The ability of intra-operative perfusion mapping with laser-assisted indocyanine green angiography to predict mastectomy flap necrosis in breast reconstruction: A prospective trial

doi:10.1016/j.bjps.2013.12.040

Journal of Plastic, Reconstructive & Aesthetic Surgery

Volume 67, Issue 4, April 2014, Pages 449-455

https://doi.org/10.1016/j.bjps.2013.12.040 Get rights and content

Summary

Mastectomy skin flap ischaemia leading to necrosis is a common occurrence. Laser-assisted indocyanine green (ICG) angiography can assist to locate these poorly perfused areas intra-operatively. Our study aims to identify specific perfusion values produced by ICG angiography that accurately predict mastectomy flap necrosis. A total of 42 patients undergoing autologous or implant-based breast reconstruction had mastectomy flaps imaged using laser-assisted ICG angiography at the completion of reconstruction. Intra-operative perfusion values were correlated with postoperative skin flap outcomes. Risk factors for abnormal perfusion were recorded and analysed. A total of 62 breast reconstructions were imaged, including 48 tissue expander reconstructions, six transverse rectus abdominis myocutaneous (TRAM) flaps, six deep inferior epigastric perforator (DIEP) flaps and two direct-to-implant reconstructions. Eight cases (13%) of full-thickness skin necrosis were identified postoperatively. A SPY Elite^® value of ≤7 accurately predicted the development of flap necrosis at 88% sensitivity and 83% specificity. False-positive cases (those with perfusion values ≤7 which did not develop necrosis) were more likely to have a smoking history and/or to have had an epinephrine-containing tumescent solution used during mastectomy. Excluding patients with smoking or epinephrine use, a SPY value of ≤7 predicted flap necrosis with a sensitivity of 83% and specificity of 97%. Thus, these data suggest that laser-assisted ICG angiography predicts postoperative outcomes with high accuracy. In our series, a SPY value of ≤7 correlated well with mastectomy flap necrosis. Furthermore, smoking and intra-operative injections containing epinephrine should be considered when evaluating low perfusion values as they can lead to false-positive test results.

Section snippets

Background

Breast reconstruction is a common procedure that can dramatically improve the quality of life and satisfaction for women who have undergone mastectomy, with over 91,000 procedures performed in 2012.¹ The success of the procedure, however, is limited by its complications, including mastectomy skin flap necrosis, which occurs at a rate of 10–15% but has been reported as high as 52% in some studies.2, 3, 4 Postoperative necrosis can have significant consequences including major morbidity, delays

Patients and methods

A prospective clinical trial was designed to evaluate the ICG angiography perfusion values associated with mastectomy skin flap necrosis. Institutional Review Board approval was obtained from the Columbia University Medical Center prior to patient enrolment. Patients presenting for tissue expander, direct-to-implant or autologous reconstruction between June 2011 and January 2013 were considered for enrolment. Verbal and written informed consent was obtained from each patient preoperatively.

Results

A total of 62 breast reconstructions were completed in 42 patients, including 48 tissue expander reconstructions, six pedicled transverse rectus abdominis myocutaneous (TRAM) flaps, six deep inferior epigastric perforator (DIEP) flaps and two direct-to-implant reconstructions. The average patient age was 53.2 years with an average follow-up of 8.8 months (a range of 3.9–22.2 months). Seven patients, comprising 11 of the 62 breasts, were active smokers at the time of surgery. Demographics and

Discussion

Currently, the standard approach to evaluating mastectomy skin flap viability is via clinician assessment intra-operatively. Prior to closure, the surgeon must assess tissue quality and excise skin based on the likelihood of necrosis in the postoperative period. With this clinically guided approach, the literature reports mastectomy skin flap necrosis rates of approximately 10–15%.7, 8 Our current study yielded a 13% rate of necrosis, consistent with the literature, with two out of eight cases

Conflict of interest statement

All of the authors have no financial interests to disclose.

Acknowledgement

We would like to thank Dr. Fatih Balci for his assistance in performing the SPY recordings in many of our patients. Additionally, we thank LifeCell Corporation and the Department of Surgery at Columbia University, who both generously sponsored our research. LifeCell Corporation assisted the authors with data collection. Neither sponsor, however, was involved in study design, interpretation of data, writing of the manuscript or the decision to submit the manuscript for publication.

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Cited by (137)

A feasibility study assessing quantitative indocyanine green angiographic predictors of reconstructive complications following nipple-sparing mastectomy
2024, JPRAS Open
Immediate post-mastectomy breast reconstruction offers benefits; however, complications can compromise outcomes. Intraoperative indocyanine green fluorescence angiography (ICGFA) may mitigate perfusion-related complications (PRC); however, its interpretation remains subjective. Here, we examine and develop methods for ICGFA quantification, including machine learning (ML) algorithms for predicting complications.
ICGFA video recordings of flap perfusion from a previous study of patients undergoing nipple-sparing mastectomy (NSM) with either immediate or staged immediate (delayed by a week due to perfusion insufficiency) reconstructions were analysed. Fluorescence intensity time series data were extracted, and perfusion parameters were interrogated for overall/regional associations with postoperative PRC. A naïve Bayes ML model was subsequently trained on a balanced data subset to predict PRC from the extracted meta-data.
The analysable video dataset of 157 ICGFA featured females (average age 48 years) having oncological/risk-reducing NSM with either immediate (n=90) or staged immediate (n=26) reconstruction. For those delayed, peak brightness at initial ICGFA was lower (p<0.001) and significantly improved (both quicker-onset and brighter p=0.001) one week later. The overall PRC rate in reconstructed patients (n=116) was 11.2%, with such patients demonstrating significantly dimmer (overall, p=0.018, centrally, p=0.03, and medially, p=0.04) and slower-onset (p=0.039) fluorescent peaks with shallower slopes (p=0.012) than uncomplicated patients with ICGFA. Importantly, such relevant parameters were converted into a whole field of view heatmap potentially suitable for intraoperative display. ML predicted PRC with 84.6% sensitivity and 76.9% specificity.
Whole breast quantitative ICGFA assessment reveals statistical associations with PRC that are potentially exploitable via ML.
Prepectoral Versus Subpectoral Implant-Based Reconstruction: How Do We Choose?
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Evaluation of the Angiosome Concept Using Near-Infrared Fluorescence Imaging with Indocyanine Green
2023, Annals of Vascular Surgery
The angiosome concept is defined as the anatomical territory of a source artery within all tissue layers. When applying this theory in vascular surgery, direct revascularization (DR) is preferred to achieve increased blood flow toward the targeted angiosome of the foot in patients with lower extremity arterial disease (LEAD). This study evaluates the applicability of the angiosome concept using quantified near-infrared (NIR) fluorescence imaging with indocyanine green (ICG).
This study included patients undergoing an endovascular- or surgical revascularization of the leg between January 2019 and December 2021. Preinterventional and postinterventional ICG NIR fluorescence imaging was performed. Three angiosomes on the dorsum of the foot were determined: the posterior tibial artery (hallux), the anterior tibial artery (dorsum of the foot) and the combined angiosome (second to fifth digit). The angiosomes were classified from the electronic patient records and the degree of collateralization was classified based on preprocedural computed tomography angiography and/or X-ray angiography. Fluorescence intensity was quantified in all angiosomes. A subgroup analysis based on endovascular or surgical revascularized angiosomes, and within critical limb threatening ischemia (CLTI) patients was performed.
ICG NIR fluorescence measurements were obtained in 52 patients (54 limbs) including a total of 157 angiosomes (121 DR and 36 indirect revascularizations [IR]). A significant improvement of all perfusion parameters in both the directly and indirectly revascularized angiosomes was found (P-values between <0.001–0.007). Within the indirectly revascularized angiosomes, 90.6% of the scored collaterals were classified as significant. When comparing the percentual change in perfusion parameters between the directly and indirectly revascularized angiosomes, no significant difference was seen in all perfusion parameters (P-values between 0.253 and 0.881). Similar results were shown in the CLTI patients subgroup analysis, displaying a significant improvement of perfusion parameters in both the direct and indirect angiosome groups (P-values between <0.001 and 0.007), and no significant difference when comparing the percentual parameter improvement between both angiosome groups (P-values between 0.134 and 0.359). Furthermore, no significant differences were observed when comparing percentual changes of perfusion parameters in directly and indirectly revascularized angiosomes for both endovascular and surgical interventions (P-values between 0.053 and 0.899).
This study proves that both DR and IR of an angiosome leads to an improvement of perfusion. This suggests that interventional strategies should not only focus on creating in-line flow to the supplying angiosome. One can argue that the angiosome concept is not applicable in patients with LEAD.
Near-infrared fluorescence angiography with indocyanine green for perfusion assessment of DIEP and msTRAM flaps: A Dutch multicenter randomized controlled trial
2023, Contemporary Clinical Trials Communications
A common complication after a DIEP flap reconstruction is the occurrence of fat necrosis due to inadequate flap perfusion zones. Intraoperative identification of ischemic zones in the DIEP flap could be optimized using indocyanine green near-infrared fluorescence angiography (ICG-NIR-FA). This randomized controlled trial aims to determine whether intraoperative ICG-NIR-FA for the assessment of DIEP flap perfusion decreases the occurrence of fat necrosis.
This article describes the protocol of a Dutch multicenter randomized controlled clinical trial: the FAFI-trial. Females who are electively scheduled for autologous breast reconstruction using DIEP or muscle-sparing transverse rectus abdominis muscle (msTRAM) flaps are included. A total of 280 patients will be included in a 1:1 ratio between both study arms. In the intervention arm, the intraoperative assessment of flap perfusion will be based on both regular clinical parameters and ICG-NIR-FA. The control arm consists of flap perfusion evaluation only through the regular clinical parameters, while ICG-NIR-FA images are obtained during surgery for which the surgeon is blinded. The main study endpoint is the difference in percentage of clinically relevant fat necrosis between both study arms, evaluated two weeks and three months after reconstruction.
The FAFI-trial, a Dutch multicenter randomized controlled clinical trial, aims to investigate the clinical added value of intraoperative use of standardized ICG-NIR-FA for assessment of DIEP/msTRAM flap perfusion in the reduction of fat necrosis.
NCT05507710; NL 68623.058.18.
Predicting Mastectomy Skin Flap Necrosis: A Systematic Review of Preoperative and Intraoperative Assessment Techniques
2023, Clinical Breast Cancer
Mastectomy skin-flap necrosis (MSFN) is one of the most feared complications of immediate implant-based breast reconstruction (IIBR). Traditionally, mastectomy skin-flap viability was based only on surgeons’ clinical experience. Even though numerous studies have already addressed the patients’ risk factors for MSFN, few works have focused on assessing quality of breast envelope. This review investigates mastectomy's flap viability-assessment methods, both preoperative (PMFA) and intraoperative (IMFA), to predict MSFN and its sequalae. Between June and November 2022, we conducted a systematic review of Pubmed/MEDLINE and Cochrane electronic databases. Only English studies regarding PMFA and IMFA applied to IIBR were selected. The use of digital mammography, ultrasound, magnetic resonance imaging, and a combination of several methods before surgery was shown to be advantageous by several authors. Indocyanine performed better than other IMFA, however both thermal imaging and spectroscopy demonstrated novel and promising results. Anyway, the best prediction comes when preoperative and intraoperative values are combined. Particularly in prepectoral reconstruction, when mastectomy flaps are essential to determine a successful breast reconstruction, surgeons' clinical judgment is insufficient in assessing the risk of MSFN. Preoperative and intraoperative assessment techniques play an emerging key role in MSFN prediction. However, although there are several approaches to back up the surgeon's processing choice, there is still a dearth of pertinent literature on the subject, and more research is required.
Immediate fine-tuning of DIEP flaps using the Wise pattern mastectomy: Description of the technique and a retrospective analysis of complication rates
2022, Annales de Chirurgie Plastique Esthetique
Citation Excerpt :
One useful tool for future studies on the subject is the BREAST-Q, a validated patient-reported outcome measure that would provide data on patient satisfaction on both traditional and Wise pattern mastectomy results [21]. There may also be a role for blood supply-quantifying modalities such as SPY Intraoperative Perfusion Assessment System (Novadaq Technologies Inc., Richmond, British Columbia, Canada) and thermal imaging in evaluating blood supply of the mastectomy flaps to improve the safety of the technique and minimize mastectomy flap necrosis and wound complications [22–25]. Another avenue of research that may be followed with this operative technique is whether incisional negative pressure wound therapy placed intraoperatively after wound closure would improve flap perfusion/survival [26–28].
Elliptical skin-sparing mastectomy in patients with large or ptotic breasts usually leaves loose mastectomy skin flaps, which need to be either resected or gathered over the DIEP flap. This results in poor control of the breast footprint and under-projected DIEP flaps in a loose mastectomy skin pocket, that tend to slip laterally towards the axilla. We believe that the use of a Wise pattern mastectomy will allow for immediate treatment of these concerns.
A retrospective, uncontrolled analysis of a prospectively-maintained database of patients operated by the five surgeons performing breast reconstructions at the University of Montreal Hospital Centre. Study population was patients with a BMI of over 25 and grade II/III breast ptosis who underwent a Wise pattern mastectomy with immediate DIEP flap reconstruction. Analysis was performed of the complication rates of the technique in the first six months after the surgery.
Out of a total of 53 breasts in 44 patients reconstructed with a DIEP flap immediately post Wise pattern mastectomy, we report nine cases of partial mastectomy-flap necrosis not needing revision, five cases of significant mastectomy flap necrosis needing debridement and skin grafting, and two cases of inability to adequately close the Wise pattern intraoperatively after DIEP placement, necessitating retention of DIEP skin in the inferior pole. None of the mastectomy flap complications occurred in irradiated breasts.
In patients with large or ptotic breasts, the Wise pattern mastectomy before an immediate DIEP reconstruction allows for immediate shaping of the breast by controlling the breast pocket, footprint, and excess skin.
La mastectomie elliptique avec conservation de la peau chez les patientes présentant des seins volumineux ou ptotiques laisse généralement des lambeaux cutanés de mastectomie lâches qui doivent être soit réséqués, soit rassemblés sur le lambeau DIEP. Il en résulte un mauvais contrôle de l’empreinte mammaire et des lambeaux DIEP sous-projetés dans une poche cutanée de mastectomie lâche, qui ont tendance à glisser latéralement vers l’aisselle. Nous pensons que l’utilisation d’une mastectomie Wise permettra un traitement immédiat de ces problèmes.
Une analyse rétrospective et non contrôlée d’une base de données prospectivement maintenue de patientes opérées par les cinq chirurgiens réalisant des reconstructions mammaires au Centre hospitalier de l’Université de Montréal. La population étudiée était constituée de patientes ayant un IMC supérieur à 25 et une ptose mammaire de grade II/III qui ont subi une mastectomie de type Wise avec reconstruction immédiate par lambeau DIEP. Une analyse a été réalisée des taux de complications de la technique dans les six premiers mois après la chirurgie.
Sur un total de 53 seins chez 44 patientes reconstruites avec un lambeau DIEP immédiatement après une mastectomie de type Wise, nous rapportons neuf cas de mastectomie partielle-nécrose du lambeau n’ayant pas besoin de révision, cinq cas de nécrose de lambeau de mastectomie significative nécessitant un débridement et une greffe de peau, et deux cas d’incapacité à fermer adéquatement les incisions Wise après la mise en place du DIEP, nécessitant la rétention de la peau du DIEP dans le pôle inférieur. Aucune des complications du lambeau de mastectomie ne s’est produite dans les seins irradiés.
Chez les patientes ayant des seins volumineux ou ptotiques, la mastectomie en mode Wise avant une reconstruction DIEP immédiate permet une mise en forme immédiate du sein en contrôlant la poche mammaire, l’empreinte et l’excès de peau.

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^☆: Abstract presentations: 1) Northeastern Society of Plastic Surgeons Annual Meeting, Washington D.C., Sept. 19–21, 2013. 2) American Society of Plastic Surgery Annual Meeting, San Diego, CA, Oct. 12–14, 2013.

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The ability of intra-operative perfusion mapping with laser-assisted indocyanine green angiography to predict mastectomy flap necrosis in breast reconstruction: A prospective trial☆

Summary

Section snippets

Background

Patients and methods

Results

Discussion

Conflict of interest statement

Acknowledgement

Chest

J Am Coll Cardiol

Management of massive mastectomy skin flap necrosis following autologous breast reconstruction

Ann Plast Surg

Complications in postmastectomy breast reconstruction: two-year results of the Michigan breast reconstruction outcome study

Plast Reconstr Surg

Intraoperative perfusion mapping with laser-assisted indocyanine green imaging can predict and prevent complications in immediate breast reconstruction

Plast Reconstr Surg

Intraoperative perfusion techniques can accurately predict mastectomy skin flap necrosis in breast reconstruction: results of a prospective trial

Plast Reconstr Surg

Predicting mastectomy skin flap necrosis with indocyanine green angiography: the gray area defined

Plast Reconstr Surg

Flap survival of skin-sparing mastectomy type IV: a retrospective cohort study of 75 consecutive cases

Ann Surg Oncol

Predicting complications following expander/implant breast reconstruction: an outcomes analysis based on preoperative clinical risk

Plast Reconstr Surg