Advice to all departments carrying out Cardiac Rhythm Management implantation and follow-up procedures – a reminder of the importance of reporting to MHRA
A concern has been raised recently of the possibility of interaction between rate response sensor activity based on minute ventilation and the increased sensitivity features available on some pacemakers and CRT-P devices. It has been suggested this could result in over-sensing and failure to deliver pacing therapy. BHRS is concerned that issues such as this could remain under-reported and dismissed as ‘simple’ lead failure due to time since implant or damage during recent generator change procedure. This in turn could result in additional invasive procedures being performed, exposing patients to unnecessary risk. BHRS would like to encourage extra vigilance when reviewing devices where the programming features using minute ventilation sensor and enhanced sensitivity are in use.
URGENT FIELD SAFETY NOTICE
Information About Cybersecurity Update for Accent™/ Anthem™, Accent
MRI™/ Accent ST™, Assurity™/ Allure™ and Assurity MRI™ devices
We are advising you of the availability of new pacemaker firmware (a type of software) that is intended to address the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications (i.e., Accent™/ Anthem™, Accent MRI™/ Accent ST™, Assurity™/ Allure™ and Assurity MRI™). This firmware update provides an additional layer of security against unauthorized access to these devices that further reduces the potential for a successful cybersecurity attack.
URGENT FIELD SAFETY NOTICE
Battery Performance Management Tool for Implantable Cardioverter Defibrillator with Risk of Premature Battery Depletion from Lithium Cluster Induced Shorts
We are writing to make you aware of an impending update to our Fortify™, Fortify Assura™, Quadra Assura™, Quadra Assura MP™, Unify™, Unify Assura™, and Unify Quadra™ devices manufactured between January 2010 and May 2015 which are subject to the October 11, 2016 Medical Device Advisory (“Impacted Devices”, see Table 1 below for affected devices).
ABBOTT / Update on ICD premature battery depletion advisory
I wanted to write to provide an update regarding the ICD premature battery depletion global medical device advisory we implemented on October 11, 2016.
As you know, our company has worked to continue to better understand the issue as new information has become available and has continued to analyze returned product to provide our customers the most accurate information available.
BHRS Council document produced in response to the NICE Medical Technology Guidance MTG33 relating to EnduraLife batteries.
Resusitation to Recovery
23 March 2017
A National Framework to improve care of people with out-of-hospital cardiac arrest (OHCA in England
National Audit of Cardiac Rhythm Management Devices 2014-15
3 August 2016
This 10th annual report of the National Audit of Cardiac Rhythm Management Devices (CRM Device Audit) describes cardiac device implants in hospitals in England, Wales, Scotland and Northern Ireland for the period April 2014 to March 2015.
Joint statement from Arrhythmia Alliance (A-A) and British Heart Rhythm Society (BHRS)
10 June 2016
The recent announcement of cost savings by the NHS through a national procurement approach should be commended in principle. However, A-A & BHRS calls for clarification and reassurance that patients and local services will not suffer due to clinical experts not being able to access or provide the most appropriate device for the needs of the specific patient.
Post-cardiac Device Implantation Movement and Mobilisation Advice Survey
01 March 2016
This survey is being carried out by the Cardiology Research Team at the Peterborough and Stamford Hospitals NHS Foundation Trust in Cambridgeshire. It is intended for all members of the cardiac rhythm team and concerns the advice that UK cardiac centres give to their patients after cardiac device implantation (PPM, CRT or ICD).
Proposed changes to National Tariffs for EP and CIEDs
3 September 2015
As you may be aware, there is a “National Tariff” for EP and device procedures, which is a pricing structure for activity under Payment by Results.
This pricing structure is currently based on Healthcare Resource Group (HRG) 4 codes e.g. “EA12Z: implantation of Cardioverter; Defibrillator only”. For such procedures, where the overall cost of the procedure is dominated by a disposable item e.g. the ICD itself, the cost is divided into a tariff, which is a fixed price paid to the Trust for the procedure based on the national average costs of hospital services. The current tariff for an elective ICD is £4,637. In addition, the Trust can also claim the cost of the ICD as an “excluded” device. How much a Trust can claim is negotiated locally between the Trust and the Specialised Commissioners. Costs that are excluded in 2015/16 are 3D mapping system disposables, ablation catheters, ICD and CRT-D devices. In 2014/15, the average cost of an ICD according to NICE TA 314 was £11,630, therefore a Trust will receive on average £16,267 reimbursement for the procedure.
The proposal from Monitor and NHS England for 2016/17 is that there will be a change from HRG4 to HRG4+ codes; the difference being that a Complexity and Comorbidity (CC) score is applied to the procedures, which has a large influence on reimbursement. Although I do not know the details of this scoring, it is likely to include comorbidities such as diabetes, renal impairment etc. The result is that, as an example, there are now 4 HRG4+ codes for ICDs (EA12A-D) based on CC scores 0-2, 3-5, 6-8 & 9+. However, of greater importance, the so-called “excluded” device costs (3D mapping, ICDs and CRT-Ds) are now included in the new tariff structure. The overall calculated tariff (procedure + device) is drastically reduced compared to current tariff.
The following table gives some examples of how this will work in practice:
For ablation procedures, as an example, the proposed tariff for an AF ablation with CC score 0-1, including 3D mapping disposables will be £2,573.
What this means is that EP and device procedures will make a significant loss to Trusts. Devices will be increasingly commoditised with stifling of innovation, cessation of industry support. Treatment for our patients will be seriously damaged: quality and features will be ignored e.g. size, MRI compatibility, battery-saving features; Trusts will be reduced to treating as few patients as possible when we are already underperforming compared to NICE and European guidelines; new centres and expansion of services will be virtually impossible.
What can you do?
Ensure your Trust appeals to Monitor by 14th September 2015
The draft prices were published on 20th August 2015 and can be viewed here. This link contains information on the proposed tariff and how to feedback to Monitor. It is important that as many Trusts and other organisations as possible (such as Strategic Clinical Networks) feedback. Be aware that the appeal rules have been changed to make rejection of the Tariff difficult; furthermore, the proposals lack transparency and validity from independent costing sources.
Prepare your department for better Clinical Coding
Make sure that the procedure is correctly identified and coded. Understand elective versus urgent versus emergency (technical meanings not obvious; emergency is poorly reimbursed). Complexity and Comorbidity scores will be important.
Prof Nick Linker – President, British Heart Rhythm Society
Statement on Device Malfunction
12 August 2015
Following recent inaccurate media reports on supposedly faulty devices, the following statement is being issued jointly by Arrhythmia Alliance and British Heart Rhythm Society.
Medical devices such as pacemakers and implantable cardioverter defibrillators (ICDs) are used to help manage and, in the case of an ICD, prevent avoidable deaths due to a potentially fatal arrhythmia (heart rhythm disorder). These devices do not cure the arrhythmia, they monitor and correct as appropriate. Similar to chemotherapy treatment for cancer, medical devices prolong life and improve the quality of life for those suffering with cardiac arrhythmias.
In the UK all devices are registered and many have the option of remote monitoring or clinical appointments, each patient has the option to be regularly checked. The centre that implants the device will follow up the individual patient on a regular basis and with the latest devices data on the function of the device and the patient’s heart rhythm is sent automatically to the hospital via a secure internet connection on a regular basis. If the settings need adjusting or the device battery is nearing the end of its life then the patient is brought back to clinic for adjustments to be made or a change of generator (battery).
On the rare occasion the device or leads are faulty, procedures are in place to recall the possible affected devices and the individual patients are contacted by their implanting hospital. This is a rare occurrence for a small number of devices.
Putting this in perspective, over 100,000 people die each year in the UK from sudden cardiac death. With greater awareness and provision of automated external defibrillators (AEDs) in public places many of these lives would be saved and patients would go on to receive an ICD which would prolong their lives.
Clinicians and professional patient organisations work tirelessly to ensure information, education and awareness is increased and more people recognise symptoms and visit their doctors to ensure they receive an early diagnosis and appropriate treatment.
Over 59,000 pacemakers and ICDs are implanted in the UK annually, saving, prolonging and improving quality of life for these people.
Many hundreds of thousands of lives would be lost if we did not have these devices and the robust procedures in place to implant and monitor each individual device.
More information on cardiac arrhythmias and devices can be found at www.heartrhythmcharity.org.uk or www.bhrs.com.
If you have any questions or concerns please contact –
Arrhythmia Alliance Helpline: 01789 867 501
Or contact the implanting centre at your hospital.
Trudie C A Lobban MBE Prof Nick Linker
Founder & Trustee, Arrhythmia Alliance President, British Heart Rhythm Society
Allied Professional Editorial Programme Competition
15 July 2015
British Heart Rhythm Society sponsorship to attend Heart Rhythm Congress 2015
The response to the British Heart Rhythm Society (BHRS) editorial programme has been significant and a notable number of case reports and review articles are available now for perusal on the website. BHRS has decided to invite new submissions from allied professionals into a competition and is offering two bursaries up to a maximum of £500 to attend Heart Rhythm Congress (HRC) 2015 taking place in Birmingham from 4-7 October 2015.
The editorial programme encourages professional development and adds academic resources for people with an interest in arrhythmias. Not only does the process open up the field of education and facilitation of discussion, but it also contributes positively to the development of the BHRS website. Encouragement to write and present such reports and articles both familiarises and helps develop and promote the scientific method and clinical appreciation amongst practitioners.
BHRS Council then invites allied professionals to submit an article for the editorial programme, which will be entered into the competition. The subject can be anything relevant to cardiac rhythm management. The work need not just be technologically or pharmacologically based, but may also involve other areas of interest such as inter-personal patient care. When considering the merits of a good report or article, a number of factors need to be taken in to account. The clinical content of the work is the main feature of interest. A good scientific approach will gain credit when presented well. Appropriate scientific referencing will also be expected. Naturally articles and case studies involving new technological developments or unusual pathologies will provoke interest but a submitted piece need not be complex, what matters is that it is both informative and relevant.
Articles should be no more than 1,500 words excluding references. The deadline has now been extended, so competition submissions can now be made up until 5pm on Friday 4 September 2015 by email to firstname.lastname@example.org. The articles will be marked by a selection of BHRS Council members and the winner will be announced by the middle of September. Please review the conditions of the competition before submission.
The BHRS Council would like to thank everyone who has so far contributed to the editorial programme. The Council also looks forward to sponsoring the first winners of the competition very soon.
Dr Mark Earley– BHRS Honorary Treasurer