We have continued to transform healthcare through new innovations in dialysis and advances in treatment of kidney disease. The Fresenius Medical Care North America (FMCNA) Medical Office highlights the top five innovations in kidney care to watch in 2021.
1. Living Donor Registry
Robert J. Kossmann, MD, FACP, FASN
Global Head of Renal Therapies
Chief Medical Officer of Fresenius Medical Care North America
A kidney transplant generally offers the highest quality of life and most additional years of life for many patients with advanced chronic kidney disease (CKD) or end stage renal disease (ESRD). Working to reduce the barriers that stand between a patient and a potential donor will help to create a brighter future for the more than 95,000 people on the national kidney transplant wait list.
With a donation from the Fresenius Medical Care Foundation, Donate Life America (DLA) is helping to encourage potential kidney donors to express their interest through a first-of-its-kind National Donate Life Living Donor Registry. The new at-home living donor testing kits, scheduled to launch in 2021, are expected to make it easier for the individual volunteers from the healthy general public to register their interest in living kidney donation and identify a preliminary match.
According to the 2020 United States Renal Data System (USRDS) Annual Data Report, 22,300 people received kidney transplants in 2018, with most receiving kidneys from deceased donors1. But we know outcomes are even better with living donation, including from unrelated donors (non-relatives). In order to provide greater access to kidney transplant for more people in desperate need, DLA is simplifying the process by which potential undirected, altruistic donors can raise their hands to be considered as kidney donors.
2. Connected Health and Remote Sensors
Michael Kraus, MD
Associate Chief Medical Officer of Fresenius Kidney Care
Ensuring timely access to information and more frequent interactions with the care team helps increase patient confidence so they can succeed with their chosen home dialysis therapy.
Our connected health platform, theHub, is an integrated solution that is making it easier for those involved in kidney care to interact and collaborate. Additionally, telehealth's rapid adoption due to the challenges of COVID-19 have increased remote video consultations between home patients and the clinical care team. Data can now flow automatically from home dialysis machines into these connected systems.
Building upon the commitment to advancing new health technologies, we also announced a strategic investment in BioIntelliSense which produces a new FDA-approved BioSticker remote monitoring tool that allows for continuous collection of physiological data in home and healthcare settings, delivering real-time data and algorithmic insight to the clinical care team. A new partnership starting with innovator Livongo enables targeted, real-time care coordination services through “Livongo Whole Person for CKD,” in an effort to slow the progression of CKD especially among those patients living with diabetes.
3. Transitional Care Units
Dinesh Chatoth, MD
Associate Chief Medical Officer of Fresenius Kidney Care
Transitional Care Units (TCUs) are separate spaces within a dialysis center with specific staff dedicated to onboarding new dialysis patients during their first weeks of treatment or supporting patients transitioning to a new dialysis treatment modality. As of the end of 2020, Fresenius Kidney Care opened more than 100 TCUs, with many more expected to open in 2021. Patients first receive emotional support to cope with their diagnosis even before being educated about their options for treatment. A TCU offers comprehensive, hands-on education on the different treatment options available for each patient. We have found that a high percentage of patients in our TCUs will ultimately choose home dialysis, which can mean fewer food restrictions, greater scheduling flexibility, less frequent transportation challenges, and better outcomes2. Many of these patients are urgent start dialysis (crash start) patients without prior chronic kidney disease (CKD) care, so TCUs give patients a smooth start into dialysis and eventually allow them to make an informed decision on their dialysis modality and transplant.
4. Removing Blood Thinners from Dialysis
Michael Anger, MD
Chief Medical Officer for the Renal Therapies Group
Eliminating the need for blood thinners in patients on dialysis would be one of the greatest changes to dialysis treatment since the single use dialyzer was introduced 20 years ago and eliminated reuse.
Anticoagulation is presently required to prevent clotting in the blood circuit during hemodialysis. Heparin is the usual blood thinner medication and comes with a set of side effects and risks.
The FDA granted breakthrough device designation in 2019 for a new system, currently in development, that aims to prevent blood clotting without the use of blood thinner medication in most patients. Endexo, a polymer that provides surface modifying molecules, is incorporated into the hollow fiber membrane of the FDA-approved Enexa dialyzer. The Enexa dialyzer is currently undergoing clinical development for use in a complete blood circuit incorporating the Endexo technology.
Eliminating use of blood thinners may help reduce risk of bleeding from anticoagulants and may help limit costly complications that can arise from their use. We are committed to continuously improving patient safety and health outcomes.
5. Improved Fluid Management
Peter Kotanko, MD, FASN
Research Director of Renal Research Institute
Fluid management is an integral component of dialysis treatment, as both too much or too little fluid can lead to adverse cardiovascular events, morbidity, and mortality. Improved awareness among physicians and monitoring technologies may lead to better outcomes for patients and more personalized care delivery3.
Crit-Line and the CLiC® device, fluid management monitoring tools that incorporate photo-optical technology, have already shown they can help better track fluid status, allowing providers to adjust treatments and reduce issues like nausea and cramping. Using data on relative blood volume (RBV) changes from the Crit-Line and CLiC®devices helps providers make adjustments timelier and more accurately.
We have developed an adaptive ultrafiltration controller that takes RBV data from the commercially available CLiC® device as an input and provides ultrafiltration rate suggestions to guide the RBV curve into the desired targets. These RBV targets are based on an observational study where 842 maintenance hemodialysis patients were followed for a median of 30.8 months4.
Last year, we presented preliminary data at the American Society of Nephrology’s Annual Kidney Week that showed promising results. That data showed this adaptive ultrafiltration controller steered patients’ RBV curves toward predefined target ranges while observing their prescribed ultrafiltration goal in approximately 63% of treatments, compared to only one-third of patients using traditional hemodialysis5.