NxStage® HHD Therapy Overview © 2010 NxStage Medical, Inc. This document is not intended to replace the NxStage System One™ ,PureFlow™ 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, PureFlow SL and Express Fluid Warmer User’s Guides and Cartridge Instructions for Use for all warnings and precautions. NxStage® is a registered trademark of NxStage Medical, Inc. System One™ and PureFlow™ are trademarks of NxStage Medical, Inc. CAUTION: Federal law restricts these devices to sale by or on the order of a physician. TM0472, Rev. B

Agenda Introduction to Home Hemodialysis Options Advantages and Challenges Successful Patient Training After listening to this presentation, you should understand basic information related to NxStage System One and ancillary equipment, short daily therapy and how to develop an initial prescription and determine adequacy. This presentation may be given over multiple sessions as time permits if desired.

First, a Look At Some of the Early Hemodialysis Technology Options

Some of the Current HHD Options Globally

In the US, Home Hemodialysis Hit a Peak in 1995

System One Enters Market and Changes the HHD Picture in the US

Why the Change?

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

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.

Why Choose Home? Lifestyle benefits Lifestyle motivators for choosing home and/or self-care dialysis3,4 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 McLauglin K, et al. Why do patients choose self-care dialysis. Oxford Journals. Nephrology Dialysis Transplantation, 2008; 23:3972-3976 4 NxStage Patient Research (data on file), 2008.

Why Choose Home? Clinical benefits Clinical benefits of more frequent hemodialysis (HD) Compared to thrice-weekly in-center hemodialysis, daily HD may offer the following clinical benefits:

Why Choose Home? Clinical benefits (cont.) Reduced left ventricular hypertrophy5 Reduced blood pressure and a decreased use of BP meds6,7 Significantly reduced post-treatment recovery time8,9 Improvements in measures of depressive symptoms9 Improved appetite and food intake10 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 S13-S17. 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; ppS30-S35.

Why Choose Home? Clinical benefits (cont.) Improvements in quality of life measures11 Improved sleep quality12 Decrease in symptoms of restless legs syndrome13 Reduced risk of death14-17 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.

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.

Home Modality Transitions Transplantation Peritoneal Dialysis 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.

Adequacy is More than Kt/V and URR Small solute clearance solute clearance Middle molecule Nutritional status Anemia Acid/base control Electrolyte and Blood pressure control Volume control Sleep quality Wellbeing / QOL Other factors to consider.

Patient Selection It is important to establish interdisciplinary team roles and responsibilities to ensure the patient and partner are given essential program information. The patient selection tools listed in subsequent slides help to delineate roles. The patient selection interdisciplinary team should include a physician, a nurse, a social worker and a dietician who evaluates the patient in relation to his/her specialty and provides the home hemodialysis coordinator with a summary of their findings identifying challenges that could affect training, require program modification or deter home therapy success. TM0234, Rev. C

Patient Selection Let’s take an overview look at the complete screening process. It is essential to determine the patient’s cognitive, psychosocial and medical suitability for home hemodialysis management. Patient Selection Tools have been developed for this purpose to facilitate consistent assessment and define roles of the multidisciplinary team. The following slides will detail the Patient Selection Tools. The screening process starts with a patient referral which can come from many sources; physician, social worker, in-center staff. The referral is the trigger that starts the screening process. This referral generally means the patient is interested in the therapy, however, they may/may not be a good candidate. The phone screening is typically completed by the Home Training Nurse to obtain baseline information about the patient’s interest in and knowledge of, home therapy. Next is the first visit to the home training clinic followed by a complete chart review and a team evaluation summary. Lastly, there is a second clinic visit to determine if the patient and care partner remain committed to home therapy. TM0234, Rev. C

Patient Selection Now that we have looked at an overview of the screening process, let’s discuss phone screening in more detail. Although at this point the patient may have very limited knowledge of home therapies, the phone screening assessment can screen for basic program requirements: i.e. does the patient have appropriate motivations for pursuing more frequent home therapy and realistic expectations, or is there a lack of knowledge regarding home therapy: training, personal responsibilities and outcomes. A patient may have an interest in home therapy but is unable/unwilling to commit to the required training. This patient is not a good candidate. Appropriate motivations may include: Better health outcomes Ability to do self-care (more control over treatment) Flexibility with treatment schedule More time with family Opportunity to travel “Heard about” better fluid control, more liberal diet, less intradialytic symptoms, better blood pressure control, more energy, better sleep etc. In addition to a basic assessment of the patient’s motivation, knowledge, expectations etc., another consideration at this time, is dialysis access. Does the patient have a working dependable access. Access problems during training are frustrating for the staff and the patient. If the access is not dependable, ask the patient to contact you again as soon as the access is working dependably. TM0234, Rev. C

Patient Selection Refer to this slide for sample nurse assessment criteria. There are similar evaluation tools for the physician, social worker and dietician. Is there anything that you would add to these assessments for your particular clinic? . TM0234, Rev. C

Patient Selection In addition to the initial clinic visit, the patient’s chart and past medical history should be reviewed to further the assessment process. If the patient is from another dialysis center, obtain a signed release of information to obtain the following information: Treatment information (last three run sheets) to provide a baseline of information. Note the anticoagulation type and dose, dry weight, intradialytic weight gain and symptoms and indicators of non-compliance. Medication list – to have a baseline for future adjustments to medication dose or route. Are there IV medications being given on dialysis that may need to be changed to oral or subcutaneous. BP medications will need to be monitored closely. Lab data (last three months) – to provide a baseline for therapy outcome measures. Note potassium, calcium, phosphorus, albumin, Carbon Dioxide adequacy. History and Physical – to provide a baseline of allergies, and any past medical disabilities and conditions which may require home training program considerations. Social History – to provide a baseline for use with the social worker interview. Dietary History – to provide a baseline used with the dietician interview. Access – Is it reliable, note the BFR, needle size and associated pressures. This affects treatment time and patient satisfaction. Is the patient self-cannulating? If not, can you schedule this prior to training? Care Plan – to provide an overall baseline of care and special considerations that may require home training program considerations. TM0234, 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 Once you have started the patient on short daily hemodialysis, it is important to monitor the patient closely.

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 Once you have started the patient on short daily hemodialysis, it is important to monitor the patient closely.

NxSTEPS™ Simple Steps to Success at Home Overview © 2011 NxStage Medical, Inc. NxStage® is a registered trademark of NxStage Medical, Inc. System One™ and PureFlow™ are trademarks of NxStage Medical, Inc. CAUTION: Federal law restricts these devices to sale by or on the order of a physician. TM0540 Rev A

Overall Goals NxSTEPS Curriculum TM0540 Rev A

NxSTEPS Home Training Nurse Goals TM0540 Rev A

Develop Curriculum and Resources TM0540 Rev A

How did we Develop the Curriculum and Resources? TM0540 Rev A

Key Design Principles Incorporated TM0540 Rev A

What is the NxSTEPS Curriculum The training curriculum content is grouped within topics (for example Prepare for Treatment) and subtopics (for example Access your Blood). Note the color coding the topic and subtopics. This coloring is consistent throughout all the NxSTEPS resources. TM0540 Rev A

Sample NxSTEPS Training Schedule Above is a sample training schedule. The topics and subtopics are listed on the left, while the “X’s” represent the newly learned concepts/ skills. Note how the “x’s” are spread out over four weeks. The schedule developed to train each patient incorporates adult learning principles by : Introducing and sequencing new learning objectives (X’s) over many weeks to avoid overwhelming the learner during one day or one week. (In general people remember seven new things, plus or minus two). Repeating newly learned skills throughout the rest of the training weeks. For example, once the learner knows how to use the System One Cycler, he / she continues to perform those skills for the remainder of the training. TM0540 Rev A

What are the Resources? The NxSTEPS curriculum uses a variety of tools and resources. The Nurse Guide direct you to these resources (flipbook, User’s Quick Reference Guide, Online Modules) to facilitate learning. Keep in mind that although these resources are intended to be used together for training the new patient, they may also be used individually as a review tor existing patients. TM0540 Rev A

what would you do?

Recent Clinical Evidence

Conclusion

FHN Study Conclusion

Conclusion

FREEDOM -12 Month Interim Results

Results of 4 Recent Surveys

What would you do?

Thank you for your time and attention

References Stress on Heart NxStage 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 NxStage 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.

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. NxStage Summary of Literature: Benefits of Daily Dialysis booklet – Section Eight: Quality of Life. Appetite/Fluid NxStage Summary of Literature: Benefits of Daily Dialysis booklet – Section Three: Fluid Overload. NxStage Summary of Literature: Benefits of Daily Dialysis booklet – Section Seven: Malnutrition. Physical and Mental Health 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.

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.

References (cont.) Energy and Vitality NxStage 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. NxStage registry data: http://www.nxstage.com/chronic_renal_care/registry/outcomes.cfm.

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.

Questions? © 2010 NxStage Medical, Inc. This document is not intended to replace the NxStage System One™ ,PureFlow™ 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, PureFlow SL and Express Fluid Warmer User’s Guides and Cartridge Instructions for Use for all warnings and precautions. NxStage® is a registered trademark of NxStage Medical, Inc. System One™ and PureFlow™ are trademarks of NxStage Medical, Inc. CAUTION: Federal law restricts these devices to sale by or on the order of a physician. TM0472, Rev. B