Ivabradine (Procorolan) for Heart Failure
The National Institute for Health and Clinical Excellence (NICE) is issuing final draft guidance recommending ivabradine (Procoralan) as a treatment option for some people with chronic heart failure.
Treatment for heart failure is designed to help improve life expectancy, quality of life and to avoid hospital admissions. We feel this decision is long overdue and is great news for some patients.
The heart-rate-lowering drug ivabradine significantly reduced the risk of cardiovascular death and hospital admissions for worsening heart failure when added to standard treatment in patients, according to a UK, US and European study in 2010.
The ‘Systolic Heart Failure treatment with the ivabradine Trial’, known as SHIFT, looked at whether lowering heart rate with ivabradine reduces cardiovascular death and admission to hospital.
The patients studied had worsening heart failure, chronic heart failure, systolic dysfunction and a high heart rate over 70 beats per minute (bpm) or higher.
6,505 patients from 37 countries were studied over around 23 months. Around half were randomly given ivabradine twice daily in addition to standard heart failure treatments. The other half had a dummy placebo treatment added instead.
Treatment with ivabradine significantly reduced the risk of major heart failure by 18% compared to the dummy treatment. 16% of patients taking ivabradine were admitted to hospital with worsening heart failure compared to 21% in the placebo group. 3% of patients in the group taking ivabradine died from heart failure compared to 5% taking the placebo.
Ivabradine brought about an average reduction in heart rate of 15 bpm.
Who would get the new treatment?
The new guidance covers ivabradine for people with classes of chronic heart failure called NYHA class II to IV and other restrictions. The new guidance says ivabradine is cost effective when used in combination with standard therapy, including beta-blockers, angiotensin-converting enzyme (ACE) inhibitors and aldosterone antagonists, or when beta-blockers are not appropriate.
The decision to use ivabradine would be taken by a heart failure specialist. The treatment would cost the NHS around £42 per patient a month.
For this cost compared to a hospital admission makes economic sense. Be aware if you have AF then ivabradine will not be prescribed.
Surgeons at Glenfield Hospital in Leicester are launching a trial into the use of an implant to treat heart failure.
Unlike existing devices which help the heart to pump, the new CardioFit, will stimulate nerves in the neck allowing the heart to pump more slowly and therefore cope better. If proven effective it could be used as an alternative to lifelong drugs and heart pumps in patients with heart failure.
Lead investigator in the trial, Dr André Ng, a senior lecturer in cardiology at the University of Leicester and consultant cardiologist at Glenfield Hospital, said: “Our aim with the INOVATE-HF study is to assess CardioFit’s safety as well as its potential to improve heart function in patients with heart failure, thereby improving their quality of life and survival.
If the hypothesis is proven in the study results, this could transform heart failure treatment and would support the use of the innovative therapy over and above tablets for standard heart failure treatment.”
The CardioFit system stimulates the “parasympathetic” nervous system, via the vagus nerve in the right side of the neck, to reduce stress on the heart. “This is a potentially ground-breaking treatment for patients with heart failure” “My University of Leicester research group has been studying the relationship between vagus nerve stimulation and heart function for almost 15 years. It is really exciting that there is finally an innovative form of treatment available that will allow us to investigate its potential use in heart failure,” Dr Ng said.
The system has already been tried in 32 patients in Germany, Italy, The Netherlands and Serbia where the results have been promising.
It was found that the heart was more flexible and able to cope with speeding up and slowing down as needed, resting heart rate was lowered and the force of the heart’s pumping action was improved. Patients who have already received the devices said they had a better quality of life and they performed better on hill walking tests.
Professor Huon Gray, Interim National Clinical Director for Cardiovascular Disease said: “We know that heart failure can have a devastating effect on people’s lives, so any potential advance in its treatment is to be welcomed.
A person’s heart rate, also known as their pulse, refers to how many times their heart beats per minute. Our heart rates vary tremendously, depending on the demands we make on our bodies – a person who is sleeping will have a much lower heart rate compared to when he/she is doing exercise.
There is a technical difference between heart rate and pulse, although they both should come up with the same number:
- Heart rate- how many times the heart beats in a unit of time, nearly always per minute. The number of contractions of the lower chambers of the heart (the ventricles).
- Pulse (pulse rate) – as the blood gushes through the artery from a heart beat, it creates a bulge in the artery. The rate at which the artery bulges can be measured by touching it with your fingers, as on the wrist or neck.
So what is your resting Heart Rate
For a human aged 18 or more years, a normal resting heart rate can be anything between 60 and 100 beats per minute. Usually the healthier or fitter you are, the lower your rate. A competitive athlete may have a resting heart rate as low as 40 beats per minute.
Champion cyclist, Lance Armstrong has had a resting heart rate of about 32 beats per minute (bpm). Fellow cyclist Miguel Indurain once had a resting heart rate of 29 bpm.
According to the NHS the following are ideal normal pulse rates at rest, in bpm (beats per minute):
- Newborn baby – 120 to 160
- Baby aged from 1 to 12 months – 80 to 140
- Baby/toddler aged from 1 to 2 years – 80 to 130
- Toddler/young child aged 2 to 6 years – 75 to 120
- Child aged 7 to 12 years – 75 to 110
- Adult aged 18+ years – 60 to 100
- Adult athlete – 40 to 60
Measuring your own Heart Rate
Although their are numerous areas you can measure your Heart Rate these are the two most common -
- The wrist (the radial artery) – place the palm of your hand facing upward. Place two fingers on the thumb side of your wrist gently, you will sense your pulse beating there. Either count them for up to one minute, or thirty seconds and then multiply by two. Counting for 15 seconds and then multiplying by four is less accurate. It is also possible to test the pulse by touching the other side of the wrist, where the ulnar artery is.
- The neck (the carotid artery) – place the index and third fingers on the neck, next to your windpipe. When you feel your pulse, either count for the whole sixty seconds, or do it in a 30 or 15 second spell and multiply by two or four.
Anxiety and your Heart
A new study has suggested that levels of anxiety sensitivity are important in choosing medical treatment for patients with heart failure and atrial fibrillation (AF).
Heart and Stroke Foundation researcher and lead author Nancy Frasure-Smith, explained that anxiety sensitivity is the degree to which a person is frightened by bodily sensations and symptoms, particularly those associated with anxiety. ”For most people, sweaty palms and an increasing heart rate are simply unpleasant symptoms that occur in stressful situations, for others these same symptoms are interpreted as a sign of impending doom.
“People with high anxiety sensitivity tend to magnify the potential consequences of their anxiety symptoms, leading to an increase in anxiety and its symptoms in a spiralling increase of fear and worry,” said Frasure-Smith. While anxiety sensitivity is known to predict the occurrence of panic attacks in cardiac and non-cardiac patients, and is associated with greater symptom preoccupation and worse quality of life in patients with AF, it has not been previously studied as a predictor of cardiac outcomes.
These results are based on a sub-study from the Atrial Fibrillation and Congestive Heart Failure Trial (AF-CHF), a randomized trial of rhythm versus rate control treatment strategies whose results were presented at the Canadian Cardiovascular Congress in 2008. Prior to randomization 933 AF-CHF study participants completed a paper and pencil measure of anxiety sensitivity. They were then randomly placed in one of two treatment groups: a ‘rhythm’ group that was treated with anti-arrhythmic medication and cardioversion (an electric shock to convert an abnormal heart rhythm back to normal rhythm); and a ‘rate’ group that received medication to help keep people’s heart rates within a certain range. Participants were followed for an average of 37 months. Results showed that, as in the overall AF-CHF trial, the majority of patients had as good a prognosis with the rate control strategy as with the rhythm control approach.
In contrast, patients with high anxiety sensitivity had significantly better outcomes if they were treated with the more complicated rhythm control strategy.
“Increased emotional responses to AF symptoms in people with high anxiety sensitivity may lead to increased levels of stress hormones making them more vulnerable to fatal arrhythmias and worsening heart failure,” said Frasure-Smith.
The findings were discussed at the Canadian Cardiovascular Congress 2010, co-hosted by the Heart and Stroke Foundation and the Canadian Cardiovascular Society. (ANI)