Given the high mortality rate associated with heart failure, and the prevalence of hospital readmissions, Matthew Mace explores the barriers to quality heart failure treatment and the urgent solutions required.
Heart failure affects over 15 million people in Europe, triggering huge healthcare costs and millions of hospitalisations each year. Political inertia surrounding preventative measures and treatments, as well as barriers to the implementation of novel devices aimed at improving patient outcomes, pose a significant risk to heart failure sufferers who often face rehospitalisation mere months after discharge. To discuss the urgent interventions needed to reduce the burden of the condition and improve heart failure treatment, including the roadblocks technology developers often face in navigating Europe’s complex regulatory landscape, Lorna Rothery spoke to Matthew Mace from Acorai.
How common is heart failure and which societal groups are most susceptible?
Heart failure affects more than 60 million people globally. In the EU, that is more than 15 million people and six million in the US alone. Heart failure disproportionately affects historically disadvantaged communities and people in lower socioeconomic groups. It is a progressive disease that increases in prevalence with age. Yet, age is not a single determining factor for the development of heart failure, and heart damage triggered by another disease often causes the syndrome.
Heart failure primarily results from conditions such as diabetes, hypertension (high blood pressure), prior cardiovascular disease (for example, heart attack) and obesity. The groups of people most susceptible to the primary diseases which lead to heart failure are, by and large, also from these disadvantaged backgrounds. In summary, an ageing population with a significant burden of other epidemic conditions results in a heart failure prevalence of 1-2% in the population, which is set to grow by 46% in the next decade.
Given that many people are diagnosed with heart failure only after an emergency hospital admission, can you explain some of the key challenges regarding symptoms, diagnosis and access to heart failure treatment?
Heart failure is a progressive syndrome categorised by shortness of breath, reduced exercise tolerance and physical signs such as swollen ankles (called oedema). These signs and symptoms are not easy to recognise, and typically, as the onset of these symptoms coincide with ageing, patients and physicians often discount these as signs of ageing.
Acute hospital admission is a serious event that occurs in 15% of patients annually; this happens when the patient cannot breathe or walk more than a few metres. The challenge is that these symptoms ‘mimic’ other conditions and are not very specific to heart failure; so, in a busy emergency department, it is also very common that these signs are missed. Practitioners do not have ready access to a fast, single test to give a conclusive diagnosis but instead rely on a series of tests requiring specialist knowledge and training. These initial tests are accurate to about 70%, but there is room to improve this.
According to the British Heart Foundation, over 52% of people do not survive more than five years after diagnosis. Can you outline some interventions that could help to strengthen preventative measures for heart failure as well as reduce rehospitalisation?
Over the last two decades, the picture of heart failure survival has not really changed, with a high mortality rate that is more than most cancers. Still, 50% of patients do not survive beyond five years from initial diagnosis, and this is because heart failure is a progressive illness causing deterioration of heart function.
Previous heart failure treatment had been focused on relieving symptoms; still, we know from the last two decades that hospitalisations are the markers of worsening disease (called deterioration), and new interventions should be focused on reducing the cause of deterioration. Intracardiac pressure (your heart’s blood pressure) has been shown as a marker that – if controlled, results in the avoidance of deterioration events and could reduce mortality. New medications have been shown to regulate this pressure.
In the future, interventions based on pressure readings from intracardiac pressure monitors can lead to better health outcomes through personalised heart failure treatment.
Are there any novel technologies aimed toward reducing rehospitalisations due to cardiovascular events and what are their limitations or associated challenges?
There have been many interventional products and monitors that have aimed to reduce heart failure hospitalisation. In the early 2000s, a device called HeartPod by St Jude Medical showed that pressure could successfully reduce rehospitalisation; however, the complication rate was almost 10% due to being an implanted technology. This illustrated the main issue with these novel technologies, as they are invasive, there is a complication risk and a significantly high cost. There has been some attempt to introduce novel non-invasive technologies to perform similar jobs to invasive devices. Yet, these are challenged by a lack of overall accuracy to assist physicians in meaningfully reducing rehospitalisation or shortening the time to diagnosing deterioration.
What obstacles do technology developers and businesses face when trying to reach different markets and ensure their devices are widely available to patients?
Most technologies are often faced with questions of transferability (due to the likeness of patients) of the clinical data that went into their clinical trials. It has not been more acutely felt than in heart failure, where some technologies, drugs or blood tests have been available for almost 20 years in some cases. Another keenly felt obstacle, specific to Europe, is that the process of MDR (medical device regulation) has created a situation where technology developers cannot even be considered for an MDR classification due to lack of capacity in the Notified Bodies, which leads to long lead times for assessment. This situation in Europe has led many new companies to abandon the EU for 12-18 months in favour of the FDA process, which is more well-defined and with a wait time of 60-90 days in most cases.
With such a high mortality rate, it is frustrating for technology developers and businesses to face delays in getting their products to the clinicians eager to adopt them. Despite devices or drugs being centrally approved, many countries require a series of in-country (or state) studies and evaluations to obtain local approvals to use technology. This can often be cost-prohibitive; therefore, some patients in countries with more stringent additional requirements do not get access to new technology such as DMDs.
When looking across the spectrum of regulations that have been brought in via MDR, DMD provisions (sometimes referred to as Software as a Medical Device – SaMD) and local regulations that govern patient technology or IoT (Internet of Things) application, there is a very complex landscape of legislation that could be difficult to navigate. This is further compounded by insufficient Notified Bodies in Europe who can evaluate and issue this regulatory certification. Many companies have been challenged by the inability to even be considered for MDR or face a 12-18 month wait.
What role can institutions like EIT Health play in supporting the uptake of DMDs across Europe?
EIT Health has enabled companies to pivot their business models to better navigate Europe’s complex regulatory landscape. It can be a driving force, to not only help start-up medical device companies successfully navigate the changing landscape of DMD regulation and regional variations, but also engage EU Member States and local governments to create a pathway of innovation introduction.
Across Europe, start-up organisations and DMD innovators need organisations such as EIT Health to lobby for ways that make Europe more competitive. Doing so in the health innovation area will yield better healthcare outcomes for European citizens and ensure that the talent inside these companies remains within Europe.
This article is from issue 23 of Health Europa Quarterly. Click here to get your free subscription today.