ESC 2023 — Dr Mads Brix Kronborg (Aarhus University Hospital, DE) joins us to discuss the findings from the DANPACE II Trial (NCT00236158).
DANPACE II (The DANPACE Investigator Group) trial aimed to compare patients who were randomised in a 1:1 ratio to either a base rate of 60 beats per minute and rate-adaptive DDD (DDDR-60 Group) or a base rate of 40bpm and non-rate adaptive DDD (DDD-40 Group). 539 patients were included in the analysis.
After 2 years, the primary endpoint of episodes of atrial fibrillation lasting over 6 minutes detected by the pacemaker had occurred in 248 (46%) of patients. Minimising atrial pacing in patients with sinus node dysfunction did not reduce the incidence of atrial fibrillation.
What was the reasoning behind this trial?
What was the patient population and study design?
What were the key findings?
What are your take-home messages?
What further study is still required?
Recorded on-site at ESC Congress 2023, Amsterdam.
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“My name is Mads Brix Kronborg. I’m from the Department of Cardiology at the Aarhus University Hospital in Denmark, and I’m here to present the results from the DANPACE II trial. And it’s about minimizing atrial pacing in patients with sinus node disease to reduce atrial fibrillation.
Reasoning Behind the Study
In patients with sinus node disease are often also have atrial fibrillation, and there are some observational studies showing that the more you pace in the atrium, the more atrial fibrillation they have. And it’s not clear whether it’s the atrial pacing that causes atrial fibrillation or that these patients just have sicker atriums and therefore need more atrial pacing. And therefore, we wanted to see if we could reduce atrial pacing and if that could reduce atrial fibrillation in this specific population.
Patient Population and Study Design
This was a national, multicenter randomised investigator-initiated trial and it was on patients with sinus node disease who received a pacemaker for the first time. And we excluded patients that already had persistent or permanent atrial fibrillation. And if a device programming of DDD 40 was contradicted, if they had severe bradycardia or tropic incompetence.
So, we tried to reduce the amount of atrial pacing by in one of the groups programming it to DDD 40 and the other group we programmed to DDDR 60. So, they had a lower base rate of 60 in the one group and 40 in the other group. And that particularly reduced the amount of atrial pacing from 49 to one percentage. But we couldn’t see any effect on the incidence of atrial fibrillation. So, after following this patient by remote monitoring for two years, there were no difference in the incidence of atrial fibrillation. What we saw, though, was that a lot of patients crossed over from the DDD 40 group and that was mainly due to chronostropic incompetence and syncope or presyncope, which was also more present in patients that were randomised to DDD 40.
Well, I think from this study is that even if you’re reducing the atrial pacing in this population does not prevent atrial fibrillation and there might be an increased risk of having presyncope or syncope.
Yeah, I think in this population we have done a lot of trials before, so I think at the moment, we are getting there to know how to program these devices and we are still continuing doing large national studies on device treatment to improve the efficacy and also to try to reduce the complications for these patients.”