1	Technical Advances in Haemodialysis What’s out there? Prof John Agar Renal Unit, Geelong Hospital Barwon Health
2	This year … a new direction In past years, my focus has been … Extended hour and frequency haemodialysis Nocturnal home haemodialysis (NHHD) The reasons for … The benefits of … The techniques for ... The pitfalls of … This year, my task has changed to … What’s new in technology ? and … Can this be married to NHHD to improve outcomes ?
3	"To answer these questions" To answer these questions Barwon Health granted me a ‘Sabbatical’
4	What is a ‘Sabbatical’ Any extended period of leave from customary work, esp. to acquire new skills, ideas or training Also called ‘sabbatical leave’ … (in a school, college, university, etc.) … a year, usually every seventh, of release from normal duties granted to a professor, as for study or travel
5	4 reasons why I took a Sabbatical My long-term personal interest in extended hour and/or longer duration dialysis therapy Geelong’s current position as a leading proponent of extended hour and frequency dialysis My desire to keep Geelong at the ‘sharp end’ of dialysis thought and implementation My sense that ANZ is … way ahead of the world in program development but … way behind the world in technological capability
6	"Background" Background
7	Conventional Haemodialysis (CHD) CHD = 3 times / wk x 4-5hrs / session Add travel and ‘getting on / getting off’ time = 1hr travel + 1hr ‘on/off’ = 6-7 hrs 3 days/wk … just to stay alive ! and … The rate of fluid/waste removal is so fast that post-dialysis recovery time can extend almost to the next treatment
8	"There had to be a..." There had to be a better way
9	Solution Slow down the rate of volume/biochemical change but … To the only ways to ‘slow’ the process are to either: Lengthen the treatment time or … Increase the number of treatments or … Do both!
10	Problem Further increasing treatment length or … Further raising the number of treatments/week means … Dialysis becomes so life-intrusive as to become intolerable … negating the old dialysis adage: “Dialyse to live, not live to dialyse” unless one could …
11	Dialysis during ‘down-time’ In practice, dialysis can only be extended in time and/or duration if it is done during a patient’s ‘down-time’ … or during sleep and at home Enter … Nocturnal Home Haemodialysis (NHHD) but … is it safe?
12	"Yes" Yes (and clearly so) But That’s another story
13	Clearly … Given my personal views (and my personal national and international vendetta) against … low frequency dialysis delivery and inadequate treatment duration … It was a natural progression to introduce home overnight dialysis in Geelong (2000) Before 2001, > 5hr session lengths and > 3/wk treatment frequencies were rare in ANZ
14	NHHD … Geelong 2001 - 2005 2000 Geelong introduced the 1^st Nocturnal Home Haemodialysis (NHHD) program in ANZ 2001 – 2005 Growth of the Geelong program Generation of outcome data Proof of cost effectiveness
15	NHHD … Geelong 2001 - 2005 2002 – 2005 Presentation and/or publication of: 39 original manuscripts and scientific abstracts 83 invited speaker presentations - ANZ and international 2002 – 2005 Widespread interest and subsequent uptake across ANZ Government interest and support, then … Federal ‘home incentivization’ scheme (2005) State funding for NHHD (2005/6)
16	"The swing to extended hour..." The swing to extended hour and duration dialysis Australia
17	Extended hour and/or frequency (% Total HD patients - Australia)
18	Combined ANZ data – hours/session
19	"Despite our program success" Despite our program success A number of unsolved/limiting problems remained!
20	Sabbatical - 2006 Purpose: To seek answers/solutions to a series of problems that we had identified from our 5 year experience in NHHD that might help to: further advance the modality improve and build our technical skills and service delivery enhance the outcomes of our patient group
21	Sabbatical Activities Practices and Programs in home haemodialysis Seattle - USA Toronto - Canada Glasgow and Stevenage - UK Available technology Machines New technology Needles Spreading the NHHD word Lectures The International Quotidian Dialysis Registry Publications
22	"HOME HAEMODIALYSIS" HOME HAEMODIALYSIS (Practices and Programs)
23	Seattle Seattle – Weaknesses Central training in city centre only … away from suburbs Dingy, dark, ‘rabbit-warren’ underground area Mechanism failures in referral and information feedback Seattle – Strengths The ‘original HHD program’ – the HHD Mecca! Using BOTH new-generation machines – Aksys and NxStage Committed +++ home training staff and well established and funded research Strong home support systems with a paid helper scheme (= good and bad)
24	Toronto Toronto – Weaknesses Poor attention at outset to funding means they now lack Health Dept ‘buy-in’ Surprisingly poor research back-up Some centres located in a cramped, inner city service with limited access and traffic gridlock! Toronto – Strengths Where NHHD began so … longest track record and experience Well set up clinical systems and a strong, multi-disciplinary staff with highly motivated medical staff
25	Scotland and England UK – Weaknesses Poor resources (NHS) .. run-down + cash-starved Staff ‘inertia’ - Drs keen but nurses less so Very high patient : Dr and patient : nurse ratios So … new practices difficult to establish Funding, not enthusiasm = main issue … great interest in how we overcame this UK – Strengths Strong HDF expertise \ opportunity for further home modality Both Glasgow and Cambridge see HDF as a home modality goal Much less ‘closed minded’ than US to non-facility care Fertile ground for new technology … if they can afford it
26	"Machines" Machines
27	Machines … Unlike in North America, Australia has very limited range of dialysis equipment ANZ HD marketplace effectively only 2 companies although many options internationally I was aware that ‘available’ and ‘suitable’ new technology was ‘out there’
28	"Seek greater machine capability and..." Seek greater machine capability and flexibility
29	Our Current Technology Good, reliable, ‘cheap’, workhorses but … Big, heavy and a bit ‘clunky’ More complex than needed Slow/complex to set up (30-35 min) Slow/complex to pull down (20 min) Too many ‘bells’ and ‘whistles’ And … oft have they been told so But … so far … still no home-sensible model has emerged
30	"Aksys" Aksys™ Seattle March - May 2006
31	Aksys
32	Aksys - a sad tale in a cutthroat industry In a nutshell … At the start … awesome, outside-the-box technology but … Were ‘squeezed’ commercially from the start After ‘commercialisation’, funding shortfalls forced ‘cost-cutting’ ‘Cost-cutting’ led to technological and service ‘corner-cutting’ ‘Corner-cutting’ led to service break-downs and unreliability Furthermore … Machine is ‘clunky’ Early on … unable to sustain NHHD – issues with dialysate tanks size Later on … when NHHD-capable … by then = battered by funding war Great concept with superb technology advances but … struggling
33	"NxStage" NxStage™ Palo Alto May 2006 Boston July 2006
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44	NxStage (1) Small and ‘portable’ … but still heavy Excellent system for home, flat, travel, caravan or mobile home Practical issues No plumbing! Nifty click-in cassette contains all filters/lines etc 22 minutes … 1^st contact to dialysis start Whisper quiet Disassembly = fast and simple Non-intuitive front screen No inbuilt heparin pump … being solved Choice of only one dialyser (F70 high flux) Generates +++ council waste
45	NxStage (2) Overview Patients and staff ‘love it’
46	NxStage (2) Overview Patients and staff ‘love it’ Easy/quick to train
47	NxStage (2) Overview Patients and staff ‘love it’ Easy/quick to train Reliable, ‘trouble-free’ work-horse
48	NxStage (2) Overview Patients and staff ‘love it’ Easy/quick to train Reliable, ‘trouble-free’ work-horse Good technical support (in US) with rapid response
49	NxStage (2) Overview Patients and staff ‘love it’ Easy/quick to train Reliable, ‘trouble-free’ work-horse Good technical support (in US) with rapid response Uses no water (pre-prepared 60L ‘dialysate’) … a great ‘arid’ option
50	NxStage (2) Overview Patients and staff ‘love it’ Easy/quick to train Reliable, ‘trouble-free’ work-horse Good technical support (in US) with rapid response Uses no water (pre-prepared 60L ‘dialysate’) … a great ‘arid’ option Suitable for anywhere from short daily HD to long nightly HD
51	NxStage (2) Overview Patients and staff ‘love it’ Easy/quick to train Reliable, ‘trouble-free’ work-horse Good technical support (in US) with rapid response Uses no water (pre-prepared 60L ‘dialysate’) … a great ‘arid’ option Suitable for anywhere from short daily HD to long nightly HD This means = ideal for hybrid therapy
52	Hybrid therapy Is this the next step? An option I have been thinking about for some time What do I mean by hybrid therapy ? Its just an idea but consider 3 or 4 evenings/week of short HD (2-2.5 hr) coupled with 2 or 3 nights/week of overnight long hour HD (8hr)
53	"With a portable machine that..." With a portable machine that needs no water source just move the machine from living room to bedside and back As desired!
54	NxStage (2) Overview Patients and staff ‘love it’ Easy/quick to train Reliable, ‘trouble-free’ work-horse Good technical support (in US) with rapid response Uses no water (pre-prepared 60L ‘dialysate’) … a great ‘arid’ option Suitable for anywhere from short daily HD to long nightly HD This means = ideal for hybrid therapy It does HDF \ as at home in an ICU as in a HD unit (one does all)
55	NxStage (2) Overview Patients and staff ‘love it’ Easy/quick to train Reliable, ‘trouble-free’ work-horse Good technical support (in US) with rapid response Uses no water (pre-prepared 60L ‘dialysate’) … a great ‘arid’ option Suitable for anywhere from short daily HD to long nightly HD This means = ideal for hybrid therapy It does HDF \ as at home in ICU as HD unit (one does all) Potential = CKD5 home care + ICU for ARF - all in one machine)
56	NxStage (3) But … ? Expensive US-centric marketing only Nil ‘off-shore’ marketing … to date Visit NxStage @ … http://www.nxstage.com
57	NxStage (4) Overall Impression A neat, nifty, cool home HD machine But … expensive hardware/software Would need $ off-sets from wage and infrastructure savings Current NHHD saves $10,000/pt/yr … these ‘savings’ would likely ‘go’ Significant cuts to ‘on’ and ‘off’ times Total on/off times: Current ±45-50 min NxStage ±35-40 min Plenty of good features but some disadvantages too Clear current new-technology market leader and ‘the one to watch’
58	"Allient" Allient™ Pittsburgh July 2006
59	Allient Eagle™
60	Allient Eagle™ (1) An old technology re-visited … 21^stC style Uses a ‘sorbent cartridge’ system to regenerate dialysate A modernization of the old ‘REDY’ machine Designed specifically for overnight home market Single needle dialysis ‘routine’ via unique flow pump but … Will dialysate regeneration ‘have enough grunt’? What will be the price and consumables cost?
61	Allient Eagle™ (2) But …its major advantages are … Water conservation The Allient uses 6L/dialysis c/w current equipment @ >500L/dialysis per treatment In water-poor countries and/or patients from tank-dependant country areas, this alone is a potent advantage Stand-alone technology No need for tap or drain connections … its free-standing Wheel and go!
62	Allient Eagle™ (3) Visit to Renal Solutions Inc. (Pittsburgh) Impressive on several counts … The machine The company management The design team and design concepts The investor and venture capital base Outcome JWMA appointed to RSI Medical Advisory Board Visit RSI @ … http://www.renalsolutionsinc.com
63	The ‘Eagle’ and the ‘Elephant’
64	Water-wise … a huge issue! Huge potential water-saving advantages with new technology Current Equipment Measured Use @ 512 litres/treatment Newer Machines Aksys @ 56 litres/treatment NxStage @ 60 litres/treatment Allient @ 6 litres/treatment
65	In _eOP … (i.e. Olympic Pool equivalents) NxStage would save (Australia-wide) ~ 621,916,000 litres/year Allient would save (Australia-wide) ~ 678,525,000 litres/year Volume of an Olympic swimming pool = 3,125,000 litres * Therefore:- NxStage would save ~ 199 Olympic pools/year Allient would save ~ 217 Olympic pools/year * http://hypertextbook.com/facts/2005/JeffreyGilbert.shtml
66	Additional observation … (non-sabbatical) Dialysis-related water wastage could also be dramatically reduced if:- R/O reject water is trapped and tanked for grey water * Gardens Washing appliances (dishwasher/washing machines) Toilet flushing NB: We do this for country-based, tank-water dependant NHHD pts Arguably we should do it for all – home and facility-based This is currently NOT funded – but should be!
67	"Access" Access and Needles and Needling Technique
68	Access
69	Needles … Problem Needling the AVF is a prime issue in NHHD due to … Increased number of 14-15g steel needle insertions 2 per dialysis x 6 treatments/wk = 12 needle episodes/wk 8 hour needle-dwell during sleep Potential risk of sepsis Solutions Buttonhole technique … we have become ‘devotees’ or … Make a dual lumen needle for single needle dialysis
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73	Dual Lumen Needle (DLN) 1984: two devices developed in Seattle: Dual lumen catheter used worldwide in every ICU and dialysis service Dual lumen needle never ‘took off’ … no perceived ‘role’ for it then NHHD ideally suited to single needle approach 1° purpose of sabbatical = re-invention of DLN So … back to Seattle and Medisystems Inc See http://www.medisystems.com
74	The old ‘Mahurkar’ DLN
75	Why a dual lumen needle? Up to 6 NHHD sessions/wk 2 needle insertions/session 12 episodes/wk of discomfort, anxiety & risk A dual lumen needle has the attraction of: ½ the number of insertions ½ the number of episodes of ‘distress’ ½ the exposure to needling ‘risk’ Disconnection, blood loss, sepsis etc
76	Medisystems.com Largest needle design/production company in US Showed immediate interest Sketch prototype within 2 weeks Potential models for strength-testing within 6 weeks Flow and strength issues identified ® →→ re-design Potential to overcome with a new extrusion polymer plastic Current state of play … New high strength/flow prototype soon to be available
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78	Needling techniques (1) Buttonholing …a personal view … Geelong are strong ‘believers’ … Also strong belief in Seattle and Toronto Infection risk is the practical issue Toronto uses mupirocin (an anti-MRSA antibiotic) to needle site ? Long-term risk of resistance … not sure I like the mupirocin answer I believe a better way is … Good training + Medi-honey General HD nurse resistance still seems strong across US but … US dialysis is $ driven, not process ± progress driven I found dialysis in the US to be very, very sad indeed
79	Needling techniques (2) 2. Antegrade – antegrade needling
80	"Why" Why?
81	A lone, lost voice … Woodson RD & Shapiro RS (D&T) … in 1974! … noted a nursing tendency… to insert the arterial needle retrograde to ‘maximize’ end-on pressure … noted the risk of … haematoma formation sheer force haematoma filling (retrograde) vs tract closure (antegrade) vein wall trauma ± aneurysm formation … recommended that … retrograde cannulation “should be avoided”
82	Retrograde v Antegrade puncture
83	"Did anyone listen" Did anyone listen? NO
84	I believe … All fistula needles should ‘point at the heart’ i.e. antegrade-antegrade needle insertion We follow that principle as, now, do many/most Australian services (let’s trust the US changes over time!)
85	"And lastly" And lastly ‘cos you’ll be as bored of me as he is
86	The ‘Nipro peg’ – buttonhole maker Toma devised an indwelling polycarbonate ‘peg’ for buttonhole (BH) track creation The BH method is rapidly gaining popularity, especially among home dialysis patients If confirmed, the peg may help to further popularize the BH technique for needling AVF Trials at St Michaels, Toronto, 2006 (in press) confirm its effectiveness and ease of use … its cost seems the major hurdle
87	The ‘Nipro peg’ Toma devised an indwelling polycarbonate ‘peg’ for buttonhole (BH) track creation The BH method is rapidly gaining popularity, especially among home dialysis patients If confirmed, the peg may help to further popularize the BH technique for needling AVF Trials at St Michaels, Toronto, 2006 (in press) confirm its effectiveness and ease of use … its cost seems the major hurdle
88	Conclusion My sabbatical was … Professionally stimulating Academically rewarding It has … Allowed overview of local practices in a wider arena Permitted clearer vision of: What we do well What we do badly Where we could advance Ways to achieve that advance
89	More importantly … It has … Triggered renewed enthusiasm to … Attract new technology here for home patients and … Widen the choices further with Single needle technology Hybrid day/night programs + portable machines Seek water conservation
90	Thanks for your patience and for information re nocturnal dialysis visit my website at http://www.nocturnaldialysis.org