REPLACE DARE Score Provides Novel Tool for Risk Stratifying Patients Requiring Pacemaker or ICD Replacement

Analysis of BIOTRONIK Sponsored REPLACE Registry Identifies Key Patient Risk Factors, Reveals Comorbidities More Relevant than Procedure-Related Complications

BERLIN, Germany, December 17, 2014 – BIOTRONIK, a leading manufacturer of cardiovascular medical technology, announced today the publication of new findings from the REPLACE Registry in Circulation: Arrhythmia and Electrophysiology. The BIOTRONIK sponsored REPLACE Registry was the first worldwide study to examine complications related to pacemaker or implantable cardioverter defibrillator (ICD) replacement.

The new analysis reveals that patient comorbidities, rather than procedure-related complications, drive near-term mortality following a cardiac device or lead replacement procedure. The manuscript also highlights how the novel REPLACE DARE (Death After Replacement Evaluation) Score helps physicians evaluate the potential risks of device replacement.

“The REPLACE DARE Score emerged from the results of the prospective multicenter REPLACE Registry, a sub-analysis of which revealed six risk factors predictive of mortality,” commented the study’s primary author Dr. Mina Chung, Cleveland Clinic, Cleveland, Ohio, US. “With the REPLACE DARE Score physicians can, for the first time, estimate the mortality risk for their own patients who are undergoing device replacement or upgrade. As most cardiac device patients will require one or more generator replacements, the REPLACE DARE Score has many practical implications.”

The REPLACE Registry (NCT 00395447) enrolled 1,744 patients with any cardiac device manufacturer’s pacemaker or ICD and leads. These patients were divided into two cohorts – with or without lead revision or addition. No deaths were seen during the replacement procedure. Six months later, the death rate was 3.6% in the group without additional lead replacement, and 4.6% in the group with additional lead replacement. The initial results of the trial were published in Circulation in 2010.

This analysis of REPLACE Registry data revealed that six easily identifiable clinical factors enable robust discrimination among patients at high and low risk for near–term mortality: prior heart failure (HF) admission, NYHA class III or IV, antiarrhythmic drug use, chronic kidney disease, cerebrovascular disease and age. By statistically incorporating these individual risk factors into a risk prediction score, the REPLACE DARE Score provides a quantitative estimation of near-term mortality, and can identify those patients with substantial mortality risk.

“The REPLACE DARE Score is particularly relevant for elderly patients or those with significant comorbidities who are considering whether the benefits of device or lead replacement outweigh the possible risks,” explained national principal investigator for the study Dr. Jeanne Poole, Director of Electrophysiology at the University of Washington, Seattle, Washington, US. “Our goal, however, is to make such calculations available to physicians who stand to benefit from a clear-eyed assessment of such a procedure’s potential risks. The score may also, importantly, help to reassure those patients for whom the procedure carries relatively little risk. We therefore created a website hosting the easy-to-use online tool which automatically scores individual patients according to the REPLACE DARE
Score’s clinical factors.”

The REPLACE DARE Mortality Risk Score calculator is now available at www.replacedare.org. It features a site design optimized for use on mobile devices like tablets and smart phones and is free to use.

“BIOTRONIK is deeply engaged in facilitating patient-centric outcomes, not only with our high-quality therapies, but also by partnering with leaders in the field of clinical research. We are honored to have supported the vital research that lead to the REPLACE DARE Score, a practical and novel tool that benefits both physicians and patients,” stated Kevin Mitchell, Vice President of Clinical Studies, BIOTRONIK, Inc. “We believe that adoption of the REPLACE DARE Score will help physicians engage patients in productive dialogue about the benefits and potential risks of
device replacement.”

  1. Investigational Device: Limited by U.S. law to investigational use.
  2. Investigational Device: Limited by U.S. law to investigational use.


At BIOTRONIK, patient well-being is our top priority and has been for 60 years. BIOTRONIK is a leading global medical technology company with products and services that save and improve the lives of millions suffering from heart and blood vessel diseases as well as chronic pain. Driven by a purpose to perfectly match technology with the human body, we are dedicated innovators who develop trusted cardiovascular, endovascular and neuromodulation solutions. BIOTRONIK is headquartered in Berlin, Germany, and is represented in over 100 countries.