Advancing dialysis.org recent findings better management of volume with intensive hemodialysis

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1. AdvancingDialysis.org Better Management of Volume with Intensive Hemodialysis STRIKING A BALANCE: HYPERVOLEMIA AND HYPOVOLEMIA MANAGEMENT 2. AdvancingDialysis.org…
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  • 1. AdvancingDialysis.org Better Management of Volume with Intensive Hemodialysis STRIKING A BALANCE: HYPERVOLEMIA AND HYPOVOLEMIA MANAGEMENT
  • 2. AdvancingDialysis.org Challenges of Managing Fluid During and Between Standard Hemodialysis Sessions • Constraint imposed by standard hemodialysis schedule: ‒ 3 sessions per week for a total of 11 treatment hours ‒ Allows three interdialytic gaps • 2 gaps of approximately 48 hours each • 1 gap of approximately 72 hours • Fluid accumulates during these gaps, particularly in the extracellular space, putting stress on the heart • Presents challenges to interventional strategies given ultrafiltration protocols ‒ Set ultrafiltration rate to remove necessary volume to during set treatment time ‒ Remove as much volume as possible within a set ultrafiltration rate limit
  • 3. AdvancingDialysis.org Approximately 4 in 5 dialysis patients have diagnoses of diabetes, heart failure, or cardiac arrhythmia. CARDIAC ARRHYTHMIA HEART FAILURE DIABETES PREVALENCE & HAZARD RATIO 14% HR = 3.2 5% HR = 2.0 16% HR = 5.0 5% HR = 3.6 7% HR = 2.5 4% HR = 1.9 27% HR = 1.7 21% HR = 1.0 Any 1 of 3 conditions: 1.7–2.0 times higher risk of CV death Any 2 of 3 conditions: 2.5–3.6 times higher risk of CV death All 3 conditions: 5.0 times higher risk Dialysis is Associated with Pressure, Volume and Heart-related Morbidity1 1Special data analyses: 2016 USRDS ESRD Database and Medicare claims data.
  • 4. AdvancingDialysis.org Changes in Volume Status Over 1-WEEK DURING STANDARD HEMODIALYSIS Volume status over 1-week during thrice weekly dialysis. The oscillation of fluid volume status reflects IDWG and dialytic ultrafiltration. Dry weight is approximated by the postdialysis weight which, however, is often not the optimal fluid volume status.1 1Ohashi Y et al. Dry weight targeting: The art and science of conventional hemodialysis. Seminars in Dialysis, Volume: 31, Issue: 6, Pages: 551-556.
  • 5. AdvancingDialysis.org Unmet Need in the Causal Path of Heart Disease in Dialysis 1Rocco MV, Burkart JM. Prevalence of missed treatments and early sign-offs in hemodialysis patients. J Am Soc Nephrol. 1993 Nov;4(5):1178-83. Fluid Overload Uncontrolled Hypertension Left Ventricular Hypertrophy Heart Failure Hospitalization and Death Early Sign-Offs and No-Shows1 High Ultrafiltration Rate Intradialytic Hypotension Cramping, Dizziness, Nausea, etc. Long Post- Dialysis Recovery Time Poor HRQoL Cardiac & organ system Stunning Limits Use of Cardioprotective Medicines Driven by interdialytic volume issues
  • 6. AdvancingDialysis.org Normal Systolic Pressure RVSP Elevated Right Heart Pressures PATTERNS IN PATIENTS UNDERGOING STANDARD HEMODIALYSIS1 1Kjellström B, Braunschweig F, Löfberg E, Fux T, Grandjean PA, Linde C. Changesin right ventricular pressures between hemodialysis sessions recorded by animplantable hemodynamic monitor. Am J Cardiol. 2009 Jan 1;103(1):119-23 Volume loading creates markedly abnormal cardiac pressure. The loading between treatments create high wall stresses, LVH, and systolic and diastolic dysfunction.
  • 7. AdvancingDialysis.org Clinically Significant Arrhythmias PATTERNS IN PATIENTS UNDERGOING STANDARD HEMODIALYSIS1 • Highest during the first hemodialysis session of the week • 2nd highest during the final 12 hours of the long interdialytic gap • 3rd highest during the 12 hours immediately following the first session of the week • Meaningfully elevated during the final 12 hours of each of the short interdialytic gaps 1Roy-Chaudhury, P., et al. Primary outcomes of the Monitoring in Dialysis Study indicate that clinically significant arrhythmias are common in hemodialysis patients and related to dialytic cycle. Kidney Int. 2018;93:941–951.
  • 8. AdvancingDialysis.org Long Interdialytic Interval is Problematic HOSPITALIZATIONS AND MORTALITY AFTER THE 2-DAY “KILLER GAP” • The long interdialytic interval, commonly referred to as the 2-day “Killer Gap,” is a time of heightened risk of mortality and morbidity with conventional hemodialysis1 • Rates of death and cardiovascular hospitalization were 23% and 124% higher after the gap, respectively, than on other days1 FIGURE: Rates of death and cardiovascular hospitalization on the day after the 2-day gap in dialysis treatment and on all others days.2 1Foley, R. N., Gilbertson, D. T., Murray, T., & Collins, A. J. (2011). Long interdialytic interval and mortality among patients receiving hemodialysis. New England Journal of Medicine, 365(12), 1099-1107. 2McCullough PA et al. Intensive Hemodialysis, Left Ventricular Hypertrophy, and Cardiovascular Disease. Vol 68 (5):1;S5-S14.
  • 9. AdvancingDialysis.org Unmet Need in the Causal Path of Heart Disease in Dialysis 1Rocco MV, Burkart JM. Prevalence of missed treatments and early sign-offs in hemodialysis patients. J Am Soc Nephrol. 1993 Nov;4(5):1178-83. Fluid Overload Uncontrolled Hypertension Left Ventricular Hypertrophy Heart Failure Hospitalization and Death Early Sign-Offs and No-Shows1 High Ultrafiltration Rate Intradialytic Hypotension Cramping, Dizziness, Nausea, etc. Long Post- Dialysis Recovery Time Poor HRQoL Cardiac & organ system Stunning Limits Use of Cardioprotective Medicines Driven by intradialytic volume issues
  • 10. AdvancingDialysis.org Dialysis Induced Stress on the Heart: VARIES BY MODALITY VOLUME OVERLOAD PRESSURE OVERLOAD INTRADIALYTIC MYOCARDIAL STUNNING CARDIOVASCULAR RELATED DEATH CARDIOMYOPATHY
  • 11. AdvancingDialysis.org - ↑ 3% ↑ 9% ↑ 15% ↑ 23% ↑ 43% 80% 90% 100% 110% 120% 130% 140% 150% 160% <6 6 to 8 8 to 10 10 to 12 12 to 14 >14 Ultrafiltration Rates over 8mL/kg/h ASSOCIATED RISK OF DEATH1 1Assimon, M.M. et al. Ultrafiltration Rate and Mortality in Maintenance Hemodialysis Patients. Am J Kidney Dis. 2016;68(6):911-922. Rate of fluid removal from the patient – mL/kg/h Increased Risk of Death 118,394 STANDARD HEMODIALYSIS PATIENTS 2008-2012
  • 12. AdvancingDialysis.org Mitigating Aggressive Ultrafiltration Rates1 • UF = ultrafiltration • IDWG = interdialytic weight gain • TT= treatment time (dialysis session length) UF rate (mL/kg/h) = TT (h) IDWG (mL) Post-weight (kg) Extend dialysis time ↓ Weight gain ↓ UF volume 1Figure 1: Assimon MM, Flythe JE. Rapid ultrafiltration rates and outcomes among hemodialysis patients: re-examining the evidence base. Curr Opin Nephrol Hypertens. 2015 Nov; 24(6): 525–530.
  • 13. AdvancingDialysis.org No Major Changes in Prescription or Dose 2010-2017 HEMODIALYSIS TREATMENT CHARACTERISTICS1 1Arbor Research Collaborative for Health. The DOPPS Practice Monitor. http://www.dopps.org/DPM/. Accessed April, 23, 2019. 180 190 200 210 220 230 240 Mean Session Duration (minutes) 85% 88% 91% 94% 97% 100% Prevalence of 3 HD Sessions 1.30 1.40 1.50 1.60 1.70 1.80 Mean single- pool Kt/V
  • 14. AdvancingDialysis.org No Significant Change in Patient Population 2010-2017 HEMODIALYSIS PATIENT CHARACTERISTICS1 1Arbor Research Collaborative for Health. The DOPPS Practice Monitor. http://www.dopps.org/DPM/. Accessed April, 23, 2019. 50 55 60 65 70 75 Age 19 24 29 34 39 Body Mass Index 0 1 2 3 4 5 Years on dialysis
  • 15. AdvancingDialysis.org Significant Reduction in Hemodialysis Ultrafiltration Rates1 1Arbor Research Collaborative for Health. The DOPPS Practice Monitor. http://www.dopps.org/DPM/. Accessed April, 23, 2019. 2Assimon MM, Flythe JE. Rapid ultrafiltration rates and outcomes among hemodialysis patients: re-examining the evidence base. Curr Opin Nephrol Hypertens. 2015 Nov; 24(6): 525–530. 9.3 9.0 9.0 9.3 9.2 8.8 8.6 8.9 8.4 8.2 8.3 7.9 8.2 8.2 8.2 8.2 8.0 7.8 8.0 7.8 7.9 7.9 7.8 2010 2011 2012 2013 2014 2015 2016 2017 Ultrafiltration Rate (mL/kg/h) POTENTIAL HARM SEEMINGLY ACKNOWLEDGED2 15% FROM 2010 - 2017
  • 16. AdvancingDialysis.org R² = 0.7842 7.2 7.7 8.2 8.7 9.2 2.6 2.7 2.8 2.9 3.0 3.1 3.2 3.3 Ultrafiltration rate (mL/kg/h) Median intradialytic weight loss (%) Arbor Research Collaborative for Health. The DOPPS Practice Monitor. http://www.dopps.org/DPM/. Accessed April, 23, 2019. Should a Decrease in Intradialytic Weight Loss be Cause for Concern? 2010 8.9 ML/KG/H ULTRAFILTRATION RATE 3.1% INTRADIALYTIC WEIGHT LOSS 2017 7.6 ML/KG/H ULTRAFILTRATION RATE 2.7% ↓14% INTRADIALYTIC WEIGHT LOSS
  • 17. AdvancingDialysis.org Sudden Upturn in Rate of Cardiovascular Hospitalizations 2018 USRDS Annual Data Report: Adjusted all-cause & cause-specific hospitalization rates for ESRD patients, by treatment modality, 2007-2016. Vol 2; Chapter 4. 0.56 0.53 0.53 0.51 0.49 0.46 0.43 0.41 0.42 0.45 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 Cardiovascular-related Hospitalization Rate: Hemodialysis Patients 7% INCREASED RATE CARDIOVASCULAR HOSPITALIZATIONS 2015-2016
  • 18. AdvancingDialysis.org Chronic Fluid Overload and Mortality Risk: INCREASED MORTALITY RISK ≥1KG OVER DRY WEIGHT 1Flythe JE, Assimon MM, Overman RA. Target weight achievement and ultrafiltration rate thresholds: potential patient implications. BMC Nephrol. 2017; 18: 185. 2Zocalli C et al. Chronic Fluid Overload and Mortality in ESRD. J Am Soc Nephrol. 2017 Aug; 28(8): 2491–2497. 3Dekker MJE et al. Impact of fluid status and inflammation and their interaction on survival: a study in an international hemodialysis patient cohort. Kidney International (2017) 91, 1214–1223. Flythe1 • 30-day follow-up • ≥50 percent of treatments leaving patients >1kg “heavy” •  35% increased risk for mortality Zocalli2 • 1-year follow-up • Average 1.6kg removed •~1Kg “heavy” •  62% increased risk for mortality Dekker3 • 1-year follow-up • 1.1 L to 2.5 L – considered moderate fluid overload •  64% increased risk of death
  • 19. AdvancingDialysis.org Addressing Consistent Volume Control INCREASED TREATMENT TIME AND FREQUENCY *See references on slides 28-30 Clinical Considerations for Number of Hemodialysis Treatments per Week:* 3 Tx 3.5 – 4 Tx 5+ Tx (“Daily”) 5+ Tx (“Nocturnal”) • Longer hemodialysis treatment time (ex. nocturnal treatments) has improved mortality in observational studies1 • Could mitigate the 2-day killer gap2 • Possibility to decrease UFR with 2-3 additional hours of time per treatment3,4 • Improved BP control & survival1,4-8 • Reduced LVH & cardiovascular hospitalizations4,7,8,10 • Reduced UFR, recovery time & hypotensive episodes3-5,10-15 • Improvements in sleep quality, RLS & HRQoL5,16-18 • Limits volume loading between treatments Benefits from 5+ days per week plus: • Improved sleep and obstructive sleep apnea14,17 • Best dialytic PO4 control4,20,21 • Increased reduction in post dialysis recovery time15
  • 20. AdvancingDialysis.org Frequency and Duration Positively Addresses Aggressive Ultrafiltration Rates1 1Analysis of NxStage Nx2me Flowsheets During Patient-Weeks with ≥4 Prescribed Treatments 48.9% 69.7% 86.2% 95.5% <6 ML/KG/H <8 ML/KG/H <10 ML/KG/H <13 ML/KG/H Diurnal Treatments by Ultrafiltration Rate Category 97.7% 99.5% 99.8% 100.0% <6 ML/KG/H <8 ML/KG/H <10 ML/KG/H <13 ML/KG/H Nocturnal Treatments by Ultrafiltration Rate Category
  • 21. AdvancingDialysis.org 1The FHN Trial Group. In-Center Hemodialysis Six Times per Week versus Three Times per Week. The New England Journal of Medicine. 010:363;2287-2300. 2Weinhandl ED et al. Hospitalization in Daily Home Hemodialysis and Matched Thrice-Weekly In-Center Hemodialysis Patients. Am J Kidney Dis. 65(1):98-108. More frequent hemodialysis associated with improvements in several cardiovascular markers and related hospitalizations1,2 Likely due to improved control of extracellular volume excess.2 Left ventricular mass Adjusted mean reduction of 16.4±2.9 g versus 2.6±3.2 (P<0.001) 12% REDUCTION FHN RANDOMIZED CLINICAL TRIAL FINDINGS: Hypotensive episodes 10.9% vs. 13.6% of monitored sessions with at least one episode, (P=0.04) 20% FEWER Systolic blood pressure Adjusted mean SPB decrease 9.7±18.2 mm Hg versus 0.9±16.2 mm Hg (P<0.001) 7% DECREASE Antihypertensive agents Change from baseline agents decreased 0.87±1.85 versus −0.23±1.35 (P< .001) 36% LESS
  • 22. AdvancingDialysis.org Summarized Findings by Eric Weinhandl, PhD, MS ADJUNCT ASSISTANT PROFESSOR UNIVERSITY OF MINNESOTA COLLEGE OF PHARMACY CLINICAL EPIDEMIOLOGIST AND STATISTICIAN NXSTAGE MEDICAL, INC. Better Management of Volume with Intensive Hemodialysis: • Not achieving dry weight during hemodialysis sessions contributes to persistent fluid overload, uncontrolled hypertension and left ventricular hypertrophy progression.1 • Controlling the high prevalence of fluid overload and the use of aggressive ultrafiltration rates are widely considered unmet clinical needs in conventional hemodialysis2 • Restricting fluid intake is not a viable strategy given 1/3 – 1/2 of patients are not adherent2 • Absent effective fluid intake strategies, frequency and time can positively address volume loading between hemodialysis sessions and ultrafiltration intensity by increasing treatment frequency and cumulative treatment hours per week3 1Zipes DP, Libby P, Bonow RO, Mann DL, Tomaselli GF. Braunwald’s Heart Disease: A Textbook of Cardiovascular Medicine. 11th ed. Elsevier; 2018. 2Rocco MV, Burkart JM. Prevalence of missed treatments and early sign-offs in hemodialysis patients. J Am Soc Nephrol. 1993 Nov;4(5):1178-83. 3Raimann, J.G., et al. The Effect of Increased Frequency of Hemodialysis on Volume-Related Outcomes: A Secondary Analysis of the Frequent Hemodialysis Network Trials. Blood Purif 2016;41:277–286.
  • 23. AdvancingDialysis.org About this presentation This presentation is one in an ongoing series focused on recent articles, clinical findings or guidelines related to issues affecting dialysis patients. AdvancingDialysis.org is dedicated to providing clinicians and patients with better access to and more awareness of the reported clinical benefits and improved quality of life made possible with home dialysis, including solo and nocturnal therapy schedules. For more information, visit AdvancingDialysis.org AdvancingDialysis.org is a project of NxStage Medical, Inc.
  • 24. AdvancingDialysis.org Risks and Responsibilities Not everyone will experience the reported benefits of home and more frequent hemodialysis. All forms of hemodialysis involve some risks. When vascular access is exposed to more frequent use, infection of the site, and other access related complications may also be potential risks. Certain risks associated with hemodialysis treatment are increased when performing solo home hemodialysis because no one is present to help the patient respond to health emergencies. Certain risks associated with hemodialysis treatment are increased when performing nocturnal therapy due to the length of treatment time and because the patient and care partner are sleeping.
  • 25. AdvancingDialysis.org Addressing Consistent Volume Control REFERENCES 1Rivara MB et al. Extended-hours hemodialysis is associated with lower mortality risk in patients with end-stage renal disease. Kidney Int. 2016 Dec;90(6):1312-1320. 2Foley, R. N., Gilbertson, D. T., Murray, T., Collins, A. J. Long interdialytic interval and mortality among patients receiving hemodialysis. NEJM. 2011;365(12):1099-1107. 3Raimann, J.G., et al. The Effect of Increased Frequency of Hemodialysis on Volume-Related Outcomes: A Secondary Analysis of the Frequent Hemodialysis Network Trials. Blood Purif 2016;41:277–286. 4FHN Trial Group, Chertow, G.M., Levin, N.W., Beck, G.J. et al. In-center hemodialysis six times per week versus three times per week. N Engl J Med. 2010; 363: 2287–2300. 5Morfin, J.A., Fluck, R.J., Weinhandl, E.D., Kansal, S., McCullough, P.A., and Komenda, P. Intensive hemodialysis and treatment complications and tolerability. Am J Kidney Dis. 2016; 68: S43–S50. 6Bakris, G.L., Burkart, J.M., Weinhandl, E.D., McCullough, P.A., and Kraus, M.A. Intensive hemodialysis, blood pressure, and antihypertensive medication use. Am J Kidney Dis. 2016; 68: S15–S23. 7Weinhandl ED, Gilbertson DT, Collins AJ. Mortality, Hospitalization, and Technique Failure in Daily Home Hemodialysis and Matched Peritoneal Dialysis Patients: A Matched Cohort Study. Am J Kidney Dis. 2016;67(1):98-110. 8Weinhandl, E.D., Liu, J., Gilbertson, D.T., Arneson, T.J., Collins, A.J. Survival in daily home hemodialysis and matched thrice- weekly in-center hemodialysis patients. J Am Soc Nephrol. 2012;23:895–904. 9Chan, C.T., Greene, T., Chertow, G.M. et al. Determinants of left ventricular mass in patients on hemodialysis: Frequent Hemodialysis Network (FHN) Trials. Circ Cardiovasc Imaging. 2012; 5: 251–261.
  • 26. AdvancingDialysis.org 10McCullough, P.A., Chan, C.T., Weinhandl, E.D., Burkart, J.M., and Bakris, G.L. Intensive hemodialysis, left ventricular hypertrophy, and cardiovascular disease. Am J Kidney Dis. 2016; 68: S5–S14. 11Weinhandl, Collins, Kraus. Ultrafiltration Rates with More Frequent Home Hemodialysis. Oral Presentation. 2017 ADC. 12Stefánsson, B.V., Brunelli, S.M., Cabrera, C. et al. Intradialytic hypotension and risk of cardiovascular disease. Clin J Am Soc Nephrol. 2014; 9: 2124–2132. 13Jefferies, H.J., et al. Frequent Hemodialysis Schedules Are Associated with Reduced Levels of Dialysis-induced Cardiac Injury (Myocardial Stunning). Clin J Am Soc Nephrol. 2011 June; 6(6): 1326–1332. 14Jaber BL, Lee Y, Collins AJ, 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;56(3):531-539. 15Lindsay RM, Heidenheim PA, Nesrallah G, Garg AX, Suri R, Daily Hemodialysis Study Group London Health Sciences Centre. Minutes to recovery after a hemodialysis session: a simple health-related quality of life question that is reliable, valid, and sensitive to change. CJASN. 2006;1(5):952-959. 16Jaber BL, et al. Impact of Short Daily Hemodialysis on Restless Legs Symptoms and Sleep Disturbances. CJASN May 2011 vol. 6 no. 5 1049-1056. 17Finkelstien FO, et al. At-home short daily hemodialysis improves the long-term health-related quality of life. Kidney International (2012) 82, 561–569. 18Kraus, Michael A. et al. Intensive Hemodialysis and Health-Related Quality of Life. Am J of Kidney Dis. 2016;68:S33-S42. Addressing Consistent Volume Control REFERENCES
  • 27. AdvancingDialysis.org 19Hanley, P.J., Pierratos, A. Improvement of sleep apnea in patients with chronic renal failure who undergo nocturnal hemodialysis. N Engl J Med: 2001; Vol. 344, No. 2. 20Daugirdas JT, Chertow GM, Larive B, et al. Effects of frequent hemodialysis on measures of CKD mineral and bone disorder. JASN. 2012;23(4):727-738. 21Copland, M. et al. Intensive Hemodialysis, Mineral and Bone Disorder, and Phosphate Binder Use. Am J Kid D: 2016; Volume 68, Issue 5, Supplement 1, Pages S24–S32. Addressing Consistent Volume Control REFERENCES
  • 28. AdvancingDialysis.org www.AdvancingDialysis.org © 2019 NxStage Medical, Inc.
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