Heart Rhythm UK. Standards for electrophysiological studies and catheter ablation HRUK, September 2010

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1 Heart Rhythm UK Standards for electrophysiological studies and catheter ablation HRUK, September ) Introduction 2) Definitions 3) Treatment indications 4) Requirements for performing electrophysiological studies and catheter ablation a. trainees b. cardiologists c. centres d. paramedical staff 5) Ablation follow-up standards 6) Audit 7) References 1) Introduction The growth and change in indications for catheter ablation over the last decade make it appropriate for HRUK to produce up to date guidelines for training and competency for catheter ablation and electrophysiological procedures. This document will address both the issue of training and maintenance of competency. The document is careful to avoid the terms consultant and SpR because it is recognised that as training times shorten and working hours are reduced some consultants may be appointed without full competency in every aspect of their speciality. HRUK considers it perfectly acceptable for physicians to continue training after consultant appointment and indeed believe that the title consultant should not imply competence to perform a particular procedure. HRUK would encourage continued training and mentorship of consultants after appointment and it would anticipate that it becomes the norm for consultants to gain some of their procedural accreditations using this approach while in post. It is absolutely mandatory that consultants who have not completed their minimum requirements for procedural numbers continue to have direct supervision and support, for all relevant cases, by accredited electrophysiologists until this is achieved. There remains a wide range of technical complexity to catheter ablation procedures depending on the rhythm being treated. This document deals with this problem by dividing catheter ablation procedures into standard and complex procedures (the definitions of which are listed below). It is accepted that the numbers of procedures that an individual requires to gain competency varies hugely and there are little data supporting that high procedure numbers result in better outcomes. For this reason previous training documents have avoided specifying procedure numbers required. Within cardiology, and in other medical specialities, there are clear examples of increased volume being associated with improved outcomes. Therefore this document has set out some minimum numbers required to establish some skill and maintain competence. Although it is possible that those performing fewer than these procedure numbers may argue that there is little data supporting these figures, HRUK feels that our primary responsibility is to ensure that all patients in the UK receive high quality care even if this is at the expense of some centres and operators failing to meet the standards HRUK sets. We are committed to a move towards demonstrating individual and institutional performance against established quality standards.

2 2) Definitions Standard catheter ablation includes: Electrophysiological study Ablation of the AV node (with pacing) Ablation of atrioventricular nodal reentry tachycardia Ablation of accessory pathways Ablation of right atrial isthmus dependent atrial flutter Ablation of regular sustained atrial tachycardia Ablation of focal ventricular tachycardia in normal hearts Complex catheter ablation includes: Ablation of atrial fibrillation Ablation of left atrial tachycardia Ablation of non-sustained regular atrial tachycardia Ablation of ventricular tachycardia in structural heart disease Ablation of arrhythmia in patients with complex congenital heart disease First line therapy- the therapy is offered as the treatment of first choice Second line therapy the therapy is offered after the patient has either refused or found other treatments (which may be antiarrhythmic drugs, pacemakers or implantable defibrillators depending on the arrhythmia) unsuccessful or intolerable. First operator (trainee) - the trainee manipulates the catheters and is making the diagnostic and therapeutic decisions under the direct supervision of a trainer First operator (accredited electrophysiologist) the electrophysiologist is either performing the case or directly supervising a trainee who is performing the case 3) Treatment indications Catheter ablation is primarily a therapy that significantly improves quality of life although rarely may improve prognosis (e.g. ablation of Wolff-Parkinson-White syndrome). The indications for catheter ablation are clearly described in numerous international guidelines (1,2,3,4,5) and the National Service Framework for Coronary Heart Disease chapter 8 (6). Catheter ablation in some forms has also been examined and approved by NICE (7,8). In summary HRUK would recommend that patients are offered catheter ablation as: 1) First line therapy for all regular SVT that are either causing symptoms or has potential to produce tachycardia cardiomyopathy 2) Second line therapy for symptomatic atrial fibrillation (AF) 3) Second line therapy for VT or ventricular ectopy that is either causing symptoms or has potential to produce tachycardia cardiomyopathy 4) Second line therapy for asymptomatic atrial fibrillation that has potential to produce or be associated with tachycardia cardiomyopathy this may be in the form of AV node ablation (in association with pacing for failed rate control) or rhythm control ablation in patients with heart failure

3 4) Requirements for performing catheter ablation Standard ablation: Electrophysiological studies have been included in standard ablation. HRUK recommends that all centres and cardiologists performing electrophysiological studies should also have competency to proceed to catheter ablation if necessary. There are very few clinical indications for a patient to undergo a electrophysiological study alone and in the vast majority of cases it is more appropriate to proceed to a catheter ablation at the same procedure. a. Training requirements Cardiologists Trainees should have completed a recognised training program (as stipulated by HRUK and the STC) in an appropriate training centre (see below). This training program should include at least 2 years of sub-speciality training in heart rhythm management with dedicated time within that program specialising in electrophysiology and ablation. Trainees should have completed a log book of procedures. Trainees should have been involved with at least 200 standard ablation procedures and performed 50 as first operator Trainees should have completed training in transseptal puncture and performed >10 transseptal punctures Trainees may also elect to train in more complex ablation techniques. To have completed training trainees should have performed: a) for complex atrial arrhythmia been involved with at least 100 complex atrial ablations (this will be primarily AF) with 50 as first operator b) for complex ventricular arrhythmia been involved with 20 ablations with 10 as first operator c) for complex congenital heart disease - been involved with 20 ablations with 10 as first operator Trainers should be in whole time employment and spend at least 80% of their working time involved in heart rhythm management. Cardiac electrophysiologists who are working part-time can and should contribute to training cardiologists but they should not be the main or primary educational supervisor Trainers should be actively involved in heart rhythm audit and research Trainers should achieve the standards required for maintenance of competence (see below) Trainers should be members of a professional body (e.g. British Cardiovascular Society or Heart Rhythm UK), have regular appraisal and continuing professional development Trainers should have completed the minimum numbers of procedures for competency for the procedures they are teaching b. Maintenance of competence Cardiologists It is possible to perform standard ablation in a centre with 1 specialist competent to perform catheter ablation however it is important that formal arrangements are made to cover out of hours emergencies by accredited heart rhythm specialists. This may be done at a regional level. Cardiologists performing complex ablation should do so in a centre where at least one other specialist accredited to perform complex ablation is practising. Although this may require the cardiologist and their patients to travel to another centre rather than have their procedure locally, HRUK believes that colleague support and oversight is critical for delivering procedures of high safety and quality. The need to

4 meet this requirement should stimulate local training and appointment of heart rhythm specialists. The cardiologist should have completed appropriate training in standard catheter ablation and undergo retraining as a consultant if ablation has not been performed for 12 months All cardiologists performing catheter ablation must undertake appropriate CPD in catheter ablation Each cardiologist performing standard catheter ablation should perform 50 catheter ablations / year as first operator (performing complex ablation can be included in this number for those physicians performing both standard and complex ablation) Cardiologists performing catheter ablation must audit their personal complications and share these in an anonymised form. If a cardiologist s complications were to exceed accepted limits practice should be reviewed and advice sought from within the centre or elsewhere (HRUK can advise). Operators performing fewer then 100 catheter ablations/ year may need to average their outcome figures over 2 or more years to account for random variation. c. Centres Non-training centres Centres performing catheter ablation procedures must have a minimum set of equipment to safely carry out these procedures. These should include: Wards with bedside monitoring equipment with effective alarm systems and capable of storing ECG data Nursing staff experienced in care and management of cardiac arrhythmias Facilities for haemodynamic monitoring in the ward and cardiac catheter laboratory Facilities for cardiopulmonary resuscitation, temporary and permanent pacing Pacemaker and implantable defibrillator programmers. Modern X-ray equipment capable of imaging with radiation doses comparable with the majority of X-ray systems currently used in the UK Facilities for anaesthesia and assisted ventilation within the catheter laboratory A digital electrophysiological recording system with at least 16 intracardiac channels and a programmable stimulator Radiofrequency generator systems capable of temperature control Equipment for pericardiocentesis A computerised database capable of submitting data to CCAD Echocardiography For centres performing complex ablation then additional facilities are required: Access to emergency cardiothoracic surgery. Where not available on-site an agreed written protocol must be in place with the local cardiac surgical centre, and local ambulance service, to provide emergency surgical cover. In addition, the time taken for a patient to thoracotomy should be of a similar order to that possible with on-site surgical facilities where a surgical team is not on stand-by. Intra-aortic balloon pump (VT ablation) Bedside anticoagulation monitoring (e.g. ACT) 3D mapping and navigation systems Facilities for cardiac catheterisation Transoesophageal echocardiography Access to MRI/CT scanning Training centres Training centres would be expected to meet the standards for a centre performing complex ablation. In addition the following would be expected: At least 2 full time cardiologists (or equivalent part-time) performing catheter ablation as their primary speciality

5 The training centre should be integrated into a tertiary cardiac centre performing complex pacing, coronary angioplasty, cardiac surgery and heart failure management. Centres that do not have all of these facilities can take part in a training program but should not be the sole training centre in a training program The training centre should be performing sufficient case numbers to have a reasonable chance of exposing a trainee to enough cases over a 2 year fellowship. This would mean that for one trainee at least 200 standard and 100 complex ablations would need to be performed. For two trainees this number would need to be the same because first operator and second operator status can be taken by trainees for the same procedure. Training centres should not allow trainees to perform unsupervised procedures until they have received a certificate of completion of specialist training and have completed their minimum training for the procedure they undertake (a trainer may allow an experienced trainee to perform some of the procedure (e.g. EP study) without supervision but the procedure should never be completed without direct supervision of a trainer). d. Paramedical staff Cardiac physiologists There should be at least 2 cardiac physiologists actively involved in catheter ablation in each centre Each physiologist should have had appropriate training in assisting with catheter ablation and the use of the equipment required for catheter ablation and resuscitation. At least 1 physiologist should have accreditation in catheter ablation and electrophysiology(hruk/hrs or IBHRE) All physiologists must undertake appropriate CPD in catheter ablation and resources made available for them to do so. Each physiologist should be actively involved in 30 catheter ablations / year Specialist arrhythmia nurses The role of specialist arrhythmia nurses varies considerably across the UK. However there remain some common quality standards that should be met regardless of the nurse role: Arrangements should be made that at least 2 nurses are denoted as specialist arrhythmia nurses/centre. This is important to allow continuity of care during periods of absence and can be achieved if necessary by nurses taking up dual or part time roles. Nurses should undertake appropriate CPD in heart rhythm management and resources made available for them to do so. Where nurses are running outpatient clinics independently they should have the opportunity to meet with a consultant with a special interest in heart rhythm management at least once a fortnight to discuss cases and protocols. Audit should be carried out on a regular basis. 5) Catheter ablation follow-up standards All patients who undergo catheter ablation should be followed up at least once in a clinic supervised by the operator to allow audit of the outcomes of the ablation performed. Some centres may choose to do this using remote follow up but time must be set aside to talk to patients (even by phone), examine their follow up data (ECG/Holter arranged locally) and log the outcome in a database. For ablation of atrial fibrillation where symptoms may not be an accurate marker of success, extended Holter monitoring or transtelephonic monitoring should be available for use in those patients where asymptomatic AF may be important (e.g. asymptomatic AF associated with heart failure). Outcomes and complications should be recorded and reported to CCAD. At present there is no evidence that atrial fibrillation ablation reduces risk of stroke and therefore

6 anticoagulation should be continued after ablation according to the risk of stroke regardless of the outcome of ablation. However it is likely in the future that studies AF may demonstrate prognostic benefit from AF ablation. If this does happen follow up procedures will need to be adapted to follow those used in such studies. 6) Audit It is mandatory that both training and other catheter ablation centres submit accurate data to CCAD for the purposes of national audit. It is however also required that formal audit of various aspects of catheter ablation are performed, presented and discussed in multidisciplinary team meeting locally at least once every 6 months. This allows trainees who are attached to a centre for 1 year to complete an audit cycle and see the effects of this audit cycle.

7 1 Aliot EM, Stevenson WG, Almendral-Garrote JM, Bogun F, Calkins CH, Delacretaz E, Della Bella P, Hindricks G, Jaïs P, Josephson ME, Kautzner J, Kay GN, Kuck KH, Lerman BB, Marchlinski F, Reddy V, Schalij MJ, Schilling R, Soejima K, Wilber D; European Heart Rhythm Association (EHRA); Registered Branch of the European Society of Cardiology (ESC); Heart Rhythm Society (HRS); American College of Cardiology (ACC); American Heart Association (AHA). EHRA/HRS Expert Consensus on Catheter Ablation of Ventricular Arrhythmias: developed in a partnership with the European Heart Rhythm Association (EHRA), a Registered Branch of the European Society of Cardiology (ESC), and the Heart Rhythm Society (HRS); in collaboration with the American College of Cardiology (ACC) and the American Heart Association (AHA). Heart Rhythm Jun;6(6): Calkins H, Brugada J, Packer DL, Cappato R, Chen SA, Crijns HJ, Damiano RJ Jr, Davies DW, Haines DE, Haissaguerre M, Iesaka Y, Jackman W, Jais P, Kottkamp H, Kuck KH, Lindsay BD, Marchlinski FE, McCarthy PM, Mont JL, Morady F, Nademanee K, Natale A, Pappone C, Prystowsky E, Raviele A, Ruskin JN, Shemin RJ; Heart Rhythm Society; European Heart Rhythm Association; European Cardiac Arrhythmia Society; American College of Cardiology; American Heart Association; Society of Thoracic Surgeons. HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of atrial fibrillation: recommendations for personnel, policy, procedures and follow-up. A report of the Heart Rhythm Society (HRS) Task Force on Catheter and Surgical Ablation of Atrial Fibrillation developed in partnership with the European Heart Rhythm Association (EHRA) and the European Cardiac Arrhythmia Society (ECAS); in collaboration with the American College of Cardiology (ACC), American Heart Association (AHA), and the Society of Thoracic Surgeons (STS). Endorsed and approved by the governing bodies of the American College of Cardiology, the American Heart Association, the European Cardiac Arrhythmia Society, the European Heart Rhythm Association, the Society of Thoracic Surgeons, and the Heart Rhythm Society. Europace Jun;9(6): Merino JL, Arribas F, Botto GL, Huikuri H, Kraemer LI, Linde C, Morgan JM, Schalij M, Simantirakis E, Wolpert C, Villard MC, Poirey J, Karaim-Fanchon S, Deront K; Accreditation Committee; European Heart Rhythm Association; European Society of Cardiology. Core curriculum for the heart rhythm specialist: executive summary. Europace. 2009;11: Natale A, Raviele A, Arentz T, Calkins H, Chen SA, Haïssaguerre M, Hindricks G, Ho Y, Kuck KH, Marchlinski F, Napolitano C, Packer D, Pappone C, Prystowsky EN, Schilling R, Shah D, Themistoclakis S, Verma A. Venice Chart international consensus document on atrial fibrillation ablation. J Cardiovasc Electrophysiol May;18(5): Tracy CM, Akhtar M, DiMarco JP, Packer DL, Weitz HH, Creager MA, Holmes DR Jr, Merli G, Rodgers GP, Tracy CM, Weitz HH; American College of Cardiology; American Heart Association; American College of Physicians Task Force on Clinical Competence and Training; Heart Rhythm Society. American College of Cardiology/American Heart Association 2006 update of the clinical competence statement on invasive electrophysiologystudies,catheterablation,andcardioversion: a report of the American College of Cardiology/American Heart Association/American College of Physicians Task Force on Clinical Competence and Training developed in collaboration with the Heart Rhythm Society. J Am Coll Cardiol ;48: National Service Framework for Coronary Heart Disease; Chapter 8http:// 280.pdf 7 NICE IPG168 Percutaneous radiofrequency ablation for atrial fibrillation - guidance NICE IPG294 Percutaneous (non-thoracoscopic) epicardial radiofrequency ablation for atrial fibrillation: guidance.