Hydroxy Ethyl Starches – are we nearing the end of the road?

When the VISEP study was published in 2008,1 proponents of colloid based resuscitation (myself included) argued that, since the study was conducted using old generation pentastarches, the data were not generalizable to all hydroxyl-ethyl fluids.2 Indeed there was an emerging body of evidence supporting the safety of newer, lower molecular weight starches; particularly those composed of balanced salt solutions. Since the mind boggling revelations about the potential scale of academic misconduct by Joachim Boldt,7 with a large number of his publications now expunged, we have all become somewhat anxious about the true safety of HES compounds. The answer is now here, following the publication of the 6S study from Scandanavia.6
       Colloid fluids have one purpose – to reduce the volume of fluid required to achieve hemodynamic goals. There is something of a transatlantic controversy – the majority of European clinicians have traditionally been colloids believers; the majority of North Americans are not. Colloids are more expensive than crystalloids, have known allergic and bleeding potential and the onus of proof is always on the intervention. Presumably, if colloids are effective, they restore the circulation rapidly, prevent organ failure, prevent fluid related morbidity (pulmonary edema, wound complications, ileus etc.), reduce the length of hospital stay and reduce mortality. If these results are not achieved then colloids are, essentially, intravenous “snake oils”. Previous literature, suggest the opposite – that HES products, in particular, are associated with allergy, renal dysfunction and bleeding. There is essentially no supportive evidence in the ICU, and evidence to support colloids in the operating room is more strongly associated with the use of devices such as esophageal Doppler to achieve resuscitation goals. 4 Nevertheless, there is an emerging consensus that fluid over-resuscitation is associated with medley complications, and that measures that restrict overall fluid volume, particularly from 8 to 72 hours following injury or surgery, may be associated with improved outcomes.3-5 Often fluid studies are single centred, compare one colloid against another, or use weak or surrogate endpoints. What we needed was a multicentre, international study, that looked at hard long term endpoints.

The Scandanavian group randomized 800 critically ill patients to a Ringer’s acetate solution that either contained 130/0.4 HES or did not.6 The patients were followed on an intention to treat basis for 90 days. Patients were enrolled if they met the criteria for severe sepsis within the previous 24 hours. Patients were given fluid by bedside clinicians in accordance with their clinical judgement (i.e. there was no fluid resuscitation protocol), and were blinded to the nature of the fluid administered. The quantity of study fluid was limited to the maximum daily dose of colloid (50ml/kg); open label Ringer’s acetate was administered if this volume was exceeded, and patients could receive saline, blood products and albumin.
This impressively simple study was conducted in 4 countries, with 50% of patients being cared for in academic medical centres and 50% in community hospitals. The study was powered to demonstrate a 10% reduction in mortality among 800 randomized patients at 90 days. What the authors demonstrated, however, was the opposite.
At 90 days following randomization, 201 of 398 patients (51%) assigned to HES 130/0.4 had died, as compared with 172 of 400 patients (43%) assigned to Ringer’s acetate (absolute risk increase of 8%, number needed to treat 12; P=0.03). In the 90-day period, 87 patients (22%) assigned to HES were treated with renal-replacement therapy versus 65 patients (16%) assigned to Ringer’s acetate (absolute risk increase of 6% NNT 16; P=0.04). The risk of bleeding did not reach statistical significance – although post hoc analysis following randomization suggests that the HES group had a greater incidence of bleeding.
Interestingly, the volume of fluid administered to each group was not different: there was not colloid-effect, no fluid sparing. This was consistent with the findings of the VISEP trial.2 Although a significant proportion of both groups received blood products or albumin, there was no statistical significance between the groups. In fact, the only difference between the groups was whether or not HES was administered; patients that received HES 130/0.4 were more likely to die or have kidney injury.

At this point in time the weight of evidence is now stacked up against the use of HES solutions in critical illness; the use of these agents in septic shock cannot be justified.

References

    1.    Brunkhorst FM, Engel C, Bloos F, Meier-Hellmann A, Ragaller M, Weiler N et al. Intensive Insulin Therapy and Pentastarch Resuscitation in Severe Sepsis. N Engl J Med 2008;358(2):125-139.

2.    Brunkhorst FM, Engel C, Bloos F, Meier-Hellmann A, Ragaller M, Weiler N et al. Intensive Insulin Therapy and Pentastarch Resuscitation in Severe Sepsis. N Engl J Med 2008;358(2):125-139.

3.    Kehlet H, Bundgaard-Nielsen M. Goal-directed Perioperative Fluid Management: Why, When, and How? Anesthesiology 2009;110(3).

4.    Lubarsky DA, Proctor KG, Cobas M. Goals Neither Validated Nor Met in Goal-directed Colloid versus Crystalloid Therapy. Anesthesiology 2009;111(4).

5.    Nisanevich V, Felsenstein I, Almogy G, Weissman C, Einav S, Matot I. Effect of Intraoperative Fluid Management on Outcome after Intraabdominal Surgery. Anesthesiology 2005;103(1).

6.    Perner A, Haase N, Guttormsen AB, Tenhunen J, Klemenzson G, +àneman A et al. Hydroxyethyl Starch 130/0.42 versus Ringer’s Acetate in Severe Sepsis. N Engl J Med 2012;367(2):124-134.

7.    Shafer SL. Shadow of Doubt. Anesthesia & Analgesia 2011;112(3):498-500.

This article is copyrighted by Patrick Neligan 2012 please do not reproduce without permission

Regional Anaesthesia Thursday Meetings Schedule Autumn 2012

26-Jul-12 TAP block Dr. J.Mc Donnell.
02-Aug-12 From TAP to Stellate Dr. Olivia Flinnerty.
09-Aug-12 Physiology of Pregnancy Dr. Aoife Quinn.
16-Aug-12 Failed block what to do?

Epidural test dose

Dr. Joye Coyne.
23-aug-12 LAST ? Dr. B. Kinirons.
30-Aug-12 Axillary brachial plexus block. ? Dr. J.Mc Donnell.
06-sep-12 Facet joint injections and medial branch blocks. Dr. Vladimir Alexiev.
13-sep-12 Pharmacology of LA. Dr. Aidan Magee.
20-sep-12 Pre-eclampsia Dr. Ahamad galal.
27-sep-12 Cardiac disease & pregnancy Dr. Dalia Abdelrahaman.
04-oct-12 Pain Talk-1 Dr. Mahesh.
11-oct-12 Obstetric Haemorrhage Dr. Pramod palhade.

 

18-oct-12 Paravertebral block Dr. Philip Johnson.
25-oct-12 Ultrasound guided obstetric block Dr. Joye Costello.
01-nov-12 Neurological Disease and Pregnancy Dr. Solmaz Nakhjavani.
08-nov-12 Interscaline/Suprascapular block Dr. Roseita Carrol.
15-nov-12 Truncal Block Dr. C. Hanley.
22-nov-12 Pain Talk-2 Dr. Mahesh.
29-nov-12 Sciatic block Dr. Michael Hurley.
06-dec-12 Femoral & Lumbar plexus block Dr. Bilal Ansari.
13-dec-12 Distal Lower Limb Block  

Tuesday 8am meetings May 2012

Tuesday 8 a.m. Meetings

 

Venue: ICU conference room 

May

1st

Thoracic anaesthesia

Dr Brian Harte

 

8th

The surgical patient with a pacemaker

Dr Leo Kevin

15th

Cardiac anaesthesia

Dr Paul Naughton

22nd

Oral opioids for acute pain: do you know your oxycontin from your oxynorm?

Dr Tadgh Lynch

29th

Pre-operative optimisation (Provisional title)

Dr Scully

 

WAS speakers at international events in 2012

WAS speakers will travel a little beyond Galway in 2012!  Here are some 2012 international events that feature lectures from WAS regulars:

Dr Brian Harte on advanced airway management

ESA Paris June 9 – 12

http://www.euroanesthesia.org/sitecore/Content/Congresses/Euroanaesthesia%202012.aspx

Dr Patrick Neligan on bariatric anaesthesia

World Congress of Anesthesia, Buenos Aires, Argentina, March 25 -30

http://www.wca2012.com/en/

Dr Leo Kevin on surgery for carotid endarterectomy

Society of Cardiovascular Anaesthesia (SCA), Boston ,USA April 28 – 31

http://www2.scahq.org/sca3/events/2012/annual/

Dr John McDonell on regional anesthesia

(ESRA), Bordeaux, France September 5 – 8

http://www2.kenes.com/esra/Pages/Home.aspx?gclid=COOc7oG65q4CFcZc3wodfiqnjg

If you are attending any of these meetings, why not drop by the ‘WAS International’ desk at the exhibit hall!

Ultrasound for central venous access

The ASA has published its guidelines for central venous access (see link below).  I am regularly amused by the slavish credence given by trainees to use of ultrasound as ‘mandatory’ for central  venous access.  Why I ask?  That ‘s what the NICE guideline says, they reply.  Do you work in the NHS I ask?

Yes ultrasound has undoubted utility for central venous access at times, and I have made good use of it.  But should it be a standard of care? Are landmark-based techniques worth learning in the modern age?  The ASA is much more luke-warm about ultrasound, as is the rest of the world! ‘Equivocal’ is the operative term throughout…

Studies show how useful US can be – but that is what the studies were meant to show!  They were performed by enthusiastic users of a new technology.

Maybe its our colonial heritage that makes us absorb NICE (and similar) admonitions as if they were coming from a high authority to which we owe allegiance.  Incidentally, the best informed UK anesthetists (several of whom with which I have worked) have many amusing things to say about the level of expertise that goes into NICE guidelines.  There has also been some thoughtful discussion in recent editions of anesthesia.

Here is the ASA link in Anesthesiology.

http://journals.lww.com/anesthesiology/Fulltext/2012/03000/Practice_Guidelines_for_Central_Venous_Access__A.13.aspx?WT.mc_id=HPxADx20100319xMP

Anaesthesia Ireland – present tense, future – bright but scary

Run through training at last – this will guarantee a bright future for our specialty and correct the wrongs of a previous generation. But some questions must be asked. This process may open a Pandora’s box regarding anaesthesia staffing around the country and may ultimately hasten the implementation of a sub consultant grade.

In the late 1990s the Specialist Registrar System (SRP) was introduced – and it ambushed the Department of Health. They could not distinguish SPR from senior registrar (SR) with the result that trainees essentially went from SHO  to SR salaries, they received SR contracts and started looking for non clinical days in addition to study leave. Softened up by higher incomes and the removal of the SR bottleneck, trainees were bamboozled into significant changes in training. The first was the 7 year rule – a minimal of 7 years of training. The logic behind this was the UK trainees were quoted as stating that they “didn’t feel that they were ready for consultancy after 6 years” [nobody bothered to ask the Irish trainees – but we told them anyway that we disagreed]. This was a patent absurdity – all Irish graduates went on to do fellowships abroad at that stage, so training time was at least 8 years plus a year in the doldrums if you failed your primary or didn’t accrue sufficient brownie points to get into the SPR system. As a hedge, the College, then in it’s infancy, introduced the “year 3 out” system: you could take a year off at year 3 SPR and do a fellowship then; of course you had to be back in a year to recommence your training. It was inevitable that this would leave a huge hole in training numbers – year out trainees couldn’t be replaced – there would be empty slots. Would anybody be back within a year? Unsurprisingly, chaos followed. Hospitals never knew from one 6 month period to the next whether or not they would be getting a full compliment of SPRS.

Simultaneously, the number of anesthesia trainees in Ireland mushroomed, driven principally by the need to have an epidural service in every general hospital in the country. Hospitals clamoured to obtain BSTs, hired lots of “non scheme” NCHDs, and loose criteria for training, the need to reduce the frequency of call and various college sponsored “programs” (7/6 etc) meant that the number of NCHDs in anesthesia in Ireland grew relentlessly over the past decade. With the bloated SPR system and light touch regulation of training, NCHDs that in the past spent most of their training time in Dublin, Cork or Galway, were now trotting up and down the country every 6 months, often on a provincial towns circuit to provide service, rather than obtaining competency based training. This led to a generation of tired, bored NCHDs, that often found it difficult to return from Australia to finish their “training”. Yes, after 7-8 years you couldn’t help but be a competent anesthetist – but it only takes 3 years in the United States.

Drunk on high salaries and 21st Century Irish hubris, the trainees plodded along: the Anaesthetist in Training Group – once a potent force with year reps, reps to AAGBI, IMO and GAT, became a shadow of itself (an now appears to have disbanded).* The caliber of trainees, frankly, fell – in some cases – quite sharply. In recent times, the economic crisis seems to have snapped a lot of heads into focus….

The last 12 months has seen the resurrection of Irish anaesthesia. The BST programmes have become hyper-competitive to access. The distribution of trainees has streamlined. The year out has been closed off. And now, training has been shortened to 5+1 (as opposed to 7+whatever). Five plus 1 means that you only have to do 5 years of training in Ireland: the 6 year, required for CCST, can be spent doing fellowship training abroad – assuming that your competencies are in place. In this the College is taking a calculated risk – 1. that among all of those “general” jobs around the country, the competencies are actually there, 2. with theatre closures and other austerity measures modules may suddenly evaporate, 3. senior registrars at year 5 will want to stay and do fellowships. On the surface one would assume that the more ambitious would head for the stars after 5 years – but this has not been the case in other specialties, particularly radiology, that introduced a +1 year. Do you really need to do a fellowship abroad to be an anesthetist in Ireland? No – but all of us that have travelled believe that training abroad has improved us as doctors, as people, and broadened our viewpoints.

Where are the other challenges in this system? Our specialty needs to become more family friendly – too many trainees are spending their weekends (and non clinical days I would think) criss crossing the country to spend time with loved ones and children, while exiled away from home. The re-regionalisation of training will certainly, and welcomingly, improve this. For example, trainees in the WRAT`s/SPR scheme will come to the West for 3 full years – 2 of which will be spent (one presumes) in Galway. Presumably they will then move on to Dublin and stay there for the next 2 years and decide themselves how to spend their fellowship year.

Annualised intake is going to be a problem: with staggered intake, most large hospitals had 1 or 2 beginners every 6 months, and they gradually moved onto the call system three months in. This was not problematic – now beginners will arrive once a year and there will be a lot of them. In the United States, of course, 30% of residents switched over every July – summer was a very busy time for everybody concerned, but once September came, the new residents carried a relatively greater burden of call. We really cannot do that in Ireland – particularly if the European Work Time Directive ever becomes enforced. Summer may be savagely busy for mid level trainees.

Further, there appears to be an evaporating pool of non training NCHDs in Ireland. Those that were hired from India & Pakistan during the HSEs global recruitment drive were underwhelming (to say the least) – with no obvious career plan or pathway. It has to be said – that after decades of training non EU medical graduates in anesthesia, we do have a responsibility to continue this into the future. It is inconceivable that non EU graduates will get into BST places in any quantity for the foreseeable future. So why come to Ireland at all? There is going to be an inevitable service gap in anesthesia in Ireland: who will fill the clogs of non training NCHDs in the future? Will it be nurse anesthetists (unlikely and unacceptable), nurse practitioners (certainly in pain and maybe ICU), permanent registrars (yes – they already exist and they will become more plentiful) or will they be post-CCST “specialists”?

I would hate to think that we are training a generation of talented young anesthetists to fill service level jobs in the HSE; with little career progression, subordinate to their consultant colleagues. Certainly promotional grades within the consultant body is a good idea (to prevent premature “retirement”), but the subconsultant grade is just a yellow-pack alternative. Not even the British have gone down this line. While it remains possible for our medical graduates to obtain employment in more remunerative health systems (North America, Australia, New Zealand), the Department of Health should thread lightly when dealing with future medical manpower. The current “high cost” model of consultancy is one of the great myths of Irish medicine: healthcare workers become expensive when they start getting additional payments for nights, weekends and bank holidays. Consultants provide out of hours services for very little reimbursement. Interestingly, many North American academic centers have replaced nurse anesthetists with physician anesthesiologists because, overall, they are less expensive: doctors are more flexible in terms of working hours, rest times, breaks and can do everything (a nurse cannot consent a patient for anesthesia!). The DOHC might be better of re-negotiating with the current consultant group than dumping on the specialists of the future.

Will the run-through training scheme produce a generation of anesthetists that are more likely than those currently finishing off their training to take “Specialist” (sub consultant) positions? You better believe it: a young doctor told day 1 that they would be guaranteed a consultant slot in 10 years – after 6 years of training and 4 years as a specialist – would jump at it [See Maslow’s hierarchy of needs (click here) – level 2 SECURITY!]. Don’t kid yourself, the majority of trainees engaging in anesthesia in 2012 will not head off to Australia or North America for 2 or 3 years, they won’t have a pile of publications when they apply for permanent positions, and they will likely, keenly, take permanent “specialist” posts.

How do we, as a fraternity combat the inevitable “dumbing down” of anesthesia:
1. We need to encourage research and academic endeavors as aggressively as we do exam preparation. Academics must be seen as a lifelong obligation – not just a box-ticking process to “get a job.”
2. There needs to be specialist pathways within the career of anesthetists: you need to decide that you are a researcher, an educator, a manager or an expert clinician. WIthout being one of the above you cannot become a consultant (as we know them today).
3. There needs to be a late training challenge: an exit exam, a thesis or the requirement to obtain an advanced degree to obtain CCST. For example – all final year SPRs might be required to submit a thesis to obtain a Masters in Anaesthesia.
4. There needs to be a secondary pathway into anesthesia in Ireland, for those that commenced training in equivalent systems abroad.
5. Fellowship training should be targeted towards need: there has been a constant stream of trainees going to Australia to become intensivists over the past decade – but where are the obstetric anesthetists, neuroanaesthetists, those that did ambulatory care, masters in education etc? If the HSE want s to employ the highest quality “specialists” they need to finance specific fellowships abroad – needs based – and trainees will travel knowing the type of job that they are coming home to.
6. Continued professional development needs to be encouraged, but not the current CME points accrual system. It astonishes me how few of our trainees are inquisitive – how little time is spent reading journals and researching dogma, how little time is spent in the library, how few “read” after passing their FCAI exam. Everything is easily obtained online now, everybody has smartphones and tablets – there is NO EXCUSE for anybody practicing anaesthesia not to be familiar with the contents of the current journals. On this site we share a twitter feed that points our visitors to worthwhile reading material. This is a strange phenomenon that appears specific to our specialty – can you imagine encountering an oncologist or a cardiologist that is unfamiliar with the latest literature in their field?

Overall, congratulations to the College for a brave effort to brighten up the future of our specialty. We don’t know where it will lead, but with good husbandry, collegiality and engagement, we might have to “wear shades.”

* I see that the College has gotten so fed up with lack of trainee representation that they have created the Group of Anaesthetists in Training (to essentially replace the ATI), and are providing facilities, IT support and secretarial assistance. While this is wonderful, one has to wonder – why they had to do it?