System upgrade and its complications in patients with a single lead atrial pacemaker: data from the DANPACE trial

Europace. 2013 Aug;15(8):1166-73. doi: 10.1093/europace/eut039. Epub 2013 Feb 28.

Abstract

Aims: To investigate the indications for system upgrade with single lead atrial pacing (AAIR), complications associated with these re-interventions, and possible predictors for system upgrade among patients included in the Danish Multicenter Randomized Trial on AAIR vs. dual-chamber pacing (DDDR) in sick sinus syndrome (DANPACE).

Methods and results: A total of 707 of 1415 patients were randomized to AAIR pacing. Mean follow-up was 5.5 ± 2.6 years. Information on indications for system upgrade and complications were collected by reviewing patient charts. Multiple logistic regression was used to estimate adjusted odds ratios (aOR) with 95% confidence intervals (CI) for the association between predictors and system upgrade. Sixty-six patients (9.3%) in the AAIR group underwent system upgrade. Fifty-nine of these patients (89.3%) had a documented class I indication for system upgrade. Age (aOR 0.98 for each 1-year increase in age; 95% CI 0.6-1.0), and left atrial enlargement (aOR 1.9; 95% CI 1.0-3.8) were predictors for system upgrade. No single clinically applicable predictor for upgrade was identified. A total of 11 patients (16.7%) experienced at least one major complication after system upgrade.

Conclusion: The majority of patients with AAIR pacing who underwent system upgrade had a class I indication. The incidence of major complications after system upgrade was high. The present data support the use of DDDR pacing rather than AAIR pacing in sick sinus syndrome.

Trial registration: ClinicalTrials.gov NCT00236158.

Keywords: Atrioventricular block; Complications; DANPACE; Pacing; Sick sinus syndrome; Upgrade.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Atrioventricular Block / epidemiology*
  • Atrioventricular Block / prevention & control*
  • Cardiac Resynchronization Therapy / statistics & numerical data*
  • Causality
  • Cohort Studies
  • Comorbidity
  • Denmark / epidemiology
  • Device Removal / statistics & numerical data
  • Electrodes, Implanted / statistics & numerical data*
  • Female
  • Humans
  • Male
  • Prevalence
  • Risk Factors
  • Sick Sinus Syndrome / epidemiology*
  • Sick Sinus Syndrome / prevention & control*
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT00236158