Innovation in Heart Failure is about moving forward, maintaining momentum in the development of new therapies to help people live their life as best they can. As Heart Failure is a complex condition innovation can appear in many ways.
– Pharmaceutical innovation – drugs
– Medical Technology innovation – engineering
– Digital innovation – how we may use technology to improve our understanding or maybe monitoring of people with heart failure
– Innovation to access of knowledge and learning – as our lives become centric around wearable tech and smartphones how does information flow to patients and doctors. How to use this to make the conversations meaningful and seamless?
Innovation in health demonstrates an inexhaustible list of progression. The above are just examples of where progression will make a big difference. It could be as simple as ensuring patients are sent home from hospital with appropriate knowledge around their condition. This enables them to take their first steps into managing their own condition. We know it should be done but it doesn’t happen consistently. The first person to enable appropriate discharge support for all heart failure patients will be an innovator, never mind a pioneer.
Innovation is often very much misunderstood in health so here’s the definition.
“To introduce something new”
The important phrase is<strong>”introducing”<strong> as it will have already been “invented”
Below you will find a list of innovative ways of making the lives of people living with heart failure better. We will be adding to this page as we learn about innovation so keep popping back here once a month to see what we’ve found.
Sacubitril Valsartan (Brand Name Entresto)
Sacubitril/valsartan Entresto has recently been granted approval by both NICE (National Institute Health and Clinical Effectiveness) and the SMC (Scottish Medicine Agency).
How does it work?
This drug belongs to a new class of mediation called angiotensin receptor neprilysin inhibitors (ARNIs). It works in two ways, firstly by increasing the body’s natural defences against heart failure and secondly it blocks the body’s natural system which has a harmful effect on the heart. It combines two drugs a new one called sacubitril and valsartan a drug that has been used for some time in heart failure. It is the combination of these two drugs which proved in a clinical trial (Paradigm-HF) that improved both death rates and hospitalisation in heart failure by up to 20%.
How do I know if I will be suitable for the new drug?
NICE have recommended Sacubitril/valsartan for patients who have continuing symptoms of heart failure. They have related this to the New York Heart Association classification. The NYHA is a very useful tool for assessing how patients are in terms of their heart failure, it’s useful for both patients and healthcare professionals in order to assess how they are coping with their current symptoms.
|New York Heart Classification|
|I||No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnoea (shortness of breath).|
|II||Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnoea (shortness of breath).|
|III||Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnoea.|
|IV||Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.|
NICE have recommended that patients that are NYHA II and III will be suitable for Sacubitril/valsartan and may be considered for patients who are NYHA IV. They have also stipulated that patients should have had an ECHO showing an ejection fraction of <35%. They must already have been taking an ACE inhibitor such as Ramipril or Lisinopril or an angiotensin-II receptor blocker ARB for example Losartan, or Irbersartan.
In order to be prescribed Sacubitril/valsartan, you must be seen by the member of the heart failure specialist team, and the monitoring and increasing of the drug should be done by the most appropriate member of the multi-disciplinary team.
If you are not under the cardiologist, heart failure specialist nurse, or a GP who specialises in cardiology, then you will need a referral to one.
Can I be transferred to the new drug immediately?
You will have to stop the ACE inhibitor drug or ARB that you are on for a period of 48 hours before starting the new drug, this is called the wash out period. You will be commenced on a low dose and then have this increased according to how well your clinician feels that you are adapting to the new drug. If they feel that you are having no problems with the drug, by ensuring your blood pressure has not dropped to low, or that it has not affected how efficiently your kidneys are working they will increase the drug until you are on the optimum dose (see details below).
Recommended starting dose
Sacubitril 48.6mg/Valsartan51.4mg (49/51) twice daily
After to 2 -4 weeks doubled to 97/103mg twice daily.
What are the main side effects?
Generally the drug is well tolerated, if there are any side effects these are likely to be light headedness due to low blood pressure, or an increase in potassium levels. This is why you will have your blood pressure and a blood test to ensure your kidneys have not been effected, including your potassium levels each time you have the drug increased. There may be other side effects, and we would recommend you reading the patient information that comes with all drugs.
If I am newly diagnosed with heart failure can I start the drug immediately?
The clinical trial compared the new drug with the previous treatment that is usually prescribed (ACE ARB inhibitor or ARB). They believed that as this was a new drug, they would replicate the trial and ensure that the drug would be prescribed by a specialist in the team.
I am feeling relatively well although I do still have some symptoms, why should I change drugs?
The evidence for the new drug is impressive and has shown to have a significant improvement to avoid being admitted into hospital and increase life expectancy.
How then do I get on the new drug?
Visit your GP, or specialist nurse and discuss the new drug with them and see if you meet the criteria for being prescribed Sacubitril/valsartan.
Medical Technology Innovation
What is CardioMEMS?
CardioMEMS, is a monitoring system, the full name is wireless pulmonary artery haemodynamic monitoring. It works by measuring the pressures in your pulmonary artery, which will rise before a patient notices a deterioration in their heart failure symptoms, e.g. breathlessness or swelling. The device went through trials in the USA, whereby a number of patients who were NYHA III were fitted with the device, and then compared with a group of patients who were not. The results over an 18 month period showed a reduction in hospital admissions of over 37%. This was due to the better management of their condition as the clinician was able to adjust the patient’s medication prior to their symptoms appearing, thus avoiding a deterioration and admission into hospital. Patients also reported a better quality of life and there were some reduction in deaths.
How does it work?
The device is small (need image). A patient is admitted into a hospital catheter lab and given a small amount of sedation, although fully awake to understand what is happening. A local anaesthetic is given in the groin in order to make a small cut into the femoral artery. A wire is then fed up to the pulmonary artery so that the device can then be fed through into position (diagram). If you have had an angiogram, angioplasty or stent fitted, then you will be familiar with this form of procedure. You are asked to lie down afterwards to prevent any bleeding, and may remain in hospital overnight, but will be then free to take up your normal activities. You will be given a monitor which will sit at your bedside and a special pillow. Once a day you will be asked to lie down whilst the pillow will pick up data from your device which will then send it via the monitor to your clinician. Your clinician can adjust your medication if need be without you having to leave home, thus avoiding having to attend clinic or be admitted into hospital.
Are these devices available in the UK?
NICE have reviewed the evidence only at this stage, however the Royal Brompton Hospital inserted seven of the devices into patients in 2015. We await further details at this stage. The devices are expensive, but the company that produces the device believe that they are cost effective, due to the savings in hospital admissions. Professor Marti Cowie form the Royal Brompton has spoken of the major potential of the device, as he believes that treatment can be tailored to an individual patient. Currently such devices as CardioMEMS are not funded by the NHS.
Are there any side effects?
As with all procedures there are risks, the procedure is minimally invasive, but you can expect some tenderness at the site of insertion for a short period. As with similar procedures, such as angioplasty you may experience some risk, including arrhythmias, bleeding, haematoma, infection, and thrombus.
Relative size of CardioMEMS device
CardioMEMS device pillow
From the News Pages
Keep in touch with what is going on around the world in heart failure. Keep up to date with the latest activity at the Pumping Marvellous Foundation
Medical Technology Innovation
What is a Mitra Clip?
What do valves do and why is it important?
The heart is divided into four chambers and in order for the blood to flow from one chamber to another there are valves that function as gates. They open and close so that the blood does not flow backwards and ensures it flows in the right direction. If there are problems with one or more of the valves, this can affect how efficiently the heart pumps, this is termed heart failure. If your doctors have found that you have a problem with a valve in your heart as result of it being damaged or diseased. There are usually two problems that your doctor may say is wrong with the valve:
Stenosis- the valve is stiff so cannot open and close properly, meaning that the heart has to work harder having to force the blood to pass through the stiff valve.
Regurgitation- this means that the valve leaks, as a result the heart has to pump harder due to the blood leaking backwards, so it has extra work to do to get the blood to where it should be flowing.
The mitral valve is a one way valve that sits between the right ventricle and the left ventricle. There are two reasons why you may have mitral regurgitation, either as a result of degenerative disease thereby the valve does not function well or it will leak as a result of the left ventricle being enlarged (dilated), thus unable to eject the blood efficiently blood flows back into the right atrium. This can result in symptoms of heart failure, including breathlessness, the gathering of fluid in the legs, extreme tiredness and lethargy.
How can it be fixed?
If the problem with the mitral valve is severe than the traditional way of fixing the valve would be to have open heart surgery and either to repair it or replace it. However for some patients this is not an option, perhaps due to poor general health, or an already poor functioning heart.
Over the last decade a new device has been created called a mitra clip that can be fitted without need of open heart surgery. The device is fitted via a catheter that is inserted via the femoral vein situated in the groin, and guided into place by x ray.
The device clips the mitral valve leaflets together so that a smaller orifice does not allow the blood to flow backwards into the right atrium.
Are there any side effects?
As with any form of surgery there is always a chance of bleeding or infection. The device has undergone considerable trials in the USA and continues to be assessed here in the UK.
How can I get this device fitted?
A careful history and a vast range of investigations are undertaken to assess suitability for Mitra Clip. Currently only three centres in the UK who are fitting the device by means of a specialist fund by the NHS Commissioning through evaluation programme. Currently the funding is under threat of being cut in April 2017. Research continues to measure the cost effectiveness and the improvement in a patients symptoms as a result of the Mitral Clip.
Watch the Mitra Clip procedure