no benefit
• NYHA II barely reached the unity line
• <152 ms: no benefit
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RAFT
• NYHA II, LVEF <30%, QRS >120• Overall
– 1798 patients, FU for 40 months– LVEF: 0.22– NYHA II: 80%– Mean QRS duration 158 ms– BB and ACEI in max possible dose: 90- 97%
Funded by Medtronic
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RAFT results
- Death or hospitalisation: 33% in CRT and 40% in non-CRT (ARR 7%)
- 14 patients treated for 9 years to prevent 1 death (cost @ Rs. 1.4 crore)
- 11 patients treated for 5 years to prevent 1 hospitalisation (cost @ Rs. 66 lakhs)
- Device related hospitalization in one year: 20%
- Non responders: not mentioned
- QRS <150 ms: not benefited
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MADIT - CRT• 1820 patients, QRS >130, EF <30%, NYHA I and II• 3:2 (CRT-D/ICD)
• Overall– NYHA II: 85%– QRS duration >150 ms: 65%– LVEF: 0.24– BB and ACEI: 93 - 94%
Funded by Boston Scientific
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MADIT –CRT results• Non-responders: not mentioned
• Complication– Total device related intervention in 30 days: 5%
• Result– Over 2.5 years– Death and hospitalization (17% vs 25%; ARR: 8%)
• NNT:12 patients to be treated for 2.5 yrs to prevent one death or hospitalization (cost @ Rs. 60 lakhs)
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MADIT-CRT
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MADIT CRT – 7 yr follow up
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Inferences• NYHA definition: should be on maximum tolerable
dosages• NYHA I: do not benefit• NYHA II
• Quantum of benefit questionable• Upto 15 patients to be treated for 2.5 to 5 years to
prevent one hospitalization or death• Non-responders: upto 30%• Complications: 20% in one year• Cost - to the family ?
- to public funds ???
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Practical issues
• Understanding of cardiac activation• Expertise in implanting CRT• Availability of thoracotomy option• Ability to troubleshoot the device• Ability to assess and program the device to get
maximum benefit
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Is it worth it or is it overkill?
• We cardiologists are aggressive people
• Anything difficult is always challenging for us
• We say calculated risk– Calculation by cardiologist– Risk for the patient
• Let us be careful in our case selection so that this therapy is maximally useful
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Recommendations ACC/AHA/ESC/EHRA/HRS
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Thank You !!