Interest in the device was boosted by a recent study in the New England Journal of Medicine (1) from Dr Gust Bardy and others. Using this system they evaluated four subcutaneous ICD configurations in 78 candidates for ICD implantation and subsequently tested the best configuration in 49 additional patients to determine the subcutaneous defibrillation threshold in comparison with that of the standard transvenous ICD. They also evaluated long-term use of S-ICDs in a pilot of six patients, which was followed by a European trial involving 55 patients.

The best device configuration consisted of a parasternal electrode and a left lateral thoracic pulse generator, similar to that illustrated. This configuration was as effective as a transvenous ICD for terminating induced ventricular fibrillation (VF), but requiring a significantly higher mean energy requirement, 36.6 versus 11.1 Joules.

Among those who received a permanent S-ICD, VF was successfully detected in all 137 induced episodes. Induced VF was terminated twice in 58 of 59 patients with the delivery of 65 Joules in two consecutive tests.

In the European single-group trial of 55 patients (53 of whom were evaluated) the mean time to delivery of a shock was 14 secs. The mean duration of the procedure, including device insertion and testing, was 67 mins, a time which was reduced to 55 mins by practitioners who had done at least three implantations. After ten months follow-up 54 of 55 patients were alive, one having died from renal failure. A pocket infection developed in two patients but no cases of pocket erosion occurred. There were no lead fractures and no generator migration occurred.

The new device is reported to cost around £12,000 and does not need replacement for five years.

Speaking at a meeting in London recently, Dr Andrew Grace, Consultant Cardiologist, Papworth Hospital, Cambridge, UK, described leads as “the Achilles heel of defibrillator therapy”. He described also how about 36% of shocks from conventional ICDs are inappropriate. “This is absurd” said Dr Grace, who helped develop the new device and who is also a senior author on the NEJM paper.

He summarised the benefits of the new device saying that it delivered significantly fewer false shocks, it was faster to implant and safe to remove. It also eliminated the need for fluoroscopic guidance for lead placement and it “leaves the venous system alone”.

The device is approved in the UK and approximately 50 have been implanted.

Reference

1. Bardy GH, Smith WM, Hood MA et al. An entirely subcutaneous implantable-defibrillator. New Engl J Med 2010. ((10.1056/NEJMoa0909545) published 12 May 2010.

We will feature news about subcutaneous lead ICDs again in the near future.  We will also soon feature news about newer ICD systems which are also less prone to inappropriate shock delivery

those people with non-permanent AF patients whose AF is not controlled by first-line therapy (usually including beta blockers) and who have at least one of the following risk factors:

• Hypertension requiring 2 drugs of at least 2 different classes
• Diabetes mellitus
• Previous transient attack (TIA), stroke or systemic embolism
• Left atrial diameter ≥50 mm
• Left ventricular ejection fraction <40% (dronedarone not recommended for  those with LVEF <35%) or age 70 years or more and who do not have unstable New York Heart Association (NYHA) class III or IV heart failure.

People who do not meet these criteria, who are currently receiving dronedarone should have the option to continue treatment until they or their clinicians consider it appropriate to stop.

The recommendations from NICE have been broadly welcomed. They follow a sustained campaign by cardiologists and other healthcare professionals (HCP) along with the Arrhythmia Alliance to have dronedarone available for prescription with NHS funding.

A new website, www.multaq.co.uk is available for HCPs, which has specific section for patients, and carries general information about atrial fibrillation and Multaq in particular.

Reference

• Final appraisal determination for the treatment of non-permanent atrial fibrillation. National Institute for Health and Clinical Excellence (NICE) July 2010. Available at: http://www.nice.org.uk/nicemedia/live/11750/49792/49792.pdf

This prospective, multi-center, randomized (2:1), controlled, two-arm clinical study will enroll up to 350 patients at up to 15 sites throughout Europe. Patients in this study will be followed for one year after ablation.

The study is intended to test the hypothesis that the NAVISTAR(R) THERMOCOOL(R) catheter using the CARTO(R) 3 System is superior to fluoroscopy-guided PVAC(R) for efficacy and safety and will demonstrate non-inferiority for efficiency comparing the NAVISTAR(R) THERMOCOOL(R) catheter used with the CARTO(R) 3 System to the PVAC(R) catheter. Interim results from the study will be disclosed after completion of the enrollment phase and the final results will be available at the end of the 1-year follow up period.

“The CLARITY-AF trial is the first multi-center randomized trial comparing atrial fibrillation ablation devices. This trial will compare the Medtronic PVAC(R) catheter to the Biosense Webster NAVISTAR(R) THERMOCOOL(R) catheter. Primary endpoints are freedom from any atrial fibrillation, atrial tachycardia, pulmonary vein stenosis and procedure time. Given the growing epidemic of atrial fibrillation, the results of this trial will guide optimal treatment in a large patient population” said Prof. Mattias Duytschaever from AZ St Jan Hospital in Bruges, Belgium, and principal investigator of the CLARITY-AF study.

CARTO(R) 3 is the third generation of the CARTO(R) electro-anatomical mapping system. The system is built on the core magnetic based CARTO(R) proprietary technology, with a special focus on increased performance, ease of use and Electrophysiology-lab efficiency.

Dr Ian Starke, RCP Medical Director for Revalidation, said that the detailed investigation and report would be crucial in improving the appraisal and revalidation processes and in meeting the concerns of UK doctors:

“In ensuring we covered every aspect of appraisal, we were able to collect and fully represent the views of the pilot appraisers and appraisees from many specialties, gathering vital information about the positive and negative aspects, and perceptions of the proposed system.  This means that the rumours and media speculation about the way in which the appraisal process may or may not work are now replaced with firm conclusions and recommendations.

The medical royal colleges, UK Programme Board,  Revalidation Support Team, GMC and BMA can now work together to implement those recommendations.  The findings of this study have already been shared with those developing the next series of revalidation pilot studies, and this process will continue. I am optimistic that the work carried out by the RCP will lead to improvements all round for any future pilots and the final roll-out of revalidation, and we will be able to use effectively the extra year before implementation suggested by the Secretary of State for Health, Andrew Lansley.”

Notes

The full report is available on the Revalidation Support Team website, the Executive Summary begins at page 6 of the pdf:

http://www.revalidationsupport.nhs.uk/files/RCPMerseyFinalReport17.06.10.pdf

The project was led by a Steering Group including representatives from those directly involved in revalidation and appraisal programmes and medical education, the Revalidation Support Team, GMC, BMA, and also included a patient representative.  The pilot project was managed by the Revalidation Programme Manager at the Royal College of Physicians in London. Most of the day-to-day on-site project management was carried out by a local Project Co-ordinator who was appointed in February 2009 and was based within the Liverpool Medical Institution (LMI). The Project Co-ordinator provided day-to-day project management, co-ordination of electronic linkage of appraiser/appraisee pairs, regular site visits to individual Trusts and participants, a general help-line in relation to the practicalities of the pilot process and administrative support for the Project Steering Group. The steering group met every two months throughout the project.

Nonetheless the task of putting into place measures that are genuinely useful to patients and clinicians should not be underestimated. It is essential that commissioning groups work collaboratively with specialists to develop integrated care pathways and that any shift in clinical priorities is carefully considered to ensure that the desired outcome is not overshadowed by unintended consequences.

Delivering public health should be the responsibility of all health professionals and the drive to address the wider determinants of health to enable positive behaviour change are encouraging.

The vision for the NHS outlined today offers a real opportunity for forging positive clinical engagement but this can only be fully achieved by ensuring that policy is underpinned by clear, practical and evidence-based systems” Sir Ian concluded.

The Affinity Pixie Oxygenation System with BalanceTM Biosurface* gained CE Mark for clinical use throughout the European Union on 30th May 2010. It is not yet available in the United States for clinical use. The Affinity Pixie is designed for use with a broader range of patients and can be used to support approximately 75% of the neonate, infant and paediatric population undergoing cardiopulmonary bypass (it has a maximum flow rate of 2.0 L/min and a low prime volume of just 48 mL). The system also features the Affinity OrbitTM Holder System, which provides versatile device positioning and port orientation to aid reductions in circuit tubing length and associated prime volume.

Additionally, it includes new design elements such as a hydrophilic biosurface without heparin (Balance Biosurface) to minimize the interaction of the patient’s blood with foreign surfaces inside the device.

The Affinity Pixie Oxygenation System is an additional step in a larger programme by Medtronic to develop a range of innovative new perfusion products to assist surgery for both for children and adults over the next few years.

Medtronic is launching a “Commitment to Perfusion” campaign around the world, for more information please use the following link: www.perfusion.medtronic.com or to become part of the Perfusion Insider community go to: www.committedtoperfusion.com

* Technology licensed under agreement from BioInteractions Limited, United Kingdom.

ZOLL also won joint supplier status Level 2 and Level 3 for its AED Pro^® for the next three years.  If fully exercised, the potential revenue for the contract could exceed £1.5 million for all three levels.

The tender process included leading professionals from both the medical community and ambulance services. It scrutinized all aspects vital to the delivery of the BHF Community Resuscitation programme including the clinical aspects of the devices, account management, compliance with resuscitation guidelines and compatibility with the ambulance service.

“One in three people who experience sudden cardiac arrest die before reaching the hospital. Experts believe these figures could be reduced drastically if there were more defibrillators in public places,” stated Claire O’Neill, Community Resuscitation Lead, British Heart Foundation. “We are delighted to be continuing our productive working relationship with ZOLL to place more AEDs in the community.”

Anticoagulants can reduce the risk of stroke by up to 80% here,“ says  Prof. Einhäupl. New substances such as dabigatran and rivaroxaban which can be taken orally, and overcome the need for INR monitoring, should make life easier for doctors and patients once they are approved, in his view.

Fewer side effects  – equal effectiveness

The effects of dabigatran were tested in the  RE-LY study on 18,000 participants, and its findings were discussed at the neurology congress in Berlin. “In general, the substance proved to be well tolerated. With the same efficacy, dabigatran had fewer side effects, and with higher efficacy approximately the same side effects as standard drugs,“ says Prof. Einhäupl. However it is too early for euphoria. „”We still don’t know enough about the long term effects of the drugs. Dabigatran has yet to be approved and is expected to be on the market by year’s end. The effects of  rivaroxaban are now being tested on patients with atrial fibrillation. There is of course always some level of risk „that a patient becomes a ‘bleeder’ as a result of the drugs,“  says Prof. Einhäupl. „Each individual case must be carefully weighed up. But as soon as an additional risk factor arises, when atrial fibrillation is already present, these measures should be employed.“ Among patients at risk are those over 60, diabetics and heavy smokers.

Stroke prevention through rhythm control in AF

A new antiarrhythmic drug (dronedarone) could be of great importance in future in treating atrial fibrillation. A major international study (ATHENA) demonstrated that stroke risk was reduced relatively by 34%. Because stroke was not the primary objective of the study, further investigations are now necessary to confirm this surprising result. „And the mechanisms by which this effect is achieved are still unclear,“ says Prof. Einhäupl. The lower rate of side effects observed, compared to the precursor chemical amiodarone, is also a benefit.

Secondary prevention in stroke patients

Further study results on the theme of operative secondary prevention of stroke were also presented. The German Stroke Society compared carotid endarterectomy with the insertion of stents in the carotid artery. Our suspicions were confirmed. Stent implantation offers no advantage over a well conducted carotid operation, but probably carries disadvantages,“ says Prof. Einhäupl. “The mortality risk or the risk of a further stroke are  marginally higher for patients with stents. “I would then, other than in a  few exceptions, always give preference to a well conducted carotid operation“, he said.

Longer therapeutic window for thrombolysis

Studies on thrombolysis presented at the neurology congress also demonstrate improved prospects for stroke victims. Medical guidelines until now have stipulated that thrombolysis should be carried out only within three hours of a stroke. “For this reason, and others, this treatment has been available to only a few patients,“ says Prof. Einhäupl. A large scale European study has now demonstrated that thrombolysis can be used safely and effectively up to four and a half hours later.

Experience at the Berlin Charité has shown that comprehensive rapidly conducted MRI examinations on acute stroke patients can offer new treatment options. In the course of clinical observation of 11 stroke patients with ischaemia, after MRI examination thrombolysis was safely conducted. This was done although it was unclear when the patient had suffered the stroke. “The results show that those patients in whom the course of the stroke is unclear can also receive  thrombolysis. The precondition is that the decision be made on the basis of precise MRT results,“ says Prof. Einhäupl. Further examinations show that thrombolysis can also be carried out on patients with acute stroke but mild symptoms.

Current advice is often confused and this can result in inappropriate restrictions being placed on the travel plans of thousands of patients. Healthcare professionals and patients have not had, until now, clear guidance based on the latest evidence to help give them the right advice. This is going to change in August when the British Cardiovascular Society (BCS)  publishes a report on passengers’ cardiovascular ‘Fitness to Fly’ in the journal, Heart.

On Tuesday 20 July, the report will be launched online at BMJ’s Heart website (http://heart.bmj.com) and on the BCS website (www.bcs.com).  The ‘Fitness to Fly’ report shows that there are very few heart conditions that mean that patients can’t fly safely. However, passengers are advised to inform their airline of any pre-existing heart conditions that they may have and take other precautions in their preparation to fly.

Whilst airlines do have the right to deny passage on the basis of a pre-existing heart condition, this report gives clear evidence that such denial is unnecessary in the vast majority of cases. This will be of great use to the travelling public and to all healthcare professionals and will mean that thousands of heart patients will be able to travel by air, reassured that expert guidelines have shown that it is safe to do so.

The comprehensive report includes a summary table of various specific heart conditions with advice on any necessary guidance or restrictions that should be considered for the passenger, as well as a thorough review and consideration of current evidence within this area.

The report is the result of a working group formed by the British Cardiovascular Society (BCS) at the end of 2008, at the prompting of the House of Lords’ Science and Technology Committee. The working group was led by Dr David Smith, a Consultant Cardiologist based at the Royal Devon and Exeter Foundation Trust, and included representation from Airlines, Aviation authorities and experts from the field of Cardiology.

Keith Fox, President of the BCS said, “The new guidelines on fitness to fly for patients with heart conditions are good news for patients and good news for doctors. The British Cardiovascular Society publication (led by Dr David Smith) advises that there are very few heart conditions that mean a person should not fly.  For the first time, doctors have also been provided with clear and straightforward guidelines.”

Notes

• The Fitness to Fly report was written by David Smith¹,William Toff², Michael Joy³ , Nigel Dowdall⁴, Raymond Johnston⁵, Liz Clark⁶, Simon Gibbs⁷, Nick Boon⁸, David Hackett⁹, Chris Aps¹⁰, Mark Anderson¹¹, John Cleland¹²

1. Cardiac Department, Royal Devon and Exeter NHS Foundation Trust, Exeter, UK
2. Department of Cardiovascular Sciences, University of Leicester, Faculty Member of the NIHR Leicester Cardiovascular Biomedical Research Unit, Leicester, UK
3. Postgraduate Medical School, Surrey University, UK
4. British Airways, UK
5. UK Civil Aviation Authority, UK
6. Peninsula Heart and Stroke Network, Plymouth, UK
7. National Heart and Lung Institute, Imperial College London and Department of Cardiology, Hammersmith Hospital, London, UK
8. Past President, British Cardiovascular Society, London, UK
9. British Cardiovascular Society, West Hertfordshire Hospitals NHS Trust, Hemel Hempstead General Hospital, UK
10. Guy’s and St Thomas’ NHS Foundation Trust, London, UK
11. The Cardiac Centre, Morriston Hospital, Swansea, UK
12. Department of Cardiovascular and Respiratory Disease, University of Hull, Castle Hill Hospital, Hull, UK

He presented data during the 20^th European Meeting  on Hypertension, in Oslo, recently, from 2014 apparently healthy men aged 45-59 years who were included in the Oslo Ischemia Study, between 1972-75 and who were followed for 35 years. By this time some 272 men (14% of total) had a diagnosis of AF.

The adjusted risk of developing AF was increased by 63% for study participants with baseline BP>128 mmHg (p=0.0003) compared to participants with SBP <128 mmHg. This therefore represented a “strong, independent long-term predictor of AF” according to these investigators.