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 | Updating Practices in an Evolving IV Iron and Anemia Environment: Practical Solutions  ANNA 2007 Satellite Symposium Establishing a Maintenance IV Iron Protocol to Enhance Patient Outcomes |
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00:00
Introduction
Mr. Juergensen: Andrea, thank you very much.
00:02
IV Iron Protocol to Enhance Patient Outcomes
It's a pleasure being here today to talk to you about protocols and the issue of managing anemia in our dialysis population, which, as you know, is so important so that we can control and enhance the lives of our patients on dialysis and improve their outcome. As Andrea has mentioned, it's a very complicated process. Anemia management is not just an issue of having the EPO dose ordered everyday, every time the patient comes to dialysis, or giving the iron. But it's a complicated process of numerous factors affecting anemia, and there is some team approach with everybody involved in the patient management so that you can correct the anemia in these patients. And the process can be helped dramatically by having an adequate protocol, so that if your unit does not have an adequate protocol, know that anemia management is markedly improved if you have the correct protocol in place to help with the patients. So what I would like to do is see if we can talk a little about anemia protocols and management and iron protocols in our dialysis population.
01:10
Objectives
First of all, what we like to do is identify tactics for proposing improvements in the current process. Go back and look at your protocol to see if it's inadequate. Is it up-to-date? Was it made way back; did you establish it 5 years ago when the unit started, or 10 years ago? Has it not been updated? It's clear that you need to update your protocols at least on a yearly basis. Evaluate factors that may influence the decision to introduce some maintenance IV iron protocol into your facility. It's always easy to give iron at a loading dose. Besides, the patient needs iron based on certain parameters that you have in your protocol. But the decision to give a maintenance dose is really the key, so that, as Andrea mentioned before, it's always day 19 for some red cell precursor in the patient's body, so that you have to have a constant iron supply going into that patient. Define strategies for piloting a new iron protocol if one has not been piloted in a while, and examine the effectiveness of an IV iron maintenance protocol in improving patient outcomes through case studies. I have a few case studies that we can look at, but it's always good for you to go through CQI (Continuous Quality Improvement) in your own dialysis unit to determine if you are looking at the outliers. Are you looking at the difficult patients? And look at those case studies to improve your management, so that the rest of the patients can benefit, not just that one patient that you are talking about.
02:29
Iron and Anemia Management: Concerns in HD Patients
Going back to the data, here we are looking at the DOPPS data, the Dialysis Outcomes and Practice Patterns Study, that looks at units both in the United States and in Europe. And this demonstrated clearly, that over 30% of our patients on hemodialysis in the years 2002 and 2003 presented with iron deficiency. So as you know, you have to clearly look at the new patients coming into the unit. Do they need a loading dose of iron to correct their iron deficiency? And it's also a sad reflection, that those patients are not treated adequately in the CKD stage, where the iron was not dosed or given in CKD to get them up to where they should be.
So the bottom line is, that we know that patients are iron deficient, we need to aggressively identify the new patients and administer iron, because the odds are that they're probably going to be, to some degree, iron deficient. And ESA therapy can lead to what is called functional iron deficiency, or a new term—iron-restricted erythropoiesis—where you think that they have enough iron based on a high serum ferritin, but in reality, that iron is in storage in the hepatocytes or in the macrophages and is not coming out. So in the bone marrow, the precursor cell has no iron available, or very little iron available, to make new red cells. And if you give a lot of EPO, that actually can occur—where whatever iron is in circulation or in the bone marrow is quickly used up, but no new iron is coming to the marrow, and so you have this functional iron deficiency. Then, as Andrea mentioned before, there is considerable variability observed within dialysis units regarding iron dosing, TSAT levels—again, that can be affected by nutritional status—and serum ferritin.
04:15
Benefits of a Maintenance IV Iron Protocol
What are the benefits of a maintenance IV iron protocol? 1) It prevents this absolute iron deficiency. On a weekly or biweekly basis, you are giving IV iron, so that you always have some iron available for the bone marrow to make new red cells. It helps to avoid this iron-restricted erythropoiesis. It reduces the fluctuation in iron dosing and iron supplies. In other words, you have the protocol in place, the patient is getting what you perceive to be the iron need for that patient. And as Andrea mentioned before in a previous slide, you can estimate what the needs are for iron in a patient over a year, so on an average they tend to lose at least 1 gram of iron, and it can be up to 3 grams of iron, in a year's period of time, depending on the hospitalization admissions, if there have been bleeding episodes, and other factors that may cause that patient to lose a tremendous amount of iron. So at least you know that 1 gram is needed per year—and that you can translate that into a monthly dosing. The benefits of a maintenance IV iron protocol? Obviously it stabilizes your hemoglobin levels, because there is a constant supply of iron to the marrow, so that you can induce erythropoiesis.
05:24
Tactics for Improving Anemia Outcomes: Getting Started
What are some of the tactics that we can use to improve anemia outcome? First of all, you've got to get started. You identify factors that can result in improvement, such as when assessing anemia management, start with the most recent hemoglobin, TSAT, and serum ferritin. And then you just cannot look at that. You have to go back and say, "Okay, what has happened in the last 3 months, and the last 4 months, in the patient?" And if you can get a nice flow sheet on each individual patient, you can see a trend as to what has happened to that patient. Has the hemoglobin been steady? Has the TSAT and ferritin been steady at whatever level? Or has there been a sudden fluctuation one way up or down? Analyze your IV iron and ESA use, along with notable lab changes in those patients. Have there been admissions into the hospital? Have there been missed doses of iron or EPO doses while the patient was hospitalized? Many times patients go into hospitalization for short term surgery, they have been gone for 1 or 2 days, they have the surgery, but you never even know about it. They come back the next day and they tell you 2 weeks later that they had some sort of procedure. Maybe they came in for a day or two, and they did not get their EPO dosing on the floor. So the issue is, you have to go back and track what the EPO and iron dosings were during the hospitalization period, and if trending is inconclusive, review other lab indices like the nutrition, albumin, and patient-specific conditions. Is there any evidence of GI bleeding? Is there any evidence of recent infection? All those factors have to be included in the anemia management protocol.
06:58
Analyze Your Current Protocol
Issues that you need to go back to include, do you track the hemoglobin of your incident patients? And yes, you have to do that, you just cannot go and say, "Okay, my monthly labs have come back, my hemoglobin dropped to 10.5. I am going to increase the EPO dose 25%" and then go on to your next patient. You really have to go back and see why it is that, that patient now has a Hb of 10.5 when it was 11.5 the month before. What has happened to that patient? You just cannot merely increase the EPO dose and ignore what has transpired to that patient. How do you treat the sub-11 values? How aggressive do you get in those patients in managing their hemoglobin? And with these sub-11's, obviously, now we have a much narrower target to play with. Before, we felt comfortable if the hemoglobins went up to 12.5 or 13, but now KDOQI is telling us that we have to stay between the 11 and 12, so it's a much more difficult game that we're playing in managing these patients.
So we have to be not only aggressive in treating the sub-11's, but, as Andrea also mentioned before, you do not want to zap them with tons of EPO and shoot their hemoglobins too high. So one nice thing about the standard maintenance dose of iron is, that it tends to keep the hemoglobin level more stable.
09:16
The Art of Negotiating Change
So you need to negotiate a change. Propose changes to all the team members that they will accept and support, so that you can get an adequate protocol in place. Implement a protocol that has proven itself, thereby improving patient outcome. It balances EPO use and iron dosing and simplifies the anemia and iron management process in those dialysis patients, so that you can have a protocol that is effective, that is not just sitting on paper, but is actually an implemented protocol.
09:47
Factors That Influence the Introduction of a Maintenance IV Iron Protocol
Factors that influence the introduction of a maintenance protocol. Each clinician has their own style, their own style of treating anemia within a unit, and if you have 3 to 4 different units in your system, that is probably not the right thing to do. You want to have a system in place that everybody understands, it's proven that it works. And this way, you can have a much better outcomes in the patient population. If you lack an existing IV iron protocol, then obviously, in my opinion that needs to be changed. If you have no anemia manager, you are in deep trouble. You want to have an anemia manager—they're the most wonderful thing that exists, and if you have a good anemia manager and a good anemia team, the patients tend to do much better. A facility may have poor anemia outcomes compared to other units or US trends, so you can look back. I know we got a report card in our RRI (Renal Research Institute) units as to where we fall within the Renal Research Institute units that we have, and we can look at them and see where we stand. Are we doing an adequate job compared to the other units? So if we are not, then there is something wrong.
10:52
More Patients Could Benefit From IV Iron
In this Annual Report, where we look at the percentage of adult in-center hemodialysis patients in 2004, compared to previous years, 1996 going to 2004, and you look at the percent of patients prescribed IV iron and the transferrin saturations. You can see that there has been a trend going north. So that more patients are getting IV iron and the TSATs have improved somewhat. But if you still look at the other end of the spectrum, you have a fair number of patients who are not getting the IV iron that they should be getting. So the issue is, even if there have been protocols in place, we're still not achieving the target that we would like to achieve in getting that iron into those patients.
11:38
Sufficient IV Iron Dosing to Meet Iron Demands
Many patients may not be receiving sufficient iron dosing to meet these iron demands. So if you look at, again, the 2005 Annual Report, if you look at percentage of patients and the mean IV iron dose, in this slide it's shown to be 261 mg per month. So that translates into over 2 g, or close to 3 g, per year. But if you look at the number of the mean iron doses of less than 100 mg per month, and you know you are going to have more losses than a 100 mg per month in most patients, it's a large percentage; 26% of patients are not getting enough iron. So again, I think an adequate IV iron protocol, if you have it in place, will prevent that from happening.
12:23
Strategies for Piloting a New IV Iron Protocol
What are the strategies for piloting a new IV iron protocol? Well, you have the KDOQI guidelines and recommendations. You have a variety of good renal journals and Web sites that are available for you. You have clinical support specialists that can help you in any process, and best demonstrated practices, and package inserts. So you have a tremendous amount of information out there that can help you in managing these patients.
12:50
Anemia Team / Manager
The anemia team and manager can help improve the process dramatically. Team members involved in the decision making should have a strong understanding, so the anemia team should be well educated, should understand the whole process of anemia, that it's a complicated process, that managing anemia with IV iron and EPO therapy is a balanced approach. You need to understand how to interpret the iron measures and assess infection and inflammation, and this was, again, brought up by Andrea. This whole process of inflammation and infection, so that if somebody has an acute infection, that is easy to make a diagnosis. They have a high white count. They have a fever. But then if you look at inflammatory markers, you have somebody who is on a high EPO dose, somebody who looks chronically ill, somebody who has a low albumin—all those factors are indicators of some inflammatory process going on. And one of the wonderful things about having patients going through a pretransplant workup is, they have to have a dental exam. And there are clear data showing that mortality is higher in those patients who have horrible dentition. So the issue is, that you need to carefully look at each individual patient, and especially at the outliers who are not being managed appropriately.
14:08
A Simplified IV Iron Protocol
Here, for example, is a simplified IV iron protocol that is available, and I am going to show you 2 different protocols here. So if you look at their repletion scheme, where you load the patients, you have a TSAT of less than 20%, you have serum ferritin according to the new KDOQI guidelines—less than 200, not less than 100. And here you can IV load those patients with 125 mg of ferric gluconate over 10 minutes, for 8 sessions, and so load them up with 1 g of iron. Then you draw the labs again 5 to 7 days after that, and if this TSAT is still low and the ferritin is still low, you can then repeat the whole loading process again. If that has been done, and the patient has been loaded and the TSAT and the ferritin numbers have improved, then you look at the maintenance protocol that is available for you. And that protocol in this example here is, in all the settings in the first 2 to 3 lines, with TSATs of greater than 20%, and then you look at the serum ferritins. And the ferritin of less than 500, 500-1200, or greater than 1200. And those are the sort of recommendations that are suggested in this protocol, which I think are fairly reasonable, that you give the iron either on a weekly or biweekly basis, depending on what the serum ferritin is. Again, remember that as you get closer to the 1000-1200 mark, that tends to imply that the patient has an inflammatory process going on.
15:36
Final Steps: Future Actions
The issues that we then look at are, to assess impact of changes, and to determine if objectives have been accomplished. We continue to monitor outcomes and develop an effective triage tool for troubleshooting patients with high EPO doses and suboptimal hemoglobin levels.
15:52
Case Study 1
I have a case here for an example. This is a 68-year-old male on dialysis, diabetic, with a chronically infected toe. Back in November of 2006, he was anemic, he had a hematocrit of 27.5, hemoglobin 9.3, a serum ferritin that was below the KDOQI guidelines, but a TSAT that was quite normal; and he was what we call EPO-resistant. He was getting more than 400 units of EPO per kilogram per treatment of therapy. So finally, it was decided to have his toe amputated. And as you can see, over that period of time his hemoglobin went up and actually shot up way over 13, and his EPO was stopped. The only reason I brought up this slide was to really show you the effect that inflammation has on your EPO requirement, so that clearly, if you have high-dose EPO in a patient, EPO resistance, inflammation is there and it's very important to sort of step back and look at that patient critically. Does he need a workup, or does she need a workup for his or her problem?
16:57
Case Study 2
In case #2, we have a 78-year-old male with end-stage renal disease on dialysis and with multiple medical problems. This patient was anemic also, and in this case his ferritin was quite high. His TSAT was on the low side. He was getting maximum-dose EPO in our unit, which was 35,000 units per treatment. At that time we decided to increase his iron dose from 31 mg per week to 125 mg per week. Being quite aware of the fact that KDOQI suggests that if you have a ferritin over 500, it does not mean you stop iron, and that is one of the problems— that people have understood the new KDOQI recommendations to be, that if the ferritin is above 500, we have to stop. That is not what they (KDOQI) are saying. they're saying that you have to individually look at that patient—can he still benefit from iron therapy? In this case we have felt that that was clearly the case. We bumped up the iron, and as you can see, the hemoglobin increased over a period of time, so that by February we were able to decrease his EPO dose.
18:03
Milford Dialysis Unit: Iron Protocol
In our unit, this is the protocol that we have. This is somewhat different than the one I showed you before, so the easy one is in the outliers. If they are low, you load them. If the ferritin is between 200 and 800 and the TSAT is between 20 and 50, we give a maintenance dose of iron, either 31.25 or 62.5 mg per treatment, and then follow their hemoglobin, ferritin, and TSAT. And if the patient stays stable in that range, we continue with that. If the ferritin is greater than 800 and the TSAT is greater than 50, that is easy, that is another outlier, you hold the iron and then you follow monthly labs on those patients, because we follow monthly ferritins and TSATs in our patients. If the ferritin is greater than 800, that does not mean that you need to hold iron in these patients, as they still may need it. So if their TSAT is in the normal range, and they may be getting high dose EPO, they still will need iron, because that ferritin is only an indicator of an inflammatory state, and they may have this functional iron deficiency, and they still need to get their iron to the bone marrow.
19:13
Conclusions
In conclusion, an IV iron protocol is easy to implement into any practice. You just need to think about it. There is plenty of information out there, lots of data that you can use to get your iron protocol. It improves anemia outcomes, it reduces EPO utilization, it allows more patients to benefit from the treatment, and ensures patients are receiving an adequate dose of iron to manage their anemia.
So thank you very much! It has been a pleasure talking to you.
References
- Besarab A. Resolving the paradigm crisis in intravenous iron and erythropoietin management. Kidney Int Suppl. 2006 May;(101):S13-8.
- US Department of Health and Human Services.. 2005 Annual Report. ESRD Clinical Performance Measures Project 2005 Annual Report: ESRD CPM Project
- Locatelli F, Pisoni RL, Combe C, Bommer J, Andreucci VE, Piera L, Greenwood R, Feldman HI, Port FK, Held PJ. Anaemia in haemodialysis patients of five European countries: association with morbidity and mortality in the Dialysis Outcomes and Practice Patterns Study (DOPPS). Nephrol Dial Transplant. 2004 Jan;19(1):121-32.
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