The Use of Laser-Assisted Indocyanine Green Dye Angiography to Predict Mastectomy Skin Flap Viability
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer, Cosmetic |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | January 2014 |
| End Date: | May 2015 |
| Contact: | Brett T Phillips, MD |
| Email: | brett.phillips@stonybrook.edu |
| Phone: | 631-444-8020 |
The Use of Laser-Assisted Indocyanine Green Dye Angiography to Predict Intraoperative Mastectomy Skin Flap Viability During Breast Reconstruction
In the investigators previous study of 51 breast reconstructions (32 patients), we compared
three different assessments of vascular perfusion of tissue; clinical judgment, fluorescein
dye angiography (FDA) and laser-assisted indocyanine green dye angiography (ICG). Because
tissue with poor perfusion becomes necrotic and can compromise the success of breast
reconstruction, it is important that tissue with poor perfusion be removed at the time of
the reconstructive surgery. However, it is also important to remove the least amount of
potentially necrotic tissue as possible so that the breast reconstruction is not compromised
by lack of skin. Therefore finding the best way to assess potentially necrotic tissue is a
vital clinical question. In the initial study the 3 different assessment methods which were
made at the time of surgery were compared to the subsequent development of necrotic tissue.
In the initial study, clinical judgment was the basis for determining the tissue removed
because it had the potential to become necrotic. The investigators collected data with the
FDA system and ICG system, but this data was not used in making the clinical decisions. The
study followed the progression of tissue to overt necrosis and this clinical outcome was
then compared to the predictions made by the three different assessment strategies. The
investigators found that clinical judgment failed to detect tissue which subsequently became
necrotic in 21 out of 51 instances for a failure rate of 41%. The FDA system predicted
larger areas of potentially necrotic tissue than clinical judgment, but was found to
over-predict the area that became necrotic by 82% - 88% (88% if all cases were included and
82% if only those cases which subsequently developed necrosis were included). Although the
ICG system is similar to the FDA system in that a dye is used to assess perfusion, the ICG
system has enhanced software which improves the estimated perfusion. The ICG system provided
90% sensitivity and 100% specificity in the predicted vs. actual necrotic tissue at specific
absolute perfusion units values.
Hypothesis: Using the values of absolute perfusion units discovered in the previous study
and implementing its use in the operating room will decrease all-inclusive necrosis rates to
below 10%, reflecting a 31% decrease in the investigators necrosis rate.
three different assessments of vascular perfusion of tissue; clinical judgment, fluorescein
dye angiography (FDA) and laser-assisted indocyanine green dye angiography (ICG). Because
tissue with poor perfusion becomes necrotic and can compromise the success of breast
reconstruction, it is important that tissue with poor perfusion be removed at the time of
the reconstructive surgery. However, it is also important to remove the least amount of
potentially necrotic tissue as possible so that the breast reconstruction is not compromised
by lack of skin. Therefore finding the best way to assess potentially necrotic tissue is a
vital clinical question. In the initial study the 3 different assessment methods which were
made at the time of surgery were compared to the subsequent development of necrotic tissue.
In the initial study, clinical judgment was the basis for determining the tissue removed
because it had the potential to become necrotic. The investigators collected data with the
FDA system and ICG system, but this data was not used in making the clinical decisions. The
study followed the progression of tissue to overt necrosis and this clinical outcome was
then compared to the predictions made by the three different assessment strategies. The
investigators found that clinical judgment failed to detect tissue which subsequently became
necrotic in 21 out of 51 instances for a failure rate of 41%. The FDA system predicted
larger areas of potentially necrotic tissue than clinical judgment, but was found to
over-predict the area that became necrotic by 82% - 88% (88% if all cases were included and
82% if only those cases which subsequently developed necrosis were included). Although the
ICG system is similar to the FDA system in that a dye is used to assess perfusion, the ICG
system has enhanced software which improves the estimated perfusion. The ICG system provided
90% sensitivity and 100% specificity in the predicted vs. actual necrotic tissue at specific
absolute perfusion units values.
Hypothesis: Using the values of absolute perfusion units discovered in the previous study
and implementing its use in the operating room will decrease all-inclusive necrosis rates to
below 10%, reflecting a 31% decrease in the investigators necrosis rate.
The investigators current rate of the development of all-inclusive mastectomy skin necrosis
was approximately 41%. This means that current methods of clinical assessment fail to
identify regions of mastectomy skin with poor blood flow that lead to necrosis in 41% of
patients. The investigators know that using the SPY imaging system is more sensitive for
necrosis than clinical assessment. With SPY Q analysis the investigators hope to obtain 90%
sensitivity, 100% specificity at absolute perfusion unit values identified in the previous
study. The investigators do not anticipate obtaining a 0% all-inclusive necrosis rate but do
believe they can eliminate all clinically significant necrosis that would result in
operative debridement or removal of implant. The less severe forms of necrosis including
epidermolysis and incisional necrosis are self-limiting and usually do not require invasive
interventions.
was approximately 41%. This means that current methods of clinical assessment fail to
identify regions of mastectomy skin with poor blood flow that lead to necrosis in 41% of
patients. The investigators know that using the SPY imaging system is more sensitive for
necrosis than clinical assessment. With SPY Q analysis the investigators hope to obtain 90%
sensitivity, 100% specificity at absolute perfusion unit values identified in the previous
study. The investigators do not anticipate obtaining a 0% all-inclusive necrosis rate but do
believe they can eliminate all clinically significant necrosis that would result in
operative debridement or removal of implant. The less severe forms of necrosis including
epidermolysis and incisional necrosis are self-limiting and usually do not require invasive
interventions.
Inclusion Criteria:
1. Being scheduled for unilateral or bilateral mastectomy (prophylactic or for the
treatment of cancer) followed by breast construction using a Tissue Expander
2. Consent to participation in the study.
Exclusion Criteria:
1. Refusal to consent to participation in the study
2. Inability to tolerate the administration of indocyanine green dye due to iodine
allergy
3. A positive pregnancy test during preoperative evaluation.
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