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Indications on cardiac pacing and cardiac resynchronization therapy
Michele Brignole
Centro Aritmologico, Ospedali del Tigullio, Lavagna, Italy
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)
Task Force members
European Heart Journal2013; 34: 2281–2329
Europace2013; 15: 1070-1118
Chair invitation letter 14 March 2011
1° plenary meeting 13-14 June 2011 Table of contents & assignments
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 Sent to Eur Heart J and Euroapce
Timelines
European Heart Journal2013; 34: 2281–2329
Europace2013; 15: 1070-1118
70Contributors
18Task Force Members
26CPG Members
26Reviewers
Contributors
690 comments(98 pages)
European Heart Journal2013; 34: 2281–2329
Europace2013; 15: 1070-1118
www.escardio.org/guidelines
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
European Heart Journal2013; 34: 2281–2329
Europace2013; 15: 1070-1118
www.escardio.org/guidelines
Classification of bradyarrhythmias based on the patient’s clinical presentation
AV block:• Sinus rhythm• Atrial fibrillation
Sinus node
disease
Patients considered for antibradycardia PM therapy
• Parox AVB• SSS (brady- tachy)
ECG-documented
Intrinsic Extrinsic (functional)
• Vagal • Idiopathic AVB
BBB Reflex syncope
Unexplained syncope
• Carotid sinus • Tilt-induced
Suspected (ECG-undocumented)
Intermittent bradycardiaPersistent bradycardia
European Heart Journal2013; 34: 2281–2329
Europace2013; 15: 1070-1118
www.escardio.org/guidelines
New classification of bradyarrhythmias: ECG instead of etiology
Look for bradycardia
Obtain an ECG documentation
No ECG documentation(bradycardia suspected)
ECG documentation(bradycardia established)
Consider PM
European Heart Journal2013; 34: 2281–2329
Europace2013; 15: 1070-1118
www.escardio.org/guidelines
Recommendations Class Level
1) Sinus node disease.Pacing is indicated when symptoms can clearly be attributed to bradycardia. I B
2) Sinus node disease.Pacing may be indicated when symptoms are likely to be due to bradycardia, even if the evidence is not conclusive.
IIb C
3) Sinus node disease.Pacing is not indicated in patients with sinus bradycardia which is asymptomatic or due to reversible causes.
III C
4) Acquired AV block.Pacing is indicated in patients with third- or second-degree type 2 AV block irrespective of symptoms.
I C
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.
IIa C
6) Acquired AV block.Pacing is not indicated in patients with AV block which is due to reversible causes.
III C
Indication for pacing in patients with persistent bradycardia
European Heart Journal2013; 34: 2281–2329
Europace2013; 15: 1070-1118
www.escardio.org/guidelines
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 third- or 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
Indication for pacing in intermittent documented bradycardia
European Heart Journal2013; 34: 2281–2329
Europace2013; 15: 1070-1118
www.escardio.org/guidelines
Recommendations Class Level
1) Carotid sinus syncope.Pacing is indicated in patients with dominant cardioinhibitory carotid sinus syndrome and recurrent unpredictable syncope.
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
Indication for cardiac pacing in patientswith undocumented bradycardia (reflex syncope)
European Heart Journal2013; 34: 2281–2329
Europace2013; 15: 1070-1118
CSS: Syncope recurrence rate
0 0.5 1 1.5 2 2.5 3 3.5 4 4.50
10
20
30
40
50
60%
Years
Blanc 84
Brignole 92 (a)
Brignole 92 (b)
Claesson 07Claesson 07
Menozzi 93
Sugrue 86
Walter 78
Claesson 07
Claesson 07Brignole 92 (a)
Brignole 92 (b)Morley 82
Blanc 84 Stryjer 86
Sugrue 86
Crilley 97
Lopes 11
PacemakerNo therapy
Clinical perspectives
New
Recommendations Class Level
1) Carotid sinus syncope.Pacing is indicated in patients with dominant cardioinhibitory carotid sinus syndrome and recurrent unpredictable syncope.
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……
www.escardio.org/guidelines
Recommendations Class Level
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.
I B
2) Alternating BBB.
Pacing is indicated in patients with alternating BBB with or without symptoms.I C
3) BBB, unexplained syncope with non-diagnostic investigations.
Pacing may be considered in selected patients with unexplained syncope and BBB.
IIb B
4) Asymptomatic BBB.
Pacing is not indicated for BBB in asymptomatic patientsIII B
Indication for cardiac pacing in patients with undocumented bradycardia (BBB)
European Heart Journal2013; 34: 2281–2329
Europace2013; 15: 1070-1118
www.escardio.org/guidelines
Algorithm for patientswith unexplained syncope and BBB
BBB and unexplained syncope
Reduced EF (<35%)
ConsiderCSM/EPS
Preserved EF (>35%)
ConsiderICD/CRT-D
(if negative) Consider ILR
Appropriate therapy
Appropriate therapy
(if negative) Clinical follow-up
European Heart Journal2013; 34: 2281–2329
Europace2013; 15: 1070-1118
www.escardio.org/guidelines
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
European Heart Journal2013; 34: 2281–2329
Europace2013; 15: 1070-1118
www.escardio.org/guidelines
Choice of pacing mode
Sinus node disease AV block
Persistent
Chronotropicincompetence
No chronotropicincompetence
1° choice DDDR + AVM
2° choice AAIR
1° choice DDD + AVM2° choice
AAI
Intermittent
1° choice DDDR + AVM
2° choice DDDR, no AVM
3° choice AAIR
Persistent
SND No SND AF
1° choiceDDDR
2° choiceDDD
3° choiceVVIR
1° choiceDDD
2° choiceVDD
3° choiceVVIR
VVIR
Intermittent
DDD + AVM(VVI if AF)
Consider CRT if low EF/HF
European Heart Journal2013; 34: 2281–2329
Europace2013; 15: 1070-1118
www.escardio.org/guidelines
All LBBB n=1283Women n=396
Men n=887Class I n=145
Class II n=1138QRS <150 n=302QRS ≥150 n=981
US n=871OUS n=412
All Non-LBBB n=537Women n=59
Men n=478Class I n=121
Class II n=416QRS <150 n=343QRS ≥150 n=194
US n=398OUS n=139
Challenging indications for CRT: the “Entry criterium”
LBBBNon LBBB
0.1 0.2 0.5 1 2 5 10
Hazard ratioFont: MADIT CRT
Favors CRT-D Favors ICD
European Heart Journal2013; 34: 2281–2329
Europace2013; 15: 1070-1118
www.escardio.org/guidelines
Magnitude of benefit from CRT
Indications for CRTin patients in sinus rhythm
European Heart Journal2013; 34: 2281–2329
Europace2013; 15: 1070-1118
Highest(responders)
Lowest(non-responders)
Wider QRS, LBBB, females, non-ischemic cardiomyopathy
Males, ischemic cardiomyopathy
Narrower QRS, non-LBBB
www.escardio.org/guidelines
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. (*)
IIaB
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
Indications for CRTin patients in sinus rhythm
European Heart Journal2013; 34: 2281–2329
Europace2013; 15: 1070-1118
www.escardio.org/guidelines
Recommendations Class Level
1) Patients with HF, wide QRS and reduced LVEF: 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
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.
IIa B
Indication for CRT in patients with permanent AF
European Heart Journal2013; 34: 2281–2329
Europace2013; 15: 1070-1118
www.escardio.org/guidelines
Indications for AVJ ablation (± CRT)in permanent AF
AVJ ablation
Heart failure, NYHA class III-IV and EF <35%
Reduced EF and uncontrollable HR, any QRS
Incomplete BiV pacing
No AVJ ablation
No AVJ ablNo CRT*
Adequaterate control
Inadequaterate control
AVJ abl & CRT
* Consider ICD according guidelines
AVJ abl& CRT
Complete BiV pacing
QRS <120 ms
CRT *
QRS ≥120 ms
European Heart Journal2013; 34: 2281–2329
Europace2013; 15: 1070-1118
www.escardio.org/guidelines
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
Upgraded or de novo CRT in patients withconventional pacemaker indications and HF
European Heart Journal2013; 34: 2281–2329
Europace2013; 15: 1070-1118
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.
www.escardio.org/guidelines
Time to death of any cause
in the European CRT Survey1,00
0,98
0,96
0,94
0,92
0,90
0,88
0,86
0,84
0,82
0,800 50 100 150 200 250 300 350 400 450 500
Days after implantation
Pro
por
tion
of p
atie
nts
surv
ivin
g
De-novo implantations
Upgrades
p=0.85
European Heart Journal2013; 34: 2281–2329
Europace2013; 15: 1070-1118
Backup ICD in patients indicated for CRT
Factors favouring CRT-D Factors favouring CRT-P
Life expectancy >1 year Advanced heart failure Stable heart failure, NYHA II Severe renal insufficiency or dialysis
Ischemic heart disease (low and intermediate MADIT risk score) Other major co-morbidities
Lack of comorbidities FrailtyCachexia
CRT-D CRT-P
Mortality reduction Similar level of evidence but CRT-D slightly better
Similar level of evidence but CRT-P slightly worse
Complications Higher Lower
Costs Higher Lower
Comparative results of CRT-D versus CRT-P in primary prevention
Clinical guidance to the choice of CRT-P or CRT-D in primary prevention
European Heart Journal2013; 34: 2281–2329
Europace2013; 15: 1070-1118
New
www.escardio.org/guidelines
Recommendations Class Level
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.
Choice of pacing mode(and CRT optimization)
European Heart Journal2013; 34: 2281–2329
Europace2013; 15: 1070-1118
New
www.escardio.org/guidelines
Indication for prevention and terminationof atrial tachyarrhythmias
Recommendations Class Level
De novo indications.Prevention and termination of atrial tachyarrhythmias does not represent a stand-alone indication for pacing.
III A
European Heart Journal2013; 34: 2281–2329
Europace2013; 15: 1070-1118
New
www.escardio.org/guidelines
Optimal pacing mode in children
Sinus node dysfunction
Preventdyssynchrony
Atrial pacing only
(Complete) AV block
Preventdyssynchrony
(Left) ventricular
pacing only
Intrinsic LBBB
Treatdyssynchrony
Single-site LV(or BIV) pacing
RV pacing induced
dyssynchrony
Treatdyssynchrony
Single-site LV(or BIV) pacing
BradycardiaDyssynchrony associated HF
European Heart Journal2013; 34: 2281–2329
Europace2013; 15: 1070-1118
New
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.
www.escardio.org/guidelines
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
MRI in patients with implantedcardiac devices
European Heart Journal2013; 34: 2281–2329
Europace2013; 15: 1070-1118
New
www.escardio.org/guidelines
Conventional devices
• Monitoring by qualified personnel during MRI is essential.
• Exclude patients with leads <6 weeks and those with epicardial and abandoned leads.
• Program an asynchronous mode inPM-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.
• Deactivate other pacing functions.
• Deactivate tachyarrhythmia monitoring and therapies (ATP/shock).
• Reprogram device immediately after the MRI examination.
MRI-conditional devices
According to manifacturer conditions:
• Monitoring by qualified personnel during MRI is essential.
• Exclude patients with leads <6 weeks and those with epicardial and abandoned leads.
• Automatically performed by an external physician-activated device.
• Reprogram device immediately after the MRI examination
European Heart Journal2013; 34: 2281–2329
Europace2013; 15: 1070-1118
www.escardio.org/guidelines
Recommendations Class Level
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).
IIa A
Remote managementof arrhythmias and device
European Heart Journal2013; 34: 2281–2329
Europace2013; 15: 1070-1118
New