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Single lead atrial vs. dual chamber pacing in sick sinus syndrome: extended register-based follow-up in the DANPACE
Niels H Brandt1, Rikke Esberg Kirkfeldt2, Jens Cosedis Nielsen2
1Department of Cardiology, Zealand University Hospital, Roskilde, Denmark.
Insights
Long-term follow-up of the DANPACE trial shows no significant difference in mortality between single lead atrial (AAIR) and dual chamber (DDDR) pacemakers for sick sinus syndrome. Risks of atrial fibrillation hospitalization, stroke, and heart failure also remained similar.
Area of Science:
- Cardiology
- Electrophysiology
- Medical Device Research
Background:
- The DANPACE trial initially compared single lead atrial (AAIR) versus dual chamber (DDDR) pacemakers for sick sinus syndrome (SSS).
- Early follow-up revealed no survival benefit but increased risks of atrial fibrillation and reoperation with AAIR pacing.
- Very long-term outcomes and pacing mode changes require further investigation.
Purpose of the Study:
- To evaluate the very long-term risks of death, atrial fibrillation (AF) hospitalization, stroke, and heart failure (HF) in SSS patients randomized to AAIR or DDDR pacing.
- To assess the rate of pacing mode changes from AAIR to DDDR over an extended follow-up period.
Main Methods:
- Utilized national register-based data for long-term follow-up of all 1384 patients from the DANPACE trial.
- Intention-to-treat analysis was performed on data obtained from Danish national registers.
- Mean follow-up duration was 8.9 years.
Main Results:
- No significant difference in overall mortality was observed between the AAIR (59.3% death) and DDDR (53.3% death) groups (adjusted hazard ratio 1.03).
- The risk of AF hospitalization, stroke, and HF did not differ between the two pacing groups.
- The annual rate of pacing mode change to DDDR in the AAIR group was 4.5% during extended follow-up, higher than the 2.3% during the trial.
Conclusions:
- Very long-term follow-up confirms no significant difference in mortality between AAIR and DDDR pacing for SSS patients.
- There is no increased long-term risk of AF hospitalization, stroke, or HF with either pacing mode.
- The increased rate of pacing mode change to DDDR in the AAIR group suggests evolving clinical management strategies post-trial.
Aims:
The DANPACE trial randomized patients with sick sinus syndrome (SSS) to single lead atrial (AAIR) or dual chamber (DDDR) pacemaker (PM). After 5 years follow-up, no difference in overall survival, stroke or heart failure (HF) was observed, whereas risk of atrial fibrillation (AF) and PM reoperation were increased in the AAIR group. The present study aimed to investigate very long term risk of death, AF hospitalization, stroke, HF and rate of change in pacing mode using national register-based data.
Methods And Results:
The study population consisted of all 1384 patients included at Danish PM centres in the DANPACE trial randomized to AAIR (n = 696) or DDDR (n = 688). Long-term follow-up data was obtained from Danish national registers. Analysis was intention-to-treat. results: During mean follow-up of 8.9 years, 413 patients (59.3%) died in the AAIR-group compared to 367 (53.3%) in the DDDR-group (adjusted hazard ratio 1.03; 95% confidence interval 0.90-1.19; P = 0.65). We observed no difference in risk of AF hospitalization, stroke or HF. During extended follow-up, annual rate of pacing mode change to DDDR in the AAIR group was 4.5%, and higher than the 2.3% observed during trial conduct.
Conclusion:
This register-based long-term follow-up study indicates that there is no difference in mortality among patients with SSS randomized to AAIR or DDDR pacing, even with very long follow-up. Nor is there any difference in risk of AF hospitalization, stroke or HF. The higher rate of pacing mode-change to DDDR in the AAIR group suggests a different management of patients with an AAIR PM after the DANPACE trial.
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