Pacing og CRT

Hvad er nyt i 2021 guidelines

Recommendation

Class

Kommentar

Evaluation of the patient with suspected or documented bradycardia or conduction system disease

Monitoring

In patients with infrequent (less than once a month) unexplained syncope or other symptoms suspected to be caused by bradycardia, in whom a comprehensive evaluation did not demonstrate a cause, long-term ambulatory monitoring with an ILR is recommended.

I

Tilsluttes

Ambulatory electrocardiographic monitoring is recommended in the evaluation of patients with suspected bradycardia to correlate rhythm disturbances with symptoms.

I

Tilsluttes

Carotid massage

Once carotid stenosis is ruled out, carotid sinus massage is recommended in patients with syncope of unknown origin compatible with a reflex mechanism or with symptoms related to pressure/manipulation of the carotid sinus area.

I

Tilsluttes, ved patienter > 40 år.

Tilt test

Tilt testing should be considered in patients with suspected recurrent reflex syncope.

IIa

Tilsluttes

Exercise test

Exercise testing is recommended in patients who experience symptoms suspicious of bradycardia during or immediately after exertion.

I

Tilsluttes

In patients with suspected chronotropic incompetence, exercise testing should be considered to confirm the diagnosis.

IIa

Tilsluttes

In patients with intraventricular conduction disease or AVB of unknown level, exercise testing may be considered to expose infranodal block.

IIb

Tilsluttes

Imaging

Cardiac imaging is recommended in patients with suspected or documented symptomatic bradycardia to evaluate the presence of structural heart disease, to determine left ventricular systolic function, and to diagnose potential causes of conduction disturbances.

I

Tilsluttes

Multimodality imaging (CMR, CT, PET) should be considered for myocardial tissue characterization in the diagnosis of specific pathologies associated with conduction abnormalities needing pacemaker implantation, particularly in patients younger than 60 years.

IIa

Tilsluttes

Laboratory tests

In addition to preimplant laboratory tests, 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 and treat these conditions.

I

Tilsluttes

Sleep evaluation

Screening for SAS is recommended in patients with symptoms of SAS and in the presence of severe bradycardia or advanced AVB during sleep.

I

Det anbefales at vurdere om patienter med dokumentation for svær bradykardi og/eller avanceret AV-blok under søvn kunne have søvnapnø, da det kan være årsag til arytmien.  

Electrophysiological study

In patients with syncope and bifascicular block, EPS should be considered when syncope remains unexplained after non-invasive evaluation or when an immediate decision about pacing is needed due to severity, unless empirical pacemaker implantation is preferred (especially in elderly and frail patients).

IIa

Tilsluttes

In patients with syncope and sinus bradycardia, EPS may be considered when non-invasive tests have failed to show a correlation between syncope and bradycardia.

IIb

Tilsluttes

Genetics

Genetic testing should be considered in patients with early onset (age <50 years) of progressive cardiac conduction disease.

IIa

Tilsluttes

Genetic testing should be considered in family members following the identification of a patho- genic genetic variant that explains the clinical phenotype of cardiac conduction disease in an index case.

IIa

Tilsluttes

Cardiac pacing for bradycardia and conduction system disease

Pacing is indicated in symptomatic patients with the bradycardia-tachycardia form of SND to correct brady-arrhythmias and enable pharmacological treatment, unless ablation of the tachyarrhythmia is preferred.

I

Tilsluttes

Pacing is indicated in patients with atrial arrhythmia (mainly AF) and permanent or paroxysmal third- or high-degree AVB irrespective of symptoms.

I

Tilsluttes

In patients with SND and DDD PM, minimization of unnecessary ventricular pacing through programming is recommended.

I

Tilsluttes

Dual chamber cardiac pacing is indicated to reduce recurrent reflex syncope in patients aged >40 years with severe, unpredictable, recurrent syn- cope who have:

·        spontaneous documented symptomatic asystolic pause/s >3 s or asymptomatic pause/s >6 s due to sinus arrest or AVB; or

·        cardioinhibitory carotid sinus syndrome; or

·        asystolic syncope during tilt testing.

I

Tilsluttes (vurderes at være tale om få patienter, klinisk erfaring er at der oftest er tale om yngre patienter <40 år).

In patients with recurrent unexplained falls, the same assessment as for unexplained syncope should be considered.

IIa

Tilsluttes

AF ablation should be considered as a strategy to avoid pacemaker implantation in patients with AF-related bradycardia or symptomatic pre- automaticity pauses, after AF conversion, taking into account the clinical situation.

IIa

Der vurderes at dokumentationen for denne rekommendation er meget svag, og det det kan kun undtagelsesvist komme på tale hos yngre patienter. Den betydelige risiko for recidiv af atrieflimren efter ablation må haves in mente. Derudover er de medicolegale aspekter ved f.eks. bilkørsel uklare. Det bemærkes dog at tilsvarende anbefaling er nævnt i AF guidelines, hvorfor den bibeholdes her.

In patients with the bradycardia-tachycardia variant of SND, programming of atrial ATP may be considered.

IIb

Tilsluttes

Dual-chamber cardiac pacing may be considered to reduce syncope recurrences in patients with the clinical features of adenosine-sensitive syncope.

IIb

Tilsluttes

Cardiac resynchronization therapy

In patients who are candidates for an ICD and who have CRT indication, implantation of a

CRT-D is recommended.

I

Tilsluttes

In patients who are candidates for CRT, implantation of a CRT-D should be considered after

individual risk assessment and using shared decision-making.

IIa

Tilsluttes

In patients with symptomatic AF and an uncontrolled heart rate who are candidates for AVJ ablation (irrespective of QRS duration), CRT rather than standard RV pacing should be considered in patients with HFmrEF.

IIa

Tilsluttes

In patients with symptomatic AF and an uncontrolled heart rate who are candidates for AVJ

ablation (irrespective of QRS duration), RV pacing should be considered in patients with HFpEF..

IIa

Tilsluttes

In patients with symptomatic AF and an uncontrolled heart rate who are candidates for AVJ

ablation (irrespective of QRS duration), CRT may be considered in patients with HFpEF.

IIb

Tilsluttes

Alternate site pacing

His bundle pacing

In patients treated with HBP, device programming tailored to specific requirements of His

bundle pacing is recommended

I

Tilsluttes

In CRT candidates in whom coronary sinus lead implantation is unsuccessful, HBP should be considered as a treatment option along with other techniques such as surgical epicardial lead.

IIa

Tilsluttes

In patients treated with HBP, implantation of a right ventricular lead used as “backup” for pacing should be considered in specific situations (e.g. pacemaker-dependency, high-grade AVB, infranodal block, high pacing threshold, planned AVJ ablation), or for sensing in case of issues with detection (e.g. risk of ventricular undersensing or oversensing of atrial/His potentials).

IIa

Tilsluttes

HBP with a ventricular backup lead may be considered in patients in whom a “pace-and-ablate”

strategy for rapidly conducted supraventricular arrhythmia is indicated, particularly when intrinsic QRS is narrow.

IIb

Tilsluttes

HBP may be considered as an alternative to right ventricular pacing in patients with AVB and LVEF >40%, who are anticipated to have >20% ventricular pacing.

IIb

Langtidsresultaterne og patientsikkerheden er fortsat ikke velbelyst. Det anbefales at HBP udelukkende udføres protokolleret.

Leadless pacing

Leadless pacemakers should be considered as an alternative to transvenous pacemakers when no upper extremity venous access exists or when risk of device pocket infection is particularly

high, such as previous infection and patients on haemodialysis.

IIa

Tilsluttes

Leadless pacemakers may be considered as an alternative to standard single lead ventricular

pacing, taking into consideration life expectancy and using shared decision-making

IIb

Tilsluttes

Indications for pacing in specific conditions

Pacing in acute myocardial infarction

Implantation of a permanent pacemaker is indicated with the same recommendations as in a general population (section 5.2) when AVB does not resolve within a waiting period of at least 5 days after MI.

I

Tilsluttes

In selected patients with AVB in context of anterior wall MI and acute HF, early device implantation (CRT-D/CRT-P) may be considered

IIb

Tilsluttes

Pacing in cardiac surgery

High-degree or complete AVB after cardiac surgery. A period of clinical observation for at least 5 days is indicated in order to assess whether the rhythm disturbance is transient and resolves. However, in the case of complete AVB with low or no escape rhythm when resolution is unlikely, this observation period can be shortened.

I

Tilsluttes

SND after cardiac surgery and heart transplantation. Before permanent pacemaker implantation, a period of observation for up to 6 weeks should be considered.

IIa

Tilsluttes

Chronotropic incompetence after heart transplantation. Cardiac pacing should be considered for chronotropic incompetence persisting more than 6 weeks after heart transplantation to improve quality of life.

IIa

Tilsluttes

Surgery for valvular endocarditis and intraoperative complete AVB. Immediate epicardial pacemaker implantation should be considered in patients with surgery for valvular endocarditis

and complete AVB if one of the following predictors of persistence is present: preoperative conduction abnormality, Staphylococcus aureus infection, intracardiac abscess, tricuspid valve

involvement, or previous valvular surgery.

IIa

Tilsluttes

Patients requiring pacing at the time of tricuspid valve surgery. Transvalvular leads should be

avoided and epicardial ventricular leads used. During tricuspid valve surgery, removal of preexisting transvalvular leads should be considered and preferred over sewing-in the lead between the annulus and a bio-prosthesis or annuloplasty ring. In the case of an isolated tricuspid annuloplasty based on an individual risk-benefit analysis, a pre-existing right ventricular lead may be left in place without jailing it between ring and annulus.

IIa

Tilsluttes

Patients requiring pacing after biological tricuspid valve replacement/tricuspid valve ring repair. When ventricular pacing is indicated, transvenous implantation of a coronary sinus lead or minimally invasive placement of an epicardial ventricular lead should be considered and preferred over a transvenous transvalvular approach.

IIa

Tilsluttes

Patients requiring pacing after mechanical tricuspid valve replacement. Implantation of a transvalvular right ventricular lead should be avoided

III

Tilsluttes

Pacing in transcatheter aortic valve implantation

Permanent pacing is recommended in patients with complete or high-degree AVB that persists for 24 - 48 h after TAVI.

I

Tilsluttes

Permanent pacing is recommended in patients with new onset alternating BBB after TAVI

I

Tilsluttes

Early permanent pacing should be considered in patients with pre-existing RBBB who develop any further conduction disturbance during or after TAVI.

IIa

Tilsluttes

Ambulatory ECG monitoring or an electrophysiology study should be considered for patients with new LBBB with QRS >150 ms or PR >240 ms with no further prolongation during >48 h after TAVI.

IIa

Tilsluttes

Ambulatory ECG monitoring or electrophysiology study may be considered for TAVI patients with pre-existing conduction abnormality who develop further prolongation of QRS or PR >20 ms.

IIa

Tilsluttes

Prophylactic permanent pacemaker implantation is not indicated before TAVI in patients with RBBB and no indication for permanent pacing

III

Tilsluttes (dog kan profylaktisk implantation overvejes i protokolleret regi hos patienter med høj risiko for udvikling af AV blok efter TAVI [herunder: RBBB og QRS >160 ms; RBBB og LAFB/LPFB; RBBB og PR >240 ms; membranøs septumlængde < 3 mm]).

Various syndromes

In patients with neuromuscular diseases such as myotonic dystrophy type 1 and any second- or third-degree AVB or HV >70 ms, with or without symptoms, permanent pacing is indicated.

I

Tilsluttes

In patients with LMNA gene mutations, including Emery-Dreifuss and limb girdle muscular dystrophies who fulfil conventional criteria for pacemaker implantation or who have prolonged PR with LBBB, ICD implantation with pacing capabilities should be considered if at least 1-year survival is expected

IIa

Tilsluttes

In patients with Kearns-Sayre syndrome who have PR prolongation, any degree of AVB, bundle branch block, or fascicular block, permanent pacing should be considered.

IIa

Tilsluttes

In patients with neuromuscular disease such as myotonic dystrophy type 1 with PR >_240 ms or QRS duration >_120 ms, permanent pacemaker implantation may be considered.

IIb

Tilsluttes

In patients with Kearns-Sayre Syndrome without cardiac conduction disorder, permanent pacing

may be considered prophylactically.

IIb

Tilsluttes

Sarcoidosis

In patients with cardiac sarcoidosis who have permanent or transient AVB, implantation of a device capable of cardiac pacing should be considered.

IIa

Tilsluttes (i henhold til HRS consensus-rapport fra 2014 vil man i praksis ofte implantere en ICD [klasse IIa-rekommendation]).

In patients with sarcoidosis and indication for permanent pacing who have LVEF <50%, implantation of a CRT-D should be considered

IIa

Tilsluttes

Special considerations on device implantations and perioperative management

Administration of preoperative antibiotic prophylaxis within 1 h of skin incision is recommended to reduce risk of CIED infection

I

Tilsluttes

Chlorhexidine alcohol instead of povidoneiodine alcohol should be considered for skin antisepsis.

IIa

Tilsluttes

For venous access, the cephalic or axillary vein should be considered as first choice.

IIa

Tilsluttes

For implantation of coronary sinus leads, quadripolar leads should be considered as first choice

IIa

Tilsluttes

To confirm target ventricular lead position, use of multiple fluoroscopic views should be considered

IIa

Tilsluttes

Rinsing the device pocket with normal saline solution before wound closure should be considered.

IIa

Tilsluttes

In patients undergoing a reintervention CIED procedure, the use of an antibiotic-eluting envelope may be considered.

IIb

Tilsluttes. Et nyere dansk studie støtter anbefalingen yderligere, især ved CRT-P/CRT-D reintervention.

Pacing of the mid-ventricular septum may be considered in patients with a high risk of perforation (elderly, previous perforation).

IIb

Tilsluttes

In pacemaker implantations in patients with possible pocket issues such as increased risk of erosion due to low body mass index, Twiddler’s syndrome or aesthetic reasons, a submuscular device pocket may be considered.

IIb

Tilsluttes

Heparin-bridging of anticoagulated patients is not recommended

III

Tilsluttes

Permanent pacemaker implantation is not recommended in patients with fever. Pacemaker implantation should be delayed until the patient has been afebrile for at least 24 h.

III

Tilsluttes

Management considerations

Remote monitoring

Remote device management is recommended to reduce number of in-office follow-up in patients with pacemakers who have difficulties to attend in-office visits (e.g due to reduced mobility or other commitments or according to patient preference).

I

Tilsluttes

Remote monitoring is recommended in case of a device component that has been recalled or is on advisory, to enable early detection of actionable events in patients, particularly those who are at increased risk (e.g. in case of pacemaker dependency).

I

Tilsluttes

In-office routine follow-up of single- and dual chamber pacemakers may be spaced by up to 24 months

in patients on remote device management.

IIa

Tilsluttes (af logistiske årsager genneføres PM kontrol hvert 2. år flere steder i Danmark hos patienter med velfungerende PM uden remote monitoring).

Temporary pacing

Temporary transvenous pacing is recommended in cases of haemodynamic-compromising bradyarrhythmia refractory to intravenous chronotropic drugs

I

I Danmark bør patienter med hæmodynamisk betydende bradykardi tilbydes akut implantation af temporær eller permanent PM på baggrund af potentiel behandlingssvigt og bivirkninger til Isoporenalin. Der kan anvendes Isoprenalin under transport til kardiologisk laboratorium).

Transcutaneous pacing should be considered in cases of haemodynamic compromising bradyarrhythmia when temporary transvenous pacing is not possible or available

IIa

I Danmark skal transcutan pacing kun anvendes under transport til anlæggelse af temporær eller permanent PM.

Temporary transvenous pacing should be considered when immediate pacing is indicated and pacing indications are expected to be reversible, such as in the context of myocardial ischaemia, myocarditis, electrolyte disturbances, toxic exposure, or after cardiac surgery

IIa

Tilsluttes

Temporary transvenous pacing should be considered as a bridge to permanent pacemaker implantation, when this procedure is not immediately available or possible due to concomitant infection.

IIa

Tilsluttes

For long-term temporary transvenous pacing, an active fixation lead inserted through the skin and connected to an external pacemaker should be considered.

IIa

Tilsluttes

Miscellaneous

When pacing is no longer indicated, a decision on the management strategy should be based on an individual risk-benefit analysis in a shared decision-making process together with the patient.

I

Tilsluttes

MRI may be considered in pacemaker patients with abandoned transvenous leads if no alternative imaging modality is available

IIb

Tilsluttes

Pantient-centred care

In patients considered for pacemaker or CRT, the decision should be based on the best available evidence with consideration of individual risk-benefits of each option, the patient preferences, and goals of care, and it is recommended to follow an integrated care approach and use the principles of patient-centred care and shared decision making in the consultation.

I

Tilsluttes

Ændringer I forhold til 2013 guidelines

2013

2021

Class

Kommentar

Cardiac pacing for bradycardia and conduction system disease

In patients with syncope, cardiac pacing may be considered to reduce recurrent syncope when asymptomatic pause(s) >6 s due to sinus arrest

are documented.

IIa

IIb

Tilsluttes

Cardiac resynchronization therapy

Patients who have received a conventional pacemaker or an ICD and who subsequently develop symptomatic HF with LVEF <_35% despite OMT and who have a significantb proportion of RV pacing should be considered for upgrade to CRT.

I

IIa

Tilsluttes (hos patienter med betydelig andel nødvendig RV pacing og uden mulighed for omprogrammering af device for at reducere andel af RV pacing).

CRT rather than RV pacing is recommended for patients with HFrEF (<40%) regardless of NYHA class who have an indication for ventricular pacing and high-degree AVB in order to reduce morbidity. This includes patients with AF.

IIa

I

Tilsluttes

CRT should be considered for symptomatic patients with HF in SR with LVEF <35%, a QRS duration of 130_149 ms, and LBBB QRS morphology despite OMT, to improve symptoms and reduce morbidity and mortality.

I

IIa

Tilsluttes

In patients with symptomatic AF and uncontrolled heart rate who are candidates for AVJ ablation (irrespective of QRS duration), CRT is recommended in patients with HFrEF.

IIa

I

Tilsluttes

Specific indications for pacing

In patients with congenital heart disease, pacing may be considered for persistent postoperative bifascicular block associated with transient complete AVB.

IIa

IIb

Tilsluttes

Management considerations

In patients with MRI-conditional pacemaker systems, MRI can be performed safely following manufacturer instructions

IIa

I

Tilsluttes, stemmer overens med DCS holdningspapir omkring MR hos patienter med CIED.

In patients with non-MRI-conditional pacemaker systems, MRI should be considered if no alternative imaging mode is available and if no epicardial leads, abandoned or damaged leads, or lead adaptors/extenders are present

IIb

IIa

Tilsluttes, stemmer overens med DCS holdningspapir omkring MR hos patienter med CIED.