Mina K Chung1, Richard G Holcomb2, Suneet Mittal2, Jonathan S Steinberg2, Marye J Gleva2, Theofanie Mela2, Daniel Z Uslan2, Kevin Mitchell2, Jeanne E Poole2. 1. From the Department of Cardiovascular Medicine, Heart & Vascular Institute, Cleveland Clinic, OH (M.K.C.); Minnetonka, MN (R.G.H.); the Arrhythmia Institute, Valley Health System, New York, NY (S.M., J.S.S.); Division of Cardiology, Department of Medicine, Washington University, St. Louis, MO (M.J.G.); Cardiology Division, Department of Medicine, Massachusetts General Hospital & Harvard Medical School, Boston (T.M.); Division of Infectious Diseases, David Geffen School of Medicine at UCLA, Los Angeles, CA (D.Z.U.); BIOTRONIK, Lake Oswego, OR (K.M.); Division of Cardiology, University of Washington, Seattle (J.E.P.) chungm@ccf.org. 2. From the Department of Cardiovascular Medicine, Heart & Vascular Institute, Cleveland Clinic, OH (M.K.C.); Minnetonka, MN (R.G.H.); the Arrhythmia Institute, Valley Health System, New York, NY (S.M., J.S.S.); Division of Cardiology, Department of Medicine, Washington University, St. Louis, MO (M.J.G.); Cardiology Division, Department of Medicine, Massachusetts General Hospital & Harvard Medical School, Boston (T.M.); Division of Infectious Diseases, David Geffen School of Medicine at UCLA, Los Angeles, CA (D.Z.U.); BIOTRONIK, Lake Oswego, OR (K.M.); Division of Cardiology, University of Washington, Seattle (J.E.P.).
Abstract
BACKGROUND: Identifying factors predictive of mortality may be important to decrease risk associated with cardiac implantable electrical device (CIED) replacement procedures. This study aimed to determine whether clinical factors and complications independently associate with death and to develop a mortality risk prediction tool after CIED replacement. METHODS AND RESULTS: The prospective REPLACE Registry determined 6-month complication and mortality rates after CIED replacement with or without planned lead addition or revision. Vital status was collected. Kaplan-Meier survival and multivariable Cox proportional hazards regression analyses were performed to identify patient, procedural, or complication variables predictive of death. The REPLACE DARE (Death After Replacement Evaluation) Score was constructed using hazard ratios, reflecting relative risk contributions of each variable, combined into an additive mortality risk score equation. At 6 months, 70 of 1744 (4.0%) patients had died. Cox regression analysis found no significant association between major complications and death. However, recent heart failure admission, New York Heart Association class III/IV, antiarrhythmic drug use, cerebrovascular disease, and chronic kidney disease stage were independently associated with 6-month mortality. The REPLACE DARE Score was 2.0±1.4 in survivors versus 3.5±1.8 in nonsurvivors (P<0.001), with predictive receiver operating characteristic value=0.758 (P<0.001). Risk of death was 1.0% for DARE=0 and 55.6% for DARE=7. The hazard ratio was 1.8 for each change of 1 DARE unit. CONCLUSIONS: Comorbidities, but not complications, were significantly associated with mortality after CIED replacement. The REPLACE DARE Score is a novel tool that can identify patients with substantial mortality risk. Such patients should have the relative risk and benefit of their procedure considered carefully. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00395447.
BACKGROUND: Identifying factors predictive of mortality may be important to decrease risk associated with cardiac implantable electrical device (CIED) replacement procedures. This study aimed to determine whether clinical factors and complications independently associate with death and to develop a mortality risk prediction tool after CIED replacement. METHODS AND RESULTS: The prospective REPLACE Registry determined 6-month complication and mortality rates after CIED replacement with or without planned lead addition or revision. Vital status was collected. Kaplan-Meier survival and multivariable Cox proportional hazards regression analyses were performed to identify patient, procedural, or complication variables predictive of death. The REPLACE DARE (Death After Replacement Evaluation) Score was constructed using hazard ratios, reflecting relative risk contributions of each variable, combined into an additive mortality risk score equation. At 6 months, 70 of 1744 (4.0%) patients had died. Cox regression analysis found no significant association between major complications and death. However, recent heart failure admission, New York Heart Association class III/IV, antiarrhythmic drug use, cerebrovascular disease, and chronic kidney disease stage were independently associated with 6-month mortality. The REPLACE DARE Score was 2.0±1.4 in survivors versus 3.5±1.8 in nonsurvivors (P<0.001), with predictive receiver operating characteristic value=0.758 (P<0.001). Risk of death was 1.0% for DARE=0 and 55.6% for DARE=7. The hazard ratio was 1.8 for each change of 1 DARE unit. CONCLUSIONS: Comorbidities, but not complications, were significantly associated with mortality after CIED replacement. The REPLACE DARE Score is a novel tool that can identify patients with substantial mortality risk. Such patients should have the relative risk and benefit of their procedure considered carefully. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00395447.