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The best way to prevent further stroke in intracerebral haemorrhage (ICH) survivors with atrial fibrillation (AF) continues to be an area of uncertainty for clinicians.

Left atrial appendage occlusion (LAAO) is considered an alternative treatment option to anticoagulants for these patients.

However, ICH survivors with AF have historically been excluded from randomised controlled trials about LAAO, meaning there is only limited evidence from observational studies regarding its role in treating this high-risk patient population.

In conversation with Professor Gregory Lip

In this interview, Dr Eleni Korompoki and Professor Gregory Lip discuss the evidence behind LAAO for ICH survivors with AF, and what the right course of action might be for these patients.

Watch their conversation on YouTube:

Or listen on SoundCloud:

Take home messages

After discussing with Professor Lip, Dr Korompoki summarises the take home messages as the following:

1. Compared to trials studying oral anticoagulants for stroke prevention in cases of atrial fibrillation, randomised controlled trials comparing LAAO and anticoagulation were very small;
2. Available data for LAAO in ICH patients with AF is only based on observational studies with substantial risk of bias;
3. Enrolling ICH patients with AF into randomised controlled trials comparing LAAO and anticoagulants is currently the best option for these patients.

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Use the following guide to direct yourself to different sections of the conversation:

00:00 – introduction

01:55 – could you please give us an overview of data supporting stroke prevention in patients with AF by LAAO?

04:27 – what are the strengths and limitations of available trials on LAAO?

07:29 – what about PRAGUE-17 that compares LAAO with direct oral anticoagulants?

09:20 – looking specifically at ICH patients with AF, what is the current evidence for stroke prevention using LAAO?

11:10 – what are the limitations of LAAO for these patients?

12:59 – what about anti-thrombotics post-LAAO?

13:55 – in your opinion, should stroke centres recommend participation in randomised controlled trials of anticoagulation vs no anticoagulation, or refer patients for LAAO?

15:39 – how many ICH patients with AF do you usually refer to LAAO? The majority or just a few?

16:58 – in conclusion, what is your current recommendation for stroke prevention for ICH patients with AF?

20:00 – take home messages

With an ageing population, clinicians are more frequently encountering patients with atrial fibrillation (AF) who are also at risk of intracerebral haemorrhage due to cerebral amyloid angiopathy.

Cerebral amyloid angiopathy (CAA) is a condition common among elderly patients that is characterised by β-amyloid deposition in small blood vessels in the brain, making them more fragile.

Whilst this is often asymptomatic for most patients, CAA increases the risk of a brain haemorrhage when combined with other risk factors, such as blood pressure fluctuations or the use of anticoagulants.

The presence and severity of CAA should be considered when deciding on the best stroke-prevention treatment for patients with AF and a recent lobar intracerebral haemorrhage, as they may benefit from anticoagulant treatment.

In conversation with Dr Andreas Charidimou

Given the current scarcity of randomised trial data to guide stroke prevention strategies, Dr Lucio D’Anna, a consultant in stroke medicine at Imperial College Healthcare NHS Trust, discusses the use of pharmacologic and non-pharmacologic approaches, such as left atrial appendage occlusion, to decrease stroke risk in this challenging patient group with Dr Andreas Charidimou, an instructor in neurology at Boston University Medical Center.

Watch on YouTube:

Or you can listen to their conversation on SoundCloud:

Take home messages

After discussing with Dr Charidimou, Dr D’Anna summarises the take home messages as the following:

1. Given limited data from randomised trials regarding anticoagulation in intracerebral haemorrhage patients with probable cerebral amyloid angiopathy and atrial fibrillation, currently the best choice for patients is to enrol them into randomised clinical trials such as PRESTIGE-AF.
2. There is not enough evidence to support the conclusion that left atrial appendage occlusion is safe and effective in intracerebral haemorrhage patients with cerebral amyloid angiopathy and atrial fibrillation.
3. The risk of thromboembolism in patients with atrial fibrillation after an intracerebral haemorrhage should be weighted carefully even if the patient has imaging markers of cerebral amyloid angiopathy such as cerebral microbleeds, cortical superficial siderosis and white matter hyperintensities.

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Use the following guide to direct yourself to different sections of the conversation:

00:00 – introduction

01:45 – what is cerebral amyloid angiopathy (CAA)?

03:35 – why is it important to consider CAA in patient management?

05:03 – what are the signs and symptoms of CAA?

06:34 – what are the main neuroimaging features that can be related to higher risk of future intracerebral haemorrhage?

09:20 – what are the updates recently made to the Boston criteria for CAA diagnosis?

13:21 – what is the risk of an ischaemic stroke for a patient with atrial fibrillation and CAA who recently suffered an intracerebral haemorrhage?

15:17 – what is the evidence to start anticoagulants in these patients?

16:55 – when do you think a patient with atrial fibrillation and CAA would be unsuitable for anticoagulation?

18:17 – what are observational studies telling us about the risk of vascular events in patients with CAA?

20:05 – how does CAA affect the risk of a recurrent haemorrhage for patients who have had a lobar intracerebral haemorrhage?

21:30 – and how about for deep intracerebral haemorrhages?

22:45 – what is the role of microbleeds in the risk of intracerebral haemorrhages for patients with/without CAA?

25:26 – should we enrol patients with a lobar intracerebral haemorrhage and CAA into an anticoagulant clinical trial?

27:38 – are there particular patients you wouldn’t recommend participating in one of these trials?

28:58 – do you think left atrial appendage occlusion could be a better option for stroke prevention for these patients?

30:07 – do you routinely send these patients for left atrial appendage occlusion?

31:14 – summarise what you currently think is the best management for patients with intracerebral haemorrhage and CAA?

33:04 – take home messages

New materials to support clinicians in involving intracerebral haemorrhage (ICH) patients with atrial fibrillation (AF) in the decision-making process for their treatment are now available as part of the PRESTIGE-AF project.

Why have these materials been produced?

PRESTIGE-AF-funded research has shown that clinicians view the process of deciding on stroke prevention in patients with AF post-ICH as “challenging” due to considerable “clinical equipoise”.

“Patients with ICH were largely excluded from seminal trials on the safety and efficacy of oral anticoagulants (OAC) in patients with AF, and much of the current evidence on the use of OAC and/or antiplatelets in patients with AF and ICH comes from observational studies,” says Elena Ivany, Research Associate at the University of Liverpool’s Centre for Cardiovascular Science. “These are major factors in the uncertainty of how to treat these patients, which PRESTIGE-AF is aiming to resolve.”

Physicians who are required to advise on appropriate stroke prevention therapy for patients with AF and ICH have described a desire to involve patients in the decision-making process. However, at the same time, there is some uncertainty as to how shared decision-making is best achieved.

Supporting shared decision-making

Developed by the University of Liverpool team, these educational materials aim to facilitate patient involvement in the decision-making process by providing physicians with a range of information that can be used during patient-facing consultations.

The materials that are included in the pack are based on key patient-related outcomes related to stroke prevention in AF, such as risk of ischaemic/thromboembolic events, risk of bleeding, and lifestyle considerations.

Physicians may wish to use the materials to initiate conversations about patients’ goals of care and to identify patients’ preferred treatments or therapies for stroke prevention. Some of the materials are interactive, while others can be used as supporting information to promote patient understanding of the benefits and risks of OAC.

Additionally, there are links to resources that physicians may wish to share with patients who are interested in learning more about their disease and the stroke prevention therapies available to them.

The materials have been peer-reviewed by physicians and patients to ensure that the information provided is clinically relevant and accurate.

Overall, it is hoped that these educational materials can be a positive tool to promoting patient engagement in discussions about stroke prevention therapy in individuals with AF and ICH.

The PRESTIGE-AF trial has officially recruited 150 patients, which is a fantastic achievement and brings us closer to determining the best treatment for patients with atrial fibrillation who have suffered an intracerebral haemorrhage.

A special thank you goes to Dr Bernd Kallmünzer, Manuela Plischke, Anja Schmidt, Katherine Wallner, Petra Burkardt, Stefanie Balk, David Haupenthal and Bastian Volbers from Site 225, Universitätsklinikum Erlangen, who recruited the 150^th patient.

We have asked the Principal Investigator, Dr Bernd Kallmünzer, a few questions about the trial:

You have recruited 5 participants to the trial, how have you achieved this?

“Continuous screening, empathic and transparent communication with patients, regular team meetings.”

Why do you think it’s important to offer participation in the trial to all potential patients?

“Decisions on treatment should be based on scientific evidence. PRESTIGE-AF helps to generate evidence on a clinical relevant question.”

Why do you think PRESTIGE-AF is still a relevant and important trial to recruit to?

“Currently available evidence is not sufficient to use OAC after ICH in all patients. The evidence for alternative treatment options (e.g. LAAO) is still weak.”

The second event in Stroke Alliance for Europe’s #LifeAfterStroke series, this free webinar will explore intimacy and sex after stroke.

This event is taking place on Thursday 20 May at 10:00 – 11:15 (Central European Summer Time), and 09:00 – 10:15 (British Summer Time).

Registration is free and welcome to all. Register via the EventBrite page

Further information

Intimacy and sex are important. However, for many stroke survivors this is an uncomfortable subject with many struggling to come to terms with their ‘new’ body or identity and coping with the implications of this. Additionally, many healthcare professionals do not feel confident or able to talk about sex, or to know how to best advise and support patients or their families.  This session will share insights from several perspectives and suggest how we might begin positive and open conversations about sex. It also underlines the need for greater awareness about sex and intimacy after stroke. 

#LifeAfterStroke is Stroke Alliance for Europe‘s series of interactive webinars focusing on bringing together the life after stroke community to stimulate debate and improve care.