Nx Stage HHD Therapy Overview 2010 Nx Stage

Nx. Stage HHD Therapy Overview ® © 2010 Nx. Stage Medical, Inc. This document is not intended to replace the Nx. Stage System One™ , Pure. Flow™ SL or Express Fluid Warmer User’s Guide or Cartridge Instructions for Use. Patients, partners, and providers should review and refer to the System One, Pure. Flow SL and Express Fluid Warmer User’s Guides and Cartridge Instructions for Use for all warnings and precautions. Nx. Stage® is a registered trademark of TM 0472, Rev. B Nx. Stage Medical, Inc. System One™ and Pure. Flow™ are trademarks of Nx. Stage Medical, Inc. CAUTION: Federal law restricts these devices to sale by or on the order of a physician. TM 0472, Rev. B

Agenda § Introduction to Home Hemodialysis Options § Advantages and Challenges § Successful Patient Training TM 0472, Rev. B

TM 0472, Rev. B

TM 0472, Rev. B

TM 0472, Rev. B

TM 0472, Rev. B

TM 0472, Rev. B

TM 0472, Rev. B

Modality Decisions § End-Stage Renal Disease (ESRD) requires patients to make difficult personal choices about renal replacement therapy (RRT). Their care team plays a critical role in this process, as underscored by the 2008 CMS Conditions for Coverage. 1 1 2008 ESRD Conditions Final Rule- April 15, 2008. Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations TM 0472, Rev. B

Modality Decisions 2 U. S. Renal Data System, USRDS 2010 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States , National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2010. TM 0472, Rev. B

Why Choose Home? Lifestyle benefits Lifestyle motivators for choosing home and/or self-care dialysis 3, 4 § Ability to take control of one’s own care § Greater freedom to travel and freedom from specific time constraints § Greater ability to work and participate in “normal” life activities § Reduced need to travel to and from the dialysis center 3 Mc. Lauglin K, et al. Why do patients choose self-care dialysis. Oxford Journals. Nephrology Dialysis Transplantation, 2008; 23: 3972 -3976 4 Nx. Stage Patient Research (data on file), 2008. TM 0472, Rev. B

Why Choose Home? Clinical benefits § Clinical benefits of more frequent hemodialysis (HD) Compared to thriceweekly in-center hemodialysis, daily HD may offer the following clinical benefits: TM 0472, Rev. B

Why Choose Home? Clinical benefits (cont. ) § Reduced left ventricular hypertrophy 5 § Reduced blood pressure and a decreased use of BP meds 6, 7 § Significantly reduced post-treatment recovery time 8, 9 § Improvements in measures of depressive symptoms 9 § Improved appetite and food intake 10 5 Ayus J, et al. Effects of SDHD vs CHD on LVH and Inflammatory markers. J Am Soc Nephrol, July 2005 6 Nesrallah G, et al. Volume control and Blood Pressure Management in patients undergoing Quotidian HD. Am J Kidney Dis, 2003, Vol 42, No 1 Suppl 1 pp S 13 -S 17. 7 Jaber B, et al. Daily Hemodialysis reduces the need for anti-hypertensive medications. Abstract presented as posted at American Society of Nephrology Conference, October 31, 2008. 8 Lindsay R, et al. Minutes to recovery after a Hemodialysis session: A simple Health Related Quality of Life Question that is reliable, valid and sensitive to change. Clin J Am Soc Nephrol, July 2006. 9 Jaber B, et al. Effect of Daily Hemodialysis on Depressive Symptoms and Postdialysis Recovery Time: Interim Report From the FREEDOM(Following Rehabilitation, Economics and Everyday-Dialysis Outcome Measurements) Study. Am J Kidney Dis. 2010 Sep; 56(3): 531 -9. Epub 2010 Jul 29 10 Spanner E, et al. The impact of Quotidian Hemodialysis on Nutrition. Am J Kidney Dis, 2003 Vol 42, No 1 Supp 1; pp. S 30 -S 35. TM 0472, Rev. B

Why Choose Home? Clinical benefits (cont. ) § Improvements in quality of life measures 11 § Improved sleep quality 12 § Decrease in symptoms of restless legs syndrome 13 § Reduced risk of death 14 -17 Treating at home can make more frequent hemodialysis practical for more patients. However, home hemodialysis is not right for everyone and requires a serious commitment from patients and their care partners. They must be trained to follow the guidelines for proper system operation, as well as the patient’s dialysis prescription, which may require treatments up to six days per week. In addition, there are certain risks unique to treating in the home environment, and patients and care partners must understand when it is appropriate to seek medical or technical assistance. 11 Finkelstein F, et al. Daily home HD (DHD) improves quality of life measures, depressive symptoms and recovery time: interim results from the FREEDOM study. American Society of Nephrology. 2008; presentation at ASN 2008 Annual Congress, November 7, 2008. 12 Schiller B et al. Daily Hemodialysis (DHD) Improves Sleep Quality: Interim Results from the FREEDOM study. Abstract presentation at Annual Dialysis Conference, March 8, 2010. 13 Finkelstein F et al. Daily Hemodialysis (DHD) improves Restless Legs Syndrome (RLS): Interim results from the FREEDOM study. Abstract presentation at Annual Dialysis Conference, March 8, 2010. 14 Woods J, et al: Comparison of mortality with home hemodialysis and center hemodialysis: A national study. Kidney Int, Vol. 49 (1996), pp. 1464 -1470 15 Blagg C, et al. Comparison of survival between short-daily hemodialysis and conventional hemodialysis using the standardized mortality ratio. Hemo Int, 2006; 10: 371 -374 16 Kjellstrand C, et al Short daily haemodialysis: Survival in 415 patients treated for 1006 patient years Nephrol Dial Transplant (2008). 17 Miller, B et al. Daily hemodialysis is associated with lower than expected mortality. Abstract presented as poster at American Society of Nephrology Conference, October 29, 2009. TM 0472, Rev. B

Home Modality Transitions § ESRD is a disease state that often requires shifts in treatment modality. It is during these modality shifts that a patient’s desire to stay home may be challenged. TM 0472, Rev. B

Home Modality Transitions Transplantation Peritoneal Dialysis TM 0472, Rev. B Home Hemodialysis

Transplantation Transplant Failure: Can They Transition to HHD? § Thousands of patients return to dialysis as the result of a failed kidney transplant. 2 2 U. S. Renal Data System, USRDS 2010 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States , National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2010. TM 0472, Rev. B

Adequacy is More than Kt/V and URR Small solute clearance Middle molecule solute clearance Wellbeing / QOL Nutritional status Sleep quality ADEQUACY Anemia status Volume control Blood pressure control TM 0472, Rev. B Electrolyte and Acid/base control

Patient Selection TM 0472, Rev. B TM 0234, Rev. C

Patient Selection TM 0472, Rev. B TM 0234, Rev. C

Patient Selection TM 0472, Rev. B TM 0234, Rev. C

Patient Selection TM 0472, Rev. B TM 0234, Rev. C

Patient Selection TM 0472, Rev. B TM 0234, Rev. C

Clinical Observations – Daily Therapy § Blood pressure – Monitor blood pressure and antihypertensive medications daily, you may see changes immediately – Monitor closely until equilibrium is reached – Evaluate new dry weight with medication changes § Renal bone disease – Observe phosphorous levels as appetite increases § Acid/base – Monitor bicarbonate levels – May decrease with increased protein intake – Evaluate need to adjust lactate level TM 0472, Rev. B

Clinical Observations – Daily Therapy (cont). § Nutrition – Appetite generally increases – Diet liberalization may be indicated – Consider muscle mass may increase with rise in activity level § Anemia – Make sure rinseback fluid is CLEAR to minimize blood cell loss – May see a decrease in erythropoietin needs § Adequacy – Initial starting dose provided – In addition, assess clinical indicators of adequacy TM 0472, Rev. B

Nx. STEPS™ Simple Steps to Success at Home Overview © 2011 Nx. Stage Medical, Inc. Nx. Stage ® is a registered trademark of Nx. Stage Medical, Inc. System One™ and Pure. Flow™ are trademarks of Nx. Stage Medical, Inc. CAUTION: Federal law restricts these devices to sale by or on the order of a physician. TM 0540 Rev A TM 0472, Rev. B

Overall Goals Nx. STEPS Curriculum TM 0540 Rev A TM 0472, Rev. B

Nx. STEPS Home Training Nurse Goals TM 0540 Rev A TM 0472, Rev. B

Develop Curriculum and Resources TM 0540 Rev A TM 0472, Rev. B

How did we Develop the Curriculum and Resources? TM 0540 Rev A TM 0472, Rev. B

Key Design Principles Incorporated TM 0540 Rev A TM 0472, Rev. B

What is the Nx. STEPS Curriculum TM 0540 Rev A TM 0472, Rev. B

Sample Nx. STEPS Training Schedule TM 0540 Rev A TM 0472, Rev. B

What are the Resources? TM 0540 Rev A TM 0472, Rev. B

TM 0472, Rev. B

TM 0472, Rev. B

TM 0472, Rev. B

TM 0472, Rev. B

TM 0472, Rev. B

TM 0472, Rev. B

TM 0472, Rev. B

TM 0472, Rev. B

TM 0472, Rev. B

Thank you for your time and attention TM 0472, Rev. B

References Stress on Heart § Nx. Stage Summary of Literature: Benefits of Daily Dialysis booklet – Section One: Left Ventricular Hypertrophy. § Ayus J, et al. Effects of SDHD vs CHD on LVH and Inflammatory markers. J Am Soc Nephrol 16: 2778 -2788, 2005. § Fagugli R, et al. SDHD: Blood pressure control and LVM reduction in hypertensive HD patients. Am J Kidney Dis Vol. 38, No. 2 2001 371 -376. § Culleton B, et al. Effect of Frequent NHD vs CHD on Left Ventricular Mass and Quality of Life. JAMA 2007. Vol. 298, No. 11, 1291 -1299. Blood Pressure Control § Nx. Stage Summary of Literature: Benefits of Daily Dialysis booklet – Section Two: Hypertension. § Chan C. Cardiovascular Effects of Home Intensive Hemodialysis. Adv Chronic Kidney Dis Vol. 16, No. 3 2009 173 -178. § Kraus M, et al. A comparison of center-based vs. home-based daily hemodialysis for patients with end-stage renal disease. Hemodialysis International 2007; 11: 468 -77 § Jaber BL, et al. Daily hemodialysis (DHD) reduces the need for anti-hypertensive medications. Abstract presentation at the American Society of Nephrology 2009 Annual Congress. TM 0472, Rev. B

References (cont. ) Recovery Time § Finkelstein F, et al. Daily home HD (DHD) improves quality of life (QOL) measures, depressive symptoms and recovery time: Interim results from the FREEDOM study. Abstract presentation at the American Society of Nephrology 2008 Annual Congress. § Nx. Stage Summary of Literature: Benefits of Daily Dialysis booklet – Section Eight: Quality of Life. Appetite/Fluid § Nx. Stage Summary of Literature: Benefits of Daily Dialysis booklet – Section Three: Fluid Overload. § Nx. Stage Summary of Literature: Benefits of Daily Dialysis booklet – Section Seven: Malnutrition. Physical and Mental Health § Finkelstein F, et al. Daily home HD (DHD) improves quality of life (QOL) measures, depressive symptoms and recovery time: Interim results from the FREEDOM study. Abstract presentation at the American Society of Nephrology 2008 Annual Congress. § Mapes DL, et al. Health-related quality of life as a predictor of mortality and hospitalization: The Dialysis Outcomes and Practice Patterns Study (DOPPS). Kidney International. 2003; 64: 339 -349. § Goldfarb-Rumyantzev A, et al. A crossover study of short daily haemodialysis. Nephrol Dial Transplant. 2006. 21: 166 -175. TM 0472, Rev. B

References (cont. ) Depression § Finkelstein F, et al. Daily home HD (DHD) improves quality of life (QOL) measures, depressive symptoms and recovery time: Interim results from the FREEDOM study. Abstract presentation at the American Society of Nephrology 2008 Annual Congress. § Finkelstein F, et al. Daily hemodialysis improves depressive symptoms at 12 months of follow-up: Interim results from the FREEDOM study. Hemodialysis International. 2009; 13(1): 111. § Finkelstein F, et al. Depression and end-stage renal disease: a therapeutic challenge. Kidney International. 2008; 74: 843 -845. § Lopes AA, et al. Screening for depression in hemodialysis patients: associations with diagnosis, treatment, and outcomes in the DOPPS. Kidney International. 2004; 66: 2047 -2053. § Kimmel PL, et al. Multiple measurements of depression predict mortality in a longitudinal study of chronic hemodialysis outpatients. Kidney International. 2000; 57: 2093 -2098. § Lopes AA, et al. Depression as a predictor of mortality and hospitalization among hemodialysis patients in the United States and Europe. Kidney International. 2002; 62: 199 -207. TM 0472, Rev. B

References (cont. ) Energy and Vitality § Nx. Stage Summary of Literature: Benefits of Daily Dialysis booklet – Section Eight: Quality of Life. § Kraus M, et al. Work and Travel in a Large Short Daily Hemodialysis (SDHD) Program. Abstract presentation at the American Society of Nephrology 2007 Annual Congress. Risk of Death § U. S. Renal Data System, USRDS 2008 Annual Data Report: Atlas of Chronic Kidney Disease and End. Stage Renal Disease in the United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2008. § Bleyer A, et al. Sudden and cardiac death rates in hemodialysis patients. Kidney International. 1999; 55: 1553 -1559, Woods JD, et al. Comparison of mortality with home hemodialysis and center hemodialysis: a national study. Kidney International. 1996; 49: 1464 -1470. § Blagg CR, et al. Comparison of survival between short-daily hemodialysis and conventional hemodialysis using the standardized mortality ratio. Hemodialysis International. 2006; 10: 371 -374. § Agar J, et al. Comparing the relative survival of an Australian nocturnal home HD cohort with a matched USRDS conventional HD cohort using Standardized Mortality Ratios. Abstract presentation at the American Society of Nephrology 2007 Annual Congress presented at ASN 2007 Annual Congress, October 31, 2007. § Kjellstrand C, et al. Short daily hemodialysis: survival in 415 patients treated for 1006 patient-years. Nephrol Dial Transplant. 2008; 23: 3283 -3289. § Nx. Stage registry data: http: //www. nxstage. com/chronic_renal_care/registry/outcomes. cfm. TM 0472, Rev. B

References (cont. ) Improved Sleep Quality § Schiller, B et al. Daily Hemodialysis (DHD) Improves Sleep Quality: Interim Results from the FREEDOM study. Abstract presentation at Annual Dialysis Conference march 8, 2010. Improved Restless Legs Syndrome § Finkelstein F, et al. Daily Hemodialysis (DHD) improves Restless Legs Syndrome (RLS): Interim results from the FREEDOM study. Abstract presentation at Annual Dialysis Conference, March 8, 2010. TM 0472, Rev. B

Questions? 439 South Union Street, Lawrence, MA 01843 www. nxstage. com tel: 978 -687 -4700 © 2010 Nx. Stage Medical, Inc. This document is not intended to replace the Nx. Stage System One™ , Pure. Flow™ SL or Express Fluid Warmer User’s Guide or Cartridge Instructions for Use. Patients, partners, and providers should review and refer to the System One, Pure. Flow SL and Express Fluid Warmer User’s Guides and Cartridge Instructions for Use for all warnings and precautions. Nx. Stage® is a registered trademark of Nx. Stage Medical, Inc. System One™ and Pure. Flow™ are trademarks of Nx. Stage Medical, Inc. CAUTION: Federal law restricts these devices to sale by or on the order of a physician. TM 0472, Rev. B