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Randomized Controlled Trial
. 2023 Oct 21;44(40):4246-4255.
doi: 10.1093/eurheartj/ehad564.

Atrial pacing minimization in sinus node dysfunction and risk of incident atrial fibrillation: a randomized trial

Mads Brix Kronborg  1   2 , Maria Hee Jung Park Frausing  1   2 , Jerzy Malczynski  3 , Sam Riahi  4   5 , Jens Haarbo  6 , Katja Fiedler Holm  4   5 , Charlotte Ellen Larroudé  6 , Andi Eie Albertsen  7 , Lene Svendstrup  8 , Ulrik Hintze  9 , Ole Dyg Pedersen  10 , Ulla Davidsen  11 , Thomas Fischer  12 , Jens Brock Johansen  13 , Jens Kristensen  1 , Christian Gerdes  1 , Jens Cosedis Nielsen  1   2 ; DANPACE II Investigators
Collaborators, Affiliations
Randomized Controlled Trial

Atrial pacing minimization in sinus node dysfunction and risk of incident atrial fibrillation: a randomized trial

Mads Brix Kronborg et al. Eur Heart J. .

Abstract

Background and aims: High percentages of atrial pacing have been associated with an increased risk of atrial fibrillation. This study is aimed at evaluating whether atrial pacing minimization in patients with sinus node dysfunction reduces the incidence of atrial fibrillation.

Methods: In a nationwide, randomized controlled trial, 540 patients with sinus node dysfunction and an indication for first pacemaker implantation were assigned to pacing programmed to a base rate of 60 bpm and rate-adaptive pacing (DDDR-60) or pacing programmed to a base rate of 40 bpm without rate-adaptive pacing (DDD-40). Patients were followed on remote monitoring for 2 years. The primary endpoint was time to first episode of atrial fibrillation longer than 6 min. Secondary endpoints included longer episodes of atrial fibrillation, and the safety endpoint comprised a composite of syncope or presyncope.

Results: The median percentage of atrial pacing was 1% in patients assigned to DDD-40 and 49% in patients assigned to DDDR-60. The primary endpoint occurred in 124 patients (46%) in each treatment group (hazard ratio [HR] 0.97, 95% confidence interval [CI] 0.76-1.25, P = .83). There were no between-group differences in atrial fibrillation exceeding 6 or 24 h, persistent atrial fibrillation, or cardioversions for atrial fibrillation. The incidence of syncope or presyncope was higher in patients assigned to DDD-40 (HR 1.71, 95% CI 1.13-2.59, P = .01).

Conclusions: Atrial pacing minimization in patients with sinus node dysfunction does not reduce the incidence of atrial fibrillation. Programming a base rate of 40 bpm without rate-adaptive pacing is associated with an increased risk of syncope or presyncope.

Keywords: Atrial fibrillation; Atrial pacing; Pacemaker; Quality of life; Sinus node disease; Syncope.

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Figures

Structured Graphical Abstract
Structured Graphical Abstract
Consort diagram of the DANPACE II trial. Median percentage of atrial pacing in the two groups. Primary endpoint defined as time to first episode of atrial fibrillation > 6 min. Secondary and safety endpoints including syncope/presyncope, crossover, quality of life assessment, and 6 min walk test.
Figure 1
Figure 1
CONSORT diagram
Figure 2
Figure 2
(A) Time to first episode of atrial fibrillation longer than 6 min. (B) Time to first episode of syncope or presyncope. (C) Time to crossover including indication for crossover
Figure 3
Figure 3
Risk of atrial fibrillation longer than 6 min according to selected baseline characteristics
Figure 4
Figure 4
Quality of life assessed by SF-36 at 12 months including the mental and physical scores
See this image and copyright information in PMC

References

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