The Impact of Breast Lumpectomy Tray Utilization on Cost Savings.

BACKGROUND: Right-sizing instrument trays reduce processing and replacement costs, physical strain, and turnover times. Historically, a 98-instrument head and neck tray has been used for breast lumpectomy cases at our institution. Observations revealed that many instruments on the tray were not used during the breast cases. With the significant number of surgical breast lumpectomies performed annually, tray downsizing could significantly reduce costs and physical strain. METHODS: Surgical technicians identified instruments needed for a standard breast lumpectomy. Breast surgeons reviewed the list and made final recommendations. Three of 13 existing head and neck trays were converted to breast lumpectomy trays. The number of breast lumpectomies in 2017 was pulled from the institution's health information system. Instrument quantities were verified using instrument management software. Weights were taken on a digital scale, and processing cost was estimated by a consultant. RESULTS: The new breast trays included 51 instruments rather than the standard 98-instrument trays. Reprocessing cost decreased from $49.98 to $26.01. With 449 breast lumpectomies performed at the institution in 2017, the annual reprocessing savings totaled $10,763. The tray weight was reduced from 27 to 16 pounds. Setup time decreased from 7 to 4 min per use (22.5 h saved annually). CONCLUSIONS: Downsizing from a head and neck tray to a specific breast lumpectomy tray demonstrated a reduction in reprocessing cost, tray weight, and setup time. Lighter trays allow for safer handling and transport by surgical personnel. In the current health-care environment, it is important to maximize operating room efficiency and minimize cost.

Miniature spectral imaging device for wide-field quantitative functional imaging of the morphological landscape of breast tumor margins.

We have developed a portable, breast margin assessment probe leveraging diffuse optical spectroscopy to quantify the morphological landscape of breast tumor margins during breast conserving surgery. The approach presented here leverages a custom-made 16-channel annular photodiode imaging array (arranged in a 4 × 4 grid), a raster-scanning imaging platform with precision pressure control, and compressive sensing with an optimized set of eight wavelengths in the visible spectral range. A scalable Monte-Carlo-based inverse model is used to generate optical property [ ? s ? ( ? ) and ? a ( ? ) ] measures for each of the 16 simultaneously captured diffuse reflectance spectra. Subpixel sampling (0.75 mm) is achieved through incremental x , y raster scanning of the imaging probe, providing detailed optical parameter maps of breast margins over a 2 × 2 ?? cm 2 area in ? 9 ?? min . The morphological landscape of a tumor margin is characterized using optical surrogates for the fat to fibroglandular content ratio, which has demonstrated diagnostic utility in delineating tissue subtypes in the breast.

Monte Carlo simulation to analyze the cost-benefit of radioactive seed localization versus wire localization for breast-conserving surgery in fee-for-service health care systems compared with accountable care organizations.

OBJECTIVE: In breast-conserving surgery for nonpalpable breast cancers, surgical reexcision rates are lower with radioactive seed localization (RSL) than wire localization. We evaluated the cost-benefit of switching from wire localization to RSL in two competing payment systems: a fee-for-service (FFS) system and a bundled payment system, which is typical for accountable care organizations. MATERIALS AND METHODS: A Monte Carlo simulation was developed to compare the cost-benefit of RSL and wire localization. Equipment utilization, procedural workflows, and regulatory overhead differentiate the cost between RSL and wire localization. To define a distribution of possible cost scenarios, the simulation randomly varied cost drivers within fixed ranges determined by hospital data, published literature, and expert input. Each scenario was replicated 1000 times using the pseudorandom number generator within Microsoft Excel, and results were analyzed for convergence. RESULTS: In a bundled payment system, RSL reduced total health care cost per patient relative to wire localization by an average of $115, translating into increased facility margin. In an FFS system, RSL reduced total health care cost per patient relative to wire localization by an average of $595 but resulted in decreased facility margin because of fewer surgeries. CONCLUSION: In a bundled payment system, RSL results in a modest reduction of cost per patient over wire localization and slightly increased margin. A fee-for-service system suffers moderate loss of revenue per patient with RSL, largely due to lower reexcision rates. The fee-for-service system creates a significant financial disincentive for providers to use RSL, although it improves clinical outcomes and reduces total health care costs.

A randomized prospective study of lumpectomy margin assessment with use of MarginProbe in patients with nonpalpable breast malignancies.

BACKGROUND: The presence of tumor cells at the margins of breast lumpectomy specimens is associated with an increased risk of ipsilateral tumor recurrence. Twenty to 30 % of patients undergoing breast-conserving surgery require second procedures to achieve negative margins. This study evaluated the adjunctive use of the MarginProbe device (Dune Medical Devices Ltd, Caesarea, Israel) in providing real-time intraoperative assessment of lumpectomy margins. METHODS: This multicenter randomized trial enrolled patients with nonpalpable breast malignancies. The study evaluated MarginProbe use in addition to standard intraoperative methods for margin assessment. After specimen removal and inspection, patients were randomized to device or control arms. In the device arm, MarginProbe was used to examine the main lumpectomy specimens and direct additional excision of positive margins. Intraoperative imaging was used in both arms; no intraoperative pathology assessment was permitted. RESULTS: In total, 596 patients were enrolled. False-negative rates were 24.8 and 66.1 % and false-positive rates were 53.6 and 16.6 % in the device and control arms, respectively. All positive margins on positive main specimens were resected in 62 % (101 of 163) of cases in the device arm, versus 22 % (33 of 147) in the control arm (p < 0.001). A total of 19.8 % (59 of 298) of patients in the device arm underwent a reexcision procedure compared with 25.8 % (77 of 298) in the control arm (6 % absolute, 23 % relative reduction). The difference in tissue volume removed was not significant. CONCLUSIONS: Adjunctive use of the MarginProbe device during breast-conserving surgery improved surgeons' ability to identify and resect positive lumpectomy margins in the absence of intraoperative pathology assessment, reducing the number of patients requiring reexcision. MarginProbe may aid performance of breast-conserving surgery by reducing the burden of reexcision procedures for patients and the health care system.

MarginProbe: intraoperative margin assessment during breast conserving surgery by using radiofrequency spectroscopy.

In breast conserving surgery, the tumor should be removed with a clean margin, a rim of healthy tissue surrounding. Failure to achieve clean margins in the initial surgery results in a re-excision procedure. Re-excision rates are reported as being 11-46% for invasive carcinoma and ductal carcinoma in situ (DCIS). Re-excisions can have negative consequences such as increased postoperative infections, negative impact on cosmesis, patient anxiety and increased medical costs. Therefore, the surgical margin of invasive and intraductal (DCIS) breast tissue is a subject of intense discussion. Different options for intraoperative assessment are available, but all in all, they are unsatisfying. Frozen section margin examination is possible but is time consuming and restricted to the assessment of invasive carcinoma. In the case of DCIS, there is no procedure for intraoperative margin assessment. Thus, a solution for efficient intraoperative surgical margin assessment is needed. For this purpose, an innovative, real-time, intraoperative margin-assessment device (MarginProbe, Dune Medical Devices, Caesarea, Israel) was designed, and recent published clinical data reported a reduction of re-excisions by more than 50%.

Development of a spatially offset Raman spectroscopy probe for breast tumor surgical margin evaluation.

The risk of local recurrence for breast cancers is strongly correlated with the presence of a tumor within 1 to 2 mm of the surgical margin on the excised specimen. Previous experimental and theoretical results suggest that spatially offset Raman spectroscopy (SORS) holds much promise for intraoperative margin analysis. Based on simulation predictions for signal-to-noise ratio differences among varying spatial offsets, a SORS probe with multiple source-detector offsets was designed and tested. It was then employed to acquire spectra from 35 frozen-thawed breast tissue samples in vitro. Spectra from each detector ring were averaged to create a composite spectrum with biochemical information covering the entire range from the tissue surface to ∼2 mm below the surface, and a probabilistic classification scheme was used to classify these composite spectra as "negative" or "positive" margins. This discrimination was performed with 95% sensitivity and 100% specificity, or with 100% positive predictive value and 94% negative predictive value.

A device for real-time, intraoperative margin assessment in breast-conservation surgery.

BACKGROUND: This trial was designed to study performance of a novel handheld probe (Dune Medical Devices, Caesarea, Israel) in intraoperative detection of positive margins and its potential benefit toward minimizing the positive margin rate. METHODS: The probe was intraoperatively applied to 57 lumpectomy specimens. Surgeons were blinded to device output, and surgical decisions were not affected by probe data. Probe readings were compared with histological analysis per margin and per patient. RESULTS: Nineteen of 22 (86%) pathology-positive patients were intraoperatively detected with device use. Per-margin sensitivity was .71, and specificity was .68, maintained within a range of positive margin definitions (0-.4 cm). CONCLUSIONS: The device is an effective tool for intraoperative detection of positive margins with the potential for significant positive margin rate reduction.

A method to evaluate human spatial coordination interfaces for computer-assisted surgery.

Computer assistance for breast conserving surgery requires a guidance method to assist a surgeon in locating tumor margin accurately. A wide array of guidance methods can be considered ranging from various pictorial representations, symbolic graphical interfaces as well as those based on other sensory cues such as sound. In this study, we present an experimental framework for testing candidate guidance methods in isolation or in combination. A total of 22 guidance approaches, based on stereographic, non-stereographic, symbolic and auditory cues were tested in a simulation of breast conserving surgery. Observers were asked to circumscribe a virtual tumor with a magnetically tracked scalpel while measuring the spatial accuracy, time and the frequency with which the tumor margin was intersected. A total of 110 studies were performed with 5 volunteers. Based on these findings, we demonstrated that a single view of the tumor with a stereo presentation in conjunction with an auditory guidance cue provided the best balance of accuracy, speed and surgical integrity. This study demonstrates a practical and helpful framework for testing guidance methods in a context dependent manner.

[New methods for minimal invasive assessment of uncertain mammography and MRI tomography findings]. / Neue Methoden zur minimal-invasiven Abklärung unklarer mammographischer und MR-tomographischer Befunde.

Results of 3 minimal invasive techniques for breast biopsy of clinically occult lesion are presented. 1. Mammographically guided Site-Select biopsies allow removal of tissue in one piece using a large diameter core biopsy instrument (similar to the ABBI-principle). However the overlying subcutaneous tissue is saved. No technical problems occurred in 13/13 diagnostic biopsies. Complete removal was, however, only possible in 2/4 tumors < 1 cm due to tissue shift during insertion of the instrument. 2. Mammographically guided vacuum biopsy also allows contiguous removal of areas of 1.2-1.8 cm diameter, while blood is suctioned out, as well. 3 stereotaxic miscalculations were immediately recognized. Diagnostic accuracy in 405 biopsies so far is 100%. The examination was very well tolerated by the patients. 3. By means of a specially developed biopsy coil and vacuum biopsy percutaneous in- or excisional biopsy of enhancing lesions visible by MRI alone has been realized by us for the first time. 24/25 diagnoses are definitely representative--as proven by lack of enhancement after biopsy. One diagnosis, which was uncertain due to overlying blood, is being followed. Minimal invasive methods may open up new perspectives.