Abstract 18458: A Simple Approach to Determine Risk Associated with Pacemaker and Implantable Cardioverter Defibrillator Replacements: The REPLACE Score
Introduction: The prospective multicenter REPLACE registry quantified complication rates in patients who underwent pacemaker (PM) and implantable cardioverter defibrillator (ICD) generator replacements with or without a planned lead addition. We sought to determine if there were clinical and/or procedural factors that would contribute independently and incrementally to procedure risk, and devise a risk score.
Methods: REPLACE included predefined definitions for major complication and infection; extensive data on baseline variables were collected and events were independently adjudicated to determine complication rates. Univariate and multivariate logistic regression were performed to identify which associations between major complication and infection endpoints and clinical/procedural variables had predictive value. For each factor identified as predictive in the multivariate analysis, a value of 1 was assigned. The REPLACE Score was defined as the numerical sum ranging from 0 to 4. Event rates were determined for each score quintile.
Results: A total of 1744 patients with PM, ICDs or cardiac resynchronization devices (CRT) were enrolled at 72 US centers in the registry. In 1031 patients, a generator replacement only was performed; 713 patients underwent generator replacement with a new lead addition (upgrade). Four independent factors were found to be predictive of a major complication or infection: 1) planned lead addition, 2) implanted ICD, 3) upgrade to CRT, and 4) presence of chronic pulmonary disease. NYHA Class III/IV, an independent univariate predictor, was highly correlated to CRT upgrade. The risk scores and event rates are shown in the Table. The difference in rates across the groups was significant (p<0.001).
Conclusions: The REPLACE Score stratifies the risk for PM, ICD or CRT generator replacement using three procedure variables with the addition of chronic pulmonary disease. Its simplicity may facilitate a rapid assessment of risk.
- Implantable cardioconvert defibrillator
- Resynchronization therapy
- Risk factors
- Clinical trials
- © 2010 by American Heart Association, Inc.