Overview

The REPLACE DARE (Death After Replacement Evaluation) mortality risk score is tool designed to further assist physicians in predicting expected 6-month all-cause mortality rates for patients prior to replacing or implanting a new cardiac implantable electrical device (CIED).

Intended Use

Current physician practice guidelines and Medicare coverage policies recommend against cardiac implantable electrical device (CIED) implantation IF expected longevity is less than 1 year. A determination of high patient mortality risk, using a tool such as the REPLACE DARE mortality risk score, may be of particular importance in deciding whether to reevaluate use of antiarrhythmic drugs, optimization of heart failure and renal function, and/or reassess CIED implant or replacement. More than 55% of patients in the REPLACE registry with a mortality risk score of > 7 died within 6 months following device implant. Revaluation of antiarrhythmic drugs, optimization of heart failure and renal function, and/or reassessment of CIED replacement may be appropriate in patients with high mortality risk scores.

Methodology

The REPLACE DARE mortality risk score was developed based on a special study of data collected within the REPLACE registry. The study evaluated multiple patient factors, including age, comorbid conditions, and procedure related complications to determine if certain factors might reliably predict patient all-cause mortality within 6 months after CIED replacement. Risk factors for mortality after CIED replacement included higher NYHA heart failure class, heart failure hospitalization within the past 12 months, use of antiarrhythmic medications, cerebrovascular disease, CKD stage, and advanced age. Based on a Cox Regression analysis, comorbidities including heart failure, kidney, cerebrovascular disease, and age 80 years old, rather than complications, were found to be the most likely contributors to mortality after CIED replacement.

Mortality Risk Score

Mortality Risk Score =
((3.097^ HF)+(1.959^NYHA)+(1.425^(CKD1))+(1.901^ANTI)+(1.801^CEREB)+(1.238^(AGE - 1)))-6

Variable

Description

HF

Admitted for Heart Failure in Previous 12 Months (0=No, 1=Yes)

NYHA

NYHA Class (0=0/I/II, 1=III/IV)

CKD

Chronic Kidney Disease Stage (1-5)

ANTI

Anti-arrhythmia Drug Use (0=No, 1=Yes)

CEREB

History of Cerebrovascular Disease (0=No, 1=Yes)

AGE

Age Quartile (1-4)

Validation

To evaluate the robustness of the predictors used in the REPLACE DARE Score, a bootstrapping validation was performed estimating the variability and confidence intervals associated with the predictors based on 10,000 simulated trials created by sampling with replacement from the original REPLACE Study population of 1744 patients. At 6 months 70/1744(4.0%) patients had died. Kaplan-Meier analyses showed higher mortality after upgrade to a cardiac resynchronization therapy device (p=0.003) and similar trends after a major complication (p=0.062). The REPLACE DARE mortality risk score was 2.0±1.3 in survivors versus 3.5±1.8 in non-survivors (p<0.001) with predictive ROC 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.

Limitations

Although this sub-analysis of the REPLACE registry was retrospective, the REPLACE data, including mortality, were collected prospectively. Data collection, though extensive, may have missed some confounding factors. The study was also not powered to detect significant differences in short-term mortality in all subgroup analyses. Although the REPLACE DARE Score significantly identified patients with varying risk for mortality, including a very high risk group, the Score will require external validation in other populations.

The REPLACE Registry study was sponsored by BIOTRONIK, Inc.

REPLACE Registry Publications

Poole JE, Gleva MJ, Mela T, Chung MK, Uslan DZ, Borge R, Gottipaty V, Shinn T, Dan D, Feldman LA, Seide H, Winston SA, Gallagher JJ, Langberg JJ, Mitchell K, Holcomb R; REPLACE Registry Investigators. Complication rates associated with pacemaker or implantable cardioverter-defibrillator generator replacements and upgrade procedures: results from the REPLACE registry. Circulation 2010 Oct 19;122(16):1553-61.
The following link will open in a new window. Retrieved from: http://www.ncbi.nlm.nih.gov/pubmed/20921437

Uslan DZ, Gleva MJ, Warren DK, Mela T, Chung MK, Gottipaty V, Borge R, Dan D, Shinn T, Mitchell K, Holcomb RG, Poole JE. Cardiovascular implantable electronic device replacement infections and prevention: results from the REPLACE Registry. Pacing Clin Electrophysiol 2012 Jan;35(1):81-7
The following link will open in a new window. Retrieved from: http://www.ncbi.nlm.nih.gov/pubmed/22077194

Chung MK, Holcomb RG, Mittal S, Steinberg JS, Gleva MJ, Mela T, Uslan DZ, Mitchell K, Poole JE REPLACE DARE (Death After Replacement Evaluation) Score: Determinants of All-Cause Mortality After Implantable Device Replacement Or Upgrade from the REPLACE Registry. Circ Arrhythm Electrophysiol. 2014;7:1048-1056
The following link will open in a new window. Retrived from: http://www.ncbi.nlm.nih.gov/pubmed/25221331