EP Europace · 2008 · 61 citations · 93 references
MedicineCardiologyClinical CardiologyElectrophysiologyInterventional CardiologyAntithrombotic TherapyCardiac ArrhythmiasCardiac CatheterizationCardiac PacingCatheter AblationIntracardiac ElectrophysiologyCardiac Electrophysiology StudyCoagulation Cascade AmplificationCoagulation Cascade DysregulationElectrophysiological FindingsElectrophysiological RecordingsElectrophysiological StudyIntracardiac Pacing
Guidelines and Expert Consensus documents are proposed to help physicians to select the best possible diagnostic or therapeutic strategies for an individual patient with a specific disease. Recommendations issued from these documents are based on an extensive review of the literature and on discussions among experts when hard data are incomplete or missing. It has been shown that patient outcomes improve when guidelines recommendations are applied in clinical practice. Publication and promotion of these guidelines is one of the most important tasks of scientific societies. The recently created European Heart Rhythm Association (EHRA) wants to meet this commitment in its specific field of competence and one assignment of the scientific committee of EHRA is to propose and promote Guidelines in the management of heart rhythm disturbances not already covered by the European Society of Cardiology (ESC). Electrophysiological studies (EPSs), whether or not associated with therapeutic procedures (ablation using different sources of energy or reduction of tachycardia), show the percutaneous introduction of one or multiple catheters to record the electrical activity of the heart or to pace its different cavities. The introduction and manipulation of these catheters in arteries, veins, or cardiac cavities have multiple pathophysiological consequences and one of the most evident is to activate the coagulation cascade with the risk to induce new clots or to mobilize pre-existing ones. Furthermore, withdrawal of catheters induces haemorrhage usually limited by the compression of the site of venous or arterial puncture. There is also a close relationship between EPS and thrombus formation (thrombogenesis) and thus, rhythmologists need to balance the risks between thrombo-embolism and bleeding. There are no guidelines on the use of antithrombotic therapies in the setting (before, during, and after) of EPS. Generally, different laboratories have their own approaches to this clinical problem. The aim of the present document is to propose consensus recommendations written according to the ‘Guidelines for guidelines’ published by the Guidelines committee of the ESC. It should be stressed that this topic has been poorly studied in clinical trials and that very few well-designed studies are at our disposal to guide evidence-based management. This is a major limitation to give hard recommendations and explains why the level of recommendation in most instances is Grade C (‘expert opinion’). The present document has been divided into five main sections: the first three deals with the general risks of thrombo-embolism or bleeding, whereas the fourth section relates more to the risks of venous or arterial access and the last section relates to some special situations. The division between low-, intermediate-, and high-risk procedures for thrombo-embolism or bleeding is partly arbitrary, as a ‘low-risk’ intervention in a high-risk patient becomes an intermediate-risk procedure. Even with these limitations, such a division could be helpful for readers. It is the hope of the task force that this document will prompt well-designed trials that would hopefully strengthen the impact of the following recommendations. Radiofrequency (RF) catheter ablation, because of its curative nature and high success and low complication rates, has become the treatment of choice for a wide variety of arrhythmias. Indications have recently expanded to include even complex arrhythmias such as atrial fibrillation (AF), atrial flutter (AFL), and ventricular tachycardia (VT) associated with structural heart disease. A recent review indicates an overall low incidence of 0.6% of reported thrombo-embolic complications; the risk was increased when an ablation procedure was performed in the left heart (1.6–2.8%). 1–3 In an earlier survey, 2 the reported procedure-related complications of RF ablation occur in ∼5.1%. The risk is also high when the ablation procedure is performed in the left heart (1.8–2%) and for VT (2.8%). 3 Non-pharmacological measures play an increasing role in AF management and, in many instances, offer the possibility of a ‘cure’. 4 However, AF recurrence rates with catheter ablation techniques are significant. For example, only 54 and 82% of the of at the ablation and ablation for AF occur and be increased catheter ablation, among In a of the and of catheter ablation for was a of success and complications to and complications occur in and for procedures left atrial ablation, the of was and that of was This to be in of and from individual from a of reported that thrombo-embolic in the rates of thrombo-embolism and and In the the only of was the of There was a low incidence of thrombo-embolic ablation and for high recently reported a of percutaneous RF ablation in with or of one or more risk for with for RF in 2 of RF ablation, whereas thrombo-embolism ablation in one of therapeutic in of the in was a thrombo-embolic of that the risk of thrombo-embolism RF ablation is with most 2 the procedure. thrombo-embolism the of rhythm Radiofrequency catheter ablation of is the therapeutic of reported a of with not on therapeutic and a risk for thrombo-embolism of The of thrombo-embolism have been to proposed a of that to thrombus of the and The of thrombo-embolism is increasing to the of in the of an procedure to a or In the setting of complex catheter ablation thrombo-embolic complications most from the of of an example, in AF ablation, include a reduction in the to a on the of coagulation and and However, this be an as from major arteries, from and in the of the have been shown to give to of are into catheter withdrawal and be into the by or catheter in the with an catheter or also be thrombus be into the by a by a in by the of electrical or by catheter manipulation or as or catheter In the clinical setting multiple usually a is to or these of rhythm by ablation in of in with whereas in with catheter ablation in ablation of has been associated with and the of more the left is by atrial that of AF to It has been reported with of of RF in reduction of and There is to that this is for an increased risk of thrombo-embolism for to of AF in to rhythm and in a in the risk of The for atrial to is on the of the the atrial and heart disease. atrial by ablation to and extensive in the left are to one that AF ablation in atrial In of rhythm following ablation should in atrial and of atrial In a by of AF recurrence ablation in whereas in with increased with In in was by in with ablation in more when with In with was of In the was that in the of the left is to to thrombus formation of AF to be The of RF or energy with an a that the coagulation even in with The of the nature of the the as as the procedure would have for In one in thrombus formation was by of the RF and and in the RF In to the or to the catheter and to the ablation no or thrombus to RF was In one of the studies to at clinical AF and left the a high incidence with a of low of the to a high of the into the left no more in 54 limited by its this an important of thrombus and the to the formation of a is into the left by of an or The of many and their to the this a should be of of from and more from with use of a should with the use of of already the this should be a high is and also a new catheter is into the a catheter should be be and not be The of ablation procedure and the of with or is to Radiofrequency energy in a of by a because of of the studies in have shown thrombus formation on the In RF thrombus at the of the ablation formation the of RF and is also a of also be in the is to from when a catheter is of the and into the left the clinical is in a with the with a or the or the a few on the to catheter withdrawal and this of are in to ablation formation or thrombus In thrombus is and is by data and by the reduction of with when with of with in AF is to the reduction of by in in is In thrombus formation is and thus, is This is evident in the setting of disease. increased in AF has been by the in AF is not that would be from associated disease. ablation, is some of For example, reported increased an of of In that coagulation and and ablation this to by In a on and of at ablation, at the of the and at increased from There was a was performed and a not was at was the only of increased of ablation in the of and coagulation For example, an RF procedure induces more and the procedure. that is one of the most of will the of antithrombotic management the role of as or or with the of clinical trials this In a by the of of for have been to the thrombo-embolic risk of not of have been studied AF the into and thrombo-embolism following a rhythm with a is that is an of recommendations for the need for of 4 is a high risk of AF recurrence risk are formation AF ablation as by could be to increased and The most important of thrombus formation was the of as as of the with this In and heart are associated with increased incidence of atrial also thrombus The of specific of of RF ablation, and catheter could the risk of thrombo-embolism trials are and of the is based on clinical or In a for example, was with an of by for the of the procedure in and was complication and was in three physicians following RF However, the of this has not been RF is performed atrial following to rhythm thrombo-embolic complications and, should at be of atrial is a of of AF and the heart disease. However, to the risk of guidelines that should be in with risk and at high risk of AF that is no recurrence of be In a of AF ablation, thrombo-embolic In of the thrombo-embolism 2 of the and in thrombo-embolism was at therapeutic in and no risk was in at a of 4 in rhythm and one or more risk was in of the at a of In AF recurrence was in of the of the thrombo-embolism the of or with a of more to of AF the of the of this is to in with ablation of AF and no risk or with risk and of There are data to of in or with a of In in was with no thrombo-embolism was following thrombo-embolism was in of the in the ablation and of the in the 54 and of and thrombo-embolism complications more among AF recurrence the of in with of is to thrombo-embolic complications of RF performed in cavities. thrombus formation is not by increased of the risk of AF performed a on AF coagulation between and to or have in the was between and reported risk of thrombus in with by the The use of with not have data are on the role of as in many ablation have associated the use of such and bleeding complications be an have some to the to when with In a on RF ablation, with or not the of RF ablation, with and a as by the of when with these are data based on and should be in of data in to the of of in in AF and clinical trials that show of For to occur RF a of at be also However, coagulation with of RF the of It has been that an of thrombus was in of RF of when the was of the ablation has been to the risk of thrombus formation at the of the A in between an catheter and a ablation catheter that very with and that or no was with an In a on with the use of catheter was to be with low complication rates and a success of the in of the of the ablation no of formation present the of the In an the use of in thrombus formation RF was also associated with 3 However, studies are to and of this in the ablation of energy sources such as or energy in clinical data are is no to reduction in thrombo-embolic data on therapeutic strategies for with thrombus should be possible with and such are in the management of and on the of of such as as of thrombus RF of that be by withdrawal of the and catheter into the However, the clinical of these is not reported a incidence of thrombus formation as by In most of AF ablation the incidence of clinical thrombo-embolism is this In with are more to thrombus RF procedure. of these by In increased of risk of thrombus AF ablation in with that is when was thrombus was in only of the whereas when was between and the risk of thrombus was has also been to formation RF to that RF reduction by an in the formation was associated with the incidence of thrombo-embolism and is to is associated with an increased incidence of thrombus formation and to thrombus to rhythm following ablation, be helpful to the of by and In the 2 among performed ablation tachycardia or of 4 of and of venous three of of and of major In the catheter ablation among with ablation ablation, or atrial three of thrombo-embolism or of and of major In the performed in complications RF ablation in risk for in 4 of procedures and in 3 of procedures three of these venous and to catheter manipulation the in the of of and of major In a was with an of by for the of the procedure in and was complication and was in three However, cardiac in three and one of in three In the performed in among for three and one and also five on and on complications could not be to the use of or the because a wide of and and no was associated with a incidence of thrombo-embolic that complications and In the catheter ablation was in in and no specific in The incidence of thrombo-embolism or bleeding complications was and no in these complications among of or bleeding complications of ablation in at low risk and of or bleeding complications of ablation in at low risk and In no relationship has been between ‘low-risk’ procedures with thrombo-embolic complications and the procedure or of RF procedures are at low risk of thrombo-embolism and the procedure. the risk of bleeding to be with is not for procedures (before, during, and the risk for are with are at increased risk for this risk to be that in with studies of electrical with that this risk to be high in to of the nature of this risk from studies the of atrial and This risk a of the of because electrical of atrial not rhythm a few studies have with these in the of rhythm with catheter ablation, in these In an ablation procedure by is not to a risk for because and catheter manipulation are in the the risk of the procedure be to that of the ‘low-risk’ as In as ablation in a patient with the of is a risk for procedure-related not because of the procedure because of the and that this risk for a of the procedure. is the thrombo-embolic risk to is not to be present at the of the ablation procedure. Furthermore, no risk is the as is no rhythm in the of the ablation procedure in is not to a risk for the ablation procedure be to the ‘low-risk’ as studies have shown that RF catheter ablation procedures some thrombo-embolic the use of and different of A review of the literature a in the incidence of thrombo-embolic complications of RF ablation procedures (1.8–2%) when with an overall of only 0.6% when ablation procedures are ablation procedures not in this The of a incidence in are not the risk of associated with RF catheter ablation in the left 2 reported an incidence of and arterial In the of RF procedures in reported the three complications in the use of the procedure and for 3 the In the a one the ablation of a with a and the the ablation of the with a the of more as major the no the ablation of left in The reported in these their and possible management recommendations. The incidence of ablation procedures in with is The of structural heart in these a incidence of when with with left ventricular and to that in energy sources such as have the incidence of thrombus the is no scientific that therapies in RF ablation our recommendations are based on the of However, consequences be as to an antithrombotic to its even the of the is very as as the risk not become In is no between and the incidence of bleeding complications in these However, an incidence of bleeding from 2 to to of In with the with the Guidelines for the management of with and with the Guidelines for the management of with that antithrombotic is during, and the ablation procedure. The following is for atrial ablation rhythm for 3 or to the ablation procedure. for the ablation procedure. with the the ablation procedure is after) the ablation at of a of and is for this is for 4 the ablation procedure. the of In a for recommendations for atrial fibrillation and with structural heart to the intervention is not in this clinical is the ablation arterial access at of a of by the procedure. more also be in the individual such as and extensive RF complications reported that incidence is when the RF ablation is performed in The ablation of AF a risk of thrombo-embolic complication that is to the procedure and has been reported in to of the In a on and of the RF ablation for 4 reported in 2 of from The reported risk of was and in of the In of AF ablation, thrombo-embolism in of the of 2 of the the use of in of these In thrombo-embolism in of the the therapeutic of these recurrence of In a RF ablation of AF with no thrombo-embolic complication was in the thrombo-embolism more in in the and was associated with a recurrence of AF these to the incidence of thrombus formation that in of a performed with to thrombus formation in more of the In of the the thrombus could be into the by the and the In the the thrombus was in the and was in the or was only on review of of these following the procedure. In the of and is not possible to recommendations. a of recommendations are based on pathophysiological and for a of to the intervention is by a the intervention on the or is to the of thrombus or to is an that should be to the to be important to of in at high or risk of atrial formation with a of thrombo-embolic with or with and or is to the between of and the procedure. This is to that the to the risk of bleeding or and the of the from to no data are most that an RF ablation be performed the is an and to and on the of the are the measures the procedure. the of and help the complication an catheter is not for as low as with the formation of and measures such as a the of be catheter the into the the ablation or catheter into the left and the procedure and ablation should be such as the of the has from one to from an of to and even to no A is the of of most physicians the of the are of even puncture. The aim of management this is to a at the of published are is usually for a or the to and are the risk of and the first is to this in of to its with or and to with arterial to and some physicians this by arterial or by a only for The of should be not be choice in the of of are with the following and with is on the of the and an 2 is Radiofrequency ablation be applied in the treatment of VT in with left ventricular because of and of the risk of thrombo-embolic complications associated with be as high as are no recommendations with to in In most studies of VT ablation, of is the of by a of at with no the procedure. performed the procedure with the of not for ablation of AF for the access is usually arterial with of the with a catheter into a high in to a access into the low a a a is only for a access to the and would be to use the as for AF is to the of the of the its for at 4 to the ablation procedure. the ablation procedure. with or the the ablation procedure. and of a of or by of in to at in of is the of the is and when the is to be for at a of a that will a at or at the to be the of the procedure. with when the 2 3 is therapeutic for a of the ablation procedure. Recommendations for catheter ablation of ventricular tachycardia with heart In the of with with therapeutic the ablation procedure. be with or the the ablation procedure. of a of or by of in to the level of the of the is and when the is be for in of for in to be the of the procedure. with when the 2 3 is therapeutic as at for In the of for as by or for and for at 2 venous and complications associated with complications because of access are associated with no the of or with the site to the best of our been The clinical has with scientific reported from a few studies are in 3 The overall of complications from to from the literature on complications associated with site procedures in from the literature on complications associated with site procedures in complications following catheter ablation for atrial fibrillation complications following catheter ablation for atrial fibrillation A complication has been reported in the in or RF ablation The incidence of complications on of access or site of access or of of the and coagulation of management of site the procedure and catheter and of and use of and The most complications associated with venous access are and venous of the of the introduction of one site the risk of as the use of for In the of be as by the of However, the a high of in in one patient the procedure. This also that the complication was not associated with the of catheters or such clinical as procedure or the high incidence of of a clinical is of However, be a of the consequences of are The most complication associated with arterial access is by and reported an incidence of complications percutaneous with In a literature arterial to be in of to when at the studies with a complications such as and formation more when in of the compression has the need for of in some close the of and of of are and usually by has been reported in 3 of is very is an complication when the is and very puncture. trials with clinical for the of and as as for There is a of and to and to the of and the in and of the venous not the introduction of the venous also the studies have the of measures of coagulation that catheter that with could the incidence of thrombo-embolic In and to be to the of the no bleeding or thrombo-embolic complications in the or clinical of such an could not be only the risk of in high-risk and and are no studies on use in some is for 1–3 the RF clinical that is that even would be and are in venous from laboratories that use for procedures The most reported is the of procedures in and whereas procedures usually not are for or the procedure is and with RF However, no has and in a studied the of on the of complications associated with access The of complications in ablation of AF that treatment be associated with an increased risk of The Guidelines that for procedures the should be an that could is or when or ablation that the risk of thrombus formation are also be on an individual for of catheter has been in some no was performed to this of venous of arterial the use of be as in the in with a of venous is only compression at the site and of with withdrawal in to thrombus from to the the of or on the compression or as and of of or and compression EPS and catheter ablation in or are increasing in and to be The with this is that among and is a with to heart and There are different such as risk of cardiac bleeding, and risk of Furthermore, when with is an increasing risk of arterial or venous because of the between and catheter There are data from the RF that an on the general risk of is no on the The risk of or was for ablation of in the new the risk of bleeding was not In the of the on and published in the following recommendations for in diagnostic cardiac in and are a ablation is the of is and at an as in to in on the have to been into It be that in to or the risk of arterial or venous has to be because of and in and For and cardiac an is It is to use of as a be in procedures Grade In this is to as from to of for and to as from of to For and diagnostic cardiac an is It is to use at as a be in a ablation is the of is and at an level as in to For no specific recommendations are Electrophysiological catheter ablation in with the need for is a and setting in practice. with heart AF and risk and or left ventricular thrombus will need and the procedure. The thrombo-embolic risk for on the such as or is very low However, are no specific data on For management in the Guidelines for the management of with heart or the guidelines for the management of with AF could be For the specific recommendations for section on in high-risk the increasing use of and the of and and catheter ablation is There are different the risk of bleeding and the risk of cardiac to cardiac be a of whether the risk of bleeding and the of cardiac are different when the patient is on For the introduction and of the and the risk of bleeding or complications when using and is In a on the use of and for the of the risk of major bleeding was 0.6% and the risk of complication was In these use of was present and to the risk of bleeding that the risk in or approaches is the risk for should be no In the general risk of complications or ablation in the is in the of these the use of should not be a to the the bleeding risk should be with because usually only one arterial with is when with The be the management of cardiac or because of when the patient is on and are no data in the literature on this specific and no be However, the risk of in catheter ablation is low and for also in the ablation of AF of It be that bleeding is more and more to be when the patient is on and procedures and such as ablation of be performed with a low of AF should not be performed in on and because of an increased risk of major bleeding to cardiac In these ablation should be to a when and be of
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