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Randomized Controlled Trial

Optimized post-operative surveillance of permanent pacemakers by home monitoring: the OEDIPE trial

Franck Halimi et al. Europace. 2008 Dec.

Abstract

Aims: The OEDIPE trial examined the safety and efficacy of an abbreviated hospitalization after implantation or replacement of dual-chamber pacemakers (PM) using a telecardiology-based ambulatory surveillance programme.

Methods and results: Patients were randomly assigned to (i) an active group, discharged from the hospital 24 h after a first PM implant or 4-6 h after replacement, and followed for 4 weeks with Home-Monitoring (HM), or (ii) a control group followed for 4 weeks according to usual medical practices. The primary objective was to confirm that the proportion of patients who experienced one or more major adverse events (MAE) was not higher in the active than in the control group. The study included 379 patients. At least one treatment-related MAE was observed in 9.2% of patients (n = 17) assigned to the active group vs. 13.3% of patients (n = 26) in the control group (P = 0.21), a 4.1% absolute risk reduction (95% CI -2.2 to 10.4; P = 0.98). By study design, the mean hospitalization duration was 34% shorter in the active than in the control group (P < 0.001), and HM facilitated the early detection of technical issues and detectable clinical anomalies.

Conclusion: Early discharge with HM after PM implantation or replacement was safe and facilitated the monitoring of patients in the month following the procedure.

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Figures

Figure 1
Figure 1
Overall study design.
Figure 2
Figure 2
Cumulative number of adverse events (AE) and major adverse events (MAE), up to 35 days of follow-up, in each study group.
Figure 3
Figure 3
Types of messages transmitted by 108 patients assigned to the active group.
See this image and copyright information in PMC

References

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