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J Am Coll Cardiol, 2006; 48:1503-1517, doi:10.1016/j.jacc.2006.06.043 © 2006 by the American College of Cardiology Foundation |
| Table of Contents |
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Introduction......1504
Clinical Competence in Invasive EPS, Catheter Ablation, and Cardioversion: Overview of the Procedure......1504
Justification for Recommendations......1505
Minimum Training Necessary for Competence......1506
Alternate Routes to Achieve Competence......1507
Maintenance of Competence......1507
Catheter Ablation: Overview of the Procedure......1507
Justification for Recommendations......1508
Minimum Training Necessary for Competence......1509
Alternate Routes to Achieve Competence......1509
Maintenance of Competence......1510
Use of Emerging Technology and New Techniques: Assessment of Clinical Competence in Invasive Cardiac Electrophysiologic Procedures......1510
Competence in the Use of Emerging Technology......1510
Specific Training Requirements......1510
Clinical Competence in Elective DCCV: Overview of the Procedure......1511
A. External Cardioversion......1511
B. Internal Cardioversion......1512
Justification for Recommendations......1512
Minimum Training Necessary for Competence......1512
Maintenance of Competence......1513
References......1514
Appendix 1......1516
Appendix 2......1517
| Preamble |
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The American College of Cardiology Foundation/American Heart Association/American College of Physicians (ACCF/AHA/ACP) Task Force on Clinical Competence and Training was formed in 1998 to develop recommendations for attaining and maintaining the cognitive and technical skills necessary for the competent performance of a specific cardiovascular service, procedure, or technology. These documents are evidence based, and where evidence is not available, expert opinion is utilized to formulate recommendations. Indications and contraindications for specific services or procedures are not included in the scope of these documents. Recommendations are intended to assist those who must judge the competence of cardiovascular health care providers entering practice for the first time and/or those who are in practice and undergo periodic review of their practice expertise. The assessment of competence is complex and multidimensional; therefore, isolated recommendations contained herein may not necessarily be sufficient or appropriate for judging overall competence. The current document addresses competence in electrophysiology, catheter ablation, and cardioversion and is authored by representatives of the ACCF, the AHA, and the Heart Rhythm Society (HRS).
The ACCF/AHA/ACP Task Force makes every effort to avoid any actual or potential conflicts of interest that might arise as a result of an outside relationship or a personal interest of a member of the ACCF/AHA/ACP Writing Committee. Specifically, all members of the Writing Committee are asked to provide disclosure statements of all such relationships that might be perceived as real or potential conflicts of interest relevant to the document topic. These changes are reviewed by the Writing Committee and updated as changes occur. The relationships with industry information for authors and peer reviewers are published in Appendix 1 and Appendix 2, respectively.
Mark A. Creager, MD, FACC, FAHA, Chair ACCF/AHA/ACP Task Force on Clinical Competence and Training
| Introduction |
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In addition to members of ACC and AHA, the Writing Committee included a representative from the HRS. Representation by an outside organization does not necessarily imply endorsement. In addition to content peer reviewers, "official" reviewers were provided by ACC and AHA. This document was approved for publication by the governing bodies of ACC and AHA. In addition, HRSs governing board formally endorsed this document.
| Clinical competence in invasive EPS, catheter ablation, and cardioversion: Overview of the procedure |
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In this report, the term "EPS" refers to a procedure that involves the recording of intracardiac electrical signals and programmed electrical stimulation. The EPS either may be performed for diagnostic purposes only or may be part of a combined diagnostic and therapeutic (e.g., ablation) procedure. Although a thorough description of EPS is beyond the scope of this document, the procedure is briefly outlined here.
An EPS requires the placement of electrode catheters for pacing and recording in multiple cardiac chambers. The designs of the catheters and the sites appropriate for their placement are determined according to the nature of the arrhythmia under investigation. Typically, each catheter will have multiple electrode poles for both recording and local stimulation. Many types of specially designed catheters have been developed to facilitate recording and stimulation, and new catheters are frequently introduced into clinical practice. The intracardiac signals are acquired, amplified, filtered, displayed, stored, and analyzed, either in real time or for subsequent offline review. A potentially important part of an EPS is the use of intracardiac recordings to determine activation sequences during arrhythmias. This process is usually called "mapping." Analysis of the responses of an arrhythmia to various pacing techniques is also a component of the mapping process.
Electrophysiologic studies provide clinically valuable diagnostic information. In patients with bradyarrhythmias, EPS are occasionally necessary to clarify electrocardiographic phenomena or to explain symptoms that are possibly due to a transient, clinical bradyarrhythmia. Electrophysiologic studies are useful to determine the mechanisms and physiological characteristics and drug responses of supraventricular tachycardias and to determine whether arrhythmias are suitable for drug, device, or ablation therapy, as described later in this document. In patients with ventricular tachycardia, EPS are useful to confirm the mechanism of the arrhythmia, to assess the effects of pharmacologic therapy, and to select patients for nonpharmacologic treatment. Acute or follow-up testing for antiarrhythmic device efficacy falls under the definition of "EPS." These studies can often be performed noninvasively through the device, but the placement of temporary catheters may be necessary.
Electrophysiologic studies have also been used to assess the future risk of serious antiarrhythmic events and to provide data on which prophylactic therapy may be based (14). In patients with undocumented symptoms that suggest an arrhythmia that was not previously documented (e.g., syncope or palpitations), EPS are frequently used to assess the patients predisposition for spontaneously occurring arrhythmias (15).
Physicians involved in the performance of invasive EPS should be cognizant of the indications, contraindications, and potential complications of the procedure in a given patient (15,16). Absolute contraindications to EPS are few but include unstable angina, bacteremia or septicemia, acute decompensated congestive heart failure not caused by the arrhythmia, major bleeding diathesis, and acute lower extremity venous thrombosis, if femoral vein cannulation is desired. The appropriate use of invasive EPS, therefore, requires a careful nonprocedural assessment to ensure that the patient is stable and able to tolerate the procedure. In the vast majority of situations, an EPS is performed on an elective basis. However, an EPS is justifiable in such situations if an arrhythmia is the main or major cause of the emergency, as occurs in patients with incessant ventricular or supraventricular tachycardia. General indications for invasive EPS were described by the ACC/AHA Task Force on Practice Guidelines, in conjunction with the HRS (17).
| Justification for recommendations |
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| Minimum training necessary for competence |
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| Alternate routes to achieve competence |
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| Maintenance of competence |
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| Catheter ablation: Overview of the procedure |
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The lesions created by radiofrequency are well demarcated. This characteristic, along with improved catheter technology, allows very specific and focal energy delivery, which permits the cure or modification of many arrhythmias. Through targeting of the specific site of origin of the arrhythmia, as with atrial tachycardia, or through interruption of a critical pathway needed for the maintenance of a re-entrant arrhythmia, such as an accessory pathway, many arrhythmias of various mechanisms can be eliminated. Since its inception, catheter ablation has grown tremendously in its application. The number of reported ablation procedures performed annually in the U.S. has increased from 450 in 1989 to 15 000 annually in the most recent U.S. survey (32). The success rates reported in the 1995 Scheinman (32) survey of 157 laboratories in the U.S. were 97% for AV node ablations, 90% for accessory pathways in all locations, 94% for AV node modifications in the treatment of AV nodal re-entry, 72% for the treatment of atrial flutter, and 71% for the treatment of atrial tachycardia. Complication rates derived from the Scheinman (32) survey and the 1993 Multicentre European Radiofrequency Survey (MERFS) from 86 institutions (33) were reported in just under 4% of AV node interruptions, 2.6% of accessory pathway ablations, 1.7% of AV node modifications, and 1.6% of flutter and atrial tachycardia ablations.
Although the incidence of complications is low, serious complications can occur and include valvular disruption, coronary occlusion, cerebrovascular accident, and death. In U.S. centers, procedural deaths occur in 0.2% of patients who undergo AV node ablation and 0.1% of patients with accessory pathways (32). The most common complication in AV node modification has been the development of heart block through the inadvertent ablation of both the fast and slow AV nodal pathways. In the 1996 study from the MERFS (Multicenter European Radiofrequency Survey) (34), 4.7% of patients developed heart block during AV node modification. Heart block was significantly higher in patients in whom the fast pathway was targeted (5.3%) rather than the slow pathway (2%). This is higher than the overall rate of inadvertent heart block reported by Calkins et al. (35) from the Akhtar Multicenter Ablation Investigators Group, in which the incidence of inadvertent heart block in patients who underwent AV node modification was 1.3%. Importantly, a slow pathway ablation approach was used in this study. This study also reported serious complications in 3% of patients and minor complications in 8%.
Despite these complications, studies have clearly shown that symptomatic patients are afforded important improvements in the quality of life with catheter ablation (3639). The benefit gained through arrhythmia treatment with catheter ablation is superior to that achieved through medical therapy. The cost of catheter ablation, although not trivial, is less over time than the cost of alternatives such as medical therapy or surgical interventions (36,40).
Catheter ablation provides a safe and highly effective treatment for symptomatic patients with supraventricular tachycardia. Ablation should not be reserved as a last resort treatment but is appropriate to consider, in some cases, as first-line therapy (e.g., a symptomatic patient with Wolff-Parkinson-White syndrome) (4146). However, for patients with rhythm disturbances that are likely to spontaneously resolve (e.g., atrial tachycardia) or unlikely to recur (e.g., a first episode of atrial flutter), ablation would not be appropriate first-line therapy (47). Its role would be limited to patients in whom medical therapy is intolerable or in whom there is evidence for adverse consequences of the arrhythmia. The complete list of indications is detailed in the ACC/AHA guidelines for CCEP and catheter ablation procedures (17).
Atrioventricular node re-entry in a structurally normal heart typically is a benign arrhythmia, and there is a reasonable chance that no therapy is required (48). However, if patients have other compounding heart disease, such as coronary artery disease, or if the arrhythmia produces hemodynamic compromise or intolerable side effects, ablation can be considered as first-line treatment because of the high likelihood of recurrence or of serious consequences to the arrhythmia (48).
The area of atrial fibrillation (AF) ablation has undergone rapid evolution over the last 3 to 5 years. Initial attempts at catheter ablation attempting to recreate the maze procedure were only marginally successful and carried relatively high complication rates. However, the transition to focal ablation and to now substrate modification with wide area circumferential ablation has led to greater application of this technique.
In a recent survey of electrophysiologists, 30% (n = 92 of 304 respondents) reported that they performed AF ablations. In this self reporting study, the number of reported AF ablations from 2000 to 2003 was 5 592 AF ablations of 72 575 total ablation procedures during the same time period. The self reported 1-month, 1-year, and 2-year success rates were: 71 ± 4%, 66 ± 5%, 63 ± 6%, respectively. Respondents reported procedure times of 4.5 ± 0.4 h (49). Other published series of ablation for paroxysmal AF ablation report success rates of approximately 85%, which may require more than 1 ablation procedure to achieve (50,51). Large series report complications in the 2% to 11% range including perforation, tamponade, stroke, pulmonary vein stenosis, and, with certain lesion sets, atrioesophageal fistula, which is often fatal (52).
It is not anticipated that all trainees would want to pursue training in AF ablation nor should it be a mandatory part of training. Atrial fibrillation ablation is of higher risk than ablation of other arrhythmia substrates, and the trainee must be aware of the special risks such as pulmonary vein stenosis; atrioesoghageal fistula; and the higher risk of stroke, perforation, and tamponade. They must also be proficient in acute management of potential complications.
While the exact lesion set required to treat AF remains debatable, there are several common elements to the ablation procedures that are currently being performed (53,54). Access to the left atrium is achieved via transseptal puncture. It is anticipated that the operator will have already acquired experience at performance of transseptal punctures before performing AF ablation. There are no established norms for achieving competency in transseptal puncture, but, for a reasonably experienced operator, it would be expected that performance of 20 supervised transseptal punctures would display a reasonable amount of competence (55). The operator should have ready access to transthoracic echocardiography and be proficient in performing pericardiocentesis.
Often visualization with intracardiac echocardiography is utilized to improve safety and to monitor therapy during energy delivery during AF ablation (5658). As such, the electrophysiologist should be familiar with the placement of the intracardiac echocardiography catheter and the use of and interpretation of data acquired. Frequently, AF ablation is facilitated by using imported 3-dimensional images of the left atrium acquired either through cardiac magnetic resonance imaging or computed tomography scan (59,60). These imported data are used in conjunction with real-time 3-dimensional images created with 1 of several electroanotomic mapping systems during the ablation procedure. The electrophysiologist must be familiar with the utility of and interpretation of these data.
Radiofrequency ablation has been applied in the treatment of ventricular tachycardia in ischemic disease, bundle-branch re-entry, and idiopathic tachycardia (6164). A decision to perform an ablation in a patient with ventricular tachycardia must take into account the risks and benefits of doing so as well as subsequent risks of arrhythmia occurrence in abnormal but unablated tissue. Techniques such as ablation of ventricular fibrillation are not within the realm of standard training in CCEP.
| Justification for recommendations |
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Because the possibility of creating AV heart block through the application of radiofrequency energy exists either as a desired end point or as an inadvertent result of energy application, physicians who perform ablations should be capable of managing the bradyarrhythmia and AV heart block.
| Minimum training necessary for competence |
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The performance of catheter ablation procedures requires skills that are developed over time. Several studies have shown that success rates improve and fluoroscopy times decrease with experience (6770). Although there are many determinants of arrhythmia recurrences, recurrence rates drop with operator experience (71). Each of these studies involved operators with extensive prior experience in electrophysiology, and it would be expected that the number of procedures required for a new trainee to gain expertise in ablation would be higher than that for an experienced electrophysiologist. The risks of ablation similarly have been reported by experienced operators. The MERFS volunteer registry reported an overall complication rate of 4.6% at high-volume centers (100 ablations/year) compared with 5.6% at low-volume centers (50 ablations/year) (33). Similar data were reported in the 1994 North American Society of Pacing and Electrophysiology survey, with a 1.5% complication rate at high-volume centers (50 cases/year) and a 3.2% rate at low-volume centers (20 ablations/year) (64).
It is strongly recommended that all physicians who perform ablations in the U.S. meet the minimum ACGME training requirements for education in CCEP. Although credentialing at most institutions does not require board certification in CCEP, applicants should have met board requirements. As stated by the ACGME, the current program requirements for training in electrophysiology are for 12 months of specialty training after the completion of training in cardiovascular disease. This should provide adequate training for the performance of routine electrophysiologic procedures. Training in electrophysiology and ablation techniques can occur simultaneously with incremental responsibility for the trainee during the entire period. However, most training program directors agree that to gain proficiency in interventional electrophysiology and catheter ablation, additional training is required. Adequate training in all aspects of electrophysiology, including ablation, is expected to take up to 2 years depending on the skills of the trainee. The certified year in EP must occur after the completion of a 3-year training program in cardiovascular disease (19,38,40,41,72,73). Much discussion is underway to recognize the sentiment that 2 years of training in CCEP is optimal but may require adjustment in the overall training of the cardiovascular specialist, but this is beyond the purview of this paper.
It is anticipated that the more experienced the electrophysiologist, the quicker she or he will learn new techniques. As such, it is difficult to set requirements for a number of procedures to gain proficiency. The HRS Ad Hoc Committee on Catheter Ablation has recommended that a physician who performs catheter ablation procedures should have been the primary operator on 30 ablations (74); this should include 15 accessory pathway ablations. The Canadian Cardiovascular Society Committee (19) recommends a training experience that includes the performance of 50 transvenous catheter ablations. The ACGME recommends a minimum of 75 catheter ablative procedures, including a mix of AV nodal re-entrant tachycardia, atrial flutter, AV junction ablation, and ventricular tachycardia (22). For left-sided mapping procedures, the COCATS guidelines (21) recommend 15 cases with the retrograde aortic approach. For transseptal catheterization experience, greater than 10 procedures are recommended. The COCATS guidelines also recommend participation in 75 catheter ablation procedures. It is the consensus of this task force that, for new trainees, the physician should be involved in 75 ablation procedures. It is notable that, for candidates who take the first cardiac electrophysiology examination given by the ABIM, the pass rates were significantly higher for those who performed a greater number of ablations compared with those who performed a lesser number of procedures (75). The CCEP Training Program Directors Survey indicated that a minimum of 90 (mean; median, 100) cases were required to acquire clinical competence in catheter ablation.
No numeric guidelines have been established for training in AF ablation, but it is anticipated that the trainee should participate in 30 to 50 mentored AF ablations. These are in addition to the 75 procedures required to achieve competency for other ablation procedures.
| Alternate routes to achieve competence |
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| Maintenance of competence |
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With the future development of new techniques, it is likely that some form of retraining will be required. Every 2 years, physicians who are involved in ablation therapy should attend CME activities that pertain to interventional electrophysiology. For novel treatments, some form of monitoring should be considered. The CCEP Training Program Directors Survey results indicated that, to maintain competency in the performance of diagnostic EPS, a mean of 49 (median, 50) cases/year was required and that a mean of 49 (median, 50) could be in association with the performance of ablation procedures.
| Use of emerging technology and new techniques: Assessment of clinical competence in invasive cardiac electrophysiologic procedures |
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Electroanatomic magnetic mapping capabilities, for example, are being applied to aid in the diagnosis and nonpharmacologic treatment of arrhythmias (76,77). These systems involve the interaction of a sensing unit in the catheter tip positioned within a triangulating magnetic field to display temporal activation in a 3-dimensional pseudoanatomic context. Noncontact mapping probes are also being used to record actual and virtual electrograms from the endocardial surface of each heart chamber. With this technology, cardiac activation can be displayed in terms of 3-dimensional isochronal and full cardiac cycle isopotential maps (78,79). Several other systems that use active signaling between multiple exclusively intracardiac catheter electrodes or the body surface and catheter electrodes are being developed to provide a 3-dimensional framework for cardiac arrhythmias (80). In each case, these new technologies increase the amount and complexity of data generated during a mapping procedure.
Use of cryoablation is gaining popularity in certain patient populations although its use has not become widespread (81,82). Those in training or who have completed training must be aware of ongoing developments in energy delivery systems including new energy sources and other components of energy delivery systems (e.g., catheter modifications, manipulable sheaths, and so on).
Two-dimensional fluoroscopic imaging is also being supplemented with intracardiac echocardiography. This approach has capabilities of visualizing cardiac structures, endocardial surfaces, and the interaction between interventional catheters and targeted structures that are superior to those available with fluoroscopy (8385). Although not yet established as requisite or "core" equipment for the electrophysiology laboratory, these and other emerging technologies have had, and will continue to have, a major impact on the practice of cardiac arrhythmia management. It is also anticipated that additional new technologies will be developed at ever faster rates in the future.
| Competence in the use of emerging technology |
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| Specific training requirements |
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In other cases, however, application of the emerging techniques and technology will undoubtedly represent a major paradigm shift in interventional approaches thus requiring the accumulation of very different technical and cognitive skills than those required to use the current procedures or technology. In such cases, sufficient education and experience are imperative for both understanding the general operational principles behind that technology and ensuring sufficient technical abilities for the safe and efficient application of the technology. This exposure may come from national and local CME seminars; emerging scientific information from reputable, established scientific journals; local or regional training sessions; or on-site teaching by certified industry engineers. In any event, sufficient experience should be acquired such at the actual application of the technology and performance of the procedure are conducted safely under the direction of the practicing physician, without relegation of this responsibility to an industry representative. This obviously requires that a practitioner have a sufficient understanding of appropriate indications, contraindications, and risks for the application of that technology.
The duration of training or number of procedures required to establish competence will be dependent on the new techniques or technology used. This should be based on definable measures of individual competence and should include appropriate documentation of the specific cases undert