News in brief from the world of cardiology
First UK operation for HF with nerve-stimulating implant
The UK’s first operation to tackle heart failure (HF) with a novel nerve-stimulating device was performed recently at Glenfield Hospital, Leicester. The operation was part of the INOVATE-HF clinical trial, a global investigation to determine the safety and efficacy of the an implantable electrical stimulation device (CardioFit,® BioControl Medical), designed to improve heart function in patients with HF. The study will evaluate the system’s ability to reduce hospitalisation and death among patients with HF, while also exploring whether combined treatment with the system and prescription drug therapy is more effective than drug therapy alone.
NHS Employers urge medical revalidation
Mandatory medical revalidation, to ensure all doctors’ skills are regularly and formally assessed for the first time, should be introduced later this year, according to a statement from the NHS Employers organisation.
The Organisational readiness self-assessment report, published recently by the Government’s NHS Revalidation Support Team, says most organisations are ready to support doctors with revalidation, and urges a Government decision to start the process.
Dean Royles, director of the NHS Employers organisation, said: “The introduction of regular tests and more appraisals for doctors will be a milestone which should reassure the public that their medical care is up to date, safe and effective. Employers will ensure that all doctors are engaged with the process and have access to appraisals, which will become a mandatory part of retaining their licence to practise”.
£4 million for prevention of stroke and dementia
The Wolfson Foundation has recently announced an award of £4 million to Oxford University for research into the prevention of stroke and dementia, to create a new Centre for Prevention of Stroke & Dementia located at the John Radcliffe Hospital, Oxford.
Paul Ramsbottom, Chief Executive of the Wolfson Foundation, said, “This investment will help Oxford build on its existing strengths in stroke and dementia research. Research into neurological conditions has been comparatively underfunded in recent years in the UK – but these diseases have a devastating impact on individuals and their families. We are excited by the possibility for significant advances in understanding these debilitating conditions”.
European statistics show drop in heart disease mortality
There has been significant improvement in Europe’s heart health in the last few years, according to figures on the burden of heart disease released by the European Society of Cardiology (ESC) and the European Heart Network (EHN), to mark World Heart Day (29th September).
CVD is now responsible for four million European deaths annually, down from 4.3 million in 2008 (which represents a drop from 48% to 47% of total European deaths).
Dr Hans Stam, President of the EHN, said: “A few years ago it seemed that the rise in cardiovascular disease was unstoppable; this report shows that we have reversed that trend, and that lives are being saved”. He cautioned though that there are potential problems ahead with diabetes and obesity rising, with smoking still a major issue, and people not exercising enough.
TAVI: coming of age
Trancatheter aortic valve implantation (TAVI) is to be made available to patients in Scotland for the first time, following agreement by the Scottish Government. A specialist TAVI clinic based at the Edinburgh Royal Infirmary will undertake 50 TAVI procedures per year.
This follows increasing strong clinical data that it is cost-effective in carefully selected high-risk populations.
TAVI has been included for the first time in the European Society of Cardiology (ESC)/European Association for Cardiothoracic Surgery Guidelines on the Management of Valvular Disease published in August. The guidelines recommend that in severe symptomatic aortic stenosis, TAVI should be indicated in patients who are not suitable for surgery, as assessed by a heart team. High-risk patients that may still be candidates for surgery, but in whom a less invasive approach is favoured by the heart team based on an individual risk profile should also be considered, say the guidelines.
Earlier this year, in March, the National Institute for Health and Clinical Excellence published updated guidance recommending the use of TAVI under normal arrangements for patients for whom surgical aortic valve replacement is considered “unsuitable”. TAVI must continue to be used under special arrangements for patients with aortic stenosis for whom surgical aortic valve replacement is considered suitable but poses a high risk.
European device regulations do not protect patients with diabetes
European medical device regulations are inadequate to protect people with diabetes, according to a recent statement from the European Association for the Study of Diabetes (EASD). The statement was made by EASD President Professor Andrew Boulton (University of Manchester) during the Association’s annual meeting held recently in Berlin.
Professor Boulton said: “The general public, including diabetes patients, were rightly extremely concerned when the various medical device scandals came to light earlier this year. The European Commission appears to have missed its opportunity to tighten up these regulations. Without tougher rules governing approval and surveillance for medical devices, how can we ensure the public has confidence in the system?”
EASD, in collaboration with device manufacturers, wishes to establish conventional standards and calls upon the European Union to implement them in the near future.
EU gives nod to apixaban for AF
The oral factor Xa inhibitor, apixaban, has been given a positive review from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for the reduction in risk of stroke or systemic embolisation associated with nonvalvular atrial fibrillation (AF).
The decision was based on results from the ARISTOTLE and AVERROES trials. ARISTOTLE showed that apixaban was more effective than warfarin at preventing stroke or systemic embolism in AF patients, while AVERROES showed apixaban was better than aspirin at reducing strokes and systemic embolisms without increasing major or intracranial bleeding in AF patients unsuitable for warfarin therapy.
Final approval of apixaban for this new indication now awaits the formal decision of the European Commission.
ECG telemedicine in primary care
Costly referrals to secondary care could be reduced by commissioning electrocardiogram (ECG) interpretation to an external service, according to the NHS Technology Adoption Centre.
The service allows GP surgeries to record 12-lead ECG onto a handheld device (HeartView, Broomwell Healthwatch) and transmit the recording by phone to a UK-based centre. An immediate verbal interpretation is provided by a cardiac nurse or cardiologist, with a full written report and copy of the ECG following within minutes.
Staff at the centre are all UK registered cardiac nurses, physiologists or specialist registrars with experience in cardiology departments. Their interpretation skills are continually tested, and they are supervised by consultant cardiologists.
Following several successful NHS Pilots, the service should now be rolled out and commissioned for practices across primary care trusts in the UK according to Dr Derek Rowlands, who provides several annual teaching days for Broomwell Healthwatch, as well as setting and marking a further annual ECG exam.