Arrhythmias & electrophysiology
A Modular Communicative Leadless Pacing–Defibrillator System
Authors' conclusion
The leadless pacemaker in wireless communication with a subcutaneous ICD exceeded performance goals for freedom from major complications related to the leadless pacemaker, for communication between the leadless pacemaker and subcutaneous ICD, and for the percentage of patients with a pacing threshold up to 2.0 V at a 0.4-msec pulse width at 6 months.
Study context
- Population
- Patients at risk for sudden death from ventricular arrhythmias162 in 6-month end-point cohort
- Participants
- 293 patients
- Outcome
- Successful pacemaker–ICD communication (performance goal 88%) and pacing threshold ≤2.0 V at 0.4-msec pulse width (performance goal 80%)
- Follow-up
- 6 months
Methodological detailsmultinational, prespecified performance goals
- Multinational
- Prespecified performance goals
Main finding
As reported in the abstract
Successful wireless communication (% of communication tests); exceeded prespecified goal
98.8%
Pacing threshold ≤2.0 V (147 of 151 patients); exceeded prespecified goal
97.4%
Further findings
Arrhythmia episodes successfully terminated by ATP
- Episodes successfully terminated by ATP
- 61.3%
- Episodes with ATP not delivered owing to communication failure
- 0
Deaths
- Deaths among 162 patients
- 8 (4.9%)
- Deaths related to arrhythmias or implantation procedure
- 0
Safety
Freedom from leadless pacemaker-related major complications (performance goal 86%) · 6 months
- Free from leadless pacemaker-related major complications; exceeded prespecified goal
- 97.5%
Original publication
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