indications on cardiac pacing and cardiac resynchronization therapy michele brignole

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

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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


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70Contributors

18Task Force Members

26CPG Members

26Reviewers

Contributors

690 comments(98 pages)


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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


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http://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


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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


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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


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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


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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)


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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


1) Carotid sinus syncope.Pacing is indicated in patients with dominant cardioinhibitory carotid sinus syndrome and recurrent unpredictable syncope.

I B


• 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……



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)


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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


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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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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


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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


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Magnitude of benefit from CRT

Indications for CRTin patients in sinus rhythm


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Highest(responders)

Lowest(non-responders)

Wider QRS, LBBB, females, non-ischemic cardiomyopathy

Males, ischemic cardiomyopathy

Narrower QRS, non-LBBB




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


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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


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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


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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


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• 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.



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


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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


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New



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


• 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)


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New



Indication for prevention and terminationof atrial tachyarrhythmias


De novo indications.Prevention and termination of atrial tachyarrhythmias does not represent a stand-alone indication for pacing.

III A


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New



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


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New


• 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.




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


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New



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


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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


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New


• 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

Style innovation


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indications on cardiac pacing and cardiac resynchronization therapy michele brignole

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