Cardio Renal (EN) – CHRONIC DISEASE PRECISION MEDICINE

Potassium Imbalance in Chronic Kidney Disease (CKD)

The Huge Burden of Potassium in CKD

Potassium imbalance has long been recognised as a potential “silent killer”, as it can be asymptomatic and can cause abnormal heart rhythms and sudden death¹.

40-50% of Chronic Kidney Disease (CKD) patients suffer from hyperkalemia (serum potassium level above the normal range), compared to 2-3% in the general population².
Dyskalemia (serum potassium level above or below the normal range) is associated with higher risk of mortality in CKD patient, which is 2-7 times higher than in general population³.
Developed countries spend more than 2–3% of their health care budgets on End Stage Kidney Disease treatment therapy⁴.
Hyperkalemia contributes to high healthcare utilization and costs, primarily driven by inpatient care and dialysis costs⁵.

CardioRenal solution

CardioRenal breakthrough solution is a connected device that is intended to allow frequent self blood potassium quantitative measurement by the patient at home:

The procedure is minimally invasive, and the results are available in less than 5 minutes.
The device is easy-to-use and connected to the cloud allowing treating physicians to access patient data whenever they want.

Product under development not approved for sales

Why is it a challenge to manage potassium in CKD patients?

Dyskalemia occurs frequently in CKD patients as it is a common secondary effect of CKD medical treatment (RAASi, diuretics). While renin-angiotensin-aldosterone system inhibitors (RAASi) drugs are beneficial for these patients, they are also the most prominent cause of hyperkalaemia².

CKD patients with hyperkalaemia risks are also recommended to have a low potassium diet, meaning low intake of healthy food such as fruits, vegetables... This diet regimen may deprive patients from the beneficial effects of potassium-rich diets, leading to malnutrition and poor quality of life⁶.

What are the consequences?

The Life-saving drugs RAASi are generally under-dosed or discontinued by physiscians because of fears for hyperkalemia. The sub-optimal dose is associated with higher adverse outcomes, including CKD progression and progression to End Stage Renal Disease, and mortality⁷.

	Patient (%)	Patient with mortality (%)
At optimal dose	19-26	4.1
At suboptimal dose	58-65	8.2
Discontinued	14-16	11

Why is Potassium monitoring an immense unmet need ?

What Clinicians would like:

Monitoring strategies and measurement methods allowing more frequent potassium testing⁶.

Strategies that can maintain the use of beneficial medications (i.e. RAASi) while controlling potassium balance².

Methods that can evaluate the impact of dietary potassium on serum concentration in people with CKD⁶.

What patients say about Potassium monitoring:

“A trustable home potassium test, because I have very unstable potassium levels and have to control my potassium at the hospital several times a week”.

“Are there any new developments in the home potassium meters? It gets very frustrating having to wait for blood work to come back in order for the Doctor to give me an IV potassium drip”.

“I am very interested in a home potassium meter/test. Monthly we have to get his blood work done. Having a test for home use would be incredibly helpful to see when he is starting to get high again. Kidney failure patients, and heart failure patients definitely have a need for it” .

What if we could improve potassium management thanks to frequent minimally invasive measurement of blood potassium ?

By allowing more frequent potassium measurement by the patients, physicians migth have a clearer view of their patient clinical status and optimize their drug treatment.

Product under development not approved for sales

References:

1. Weiner & Wingo. Hyperkalemia: a potential silent killer. J Am Soc Nephrol 9:1533-1543, 1998

2. Kovesdy et al. Management of hyperkalaemia in chronic kidney disease. Nat Rev Nephrol. 2014 Sep 16.

3. Collins AJ et al. Association of Serum Potassium With All-Cause Mortality in Patients With and Without Heart Failure, Chronic Kidney Disease, and/or Diabetes. Am J Nephrol. 2017;46:213-21

4. WHO, Global burden of kidney disease

5. Desai et al. The Economic Implications of Hyperkalemia in a Medicaid Managed Care Population. Am Health Drug Benefits. 2019;12(7):352-361

6. Clase et al. Potassium homeostasis and management of dyskalemia in kidney disease: conclusions from a Kidney Disease: Improving Global Outcomes (KDIGO) Controversies Conference. Kidney Int (2020) 97, 42-61

7. Epstein et al. Evaluation of the treatment gap between clinical guidelines and the utilization of renin-angiotension-aldosterone system inhibitors. Am J Manag Care. 2015: S212-20

Heart failure management

The Huge Burden Of Heart Failure Disease

After discharge from a Heart Failure hospitalization, patients are at an unacceptably high risk of recurrent hospitalizations or death.

One major origin of post discharge events is the residual patient congestion that is not optimally alleviated at discharge.¹
In fact, many patients leave hospital before their diuretic therapy is optimized.
Another important fact is that patients are discharged before lifesaving renin angiotensin antagonists and mineralocorticoid receptor antagonists could be optimized to reach the highest tolerable doses.²

Cardiorenal solution

Optimizing heart failure patient treatment at home by using:

Microfluidics
Artificial Intelligence
Data analysis

Guidelines recommend optimizing pharmacotherapy to improve outcomes for patients with heart failure _{(grade 1, level of evidence A)}

Optimizing medications belonging to the RAAS inhibitor class (ACE-Is, ARBs and MRAs) have been proven to improve survival and reduce hospitalizations in patients with heart failure.² In addition, optimizing diuretics reduces volume overload, eases the signs and symptoms of pulmonary congestion and keeps patients out of hospital.²

Then why are these life-saving medication often under-utilized and under-dosed ?

The concerns for raising serum potassium levels, worsening renal function, or inadequate decongestion limit the way these medicines are utilized and dosed.³ Complicating the management of patients with heart failure is the fact that physicians do not have simple, patient-friendly tools to easily keep track of these issues with their patients at home.

So, what is the expressed need here?

We know that optimizing care through disease management programs improves outcomes in patients with heart failure. Up until recently, the focus has been on monitoring pulmonary congestion so that physicians can optimize diuretic doses and reduce admissions.⁴
But this is only part of the solution ... We also need to be monitoring serum potassium and renal function so that physicians can optimize not just the dose of a diuretic, but also optimize doses of ACE-I, ARB or MRA. With such a complete view of the status of their HF patient overtime, physicians would feel safe and confident so as to optimize medication precisely to each patient status.

What if we could ...

If there was a way to reliably, simply and cost-effectively monitor serum potassium, renal function and the degree of congestion in our heart failure patients at home, could we then optimize the use of these life-saving medicines? With a more comprehensive approach like this, we may be able to reduce not just hospital readmissions, but we may also be able to improve the quality of life and survival of HF patients.

References:

Coiro S et al , Prognostic value of residual pulmonary congestion at discharge assessed by lung ultrasound imaging in heart failure. Eur J Heart Fail 2015;17:1172–1181.

2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure , European Heart Journal (2016) 37, 2129–2200

Epstein M et al , Evaluation of the gap between guidelines and the utilization of RAAS Inhibitors; Am J of Managed Care, 2015, 21, S212-S220

Abraham W et al , Wireless pulmonary artery hemodynamic monitoring in chronic heart failure: a randomized controlled trial; Lancet 2011; 377: 658–66