BERLIN--(BUSINESS WIRE)--The BIOTRONIK sponsored REPLACE study^1,2 is the first prospective, multicenter trial to examine a broad range of complications related to replacement of all companies’ cardiovascular implantable electronic devices (CIED) which includes both pacemakers and ICDs (implantable cardiac defibrillators). REPLACE demonstrates BIOTRONIK’s ongoing commitment to supporting landmark trials of major significance to the entire medical community.

The REPLACE study enrolled a total of 1,744 patients in 72 centers located across the United States, dividing them into two cohorts: one undergoing generator (implantable device) replacement only (1,031 patients) and another undergoing generator replacement with a new transvenous lead addition or revision (713 patients). Postoperative wound assessment was completed after 3 months and 6 months, with a full 100% of patients having received preoperative antibiotics.

The incidence of overall infection was low at 6 months, with only 1.3% of patients suffering these complications. Major infections contributed 0.8% to the overall rate. “The systematic collection and adjudication of infectious complications provided a very accurate assessment of the risks of infection,” according to Dr. Daniel Z. Uslan, Infectious Diseases specialist at the University of California (UCLA), Los Angeles, United States, and lead author on the study. “Patients can be effectively counseled about the risk of infection following CIED replacement.”

The results revealed an intriguing clustering of infections within the study sites. Eighteen percent of sites (13 of the 72 centers) had patients with infection complications, and 6 of those 13 sites had an incidence rate of more than 5% of enrolled patients. The patients within these 6 sites accounted for 14 (64%) of the 22 total infections experienced during the study. Further investigation of aseptic technique as a potential causal factor revealed that sites experiencing higher infection rates were more likely to use povidone-iodine instead of chlorhexidine for topical antisepsis. Comorbidities, as measured by the Charlson Comorbidity Index (CCI) were also more prevalent in the patient cohorts from these six centers.

Furthermore the study showed patients with infections were more likely to have had postoperative hematomas than those without infection (22.7% versus 0.98%), and patients receiving abdominal generator replacements had higher infection rates. Infection prevention strategies such as postoperative systematic antibiotics were widely used.

“REPLACE was the first study to systematically show the current state of practices for infection prevention for CIED implantation,” noted Dr. Uslan. “Practices such as postoperative systemic antibiotics were widespread despite a lack of data on their efficacy. While this indicates a commitment to prevent infection among practitioners, it also highlights the need for large randomized trials examining the potential benefits and risks of these practices.”

“The REPLACE Registry demonstrates BIOTRONIK’s commitment as a leader in clinical excellence,” commented Kevin Mitchell, BIOTRONIK’s Vice President of Clinical Studies, BIOTRONIK, Inc., USA. “We invest in clinical research of clear significance, rigorously run trials to achieve unquestionable endpoint conclusions, and strive to advance patient care and evidence-based medicine by exploring unanswered questions.” BIOTRONIK has a well established reputation for support of landmark clinical trials such as TRUST^3,4, IMPACT⁵ and EchoCRT⁶.

About BIOTRONIK SE & Co. KG

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 5,600 employees. Known for having its fingers 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 and treatment to patient management. Quality, innovation and clinical excellence define BIOTRONIK and its growing success—and deliver confidence and peace of mind to physicians and their patients worldwide.

For more information: www.biotronik.com

References

¹Uslan, Daniel Z, et al., Cardiovascular Implantable Electronic Device Replacement Infections and Prevention: Results from the REPLACE Registry: PACE, Vol. 35, January 2012, pp 81-87.

²Poole JE, et al., Complication Rates Associated With Pacemaker or Implantable Cardioverter-Defibrillator Generator Replacements and Upgrade Procedures: Results From the REPLACE Registry. Circulation; Oct. 4, 2010, Vol 122 (16) 1553-1561.

³Varma et al., Circulation 2010, 122, 325–332.

⁴Varma et al., Circ Arrhythm Electrophysiol 2010, 3:428–436.

⁵Ip J, et. Al., Multicenter randomized study of anticoagulation guided by remote rhythm monitoring in patients with implantable cardioverter-defibrillator and CRT-D devices: Rationale, design, and clinical characteristics of the initially enrolled cohort: The IMPACT study. Am Heart J 2009;158:364-370.e1

⁶ Van Bommel RJ et al., Association of intraventricular mechanical dyssynchrony with response to cardiac resynchronization therapy in heart failure patients with a narrow QRS complex. European Heart Journal (2010) 31, 3054–3062.

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