2405When do cardiac rhythm management device complications occur?

Abstract Background The rate of implantation of cardiac rhythm management devices continues to increase but it is difficult to compare the complication rates of routine cardiac implantable electronic device procedures as the follow-up durations published in literature vary widely (peri-procedure to 3 years). Purpose We demonstrate the appropriate follow-up duration for a complication to be attributed to an index procedure, by analysing the complications within the first year of routine cardiac implantable electronic device procedures (primary implant, generator replacement, lead revision only, generator and lead revision, system upgrade and reburial) and the timing of complication interventions. Methods A retrospective database was constructed of all de novo CIED operations performed at a tertiary cardio-thoracic centre between April 2008 – March 2016. Procedures were identified from theatre logbooks, with demographic and procedural data extracted from contemporaneously maintained health records (paper and electronic). Objective complications were defined as follows; 1. Any pneumothorax identified on chest x-ray, 2. Any pericardial effusion identified on transthoracic echocardiogram performed post procedure due to intra-operative clinical concern, 3. Haematoma requiring surgical evacuation, 4. Device pocket revision or system reburial, 5. Lead intervention requiring repositioning or placement of a new lead and 6. System explant/ extraction due to any indication. Post-operative complications were identified through theatre log books and cross-referenced with 3 contemporaneously maintained records (clinical health records, TOMCAT electronic database, audit department archive). All data collection was performed by a single investigator, independent of the procedures performed and operating physicians. Results 10,125 procedures were reviewed; 6,583 primary implant procedures, 2,170 generator replacements, 382 lead revisions, 253 generator and lead interventions, 575 system upgrades and 162 reburial procedures. The procedures involved 3,403 female patients and 6,722 male, with a median age 73 years (±13.7). 2,303 procedures were acute and 7,822 elective. The complication rates were; 4.3% primary implant, 4.0% generator replacements, 12.6% lead revisions, 13.0% generator and lead interventions, 6.9% system upgrades and 22.8% reburial procedures. The timing of complication intervention varied significantly (Figure 1). Timing of Complication Intervention Conclusio