Transcript Diapositiva 1

Indications on cardiac pacing and
cardiac resynchronization therapy
Michele Brignole
Centro Aritmologico, Ospedali del Tigullio, Lavagna, Italy
Task Force members
Michele Brignole (Italy)
Angelo Auricchio (Switzerland)
Gonzalo Baron-Esquivias (Spain)
Pierre Bordachar (France)
Giuseppe Boriani (Italy)
Ole-A Breithardt (Germany)
John Cleland (UK)
Jean-Claude Deharo (France)
Victoria Delgado (Nertherlands)
Perry M. Elliott (UK)
Bulent Gorenek (Turkey)
Carsten W. Israel (Germany)
Christophe Leclercq (France)
Cecilia Linde (Sweden)
Lluís Mont (Spain)
Luigi Padeletti (Italy)
Richard Sutton (UK)
Panos E. Vardas (Greece)
European Heart Journal
2013; 34: 2281–2329
Europace
2013; 15: 1070-1118
Timelines
Chair invitation letter
14 March 2011
1° plenary meeting
13-14 June 2011
2° plenary meeting
21-22 November 2011 Mastercopy
3° plenary meeting
2-3 March 2012
Version 2
4° plenary meeting
27 August 2012
Revision round 1
5° plenary meeting
28 November 2012
Revision round 2
CPG comments
28 February 2013
CPG revision
Ready for publication 9 April 2013
European Heart Journal
2013; 34: 2281–2329
Table of contents &
assignments
Sent to Eur Heart J
and Euroapce
Europace
2013; 15: 1070-1118
Contributors
70
Contributors
18
Task Force
Members
26
CPG Members
26
Reviewers
690 comments
(98 pages)
European Heart Journal
2013; 34: 2281–2329
Europace
2013; 15: 1070-1118
General structure of the document
1. Pacing for bradycardia
– Indications
– mode of pacing
2. Cardiac resynchronization therapy
– Indications
– mode of pacing
3. Complication of pacing and CRT
4. Management considerations
www.escardio.org/guidelines
European Heart Journal
2013; 34: 2281–2329
Europace
2013; 15: 1070-1118
Classification of bradyarrhythmias based on
the patient’s clinical presentation
Patients considered for
antibradycardia PM therapy
Persistent bradycardia
Sinus
node
disease
AV block:
• Sinus rhythm
• Atrial fibrillation
Intermittent bradycardia
ECGdocumented
Intrinsic
• Parox AVB
• SSS (bradytachy)
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Extrinsic
(functional)
Suspected
(ECG-undocumented)
BBB
Reflex
syncope
• Vagal
• Idiopathic
AVB
• Carotid sinus
• Tilt-induced
European Heart Journal
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Unexplained
syncope
New classification of bradyarrhythmias:
ECG instead of etiology
Look for bradycardia
ECG documentation
(bradycardia established)
No ECG documentation
(bradycardia suspected)
Consider PM
Obtain an ECG
documentation
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European Heart Journal
2013; 34: 2281–2329
Europace
2013; 15: 1070-1118
Indication for pacing
in patients with persistent bradycardia
Recommendations
Class
Level
I
B
IIb
C
III
C
I
C
IIa
C
III
C
1) Sinus node disease.
Pacing is indicated when symptoms can clearly be attributed to bradycardia.
2) Sinus node disease.
Pacing may be indicated when symptoms are likely to be due to bradycardia,
even if the evidence is not conclusive.
3) Sinus node disease.
Pacing is not indicated in patients with sinus bradycardia which is
asymptomatic or due to reversible causes.
4) Acquired AV block.
Pacing is indicated in patients with third- or second-degree type 2 AV block
irrespective of symptoms.
5) Acquired AV block.
Pacing should be considered in patients with second-degree type 1 AV block
which causes symptoms or is found to be located at intra- or infra-His levels
at EPS.
6) Acquired AV block.
Pacing is not indicated in patients with AV block which is due to reversible
causes.
www.escardio.org/guidelines
European Heart Journal
2013; 34: 2281–2329
Europace
2013; 15: 1070-1118
Indication for pacing
in intermittent documented bradycardia
Recommendations
Class
Level
1) Sinus node disease (including brady-tachy form).
Pacing is indicated in patients affected by sinus node disease who have the
documentation of symptomatic bradycardia due to sinus arrest or sinus-atrial
block.
I
B
2) Intermittent/paroxysmal AV block (including AF with slow ventricular
conduction).
Pacing is indicated in patients with intermittent/paroxysmal intrinsic thirdor second-degree AV block.
I
C
3) Reflex asystolic syncope.
Pacing should be considered in patients ≥40 years with recurrent,
unpredictable reflex syncopes and documented symptomatic pause/s due to
sinus arrest or AV block or the combination of the two.
IIa
B
4) Asymptomatic pauses (sinus arrest or AV block).
Pacing should be considered in patients with history of syncope and
documentation of asymptomatic pauses >6 s due to sinus arrest, sinus-atrial
block or AV block.
IIa
C
5) Pacing is not indicated in reversible causes of bradycardia.
III
C
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European Heart Journal
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2013; 15: 1070-1118
Indication for cardiac pacing in patients
with undocumented bradycardia (reflex syncope)
Recommendations
Class
Level
I
B
2) Tilt-induced cardioinhibitory syncope.
Pacing may be indicated in patients with tilt-induced cardioinhibitory response
with recurrent frequent unpredictable syncope and age >40 years after
alternative therapy has failed.
IIb
B
3) Tilt-induced non-cardioinhibitory syncope.
Cardiac pacing is not indicated in the absence of a documented
cardioinhibitory reflex.
III
B
4) Unexplained syncope and positive adenosine triphosphate test.
Pacing may be useful to reduce syncopal recurrences.
IIb
B
5) Unexplained syncope.
Pacing is not indicated in patients with unexplained syncope without evidence
of bradycardia or conduction disturbance.
III
C
6) Unexplained falls.
Pacing is not indicated in patients with unexplained falls.
III
B
1) Carotid sinus syncope.
Pacing is indicated in patients with dominant cardioinhibitory carotid sinus
syndrome and recurrent unpredictable syncope.
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2013; 15: 1070-1118
CSS: Syncope recurrence rate
%
60
Brignole 92 (a)
No therapy
Pacemaker
50
Blanc 84
40
Claesson 07
Claesson 07
Menozzi 93
30
Brignole 92 (b)
Sugrue 86
20
Crilley 97
Morley 82
Claesson 07
10
Brignole 92 (b)
Lopes 11
Sugrue 86
Brignole 92 (a)
Walter 78
Claesson 07
Blanc 84
0
0
1
Stryjer 86
2
3
Years
4
5
Clinical perspectives
Recommendations
1) Carotid sinus syncope.
Pacing is indicated in patients with dominant cardioinhibitory
carotid sinus syndrome and recurrent unpredictable syncope.
Class
Level
I
B
Clinical perspectives
• The decision to implant a pacemaker should be made in the context of a
relatively benign condition ……….
• ……. carotid sinus syndrome does not affect survival,…….
• …….. syncopal recurrences are still expected to occur in up to 20% of
paced patients within 5 years……
Indication for cardiac pacing
in patients with undocumented bradycardia (BBB)
Recommendations
Class
Level
I
B
I
C
IIb
B
III
B
1) BBB, unexplained syncope and abnormal EPS.
Pacing is indicated in patients with syncope, BBB and positive EPS defined as
HV interval of ≥70 ms, or second- or third-degree His-Purkinje block
demonstrated during incremental atrial pacing or with pharmacological
challenge.
2) Alternating BBB.
Pacing is indicated in patients with alternating BBB with or without symptoms.
3) BBB, unexplained syncope with non-diagnostic investigations.
Pacing may be considered in selected patients with unexplained syncope
and BBB.
4) Asymptomatic BBB.
Pacing is not indicated for BBB in asymptomatic patients
www.escardio.org/guidelines
European Heart Journal
2013; 34: 2281–2329
Europace
2013; 15: 1070-1118
Algorithm for patients
with unexplained syncope and BBB
BBB and unexplained syncope
Reduced EF (<35%)
Preserved EF (>35%)
Consider
ICD/CRT-D
Consider
CSM/EPS
Appropriate therapy
(if negative)
Consider ILR
Appropriate therapy
(if negative)
Clinical follow-up
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European Heart Journal
2013; 34: 2281–2329
Europace
2013; 15: 1070-1118
Dual-chamber versus ventricular pacing
Outcome
Dual-chamber benefit over ventricular pacing
All-cause deaths
No benefit
Stroke, embolism
Benefit (in meta-analysis only, not in single trial)
Atrial fibrillation
Benefit
HF, hospitalization for HF
No benefit
Exercise capacity
Benefit
Pacemaker syndrome
Benefit
Functional status
No benefit
Quality of life
Variable
Complications
More complications with dual-chamber
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European Heart Journal
2013; 34: 2281–2329
Europace
2013; 15: 1070-1118
Choice of pacing mode
Sinus node disease
Persistent
Chronotropic
incompetence
No chronotropic
incompetence
1° choice
DDDR + AVM
2° choice
AAIR
1° choice
DDD + AVM
2° choice
AAI
AV block
Intermittent
1° choice
DDDR + AVM
2° choice
DDDR, no AVM
3° choice
AAIR
Persistent
Intermittent
SND
No SND
AF
1° choice
DDDR
2° choice
DDD
3° choice
VVIR
1° choice
DDD
2° choice
VDD
3° choice
VVIR
VVIR
DDD + AVM
(VVI if AF)
Consider CRT if low EF/HF
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European Heart Journal
2013; 34: 2281–2329
Europace
2013; 15: 1070-1118
Challenging indications for CRT: the “Entry criterium”
Favors CRT-D
All LBBB
Women
Men
Class I
Class II
QRS <150
QRS ≥150
US
OUS
All Non-LBBB
Women
Men
Class I
Class II
QRS <150
QRS ≥150
US
OUS
Favors ICD
n=1283
n=396
n=887
n=145
n=1138
n=302
n=981
n=871
n=412
n=537
n=59
n=478
n=121
n=416
n=343
n=194
n=398
n=139
0.1
Font: MADIT CRT
www.escardio.org/guidelines
LBBB
Non LBBB
0.2
0.5
1
2
5
Hazard ratio
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2013; 34: 2281–2329
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2013; 15: 1070-1118
10
Indications for CRT
in patients in sinus rhythm
Magnitude of benefit from CRT
Highest
(responders)
Wider QRS, LBBB, females,
non-ischemic cardiomyopathy
Males, ischemic cardiomyopathy
Lowest
(non-responders)
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Narrower QRS, non-LBBB
European Heart Journal
2013; 34: 2281–2329
Europace
2013; 15: 1070-1118
Indications for CRT
in patients in sinus rhythm
Recommendations
Class
Level
1) LBBB with QRS duration >150 ms is recommended in chronic HF
patients and LVEF ≤35% who remain in NYHA functional class II, and
ambulatory IV despite adequate medical treatment. (*)
I
A
2) LBBB with QRS duration 120-150 ms should be considered in chronic
HF patients and LVEF ≤35% who remain in NYHA functional class II, and
ambulatory IV despite adequate medical treatment. (*)
I
B
3) Non-LBBB with QRS duration >150 ms should be considered in chronic
HF patients and LVEF ≤35% who remain in NYHA functional class II, and
ambulatory IV despite adequate medical treatment. (*)
IIa
4) Non-LBBB with QRS duration 120-150 ms may be considered in chronic
HF patients and LVEF ≤35% who remain in NYHA functional class II, and
ambulatory IV despite adequate medical treatment. (*)
IIb
B
5) QRS duration <120 ms CRT in patients with chronic HF with QRS duration
<120 ms is not recommended.
III
B
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European Heart Journal
2013; 34: 2281–2329
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2013; 15: 1070-1118
B
Indication for CRT
in patients with permanent AF
Recommendations
Class
Level
1a) should be considered in chronic HF patients, intrinsic QRS ≥120 ms
and LVEF ≤35% who remain in NYHA functional class III and ambulatory IV
despite adequate medical treatment (*), provided that a biventricular
pacing as close to 100% as possible can be achieved.
IIa
B
1b) AV junction ablation should be added in case of incomplete
biventricular pacing.
IIa
B
IIa
B
1) Patients with HF, wide QRS and reduced LVEF:
2) Patients with uncontrolled heart rate who are candidates for AV
junction ablation. CRT should be considered in patients with reduced
LVEF who are candidates for AV junction ablation for rate control.
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European Heart Journal
2013; 34: 2281–2329
Europace
2013; 15: 1070-1118
Indications for AVJ ablation (± CRT)
in permanent AF
Heart failure, NYHA class III-IV
and EF <35%
QRS ≥120 ms
CRT *
Incomplete
BiV pacing
AVJ
ablation
Complete
BiV pacing
No AVJ
ablation
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Reduced EF and
uncontrollable HR, any QRS
QRS <120 ms
Adequate
rate control
Inadequate
rate control
No AVJ abl
No CRT*
AVJ abl
& CRT
AVJ abl
& CRT
* Consider ICD according guidelines
European Heart Journal
2013; 34: 2281–2329
Europace
2013; 15: 1070-1118
Upgraded or de novo CRT in patients with
conventional pacemaker indications and HF
Recommendations
Class
Level
1) Upgrade from conventional PM or ICD is indicated in HF
patients with LVEF <35% and high percentage of ventricular pacing
who remain in NYHA class III and ambulatory IV despite adequate
medical treatment.
I
B
2) “De novo” implantation should be considered in HF patients,
reduced EF and expected high percentage of ventricular pacing in
order to decrease the risk of worsening HF.
IIa
B
Clinical perspectives
•
A strategy of initially conventional antibrady pacing with late upgrade in case of
worsening symptoms seems reasonable
•
In the decision process physicians should take into account the excess
complication rate related to the more complex biventricular system, the shorter
longevity of CRT devices and the excess of costs.
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European Heart Journal
2013; 34: 2281–2329
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2013; 15: 1070-1118
Time to death of any cause
in the European CRT Survey
1,00
Proportion of patients surviving
0,98
p=0.85
0,96
0,94
0,92
0,90
0,88
0,86
De-novo implantations
0,84
Upgrades
0,82
0,80
0
50
100
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150
200
250
300
Days after implantation
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350
400
450
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500
Backup ICD in patients indicated for CRT
Comparative results of CRT-D versus CRT-P in primary prevention
CRT-D
Mortality reduction
Complications
Costs
CRT-P
Similar level of evidence
but CRT-D slightly better
Higher
Higher
Similar level of evidence but
CRT-P slightly worse
Lower
Lower
Clinical guidance to the choice of CRT-P or CRT-D in primary prevention
Factors favouring CRT-D
Factors favouring CRT-P
Life expectancy >1 year
Stable heart failure, NYHA II
Ischemic heart disease
(low and intermediate MADIT risk score)
Lack of comorbidities
Advanced heart failure
Severe renal insufficiency or dialysis
Other major co-morbidities
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Frailty
Cachexia
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Choice of pacing mode
(and CRT optimization)
Class Level
Recommendations
1) The goal of should be to achieve biventricular pacing as close to 100% as
possible since the survival benefit and reduction in hospitalization are strongly
associated with an increasing percentage of biventricular pacing.
IIa
B
2) Apical position of the LV lead should be avoided when possible.
IIa
B
3) LV lead placement may be targeted at the latest activated LV segment.
IIb
B
Clinical perspectives
• The usual (standard) modality of CRT pacing consists of simultaneous biventricular pacing
(RV and LV) with a fixed 100-120 ms AV delay with LV lead located in a posterolateral
vein, if possible.
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European Heart Journal
2013; 34: 2281–2329
Europace
2013; 15: 1070-1118
Indication for prevention and termination
of atrial tachyarrhythmias
Recommendations
De novo indications.
Prevention and termination of atrial tachyarrhythmias does not
represent a stand-alone indication for pacing.
www.escardio.org/guidelines
European Heart Journal
2013; 34: 2281–2329
Class
Level
III
A
Europace
2013; 15: 1070-1118
Optimal pacing mode in children
Dyssynchrony
associated HF
Bradycardia
Sinus node
dysfunction
(Complete)
AV block
Intrinsic LBBB
RV pacing
induced
dyssynchrony
Prevent
dyssynchrony
Prevent
dyssynchrony
(Left)
ventricular
pacing only
Treat
dyssynchrony
Single-site LV
(or BIV)
pacing
Treat
dyssynchrony
Single-site LV
(or BIV)
pacing
Atrial pacing
only
Clinical perspectives
• LV pacing alone… seems to be non-inferior to biventricular pacing for improving soft end-points (quality
of life, exercise capacity and LV reverse remodelling) …. LV pacing alone seems particularly appealing
in children and young adults.
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European Heart Journal
2013; 34: 2281–2329
Europace
2013; 15: 1070-1118
MRI in patients with implanted
cardiac devices
Recommendations
Class
Level
1) Conventional cardiac devices.
In patients with conventional cardiac devices, MRI at 1.5 T can be
performed with a low risk of complications if appropriate precautions
are taken (see additional advice).
IIb
B
2) MRI-conditional PM systems.
In patients with MR-conditional PM systems, MRI at 1.5 T can be
done safely following manufacturer instructions.
IIa
B
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European Heart Journal
2013; 34: 2281–2329
Europace
2013; 15: 1070-1118
Conventional devices
MRI-conditional devices
According to manifacturer conditions:
• Monitoring by qualified personnel during
MRI is essential.
• Monitoring by qualified personnel during
MRI is essential.
• Exclude patients with leads <6 weeks and
those with epicardial and abandoned leads.
• Exclude patients with leads <6 weeks and
those with epicardial and abandoned leads.
• Program an asynchronous mode in
PM-dependent and an inhibited mode in
non PM-dependent patients.
• In contrast, use an inhibited pacing mode
for patients without PM dependence, to
avoid inappropriate pacing due to tracking
of electromagnetic interference.
• Automatically performed by an external
physician-activated device.
• Deactivate other pacing functions.
• Deactivate tachyarrhythmia monitoring and
therapies (ATP/shock).
• Reprogram device immediately after the
MRI examination.
www.escardio.org/guidelines
• Reprogram device immediately after the
MRI examination
European Heart Journal
2013; 34: 2281–2329
Europace
2013; 15: 1070-1118
Remote management
of arrhythmias and device
Recommendations
Device-based remote monitoring should be considered in order to
provide earlier detection of clinical problems (e.g. ventricular
tachyarrhythmias, atrial fibrillation) and technical issues (e.g. lead
fracture, insulation defect).
www.escardio.org/guidelines
European Heart Journal
2013; 34: 2281–2329
Class
Level
IIa
A
Europace
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Style innovation
• Clinically oriented, simple, ready for use
• Short and simple articulation of
recommendations
• Description of benefit and harm
• Rating of quality of evidence
• Acknowledgment of differences of opinion
European Heart Journal
2013; 34: 2281–2329
Europace
2013; 15: 1070-1118