2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation: Executive summary Article Swipe

Document Reviewers: Carina Blomström-Lundqvist, MD, PhD; Angelo A.V. De Paola, MD, PhD; Peter M. Kistler, MBBS, PhD; Gregory Y.H. Lip, MD; Nicholas S. Peters, MD; Cristiano F. Pisani, MD; Antonio Raviele, MD; Eduardo B. Saad, MD, PhD; Kazuhiro Satomi, MD, PhD; Martin K. Stiles, MB ChB, PhD; Stephan Willems, MD, PhD During the past three decades, catheter and surgical ablation of atrial fibrillation (AF) have evolved from investigational procedures to their current role as effective treatment options for patients with AF. Surgical ablation of AF, using either standard, minimally invasive, or hybrid techniques, is available in most major hospitals throughout the world. Catheter ablation of AF is even more widely available, and is now the most commonly performed catheter ablation procedure. In 2007, an initial Consensus Statement on Catheter and Surgical AF Ablation was developed as a joint effort of the Heart Rhythm Society (HRS), the European Heart Rhythm Association (EHRA), and the European Cardiac Arrhythmia Society (ECAS).1 The 2007 document was also developed in collaboration with the Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC). This Consensus Statement on Catheter and Surgical AF Ablation was rewritten in 2012 to reflect the many advances in AF ablation that had occurred in the interim.2 The rate of advancement in the tools, techniques, and outcomes of AF ablation continue to increase as enormous research efforts are focused on the mechanisms, outcomes, and treatment of AF. For this reason, the HRS initiated an effort to rewrite and update this Consensus Statement. Reflecting both the worldwide importance of AF, as well as the worldwide performance of AF ablation, this document is the result of a joint partnership between the HRS, EHRA, ECAS, the Asia Pacific Heart Rhythm Society (APHRS), and the Latin American Society of Cardiac Stimulation and Electrophysiology (Sociedad Latinoamericana de Estimulación Cardíaca y Electrofisiología [SOLAECE]). The purpose of this 2017 Consensus Statement is to provide a state-of-the-art review of the field of catheter and surgical ablation of AF and to report the findings of a writing group, convened by these five international societies. The writing group is charged with defining the indications, techniques, and outcomes of AF ablation procedures. Included within this document are recommendations pertinent to the design of clinical trials in the field of AF ablation and the reporting of outcomes, including definitions relevant to this topic. The writing group is composed of 60 experts representing 11 organizations: HRS, EHRA, ECAS, APHRS, SOLAECE, STS, ACC, American Heart Association (AHA), Canadian Heart Rhythm Society (CHRS), Japanese Heart Rhythm Society (JHRS), and Brazilian Society of Cardiac Arrhythmias (Sociedade Brasileira de Arritmias Cardíacas [SOBRAC]). All the members of the writing group, as well as peer reviewers of the document, have provided disclosure statements for all relationships that might be perceived as real or potential conflicts of interest. All author and peer reviewer disclosure information is provided in Table A1 and Table B1. In writing a consensus document, it is recognized that consensus does not mean that there was complete agreement among all the writing group members. Surveys of the entire writing group were used to identify areas of consensus concerning performance of AF ablation procedures and to develop recommendations concerning the indications for catheter and surgical AF ablation. These recommendations were systematically balloted by the 60 writing group members and were approved by a minimum of 80% of these members. The recommendations were also subject to a 1-month public comment period. Each partnering and collaborating organization then officially reviewed, commented on, edited, and endorsed the final document and recommendations. The grading system for indication of class of evidence level was adapted based on that used by the ACC and the AHA.3, 4 It is important to state, however, that this document is not a guideline. The indications for catheter and surgical ablation of AF, as well as recommendations for procedure performance, are presented with a Class and Level of Evidence (LOE) to be consistent with what the reader is familiar with seeing in guideline statements. A Class I recommendation means that the benefits of the AF ablation procedure markedly exceed the risks, and that AF ablation should be performed; a Class IIa recommendation means that the benefits of an AF ablation procedure exceed the risks, and that it is reasonable to perform AF ablation; a Class IIb recommendation means that the benefit of AF ablation is greater or equal to the risks, and that AF ablation may be considered; and a Class III recommendation means that AF ablation is of no proven benefit and is not recommended. The writing group reviewed and ranked evidence supporting current recommendations with the weight of evidence ranked as Level A if the data were derived from high-quality evidence from more than one randomized clinical trial, meta-analyses of high-quality randomized clinical trials, or one or more randomized clinical trials corroborated by high-quality registry studies. The writing group ranked available evidence as Level B-R when there was moderate-quality evidence from one or more randomized clinical trials, or meta-analyses of moderate-quality randomized clinical trials. Level B-NR was used to denote moderate-quality evidence from one or more well-designed, well-executed nonrandomized studies, observational studies, or registry studies. This designation was also used to denote moderate-quality evidence from meta-analyses of such studies. Evidence was ranked as Level C-LD when the primary source of the recommendation was randomized or nonrandomized observational or registry studies with limitations of design or execution, meta-analyses of such studies, or physiological or mechanistic studies of human subjects. Level C-EO was defined as expert opinion based on the clinical experience of the writing group. Despite a large number of authors, the participation of several societies and professional organizations, and the attempts of the group to reflect the current knowledge in the field adequately, this document is not intended as a guideline. Rather, the group would like to refer to the current guidelines on AF management for the purpose of guiding overall AF management strategies.5, 6 This consensus document is specifically focused on catheter and surgical ablation of AF, and summarizes the opinion of the writing group members based on an extensive literature review as well as their own experience. It is directed to all health care professionals who are involved in the care of patients with AF, particularly those who are caring for patients who are undergoing, or are being considered for, catheter or surgical ablation procedures for AF, and those involved in research in the field of AF ablation. This statement is not intended to recommend or promote catheter or surgical ablation of AF. Rather, the ultimate judgment regarding care of a particular patient must be made by the health care provider and the patient in light of all the circumstances presented by that patient. The main objective of this document is to improve patient care by providing a foundation of knowledge for those involved with catheter ablation of AF. A second major objective is to provide recommendations for designing clinical trials and reporting outcomes of clinical trials of AF ablation. It is recognized that this field continues to evolve rapidly. As this document was being prepared, further clinical trials of catheter and surgical ablation of AF were under way. This section of the document provides definitions for use in the diagnosis of AF. This section also provides an in-depth review of the mechanisms of AF and rationale for catheter and surgical AF ablation (Table 1, 1-6). Anatomical drawings of the heart relevant to AF ablation. This series of drawings shows the heart and associated relevant structures from four different perspectives relevant to AF ablation. This drawing includes the phrenic nerves and the esophagus. A: The heart viewed from the anterior perspective. B: The heart viewed from the right lateral perspective. C: The heart viewed from the left lateral perspective. D: The heart viewed from the posterior perspective. E: The left atrium viewed from the posterior perspective. Illustration: Tim Phelps © 2017 Johns Hopkins University, AAM. This figure includes six CT or MR images of the left atrium and pulmonary veins viewed from the posterior perspective. Common and uncommon variations in PV anatomy are shown. A: Standard PV anatomy with 4 distinct PV ostia. B: Variant PV anatomy with a right common and a left common PV. C: Variant PV anatomy with a left common PV with a short trunk and an anomolous PV arising from the right posterior left atrial wall. D and E: Variant PV anatomy with a common left PV with a long trunk. F: Variant PV anatomy with a massive left common PV. Schematic drawing showing various hypotheses and proposals concerning the mechanisms of atrial fibrillation. A: Multiple wavelets hypothesis. B: Rapidly discharging automatic foci. C: Single reentrant circuit with fibrillatory conduction. D: Functional reentry resulting from rotors or spiral waves. E: AF maintenance resulting from dissociation between epicardial and endocardial layers, with mutual interaction producing multiplying activity that maintains the arrhythmia. Structure and mechanisms of atrial fibrillation. A: Schematic drawing of the left and right atria as viewed from the posterior perspective. The extension of muscular fibers onto the PVs can be appreciated. Shown in yellow are the five major left atrial autonomic ganglionic plexi (GP) and axons (superior left GP, inferior left GP, anterior right GP, inferior right GP, and ligament of Marshall). Shown in blue is the coronary sinus, which is enveloped by muscular fibers that have connections to the atria. Also shown in blue is the vein and ligament of Marshall, which travels from the coronary sinus to the region between the left superior PV and the left atrial appendage. B: The large and small reentrant wavelets that play a role in initiating and sustaining AF. C: The common locations of PV (red) and also the common sites of origin of non-PV triggers (shown in green). D: Composite of the anatomic and arrhythmic mechanisms of AF.Adapted with permission from Calkins et al. Heart Rhythm 2012; 9:632--696.e21.2 Schematic drawing showing mechanisms of atrial flutter and atrial tachycardia. A: Isthmus-dependent reverse common (clockwise) atrial flutter. B: Isthmus-dependent common (counter clockwise) atrial flutter. C: Focal atrial tachycardia with circumferential spread of activation of the atria (can arise from multiple sites within the left and right atrium). D: Microreentrant atrial tachycardia with circumferential spread of activation of the atria. E: Perimitral atrial flutter. F: Roof-dependent atrial flutter. Schematic of common lesion sets employed in AF ablation. A: The circumferential ablation lesions that are created in a circumferential fashion around the right and the left PVs. The primary endpoint of this ablation strategy is the electrical isolation of the PV musculature. B: Some of the most common sites of linear ablation lesions. These include a "roof line" connecting the lesions encircling the left and/or right PVs, a "mitral isthmus" line connecting the mitral valve and the lesion encircling the left PVs at the end of the left inferior PV, and an anterior linear lesion connecting either the "roof line" or the left or right circumferential lesion to the mitral annulus anteriorly. A linear lesion created at the cavotricuspid isthmus is also shown. This lesion is generally placed in patients who have experienced cavotricuspid isthmus-dependent atrial flutter clinically or have it induced during EP testing. C: Similar to 6B, but also shows additional linear ablation lesions between the superior and inferior PVs resulting in a figure of eight lesion sets as well as a posterior inferior line allowing for electrical isolation of the posterior left atrial wall. An encircling lesion of the superior vena cava (SVC) directed at electrical isolation of the SVC is also shown. SVC isolation is performed if focal firing from the SVC can be demonstrated. A subset of operators empirically isolates the SVC. D: Representative sites for ablation when targeting rotational activity or CFAEs are targeted. Modified with permission from Calkins et al. Heart Rhythm 2012; 9:632--696.e21.2 Management of patients with AF has traditionally consisted of three main components: (1) anticoagulation for stroke prevention; (2) rate control; and (3) rhythm control. With the emergence of large amounts of data, which have both defined and called attention to the interaction between modifiable risk factors and the development of AF and outcomes of AF management, we believe it is time to include risk factor modification as the fourth pillar of AF management. This section of the document reviews the link between modifiable risk factors and both the development of AF and their impacts on the outcomes of AF ablation. Shown in Table 2, and summarized in Figures 7 and 8 of this document, are the Consensus Indications for Catheter and Surgical Ablation of AF. As outlined in the introduction section of this document, these indications are stratified as Class I, Class IIa, Class IIb, and Class III indications. The evidence supporting these indications is provided, as well as a selection of the key references supporting these levels of evidence. In making these recommendations, the writing group considered the body of published literature that has defined the safety and efficacy of catheter and surgical ablation of AF. Also considered in these recommendations is the personal lifetime experience in the field of each of the writing group members. Both the number of clinical trials and the quality of these trials were considered. In considering the class of indications recommended by this writing group, it is important to keep several points in mind. First, these classes of indications only define the indications for catheter and surgical ablation of AF when performed by an electrophysiologist or a surgeon who has received appropriate training and/or who has a certain level of experience and is performing the procedure in an experienced center (Section 11). Catheter and surgical ablation of AF are highly complex procedures, and a careful assessment of the benefit and risk must be considered for each patient. Second, these indications stratify patients based only on the type of AF and whether the procedure is being performed prior to or following a trial of one or more Class I or III antiarrhythmic medications. This document for the first time includes indications for catheter ablation of select asymptomatic patients. As detailed in Section 9, there are many other additional clinical and imaging-based variables that can be used to further define the efficacy and risk of ablation in a given patient. Some of the variables that can be used to define patients in whom a lower success rate or a higher complication rate can be expected include the presence of concomitant heart disease, obesity, sleep apnea, left atrial (LA) size, patient age and frailty, as well as the duration of time the patient has been in continuous AF. Each of these variables needs to be considered when discussing the risks and benefits of AF ablation with a particular patient. In the presence of substantial risk or anticipated difficulty of ablation, it could be more appropriate to use additional antiarrhythmic drug (AAD) options, even if the patient on face value might present with a Class I or IIa indication for ablation. Third, it is important to consider patient preference and values. Some patients are reluctant to consider a major procedure or surgery and have a strong preference for a pharmacological approach. In these patients, trials of antiarrhythmic agents including amiodarone might be preferred to catheter ablation. On the other hand, some patients prefer a nonpharmacological approach. Fourth, it is important to recognize that some patients early in the course of their AF journey might have only infrequent episodes for many years and/or could have AF that is responsive to well-tolerated AAD therapy. And finally, it is important to bear in mind that a decision to perform catheter or surgical AF ablation should only be made after a patient carefully considers the risks, benefits, and alternatives to the procedure. Indications for catheter ablation of symptomatic atrial fibrillation. Shown in this figure are the indications for catheter ablation of symptomatic paroxysmal, persistent, and long-standing AF. The Class for each indication based on whether ablation is performed after of antiarrhythmic drug or as is shown. refer to Table and the for the indications for catheter ablation of asymptomatic AF. Indications for surgical ablation of atrial fibrillation. Shown in this figure are the indications for surgical ablation of paroxysmal, persistent, and long-standing AF. The Class for each indication based on whether ablation is performed after of antiarrhythmic drug or as is shown. The indications for surgical AF ablation are whether the AF ablation procedure is performed with an surgical procedure as mitral valve a surgical procedure as coronary or as a surgical AF ablation procedure performed for treatment of atrial fibrillation. The writing group recommendations for to be used for ablation of and long-standing AF (Table ablation to improve outcomes of AF ablation, and for ablation of paroxysmal, persistent, and long-standing AF are in this A of common lesion sets created during an AF ablation procedure is shown in This section of the consensus statement provides an update on many of the and that are employed for AF ablation procedures. It is important to recognize that this is not a and that tools, and are being It is also important to recognize that is the source available for ablation of and atrial flutter is a commonly employed for AF ablation, it is not well for ablation of or and are available in some of the and/or are in various of development and/or clinical Shown in are drawings of AF ablation using and AF ablation using the system Schematic drawing showing catheter ablation of atrial fibrillation using either or AF ablation. A: a lesion created using Ablation lesions are in a figure of eight around the left and right PV Also shown is a linear cavotricuspid isthmus lesion created for ablation of atrial flutter in a patient with a prior of atrial flutter or isthmus-dependent atrial flutter at the time of ablation. A catheter is in the left inferior PV. B: an ablation procedure using the Ablation lesions have been created the right PVs, and the ablation catheter is in the left superior PV. A the catheter is in the left superior Tim Phelps © 2017 Johns Hopkins University, AAM. and ablation of AF (Table and of that can within the first several following ablation (Table or during ablation; and to risk of an atrial are in this AF ablation is an procedure that risks, most of which are present during the period. can also in the or following ablation. common after AF ablation and those that and to an electrophysiologist is an important of after AF ablation. The success of AF ablation is based in large on from AF based on Arrhythmia can be performed with the use of or continuous (Table This section also the important of AAD and use prior to and following AF ablation, the role of as well as the indications for and of AF ablation procedures. This section provides a review of the outcomes of catheter ablation of AF. Table 7 summarizes the main findings of the most important clinical trials in this of AF ablation in of patients not well in these trials are for ablation and ablation, rotational activity ablation, and are also Catheter ablation of AF is one of the most complex procedures. AF ablation by catheter and ablation in the which are in to other important and structures that can be It is not that AF ablation is associated with a risk of some of which might result in and/or This section reviews the associated with catheter ablation procedures performed to AF. The and of are their mechanisms are and the to and treatment is 8 and of a focal or with at one of the in level of or one of the or or other or consistent with stroke of a focal or if were performed or available a or the in other for the clinical pharmacological of the diagnosis by at one of the or procedure or CT or of definitions focal with to within as with at and at and This section of the document the training for those who to perform catheter ablation of AF. refer to Table and 8 presented in this there have been many advances made in the field of catheter and surgical ablation of AF, there is to be the mechanisms of and maintenance of AF and to this knowledge to the of AF ablation. observational have the early of this we are an in which hypotheses are the of in well-designed, clinical trials. It is as a result of these trials that the techniques, success complication and outcomes AF as and being to the The ablation literature has also a of meta-analyses and other which the for in the to reporting the of clinical trials. This section reviews the minimum for reporting on AF ablation trials. It also the potential limitations of using primary outcomes and the for and consistent reporting of outcomes to the in not only the but also the clinical of the been in use for many years be used to of trials with trials a for AF systematically the efficacy of AF ablation, particularly for AF, if is used well for AF outcomes of other than as to be as of patients from or time to for trials in which is more for by ablation than of all consistent of what a duration of AF from 6 to in literature than could be a based on of trial be as of patients from or time to provide an endpoint more relevant to of AF relevant efficacy of ablation by episodes not that might be important to quality of or stroke of what is an must be in and to or in the trial for trials additional modification in AF systematically the efficacy of AF ablation, particularly for AF continuous to if is patient maintains sinus rhythm on drug this may be considered a clinically increase the success rate with success not be relevant to patients to drug drug and of drug should be to drug and be in AF studies, but might not be for AF studies continuous using an showing that a in AF impacts including heart and AF can be by and reporting of patient and like a in report for also in number and duration of AF episodes there is no for the of this prior recommendation is provided only as an of what clinical trials may to use as a of success not that of AF is for or AF studies in which is to to AF in might be for stroke or outcomes time might be is continuous be for such as heart or in which to AF can to not that of AF is for AF studies in which is to to AF, which might be to with drug endpoint efficacy of AF ablation continuous drug be particularly for long-standing AF with heart disease, heart provide indication of modification of for AF, most relevant to or long-standing AF studies have AF to success of AF has not been shown to to success might not be relevant to AF patients in whom AF might Some studies of or during ablation that could consider as to sinus consider to tachycardia as of or are are their use and and during the ablation should be to sinus rhythm and to tachycardia or should be AF ablation and modification of stroke risk and for anticoagulation The was developed for patients with clinical AF. a patient has received a ablation such that no has clinical AF or no then what is the for there patients in whom ablation could to of modification in management of for is the lesion pulmonary vein and complex atrial have these or is the role of targeting rotational we a rotational can be and for we to the the right atrium to be as well as the left in clinical AF an autonomic of plexi there a role for autonomic for or and of risk factors on outcomes of AF has been shown to AF and in patients ablation. is the role of the of other risk factors such as sleep apnea, and in ablation of benefit from AF heart has been in trials, but trials are data are in patients with patients with on and the Surgical hybrid should be more between and minimally surgical Both report outcomes, but there is a of there patient benefit to hybrid we patients who are for might identify patients with of who are to to ablation. These must and and must be in trials. to be including and clinical based on risk The role of As and more are for AF ablation, their value must be in to in or These include techniques, ablation for lesion for lesions in the including ablation, and ablation, must be in of AF to the clinical of ablation is the of time to of of we AF these outcomes to quality of and stroke is the role of surgical left atrial or improve of AF ablation with an in ablation atrial is the of and does this the clinical of in is the role of the entire heart in AF a outcomes than a the safety of catheter As ablation to more operators and experienced the of to and for operators to improve the of ablation and safety at a of does catheter ablation and in and patient catheter ablation for Management of patients who initial attempts at catheter there be for atrial size, body patients be for surgery for In to these and other important in the field of catheter and surgical AF ablation, we to and in and research with of and on the to the of AF also to these important Catheter ablation of AF is a commonly performed procedure in hospitals throughout the world. This document provides an review of the indications, techniques, and outcomes of catheter and surgical ablation of AF. for which a consensus can be concerning AF ablation are and a series of consensus definitions have been developed for use in clinical trials of AF ablation. Also within this document are recommendations concerning indications for AF ablation, performance of this and It is to improve patient care by providing a foundation for those involved with care of patients with AF as well as those who perform AF ablation. It is recognized that this field continues to evolve and that this document to be AF ablation should of a of and to appropriate indications, procedure and The the of MD, PhD; MD; and at the of for and and during the of this This document does not the or recommendations of the data associated with this can be in the at The is not for the or of supporting information by the than should be directed to the author for the