WBDE Training Video

Screen new patient

Once you log into the Intermacs application for patient data entry, click Screen Patient.

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wbde guide log
*Note: For patients that do not meet the inclusion criteria, please answer the reason the device was excluded.
You will then need to complete the required 7 questions regarding excluded devices.

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After you have completed the screening log, the following forms will be generated in this order:
  • Demographics
  • Pre-Implant
Once the pre-implant form is completed and submitted, then you will be able to complete the implant form.

Please refer to the most recent Intermacs User's Guide posted here for follow up guidelines.

Add new device

Once you have navigated to the patient summary page, click Add New Device.

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*Note: A durable LVAD must be implanted before you can add a temporary RVAD (or any temporary device)
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Once you click on add new device, you will see what devices are allowed for the patient.
You will then click on Add New Device again in the message box.

wbde guide add confirmation
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You will be taken to a new pre-implant form and implant form for the patient.
Please complete the new pre-implant and implant form.
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To Explant this device, you will click on Create Event.

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Complete label section and click on Validate and Save.

wbde guide add label
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Click on Explant and answer Yes
Then click on Validate and Save.

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Complete the form. Please note the device type will say RVAD in real time.
Once you have entered the correct information, please hit Validate and Save.
You have successfully and correctly explanted this RVAD!

wbde guide adverse

Create new event

Once you have navigated to the patient summary page, click Create Event.

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Enter date of explant (date of transplant in this case)
Complete this AE label (you can say 'Patient Transplanted')
Then click on Validate and Save.

wbde guide ae status
What are considered thrombolytic medications?
  • Streptokinase
  • Alteplase (tPA)
  • Reteplase (rPA)
  • Tenecteplase (TNKY-tPA)
  • Lanotoplase (nPA)
  • Anistreplase (APSAC)
  • Urokinase

Pre-implant form: hospitalizations in the past 12 months?
You will not count the implant hospitalization as a hospitalization in the past 12 months to prevent since that is already known and accounted for on the implant discharge form (and on the re-hospitalization if for the device exchange.

When is the 6 minute walk test done?
Pre-implant, 3 months follow-up, 6 months follow-up, and every 6 months thereafter.

How do I transfer a patient?
Complete all follow-up forms and adverse events on the patient, then click on “add patient transfer” which is near the “create event” and “add new device” button and complete with the transfer date (the last date your site had contact with the patient). The receiving hospital will contact Jeanne Anne Love (jfowler@uabmc.edu) to have patient transferred to their site and will need to complete any follow-up and adverse event forms that occur after the transfer date.

When I’m entering a device thrombus, what do I answer to the question, "Did the patient experience a device malfunction?"
This answer will always be yes because a device thrombus meets the definition of major device malfunction because it either directly causes or could potentially cause a state of inadequate circulatory support or death.

Who do I contact for INTERMACS password or login issues?
Chase Lenderman (joshualenderman@uabmc.edu)

What is meant by console change, does it mean the controller or PPM?
No, it is for the TAH freedom driver or Berlin Heart Console changes only.

Modified Rankin Scale – do you need to be certified to answer this?
No, only if your site requires you to be certified. This information can be collected from documentation in the chart.

Save for Later versus Validate and Save:
Save for later can be used when you are interrupted when entering data and want to save the information you have entered, but you are not completely finished with the form and need to come back to is to complete. Validate and Save can be used when you have entered everthing needed on the form, validate and save must be used before you can submit a form. If you are changing any information on a form that has already been submitted, you will need to validate and save then submit again.

How are the zone adverse events (hemolysis, right heart failure, hypertension) counted?
You no longer need to directly enter these adverse events, the information entered at each follow-up visit is used to internally identify these events.  These events will be analyzed over a period of time using prevalence, not incidence. For example, during the first 6 months post-implant hypertension occurred “x” amount of times.

Do I need to enter a patient in the Heartware DT trial (U.S. Endurance Destination Therapy Trial) into INTERMACS?
Yes as of 9/27/2017

Do I need to enter a Heartmate 3 LVAS?
Yes, as of 8/28/2017

Do I need to enter a patient in the Abiomed Impella RP study in INTERMACS?
Yes, the patient has a qualifying FDA-approved LVAD.  Please enter the name of the study on the demographics form for question, “Is patient involved in a VAD related study?”

How do I enter a patient that was explanted for recovery or transplant, but then later needed another VAD?
This is the only scenario where a patient will need to be entered with a separate patient ID number, so you will add a new patient, and enter “99999” for the SSN under the demographics form.  All other additional device scenarios (RVAD needed after LVAD implant, device exchange, etc.) will be accounted for under the same patient ID number with the add a device button.

Pre-implant form primary LVAD or TAH question, how do you answer when the patient has had a temporary device in place?
You will select LVAD, RVAD, or previous ECMO for the previous cardiac operation to account for the temporary device. For the question, “Is this implant the primary MCSD (LVAD or TAH) for the patient?” Answer yes only if this is the first FDA-approved durable device that has been implanted in this patient, otherwise answer no.

What is the Health Insurance Claim Number (HICN)?
This is the patient’s Medicare ID number issued by CMS.  If the patient does not have one or your site does not allow you to report this for privacy reasons, please select unknown.

Do I need to report all re-hospitalizations, even if unrelated to the VAD?
Yes, all re-hospitalizations that are 24 hours or greater need to be reported in INTERMACS, even if for an elective procedure or an event that is not related to the VAD like a car accident or gallbladder surgery.

For the one week follow-up, on the questions that say since last visit, what does that refer to?
In this case, this would be considered since the date of implant.

Where do I find the Waitlist ID?
To access the Waitlist ID:
  1. Log into Secure Enterprise at https://portal.unos.org
  2. Click on the waitlist icon on the left hand side of the screen
  3. Depending on if the patient is actively listed or removed click on Active list or Removal History on the left hand side of the screen
  4. Select the access key at the top right hand side of the screen and then select the appropriate institution and click go
  5. Type in the SSN of the patient and click Search
  6. Click on the SSN link
  7. The page with the Waitlist ID appears:

Active list view:
active list

Removal History view:
removal list

Hemolysis Zone Scenario:
Reminder: This is over a span of time.

Patient Implanted 4/1/2014
1 Week Visit: 4/8/2014
1 Month Visit: 5/1/2014
3 Month Visit: 7/1/2014

Example #1:
Patient is NOT re-hospitalized and NOT seen in clinic between the 1 week and 1 month visit.
For the 1 month Hemolysis Zone, you would use labs from 4/9/2014 thru the 1 month visit date (5/1/2014).
Please enter the peak labs since the last Follow-Up

Example#2:
Patient is re-hospitalized on 6/1/2014. At the 3 month zone, you would enter the labs spanning from 5/1/2014 thru the 3 month visit (7/1/2014).
Please enter the peak labs since the last Follow-Up

Intermacs Implant Discharge Scenario:
LVAD Exchange during Primary Implant Hospitalization
Implant Discharge is now per device (LVAD)

  1. If patient has an LVAD exchange during the primary implant hospitalization then please choose LVAD exchange and enter exchange date as the discharge date.
  2. Implant discharge date:
    • Date of Transplant
    • Explant for Recovery
    • Date of Death
    • Date of LVAD Exchange
Another Implant Discharge form is to be generated at new implant.Example:
  1. Primary LVAD implanted 06/01/2014
    6/8/2014 LVAD clotted off and device exchanged
    Discharge Reason: LVAD Exchange excluding RVAD
    Discharge Date: 6/8/2014
    Implant Discharge days: 6/1/2014 to exchange date (6/8/2014)
  2. New LVAD implanted 06/08/2014
    Implant Discharge form will be generated for this new LVAD
    Discharge from Implant Hospitalization on 6/20/2014
    Discharge Reason: Patient Discharged alive with device in place
    Discharge Date: 6/20/2014
    Implant Discharge days: count days from 6/8/2014 to 6/20/2014.