Novel fluid replacement and balance system featured in two presentations at Devices in Heart Failure Congress
RenalGuard Solutions Inc. reported positive results from a first-in-man feasibility study focusing on a novel use of the RenalGuard System to manage fluids during diuretic therapy in congestive heart failure patients suffering from fluid overload. The results were recently presented at the annual Devices in Heart Failure (D-HF) Congress, Dec. 15-16 in Berlin, Germany, by Prof. Piotr Ponikowski, M.D., of the Wroclaw Medical University, Poland, and Prof. Felix Mahfoud, M.D., of the Saarland University Hospital, Homburg, Germany.
The presentation reviewed the ways in which current treatment strategies for hospitalized patients with heart failure remain inadequate. Annual hospitalizations for heart failure exceed 1 million in both the United States and Europe, and more than 90 percent are due to symptoms and signs of fluid overload. Recurrent fluid overload in heart failure patients has uniformly been associated with worse outcomes independent of age and renal function; 25 percent of hospitalized patients will be re-hospitalized within three months, with a one-year mortality rate of 26 percent.
The presenters also identified the drawbacks of diuretic therapy, the cornerstone therapy for fluid overload, which acts primarily by inducing fluid loss. An individual patient’s response to diuretic therapy is often variable and unpredictable. If the patient sees excessive urine output due to the diuretic, this rapid fluid loss can induce a condition termed “diuretic resistance,” which blunts the continued function of diuretics and may result in acute kidney injury.
Originally developed for the treatment of contrast-induced acute kidney injury (CI-AKI), RenalGuard Therapy offers a potential solution to improve the impact of diuretic therapy in the treatment of fluid overload in heart failure patients. The results presented at D-HF followed the treatment of 10 diuretic resistant patients with heart failure symptoms receiving diuretic therapy while their fluid management was controlled by the RenalGuard System.
“None of the patients we treated experienced a fluid loss rate greater than the settings we established,” said Ponikowski, who also serves as the Chairman of the European Society of Cardiology 2016 Heart Failure Guidelines Committee. “RenalGuard Therapy is remarkably simple and safe, and works automatically to carefully achieve and control the desired fluid balance.”
The RenalGuard System measures the patient’s urine output, then infuses a volume of saline to maintain the desired fluid balance. The clinician can set a maximum fluid loss rate, beyond which RenalGuard will not allow the patient’s fluid balance to drop, thus limiting the potential of excessive fluid loss. This may allow clinicians to increase the dose of diuretic without increasing the risk of diuretic resistance.
“There is a clear unmet clinical need for alternative methods of fluid removal with superior efficacy in patients with heart failure. This first-in-man study demonstrated that RenalGuard can safely be used in these patients while maintaining the proper conditions to both prevent diuretic resistance, and increase the removal of excess fluid from the patient,” said Mahfoud. “Our initial experience with the RenalGuard System in heart failure patients is very promising, and we look forward to advancing our understanding of the benefits of this therapy to patients at risk.”
The RenalGuard System is CE-marked and commercially available in Europe. A pivotal study is underway in the United States to support a planned premarket approval (PMA) filing with the U.S. Food and Drug Administration (FDA) in 2018 for the prevention of CI-AKI.
Researchers at the University of Oxford have developed a new type of MRI scan to predict the risk of having a stroke, thanks to funding from the British Heart Foundation (BHF).
The non-invasive technique, described in a paper published in the journal JACC: Cardiovascular Imaging, produces a quantitative result that can accurately indicate whether plaques in the carotid arteries – those that supply the brain with blood - are rich in cholesterol, and therefore more likely to cause a stroke.
The rupture of fatty plaques can block the arteries and cause potentially debilitating and life-threatening strokes as the brain is starved of oxygen.
At present, the risk of stroke is measured by the size of the plaque in the carotid artery. If the plaque is deemed to be too big, people are treated surgically to remove it. However, this method can miss fatty plaques that are not big, but have a high risk of rupturing.
The new MRI technique was developed to differentiate between the risky plaques that contain a lot of cholesterol, and those that are more stable.
In the study, the researchers used the new MRI scan to measure the amount of cholesterol in the carotid plaques of 26 patients scheduled for surgery. After the plaques were surgically removed, the team looked at the actual cholesterol content in each plaque and found that the new technique was accurate and the more cholesterol they detected within the plaque, the greater the risk.
The work was a collaboration between researchers at the University of Oxford and surgeons working within the John Radcliffe Hospital and was supported by the BHF Centre of Research Excellence in Oxford and the NIHR Oxford Biomedical Research Centre.
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Potential for genetic diseases, like Down’s Syndrome, Edwards Syndrome, and Patau Syndrome can cause a great deal of stress, especially due to the vague and uncertain results of present tests. Now a novel diagnostic has been developed that will measure the fetal DNA in the mother’s blood at 10 weeks, when 10% of the DNA in the blood belongs to the fetus. Studies show that the DNA testing dramatically decreased the false positives for Down and Edwards syndromes, while increasing the rate of a correct prediction by 10 and 5 times respectively. All cases of aneuploidy were detected.
In 2016, companies reemerged to reveal how a couple of new medications were dropping the rates in the double digits. The first drug, empagliflozin, was approved in 2014 as a prescription medication to improve glycemic control. A study of the drug’s benefits in 2015 yielded significant results: patients showed reduction in non-fatal heart attack or non-fatal stroke by 14 percent when added to standard of care. This showed to reduce CV death by 38% and all mortality by 32%. This past June, the FDA Advisory Committee recommended the approval of the cardiovascular indication of empagliflozin. In the same month, liraglutide, an injected medicine approved in 2010, also showed a marked reduction in major CV events by 13% in CV death by 22%, and all mortality by 15%.
When it comes to life-saving potential and market opportunities, it turns out the gut is a gold mine. The FDA has begun reviewing targeted prevention products, including protective microbial colonies for oral disease. Meanwhile, therapeutics and diagnostics companies are targeting diseases ranging from C. difficile gastroenteritis, inflammatory bowel disease, and irritable bowel syndrome to acne, and diabetes, and cancer. The cancer efforts are centering around the ability to use bacteria to starve out tumors by competing for the same nutrients, as well as the ability for bacteria to activate the immune system to fight off tumor cells on their own.
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