2021 ESC Guidelines On Cardiac Pacing and
2021 ESC Guidelines On Cardiac Pacing and
* Corresponding authors: Michael Glikson, Jesselson Integrated Heart Center, Shaare Zedek Medical Center and Hebrew University Faculty of Medicine, Jerusalem, Israel,
Tel: þ972 2 6555975, Email: [email protected].
Jens Cosedis Nielsen, Department of Clinical Medicine, Aarhus University and Department of Cardiology, Aarhus University Hospital, Aarhus N, Denmark,
Tel: þ45 78 45 20 39, Email: [email protected].
Author/Task Force Member affiliations: listed in Author information.
ESC Clinical Practice Guidelines Committee (CPG): listed in the Appendix.
ESC subspecialty communities having participated in the development of this document:
Associations: Association for Acute CardioVascular Care (ACVC), Association of Cardiovascular Nursing & Allied Professions (ACNAP), European Association of
Cardiovascular Imaging (EACVI), European Association of Percutaneous Cardiovascular Interventions (EAPCI), European Heart Rhythm Association (EHRA), Heart Failure
Association (HFA).
Councils: Council for Cardiology Practice, Council on Basic Cardiovascular Science, Council on Cardiovascular Genomics, Council on Hypertension, Council on Stroke.
Working Groups: Adult Congenital Heart Disease, Cardiac Cellular Electrophysiology, Cardiovascular Regenerative and Reparative Medicine, Cardiovascular Surgery, e-
Cardiology, Myocardial and Pericardial Diseases.
Patient Forum
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2 ESC Guidelines
Document Reviewers: Francisco Leyva (CPG Review Coordinator) (United Kingdom), Cecilia Linde
(CPG Review Coordinator) (Sweden), Magdy Abdelhamid (Egypt), Victor Aboyans (France), Elena Arbelo
(Spain), Riccardo Asteggiano (Italy), Gonzalo Baro n-Esquivias (Spain), Johann Bauersachs (Germany),
...................................................................................................................................................................................................
Keywords Guidelines • cardiac pacing • cardiac resynchronization therapy • pacemaker • heart failure • syncope •
atrial fibrillation • conduction system pacing • pacing indications • alternate site pacing • complications •
pacing in TAVI • bradycardia • temporary pacing
..
Table of contents ..
..
3.4.3 Cardiac resynchronization therapy (endo-and/or
epicardial) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
1 Preamble . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
..
.. 3.4.4 Alternative methods (conduction system pacing,
2 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 .. leadless pacing) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
..
2.1 Evidence review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 .. 3.4.4.1 Conduction system pacing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
2.2 Relationships with industry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 .. 3.4.4.2 Leadless pacing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
.. 3.4.5 Pacing modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
2.3 What is new in these guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 ..
2.3.1 New concepts and new sections . . . . . . . . . . . . . . . . . . . . . . . . . . 8 .. 3.4.6 Rate-responsive pacing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
..
2.3.2 New recommendations in 2021 . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 .. 3.5 Sex differences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
2.3.3 Changes in cardiac pacing and cardiac resynchronization .. 4 Evaluation of the patient with suspected or documented
..
therapy guideline recommendations since 2013 . . . . . . . . . . . . . . . . 13 .. bradycardia or conduction system disease . . . . . . . . . . . . . . . . . . . . . . . . . . 16
3 Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 .. 4.1 History and physical examination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
..
3.1 Epidemiology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 .. 4.2 Electrocardiogram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
3.2 Natural history . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 .. 4.3 Non-invasive evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
..
3.3 Pathophysiology and classification of bradyarrhythmias .. 4.3.1 Ambulatory electrocardiographic monitoring . . . . . . . . . . . . . 19
considered for permanent cardiac pacing therapy . . . . . . . . . . . . . . . . 14 .. 4.3.2 Exercise testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
..
3.4 Types and modes of pacing: general description . . . . . . . . . . . . . . . 15 .. 4.3.3 Imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
3.4.1 Endocardial pacing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
.. 4.3.4 Laboratory tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
..
3.4.2 Epicardial pacing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 . 4.3.5 Genetic testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
ESC Guidelines 3
HFrEF Heart failure with reduced ejection ... SAR Specific absorption rate
fraction
.. SAS Sleep apnoea syndrome
..
HOT-CRT His-optimized cardiac resynchronization .. SCD Sudden cardiac death
therapy
.. SND Sinus node dysfunction
..
HR Hazard ratio .. SR Sinus rhythm
HV Hisventricular interval (time from the
.. TAVI Transcatheter aortic valve implantation
..
beginning of the H deflection to the .. VKA Vitamin K antagonist
..
Wording to use
Classes of recommendations
©ESC 2021
useful/effective, and in some cases
may be harmful.
..
real or potential sources of conflicts of interest. Their declarations of .. endorsement process of these Guidelines. The ESC Guidelines
interest were reviewed according to the ESC declaration of interest .. undergo extensive review by the CPG and external experts. After
..
rules and can be found on the ESC website (http://www.escardio.org/ .. appropriate revisions, the guidelines are signed-off by all the
guidelines) and have been compiled in a report and published in a .. experts involved in the Task Force. The finalized document is
..
supplementary document simultaneously with the guidelines. .. signed-off by the CPG for publication in the European Heart
This process ensures transparency and prevents potential biases in .. Journal. The guidelines were developed after careful consideration
..
the development and review processes. Any changes in declarations .. of the scientific and medical knowledge and the evidence available
of interest that arose during the writing period were notified to the .. at the time of their dating.
..
ESC and updated. The Task Force received its entire financial support .. The task of developing ESC Guidelines also includes the creation
from the ESC without any involvement from the healthcare industry. .. of educational tools and implementation programmes for the recom-
..
The ESC CPG supervises and coordinates the preparation of .. mendations including condensed pocket guideline versions, summary
new guidelines. The Committee is also responsible for the .. slides, summary cards for non-specialists, and an electronic version
8 ESC Guidelines
..
for digital applications (smartphones, etc.). These versions are .. Pericardial Diseases, as well as the Association of Cardiovascular
abridged and thus, for more detailed information, the user should .. Nursing & Allied Professions.
..
always access to the full text version of the guidelines, which is freely ..
available via the ESC website and hosted on the EHJ website. The .. 2.1 Evidence review
..
National Cardiac Societies of the ESC are encouraged to endorse, .. This document is divided into sections, each with a section coordina-
adopt, translate, and implement all ESC Guidelines. Implementation .. tor and several authors. They were asked to thoroughly review the
..
programmes are needed because it has been shown that the out- .. recent literature on their topics, and to come up with recommenda-
.. tions and grade them by classification as well as by level of evidence.
the field of pacing, the Task Force was enhanced by representatives .. tive management, sport activity, and follow up
from the Association for Acute CardioVascular Care, the Heart ..
.. A new section on patient-centred care 12
Failure Association, the European Association of Cardiothoracic ..
Surgery, the European Association of Percutaneous Cardiovascular .. CIED = cardiovascular implantable electronic device; CRT = cardiac resynchroni-
.. zation therapy; MRI = magnetic resonance imaging; TAVI = transcatheter aortic
Interventions, the ESC Working Group on Myocardial and .. valve implantation.
ESC Guidelines 9
In patients with recurrent unexplained falls, the ... HBP with a ventricular backup lead may be con-
IIa C
..
same assessment as for unexplained syncope .. sidered in patients in whom a “pace-and-ablate”
should be considered. .. strategy for rapidly conducted supraventricular IIb C
..
AF ablation should be considered as a strategy .. arrhythmia is indicated, particularly when intrin-
to avoid pacemaker implantation in patients with .. sic QRS is narrow.
..
AF-related bradycardia or symptomatic pre- IIa C .. HBP may be considered as an alternative to right
automaticity pauses, after AF conversion, taking .. ventricular pacing in patients with AVB and LVEF
.. IIb C
..
For venous access, the cephalic or axillary vein
IIa C
.. In-office routine follow-up of single- and dual-
should be considered as first choice. .. chamber pacemakers may be spaced by up to 24
.. IIa A
For implantation of coronary sinus leads, quadri- .. months in patients on remote device
polar leads should be considered as first choice.
IIa C .. management.
..
To confirm target ventricular lead position, use .. Temporary pacing
..
of multiple fluoroscopic views should be IIa C .. Temporary transvenous pacing is recommended
considered. .. in cases of haemodynamic-compromising bra-
..
ESC 2021
centred care and shared decision making in .. patients with HFrEF (<40%) regardless of NYHA
the consultation.
.. class who have an indication for ventricular pac- IIa I
..
.. ing and high-degree AVB in order to reduce
AF = atrial fibrillation; ATP = antitachycardia pacing; AV = atrioventricular; AVB ..
= atrioventricular block; AVJ = atrioventricular junction; BBB = bundle branch .. morbidity. This includes patients with AF.
block; BMI = body mass index; CIED = cardiovascular implantable electronic .. CRT should be considered for symptomatic
device; CMR = cardiovascular magnetic resonance; CRT = cardiac resynchroniza- ..
tion therapy; CRT-D = defibrillator with cardiac resynchronization therapy; .. patients with HF in SR with LVEF <_35%, a QRS
CRT-P = cardiac resynchronization therapy-pacemaker; CSM = carotid sinus
.. duration of 130149 ms, and LBBB QRS mor- I IIa
massage; CT = computed tomography; DDD = dual-chamber, atrioventricular
..
.. phology despite OMT, to improve symptoms
pacing; ECG = electrocardiogram; EPS = electrophysiology study; HBP = His .. and reduce morbidity and mortality.
bundle pacing; HF = heart failure; HFmrEF = heart failure with mildly reduced ..
ejection fraction; HFpEF = heart failure with preserved ejection fraction; HV = .. In patients with symptomatic AF and uncon-
Hisventricular interval; ICD = implantable cardioverter-defibrillator; ILR = .. trolled heart rate who are candidates for AVJ
implantable loop recorder; LBBB = left bundle branch block; LV = left ventricular; .. IIa I
LVEF = left ventricular ejection fraction; MI = myocardial infarction; MRI = mag- .. ablation (irrespective of QRS duration), CRT is
netic resonance imaging; OMT = optimal medical therapy; PET = positron emis-
..
.. recommended in patients with HFrEF.
sion tomography; PR = PR interval; QRS = Q, R, and S waves; RBBB = right .. Specific indications for pacing
bundle branch block; RV = right ventricular; SAS = sleep apnoea syndrome; SND ..
= sinus node dysfunction; SR = sinus rhythm; TAVI = transcatheter aortic valve .. In patients with congenital heart disease, pacing
implantation. .. may be considered for persistent postoperative
a
Class of recommendation. .. IIa IIb
b
Level of evidence. .. bifascicular block associated with transient com-
c
CSM should not be undertaken in patients with previous transient ischaemic
.. plete AVB.
..
attack, stroke, or known carotid stenosis. Carotid auscultation should be per- .. Management considerations
formed before carotid sinus massage. If a carotid bruit is present, carotid ultra- ..
sound should be performed to exclude carotid disease .. In patients with MRI-conditional pacemaker sys-
d
Complete blood counts, prothrombin time, partial thromboplastin time, serum .. temsc, MRI can be performed safely following IIa I
creatinine, and electrolytes. ..
e
Immediately after procedure or within 24 h. .. manufacturer instructions.
f
Transient high-degree AVB, PR prolongation, or QRS axis change.
..
g
.. In patients with non-MRI-conditional pacemaker
Ambulatory continuous ECG monitoring (implantable or external) for 730 .. systems, MRI should be considered if no alterna-
days. ..
h
.. tive imaging mode is available and if no epicardial IIb IIa
ESC 2021
Electrophysiology study with HV >_70 ms may be considered positive for perma-
nent pacing. .. leads, abandoned or damaged leads, or lead
i
Whenever pacing is indicated in neuromuscular disease, an ICD should be con- ..
sidered according to relevant guidelines. .. adaptors/extenders are present.
..
.. AF = atrial fibrillation; AVB = atrioventricular block; AVJ = atrioventricular junc-
.. tion; CRT = cardiac resynchronization therapy; HFrEF = heart failure with
.. reduced ejection fraction; ICD = implantable cardioverter-defibrillator; LBBB =
.. left bundle branch block; LVEF = left ventricular ejection fraction; MRI = magnetic
2.3.3 Changes in cardiac pacing and cardiac .. resonance imaging; NYHA = New York Heart Association; OMT = optimal med-
resynchronization therapy guideline recommendations .. ical therapy; RV = right ventricular; SR = sinus rhythm.
..
since 2013 a
.. Class of recommendation.
b
.. A limit of 20% RV pacing for considering interventions for pacing-induced HF is
... supported by observational data. However, there are no data to support that any
.. percentage of RV pacing can be considered as defining a true limit below which
Table 5 Changes in cardiac pacing and cardiac .. RV pacing is safe and beyond which RV pacing is harmful.
resynchronization therapy guideline recommendations
c
.. Combination of MRI conditional generator and lead(s) from the same
since 2013
.. manufacturer.
..
..
2013 2021 ..
..
Classa
.. 3 Background
............................ ..
Cardiac pacing for bradycardia and conduction system disease ..
.. 3.1 Epidemiology
In patients with syncope, cardiac pacing may be .. The prevalence and incidence of pacemaker implantation are
considered to reduce recurrent syncope when
..
IIa IIb .. unknown in many countries, yet several estimations have been pub-
asymptomatic pause(s) >6 s due to sinus arrest .. lished based on the analysis of large observational studies and data-
are documented.
..
.. bases. There is considerable variability in reported pacemaker
Continued .. implant rates between European countries, ranging from <25
.
14 ESC Guidelines
HBP in bradycardia
Leadless pacing
or CRT
Figure 1 The 2021 ESC Guidelines on cardiac pacing and CRT present new and updated recommendations for these treatments in relevant patient
populations.
..
pacemaker implantations per million people in Azerbaijan, Bosnia and .. pacemaker-treated patients.912 In contrast, SND follows an unpre-
Herzegovina, and Kyrgyzstan, to >1000 implantations per million .. dictable course, and there is no evidence to show that pacemaker
..
people in France, Italy, and Sweden.1 These differences may result .. therapy results in improved prognosis.1315
from under- or overtreatment with pacemaker therapy in some .. Improving life expectancy is not, however, the only objective of
..
countries, or from variations in sociodemographic characteristics .. pacemaker therapy. Quality of life is an essential metric for measuring
and pathological conditions. There is a continuous growth in the .. a patient’s clinical status and outcome, and provides a holistic picture
..
use of pacemakers due to the increasing life expectancy and age- .. of clinical treatment effectiveness.16 Studies have been unanimous in
ing of populations.28 The estimated number of patients globally .. finding improved quality of life in patients receiving pacing
..
undergoing pacemaker implantation has increased steadily up to .. therapy.1722
an annual implant rate of 1 million devices.2 Degeneration of the ..
..
cardiac conduction system and changes in intercellular conduc- .. 3.3 Pathophysiology and classification of
tion can be manifestations of cardiac pathology or non-cardiac
..
.. bradyarrhythmias considered for
disease, and are most prevalent in older patients. Therefore, most ..
bradycardias requiring cardiac pacing are observed in the elderly,
.. permanent cardiac pacing therapy
.. Definitions of various conduction disturbances are presented in
with >80% of pacemakers being implanted in patients above the ..
age of 65 years.
.. Supplementary Table 1.
.. Sinus bradycardia can be considered physiological in response to
..
.. specific situations, such as in well-conditioned athletes, young individ-
3.2 Natural history .. uals, and during sleep. Pathological bradyarrhythmias are dependent
..
High-degree atrioventricular block (AVB) and sinus node dysfunction .. on their underlying cause and can be broadly categorized into intrin-
(SND) are the most common indications for permanent pacemaker
.. sic and extrinsic aetiologies. Advanced age and age-related degenera-
..
therapy. Conservatively treated (i.e. non-paced) patients with high- .. tive changes are important intrinsic causes of modifications in
degree AVB have notably poorer survival compared with
.. electrical impulse initiation and propagation of the conduction
ESC Guidelines 15
Y Persistent bradycardia
Documented arrhythmia
(ECG/Holter/monitor)
Y N
(suspected)
Intrinsic
BBB
Paroxysmal AV block
Sino-atrial block and sinus arresta
Reflex syncope
Atrial fibrillation with slow ventricular condition
Carotid sinus
Extrinsic (functional) Tilt-induced
Vagally induced sinus arrest or AV block
Adenosine hypersensitivityb
Idiopathic AV block Unexplained syncope
Figure 2 Classification of documented and suspected bradyarrhythmias. AV = atrioventricular; BBB = bundle branch block; ECG = electrocardiogram.
a
Including the bradycardiatachycardia form of sick sinus syndrome. bDeharo et al.32 Figure adapted from Brignole et al.33
..
3.4.3 Cardiac resynchronization therapy (endo- and/or .. heart rate during emotional or physical activity by sensing body
epicardial) .. motion/acceleration, minute ventilation, intracardiac impedance, or
..
Cardiac dyssynchrony is a difference in the timing of electrical and .. other surrogates of physical and mental stress, and are indicated in
mechanical activation of the ventricles, which can result in impaired .. cases of chronotropic incompetence.5157 Dual-sensing rate-respon-
..
cardiac efficiency. CRT delivers biventricular pacing to correct elec- .. sive pacing (e.g. accelerometer and minute ventilation) may be used
tromechanical dyssynchrony in order to increase cardiac output.36 In .. in selected patients.58 A brief overview of the most commonly used
..
multiple trials, CRT has shown a significant morbidity and mortality .. rate-responsive pacing sensors is given in Supplementary Table 3.
..
Figure 3 Initial evaluation of patients with symptoms suggestive of bradycardia. AVB = atrioventricular block; ECG = electrocardiogram; SND = sinus
node dysfunction.
..
Table 6 Drugs that may cause bradycardia or conduction .. Table 6 Continued
disorders ..
.. Sinus node AVB
Sinus node AVB .. bradycardia
bradycardia
..
.. Others
Beta-blockers 1 1 ..
.. Muscle relaxants 1 –
Antihypertensives .. Cannabis 1 –
Non-dihydropyridine calcium channel 1 1 ..
.. Propofol 1 –
blockers ..
Methyldopa 1 –
.. Ticagrelor 1 1
.. High-dose corticosteroids 1 –
Clonidine 1 – ..
.. Chloroquine – 1
Antiarrhythmics ..
1 1
.. H2 antagonists 1 1
Amiodarone .. Proton pump inhibitors 1 –
Dronedarone 1 1 ..
.. Chemotherapy
Sotalol 1 1 ..
.. Arsenic trioxide 1 1
Flecainide 1 1 .. Bortezomib 1 1
Propafenone 1 1 ..
.. Capecitabine 1 –
Procainamide – 1 ..
.. Cisplatin 1 –
Disopyramide 1 1 .. Cyclophosphamide 1 1
Adenosine 1 1 ..
.. Doxorubicin 1 –
Digoxin 1 1 ..
.. Epirubicin 1 –
Ivabradine 1 – .. 5-fluorouracil 1 1
Psychoactive and neuroactive drugs ..
.. Ifosfamide 1 –
Donepezil 1 1 ..
.. Interleukin-2 1 –
Lithium 1 1 .. Methotrexate 1 –
Opioid analgesics 1 – ..
.. Mitroxantrone 1 1
Phenothiazine 1 1 ..
.. Paclitaxel 1 –
Phenytoin 1 1 .. Rituximab 1 1
Selective serotonin reuptake inhibitors – 1 ..
.. Thalidomide 1 1
..
ESC 2021
Tricyclic antidepressants – 1
.. Anthracycline – 1
Carbamazepine 1 1 .. Taxane – 1
Continued ..
.. AVB = atrioventricular block.
18 ESC Guidelines
ESC 2021
Genetic disorders 1 1 ..
.. Temporal epilepsy 1 1
Infiltrative diseases .. Obstructive sleep apnoea 1 1
..
Sarcoidosis 1 1 .. AV = atrioventricular; AVB = atrioventricular block; AVJ = atrioventricular junc-
Amyloidosis 1 1
.. tion; SND = sinus node dysfunction.
.. Adapted from Mangrum et al. and Da Costa et al.
71 72a
Haemochromatosis 1 1 ..
..
Collagen vascular diseases ..
Rheumatoid arthritis 1 1
..
..
Scleroderma 1 1 ..
.. Carotid sinus massage (CSM) can be helpful in any patient >_40
Systemic lupus erythematosus 1 1 .. years old with symptoms suggestive of carotid sinus syndrome (CSS):
Storage diseases 1 1
..
.. syncope or near syncope elicited by tight collars, shaving, or turning
Neuromuscular diseases 1 1 ..
.. the head.66,67 Methodology and response to CSM are described in
Infectious diseases .. section 4.1 in the Supplementary data. Diagnosis of CSS requires both
Endocarditis (perivalvular abscess) – 1 ... the reproduction of spontaneous symptoms during CSM and clinical
..
Chagas disease 1 1 .. features of spontaneous syncope compatible with a reflex
Myocarditis – 1 .. mechanism.6870
..
Lyme disease – 1 ..
..
Diphtheria – 1 .. 4.2 Electrocardiogram
Toxoplasmosis – 1 .. Together with the history and physical examination, the resting ECG
..
Congenital heart diseases 1 1 .. is an essential component of the initial evaluation of patients with
.. documented or suspected bradycardia. A 12-lead ECG or a rhythm
Cardiac surgery ..
Coronary artery bypass grafting 1 1 .. strip during the symptomatic episode provides the definitive
.. diagnosis.
Valve surgery (including 1 1 ..
.. For those in whom physical examination suggests a bradycardia, a
transcatheter aortic valve ..
replacement) .. 12-lead ECG is useful to confirm the rhythm, rate, nature, and extent
.. of conduction disturbance (Supplementary Table 1). Furthermore, an
Maze operation 1 – ..
Heart transplant 1 1
.. ECG may provide information about structural heart or systemic ill-
.. ness (e.g. LV hypertrophy, Q waves, prolonged QT interval, and low
Radiation therapy 1 1 ..
.. voltage) that predict adverse outcomes in symptomatic patients.62
Intended or iatrogenic AVB – 1 ..
Sinus tachycardia ablation 1 –
..
.. 4.3 Non-invasive evaluation
Extrinsic ..
..
Physical training (sports) 1 1 .. Recommendations for non-invasive evaluation
Vagal reflex 1 1
..
.. Recommendations Classa Levelb
Drug effects 1 1 ..
..
Idiopathic paroxysmal AVB – 1 .. Once carotid stenosis is ruled out,c CSM is rec-
Electrolyte imbalance
.. ommended in patients with syncope of unknown
..
.. origin compatible with a reflex mechanism or I B
ESC 2021
Hypokalaemia 1 1
.. with symptoms related to pressure/manipulation
Hyperkalaemia 1 1 ..
Hypercalcaemia 1 1
.. of the carotid sinus area.6870
..
Hypermagnesaemia 1 1 .. CSM = carotid sinus massage.
a .. Class of recommendation.
Metabolic disorders b .. Level of evidence.
Hypothyroidism 1 1 c ..
.. attack,
CSM should not be undertaken in patients with previous transient ischaemic
Anorexia 1 1 .. stroke, or known carotid stenosis. Carotid auscultation should be per-
.. formed before CSM. If a carotid bruit is present, carotid ultrasound should be
Hypoxia 1 1 .. performed to exclude the presence of carotid disease.
Acidosis 1 1
..
Continued
ESC Guidelines 19
..
4.3.1 Ambulatory electrocardiographic .. Exercise testing can be used to diagnose symptomatic chrono-
monitoring .. tropic incompetence, defined as an inability to increase the heart rate
..
The intermittent nature of most symptomatic bradycardia secondary .. commensurate with the increased metabolic demands of physical
to conduction system disease often requires prolonged ambulatory .. activity.74,75 The most commonly used definition of chronotropic
..
ECG monitoring to correlate rhythm disturbances with symptoms. .. incompetence has been failure to reach 80% of the expected heart
This monitoring allows detection of interruption of AV conduction
.. rate reserve. Expected heart rate reserve is defined as the difference
..
by either primary disease of the conductive system, a vagal or neuro- .. between the age-predicted maximal heart rate (220 age) and the
cardiogenic mechanism, or reflex AV block.72,72a
..
..
recorder/handheld ECG recorder ..
<1 per month ILR .. Recommendations Classa Levelb
..
ECG = electrocardiogram; ILR = implantable loop recorder. .. Exercise testing is recommended in patients
Adapted from Brignole et al.33 ..
.. who experience symptoms suspicious of brady-
.. cardia during or immediately after
I C
..
.. exertion.62,7480
..
.. In patients with suspected chronotropic incom-
Recommendation for ambulatory electrocardiographic .. petence, exercise testing should be considered IIa B
monitoring
..
.. to confirm the diagnosis.74,75
.. In patients with intraventricular conduction dis-
Recommendation Classa Levelb ..
.. ease or AVB of unknown level, exercise testing
ESC 2021
Ambulatory ECG monitoring is recommended in
.. may be considered to expose infranodal
IIb C
..
the evaluation of patients with suspected brady- .. block.76,77,79
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context of haemodynamic instability. When coronary artery disease .. Recommendations for laboratory tests
is suspected, coronary computed tomography (CT), angiography, or ..
..
stress imaging is recommended.82 Cardiovascular magnetic reso- .. Recommendations Classa Levelb
nance (CMR) and nuclear imaging techniques provide information on
..
.. In addition to pre-implantation laboratory tests,c
tissue characterization (inflammation, fibrosis/scar) and should be ..
considered before pacemaker implantation when specific aetiologies
.. specific laboratory tests are recommended in
.. patients with clinical suspicion for potential
associated with conduction abnormalities are suspected (specially in ..
.. underlying causes of reversible bradycardia (e.g. I C
ESC 2021
CMR techniques allow the diagnosis of specific causes of conduction
.. potassium, calcium, and pH) to diagnose and
disturbances (i.e. sarcoidosis and myocarditis). Late gadolinium con- ..
.. treat these conditions.9094
trast enhancement CMR helps in the decision-making of individuals
..
with arrhythmic events; the presence of large areas of LGE (scar/fib- .. a
Class of recommendation.
rosis) has been linked to an increased risk of ventricular arrhythmias .. b
Level of evidence.
.. c
Complete blood counts, prothrombin time, partial thromboplastin time, serum
regardless of LVEF and may indicate the need for an implantable .. creatinine, and electrolytes.
cardioverter-defibrillator (ICD).8385 T2 CMR sequences are suited ..
..
for the detection of myocardial inflammation (i.e. oedema and hyper- ..
aemia) as a potential cause of transitory conduction abnormalities ..
..
that may not need permanent pacemaker implantation.86 Similarly, .. 4.3.5 Genetic testing
positron emission tomography (PET) combined with CMR or CT .. Most cardiac conduction disorders are due to either ageing or struc-
..
helps in the diagnosis of inflammatory activity status of infiltrative car- .. tural abnormalities of the cardiac conduction system caused by
diomyopathies (i.e. sarcoidosis).87,88 .. underlying structural heart disease. Genes responsible for inherited
..
.. cardiac diseases associated with cardiac conduction disorders have
.. been identified.65,95,96
Recommendations regarding imaging before ..
implantation .. Genetic mutations have been linked to a range of abnormalities
.. that may present in isolated forms of cardiac conduction disorder or
..
Recommendations Classa Levelb .. in association with cardiomyopathy, congenital cardiac anomalies, or
.. extra-cardiac disorders. Most genetically mediated cardiac conduc-
Cardiac imaging is recommended in patients ..
.. tion disorders have an autosomal dominant mode of inheritance65,95
with suspected or documented symptomatic .. (Supplementary Table 5).
bradycardia to evaluate the presence of struc- ..
I C .. Progressive cardiac conduction disease (PCCD) may be
tural heart disease, to determine LV systolic .. diagnosed in the presence of unexplained progressive conduction
function, and to diagnose potential causes of ..
.. abnormalities in young (<50 years) individuals with structurally nor-
conduction disturbances. .. mal hearts in the absence of skeletal myopathies, especially if there is
Multimodality imaging (CMR, CT, or PET) should
..
.. a family history of PCCD.97 Common PCCD-associated genes are
be considered for myocardial tissue character- .. SCN5A and TRPM4 for isolated forms and LMNA for PCCD associ-
ization in the diagnosis of specific pathologies
..
IIa C .. ated with HF.
associated with conduction abnormalities need- ..
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phenotype of cardiac conduction disease in an .. high probability, asystolic spontaneous syncope; this finding is rele-
.. vant for therapy when cardiac pacing is considered (see section 5.4).
index case.65 ..
.. Conversely, the presence of a positive vasodepressor, a mixed
a
Class of recommendation. .. response, or even a negative response does not exclude asystole dur-
b
Level of evidence. ..
c
Progressive cardiac conduction disease: prolonged P wave duration, PR interval,
.. ing spontaneous syncope.62
and QRS widening with axis deviation.96 ...
..
.. Recommendation for tilt testing
..
..
4.3.6 Sleep evaluation .. Recommendation Classa Levelb
..
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Nocturnal bradyarrhythmias are common in the general population. .. Tilt testing should be considered in patients with
In most circumstances, these are physiological, vagally mediated .. IIa B
.. suspected recurrent reflex syncope.62
asymptomatic events, which do not require intervention.98100 ..
Patients with sleep apnoea syndrome (SAS) have a higher preva- ..
a
Class of recommendation.
b.. Level of evidence.
lence of sleep-related bradycardia (both sinus and conduction system ..
related) during apnoeic episodes.101,102 SAS-induced hypoxaemia is a ..
..
key mechanism leading to an increased vagal tone and bradycardic ..
rhythm disorders.101,102 Another rare mechanism of sleep-related
..
..
bradycardia (usually in the form of prolonged sinus arrest) is rapid .. 4.4 Implantable monitors
eye movement sleep-related bradycardia, unrelated to apnoea. This
..
.. Patients with infrequent symptoms of bradycardia (less than once per
mechanism can also be diagnosed by polysomnography.103 Although .. month) need a longer duration of ECG monitoring. For these
most cases quoted in the literature have been treated with pace-
..
.. patients, the implantable loop recorder (ILR) is an ideal diagnostic
makers, the evidence for this is scant, and there is no consensus on .. tool given its capacity for prolonged monitoring (up to 3 years) and
how to treat these patients.103
..
.. without the need for active patient participation (Table 8).
Treatment with continuous positive airway pressure (CPAP) alle- .. In patients with unexplained syncope after the initial evaluation
..
viates obstructive sleep apnoea-related symptoms and improves car- .. and infrequent symptoms (less than once a month), several studies
diovascular outcomes. Appropriate treatment reduces episodes of .. have demonstrated a higher efficacy of initial ILR implantation com-
..
bradycardia by 7289%,104 and patients are unlikely to develop .. pared with a conventional strategy. Many conditions diagnosed by
symptomatic bradycardia at long-term follow-up.104106 Therefore, .. ILR are bradycardia mediated.108112 For further discussion on the
..
patients with asymptomatic nocturnal bradyarrhythmias or cardiac .. diagnostic roles of ILR and ambulatory ECG, and indications for their
conduction diseases should be evaluated for SAS. If the diagnosis is .. use, refer to the ESC Guidelines for the diagnosis and management of
..
confirmed, treatment of sleep apnoea with CPAP and weight loss can .. syncope.62
be effective in improving bradyarrhythmias occurring during sleep, ..
..
and permanent pacing should be avoided. In patients with known or ..
suspected SAS and symptomatic bradyarrhythmias not associated ..
.. Recommendation for implantable loop recorders
with sleep, a more complex assessment of the risks associated with ..
bradyarrhythmias vs. the benefit of cardiac pacing is needed. .. Recommendation Classa Levelb
..
..
.. In patients with infrequent (less than once a
Recommendation for sleep evaluation .. month) unexplained syncope or other symp-
..
Recommendation Classa Levelb .. toms suspected to be caused by bradycardia, in
.. whom a comprehensive evaluation did not I A
..
Screening for SAS is recommended in patients .. demonstrate a cause, long-term ambulat
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with symptoms of SAS and in the presence of .. ory monitoring with an ILR is
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I C ..
severe bradycardia or advanced AVB during .. recommended.108112
sleep.101106 ..
.. ILR = implantable loop recorder.
a .. Class of recommendation.
AVB = atrioventricular block; SAS = sleep apnoea syndrome.
a b .. Level of evidence.
b
Class of recommendation. ..
Level of evidence.
22 ESC Guidelines
4.5 Electrophysiology study .. In patients with syncope and sinus bradycardia, the pre-test
..
The development of non-invasive ambulatory ECG technologies has .. probability of bradycardia-related syncope increases when there is a
..
reduced the need for the electrophysiology study (EPS) as a diagnos- .. sinus bradycardia (<50 b.p.m.) or sinoatrial block. Observational
tic test. EPS is generally an adjunctive tool in the evaluation of patients .. studies have shown a relationship between prolonged sinus node
..
with syncope in whom bradycardia is suspected but has not been .. recovery time with syncope and the effect of pacing on
documented after non-invasive evaluation (Figure 4). The goal of an .. symptoms.113,114
..
EPS in the context of bradycardia evaluation is to identify abnormal .. In patients with syncope and bifascicular block, a prolonged
Early onset
of progressive
Bradycardia cardiac Clinical
Suspected Suspected
or cardiac conduction suspicion Syncope and Exercise
scar or recurrent
conduction disease or for potential bifascicular induced
infiltrative reflex
disorders family history causes of block symptoms
cardiomyopathy syncope
during sleep inherited cardiac bradycardia
conduction
disorder
EPS or ET for
exercised-
Further
induced block
Polysomnography Genetic Laboratory imaging CSM/ tilt
or empirical ET
/sleep study test test (CMR, CT, test
pacemaker in
PET etc.)
elderly and
frail patients
Diagnostic
Y N (non-diagnostic)
Symptoms
AECG
SND AV block <1 per ILR
monitoring
(See section 5.1) (See section 5.2) month
CCD without
Reflex syncope
AV block Non- Clinical
(See section 5.4)
(See section 5.3) diagnostic follow-up
Figure 4 Evaluation of bradycardia and conduction disease algorithm. AECG = ambulatory electrocardiographic monitoring; AV = atrioventricular;
CCD = cardiac conduction disease (or disorder); CMR = cardiovascular magnetic resonance; CSM = carotid sinus massage; CT = computed tomography;
ECG = electrocardiogram; EPS = electrophysiology study; ET = exercise test; ILR = implantable loop recorder; PET = positron emission tomography;
SND = sinus node dysfunction.
ESC Guidelines 23
..
pharmacological stress, identifies a group at higher risk of developing .. be considered as an appropriate indication for permanent pacing
AVB.115122 .. only when bradycardia due to SND is symptomatic.126 Patients with
..
The efficacy of EPS for the diagnosis of syncope is highest in .. SND may manifest symptoms attributable to bradyarrhythmia and/or
patients with sinus bradycardia, bifascicular block, and suspected .. symptoms of accompanying atrial tachyarrhythmias in the bradycar-
..
tachycardia,62 and lowest in patients with syncope, a normal ECG, no .. diatachycardia form of the disease. Symptoms may be present
structural heart disease, and no palpitations. Therefore, EPS is pre- .. either at rest or at the end of the tachyarrhythmic episode (conver-
..
ferred over ILR in patients with syncope who have a high pre-test .. sion pause also named pre-automaticity pause), or develop during
..
IIb B ..
have failed to show a correlation between syn- In some cases, symptomatic bradyarrhythmias may be related to
.. transient, potentially reversible, or treatable conditions (section 4,
cope and bradycardia.113,114 ..
.. Table 7). In such cases, correction of these factors is required,
EPS = electrophysiology study. .. whereas permanent pacing is not indicated. In clinical practice, it is
a
Class of recommendation. ..
b
Level of evidence. .. crucial to distinguish physiological bradycardia (due to autonomic
.. influences or training effects) from inappropriate bradycardia that
..
.. requires permanent cardiac pacing. For example, sinus bradycardia,
.. even when it is 4050 b.p.m. while at rest or as slow as 30 b.p.m.
..
.. while sleeping, particularly in trained athletes, could be accepted as a
.. physiological finding that does not require cardiac pacing.
..
.. Asymptomatic bradycardia (due to either sinus pauses or AVB epi-
5 Cardiac pacing for bradycardia ..
.. sodes) is not uncommon and warrants interpretation in the clinical
and conduction system disease .. context of the patient: in healthy subjects, pauses >2.5 s are uncom-
..
.. mon, but this per se does not necessarily constitute a clinical disorder;
5.1 Pacing for sinus node dysfunction .. asymptomatic bradyarrhythmias are common in athletes.132 In the
SND, also known as sick sinus syndrome, comprises a wide spectrum ..
.. absence of published trials, no recommendations for bradycardia
of sinoatrial dysfunctions, ranging from sinus bradycardia, sinoatrial .. detected in asymptomatic patients can be made. On the other hand,
block, and sinus arrest to bradycardiatachycardia syndrome.124,125 ..
.. in patients investigated for syncope in whom asymptomatic pause(s)
An additional manifestation of SND is an inadequate chronotropic .. >6 s due to sinus arrest are eventually documented, pacing may be
response to exercise, reported as chronotropic incompetence. ..
.. indicated. Indeed, such patients constituted a small minority of those
.. included in an observational study and a randomized trial on pacing in
..
5.1.1 Indications for pacing .. reflex syncope.133,134 In patients presenting with sleep-related
5.1.1.1 Sinus node dysfunction
.. asymptomatic intermittent bradycardia (sinus bradycardia or AVB),
..
In general, pacing for asymptomatic SND has never been shown to .. sleep apnoea and rapid eye movement sleep-related bradycardia
affect prognosis, as opposed to pacing for AVB. Therefore, SND can
.. should be considered as possible causes.
24 ESC Guidelines
..
5.1.1.2 Bradycardiatachycardia form of sinus node dysfunction .. Syndrome (DANPACE), which enrolled 1415 patients followed for a
The bradycardiatachycardia variant of SND is the most common .. mean of 5.4 years, found no difference between DDD(R) and AAIR
..
form, and is characterized by progressive, age-related, degenerative .. pacing in all-cause mortality.127 The DANPACE trial also found a
fibrosis of the sinus node tissue and atrial myocardium. .. higher incidence of paroxysmal AF [hazard ratio (HR) 1.27] and a
..
Bradyarrhythmias can be associated with various forms of atrial .. two-fold increased risk of pacemaker reoperation with AAIR, with
tachyarrhythmias, including AF.125 In this form of SND, the bradyar- .. AVB developing in 0.61.9% of patients every year.127 These findings
..
rhythmias may correspond to atrial pauses due to sinoatrial blocks or .. support the routine use of DDD(R) rather than AAIR pacing in
..
SND AV block
Chronotropic
incompetence?
SND no SND AF
Y N
Sinus rhythm:
Default DDDR DDD DDD(R)a DDD + AVM
DDD(R) a DDD VVIR
option + AVM + AVM + AVM AF: VVI +
rate hysteresis
Single
Any reason Single Single
chamber
to avoid 2 chamber chamber VVI(R)a VDD VDD
AAI(R)a
leadsb AAIR AAI
VVI(R)a
Figure 5 Optimal pacing mode and algorithm selection in sinus node dysfunction and atrioventricular block. AF = atrial fibrillation; AV = atrioventricular;
AVM = atrioventricular management [i.e. AV delay programming (avoiding values >230 ms) or specific algorithms to avoid/reduce unnecessary ventricular
pacing]; CRT = cardiac resynchronization therapy; SND = sinus node dysfunction. a(R) indicates that the programming of such a pacing mode is preferred
only in the case of chronotropic incompetence. bReasons to avoid two leads include young age and limited venous access. Note: in patients who are candi-
dates for a VVI/VDD pacemaker, a leadless pacemaker may be considered (see section 7). For combined CRT indications, see section 6. Adapted from
Brignole et al.62
..
Recommendations for pacing in sinus node dysfunction .. AVB, manifestations of fatigue, exertional intolerance, and HF are
.. sometimes underestimated. Deterioration of cognitive functions is
..
Recommendations Classa Levelb .. often only speculative so that the possibilities of improvement after
.. implantation of a pacemaker are unpredictable and unlikely. Death in
In patients with SND and a DDD pacemaker, ..
.. patients with untreated AVB is due not only to HF secondary to low
minimization of unnecessary ventricular
I A .. cardiac output, but also to SCD caused by prolonged asystole or
pacing through programming is ..
.. bradycardia-triggered ventricular tachyarrhythmia. Although RCTs of
recommended.144,151,159,164,166169 ..
..
rate (brady-dependent AVB), support a diagnosis of intrinsic infrano- .. symptoms due to bradycardia and of high-degree or infranodal block,
dal AVB.27 .. pacing is unlikely to be beneficial and is not indicated.
..
.. In patients with AF who undergo atrioventricular junction (AVJ)
.. ablation to control rapid ventricular rates, there is evidence to show
5.2.2 Pacing mode and algorithm selection ..
5.2.2.1 Dual-chamber vs. ventricular pacing
.. that AVJ ablation plus RV pacing improves symptoms and quality of
.. life.192 In contrast, neutral results were found regarding the progres-
Large, randomized, parallel trials that included patients with only ..
.. sion of HF, hospitalization, and mortality,193 except in one study.194
AVB181 or with AVB and/or SND140 failed to show superiority of ..
..
In patients with AF, compared with fixed rate pacing, rate- .. Isolated fascicular block and BBB are rarely associated with symp-
responsive pacing is associated with better exercise performance, .. toms; however, their presence may be a marker for underlying struc-
..
improved daily activities, a decrease in symptoms of shortness of .. tural heart disease. The presence or absence of symptoms referable
breath, chest pain, and palpitations, and improved quality of .. to intermittent bradycardia will guide the evaluation of these patients.
..
life.201203 It has also been shown to improve heart rate and blood ..
pressure response to mental stress compared with fixed rate pac- .. 5.3.1 Indications for pacing
..
ing.204 Therefore, rate-adaptive pacing is the pacing mode of first .. 5.3.1.1 Bundle branch block and unexplained syncope
..
Bifascicular block
Y LVEF ≤ 35%
EPS/CSM
No diagnosis Diagnosis
ILR
No diagnosis Diagnosis
Figure 6 Decision algorithm for patients with unexplained syncope and bundle branch block. BBB = bundle branch block; CRT-D = defibrillator with
cardiac resynchronization therapy; CSM = carotid sinus massage; EPS = electrophysiology study; ICD = implantable cardioverter-defibrillator; ILR =
implantable loop recorder; LVEF = left ventricular ejection fraction.
ESC Guidelines 29
pharmacological provocation (ajmaline, procainamide, or flecainide). .. Recommendations for pacing in patients with bundle
Scheinman et al. studied the prognostic value of the HV: the progres-
.. branch block
..
sion rate to AVB at 4 years was 4% in patients with HV <70 ms, 12% ..
in patients with HV between 70 and 100 ms, and 24% in patients with
.. Recommendations Classa Levelb
..
HV >100 ms.121 Development of intra- or infra-His block at incre- .. In patients with unexplained syncope and bifas-
mental atrial pacing or by pharmacological stress test increases the
..
.. cicular block, a pacemaker is indicated in the
sensitivity and positive predictive value of the EPS to identify patients .. presence of either a baseline HV of >_70 ms, sec-
.. I B
who will develop AVB.116118,120,122,212 A positive EPS yielded a posi-
ESC 2021
AVB as the cause of syncope. Indeed, in patients with a negative EPS, .. Pacing is not recommended for asymptomatic
intermittent or stable AVB was documented by ILR in 50% of cases. .. BBB or bifascicular block.115,121,215
III B
Therefore, elderly patients with bifascicular block and unexplained ..
..
syncope might benefit from an empirical pacemaker, especially in .. BBB = bundle branch block; EPS = electrophysiology study; HV =
unpredictable and recurrent syncope that exposes the patient to a .. Hisventricular interval.
.. a
Class of recommendation.
high risk of traumatic recurrences. The decision to implant a pace- .. b
Level of evidence.
maker in these patients should be based on individual riskbenefit
..
..
evaluation.213 ..
..
.. 5.3.2 Pacing mode and algorithm selection
5.3.1.3 Alternating bundle branch block .. In intermittent bradycardia, pacing may be required only for short
This rare condition refers to situations in which there is clear ECG
..
.. periods. In this situation, the benefits of bradycardia and pause pre-
evidence for block in all three fascicles on successive ECGs; examples .. vention must be weighed against the detrimental effects of perma-
..
are LBBB and RBBB morphologies on successive ECGs, or RBBB
... nent pacing, particularly pacing-induced HF. Low base-rate
with associated left anterior fascicular block on one ECG and left .. programming to achieve backup pacing, and manual adaptation of AV
posterior fascicular block on another ECG.214 There is general con- .. interval, programming AV hysteresis, or other specific algorithms
..
sensus that this phenomenon is associated with significant infranodal .. preventing unnecessary RV pacing, play a particularly important role
disease and that patients will progress rapidly toward AVB. ..
.. in this patient group.144,148
Therefore, a pacemaker should be implanted as soon as the alternat- .. In patients in SR, the optimal pacing mode is DDD. The strong evi-
ing BBB is detected, even in the absence of symptoms. ..
.. dence of superiority of DDD vs. VVI pacing is limited to improvement
.. in symptoms and quality of life. Conversely, there is strong evidence
5.3.1.4 Bundle branch block without symptoms ..
.. of non-superiority with regard to survival and morbidity.20
Permanent pacemaker implantation is not indicated for BBB without .. Therefore, in elderly or frail patients with intermittent bradycardia,
symptoms, with the exception of alternating BBB, because only a ..
.. the decision regarding the pacing mode should be made on an individ-
minority of these patients will develop AVB (12% per .. ual basis, taking into consideration the increased complication risk
year).115,121,215 The risks of pacemaker implantation and long-term ..
.. and costs of DDD (Figure 5).
transvenous lead complications are higher than the benefits of pace- .. VDD may be a pacing mode alternative for patients with advanced
maker implantation.216,217
..
.. AV conduction abnormalities and spared sinus node function. In
.. comparison with DDD, VDD system implantation is associated with
5.3.1.5 Patients with neuromuscular diseases
..
.. fewer complications, shorter procedure and fluoroscopy times, and a
In patients with neuromuscular diseases, cardiac pacing should be .. high incidence of atrial undersensing.218 Potential atrial undersensing
considered, as any degree of fascicular block can progress unpredict-
..
.. is contributing to the low use of this system as most operators are
ably, even in the absence of symptoms (see section 8.5). .. aiming for AV synchrony.
30 ESC Guidelines
Cardioinhibitory carotid
Y Positive tilt-test N
sinus syndrome
N Y
Asystolic tilt-test Y
Implant a DDD PM
and counteract Implant a DDD PM
N hypotensive susceptibility (Class I)
(Class I)
Implantable loop
recorder
Y
N
Pacing not indicated
(Class III)
Figure 7 Decision pathway for cardiac pacing in patients with reflex syncope. DDD = dual-chamber, atrioventricular pacing. Note: cardioinhibitory
carotid sinus syndrome is defined when the spontaneous syncope is reproduced by the carotid sinus massage in the presence of an asystolic pause >3 s;
asystolic tilt positive test is defined when the spontaneous syncope is reproduced in the presence of an asystolic pause >3 s. A symptomatic asystolic
pause(s) >3 s or asymptomatic pause(s) >6 s due to sinus arrest, atrioventricular block, or the combination of the two similarly define asystole detected by
implantable loop recorder. Figure adapted from Brignole et al.62
ESC Guidelines 31
CI-CSS
Pacing indicated
(Class I)
Extrinsic (functional)
vagally-mediated or Asystolic tilt Undocumented syncope
adenosine-sensitive
Pacing indicated Pacing not indicated
Pacing indicated (Class I) (Class III)
(Class I)
Adenosine induced
AV block > 10 sec
Pacing indicated
(Class IIb)
Figure 8 Summary of indications for pacing in patients >40 years of age with reflex syncope. CI-CSS = cardioinhibitory carotid sinus syndrome. Note:
spontaneous asystolic pause = 3 s symptomatic or 6 s asymptomatic. Adapted from Brignole et al.62
32 ESC Guidelines
..
selected elderly patients with unexplained unpredictable syncope .. 5.5.1 Recurrent undiagnosed syncope
who had induction of third-degree AVB of >_10 s to intravenous injec- .. In patients with unexplained syncope at the end of a complete work-
..
tion of a bolus of 20 mg of adenosine triphosphate, DDD significantly .. up and absence of any conduction disturbance, the lack of a rationale
reduced the 2-year syncope recurrence rate from 69% in the control .. and the negative results of small studies234,235 give sufficient evidence
..
group to 23% in the active group.230 Finally, cardiac pacing is not indi- .. of inefficacy of cardiac pacing. Thus, cardiac pacing is not recom-
cated in the absence of a documented cardioinhibitory reflex.231,232
.. mended until a diagnosis is made (Figure 8).
..
..
..
ESC 2021
reduce recurrent syncope in patients aged >40
.. III C
years, with severe, unpredictable, recurrent syn- .. unexplained syncope without evidence of SND
cope who have:
.. or conduction disturbance. 234,235
..
• spontaneous documented symptomatic asys- .. SND = sinus node dysfunction.
tolic pause(s) >3 s or asymptomatic pause(s)
I A .. a
.. Class of recommendation.
>6 s due to sinus arrest or AVB; or .. b
Level of evidence.
Cardiac pacing is not indicated in the absence of .. pathophysiology of heart failure suitable
a documented cardioinhibitory reflex.231,232
III B ..
.. for cardiac resynchronization therapy by
.. biventricular pacing
AVB = atrioventricular block. ..
a
Class of recommendation. .. The prevalence of HF in the developed world approximates 12%
b
Level of evidence. ..
.. of the adult population, rising to >_10% among people aged >70
.. years.237 The prevalence of HF is increasing (by 23% over the past
..
.. decade according to one estimate) mainly due to the ageing of the
5.5 Pacing for suspected .. population, with the age-specific incidence actually declining.238241
..
(undocumented) bradycardia .. There are three distinct phenotypes of HF based on the measure-
In patients with recurrent unexplained syncope or falls at the end of .. ment of LVEF [<40%, HF with reduced EF (HFrEF); 4049%, HF
..
the conventional work-up, ILR monitoring should be considered in .. with mildly reduced EF (HFmrEF); and >_50%, HF with preserved EF
an attempt to document a spontaneous relapse instead of embarking .. (HFpEF)].242 CRT is clinically useful mainly for patients with HFrEF
..
on empiric cardiac pacing.62 . and LVEF <_35%. Patients with HFrEF constitute 50% of the entire
ESC Guidelines 33
..
population with HF, and HFrEF is less prevalent among individuals .. had an ischaemic cardiomyopathy. At 7-year follow-up, the subgroup
aged 70 years or older. The prognosis of HF varies according to the .. of patients with LBBB, NYHA functional class I, and ischaemic cardio-
..
defined population. In contemporary clinical trials of HFrEF, 1-year .. myopathy showed a non-significant trend towards lower risk of death
mortality rates of 6% are seen, whereas in large registry-based sur- .. from any cause [relative risk 0.66, 95% confidence interval (CI)
..
veys, 1-year mortality rates exceed 20% in patients recently hospital- .. 0.301.42; P = 0.29]. Therefore, present CRT recommendations are
ized for HF, but are closer to 6% in those recruited with stable .. applicable to all patients in NYHA functional class IIIV of any
..
outpatient HF.243 The concept of CRT is based on the fact that in .. aetiology.
.. The MUltisite STimulation In Cardiomyopathies (MUSTIC),256,257
..
RBBB.272277 Patients with RBBB do not benefit from CRT278 unless .. ECG criteria of intraventricular conduction disturbance, LBBB, and
they show a so-called masked LBBB on ECG,277 characterized by a .. non-LBBB have not been consistently defined and reported in any of
..
broad, slurred, sometimes notched R wave on leads I and aVL, .. the past CRT studies.287,288 Similarly, the modality of QRS measure-
together with a leftward axis deviation. Individualized positioning of .. ment (automatic or manual, and ECG recording machine) was not
..
the LV lead is crucial in these patients. .. reported in CRT studies. However, the selection of ECG criteria
An important recent notion is the possible role played by a pro-
.. appears to influence hard endpoints.287290 Similarly, ECG recording
..
longed PR in HF patients with non-LBBB. A few single-centre studies .. modality and ECG manufacturer have been shown to possibly affect
..
..
6.3 Patients in atrial fibrillation .. In conclusion, despite the weak evidence due to lack of large,
.. randomized trials, the prevailing opinion of experts is in favour of the
This section considers indications for CRT in patients with perma- ..
nent AF or persistent AF unsuitable for AF ablation or after unsuc- .. usefulness of CRT in patients with permanent AF and NYHA class III
.. and IV with the same indications as for patients in SR, provided that
cessful AF ablation. AF ablation has been reported to improve LVEF ..
and reduce the HF hospitalization rate in selected patients. In particu-
.. AVJ ablation is added in those patients with incomplete (<90 - 95%)
.. biventricular capture due to AF (Figure 9). However, there are other
lar, AF ablation is recommended for reversing LV dysfunction in AF ..
patients when tachycardia-induced cardiomyopathy is highly prob-
.. causes for incomplete biventricular pacing such as frequent prema-
..
Y N
CRT
(Class IIb)
OR
HBP HBP
(Class IIb) (Class IIb)
Figure 9 Indication for atrioventricular junction ablation in patients with symptomatic permanent atrial fibrillation or persistent atrial fibrillation unsuit-
able for atrial fibrillation ablation. AF = atrial fibrillation; AVJ = atrioventricular junction; BiV = biventricular; CRT = cardiac resynchronization therapy; ESC
= European Society of Cardiology; HBP = His bundle pacing; HFmrEF = heart failure with mildly reduced ejection fraction; HFrEF = heart failure with
reduced ejection fraction; LVEF = left ventricular ejection fraction; QRS = Q, R, and S waves; RV = right ventricular/right ventricle. aDue to a rapid ventric-
ular response. Note: the figure is based on the recommendations in the ESC Guidelines on AF.296
a
Class of recommendation. ..
b
Level of evidence. .. pacing, should be considered for upgrade to
.. CRT.37,148,185,190,324352
..
..
.. CRT = cardiac resynchronization therapy; HF = heart failure; ICD = implantable
6.4 Patients with conventional .. cardioverter-defibrillator; LVEF = left ventricular ejection fraction; OMT = opti-
.. mal medical therapy; RV = right ventricular.
pacemaker or implantable cardioverter .. a
Class of recommendation.
defibrillator who need upgrade to .. b
Level of evidence.
.. c
A limit of 20% RV pacing for considering interventions for pacing-induced HF is
cardiac resynchronization therapy .. supported by observational data. However, there are no data to support that any
..
Several studies have demonstrated the deleterious effect of chronic .. percentage of RV pacing can be considered as defining a true limit below which
..
6.5 Pacing in patients with reduced left .. over CRT-P by reducing arrhythmic death, it does also add ICD-
.. specific risks such as lead failure and inappropriate shocks, as well as
ventricular ejection fraction and a ..
conventional indication for .. costs.
.. COMPANION is the only trial to randomize patients to CRT-P or
antibradycardia pacing ..
.. CRT-D, but was designed to assess the effects of CRT compared
Three randomized trials proved the superiority of biventricular pac- .. with OMT.260 Crucially, it was not designed to compare CRT-D and
ing over RV pacing in patients with moderate to severe systolic dys- ..
.. CRT-P. CRT-P was associated with a marginally non-significant
function who required antibradycardia pacing to improve quality of ..
IIa B .. regurgitation is frequent among candidates for CRT and has been
individual risk assessment and using shared deci- .. shown to affect long-term survival as well as response to ther-
sion-making.382,383 ..
.. apy.406,410 CRT can improve mitral regurgitation in as many as 40% of
.. patients.406 However, in 60% of patients, significant mitral regurgita-
CRT = cardiac resynchronization therapy; CRT-D = defibrillator with cardiac ..
resynchronization therapy; ICD = implantable cardioverter-defibrillator. .. tion is not corrected and, at long-term follow-up, progression of the
a
Class of recommendation. .. underlying disease may lead to further deterioration of mitral valve
b
Level of evidence. ..
.. function and poor prognosis. Transcatheter edge-to-edge mitral
.. valve repair has been demonstrated to improve the response to CRT
..
.. in registries.411414 However, results from recent RCTs including
.. patients with symptomatic severe secondary mitral regurgitation
6.7 Factors influencing the efficacy of ..
.. despite guideline-directed medical therapy (including CRT when indi-
cardiac resynchronization therapy: role ..
.. cated) have not consistently shown a benefit from transcatheter
of imaging techniques .. edge-to-edge mitral valve repair.415,416
The role of cardiac imaging in selecting HF patients for CRT has
..
.. Therefore, selection of patients for CRT based on imaging is lim-
been evaluated mostly in observational analyses. Cardiac dys- .. ited to the measurement of LVEF, whereas the assessment of other
synchrony,384386 myocardial scar,387,388 and site of latest activation
..
. factors such as extent of myocardial scar, presence of mitral
40 ESC Guidelines
+
+ CRT-P
CRT-D
-
Figure 10 Patient’s clinical characteristics and preference to be considered for the decision-making between cardiac resynchronization therapy pace-
maker or defibrillator. CRT-P = cardiac resynchronization therapy-pacemaker; CRT-D = defibrillator with cardiac resynchronization therapy; CMR = car-
diovascular magnetic resonance.
A V
B V
C V
Figure 11 Three patients with different types of transitions in QRS morphology with His bundle pacing and decrementing pacing output. BBB = bundle
branch block; Corr± = with/without correction of bundle branch block; LBBB = left bundle branch block; LOC = loss of capture; Myo = myocardium;
NSHBP = non-selective His bundle pacing; S-HBP = selective His bundle pacing. (A) Non-selective to selective His capture. Note the presence of a
‘pseudo-delta’ wave with non-selective capture and an isoelectric interval after the pacing spike with selective capture. (B) Non-selective His capture to
myocardial capture only. (C) Selective His capture with correction of BBB to selective His capture with LBBB. Note: the graph on the right of the panel
shows a schematic representation of the different thresholds in the three instances.
42 ESC Guidelines
..
Table 9 Advantages and disadvantages of a ‘backup’
.. fare better in terms of HF hospitalizations than patients with RV pac-
.. ing if the percentage of ventricular pacing is >20% (HR 0.54; P =
ventricular lead with His bundle pacing ..
.. 0.01).42 Of note, the average baseline LVEF in patients with HBP in
Advantages .. that study was 55% and the average QRS duration was 105 ms. HBP
• Increased safety (in case of loss of capture of the HBP lead)
..
.. may therefore avoid clinical deterioration in these patients, particu-
• Can be used for sensing (lower risk of ventricular undersensing, no .. larly if the intrinsic QRS is narrow or if BBB is corrected by HBP.
risk of His or atrial oversensing)
..
.. In a series of 100 patients with AVB undergoing HBP by experi-
• Programming of pacing output with lower safety margins ..
ESC 2021
• “Off-label” use (current regulatory approval and MRI-conditionality .. is indicated.
for HBP is only granted for His leads connected to the RV port) .. There is a need for RCTs to compare the safety and efficacy of
.. HBP with RV pacing. It is important to balance the potential benefits
..
HBP = His bundle pacing; MRI = magnetic resonance imaging; RBBB = right bun- .. of HBP with the aforementioned issues of higher capture thresholds
dle branch block. .. and shorter battery longevity, a higher rate of lead revision, and more
..
.. frequent sensing issues, compared with RV pacing. It is also important
Compared with RV pacing, HBP capture thresholds are on average
..
.. to consider the operator’s experience and expertise with HBP, and
higher and sensing amplitudes lower. A recent observational study .. whether a backup ventricular pacing lead is indicated. The patient’s
..
raised concern with regard to increasing HBP pacing thresholds with .. safety should be first and foremost in decision-making.
intermediate follow-up.426 The higher capture thresholds lead to ..
..
shorter battery longevity (at 5 years there were 9% generator .. 7.2.2.2 Pace and ablate
changes with HBP compared with 1% with RVP).427 Capture thresh- .. Seven observational series, totalling >240 patients treated with a
..
olds of HBP at implantation should aim to be <2.0 V/1 ms (or <2.5 V/ .. ‘pace-and-ablate’ strategy for rapidly conducted AF, found an
0.4 ms) and bipolar R-wave sensing amplitude >2.0 mV. With experi- .. improvement in LVEF and NYHA class compared with baseline with
..
ence, thresholds decrease as implanters gain confidence to reposition .. HBP.197199,434 Long-term results with a median of 3 years of follow-
leads. Sensing issues include not only ventricular undersensing, but .. up have been reported, with favourable outcomes.434 A single-
..
also oversensing of atrial or His potentials (which may be potentially .. blinded, randomized, crossover study in 16 patients compared HBP
lethal in a pacemaker-dependent patient). .. with RVA pacing over 6 months and found better NYHA and 6-min
..
An RV backup lead should be considered if the implanter is inex- .. walk distance with HBP, without differences in echocardiographic
perienced, or if there are high capture thresholds or sensing issues in .. parameters.200 However, only four patients in this study had con-
..
pacemaker-dependent patients, in those scheduled for AVN ablation .. firmed HBP (with para-Hisian pacing in the remaining patients).
(where there is a risk of compromising HBP), or in patients with high- .. These studies included patients with reduced as well as preserved
..
degree or infranodal block. Pros and cons are listed in Table 9. .. LVEF,197,198 and QRS width was on average <120 ms. HBP is of par-
Several series have shown that the rate of mid-term lead revision
.. ticular interest in patients with a normal baseline QRS morphology as
..
is relatively high at 7%,318,423,427,428 (and reported to be as high as .. it preserves intrinsic ventricular synchrony, However, a caveat is that
11%426), and is higher than RV pacing, which is 23%.427,429
.. AVJ ablation may result in an increase in HBP capture thresholds or
..
Therefore, it is advisable to follow-up these patients at least once .. in lead dislodgments in a minority of patients.197,199,318,426 Owing to
every 6 months or place them on remote monitoring (ensuring that
.. these issues and risk of HBP lead failure, a backup RV lead should be
..
automatic threshold measurements correspond to those measured .. considered.
manually, as this may not be the case and depends on device configu-
..
..
ration).430 Device programming should take into account specific .. 7.2.2.3 Role in cardiac resynchronization therapy
..
requirements for HBP, which are covered in detail elsewhere.431,432 .. In 1977, Narula showed that pacing of the His bundle can correct
.. LBBB in a subset of patients, implying a proximal site of conduction
..
7.2.2 Indications .. disturbance with longitudinal dissociation within the His bundle.435 A
7.2.2.1 Pacing for bradycardia .. recent mapping study reported intra-Hisian block in 46% of patients
..
One study reported that in patients with AVB and normal baseline .. with LBBB, in whom 94% were corrected by temporary HBP.436 HBP
LVEF, the incidence of RV pacing-induced cardiomyopathy was .. may therefore be used in lieu of biventricular pacing for HBP-based
..
12.3% and the risk was increased if the percentage of ventricular pac- .. CRT, as some data have shown that results are comparable (see
ing was >_20% (HR 6.76; P = 0.002).188 However, there are no data to .. Supplementary Table 10).437439 Nevertheless, especially in CRT can-
..
support that any percentage of RV pacing can be considered as defin- .. didates with LBBB, biventricular pacing has more solid evidence of
ing a true limit below which RV pacing is safe and beyond which RV
.. efficacy and safety, and therefore remains first-line therapy. However,
..
pacing is harmful. Observational data indicate that patients with HBP . HBP should be considered as a bailout solution in the case of failed
ESC Guidelines 43
LV lead implantation along with other options such as surgical epicar- .. HBP may be considered as an alternative to RV
dial leads424,440 (see section 6.7). An interesting population is patients ..
.. pacing in patients with AVB and LVEF >40%,
ESC 2021
IIb C
with RBBB, who are known to respond less well to biventricular pac- .. who are anticipated to have >20% ventricular
ing, in whom HBP has shown promising preliminary results in a series ..
.. pacing.42,433
of 37 patients.441 HBP may sometimes incompletely correct BBB, and ..
can be used in conjunction with RV, LV, or biventricular pacing, as in .. AVB = atrioventricular block; AVJ = atrioventricular junction; CRT = cardiac
.. resynchronization therapy; HBP = His bundle pacing; LVEF = left ventricular ejec-
the HOT-CRT study.319 This is of particular interest in patients with .. tion fraction; RV = right ventricular.
..
..
or previous cardiovascular implantable electronic device (CIED) .. recommended in patients with AVB who have not yet received
infection]. Observational data showed that a leadless pacemaker was .. reperfusion therapy.469 AVB may require temporary pacing in the
..
a safe pacing alternative in patients with previous device infection and .. presence of refractory symptoms or haemodynamic compromise,
explant, and in patients on chronic haemodialysis. Whereas observa- .. but most often resolves spontaneously within a few days and only a
..
tional data indicate high efficacy and low complication rates with lead- .. minority of patients require permanent pacing.451,454,456,458,462 In
less pacemakers,50 there are currently no data from RCTs .. patients with persistent intraventricular conduction abnormalities
..
documenting the long-term safety and efficacy of leadless vs. standard .. and transient AVB in whom permanent pacing was recommended in
.. the past, there is no evidence that permanent cardiac pacing
ESC 2021
due to autonomic influences or damage of the conduction system ..
by ischaemia and/or reperfusion. The right coronary artery supplies .. Pacing is not recommended if AVB resolves after
.. revascularization or spontaneously.454456,458 III B
the sinus node in 60% and the AVN and His bundle in 90% ..
of patients.451,452 AVB is located above the His bundle in most ..
.. AVB = atrioventricular block; CRT-D = defibrillator with cardiac resynchroniza-
patients with inferior infarction, but is usually infra-Hisian and pre- .. tion therapy; CRT-P = cardiac resynchronization therapy-pacemaker; MI = myo-
ceded by intraventricular conduction disturbances in anterior
.. cardial infarction.
a .. Class of recommendation.
infarction.451,453457 b .. Level of evidence.
The incidence of high-degree AVB in patients with ST-segment ele-
..
..
vation MI has declined to 34% in the primary percutaneous coro- ..
nary intervention era.458460 High-degree AVB is most frequent in
.. 8.2 Pacing after cardiac surgery and
..
inferior or inferolateral infarctions.455,458461 .. heart transplantation
Patients with high-degree AVB have higher clinical risk and
..
.. 8.2.1 Pacing after coronary artery bypass graft and
larger infarctions especially when AVB complicates an anterior .. valve surgery
..
infarction.458460,462,463 New-onset intraventricular conduction dis- .. AVB may occur in 14% of cases after cardiac surgery and in
turbance is also associated with larger infarctions.464467 .. 8% after repeat valve surgery.472476 SND may occur after right
..
Sinus bradycardia and AVB at presentation can be vagally me- .. lateral atriotomy or transseptal superior approaches to the mitral
diated and may respond to atropine.455,468 Revascularization is .. valve.473,474
ESC Guidelines 45
..
Pacemaker implantation is more frequent after valvular than after .. or third-degree AVB. There have been doubts about the long-term
coronary artery bypass graft (CABG) surgery.477 In clinical practice, .. performance of epicardial leads, but recent data indicate, at least for
..
an observation period of 37 days is usually applied before implant- .. epicardial LV leads, performance comparable with transvenous
ing a permanent pacemaker473 to allow regression of transient brady- .. leads.486
..
cardias. The ideal timing of pacemaker implantation after cardiac .. Ventricular pacing after mechanical tricuspid valve replacement
surgery remains a topic of controversy, due to the fact that 6070% .. using a coronary sinus lead appears safe and feasible, but only results
..
of patients implanted for SND and up to 25% of those implanted for .. from small patient cohorts have been published. Procedural success
AVB are not pacemaker dependent at follow-up.473,478 In the case of
..
ESC 2021
.. III C
Recommendations Classa Levelb
.. Implantation of a transvalvular RV lead should
.. be avoided.
..
1) High-degree or complete AVB after .. AVB = atrioventricular block; RV = right ventricular; SND = sinus node
cardiac surgery .. dysfunction.
..
A period of clinical observation of at least 5 ..
a
Class of recommendation.
..
Table 10 Predictors for permanent pacing after transcatheter aortic valve implantation
Characteristics References
ECG
512528
Right BBB
517,521,525,527
PR-interval prolongation
517,525
Left anterior hemiblock
Patient
ESC 2021
519,521,529
Balloon post-dilatation
531
TAVI in valve-in-valve vs. native valve procedure
AVB = atrioventricular block; BBB = bundle branch block; ECG = electrocardiogram; LV = left ventricular; TAVI = transcatheter aortic valve implantation.
For more detailed data, see Supplementary Tables 14 and 15.
Persistent new
Pre-existing
LBBB with
Pre-existing RBBB conduction
QRS > 150 ms
with new abnormality with
Persistenta New onset or PR > 240 ms
post-procedure prolongation of
high degree AVB alternating BBB with no further
conduction QRS (> 20 ms) or
prolongation
disturbanceb PR (> 20 ms)f
during > 48h
after procedurec
OR OR
Figure 12 Management of conduction abnormalities after transcatheter aortic valve implantation. AF = atrial fibrillation; AV = atrioventricular; AVB =
atrioventricular block; BBB = bundle branch block; ECG = electrocardiogram; EPS = electrophysiology study; HV = Hisventricular interval; LBBB = left
bundle branch block; LVEF = left ventricular ejection fraction; PM = pacemaker; QRS = Q, R, and S waves; RBBB = right bundle branch block; TAVI =
transcatheter aortic valve implantation. a24-48 h post-procedure. bTransient high-degree AVB, PR prolongation, or axis change. cHigh-risk parameters for
high-degree AV block in patients with new-onset LBBB include: AF, prolonged PR interval, and LVEF <40%. dAmbulatory continuous ECG monitoring for
7 - 30 days. eEPS with HV >_70 ms may be considered positive for permanent pacing. fWith no further prolongation of QRS or PR during 48-h observation.
48 ESC Guidelines
..
<150 ms may not require further evaluation during hospitalization. .. for pacemaker therapy in patients with CHD is based on expert con-
When EPS is contemplated, it should be performed >_3 days post- .. sensus and individual evaluation due to lack of evidence from RCTs.
..
procedure and after the conduction abnormalities have stabilized. .. In the presence of an intracardiac shunt between the systemic and
The type of permanent pacemaker implanted should follow stand- .. pulmonary circulation, endovascular lead placement is relatively con-
..
ard guidance (see sections 5, 6, and 7). Given the low rates of long- .. traindicated due to the risk of arterial embolism.551
term dependency on pacing,544,545 algorithms promoting spontane- .. The clinical presentation may vary considerably; even severe bra-
..
ous AV conduction should be used. .. dycardia in congenital AVB may remain oligosymptomatic or asymp-
..
is strong consensus that patients with third- or second-degree AVB .. In patients with persistent post-operative bifas-
(Mobitz type II) must receive permanent cardiac pacing therapy if ..
.. cicular block associated with transient complete IIb C
symptomatic or with risk factors. In asymptomatic patients without .. AVB, permanent pacing may be considered.572
risk factors, opinion on the benefit of cardiac pacing diverges, and ..
.. In patients with complex CHD and asympto-
permanent pacing may be considered.567,569 .. matic bradycardia (awake resting heart rate <40
..
ESC 2021
IIb C
.. b.p.m. or pauses >3 s), permanent pacing may be
8.4.3 Post-operative atrioventricular block .. considered on an individual basis.
..
IIb C
8.6.1 Long QT syndrome .. QRS duration >_120 ms, permanent pacemaker
.. implantation may be considered.c 600,603,604
There are multiple inter-relationships between the different forms of ..
long QT syndrome (LQTS) and bradycardia: LQTS can be associated ..
.. AVB = atrioventricular block; CRT = cardiac resynchronization therapy; HV =
with sinus bradycardia; very long ventricular myocardial refractory .. Hisventricular interval; ICD = implantable cardioverter-defibrillator.
periods can cause 2:1 AVB; sudden rate changes can trigger torsades-
.. a
Class of recommendation.
.. b
Level of evidence.
de-pointes tachycardia; and treatment with beta-blockers to suppress .. c
Whenever pacing is indicated in neuromuscular disease, CRT or an ICD should
sympathetic triggers of torsades-de-pointes may cause bradycardia.
.. be considered according to relevant guidelines.
ESC Guidelines 51
ESC 2021
preserved or only mildly decreased LV contractility.610615 .. pacing may be considered
IIb C
..
Pacemaker implantation does not reduce the risk of SCD in these .. prophylactically. c 621625
capabilities should be considered if at least 1- .. cate involvement of the septum in the inflammatory process and is a
.. predictor of adverse outcome. Ventricular arrhythmias may also
year survival is expected.616 ..
.. occur because of myocardial pathology.
ICD = implantable cardioverter-defibrillator; LBBB, left bundle branch block. .. When inflammatory heart disease is complicated by bradycardia,
a
Class of recommendation. ..
b
Level of evidence.
.. especially AVB, specific therapy should be applied if available, eventu-
.. ally backed-up by temporary pacing or intravenous administration of
..
.. isoprenaline. Otherwise, immunosuppressive therapy or awaiting
.. spontaneous resolution may be sufficient. If bradycardia does not
..
8.6.4 Mitochondrial cytopathies .. resolve within a clinically reasonable period or cannot be expected
Mitochondrial cytopathies are a heterogeneous group of hereditary .. to resolve (e.g. after radiation therapy), permanent pacing is indi-
..
disorders, in which cardiomyopathies, conduction defects, and ven- .. cated. Before choosing a device type, the indication for an ICD and/
tricular arrhythmias are the most common cardiac .. or CRT rather than a single-chamber or DDD pacemaker should be
52 ESC Guidelines
..
considered because most causes of inflammatory disease causing bra- .. pauses >3 the cycle length of the ventricular escape rhythm, wide
dycardia may also result in reduced myocardial contractility and ven- .. QRS escape rhythm, prolonged QT interval, complex ventricular
..
tricular fibrosis. .. ectopy, mean daytime heart rate <50 b.p.m.) is present. However,
.. women with complete heart block who exhibit a slow, wide QRS
..
8.6.6.1 Sarcoidosis .. complex escape rhythm should undergo pacemaker implantation
Persistent or intermittent AVB can occur in sarcoidosis, which shows
.. during pregnancy. The risks of pacemaker implantation are generally
..
a propensity to involve the basal intraventricular septum. In a Finnish .. low and can be performed safely, especially if the foetus is beyond 8
..
permanent pacing who have LVEF <50%, implan- IIa C .. dose of prophylactic antibiotic (cefazolin 12 g i.v. or flucloxacillin
tation of a CRT-D should be considered.631,634
.. 12 g i.v.) given within 3060 min [90120 min for vancomycin
..
.. (15 mg/kg)] before the procedure.640643 The antibiotic prophylaxis
AVB = atrioventricular block; CRT-D = defibrillator with cardiac resynchroniza- .. should cover S. aureus species, but routine coverage of methicillin-
tion therapy; ICD = implantable cardioverter-defibrillator; LVEF = left ventricular ..
ejection fraction. .. resistant S. aureus is not recommended. The use of vancomycin
a
Class of recommendation. .. should be guided by patient risk for methicillin-resistant S. aureus col-
b
Level of evidence.
..
c
.. onization and the prevalence of the bacterium in the corresponding
Whenever pacing is indicated in sarcoidosis, an ICD should be considered .. institution.638
according to the relevant guidelines. ..
.. In contrast, post-operative antibiotic prophylaxis does not reduce
.. the incidence of infection.644,645
..
8.7 Cardiac pacing in pregnancy ..
.. 9.3 Operative environment and skin
Vaginal delivery carries no extra risks in a mother with congenital ..
complete heart block, unless contraindicated for obstetric rea- .. antisepsis
..
sons.635 For women who have a stable, narrow complex junctional .. The pacemaker implantation procedure should be performed in an
escape rhythm, pacemaker implantation may not be necessary or can .. operating environment that meets the standards of sterility as
..
be deferred until after delivery if none of the risk factors (syncope, . required for other surgical implant procedures.638,646
ESC Guidelines 53
..
Based on data from surgical and intravascular catheter procedures, .. depending on the clinical scenario and concomitant antiplatelet ther-
skin antisepsis should be performed using chlorhexidinealcohol .. apy, either stopping or continuing non-vitamin K antagonist oral anti-
..
instead of povidone-iodinealcohol.647,648 In a large RCT comprising .. coagulants might be reasonable at the time of device implantation.652
2546 patients, chlorhexidinealcohol was associated with a lower .. Patients on dual antiplatelet therapy have a significantly increased
..
incidence of short-term intravascular catheter-related infections (HR .. risk of post-operative pocket haematoma compared with patients
0.15, 95% CI 0.05 - 0.41; P = 0.0002).647
.. treated with aspirin alone or without antiplatelet therapy. In such
..
.. cases, P2Y12 receptor inhibitors should be discontinued for 37
.. days (according to the specific drug) before the procedure where
..
increased risk of pneumothorax.658 Prospective data on axillary vein .. developed to allow for full extractability in the long term. However,
puncture suggest a lower risk of access-related complications com- .. the ease of extractability at long term has not yet been
..
pared with subclavian puncture.659 Ultrasound guidance for axillary .. proven.667669
vein puncture has been described as a helpful technique for achieving ..
..
a safe and uncomplicated puncture.660 .. 9.7 Lead position
With regards to lead failure after implantation, there is evidence .. Ventricular pacing has traditionally been performed from the RV
..
that the axillary vein route is associated with a lower rate of lead fail- .. apex. Since the introduction of active fixation leads, alternative pacing
.. sites such as the RVOT septum or the mid-septum have been eval-
Historical data from 1000 patients with ICD implants showed signifi- .. In pacemaker implantations in patients with pos-
cantly shorter procedural times for patients with subcutaneous
..
.. sible pocket issues such as increased risk of ero-
device pockets. No significant differences with regard to pocket hae- .. sion due to low body mass index, Twiddler’s IIb C
matomas were found. There were no significant differences in the
..
.. syndrome, or for aesthetic reasons, a submuscu-
cumulative percentages of patients free from complication during fol- .. lar device pocket may be considered.
..
low-up.682 .. Heparin bridging of anticoagulated patients is
Pocket irrigation at the end of the procedure with normal saline ... not recommended.650,689 III A
..
ESC 2021
solution does not reduce the risk of device infections.683 III B
.. implantation should be delayed until the patient
The World-wide Randomized Antibiotic Envelope Infection .. has been afebrile for at least 24 h.638,639
Prevention Trial (WRAP-IT study) investigated the effect of an ..
..
absorbable antibiotic-eluting envelope on the development of post- .. CIED = cardiovascular implantable electronic device.
operative CIED infections. A total of 6983 patients undergoing a
a
.. Class of recommendation.
b .. Level of evidence.
CIED pocket revision, generator replacement, or system upgrade, or ..
initial implantation of a CRT-D were randomly assigned, in a 1:1 ratio, ..
..
to receive the antibiotic envelope or not. The rate of CIED infection ..
in patients who had the antibacterial envelope was 0.7% vs. 1.2% in ..
..
the control group (HR 0.6, 95% CI 0.360.98; P = 0.04).685 No effect .. 10 Complications of cardiac
on infection rate was observed in the subgroup with pacemakers.685
..
.. pacing and cardiac
Considering cost-effectiveness aspects, the use of an antibiotic enve- ..
.. resynchronization therapy
lope may be considered in pacemaker patients at high risk for CIED ..
infections. Risk factors to be considered in this context are end-stage ...
renal disease, chronic obstructive pulmonary disease, diabetes melli- .. 10.1 General complications
.. Cardiac pacing and CRT are associated with a substantial risk of com-
tus, and device replacement, revision, or upgrade procedures.638 ..
.. plications (Table 12), most of which occur in the perioperative
.. phase,429,690 but a sizable risk remains during long-term follow-up.691
..
Recommendations regarding device implantations and .. Complication rates after dual-chamber pacemaker implantation in
peri-operative management .. the MOST trial were 4.8% at 30 days, 5.5% at 90 days, and 7.5% at 3
..
.. years.692 However, ‘real-life’ data indicate a higher risk.690,693 In a
Recommendations Classa Levelb .. recent study of >81 000 patients receiving de novo CIED implanta-
..
Administration of pre-operative antibiotic pro- .. tions, major complications occurred in 8.2% within 90 days of hospi-
.. tal discharge.694 Mortality in hospital (0.5%) and within 30 days (0.8%)
phylaxis within 1 h of skin incision is recom-
I A
..
mended to reduce risk of CIED .. was low.
..
infection.641,643.686 .. Complication risks generally increase with the complexity of the
Chlorhexidinealcohol instead of povidone-
.. device and are more common in the context of a device upgrade or
..
iodinealcohol should be considered for skin IIa B .. lead revisions compared with de novo implantation. In a Danish
antisepsis.647,648
.. population-based cohort study, complications were observed in
..
For venous access, the cephalic or axillary vein .. 9.9% of patients at first device implantation and in 14.8% upon
IIa B .. upgrade or lead revision.354 Procedures limited to replacement of
should be considered as first choice.658,659 ..
To confirm target ventricular lead position, use
.. the generator had a lower complication risk (5.9%). In the prospec-
.. tive REPLACE registry, a similar proportion (4%) of complication
of multiple fluoroscopic views should be IIa C ..
considered.
.. risks in the setting of generator replacement was reported, but much
.. higher risks were found in those with one or more additional lead
For implantation of coronary sinus leads, quadri- ..
.. insertions (up to 15.3%).695 Accordingly, major complications were
polar leads should be considered as first IIa C .. particularly more common with CRT upgrade procedures, a finding
choice.665,666,687 ..
.. that was corroborated in a large US inpatient cohort339 and a pro-
Rinsing the device pocket with normal saline sol- .. spective Italian observational study.696 The rate of procedural com-
ution before wound closure should be IIa C ..
.. plications also increases with comorbidity burden.697
considered.683,684 .. Thus, careful shared decision-making is warranted when consider-
..
In patients undergoing a reintervention CIED .. ing upgrades to more complex systems. This also applies to prophy-
procedure, the use of an antibiotic-eluting enve- IIb B .. lactic replacement of recalled CIED generators and leads, a scenario
..
lope may be considered.685,688 .. in which procedural risks should be carefully weighed against the risks
Pacing of the mid-ventricular septum may be .. associated with device or lead failure.698
..
considered in patients at high risk of perforation
IIb C
.. Overall, complication rates are closely linked to individual and
(e.g. elderly, previous perforation, low body .. 429,658,693
.. centre implantation volumes. Complications were increased
mass index, women).420,674 .. by 60% in inexperienced operators who had performed fewer than
Continued
56 ESC Guidelines
..
25 implantations.429 Data from a large national quality assurance pro- .. passive fixation RA lead (OR 2.2) were the most important risk
gramme for pacemakers and CRT-P showed that the annual hospital .. predictors.
..
implantation volume was inversely related to complication rates, .. A meta-analysis of 25 CRT trials noted mechanical complications
with the greatest difference observed between the lowest (1 - 50 .. in 3.2% (including coronary sinus dissection or perforation, pericar-
..
implantations/year) and the second lowest quintile (5190 implanta- .. dial effusion or tamponade, pneumothorax, and haemothorax), other
tions/year).699 Furthermore, emergency and out-of-hours proce- .. lead problems in 6.2%, and infections in 1.4%. Peri-implantation
..
dures are associated with increased complication rates.354 These .. deaths occurred in 0.3%.369
..
..
Any complication354,639,690,692,695,707,722,723 515 .. alence of significant tricuspid regurgitation (defined as grade 2 or
Mortality (<30 days)354,694 0.81.4 .. above) following CIED implantation varies between 10% and 39%.
..
CIED = cardiovascular implantable electronic device. . Most studies attribute a greater harm with ICD leads and in the
ESC Guidelines 57
..
presence of multiple RV leads.45,46,49,445,642,685,697,709,728,730732 The .. decision-making. The integrated-care approach has its origins in the
issue of lead interference with bioprosthetic tricuspid valves or after .. chronic care model developed by Wagner et al.,740 and has the
..
annuloplasty or repair is debated. Furthermore, there is no firm evi- .. potential to improve clinical and patient outcomes in arrhythmia
dence supporting that pacing-induced RV dyssynchrony significantly .. management741743 (see section 12). Relevant specialists to be
..
contributes to tricuspid regurgitation. A recent study randomizing 63 .. included in the interdisciplinary team are included according to the
patients to pacing lead positions in the RV apex, RVS, or LV pacing via .. patient’s needs and local service availability (Figure 13).
..
the coronary sinus did not affect the development of tricuspid regur- ..
gitation.734 The diagnostic work-up of CIED lead-related tricuspid ..
Patient education/
Including personal goals and/or action plan
self-management
Psychosocial management
Psychological assessment and/or treatment
and support
Strategies to promote Educate patients about what to expect from the device and
medical adherence medical treatment using available technologies
Clear communication
between primary and Including timely end-of-life discussions
secondary care
Figure 13 Integrated management of patients with pacemaker and cardiac resynchronization therapy. CRT = cardiac resynchronization therapy.
..
Evaluation must be made on a case by case basis by balancing the .. A flowchart summarizing the management of patients with a pace-
advantages of MRI with the potential risks and availability of alterna- .. maker undergoing MRI is shown in Figure 14.
..
tive imaging methods and using shared decision-making. .. There is evidence indicating that 1.5 T MRIs may be performed in
In general, MRIs should always be performed in the context of a .. patients with temporary epicardial wires756 as well as with transve-
..
rigorously applied standardized institutional workflow, following the .. nous pacemaker active fixation leads implanted to externalized pace-
appropriate conditions of use (including programming).744,746,753755 .. makers used for temporary pacing.751
.
ESC Guidelines 59
Y MRI-conditional system
Y N Y N
Presence of
abandoned leads
N
Y
Figure 14 Flowchart for evaluating magnetic resonance imaging in pacemaker patients. MRI = magnetic resonance imaging; SAR = specific absorption
rate. aConsider only if there is no imaging alternative and the result of the test is crucial for applying life-saving therapies for the patient.
..
Recommendations for performing magnetic resonance ..
imaging in pacemaker patients .. 11.2 Radiation therapy in pacemaker
.. patients
..
Recommendations Classa Levelb .. An increasing number of patients with CIEDs are referred for radio-
..
In patients with MRI-conditional pacemaker sys- .. therapy,757 with a reported annual rate of 4.33 treatments per 100
.. 000 person-years. Radiotherapy uses high-energy ionizing radiation
tems,c MRIs can be performed safely following I A ..
the manufacturer’s instructions.745,753755 .. including X-rays, gamma rays, and charged particles, which might
.. cause software and hardware errors in CIEDs, especially when pho-
In patients with non-MRI-conditional pacemaker ..
systems, MRI should be considered if no alterna-
.. ton radiation beam energy exceeds 610 MV, and the radiation dose
.. to the device is high (>210 Gy).758,759 Hard errors are rare, and are
tive imaging mode is available and if no epicardial IIa B ..
leads, abandoned or damaged leads, or lead
.. most often due to direct irradiation to the device. This can cause irre-
.. versible hardware damage, requiring device replacement. Soft errors
adaptors/extenders are present.744,746 ..
.. are more common, and are associated with secondary neutron pro-
MRI may be considered in pacemaker patients .. duction by irradiation.760 Such errors typically include resets of the
ESC 2021
..
with adequate tumour treatment or in very selected high-risk .. prophylactically when the need for pacing is anticipated (e.g. after car-
cases.757,761 .. diac surgery).764,765 Modalities for emergency temporary pacing
..
According to published recommendations for CIED .. include transvenous, epicardial, and transcutaneous approaches. The
patients,745,759,762 the risk of malfunction (or adverse events) is higher .. transvenous approach often requires fluoroscopic guidance, although
..
in the following situations for pacemaker patients: .. echo-guided placement is also feasible.766 Balloon-tipped floating
.. catheters are easier to insert, more stable, and safer than semi-rigid
• With photon radiation applying energy >610 MV: the risk of mal- ..
.. catheters.767,768 Patients who undergo transvenous temporary car-
functions (usually soft errors) is due to secondary neutron pro- ..
Neutron-producing
treatment ( > 10 MV)
Y N
Figure 15 Pacemaker management during radiation therapy ECG = electrocardiographic; PM = pacemaker. aRelocation of the device, continuous ECG
monitoring, reprogramming, or magnet application are very rarely indicated.
ESC Guidelines 61
ESC 2021
.. and use the principles of patient-centred care
pacing and cardiac ..
..
and shared decision-making in the
consultation.831836
resynchronization therapy ..
..
.. CRT = cardiac resynchronization therapy.
Providing patient-centred care is a holistic process that emphasizes .. a
Class of recommendation.
partnerships in health between patient and clinician, acknowledging .. b
Level of evidence.
..
the patient’s needs, beliefs, expectations, healthcare preferences, ..
goals, and values.811813 In patient-centred care, the focus is on ..
..
shared decision-making, accepting that patients generally prefer to ..
take an active role in decisions about their health.814,815 This ..
..
approach has been shown to improve health outcomes and health- .. 13 Quality indicators
care experiences.814,816 Clinicians have a duty to define and explain ..
..
the healthcare problem and make recommendations about the best .. Quality indicators are tools that may be used to evaluate care quality,
available evidence across all available options at the time, including no .. including that of processes of care and clinical outcomes.837 They
..
treatment, while ensuring that the patient’s values and preferences .. may also serve as a mechanism for enhancing adherence to guideline
are considered (Figure 16).817820 ..
.. recommendations through quality assurance endeavours and bench-
Decision aids, such as written information and/or the use of inter- .. marking of care providers.838 As such, the role of quality indicators in
active websites or web-based applications, can complement the clini-
..
.. driving quality improvement is increasingly recognized and attracts
cians’ counselling and thus facilitate shared decision-making.822 When .. interest from healthcare authorities, professional organizations,
..
decision aids are used, patients feel more knowledgeable, have more .. payers, and the public.839
accurate risk perceptions, and take a more active part in the deci- .. The ESC recognizes the need for measuring and reporting quality
sion.823 In patients with poor language or literacy skills, as well as in
..
.. and outcomes of cardiovascular care. One aspect of this is the devel-
those with cognitive impairment, communication strategies, including .. opment and implementation of quality indicators for cardiovascular
..
the help of a qualified interpreter, is recommended, as this helps the .. disease. The methodology by which the ESC quality indicators are
64 ESC Guidelines
Define and explain the healthcare problem and communicate that a choice exists. Discuss possible
alternative treatment options, including that patients with decision-making capacity have the right
to refuse PM/CRT therapy, even if the patient is pacemaker dependent.
The consultation should be discussed in a way that can be understood by everyone involved
in the discussion.
Encourage the patient to become involved in the consultation and invite family to participate.
Provide an overview of the implantation process, and address all aspects of how the device works
and the conditions it treats.
Discuss the benefits and risks with each option, including potential complications and
treatment refusal.
Supplement the counselling with different decision aids to facilitate SDM. In patients with poor
language skills, cognitive impairment, or low health literacy, a variety of communication strategies
should be used in order for the patient to make a deliberate decision.
Take into account the patient´s preferences and goals of care, and what matters most to the patient.
Make evidence based recommendations with consideration of individual risk-benefits of each option,
while ensuring that the patient's beliefs, expectations, values, goals, and preferences are considered.
Decide together on the best available option.
Figure 16 Example of shared decision-making in patients considered for pacemaker/CRT implantation. Modified from the principles of the SHARE
Approach.821CRT = Cardiac resynchronization therapy; PM = pacemaker; SDM = Shared Decision Making.
Table 15 A selection of the developed quality indicators for patients undergoing cardiovascular implantable electronic
device implantation
Quality indicator Domain
Centres providing CIED services should participate in at least one CIED registry Structural quality indicatora
Numerator: Number of centres participating in at least one registry for CIED
Centres providing CIED services should monitor and report the volume of procedures performed by individ- Structural quality indicator
ESC 2021
Numerator: Number of patients who develop one or more procedural complicationsb within 30 days of CIED implantation
Denominator: Number of patients undergoing CIED implantation procedure
CIED = cardiovascular implantable electronic device; ECG = electrocardiogram.
a
Structural quality indicators are binary measurements (yes/no), and thus only the numerator is defined.
b
CIED-related bleeding, pneumothorax, cardiac perforation, tamponade, pocket haematoma, lead displacement (all requiring intervention), or infection.
..
developed has been published.839 To date, a suite of quality indicators .. 14 Key messages
for an initial tranche of cardiovascular conditions has been pro- ..
..
duced.839,840 To facilitate quality improvement initiatives, the disease- ..
.. • In the evaluation of candidates for permanent pacemaker implan-
specific ESC quality indicators are included in corresponding ESC
.. tation, a thorough and detailed pre-operative evaluation is rec-
Clinical Practice Guidelines.296,841 This is further enhanced by way of ..
.. ommended. This should always include careful history taking and
their integration in the ESC registries, such as the EurObservational .. physical examination, laboratory testing, documentation of the
Research Programme (EORP) and the European Unified Registries .. type of bradyarrhythmia requiring treatment, and cardiac imag-
On Heart Care Evaluation and Randomized Trials (EuroHeart) ..
.. ing. In selected cases, additional tests, EPS, and/or genetic testing
project.842 ..
.. are indicated.
A number of registries exist for patients undergoing CIED implan- .. • Ambulatory ECG monitoring is useful in the evaluation of
tation,843 providing ‘real-world’ data about the quality and outcomes .. patients with suspected bradycardia or cardiac conduction disor-
of CIED care.702 However, there is a lack of a widely agreed set of
..
.. der, to correlate rhythm disturbances with symptoms. Choice of
quality indicators that encompasses the multifaceted nature of CIED .. type of monitoring should be based on frequency and nature of
care, and that serves as a bridge between clinical registries and
..
.. symptoms and patient preferences.
guideline recommendations. Thus, and in parallel with the writing of .. • In patients with SND including those with bradycar-
these guidelines, a suite of quality indicators for patients undergoing
..
.. diatachycardia type of SND, when symptoms can clearly be
CIED implantation was developed. The full list of these quality indica- .. attributed to bradyarrhythmia, cardiac pacing is indicated.
tors, as well as their specifications and development methodology,
..
.. • In patients with SR and permanent or paroxysmal third- or
has been published elsewhere,844 with a selection presented in .. second-degree type 2 or high-degree AVB, cardiac pacing is indi-
..
Table 15. .. cated irrespective of symptoms.
66 ESC Guidelines
..
• In patients with permanent AF and permanent or paroxysmal .. chlorhexidinealcohol should be preferred for skin antisepsis,
AVB, single-lead ventricular pacing is indicated. .. and cephalic or axillary vein access should be attempted as first
• In patients with syncope and unexplained falls, the diagnosis
.. choice.
..
should be ascertained using the available diagnostic methods .. • Heparin bridging should be avoided in CIED procedures to mini-
before pacemaker treatment is considered.
.. mize the risk of haematoma and pocket infection.
..
• In patients with symptomatic HF and LVEF <_35% despite OMT .. • In patients undergoing a CIED reintervention procedure, using
who are in SR and have LBBB QRS morphology, CRT is recom-
.. an antibiotic-eluting envelope may be considered to reduce the
..
mended when QRS duration is >_150 ms, and should be consid- .. risk of infection.
..
• The beneficial effects of upgrading to CRT from a standard pace- .. • In symptomatic patients with end-stage HCM and LBBB, there is
maker or ICD in patients with HF and a high frequency of RV .. a need to better define the criteria for CRT implantation and
..
pacing need to be documented. .. document the clinical features associated with sustained benefit
• When implanting the LV electrode, it is unknown whether tar- .. from the procedure.
..
geting the latest local activation mechanically or electrically .. • Optimal treatment including cardiac pacing for patients with
causes an improved effect of CRT and a better patient outcome. .. congenital AVB should be investigated.
..
• It is unknown whether employing any type of pre-implant imag- .. • In pacemaker candidates with cardiomyopathies with >1 year
ing to decide about LV and RV lead placement in CRT may cause .. expected survival who do not fulfil standard criteria for ICD
16 ‘What to do’ and ‘what not to do’ messages from the Guidelines
Recommendations Classa Levelb
............ ............
Evaluation of the patient with suspected or documented bradycardia or conduction system disease
Monitoring
Ambulatory ECG monitoring is recommended in the evaluation of patients with suspected bradycardia to correlate rhythm
I C
disturbances with symptoms.
Carotid massage
Once carotid stenosis is ruled out,c CSM is recommended in patients with syncope of unknown origin compatible with a
I B
reflex mechanism or with symptoms related to pressure/manipulation of the carotid sinus area.
Exercise test
Exercise testing is recommended in patients who experience symptoms suspicious of bradycardia during or immediately after
I C
exertion.
Imaging
Cardiac imaging is recommended in patients with suspected or documented symptomatic bradycardia to evaluate the pres-
ence of structural heart disease, to determine LV systolic function, and to diagnose potential causes of conduction I C
disturbances.
Laboratory tests
In addition to pre-implant laboratory tests,d specific laboratory tests are recommended in patients with clinical suspicion for
potential causes of bradycardia (e.g. thyroid function tests, Lyme titre, digitalis level, potassium, calcium, and pH) to diagnose I C
and treat these conditions.
Continued
68 ESC Guidelines
Sleep evaluation
Screening for SAS is recommended in patients with symptoms of SAS and in the presence of severe bradycardia or advanced
I C
AVB during sleep.
Recommendation for implantable loop recorder
In patients with infrequent (less than once a month) unexplained syncope or other symptoms suspected to be caused by bra-
dycardia in whom a comprehensive evaluation did not demonstrate a cause, long-term ambulatory monitoring with an ILR is I A
recommended.
Recommendations for cardiac pacing after cardiac surgery and heart transplantation
High-degree or complete AVB after cardiac surgery: a period of clinical observation of at least 5 days is indicated to assess
whether the rhythm disturbance is transient and resolves. However, this observation period can be shortened in the case of I C
complete AVB with low or no escape rhythm when resolution is unlikely.
Patients requiring pacing after mechanical tricuspid valve replacement: implantation of a transvalvular RV lead should be avoided. III C
Recommendations for cardiac pacing after TAVI
Permanent pacing is recommended in patients with complete or high-degree AVB that persists for 24 - 48 h after TAVI. I B
tion of individual riskbenefits of each option, the patient’s preferences, and goals of care, and it is recommended to follow I C
an integrated care approach and use the principles of patient-centred care and shared decision-making in the consultation.
AF = atrial fibrillation; AVB = atrioventricular block; AVJ = atrioventricular junction; BBB = bundle branch block; b.p.m. = beats per minute; CIED = cardiovascular implantable
electronic device; CRT = cardiac resynchronization therapy; CRT-D = defibrillator with cardiac resynchronization therapy; CSM = carotid sinus massage; DDD = dual-chamber,
atrioventricular pacing; ECG = electrocardiogram; EPS = electrophysiology study; HF = heart failure; HFrEF = heart failure with reduced ejection fraction; HV =
Hisventricular interval; ICD = implantable cardioverter-defibrillator; ILR = implantable loop recorder; LBBB = left bundle branch block; LV = left ventricular; LVEF = left ven-
tricular ejection fraction; MI = myocardial infarction; MRI = magnetic resonance imaging; NYHA = New York Heart Association; OMT = optimal medical therapy; RBBB = right
bundle branch block; RV = right ventricular; SAS = sleep apnoea syndrome; SND = sinus node dysfunction; SR = sinus rhythm; TAVI = transcatheter aortic valve implantation.
a
Class of recommendation.
b
Level of evidence.
c
CSM should not be undertaken in patients with previous transient ischaemic attack, stroke, or known carotid stenosis. Carotid auscultation should be performed before CSM.
If a carotid bruit is present, carotid ultrasound should be performed to exclude carotid disease.
d
Complete blood counts, prothrombin time, partial thromboplastin time, serum creatinine, and electrolytes.
e
In asymptomatic narrow QRS complex and 2:1 AVB, pacing may be avoided if supra-Hisian block is clinically suspected (concomitant Wenckebach is observed and block disap-
pears with exercise) or demonstrated at EPS.
f
Whenever pacing is indicated in neuromuscular disease, CRT or an implantable cardioverter-defibrillator should be considered according to relevant guidelines.
g
Combination of MRI conditional generator and lead(s) from the same manufacturer.
70 ESC Guidelines
..
17 Supplementary data ..
..
Coordinator) (Sweden), Magdy Abdelhamid (Egypt), Victor Aboyans
(France), Elena Arbelo (Spain), Riccardo Asteggiano (Italy), Gonzalo
Supplementary data with additional Supplementary Figures, Tables, and
..
.. Baron-Esquivias (Spain), Johann Bauersachs (Germany), Mauro Biffi
text complementing the full text are available on the European Heart .. (Italy), Ulrika Birgersdotter-Green (United States of America ), Maria
Journal website and via the ESC website at https://www.escardio.org/ ..
.. Grazia Bongiorni (Italy), Michael A. Borger (Germany), Jelena
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