ASDIN 7th Annual Scientific Meeting

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Strategies for Decreasing the Use of Hemodialysis Catheters ASDIN 7 th Annual Scientific Meeting Outline Late referral Primary failure Why Not PD?

1 Strategies for Decreasing the Use of Hemodialysis Catheters ASDIN 7 th Annual Scientific Meeting Outline Late referral Primary failure Why Not PD? Summary Micah Chan MD MPH FACP Assistant Professor of Medicine University of Wisconsin School of Medicine and Public Health CVCs first described by Teschan in 1959 as a form of hemodialysis access TDCs developed d in 8s as an alternative ti to temporary catheters Despite significant innovations along the way, after 5 years clinicians still remain dependant on an access modality that is universally regarded as inadequate Lacson et al AJKD 27: 5 The USRDS reported that catheters have the highest overall cost per person per year in 26 with $77,93 in expenditures; a large proportion of this cost is due to catheter-related infection Despite these well described complications, according to the ESRD Networks, 21% of prevalent HD patients were dialyzing with a CVC for 9 days or longer. This is far greater than the NKF K/DOQI published recommendations of less than 1% CVC prevalence RR of death associated with catheter use as compared to AVF is 1.4 to 3.4 fold greater Dhingra and collegues in 21, using the USRDS Dialysis Morbidity and Mortality Study Wave 1 (DMMS), did the first national study on vascular access in 5 prevalent dialysis patients from 55 dialysis units across the U.S. In both diabetic and non-diabetic ESRD patients, the adjusted relative risk of death was 79% and 8% higher in the TDC group as compared to the AVF group respectively on two-year follow-up. Subsequent reports uphold the evidence that TDCs are associated with a 4-7% increased risk of death as compared to autogenous AVF in the K/DOQI era 1

Adjusted Relative Risk of Death by Vascular Access Type Among Non-Diabetic Patients 2 2 Adjusted Relative Risk of Death by Vascular Access Type Among Diabetic Patients 1.

2 Adjusted Relative Risk of Death by Vascular Access Type Among Non-Diabetic Patients 2 2 Adjusted Relative Risk of Death by Vascular Access Type Among Diabetic Patients 1.91 ortality Risk Relative Mo p< p<.35 ref p<..55 p<.65 ref ortality Risk Relative Mo p<.2 p<.3 1. ref p< p< ref CVC AVG AVF CVC AVG AVF Prevalent Incident CVC AVG AVF CVC AVG AVF Prevalent Incident Dhingra et al. Type of vascular access and mortality in U.S. HD patients. KI Oct 21 Dhingra et al. Type of vascular access and mortality in U.S. HD patients. KI Oct 21 Fistula First Breakthrough Initiative This seminal study was the impetus for the 26 KDOQI updated guidelines on vascular access FFBI was a coalition sponsored by the Centers for Medicare and Medicaid Services (CMS) that launched in 24 It met its 4% prevalence goal by 26, a year early Subsequently, due to its success, stipulated a 66% fistula rate ents % of Patie Percent of Incident Patients with AV Fistula 51 42% US Network ents % of Patie Percent of Prevalent Patients with Catheter 27% US Network ents % of Pati Percent of Prevalent Patients with Catheter > 9 days 28 21% US Network 2

Astor, et al showed that patients with delayed referral to nephrologists prior to initiation of dialysis, were more likely to initiate with a chronic catheter and use one for longer periods of time

3 Astor, et al showed that patients with delayed referral to nephrologists prior to initiation of dialysis, were more likely to initiate with a chronic catheter and use one for longer periods of time compared to timely referral. They subsequently showed increased mortality risks directly attributable to this delayed timing of nephrologist referral. USRDS reported that in 27 among incident hemodialysis patients mortality peaked in the second and third month after initiation of dialysis and that in the first month of initiation, hospital admissions for infection were twice as high as in months 1-12 Astor BC, et al. AJKD 21; 38 Chan MR, et al. Am J Med 27;12 Figure 1. Graph from 26 ESRD CPM Project 5 (Fig. 3, p 36) shows percent of incident* adult in-center hemodialysis patients with different types of vascular access 9 days after initiation of dialysis 57% USRDS 29 I. KDOQI CLINICAL PRACTICE GUIDELINES FOR VASCULAR ACCESS GUIDELINE 1. PATIENT PREPARATION FOR PERMANENT HEMODIALYSIS ACCESS Appropriate planning allows for the initiation of dialysis therapy at the appropriate time with a permanent access in place at the start of dialysis therapy. 1.3 Patients should have a functional permanent access at the initiation of dialysis therapy A fistula should be placed at least 6 months before the anticipated start of HD treatments. This timing allows for access evaluation and additional time for revision to ensure a working fistula is available at initiation of dialysis therapy. (B) Education for PCP on egfr referral based protocols Multidisciplinary team engaged g to: educate on modality selection vessel mapping surgical evaluation CQI reviews monitoring and surveillance What is a trigger for referral? egfr 2-25ml/min/1.73m225ml/min/1.73m2 Rapid egfr decline 1/creat slope At least 4-8months from referral to initiation 4-8wk lag from referral to first visit to neph clinic 4-8wk lag from first neph visit to surgical appt 2-4wk lag from surgical appt to AVF 6-12wk lag from surgery to AVF use Lenz Asif, Semin Dial 26: 19 Lacson et al AJKD27: 5 3

The Multidisciplinary Team The Multidisciplinary Team ESRD Network 7 conducted a study called gap-reduction assisted catheter elimination (GRACE) strategy Goal was a gap reduction of 5% from the

with high catheter rates (>25%) were included in the study with n=891 Multidisciplinary team approach Focused vascular access education for medical staff Complications Types Vascular mapping

Application of interventions resulted in catheter reduction to 12.22 ± 8.5% in May 27 (p =.1) 1) Medical director s involvement had a positive impact in achieving the goal (p =.3).

arteriovenous access had suitable veins for access placement 9% with previously failed arteriovenous access (18/2) also had suitable veins AVF were made in 94% of those that agreed to surgery (68/72)

4 The Multidisciplinary Team The Multidisciplinary Team ESRD Network 7 conducted a study called gap-reduction assisted catheter elimination (GRACE) strategy Goal was a gap reduction of 5% from the baseline catheter rate of the given facility when compared with the Network 7 mean facility catheter rate and the sustainability of catheter reduction for at least 3 consecutive months 15 facilities with high catheter rates (>25%) were included in the study with n=891 Multidisciplinary team approach Focused vascular access education for medical staff Complications Types Vascular mapping techniques Early referral for primary failure Monthly catheter tracking Regular conference calls and site visits The preintervention catheter rate in these facilities was 31.5± 5.3%. Application of interventions resulted in catheter reduction to ± 8.5% in May 27 (p =.1) 1) Medical director s involvement had a positive impact in achieving the goal (p =.3). Kulawik Asif, Semin Dial 29: 22 Kulawik Asif, Semin Dial 29: 22 Vascular education and mapping Prospective study of 86 patients with TDCs showed with vascular mapping that 94% (64/66) with no prior arteriovenous access had suitable veins for access placement 9% with previously failed arteriovenous access (18/2) also had suitable veins AVF were made in 94% of those that agreed to surgery (68/72) Catheter use significantly decreased from 34 to 14% Primary Failure: The Challenge Radiocephalic (Brescia-Cimino) 85% 1-year patency 1-3% primary failure rate Asif et al. KI 25;67:2399 Primary Failure: The Challenge Brachiocephalic 75% 1-year patency 2-3% primary failure rate Primary Failure: The Challenge Brachiobasilic (transposition) 77% 1-year patency 1-4% primary failure rate 4

Primary Failure: Reasons Whether it is a primary or secondary access (after >=1 failed) Blood vessel selection Experience of surgeon Patient care staff education and early cannulation Primary

21) -NDT 24;19:2325 Subsequently Polinghorne et al demonstrated in a RCT of 137 pts that Qa surveillance detects significant stenoses NDT 26;21:2498 Beathard demonstrated in a prospective

5 Primary Failure: Reasons Whether it is a primary or secondary access (after >=1 failed) Blood vessel selection Experience of surgeon Patient care staff education and early cannulation Primary Failure: Solutions Tessitore et al showed in a 5-year RCT in 79 pts that preemptive treatment reduced failure rate (P=.3) and resulted in longer primary patency (p=.21) -NDT 24;19:2325 Subsequently Polinghorne et al demonstrated in a RCT of 137 pts that Qa surveillance detects significant stenoses NDT 26;21:2498 Beathard demonstrated in a prospective observational study of 1 pts successful salvage of primary failure KI 23;64:1487 Primary Failure: Solutions Primary Failure: Solutions Success rate of angioplasty of 98% and vein obliteration of 1% After intervention, possible to initiate dialysis with AVF in 92% cases Beathard KI 23;64:1487 Lok CE, et al JASN 26:17 Why Not PD? Surveys of practicing nephrologists believe the optimal ratio of HD to PD would be 65:35 in Canada and U.S. 6:4 in the UK (Am J Kidney Dis. 21 Jan;37(1):22-29.) When asked what they would do if were on dialysis, 98% of medical directors would do a home-based therapy ( If the PD share of total dialysis were to decrease from current 8% to 5%, Medicare spending for dialysis would increase by an additional $41 million over a 5-year period. Alternatively, if the PD share of total dialysis were to increase to 15%, Medicare could realize a savings of >$1.1 billion over 5 years. (Clin Ther. 29 Apr;31(4):88-8) 8) Comparison of HD with CVC to PD Starting HD with CVC Inadequate HD when compared to AVF and AVG CVC induced central vein stenosis and thrombosis poses a threat to successful AVF and AVG placement A very high incidence of catheter-associated associated blood stream infections resulting in a high mortality Starting with PD Preserve vascular access sites Bridge therapy to HD Equal or better survival in the first 2 years of dialysis Preservation of residual renal function Greater patient satisfaction Infections are fewer & milder Financial superiority Courtesy of K. Abreo 5

PDC Infections Same as AVF! Can PD be Initiated in the Late-Referred ESRD Patient (no vascular access or immature AVF)? PC AVF PD HR 95%CI PC 195 1.95 147257 1.47-2.57 TC 1.76 1.29-2.41 AVG 1.5.82-1.

6 PDC Infections Same as AVF! Can PD be Initiated in the Late-Referred ESRD Patient (no vascular access or immature AVF)? PC AVF PD HR 95%CI PC TC AVG AVF 1 Ref PD patients with ESRD started on 12-hour APD Coiled, double-cuffed Tenkhoff catheters inserted by open surgery under local anesthesia and without the use of prophylactic antibiotics Exceptionally good surgical support 7 days a week Standard prescription for acute APD was: 12h overnight, total volume 1L with maximum dwell volume 1.2L (BW<6 Kg) or 14L with maximum dwell volume 1.5L (BW>6Kg), tidal volume 5-75% Supine at night, free to walk during dry day Ishani et al, KI 68:311, 25 Courtesy of K. Abreo Povlsen & Ivarson, NDT 26 Comparison of Acute and Planned PD Increase in PD Patients When Nephrologists Place Catheters Acute Planned P 52(%) 52(%) Infectious complications 1 (19.2) 11 (21.2) NS Mechanical complications 15 (28.9) 4 (7.7) <.1 Surgical replacement 1 (19.2) 2 (3.9) <.2 2 PD technique survival at 3 mo. 39/52 (75) 45/52 (86.5) NS PD technique survival, censored for death & transplantation 39/45 (86.7) 45/5 (9) NS Povlsen & Ivarson, NDT 26 Asif et al, Seminars in Dialysis 18: 157, 25 Why Not PD? Why Not PD? It is important to note that there has never been a robust randomized controlled trial comparing HD vs PD. The only trial to design and implement an RCT was from the Netherlands. They screened 735 eligible patients from the NECOSAD cohort but only 38 patients agreed to randomization. (Kidney International, Vol. 64 (23), pp. 2222) Indeed, when fully educated and given a free choice, approximately 5% pts choose PD. Recent study showed that among patients with CKD stage 5, 96% had knowledge of HD and only 78% had knowledge of PD. (Kidney Int. 28 Nov;74(9):.) Most recent study of cohort of 98,875 adults who initiated dialysis in 23 showed cumulative survival was higher for peritoneal dialysis patients than for hemodialysis patients (hazard ratio.92; 95% CI.86 to 1., P =.4) followed up to 5 years. (JASN 21:21;499) PD has many advantages over HD with a CVC in the early months of dialysis: Decreased infection-related mortality and preservation of veins for vascular access PD offers improved survival after transplant Patient and physician education play an important role in promoting PD as the best early dialysis modality PD catheter embedding technique would allow placement of the catheter in CKD4 The PD population grows in centers where Interventional Nephrologists are actively involved in catheter placement Back-up AVF in PD patients allows for a smooth transition to HD without CVC placement 6

7 Summary Points Adopt a Catheter Last program Nephrologist must take the lead and gain appropriate buy in from staff, surgeons, interventionalists, hospital Multidisciplinary team to educate patients, staff and physicians Review the evidence and best practices Establish algorithms and routine CQI program Early referral process with egfr based protocols and PCP education Monitoring and surveillance Early salvage PD as a bridge to AVF 7

ASDIN 8th Annual Scientific Meeting

ASDIN 8th Annual Scientific Meeting Fistula First Breakthrough Initiative Fistula First Breakthrough Initiative Marianne Neumann, RN, CNN FFBI Clinical Lead New Orleans, LA February 26, 2012 Initiated in 2003 by CMS, Goals Include: to ensure