BIOTRONIK Announces Results of REPLACE Registry, the First Prospective Study of Device Upgrade Procedures

Presented at the American Heart Association Scientific Sessions, REPLACE Registry analysis reports on device upgrades for all types of CRM devices from all manufacturers

Business Wire

posted: 8 DAYS 13 HOURS AGO

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BIOTRONIK, Inc. announced the results from the second group of patients from the REPLACE Registry – patients receiving a device upgrade to any CRM manufacturer’s device – presented by Jeanne Poole, MD at the Late-Breaking Clinical Science session of the American Heart Association (AHA) 2009 Scientific Sessions.

BIOTRONIK sponsored the REPLACE Registry to help physicians make more informed decisions with their patients regarding device replacements and upgrades from any CRM device manufacturer. A device upgrade is considered a change from a pacemaker to an implantable defibrillator (ICD), or an ICD to a heart failure therapy device (CRT-D).

“The results of the REPLACE Registry should provide important data for implanting physicians. In particular, complication rates have been shown to vary among categories of replacement procedures. Implanting physicians can now consider the risk associated with a specific procedure before proceeding,” stated Dr. Poole, National Principal Investigator of the REPLACE Registry.

Dr. Poole continued, “Overall, the risk of infection resulting from the surgery is relatively low; perioperative procedure risks are modest; and the longer-term complications are more prevalent. The long-term complication rate was highest among patients undergoing ‘upgrade’ to cardiac resynchronization, but one can speculate that this risk may be related to the poor health status in patients with advanced heart failure.”

In contrast to the findings from the device upgrade patient group, the major complication rate associated with simple device replacement was much lower, though the infection rate was similar among the two groups.

“The benefit of the REPLACE Registry data is that the implanting physician now has comprehensive data that was collected prospectively from multiple sites, both academic and private-practice, and with devices from all manufacturers, to consider when evaluating a patient for one of these procedures,” Dr. Poole added.

As one of the world’s leading cardiovascular medical device companies, with several million implanted devices, BIOTRONIK is represented in over 100 countries with its global workforce of more than 4,500 employees. Known for having its finger on the pulse of the medical community, BIOTRONIK assesses the challenges physicians face, and provides the best solutions for all phases of patient care, ranging from diagnosis to treatment to patient management. Quality, innovation and reliability define BIOTRONIK and its growing success, and deliver confidence and peace of mind to physicians and their patients worldwide.