Randy’s Ruminations – ECMO Advantage

ECMO Outcomes Updated

ECMO Outcomes Updated Dec 2015

Are ECMO outcomes dependent on the number of ECMO patients supported at your institution? Does it really matter how many ECMO patients your program supports? Do patients suffer by being on ECMO at smaller ECMO programs? There have been a couple of publications recently suggesting that it does matter. A recent abstract I came across a few months ago has an interesting twist to it. The results summary would make it sound like there is significant benefit to a patient on ECMO if they are supported at a high volume center. But if you read the message carefully, you will see that there was NO SIGNIFICANT SURVIVAL BENEFIT for the pediatric age group for the period of study between 1989-2013. When broken down into relative data from the time period of 2008-2013, there was NO SIGNIFICANT SURVIVAL BENEFIT for the neonatal nor pediatric group. Only the Adult group was implicated in improved survival in “larger” ECMO programs (those who supported > 30 ECMO patients per year) compared to the smallest ECMO Programs (those supporting < 6 ECMO patients per year). It’s also interesting to note that they didn’t report on the Adult ECMO Programs supporting between 6 and 30 patients per year.

More recently an article was presented in Pediatric Critical Care Medicine:November 2015 – Volume 16 – Issue 9 – p 868–874 that looks specifically at Cardiac patients <16 years old supported with ECMO either before or after surgery. The conclusion from this group states: “We demonstrated no relationship between extracorporeal membrane oxygenation center volume and mortality. Further analyses are needed to evaluate this relationship.”

So what really makes the difference in the care that ECMO patients receive that allow them to survive to home?

The primary purpose of ECMO Advantage is to help raise the level of ECMO support to the absolute highest quality no matter how small or large your ECMO program is. Our primary objective is to help Hospitals develop ECMO Programs that have the proper structure, training, education, expertise and quality to safely and effectively support patients on ECMO and return them home to their families.

If your outcomes are not as good as they should be, contact us. We have a proven track record assisting both new and experienced ECMO programs develop into high quality programs with better then ELSO average survival to home.

Randy Bartilson, President of ECMO Advantage – Serving the ExtraCorporeal Community

Successful Use of the CARDIOHELP system for Neonates

The ECMO Advantage team has completed successful use of the CARDIOHELP system for neonates. After several months of planning, training, reconfiguring circuit, and waiting, the ECMO Advantage team has finally had the opportunity to manage three patients with Maquet’s CARDIOHELP. For the two neonatal patients, we used a modified 1/4 inch circuit adapted to the standard 3/8 inch CARDIOHELP circuit. There were no circuit complications noted in any of the runs.

For the last couple of years as the transition from roller head to centrifugal systems has been underway, there has been some hesitancy by some neonatal ECMO programs to switch due to the general lack of a “neonatal or pediatric” centrifugal circuits.

Several of the individuals that make up the ECMO Advantage Specialist team have had extensive experience with the CARDIOHELP. But this was the first time an ECMO Advantage client that our team supported has used the CARDIOHELP on infants. There of course have been other ECMO programs that have used the CARDIOHELP on neonatal patients. I would encourage them to publish their use so that others can have some insight into this particular application.

Will ExtraCorporeal Support Replace the Ventilator?

Will extracorporeal support replace the ventilator? Traditional ECMO has focused on providing life support for the sickest of the sick once conventional ventilation methods are maximized. But what about using minimally invasive or smaller extracorporeal systems to provide support that would prevent patients from needing to be intubated? Or what if extracorporeal support was used to wean very sick patients off of the ventilator. Is is feasible that we advance the safety and efficacy of extracorporeal support to significantly reduce or even eliminate the need for invasive positive pressure ventilation?

Sklar et al recently published in Intensive Care Medicine June 2015 an abstract indicating the possibility of beneficial use of extracorporeal support for selective patients to either assist in weaning patients off of the ventilator or preventing them from needing invasive positive pressure ventilation. Their abstract also points out that complications of extracorporeal support where not benign.

A company called Alung Technologies has been perfecting a device what they refer to as The Hemolung® RAS to provide Respiratory Dialysis®. As stated on their web site…”A simple, minimally invasive approach to extracorporeal CO2 removal for patients with acute hypercapnic respiratory failure.” Hemolung is not yet FDA approved for open use in the United States. But it has been used in over 75 hospitals in at least 19 countries. It has reportedly been used at least twice in the United States under the FDA’s emergency use regulation.

So maybe the question “Will extracorporeal support replace the ventilator?” isn’t as far fetched as one might think.

Ventilator Management on ECMO

Ventilator Management on ECMO has been a debatable topic for many years. There have been many approaches to managing the sick lung without ECMO support that still create a lot of debate. But when you add in the complexities of the ECMO system and support processes it becomes even more difficult to find consensus on the best way to adjust ventilator settings. A small percentage of ECMO Centers have begun actually extubating patients on ECMO. Some centers manage the ventilator the same as if the patient were not on ECMO. Some centers perform tracheostomy, some just leave an endotracheal tube in even for prolonged ECMO runs that may last for weeks or months.

A recent article found in Europe PubMed Central entitled International survey on the management of mechanical ventilation during extracorporeal membrane oxygenation in adults with severe respiratory failure. highlights the wide variety of thoughts and practices across the globe.

ELSO (Extracorporeal Life Support Organization) has long recommended “rest” ventilator settings while on ECMO. The ELSO H1N1 Specific Supplements to the ELSO General Guidelines during the H1N1 crisis was to:

keep plateau pressures under 25
adjust FiO2 to under 40%
allow SaO2 in the 70’s and 80’s on VV patients
keep hematocrit in normal range to aid with oxygen delivery
early tracheostomy
minimize sedation
perform frequent bronchoscope
consider HFOV at low settings (MAP of 12-14 cmH2O) to help with lung recruitment

The recommendations go on to suggest there is no benefit in attempting recruitment maneuvers until there is some sign of some native gas exchange and aeration on x-ray noted in lung fields. In addition, they mention that some have reported surfactant, prone positioning, fluorocarbon lavage, and percussive ventilation to be beneficial in some patients.

I’m a fan of this approach. I’m a believer in the concept of rest ventilator settings even in the face of complete and total whiteout of the lungs and then allowing TIME for the lungs to begin to recover before forcing recruitment procedures. But there are a lot of smart clinicians out there that take other approaches and have good success as well.

How does your center manage the ventilator on ECMO patients?

D-Dimer Monitoring for ECMO Coagulopathy Management…One More Piece of the Puzzle?

Could D-dimer monitoring for ECMO coagulation management be a critical piece of the puzzle? The ability to keep a circuit from clotting off while at the same time not allowing the patient to bleed to death has been a battle in the extracorporeal world for many years. In an I listed my top 5 lab tests to assist with anticoagulation for ECMO patients. D-dimer was not one of them. But should it be?

This may encourage me to add it to the list as a critical piece of the puzzle.
Dornia, C., Philipp, A., Bauer, S., Stroszczynski, C., Schreyer, A. G., Müller, T., Koehl, G. E. and Lehle, K. (2015), D-dimers Are a Predictor of Clot Volume Inside Membrane Oxygenators During Extracorporeal Membrane Oxygenation. Artificial Organs. doi: 10.1111/aor.12460

The case for D-dimer monitoring is a tricky one. This article mentions that increasing D-dimer in the face of unexplained causes could very well be due to clotting in the oxygenator. It is important to rule out other causes. D-dimer may significantly increase due to clots in the cannula, in a CRRT filter or CRRT device added into the ECMO circuit, pulmonary embolus, deep vein thrombosis, or other areas of bleeding that has formed a clot and begun to break down. D-dimer is actually an indicator of clot degradation. It’s a measure of the product that is produced when a clot breaks down. D-dimer test is commonly used when pulmonary embolism or deep vein thrombosis is suspect.

In a recent ECMO case, a sharp rise in D-dimer essay was reported shortly after adding a CRRT system to the ECMO circuit. It was noted that the CRRT lines were attached to the ECMO circuit using clave stop-cocks. The clave stop-cocks were replaced with a high flow adaptor and the D-dimer essays decreased markedly. This highlights the need to rule out other explainable causes of increasing D-dimer before jumping to changing out the oxygenator. But it also strengthens the case for monitoring D-dimer essays to shed light on problems in the ECMO circuit that may be fixed before creating complete “circuit DIC” type complications. It can also highlight undiagnosed bleeding problems within the patient.

Will D-dimer monitoring “fix” all our ECMO anticoagulation issues? No. But could it be an important part of the puzzle to help us see the whole picture as we care for our very complex ECMO patients? It’s worth considering.

Moving ECMO from “Last Ditch Effort” to ECMO as Mode of Support to Improve Quality of Life

As with almost everything in healthcare, weighing the benefits of a therapy or support vs. the adverse effects of that therapy or support can result in widely variable opinions. I think most involved in ECMO support would agree that historically, many institutions too often use ECMO as a “last ditch effort”. Often we hear doctors tell families, “If we don’t put your loved on on ECMO now, they will die.” Or, “This is their only chance of surviving.” Or, “We have done everything we can do. The only other thing we have to try is ECMO.” And admittedly there is a subset of patients where this may be the case.However, I’d like to encourage you to consider that ECMO/ECLS should be more readily considered as a frontline life support modality initiated early in a disease process for the purpose of improving quality of life outcomes rather than just to attempt to save a life.

I recently came across this pair of opposing view editorials in the March 2015 edition of Intensive Care Medicine.

Continue reading “Moving ECMO from “Last Ditch Effort” to ECMO as Mode of Support to Improve Quality of Life” →

ECMO Outcomes

Are ECMO outcomes dependent on the number of ECMO patients supported at your institution? Does it really matter how many ECMO patients your program supports? Do patients suffer by being on ECMO at smaller ECMO programs? There have been a couple of publications recently suggesting that it does matter. The most recent abstract I came across has an interesting twist to it. The results summary would make it sound like there is significant benefit to a patient on ECMO if they are supported at a high volume center. But if you read the message carefully, you will see that there was NO SIGNIFICANT SURVIVAL BENEFIT for the pediatric age group for the period of study between 1989-2013. When broken down into relative data from the time period of 2008-2013, there was NO SIGNIFICANT SURVIVAL BENEFIT for the neonatal nor pediatric group. Only the Adult group was implicated in improved survival in “larger” ECMO programs (those who supported > 30 ECMO patients per year) compared to the smallest ECMO Programs (those supporting < 6 ECMO patients per year). It’s also interesting to note that they didn’t report on the Adult ECMO Programs supporting between 6 and 30 patients per year.

So what really makes the difference in the care that ECMO patients receive that allow them to survive to home?

Randy Bartilson, President of ECMO Advantage – Serving the ExtraCorporeal Community

New Extracorporeal Technologies

There are a lot of projects ongoing in the world of extracorporeal support with new extracorporeal technologies being worked on all the time. In this post I want to highlight one that is not a life support system, but it could prove to be very beneficial especially to patients who are on extracorporeal life support systems like “ECMO” or “ECLS” as well as “CPB”.

I’ll make some disclaimers before beginning. 1) I have no official or unofficial association with this product nor with the company that created this product. 2) This product is not yet FDA approved. 3) I am not endorsing this product…just simply sharing what I learned about it with our ECMOlogy followers as I find it quite intriguing and see potential for it’s future use in our ECMO patient population.

CytoSorb® extracorporeal cytokine adsorber to treat critically-ill and cardiac surgery patients. According to the company’s web site (http://www.cytosorbents.com/tech.htm), this technology is available in 29 countries for patient use now. And “CytoSorbents received FDA approval of its IDE application to run an initial cardiac surgery safety study in the U.S. in 2015 using CytoSorb® intra-operatively during cardiac surgery.” The primary use of CytoSorb® as stated on the company’s web site: “CytoSorb® is clinically proven to reduce cytokines in the company’s multi-center, randomized, controlled European Sepsis Trial conducted in Germany. Treatment was safe and well-tolerated in more than 300 human treatments in very sick patients with the worst forms of sepsis and lung injury, and treatment has been safe in nearly 5,000 human treatments overall. Early data suggests that CytoSorb® can reduce organ injury and improve survival in patients at high risk of cytokine injury, particularly those patients with very high cytokine levels, and patients older than age 65.”

As an ECMO Specialist, I immediately think of all of those very sick, septic patients that I have cared for on ECMO over the years. The helpless feeling of knowing we can oxygenate and pump their blood, yet seeing the damage done and ultimately life lost due to the severe sepsis process that ECMO simply could not do anything for. How great it would be to have a product like CytoSorb®…

Looking forward to seeing this make it’s way through the FDA process and ultimately being able to use it as another weapon in our fight to make life better for the patients and families we serve.

Written by R Bartilson, ECMO Specialist

The Cost of ECMO…Is It Worth It?

O 468769517 ver the years as I have consulted for ECMO programs and talked with Administrators, Physicians, etc. as well as ECMO Specialists, a common question has been: “What does it cost to run an ECMO program?”. Or, “What does it cost to provide ECMO support?” What is the cost of ECMO support? And although it’s often unstated, the underlying question may be, Is this really worth it? We are spending a LOT of money and resources on a small number of patients. Could the expense be put towards other services, or modalities, or resources that could make a much bigger difference for a larger patient population? Is the cost of ECMO really better than providing standard care without ECMO?

I think for most ECMOlogists…we answer that with a resounding “YES! It’s worth it.” But can we really justify it financially?

Well, I won’t bore you with all the details, but suffice it to say, there is a lot of debate surrounding these questions. The answers to these questions are often contested as well. Most reports that I have found over the years typically use terms like “Quality Adjusted Life Year” (QALY) to help create a standard for comparison. Or another common phrase you may see in literature is “cost per life year”. And you may hear people talk about cost effectiveness or cost effectiveness ratios. There’s a life time of reading and debate just regarding the terms or methods used to determine value of a medication, therapy, or modality.

So here are just a few reports that may indicate support for the expense:benefit ratio of ECMO.

Then there is the whole issue of what does it cost the hospital versus how will insurance reimburse the hospital? This may be a topic for another post.

We address these issues in our ECMO Consulting Services. We have also added a new service feature that provides access to reimbursement specialists to help our clients learn to properly code, bill, and seek reimbursement for extracorporeal related services. This is particularly important with all of the changes that occurred in 2015.

So what do you say? The cost of ECMO…Is it worth it?

Randy Bartilson, President of ECMO Advantage – Serving the ExtraCorporeal Community.