PhD student Anders Sjørslev Schmidt from Aarhus University and Randers Regional Hospital is the first person to show that there is a difference in how well new equipment treats atrial fibrillation. His results can help to ensure effective treatment for patients with atrial fibrillation.

2017.06.30 | Cecilia Honores Møller, RM

Treatment with Defigard 5000 gives patients short, intermittent shocks instead of the longer shock given by the standard equipment. The effect of the new equipment is worse than first assumed. Photo: Helle Brandstrup Larsen.

Some years ago, the Swiss company Schiller launched new equipment in the form of the Defigard 5000 Multipulse Biowave®. Among other things, the equipment is used for the treatment of atrial fibrillation. The new equipment gives the patients short, intermittent shocks instead of one longer shock as is the case with the previous equipment on the market. The studies that form the basis of the new pulsed technology conclude that it is gentle and effective. However, in an independent research project based at Randers Regional Hospital, Master’s degree student in medicine and PhD student Anders Sjørslev Schmidt shows that the equipment does not deliver the expected high efficiency. 

New equipment works approximately 25 per cent worse

The research project was recently published in the recognised scientific journal JAHA: Journal of the American Heart Association. It shows that patients with atrial fibrillation have a significantly lower effect of Defigard 5000 compared with the standard equipment used at many Danish hospitals today.

"My hypothesis was that the new equipment would work better than the standard equipment that we use today. But very surprisingly, it turned out that the effect of the new equipment is approx. 25 percentage points lower, which is to say that every fourth patient that cannot be treated with the new equipment would experience an effect with the standard equipment. Furthermore, the Defigard 5000 also had a security breach which meant we had to stop the study early, since it was not ethically justifiable to treat more patients," says Anders Sjørslev Schmidt.

The result has led to some serial numbers of the equipment having a safety warning added. 

Forskning med praktisk relevans

Når ny medicin skal godkendes til markedsføring, er det et lovkrav, at det skal være testet i lodtrækningsstudier, hvor patienterne behandles med enten det nye eller et eksisterende præparat. For medicinsk udstyr gælder der et andet regelsæt. Defigard 5000, som er i klinisk brug, var ikke tidligere sammenlignet i et klinisk lodtrækningsstudie med det standardapparatur, der anvendes i dag.

"Tidligere studier af andre nye apparater til hjertestød har ikke vist forskelle i effektivitet eller sikkerhed i forhold til standardapparatur. Men resultatet af mit studie gør det klart, at det ikke er sikkert at antage, at det altid hænger sådan sammen," siger Anders Sjørslev Schmidt og tilføjer:

"Min forskning er blot en lille brik i forhold til at optimere behandlingen af de mere end 100.000 danskere med forkammerflimren, men ikke desto mindre er det tilfredsstillende at kunne bidrage med ny viden, der kan være med til at gøre en forskel for patienterne."

Research with practical relevance

When new medicine is approved for marketing, there is a statutory requirement for it to have been tested in randomised tests, where the patients are treated with either a new or an existing product. But the rules for medical equipment are different. Defigard 5000, which is in clinical use, was not previously compared with the standard equipment in use today in a clinical randomised test.

"Previous studies of other new equipment for defibrillation have not shown any differences in efficiency or safety in relation to standard equipment. But the result of my study makes it clear that we cannot reliably assume that this is always the case," says Anders Sjørslev Schmidt, before adding:

"My research is just a small element in optimising the treatment of the more than 100,000 Danes with atrial fibrillation, but it is nevertheless satisfying to be able to contribute with new knowledge that can help to make a difference for these patients."

Three research prizes already

In addition to publishing in JAHA, Anders Sjørslev Schmidt has received three prizes for his research, including a prestigious research communication prize in a competition held by the Danish Society of Cardiology.

The large amount of attention which the study has generated has motivated and inspired him to continue with his research career. He is presently writing his PhD project on energy-settings for defibrillation – a field in which there is very limited knowledge at present.

Anders Sjørslev Schmidt's study has included 135 heart patients with atrial fibrillation. Of these, half where selected for treatment with Defigard 5000, while the other half were treated with the hospital's standard equipment, LIFEPAK 20. The study was designed as an interdisciplinary collaboration between medical doctors, nurses and biomedical laboratory scientists from medical, anaesthesiology and clinical biochemistry departments. According to the young researcher, it would not have been possible to conduct the study without a great deal of goodwill and support from all the involved departments.

The research results – more information

• The study is a prospective randomised study.
• Partners: The study was designed as an interdisciplinary collaboration between medical doctors, nurses and biomedical laboratory scientists from medical, anaesthesiology and clinical biochemistry departments.
• Read the article Cardioversion Efficacy Using Pulsed Biphasic or Biphasic Truncated Exponential Waveforms: A Randomized Clinical Trial in JAHA.

Contact 

PhD student Anders Sjørslev Schmidt
Aarhus University, Department of Clinical Medicine and
Randers Regional Hospital
Tel.: (+45) 2124 3181
as@clin.au.dk