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DOPPS Practice Monitor (DPM): Emerging Trends & Hot Topics
DF Arbor Research Collaborative for Health May 3rd, 2018
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Topics and Speakers Today
Welcome and Introduction (5 min) Bruce Robinson Recent US Trends (15 min) Doug Fuller Focus topic: Pruritus (20 min) Hugh Rayner Vascular Access (20 min) Ron Pisoni DF Bruce Robinson Doug Fuller Hugh Rayner Ron Pisoni
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Country/Project-Specific Support:
Acknowledgements, 2018 The DOPPS Program would not be possible without the support for independent scientific research to improve patient care from the following organizations: Principal Funders: Amgen Baxter Healthcare Kyowa Hakko Kirin Country/Project-Specific Support: ERA-EDTA, Vifor Fresenius Renal Pharma, Keryx, Amgen, AstraZeneca, Relypsa, Roche, Proteon, Janssen, Hexal, Japanese Society for PD, Societies of Nephrology in Germany, Italy & Spain Public Funding of Projects/Ancillary Studies In: Australia, Canada, France, Thailand, United Kingdom, United States All support for the DOPPS program is provided without restrictions on publications
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New AHRQ* grant: To study prevention of peritonitis in PD patients, & to promote knowledge dissemination strategies Investigators: Drs. Jeff Perl and Ron Pisoni (Co-PIs), Neil Boudville, Beth Piraino, Doug Schaubel, Martin Schreiber, IsaacTeitelbaum. Stakeholders: - International Society for Peritoneal Dialysis (ISPD) - ASN (Nephrologists Transforming Dialysis Safety, NTDS) - CDC NHSN members - International Pediatric PD Network (IPPN) - Standardizing Care to Improve Outcomes in Pediatric End- Stage Renal Disease (SCOPE) collaborative - US dialysis providers - Patient representatives *AHRQ = Agency for Healthcare Research and Quality (US DHHS)
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Join the conversation on Twitter
Follow Use #DOPPS for tweets about today’s presentation
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Submitting Questions We welcome your questions throughout the session and will pause to answer them at the end of each section Please submit your questions using the “Chat with Presenter” feature, accessed by the blue icon located at the bottom left corner of the screen DF
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Interactive Polling Throughout today’s presentation, we will offer several poll questions about treatment practices in your unit. Please be assured that individual responses will remain confidential. When the poll is opened and displays on your screen, please answer the question and don’t forget to hit the ‘Submit’ button. DF
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US DOPPS Practice Monitor: Highlights May 2018
DF Doug Fuller, MS Arbor Research Collaborative for Health
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Stratified random sample (since 2010)
US DPM: Monthly data, updates every 4 months; >1500 figures & tables Stratified random sample (since 2010) Now ~200 US facilities, 14,000+ patients with data from 2 LDOs and Visonex DF
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Uptake of Newer Medications
DF
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Iron-containing Phosphate Binder Use – Prior 3 Months –
DF Values for each month reflect any prescription during prior 3 months. Source: US-DOPPS Practice Monitor, April 2018;
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ESA Use, by Type – by Dialysis Organization (DO) Size –
DF Overall: 38.5% PEG-EB Values for each month reflect prescription among ESA-treated patients. Source: DOPPS Practice Monitor, April 2018
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Anemia DF
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Hemoglobin Trends – National Sample –
DF Most recent (single) monthly value; vertical lines extend from 10th to 25th (lower) and 75th to 90th (upper) percentiles; circle represents median. Source: US-DOPPS Practice Monitor, April 2018;
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Prescription of Anemia Therapies (% patients) – Prior 3 Months –
DF Values for each month reflect any use during the prior three months. Source: US-DOPPS Practice Monitor, April 2018;
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Serum Ferritin – National Sample –
DF Values at each month are based on the most recent measurement obtained within the prior 3 months; vertical lines extend from 10th to 25th (lower) and 75th to 90th (upper) percentiles; circle represents median. Source: US-DOPPS Practice Monitor, April 2018;
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Mineral and Bone Disorder
DF
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Parathyroid Hormone (PTH) – National Sample –
DF Values at each month are based on the most recent measurement obtained within the prior 3 months; vertical lines extend from 10th to 25th (lower) and 75th to 90th (upper) percentiles; circle represents median. Source: US-DOPPS Practice Monitor, April 2018;
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Prescription of MBD Therapies (% of Patients) – Prior 3 Months –
IV: 54% Oral: 40% DF Values for each month reflect any prescription during the prior three months. Vitamin D includes active or analog forms. Source: DOPPS Practice Monitor, April 2018
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Vitamin D Prescription, by Type – National Sample –
DF Values for each month reflect prescription among patients receiving IV or oral vitamin D (active or analog) Source: US-DOPPS Practice Monitor, April 2018;
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Dialysis Dose and Prescription
DF
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Dialysis Session Length – National Sample –
DF Source: DOPPS Practice Monitor, April 2018
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Polling Question 1 Which of the following best describes the trend in ultrafiltration rate (UFR) among hemodialysis patients in your unit? Increasing No change Decreasing
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Ultrafiltration rate – National Sample –
DF Source: DOPPS Practice Monitor, April 2018
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Polling Question 2 If the average UFR is declining in your unit, what reason best describes the cause of the decline? Better management of water and salt intake Longer average treatment times Practices to preserve residual kidney function Other
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Summary of Recent US Trends
Darbepoetin use in SDO, independents, and HB units Long-acting ESA use: 63% overall Drives reduction in % subcutaneous ESA use High PTH levels still getting higher PTH 600+ pg/ml: 33% (black pts), 20% (non-black pts) Ongoing reductions in ultrafiltration rate UFR 13+ ml/kg/hr: Declined from 18% to 9% DF
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Discussion: Please submit your questions using the “Chat with Presenter” feature, accessed by the blue icon located at the bottom left corner of the screen DF
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CKD-associated pruritus: time to think differently
Dr Hugh Rayner, MD
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Trends in prevalence of pruritus among HD patients in the DOPPS
How much are you bothered by itchy skin? This shows the extent to which HD patients were bothered by itchy skin during a 4 week period, based upon self-reported data collected from a prevalent cross section of patients. Those moderately to extremely bothered by itchy skin are considered to have pruritus 45% of DOPPS I patients are considered to have pruritus 42% of DOPPS II patients are considered to have pruritus Phase: Years: N: 6512 7224 6780 7307 7629 Rayner HC et al. Clin J Am Soc Nephrol Dec 7;12(12):
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Effects on daily life among patients nearly always or always bothered by itchy skin during the past week Frequency of being bothered by: Never 1 to 3 Always 4 to 6 Being annoyed about your itching 3 15 81 Frustration about your itching 6 17 77 Appearance of your skin from scratching 9 22 69 Feeling depressed about your itching 13 29 58 Feeling embarrassed about your itching 33 45 Effect of itching making it hard to work 23 Effects of itching on desire to be with people 32 35 Effects of itching on interactions with others 37 34 Rayner HC et al. Clin J Am Soc Nephrol Dec 7;12(12):
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To what extent were you bothered by itchy skin during the past 4 weeks?
Rayner HC et al. Clin J Am Soc Nephrol Dec 7;12(12):
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69% of MDs underestimate pruritus prevalence in their dialysis unit
MD estimate matched patient reported pruritus prevalence MD estimate % pts with severe pruritus: Supplemental Fig 1 *note: results are from 1 MD per facility MD estimate of severe pruritus pts vs facility % of pts very bothered by itchy skin Interpretation: in 27 facilities that had <5% of patients being very bothered by itchy skin: 74% of MDS estimated that there were <5% of patients in their facilities with severe pruritus (so they were correct!), however also among those facilities 15% of MDS estimated that they had 21-50% patients with severe pruritus (while in fact only <5% pt reported being very bothered) Facility % of patients very much or extremely bothered by itchy skin N Facilities = 27 124 93 Rayner HC et al. Clin J Am Soc Nephrol Dec 7;12(12):
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Interventions for patients with severe pruritus
% of medical directors Rank of importance Most 1 2 3 4 Least 5 Phosphorus control (in patients with high PO4) 60% 16% 15% 8% 1% Increasing dialysis dose (in patients with low Kt/V) 25% 29% 24% 6% Use of prescription medications for pruritus 13% 14% 45% Increasing prescribed treatment time (in patients with short treatment time) 11% 18% 21% 26% Lowering PTH levels (in patients with high PTH) 2% 28% 23% Rayner HC et al. Clin J Am Soc Nephrol Dec 7;12(12):
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No association with serum phosphorus
To what extent were you bothered by itchy skin during the past 4 weeks? AOR [95% CI] Not at all Somewhat Moderately Very much Extremely Total sample, N 2111 1840 1188 692 425 Phosphorus <3.5 mg/dL 11% 13% 1.00 [0.88, 1.14] 3.5 - <5.5 56% 51% 52% 50% [reference] 5.5 - <6.7 20% 23% 21% 22% 1.01 [0.91, 1.13] ≥ 6.7 15% 14% 16% 1.07 [0.95, 1.21] Rayner HC et al. Clin J Am Soc Nephrol Dec 7;12(12):
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No association with serum Ca, Ca x PO4 or Kt/V
To what extent were you bothered by itchy skin during the past 4 weeks? Not at all Somewhat Moderately Very much Extremely Calcium (mg/dL) 8.9 (0.8) Calcium x Phosphorus product (mg2/dL2) 43 [36,52] 45 [36,55] 44 [35,52] 44 [36,53] 44 [36,54] Single Pool Kt/V 1.5 (0.3) Rayner HC et al. Clin J Am Soc Nephrol Dec 7;12(12):
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Breakdown in communication
17% of patients nearly always or always bothered by itchy skin had not reported their symptoms to any healthcare professional 18% of patients nearly always or always bothered by itchy skin used no treatment for it Rayner HC et al. Clin J Am Soc Nephrol Dec 7;12(12):
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Two itch pathways a) Cowhage b) Histamine
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fMRI responses evoked by cowhage itch Papoiu et al
fMRI responses evoked by cowhage itch Papoiu et al. J Neurophysiol 112: 1729–1738, 2014 ESRD patients = red-yellow, normal = blue Histamine itch responses were normal 57% of medical directors used oral antihistamines for first-line chronic treatment of pruritus
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In total, 4 RCT’s involving
Gabapentin 300mg after HD Gunal et al. NDT 2004; 19: In total, 4 RCT’s involving 138 patients with severe CKD-aP show the same effect
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Pregabalin 75mg twice weekly 62 patients in RCT Yue J et al
Pregabalin 75mg twice weekly 62 patients in RCT Yue J et al. Int Urol Nephrol. 2014 Sleep quality and quality of life also improved significantly
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Our experience n=71: 25 CKD (median eGFR = 17, 9 – 30), 40 HD, 6 PD
Gabapentin starting dose 100mg after dialysis. If not tolerated, pregabalin 25mg. 85% of patients gained relief of itching with gabapentin or pregabalin Mean severity reduced from 8/10 to 1/10 Rayner HC et al. Nephron Clinical Practice, 2013
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The majority of nephrologists do not use gabapentin for pruritus
**make a note that Jpn uses nalfuarfine (9% in phase 5 that is not shown) Drug use for HD patients with pruritus - Gabapentin 56 10 18 17 24 12 14 49 9 N: Rayner HC et al. Clin J Am Soc Nephrol Dec 7;12(12):
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Summary The prevalence of people on haemodialysis very much or extremely bothered by itching declined from 28% in 1996 to 18% in 2015 69% of nephrologists underestimate the prevalence of pruritus in their facility The interventions currently most often used to treat pruritus are not supported by evidence Large numbers of hemodialysis patients with severe pruritus do not receive any treatment
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Summary There is wide variation between countries in the use of gabapentin and pregabalin for the treatment of pruritus Overall, the majority of nephrologists never use these drugs Hemodialysis patients’ quality of life could be significantly improved through the systematic raising of awareness, reporting and effective treatment of pruritus
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Polling Question 3 Do you find that dialysis patients get a lot of side effects from gabapentin when it is prescribed for itching? Yes No
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International Variability in Arteriovenous Fistula Placement Location, Successful Use, Cannulation Time, & Catheter Days R Pisoni, L Zepel, R Fluck, C Lok, R Fluck, H Kawanishi, G Süleymanlar, H Wasse, F Tentori, J Zee, Y Li, D Schaubel, S Burke, H Morgenstern, K Woodside, and B Robinson
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Variations in Vascular Access Use
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Vascular access usea – prevalent patients DOPPS 5 (2012-2014)
% of Patients Figure 1B: Distribution of vascular access use, by country Data from GCC, Russia, Turkey, Belgium, Sweden, and China based on patient’s vascular access at the initial cross-section of DOPPS 5; data from remaining countries based on cross-section of HD patients in August 2013 * Data from GCC, Rus, Tur, Bel, Swe, Chi based on VA at the initial cross-section of DOPPS 5; data from remaining countries based on cross-section of HD patients in Aug 2013 N Patients: a At study entry regardless of time on dialysis since at DOPPS enrollment Pisoni et al. Am J Kidney Dis. 2015;65(6):
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Vascular Access in Use – US only – National Sample –
DF Source: US-DOPPS Practice Monitor, April 2018;
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Vascular access by age group
US DOPPS 5 (August 2013 cross-section) Figure 2A: Distribution of vascular access use, by age group (US only) Based on cross-section of in-center HD patients in August 2013. Pisoni et al. Am J Kidney Dis. 2015;65(6):
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Vascular access by ethnicity
US DOPPS 5 (August 2013 cross-section) Figure 2B: Distribution of vascular access use, by ethnicity (US only) Based on cross-section of in-center HD patients in August 2013 Pisoni et al. Am J Kidney Dis. 2015;65(6):
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Vascular access by race and sex
US DOPPS 5 (August 2013 cross-section) Figure 2C: Distribution of vascular access use, by race and sex (US only) Based on cross-section of in-center HD patients in August P < 0.05 for difference in catheter use for black females versus males; p <0.001 for difference in catheter use for non-black females versus males. Pisoni et al. Am J Kidney Dis. 2015;65(6):
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AV access placement (%) before HDa,b DOPPS 5 (2012-2014)
In US: ~80% of new pts start HD with a catheter % of Patients Figure 5C: AV access placed prior to ESRD among patients with ≥ 4 months pre-ESRD care Based on responses to the question “Did the patient have an AV fistula or graft placed prior to start of chronic hemodialysis?” included on the baseline medical questionnaire administered during DOPPS 5. Restricted to patients who saw a nephrologist at least 4 months before starting dialysis. Australia-New Zealand, France, and Turkey not shown due to limited data. N Patients: On dialysis ≤ 60 days at DOPPS enrollment b. Provided ≥4 months of pre-dialysis nephrology care Pisoni et al. Am J Kidney Dis. 2015;65(6):
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- With support from Proteon Therapeutics -
International variability in AVF placement, successful use, & time to first cannulation of newly created AV fistulae Based upon AVFs created during DOPPS 4 and 5 (2009–2015) in the US, Japan, Europe, Australia and New-Zealand (ANZ). Successful AVF maturation was defined as use for ≥ 30 days - With support from Proteon Therapeutics -
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NKF-KDOQI Vascular Access Guideline
“There are no randomized controlled trials (RCTs) comparing the recommended anatomic order of distal-to-proximal access construction. However, good surgical practice makes it obvious that when planning permanent access placement, one should always consider the most distal site possible to permit the maximum number of future possibilities for access.” NKF KDOQI 2006 Updates Clinical Practice Guidelines and Recommendations for Vascular Access
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Arm location of AVF*, by region
Japan Europe/ANZ US DOPPS Phase: N AVFs: Fig 3 Based upon location of AVF in use at study entry in the initial round of each study phase: DOPPS 1 ( ), DOPPS 2 ( ), DOPPS 3 ( ), DOPPS 4 ( ), DOPPS 5 ( ). Europe/ANZ includes France, Germany, Italy, Spain, and UK (DOPPS phase 1) and Australia, New Zealand, Belgium, France, Germany, Italy, Spain, Sweden, and UK (DOPPS phases 2-5). Results were similar when Europe/ANZ was restricted to countries present in all phases. N Fac: *Based upon the access in use in prevalent cross-sections of patients in each study phase. Pisoni et al, AJKD (2018) 71(4):
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Facility distribution of AVF location in the lower arm, by region
Facility % of AVFs in lower arm Facility Percentile 95th 75th 50th 25th 5th Vintage: N Fac: Japan Europe/ANZ US Restricted to AVFs created in DOPPS4-5 ( ) in the United States, Europe, Australia and New-Zealand, and Japan; facility distributions for vintage <1 year were similar to <2 years. Pisoni et al, AJKD (2018) 71(4):
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AVF (%) placed in lower arm, by age group, in males
Fig 4a AVF placement in lower arm, by age and region Restricted to males Age: N AVFs: Japan Europe/ANZ US Pisoni et al, AJKD (2018) 71(4):
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Adjusted Odds Ratios of AVF Placement Location (Lower vs Upper Arm), by Patient Characteristic in US, for All AVFs Created During the Study Characteristic AOR (95% CI) Male sex (vs female) 1.64 ( ) Black race (vs non-black) 0.88 ( ) Age, per 5 yrs older 0.98 ( ) BMI, per 5-kg/m2 greater 1.01 ( ) Cardiovascular disease (vs no) 0.99 ( ) Congestive heart failure (vs no) 0.81 ( ) Diabetes (vs no) 0.99 ( ) Peripheral vascular disease (vs no) 0.64 ( ) Dialysis vintage, per 1-yr greater 0.86 ( ) N=1709 AVFs Pisoni et al, AJKD (2018) 71(4):
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AVF successful use*, by arm location and region
% of AVFs *AVF successful use was defined as use ≥ 30 days Restricted to AVFs created in DOPPS 4 and 5 ( ) in North America, Europe, Australia and New-Zealand, and Japan Pisoni et al, AJKD (2018) 71(4):
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Hazard Ratios of Time from AVF Creation Until Successful Use by Cox Regression: Association with Patient Characteristics – US Only Characteristic HR (95% CI) Male sex (vs female) 1.38 ( ) Black race (vs non-black) 0.96 ( ) Age, per 5 yrs older 1.01 ( ) Dialysis vintage, per 1-yr greater 0.99 ( ) BMI, per 5-kg/m2 greater 1.00 ( ) Cardiovascular disease (vs no) 1.02 ( ) Congestive heart failure (vs no) 0.96 ( ) Diabetes (vs no) 0.92 ( ) Peripheral vascular disease (vs no) 0.99 ( ) Facility % AVF use, per 5% greater 1.00 ( ) Facility median blood flow rate, per 20 mL/min greater 1.02 ( ) Upper arm vs lower arm 1.29 ( ) HR > 1.0 indicates shorter time to successful AVF use or greater AVF use; N=1266 AVFs; in Japan and EUR/ANZ – upper arm location not assoc with higher HR
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Very similar results seen for AVFs created in the lower or upper arm
Time to First Successful AVF Use, by Region AVFs Very similar results seen for AVFs created in the lower or upper arm Percentile 95th 75th 50th 25th 5th Fig 2a Sample: restricted to AVFs/AVGs that were created within the study and were successfully used for at least 30 days. Excludes AVFs/AVGs that were created within the study and never used. N AVFs: Pisoni et al, AJKD (2018) 71(4):
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Summary Large variability is seen across international regions in AVF use, AVF location, successful use of new AVFs, and time to first successful AVF use. Time until becoming catheter-free differs considerably between Japan, EUR/ANZ, and the US. Lower arm AVF placement is much less common in the US (32%) – even among younger patients and patients new to HD.
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Summary (cont.) The large US shift from lower- to upper-arm AVFs during the last 2 decades raises concerns regarding the long-term implications for HD patients: - greater risk of exhausting available sites for future AVFs - greater potential adverse long-term effects of upper-arm AVFs (eg, higher frequency of steal syndrome, symptomatic cephalic arch and central vein stenosis, and high AVF blood flow effects on cardiac function). Although an upper-arm AVF may provide a higher rate of success for an individual procedure, AVF creation must be viewed in the context of lifetime access planning. Activities to increase awareness, promote best practices, and maximize training could foster increased lower-arm AVF use.
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Vascular Access: Mortality Risk Facility Based Model
Insert footpath here. Example - U:\slides\ASN 2003 Publication Graphics CD\Working Drafts\Lopes_QoL and Ethnicity\Lopes_QoL and ethnicity_Rev1 Vascular Access: Mortality Risk Facility Based Model RR of Death among Facility Patients per 20% more facility use of indicated access type Recently, we have analysed vascular access as a facility practice, and have found that a patient’s mortality risk is 21% higher for every 20% greater CATHETER use in the dialysis facility compared with AV fistula use. Furthermore, a patient’s mortality risk was found to be 11% higher for every 20% greater GRAFT use in the dialysis facility. These analyses were adjusted for patient demographics, baseline comorbidity, single pool Kt/V, and serum calcium and phosphorus levels. p<0.0001 p=0.008 Ref. *DOPPS 1+2, ; n=27,892; adjusted for age, gender, black race, yrs with ESRD, 14 comorbidity classes, weight, facility median treatment time, facility % serum Ca >10 mg/dl, facility % serum PO4 >5.5 mg/dl, whether hosp unit, & accounted for facility clustering effects; stratified by study phase & region. Facility access use adjusted for facility case-mix. Pisoni et al AJKD (2009) Created By:____________________ Date: __________ Contributing Analyst: ____________ Date: __________
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Ultimate Polling Question
Princess Kate and Prince William welcomed the birth of their third child on April 23rd. What is the child’s first name? William Elizabeth Catherine George Louis Mary Ringo John
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US DOPPS Practice Monitor
Updates every 4 months Next in January 2018 (data through October 2017) DF Give special thanks to – NNI - Web conference AJKD - Detailed analysis + editorial comment
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If you want to re-listen to this WebEx or download the slides, go to:
DF
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