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Commentary: Critical Elements for a Bright Future in Renal Replacement Therapy

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“Let’s start with a simple, tragic fact. Kidney failure affects far too many people. For the vast majority of human history, this meant a steady, irreversible buildup of fluids and toxins leading to an inevitable death. This is no longer the case today. Thanks to the pioneering efforts of scientists over the past 150+ years, millions of people worldwide are able to continue living with regular dialysis, and others—though far too few—receive transplants.

The story of how we’ve been able to get here, and the inflection point that the kidney disease care paradigm finds itself in today, is a testament not only to the innate desire within us to heal and alleviate suffering, but to the critical elements of curiosity, ingenuity and perseverance that are once again needed today, to recalibrate in a patient-focused way.”

Read full article, here.

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New Generation Artificial Heart Implanted in Patient at Duke – First in U.S.

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 “A surgical team at Duke University Hospital, led by Drs. Jacob Schroder and Carmelo Milano, successfully implanted a new-generation artificial heart in a 39-year-old man with heart failure, becoming the first center in North America to perform the procedure. 

The artificial heart was developed by CARMAT and has been studied in Europe, where it is approved for use. Last year, the company received FDA approval to begin studies in the U.S. to potentially enroll 10 patients with end-stage biventricular heart failure. The study will evaluate whether the artificial heart is a viable option as a life-saving step before transplant.”

Read more, here.

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Antibody Response After a Third Dose of the Vaccine in Kidney Transplant Recipients With Minimal Serologic Response to 2 Doses

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“Studies have reported low seroconversion rates (58% after the second dose) in solid organ transplant recipients who received a messenger RNA (mRNA) SARS-CoV-2 vaccine.1,2 Based on this evidence, the French National Authority for Health issued a recommendation in April 2021 to administer a third vaccine dose in immunosuppressed patients who did not respond after 2 doses. We examined the antibody responses of kidney transplant recipients who did not respond to 2 doses and received a third dose (100 μg) of the mRNA-1273 vaccine (Moderna).

Methods

All kidney transplant recipients followed up in the outpatient Kidney Transplantation Department of Strasbourg University Hospital between January 20, 2021, and June 3, 2021, with a negative history for COVID-19 and SARS-CoV-2 antispike IgG levels less than 50 arbitrary units (AU)/mL on the day of the first vaccine injection and 1 month after the second dose were included. All patients received a third vaccine dose between April 9, 2021, and May 12, 2021. The study protocol was approved by the local ethics committee and written informed consent was obtained.”

Learn more, here.

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FDA advisory committee unanimously agrees donor liver portable system is safe, effective

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“The FDA’s Gastroenterology and Urology Devices Panel, Medical Devices Advisory Committee voted unanimously that a portable system for near-normothermic continuous perfusion of donor livers with perfusate was safe and effective.

The system will be prepared by hospital pharmacy and include compatible packed red blood cells.

The panel addressed three questions related to the premarket approval of the device Organ Care System Liver System (TransMedics). The entire 14-member panel voted that the device is safe, all voted that the device is effective and voted 12 to 1 with 1 abstaining that the benefits of the OCS Liver System outweigh the risks.”

Read more, here.

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Even Dialysis Patients Can Maintain COVID Antibodies for Months

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“The vast majority of dialysis patients infected with COVID-19 maintained antibodies for at least 6 months, a new study found.

In a prospective analysis of over 2,000 adults on dialysis, 93% of seroprevalent patients reached an assay detectable response — a SARS-CoV-2 receptor-binding domain (RBD) IgG index value of 1 or higher — and maintained this level throughout a 6-month follow-up, reported Shuchi Anand, MD, of Stanford University in California, and colleagues.

On top of that, 60% of patients had IgG index values of 10 or greater — classified as high — the group wrote in Annals of Internal Medicine. Of these patients, 76% maintained this antibody level throughout the 6-month follow-up.”

Read more, here.

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Safety Concerns Turn FDA Panel Thumbs Down for Novel CKD-Anemia Drug

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An FDA advisory committee almost unanimously agreed that the risks were just too high for the chronic kidney disease (CKD)-related anemia drug roxadustat in any patient population.

In a 13-1 vote Thursday, members of the Cardiovascular and Renal Drugs Advisory Committee felt that although there’s an unmet need for new anemia therapeutics, this particular drug carried too strong of a safety signal for thrombotic risk in a non-dialysis dependent patient population.

Read more, here.

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How Does Phosphate Binder Type Affect the Heart in Hemodialysis?

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“Trial compared calcium-based vs non-calcium-based binders.

Non-calcium-based phosphate binders weren’t any better at reducing cardiovascular events than calcium-based binders in dialysis patients, the LANDMARK trial determined.

In the open-label randomized trial of over 2,300 Japanese patients on hemodialysis, there were no significant differences in composite cardiovascular events between the lanthanum carbonate group versus the calcium carbonate group (HR 1.11, 95% CI 0.88-1.41, P=0.37), reported Hiroaki Ogata, MD, of Showa University Northern Yokohama Hospital in Kanagawa, Japan, and colleagues.”

Read more, here.

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Heart, Death Risks Linked With CKD-Related Iron Deficiency

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Regardless of anemia, iron deficiency in patients with late-stage chronic kidney disease (CKD) was linked with adverse health outcomes, an observational study found.

In 5,145 patients with stage 3-5 CKD not on dialysis, a transferrin saturation (TSAT) of 15% or less was associated with a higher risk for all-cause mortality before reaching dialysis or kidney transplant, as compared to TSAT levels of 26-35% (HR 1.44, 95% CI 1.03-2.01), according to Roberto Pecoits-Filho, MD, PhD, of the Arbor Research Collaborative for Health in Ann Arbor, Michigan, and colleagues.

Read more, here.

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MAYO CLINIC STUDY EXPANDS CRITERIA TO BE A LIVING KIDNEY DONOR

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Mayo Clinic says the pool of people who can be living kidney donors has expanded following the results of a recent study. Doctors say the results can help save more lives.

Previously transplant physicians were concerned about transplanting kidneys from patients with high blood pressure because of the possible long-term health impacts to them while living with just one kidney.

The study from Mayo Clinic included more than 100 patients and was conducted over 20 years. Dr. Mark Stegall, the Professor of Surgery at Mayo Clinic Rochester, says researchers found certain individuals with controlled hypertension can safely donate a kidney.

Read more, here.

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What Evidence Do We Need to Move Forward With COVID Boosters?

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“More data and an evaluation of several factors at home and abroad are key.

On Monday, employees of Pfizer met with high level executives in the Biden administration to discuss the role of boosters — a.k.a. a third vaccination with an mRNA vaccine for SARS-CoV-2. Some have speculated that, as with the first two doses, the emergency use authorization pathway will again be used to market boosters. With the rise of the Delta variant and others, enthusiasm in the media and the Twitter commentariat for boosters is growing. However, there are certain criteria that must be met before we jump on the booster bandwagon. Some of these criteria apply at home, and others apply abroad.”

Learn more, here.

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