Abstract
Background Dialysis patients have high rates of cardiovascular morbidity and mortality, but data on arrhythmia burden, arrhythmia type, arrhythmia triggers, and the identity of terminal arrhythmias have historically been limited by an inability to monitor heart rhythm for prolonged periods. Objectives To investigate arrhythmia and its association with sudden death in dialysis-dependent ESRD, describe the potential for implantable devices to advance study of dialysis physiology, review the ethical implications of using implantable devices in clinical studies, and report on the protocol and baseline results of the Monitoring in Dialysis Study (MiD). Design, setting, participants, & measurements In this multicenter, interventional-observational, prospective cohort study, we placed implantable loop recorders in patients undergoing long-term hemodialysis. The proportion of patients experiencing clinically significant arrhythmias was the primary endpoint. For 6 months, we captured detailed data on the primary endpoint, symptomatic arrhythmias, other electrocardiographic variables, dialysis prescription, electrolytes, dialysis-related variables, and vital signs. We collected additional electrocardiographic data for up to 1 year. Results Overall, 66 patients underwent implantation in sites in the United States and India. Diabetes was present in 63.6% of patients, 12.1% were age ≥70 years, 69.7% were men, and 53.0% were black. Primary and secondary endpoint data are expected in 2016. Conclusions Cardiac arrhythmia is an important contributor to cardiovascular morbidity and mortality in dialysis patients, but available technology has previously limited the ability to estimate its true burden and triggers and to define terminal rhythms in sudden death. Use of implantable technology in observational studies raises complex issues but may greatly expand understanding of dialysis physiology. The use of implantable loop recorders in MiD is among the first examples of such a trial, and the results are expected to provide novel insights into the nature of arrhythmia in hemodialysis patients.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 721-734 |
| Number of pages | 14 |
| Journal | Clinical Journal of the American Society of Nephrology |
| Volume | 11 |
| Issue number | 4 |
| DOIs | |
| State | Published - Apr 7 2016 |
Bibliographical note
Funding Information:The authors would like to acknowledge the support and feedback from the study team at Medtronic including John Burnes and Amy Roettger. The MiD study was funded by Medtronic and designed by Medtronic in collaboration with an advisory committee that included the authors. The MiD investigators and committees are listed in the Supplemental Material. All of the authors received research support and/or consulting fees from Medtronic (Minneapolis, MN) in relationship to the design of the study. D.M.C. received consulting from Questcor Pharmaceuticals (Anaheim, CA), expert witness fees related to dialysate composition from Fresenius Medical Care (Waltham, MA), and fees related to service on clinical events committee from PLC Medical Systems (Milford, MA). J.D.R. received speakers bureau, consultant, and research support from Medtronic; speakers bureau and research support from St Jude Medical (St. Paul, MN); and speakers bureau from Biotronik (Berlin, Germany). C.A.H. received research support from Zoll (Chelmsford, MA) and stock/equity interest from Cambridge Heart, Boston Scientific (Tewksbury, MA).
Publisher Copyright:
© 2016 by the American Society of Nephrology.
Keywords
- Arrhythmias
- Cardiac
- Cardiovascular disease
- Chronic
- Clinical trial
- Cohort studies
- Death
- Heart conduction system
- Hemodialysis
- Humans
- Kidney failure
- Renal dialysis
- Sudden
