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Katheterablatie

Beoordeeld: 01-09-2022

Uitgangsvraag

Wanneer wordt katheterablatie voor ritme-regulatie bij patiënten met atriumfibrilleren gekozen?

Deze uitgangsvraag bevat de volgende deelvragen:

  1. Welke aanvullende ablatiestrategie wordt gekozen wanneer de pulmonaal venen al geïsoleerd zijn na een eerdere ablatie en dit onvoldoende effect heeft op het atriumfibrilleren?
  2. Wanneer dient katheterablatie te worden overwogen na het falen van medicamenteuze ritme-regulatie therapie?

Aanbeveling

Betere uitkomsten na ablatie:

Behandel modificeerbare risicofactoren (overgewicht, hypertensie en OSA) en adviseer het vermijden van uitlokkende factoren, voor en na katheterablatie om uitkomsten van ablatie te verbeteren (Zie ook Supplementary Box 2).

 

Ablatie indien geneesmiddelen niet voldoende effectief zijn of bijwerkingen geven:

  • Indien ritme-regulatie met een antiaritmicum (klasse I of III) onvoldoende effect op de klachten van atriumfibrilleren heeft, bespreek met patiënt om een katheterablatie te verrichten zowel bij paroxysmaal als persistent atriumfibrilleren.
  • Overweeg dit ook als alleen een bètablokker niet effectief is.

Ablatie als eerste behandeling:

  • Overweeg als eerste behandeling een katheterablatie bij paroxysmaal of persistent atriumfibrilleren, als alternatief voor antiaritmica.
  • Overweeg bij LV-dysfunctie als gevolg van tachycardie-geïnduceerd hartfalen een katheterablatie, ongeacht symptomen.
  • Overweeg katheterablatie bij patiënten met hartfalen bij verminderde EF om hospitalisatie en mortaliteit te verminderen.
  • Overweeg katheterablatie bij patiënten met atriumfibrilleren en bradycardieën, om pacemakerimplantatie te voorkomen.

Ablatietechnieken:

  • Isoleer de pulmonaal venen bij alle ablatieprocedures.
  • Overweeg ook ablatie van de cavotricuspidale isthmus indien de patiënt ook typische atriumflutters heeft laten zien.
  • Overweeg additionele ablatiestrategieën naast isolatie van de pulmonaal venen, hoewel de effectiviteit hiervan niet vaststaat.

Overweeg opnieuw een katheterablatie na recidiverend atriumfibrilleren.

Overwegingen

AF catheter ablation is a well-established treatment for the prevention of AF recurrences (Calkins, 2018; Arbelo, 2012; Arbelo, 2014; Arbelo, 2017). When performed by appropriately trained operators, AF catheter ablation is a safe and superior alternative to AADs for maintenance of sinus rhythm and symptom improvement (Nyong, 2016; Jais, 2008; Oral, 2006; Mont, 2014; Forleo, 2009; Wilber, 2010; Wazni, 2005; Morillo, 2014; Cosedis Nielsen, 2012; Blomstrom-Lundqvist, 2019; Mark, 2019; Krittayaphong,  2003; Stabile, 2006; Pappone, 2006; Calkins, 2009; Packer, 2013; Ganesan, 2013; Di Biase, 2016; Kuck, 2016; Sohara, 2016; Hakalahti, 2015; Nielsen, 2017; Chen, 2018; Packer, 2019; Noseworthy, 2019). It is advised to discuss the efficacy and complication rates of AF catheter ablation and AADs with the patient once rhythm control as long-term management has been selected.

 

Indications

In the following section, indications for AF catheter ablation are presented for paroxysmal and persistent AF in patients with and without risk factors for post-ablation AF recurrence. Differentiation of persistent and long-standing persistent AF was omitted because the latter only expresses the duration of persistent AF above an arbitrary and artificial cut-off at 12 months’ duration. The significance of such a cut-off as a single measure has never been substantially proven.

 

A number of risk factors for AF recurrence after AF ablation have been identified, including LA size, AF duration, patient age, renal dysfunction, and substrate visualization by means of MRI (Teh, 2012; D’Ascenzo, 2013; Berruezo, 2007; Nedios, 2015; Njoku, 2018; Costa, 2015; Marrouche, 2014). Recent systematic reviews on prediction models for AF recurrence after catheter ablation showed the potential benefits of risk predictions, but a more robust evaluation of such models is desirable (Deng, 2017; Kosich, 2019). The model variables can be measured before ablation; therefore, models could be used pre-procedurally to predict the likelihood of recurrence (Kornej, 2015; Kornej, 2017; Kornej, 2018; Kosiuuk, 2015; Mujovic, 2017; Mesquita, 2018; Winkle, 2016; Canpolat, 2013; Wojcik, 2013). However, no single score has been presently identified as consistently superior to others. Thus, at present, for an improved and more balanced indication for ablation in patients with persistent AF and risk factors for recurrence, the most intensely evaluated risk predictors (including duration of AF) should be considered and adjusted to the individual patient’s situation including their preferences. Notably, patients must also be explicitly informed about the importance of treating modifiable risk factors to reduce risk of recurrent AF (Berruezo, 2007; Pathak, 2014; Trines, 2019; Wong, 2015; Wokhlu, 2010; Arya, 2010; Santoro, 2015; Letsas, 2009; Jongnarangsin, 2008; Patel, 2010; Matiello, 2010; Chilukuri, 2010; Ng, 2011; Naruse, 2013; Li, 2014; Kawakami, 2016; Congrete, 2018; Deng, 2018).

The indications for AF catheter ablation are summarized in Figure 1. AF catheter ablation is effective in maintaining sinus rhythm in patients with paroxysmal and persistent AF Nyong, 2016; Jais, 2008; Oral, 2006; Mont, 2014; Forleo, 2009; Wilber, 2010; Wazni, 2005; Morillo, 2014; Cosedis Nielsen, 2012; Krittayaphong, 2003; Stabile, 2006; Pappone, 2006; Calkins, 2009; Packer, 2013; Ganesan, 2013; Di Biase, 2016; Kuck, 2016; Sohara, 2016; Hakalahti, 2015; Nielsen, 2017; Chen, 2018). The main clinical benefit of AF catheter ablation is the reduction of arrhythmia-related symptoms (Blomstrom-Lundqvist, 2019; Mark, 2019; Arbelo, 2014; Arbelo, 2017; Pappone, 2006; Packer, 2019; Wokhlu, 2010; Reddy, 2015). This has been confirmed in a recent RCT showing that the improvement in QoL was significantly higher in the ablation versus medical therapy group, as was the associated reduction in AF burden (Blomstrom-Lundqvist, 2019). Symptom improvement has also been confirmed in the recent large CABANA (Catheter ABlation versus ANtiarrhythmic Drug Therapy for Atrial Fibrillation) RCT (Mark, 2019), but the trial showed that the strategy of AF catheter ablation did not significantly reduce the primary composite outcome of death, disabling stroke, serious bleeding, or cardiac arrest compared with medical therapy (Packer, 2019). As no RCT has yet demonstrated a significant reduction in all-cause mortality, stroke, or major bleeding with AF catheter ablation in the ’general’ AF population, the indications for the procedure have not been broadened beyond symptom relief (Packer, 2019), and AF catheter ablation is generally not indicated in asymptomatic patients. Further important evidence regarding the impact of ablation on major cardiovascular events is expected from the EAST trial (Kirchhof, 2013).

 

Figure 1 Indications for catheter ablation of symptomatic AF

The arrows from AAD to ablation indicate failed drug therapy. AAD = antiarrhythmic drug; AF = atrial fibrillation; EF = ejection fraction; LA = left atrial. aSignificantly enlarged LA volume, advanced age, long AF duration, renal dysfunction, and other cardiovascular risk factors. bIn rare individual circumstances, catheter ablation may be carefully considered as first-line therapy. cRecommended to reverse LV dysfunction when tachycardiomyopathy is highly probably. dTo improve survival and reduce hospitalization. Adapted from Hindricks (2020)

 

In selected patients with HF and reduced LVEF, two RCTs have shown a reduction in all-cause mortality and hospitalizations with AF catheter ablation (Di Biase, 2016; Marrouche, 2018), although combined mortality and HF hospitalization was a primary endpoint only in the CASTLE-AF (Catheter Ablation versus Standard conventional Treatment in patients with Left ventricular dysfunction and Atrial Fibrillation) trial (Marrouche, 2018). The generalizability of the trial has recently been evaluated in a large HF patient population (Noseworthy, 2020). This analysis showed that only a small number of patients met the trial inclusion criteria (< 10%) and patients who met the CASTLE-AF inclusion criteria had a significant benefit from treatment as demonstrated in the trial (Noseworthy, 2020). The smaller AMICA (Atrial Fibrillation Management in Congestive Heart Failure With Ablation) RCT, which included patients with more advanced HFrEF, did not show benefits gained by AF catheter ablation at 1-year follow-up (Kuck, 2019), whereas a recent CABANA subgroup analysis supported the benefits of AF catheter ablation in patients with HFrEF, showing a significant reduction in the study primary endpoint (death, stroke, bleeding, cardiac arrest) and reduced mortality in the ablation group (Packer, 2019a; Packer, 2019b). Overall, AF catheter ablation in patients with HFrEF results in higher rates of preserved sinus rhythm and greater improvement in LVEF, exercise performance, and QoL compared with AAD and rate control (Di Biase, 2016; Marrouche, 2018; Khan, 2008; MacDonald, 2011; Jones, 2013; Hunter, 2014; Al Halabi, 2015; Prabhu, 2017; Elgendy, 2018; Briceno, 2018; Ma, 2018; Kheiri, 2018; Khan, 2018). Accordingly, ablation should be considered in patients with HFrEF who have been selected for rhythm control treatment to improve QoL and LV function, and to reduce HF hospitalization and, potentially, mortality.

 

When AF-mediated tachycardia-induced cardiomyopathy (i.e., ventricular dysfunction secondary to rapid and/or asynchronous/irregular myocardial contraction, partially or completely reversed after treatment of the causative arrhythmia) is highly suspected, AF catheter ablation is recommended to restore LV function (Martin, 2017; Raymond-Pagquin, 2018; Brembilla-Perrot, 2016; Dagres, 2011; Prabhu, 2018).

 

Ablation is recommended, in general, as a second-line therapy after failure (or intolerance) of class I or class III AADs. This recommendation is based on the results of multiple RCTs showing superiority of AF catheter ablation versus AADs regarding freedom from recurrent arrhythmia or improvement in symptoms, exercise capacity, and QoL after medication failure (Jais, 2008; Oral, 2006; Mont, 2014; Forleo, 2009; Wilber, 2010; Blomstrom-Lundqvist, 2019; Mark, 2019; Krittayaphong, 2003; Stabile, 2006; Pappone, 2006; Di Biase, 2016; Sohara, 2016; Hakalahti, 2015; Nielsen, 2017; Chen, 2018; Packer, 2019a). Clinical trials considering AF catheter ablation before any AAD suggest that AF catheter ablation is more effective in maintaining sinus rhythm, with comparable complication rates in experienced centres (Wazni, 2005; Morillo, 2014; Cosedis Nielsen, 2012; Hakalahti, 2015). The 5-year follow-up in the MANTRA-PAF (Medical Antiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation) trial showed a significantly lower AF burden in the ablation arm that did not, however, translate into improved QoL compared with AAD treatment (Nielsen, 2017), whereas the CAPTAF (Catheter Ablation compared with Pharmacological Therapy for Atrial Fibrillation) study showed that, in AF patients mostly naive to class I and III AADs, the greater improvement in QoL in the ablation arm was directly associated with greater reduction in AF burden compared with the AAD arm (Blomstrom-Lundqvist, 2019). Based on these studies and patient preferences, AF catheter ablation should be considered before a trial of AAD in patients with paroxysmal AF episodes (class IIa), or may be considered in patients with persistent AF without risk factors for recurrence (class IIb).

 

Techniques and technologies

The cornerstone of AF catheter ablation is the complete isolation of pulmonary veins by linear lesions around their antrum, either using point-by-point radiofrequency ablation or single-shot ablation devices (Jais, 2008; Mont, 2014; Wilber, 2010; Pappone, 2006; Calkins, 2009; Packer, 2013; Kuck, 2016 Sohara, 2016; Reddy, 2015; Tamborero, 2009; Natale, 2014; McLellan, 2015; Verma, 2015; Luik, 2015; Dukkipati, 2015; Kuck, 2016; Nery, 2016; Bassiouny, 2016; Hindricks, 2018). Unfortunately, persistent pulmonary vein electrical isolation is difficult to achieve (pulmonary vein reconnection rates of > 70% are reported (Kuck, 2016; Nanthakumar, 2004; Verma, 2005; Ouyang, 2005; Cheema, 2007; Pratola, 2008; Rajappan, 2008; Bansch, 2013; Nakamura, 2013; Neuzil, 2013; Jiang, 2014; Kim, 2017), but could be significantly lower with the newer generation of catheters (Bordignon, 2015; Ullah, 2016; Phlips, 2018)).

 

Particularly in persistent and long-standing persistent AF, more extensive ablation has been advocated. This may include linear lesions in the atria, isolation of the LAA or of the superior vena cava, ablation of complex fractionated electrograms, rotors, non-pulmonary foci, or ganglionated plexi, fibrosis-guided voltage and/or MRI-mapping, or ablation of high dominant frequency sites (Shad, 2003; Nademanee, 2004; Haissaguerre, 2005a; Haissaguerre, 2005b; Jais, 2006; Atienza, 2009; Stavrakis, 2015; Di Biase, 2016; Gianni, 2016; Santangeli, 2016). However, additional benefit versus pulmonary vein isolation (PVI) alone, justifying its use during the first procedure, is yet to be confirmed (Tamborero, 2009; Verma, 2015; Katritsis, 2013; Arbelo, 2014; Da Costa, 2015; Wong, 2015; Vogler, 2015; Faustino, 2015; Scott, 2016; Driessen, 2016; Qin, 2016; Hu, 2016; Wynn, 2016; Zhang, 2016; Fink, 2017; Kim, 2017; Kircher, 2018; Ammar-Busch, 2017; Blandino, 2017; Yang, 2017; Yu, 2017; Wang, 2018). A RCT-based data suggest improved outcome with targeting extrapulmonary (particularly the LAA) foci and selective ablation of low-voltage areas as adjunct to PVI (Di Biase, 2016; Kircher, 2018). In patients with documented cavotricuspid isthmus (CTI)-dependent flutter undergoing AF catheter ablation, right isthmus ablation may be considered (Perez, 2009; Natale, 2000; Wazni, 2003; Shah, 2007). In case of non-CTI-dependent atrial tachycardia, the ablation technique depends on the underlying mechanism and tachycardia focus or circuit (Calkins, 2018; Hakalahti, 2015).

 

Several RCTs and observational studies have compared point-by-point radiofrequency and cryoballoon ablation, mostly in the first procedure for paroxysmal AF (Kuck, 2016; Luik, 2015; Neumann, 2011; Herrera Siklody, 2011; Herrera Siklody, 2012; Pokushalov, 2013; Schmidt, 2014; Perez-Castellano, 2014; Hunter, 2015; Squara, 2015; Straube, 2016; Schmidt, 2016; Boveda, 2016; Kuck, 2016; Buist, 2018; Gunawardene, 2018; Mortsell, 2019; Akkaya, 2018; Murray, 2018; Chen, 2017; Buiatti, 2017; Cardoso, 2016; Kabunga, 2916). They reported broadly similar arrhythmia-free survival and overall complications with either technique, with slightly shorter procedure duration but longer fluoroscopy time with cryoballoon ablation (Kuck, 2016; Luik, 2015; Neumann, 2011; Herrera Siklody, 2011; Herrera Siklody, 2012; Pokushalov, 2013; Schmidt, 2014; Perez-Castellano, 2014; Hunter, 2015; Squara, 2015; Straube, 2016; Schmidt, 2016; Boveda, 2016; Kuck, 2016; Buist, 2018; Gunawardene, 2018; Mortsell, 2019; Akkaya, 2018; Murray, 2018; Chen, 2017; Buiatti, 2017; Cardoso, 2016; Kabunga, 2016). However, some studies showed reduced hospitalization and lower complication rates with cryoballoon ablation (Kuck, 2016; Bollmann, 2018; Ueberham, 2018). The choice of energy source may depend on centre availability, operator preference/experience, and patient preference. Alternative catheter designs and energy sources have been developed in an attempt to simplify the ablation procedure and improve outcomes (Sohara, 2016; Kabunga, 2016; Hummel, 2014; Boersma, 2016; Nagashima, 2018; Ucer, 2018), but further evidence is required before changing current recommendations.

 

Complications

Prospective, registry-based data show that approximately 4 to 14% of patients undergoing AF catheter ablation experience complications, 2 to 3% of which are potentially life-threatening (Arbelo, 2012; Arbelo, 2014; Arbelo, 2017; De Greef, 2018; Steinbeck, 2018; Fink, 2019; Szegedi, 2019). In the recent CABANA-trial, mostly including experienced high-volume centres, complications occurred in the lower range of these rates (Packer, 2019). Complications occur mostly within the first 24 h after the procedure, but some may appear 1 to 2 months after ablation (Calkins, 2018; Arbelo, 2012; Arbelo, 2014; Arbelo, 2017) (Table 1 and supplementary table 10). Periprocedural death is rare (< 0.2%) and usually related to cardiac tamponade (Arbelo, 2014; Arbelo, 2017; Cappato, 2010; Lee, 2011; Deshmukh, 2013; Tripathi, 2018; Voskoboinik, 2018).

 

 

 

Table 1 Procedure-related complications in catheter ablation and thoracoscopic ablation of AF

NA = not available

Adapted from Hindricks (2020)

 

AF catheter ablation outcome and impact of modifiable risk factors

Multiple RCTs have compared AADs with AF catheter ablation using different technologies/ energy sources, either as ‘first-line’ therapy or after AAD failure, showing superiority of AF catheter ablation in arrhythmia-free survival (Nyong, 2016; Jais, 2008; Oral, 2006; Mont, 2014; Forleo, 2009; Wilber, 2010; Wazni, 2005; Morillo, 2014; Cosedis Nielsen, 2012; Krittayaphong, 2003; Stabile, 2006; Pappone, 2006; Calkins, 2009; Packer, 2013; Ganesan, 2013; Di Biase, 2016; Kuck, 2016; Sohara, 2016; Hakalahti, 2015; Nielsen, 2017; Chen, 2018). However, many patients require several procedures and late recurrences are not infrequent (Gaita, 2018; Wokhlu, 2010; Shah, 2008; Sawhney, 2009; Ouyang, 2010; Bertaglia, 2010; Weerasooriya, 2011; Medi, 2011; Schreiber, 2015; Scherr, 2015; Bertaglia, 2017).

 

Key outcomes include QoL, HF, stroke, and mortality (Shi, 2015; Siontis, 2016; Kim, 2016; Di Biase, 2016; Skelly, 2015; Zheng, 2015). Compared with AADs, AF catheter ablation was associated with significant and sustained improvement in QoL scores in several RCTs and meta-analyses (Calkins, 2018; Jais, 2008; Wilber, 2010; Wazni, 2005; Morillo, 2014; Cosedis Nielsen, 2012; Blomstrom-Lundqvist, 2019; Mark, 2019; Shi, 2015; Siontis, 2016; Kim, 2016; Reynolds, 2010; Walfridsson, 2015). To date, there is no RCT sufficiently large to properly evaluate a reduction in stroke by catheter ablation.

 

Several factors, including AF type and duration (Jais, 2008; Oral, 2006; Mont, 2014; Wilber, 2010; Pappone, 2006; Packer, 2013; Kuck, 2016; Sohara, 2016; Reddy; 2015; Verma, 2015; Dukkipati, 2015; De Greef, 2018), and the presence of comorbidities such as hypertension (Berruezo, 2007; Wokhlu, 2010; Arya, 2010; Santoro, 2015), obesity (Wong, 2015; Wokhlu, 2010; Jongnarangsin, 2008; Chilukuri, 2010; Shah, 2008; Wong, 2011; Kang, 2012; Mahajan, 2015; Winkle, 2017; De Maat, 2018; Glover, 2019), metabolic syndrome (Chang, 2009; Tang, 2009; Mohanty, 2012), and sleep apnoea (Jongnarangsin, 2008; Patel, 2010; Matiello, 2010; Ng, 2011; Naruse, 2013; Li, 2014; Kawakami, 2016; Congrete, 2018; Deng, 2018) may influence the outcome of catheter ablation (Figure 2 and supplementary box 2). Prospective cohort studies suggest that aggressive control of modifiable risk factors may improve arrhythmia-free survival after catheter ablation (Pathak, 2014).

 

 

 

Figure 2 Risk factors for AF contributing to the development of an abnormal substrate translating into poorer outcomes with rhythm control strategies

AF = atrial fibrillation; BMI = body mass index; CPAP = continuous positive airway pressure; HbA1C = haemoglobin A1c; OSA = obstructive sleep apnoea. Several AF risk factors may contribute to the development of LA substrates and thus affect the outcome of AF catheter ablation, predisposing to a higher recurrence rate. Aggressive control of modifiable risk factors may reduce recurrence rate.

Adapted from Hindricks (2020)

 

Follow-up after atrial fibrillation ablation

AF catheter ablation is a complex procedure that may be associated with a range of specific post-procedural complications (module 6.3) (Arbelo, 2014; Arbelo, 2017; Cappato, 2010; Lee, 2011; Deshmukh, 2013; Tripathi, 2018; Voskoboinik, 2018). Although mostly rare, potentially catastrophic complications may initially present with non-specific symptoms and signs to which managing physicians should be attuned. Key issues in follow-up are shown in Table 2.

 

Table 2 Key issues in follow-up after AF catheter ablation

Key issues

Recognition and management

  • Patients must be fully informed about the clinical signs and symptoms of rare but potentially dangerous ablation-related complications that may occur after hospital discharge (e.g. atrio-oesophageal fistula, pulmonary vein stenosis).

Follow-up monitoring:

Useful to assess procedural success and correlate symptom status with rhythm. Recurrences beyond the first month post-ablation are generally predictive of late recurrences, but recurrent symptoms may be due to ectopic beats or other non-sustained arrhythmia; conversely the presence of asymptomatic AF after ablation is well described.

Monitoring may be performed with intermittent ECG, Holter, Patch recordings, external or implanted loop recorder, or smart phone monitor (although the latter has not been validated for such use). Patients should be first reviewed at a minimum of 3 months and annually thereafter.

Management of antiarrhythmic medication and treatment of AF recurrences

  1. Continuing AAD treatment for 6 weeks to 3 months may reduce early AF recurrences, rehospitalizations and cardioversions during this period

Clinical practice regarding routine AAD treatment after ablation varies and there is no convincing evidence that such treatment is routinely needed.

  1. Subsequently, AADs may be weaned, ceased, or continued according to symptoms and rhythm status. Recent findings suggest that in AAD-treated patients remaining free of AF at the end of the blanking period, AAD continuation beyond the blanking period reduces arrhythmia recurrences.

Management of anticoagulation therapy

  1. In general, OAC therapy is continued for 2 months following ablation in all patients.1,806 Beyond this time, a decision to continue OAC is determined primarily by the presence of CHA2DS2-VASc stroke risk factors rather than the rhythm status.

AAD = antiarrhythmic drug; AF = atrial fibrillation; CHA2DS2-VASc = Congestive heart failure, Hypertension, Age >_75 years, Diabetes mellitus, Stroke, Vascular disease, Age 65 to 74 years, Sex category (female); ECG=electrocardiogram; OAC = oral anticoagulant.

Adapted from Hindricks (2020)

 

Risk assessment for recurrence of atrial fibrillation post catheter ablation

Recurrence of AF after catheter ablation is driven by the complex interaction of various factors. These include increasing AF duration, age, and LA size (The, 2012; D’Ascenzo, 2013; Berruezo, 2007; Njoku, 2018; Costa, 2015), and structural factors such as the abundance of epicardial fat tissue (Nakahara, 2014; Chao, 2013; Masuda, 2015; Sepehri Shamloo, 2019) and the presence of atrial substrate as evident from electrical or morphological markers (Blanche, 2013). A number of risk-prediction scores have been evaluated (for detailed description see supplementary table 11 and Supplementary Box 2).Whereas these scores only moderately predict AF recurrence, one of the strongest predictors is early recurrent AF, indicating the need for further refinement of these scoring systems (Kornej, 2018).

Onderbouwing

To answer the clinical question, the ESC-guideline for the diagnosis and management of atrial fibrillation from 2020 (Hindricks, 2020) was used.

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  184. Szegedi N, Szeplaki G, Herczeg S, Tahin T, Sallo Z, Nagy VK, Osztheimer I, Ozcan EE, Merkely B, Geller L. Repeat procedure is a new independent predictor of complications of atrial fibrillation ablation. Europace 2019;21:732-737.
  185. Tamborero D, Mont L, Berruezo A, Matiello M, Benito B, Sitges M, Vidal B, de Caralt TM, Perea RJ, Vatasescu R, Brugada J. Left atrial posterior wall isolation does not improve the outcome of circumferential pulmonary vein ablation for atrial fibrillation: a prospective randomized study. Circ Arrhythm Electrophysiol 2009;2:35-40.
  186. Tang RB, Dong JZ, Liu XP, Long DY, Yu RH, Kalifa J, Ma CS. Metabolic syndrome and risk of recurrence of atrial fibrillation after catheter ablation. Circ J 2009;73:438-443.
  187. Teh AW, Kistler PM, Lee G, Medi C, Heck PM, Spence SJ, Sparks PB, Morton JB, Kalman JM. Electroanatomic remodeling of the left atrium in paroxysmal and persistent atrial fibrillation patients without structural heart disease. J Cardiovasc Electrophysiol 2012;23:232-238.
  188. Trines SA, Stabile G, Arbelo E, Dagres N, Brugada J, Kautzner J, Pokushalov E, Maggioni AP, Laroche C, Anselmino M, Beinart R, Traykov V, Blomstrom-Lundqvist C. Influence of risk factors in the ESC-EHRA EORP atrial fibrillation ablation long-term registry. Pacing Clin Electrophysiol 2019;42:1365-1373.
  189. Tripathi B, Arora S, Kumar V, Abdelrahman M, Lahewala S, Dave M, Shah M, Tan B, Savani S, Badheka A, Gopalan R, Shantha GPS, Viles-Gonzalez J, Deshmukh A. Temporal trends of in-hospital complications associated with catheter ablation of atrial fibrillation in the United States: an update from Nationwide Inpatient Sample database (20112014). J Cardiovasc Electrophysiol 2018;29:715-724.
  190. Ucer E, Janeczko Y, Seegers J, Fredersdorf S, Friemel S, Poschenrieder F, Maier LS, Jungbauer CG. A RAndomized Trial to compare the acute reconnection after pulmonary vein ISolation with Laser-BalloON versus radiofrequency Ablation: RATISBONA trial. J Cardiovasc Electrophysiol 2018;29:733-739.
  191. Ueberham L, Schuler E, Hindricks G, Kuhlen R, Bollmann A. SAFER. Eur Heart J 2018;39:2023-2024.
  192. Ullah W, McLean A, Tayebjee MH, Gupta D, Ginks MR, Haywood GA, O’Neill M, Lambiase PD, Earley MJ, Schilling RJ, Group UKMT. Randomized trial comparing pulmonary vein isolation using the SmartTouch catheter with or without real-time contact force data. Heart Rhythm 2016;13:1761-1767.
  193. Verma A, Jiang CY, Betts TR, Chen J, Deisenhofer I, Mantovan R, Macle L, Morillo CA, Haverkamp W, Weerasooriya R, Albenque JP, Nardi S, Menardi E, Novak P, Sanders P; STAR AF II Investigators. Approaches to catheter ablation for persistent atrial fibrillation. N Engl J Med 2015;372:1812-1822.
  194. Verma A, Kilicaslan F, Pisano E, Marrouche NF, Fanelli R, Brachmann J, Geunther J, Potenza D, Martin DO, Cummings J, Burkhardt JD, Saliba W, Schweikert RA, Natale A. Response of atrial fibrillation to pulmonary vein antrum isolation is directly related to resumption and delay of pulmonary vein conduction. Circulation 2005;112:627-635.
  195. Vogler J, Willems S, Sultan A, Schreiber D, Luker J, Servatius H, Schaffer B, Moser J, Hoffmann BA, Steven D. Pulmonary vein isolation versus defragmentation: the CHASE-AF clinical trial. J Am Coll Cardiol 2015;66:2743-2752.
  196. Voskoboinik A, Sparks PB, Morton JB, Lee G, Joseph SA, Hawson JJ, Kistler PM, Kalman JM. Low rates of major complications for radiofrequency ablation of atrial fibrillation maintained over 14 years: a single centre experience of 2750 consecutive cases. Heart Lung Circ 2018;27:976-983.
  197. Walfridsson H, Walfridsson U, Nielsen JC, Johannessen A, Raatikainen P, Janzon M, Levin LA, Aronsson M, Hindricks G, Kongstad O, Pehrson S, Englund A, Hartikainen J, Mortensen LS, Hansen PS. Radiofrequency ablation as initial therapy in paroxysmal atrial fibrillation: results on health-related quality of life and symptom burden. The MANTRA-PAF trial. Europace 2015;17:215-221.
  198. Wang YL, Liu X, Zhang Y, Jiang WF, Zhou L, Qin M, Zhang DL, Zhang XD, Wu SH, Xu K. Optimal endpoint for catheter ablation of longstanding persistent atrial fibrillation: a randomized clinical trial. Pacing Clin Electrophysiol 2018;41:172-178.
  199. Wazni O, Marrouche NF, Martin DO, Gillinov AM, Saliba W, Saad E, Klein A, Bhargava M, Bash D, Schweikert R, Erciyes D, Abdul-Karim A, Brachman J, Gunther J, Pisano E, Potenza D, Fanelli R, Natale A. Randomized study comparing combined pulmonary vein-left atrial junction disconnection and cavotricuspid isthmus ablation versus pulmonary vein-left atrial junction disconnection alone in patients presenting with typical atrial flutter and atrial fibrillation. Circulation 2003;108:2479-2483.
  200. Wazni OM, Marrouche NF, Martin DO, Verma A, Bhargava M, Saliba W, Bash D, Schweikert R, Brachmann J, Gunther J, Gutleben K, Pisano E, Potenza D, Fanelli R, Raviele A, Themistoclakis S, Rossillo A, Bonso A, Natale A. Radiofrequency ablation vs antiarrhythmic drugs as first-line treatment of symptomatic atrial fibrillation: a randomized trial. JAMA 2005;293:2634-2640.
  201. Weerasooriya R, Khairy P, Litalien J, Macle L, Hocini M, Sacher F, Lellouche N, Knecht S, Wright M, Nault I, Miyazaki S, Scavee C, Clementy J, Haissaguerre M, Jais P. Catheter ablation for atrial fibrillation: are results maintained at 5 years of follow-up?J Am Coll Cardiol 2011;57:160-166.
  202. Wilber DJ, Pappone C, Neuzil P, De Paola A, Marchlinski F, Natale A, Macle L, Daoud EG, Calkins H, Hall B, Reddy V, Augello G, Reynolds MR, Vinekar C, Liu CY, Berry SM, Berry DA; ThermoCool AF Trial Investigators. Comparison of antiarrhythmic drug therapy and radiofrequency catheter ablation in patients with paroxysmal atrial fibrillation: a randomized controlled trial. JAMA 2010;303:333-340.
  203. Winkle RA, Jarman JW, Mead RH, Engel G, Kong MH, Fleming W, Patrawala RA. Predicting atrial fibrillation ablation outcome: the CAAP-AF score. Heart Rhythm 2016;13:2119-2125.
  204. Winkle RA, Mead RH, Engel G, Kong MH, Fleming W, Salcedo J, Patrawala RA. Impact of obesity on atrial fibrillation ablation: patient characteristics, long-term outcomes, and complications. Heart Rhythm 2017;14:819-827.
  205. Wojcik M, Berkowitsch A, Greiss H, Zaltsberg S, Pajitnev D, Deubner N, Hamm CW, Pitschner HF, Kuniss M, Neumann T. Repeated catheter ablation of atrial fibrillation: how to predict outcome?Circ J 2013;77:2271-2279.
  206. Wokhlu A, Hodge DO, Monahan KH, Asirvatham SJ, Friedman PA, Munger TM, Cha YM, Shen WK, Brady PA, Bluhm CM, Haroldson JM, Hammill SC, Packer DL. Long-term outcome of atrial fibrillation ablation: impact and predictors of very late recurrence. J Cardiovasc Electrophysiol 2010;21:1071-1078.
  207. Wokhlu A, Monahan KH, Hodge DO, Asirvatham SJ, Friedman PA, Munger TM, Bradley DJ, Bluhm CM, Haroldson JM, Packer DL. Long-term quality of life after ablation of atrial fibrillation the impact of recurrence, symptom relief, and placebo effect. J Am Coll Cardiol 2010;55:2308-2316.
  208. Wong CX, Abed HS, Molaee P, Nelson AJ, Brooks AG, Sharma G, Leong DP, Lau DH, Middeldorp ME, Roberts-Thomson KC, Wittert GA, Abhayaratna WP, Worthley SG, Sanders P. Pericardial fat is associated with atrial fibrillation severity and ablation outcome. J Am Coll Cardiol 2011;57:1745-1751.
  209. Wong CX, Sullivan T, Sun MT, Mahajan R, Pathak RK, Middeldorp M, Twomey D, Ganesan AN, Rangnekar G, Roberts-Thomson KC, Lau DH, Sanders P. Obesity and the risk of incident, post-operative, and post-ablation atrial fibrillation: a meta-analysis of 626,603 individuals in 51 studies. JACC Clin Electrophysiol 2015;1:139-152.
  210. Wong KC, Paisey JR, Sopher M, Balasubramaniam R, Jones M, Qureshi N, Hayes CR, Ginks MR, Rajappan K, Bashir Y, Betts TR. No benefit of complex fractionated atrial electrogram ablation in addition to circumferential pulmonary vein ablation and linear ablation: Benefit of Complex Ablation Study. Circ Arrhythm Electrophysiol 2015;8:1316-1324.
  211. Wynn GJ, Panikker S, Morgan M, Hall M, Waktare J, Markides V, Hussain W, Salukhe T, Modi S, Jarman J, Jones DG, Snowdon R, Todd D, Wong T, Gupta D. Biatrial linear ablation in sustained nonpermanent AF: results of the substrate modification with ablation and antiarrhythmic drugs in nonpermanent atrial fibrillation (SMAN-PAF) trial. Heart Rhythm 2016;13:399-406.
  212. Yang B, Jiang C, Lin Y, Yang G, Chu H, Cai H, Lu F, Zhan X, Xu J, Wang X, Ching CK, Singh B, Kim YH, Chen M; STABLE-SR Investigators. STABLE-SR (Electrophysiological Substrate Ablation in the Left Atrium During Sinus Rhythm) for the treatment of nonparoxysmal atrial fibrillation: a prospective, multicenter randomized clinical trial. Circ Arrhythm Electrophysiol 2017;10:pii: e005405.
  213. Yu HT, Shim J, Park J, Kim IS, Kim TH, Uhm JS, Joung B, Lee MH, Kim YH, Pak HN. Pulmonary vein isolation alone versus additional linear ablation in patients with persistent atrial fibrillation converted to paroxysmal type with antiarrhythmic drug therapy: a multicenter, prospective, randomized study. Circ Arrhythm Electrophysiol 2017;10:pii: e004915.
  214. Zhang Z, Letsas KP, Zhang N, Efremidis M, Xu G, Li G, Liu T. Linear ablation following pulmonary vein isolation in patients with atrial fibrillation: a meta-analysis. Pacing Clin Electrophysiol 2016;39:623-630.
  215. Zheng YR, Chen ZY, Ye LF, Wang LH. Long-term stroke rates after catheter ablation or antiarrhythmic drug therapy for atrial fibrillation: a meta-analysis of randomized trials. J Geriatr Cardiol 2015;12:507-514.

Autorisatiedatum en geldigheid

Laatst beoordeeld  : 01-09-2022

Laatst geautoriseerd  : 01-09-2022

Geplande herbeoordeling  :

Initiatief en autorisatie

Initiatief:
  • Nederlandse Vereniging voor Cardiologie

Algemene gegevens

De ontwikkeling/herziening van deze richtlijnmodule werd ondersteund door het Kennisinstituut van de Federatie Medisch Specialisten en werd gefinancierd uit de Kwaliteitsgelden Medisch Specialisten (SKMS). De financier heeft geen enkele invloed gehad op de inhoud van de richtlijnmodule.

Samenstelling werkgroep

Voor het ontwikkelen van de richtlijnmodule is in 2018 een multidisciplinaire werkgroep ingesteld, bestaande uit vertegenwoordigers van alle relevante specialismen (zie hiervoor de Samenstelling van de werkgroep) die betrokken zijn bij de zorg voor patiënten met atriumfibrilleren.

 

Werkgroep

  • Prof. dr. N.M.S. (Natasja) de Groot, cardioloog, werkzaam in het Erasmus Medisch Centrum te Rotterdam, NVVC (voorzitter)
  • P.H. (Pepijn) van der Voort, cardioloog, werkzaam in het Catharina Ziekenhuis te Eindhoven, NVVC
  • Dr. M.E.W. (Martin) Hemels, cardioloog, werkzaam in het Rijnstate Ziekenhuis te Arnhem en RaboudUMC te Nijmegen, NVVC
  • Dr. T.J. (Thomas) van Brakel, thoraxchirurg, werkzaam in het Catharina Ziekenhuis te Eindhoven, NVTNET
  • Dr. M. (Michiel) Coppens, internist-vasculair geneeskundige, werkzaam in de Amsterdam Universitair Medische Centra te Amsterdam, NIV
  • Dr. S. (Sander) van Doorn, huisarts, werkzaam in het Universitair Medisch Centrum Utrecht te Utrecht, NHG
  • Prof. dr. M.K. (Kamran) Ikram, neuroloog, werkzaam in het Erasmus Medisch Centrum te Rotterdam, NVN
  • H. (Hans) van Laarhoven, zelfstandig adviseur, werkzaam bij Laerhof Advies, Harteraad

 

Met ondersteuning van

  • Dr. B.H. (Bernardine) Stegeman, senior adviseur, Kennisinstituut van de Federatie Medisch Specialisten

Belangenverklaringen

De Code ter voorkoming van oneigenlijke beïnvloeding door belangenverstrengeling is gevolgd. Alle werkgroepleden hebben schriftelijk verklaard of zij in de laatste drie jaar directe financiële belangen (betrekking bij een commercieel bedrijf, persoonlijke financiële belangen, onderzoeksfinanciering) of indirecte belangen (persoonlijke relaties, reputatiemanagement) hebben gehad. Gedurende de ontwikkeling of herziening van een module worden wijzigingen in belangen aan de voorzitter doorgegeven. De belangenverklaring wordt opnieuw bevestigd tijdens de commentaarfase.

 

Een overzicht van de belangen van werkgroepleden en het oordeel over het omgaan met eventuele belangen vindt u in onderstaande tabel. De ondertekende belangenverklaringen zijn op te vragen bij het secretariaat van het Kennisinstituut van de Federatie Medisch Specialisten.

 

Werkgroeplid

Functie

Nevenfuncties

Gemelde belangen

Ondernomen actie

De Groot (voorzitter)

Cardioloog-elektrofysioloog, Erasmus Medisch Centrum, Rotterdam

Mede-oprichter Stichting Atrial Fibrillation Innovation Platform

Unrestricted grant voor AF bij Hartfalen, Pathofysiologische onderzoek (valt buiten de afbakening)

Geen (valt buiten de afbakening)

Brakel

Cardio-thoracaal chirurg
Catharina Ziekenhuis, Eindhoven

Verzorgen van trainingen voor chirurgische behandeling van AF (Trainingscontract met Medtronic; inkomsten voor de afdeling)

Geen

Geen

Coppens

Internist-vasculaire geneeskunde
Amsterdam Universitair Medische Centra, Amsterdam

* Wetenschappelijke adviesraad Trombosestichting Nederland (onbetaald).
* Voorzitter Werkgroep Trombose & Hemostase van de Nederlandse Vereniging van
Internisten Vasculaire Geneeskunde (NVIVG; onbetaald)
* Lid Nederlandse Vereniging van Hemofiliebehandelaars (NVHB; onbetaald)

Betaald adviseurschap of betaalde lezingen/nascholingen voor Bayer, Daiichi
Sankyo, CSL Behring, Sobi, NovoNordisk, Pfizer,  Medcon International, MeDTalks en Bureau Prevents.
NB: alle opbrengsten worden overgemaakt naar de instelling

Investigator initiated studies met externe financiële ondersteuning en door industrie geïnitieerde studies Bayer, UniQure, Roche CSL Behring and Daiichi Sankyo

Geen (valt buiten de afbakening, niet over AF-patiënten; onderzoek ging bijvoorbeeld over DOAC bij short bowel patiënten)

Van der Voort

Cardioloog-electrofysioloog Catharinaziekenhuis Eindhoven

Bestuurslid van NHRA, onbetaald

Geen

Geen

Laarhoven

Zelfstandig adviseur voor de zorg

Bestuurslid LAREB, vergoeding conform normering NTVZ

Voorzitter Raad van Toezicht stichting Leefh, vergoeding conform NVTZ

* Lid Patientenadviesraad Pfizer, vacatievergoeding

* Adviesraad ‘NOAC’ (eenmalig 2019, vacatievergoeding)

Geen

Van Doorn

* Assistant professor, Julius Centrum, UMC Utrecht
* Huisarts

Geen

* Betrokken als co-PI van het ALL-IN onderzoek, naar de substitutie van AF zorg van de 2e lijn naar de huisarts, inclusief behandeling met anticoagulantia: doe 10.1093/eurheartj/ehaa055 (afgerond)

* co-PI betrokken bij het FRAIL-AF onderzoek, een gerandomiseerd onderzoek naar de veiligheid en effectiviteit van DOAC’s bij kwetsbare ouderen: trialregister.nl NTR6721, doi 10.1136/bmjopen-2019-032488 (lopend)

* Betrokken bij onderzoek met routine zorg data (CPRD) naar de veiligheid en effectiviteit van DOAC’s, en een systematische review naar DOAC doseringen.

Geen

Hemels

* Cardioloog-elektrofysioloog Rijnstate ziekenhuis

* Programmaleider NVVC Connect atriumfibrilleren

* Associate editor van Netherlands Heart Journal, géén vergoeding

* Onderwijsactiviteiten voor medisch specialisten, huisartsen, (ziekenhuis)apothekers en arts-assistenten/physician assisants, betreft urenvergoeding

 

* Principal investigator (samen met prof. M.V. Huisman) van het Dutch AF onderzoeks en registratieproject namens de NVVC en in opdracht van VWS/ZonMw. Er gaat een vergoeding naar de vakgroep cardiologie in het Rijnstate i.v.m. mijn werkzaamheden voor dit project, ook gefinancierd door FNT

* Local principal investigator van diverse patiëntgebonden studies (hartritmestoornissen gerelateerd) in het Rijnstate ziekenhuis, géén persoonlijke vergoeding hiervoor

Geen

Ikram

Hoogleraar Klinische Neuro-epidemiologie en neuroloog, Afdelingen Neurologie & Epidemiologie, Erasmus MC, Rotterdam  

Geen

Geen

Geen

Stegeman

Senior adviseur, Kennisinstituut van de Federatie Medisch Specialisten

Geen

Geen

Geen

Meelezer

Jakulj

* Internist-nefroloog Amsterdam UMC en Dianet

* Lid richtlijnencommissie Nederlandse Federatie voor Nefrologie

Geen

Geen

Geen

Inbreng patiëntenperspectief

Er werd aandacht besteed aan het patiëntenperspectief door een afgevaardigde patiëntenvereniging in de werkgroep. De conceptrichtlijn is tevens voor commentaar voorgelegd aan Harteraad en de eventueel aangeleverde commentaren zijn bekeken en verwerkt.

 

Wkkgz & Kwalitatieve raming van mogelijke substantiële financiële gevolgen

Kwalitatieve raming van mogelijke financiële gevolgen in het kader van de Wkkgz

Bij de richtlijn is conform de Wet kwaliteit, klachten en geschillen zorg (Wkkgz) een kwalitatieve raming uitgevoerd of de aanbevelingen mogelijk leiden tot substantiële financiële gevolgen. Bij het uitvoeren van deze beoordeling zijn richtlijnmodules op verschillende domeinen getoetst (zie het stroomschema op de Richtlijnendatabase).

 

Uit de kwalitatieve raming blijkt dat er waarschijnlijk geen substantiële financiële gevolgen zijn, zie onderstaande tabel.

 

Module

Uitkomst raming

Toelichting

Module 1 Definitie en diagnose van atriumfibrilleren

Geen financiële gevolgen

Het overgrote deel voldoet aan de norm.

Module 2 Atriumfibrilleren, subtype, burden en progressie

Geen financiële gevolgen

Het overgrote deel voldoet aan de norm.

Module 3 Screenen voor atriumfibrilleren

Geen financiële gevolgen

Het overgrote deel voldoet aan de norm.

Module 4 Integrale behandeling voor patiënten met atriumfibrilleren

Geen financiële gevolgen

Het overgrote deel voldoet aan de norm.

Module 5.1 Antitrombotisch beleid ter preventie van herseninfarct

Geen financiële gevolgen

Het overgrote deel voldoet aan de norm.

Module 5.2 Afsluiting of verwijdering van het linker hartoor

Geen financiële gevolgen

Het overgrote deel voldoet aan de norm.

Module 6.1 Frequentiecontrole

Geen financiële gevolgen

Het overgrote deel voldoet aan de norm.

Module 6.2 Ritmecontrole

Geen financiële gevolgen

Het overgrote deel voldoet aan de norm.

Module 6.2.1 Ritmecontrole met antiaritmische medicatie

Geen financiële gevolgen

Het overgrote deel voldoet aan de norm.

Module 6.3 Katheterablatie

Geen financiële gevolgen

Het overgrote deel voldoet aan de norm.

Module 6.4 Chirurgie voor atriumfibrilleren en concomitante chirurgie voor atriumfibrilleren

Geen financiële gevolgen

Het overgrote deel voldoet aan de norm.

Module 6.5 Hybride katheter-/ chirurgische ablatie procedures

Geen financiële gevolgen

Het overgrote deel voldoet aan de norm.

Module 6.6 Peri-procedureel management ter preventie van herseninfarct

Geen financiële gevolgen

Het overgrote deel voldoet aan de norm.

Module 7 Cardiovasculaire risicofactoren en bijkomende ziekten

Geen financiële gevolgen

Het overgrote deel voldoet aan de norm.

Module 8.1 Atriumfibrilleren bij hemodynamische instabiliteit

Geen financiële gevolgen

Het overgrote deel voldoet aan de norm.

Module 8.2 Acute coronaire syndromen, chronisch coronairlijden, en percutane en chirurgische revascularisaties bij patiënten met atriumfibrilleren

Geen financiële gevolgen

Het overgrote deel voldoet aan de norm.

Module 8.3 Acuut herseninfarct of hersnebloeding bij patiënten met atriumfibrilleren

Geen financiële gevolgen

Het overgrote deel voldoet aan de norm.

Module 8.4 Bloeding ten tijde van antistolling

Geen financiële gevolgen

Het overgrote deel voldoet aan de norm.

Module 8.5 Atriumfibrilleren en valvulaire hartziekte

Geen financiële gevolgen

Het overgrote deel voldoet aan de norm.

Module 8.6 Atriumfibrilleren en chronische nierschade

Geen financiële gevolgen

Het overgrote deel voldoet aan de norm.

Module 8.7 De oudere en kwetsbare patiënt met atriumfibrilleren

Geen financiële gevolgen

Het overgrote deel voldoet aan de norm.

Module 8.8 Atriumfibrilleren en aangeboren hartafwijkingen

Geen financiële gevolgen

Het overgrote deel voldoet aan de norm.

Module 8.9 Atriumfibrilleren bij erfelijke hartspierziekten

Geen financiële gevolgen

Het overgrote deel voldoet aan de norm.

Module 8.10 Atriumfibrilleren tijdens de zwangerschap

Geen financiële gevolgen

Het overgrote deel voldoet aan de norm.

Module 8.11 Atriumfibrilleren in professionele sporters

Geen financiële gevolgen

Het overgrote deel voldoet aan de norm.

Module 8.12 Postoperatief atriumfibrilleren

Geen financiële gevolgen

Het overgrote deel voldoet aan de norm.

Module 9 Sekse-gerelateerde verschillen in atriumfibrilleren

Geen financiële gevolgen

Het overgrote deel voldoet aan de norm.

Module 10 Epidemiologie, implicaties en behandeling van subklinisch AF/AHRE

Geen financiële gevolgen

Het overgrote deel voldoet aan de norm.

Implementatie

De werkgroep is vooral inhoudelijk bezig geweest met het aanpassen van de ESC-richtlijn ‘Diagnosis and management of atrial fibrillation’ naar de Nederlandse praktijk. De werkgroep heeft een aantal suggesties gegeven voor het onder de aandacht brengen bij medische professionals van de nieuwe richtlijn. De verdere implementatie van de aanbevelingen uit de richtlijn valt buiten de expertise van de werkgroep.

 

Voorstel voor te ondernemen acties per partij

Hieronder wordt per partij toegelicht welke acties zij kunnen ondernemen om aandacht te geven aan de richtlijn.

 

Alle direct betrokken wetenschappelijk verenigingen/beroepsorganisaties

  • Bekend maken van de richtlijn onder de leden.
  • Publiciteit voor de richtlijn maken door over de richtlijn te publiceren in tijdschriften en te vertellen op congressen.

 

De lokale vakgroepen/individuele medisch professionals

  • Het bespreken van de aanbevelingen in de vakgroepsvergadering en lokale werkgroepen.
  • Het bespreken van de richtlijnen in de onderwijsuren van de medisch specialist in opleiding
  • Het volgen van bijscholing die bij deze richtlijn ontwikkeld gaat worden.
  • Afstemmen en afspraken maken met andere betrokken disciplines om de toepassing van de aanbevelingen in de praktijk te borgen.

 

Het Kennisinstituut van Medisch Specialisten

Toevoegen van de richtlijn aan de Richtlijnendatabase.

 

Werkwijze

Knelpuntenanalyse en uitgangsvragen

Tijdens de voorbereidende fase inventariseerde de werkgroep de knelpunten in de zorg voor patiënten met atriumfibrilleren. Tevens zijn er knelpunten aangedragen door het Zorginstituut Nederland, Zelfstandige Klinieken Nederland, Nederlandse Vereniging voor Neurologie, Vereniging Innovatieve Geneesmiddelen, Nederlandse Vereniging voor Cardiologie, Federatie voor Nederlandse Trombosediensten, Nederlandse Vereniging voor Hart- en Vaatverpleegkundigen, Nederland Huisartsen Genootschap en Inspectie Gezondheidszorg en Jeugd via Invitational conference. Een verslag hiervan is opgenomen onder aanverwante producten.

 

Overwegingen (van bewijs naar aanbevelingen)

De Engelse tekst uit de ESC-richtlijn Diagnosis and management of atrial fibrillation uit 2020 (Hindricks, 2020) is overgenomen, tenzij er argumenten voor de Nederlandse praktijk van belang zijn. De tekst is vervolgens aangepast en in het Nederlands opgesteld.

 

Formuleren van aanbevelingen

De aanbevelingen geven antwoord op de uitgangsvraag en zijn gebaseerd op het beschikbare wetenschappelijke bewijs en de belangrijkste overwegingen, en een weging van de gunstige en ongunstige effecten van de relevante interventies. De kracht van het wetenschappelijk bewijs en het gewicht dat door de werkgroep wordt toegekend aan de overwegingen, bepalen samen de sterkte van de aanbeveling. GRADE staat voor Grading Recommendations Assessment, Development and Evaluation (zie http://www.gradeworkinggroup.org/). Conform de GRADE-methodiek sluit een lage bewijskracht van conclusies in de systematische literatuuranalyse een sterke aanbeveling niet a priori uit, en zijn bij een hoge bewijskracht ook zwakke aanbevelingen mogelijk (Agoritsas, 2017; Neumann, 2016). De sterkte van de aanbeveling wordt altijd bepaald door weging van alle relevante argumenten tezamen. De werkgroep heeft bij elke aanbeveling opgenomen hoe zij tot de richting en sterkte van de aanbeveling zijn gekomen.

 

In de GRADE-methodiek wordt onderscheid gemaakt tussen sterke en zwakke (of conditionele) aanbevelingen. De sterkte van een aanbeveling verwijst naar de mate van zekerheid dat de voordelen van de interventie opwegen tegen de nadelen (of vice versa), gezien over het hele spectrum van patiënten waarvoor de aanbeveling is bedoeld. De sterkte van een aanbeveling heeft duidelijke implicaties voor patiënten, behandelaars en beleidsmakers (zie onderstaande tabel). Een aanbeveling is geen dictaat, zelfs een sterke aanbeveling gebaseerd op bewijs van hoge kwaliteit (GRADE gradering HOOG) zal niet altijd van toepassing zijn, onder alle mogelijke omstandigheden en voor elke individuele patiënt.

 

Implicaties van sterke en zwakke aanbevelingen voor verschillende richtlijngebruikers

 

Sterke aanbeveling

Zwakke (conditionele) aanbeveling

Voor patiënten

De meeste patiënten zouden de aanbevolen interventie of aanpak kiezen en slechts een klein aantal niet.

Een aanzienlijk deel van de patiënten zouden de aanbevolen interventie of aanpak kiezen, maar veel patiënten ook niet. 

Voor behandelaars

De meeste patiënten zouden de aanbevolen interventie of aanpak moeten ontvangen.

Er zijn meerdere geschikte interventies of aanpakken. De patiënt moet worden ondersteund bij de keuze voor de interventie of aanpak die het beste aansluit bij zijn of haar waarden en voorkeuren.

Voor beleidsmakers

De aanbevolen interventie of aanpak kan worden gezien als standaardbeleid.

Beleidsbepaling vereist uitvoerige discussie met betrokkenheid van veel stakeholders. Er is een grotere kans op lokale beleidsverschillen.  

 

Vertalen van aanbevelingen

De European Society of Cardiology gebruikt een standaardformulering voor de aanbevelingen op basis van de klasse en niveau van het bewijs. Deze standaardformulering met vertaling naar het Nederlands staat in de onderstaande tabel weergegeven.

 

Class of recommendations

Suggested wording to use

Nl’se vertaling, gehanteerd door onder andere de CVRM-richtlijn

I

Is recommended/is indicated

Sterke aanbeveling met een actieve, directieve formulering, zoals behandel, streef naar, et cetera

II

 

 

IIa

Should be considered

Zwakke aanbeveling met een actieve, directieve formulering, zoals overweeg

IIb

May be considerd

Zwakke aanbeveling met als formulering: kan worden overwogen

III

Is not recommended

Sterke aanbeveling met een actieve, directieve formulering, zoals behandel niet, et cetera

CVRM, CardioVasculair RisicoManagement

 

Commentaar- en autorisatiefase

De conceptrichtlijnmodule werd aan de betrokken (wetenschappelijke) verenigingen en (patiënt) organisaties voorgelegd ter commentaar. De commentaren werden verzameld en besproken met de werkgroep. Naar aanleiding van de commentaren werd de conceptrichtlijnmodule aangepast en definitief vastgesteld door de werkgroep. De definitieve richtlijnmodule werd aan de deelnemende (wetenschappelijke) verenigingen en (patiënt) organisaties voorgelegd voor autorisatie en door hen geautoriseerd dan wel geaccordeerd.

 

Literatuur

Agoritsas T, Merglen A, Heen AF, Kristiansen A, Neumann I, Brito JP, Brignardello-Petersen R, Alexander PE, Rind DM, Vandvik PO, Guyatt GH. UpToDate adherence to GRADE criteria for strong recommendations: an analytical survey. BMJ Open. 2017 Nov 16;7(11):e018593. doi: 10.1136/bmjopen-2017-018593. PubMed PMID: 29150475; PubMed Central PMCID: PMC5701989.

Hindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS) (published online ahead of print, 2020 Aug 29). Eur Heart J. 2020;ehaa612. doi:10.1093/eurheartj/ehaa612

Medisch Specialistische Richtlijnen 2.0 (2012). Adviescommissie Richtlijnen van de Raad Kwalitieit. http://richtlijnendatabase.nl/over_deze_site/over_richtlijnontwikkeling.html.

Neumann I, Santesso N, Akl EA, Rind DM, Vandvik PO, Alonso-Coello P, Agoritsas T, Mustafa RA, Alexander PE, Schünemann H, Guyatt GH. A guide for health professionals to interpret and use recommendations in guidelines developed with the GRADE approach. J Clin Epidemiol. 2016 Apr;72:45-55. doi: 10.1016/j.jclinepi.2015.11.017. Epub 2016 Jan 6. Review. PubMed PMID: 26772609.

Schünemann H, Brożek J, Guyatt G, et al. GRADE handbook for grading quality of evidence and strength of recommendations. Updated October 2013. The GRADE Working Group, 2013. Available from http://gdt.guidelinedevelopment.org/central_prod/_design/client/handbook/handbook.html.

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Chirurgie voor atriumfibrilleren én concomitante chirurgie voor atriumfibrilleren: indicaties, uitkomsten, indicaties en complicaties