Mild heart failure (NYHA I and II) patients should not receive CRT

Dr. Yash LokhandwalaArrhythmia Associates

Acknowledgement

Dr. Parag Barwad, DM: Electrophysiology Fellow, Holy Family Heart Institute

CRT in NYHA I and II

Stretching our limits

Overdoing in false hope

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.

Recommendations ACC/AHA/ESC/EHRA/HRS

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

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

Selection bias in trials

• Patients supposed to be included (Intention to treat) vs patients actually included

• Guidelines based on Intention to treat parameters

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

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%

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

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%

REVERSE TRIAL

• NYHA I: no benefit

• NYHA II barely reached the unity line

• <152 ms: no benefit

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

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

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

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)

MADIT-CRT

MADIT CRT – 7 yr follow up

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 ???

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

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

Recommendations ACC/AHA/ESC/EHRA/HRS

Thank You !!