Prospective study establishes new benchmarks for making device replacement decisions; physicians benefit from knowing complication rates associated with pacemaker or ICD generator replacement and upgrade procedures.
BIOTRONIK, Inc., a leading manufacturer of implantable cardiac devices and the pioneer of wireless remote monitoring technologies, announced today that results from the REPLACE Registry will be published in the October 19 issue of Circulation and have been published online.
The article, “Complication Rates Associated with Pacemaker or Implantable Cardioverter Defibrillator Generator Replacements and Upgrade Procedures: Results from the REPLACE Registry,” presents data from the first prospective multicenter study designed to evaluate the rate of complications from CRM device replacement and upgrade from all CRM manufacturers.
“REPLACE is the first prospective multicenter trial to examine a broad range of complications related to generator replacement. The two patient populations studied included patients who needed only a generator replacement and those who required a lead addition or revision for advanced therapy. While the major complication rate for a generator replacement alone was modest, the risk associated with upgrade procedures was markedly higher,” stated Jeanne Poole, MD, Director of Electrophysiology at the University of Washington, and National Principal Investigator of the REPLACE Registry.
Dr. Poole added, “Important ‘take home’ messages include the development of devices with long battery life to minimize the lifetime surgical risk for a patient and thoughtful consideration of the proper choice of device for each patient. Using the fewest leads necessary for the clinical need of the patient is important, and yet, our data would also support performing indicated complex procedures before the development of advanced end-stage medical and cardiac disease, situations in which the risk may be prohibitive.”
Patients were initially categorized based on whether the generator replacement procedure did not (cohort 1) or did (cohort 2) include a lead addition or revision. Definitions for major and minor complications were predefined, and all reported events were reviewed by an independent committee.
Results for cohort 1 were first presented during a Late-Breaking Clinical Trials session at the 2009 Heart Rhythm Society meeting. Using predefined complications, the study demonstrated with high confidence that 4.0 percent of these patients experienced a major complication, 7.4 percent experienced a minor complication, and 1.4 percent experienced an infection associated with the device replacement procedure.
In contrast to the findings from the simple device replacement group, the complication rates associated with device upgrades was much higher, though the infection rate was similar among the two groups. The results for cohort 2, first presented in the Late-Breaking Clinical Trials at the 2009 American Heart Association Scientific Sessions, demonstrated a major complication rate was 15.3 percent, minor complication rate was 7.6%, and 1.1 percent of patients experienced an infection.
Additional sub-analysis comparing complication rates with device type and the type of lead addition or revision, as well as specific information on the types of complications seen during the REPLACE registry, are presented in the article. In both groups, the complication rates were substantial for patients receiving upgrades or revisions of cardiac resynchronization devices, 18.7%.
“REPLACE provides important information regarding the next phase of life for patients with cardiac implantable electronic devices,” stated Marye Gleva, MD, Associate Professor of Medicine, Washington University School of Medicine, St. Louis, Missouri. “We are grateful for the participation and efforts of each of the patients, coordinators, and investigators who made REPLACE a success.”
“The REPLACE Registry demonstrates BIOTRONIK’s commitment as a leader in clinical excellence by investing in clinical research of clear significance and rigorously running trials to achieve unquestionable endpoint conclusions,” said Kevin Mitchell, BIOTRONIK Vice President, Clinical Studies. “We strive to further advance patient care and evidence-based medicine by exploring unanswered questions. Other trials of landmark potential that are sponsored by BIOTRONIK include TRUST, IMPACT, and EchoCRT
About BIOTRONIK SE & Co. KG (www.biotronik.com)
As one of the world’s leading manufacturers of cardiovascular medical devices, with several million devices implanted, BIOTRONIK is represented in over 100 countries by its global workforce of over 5,400 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.