Endorsement ESC guidelines 2020 - AF

 1

 13 tabel 3

 Definitionen på atrieflimren (AF) og de elektrokardiografiske fund er beskrevet uden ændringer. Der er tilføjet to nye begreber ”clinical AF og ”AHRE (Atrial High Rate Episodes), subclinical AF”.

Clinical AF er defineret som enten 30 sekunders AF på en rytmeafledning eller et EKG-12 med AF.

AHRE, som detekteres af implanterede devices (CIED), skal undersøges nærmere for at udelukke artefakter.

”Subclinical AF” inkluderer desuden AHRE, som bekræftes at være AF, atrieflagren eller atrial takykardi, eller AF-episoder detekteret af en loop rekorder eller ”wearable monitor”, som bekræftes ved visuel gennemgang af intrakardielle elektrokardiogrammer eller EKG.

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 2

 18

tabel 4

 Begreberne ”lone AF, Valvular/non-valvular AF og Chronich AF” forlades.

Vi tilslutter os anbefalingen. Dog vil der være risiko for forvirring ved evaluering af indikationen for patienter som skal behandles med NOAC. Den generelle indikation har været gældende for patienter med non-valvulær AF. Alternativet er at moderat/svært mitral klap stenose eller insufficiens skal nævnes som kontraindikation for NOAC behandling.

3

22

Stavefejl. ”but repeated heart associated with significantly better effectiveness compared with single assessment”

Korrektion: but repeated monitoring was associated with significantly better effectiveness compared with single assessment.

 4

 23

 Tabellen på side 23 med rekommandationer for screening for AF:

Opportunistic screening for AF by pulse taking or ECG rhythm strip is recommended in patients >_65 years of age. 

It is recommended to interrogate pacemakers and implantable cardioverter defibrillators on a regular basis for AHRE

When screening for AF it is recommended

that:

• The individuals undergoing screening are informed about the significance and treatment implications of detecting AF.

• A structured referral platform is organized for screen-positive cases for further physician-led clinical evaluation to confirm the diagnosis of AF and provide optimal management of patients with confirmed AF.

• Definite diagnosis of AF in screen-positive cases is established only after physician reviews the single-lead ECG recording of >_30 s or 12-lead ECG and confirms that it shows AF.

Systematic ECG screening should be considered to detect AF in individuals aged >_75 years, or those at high risk of stroke

Vi tilslutter os anbefalingen.

Vi mener ikke, der er evidens for at ændre de aktuelle planlagte device-kontroller. Vi tilslutter os, at man skal være opmærksom på AHRE ved aflæsning af devices.

Vi tilslutter os anbefalingen.

Vi tilslutter os denne anbefaling, men i praksis vil der være stor variation i, hvem der tilbydes denne screening. Vi anbefaler regelmæssig EKG-12 hos alle > 75 år som tilhør klassiske risikogrupper (hypertension, diabetes, IHS., nyreinsufficient) og kommer til kontroller hos e.l. eller kliniske ambulatorier (medicinsk, endokrinologisk, nyremedicinsk og lignende.) 

5

29

Recommendations about integrated AF management.

It is recommended to routinely collect PROs to ensure treatment success and improve patient care. Class I recommendation.

Vi tilslutter os anbefalingen og mener, at vi skal arbejde for systematisering af PRO indsamling

6

33

Afsnit 10.1.4.2 og tabel 11

Considering that inappropriate dose reductions are frequent in clinical practice, thus increasing the risks of stroke/systemic embolism, hospitalization, and death, but without decreasing bleeding risk, NOAC therapy should be optimized based on the efficacy and safety profile of each NOAC in different patient subgroups (Table 11).

Der bør fremgå, at afvigelse fra de rekommanderede doser frarådes. Der foreligger dokumentation for, at under-dosering med NOAC er associeret med øget risiko for stroke/systemisk emboli, hospitalisering og død uden en betydelig risikoreduktion for blødning.

7

51

afsnit 10.2.2.6.1 

When thrombus is identified on TOE, a repeat TOE to ensure thrombus resolution should be considered before cardioversion (Table Recommendations for stroke risk management peri-cardioversion) Class IIa

Fund af intrakardiel trombe ved TEE bør altid suppleres med kontrol-TEE efter 4 ugers terapeutisk AK-behandling inden kardiovertering.

8

Figur 12

For lav-risiko-patienter anføres ”No antithrombotic treatment”

Der bør tilføjes, at risikoprofilen for disse patienter bør re-evalueres mindst én gang årligt

9

Tabel 11

Table 11, indicated that the reduction of Edoxaban doses was “30 mg o.d./15 mg o.d.” and the following drugs under concomitant use involved this eduction: “verapamil, quinidine or dronedarone”.

Edoxaban reduction skal være til 30 mg o.d.

De rette medikamenter som bør føre til dosis reduktion er dronedaron, ciclosporin, erythromycin og ketokonazol.

Hvad er nyt i 2020 Guidelines

Class

Kommentar

Recommendations for diagnosis of AF

ECG documentation is required to establish the diagnosis of AF. A standard 12-lead ECG recording or a single-lead ECG tracing of ≥30 s showing heart rhythm with no discernible repeating P waves and irregular RR intervals (when atrioventricular conduction is not impaired) is diagnostic of clinical AF.

I

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Recommendations for structured characterization of AF

Structured characterization of AF, which includes clinical assessment of stroke risk, symptom status, burden of AF, and evaluation of substrate, should be considered in all AF patients, to streamline the assessment of AF patients at different healthcare levels, inform treatment decision making, and facilitate optimal management of AF patients.

IIa

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Recommendations for screening to detect AF

When screening for AF it is recommended that:

• The individuals undergoing screening are informed about the significance and treatment implications of detecting AF.

• A structured referral platform is organized for screen-positive cases for further physician-led clinical evaluation to confirm the diagnosis of AF and provide optimal management of patients with confirmed AF.

• Definite diagnosis of AF in screen-positive cases is established only after the physician reviews the single-lead ECG recording of >_30 s or 12-lead ECG and confirms that it shows AF.

I

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Recommendations about integrated AF management

It is recommended to routinely collect PROs to measure treatment success and improve patient care.

I

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Recommendations for the prevention of thrombo-embolic events in AF

For a formal risk-score-based assessment of bleeding risk, the HAS-BLED score should be considered to help address modifiable bleeding risk factors, and to identify patients at high risk of bleeding (HAS-BLED score ≥3) for early and more frequent clinical review and follow-up.

IIa

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Stroke and bleeding risk reassessment at periodic intervals is recommended to inform treatment decisions (e.g. initiation of OAC in patients no longer at low risk of stroke) and address potentially modifiable bleeding risk factors.

I

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In patients with AF initially at low risk of stroke, first reassessment of stroke risk should be made 4 - 6 months after the index evaluation.

IIa

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Estimated bleeding risk, in the absence of absolute contraindications to OAC, should not in itself guide treatment decisions to use OAC for stroke prevention.

III

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Clinical pattern of AF (i.e. first detected, paroxysmal, persistent, long-standing persistent, permanent) should not condition the indication to thromboprophylaxis.

III

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Recommendations for cardioversion

Pharmacological cardioversion of AF is indicated only in a haemodynamically stable patient, after consideration of the thrombo-embolic risk.

I

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For patients with sick-sinus syndrome, atrioventricular conduction disturbances or prolonged QTc (>500 ms), pharmacological cardioversion should not be attempted unless risks for proarrhythmia and bradycardia have been considered.

III

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Recommendations for rhythm control/catheter ablation of AF

For the decision on AF catheter ablation, it is recommended to take into consideration the procedural risks and the major risk factors for AF recurrence following the procedure and discuss them with the patient.

I

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Repeated PVI procedures should be considered in patients with AF recurrence provided the patient’s symptoms were improved after the initial PVI.

IIa

Under hensyntagen til patientens aktuelle status og komorbiditet.

AF catheter ablation for PVI should be considered for rhythm control after one failed or intolerant to beta-blocker treatment to improve symptoms of AF recurrences in patients with paroxysmal and persistent AF.

IIa

Tilslutter os med kommentar om, at data ikke er valide for ældre patienter. Der skal foretages individuel vurdering hos ældre patienter.

AF catheter ablation for PVI should/may be considered as first-line rhythm control therapy to improve symptoms in selected patientswith symptomatic:

·      Paroxysmal AF episodes, or

·      Persistent AF without major risk factors for AF recurrence as an alternative to AAD class I or III, considering patient choice, benefit, and risk.

IIa

IIb

Tilslutter os med kommentar om, at data ikke er valide for ældre patienter. Der skal foretages individuel vurdering hos ældre patienter.

Use of additional ablation lesions beyond PVI (low voltage areas, lines, fragmented activity, ectopic foci, rotors, and others) may be considered but is not well established.

IIb

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Strict control of risk factors and avoidance of triggers are recommended as part of rhythm control strategy.

I

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Recommendations for stroke risk management peri-cardioversion

It is recommended that the importance of adherence and persistence to NOAC treatment both before and after cardioversion is strongly emphasized to patients.

I

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In patients with AF duration of >24 h undergoing cardioversion, therapeutic anticoagulation should be continued for at least 4 weeks even after successful cardioversion to sinus rhythm (beyond 4 weeks, the decision about long-term OAC treatment is determined by the

presence of stroke risk factors).

IIa

Vi anbefaler, at vi fortsat behandler alle disse patienterne med minimum 4 ugers AK behandling uanset tromboseriskoen og AF durationen.

In patients with a definite duration of AF <_24 h and a very low stroke risk (CHA2DS2-VASc of 0 in men or 1 in women) post-cardioversion anticoagulation for 4 weeks may be omitted.

IIb

Vi mener ikke at evidensen er sufficient og anbefaler, at vi fortsat behandler disse patienterne med minimum 4 ugers AK behandling uanset tromboseriskoen

Recommendations for stroke risk management peri-catheter ablation

In AF patients with stroke risk factors not taking OAC before ablation, it is recommended that pre-procedural management of stroke risk includes initiation of anticoagulation and:

• Preferably, therapeutic OAC for at least 3 weeks before ablation, or

• Alternatively, the use of TOE to exclude LA thrombus before ablation.

I

IIa

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For patients undergoing AF catheter ablation who have been therapeutically anticoagulated with warfarin, dabigatran, rivaroxaban, apixaban, or edoxaban, performance of the ablation procedure without OAC interruption is recommended.

I

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Recommendations for long-term AADs

In AF patients treated with sotalol, close monitoring of QT interval, serum potassium levels, CrCl, and other pro-arrhythmia risk factors is recommended.

I

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In AF patients treated with flecainide for long-term rhythm control, concomitant use of an atrioventricular nodal-blocking drug (if tolerated) should be considered.

IIa

Vi anbefaler fortsat ordination af AV-blokkerende medikament i tillæg til flecainid behandling

Sotalol may be considered for long-term rhythm control in patients with normal LV function or with ischaemic heart disease if close monitoring of QT interval, serum potassium levels, CrCl, and other proarrhythmia risk factors is provided.

IIb

Sotalol behandling anbefales kun i særlige tilfælde, hvor andre antiarytmika er afprøvet uden effekt eller er kontraindiceret.

Recommendations for lifestyle interventions and management of risk factors and concomitant diseases in AF

Identification and management of risk factors and concomitant diseases is recommended as an integral part of treatment in AF patients.

I

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Modification of unhealthy lifestyle and targeted therapy of intercurrent conditions is recommended to reduce AF burden and symptom severity.

I

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Opportunistic screening for AF is recommended in hypertensive patients.

I

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Opportunistic screening for AF should be considered in patients with OSA.

IIa

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Recommendations for patients with AF and an ACS, PCI, or CCS

In AF patients with ACS undergoing an uncomplicated PCI, early cessation (<_1 week) of aspirin and continuation of dual therapy with an OAC and a P2Y12 inhibitor (preferably clopidogrel) for up to 12 months is recommended if the risk of stent thrombosis is low or if concerns about bleeding risk prevail over concerns about risk of stent thrombosis, irrespective of the type of stent used.

I

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After uncomplicated PCI, early cessation (<_1 week) of aspirin and continuation of dual therapy with OAC for up to 6 months and clopidogrel is recommended if the risk of stent thrombosis is low or if concerns about bleeding risk prevail over concerns about risk of stent thrombosis, irrespective of the type of stent used.

I

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Recommendations for the management of active bleeding on OAC

Four-factor prothrombin complex concentrates should be considered in AF patients on VKA who develop a severe bleeding complication.

IIa

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Recommendations for the management of AF during pregnancy

In pregnant women with HCM, cardioversion should be considered for persistent AF.

IIa

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Ibutilide or flecainide i.v. may be considered for termination of AF in stable patients with structurally normal hearts.

IIb

Ibutilide er ikke markedsført i DK. Der anbefales flecainid IV eller DC-konvertering

Flecainide, propafenone, or sotalol should be considered to prevent AF if atrioventricular nodal-blocking drugs fail.

IIa

Vi tilslutter os. Evidensen er meget begrænset. Der anbefales, at håndtering af AF hos gravide bør ske på højt specialiseret center

Digoxin or verapamil should be considered for rate control if beta-blockers fail.

IIa

Vi tilslutter os. Evidensen er meget begrænset. Der anbefales, at håndtering af AF hos gravide bør ske på højt specialiseret center

Recommendations for postoperative AF

Long-term OAC therapy to prevent thrombo-embolic events should be considered in patients at risk for stroke with postoperative AF after non-cardiac surgery, considering the anticipated net clinical benefit of OAC and informed patient preferences.

IIa

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Beta-blockers should not be used routinely for the prevention of postoperative AF in patients undergoing non-cardiac surgery.

III

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Recommendations pertaining to sex-related differences in AF

Women with symptomatic paroxysmal or persistent AF should be offered timely access to rhythm control therapies, including AF catheter ablation, when appropriate for medical reasons.

IIa

Vi mener ikke, at der er kønsforskelle i den tilbudte behandling til patienter i Danmark.

Recommendations for quality measures in AF

The introduction of tools to measure quality of care and identify opportunities for improved treatment quality and AF patient outcome should be considered by practitioners and institutions.

IIa

Vi tilslutter os dog med en bemærkning om , at der er behov for udvikling af et fælles måle metode.

2020

Class

2016

Class

Comments

Recommendations about integrated AF management

To optimize shared decision making about specific AF treatment option(s) in consideration, it is recommended that:

• Physicians inform the patient about advantages/limitations and

benefit/risks associated with considered treatment option(s);

and

• Discuss the potential burden of the treatment with the patient

and include the patient’s perception of treatment burden in the treatment decision.

I

Placing patients in a central role in decision making should be considered

in order to tailor management to patient preferences and

improve adherence to long-term therapy

IIa

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Recommendations for the prevention of thrombo-embolic events in AF

For bleeding risk assessment, a formal structured risk-scorebased bleeding risk assessment is recommended to help identify non-modifiable and address modifiable bleeding risk factors in all AF patients, and to identify patients potentially at high risk of bleeding who should be scheduled for early and more frequent clinical review and follow-up.

I

Bleeding risk scores should be considered in AF patients on oral

anticoagulation to identify modifiable risk factors for major

bleeding.

IIa

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In patients on VKAs with low time in INR therapeutic range (e.g. TTR<70%), recommended options are:

• Switching to a NOAC but ensuring good adherence and persistence with therapy; or

• Efforts to improve TTR (e.g. education/counselling and more

frequent INR checks).

I

IIa

AF patients already on treatment with a VKAs may be considered

for NOAC treatment if TTR is not well controlled despite good adherence, or if patient preference without contraindications to NOAC (e.g. prosthetic valve).

IIb

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Recommendations for rhythm control/catheter ablation of AF

AF catheter ablation after drug therapy failure

AF catheter ablation for PVI is recommended for rhythm control after one failed or intolerant class I or III AAD, to improve symptoms of AF recurrences in patients with:

• Paroxysmal AF, or

• Persistent AF without major risk factors for AF recurrence, or

• Persistent AF with major risk factors for AF recurrence.

I

Catheter or surgical ablation should be considered in patients with symptomatic persistent or long-standing persistent AF refractory to AAD therapy to improve symptoms, considering patient choice, benefit and risk, supported by an AF Heart Team.

IIa

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First-line therapy

AF catheter ablation:

Is recommended to reverse LV dysfunction in AF patients

when tachycardia-induced cardiomyopathy is highly probable,

independent of their symptom status.

Should be considered in selected AF patients with HFrEF to

improve survival and reduce HF hospitalization.

I

IIa

AF ablation should be considered in symptomatic patients with AF

and HFrEF to improve symptoms and cardiac function when tachycardiomyopathy

is suspected.

IIa

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Techniques and technologies

Complete electrical isolation of the pulmonary veins is recommended during all AF catheter-ablation procedures.

I

Catheter ablation should target isolation of the pulmonary veins

using radiofrequency ablation or cryo-balloon catheters.

IIa

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If patient has a history of CTI-dependent atrial flutter or if typical atrial flutter is induced at the time of AF ablation, delivery of a CTI lesion may be considered.

IIb

Ablation of common atrial flutter should be considered to prevent

recurrent flutter as part of an AF ablation procedure if documented

or occurring during the AF ablation

IIa

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Lifestyle modification and other strategies to improve outcomes of ablation

Weight loss is recommended in obese patients with AF, particularly those who are being evaluated to undergo AF ablation.

I

In obese patients with AF, weight loss together with management

of other risk factors should be considered to reduce AF burden

and symptoms.

IIa

Det er primær LEGACY studiet som tyder på at vægttab på ca. mindst 3 % og især fra >10% for alle med forøget BMI (>27) reducerer Afli-byrde.

Derudover en mindre studie fra samme gruppe med pat. efter RFA.

Evidensen er samlet set begrænset men virker biologisk set plausibel.

Vi mener derfor at det kan anbefales idet man også forbygger art. hypertension og diabetes.

Recommendations for stroke risk management peri-cardioversion

In patients with AF undergoing cardioversion, NOACs are recommended with at least similar efficacy and safety as warfarin.

I

Anticoagulation with heparin or a NOAC should be initiated as

soon as possible before every cardioversion of AF or atrial flutter.

IIa

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Recommendations for stroke risk management peri-catheter ablation

After AF catheter ablation, it is recommended that:

• Systemic anticoagulation with warfarin or a NOAC is continued for at least 2 months post ablation, and

• Long-term continuation of systemic anticoagulation beyond 2 months post ablation is based on the patient’s stroke risk profile and not on the apparent success or failure of the ablation

procedure.

I

All patients should receive oral  anticoagulation for at least 8 weeks

after catheter ablation.

IIa

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Recommendations for long-term antiarrhythmic drugs

Amiodarone is recommended for long-term rhythm control in all

AF patients, including those with HFrEF. However, owing to its extracardiac toxicity, other AADs should be considered first

whenever possible.

I

Amiodarone is more effective in preventing AF recurrences than

other AAD, but extracardiac toxic effects are common and

increase with time. For this reason, other AAD should be considered

first.

IIa

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Recommendations for lifestyle interventions and management of risk factors and concomitant diseases in patients with AF

Attention to good BP control is recommended in AF patients

with hypertension to reduce AF recurrences and risk of stroke

and bleeding.

I

BP control in anticoagulated patients with hypertension should be considered to reduce the risk of bleeding

IIa

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Physical activity should be considered to help prevent AF incidence or recurrence, with the exception of excessive endurance exercise, which may promote AF.

IIa

Moderate regular physical activity is recommended to prevent AF, while athletes should be counselled that long-lasting intense sports

participation can promote AF

I

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Optimal management of OSA may be considered, to reduce AF

incidence, AF progression, AF recurrences, and symptoms.

IIb

OSA treatment should be optimized to reduce AF recurrences and

improve AF treatment results.

IIa

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Recommendations for stroke prevention in AF patients after ICH

In AF patients at high risk of ischaemic stroke, (re-)initiation of OAC, with preference for NOACs over VKAs in NOAC-eligible patients, should be considered in consultation with a neurologist/stroke specialist after:

• A trauma-related ICH

• Acute spontaneous ICH (which includes subdural, subarachnoid,

or intracerebral haemorrhage), after careful consideration

of risks and benefits

IIa

After ICH oral anticoagulation in patients with AF may be reinitiated

after 4-8 weeks provided the cause of bleeding or the relevant

risk factor has been treated or controlled.

IIb

Vi tilslutter os og anbefaler at man træffer beslutningen i samråd med Neurologerne.

Recommendations for postoperative AF

Long-term OAC therapy to prevent thrombo-embolic events

may be considered in patients at risk for stroke with postoperative AF after cardiac surgery, considering the anticipated net clinical

benefit of OAC therapy and informed patient preferences.

IIb

Long-term anticoagulation should be considered in patients with AF after cardiac surgery at risk for stroke, considering individual

stroke and bleeding risk.

IIa

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