Free Flap Presentation

Need ID 111
• An objective way to evaluate free flap perfusion in patients who

have undergone flap surgery to decrease rates of unnecessary
reoperation.
Copyright © The Board of Trustees of the Leland Stanford Junior University, Byers Center for Biodesign 2023.
No further reproduction or distribution of this content is permitted by electronic transmission or any other means. 1
1
0
Need Statement 111: An objective way to evaluate free flap

perfusion in patients who have undergone flap surgery to
decrease rates of unnecessary reoperation.
Need to have Nice to have
Efficacy Detects poor flap perfusion with same Detects poor flap perfusion with better
sensitivity as current physical exam sensitivity than current physical exam
techniques techniques
Safety Does not cause flap thrombosis Causes only minor or reversible side effects
Non- or Minimally Invasive
Usability Able to be used by surgical intern Able to be used by any bedside staff
Cost Costs less than two hours of surgical Costs less than one hour of surgical intern
intern time time
Slide 2
0 Biggest risk questions:

- How many flaps and is this a high enough risk?
- Do we want to consider other flap surgery?
- Look at the amount of fellows who do surgeries?
Julia Akiko Roche, 2023-10-30T19:07:23.215
1 From Dan:
- What are the flaps that are really at risk? What is the incidence of the real problem?
- Talk with a plastic surgeon? We can connect.
Julia Akiko Roche, 2023-10-30T23:31:34.199
How many breast free flaps are incorrectly
identified as failing?
553 (60% of all
18,441 takebacks) 1
Annual Breast Free 921 total take-backs are
Flaps Failed flaps (1-4% of all
flaps) 2
368 or 40% of flaps are taken back to OR for

unnecessary exploration
Copyright © The Board of Trustees of the Leland Stanford Junior University, Byers Center for Biodesign 2023. 1. Chang.
How many breast free flaps are incorrectly
This is from ENT literature. Demonstrates

88% of takebacks are false positives.
Copyright © The Board of Trustees of the Leland Stanford Junior University, Byers Center for Biodesign 2023. 1. xxx.
How many (total, any type) flaps are incorrectly
30,000 xxx total take- xxx Failed
Annual Flaps backs flaps
Do we really want to scope

out? Does it make a
difference?
xxx% of flaps go back for unnecessary

exploration
Copyright © The Board of Trustees of the Leland Stanford Junior University, Byers Center for Biodesign 2023. 1. xxx.
Anatomy – types of flaps
• ‘Free’ means the tissue along with its blood supply is detached
from its original location and then transferred
• Free TRAM (transverse rectus abdominus) flap
• (Free) DIEP (deep inferior epigastric) flap
Anatomy – types of flaps, cont’d
Anatomy – types of flaps, cont.’d
• Pedicled TRAM flap (part still attached to its original location-
pedicle = bridge)
• Less common
Why reexplore?
• Return to the operating room within 48 hours yields the
highest rate of successful salvage.
• When recognized in a timely manner, successful
revascularization can be performed in up to 70% to 80% of
cases
Copyright © The Board of Trustees of the Leland Stanford Junior University, Byers Center for Biodesign 2023. 1. Wax, 2013..
Physician Reimbursement
1. Sheckter, 2019.
Hospital Reimbursement
“Once the S code is phased out

next year, providers will be
forced to bill this service with
CPT code 19364 (Breast
reconstruction; with free flap
[eg, fTRAM, DIEP, SIEA, GAP
flap]), which pays 50% to 70%
less than the current S code
reimbursement rate of (HCPCS
code) S2068.”
No further reproduction or distribution of this content is permitted by electronic transmission or any other means. 1. https://www.obroncology.com/article/breast-reconstruction-coding-change-called-practice-ending 11
Scenario 1:
What is the market willing to pay? breast only
TAM
Cost savings
attributable to
Breast flaps
N=18,000 x monitoring on surgical =
floor (v ICU)1 $10M -
$1937
$34M
Takebacks not requiring 50%

Median cost breast free
revascularization (false x flap reconstruction x (50-70%
positives) cost of
$22,677
N=900 failure)
1. Billig, 2017.
No further reproduction or distribution of this content is permitted by electronic transmission or any other means. 2. Pelletier, 2017. 12
Scenario 2:
What is the market willing to pay? all flaps
TAM
Breast free flap
All flaps
N=30,000 x reconstruction =
$22,677
$20M -
$680M
Failed breast
1-4% free flaps
x Breast free flap
reconstruction
failure
N=900 $22,677
Physiology / pathophysiology or
disease mechanism
• Vascular compromise may occur as a result of
• venous thrombosis (most common)
• arterial insufficiency
• hematoma
• wound dehiscence
• Risk factors for flap failure:
• Operative time (>75%ile time = AOR 2.09)
• No other RF were signif contributors
1. Wong, 2015.
Adjacent anatomy / physiology
Standards of Care
• Clinical exam remains gold standard for flap monitoring
• Reduced resident monitoring frequency does not alter flap salvage/flap
outcome1
• Alternatives
• Implantable doppler (ID) (77.8% sensitivity, 88.4% specificity)1
• External doppler (ED)
• Needle stick
1. (Patel, 2017.)
2. (Chang, 2016)
3. (Cevallos, 2023).
Pipeline
1. (Tomioka, 2022).
Mind maps
Patient Journey +/- identified gaps
Visible vs Invisible features; static vs
dynamic conditions
Relevant Environmental Variables
• Ex: temp, gravity, etc.

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Need ID 111

• An objective way to evaluate free flap perfusion in patients who

Need Statement 111: An objective way to evaluate free flap

0 Biggest risk questions:

368 or 40% of flaps are taken back to OR for

This is from ENT literature. Demonstrates

Do we really want to scope

xxx% of flaps go back for unnecessary

“Once the S code is phased out

Takebacks not requiring 50%

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