How is Your Moral Compass Today?

Editor’s Note:

Well it was a Friday morning with a pretty nondescript schedule. There was one heart on for the day , I am on call – and life is good.

I got a text at about 8:30 AM, letting me know that the case was canceled, that the circuit was completely set up and primed, and would be good to go in case any emergency popped up.

It really doesn’t get much easier than that except for one slight problematic issue. The primed pump was one day old, and mannitol as well as an antibiotic had been added to the prime prematurely.

That was a little wrinkle into the scenario, as our protocol here allows for a pump to be primed for 48 to 72 hours, so therefore a Friday set up would be good for Monday morning.

However in this case, the pump is be primed on a Thursday morning, meds have been added for the Friday morning canceled case, and anytime a pump is primed with meds- the effective shelf life diminishes down to about 18 hours or less. Complicating things a little further, was the possibility that if I came in for emergency – what would I do with a pump that was primed with an antibiotic that the patient might possibly have an allergy to?

I tabled that to the group by text, and the discussion to possibly rinse the pump with 4 L of crystalLloyd surfaced but I rejected that with a hypothetical of “what if it is an anaphylactic reaction” ?

A suggestion was forwarded that anesthesia could mitigate the potential for anaphylaxis by administering an antihistamine prior to going on bypass – but to me it seemed more like playing Russian roulette with the patient’s life, and the horrible second-guessing that would emerge if we went on bypass and our pressures tanked.

I also discussed this with one of my superiors, who coincidentally had been my mentor at St. Louis Children’s Hospital, when I was in perfusion school, and a colleague that I have tremendous respect for – Tom. His position was to trash the circuit, which I then proceeded to do.

So I drove to the hospital, talking to my wife on the phone about it, basically expressing my frustration of what a pain in the ass this kind-of was, but I also said to her “the day that I don’t take the time and make the effort to come in and change this circuit out – is the day I need to quit the profession.”

And I’ll stick by that statement because to do anything less, to take that very minuscule 1% chance that the next emergency patient I got would actually be allergic to penicillin – that would represent not only willful and lazy negligence, but a serious breach of my moral and ethical commitment to the safety of the patients under my care. It would be utterly indefensible in court or an M&M (Morbidity and Mortality) board review , not to mention a clear indication that I had lost my moral compass.

Below is a survey and discussion on the principles and rationale for timing the duration of ECC setups.

Peace 🙂

Pump Strong (bcf)

Pre-Assembled ECC’s and the Rationale Behind Them…

Authored by: 
Jeff Campbell, MPS, CCP,CCT;
Frank Aprile, BBA, LP, CCP;

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Survey Design: 
Frank Aprile, BBA, LP, CCP;
Jeff Campbell, MPS, CCP, CCT;

Discussion:

The reasons perfusionists have increasingly adopted the practice of a having pre-assembled dry or wet ECC over the past decade may be multi-factorial.  Off pump coronary artery bypass (OPCAB) surgery, which emerged in the mid to late 1990’s, requires a perfusionist and CPB to be readily available.  OPCAB is an elective procedure in which clinical conditions can deteriorate rapidly with dire consequences to the patient if CPB cannot be emergently initiated.  As a result, many perfusionists’ choose to have an ECC set-up dry or even primed, in order to emergently initiate CPB if needed.

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The fact that the ECC is an expensive, single-use item, many perfusionists have adopted to save the unused ECC for use on the next patient.  Recent surveys have identified cost as an important factor in regards to perfusion staffing, and as a major factor influencing perfusionists’ decisions on extracorporeal equipment utilization (1, 2).

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With the increasing number of occasions when the ECC may have been set up and not used, perfusionists were increasingly in the situation of having to decide to dispose of the ECC or keep it and use it later secondary to the economic impact.  The primary issue that arises is that of sterility (3-6).

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Other potential issues associated with this practice are that of security, nursing standards, and sterility in an uncontrolled, dynamic environment.  Security of the previously assembled CPB could be a concern if it is kept in an open access, uncontrolled or non-low traffic environment.  The Association of Operating Room Nurses (AORN) has guidelines regarding sterility pertaining to the opening and holding of an Operating Room relative to the start of a procedure .  The Joint Commission mandates that medications and Intravenous fluids be locked up when not being used for a procedure and they are accessed or obtained as needed for a procedure.

Purpose:

The purpose of the survey was to examine the following:

• The prevalence of pre-assembled ECC’s as a modality in every day perfusion practice.
• Differentiating and quantifying  this practice into “Wet ECC” and “Dry ECC” categories.
• Identifying pro and contrary positions regarding this practice.
• Identifying potential hazards or benefits regarding this practice.
• Examining the factors that account for the seemingly wide variances in the perfusion community- regarding this practice.
• Establish a rational  framework of peer opinion,  assisting the perfusion community in arriving at a consensus for a standard of care regarding the question of pre-assembled ECC’s.

Methods:

An Internet Survey was designed and disseminated to potential respondents via Internet Blog (website).  The structure of the design can be seen by clicking here.The goal was to have perfusionists be the only respondents to the poll, so a screening question was placed at the front end of the survey to filter unqualified participants.

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The initial strategy was to capture results reflecting responses from one institution only.  It was felt that multiple responses from members of the same institution would skew the results- as obviously they would confer disproportionate  weight-  nudging the results of the poll one way or another, depending on the number of responses from the same site.

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The two possible approaches to bypassing this issue were:

• Submitting a disclaimer of sorts- allowing for one response per institution only.  (This was abandoned due to the possibility of diminishing the number of responses- or inadvertently omitting entire clinical sites- because each person from that site- might think that the other person submitted already, thereby not submitting their own response).  Convoluted but possible.

• Allowing a question regarding “City” location of the respondent, and then filtering out ‘same-city” responses.  This delightful little contingency plan fell flat on it’s face, once we started getting back 145 + “N/A”‘s to that particular question.  Anonymity seems to be at a premium, and is obviously to be respected, however it took whatever “scientific method” there was built into this survey- right off the table.

So now we are faced with 381 responses, all validly submitted by perfusionists (or so stated) and clearly not spammed or otherwise, and what to do with the results?  Do we weed the answers?  Wipe out 145 “N/A”‘s or so?  What about the “same city” respondents, or the “USA” only geographical identifiers?

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All taken into account, it becomes clear that there is no scientific way to do any of that, where do you start and where does it end?   The only trustworthy science at that point would leave us with N = 2…

I have a high degree of confidence, based on the timing and receipt of the responses, their electronic signatures so to speak (IP addresses and so on), and the uniqueness of most of the entries to feel assured that the replies submitted are from unique individuals, working in distinctly separate clinical climates.

With that in mind, and having so many respondents, the validity of the demonstrated community interest outweighs the inexactness of the science (in my opinion) and the results are forwarded below.

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(Adios JECT and Helloooo National Enquirer …  Just kidding.)

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There are no disclaimers.  It is what it is, and my gut feeling is that it is an excellent and accurate reflection of what we are doing out there.

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This is a Blog- and there is a comments section for a reason.  Please share your thoughts, encouragements, insights, and condemnations (jk) by clicking here.

Results:

Click on Images to Enlarge or to View Extended Reports …

Out of 381 valid responses:

• 90 % (of respondents) indicating that they did pre-assemble the ECC.

10% of the respondents indicated that they did not pre-assemble the ECC.

This 90:10 % relationship remained consistent during the life of the Survey.

No external factors (geography, contract versus hospital based) were identified to play a role in the decision making process.

Respondents:

Click on Images to Enlarge or to View Extended Reports …

• 381 respondents and their self identified locations:  N / A accounted for 145 of the respondents.

Of the 381 Respondents, 236 included sufficient information to include them in this portion of the analysis by geographical location.

• Roughly 80% of the respondents identified North America as their location.

The remaining 20% were attributed primarily to Europe, Asia, and Australia, with no responses coming from Africa or South America.  Language barriers and access to technology may come to bear here has mitigating factors.

A Dry Pre-assembled ECC

This question is encountered if one has answered “yes” to the pathway question of whether or not you or your institution employs a pre-assembled ECC.  In this case 319 respondents of a possible 332 (96%) indicated that they Routinely set up a dry ECC.

• In relation to the entire surveyed population of 381 participants, that represents 87 % of all respondents Routinely pre-assemble a dry ECC.

Dry ECC Frequency:

• Perfusionists regardless of frequency (in terms of policy)  kept their circuit dry up to 24 hours 145 times out of 311 total response (46%).
• Perfusionists regardless of frequency (in terms of policy)  kept their circuit dry 0 – 48 hours 79 times out of 311 total response (25%).
• Perfusionists regardless of frequency (in terms of policy)  kept their circuit dry >48 hours 73 times out of 311 total response (23%).

Wet Pre-Assembled ECC’s

This question is encountered if one has answered “yes” to the pathway question of whether or not you or your institution employs a pre-assembled ECC.

• In this case 55 respondents of a possible 339 (16%) indicated that they Routinely set up a wet ECC.

• In relation to the entire surveyed population of 381 participants, that represents 14 % of all respondents Routinely pre-assemble a wet ECC.

• The interesting point to be observed here is that 201 respondents of a possible 339 (60%) will employ a wet ECC (infrequently) depending on clinical circumstances.
• Thus in tandem with the previous cohort, 256 of 381  (75%) perfusionists are willing to use a wet pre-assembled ECC.

Wet ECC Frequency

Click on Images to Enlarge or to View Extended Reports …

• 47% Perfusionists regardless of frequency (in terms of policy)  kept their circuit wet up to 24 hours 147 times out of 313 total responses.
• 30% Perfusionists regardless of frequency (in terms of policy)  kept their circuit wet up to 48 hours 93 times out of 313 total responses.

Duration of Pre-Assembled ECC’s

The Wet v. Dry graphs pictured above are virtual stereo isomers of each other.

The length of time each is tolerated are inversely proportional to each other.

In terms of windows of opportunity to use a pre-assembled ECC, Wet = shorter,  Dry = longer.

The graphs are self explanatory.

Is there an Institutional Policy in Place?…

• 25% : Yes
• 39% : No
• 16% : Yes- I have Read it.
• 2% : Yes- But I have never seen it
• 8% : Don’t Know
• 10% :  N/A

• 59% of respondents are either unaware of a setup policy or failed to indicate that they have read it.

What is the Rationale for Having a Pre-Assembled ECC?

• 177 Responses:  Infection Deemed to be a non-issue
• 15 Responses:  Manufacturers Guidelines are designed to protect the manufacturer from liability
• 88 Responses:  Oxygenator Performance is not an issue
• 58 Responses:  There is no clear policy
• 179 Responses:  Standard of care (community consensus)
• 112 Responses:  Published Literature
• 50 Responses:  Other

This question was posed to allow for multiple selections, therefore percentages cannot be applied here.  The number of responses per selection is however a fair reflection of what the community feels are valid points of interest or concern.

The majority responses indicated that when it comes to pre-assembled ECC’s:

• Sterility is NOT an Issue.
• It is within the Standard of Care:

What is the Rationale for Not Pre-Assembling an ECC?

• 25 Responses:   Risk of Infection
• 3 Responses:  Manufacturers Guidelines
• 3 Responses:  Oxygenator Performance
• 5 Responses:  Hospital Policy
• 0 Responses:  Pharmacy Policy
• 2 Responses:  Published Literature
• 18 Responses: Other

This question was posed to allow for multiple selections, therefore percentages cannot be applied here.  The number of responses per selection is however a fair reflection of what the community feels are valid points of interest or concern.

The majority responses indicated that when it comes to avoiding  pre-assembled ECC’s:

• Sterility is the primary concern.

Wet Setup Approach

• By far, the majority of perfusionists will prime a pre-assembled wet setup with crystalloid solution only.

Do you Test the wet ECC for cultures?

• 2 Responses:   Each setup is cultured
• 115 Responses:   We tested with cultures 1 or more times at this Institution
• 140 Responses:   We have never cultured
• 129 Responses:   We trust the literature and anectdotal evidence
• 11 Responses:

This question was posed to allow for multiple selections, therefore percentages cannot be applied here.  The number of responses per selection is however a fair reflection of what the community feels are valid points of interest or concern.

The majority responses indicated that when it comes to testing the pre-assembled ECC for bacteria:

• The majority of perfusionists have never tested their pre-assembled wet ECC for organisms.

Is there Risk Assumed with a wet pre-assembled ECC?

• 137 Responses:   There is no risk
• 100 Responses:   There is a health risk (infection)
• 67 Responses:   There is a legal risk (Liability)
• 116 Responses:   There is a functional risk (membrane failure)
• 24 Responses:   Other

This question was posed to allow for multiple selections, therefore percentages cannot be applied here.  The number of responses per selection is however a fair reflection of what the community feels are valid points of interest or concern.

The majority responses indicated that when it comes to Risk associated with a wet  pre-assembled ECC’s:

• There are substantial concerns regarding infection, legal risk, and membrane failure.

Primary Argument(s) for a Pre-assembled ECC…

• 98 Responses:   Economic
• 129 Responses:   Conserving Resources
• 167 Responses:   Patient Safety (rapid availability and deployment of CPB support)
• 72 Responses:   Lower perfusionists stress (rapid availability and deployment of CPB support)
• 104 Responses:   Surgeon Request
• 24 Responses:   Other

This question was posed to allow for multiple selections, therefore percentages cannot be applied here.  The number of responses per selection is however a fair reflection of what the community feels are valid points of interest or concern.

The majority responses indicated that when it comes to the Benefit associated with a wet  pre-assembled ECC’s:

• Pt Safety & Conserving Resources ranked highest for reasons to maintain a wet ECC.

Primary Reasons Leading to a Primed ECC:

• Canceled cases and OpCabs are the primary reasons for unused primed circuits.

Who Sets the Policy ?

Click on Images to Enlarge or to View Extended Reports …

•  In the majority of cases, the Chief of Perfusion determines the ECC policy, followed the decision being made by the individual CCP.

Conclusion:

It would have been interesting to see more responses from Africa and South America to see what role economics and the availability of disposable perfusion components plays, in terms of policies aimed at conserving those resources.

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Individual conclusions regarding specific aspects of the pre-assembled ECC argument can be reviewed above.

In Summary:

• 381 respondents
• Roughly 80% of the respondents identified North America as their location
• 90 % (of respondents) indicating that they did pre-assemble the ECC
• 87 % of all respondents Routinely pre-assemble a dry ECC

• 14 % of all respondents Routinely pre-assemble a wet ECC
• 75% perfusionists are willing to use a wet pre-assembled ECC

• 47% Perfusionists regardless of frequency (in terms of policy)  kept their circuit wet up to 24 hours 147 times out of 313 total responses.
• 30% Perfusionists regardless of frequency (in terms of policy)  kept their circuit wet up to 48 hours 93 times out of 313 total responses.
• 59% of respondents are either unaware of a setup policy or failed to indicate that they have read it.
• The majority responses indicated that when it comes to pre-assembled ECC’s:
  • Sterility is NOT an Issue.
  • It is within the Standard of Care:

• The majority of perfusionists will prime a pre-assembled wet setup with crystalloid solution only.
• The majority of perfusionists have never tested their pre-assembled wet ECC for organisms.
• There are substantial concerns regarding infection, legal risk, and membrane failure.
• Pt Safety & Conserving Resources ranked highest for reasons to maintain a wet ECC.
• Canceled cases and OpCabs are the primary reasons for unused primed circuits.
• In the majority of cases, the Chief of Perfusion determines the ECC policy

REFERENCES

1.         Conliffe J, Riley J, Clutter J, Wolf K, Murtha S. A Report of Perfusion Staffing Survey: Decision Factors That Influence Staffing of Perfusion Teams.  J Extra Corpor Technol. 2007;39:249-253.

2.         Stammers AH, Mejak BL, Rauch ED, Vang SN, Viessman TW. Factors Affecting Perfusionists Decisions on Equipment Utilization: Results of a United States Survey. J Extra Corpor Technol.  2000;32:4-10.

3.         Lonský V, Voxová B, Dominik J, Mandák J, Kubícek J, Bímová J, Marková D, Matoulková P. How long can the previously assembled cardiopulmonary bypass circuit stay sterile? Acta Medica (Hradec Kralove). 1998;41(2):91-3.

4.         Chorak J, Leader I, Patterson M, Kumar A. Sterility of assembled heart-lung pump beyond 48 hours. Am J Infect Control. 1990;18(5):328-31.

5.         Searles B, O’Leary CE, Pettit D, Alexander S, Picone A. Investigations into the sterility of manually assembled extracorporeal circuits with vented reservoirs. J Extra Corpor Technol. 1999 Sep;31(3):125-9.

6.         Young WV, Heemsoth CH, Georgiafandis G, Mitchell DC, Hackett DK, Bahna DG. Extracorporeal circuit sterility after 168 hours. J Extra Corpor Technol. 1997 ;29(4):181-4.