BIOTRONIK Announces Results of REPLACE Registry


November 6, 2009

November 4, 2009 — BIOTRONIK Inc. this week announced the results from site preparation, antibiotic use and infection sub-analysis from the REPLACE Registry. The results, based on analysis of 1,031 patients undergoing elective replacement of their implanted cardiac rhythm management (CRM) device, provides important insight on techniques for surgical site preparation and antibiotic use in device-replacement procedures.

The REPLACE Registry was designed to evaluate the rate of complications from CRM device replacement and upgrade from all CRM manufacturers. The REPLACE Registry is the first large, prospective study to look at the factors that influence infection rates in device replacement.

The sub-analysis included 1,031 replacement procedures with representative devices from five CRM manufacturers. The infection rates from the first group of patients in the REPLACE Registry were presented at the poster sessions of the Infectious Diseases Society of America Scientific Sessions. Two factors were identified that exhibited significantly different infection rates. The first factor was preoperative skin preparation. Skin preparation with povidone-iodine was associated with an increased rate of infection (2.1 percent) compared with chlorhexidine-containing compounds (0.2 percent). The second factor was post-operative antibiotic use. The incidence of infection among patients receiving no postoperative antibiotics (0.5 percent) was lower than in those receiving parenteral antibiotics postoperatively (2.3 percent).

“Postoperative IV antibiotics are often given to patients in an attempt to decrease the risk of infection,” noted Daniel Uslan, M.D., assistant clinical professor at UCLA and member of the REPLACE Registry steering committee. “In the REPLACE Registry, there did not seem to be any benefit to doing so.”

“Infections occurred uncommonly in the REPLACE Registry. It is interesting that a variety of antibiotic prophylaxis measures were used by the site investigators who participated,” added Jeanne Poole, M.D., national principal investigator for the REPLACE Registry. “All patients received intravenous antibiotics. These data will contribute significantly to the body of literature available on device related infections.”

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