Predictors of short-term complications after XXXX replacement: results from the Ontario @entity737 Database.

@entity1 @entity3126 @entity737 @entity281 @entity1410 @entity65
BACKGROUND: Complications after @entity737 ( @entity737 ) replacement are often clinically devastating, particularly when @entity281 or reoperation occurs. Identifying factors contributing to complications may permit identification of high-risk individuals that warrant incremental monitoring and therapy to attenuate risk. In addition, replacement may be a discretionary decision in the context of an advisory or borderline device performance and @entity1 , device, and implanter factors that predict adverse outcome may assist in clinical decision-making. METHODS AND RESULTS: In a prospective, multicenter, population-based registry of all @entity737 @entity1 at 18 centers in Ontario, Canada, we examined 45-day complication and all-cause mortality rates from February 2007 to August 2009 in @entity1 undergoing @entity737 generator replacement. Complications were determined longitudinally and were categorized as major or minor. @entity737 replacement was performed in 1081 of 5176 @entity1 (20.8%) undergoing @entity737 implantation (age, 64.3  12.7 years; 78.5% @entity1 ). In @entity1 undergoing @entity737 replacement, 47 @entity1 (4.3%) had a complication within 45 days, with 47 major complications in 28 @entity1 (2.6%), most commonly @entity281 (n=23), lead revision (n=35), electrical storm (n=14), and @entity3126 (n=13). Minor complications occurred in 2.3% of @entity1 , most commonly incisional @entity281 (n=10) and pocket @entity1410 (n=10). On multivariable analysis, risk factors associated with major complications were Canadian @entity65 (adjusted hazard ratio [HR], 3.70 for class 2 to 4 versus 0 to 1; P=0.027) and multiple previous procedures on the pocket (adjusted HR, 3.35 for >1 versus 1; P=0.058). Risk factors associated with any complication were the use of antiarrhythmic therapy (adjusted HR, 6.29; P=0.001), implanter volume (adjusted HR 10.4 for <60/y versus >120/y, P=0.026), and Canadian @entity65 (adjusted HR, 3.00 for class 2 to 4 versus 0 to 1; P=0.031). In a Cox model with a time-dependent variable of major complication within 45 days after replacement, major complications after @entity737 replacement were associated with an increased risk of mortality at 45, 90, and 180 days (adjusted HR, 9.61, 12.69, and 6.41, respectively; P=0.002 to 0.039). CONCLUSIONS: Risk factors associated with complications after @entity737 replacement include the presence of angina, antiarrhythmic therapy, increased number of previous procedures, and low implanter volume. Major complications may be associated with increased risk of subsequent mortality.
