device therapy in heart failure
TRANSCRIPT
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.
Acknowledgements
• Photo for title slide from Flickr User Michela: https://www.flickr.com/photos/sfagogo/