None listed
Conditions
Brief summary
Implantable cardioverter-defibrillators (ICDs) are small devices implanted in the chest to detect and treat life-threatening heart rhythm problems by delivering electrical shocks or pacing. While these devices save lives, they can sometimes deliver unnecessary shocks when they misidentify a normal or less dangerous heart rhythm as a life-threatening one. These unnecessary shocks are painful, reduce quality of life, and may themselves be harmful to the heart. International heart rhythm societies have published clear guidelines recommending that ICDs be programmed with high detection thresholds and longer confirmation intervals before delivering therapy, to reduce these unnecessary shocks. However, it is not known how widely these recommendations are followed in everyday clinical practice, nor whether following them affects how long patients live. This study aims to examine how closely real-world ICD programming across hospitals in the United States follows international guidelines, and whether devices programmed according to these guidelines are associated with fewer unnecessary shocks and better survival compared to devices that are not. We hypothesise that patients whose ICDs are programmed according to international guideline recommendations will experience significantly fewer unnecessary shocks and have a lower risk of death compared to patients whose devices are programmed outside these recommendations. Understanding this gap between guidelines and real-world practice could lead to changes in how ICDs are programmed by default when they leave the factory, potentially improving outcomes for the hundreds of thousands of patients who receive these devices each year.
Interventions
Exposure: Guideline-concordant ICD programming, defined as simultaneous fulfilment of three criteria derived from the Heart Rhythm Society/European Heart Rhythm Association/Asia Pacific Heart Rhythm Society (HRS/EHRA/APHRS) expert consensus statement: (1) ventricular fibrillation (VF) detection rate greater than or equal to 200 bpm; (2) prolonged detection intervals (number of intervals to detect greater than or equal to 30/40 or equivalent); and (3) anti-tachycardia pacing (ATP) programmed befo
Exposure: Guideline-concordant ICD programming, defined as simultaneous fulfilment of three criteria derived from the Heart Rhythm Society/European Heart Rhythm Association/Asia Pacific Heart Rhythm Society (HRS/EHRA/APHRS) expert consensus statement: (1) ventricular fibrillation (VF) detection rate greater than or equal to 200 bpm; (2) prolonged detection intervals (number of intervals to detect greater than or equal to 30/40 or equivalent); and (3) anti-tachycardia pacing (ATP) programmed before shock delivery in the ventricular tachycardia (VT) zone. Programming parameters were extracted from remote monitoring transmissions captured via the PaceMate LIVE vendor-neutral remote monitoring platform between January 2018 and December 2024. Programming was treated as a time-varying exposure, updated at each transmission. Comparator: Non-guideline-concordant programming (failure to meet any one or more of the three criteria). This is a retrospective observational study of real-world clinical practice, participants may move between the guideline-concordant (intervention) and non-guideline-concordant (control) groups over the course of follow-up. ICD programming is not fixed at implantation and may be adjusted by the treating clinician at any remote monitoring visit or in-person device check. Duration of observation: January 2018 to December 2024.To evaluate clinical adherence to evidence-based guidelines, specific device programming parameters were systematically extracted from longitudinal remote monitoring transmissions captured via the PaceMate LIVE vendor-neutral platform. For each device transmission, discrete data elements will be collected, including the programmed VF detection rate threshold (measured in beats per minute), the detection interval length or duration such as greater than 30/40 or its manufacturer-specific equivalent), and the active status of ATP therapies, specifically verifying whether ATP was programmed to deploy prior to high-voltage shock delivery within the VT zone.
Sponsors
Adelaide University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age greater than or equal to 18 years at time of device implantation. 2. Primary prevention ICD or Cardiac Resynchronization Therapy Defibrillator (CRT-D) device implanted and remotely monitored via PaceMate LIVE platform. 3. At least one interpretable remote monitoring transmission between January 2018 and December 2024. 4. Complete programming metadata available (VF detection rate, detection intervals, ATP programming status).
Exclusion criteria
1. Secondary prevention ICD indication. 2. Single-chamber ICD or pacemaker without ventricular defibrillation capability. 3. Incomplete or non-interpretable programming metadata. 4. Paediatric patients (<18 years). 5. Devices outside the study period (implanted or deactivated prior to January 2018).
Outcome results
None listed