Thus, while the use of device therapy – in particular the implantable cardioverter defibrillator (ICD) – has gained increasing acceptance and is now being used on a large scale as an adjunct to traditional drug treatment, there are still many patients at high risk of sudden death who are denied these anti-arrhythmic treatments because of limited availability and trained specialists.

These discrepancies among European countries – and building bridges to overcome them – were the subject of the European Heart Rhythm Association’s (EHRA) two-day “summit meeting” in November at which representatives from countries with low, medium and high ICD use explained the regional differences within their clinical, political and economic background.

The meeting, titled Implantable Cardioverter Defibrillator (ICD) for Life Initiative – Fighting against Sudden Cardiac Death in Emerging Economies, took place in Budapest on 26-27 November at the Hotel Zara.

A press conference preceding the opening of the meeting explained the problems and proposed solutions. Participants included:

• Professor Panos Vardas, President of EHRA and President Elect of the European Society of Cardiology
• Professor Béla Merkely, President of the Hungarian Society of Cardiology
• speakers Angelo Auricchio, Frans van der Werf, Goran Milasinovich, and Christian Wolpert
• Cardiologist Dr Christian Wolpert, from the University Hospital Mannheim, Germany, who (along with Drs Auricchio and Vardas) has researched the current status of cardiac electrophysiology in member countries of the European Society of Cardiology (ESC).

“Overall in the emerging economies of ESC member countries,” said Dr Wolpert, “we have found great disparity in access to anti-arrhythmic therapy, for a variety of reasons. The implant rates and number of treating centres and physicians certainly correlate with the economic status of their countries and budget restrictions. However, even in countries with a higher GDP and where device therapy could be implemented, we have found low awareness, a lack of information and few treating specialist, all of which leads to severe under-treatment. A higher uptake of device therapy could save many sudden cardiac deaths.”

An analysis of ICD use in ESC member countries published by the EHRA in their 2010 White Book(2) shows a great difference in the number of implantations between the countries, said Dr Bela Merkely, President of the Hungarian Society of Cardiology. He added: “It is likely that many patients who would potentially benefit from device therapy do not receive it. However, uptake does not just depend on budget, reimbursement and GDP. Implantation is a technically demanding task. Education in device therapy – concerning indications, device selection, programming and troubleshooting – and the implantation procedure must all be emphasised to increase the number of implantations.”

Dr Merkely said the meeting aimed to build bridges between the medical, political and industrial sectors “so as to procure greater political and economic care for the prevention and treatment of sudden cardiac death, heart failure and arrhythmias”.

“We are inviting representatives from countries with low, medium and high procedure numbers to highlight these regional differences and reflect their political and economical background – which is why we have the participation of Central and Eastern European cardiologists, health economists, politicians and journalists.”

Because of this broad scope, the EHRA Summit was also supported by its main patron, Dr Pál Schmitt, President of the Hungarian Republic, and by Dr Miklós Réthelyi, the Minister of National Resources.

Dr Panos Vardas, President of the EHRA, said: “This summit meeting in Budapest is not about the technical details of electrophysiology but more about its everyday benefits in the prevention of sudden cardiac death. Sudden cardiac death is responsible for for a great number of deaths each year – and indeed in industrialised countries is the leading cause of death. Device therapy can correct many rhythm disturbances and reduce mortality rates. ICDs are expensive, but their cost-effectiveness is comparable to – even more favourable than – other more commonly used treatments.”

References

1. Van Veldhuisen DJ, Maass AH, Priori SG, et al. Implementation of device therapy (cardiac resynchronization therapy and implantable cardioverter defibrillator) for patients with heart failure in Europe: changes from 2004 to 2008. Eur J Heart Fail 2009; doi:10.1093/eurjhf/hfp149.
2. More information on the White Book here

The opening day marked the start of three sessions dedicated to the Heart Rhythm UK (HRUK) certificate of accreditation course, providing a valuable resource for physiologists, arrhythmia nurses and physicians preparing to undertake this increasingly recognised exam. HRUK continue to work hard to establish a coordinated training programme, which was evident throughout the meeting with a broad range of relevant sessions directed at trainees. In such a quickly evolving and technically demanding speciality, a unified and coordinated training programme is crucial. It was reassuring to witness the time and effort being put into achieving this.

Educational sessions for the more advanced practitioner were readily available throughout the meeting. Those of particular value provided debate and insight into how colleagues have developed their practice, including tips and tricks on how they overcome common problems. In such a rapidly advancing field, it is challenging for individuals to keep abreast of evolving techniques. Some of the advanced electrophysiology on offer provided food for thought as well as reassurance that others have both similar problems as well as successes. Such sessions were all well attended, with characteristically enthusiastic crowds and often completed with a session of unknown EP traces which taxed the grey matter and allowed the application of previously presented techniques to solve clinical scenarios. Later in the meeting a review of ST elevation, Long QT syndrome and Brugada syndrome left many delegates convinced that they had missed at least one on a daily basis for most of their careers, just highlighting the difficulties in diagnosing and management of these challenging problems.

From a trainee’s view-point, one of the most useful events was the Cases and Traces section, with difficulties in diagnosis being discussed by colleagues from around the UK in a light-hearted “show and tell” confessional. The incisive questioning of some of the more technically minded delegates was in contrast to the “just look at that” intrigue of the majority, but the style enabled all involved to feel that they had finished the session having learnt valuable lessons.

The first day of the conference was once again dedicated to Patient’s Day, with meetings arranged by the Atrial Fibrillation Association (AFA), Syncope Trust And Reflex anoxic Seizures (STARS) as well as the Patient’s Day Exhibition. Once again a notable feature was the positive relationship evident between clinicians in primary, secondary and tertiary care as well as physiologists and nurse specialists; this seemed a facet which was appreciated by the patient groups represented. A light-hearted quiz pitting a team of specialists from secondary and tertiary care against one from primary care provided further entertaining evidence for this. The general practitioners demonstrated not only their specialist interest in cardiology arrhythmia management but also their supremacy in the field of general cardiology trivia and quiz technique!

Atrial fibrillation

Atrial Fibrillation (AF), particularly the interventional treatment of AF, was predictably high profile. There was ample opportunity for the experts to discuss the efficacy and evolving techniques of catheter ablation therapy for atrial fibrillation. Increasing experience and continual developments in technology have resulted in quicker and effective interventional options. This evolution has already reduced procedure times whilst still maintaining efficacy. These advances are of great interest given the massive burden of atrial fibrillation on the NHS (approximately 1% of total budget) and the potential benefits of offering a potentially curative, or at least markedly alleviating, procedure to so many people. However, the recent Government White Paper, Equity and excellence: Liberating the NHS, has focussed the minds of clinicians, managers and politicians alike as the cost effectiveness of AF ablation is called into question. This was an area of intense debate. Whilst the role of catheter ablation of AF in paroxysmal AF is valid and well established, the cost effectiveness of ablation of permanent AF is potentially more questionable. The technology and enthusiasm for utilising complex techniques has arguably got ahead of the evidence base. In these financially demanding times the profession must demonstrate outcome evidence to justify the use of expensive, time consuming and technically demanding catheter ablation strategies.

With this in mind, a timely debate about this hot topic (Any Questions on AF? Ask the experts) was stylishly chaired by Mr Jonathan Dimbleby. Although the questions were flying thick and fast from the audience, control was never in question with Mr Dimbleby in the chair. This interactive question and answer session was packed, with even more delegates squeezing into the room as Mr Dimbleby chaired a lively debate between Dr Todd and Professor Camm in which the (rather extreme) motion of left atrial ablation becoming the first-line treatment for most patients with atrial fibrillation was soundly defeated -much to the dismay of those looking for consultant appointments in the near future! Mr Dimbleby, characteristically flawless and professional throughout, could not hide his surprise at the paradox which emerged following a straw poll of the audience; this confirmed that the vast majority would opt for a catheter ablation if they themselves had problems with paroxysmal AF, yet this was considered a rationed treatment requiring measured evaluation when applied to patients. The increasingly expensive options for AF management, both pharmaceutical and interventional, allied to its increasing prevalence in an aging population, means this important debate will run for some time.

Nevertheless, AF remains a major cause of stroke, morbidity and mortality and despite major advances in both medicines and interventions to reduce symptoms and to reduce the risk of stroke, the lack of awareness of AF within the population delays the implementation of these advances. The AF Symposia and NHS improvement session once again examined some of the developments in both understanding the challenges and inducing change in practice. This provided a valuable forum for clinicians and allied professionals from primary, secondary and tertiary care to discuss relevant issues, with many sessions specifically directed toward the challenges of arrhythmia management in primary care. This was particularly evident in the interesting debate surrounding screening for atrial fibrillation, how and where best to do it and the subsequent cost benefit issues.

Atrial fibrillation and Stroke

Much time was dedicated to the central issue of anticoagulation for thrombo-embolic prophylaxis and stroke risk reduction in atrial fibrillation. The message was loud and clear; warfarin prescribing needs to increase in at risk groups, particularly in the primary care setting. Strategies were outlined as to how this may be achieved, including altering the Quality Outcomes Framework to be more specific with regard to the mode of thromboembolic prophylaxis. The identification of those individuals at risk of stroke and therefore justifying full anticoagulation was thus the topic of much discussion. The expert consensus seemed to be that all but those in the very lowest group of stroke risk should be considered to need warfarin, and refining the threshold calculated by currently used risk scores (e.g. CHADS-2: 1 point each for C=cardiac failure, H=hypertension, A=age over 75, D=diabetes, S=previous stroke 2 points) will be necessary to achieve this aim. The paradigm shift would be for a clinician to now question: “Why shouldn’t this patient be on oral anticoagulation therapy”?

The CHA²DS² VASc scoring system might better answer this question leaving less room for grey-area indecision. It scores 2 points for age over 75 (the first A) one point for age over 65 (second A) and allows consideration to be given to (V) vascular disease (including coronary) as well as female gender (S-ex c- category). A score of 2 or more means stroke risk justifies the risk of warfarin.

With this in mind, it was refreshing to see the data on bleeding risk presented in a balanced manner, specifically with regard to the elderly population, in whom the risk is often over estimated. It was clear that there is a big problem with under utilisation of effective thrombo-embolic prophylaxis, with an estimated 46% of at risk AF patients not on warfarin, potentially resulting in 1250 preventable strokes per year.

It waits to be seen whether the next few years will see an improvement in this situation, perhaps catalysed by the emergence of effective and potentially safer alternatives to warfarin. With regard to dabigatran, news on when this may become widely available was not forthcoming. Cost implications, impending changes to commissioning arrangements and recently announced changes to the processes involved in approving new drugs are likely to be major factors.

The evidence for the application of left atrial appendage (LAA) occlusion devices was the focus of some attention. As much as 90% of the thrombus leading to thrombo-emboli and stroke is believed to originate in the LAA, this has led to the development of percutaneous therapies for occluding the LAA, which ideally allow the patient to stop oral anticoagulant therapy. Essentially, the device is placed distal to the ostium of the LAA to occlude flow thus preventing the migration of thrombus from the appendage. Whilst it is clearly early days, increasing registry data seems to confirm that these devices can be implanted relatively safely (major complications in the region of 2- 5 % reducing with increasing operator experience) with supporting randomised controlled data suggesting that stroke risk reduction is non-inferior to warfarin. Routine use is some way off, with few UK centres currently having an active programme, but enthusiasm is growing and the EP profession is naturally keen to take the lead. UK experience was generously shared in the form of video presentations demonstrating the technique for delivery of both the Watchman device and Amplatzer Cardiac Plug; with Dr Murgatroyd even allowing his first ever procedure to be broadcast to the audience. Importantly, these device alternatives to oral anti coagulation offer promise for those patients with high bleeding risks who are threatened by the high risk of stroke associated with AF; developments in the application of such devices are likely to accelerate as evidence, availability and experience evolve.

Bringing all these issues together, this year’s meeting coincided with the publication of the European Society of Cardiology guidance for the management of AF. Many of the experts presented data critical to the formation of this guidance which provides an excellent resource when weighing up the evidence base for options in managing AF. It can be found at http://www.escardio.org/guidelines-surveys/esc-guidelines/Pages/atrial-fibrillation.aspx or in the European Heart Journal, 2010, Volume 31 (19) pages 2369-2429.

Pacing and Devices

State of the art indications and management of devices once again featured prominently. There was much discussion about the indications for complex devices, and how current practice and NICE guidance are often at odds. In general, we do not implant enough devices, including basic bradycardia devices. As inevitably the population of people with devices grows so too will the need for lead and device extraction. Evolving techniques with tips and tricks for percutaneous removal were discussed in detail alongside surgical options, with revealing insights from Dr Charles Byrd (Fort Lauderdale, Florida), a world leader and pioneer of lead extraction.

In order to help reduce the morbidity that is inevitably associated with implanted leads, a subcutaneous implantable cardiac defibrillator system has been pioneered, with implant experience increasing throughout the UK over the last 12 months. Early registry data seem to suggest that this is a reliable, safe and effective alternative to traditional systems which depend on implanting intravenous leads with all the potential problems which they might cause. The subcutaneous device also offers an alternative cosmetic result (device is in the mid-axillary line with minimal scarring visible on the chest itself) which may be more acceptable for certain groups of patients.

MRI conditional pacemaker systems are now routinely commercially available, and maintained a high profile at the impressive industry exhibition.  Until recently the presence of a pacemaker would have meant all other imaging modalities would had to have been exhausted, with MRI only being utilised as the absolute last resort. New leads and devices have been shown to be safe in an MRI scanner, with no damage to the function of the device or lead. However certain implant, device follow-up and scan criteria protocol must be followed and the manufacturers describe the system as MRI ‘conditional’ as oppose to MRI ‘safe’. With some minor specialist modifications of scanning technique it is therefore possible to MRI any part of the body, including the heart. The aging population with devices will no doubt be increasingly likely to require MRI imaging in the future, and this is an interesting field of development.  Implantable Cardiac Defibrillators (ICDs) due to their nature have more potential to develop electromagnetic problems, and the consequences of damage to sensing and function are potentially more serious, so for the time being ICDs remain an absolute contraindication to MRI. However, research is growing utilising specialised techniques of MRI scanning, and this, allied to the potential of MR compatible leads, may mean that MRI is even an option for certain patients with ICDs within the next few years. This field is being closely monitored with registry data.

Future developments

A session entitled ‘Star Wars’ was clearly based in a galaxy far, far away from some of the delegate’s centres, in a land where magnets and robots have taken control of the catheters. The steer-ability of the magnetic catheters was shown to lend itself readily to the treatment of complex congenital patients, where achieving catheter stability for ablation in an abnormal heart can prove even more difficult than the correct diagnosis of the arrhythmia itself. The robotic ablation for atrial fibrillation was shown to allow the consultant to relax and control the case from outside the laboratory itself, a technique which could replace the currently available but technologically inferior option for radiation dose reduction- the registrar!

The opportunity to see some of the industry’s finest and shiniest new toys and gadgets was certainly welcome, with new mapping systems for electrophysiologists and updated devices for implanters. After hearing so much about technological advances there was the welcome opportunity to get “hands-on” with some, particularly with the supportive industry colleagues keen to facilitate the learning.

The congress provided an opportunity for specialists to consider various techniques for treating other more complex and challenging arrhythmias. Case study presentations provided an interesting and informative forum for debate. One particular highlight was the evolving field of catheter ablation for ventricular tachycardia (VT). This is an increasingly necessary intervention, particularly as the population of individuals with life saving defibrillation devices continues to grow, and experience across the UK continues to develop at a rapid rate. This prompted a round table expert discussion to stimulate a consensus statement from HRUK regarding the implications, infrastructure, training issues and the delivery of VT ablation across the UK.

It seems that the face of electrophysiological intervention is evolving at a rapid rate, providing cause for optimism that challenging, intrusive and sometimes life threatening arrhythmias can be effectively treated.

Paediatric and adult congenital Electrophysiology

The field of paediatric and adult congenital cardiac electrophysiology was well represented. Of particular note were the updates on inherited cardiac disease and sudden cardiac death in the young. This emotive field was covered by some of the UK’s leading experts with real world practical discussions about cardiac genetics, how to deal with screening and family issues, and how to approach the sudden unexplained death of a young person. One of the stand-out sessions involved a multi-disciplinary approach to communicating risk to teenagers, based around a fictional diagnosis of Broad STU syndrome (which Dr Graham Stuart promises to publish on in the summer of 2012). The session brought together perspectives from clinicians, ethicists, lawyers, counsellors and parents, with lively debate both from the invited faculty members and the audience, and some important points for improving practice in this very difficult area.

Further presentation covered a tool-kit of useful “how-to” talks, including the setting up of a clinic to look after patients with inherited cardiac conditions (and the pitfalls of having patients booked into the “sudden death clinic”!), the insertion of “leadless” subcutaneous implantable defibrillators (which seem promise particular advantages for the paediatric patient – see above), the management of the transition to adult care of a patient with a complex device, the treatment of atrial fibrillation in childhood and the training of future paediatric electrophysiologists.

Syncope

There was a good deal of attention on the issue of syncope. Models to help set up and run a cost effective syncope service were particularly topical. Recently published work from Eastbourne has helped establish the role of implantable loop recording devices, capable of continually transmitting diagnostic information for analysis, in improving the cost effectiveness, quality and rapidity of diagnosis of patients with unexplained syncope. Interestingly these devices were often implanted by trained and enthusiastic emergency department physicians to facilitate early discharge. Also of note, some of the world’s leading experts on autonomic dysfunction were represented, providing useful insight into the multi-system involvement of such difficult to manage pervasive clinical problems as inappropriate sinus tachycardia (IST) and postural orthostatic tachycardia syndrome (POTS).

Trainees and Young Investigators

EP trainees were represented in large numbers and once again had their own session, with one highlight being the practical tips from a recently appointed consultant on how to tackle applying for and securing that perfect consultant job. There was a flourishing contribution from delegates including moderated and displayed posters as well as oral abstracts, the majority of which held real world value and stimulated some heated debate. Details of all this year’s abstracts will be published in Europace October 2010: Volume 12; Supplement 2.

The winners of the young investigators awards were:

Dr FZ Khan (Clinical)

A Systematic Assessment of the Optimal Left Ventricular Pacing Site during Cardiac Resynchronization Therapy: An Initial Derivation of a Novel Non Invasive Method and Subsequent Validation with a Randomized Controlled Trial

Dr KE Brack (Basic Science)

The increase in nitric oxide and antifibrillatory effect of postganglionic vagal fibres is preserved during VIP inhibition and does not involve the endothelium

Gala Dinner and awards

HRC 2010 provided a welcome opportunity to catch up with colleagues throughout the UK, both from clinical and industry settings. The annual Gala Dinner provided a focal point, with the annual awards ceremony following an impressive and engaging address from Jonathan Dimbleby. The annual Arrhythmia Alliance Excellence in Practice Awards 2010, which aim to recognise outstanding achievements and contributions to arrhythmia management services, were as follows.

1/ Charles Lobban Volunteer Award for Outstanding Contribution To Arrhythmia Services 2010

Winner – Matthew Fay

2/ Award for Outstanding Medical Contribution to Cardiac Rhythm Management Services 2010

Winner – Janet McComb

3/ Allied Professional Award for Outstanding Contribution to Arrhythmia Management 2010

Winner – Jenny Tagney

4/ Team of the Year Award 2010

Winner – BCUHB Arrhythmia Team

5/ Lifetime Achievement Award

Winnner – Dr Richard G Charles.

HRC 2010 was once again entertaining and educational, with a well balanced programme of cutting edge developments, relevant education and real world clinical management. Next year’s congress promises more of the same and can be sincerely recommended to all health care professionals involved in the management of patients with cardiac rhythm disorders.

Heart Rhythm Congress 2011, 2^nd-5^th October Birmingham, U.K.

www.heartrhythmcongress.com

The European Society of Cardiology (ESC) has published its new Clinical Practice Guidelines covering Atrial Fibrillation (AF). These are the first guidelines to be prepared solely by the ESC. Earlier guidelines on Atrial Fibrillation had been prepared collaboratively with the American Heart Association and the American College of Cardiology, but the divergence in practice, drug treatments and the regulatory environment compared with the US have now made it vital to create a European-specific version.

Atrial Fibrillation is the most common cardiac arrhythmia, affecting over six million Europeans.

The guidelines reflect notable developments in many of the conventional treatments for the condition as well as the very latest techniques to manage it:

• Rate control strategies for patients with permanent atrial fibrillation
• New risk profiling to identify patients at risk of stroke
• Availability of arrhythmic drugs with fewer side-effects
• More specific indications for the use of ablation treatment
• Upstream therapies that can halt the progression of the condition.

Professor John Camm (St George’s Hospital, London) Chair of the ESC Task Force that developed the highly detailed guidelines. Said that “atrial fibrillation has become an epidemic, and we estimate that around 1 to 2 percent of the total population are affected. This figure is expected to at least double in line with the demographics of an ageing population because it is particularly prevalent amongst older people. We needed to create up-to-date guidelines because of new drug therapies available, and also because accumulated evidence continuously refines the advice on treatment regimens that give the best outcomes.”

ESC Guidelines For Myocardial Revascularisation

The European Society of Cardiology (ESC) has published new Clinical Practice Guidelines covering Myocardial Revascularisation. These guidelines were developed following pioneering and extensive co-operation between the ESC and the European Association of Cardio-Thoracic Surgeons (EACTS). Myocardial Revascularisation.

These guidelines reflect the fact that there are many options available to treat the many forms of coronary artery disease (CAD), both acute and non-acute.  These include surgery, stent implantation and drug therapies, and the options cross traditional boundaries of medicine such as cardiology and surgery.   “Our intention in writing these guidelines was to give patient-centred recommendations that lead to the most appropriate treatment regime for the different types of CAD,” said Doctor William Wijns of the ESC and Co-Chair of the Task Force.  “We also wanted to provide reference materials based on best practice but not conditioned by the skill and preferences of individual physicians. The major challenge faced by physicians is not how to treat the CAD patient, but which of the many treatment options to select.”

The Task Force was made up of 24 experts, drawn equally from surgeons, interventional cardiologists and general cardiologists, and representing the ESC and the EACTS.  The new guidelines are noteworthy for three main reasons:

They are an example of strong co-operation between the ESC and the EACTS, and have proved to very successful in meeting the objectives.

The content addresses the full extent of CAD, and of associated diseases, which was previously covered in separate guidelines, or not at all.

The guidelines introduce the concept of Heart Teams, essentially a grouping from across disciplines ensuring – when practical – that the patient is fully informed and takes part in the key decisions. The heart team should include one of each of the following specialists; interventional cardiologist, clinical cardiologist, and cardiac surgeon.

The guidelines encompass the full extent of CAD treatment and expected outcomes, including managing stable and unstable angina, myocardial infarction, diabetes-related symptoms and associated renal failure.  Recommendations are made on all treatment options, from the technical aspects of stent implantation to the use of imaging technologies, and from risk management to follow-up activities.

The establishment of Heart Teams is a vital recommendation for medical teams everywhere, and formalises the make-up of the multi-discipline team responsible for patient care following CAD treatment.  Co-Chair, Professor Philippe Kolh of the EACTS explains, “It is important that physicians offer patients the opportunity to influence the response to their condition.  Clearly, for acute cases, such flexibility can be difficult to accommodate, but for the 30 percent of patients with stable conditions, it is an important factor. Immediate but less durable treatments such as a stent implantation may not be the right choice for some patients.  Depending on their lifestyle and responsibilities, some may prefer to elect for a surgical procedure that offers a longer-term result.”

Practitioners that will be using the new guidelines, as well as journalists, are offered the opportunity to have an open discussion and Q&A with Doctor Wijns and Professor Kolh and members of the Task Force.  A ‘Meet the Guidelines Task Force’ session takes place on Tuesday 31 August in lecture room Moscow, Zone A starting at 1005hrs.

ESC focused update of the guidelines for Device Therapy in Heart Failure

The European Society of Cardiology (ESC) has published a focused update of its Clinical Practice Guidelines covering Device Therapy in Heart Failure. This is the first time that current ESC guidelines have been updated, reflecting the pace of research in this field and the importance of recently published evidence.

The update is the result of collaboration between ESC Heart Failure Association (HFA) and European Heart Rhythm Association (EHRA),.The update focuses on the use of devices for the treatment of heart failure, with an emphasis on Cardiac Resynchronisation Therapy (CRT). Professor Kenneth Dickstein from Norway and Professor Panos Vardas from Greece were Co-Chairs of the Task Force responsible for developing the original guidelines, and were the natural choices to lead the new Task Force, which was formed of experts drawn equally from the HFA and the EHRA.

“This focused update to the guidelines provides recommendations for the use of devices to treat heart failure and includes the indications in conditions such as atrial fibrillation and those situations in which patients require pacemaker implantation,” says Professor Vardas. “A primary objective was to close some of the gaps in evidence that were apparent when the original guidelines were published.”

The changes made in the guidelines take account of:

Recently published evidence from clinical trials

New developments in device technology and performance

More extensive  understanding of treatment options and responses

The updated guidelines represent a fresh approach to analysing clinical trial outcomes. “In several areas we used a modified methodology to review the outcomes of clinical trials, with an emphasis on the cohort actually recruited for the trial rather than a strict interpretation of the protocol inclusion criteria,” says Professor Dickstein. “This increases the likelihood that the recommendations made are valid for the target patient population. This process impacts on the class of recommendations made and the determination of levels of evidence for therapy for specific patient populations.”

All guidelines can be downloaded from the ESC website at http://www.escardio.org/guidelines-surveys/esc-guidelines.

This one-day conference will highlight the important clinical overlap that exists between patients presenting with a primary cardiovascular or renal problem. It aims to raise awareness and bring together healthcare professionals who are involved in the management of such patients in order to improve patient care. Topics to be covered include:

• emerging concepts in cardiorenal disease including cardiorenal biomarkers, the genomics of diease, cardiorenal syndrome
• arterial stiffness – diagnosis and treatment
• what’s new in anaemia management
• controversies in cardiorenal disease
• including revascularisation and
• screening prior to renal transplant

Cost: £50 (to include refreshments and lunch), £30 concessions (clinical trainees and nurses)
6 CPD credits approved by the Royal College of Physicians

Nearby hotels to the meeting include: The Holiday Inn Regents Park, Melia White House Hotel, The Grange Fitzrovia and The Grange Langham Court Hotel

For further information on this event please email info@cardiorenalforum.com

Download the programme PDF

Visit cardiorenalforum.com

Wednesday 29th September
Thursday 30th September
Friday 1st October 2010

Download the Programme

Registration for this event is to be made via the website www.pccs.org.uk

Haemodynamic effects include reductions in systolic (-3-5 mmHg) and diastolic (- 2-3 mmHg) blood pressure, reducing systemic vascular resistance (↑ arterial wall compliance and vasodilatory responses but ↓ vasoconstrictive responses) while leaving cardiac output relatively unchanged. Similarly, high fish oil consuming populations have been shown to have lower heart rates (approx -2-3 beats/min) than other populations. PUFAs can also increase stroke volume (approx 4ml/beat) and improve early diastolic filling. The overall effects result in reduced levels of oxygen consumption while improving cardiac efficiency and reducing the likelihood of cardiac hypertrophy.

Other potentially beneficial pleiotropic effects include reduction of triglycerides, anti-inflammatory activity and effects at a platelet and endothelial level which, along with reducing risk of ischaemia-reperfusion injury, may, along with other metabolic and rheological factors, ‘protect’ against sudden cardiac death (SCD). Arguably, this has been observed in studies such as GISSI-Prevenzione, which showed a 44%  SCD reduction in patients randomized to daily consumption of 1g Omega-3 fish oil capsules.

Table 1. Potential coronary vascular effects of n-3 PUFA

• Reduce triglycerides
• Reduce platelet aggregation
• Blood pressure reduction
• Direct effects on endothelium
• Anti-inflammatory

Clinical Outcomes:

• Antiatherogenesis
• Increases plaque stability
• Reduces thrombosis

Professor John Camm, St George’s Hospital Medical School, London, said that  “ion channel trafficking can be fundamentally affected” by n-3 PUFAs, with dose-dependent inhibition of sodium and potassium channels, for example. Experimental evidence supports how PUFAs are anti-fibrillatory and reduce both the incidence and duration of arrhythmias. Their effects in humans is less clear, however and some studies have shown no benefits in  primary prevention or in prevention of atrial fibrillation (AF) after cardiac surgery. While sometimes considered a more benign arrhythmia, over one third on AF patients die from SCD, Professor Camm reminded. There are inconsistencies in trials (and in their meta-analysis) and fundamental problems in their design, we therefore need “large, prospective placebo-controlled trials to establish the value of PUFA treatment on arrhythmias” he proposed. “There is an antiarrhythmic effect but it is difficult to detect it with the type of trials so far”, Professor Camm concluded.

Professor Roberto Marchioli from the GISSI Group, suggested that the early benefits of n-3 PUFAs observed in the GISSI-P study, occurred without changes in the lipid pattern. Also, benefits on SCD were independent of beta blockers.  In the n-3’s trial in heart failure, GISSI-HF, modest risk reductions were seen in patients taking fish oils (but not statin) and this extended to those with depressed ejection fractions, but he said that because heart failure is a chronic disease and it is difficult to tease out any early effects of interventions when events (and event rates overall) are occurring chronically. He agreed more trials are needed. More trials are underway, eg FORWARD, OPERA, PROFI, which may help clarify what are the effects of fish oils in high risk cardiac patients, and perhaps allow for clearer guidelines on the use of n-3’s in heart failure patients. He concluded with some wisdom from Karl Popper (1902-1944), “the growth of knowledge depends entirely on disagreement”

The symposium was sponsored by Abbott Healthcare Products Ltd.

This session began with the first of a number of audience polls. When asked if they were concerned about x-ray exposure, 74% of the audience responded that they were concerned about x-rays for both themselves and the patient. Concerning the average x-ray time used during catheter ablation of AFib, 36% said between 15-30 min, while 34% responded between 30-45 min. Marco Scaglione (Asti, Italy) began his presentation by commenting that a typical catheter ablation procedure for AFib exposes the patient to an equivalent of >1000 chest x-rays. Moreover, exposition is also high for electrophysiologists, nurses and technicians. Such a high level of exposure has the potential to increase the risk of cancer from somatic DNA changes. The question then arises as to how exposure to ionising radiation can be minimised.

Possible solutions include the use of 3D-electroanatomic mapping coupled with image integration. While most operators use CT for image integration, he pointed out that a chest CT was the equivalent of around 400 chest x-rays, which would then be added to the exposure from fluorography. In this regard, he commented that Magnetic resonance imaging (MRI) may be a good first choice for image integration as it limits radiation exposure. The new Carto® 3 System is another imaging tool that may help to reduce radiation exposure, and allows for precise anatomical reconstruction. Another interesting feature of the system is the ability to visualise all catheters, which helps to eliminate fluorographic time during the ablation procedure. He presented preliminary results of an unpublished study performed in his lab in which patients were divided into 3 groups depending on the imaging system used: fluorography (n=40), CartoMerge® Module (n=40) and Carto® 3 System (n=40). Total fluoroscopy time was found to be 18 min in the fluorography group, 10 min in the CartoMerge® Module group and only 2.5 min in the Carto® 3 System group. While the total procedural time was the same across all groups, the fluoroscopic time used during the ablation was 7.5 min in the CartoMerge® Module group compared to 21 seconds in those ablated using Carto® 3 System. In his opinion, remote ablation systems were ‘still not convincing’, and the Carto® 3 System has a number of advantages over robot and magnetic navigation systems including reduced patient exposition to radiation and potential benefits in terms of costs for the healthcare system. While more studies are needed, reduction of fluoroscopic imaging time is an important issue in catheter ablation of AFib, and electrophysiologists need to share both awareness and training in this regard.

In audience polls after the presentation, 90% said that they had reduced the x-ray time with greater experience. Indeed, one-half of those polled said that ‘my own increased experience’ was the most influential tool in reducing x-ray time, while only 21% cited image integration as being the most influential tool in reducing x-ray time. Concerning barriers to reducing x-ray time, 40% cited lack of experience, while 25% said their own spatial perception ability was the biggest barrier. During the discussion, Prof. Kuck commented that ‘imaging doesn’t add too much’. He noted there is growing consensus that one of the main factors for successful catheter ablation of AFib is the use of a 3D mapping system, together with adequate training and experience.

What are we doing about….challenges in atrial anatomy?

A poll of participants before the session showed that the vast majority of ablators are already using some sort of mapping system: 39% reported using 3D mapping by electoanatomical mapping, while 35% reported using image integration with CT/MR. Interestingly, among those not using mapping procedures, 27% cited cost issues and 24% said that it has not been shown to improve ablation success or outcome.

Cardiac electrophysiologist,Professor Karl-Heinz Kuck is explaining the principles of catheter ablation to his patient Joachim Mohr.

Hein Heidbüchel (Leuven, Belgium) listed the major challenges in improving mapping procedures and visualisation of atrial anatomy during catheter ablation for AFib. These included highly accurate anatomy, perfectly registered to real-time imaging, low or no radiation dose, no increase in procedural time, easy logistics and technical set-up as well as a low added cost. In his opinion, ‘perfect anatomy is the first element’ for mapping, and noted that all merger approaches have major struggle. For rotational angiography, he is working on a protocol that will reduce the radiation dose by reducing the number of frames per second and using pulsed fluorography. Together, such approaches can lead to a reduction in radiation exposure times and provide a good resolution of anatomy that is required for successful ablation.

What are we doing about….improving mapping strategies?

Richard Schilling (London, UK, a member of Arrhythmia Watch Editorial Board) spoke of the need to improve mapping strategies, saying that the most obvious reason to do so is to improve results of the ablation. Indeed, in paroxysmal AFib the redo rate is around 40% with successful ablation in 95% of cases, and in persistent AFib a redo procedure is needed in about one-half of patients, with procedural success rates around 80%. In addition, excess and/or erroneous ablation may be common and lead to unnecessary complications and atrial damage. He also noted in this regard that the vast majority of complications are related to the ablation itself. Reviewing current techniques, he commented that while mapping ablation of paroxysmal AFib by voltage mapping and wide encircling lesions was inexpensive, simple and quick. Circular mapping catheters also have several advantages in PV isolation, and can provide a good endpoint.

The key criteria for circular mapping catheters include smooth electrodes, deflectable through 270°, have a variable loop size and contain less than 10 but no more than 20 electrodes. Considering the controversial ablation of Complex fractionated atrial electrogram (CFAEs), he noted that there has not been reproducibility in terms of outcomes. Some of these discrepancies may lie in the differences in definitions of CFAEs. However, until it is clearly established what CFAEs are, the controversies are likely to remain. Some of the newer tools that may help to provide new answers to old questions are high-density mapping and the Carto® 3 System. In the future, he envisages non-contact, high-resolution visualisation in the near-field range and beat-to-beat characterisation of wavefront propagation. He also stated that focused lesion sets, guided by mapping, are still critical to improving outcomes and that many operators are ‘still burning more than is needed in many patients’. Lastly, some of the critical burns are not transmural.

In the ensuing audience poll, when asked if rotational angiography would be helpful in their lab, 62% responded yes while 38% thought it would not be of value. When asked how often image integration with CT/MR was used, interestingly 42% responded from 0-25% of cases, and 40% responded in 75-100% of cases; 8% used the technique in 25-50% of patients and 10% said they used image integration in 50-75% of cases. Concerning the optimal mapping time for the LA in paroxysmal AFib, 18.5% answered <3 min, 20.4% <6 min and 32.1% <10 min, whilst 29% said that mapping time was not important. What are we doing about….shortening procedural time? As an example of the importance of procedural time, a poll before the session indicated that 92% of ablators believe that procedural time is an issue. Indeed, 73% reported an average procedural time for ablation of paroxysmal AFib longer than 2 hours (38%, 2-2.5 hours; 35%, >2.5 hours); only 9% reported a procedural time from 1-1.5 hours compared to 18% from 1.5-2 hours. However, 81% said that their procedural times had decreased over the years.

Gabriele Vicedomini (Cotignola, Italy) suggested that procedural times may be important, but shorter times do not always correlate with good efficacy. In his centre, he said that in fact procedural times had increased somewhat over the past year, even though largely due to an increase in investigative procedures. In his opinion, ablation should be considered as the cure for AFib as it is clearly superior to drugs and is also associated with lasting efficacy. However, its high costs and long procedural times limit access to the procedure. He further noted that longer procedural times are associated with a higher rate of complications, and are not well tolerated without deep sedation or full anaesthesia. Nonetheless, over time the complication rate has gone down, while the overall success rate has increased.

To reduce your procedural time increase your experience’ Gabriele Vicedomini

He further reiterated the importance of experience, both for the operator and for the team in the electrophysiology lab. For catheter ablation of AFib, his group always has 2 electrophysiologists, 1 biomedical engineer, 1 anaesthesiologist, 1-2 nurses and 1 radiology technician. He believes that such a coordinated group is useful for the safety of the procedure and ‘allows the operator to concentrate on the ablation’. He also realises that such an approach is only feasible in high-volume centres, and by doing so posed the question of whether or not AFib ablation should be performed only in high-volume centres. He concurred with such an idea saying that the ‘more you do the better you are’. As further evidence for this premise, according to literature data, outcomes are much better in high-volume centres. Furthermore, pre-shaped multipolar catheters or balloon catheters cannot be considered a short cut for experience. He is of the opinion that greater implementation of teamwork is needed to decrease procedural time, and that whatever ablation is not necessary should not be done.

In the poll following the presentation, 39% cited an increased incidence of complex AFib ablations as the biggest barrier to improving procedural times; 31% admitted that individual experience of the operator was the biggest barrier. Interestingly, the audience was equally split when asked the question of whether or not they had a dedicated AFib ablation staff (51%, yes; 49%, no). Lastly, 83% thought that better understanding of the pathophysiology of AFib was ‘what was really needed’, while only 17% though that better technologies were what was needed.

What are we doing about….improving ablation strategies?

Mélèze Hocini (Bordeaux, France) discussed ways of improving ablation strategies, stating that there are still many unresolved issues, such as the targets for ablation, endpoints and ablation in the presence of certain comorbidities such as heart failure. While Pulmonary vein (PV) isolation may be sufficient for the vast majority of patients, all approaches are associated with similar potential risks. Therefore, there is a need for better imaging techniques as fluoroscopic-guided ablation is insufficient for more complex ablation procedures. In this regard, 3D reconstructed anatomy may be valuable. In terms of strategies not targeting the PVs, she noted that CFAE ablation and ablation of Ganglionic Plexi (GPs), while controversial, is nonetheless feasible and safe. One important aspect is reducing the recurrences of paroxysmal AFib related to PV-LA reconduction.

In fact, she noted that most recurrences were not associated with duration of AFib, LA size, hypertension, presence of LA scarring or non-PV triggers. However, at least in experienced centres the success rates are generally over 85% in paroxysmal AFib; ablation of long-standing AFib requires a more extensive procedure and is associated with poorer success rates. To obtain improved outcomes, she noted that the following will be needed: use of a combination of techniques, identification of critical targets, more accurate mapping and ensuring completeness of ablation lines. Ablation procedures could be improved upon by better understanding of complex atrial electrograms, better definition of ablation endpoints, development of more effective tools (especially for the creation of linear lesions), validation of transmural lesions and increasing the efficacy of ablation of long-standing AFib.

In the following participant poll, when asked what approach was used for ablation of paroxysmal AFib as a primary procedure, 68% responded circumferential PV isolation plus confirmation with a circular mapping catheter. Only 12% said that they used circumferential PV isolation alone as a primary procedure for paroxysmal AFib. When asked, what is your primary procedure for persistent/permanent AFib? one-half responded that they used a stepwise approach consisting of circumferential PV ablation plus validation plus CFAE and creation of roof/mitral lines. The 3 most important considerations for ablation of AFib were considered to be: improve ablation effectiveness (87%), improve ablation safety (30%) and reducing the total procedure time (29%).

What are we doing about….improving success rates?

In considering how to improve success rates of catheter ablation of AFib, Vivek Reddy (New York, USA) first noted that success rates in ablation trials but that in randomised clinical studies versus anti-arrhythmic drugs (AADs), catheter ablation has consistently shown better outcomes. However, with time, especially as more long-term data is becoming available, recurrences tend to occur with time even up to 5 years after the primary ablation procedure. Imaging techniques may vary, but the operator should use whatever he/she is more comfortable with.

‘Whatever works for you is what you should do [in terms of imaging]’ Vivek Reddy

He also described the results of a pilot study investigating the relationship between loss of pace capture directly along the ablation line and electrogram criteria for PV isolation. It was found that complete loss of pace capture directly along the circumferential ablation line correlates with entrance block in 95% of vein pairs and can be achieved without circular mapping catheter guidance. Thus, pace capture along the ablation line can be used to identify conduction gaps. He also mentioned that in his opinion the development of catheter contact sensing strategies should aid in improving success rates as it would be easier to make more reproducible and consistent lesions. Other technologies such as direct visualisation of ablation lesions in vivo are still in the early stages of development. One of the potentially most influential factors in improving success rates might be to ablate earlier in the disease course, leading to better long-term outcomes. Similar to others, he acknowledged that better understanding of complex electrograms is needed.

The audience was then polled on their success rates in ablation of paroxysmal and persistent/permanent AFib (see Table). Regarding major complication rates (death, tamponade, PV stenosis) among ablators, 52% reported that their major complication rate was below 1%, and 41% said that it was between 1-5%. Of those polled, 6% reported a major complication rate greater than 5%.

Reported success rates at 1 year after catheter ablation

Concerning barriers to improve success rates, the audience poll indicated that 35% claimed the technology in achieving point-to-point ablation was the biggest barrier, while 33% responded that it was the complexity of the patients treated. What are we doing about….improving ablation validation? A poll at the beginning of this session indicated that there was large consensus in endpoints for PV isolation, with 92% of respondents stating that elimination of PV signals terminates the procedure for them. Nassir Marrouche (Salt Lake City, USA) presented his interesting results on the use of delayed-enhancement MRI (DE-MRI) to quantify fibrosis and to stage AFib. He also showed how pre-existing LA scarring, determined by the extent of fibrosis, may correlate with procedural outcomes.

Based on his new staging system, he has also developed a management protocol. In stages Utah 1 and 2 – for those with the least fibrosis – PV isolation is used, and discontinuation of anticoagulation may be considered. In stage Utah 3, PV isolation is used along with more extensive ablation, and the patient is maintained on anticoagulants. Finally, in stage Utah 4 – those with most extensive fibrosis – ablation is not considered as a therapeutic option as it will not be effective, and the patient is managed through rate/rhythm control and anticoagulants. A large clinical trial is also in progress to stage AFib and predict outcomes before an ablation procedure. His group has also used DE-MRI to visualise atrial scarring following ablation in an animal model, which is helping to define permanent lesion formation.

His data suggests that the absence of voltage in voltage maps does not necessarily mean transmural scarring. Taken together, DE-MRI is an excellent tool with which to measure atrial fibrosis and has also provided a novel means of classification for AFib. When participants were queried on what they use in order to improve the results of AFib ablation, 52% responded that they preselect patients; 19% said that they use all available techniques, and 18% said that they predefine their ablation strategy. Only 11% responded that they pace to validate the ablation.

My point of view on catheter ablation of AFib In this interesting and novel session, the perspectives of the referring cardiologist and the patient with AFib were presented. Firstly, however, the audience was polled to get an idea of current perceptions among electrophysiologists. Overwhelming consensus was seen when asked if they thought that good contact with the referring physician is important, with 92% responding positively; the vast majority (75%) of electrophysiologists had more than 6 referring physicians.

When asked if they thought that enough time was available to discuss AFib treatment options with your patient, participants were evenly divided, with 47% responding yes and 52% responding no. Most believed that greater awareness is needed for referring physicians (89%), whilst 65% said that they think there should be more lay publicity around AFib ablation to increase awareness. Lastly, only slightly more than one-half claimed to receive feedback from their referring physician on the patient perspective after AFib ablation (54%). Lars Hennig (Berlin, Germany) is a cardiologist who typically refers patients for AFib ablation. He firstly posed the question of what the patient with AFib is looking for in terms of treatment, to which he answered ‘it depends on the level of discomfort’. He noted that up to one-third of AFib patients are asymptomatic, and that even when symptomatic a wide range of symptoms may be present including severe palpitations and panic. It should also be remembered that the patient has ‘no chance to avoid symptoms’ and they want to know more about the disease, for which they often turn to internet sources. What most patients desire is the absence of symptoms, to avoid anticoagulation and AADs, and to have a normal life expectancy. He commented that electrophysiologists need to provide clear and simple answers for their patients as they are afraid of the procedure and will ask many questions about it and the post-interventional period. As far as the expectations of the referring cardiologist, it should be considered that they must satisfy the wishes of the patient and assure the high quality of the ablation procedure.

Electrophysiologists should also take patient fear seriously and sedate as needed. In his opinion, many of these expectations are being met. On a positive note, the success rate is doubled for catheter ablation compared to drugs, and he recommends ablation to all his patients who have problems with drugs. However, for discontinuation of anticoagulation and improvements in life expectancy more trials are needed. Interestingly, he said that he would send more patients for ablation if the patient was satisfied with the treatment and its expectations, even if the procedure was unsuccessful. Contrarily, if the patient complained about treatment, even if successful, he would not send more patients.

‘Referring cardiologists don’t like complaints from their patients’ Lars Hennig

While he didn’t feel that there was a need to increase the number of electrophysiology labs, at least in Germany, he did comment that there was a need to increase the quality of existing labs. Lastly, medical companies also need to develop new tools to help explain ablation procedures more easily to patients. Joachim Mohr (Hamburg, Germany) presented his views on AFib from the patient’s perspective. He has undergone more than 30 cardioversions and 4 ablation procedures, and is still in AFib. From his perspective, AFib makes him weak, and he’s afraid as he knows about the increased risk of stroke and decreased life expectancy. It reduces his quality of life, and he wants to rid himself of it. ‘It is a terrible feeling [being in AFib]’ Joachim Mohr As an informed patient, he gets his information from a variety of sources including the referring cardiologist, the internet and other AFib patients.

In this regard, he cautioned electrophysiologists not to “underestimate the internet presence for yourself and your lab”. Internet forums may also have significant influence on patients. In preparing patients for the procedure, they need a clear explanation of what they will undergo in simple language, and realistic expectations about outcomes, including the fact that a second procedure may be needed. Lastly, patients also desire information about what to do if the AFib returns. Follow-up To start off the session on follow-up, Gerhard Hindriks (Leipzig, Germany) attempted to answer the somewhat controversial question of what is considered success after catheter ablation of AFib. According to the latest consensus statement from the HRS/EHRA/ECAS, success should be considered as being off AADs with no episodes of AFib or atrial tachycardia. In terms of recurrence, he noted that the strongest predictor of late recurrence was early recurrence. However, there is still controversy in terms of strategies that should be used to monitor the patient during follow-up, although it is nonetheless clear that more intensive monitoring is associated with more detection of AFib. Currently, continuous ECG monitoring is the gold standard, but not widely available.

To address this issue, studies are in progress to document as much AFib as possible during long-term follow-up, which will allow for establishment of a solid basis to better understand the long-term efficacy of ablation, the true impact of asymptomatic AFib, clinical relevance of AFib recurrence and define anticoagulation strategies. In this regard, the XPECT study compared intracardiac monitoring to Holter monitoring. In considering the former system, he mentioned that one limitation of the intracardiac monitor, however, is that it although it has a high sensitivity in detecting episodes of AFib, it is not good at detecting short episodes. In addition, another key problem is that the device only stores ECG data for 30 episodes that allow for full manual verification: in some cases though, there may be more than 100 episodes detected, thus questioning the validity of the detected episodes.

Lastly, all the currently available data suggest that there is a need to establish clear follow-up standards and increase patient awareness. Christian De Chillou (Nancy, France) overviewed current strategies for follow-up of patients following catheter ablation of AFib with emphasis on complications. Cardiac tamponade occurs in 1-2% of patients undergoing ablation, and is due most often to popping or direct mechanical trauma. Recent case studies suggest that it may also occur after intervention. Regarding thromboembolic events, he discussed the possibility of using heparin as a bridge during the procedure. While the possibility of discontinuing warfarin after the procedure has been discussed, at present discontinuation of warfarin in patients with a CHADS2 score >2 is not generally recommended; warfarin should be continued for at least 2 months following catheter ablation in all patients. Notwithstanding, there is limited data on the frequency of thromboembolic events post-ablation. However, one preliminary study has revealed asymptomatic stroke by MRI in 10% of patients (2/20)

Concerning PV stenosis, there is a definite need for better follow-up instruction for both patients and physicians. PV stenosis is best detected by CT or MRI, although its optimal management is still unclear. Another potential complication is phrenic nerve injury, which is reported to be particularly high with balloon-based catheters and relatively infrequent with Radiofrequency (RF) energy sources. Atrio-oesophageal fistula, even though thankfully rare and potentially fatal, must be recognised and treated quickly. Symptoms include fever, chills and septic shock.

It is best diagnosed by contrast CT. In terms of assessing the success of the ablation procedure, there is a clear need for a blanking period, and therefore minimal monitoring may be performed for the first 3 months. As already stated by others, with more intensive monitoring, there is an increased probability of detecting episodes of AFib. He believes that it is possible to define success in terms of ‘electrical success’, with no detectable recurrence of AFib, and ‘clinical success’, in the absence of clinical symptoms. Indeed, the addition of an AAD following ablation may now be an acceptable clinical endpoint. It was also mentioned that withdrawal of oral anticoagulation should be considered very carefully. Lastly, electrophysiologists need to change practice by properly applying current and updated guidelines.
‘The desire to stop anticoagulants is not an indication for ablation’ Christian De Chillou

The participants were then polled as to current management practices. Firstly, they were asked what follow-up tools they used. Not unsurprisingly, 85% said that they used standard ECG, and 71% used 24-hour Holter monitoring; 28% used 7-day Holter monitoring, 21% an implantable device and 19% transtelephonic monitoring. In this regard, Prof. Kuck noted that there was no evidence for use of these implantable devices, in addition to having a high cost and extra intervention for the patient. There is, therefore, no need for these devices in routine clinical practice. He also stated that he did not see the need to distinguish clinical and electrical success as the need for anticoagulation depends on the CHADS2 score. Dr De Chillou countered however, reiterating that ‘clinical success is an excellent endpoint’.

Most participants follow the HRS consensus document for anticoagulation after ablation for AFib (75% ‘yes’, 10% ‘no’, 15% ‘unaware of consensus document’). When asked if they stopped anticoagulation in patients with a CHADS2 score >1, 47% responded that they never stop anticoagulation, while 39% and 19% stop anticoagulation in the absence of recurrences after 6 months and 1 year, respectively. Almost 70% of participants said they believe in a blanking period. Concerning the cessation of AADs after successful ablation for paroxysmal AFib, 69% responded that they stop after 3 months, and 18% after 6-12 months; 12% stop AADs immediately after the ablation, while only 1% never stop AADs. Relatively few participants believed that dronedarone, dabigatran or occluders would reduce the number of ablation procedures, with 76% responding that none would reduce the number of procedures.
Debate: We have all we need to successfully treat AFib

In this lively debate, Tamas Szili-Torok (Rotterdam, The Netherlands) took the pro stance, arguing that ‘We have all we need to successfully treat AFib’. He started off by saying that while the reported success rates for catheter ablation of AFib vary from centre to centre and the type of AFib, success rates were good overall. Indeed, more centres are now performing ablation on persistent and permanent AFib, and inclusion criteria such as LA size are less stringent. Considering this, we are already doing well, even if better tools might help to increase the success rates. However, the side effects of imaging like increased radiation dose, use of contrast media and costs may give a false sense of safety and should be more balanced. He further clarified that we already have everything we need to treat AFib, but that we need to have better protocols in place on how to use the available tools to improve the efficacy and safety of ablation.
‘We already treat AFib successfully’ Tamas Szili-Torok

In considering manual vs robotic approaches to ablation, he said that he sees no major differences between the two in efficacy, but large differences in the rate of complications, which are less frequent using a robotic approach providing there is the possibility to treat safely. Better ablation lesions could also give better outcomes, although electroanatomic mapping gives no substantial advantages in terms of efficacy outcomes. He believes that more basic research is needed on the pathophysiology of AFib, and that all the technology we need is already available.

Arguing that we don’t have everything we need to successfully treat AFib, Sébastian Knecht (Brussels, Belgium) began by pointing out that the perfect therapy would have 100% efficacy and 0% complications, at an acceptable cost. He claimed that catheter ablation for AFib is ‘almost’ the perfect therapy, and is certainly well-suited for young patients with clear focal triggers. However, the majority of patients are more complex, and the efficacy of the procedure is much worse, for example, in a patient with persistent AFib and structural heart disease. Moreover, many patients need more than one procedure. He did agree with his counterpart in that a better understanding of anatomy and pathophysiology is needed for better outcomes, and that the available imaging equipment is already very good.

‘We need much more’ Sébastian Knecht

Additional technological improvements could, however, improve the efficacy of ablation, such as contact force sensing for a more reproducible procedure. In persistent AFib, the role of CFAE ablation remains unclear, while the creation of linear lesions is a clear endpoint. Ablation at additional sites, with the objective of improving outcomes, is time-consuming and requires a lot of burning. Additionally, complication rates are high: citing the latest worldwide survey, major complications are seen in 4.5% patients, and death in 0.15%. Therefore, 1 in 600 patients undergoing catheter ablation die from the procedure, which is unacceptable. As previously mentioned, better understanding of the pathophysiology and anatomy is needed, and the operator should always be alert to unexpected changes.

The discussion centred around recurrence rates: Prof. Kuck commented that there is a continuous increase in recurrence even 5 years after catheter ablation for AFib. Hein Wellens responded by saying that ‘What we’re doing in most cases is postponing recurrences – cure is very rare’.

What the next generation of electrophysiologists has to say

Giuseppe Augello (Milan, Italy) works with Carlo Pappone, and he remarked that while a big lab can have several advantages, such as learning standards, the presence of such a standard also means that there is less opportunity for research and less possibility to treat other arrhythmias. In his opinion, AFib ablation now has a common rationale, and there is universal agreement that catheter ablation is better than AADs for AFib. Tom De Potter (Aalst, Belgium) trained with Karl-Heinz Kuck and presented his thoughts on the current status and future directions for AFib ablation. He cited several potential approaches for improvement which included pre-procedural patient selection, and if the ‘right patients are chosen then good results are possible’. An ideal patient would be young, with paroxysmal AFib, in good physical condition and highly symptomatic. While acknowledging that most patients don’t meet these criteria, he still believes that better patient selection could improve outcomes by identifying ‘PVI non-responders’. Daniel Scherr (Bordeaux, France) is in the laboratory of Michel Haïssaguerre, and first reminded the participants to ‘First do no harm’. This is important as there is a need to reduce the complication rates associated with catheter ablation of AFib. Pre- and intra-procedural management should focus on adequate anticoagulation. Energy delivery should be also limited. He showed the results of a preliminary study in which patients on peri-procedural warfarin may have fewer complications compared to those undergoing bridging with heparin. In terms of post-procedural anticoagulation, warfarin should be continued for at least 2 months, and should never be stopped in a high risk population.

Future directions in AFib ablation

In the closing session, Carlo Pappone (Cotignola, Italy) started off by saying that the AFib population is complex, and as a consequence electrophysiologists should begin to move beyond paroxysmal AFib, and seriously address questions about whether patients with structural heart disease, for example, are suitable candidates for ablation procedures. Treatment of these types of patient populations is a challenge for the future.

‘We should think big’ Carlo Pappone

In ‘thinking big’, he presented what he believes the future EP lab should look like, which must address hybrid ablation approaches as well as remote accessibility and navigation systems. It must be simplified, rational and provide increased communication. Wireless instrumentation and catheters would be one step in the right direction, reducing both cabling time and issues. While saying that pre-shaped catheters such as balloon catheters are ‘not for everybody’, newer flexible-tip catheters with ballpoint or brush tips may provide several advantages. Additionally, improvements in real-time lesion assessment, robotics and contact force sensing will likely provide additional benefits for both patients and operators. He concluded by saying that we need better understanding of the pathophysiology of AFib, and to achieve this ‘the future is to become cardio-arrhythmologists again’.
Karl-Heinz Kuck (Hamburg, Germany) closed the session by asking several provocative questions such as whether AFib and/or its chronic forms can be prevented by (early) catheter ablation. He also noted that there is still room for improvement of success rates after ablation, and that many patients have recurrences even in the long term. One open challenge is to achieve permanent isolation of permanent AFib after just one procedure, and in this context contact force-sensing and visually-guided ablation with direct visualisation may be the ‘next big steps’. In terms of preventing/postponing the conversion to permanent AFib, he mentioned an ongoing trial that is studying the benefits of early intervention in paroxysmal AFib.

About the 9th Atrial Fibrillation Symposium

At the end of March 2010, the „9th Atrial Fibrillation Symposium“ focused on the efficient treatment of Atrial Fibrillation by using minimally-invasive catheter ablation. The Catheter Ablation therapy, secondary line treatment, can help lead to a significant overall improvement, as well as to a complete cure of the illness. According to recently published figures by the Journal of the American Medical Association (JAMA), patients who undergo a catheter ablation show significantly less Atrial Fibrillation symptoms and enjoy a considerably enhanced quality of life at 3 months.

The 31^st Annual Heart Rhythm Convention took place on the great plains east of the Rocky Mountains in the city of Denver, Colorado.  As ever, it lived up to the usual expectations, providing a vast amount of information regarding recent clinical trials, current guidelines and more importantly an insight into the clinical decision making behind complex electrophysiological cases.

The opening session hosted by Dr Richard L Page and Dr Bruce L Wilkoff and featuring former US Senate majority leader Tom Daschle and political analyst for Fox News Juan Williams addressed the current debate surrounding health care reforms in the US. This provided an insightful perspective and lively discussion regarding the future developments and issues facing the medical community and in particular involving cardiac electrophysiology.  Clearly the fundamental goal of the Obama government is to implement a healthcare system which is easily accessible to the majority of the population and in particular the sizable number of individuals who currently have a relatively poor level of coverage including my cab driver who ran me to the meeting every morning and appeared to have exceptionally well informed opinions and strong views on this still rather divisive issue. Looking at all of this from the outside perhaps the National Health Service is not so bad after all.

Late Breaking Trials

There are always a number of important trials reported at this meeting encompassing both electrophysiology and device based studies.

One of the most anticipated was the Freedom Trial which was the first randomised multicentre study assessing the effect of frequent optimization of atrioventricular and interventricular delay intervals in cardiac resynchronisation therapy. In this study 1647 Patients were randomised to either optimisation every 3 months using the St Jude Medical algorithm QuickOpt or the control group which was decided by the cardiologist. Of interest there was no difference in terms of worsening heart failure between the two groups and this algorithm for optimisation did not appear to improve heart failure symptoms. This emphasises the fact that there is no easy equation to optimise programming and perhaps as physicians this needs to be performed on an individual basis and probably requires further evaluation.

There was also evidence showing a greater benefit from cardiac resynchronisation therapy in females rather than males in results from the MADIT-CRT study. In fact there was a significant reduction in all cause mortality in females which was not seen in males which was independent of QRS duration.   Although there are several postulated explanations for this there is no overall convincing reason to explain this difference and at present I do not think this will significantly alter our clinical practice.

The question of whether left ventricular pacing is superior to biventricular pacing was answered in the Greater-EARTH trial.  This study showed no additional benefit from left ventricular pacing in terms of exercise duration, LV ejection fraction or LV systolic volume.

There was a huge focus this year on methods to reduce ICD shocks.  A very large study involving 88,804 patients showed that strategic ICD programming reduces the incidence of shock delivery. By programming various and common parameters it was shown that SVT discriminators, programming of faster VT/VF detection rate, longer detection durations and ATP for fast VT all reduced the incidence of shocks with no overall adverse events.

Several interesting pharmacological trials were also presented. A fascinating study presented by Professor John Camm, comparing the efficacy and safety of vernakalant demonstrated superior efficacy over amiodarone for the acute conversion of recent onset AF over amiodarone. Both drugs were safe and well tolerated.

The Japanese Rhythm Management Trial II for Atrial Fibrillation (J-RHYTHM II study) compared candesartan with amlodipine as antiarrhythmic therapy for the treatment of frequent paroxysmal AF in patients with a history of hypertension. There was no significant difference between the two groups in the frequency of the number of episodes of AF. Blood pressure control was better in the amlodipine arm. Both groups resulted in a similar reduction in the number of days in AF, quality of life and adverse effects.
The highly topical issue of the effects of omega-3 polyunsaturated fatty acids were studied in the prevention of AF after coronary artery bypass surgery in 260 patients. Unfortunately there was no significant difference between the two groups in the primary endpoint of post-CABG AF and no differences between the groups in terms of post-operative complications, length of stay in hospital and rehospitalisation rates.

Given that AF ablation may result in inflammatory changes within the left atrium which may cause arrhythmias it has been postulated that steroid injection following AF ablation may result in a reduction in these arrhythmias. A prospective double blind pilot study comparing intravenous steroid versus placebo showed a trend toward a significant decrease in severe arrhythmias in the first 6 weeks post-procedure. There was a significant reduction in need for cardioversion for symptomatic AF. Based on these findings, the routine use of IV steroid administration post ablation could be considered but a larger study is required.

Outstanding Presentations

Given the colossal volume of presentations it is impossible to encapsulate them all.  However some of the highlights of the meeting are summarised as follows.  One of the most popular and indeed one of my personal favourite talks was a presentation by Dr Gregory F. Michaud. A number of interesting cases were presented with audience interaction, each demonstrating several important SVT manoeuvres. This year a new manoeuvre was added to help distinguish between AVNRT and ORT.  Rather than our traditional approach where we entrain from the right ventricle and look at the termination this technique looks at the start of the ventricular pacing and the transition from fusion to resetting of the tachycardia.  If the tachycardia is reset before the transition zone then this is more likely to be consistent with an ORT. If the tachycardia is reset after the transition zone then this is more likely to represent AVNRT.  There were several cases shown to demonstrate this technique and by the end the audience appeared to be well versed in this manoeuvre being able to make the diagnosis in the majority of cases.

From a device perspective Dr Paul Friedman provided a concise overview of shock reduction in ICD therapy. In comparing an empiric programming approach where parameters are pre-set versus a physician tailored strategy it was shown that there was no difference in the time to first shock, whether appropriate or inappropriate.  In view of this it was suggested that we use an empiric strategy for primary prevention (detect only fast VT, detect only sustained VT, use ATP and SVT discriminators and have a high output first shock) and for secondary prevention (add in more zones, programme SVT discriminators and use more ATP in slower VT zones).It was also suggested that future useful developments may include internal haemodynamic sensors which may help determine the delivery of therapy based on an associated drop in blood pressure.

For all of us interested in lead extraction we were provided with a great case based overview by Dr Laurence M. Epstein. The main emphasis was on making the decision on an individual basis. One of the important highlights was that pocket infection, which was previously a class II indication for lead extraction is now class I, given the high risk of endocarditis if the lead is left in place.  Additionally it was felt that lead abandonment was probably not a great strategy as it often results in multiple leads needing extraction at a later stage which have been in place for a longer period of time and thus are associated with a higher risk of removal (ie early versus late delayed complications). The importance of performing these procedures in a large high volume centre was emphasized with overall risk comparable to AF ablation if performed by well trained operators.

Live Cases

These are always one of the most popular components of the convention providing a unique insight into clinical decision making and individual techniques which we may all consider amalgamating into our everyday practice.

One of the complex ablation cases presented involved the management of a left atrial tachycardia following previous AF ablation. The operators performed both entrainment and activation mapping and localised the tachycardia to the mitral valve annulus which was subsequently ablated resulted in termination of the tachycardia and conduction block.

A number of lead extraction cases were presented. The first case involved laser lead extraction of a fractured ICD lead.  Following application of laser through the innominate and into the superior vena cava the left heart border was not clearly demarcated and the left lung field darkened. There was no evidence of pericardial effusion on echocardiogram and chest compressions were administered as the blood pressure dropped.  Although it was initially thought to be a haemothorax, and managed as such the cause was ascertained to be a mucous plug in the left bronchus which improved with suction. Although the clinical condition improved the procedure was aborted. This complication was not directly related to the actual lead extraction, however this case demonstrated the potential risks involved with all complex cases and the importance of good preparation in order to assess all potential eventualities. The other lead extraction cases of a dual chamber biventricular system was performed with no complications.

Awards Ceremony and Presidents Reception

The mantle was passed on from the outgoing president Dr Richard L. Page to the new president Dr Douglas L. Packer. Awards were made to Dr Nabil E. El-Sherif for his pioneering work in cardiac pacing and electrophysiology. Dr David L. Hayes was given a distinguished teacher award and the distinguished scientist award went to Dr Yoram Rudy.

Overall this meeting provided me with a very valuable update in clinical electrophysiology and device therapy as well as providing a forum to meet friends and make research and clinical contacts. We all look forward to another great meeting in San Francisco 2011.

This year’s events for AAAW will include regional pulse check sessions where professionals educate members of the public in this simple heath check procedure. A-A will also use the week to gather data surrounding the efficacy of pulse checks.

The ‘Know Your Pulse’ campaign also reflects the Department of Health’s focus on Atrial Fibrillation as a leading cause of stroke by promoting early and effective screening.   Examples of best practice are available to view at www.atrialfibrillation.org.uk. As part of this, A-A is advocating to Primary Care Trusts that they include pulse checks in the NHS cardiovascular Health Checks and in flu clinics.

A-A and AFA have also developed supporting resources for professionals and areas looking to incorporate manual pulse checks into their practice.  These include toolkits, publications, and website materials which can be viewed, downloaded and ordered through the A-A, AFA and ‘Know Your Pulse’ websites.

Over the next few months, A-A will continue to source data relating to the benefits and costs associated with performing pulse screening.  If you would like to submit evidence or require further information about the ‘Know Your Pulse’ campaign please contact Joanna Fearnley at joanna@heartrhythmcharity.org.uk or 01789 451 823.

Currently there is no formal training arrangement for registrars in the UK that can give you this experience. Interviews with a number of registrars at various levels suggests that they have acquired a lot of their current skill and knowledge by the traditional ‘osmosis’ method from bosses and the like. Many perform their procedures based on what they have seen some else do, and you can sometimes get these operators struggling to explain the rationale behind every twist and turn of catheter or sheath.

According to the JRCPTB’s current training curriculum for Cardiology registrars, their aim is,’ ….to develop both the generic and specialty specific attributes necessary to practice independently as a consultant cardiologist, and to train individuals to provide the highest standard of service to patients who have cardiovascular disorders which includes development of knowledge and skills necessary to mete out this service’

Dr Mark Hall, shown centre photo bottom row

Mark Hall, consultant cardiologist at the Liverpool Heart and Chest Hospital started this ‘Introduction to Pacing for SpR’s ‘ course, in conjunction with Medtronic in 2006. Since then over 250 Cardiology trainees have been put through this programme. The stimulus for generating a program like this was according to Mark,’…..as a final year registrar I felt there was a big training gap especially with regards pacing amongst my colleague and juniors.  No one seemed to be giving any training but we were all expected to understand pacing automatically’. ‘As one of the largest manufacturers of cardiac devices in the world, I contacted Medtronic to help design a course that would be beneficial to all comers’.

Asked what the structure of the course he intended was and he replies, ‘The idea was to create a program that would explain the basic concept of operation of pacemakers as well as provide hands on experience at lead implantation and the surgical skills required. We also aimed to stimulate interest in Electrophysiology and use of devices for trainees who may not have chosen a career path.’

The 2 day course includes a series of lectures, basic programming in a Virtual outpatient pacing clinic, a surgical implantation skills station using Pork bellies or the like as well as the use of a state of the art Virtual catheter Laboratory where training with ‘Fluoroscopy’ assisted Lead implantation takes place. All this training is delivered by a faculty which includes very experienced cardiac physiologists and about 15-20 consultant cardiologist across the UK. At the end of the 2 days, you certainly feel like you have been infused with a huge dose of knowledge and an experience that can only make you confident at your next case. One of the trainees at the course remarked;’…why isn’t this a compulsory requirement for any cardiology registrar before they are let loose on patients?’  Good question? I feel that you should be familiar with any sort of treatment or technology that you prescribe to patients. Unfortunately the way the cardiology training program is designed, you are literally constantly ‘smashing and grabbing’ in order to obtain any sort of decent experience.

A lot of trainees are more focused on getting those numbers up for the RITA’s, or towards their CCT’s than they are on learning to perform their skills properly. Who is to blame? Well I’m not sure actually. In fact I doubt that this is a blame game. How do you provide a system where you are able to provide a high level of training effectively and consistently across board to a group of people? It is certainly a budget that cannot be handled by the JRCPTB and our contributions to training.  With the focus on pacing and this excellent course by Medtronic, one would argue that you can extrapolate this to other skills training.

But, is this sort of organized and formal training necessary? To that I answer yes, because everyone should feel confident about whatever skills they will be required to use in their daily practice. The only way to achieve this is to be trained appropriately. It is clear that junior doctors cannot afford expensive training courses on a continuous basis, otherwise along with all the other fees we all pay; we’d probably end up living on the streets. The government needs to step up to be counted, as if the NHS wants high quality doctors who are skilled in their specialty, then we all have to make a contribution towards this training.

I feel privileged that I was able to attend a course like this. I genuinely feel like I have been empowered to actually effectively discharge a skill based on the very clear background knowledge provided to me. This complements quite nicely, whatever live training experience I have been and will be exposed to. Of course skills’ training is a continuous process which you cannot completely learn in one sitting, but this course certainly provides a high quality, introductory level entry point into basic pacing, implantation and programming that is highly recommended for not just any one interested in pacing and devices, but everyone who is a cardiologist and who as part of their training must have some knowledge of pacing. My advice, get in now while it’s still available.

To register to for the course, you have to contact your local Medtronic representative who will register your interest and put you on the waiting list. Unfortunately to ensure the quality of hands on training at the course is at a high standard, Medtronic can only cater for small numbers on each course.

Disclaimer:

The views expressed in this article are solely that of the author. They do not represent ideas of Medtronic, any such companies or other individuals. There are no competing interests to declare.

Photography by : HOSavage, SAVO Creative Photofactory http://savo.shutterchance.com