Medtronic Inc. is funding a study so that a multidisciplinary group of University of Cincinnati (UC) researchers will be able to conduct a clinical trial to determine if an implantable device can identify undetected heart rhythm abnormalities in hemodialysis patients. This study could also identify a link between heart rhythm abnormalities and a variety of electrolyte levels in the patient’s blood and the solution used during the dialysis process. Roy Chaudhury, a UC Health Nephrologist conducting the study with Alexandru Costea, MD Associate Professor in the Division of Cardiovascular Diseases at UC, report that dialysis patients have high hospitalization rates, high mortality, and low five year survival rates. Additionally, large shifts in electrolytes and volume during the thrice weekly dialysis sessions combined with underlying structural and functional cardiovascular disease increase the patient’s risk for arrhythmias, cardiac arrest, and sudden cardiac death.
“Sudden cardiac death occurs up to four times more frequently in end-stage kidney disease patients than in the general population according to Dr. Chaudhury. “Little is known about the frequency of arrhythmias and how they relate to the patient’s volume and electrolyte status, dialysis session patterns, or how they manifest to cause sudden cardiac death.
The FDA-approved “Medtronic Reveal” implant device is a battery-powered data storage device that monitors and records a patient’s heart rate and any abnormal arrhythmic activity 24/7 and then transmits the data electronically to a secure web site.
Subjects selected to participate in the study include those who are currently on hemodialysis at least three times per week or have begun hemodialysis within two months of the reveal implant. Regardless of whether or not hemodialysis has been initiated, data from the first six months, beginning with the first dialysis session after the device is implanted, will be used. Subjects will continue to be followed beyond the six month data collection phase through completion of this study which is defined as when the last subject completes six months of follow-up care.