A versatile cost-effective method for the analysis of fresh frozen tissue sections via matrix-assisted laser desorption/ionisation imaging mass spectrometry.

RATIONALE: There are currently multiple methods available for the preparation of fresh frozen tissue samples for analysis via matrix-assisted laser desorption/ionisation time-of-flight (MALDI-TOF) imaging mass spectrometry (IMS). Although these methods report excellent results, many are expensive automated approaches. With no published attempt to standardise less expensive manual processes, our work aims to provide a robust and repeatable method of sample preparation for MALDI-TOF-IMS that is applicable to a variety of tissue types, well explained, simple and cost effective. METHODS: Fresh frozen tissue was sectioned at 12 µm and mounted onto liquid nitrocellulose coated slides, washed in a graded alcohol series and then mounted into a modified sublimation apparatus. Matrix is deposited onto the slide to achieve a desired coating of 0.2 mg/cm(2). Once coated, the slide is mounted into a custom-built vapor chamber and recrystallised with 50% acetonitrile (ACN), 0.1% trifluoroacetic acid (TFA) for 1 h at 37°C. The slide is then analysed using MALDI-IMS. RESULTS: We have successfully implemented this method for a host of tissue samples, including brain, liver, kidney and heart, with no variation in relative spectra or processing method required. When the protocol is followed correctly, sublimations and recrystallisations are highly predictable with limited variation between samples and a very low failure rate. Additional apparatuses can be easily constructed by following the included instructions, that perform as per specifications with no variation. CONCLUSIONS: We believe that we have described a complete protocol for MALDI-IMS that is easy to use and highly reproducible. The lack of expensive commercially available equipment makes this process very cheap with a relatively low initial outlay and our hope is that more laboratories will begin IMS-based avenues of research based on the work we have performed.

Economic implications of ACOSOG Z0011 trial application into clinical practice at the European Institute of Oncology.

BACKGROUND AND OBJECTIVES: The American College of Surgeons Oncology Group (ACOSOG) Z0011 trial demonstrated that in clinically node-negative women undergoing breast-conserving therapy (BCT) and found to have metastases to 1 or 2 sentinel nodes, sentinel lymph node biopsy (SLNB) alone resulted in rates of local control, disease-free survival, and overall survival equivalent to those seen after axillary lymph node dissection (ALND), but with significantly lower morbidity. Application of the Z0011 guidelines resulted in fewer ALNDs without affecting locoregional recurrence or survival. Changes in practice inevitably affect health care costs. The current study investigated the actual impact of applying the Z0011 guidelines to eligible patients and determined the costs of care at a single institution. PATIENTS AND METHODS: We compared axillary nodal management and cost data in breast cancer patients who met the Z0011 criteria and were treated with BCT and SLNB. Patients were allocated into two mutually exclusive cohorts based on the date of surgery: pre-Z0011 (June 2013 to December 2015) and post-Z0011 (June 2016 to December 2018). RESULTS: Of 3912 patients, 433 (23%) and 357 (17.6%) patients in the pre- and post-Z0011 era had positive lymph nodes. ALND decreased from 15.3% to 1.57% in the post-Z0011 era. The mean overall cost of SLNB in the pre-Z0011 cohort was €1312 per patient, while that for SLNB with completion ALND was €2613. Intraoperative frozen section (FS) use decreased from 100% to 12%. Omitting the FS decreased mean costs from €247 to €176. The mean total cost in the pre-Z0011 cohort was €1807 per patient, while in the post-Z0011 cohort it was €1498. The application of Z0011 resulted in an overall mean cost savings of €309 for each patient. CONCLUSIONS: Application of the Z0011 criteria to patients undergoing BCT at our institution results in more than half a million Euro cost savings.

Is there a clinical role for frozen section analysis during partial nephrectomy? A multicenter experience over 10 years.

BACKGROUND: Frozen section analysis (FSA) is frequently performed during partial nephrectomy (PN). We investigate the utility of intraoperative FSA by evaluating its impact on final surgical margin (SM) status. METHODS: Between January 1995 and December 2005, a series of patients who were treated with open PN for renal cell carcinoma was prospectively analyzed. During PN, each patient underwent a FSA on renal parenchyma distal margin. If FSA was positive for infiltration a deeper excision was performed till obtaining a negative FSA. SM outcome of the FSA was compared with the final pathology report. Recurrence-free survival (RFS) and cost analysis on the FSA performed were analyzed. RESULTS: A total number of 373 patients were enrolled. FSA was performed in all the patients considered for PN. Fifteen patients had a conversion to radical nephrectomy. Positive SMs at the definitive pathological outcome were found in 36 patients (9.6%). FSA was positive in eight patients (2.1%). In that eight cases after a deeper excision the definitive pathological outcome on SM was still positive in two cases. FSA revealed just 14.3% of the positive SM. Patients with positive SM had a worse follow up considering RFS (P<0.05). Kaplan-Meier analysis revealed that FSA did not considerably contribute to prevent recurrence (P=0.35). 1438 euros was the mean cost of performing a FSA during PN. CONCLUSIONS: FSA during PN does not reduce the risk of positive SMs. The use of FSA has also a higher cost related to the procedure.

A relative value unit-based cost comparison of treatment modalities for nonmelanoma skin cancer: effect of the loss of the Mohs multiple surgery reduction exemption.

BACKGROUND: The incidence of skin cancer has increased dramatically, with as many as 2.8 million skin cancers treated in 2005. In an era of decreasing reimbursement, insurer policy changes, and increasing pressure to deliver cost effective care, physicians should understand the total cost of different skin cancer treatment modalities in order to determine which yields the best value for patients. OBJECTIVE: To estimate the costs of treating nonmelanoma skin cancers by multiple modalities based on their assigned relative value unit (RVU) values. METHODS: The cost analysis was performed for the treatment of two skin cancer examples, a basal cell carcinoma (BCC) on the central cheek and a squamous cell carcinoma (SCC) on the forearm of varying sizes. The estimated costs of treatment of each of the skin cancers was calculated for treatment with electrodessication and curettage (EDC), imiquimod immunotherapy, Mohs micrographic surgery, traditional surgical excision with permanent section margin evaluation in an office setting (with immediate repair or with repair delayed until clear margins are confirmed), surgical excision with frozen section margin control in both an ambulatory surgery center and hospital-based setting, and radiation therapy. The effect of the loss of exemption from multiple surgery reduction on the cost of Mohs surgery is also examined. RESULTS: Our estimation of costs for each of the treatment modalities reveals that EDC is the least expensive option, with average costs of $471 (BCC cheek) and $392 (SCC arm). Imiquimod treatment and office-based excision with immediate repair of the surgical defect have similar total average costs of $959 (BCC cheek) and $931 (SCC arm) and $1006 (BCC cheek) and $907 (SCC arm), respectively. If repair of the defect is delayed until negative surgical margins are confirmed by permanent section, the cost of excision increases to $1170 and $1041. The average cost of Mohs micrographic surgery is $1263 (BCC cheek) and $1131 (SCC arm). Mohs surgery's recent loss of multiple surgery reduction exemption has decreased the cost of Mohs surgery by 9% to 25%. Excision with frozen section margin control in an ambulatory surgery center results in costs of $2334 (BCC cheek) and $2200 (SCC arm). However, if the excision is performed in a hospital operating room, the procedure is substantially more expensive, at $3085 and $2680. The cost of radiation therapy treatment is $2591 to $3460 for the BCC of the cheek and $2559 to $3431 for the SCC of the arm, depending on the fractional dose used. LIMITATIONS: These are cost estimates based on literature examples and 2008 RVU values; variations related to individual practices and procedure valuations by private insurers are expected. CONCLUSION: Tumor destruction by EDC or imiquimod and office-based procedures, such as traditional surgical excision or Mohs surgery, are the lowest cost options for treatment of nonmelanoma skin cancer.

Utility of Intraoperative Frozen Section in Large Thyroid Nodules.

OBJECTIVE: To determine if the routine use of intraoperative frozen section (iFS) results in cost savings among patients with nodules >4 cm with nonmalignant cytology undergoing a thyroid lobectomy. STUDY DESIGN: Case series with chart review; cost minimization analysis. SETTING: Single academic center. SUBJECTS AND METHODS: Records were reviewed on a consecutive sample of 48 patients with thyroid nodules >4 cm and nonmalignant cytology who were undergoing thyroid lobectomy in which iFS was performed between 2010 and 2015. A decision tree model of thyroid lobectomy with iFS was created. Comparative parameters were obtained from the literature. A cost minimization analysis was performed comparing lobectomy with and without iFS and the need for completion thyroidectomy with costs estimated according to 2014 data from Medicare, the Bureau of Labor Statistics, and the Nationwide Inpatient Sample. RESULTS: The overall malignancy rate was 25%, and 33% of these malignancies were identified intraoperatively. When the malignancy rates obtained from our cohort were applied, performing routine iFS was the less costly scenario, resulting in a savings of $486 per case. When the rate of malignancy identified on iFS was adjusted, obtaining iFS remained the less costly scenario as long as the rate of malignancies identified on iFS exceeded 12%. If patients with follicular lesions on cytology were excluded, 50% of malignancies were identified intraoperatively, resulting in a savings of $768 per case. CONCLUSIONS: For patients with nodules >4 cm who are undergoing a diagnostic lobectomy, the routine use of iFS may result in decreased health care utilization. Additional cost savings could be obtained if iFS is avoided among patients with follicular lesions.

Development of Functional Requirements for Ex Vivo Pathology Applications of In Vivo Microscopy Systems: A Proposal From the In Vivo Microscopy Committee of the College of American Pathologists.

CONTEXT.­: In vivo microscopy (IVM) allows direct, real-time visualization of tissue histology in living patients without the need for tissue removal, processing, or staining. The IVM technologies in clinical use include confocal microscopy and optical coherence tomography. These technologies also show promise for use with pathology specimens (ex vivo microscopy [EVM]). However, few systems designed for EVM are commercially available, at least in part because of the lack of defined minimal functional requirements (FRs). OBJECTIVE.­: To develop minimal FRs for likely high-volume pathology applications of EVM. DESIGN.­: The IVM Committee of the College of American Pathologists identified potential EVM pathology applications based on the published literature. A subcommittee of IVM and EVM early adopters and experts then defined FRs for the most likely EVM applications. RESULTS.­: Potential EVM applications include assessment of margins, adequacy of needle biopsies and aspirates for diagnosis, and transplant tissues; selection of tissue for molecular studies or biorepository; and guidance in block selection from gross specimens. The first 3 applications were selected for development of FRs. The FRs were identified based on existing laboratory practices and guidelines and input from experts in the field and included device footprint and portability, specimen preparation, imaging time, field of view or resolution, morphologic diagnostic capability, yield, accuracy, ease of use, safety, and cost. CONCLUSIONS.­: Consensus was achieved on FRs that would accommodate the selected EVM applications. Publication and dissemination of those FRs will provide guidance to engineers, researchers, and vendors on how to optimally adapt IVM technologies for EVM for widespread adoption by pathologists.

Frozen section is not cost beneficial for the assessment of margins in oral cancer.

BACKGROUND: Routine use of frozen section (FS) is a costly procedure and sparsely available in resource poor countries. A proper cost benefit analysis may help to reduce its routine use and would empower surgeons to perform oral cancer surgeries without having FS facility. FS is performed to identify microscopic spread beyond gross disease that cannot be assessed clinically. OBJECTIVE: Our primary aim was to determine the cost benefit analysis of FS in the assessment of margins in oral cavity squamous cell carcinoma (OSCC). MATERIALS AND METHODS: Retrospective study of prospectively collected data of 1311 consecutive patients who were operated between January 2012 and October 2013. The gross and microscopic margin status of each patient was extracted from the patient's chart. The cost estimates were performed to calculate the financial burden of FS as well as expenses incurred on adjuvant treatment resulting from inadequate margins. RESULT: Microscopic spread changed the gross margin status in 5.2% (65/1237) patients. Of this entire cohort of 1237 patients, FS helped 29 (2.3%) patients to achieve tumor free margin, and it changed the adjuvant treatment plan in 9 (0.7%) patients. The cost of FS for each patient was INR 11052. The cost-benefit ratio of FS was 12:1. Gross examination alone could have identified majority of the inadequate margins. CONCLUSION: Frozen section for assessment of margin status bears poor cost-benefit ratio. Meticulous gross examination of the entire surgical specimen is sufficient to identify majority of inadequate margins.

Intraoperative immunohistochemistry staining of sentinel nodes in breast cancer: clinical and economical implications.

The study aimed to evaluate intraoperative immunohistochemistry (IHC) staining of sentinel nodes in primary breast cancer surgery. We analysed retrospectively 1209 consecutive sentinel node procedures and compared the rate of late positive metastases in sentinel node biopsy (SNB) and the duration of the surgical procedures before (n=706) and after (n=503) introducing intraoperative IHC on frozen section. We also did a cost analysis. Intraoperative IHC staining led to a lowering of the late positive SNB rate. Introducing IHC gave a decrease in the late positive rate from 93 to 52% (p<0.0001) for isolated tumour cell metastasis, from 56 to 36.4% (p<0.02) for micrometastasis, and from 16 to 5% (p<0.01) for macrometastasis. The surgical procedures were slightly prolonged for lumpectomies but not for mastectomies after introducing intraoperative IHC staining. The cost analysis showed an overall cost saving of approximately 40%. In conclusion, intraoperative IHC staining of the SNB lowered the late positive rate and gave an overall cost saving.

Economic Impact of Frozen Section for Thyroid Nodules with "Suspicious for Malignancy" Cytology.

Objective To perform a cost analysis of the routine use of intraoperative frozen section (iFS) among patients undergoing a thyroid lobectomy with "suspicious for malignancy" (SUSP) cytology in the context of the 2015 American Thyroid Association guidelines. Study Design Case series with chart review; cost minimization analysis. Setting Academic. Subjects and Methods Records were reviewed for patients with SUSP cytology who underwent thyroid surgery between 2010 and 2015 in which iFS was utilized. The diagnostic test performance of iFS and the frequency of indicated completion/total thyroidectomies based on the 2015 guidelines were calculated. A cost minimization analysis was performed comparing lobectomy, with and without iFS, and the need for completion thyroidectomy according to costs estimated from 2014 data from Medicare, the Bureau of Labor Statistics, and the Nationwide Inpatient Sample. Results Sixty-five patients met inclusion criteria. The malignancy rate was 61.5%, 45% of which was identified intraoperatively. The specificity and positive predictive value were 100%. The negative predictive value and sensitivity were 83% and 95%, respectively. Completion/total thyroidectomy was indicated for 9% of patients; 83% of these individuals had findings on iFS that would have changed management intraoperatively. Application of the new guidelines would have resulted in a significant reduction in the frequency of conversion to a total thyroidectomy when compared with the actual management (26.1% vs 7.7%, P = .005). Performing routine iFS was the less costly scenario, resulting in a savings of $474 per case. Conclusion For patients with SUSP cytology undergoing lobectomy, routine use of iFS would result in decreased health care utilization.

Costs and effects of intra-operative fluorescence molecular imaging - A model-based, early assessment.

INTRODUCTION: Successful breast conserving cancer surgeries come along with tumor free resection margins and account for cosmetic outcome. Positive margins increase the likelihood of tumor recurrence. Intra-operative fluorescence molecular imaging (IFMI) aims to focus surgery on malignant tissue thus substantially lowering the presence of positive margins as compared with standard techniques of breast conservation (ST). A goal of this paper is to assess the incremental number of surgeries and costs of IFMI vs. ST. METHODS: We developed a decision analytical model and applied it for an early evaluation approach. Given uncertainty we considered that IFMI might reduce the proportion of positive margins found by ST from all to none and this proportion is assumed to be reduced to 10% for the base case. Inputs included data from the literature and a range of effect estimates. For the costs of IFMI, respective cost components were added to those of ST. RESULTS: The base case reduction lowered number of surgeries (mean [95% confidence interval]) by 0.22 [0.15; 0.30] and changed costs (mean [95% confidence interval]) by €-663 [€-1,584; €50]. A tornado diagram identified the Diagnosis Related Group (DRG) costs, the proportion of positive margins of ST, the staff time saving factor and the duration of frozen section analysis (FSA) as important determinants of this cost. CONCLUSIONS: These early results indicate that IFMI may be more effective than ST and through the reduction of positive margins it is possible to save follow-up surgeries-indicating further health risk-and to save costs through this margin reduction and the avoidance of FSA.

Cost-effectiveness analysis of strategies for the surgical management of grade 1 endometrial adenocarcinoma.

OBJECTIVE: To estimate the costs and outcomes of various strategies used for the management of grade 1 endometrial cancer. METHODS: A cost-effectiveness analysis compared three strategies for the management of grade 1 endometrial cancer: 1) surgical staging in all patients (including hysterectomy and lymphadenectomy); 2) frozen section following hysterectomy with surgical staging based on the results of tumor grade and depth of myometrial invasion; and 3) hysterectomy without surgical staging (no staging). Surgical probabilities and recurrence rates were estimated from published data. Actual payer costs of surgery, radiation therapy, and chemotherapy were estimated for each strategy. Cost-effectiveness ratios were estimated for each strategy. Sensitivity analyses evaluated the costs of radiation and survival estimates used in the model. RESULTS: For the estimated 10,000 women diagnosed annually with grade 1 endometrial cancer in the United States, the annual cost of surgical staging is $240.4 million, compared with $252.4 million for frozen section and $255.8 million for no staging. Five-year disease-free survival for surgical staging is 87.9%, compared with 87.3% for frozen section and 86.7% for no staging. This translates into a lower cost-effectiveness ratio for surgical staging ($27,337) compared with frozen section ($28,913) or no staging ($29,513). Surgical staging yielded 64 additional disease-free patients per 10,000 patients compared with frozen section and 126 additional disease-free patients compared with no staging. Use of adjuvant radiation therapy was the lowest in the surgical staging strategy (13%). CONCLUSION: Surgical staging of all patients with grade 1 endometrial cancer is the most cost-effective strategy and decreases the use of radiation therapy without negatively impacting survival.

Intraoperative pathologic examination: cost effectiveness and clinical value in patients with cytologic diagnosis of cellular follicular thyroid lesion.

OBJECTIVE: Routine use of intraoperative pathologic examination (IOPE), including frozen section (FS) and scrape preparation cytology (SPC), during diagnostic thyroid lobectomy continues to be a source of controversy. We sought to better delineate the usefulness and cost-benefit ratio of IOPE in the context of cytologically diagnosed cellular follicular lesion (CFL) or follicular neoplasm (FN). DESIGN: Records of 205 patients who underwent thyroidectomy for cytologically diagnosed FN or CFL between 1997 and 2005 were retrospectively reviewed. IOPE results, patient demographics, and tumor characteristics were correlated to final histopathologic diagnoses. Sensitivity, specificity, predictive values, accuracy, and costs of IOPE were calculated. MAIN OUTCOME: IOPE correctly identified 3 of 16 follicular carcinomas and 9 of 36 papillary carcinomas. Sensitivity, specificity, and accuracy were 23%, 99%, and 78%, respectively. On univariate analysis, malignancy risk among follicular nodules did not correlate with age, gender, or nodule size. On multivariate analysis, nodule size was predictive of malignancy (p < 0.05). Over the entire patient series, routine IOPE resulted in a net cost savings of $74,304.33. CONCLUSIONS: IOPE reduced costs and limited the number of completion thyroidectomies necessary. IOPE is specific, cost effective, and of minimal additional risk when performed routinely for patients with CFL or FN.

Minimal Clinical Impact of Intraoperative Examination of Sentinel Lymph Nodes in Patients With Ductal Carcinoma In Situ: An Opportunity for Improved Resource Utilization.

OBJECTIVES: There is little information regarding sentinel lymph node (SLN) frozen-section examination in patients with a history of ductal carcinoma in situ (DCIS). We evaluated the usage, clinical impact, and pathology resources used for SLN cryosectioning in mastectomy cases with a DCIS history. METHODS: Mastectomies with SLNs submitted from 2012 to 2013 at a tertiary care center were analyzed. Medicare reimbursement was used to estimate pathology health care expenditures of intraoperative frozen sections. RESULTS: There was no difference in the rate of SLN frozen-section examination or parts submitted, total blocks frozen, total blocks submitted, or total SLNs identified per case between the DCIS (n = 139) and invasive (n = 369) groups. Nine patients with DCIS had SLN metastases (three macrometastases, two micrometastases, and four isolated tumor cells), all of which were examined by frozen section. Only the macrometastases were identified by cryosectioning, which led to two synchronous axillary lymph node dissections that did not yield any additional positive nodes. A total of $19,313 was spent for pathology per DCIS patient with surgical management affected, whereas only $1,019 was spent per invasive carcinoma patient affected. CONCLUSIONS: Decreasing SLN frozen-section use in patients with a history of DCIS represents an opportunity for pathology cost containment.

Sustainable Development of Pathology in Sub-Saharan Africa: An Example From Ghana.

CONTEXT: - Pathology services are poorly developed in Sub-Saharan Africa. Komfo Anokye Teaching Hospital in Kumasi, Ghana, asked for help from the pathology department of the University Hospital of North Norway, Tromsø. OBJECTIVE: - To reestablish surgical pathology and cytology in an African pathology department in which these functions had ceased completely, and to develop the department into a self-supporting unit of good international standard and with the capacity to train new pathologists. DESIGN: - Medical technologists from Kumasi were trained in histotechnology in Norway, they were returned to Kumasi, and they produced histologic slides that were temporarily sent to Norway for diagnosis. Two Ghanaian doctors received pathology training for 4 years in Norway. Mutual visits by pathologists and technologists from the 2 hospitals were arranged for the introduction of immunohistochemistry and cytology. Pathologists from Norway visited Kumasi for 1 month each year during 2007-2010. Microscopes and immunohistochemistry equipment were provided from Norway. Other laboratory equipment and a new building were provided by the Ghanaian hospital. RESULTS: - The Ghanaian hospital had a surgical pathology service from the first project year. At 11 years after the start of the project, the services included autopsy, surgical pathology, cytopathology, frozen sections, and limited use of immunohistochemistry, and the department had 10 residents at different levels of training. CONCLUSIONS: - A Ghanaian pathology department that performed autopsies only was developed into a self-supported department with surgical pathology, cytology, immunohistochemistry, and frozen section service, with an active residency program and the capacity for further development that is independent from assistance abroad.

Economic Implications of Widespread Expansion of Frozen Section Margin Analysis to Guide Surgical Resection in Women With Breast Cancer Undergoing Breast-Conserving Surgery.

PURPOSE: In the current health care environment, cost effectiveness is critically important in policy setting and care of patients. This study performed a health economic analysis to assess the implications to providers and payers of expanding the use of frozen section margin analysis to minimize reoperations for patients undergoing breast cancer lumpectomy. METHODS: A health care economic impact model was built to assess annual costs associated with breast lumpectomy procedures with and without frozen section margin analysis to avoid reoperation. RESULTS: If frozen section margin analysis is used in 20% of breast lumpectomies and under a baseline assumption that 35% of initial lumpectomies without frozen section analysis result in reoperations, the potential annual cost savings are $18.2 million to payers and $0.4 million to providers. Under the same baseline assumption, if 100% of all health care facilities adopted the use of frozen section margin analysis for breast lumpectomy procedures, the potential annual cost savings are $90.9 million to payers and $1.8 million to providers. On the basis of 10,000 simulations, use of intraoperative frozen section margin analysis yields cost saving for payers and is cost neutral to slightly cost saving for providers. CONCLUSION: This economic analysis indicates that widespread use of frozen section margin evaluation intraoperatively to guide surgical resection in breast lumpectomy cases and minimize reoperations would be beneficial to cost savings not only for the patient but also for payers and, in most cases, for providers.

Analysis of an institutional protocol for thyroid lobectomy: Utility of routine intraoperative frozen section and expedited (overnight) pathology.

BACKGROUND: Intraoperative frozen section (FS) often is performed in patients who undergo thyroid lobectomy to determine the need for completion thyroidectomy. At our institution, if FS pathology is benign, final pathology is expedited overnight. The aim of this study was to determine the utility of FS and to identify a cost-effective management algorithm for thyroid lobectomy. METHODS: A retrospective review was performed of patients who underwent thyroid lobectomy between January 2009 and May 2013. Preoperative cytology ranged from "benign" to "suspicious for malignancy." Clinically significant cancers were defined as >1 cm in size, or multifocal microcarcinomas. RESULTS: Of the 192 patients who underwent thyroid lobectomy with FS, FS was suspicious for malignancy in 5 (3%) patients; 1 (0.5%) underwent immediate completion thyroidectomy. On final pathology, 9 (5%) patients had clinically significant cancers and underwent completion thyroidectomy. FS had a sensitivity and positive predictive value of 22% and 40%, respectively, in identifying clinically significant thyroid cancer. Cost of thyroid lobectomy at varying rates of same-day discharge favored thyroid lobectomy without FS but with expedited pathology for all scenarios. CONCLUSION: At our institution, there appears to be limited utility of FS at the time of thyroid lobectomy given the low predictive value for diagnosing a clinically significant thyroid cancer. In patients who are admitted overnight, expedited pathology is slightly less costly and may improve patient quality-of-life and decrease costs by avoiding delayed completion thyroidectomy. Overnight pathology for patients who undergo thyroid lobectomy may achieve modest cost-savings depending on institutional FS results and rates of malignancy.

Are frozen sections useful and cost-effective in the era of intraoperative qPTH assays?

BACKGROUND: Since intraoperative quick parathormone (IOqPTH) assays are available, the role of frozen sections (FS) during parathyroid exploration has become questionable. This study compares the results of FS and IOqPTH in primary hyperparathyroidism (pHPT). METHODS: FS and IOqPTH assays were performed in 102 patients who underwent bilateral neck explorations or targeted parathyroidectomy for pHPT. The operation was considered complete when both an IOqPTH drop >50% and a FS diagnosis of parathyroid adenoma were obtained. RESULTS: Cure was achieved in all patients. Potential pitfalls for successful operation were encountered in 14 patients with multiglandular diseases and in 4 patients who had nonparathyroid tissue removed. FS correctly predicted the definitive histologic diagnosis with an accuracy of 81%. FS failures potentially misguided the operative therapy in 19% (14 insufficient explorations and 5 unnecessarily prolonged explorations), while IOqPTH identified all potential pitfalls and correctly guided the operative strategy, suggesting further exploration, in 100% of cases (P < .0001). After bilateral neck exploration, FS and IOqPTH correctly guided operative strategy in 86% and 100% of cases, respectively (P < .05), but both techniques were never indispensable, because potential pitfalls were already evident by macroscopic intraoperative appearance. The turnaround time and costs for IOqPTH were lower (P < .001). CONCLUSIONS: The role of FS should be reconsidered, since it can misguide the operative strategy. IOqPTH is indispensable for a focused approach and, although unnecessary in bilateral neck exploration, is more useful and cost-effective than FS.

Accuracy and cost of intraoperative lymph node frozen sections at radical prostatectomy.

AIM: To assess the value of intraoperative diagnostic examination of frozen sections of lymph nodes removed during radical prostatectomy. METHODS: Pelvic lymph nodes from patients with prostatic carcinoma were obtained (1) as frozen sections during radical prostatectomy, to exclude patients from non-curative surgery, and (2) as paraffin sections postoperatively from lymphadenectomy performed at radical prostatectomy, to stage the tumour and assess need for adjuvant treatment. Findings from the two approaches were used to assess the accuracy and cost of frozen section diagnosis, and to judge the results of omitting intraoperative diagnosis. RESULTS: In 82 patients frozen section revealed metastasis in six (7.3%), and metastases were found in a further four (4.9%) on paraffin sections (false negatives). Of the 195 patients undergoing staging lymphadenectomy (without frozen section), metastatic cancer was seen in nine cases (4.6%). The frozen section cost of metastatic cancer detection per patient was calculated as 7516 Pounds (550 Pounds x 82/6), with an associated false negative rate of 33%. CONCLUSIONS: Frozen section diagnosis of metastatic carcinoma in pelvic lymph nodes before radical prostatectomy has a high false negative rate and is costly. It may not be justified with the observed low incidence of lymph node metastasis.

Is sestamibi-guided parathyroidectomy really cost-effective?

BACKGROUND: Sestamibi-guided limited neck explorations are an alternative to the standard bilateral neck exploration for patients with primary hyperparathyroidism. A recently published meta-analysis by Denham and Norman (JACS vol.186, 1998) suggested that a sestamibi-directed approach offers a cost benefit because it decreases operative and recovery room times, hospital stay, and the number of frozen sections needed. METHODS: We reviewed 41 bilateral neck explorations for primary hyperparathyroidism and compared our results with those reported by the meta-analysis to determine whether a sestamibi-directed approach is cost effective. RESULTS: Operative and recovery room times averaged 60.3 +/- 19.3 and 45 minutes, respectively. Forty six percent of the patients were treated as outpatients, and 1.21 +/- 0.57 frozen sections were obtained per case. Our standard bilateral exploration cost 47% less than the bilateral approach and 17% less than the sestamibi-directed operation calculated in the meta-analysis. There were no cases of nerve injury or permanent hypocalcemia, 98% of patients were cured, and 61% of patients did not require narcotics postoperatively. CONCLUSIONS: Sestamibi-guided parathyroidectomy may not offer any advantage over the standard bilateral exploration. In our experience, a bilateral neck exploration can be performed on an outpatient basis and at low cost, with a high success rate and minimal morbidity. Most patients do not require narcotics, and the cosmetic results are excellent.