Risk factors of mortality after secondary procedures during the world-wide randomized antibiotic envelope infection prevention trial (WRAP-IT)

Type of funding sources: Private company. Main funding source(s): Medtronic Previous analysis of WRAP-IT (World-wide Randomized Antibiotic Envelope Infection Prevention trial) data identified both patient and procedural characteristics as risk factors for cardiac implantable electronic device (CIED) infection. In the current analysis, we sought to similarly use prospectively collected WRAP-IT data to assess risk factors of all-cause mortality. Understanding if mortality risk can be modified and identifying baseline characteristics associated with high risk can help guide physician decision making. To identify modifiable and non-modifiable risk factors for 1-year all-cause mortality after a secondary (replacement, revision, or upgrade) CIED procedure. This analysis included 5,461 secondary procedure patients from the WRAP-IT study. Included as candidate factors were patient and procedural characteristics. Patients with more than one year follow-up were censored at one year. A multivariate Cox Proportional Hazards model was reached by stepwise selection to minimize Akaike Information Criterion. The overall one-year mortality rate was 5.2% after secondary procedures. Of the 26 patient and 18 procedural characteristics analyzed, the following variables best predicted risk of a 1-year all-cause mortality: age, NYHA class, renal dysfunction, anticoagulant use, ischemic cardiomyopathy, diabetes, BMI, procedure time, myocardial infarction, valve surgery, and hypertrophic cardiomyopathy (Table). In WRAP-IT patients undergoing secondary procedures, the only procedure characteristics that had any association with all-cause 1-year mortality risk was procedure time suggesting that most of the risk factors of mortality are non-modifiable. Baseline patient characteristics and co-morbidities were the principal risk factors of all-cause 1-year mortality. Specifically, increasing age, NYHA class, and a history of renal dysfunction were strongly associated with mortality.