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INSTRUCTIONS ON TRANSMITTING CT AND FLUOROSCOPY IMAGES IN DICOM FORMAT TO NHLBI

Why:
  • To give best available guidance to perform transcaval
  • To assess for quality
  • To survey for expected and unexpected complications
What:

CT-scans WITH PATIENT NAMES. We feel strongly that treatment plans are medical consultations and should include patient identifiers to assure no accidental misidentification.

  • "De-identified and linked" aka "Coded" means having patient names and other identifiers removed and replaced with a linking code, such as medical center + subject ID. This conforms with HIPAA and Good Clinical Practice. The weak spot is that you must correctly record the linking code.
  • "Anonymized" means having all names and identifiers removed without any linking code. Depending on your local institutional procedures, the non-identifying medical images may be treatable as not-human-subjects-research. At NIH this requires a research exemption in advance.

CT and fluoroscopy and other images DE-IDENTIFIED for follow-up.

Justification:
  • For medical care (must retain and patient names)
  • For Investigational Device Exemption protocol sponsored by NHLBI
  • For NHLBI transcaval registry
General:
  • We do not accept baseline CT scans (used to make transcaval treatment plans) that do not include patient names, to avoid catastrophic misidentification.
  • Please try to transmit electronically; it makes much work for us to transfer discs to electronic format.
  • Please try to use DVDs rather than CD-ROMs. It takes more than 7 times the work to load a CT scan spread over 7 CDs compared with all studies loaded onto a single DVD.
How to de-identify studies (for research only, never for baseline studies):
How to make electronic copies ("ISO files") of CDs or DVDs for transmission
  1. Whatcha got:
    1. Folders on a hard drive or inside a ZIP file
    2. A CD or DVD
  2. Whatcha wanna make?
    1. An ISO file
      1. Advantages: you can simply "burn" this image directly onto a DVD and play it back on any computer or imaging workstation. (On a Mac this is very simple)
      2. Disadvantages: you need to install a tool to create the ISO.
      3. Instructions:
        1. On a Mac:
          1. use Disk Utility, File->New->Disk Image; select "DVD/CD Master" as image format.
        2. On a Windows PC
          1. Download and run Folder2ISO:
            http://www.trustfm.net/software/utilities/Folder2Iso.php
          2. Download and install MagicISO:
            http://www.magiciso.com/tutorials/miso-magicdisc-history.htm
            Insert the CD or DVD that you wish to copy and transmit into an available drive
          3. Run MagicDisc
          4. From the "TaskBar", typically in the lower right hand corner of Windows, right-click on the MagicDisc Icon and choose "Make CD/DVD image"
            instruction
          5. A window opens up that allows you to select the CD or DVD drive that contains the disc you want to copy. Make sure that you change the "output format" to "Standard ISO image file (.ISO)" as indicated in the figure
            instruction
          6. Now create a filename for the image (ISO) file that you are about to create, using the same dialog as above (click on the folder icon, then create a descriptive filename, such as "LASTNAME-FIRSTNAME-MEDICALIMAGE-YYYY-MM-DD.ISO"
          7. Hit "OK" and wait as the ISO file is created. Make sure that you have enough space on your hard drive.
    2. A ZIP file
      1. Advantages: easy, sometimes makes a smaller file
      2. Disadvantages: harder to play back
      3. Instructions

Commercial services that will make electronic copies of CDs or DVDs for transmission to specific outside recipients


Transcaval analysis request form

Request for analysis of CT scan for transcaval TAVR.

Please read the checklist completely

Instructions
What are you submitting?
  1. A request for a clinical consultation for transcaval planning on a baseline CT scan using patient identifiers?
  2. A transmission of follow-up imaging on a subject in the NHLBI transcaval IDE trial?
  3. A transmission of follow-up imaging on a subject in the NHLBI transcaval registry?

Create a filename based on the patient name or linking code according to these instructions:

If Baseline Study: Use Patient Names
  1. SURNAME-Firstname-Hospital-CT-YYYYMMDD
  2. Example: YALOW-Rosalyn-MSMC-CT-2014-01-31

Otherwise

Create linking code

  1. Site-Subject#-RegistryOrIDE-Schedule-Scan-AcquisitionDate
  2. Example: MSMC-003-R-1mo-CT-2014-01-31
Supply the filename here:
Indicate planned TAVR procedure for required sheath length
  • Medtronic Corevalve = 40cm x 18Fr sheath, such as Cook Large Check-Flo Performer
  • Edwards SapienXT = 35cm x 22-24Fr Edwards Retroflex3 sheath
For consultations, please confirm there are no good alternative access options. These analyses require a great deal of work.