device therapy in heart failure

Disclosures

• None

Prevent. Treat. Monitor.

Prevent.

Alfred E. Buxton Circulation. 2005;111:2537-2549 Copyright © American Heart Association, Inc. All rights reserved.

Lane et al. Heart 2005;91:674–680. doi: 10.1136/hrt.2003.025254

MERIT-HF. Lancet 1999;353:2001–7.

Severity of heart failure and the mode of death in the MERITHF study

Image from https://www.flickr.com/photos/emagineart/

Let’s use pills!

CAST Investigators. N Engl J Med. 1989;321:406-412.

CAST II. N Engl J Med 1992; 327:227-233

Diamond CHF New Eng Journal of Med 1999

STAT CHF Trial. STEVEN N. SINGH et al. N Engl J Med. 1995;333:77-82.

Julian DG, et al. Lancet. 1997;349:667-674.

EMIAT: All-Cause Mortality: LVEF and by Group

Months Since Randomization Months Since Randomization

Pro

bab

ilit

y o

f S

urv

ival

Pro

bab

ilit

y o

f S

urv

ival

Amiodarone

PlaceboEjection fraction < 30%

Ejection fraction 31%-40%

CAMIAT: All-Cause Mortality and Nonarrhythmic Death

Cairns JA, et al. Lancet. 1997;349:675-682.

Months Since Randomization

Cu

mu

lati

ve

Ris

k (

%)

Months Since Randomization

Cu

mu

lati

ve

Ris

k (

%)

P=0.072

P=0.130

Amiodarone

Placebo

D-Sotalol post Myocardial Infarction (SWORD Trial)

Total Mortality (%)

p=0.006

10

6

4

2

8

0

d-sotalol placebo

SWORD, Waldo et al., Lancet 1996

3.148/1572

5.078/1549

Antiarrhythmic Drugs to Prevent SCA

Julian et al, Journal of American Medical Association 1993Echt et al, New England Journal of Medicine 1991

Class IA

10.00.1 1.0

1.19

1.06

2.38

0.81

1.04

0.96

0.91

5.0

Class IB

Class IC (CAST)

B-blockers

Calcium Channel Blockers

DIAMOND MI

Amiodarone: EMIAT

Mortality Hazard Ratio

156145

22

48

79

12

CIBIS II (1999) MERIT-HF (1999) USCHFT (1996)

Total Deaths Sudden Deaths

1 CIBIS-II Investigators, Lancet 19992 MERIT-HF Study Group, Lancet 1999

3 Packer M, N Engl J Med 1996

Residual Risk of SCD in Treatment Arms of CHF Beta Blocker Trials

54%31% 54%% Sudden

Death

Image from https://www.flickr.com/photos/emagineart/

Pills alone… Probably not a good idea…

Trial (Follow up Analysis) Year Published

Study GroupDefined Entry Criteria

All-CauseMortality

Benefit

Control ICD RRR ARR

AVID (2 years) 1997 VF, VT with syncope,VT with EF <40%

25% 18% -27% -7%

CIDS (2 years) 2000 VF, out-of-hospital cardiacarrest due to VF or VT,VT with syncope, VT withsymptoms and EF<35%, unmonitoredsyncope withsubsequent spontaneousor induced VT

21% 15% -30% -6%

CASH (9 years) 2000 VT, VF 44% 36% -23% -8%

Adapted from Myerburg RJ, Reddy V, Castellanos A. Indications for Implantable Cardioverter-Defibrillators Based on Evidence and Judgment. J Am Coll Cardiol.

2009;54(9):747-763. doi:10.1016/j.jacc.2009.03.078.

AVID. N Engl J Med 1997; 337: 1576-83

Update of CIDS Trial:11-Year Follow-Up From One Center

• Original study randomized amiodarone vs ICD in VT/VF survivors (N=659)

• Long-term follow-up from 1 center–amiodarone (N=60)

• All-cause mortality higher in amiodarone (N=28) vs ICD (N=16)

• Annual mortality rate–amiodarone, 8.4%–ICD, 4.8%

• Amiodarone patients• 82% had side effect

• 50% had significant side effect

Bokhari FA, et al. Circulation. 2002;106(19 suppl II):II-497.

CIDS Update: 11-Year Follow-Up

ICD

Amiodarone

100

80

60

40

20

0

20 40 60 80 100 120 140

P=0.021

Months

Actu

ari

al

Su

rviv

al

(%)

Bokhari FA, et al. Circulation. 2002;106(19 suppl II):II-497.

Trial (Follow up Analysis) Year Published

Study GroupDefined Entry Criteria

All-CauseMortality

Benefit

Control ICD RRR ARR

MADIT(2-yr analysis)1996

Prior MI, EF <35%, NS VT,inducible VT, failed IV Procainamide

32% 13% -59% -19%

CABG-Patch(2-yr analysis)1997

Coronary artery bypass surgery,EF <36%, SAECG(+)

18% 18% N/A N/A

MUSTT(5-yr analysis)1999

CAD (prior MI ~95%), EF<40%, NS VT, inducible VT

55% 24% -58% -31%

Adapted from Myerburg RJ, Reddy V, Castellanos A. Indications for Implantable Cardioverter-Defibrillators Based on Evidence and

Judgment. J Am Coll Cardiol. 2009;54(9):747-763. doi:10.1016/j.jacc.2009.03.078.

Trial (Follow up Analysis) Year Published

Study GroupDefined Entry Criteria

All-CauseMortality

Benefit

Control ICD RRR ARR

MADIT-II(2-yr analysis)2002

Prior MI (>1 month), EF <30% 22% 16% -28% -6%

DEFINITE(2.5-yr analysis)2004

Nonischemic CM, history ofHF, EF <35%, >10 PVCs/h,or NS VT

14% 8% -44% -6%

DINAMIT(2.5-yr analysis)2004

Recent MI (6–40 days),EF <35%, abnormal HRV, ormean 24 heart rate >80beats/min

17% 19% N/A N/A

SCD-HeFT(5-yr analysis)2005

NYHA functional class II–IIICHF, EF ?35%

36% 29% -23% -7%

Adapted from Myerburg RJ, Reddy V, Castellanos A. Indications for Implantable Cardioverter-Defibrillators Based on

Evidence and Judgment. J Am Coll Cardiol. 2009;54(9):747-763. doi:10.1016/j.jacc.2009.03.078.

Kaplan-Meier Estimates of Death from Any Cause

Bardy, G. et al. N Engl J Med 2005;352:225-237

Kaplan-Meier Estimates of Death from Any Cause for the Prespecified Subgroups of Ischemic CHF (Panel A) and Nonischemic CHF (Panel B)

Bardy, G. et al. N Engl J Med 2005;352:225-237

Kaplan-Meier Estimates of Death from Any Cause for the Prespecified Subgroups of Ischemic CHF (Panel A) and Nonischemic CHF (Panel B)

Bardy, G. et al. N Engl J Med 2005;352:225-237

Clinical Cardiac Pacing, Defibrillation and Resynchronization Therapy (4th ed). Ellenbogen et al. p. 261

Treat.

"Cardiac resynchronisation therapy" by Gregory Marcus, MD, MAS, FACC

Image from Wikimedia User Cosmed: http://commons.wikimedia.org/wiki/File:Ergospirometry_laboratory.jpg

6MWDPeak VO2Exercise CapacityQOLNYHA FCLVEFImprovement in ventricular volumes

MUSTIC: http://bit.ly/musticPATH CHF: http://bit.ly/pathchfPATH CHF II: http://bit.ly/pathchf2MIRACLE: http://bit.ly/miracleCRT

Image from Flickr user:https://www.flickr.com/photos/imbasith/

Bristow et al. COMPANION. NEJM 2004; 350:2140-50 Cleland et al. CARE-HF. NEJM 2005;352:1539-49.

Moss et al. MADIT-CRT. N Engl J Med 2009;361:1329-38.

Tang et al. RAFT. N Engl J Med 2010;363:2385-95.

BLOCK HF Trial. N Engl J Med 2013;368:1585-93.

"Cardiac resynchronisation therapy" by Gregory Marcus, MD, MAS, FACC

Heart failure, NYHA FC II, III or ambulatory IVw/ Wide QRS (better if > 150 ms and LBBB morphology)----LV dysfunction + Heart Block

Monitor.

Risk of Stroke or Systemic EmbolismRisk of Clinical Atrial Tachyarrhythmia

ASSERT Trial. N Engl J Med 2012;366:120-9

Sm

all

RS

et

al. J

Card

Fail.

Augu

st 2009;1

5(6

):475

-48

1.

PARTNERS HF Study

Whellan DJ, et al. Late-Breaking Clinical Trials. HFSA 2008.Unadjusted Kaplan-Meier estimates

Tang WH, Warman EN, Johnson JW, et al. Threshold crossing of device-based intrathoracic impedance trends identifies relatively increased mortality risk. Eur Heart J. 2012;33(17):2189-2196

Abraham, W. T., et al. Pulmonary artery pressure management in heart failure patients

with reduced ejection fraction significantly reduces heart failure hospitalizations and

mortality above and beyond background guideline-directed medical therapy. Abstract 902-04 presented at ACC 2015, San Diego, CA.

Prevent. Treat. Monitor.

1.4 1

0.9

1.5

50

12

4

0.4

54

.3

13 16

.2

9.8

4

ICD IMPLANTATION PER MILLION INHABITANTS FOR THE YEAR 2013 IN ASIA PACIFIC

Data from Asia Pacific Heart Rhythm Society White Book 2014

1.6

1.5

33

.5

21

0.2

23

.9

3.2

6.8

3.7

CRT IMPLANTATION PER MILLION INHABITANTS FOR THE YEAR 2013 IN ASIA PACIFIC

Data from Asia Pacific Heart Rhythm Society White Book 2014

Data from Asia Pacific Heart Rhythm Society White Book 2014

Prevent. Treat. Monitor.

@HeartRhythmMD

mjagbayani@gmail.com

http://bit.ly/phatalk2015

Acknowledgements

• Photo for title slide from Flickr User Michela: https://www.flickr.com/photos/sfagogo/