MAKE- D

Dr. Punit Gupta MBBS,MD,DM, PhD, MBA FISN, FISP

Spectrum of CKD• Chronic kidney disease (CKD) is a global threat to health

in general and for developing countries in particular, because therapy is expensive and life-long.

• In the United States, the prevalence of end-stage renal disease (ESRD) is increasing . The number of patients enrolled in the ESRD Medicare-funded program has increased from approximately 10,000 beneficiaries in 1973 to 615,899 as of December 31, 2011 .[Parker F, et al and Xue JL,Louis TA et al]

• Patients with ESRD consume a disproportionate share of healthcare resources. The total cost of the ESRD program in the US was approximately $49.3 billion in 2011.

• Medicare costs per person per year were more than $75,000 overall, ranging from $32,922 for transplant patients to $87,945 for those receiving hemodialysis therapy [Parker F, Blantz R, Hostetter T et al].

• However, despite the magnitude of the resources committed to the treatment of ESRD and the substantial improvements in the quality of dialysis therapy, these patients continue to experience significant mortality and morbidity and a reduced quality of life.

• Incidence of CKD has doubled in the last 15 years. In the USA, 30 million people suffer from CKD and by 2010 >600 ∼000 patients will require renal replacement therapy, costing US$28 billion.

?India : Expecting

1,000,000 in 5 years

China Expecting 1,000,000 in 3 years?

USA:> 500,000(currently)

>2,000,000 Patients

world wide?The World Cannot Afford ESRD

ESRD in the WorldA ballooning Problem…….

Spectrum of CKD in United States• Kidney disease is the 8TH leading cause of death in the

United States.• An estimated 31 million people in the United States

(10% of the population) have chronic kidney disease (CKD).

• 9 out of 10 people who have stage 3 CKD (moderately decreased kidney function) do not know it.

• CKD is more common among women, but men with CKD are 50% more likely than women to progress to kidney failure (also called end-stage renal disease or ESRD).

• Some racial and ethnic groups are at greater risk for kidney failure.

• Relative to whites, the risk for African Americans is 3.8 times higher, Native Americans is 2 times higher, Asians is 1.3 times higher, and Hispanics also have increased risk, relative to non-Hispanics.

Carcinoma of the Breast24%

End Stage Renal Disease12- 20%

Carcinoma of the Colon17.4%

Mortality

Spectrum of CKD in India• The chronic diseases account for 60% of all deaths

worldwide. Eighty percentage of chronic disease deaths worldwide occur in low- and middle-income countries.

• Approximate prevalence of CKD- 800/ million population.• In India incidence of ESRD is 150-200/ million population.• In India, the projected number of deaths due to chronic

disease was around 5.21 million in 2008 and is expected to rise to 7.63 million in 2020 (66.7% of all deaths).

• In India, the average prevalence values for treated ESRD (not diagnosed ESRD); dialysis and transplant patients were 70, 60 and 10 ppm, respectively. This number is increasing globally at a rate of 7% every year.

• The health cost of treating a patient on HD (dialysis + erythropoietin + medications) in India is around Rupees 9,000–10,000 per month in subsidized dialysis units and between ` 20,000 and 30,000 in private hospitals in the metros.

• The availability of RRT is limited in India, which has approximately 400 dialysis units with 1000 dialysis stations with the majority being in the private sector.

• The government sector cannot afford to provide maintenance dialysis, and it runs only pre transplant dialysis units. CAPD is not practiced widely because of its exorbitant cost and reluctance of patients to perform it at home

• Treatment of ESRD in India is a low priority for cost strapped public hospitals and in the absence of health insurance plans, less than 10% of all patients receive any kind of renal replacement. India is a poor country with per capita income of $460/yr.

• Only 2.2% earn above $1000/year, and 23% of our population exists below poverty line earning less than $100/year. Our government spends only $9 per capita on health.

• The cost of HD (Hemodialysis) session in India ranges from $20 to $40 including the cost of disposables. The cost of arterio venous fistula surgery is $150 and of erythropoietin $400/month. As a result only 30% HD patients receive erythro poietin therapy.

• India currently has- - 820+ nephrologists - 710+ hemodialysis units with 2,500+ dialysis stations. • Cost of- - Single hemodialysis varies between USD 15 and 40 - Additional cost of erythropoietin being USD 150- 200/ month.

• In 2009, overall Medicare expenditures for people with CKD totalled $33.8 billion, of that total, expenditures for people with CKD and diabetes accounted for $18 billion.

• The savings to Medicare for each kidney disease patient who does not progress on to dialysis is estimated to be $250,000.

• In 2009, Medicare spent $29 billion (6.7% of its total budget) on kidney failure.

• Treatment costs to Medicare per patient, per year in 2009 were:• $82,285 for hemodialysis patients• $61,588 for peritoneal dialysis patients• $29,983 for transplant patients*

INTRODUCTION- Dialysis machines are far from perfect. Their

efficiency is only around 10% of that of a functioning kidney, and when used three times per week, they are incapable of controlling unhealthy fluctuations in the concentrations of metabolites such as urea in the blood.

End stage kidney disease is a global public health problem with an estimated 2.4 million patients on dialysis. The number of new cases is rising (7-8% annually) due to population ageing and increased diabetes prevalence.

MAKE –D :- The Mobile Artificial Kidney Extended Devices,

also known as the MAKE-D, is a miniaturized dialysis device that can be worn like a jacket bag.

It connects to a patient via a catheter. Like more sizable dialysis machines, it is designed to filter the blood of people whose kidneys are no longer working.

Unlike current portable or stationary dialysis machines, it runs continuously on batteries and is not plugged into an electrical outlet or attached to a large water pipeline.

ADVANTAGE OF THE PROJECT –

• One reason for developing the device is to allow patients more mobility during a dialysis session and With present-day dialysis treatment, patients are tethered to a cumbersome machine.

• Another reason the researchers entered this device-development field is because they were concerned about the lack of progress in treating patients with end-stage renal disease. People with this condition have a relatively poor quality of life and a high mortality rate.

Difference From Old Dialysis Machine- To mention a few of many differences:

• Hemodialysis is now delivered with equipment that is much larger than MAKE-D.

• No other machines run on batteries and all of them require an abundant amount of fresh water- about 40 gallons per treatment .As a consequence, the patient is tethered to the equipment and cannot walk around or move too much.

• All existing equipments run intermittently for about few hours only each time. The MAKE- D will work continuously. It operates on batteries and takes about a pint of water a day.

These features will allow patients to walk , go out for shopping, work or do errands in other words be active instead of confined during the dialysis session.

• The MAKE- D works continuously and slowly to remove fluids from the body at the same pace as healthy kidney do naturally.

• Experimental Phase-a) Lab study- For the MAKE-D experimental study, blood

was collected from blood bank which will be passed through artificial kidney i.e. dialyzer through special size prepared tubing through the MAKE –D Device.

This blood was mixed with different chemicals to make it blood of renal failure.

• Lab study- MAKE-D-

i. Number of study – 28ii. Mean creatinine value pre-procedure-iii. Mean creatinine value post-procedure-iv. Mean urea value pre- procedure-v. Mean urea value post- procedure-vi. Mean sodium value pre- procedure-vii. Mean sodium value post- procedure-viii. Mean potassium value pre- procedure-ix. Mean potassium value post- procedure-

x. Mean phosphate value pre- procedure-xi. Mean phosphate value post- procedure-xii. Mean Kt/v -xii. Mean Urea Reduction Ratio-

.

• Animal study MAKE- D-

After taking all the permissions from Ethical Committee, animal study for dialysis by MAKE- D was done on dogs.

For the experimental study twelve Mogrel dogs were taken.

In the above study, both pre-procedure and post- procedure hematological and biochemical parameters were done to access the severity of disease.

• Animal study- MAKE-D-

i. Number of study – 12ii. Mean creatinine value pre-procedure-iii. Mean creatinine value post-procedure-iv. Mean urea value pre- procedure-v. Mean urea value post- procedure-vi. Mean sodium value pre- procedure-vii. Mean sodium value post- procedure-viii. Mean potassium value pre- procedure-ix. Mean potassium value post- procedure-

x. Mean phosphate value pre- procedure-xi. Mean phosphate value post- procedure-xii. Mean Kt/v -xii. Mean Urea Reduction Ratio-

• No hemodynamic change(steady BP and HR)• No Hemolysis• No Electrolytes or Acid base changes

Longer and more frequent dialysis is unfeasible for most patients

NOWHERE TO DO IT! -Society cannot keep building dialysis units. -Home market limited and yet to gain wide acceptance. Nobody to do it! -There are not enough nurses and technicians.• Patients wants freedom to have a life beyond being

attached to a big machine for hours on end.

Daily Hemodialysis, the promise…Improved quality and length of life

• Improved volume control.

• No sodium retention.• Less hypertension• No hyperkalemia.• No hyperphosphatemia.• No metabolic acidosis.• Improved serum

albumin.

• Improved sleep patterns.• Eliminate need for

phosphate binders.• Improved appetite and

nutrition.• Decrease need for BP

drugs.• Less LVH.• Decreased morbidity and

mortalityBut….Increased vascular surgical interventions

• Expected Impact of the MAKE-D on Dialysis PatientsProblem Hypothetical Solution Expected Impact

Malnutrition and lack of appetite

No food restrictions including salt, potassium and phosphorus

Fluid overload Steady removal of fluid prevents edema of lungs, legs and bloating

No hospitalization for pulmonary edema and fluid overload?

Anemia Less inflammation. Less red cell loss, better nutrition

Reduced Epogen utilization. Reduced iron infusion?

Bone disease No hyperphosphatemia. Less Hyperparathyroidism?

Phosphate binders obsolete. Less Cinacalcet?

Problem Hypothetical Solution Expected Impact

Hypertension No fluid or sodium accumulation

Decreased need for antihypertensive drugs?

Hypotensive episodes

Physiological removal rate of fluid. No blunt blood pressure drops.

No saline infusions during dialysis?

Heart disease Less hypertension. Steady electrolytes. Less arrythmias and sudden deaths?

Decrease hospitalization and drug utilization?

Cerebrovascular events

Less inflammation? Better control of blood pressure?

Decrease hospitalization, rehabilitation and drug