- Record: found
- Abstract: found
- Article: found
2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation: Executive summary
research-article
Hugh Calkins , MD
1 ,
Gerhard Hindricks , MD
2 ,
Riccardo Cappato , MD
3 ,
Young-Hoon Kim , MD, PhD
4 ,
Eduardo B Saad , MD, PhD
5 ,
Luis Aguinaga , MD, PhD
6 ,
Joseph G Akar , MD, PhD
7 ,
Vinay Badhwar , MD
8 ,
Josep Brugada , MD, PhD
9 ,
John Camm , MD
10 ,
Peng-Sheng Chen , MD
11 ,
Shih-Ann Chen , MD
12 ,
Mina K Chung , MD
13 ,
Jens Cosedis Nielsen , DMSc, PhD
14 ,
Anne B Curtis , MD
15 ,
D Wyn Davies , MD
16 ,
John D Day , MD
17 ,
André d’Avila , MD, PhD
18 ,
N M S (Natasja) de Groot , MD, PhD
19 ,
Luigi Di Biase , MD, PhD
20 ,
Mattias Duytschaever , MD, PhD
21 ,
James R Edgerton , MD
22 ,
Kenneth A Ellenbogen , MD
23 ,
Patrick T Ellinor , MD, PhD
24 ,
Sabine Ernst , MD, PhD
25 ,
Guilherme Fenelon , MD, PhD
26 ,
Edward P Gerstenfeld , MS, MD
27 ,
David E Haines , MD
28 ,
Michel Haissaguerre , MD
29 ,
Robert H Helm , MD
30 ,
Elaine Hylek , MD, MPH
31 ,
Warren M Jackman , MD
32 ,
Jose Jalife , MD
33 ,
Jonathan M Kalman , MBBS, PhD
34 ,
Josef Kautzner , MD, PhD
35 ,
Hans Kottkamp , MD
36 ,
Karl Heinz Kuck , MD, PhD
37 ,
Koichiro Kumagai , MD, PhD
38 ,
Richard Lee , MD, MBA
39 ,
Thorsten Lewalter , MD, PhD
40 ,
Bruce D Lindsay , MD
41 ,
Laurent Macle , MD
42 ,
Moussa Mansour , MD
43 ,
Francis E Marchlinski , MD
44 ,
Gregory F Michaud , MD
45 ,
Hiroshi Nakagawa , MD, PhD
46 ,
Andrea Natale , MD
47 ,
Stanley Nattel , MD
48 ,
Ken Okumura , MD, PhD
49 ,
Douglas Packer , MD
50 ,
Evgeny Pokushalov , MD, PhD
51 ,
Matthew R Reynolds , MD, MSc
52 ,
Prashanthan Sanders , MBBS, PhD
53 ,
Mauricio Scanavacca , MD, PhD
54 ,
Richard Schilling , MD
55 ,
Claudio Tondo , MD, PhD
56 ,
Hsuan-Ming Tsao , MD
57 ,
Atul Verma , MD
58 ,
David J Wilber , MD
59 ,
Teiichi Yamane , MD, PhD
60
15 September 2017
Read this article at
There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.
Abstract
Table of Contents
Abbreviations159
Section 1: Introduction159
Section 2: Definitions, Mechanisms, and Rationale for AF Ablation163
Section 3: Modifiable Risk Factors for AF and Impact on Ablation163
Section 4: Indications163
Section 5: Strategies, Techniques, and Endpoints166
Section 6: Technology and Tools166
Section 7: Technical Aspects of Ablation to Maximize Safety and Anticoagulation166
Section 8: Follow-up Considerations167
Section 9: Outcomes and Efficacy176
Section 10: Complications176
Section 11: Training Requirements182
Section 12: Surgical and Hybrid AF Ablation182
Section 13: Clinical Trial Design182
Unanswered Questions in AF Ablation182
Section 14: Conclusion186
Acknowledgments198
Appendix A187
Appendix B196
References198
Abbreviations
AAD
antiarrhythmic drug
AF
atrial fibrillation
AFL
atrial flutter
CB
cryoballoon
CFAE
complex fractionated atrial electrogram
LA
left atrial
LAA
left atrial appendage
LGE
late gadolinium-enhanced
LOE
level of evidence
MRI
magnetic resonance imaging
OAC
oral anticoagulation
RF
radiofrequency
Section 1: Introduction
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 Appendix
A and Appendix B.
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.
Section 2: Definitions, Mechanisms, and Rationale for AF Ablation
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
, Figures 1–6
).
Table 1
Atrial fibrillation definitions
AF episode
An AF episode is defined as AF that is documented by ECG monitoring or intracardiac
electrogram monitoring and has a duration of at least 30 seconds, or if less than
30 seconds, is present throughout the ECG monitoring tracing. The presence of subsequent
episodes of AF requires that sinus rhythm be documented by ECG monitoring between
AF episodes.
Chronic AF
Chronic AF has variable definitions and should not be used to describe populations
of AF patients undergoing AF ablation.
Early persistent AF
Early persistent AF is defined as AF that is sustained beyond 7 days but is less than
3 months in duration.
Lone AF
Lone AF is a historical descriptor that is potentially confusing and should not be
used to describe populations of patients with AF undergoing AF ablation.
Long-standing persistent AF
Long-standing persistent AF is defined as continuous AF of greater than 12 months’
duration.
Paroxysmal AF
Paroxysmal AF is defined as AF that terminates spontaneously or with intervention
within 7 days of onset.
Permanent AF
Permanent AF is defined as the presence of AF that is accepted by the patient and
physician, and for which no further attempts to restore or maintain sinus rhythm will
be undertaken. The term permanent AF represents a therapeutic attitude on the part
of the patient and physician rather than an inherent pathophysiological attribute
of AF. The term permanent AF should not be used within the context of a rhythm control
strategy with antiarrhythmic drug therapy or AF ablation.
Persistent AF
Persistent AF is defined as continuous AF that is sustained beyond 7 days.
Silent AF
Silent AF is defined as asymptomatic AF diagnosed with an opportune ECG or rhythm
strip.
AF, atrial fibrillation; ECG, electrocardiogram.
Figure 1
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.
Figure 2
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.
Figure 3
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.
Figure 4
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
Figure 5
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.
Figure 6
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
Section 3: Modifiable Risk Factors for AF and Impact on Ablation
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.
Section 4: Indications
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.
Table 2
Indications for catheter (A and B) and surgical (C, D, and E) ablation of atrial fibrillation
Recommendation
Class
LOE
References
Indications for catheter ablation of atrial fibrillation
A. Indications for catheter ablation of atrial fibrillation
Symptomatic AF refractory or intolerant to at least one Class I or III antiarrhythmic
medication
Paroxysmal: Catheter ablation is recommended.
I
A
7–18
Persistent: Catheter ablation is reasonable.
IIa
B-NR
8
,
16–26
Long-standing persistent: Catheter ablation may be considered.
IIb
C-LD
8
,
16–26
Symptomatic AF prior to initiation of antiarrhythmic therapy with a Class I or III
antiarrhythmic medication
Paroxysmal: Catheter ablation is reasonable.
IIa
B-R
27–35
Persistent: Catheter ablation is reasonable.
IIa
C-EO
Long-standing persistent: Catheter ablation may be considered.
IIb
C-EO
B. Indications for catheter atrial fibrillation ablation in populations of patients
not well represented in clinical trials
Congestive heart failure
It is reasonable to use similar indications for AF ablation in selected patients with
heart failure as in patients without heart failure.
IIa
B-R
36–52
Older patients (>75 years of age)
It is reasonable to use similar indications for AF ablation in selected older patients
with AF as in younger patients.
IIa
B-NR
53–59
Hypertrophic cardiomyopathy
It is reasonable to use similar indications for AF ablation in selected patients with
HCM as in patients without HCM.
IIa
B-NR
60–62
Young patients (<45 years of age)
It is reasonable to use similar indications for AF ablation in young patients with
AF (<45 years of age) as in older patients.
IIa
B-NR
63
,
64
Tachy-brady syndrome
It is reasonable to offer AF ablation as an alternative to pacemaker implantation
in patients with tachy-brady syndrome.
IIa
B-NR
33–35
Athletes with AF
It is reasonable to offer high-level athletes AF as first-line therapy due to the
negative effects of medications on athletic performance.
IIa
C-LD
27
,
28
,
65
Asymptomatic AF
∗∗
Paroxysmal: Catheter ablation may be considered in select patients.
∗∗
IIb
C-EO
66
,
67
Persistent: Catheter ablation may be considered in select patients.
IIb
C-EO
68
Indications for surgical ablation of atrial fibrillation
C. Indications for concomitant open (such as mitral valve) surgical ablation of atrial
fibrillation
Symptomatic AF refractory or intolerant to at least one Class I or III antiarrhythmic
medication
Paroxysmal: Surgical ablation is recommended.
I
B-NR
69–82
Persistent: Surgical ablation is recommended.
I
B-NR
69–82
Long-standing persistent: Surgical ablation is recommended.
I
B-NR
69–82
Symptomatic AF prior to initiation of antiarrhythmic therapy with a Class I or III
antiarrhythmic medication
Paroxysmal: Surgical ablation is recommended.
I
B-NR
69–82
Persistent: Surgical ablation is recommended.
I
B-NR
69–82
Long-standing persistent: Surgical ablation is recommended.
I
B-NR
69–82
D. Indications for concomitant closed (such as CABG and AVR) surgical ablation of
atrial fibrillation
Symptomatic AF refractory or intolerant to at least one Class I or III antiarrhythmic
medication
Paroxysmal: Surgical ablation is recommended.
I
B-NR
83–88
Persistent: Surgical ablation is recommended.
I
B-NR
83–88
Long-standing persistent: Surgical ablation is recommended.
I
B-NR
83–88
Symptomatic AF prior to initiation of antiarrhythmic therapy with a Class I or III
antiarrhythmic medication
Paroxysmal: Surgical ablation is reasonable.
IIa
B-NR
83–88
Persistent: Surgical ablation is reasonable.
IIa
B-NR
83–88
Long-standing persistent: Surgical ablation is reasonable.
IIa
B-NR
83–88
E. Indications for stand-alone and hybrid surgical ablation of atrial fibrillation
Symptomatic AF refractory or intolerant to at least one Class I or III antiarrhythmic
medication
Paroxysmal: Stand-alone surgical ablation can be considered for patients who have
failed one or more attempts at catheter ablation and also for those who are intolerant
or refractory to antiarrhythmic drug therapy and prefer a surgical approach, after
review of the relative safety and efficacy of catheter ablation versus a stand-alone
surgical approach.
IIb
B-NR
83–85
,
89–103
Persistent: Stand-alone surgical ablation is reasonable for patients who have failed
one or more attempts at catheter ablation and also for those patients who prefer a
surgical approach after review of the relative safety and efficacy of catheter ablation
versus a stand-alone surgical approach.
IIa
B-NR
83–85
,
89–103
Long-standing persistent: Stand-alone surgical ablation is reasonable for patients
who have failed one or more attempts at catheter ablation and also for those patients
who prefer a surgical approach after review of the relative safety and efficacy of
catheter ablation versus a stand-alone surgical approach.
IIa
B-NR
83–85
,
89–103
It might be reasonable to apply the indications for stand-alone surgical ablation
described above to patients being considered for hybrid surgical AF ablation.
IIb
C-EO
103–108
AF, atrial fibrillation; LOE, Level of Evidence; HCM, hypertrophic cardiomyopathy.
∗∗
A decision to perform AF ablation in an asymptomatic patient requires additional discussion
with the patient because the potential benefits of the procedure for the patient without
symptoms are uncertain.
Figure 7
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 persistent AF. The Class for each indication based on whether ablation
is performed after failure of antiarrhythmic drug therapy or as first-line therapy
is shown. Please refer to Table 2B and the text for the indications for catheter ablation
of asymptomatic AF.
Figure 8
Indications for surgical ablation of atrial fibrillation. Shown in this figure are
the indications for surgical ablation of paroxysmal, persistent, and long-standing
persistent AF. The Class for each indication based on whether ablation is performed
after failure of antiarrhythmic drug therapy or as first-line therapy is shown. The
indications for surgical AF ablation are divided into whether the AF ablation procedure
is performed concomitantly with an open surgical procedure (such as mitral valve replacement),
a closed surgical procedure (such as coronary artery bypass graft surgery), or as
a stand-alone surgical AF ablation procedure performed solely for treatment of atrial
fibrillation.
Section 5: Strategies, Techniques, and Endpoints
The writing group recommendations for techniques to be used for ablation of persistent
and long-standing persistent AF (Table 3
), adjunctive ablation strategies, nonablative strategies to improve outcomes of AF
ablation, and endpoints for ablation of paroxysmal, persistent, and long-standing
persistent AF are covered in this section. A schematic overview of common lesion sets
created during an AF ablation procedure is shown in Figure 6
.
Table 3
Atrial fibrillation ablation: strategies, techniques, and endpoints
Recommendation
Class
LOE
References
PV isolation by catheter ablation
Electrical isolation of the PVs is recommended during all AF ablation procedures.
I
A
7–16
,
19–26
,
109
Achievement of electrical isolation requires, at a minimum, assessment and demonstration
of entrance block into the PV.
I
B-R
7–16
,
19–26
,
109
Monitoring for PV reconnection for 20 minutes following initial PV isolation is reasonable.
IIa
B-R
9
,
110–120
Administration of adenosine 20 minutes following initial PV isolation using RF energy
with reablation if PV reconnection might be considered.
IIb
B-R
109
,
111–114
,
120–128
Use of a pace-capture (pacing along the ablation line) ablation strategy may be considered.
IIb
B-R
129–133
Demonstration of exit block may be considered.
IIb
B-NR
134–139
Ablation strategies to be considered for use in conjunction with PV isolation
If a patient has a history of typical atrial flutter or typical atrial flutter is
induced at the time of AF ablation, delivery of a cavotricuspid isthmus linear lesion
is recommended.
I
B-R
140–143
If linear ablation lesions are applied, operators should use mapping and pacing maneuvers
to assess for line completeness.
I
C-LD
19
,
141–149
If a reproducible focal trigger that initiates AF is identified outside the PV ostia
at the time of an AF ablation procedure, ablation of the focal trigger should be considered.
IIa
C-LD
150–161
When performing AF ablation with a force-sensing RF ablation catheter, a minimal targeted
contact force of 5 to 10 grams is reasonable.
IIa
C-LD
13
,
14
,
128
,
162–178
Posterior wall isolation might be considered for initial or repeat ablation of persistent
or long-standing persistent AF.
IIb
C-LD
21
,
179–185
Administration of high-dose isoproterenol to screen for and then ablate non-PV triggers
may be considered during initial or repeat AF ablation procedures in patients with
paroxysmal, persistent, or long-standing persistent AF.
IIb
C-LD
150–161
DF-based ablation strategy is of unknown usefulness for AF ablation.
IIb
C-LD
186–193
The usefulness of creating linear ablation lesions in the right or left atrium as
an initial or repeat ablation strategy for persistent or long-standing persistent
AF is not well established.
IIb
B-NR
19
,
20
,
142
,
145–149
,
194–201
The usefulness of linear ablation lesions in the absence of macroreentrant atrial
flutter is not well established.
IIb
C-LD
19
,
20
,
142
,
145–149
,
194–201
The usefulness of mapping and ablation of areas of abnormal myocardial tissue identified
with voltage mapping or MRI as an initial or repeat ablation strategy for persistent
or long-standing persistent AF is not well established.
IIb
B-R
179
,
202–211
The usefulness of ablation of complex fractionated atrial electrograms as an initial
or repeat ablation strategy for persistent and long-standing persistent AF is not
well established.
IIb
B-R
19
,
20
,
195–197
,
212–220
The usefulness of ablation of rotational activity as an initial or repeat ablation
strategy for persistent and long-standing persistent AF is not well established.
IIb
B-NR
221–241
The usefulness of ablation of autonomic ganglia as an initial or repeat ablation strategy
for paroxysmal, persistent, and long-standing persistent AF is not well established.
IIb
B-NR
19
,
89
,
242–259
Nonablation strategies to improve outcomes
Weight loss can be useful for patients with AF, including those who are being evaluated
to undergo an AF ablation procedure, as part of a comprehensive risk factor management
strategy.
IIa
B-R
260–288
It is reasonable to consider a patient's BMI when discussing the risks, benefits,
and outcomes of AF ablation with a patient being evaluated for an AF ablation procedure.
IIa
B-R
260–288
It is reasonable to screen for signs and symptoms of sleep apnea when evaluating a
patient for an AF ablation procedure and to recommend a sleep evaluation if sleep
apnea is suspected.
IIa
B-R
270
,
276–278
,
289–307
Treatment of sleep apnea can be useful for patients with AF, including those who are
being evaluated to undergo an AF ablation procedure.
IIa
B-R
270
,
276–278
,
289–307
The usefulness of discontinuation of antiarrhythmic drug therapy prior to AF ablation
in an effort to improve long-term outcomes is unclear.
IIb
C-LD
308–312
The usefulness of initiation or continuation of antiarrhythmic drug therapy during
the postablation healing phase in an effort to improve long-term outcomes is unclear.
IIb
C-LD
308–312
Strategies to reduce the risks of AF ablation
Careful identification of the PV ostia is mandatory to avoid ablation within the PVs.
I
B-NR
313–335
It is recommended that RF power be reduced when creating lesions along the posterior
wall near the esophagus.
I
C-LD
68
,
336–365
It is reasonable to use an esophageal temperature probe during AF ablation procedures
to monitor esophageal temperature and help guide energy delivery.
IIa
C-EO
68
,
336
,
345
,
365
AF, atrial fibrillation; LOE, Level of Evidence; PV, pulmonary vein; RF, radiofrequency;
MRI, magnetic resonance imaging; BMI, body mass index.
Section 6: Technology and Tools
This section of the consensus statement provides an update on many of the technologies
and tools that are employed for AF ablation procedures. It is important to recognize
that this is not a comprehensive listing and that new technologies, tools, and approaches
are being developed. It is also important to recognize that radiofrequency (RF) energy
is the dominant energy source available for ablation of typical and atypical atrial
flutter (AFL). Although cryoablation is a commonly employed tool for AF ablation,
it is not well suited for ablation of typical or atypical AFL. Other energy sources
and tools are available in some parts of the world and/or are in various stages of
development and/or clinical investigation. Shown in Figure 9
are schematic drawings of AF ablation using point-by-point RF energy (Figure 9A) and
AF ablation using the cryoballoon (CB) system (Figure 9B).
Figure 9
Schematic drawing showing catheter ablation of atrial fibrillation using either RF
energy or cryoballoon AF ablation. (A) Shows a typical wide area lesion set created
using RF energy. Ablation lesions are delivered in a figure of eight pattern around
the left and right PV veins. Also shown is a linear cavotricuspid isthmus lesion created
for ablation of typical atrial flutter in a patient with a prior history of typical
atrial flutter or inducible isthmus-dependent typical atrial flutter at the time of
ablation. A multielectrode circular mapping catheter is positioned in the left inferior
PV. (B) Shows an ablation procedure using the cryoballoon system. Ablation lesions
have been created surrounding the right PVs, and the cryoballoon ablation catheter
is positioned in the left superior PV. A through the lumen multielectrode circular
mapping catheter is positioned in the left superior PV. Illustration: Tim Phelps ©
2017 Johns Hopkins University, AAM.
Section 7: Technical Aspects of Ablation to Maximize Safety and Anticoagulation
Anticoagulation strategies pre-, during, and postcatheter ablation of AF (Table 4
); signs and symptoms of complications that can occur within the first several months
following ablation (Table 5
); anesthesia or sedation during ablation; and approaches to minimize risk of an atrial
esophageal fistula are discussed in this section.
Table 4
Anticoagulation strategies: pre-, during, and postcatheter ablation of AF
Recommendation
Class
LOE
References
Preablation
For patients undergoing AF catheter ablation who have been therapeutically anticoagulated
with warfarin or dabigatran, performance of the ablation procedure without interruption
of warfarin or dabigatran is recommended.
I
A
366–373
For patients undergoing AF catheter ablation who have been therapeutically anticoagulated
with rivaroxaban, performance of the ablation procedure without interruption of rivaroxaban
is recommended.
I
B-R
374
For patients undergoing AF catheter ablation who have been therapeutically anticoagulated
with a NOAC other than dabigatran or rivaroxaban, performance of the ablation procedure
without withholding a NOAC dose is reasonable.
IIa
B-NR
375
Anticoagulation guidelines that pertain to cardioversion of AF should be adhered to
in patients who present for an AF catheter ablation procedure.
I
B-NR
5
,
6
For patients anticoagulated with a NOAC prior to AF catheter ablation, it is reasonable
to hold one to two doses of the NOAC prior to AF ablation with reinitiation postablation.
IIa
B-NR
372
,
376–380
Performance of a TEE in patients who are in AF on presentation for AF catheter ablation
and who have been receiving anticoagulation therapeutically for 3 weeks or longer
is reasonable.
IIa
C-EO
5
,
6
Performance of a TEE in patients who present for ablation in sinus rhythm and who
have not been anticoagulated prior to catheter ablation is reasonable.
IIa
C-EO
5
,
6
Use of intracardiac echocardiography to screen for atrial thrombi in patients who
cannot undergo TEE may be considered.
IIb
C-EO
381–386
During ablation
Heparin should be administered prior to or immediately following transseptal puncture
during AF catheter ablation procedures and adjusted to achieve and maintain an ACT
of at least 300 seconds.
I
B-NR
369
,
380–382
,
387–393
Administration of protamine following AF catheter ablation to reverse heparin is reasonable.
IIa
B-NR
394
Postablation
In patients who are not therapeutically anticoagulated prior to catheter ablation
of AF and in whom warfarin will be used for anticoagulation postablation, low molecular
weight heparin or intravenous heparin should be used as a bridge for initiation of
systemic anticoagulation with warfarin following AF ablation.∗
I
C-EO
Systemic anticoagulation with warfarin∗ or a NOAC is recommended for at least 2 months
postcatheter ablation of AF.
I
C-EO
1
,
2
Adherence to AF anticoagulation guidelines is recommended for patients who have undergone
an AF ablation procedure, regardless of the apparent success or failure of the procedure.
I
C-EO
5
,
6
Decisions regarding continuation of systemic anticoagulation more than 2 months post
ablation should be based on the patient's stroke risk profile and not on the perceived
success or failure of the ablation procedure.
I
C-EO
5
,
6
In patients who have not been anticoagulated prior to catheter ablation of AF or in
whom anticoagulation with a NOAC or warfarin has been interrupted prior to ablation,
administration of a NOAC 3 to 5 hours after achievement of hemostasis is reasonable
postablation.
IIa
C-EO
372
,
376–380
Patients in whom discontinuation of anticoagulation is being considered based on patient
values and preferences should consider undergoing continuous or frequent ECG monitoring
to screen for AF recurrence.
IIb
C-EO
AF, atrial fibrillation; LOE, Level of Evidence; NOAC, novel oral anticoagulant; TEE,
transesophageal electrocardiogram; ACT, activated clotting time.
∗Time in therapeutic range (TTR) should be > 65% – 70% on warfarin.
Table 5
Signs and symptoms following AF ablation
Differential
Suggested evaluation
Signs and symptoms of complications within a month postablation
Back pain
Musculoskeletal, retroperitoneal hematoma
Physical exam, CT imaging
Chest pain
Pericarditis, pericardial effusion, coronary stenosis (ablation related), pulmonary
vein stenosis, musculoskeletal (after cardioversion), worsening reflux
Physical exam, chest X-ray, ECG, echocardiogram, stress test, cardiac catheterization,
chest CT
Cough
Infectious process, bronchial irritation (mechanical, cryoballoon), pulmonary vein
stenosis
Physical exam, chest X-ray, chest CT
Dysphagia
Esophageal irritation (related to transesophageal echocardiography), atrioesophageal
fistula
Physical exam, chest CT or MRI
Early satiety, nausea
Gastric denervation
Physical exam, gastric emptying study
Fever
Infectious process, pericarditis, atrioesophageal fistula
Physical exam, chest X-ray, chest CT, urinalysis, laboratory blood work
Fever, dysphagia, neurological symptoms
Atrial esophageal fistula
Physical exam, laboratory blood work, chest CT or MRI; avoid endoscopy with air insufflation
Groin pain at site of access
Pseudoaneurysm, AV fistula, hematoma
Ultrasound of the groin, laboratory blood work; consider CT scan if ultrasound negative
Headache
Migraine (related to anesthesia or transseptal access, hemorrhagic stroke), effect
of general anesthetic
Physical exam, brain imaging (MRI)
Hypotension
Pericardial effusion/tamponade, bleeding, sepsis, persistent vagal reaction
Echocardiography, laboratory blood work
Hemoptysis
PV stenosis or occlusion, pneumonia
Chest X-ray, chest CT or MR scan, VQ scan
Neurological symptoms
Cerebral embolic event, atrial esophageal fistula
Physical exam, brain imaging, chest CT or MRI
Shortness of breath
Volume overload, pneumonia, pulmonary vein stenosis, phrenic nerve injury
Physical exam, chest X-ray, chest CT, laboratory blood work
Signs and symptoms of complications more than a month postablation
Fever, dysphagia, neurological symptoms
Atrial esophageal fistula
Physical exam, laboratory blood work, chest CT or MRI; avoid endoscopy with air insufflation
Persistent cough, atypical chest pain
Infectious process, pulmonary vein stenosis
Physical exam, laboratory blood work, chest X-ray, chest CT or MRI
Neurological symptoms
Cerebral embolic event, atrial esophageal fistula
Physical exam, brain imaging, chest CT or MRI
Hemoptysis
PV stenosis or occlusion, pneumonia
CT scan, VQ scan
AF, atrial fibrillation; ECG, electrocardiogram; CT, computed tomography; MRI, magnetic
resonance imaging; VQ, ventilation-perfusion.
Section 8: Follow-up Considerations
AF ablation is an invasive procedure that entails risks, most of which are present
during the acute procedural period. However, complications can also occur in the weeks
or months following ablation. Recognizing common symptoms after AF ablation and distinguishing
those that require urgent evaluation and referral to an electrophysiologist is an
important part of follow-up after AF ablation. The success of AF ablation is based
in large part on freedom from AF recurrence based on ECG monitoring. Arrhythmia monitoring
can be performed with the use of noncontinuous or continuous ECG monitoring tools
(Table 6
). This section also discusses the important topics of AAD and non-AAD use prior to
and following AF ablation, the role of cardioversion, as well as the indications for
and timing of repeat AF ablation procedures.
Table 6
Types of ambulatory cardiac monitoring devices
Type of recorder
Typical monitoring duration
Continuous recording
Event recording
Auto trigger
Unique features
Holter monitor
24–48 hours, approximately 7–30 days
Yes
Yes
N/A
Short term, provides quantitative data on arrhythmia burden
Patch monitor
1–3 weeks
Yes
Yes
N/A
Intermediate term, can provide continuous data for up to several weeks; improved patient
compliance without lead wires
External loop recorder
1 month
Yes
Yes
Variable
Good correlation between symptoms and even brief arrhythmias
External nonloop recorder
Months
No
Yes
No
May be used long term and intermittently; will not capture very brief episodes
Smartphone monitor
Indefinite
No
Yes
No
Provides inexpensive long-term intermittent monitoring; dependent on patient compliance;
requires a smartphone
Mobile cardiac telemetry
30 days
Yes
Yes
Yes
Real time central monitoring and alarms; relatively expensive
Implantable loop recorder
Up to 3 years
Yes
Yes
Yes
Improved patient compliance for long-term use; not able to detect 30-second episodes
of AF due to detection algorithm; presence of AF needs to be confirmed by EGM review
because specificity of detection algorithm is imperfect; expensive
Pacemakers or ICDs with atrial leads
Indefinite
Yes
Yes
Yes
Excellent AF documentation of burden and trends; presence of AF needs to be confirmed
by electrogram tracing review because specificity of detection algorithms is imperfect;
expensive
Wearable multisensor ECG monitors
Indefinite
Yes
Yes
Yes
ECG 3 leads, temp, heart rate, HRV, activity tracking, respiratory rate, galvanic
skin response
AF, atrial fibrillation; ICD, implantable cardioverter defibrillator; ECG, electrocardiogram;
HRV, heart rate variability.
Section 9: Outcomes and Efficacy
This section provides a comprehensive review of the outcomes of catheter ablation
of AF. Table 7
summarizes the main findings of the most important clinical trials in this field.
Outcomes of AF ablation in subsets of patients not well represented in these trials
are reviewed. Outcomes for specific ablation systems and strategies (CB ablation,
rotational activity ablation, and laser balloon ablation) are also reviewed.
Table 7
Selected clinical trials of catheter ablation of atrial fibrillation and/or for FDA
approval
Trial
Year
Type
N
AF type
Ablation strategy
Initial time frame
Effectiveness endpoint
Ablation success
Drug/ Control success
P value for success
Ablation complications
Drug/ Control complications
Comments
Clinical Trials Performed for FDA Approval
JAMA 2010; 303: 333-340 (ThermoCool AF)
14
2010
Randomized to RF ablation or AAD, multicenter
167
Paroxysmal
PVI, optional CFAEs and lines
12 months
Freedom from symptomatic paroxysmal atrial fibrillation, acute procedural failure,
or changes in specified drug regimen
66%
16%
<0.001
4.9%
8.8%
FDA approval received
JACC 2013; 61: 1713-1723 (STOP AF)
9
2013
Randomized to cryoballoon ablation or AAD, multicenter
245
Paroxysmal
PVI
12 months
Freedom from any detectable AF, use of nonstudy AAD, or nonprotocol intervention for
AF
70%
7%
<0.001
3.1%
NA
FDA approval received
Heart Rhythm 2014; 11: 202-209 (TTOP)
22
2014
Randomized to phased RF ablation or AAD/cardioversion, multicenter
210
Persistent
PVI + CFAEs
6 months
Acute procedural success, ≥90% reduction in AF burden, off AAD
56%
26%
<0.001
12.3%
NA
Not FDA approved
JACC 2014; 64: 647-656 (SMART-AF)
13
2014
Nonrandomzied multicenter study of contact force-sensing RF catheter, comparing to
performance goals
172
Paroxysmal
PVI, optional CFAEs and lines
12 months
Freedom from symptomatic AF, flutter, tachycardia, acute procedural failure, or changes
in AAD
72.5%
N/A
<0.0001
7.5%
NA
FDA approval received
Circulation 2015; 132: 907-915 (TOCCASTAR)
12
2015
Randomized to contact force sensing RF catheter or approved RF catheter, multicenter
300
Paroxysaml
PVI, optional triggers, CAFEs and lines in both arms
12 months
Acute procedural success + Freedom from Symptomatic AF/Flutter/Tachycardia off AAD
67.8%
69.4%
0.0073 for noninferiority
7.2%
9.1%
FDA approval received
JACC 2015; 66: 1350-1360 (HeartLight)
11
2015
Randomized to laserballoon or approved RF catheter, multicenter
353
Paroxysmal
PVI ± CTI ablation vs PVI, optional CFAEs, and Lines
12 months
Freedom from Symptomatic AF/Flutter/Tachycardia, acute procedural failure, AAD, or
non-prototocol intervention
61.1%
61.7%
0.003 for noninferiority
5.3%
6.4%
FDA approval received
First-Line Therapy Trials
JAMA 2005; 293: 2634-2640 (RAAFT)
29
2005
Randomized to drug, multicenter
70
Paroxysmal (N=67), persistent (N= 3)
PVI
12 months
Freedom from detectable AF
84%
37%
<0.01
9%
11%
NEJM 2012; 367:1587-1595 (MANTRA-PAF)
30
2012
Randomized to drug, multicenter
294
Paroxysmal AF
PVI, roof line, optional mitral and tricuspid line
24 months
Cumulative AF burden
13% AF burden
19% AF burden
NS
17%
15%
JAMA 2014; 311: 692-700 (RAAFT-2)
31
2014
Randomized to drug multicenter
127
Paroxysmal AF
PVI plus optional non-PVI targets
24 months
Freedom from detectable AF, flutter, tachycardia
45%
28%
0.02
9%
4.9%
Other Paroxysmal AF Ablation Trials
JACC 2006; 48: 2340-2347 (APAF)
16
2006
Randomized to drug single center
198
Paroxysmal AF
PVI, mitral line and tricuspid line
12 months
Freedom from detectable AF, flutter, tachycardia
86%
22%
<0.001
1%
23%
Circulation 2008; 118: 2498-2505 (A4)
7
2008
Randomized to drug
112
Paroxysmal
PVI (optional LA lines, CTI, focal)
12 months
Freedom from AF
89%
23%
<0.0001
5.7%
1.7%
NEJM 2016; 374: 2235-2245 (FIRE AND ICE)
10
2016
Randomized RF vs Cryo, multicenter
762
Paroxysmal AF
PVI
12 months
Freedom from detectable AF, flutter, tachycardia
64.1% (RF)
65.4% (cryo)
NS
12.8%
10.2%
JACC 2016; 68: 2747-2757
15
2016
Randomized to hot balloon or drug, multicenter
100
Paroxysmal AF
PVI
12 months
Freedom from AF
59%
5%
<0.001
10.4%
4.7%
Other Persistent AF Ablation Trials
NEJM 2006; 354: 934-941
25
2006
Randomized to RF ablation or to CV and short term amio
146
Persistent
PVI, roof, mitral line
12 months
No AF or flutter month 12
74%
58%
0.05
1.3%
1.4%
EHJ 2014; 35: 501-507 (SARA)
26
2014
Randomized to drug (2:1 ablation to drug), multicenter
146
Persistent
PVI (optional LA lines, CFAEs)
12 months
Freedom from AF/flutter lasting >24h
70%
44%
0.002
6.1%
4.20%
NEJM 2015; 372: 1812-1822
19
2015
Randomized ablation strategies, multicenter
589
Persistent
PVI alone versus PVI & CFAEs or PVI & lines
18 months
Freedom from afib with or without drugs
59% (PVI alone)
49% & 46%
NS
6%
4.3% & 7.6%
Other Mixed Paroxysmal and Persistent AF Ablation Trials
J Med Assoc Thai 2003; 86 (Suppl 1): S8-S16
24
2003
Randomized to RF ablation or amiodarone
30
Paroxysmal (70%), Persistent (30%)
PVI, mitral line, CTI, SVC to IVC
12 months
Freedom from AF
79%
40%
0.018
6.70%
47%
EHJ 2006; 27: 216-221
17
2006
Randomized to RF ablation or drug, multicenter
137
Paroxysmal (67%), Persistent (33%)
PVI, mitral line, CTI
12 months
Freedom from AF, flutter, tachycardia
66%
9%
<0.001
4.40%
2.90%
JCVEP 2009, 20: 22-28
18
2009
Randomized to RF ablation or drug, multicenter
70
Paroxysmal (41%), Persistent (59%) & type 2 DM
PVI, CTI, optional mitral line and roof line
12 months
Freedom from AF and atypical atrial flutter
80%
43%
0.001
2.90%
17%
Randomized Trials of AF Ablation in Patients with Heart Failure
NEJM 2008; 359: 1778-1785 (PABA-HF)
38
2008
Randomized to RF ablation of AVJ abl and BiV pacing
81
Persistent (50%), Paroxysmal (50%), EF 27% abl, 29% AVJ
PVI, optional linear abl and CFAEs
6 months
Composite EF, 6 min walk, MLWHF score; freedom from AF (secondary, mult proc, +/-
AA drugs)
88% AF free, EF 35% abl, 28% AVJ (P <.001), > QOL and 6 min walk increase with abl
<0.001
14.60%
17.50%
Heart 2011; 97: 740-747
39
2011
Randomized to RF ablation or pharmacological rate control
41
Persistent, EF 20% abl, 16% rate control
PVI, roof line, CFAEs
6 months
Change in LVEF, sinus rhythm at 6 months (secondary)
50% in NSR, LVEF increase 4.5%
0% in NSR, LVEF increase 2.8%
0.6 (for EF increase)
15%
Not reported
JACC 2013; 61: 1894-1903
46
2013
Randomized to RF ablation or pharmacological rate control
52
Persistent AF (100%), EF 22% abl, 25% rate control
PVI, optional linear abl and CFAEs
12 months
Change in peak O2 consumption (also reported single procedure off drug ablation success)
Peak O2 consumption increase greater with abl, 72% abl success
0.018
15%
Not reported
Circ A and E 2014; 7: 31-38
40
2014
Randomized to RF ablation or pharmacological rate control
50
Persistent AF (100%), EF 32% abl, 34% rate control
PVI, optional linear abl and CFAEs
6 months
Change in LVEF at 6 months, multiple procedure freedom from AF also reported
LVEF 40% with abl, 31% rate control, 81% AF free with abl
0.015
7.70%
AF, atrial fibrillation; RF, radiofrequency; AVJ, atrioventricular junction; abl,
ablation; BiV, biventricular; EF, ejection fraction; PVI, pulmonary vein isolation;
CFAEs, complex fractionated atrial electrograms; MLWHF, Minnesota Living with Heart
Failure; LVEF, left ventricular ejection fraction; QOL, quality of life; NSR, normal
sinus rhythm.
Section 10: Complications
Catheter ablation of AF is one of the most complex interventional electrophysiological
procedures. AF ablation by its nature involves catheter manipulation and ablation
in the delicate thin-walled atria, which are in close proximity to other important
organs and structures that can be impacted through collateral damage. It is therefore
not surprising that AF ablation is associated with a significant risk of complications,
some of which might result in life-long disability and/or death. This section reviews
the complications associated with catheter ablation procedures performed to treat
AF. The types and incidence of complications are presented, their mechanisms are explored,
and the optimal approach to prevention and treatment is discussed (Tables 8
and
9
).
Table 8
Definitions of complications associated with AF ablation
Asymptomatic cerebral embolism
Asymptomatic cerebral embolism is defined as an occlusion of a blood vessel in the
brain due to an embolus that does not result in any acute clinical symptoms. Silent
cerebral embolism is generally detected using a diffusion weighted MRI.
Atrioesophageal fistula
An atrioesophageal fistula is defined as a connection between the atrium and the lumen
of the esophagus. Evidence supporting this diagnosis includes documentation of esophageal
erosion combined with evidence of a fistulous connection to the atrium, such as air
emboli, an embolic event, or direct observation at the time of surgical repair. A
CT scan or MRI scan is the most common method of documentation of an atrioesophageal
fistula.
Bleeding
Bleeding is defined as a major complication of AF ablation if it requires and/or is
treated with transfusion or results in a 20% or greater fall in hematocrit.
Bleeding following cardiac surgery
Excessive bleeding following a surgical AF ablation procedure is defined as bleeding
requiring reoperation or ≥ 2 units of PRBC transfusion within any 24 hours of the
first 7 days following the index procedure.
Cardiac perforation
We recommend that cardiac perforation be defined together with cardiac tamponade.
See “Cardiac tamponade/perforation.”
Cardiac tamponade
We recommend that cardiac tamponade be defined together with cardiac perforation.
See “Cardiac tamponade/perforation.”
Cardiac tamponade/perforation
Cardiac tamponade/perforation is defined as the development of a significant pericardial
effusion during or within 30 days of undergoing an AF ablation procedure. A significant
pericardial effusion is one that results in hemodynamic compromise, requires elective
or urgent pericardiocentesis, or results in a 1-cm or more pericardial effusion as
documented by echocardiography. Cardiac tamponade/perforation should also be classified
as “early” or “late” depending on whether it is diagnosed during or following initial
discharge from the hospital.
Deep sternal wound infection/mediastinitis following cardiac surgery
Deep sternal wound infection/mediastinitis following cardiac surgery requires one
of the following: (1) an organism isolated from culture of mediastinal tissue or fluid;
(2) evidence of mediastinitis observed during surgery; (3) one of the following conditions:
chest pain, sternal instability, or fever (>38 °C), in combination with either purulent
discharge from the mediastinum or an organism isolated from blood culture or culture
of mediastinal drainage.
Esophageal injury
Esophageal injury is defined as an erosion, ulceration, or perforation of the esophagus.
The method of screening for esophageal injury should be specified. Esophageal injury
can be a mild complication (erosion or ulceration) or a major complication (perforation).
Gastric motility/pyloric spasm disorders
Gastric motility/pyloric spasm disorder should be considered a major complication
of AF ablation when it prolongs or requires hospitalization, requires intervention,
or results in late disability, such as weight loss, early satiety, diarrhea, or GI
disturbance.
Major complication
A major complication is a complication that results in permanent injury or death,
requires intervention for treatment, or prolongs or requires hospitalization for more
than 48 hours. Because early recurrences of AF/AFL/AT are to be expected following
AF ablation, recurrent AF/AFL/AT within 3 months that requires or prolongs a patient's
hospitalization should not be considered to be a major complication of AF ablation.
Mediastinitis
Mediastinitis is defined as inflammation of the mediastinum. Diagnosis requires one
of the following: (1) an organism isolated from culture of mediastinal tissue or fluid;
(2) evidence of mediastinitis observed during surgery; (3) one of the following conditions:
chest pain, sternal instability, or fever (>38 °C), in combination with either purulent
discharge from the mediastinum or an organism isolated from blood culture or culture
of mediastinal drainage.
Myocardial infarction in the context of AF ablation
The universal definition of myocardial infarction
395
cannot be applied in the context of catheter or surgical AF ablation procedures because
it relies heavily on cardiac biomarkers (troponin and CPK), which are anticipated
to increase in all patients who undergo AF ablation as a result of the ablation of
myocardial tissue. Similarly, chest pain and other cardiac symptoms are difficult
to interpret in the context of AF ablation both because of the required sedation and
anesthesia and also because most patients experience chest pain following the procedure
as a result of the associated pericarditis that occurs following catheter ablation.
We therefore propose that a myocardial infarction, in the context of catheter or surgical
ablation, be defined as the presence of any one of the following criteria: (1) detection
of ECG changes indicative of new ischemia (new ST-T wave changes or new LBBB) that
persist for more than 1 hour; (2) development of new pathological Q waves on an ECG;
(3) imaging evidence of new loss of viable myocardium or new regional wall motion
abnormality.
Pericarditis
Pericarditis should be considered a major complication following ablation if it results
in an effusion that leads to hemodynamic compromise or requires pericardiocentesis,
prolongs hospitalization by more than 48 hours, requires hospitalization, or persists
for more than 30 days following the ablation procedure.
Phrenic nerve paralysis
Phrenic nerve paralysis is defined as absent phrenic nerve function as assessed by
a sniff test. A phrenic nerve paralysis is considered to be permanent when it is documented
to be present 12 months or longer following ablation.
Pulmonary vein stenosis
Pulmonary vein stenosis is defined as a reduction of the diameter of a PV or PV branch.
PV stenosis can be categorized as mild <50%, moderate 50%–70%, and severe ≥70% reduction
in the diameter of the PV or PV branch. A severe PV stenosis should be considered
a major complication of AF ablation.
Serious adverse device effect
A serious adverse device effect is defined as a serious adverse event that is attributed
to use of a particular device.
Stiff left atrial syndrome
Stiff left atrial syndrome is a clinical syndrome defined by the presence of signs
of right heart failure in the presence of preserved LV function, pulmonary hypertension
(mean PA pressure >25 mm Hg or during exercise >30 mm Hg), and large V waves ≥10 mm
Hg or higher) on PCWP or left atrial pressure tracings in the absence of significant
mitral valve disease or PV stenosis.
Stroke or TIA postablation
Stroke diagnostic criteria
Rapid onset of a focal or global neurological deficit with at least one of the following:
change in level of consciousness, hemiplegia, hemiparesis, numbness or sensory loss
affecting one side of the body, dysphasia or aphasia, hemianopia, amaurosis fugax,
or other neurological signs or symptoms consistent with stroke
Duration of a focal or global neurological deficit ≥24 hours; OR < 24 hours if therapeutic
intervention(s) were performed (e.g., thrombolytic therapy or intracranial angioplasty);
OR available neuroimaging documents a new hemorrhage or infarct; OR the neurological
deficit results in death.
No other readily identifiable nonstroke cause for the clinical presentation (e.g.,
brain tumor, trauma, infection, hypoglycemia, peripheral lesion, pharmacological influences).
∗
Confirmation of the diagnosis by at least one of the following: neurology or neurosurgical
specialist; neuroimaging procedure (MRI or CT scan or cerebral angiography); lumbar
puncture (i.e., spinal fluid analysis diagnostic of intracranial hemorrhage)
Stroke definitions
Transient ischemic attack: new focal neurological deficit with rapid symptom resolution
(usually 1 to 2 hours), always within 24 hours; neuroimaging without tissue injury
Stroke: (diagnosis as above, preferably with positive neuroimaging study);
Minor—Modified Rankin score <2 at 30 and 90 days
†
Major—Modified Rankin score ≥2 at 30 and 90 days
Unanticipated adverse device effect
Unanticipated adverse device effect is defined as complication of an ablation procedure
that has not been previously known to be associated with catheter or surgical ablation
procedures.
Vagal nerve injury
Vagal nerve injury is defined as injury to the vagal nerve that results in esophageal
dysmotility or gastroparesis. Vagal nerve injury is considered to be a major complication
if it prolongs hospitalization, requires hospitalization, or results in ongoing symptoms
for more than 30 days following an ablation procedure.
Vascular access complication
Vascular access complications include development of a hematoma, an AV fistula, or
a pseudoaneurysm. A major vascular complication is defined as one that requires intervention,
such as surgical repair or transfusion, prolongs the hospital stay, or requires hospital
admission.
AF, atrial fibrillation; CT, computed tomography; MRI, magnetic resonance imaging;
PRBC, packed red blood cell; AFL, atrial flutter; AT, atrial tachycardia; CPK, creatine
phosphokinase; ECG, electrocardiogram; LBBB, left bundle branch block.
∗Patients with nonfocal global encephalopathy will not be reported as a stroke without
unequivocal evidence based on neuroimaging studies.
†
Modified Rankin score assessments should be made by qualified individuals according
to a certification process. If there is discordance between the 30- and 90-day modified
Rankin scores, a final determination of major versus minor stroke will be adjudicated
by the neurology members of the clinical events committee.
Table 9
Incidence, prevention, diagnosis, and treatment of selected complications of AF ablation
Complication
Incidence
Selected prevention techniques
Diagnostic testing
Selected treatment options
References
Air embolism
<1%
Sheath management
Nothing or cardiac catheterization
Supportive care with fluid, oxygen, head down tilt, hyperbaric oxygen
388
,
396–401
Asymptomatic cerebral emboli (ACE)
2% to 15%
Anticoagulation, catheter and sheath management, TEE
Brain MRI
None
402–419
Atrial esophageal fistula
0.02% to 0.11%
Reduce power, force, and RF time on posterior wall, monitor esophageal temp, use proton
pump inhibitors; avoid energy delivery over esophagus
CT scan of chest, MRI; avoid endoscopy with air insufflation
Surgical repair
337–365
,
420–456
Cardiac tamponade
0.2% to 5%
Cather manipulation, transseptal technique, reduce power, force, and RF time
Echocardiography
Pericardiocentesis or surgical drainage
338
,
343
,
347
,
457–467
Coronary artery stenosis/occlusion
<0.1%
Avoid high-power energy delivery near coronary arteries
Cardiac catheterization
PTCA
468–476
Death
<0.1% to 0.4%
Meticulous performance of procedure, attentive postprocedure care
NA
NA
338
,
343
,
347
,
458
,
477
Gastric hypomotility
0% to 17%
Reduce power, force, and RF time on posterior wall
Endoscopy, barium swallow, gastric emptying study
Metoclopramide, possibly intravenous erythromycin
478–490
Mitral valve entrapment
<0.1%
Avoid circular catheter placement near or across mitral valve; clockwise torque on
catheter
Echocardiography
Gentle catheter manipulation, surgical extraction
491–498
Pericarditis
0% to 50%
None proven
Clinical history, ECG, sedimentation rate, echocardiogram
NSAID, colchicine, steroids
499–506
Permanent phrenic nerve paralysis
0% to 0.4%
Monitor diaphragm during phrenic pacing, CMAP monitoring, phrenic pacing to identify
location and adjust lesion location
CXR, sniff test
Supportive care
9
,
11
,
156
,
347
,
367
,
446
,
457
,
478
,
479
,
487–490
,
507–528
Pulmonary vein stenosis
<1%
Avoid energy delivery within PV
CT or MRI, V/Q wave scan
Angioplasty, stent, surgery
9
,
11
,
313
,
316–335
,
457
,
529–531
Radiation injury
<0.1%
Minimize fluoroscopy exposure, especially in obese and repeat ablation patients, X-ray
equipment
None
Supportive care, rarely skin graft
513
,
532–550
Stiff left atrial syndrome
<1.5%
Limit extent of left atrial ablation
Echocardiography, cardiac catheterization
Diuretics
551–558
Stroke and TIA
0% to 2%
Pre-, post-, and intraprocedure anticoagulation, catheter and sheath management, TEE
Head CT or MRI, cerebral angiography
Thrombolytic therapy, angioplasty
10–13
,
338
,
347
,
367
,
458
,
559–565
Vascular complications
0.2% to 1.5%
Vascular access techniques, ultrasound-guided access, anticoagulation management
Vascular ultrasound, CT scan
Conservative treatment, surgical repair, transfusion
338
,
347
,
371
,
373
,
374
,
380
,
458
,
511
,
566–575
AF, atrial fibrillation; CT, computed tomography; MRI, magnetic resonance imaging;
TEE, transesophageal electrocardiogram; RF, radiofrequency; PTCA, percutaneous transluminal
coronary angioplasty; NA, not applicable; ECG, electrocardiogram; NSAID, nonsteroidal
anti-inflammatory drug; CMAP, compound motor action potentials; CXR, chest X-ray;
TIA, transient ischemic attack.
Section 11: Training Requirements
This section of the document outlines the training requirements for those who wish
to perform catheter ablation of AF.
Section 12: Surgical and Hybrid AF Ablation
Please refer to Table 2
and Figure 8
presented earlier in this Executive Summary.
Section 13: Clinical Trial Design
Although there have been many advances made in the field of catheter and surgical
ablation of AF, there is still much to be learned about the mechanisms of initiation
and maintenance of AF and how to apply this knowledge to the still-evolving techniques
of AF ablation. Although single-center, observational reports have dominated the early
days of this field, we are quickly moving into an era in which hypotheses are put
through the rigor of testing in well-designed, randomized, multicenter clinical trials.
It is as a result of these trials that conventional thinking about the best techniques,
success rates, complication rates, and long-term outcomes beyond AF recurrence—such
as thromboembolism and mortality—is being put to the test. The ablation literature
has also seen a proliferation of meta-analyses and other aggregate analyses, which
reinforce the need for consistency in the approach to reporting the results of clinical
trials. This section reviews the minimum requirements for reporting on AF ablation
trials. It also acknowledges the potential limitations of using specific primary outcomes
and emphasizes the need for broad and consistent reporting of secondary outcomes to
assist the end-user in determining not only the scientific, but also the clinical
relevance of the results (Tables 10–13
).
Table 10
Definitions for use when reporting outcomes of AF ablation and in designing clinical
trials of catheter or surgical ablation of AF
Acute procedural success (pulmonary vein isolation)
Acute procedural success is defined as electrical isolation of all pulmonary veins.
A minimal assessment of electrical isolation of the PVs should consist of an assessment
of entrance block. If other methods are used to assess PVI, including exit block and/or
the use of provocative agents such as adenosine or isoproterenol, they should be prespecified.
Furthermore, it is recommended that the wait time used to screen for early recurrence
of PV conduction once initial electrical isolation is documented be specified in all
prospective clinical trials.
Acute procedural success (not related by pulmonary vein isolation)
Typically, this would apply to substrate ablation performed in addition to PVI for
persistent AF. Although some have proposed AF termination as a surrogate for acute
procedural success, its relationship to long-term success is controversial. Complete
elimination of the additional substrate (localized rotational activation, scar region,
non-PV trigger, or other target) and/or demonstration of bidirectional conduction
block across a linear ablation lesion would typically be considered the appropriate
endpoint.
One-year success∗
One-year success is defined as freedom from AF/AFL/AT after removal from antiarrhythmic
drug therapy as assessed from the end of the 3month blanking period to 12 months following
the ablation procedure. Because cavotricuspid isthmus-dependent atrial flutter is
easily treated with cavotricuspid isthmus ablation and is not an iatrogenic arrhythmia
following a left atrial ablation procedure for AF, it is reasonable for clinical trials
to choose to prespecify that occurrence of isthmus-dependent atrial flutter, if confirmed
by entrainment maneuvers during electrophysiology testing, should not be considered
an ablation failure or primary effectiveness endpoint.
Alternative one-year success
Although the one-year success definition provided above remains the recommended end
point that should be reported in all AF ablation trials, and the endpoint for which
the objective performance criteria listed below were developed, the Task Force recognizes
that alternative definitions for success can be used if the main goal of therapy in
the study is to relieve AF-related symptoms and to improve patient QOL. In particular,
it is appropriate for clinical trials to define success as freedom from only symptomatic
AF/AFL/AT after removal from antiarrhythmic drug therapy as assessed from the end
of the 3-month blanking period to 12 months following the ablation procedure if the
main goal of therapy in the study is to relieve AF-related symptoms and to improve
patient QOL. However, because symptoms of AF can resolve over time, and because studies
have shown that asymptomatic AF represents a greater proportion of all AF postablation
than prior to ablation, clinical trials need to continue to report freedom from both
symptomatic and asymptomatic AF even if this alternative one year success definition
is used as the primary trial endpoint.
Clinical/partial success∗
It is reasonable for clinical trials to define and incorporate one or more secondary
definitions of success that can be referred to as “clinical success” or “partial success.”
If these alternative definitions of success are included, they should be defined prospectively.
In prior Consensus Documents the Task Force has proposed that clinical/partial success
be defined as a “75% or greater reduction in the number of AF episodes, the duration
of AF episodes, or the % time a patient is in AF as assessed with a device capable
of measuring AF burden in the presence or absence of previously ineffective antiarrhythmic
drug therapy.” Because there is no firm scientific basis for selecting the cutoff
of 75% rather than a different cutoff, this prior recommendation is provided only
as an example of what future clinical trials may choose to use as a definition of
clinical/partial success.
Long-term success∗
Long-term success is defined as freedom from AF/AFL/AT recurrences following the 3-month
blanking period through a minimum of 36-month follow-up from the date of the ablation
procedure in the absence of Class I and III antiarrhythmic drug therapy.
Recurrent AF/AFL/AT
Recurrent AF/AFL/AT is defined as AF/AFL/AT of at least 30 seconds' duration that
is documented by an ECG or device recording system and occurs following catheter ablation.
Recurrent AF/AFL/AT may occur within or following the post ablation blanking period.
Recurrent AF/AFL/AT that occurs within the postablation blanking period is not considered
a failure of AF ablation.
Early recurrence of AF/AFL/AT
Early recurrence of AF/AFL/AT is defined as a recurrence of atrial fibrillation within
three months of ablation. Episodes of atrial tachycardia or atrial flutter should
also be classified as a “recurrence.” These are not counted toward the success rate
if a blanking period is specified.
Recurrence of AF/AFL/AT
Recurrence of AF/AFL/AT postablation is defined as a recurrence of atrial fibrillation
more than 3 months following AF ablation. Episodes of atrial tachycardia or atrial
flutter should also be classified as a “recurrence.”
Late recurrence of AF/ AFL/AT
Late recurrence of AF/AFL/AT is defined as a recurrence of atrial fibrillation 12 months
or more after AF ablation. Episodes of atrial tachycardia or atrial flutter should
also be classified as a “recurrence.”
Blanking period
A blanking period of three months should be employed after ablation when reporting
efficacy outcomes. Thus, early recurrences of AF/AFL/AT within the first 3 months
should not be classified as treatment failure. If a blanking period of less than 3 months
is chosen, it should be prespecified and included in the Methods section.
Stroke screening
A risk-based approach to determine the level of postablation stroke screening in clinical
trials is recommended by the Task Force. For ablation devices with a lower risk of
stroke and for which a stroke signal has not been reported, a minimum standardized
neurological assessment of stroke should be conducted by a physician at baseline and
at hospital discharge or 24 hours after the procedure, whichever is later. If this
neurological assessment demonstrates new abnormal findings, the patient should have
a formal neurological consult and examination with appropriate imaging (i.e., DW-MRI),
used to confirm any suspected diagnosis of stroke. For devices in which a higher risk
of stroke is suspected or revealed in prior trials, a formal neurological examination
by a neurologist at discharge or 24 hours after the procedure, whichever is later,
is recommended. Appropriate imaging should be obtained if this evaluation reveals
a new neurological finding. In some studies in which delayed stroke is a concern,
repeat neurological screening at 30 days postablation might be appropriate.
Detectable AF/AFL/AT
Detectable AF is defined as AF/AFL/AT of at least 30 seconds' duration when assessed
with ECG monitoring. If other monitoring systems are used, including implantable pacemakers,
implantable defibrillators, and subcutaneous ECG monitoring devices, the definition
of detectable AF needs to be prespecified in the clinical trial based on the sensitivity
and specificity of AF detection with the particular device. We recommend that episodes
of atrial flutter and atrial tachycardia be included within the broader definition
of a detectable AF/AFL/AT episode.
AF/AFL/AT burden
It is reasonable for clinical trials to incorporate AF/AFL/AT burden as a secondary
endpoint in a clinical trial of AF ablation. In stating this it is recognized that
there are no conclusive data that have validated a rate of AF burden reduction as
a predictor of patient benefit (i.e. reduction in mortality and major morbidities
such as stroke, CHF, QOL, or hospitalization). If AF burden is included, it is important
to predefine and standardize the monitoring technique that will be used to measure
AF burden. Available monitoring techniques have been discussed in this document. Should
AF burden be selected as an endpoint in a clinical trial, the chosen monitoring technique
should be employed at least a month prior to ablation to establish a baseline burden
of AF.
Entrance block
Entrance block is defined as the absence, or if present, the dissociation, of electrical
activity within the PV antrum. Entrance block is most commonly evaluated using a circular
multielectrode mapping catheter positioned at the PV antrum. Entrance block can also
be assessed using detailed point-by-point mapping of the PV antrum guided by an electroanatomical
mapping system. The particular method used to assess entrance block should be specified
in all clinical trials. Entrance block of the left PVs should be assessed during distal
coronary sinus or left atrial appendage pacing in order to distinguish far-field atrial
potentials from PV potentials. It is recommended that reassessment of entrance block
be performed a minimum of 20 minutes after initial establishment of PV isolation.
Procedural endpoints for AF ablation strategies not targeting the PVs
Procedural endpoints for AF ablation strategies not targeting the PVs: The acute procedural
endpoints for ablation strategies not targeting the PVs vary depending on the specific
ablation strategy and tool. It is important that they be prespecified in all clinical
trials. For example, if a linear ablation strategy is used, documentation of bidirectional
block across the ablation line must be shown. For ablation of CFAEs, rotational activity,
or non-PV triggers, the acute endpoint should at a minimum be elimination of CFAEs,
rotational activity, or non-PV triggers. Demonstration of AF slowing or termination
is an appropriate procedural endpoint, but it is not required as a procedural endpoint
for AF ablation strategies not targeting the PVs.
Esophageal temperature monitoring
Esophageal temperature monitoring should be performed in all clinical trials of AF
ablation. At a minimum, a single thermocouple should be used. The location of the
probe should be adjusted during the procedure to reflect the location of energy delivery.
Although this document does not provide formal recommendations regarding the specific
temperature or temperature change at which energy delivery should be terminated, the
Task Force does recommend that all trials prespecify temperature guidelines for termination
of energy delivery.
Enrolled subject
An enrolled subject is defined as a subject who has signed written informed consent
to participate in the trial in question.
Exit block
Exit block is defined as the inability to capture the atrium during pacing at multiple
sites within the PV antrum. Local capture of musculature within the pulmonary veins
and/or antrum must be documented to be present to make this assessment. Exit block
is demonstrated by a dissociated spontaneous pulmonary vein rhythm.
Nonablative strategies
The optimal nonablative therapy for patients with persistent and long-standing persistent
AF who are randomized to the control arm of an AF ablation trial is a trial of a new
Class I or III antiarrhythmic agent or a higher dose of a previously failed antiarrhythmic
agent. For patients with persistent or long-standing persistent AF, performance of
a direct-current cardioversion while taking the new or dose adjusted antiarrhythmic
agent should be performed, if restoration of sinus rhythm is not achieved following
initiation and/or dose adjustment of antiarrhythmic drug therapy. Failure of pharmacological
cardioversion alone is not adequate to declare this pharmacological strategy unsuccessful.
Noninducibility of atrial fibrillation
Noninducibility of atrial fibrillation is defined as the inability to induce atrial
fibrillation with a standardized prespecified pharmacological or electrical stimulation
protocol. The stimulation protocol should be prespecified in the specific clinical
trial. Common stimulation approaches include a high-dose isoproterenol infusion protocol
or repeated atrial burst pacing at progressively more rapid rates.
Patient populations for inclusion in clinical trials
It is considered optimal for clinical trials to enroll patients with only one type
of AF: paroxysmal, persistent, or long-standing persistent. If more than one type
of AF patient is enrolled, the results of the trial should also be reported separately
for each of the AF types. It is recognized that “early persistent” AF responds to
AF ablation to a similar degree as patients with paroxysmal AF and that the response
of patients with “late persistent AF” is more similar to that in those with long-standing
persistent AF.
Therapy consolidation period
Following a 3-month blanking period, it is reasonable for clinical trials to incorporate
an additional 1- to 3-month therapy consolidation period. During this time, adjustment
of antiarrhythmic medications and/or cardioversion can be performed. Should a consolidation
period be incorporated into a clinical trial design, the minimum follow-up duration
should be 9 months following the therapy consolidation period. Performance of a repeat
ablation procedure during the blanking or therapy consolidation period would “reset”
the endpoint of the study and trigger a new 3-month blanking period. Incorporation
of a therapy consolidation period can be especially appropriate for clinical trials
evaluating the efficacy of AF ablation for persistent or long-standing persistent
AF. The challenge of this approach is that it prolongs the overall study duration.
Because of this concern regarding overall study duration, we suggest that the therapy
consolidation period be no more than 3 months in duration following the 3-month blanking
period.
Recommendations regarding repeat ablation procedures
It is recommended that all clinical trials report the single procedure efficacy of
catheter ablation. Success is defined as freedom from symptomatic or asymptomatic
AF/AFL/AT of 30 seconds or longer at 12 months postablation. Recurrences of AF/AFL/AT
during the first 3-month blanking period post-AF ablation are not considered a failure.
Performance of a repeat ablation procedure at any point after the initial ablation
procedure should be considered a failure of a single procedure strategy. It is acceptable
for a clinical trial to choose to prespecify and use a multiprocedure success rate
as the primary endpoint of a clinical trial. When a multiprocedure success is selected
as the primary endpoint, efficacy should be defined as freedom from AF/flutter or
tachycardia at 12 months after the final ablation procedure. In the case of multiple
procedures, repeat ablation procedures can be performed at any time following the
initial ablation procedure. All ablation procedures are subject to a 3-month post
blanking window, and all ablation trials should report efficacy at 12 months after
the final ablation procedure.
Cardioversion definitions
Failed electrical cardioversion
Failed electrical cardioversion is defined as the inability to restore sinus rhythm
for 30 seconds or longer following electrical cardioversion.
Successful electrical cardioversion
Successful electrical cardioversion is defined as the ability to restore sinus rhythm
for at least 30 seconds following cardioversion.
Immediate AF recurrence postcardioversion
Immediate AF recurrence postcardioversion is defined as a recurrence of AF within
24 hours following cardioversion. The most common time for an immediate recurrence
is within 30–60 minutes postcardioversion.
Early AF recurrence postcardioversion
Early AF recurrence postcardioversion is defined as a recurrence of AF within 30 days
of a successful cardioversion.
Late AF recurrence postcardioversion
Late AF recurrence postcardioversion is defined as recurrence of AF more than 30 days
following a successful cardioversion.
Surgical ablation definitions
Hybrid AF surgical ablation procedure
Hybrid AF surgical ablation procedure is defined as a joint AF ablation procedure
performed by electrophysiologists and cardiac surgeons either as part of a single
“joint” procedure or performed as two preplanned separate ablation procedures separated
by no more than 6 months.
Surgical Maze ablation procedure
Surgical Maze ablation procedure is defined as a surgical ablation procedure for AF
that includes, at a minimum, the following components: (1) line from SVC to IVC; (2) line
from IVC to the tricuspid valve; (3) isolation of the PVs; (4) isolation of the posterior
left atrium; (5) line from MV to the PVs; (6) management of the LA appendage.
Stand-alone surgical AF ablation
A surgical AF ablation procedure during which other cardiac surgical procedures are
not performed such as CABG, valve replacement, or valve repair.
Nomenclature for types of surgical AF ablation procedures
We recommend that the term “Maze” procedure is appropriately used only to refer to
the biatrial lesion set of the Cox-Maze operation. It requires ablation of the RA
and LA isthmuses. Less extensive lesion sets should not be referred to as a “Maze”
procedure, but rather as a surgical AF ablation procedure. In general, surgical ablation
procedures for AF can be grouped into three different groups: (1) a full biatrial
Cox-Maze procedure; (2) PVI alone; and (3) PVI combined with left atrial lesion sets.
Hybrid epicardial and endocardial AF ablation
This term refers to a combined AF ablation procedure involving an off-pump minimally
invasive surgical AF ablation as well as a catheter-based AF ablation procedure designed
to complement the surgical lesion set. Hybrid ablation procedures may be performed
in a single-procedure setting in a hybrid operating room or a cardiac catheterization
laboratory environment, or it can be staged. When staged, it is most typical to have
the patient undergo the minimally invasive surgical ablation procedure first following
by a catheter ablation procedure 1 to 3 months later. This latter approach is referred
to as a “staged Hybrid AF ablation procedure.”
Minimum AF documentation, endpoints, TEE performance, and success rates in clinical
trials
Minimum documentation for paroxysmal AF
The minimum AF documentation requirement for paroxysmal AF is (1) physician's note
indicating recurrent self-terminating AF and (2) one electrocardiographically documented
AF episode within 6 months prior to the ablation procedure.
Minimum documentation for persistent AF
The minimum AF documentation requirement for persistent AF is (1) physician's note
indicating continuous AF > 7 days but no more than 1 year and (2) a 24-hour Holter
within 90 days of the ablation procedure showing continuous AF.
Minimum documentation for early persistent AF
The minimum AF documentation requirement for persistent AF is (1) physician's note
indicating continuous AF > 7 days but no more than 3 months and (2) a 24-hour Holter
showing continuous AF within 90 days of the ablation procedure.
Minimum documentation for long-standing persistent AF
The minimum AF documentation requirement for long-standing persistent AF is as follows:
physician's note indicating at least 1 year of continuous AF plus a 24-hour Holter
within 90 days of the ablation procedure showing continuous AF. The performance of
a successful cardioversion (sinus rhythm >30 seconds) within 12 months of an ablation
procedure with documented early recurrence of AF within 30 days should not alter the
classification of AF as long-standing persistent.
Symptomatic AF/AFL/AT
AF/AFL/AT that results in symptoms that are experienced by the patient. These symptoms
can include but are not limited to palpitations, presyncope, syncope, fatigue, and
shortness of breath. For patients in continuous AF, reassessment of symptoms after
restoration of sinus rhythm is recommended to establish the relationship between symptoms
and AF.
Documentation of AF-related symptoms
Documentation by a physician evaluating the patient that the patient experiences symptoms
that could be attributable to AF. This does not require a time-stamped ECG, Holter,
or event monitor at the precise time of symptoms. For patients with persistent AF
who initially report no symptoms, it is reasonable to reassess symptom status after
restoration of sinus rhythm with cardioversion.
Minimum effectiveness endpoint for patients with symptomatic and asymptomatic AF
The minimum effectiveness endpoint is freedom from symptomatic and asymptomatic episodes
of AF/AFL/AT recurrences at 12 months following ablation, free from antiarrhythmic
drug therapy, and including a prespecified blanking period.
Minimum chronic acceptable success rate: paroxysmal AF at 12-month follow-up
If a minimum chronic success rate is selected as an objective effectiveness endpoint
for a clinical trial, we recommend that the minimum chronic acceptable success rate
for paroxysmal AF at 12-month follow-up is 50%.
Minimum chronic acceptable success rate: persistent AF at 12-month follow-up
If a minimum chronic success rate is selected as an objective effectiveness endpoint
for a clinical trial, we recommend that the minimum chronic acceptable success rate
for persistent AF at 12-month follow-up is 40%.
Minimum chronic acceptable success rate: long-standing persistent AF at 12-month follow-up
If a minimum chronic success rate is selected as an objective effectiveness endpoint
for a clinical trial, we recommend that the minimum chronic acceptable success rate
for long-standing persistent AF at 12-month follow-up is 30%.
Minimum follow-up screening for paroxysmal AF recurrence
For paroxysmal AF, the minimum follow-up screening should include (1) 12-lead ECG
at each follow-up visit; (2) 24-hour Holter at the end of the follow-up period (e.g.,
12 months); and (3) event recording with an event monitor regularly and when symptoms
occur from the end of the 3-month blanking period to the end of follow-up (e.g., 12 months).
Minimum follow-up screening for persistent or long-standing AF recurrence
For persistent and long-standing persistent AF, the minimum follow-up screening should
include (1) 12-lead ECG at each follow-up visit; (2) 24-hour Holter every 6 months;
and (3) symptom-driven event monitoring.
Requirements for transesophageal echocardiogram
It is recommended that the minimum requirement for performance of a TEE in a clinical
trial should be those requirements set forth in ACC/AHA/HRS 2014 Guidelines for AF
Management pertaining to anticoagulation at the time of cardioversion. Prior to undergoing
an AF ablation procedure a TEE should be performed in all patients with AF of > 48 hours'
duration or of unknown duration if adequate systemic anticoagulation has not been
maintained for at least 3 weeks prior to AF ablation. If a TEE is performed for this
indication, it should be performed within 24 hours of the ablation procedure.
AF, atrial fibrillation; DW-MRI, diffusion-weighted magnetic resonance imaging; CHF,
congestive heart failure; QOL, quality of life; ECG, electrocardiogram; CABG, coronary
artery bypass grafting; PV, pulmonary vein; SVC, superior vena cava; IVC, inferior
vena cava; CFAE, complex fractionated atrial electrogram; PVI, pulmonary vein isolation;
AFL, atrial flutter; AT, atrial tachycardia; ACC, American College of Cardiology;
AHA, American Heart Association; HRS, Heart Rhythm Society.
∗When reporting outcomes of AF ablation, the development of atrial tachycardia or
atrial flutter should be included in the broad definition of recurrence following
AF ablation. All studies should report freedom from AF, atrial tachycardia, and atrial
flutter. These endpoints can also be reported separately. All studies should also
clearly specify the type and frequency of ECG monitoring as well as the degree of
compliance with the prespecified monitoring protocol.
Table 11
Quality-of-life scales, definitions, and strengths
Scale
Definition/Details
Strengths/Weaknesses
Short Form (36) Health Survey (SF36)38 (General)
Consists of 8 equally weighted, scaled scores in the following sections: vitality,
physical functioning, bodily pain, general health perceptions, physical role functioning,
emotional role functioning, social role functioning, mental health. Each section receives
a scale score from 0 to 100.
Physical component summary (PCS) and mental component summary (MCS) is an average
of all the physically and mentally relevant questions, respectively.
The Short Form (12) Health Survey (SF12) is a shorter version of the SF-36, which
uses just 12 questions and still provides scores that can be compared with SF-36 norms,
especially for summary physical and mental functioning.
Gives more precision in measuring QOL than EQ-5D but can be harder to transform into
cost utility analysis.
Advantages: extensively validated in a number of disease and health states. Might
have more resolution than EQ-50 for AF QOL.
Disadvantages: not specific for AF, so might not have resolution to detect AF-specific
changes in QOL.
EuroQol Five Dimensions Questionnaire (EQ-5D)39 (General)
Two components: Health state description is measured in five dimensions: mobility,
self-care, usual activities, pain/discomfort, anxiety/depression. Answers may be provided
on a three-level (3L) or five-level (5L) scale. In the Evaluation section, respondents
evaluate their overall health status using a visual analogue scale (EQ-VAS). Results
can easily be converted to quality-adjusted life years for cost utility analysis.
Advantages: extensively validated in a number of disease and health states. Can easily
be converted into quality-adjusted life years for cost-effectiveness analysis.
Disadvantages: might not be specific enough to detect AF-specific changes in QOL.
Might be less specific than SF-36.
AF effect on Quality of Life Survey (AFEQT)40 (AF specific)
20 questions: 4 targeting AF-related symptoms, 8 evaluating daily function, and 6
assessing AF treatment concerns. Each item scored on a 7-point Likert scale.
Advantages: brief, simple, very responsive to AF interventions. Good internal validity
and well validated against a number of other global and AF-specific QOL scales. Used
in CABANA.
Disadvantages: validation in only two published studies (approximately 219 patients).
Quality of Life Questionnaire for Patients with AF (AF-QoL)41 (AF specific)
18-item self-administered questionnaire with three domains: psychological, physical,
and sexual activity. Each item scores on a 5-point Likert scale.
Advantages: brief, simple, responsive to AF interventions; good internal validity;
used in SARA trial.
Disadvantages: external validity compared only to SF-36; formal validation in 1 study
(approximately 400 patients).
Arrhythmia-Related Symptom Checklist (SCL)42 (AF specific)
16 items covering AF symptom frequency and symptom severity.
Advantages: most extensively validated in a number of arrhythmia cohorts and clinical
trials.
Disadvantages: time-consuming and uncertain generalizability.
Mayo AF Specific Symptom Inventory (MAFSI)43 (AF specific)
10 items covering AF symptom frequency and severity. Combination of 5- point and 3-point
Likert scale responses.
Used in CABANA trial.
Advantages: validated in an AF ablation population and responsive to ablation outcome;
used in CABANA trial.
Disadvantages: external validity compared only to SF-36; 1 validation study (approximately
300 patients).
University of Toronto Atrial Fibrillation Severity Scale (AFSS) (AF specific)44
10 items covering frequency, duration, and severity. 7-point Likert scale responses.
Advantages: validated and reproducible; used in CTAF trial.
Disadvantages: time-consuming and uncertain generalizability.
Arrhythmia Specific Questionnaire in Tachycardia and Arrhythmia (ASTA)45 (AF specific)
Records number of AF episodes and average episode duration during last 3 months. 8
symptoms and 2 disabling symptoms are recorded with scores from 1–4 for each.
Advantages: validated in various arrhythmia groups; external validity compared with
SCL, EQ5D, and SF-36; used in MANTRA-PAF; brief; simple.
Disadvantages: one validation study (approximately 300 patients).
European Heart Rhythm Association (EHRA)46 (AF specific)
Like NYHA scale. I = no symptoms, II = mild symptoms not affecting daily activity,
III = severe symptoms affecting daily activity, and IV = disabling symptoms terminating
daily activities.
Advantage: very simple, like NYHA.
Disadvantages: not used in studies and not well validated; not very specific; unknown
generalizability.
Canadian Cardiovascular Society Severity of Atrial Fibrillation Scale (CCS-SAF)47
(AF specific)
Like NYHA scale. O = asymptomatic, I = AF symptoms have minimal effect on patient's
QOL, II = AF symptoms have minor effect on patient QOL, III = symptoms have moderate
effect on patient QOL, IV= AF symptoms have severe effect on patient QOL.
Advantages: very simple, like NYHA; validated against SF-36 and University of Toronto
AFSS.
Disadvantages: poor correlation with subjective
AF burden; not very specific.
AF, atrial fibrillation; QOL, quality of life; CABANA, Catheter Ablation vs Anti-arrhythmic
Drug Therapy for Atrial Fibrillation; SARA, Study of Ablation Versus antiaRrhythmic
Drugs in Persistent Atrial Fibrillation; CTAF, Canadian Trial of Atrial Fibrillation;
MANTRA-PAF, Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal
Atrial Fibrillation; NYHA, New York Heart Association; AFSS, atrial fibrillation severity
scale.
Table 12
Non-AF recurrence–related endpoints for reporting in AF ablation trials
Stroke and bleeding endpoints
Definitions/Details
Stroke (2014 ACC/AHA Key Data Elements)
An acute episode of focal or global neurological dysfunction caused by brain, spinal
cord, or retinal vascular injury as a result of hemorrhage or infarction. Symptoms
or signs must persist ≥24 hours, or if documented by CT, MRI or autopsy, the duration
of symptoms/signs may be less than 24 hours. Stroke may be classified as ischemic
(including hemorrhagic transformation of ischemic stroke), hemorrhagic, or undetermined.
Stroke disability measurement is typically performed using the modified Rankin Scale
(mRS).
Transient ischemic attack (2014 ACC/AHA Key Data Elements)
Transient episode of focal neurological dysfunction caused by brain, spinal cord,
or retinal ischemia without acute infarction and with signs and symptoms lasting less
than 24 hours.
Major bleeding (ISTH definition)
Fatal bleeding AND/OR symptomatic bleeding in a critical area or organ, such as intracranial,
intraspinal, intraocular, retroperitoneal, intraarticular, pericardial, or intramuscular
with compartment syndrome AND/OR bleeding causing a fall in hemoglobin level of 2 g/dL
(1.24 mmol/L) or more, or leading to transfusion of two or more units of blood.
Clinically relevant nonmajor bleed (ISTH definition)
An acute or subacute clinically overt bleed that does not meet the criteria for a
major bleed but prompts a clinical response such that it leads to one of the following:
hospital admission for bleeding; physician-guided medical or surgical treatment for
bleeding; change in antithrombotic therapy (including interruption or discontinuation).
Minor bleeding (ISTH definition)
All nonmajor bleeds. Minor bleeds are further divided into clinically relevant and
not.
Incidence and discontinuation of oral anticoagulation
The number of patients receiving oral anticoagulation and the type of oral anticoagulation
should be documented at the end of follow-up. If patients have their oral anticoagulation
discontinued, the number of patients discontinuing, the timing of discontinuation,
and the reasons for discontinuation of oral anticoagulation, as well as the clinical
characteristics and stroke risk profile of the patients should be reported.
AF, atrial fibrillation; CT, computed tomography; MRI, magnetic resonance imaging.
Table 13
Advantages and disadvantages of AF-related endpoints in AF ablation trials
Endpoint
Advantages
Disadvantages
Relevance and Comments
Freedom from AF/AFL/AT recurrence “gold standard” is 30 seconds
- Has been in use for many years
- Can be used to compare results of new trials with historical trials
- Sets a high bar for AF elimination
- Can systematically underestimate the efficacy of AF ablation, particularly for persistent
AF, if 30-second cutoff is used
- Particularly well suited for paroxysmal AF outcomes
- Reporting of cutoffs other than 30 seconds encouraged as secondary endpoints to
better contextualize results
- May be reported as proportion of patients free from arrhythmia or time to recurrence
Freedom from stroke-relevant AF/AFL/AT-duration cutoff of 1 hour
- Useful for trials in which interest is more for prognostic change conferred by ablation
rather than elimination of all arrhythmias
- No consistent definition of what a stroke-relevant duration of AF is: ranges from
6 minutes to 24 hours in literature
- More than 1 hour could be a useful cutoff based on results of 505 trial
- May be reported as proportion of patients free from arrhythmia or time to recurrence
Freedom from AF/AFL/AT requiring intervention (emergency visits, cardioversion, urgent
care visit, reablation, etc.)
- Can provide an endpoint more relevant to systemic costs of AF recurrence
- Clinically relevant
- Will overestimate efficacy of ablation by ignoring shorter episodes not requiring
intervention that still might be important to quality of life or stroke
- Determination of what is an “intervention” must be prespecified in protocol and
biases mitigated to avoid over- or underintervention in the trial
Freedom from persistent AF/AFL/AT-duration cutoff of 7 days
- Useful for trials assessing additional substrate modification in persistent AF
- Can systematically overestimate the efficacy of AF ablation, particularly for persistent
AF
- Can require continuous monitoring to definitively assess if episode is > 7 days
Freedom from AF/AFL/AT on previously ineffective antiarrhythmic therapy
- If patient maintains sinus rhythm on previously ineffective drug therapy, this may
be considered a clinically relevant, successful outcome
- Will increase the success rate compared with off-drug success
- May not be relevant to patients hoping to discontinue drug therapy
- Postablation drug and dosage of drug should be identical to preablation drug and
dosage
Significant reduction in AF burden: >75% reduction from pre- to postablation and/or
total postablation burden <12%
- Can be useful in persistent AF studies, but might not be suited for early, paroxysmal
AF studies
- Ideally requires continuous monitoring using an implantable device
- No scientific basic exists showing that a 75% reduction in AF burden impacts hard
endpoints, including heart failure, stroke, and mortality
- AF burden can be estimated by intermittent monitoring and reporting of patient symptoms
and recurrences like a “time in therapeutic range” report for oral anticoagulation;
see text
- Could also see 75% reduction in number and duration of AF episodes
- Because there is no firm scientific basis for selecting the cutoff of 75%, this
prior recommendation is provided only as an example of what future clinical trials
may choose to use as a definition of clinical/partial success
Prevention in AF progression: time to first episode of persistent AF (>7 days)
- Does not assume that total elimination of AF is required
- Well suited for paroxysmal or “early” AF studies in which goal is to prevent progression
to persistent AF
- Prevention in progression might be irrelevant for stroke or thromboembolic outcomes
- Long follow-up time might be required unless population is “enriched”
- Can ideally require continuous implantable monitoring
- Might be useful for specific populations such as heart failure or hypertrophic cardiomyopathy,
in which progression to persistent AF can lead to increased hospitalization
Regression of AF: reduction in burden to a given threshold or conversion of persistent
to paroxysmal AF
- Does not assume that total elimination of AF is required
- Well suited for persistent “late” AF studies in which goal is to regress to paroxysmal
AF, which might be easier to control with drug therapy
- Regression endpoint will overestimate efficacy of AF ablation
- Might ideally require continuous implantable monitoring
- Patients will require ongoing drug therapy
- Could be particularly useful for long-standing persistent AF populations with structural
heart disease, heart failure, etc.
Acute AF termination during ablation procedure
- Could provide indication of successful modification of substrate responsible for
maintaining AF, most relevant to persistent or long-standing persistent AF
- Limited studies have linked acute AF termination to long-term success
- Relevance of acute AF termination has not consistently been shown to correlate to
long-term success
- Endpoint might not be relevant to paroxysmal AF patients in whom AF might terminate
spontaneously
- Some studies employ administration of intravenous or oral antiarrhythmics during
ablation that could cause spontaneous termination
- Studies consider termination as reversion to sinus rhythm, whereas others consider
reversion to any regular tachycardia as termination
- Intraprocedural administration of preprocedural oral antiarrhythmics or intraprocedural
intravenous antiarrhythmics are discouraged
- If antiarrhythmics are used, their use and dosage before and during the ablation
should be clearly documented
- Termination to sinus rhythm and termination to another regular tachycardia (AT or
AFL) should be separately reported
AF, atrial fibrillation; AFL, atrial flutter; AT, atrial tachycardia.
Unanswered Questions in AF Ablation
There is still much to be learned about the mechanisms of AF, techniques of AF ablation,
and long-term outcomes. The following are unanswered questions for future investigation:
AF ablation and modification of stroke risk and need for ongoing oral anticoagulation
(OAC): The CHA2DS2-VASc score was developed for patients with clinical AF. If a patient
has received a successful ablation such that he/she no longer has clinical AF (subclinical,
or no AF), then what is the need for ongoing OAC? Are there any patients in whom successful
ablation could lead to discontinuation of OAC?
Substrate modification in catheter-based management of AF—particularly for persistent
AF: What is the proper lesion set required beyond pulmonary vein isolation? Do lines
and complex fractionated atrial electrogram (CFAE) have any remaining role? Are these
approaches ill-advised or simply discouraged?
What is the role of targeting localized rotational activations? How do we ablate a
localized rotational activation? How can scar be characterized and targeted for ablation?
Do we need to replicate the MAZE procedure? Does the right atrium need to be targeted
as well as the left atrium?
Autonomic influence in AF: Is clinical AF really an autonomic mediated arrhythmia?
Is elimination of ganglionated plexi required? Is there a role for autonomic modulation,
for example, spinal cord or vagal stimulation?
Contribution and modulation of risk factors on outcomes of AF ablation: Obesity reduction
has been shown to reduce AF burden and recurrence in patients undergoing ablation.
What is the role of bariatric surgery? Does the modulation of other risk factors influence
outcome such as hypertension, sleep apnea, and diabetes?
Outcomes in ablation of high-risk populations: Do high-risk populations benefit from
AF ablation? Congestive heart failure has been assessed in smaller trials, but larger
trials are required. Outcome data are needed in patients with very enlarged LAs, hypertrophic
cardiomyopathy, patients with renal failure on dialysis, and the very elderly.
Surgical vs catheter-based vs hybrid ablation: There should be more comparative work
between percutaneous and minimally invasive surgical approaches. Both report similar
outcomes, but there is a dearth of comparative data. Is there any patient benefit
to hybrid procedures?
How do we characterize patients who are optimal candidates for ablation? Preablation
late gadolinium-enhanced (LGE)-magnetic resonance imaging (MRI) might identify patients
with heavy burdens of scar who are unlikely to respond to ablation. These techniques
must become reproducible and reliable and must be assessed in multicenter trials.
Other markers need to be investigated, including genetic markers, biochemical markers,
and clinical markers based on aggregated risk scores.
The incremental role of new technologies: As newer and often more expensive technologies
are produced for AF ablation, their definitive incremental value must be determined
in order to justify change in practice or case cost. These technologies include global
(basket) mapping techniques, newer ablation indices for assessing lesion durability,
advanced imaging for viewing lesions in the myocardium, etc. New energy sources, including
laser, low-intensity ultrasound, photonic particle therapy, external beam ablation,
and MRI-guided ablation, must be assessed in comparative fashion.
Outcomes of AF ablation: We need to better understand the clinical relevance of ablation
outcomes. What is the significance of time to recurrence of 30 seconds of arrhythmia?
How do we best quantify AF burden? How do these outcomes relate to quality of life
and stroke risk?
What is the role of surgical LA reduction? Does left atrial appendage (LAA) occlusion
or obliteration improve outcome of persistent AF ablation with an accompanying reduction
in stroke? Does ablation work through atrial size reduction? What is the incidence
of “stiff atrial” syndrome and does this mitigate the clinical impact of ablation?
Working in teams: What is the role of the entire heart team in AF ablation? Does a
team approach achieve better outcomes than a “silo” approach?
Improving the safety of catheter ablation: As ablation extends to more operators and
less experienced operators, the statistical occurrence of complications will increase.
We need newer techniques to minimize complications and institute standards for operators
to improve the reproducibility of ablation results and safety profiles at a variety
of centers worldwide.
How does catheter ablation affect mortality, stroke, and hospitalization in broad
and selected patient populations receiving catheter ablation for AF?
Management of patients who fail initial attempts at catheter ablation: Should there
be specific criteria for repeat ablations (e.g., atrial size, body mass index)? Should
patients be referred for surgery for repeat ablation?
In order to address these and other important questions in the field of catheter and
surgical AF ablation, we urge investigators to create and participate in multisite
collaborations and electrophysiology research networks with involvement of senior
and junior investigators on the steering committees to push forward the next phase
of AF research. We also urge funding bodies to support these important initiatives.
Section 14: Conclusion
Catheter ablation of AF is a very commonly performed procedure in hospitals throughout
the world. This document provides an up-to-date review of the indications, techniques,
and outcomes of catheter and surgical ablation of AF. Areas for which a consensus
can be reached concerning AF ablation are identified, and a series of consensus definitions
have been developed for use in future clinical trials of AF ablation. Also included
within this document are recommendations concerning indications for AF ablation, technical
performance of this procedure, and training. It is our hope 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
rapidly and that this document will need to be updated. Successful AF ablation programs
optimally should consist of a cooperative team of cardiologists, electrophysiologists,
and surgeons to ensure appropriate indications, procedure selection, and follow-up.
The full article HRS/EHRA/APHRS/ECAS/SOLAECE Expert Consensus Statement on Catheter
and Surgical Ablation of Atrial Fibrillation can be read in full online. When referencing
please cite the full article [10.1093/europace/eux274].
Related collections
Most cited references475
- Record: found
- Abstract: found
- Article: not found
Updated worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation.
Riccardo Cappato, Hugh Calkins, Shih-Ann Chen … (2010)
- Record: found
- Abstract: not found
- Article: not found
Universal definition of myocardial infarction.
Kristian Thygesen, Joseph Alpert, Harvey White (2007)
- Record: found
- Abstract: found
- Article: not found