News | January 07, 2015

REPLACE DARE Score Proves Strong Risk Indicator for Pacemaker or ICD Replacement

Analysis of REPLACE Registry identifies six key patient risk factors, reveals comorbidities more relevant than procedure-related complications

January 7, 2015 — Biotronik announced 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  Mina Chung, M.D., Cleveland Clinic, Cleveland, Ohio. “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 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 percent in the group without additional lead replacement, and 4.6 percent 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; New York Heart Association (NYHA) class III or IV heart failure; 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 Jeanne Poole, M.D., director of electrophysiology at the University of Washington, Seattle. “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 replacedare.org. It features a site design optimized for use on mobile devices like tablets and smartphones and is free to use.

For more information: www.biotronik.com

Related Content

The first 3-D images have been created of an RNA molecule known as "Braveheart" for its role in transforming stem cells into heart cells. Credit: Image courtesy Los Alamos National Laboratory

The first 3-D images have been created of an RNA molecule known as "Braveheart" for its role in transforming stem cells into heart cells. Credit: Image courtesy Los Alamos National Laboratory

News | Cardiovascular Clinical Studies | January 20, 2020
January 20, 2020 — Scientists at Los Alamos and international partners have created the first 3-D images of a special
Top Cardiology New in 2019 From the European Society of Cardioloigy (ESC)
News | Cardiovascular Clinical Studies | December 23, 2019
Environmental and lifestyle issues were popular this year, with pick up from both...
News | Cardiovascular Clinical Studies | November 26, 2019
November 26, 2019 — The University of Connecticut (UConn) Department of Kinesiology and Hartford Healthcare have sele
FDA Issues Final Guidance on Live Case Presentations During IDE Clinical Trials
News | Cardiovascular Clinical Studies | July 10, 2019
The U.S. Food and Drug Administration (FDA) issued the final guidance “Live Case Presentations During Investigational...
Veradigm Partners With American College of Cardiology on Next-generation Research Registries
News | Cardiovascular Clinical Studies | July 03, 2019
The American College of Cardiology (ACC) has partnered with Veradigm, an Allscripts business unit, to power the next...
New FDA Proposed Rule Alters Informed Consent for Clinical Studies
News | Cardiovascular Clinical Studies | November 19, 2018
The U.S. Food and Drug Administration (FDA) is proposing to add an exception to informed consent requirements for...
A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo