Cost minimization in breast conserving surgery: a comparative study of radiofrequency spectroscopy and full cavity shave margins.

BACKGROUND: In an effort to minimize positive margins and subsequent re-excision after breast conserving surgery (BCS), many providers and facilities have implemented either a Full Cavity Shave (FCS) approach or adding the MarginProbe Radiofrequency Spectroscopy System. OBJECTIVE: We sought to create a functioning Pro-Forma for use by facilities and payers to evaluate and compare the cost savings of implementing FCS or MarginProbe based on personalized variable inputs. METHODS: A decision tree demonstrating three possible surgical pathways, BCS, BCS + FCS, and BCS + MarginProbe was developed with clinical inputs for re-excision rate, mastectomy as 2nd surgery, rate of reconstruction, and rate of 3rd surgery derived by a literature review. A surgical pathway cost formula was created using the decision tree and financial inputs derived by utilizing the nation's largest database of privately billed health insurance claims and Medicare claims data (fairhealth.org). Using the surgical pathway formula and financial inputs, a customizable Pro-Forma was created for immediate cost savings analysis of BCS + FCS and BCS + Marginprobe using variable inputs. Costs are from the perspective of third-party payers. RESULTS: Utilizing MarginProbe to reduce re-excisions for positive margins can be associated with better cost-savings than FCS due to the increased pathology processing costs by using an FCS approach. The reduction in re-excision provided by both FCS and MarginProbe offset their increased expense to various degrees with cost savings of each method improving as baseline re-excisions rates increase, until ultimately each may become cost-neutral or cost-prohibitive when compared to BCS alone. Our data suggest that in the privately insured population, MarginProbe provides a cost-savings over BCS alone when baseline re-excision rates are over 20% and that FCS becomes cost-saving when baseline re-excision rates are over 29%. For Medicare patients, MarginProbe provides a cost-savings when baseline re-excision rates exceed 34%, and FCS becomes cost-saving for re-excision rates over 52%. Our Pro-Forma allows an individual provider or institution to evaluate the cost savings of the FCS approach and/or utilization of the MarginProbe device such that the additional cost or cost-savings of utilizing one or both of these methods can be quickly calculated based on their facility's volume and baseline re-excision rate. CONCLUSIONS: Our data suggest that utilizing either an FCS approach or the MarginProbe radiofrequency spectroscopy system may be a cost-saving solution to reducing the rate of re-excisions depending on a facility or practice's surgical volume and baseline re-excision rate. The degree to which each of these interventions provides an added cost or cost-savings to healthcare payers can be evaluated by utilizing the Pro-Forma outlined herein with customizable variable inputs.

Minimizing re-excision after breast conserving surgery - a review of radiofrequency spectroscopy for real-time, intraoperative margin assessment.

INTRODUCTION: For early-stage breast cancer, breast-conserving surgery (BCS) plus radiation is standard-of-care. Nationwide, >20% of BCS patients require re-excision for positive margins, resulting in delayed adjuvant therapy, increased complications, emotional and financial stress for patients, and additional cost to the healthcare system. Although several methods may be employed to mitigate positive margins, no technique can fully address the need. MarginProbe® is an adjunctive tool for real-time intraoperative margin assessment and is shown to reduce positive margins by >50%. AREAS COVERED: Discussion of the impact of re-excision following BCS, a review of currently available methods for intraoperative margin management, followed by a technology and literature review of the MarginProbe® Radiofrequency Spectroscopy System. EXPERT OPINION: Re-excision significantly impacts patients, providers and payers. Limitations in the ability to assess margins at time of surgery warrant more advanced methods of residual disease detection. MarginProbe facilitates the most efficient pathway for breast cancer patients through the surgical phase of treatment. The device is well-suited for adoption as the healthcare focus shifts from volume to value and supports the three pillars of the US Department of Health and Human Services' 'Triple-Aim' strategy: improve population health, improve patient experience of care, and reduce per-capita costs.

A Single institution's randomized double-armed prospective study of lumpectomy margins with adjunctive use of the MarginProbe in nonpalpable breast cancers.

Breast conservation surgery (BCS) aims to excise all cancerous tissue while minimizing the amount of healthy breast tissue removed. Up to 30% of patients undergoing BCS require a second operation for re-excision to obtain negative margins. Previous studies reported a lower re-excision rate with intraoperative use of the MarginProbe device (Dune Medical Devices). This device utilizes radiofrequency spectroscopy to detect differences between cancerous and normal tissue. From July 2009 to January 2010, our institution enrolled 46 patients electing for BCS in a prospective double-arm randomized controlled trial and had a significantly lower re-excision rate than that reported in the multicenter trial. Intraoperatively, after performing conventional lumpectomy with excision of any additional shavings deemed necessary based on palpation and visual inspection alone, patients were then randomized. In the device arm, the surgeon used the MarginProbe to interrogate the lumpectomy specimen, taking additional shavings from the cavity surfaces corresponding to the parts of the specimen read as positive by the device. In the control arm, only standard intraoperative assessments were performed. All specimens were evaluated by pathologists who were blinded to the study arm. In this population, 72% had invasive ductal carcinoma (IDC), 20% had ductal carcinoma in situ (DCIS), and 8% had invasive lobular carcinoma (ILC). Average age was 64 years old. The average size of the specimen was 5.6 cm, the average volume was 37.8 cm3 , and the average weight was 32.7 g. The mean size of DCIS was 1.4 cm. For invasive specimens, 32 were T1 and 7 were T2. Prior to randomization, 43 patients were thought to have positive or close margins and therefore underwent additional shavings. Twenty-three patients were randomized to the device arm and 23 to the control arm. In the device arm, 14 (60%) patients had IDC, 7 (30%) had DCIS, and 2 (8%) had ILC, vs the control arm where 19 (82%) patients had IDC, 2 (8%) had DCIS, and 2 (8%) had ILC. Eight (35%) patients in the control group vs 1 (4%) in the device group underwent re-excision for margin involvement (P < .05). The use of the MarginProbe device at our institution significantly improved the ability of our surgeons to obtain clear margins during initial BCS. Our results show a lower re-excision rate (4%) than those published in the multicenter trial (19.8%). We postulate that in the face of more patients having DCIS in our device group (30%), our surgeons responded by taking thicker shavings when the MarginProbe device reported margin involvement during the initial lumpectomy, resulting in greater success achieving clear final margins on the shaved tissue and a significantly lower re-excision rate than previously reported with the MarginProbe device.