Carina Blomström-Lundqvist, Uppsala University

TOWARDS A BETTER QUALITY OF LIFE FOR HEART PATIENTS

Nearly 400,000 Swedes live with the cardiovascular condition atrial fibrillation, but current drugs do not fully relieve the symptoms. In a large study Carina BlomströmLundqvist wants to investigate whether a procedure in the heart produces better results – in terms of both the recurrence of fibrillation and the patients’ quality of life.

Atrial fibrillation is common and between 350,000 and 400,000 Swedes are living with the diagnosis. Fibrillation means that the heart beats irregularly and often quickly. It is caused by incorrect electrical signals from areas in the heart’s left atrium, often at the opening for the pulmonary veins. The result is a chaotic heart rhythm in the atria at speeds of up to 300 beats a minute, compared with the normal 50–80 beats. The atria cannot contract at that rate and the heart’s ability to pump out oxygen-saturated blood reduces by up to 15 percent.

Carina Blomström-Lundqvist, a professor in the Department of Medical Sciences at the universities of Uppsala and Örebro and senior consultant in cardiology at Uppsala University Hospital and Örebro University Hospital, meets these patients daily.

“Atrial fibrillation also produces complications in the form of an increased risk of stroke, and people also experience a clear reduction in quality of life because they don’t have the energy to do what they want to,” she says.

Increasing age is a risk factor for being affected, as are high blood pressure, diabetes, heart failure, obesity and high alcohol consumption.

“But atrial fibrillation can also affect those who train extra hard, such as elite athletes,” she says.

Of the cardiac conditions that result in arrhythmia, atrial fibrillation is the most common cause of hospital admissions. One big problem is that the drugs used to stabilise the heart rhythm are not sufficiently effective.

“You might expect that 80–90 percent of patients would be free of fibrillation after a year, but it’s not like that. The drug only eliminates fibrillation in 20–30 percent of patients after a year’s medication, which is not good enough,” she says.

But there is another way to control the heart rhythm. In the 1990s French doctors developed a method known as pulmonary vein isolation using ablation. It involves using heat or cold to create tissue damage just where the cells in the atrium send the irregular signals. This creates scarring that forms a barrier to the electrical pulses. Since there is a small risk of complications, however, this method is only recommended as a secondary treatment after treatment with drugs has been tried without success.

In the project ‘CryoStopPersAF – First-line cryoablation for early treatment of persistent Atrial Fibrillation – a randomized study comparing early trigger isolation using the Cryoballoon versus antiarrhythmic medication’ – Carina BlomströmLundqvist and her colleagues now want to compare the two methods.

“We want to give half of those taking part in the study ablation straight away, without first taking the drug treatment route. Registry studies have shown that the sooner ablation is used, the better its effect. It reduces the risk of the fibrillation worsening, as well as the risk of the musculature in the atria changing such that the patient suffers chronic fibrillation.”

A total of 220 patients will be randomly assigned ablation or drug treatment. The study will be carried out at various Swedish hospitals and at some hospitals in other countries. One aim is to include a higher proportion of women than would normally be the case. Carina Blomström-Lundqvist says that generally only a fifth of the patients in cardiac studies are women, even though the proportion of women

Carina Blomström-Lundqvist wants to help patients with atrial fibrillation. The heart’s four pulmonary veins open into the left atrium. Freezing these results in scarring, which forms a barrier that prevents atrial fibrillation.

A patient undergoes treatment in the arrhythmia lab. The heart’s electrical signals are monitored from the control room, which also registers when the pulmonary veins have been frozen and are isolated.

with cardiovascular conditions is significantly higher – in the case of atrial fibrillation, just over a third of patients are women.

“We want to curb the tendency for women not to be offered as advanced cardiac care as is offered to men and push the participating hospitals not to forget the women,” she says.

To continually measure the incidence of fibrillation all participants will have a small box inserted under the skin to monitor their heart rhythm for a period of three years. The signals can be read remotely, so the patient does not need to go to the hospital.

In an earlier study published in JAMA in 2019 the researchers used such readings to measure objectively the incidence of fibrillation and its link to quality of life.

“We were then able to see a reduced incidence of atrial fibrillation, clearly co-varying with an increased quality of life, which had not been shown previously,” she says.

One catch is that the boxes for monitoring cost more than SEK 15,000 each.

“That’s why the support from the Erling-Persson Foundation is so incredibly important to us. Without it we would not be able to carry out such a large and meticulous study,” says Carina Blomström-Lundqvist. The first results measured will be to compare the recurrence of fibrillation after a year.

“Then we will continue to measure for three years in total, to see whether the results are sustained,” she says.

The study will also measure biomarkers that provide evidence of inflammation and cardiac muscle damage. Using electrocardiograms (ECGs) and ultrasound they will track the left atrium’s ability to contract. The researchers will also measure cognitive effect, as well as how cost effective the treatments are.

To get a clear picture of the patients’ quality of life this will also be measured using three different formulas. Carina Blomström-Lundqvist believes that those with atrial fibrillation are a neglected patient group.

“If you don’t get the best treatment, you adapt to a circumscribed life. You might give up playing tennis because you don’t have the energy or decide not to travel because of the risk of having attacks,” she says.

The fact that the study is so extensive and has a long follow-up period guarantees that it will provide a clear result.

“We want the study to come down firmly and show clearly which treatment is most effective. It is the only way to implement a change in the care that these patients get,” says Carina Blomström-Lundqvist.

≤400,000

350,000–400,000 Swedes live with a diagnosis of atrial fibrillation, representing 3–4 percent of the entire population.

15%

The amount by which heart capacity is reduced by atrial fibrillation. It means the difference between having the energy to go up stairs or not.

35%

The proportion of patients with atrial fibrillation who are women.

ABOUT THE PROJECT Project manager: Carina Blomström-Lundqvist, a professor in the Department of Medical Sciences, Uppsala University and at the School of Medical Sciences, Örebro University, and senior consultant in cardiology at Örebro University Hospital and Uppsala University Hospital.

Co-applicants: Espen Fengsrud (Örebro University Hospital), Frank Flachskampf, Stefan Lönnerholm, (Uppsala University Hospital), David Mörtsell (Lund University), Runa Sigurjonsdottir, Dritan Poci (Sahlgrenska University Hospital), Dhiraj Gupta (Liverpool Heart and Chest Hospital, UK).

Title: ‘First-line cryoablation for early treatment of persistent Atrial Fibrillation – a randomized study comparing early trigger isolation using the Cryoballoon versus antiarrhythmic medication’.

What it involves: The researchers want to compare two methods of treating atrial fibrillation: removing the irregular signals that create fibrillation by means of freezing as an initial treatment, or giving rhythm-stabilising drugs.

Funding: The Erling-Persson Foundation is supporting the project with a total of SEK 9 million over three years.

On a big screen in the arrhythmia lab X-ray images of the heart are shown at two levels: a computer tomography image showing the heart’s pulmonary veins (red) and electrical signals from the heart cavity.