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Unmet needs in the treatment of heart failure: clinical and real-world evidence

Martin R. Cowie (UK)

Martin Cowie discusses the unmet needs in heart failure, including his own top six: improved QoL, longer life, more equitable care, better experience of care, more efficient healthcare usage, and value for money.  

Unmet needs in the treatment of heart failure- clinical and real-world evidence

Transcript

Unmet needs in the treatment of heart failure: clinical and real-world evidence - Martin R Cowie

Unmet needs in the treatment of heart failure: clinical and real-world evidence - Martin R Cowie

Thank you very much indeed, John, so unmet needs in the treatment of heart failure. I think it is really important that we just stop ourselves from being complacent; yes, we have so many more therapies than we had, but we still have a battle, in terms of improving outcomes for our patients.

Declaration of interests

These are my declarations of interest, looking at many, many different innovations in the heart failure space.

Different perspectives?

But let’s, for a second, just think about various different people’s perspectives on this, yes, we, as physicians or nurses or healthcare professionals, have our perspective, but also the patients, as you have just seen, have their perspective and what they want to achieve from interaction with us.

Untitled slide [Image of striped dress]

Now I don’t know if many of you saw this on the internet, this was a few months ago when there was a big fuss about whether this dress was gold and blue or black and white. Now I see it as gold and blue, I don’t know what you see it as, but the point is this is a real situation, we can all be looking at exactly the same thing and see it from very different points of view. I think it is often very useful to listen to other people’s perspectives and to challenge ourselves.

Different perspectives?

For example, as you have seen in the patient videos, the patient may come to our consultation with a whole lot of issues and questions and things they would like to discuss with the doctor or nurse, there are things they can’t do anymore, what does the future look like, and they assume that we know what we are talking about, we know what the best treatment for them would be, they very rarely will challenge that, which makes it even more our responsibility to make sure that we review what their current treatment is and then, at the end of the day, they are taking all of this medication, they have got some devices and they assume that it must be doing some good for them, but there is a huge element of trust in this interaction.

Different perspectives?

Now that might be the patient’s perspective, what about the physician’s perspective and you can see these are very, very different things in the physician’s mind. They are thinking, ‘Well, here is an elderly patient, lots of medical problems, I am just going to narrow the discussion down to heart failure. What were the recent guidelines?’ We have all seen them today, can we actually remember what they say and how they relate to the patient in front of us? Then, what often happens, the patient doesn’t complain, you are pressed for time, you say ‘Let’s just continue things as they were,’ and I think that is something that we have to fight against, there is no point a patient seeing you if you are not constantly thinking ‘Is their current treatment the best treatment for them?’

Ask 3 Questions

In my own healthcare system, in England, patients are encouraged to ask their nurses and doctors three simple questions ‘What are my options? What are the range of things open to me, you know me, what are my options?’ and ‘What are the fors and against, the pros and the cons, for each of those options?’ and then ‘Help me make a decision that I am comfortable with?’ and that is the modern consultation between the patient and the physician or nurse, and it is not, of course, just in England, it is right across the world, very similar issues that we are facing.

A global call to action in heart failure

The Global Heart Failure Awareness Programme, I am sure you are familiar with, 49 countries have signed up to this and there are some very key aspects to this.

Policymakers urged to act on eight recommendations

For example, and I am not going to talk about all of these, but the care transitions, going from a home into hospital and from hospital back into a home, making sure that all patients have access to care, not just young patients, and also having heart failure physicians and nurses to lead things forward.

We will have to do things differently...

It is great to see so many people at this excellent conference, but it will fail if you don’t go back and engineer change where you are in your area of influence and it is quite clear – and I am sure John will pick up on this – that we will have to do things differently, the status quo is not adequate. We have more and more patients who tend to be older with more comorbidity, we do not have more doctors and nurses and you and I both know we are not going to have any more money to do this, we have to try and get better outcomes doing what we know works best, and that is not going to change.

Tough times are here to stay...

I didn’t want to depress you, but look at the GDPs of all of our countries there, very few of them have got back to where they were in 2008 and for many of us it is a real struggle, so that is the reality of the situation, in terms of unmet need.

National Heart Failure Audit

Let me just share with you some data, once again, from England, but where we are very, very good at collecting data, so this is nearly every heart failure patient in England, so this is tens and tens of thousands of patients.

Length of stay and discharge planning

The key points of the report, look at this, one small country, relatively wealthy, one set of guidelines from NICE, no patient has to pay for anything when they use healthcare, and you can see the variation in length of stay for these patients, so, despite all of that uniformity, physicians/hospitals are treating these patients very differently. These patients are in hospital for a long time, there is a huge opportunity to improve their therapies, to fine tune things, but often that doesn’t take place, and then perhaps one of the most challenging things is that only about half of the patients get any heart failure follow-up after discharge, and if you do get follow-up only a third of those get it within two weeks, so in other words there is a major problem in terms of delivery of care.

Cardiology follow-up after discharge in English hospitals

These data have not been seen before; it has just been accepted for publication in the BMJ Open. This is English hospitals looking at the time to first cardiology follow-up after discharge from hospital.

Now you can see in the youngest age group here that only about 70% or 80% will ever see a cardiologist after discharge from hospital and it takes quite some time to see them; it takes about six weeks, on average, for them to see a cardiologist.

But if you are older, and most of our patients are older than that, you can see the proportion that ever see a cardiologist goes down and down and the time to them seeing them gets longer and longer, so we really have a crisis here, we need to make sure we see our patients, we optimise their therapy and they have confidence in us that they are on the best 2016 treatment, not the best 2010 treatment.

Treatment

In terms of using drug classes, well we have had evidence for these drug classes for decades now and you can see that most patients in England are discharged at least on some dose, perhaps suboptimal, but look at the effect of age, even from a young age it just tails down, with the chances of you being on these drugs goes down with age, and remember most of our heart failure patients are here, so there is a lot of unmet need in our system.

Comorbidity is universal

This slide is to remind me to talk about comorbidity – and I will come back to this with the trials that we do – you can see this is North American data, the most recently available. If you are admitted to a North American hospital with heart failure, or a USA hospital at least, 55% of these patients have at least five other medical conditions, so it is complex medicine, lots of needs there, we need to be able to deliver to our patients.

Evidence-based medicine

One of the ways that medicine has tried to tailor delivery of care appropriately to patients is so called evidence-based medicine. Here is David Sackett, who was really the grandfather or father of evidence-based medicine, and basically you would have a clinical problem, you would define it very clearly, you would look for randomised trial evidence and then that would tell you what to do, and that is the way that our guidelines, of course, are now created, so looking at the evidence in that simple flow.

National & international guidelines

But I just want to challenge you a little bit about that, do not assume that because you have the trial and because you have the guideline that other physicians and nurses will actually put it into practice.

Untitled slide [Image of sword]

Looking at the evidence – and this is work I have done at Imperial with an organisational sociologist – looking at the evidence of the impacts of that approach you see that it actually can go both ways.

In a way it helps physicians feel empowered, because you can say ‘Here is the trial, here is the guideline, I know I am doing the right thing,’ but in another way it disempowers the physicians, so they feel disengaged from this process, it is all about somebody else doing a trial, different population of patients and their own personal experience as a physician is rather downplayed, and that really goes against the ethos of the physician community. So evidence-based medicine is fine, but it is not sufficient on its own.

Let me just show you some quotes and this is work we did after the beta-blockers came in for heart failure, so since the ’60s to late ’90s beta-blockers were bad for heart failure and then suddenly they were good for heart failure. How did physicians change their behaviour? How did they adopt new evidence?

Untitled slide

This is the summary of looking at that process. Quite often people challenge the value of the trials, they say ‘No, I want to do what I feel is best, I am interested in other people’s opinions, but it is ultimately what I will do and that is based on my clinical experience.’

Cast studies

Now, if you don’t believe me, here are some quotes from physicians in response to the change in the evidence base, so this is a general physician saying that:

“It used to be that the tertiary centre gave you the answer and then you were expected to roll it out into practice, but you soon realised this was utterly inappropriate.”

Very strong language for an Englishman, “utterly inappropriate.”

Or:

“The specialist centres get a highly refined group of patients who they do the research on, it is totally inappropriate.”

You can almost see the excuses for not moving from trial guideline into practice.

Case studies

This is a nurse that was interviewed, who actually doesn’t comment on the evidence base, but her description of the physicians and how they behaved:

“Why don’t the doctors just get together, decide what needs to happen and make it happen.”

You can almost sense the kind of lack of enthusiasm in this sentence, so we have a way to go with what we do.

Case studies

Then the managers and the reimbursement authorities, for example, saying to us, as physicians and nurses:

“Why don’t you adopt something, you can’t do everything in every country, you can’t redo trials in every centre, if it is not invented here we won’t do it.”

Creating change

I think it makes the important point that publishing trials and guidelines is absolutely essential, but we have to connect with people, with patients, with our fellow physicians, with our hospital staff, to persuade them that it is worthwhile to do something new and what the benefits are.

National and international guidelines

So very briefly and hopefully this will link nicely with Professor McMurray’s talk on the excellent data for innovation in heart failure care.

End-points”

These are the kind of hard endpoints we, as physicians, are impressed by and we try and communicate with our patients, so it is mortality, hospitalization, adverse events and less important to us, but very important for patients, is their quality of life.

Remember “typical” patient profile in PARADIGM-HF

So let’s take one example of one of the most important new studies in chronic heart failure likely to make a change in practice, so the PARADIGM study. Now this is not Professor McMurray, this is Pierce Brosnan, just in case you got confused!

Here is a typical PARADIGM patient, so male, middle sixties, but the point I want to make is that actually he is feeling very well, 70% of the patients in the trial only had mild symptoms and they were on very good conventional therapy. You can imagine this individual coming into clinic saying ‘I am feeling fine, Doctor, thank you so much for making me feel better,’ and you look at their therapy, beta-blocker, ACE inhibitor, mild symptoms and think ‘Super, short consultation, don’t need to do anything.’

PARADIGM-HF: components of primary end-point: death from CV causes

But let me just remind you it is exactly this type of patient who has this risk of death, never mind hospitalization or poor quality of life developing, this is a risk of cardiovascular death in that seemingly well man, and you can see it is about 15% over two years, so we shouldn’t be complacent. Looking at the person in front of you, you have to decide that you need to optimise his therapy.

Quality of life

I just want to finish off also with the quality of life aspect, because I think increasingly patients and patient organisations say to us that we undervalue this, this for them is hugely important.

This was an advert, the only advert run by a medical charity in England that was banned by the Advertising Standards Authority, and the reason for that was they thought it was very good to raise the profile of heart failure and they said, at the top, it says “I’ve got heart failure. And this is what it feels like every morning,” and it really conveys the importance of controlling the symptoms. It was banned, by the way, because they thought children would look at this and think ‘What a great idea, let’s put a plastic bag over our heads,’ I think British children are a little bit more intelligent than that, but who knows, it was banned.

Improvement in health-related QoL related to heart-rate lowering

This is data from the other heart failure innovation in the drugs space in the last five years for Europe and that is ivabradine for better heart-rate control.

Now look at the effect on quality of life, and this is the Kansas City Cardiomyopathy Questionnaire, I know John will refer to it later, a very good, well validated quality of life questionnaire. Looking at the patients with better heart-rate control with ivabradine, you can see here that actually 40% of those patients had 7/8/9/10/11 point shift in how they felt in this placebo controlled trial, that is a huge impact on how well you are feeling and I think that is an important element to capture.

Unmet needs in heart failure

So unmet needs, I would like you to leave this seminar feeling that actually there is a huge amount we need to do, even in patients who seem to have mild heart failure, we need to improve this, you have your perspective, the patient has other perspectives.

Instead of “What is the matter?”

I think instead of asking them ‘What is the matter?’ –

Ask “What matters?”

– we need to say to them ‘What matters?’ and listen more to what they say, they will give us the cues as to what is important to them and for us to reflect on what best evidence-based medicines we should be using.

My top 6 unmet needs...

This is my personal list, my wish list for heart failure. I would like my patients to feel better, that is our huge priority. I would also like them not to sacrifice life to feel better, so I want safety, but I want a longer life for them. I also want everybody with heart failure in my district to get access to modern therapies, not just little subgroups of patients. I also want that experience of care for the patient and the family to be a hell of a lot better than it has been traditionally in many parts of the world. Of course, I do pay tax, contrary to rumour I do pay tax, and I think it is also important that we use our resource appropriately, so we get value for money in improving that.

On that point, I would like to finish, but there are many, many unmet needs for heart failure patients. Thank you very much. [Applause]

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