Cost-Effectiveness of Radar Localisation Versus Wire Localisation for Wide Local Excision of Non-palpable Breast Cancer.

BACKGROUND: Wire localisation (WL) is the "gold standard" localisation technique for wide local excision (WLE) of non-palpable breast lesions but has disadvantages that have led to the development of wireless techniques. This study compared the cost-effectiveness of radar localisation (RL) to WL. METHODS: This was a single-institution study of 110 prospective patients with early-stage breast cancer undergoing WLE using RL with the SCOUT® Surgical Guidance System (2021-2023) compared with a cohort of 110 patients using WL. Margin status, re-excision rates, and surgery delays associated with preoperative localisation were compared. Costs from a third-party payer perspective in Australian dollars (AUD$) calculated by using microcosting, break-even point, and cost-utility analyses. RESULTS: A total of 110 WLEs using RL cost a total of AUD$402,281, in addition to the device cost of AUD$77,150. The average additional cost of a surgery delay was AUD$2318. Use of RL reduced the surgery delay rate by 10% (p = 0.029), preventing 11 delays with cost savings of AUD$25,496. No differences were identified in positive margin rates (RL: 11.8% vs. WL: 17.3%, p = 0.25) or re-excision rates (RL: 14.5% vs. WL: 21.8%, p = 0.221). In total, 290 RL cases are needed to break even. The cost of WLE using RL was greater than WL by AUD$567. There was a greater clinical benefit of 1.15 quality-adjusted life-years (QALYs) and an incremental cost-utility ratio of AUD$493 per QALY favouring RL. CONCLUSIONS: Routine use of RL was a more cost-effective intervention than WL. Close to 300 RL cases are likely needed to be performed to recover costs of the medical device. CLINICAL TRIAL REGISTRATION: ACTRN12624000068561.

Durability of radiofrequency ablation for long-segment and ultralong-segment Barrett's esophagus over 10 years.

BACKGROUND: Long-term durability data for radiofrequency ablation (RFA) to prevent esophageal adenocarcinoma in long-segment (LSBE) and ultralong-segment Barrett's esophagus (ULSBE) is lacking. This study aimed to determine 10-year cancer progression, eradication, and complication rates in LSBE and ULSBE patients treated with RFA. METHODS: Single-surgeon prospective database of patients with LSBE (≥ 3 to < 8 cm) and ULSBE (≥ 8 cm) who underwent RFA (2001-2021) were retrospectively analyzed. Ten-year cancer progression calculated with Kaplan-Meier analysis. Eradication rates, including complete remission of dysplasia (CR-D) and intestinal metaplasia (CR-IM), and rates of recurrence and complications, compared between LSBE and ULSBE groups. RESULTS: Ten years after starting treatment, the cancer rate was 14.3% in 56 patients. CR-D and CR-IM rates were 87.5% and 67.9%, respectively. Relapse rates from CR-D were 1.8% and 3.6% from CR-IM. Eradication rates for dysplasia in LSBE and ULSBE patients (90.6% versus 83.3%) and IM (71.9% versus 62.5%) were not significantly different. ULSBE patients required higher mean number of ablation sessions for IM eradication (4.7 versus 3.7, p = 0.032), while complication rates including strictures (4.2% versus 6.2%), perforation (0 versus 0), and bleeding (4.2% versus 3.1%), were similar between ULSBE and LSBE patients, respectively. On multivariate analysis, shorter Barrett's segment and baseline low-grade dysplasia were associated with increased likelihood for eradication of IM and dysplasia. A total number of ablation sessions or endoscopic resections ≥ 3 was associated with reduced likelihood for eradication. CONCLUSION: RFA was durable in maintaining dysplasia and IM eradication in both LSBE and ULSBE over 10 years, and with low complication rates. IM eradication was more difficult to achieve in ULSBE. Late development of cancer occurred in 14.3%.

Risk of lymph node metastasis in T1 esophageal adenocarcinoma: a meta-analysis.

Patients with early (T1) esophageal adenocarcinoma (EAC) are increasingly having definitive local therapy endoscopically. Endoscopic resection is not able to pathologically stage or treat lymph node metastasis (LNM). Accurate identification of patients having nodal metastasis is critical to select endoscopic therapy over surgery. This study aimed to define the risk of LNM in T1 EAC. A meta-analysis of studies of patients who underwent surgery and lymphadenectomy with assessment of LNM was performed according to PRISMA. Main outcome was probability of LNM in T1a and T1b disease. Secondary outcomes were risk factors for LNM and rate of LNM in submucosal T1b (SM1, SM2, and SM3) disease. Registered with PROSPERO (CRD42022341794). Twenty cohort studies involving 2264 patients with T1 EAC met inclusion criteria: T1a (857 patients) with 36 (4.2%) node positive and T1b (1407 patients) with 327 (23.2%) node positive. Subgroup analysis of T1b lesions was available in 10 studies (405 patients). Node positivity for SM1, SM2, and SM3 was 16.3%, 16.2%, and 29.4%, respectively. T1 substage (odds ratio [OR] 7.72, 95% confidence interval [CI] 4.45-13.38, P < 0.01), tumor differentiation (OR 2.82, 95% CI 2.06-3.87, P < 0.01), and lymphovascular invasion (OR 13.65, 95% CI 6.06-30.73, P < 0.01) were associated with LNM. T1a disease demonstrated a 4.2% nodal metastasis rate and T1b disease a rate of 23.2%. Endoscopic therapy should be reserved for T1a disease and perhaps select T1b disease, which has a moderately high rate of nodal metastasis. There were inadequate data to stratify T1b SM disease into 'low-risk' and 'high-risk' based on tumor differentiation and lymphovascular invasion.

Novel Dual Tracer Indocyanine Green and Radioisotope Versus Gold Standard Sentinel Lymph Node Biopsy in Breast Cancer: The GREENORBLUE Trial.

BACKGROUND: The methods for sentinel lymph node (SLN) biopsy in breast cancer have been variable in type and number of tracers. Some units have abandoned the use of blue dye (BD) due to adverse reactions. Fluorescence-guided biopsy with indocyanine green (ICG) is a relatively novel technique. This study compared the clinical efficacy and costs between novel dual tracer ICG and radioisotope (ICG-RI) with "gold standard" BD and radioisotope (BD-RI). METHODS: Single-surgeon study of 150 prospective patients with early breast cancer undergoing SLN biopsy (2021-2022) using ICG-RI compared with a retrospective cohort of 150 consecutive previous patients using BD-RI. Number of SLNs identified, rate of failed mapping, identification of metastatic SLNs, and adverse reactions were compared between techniques. Cost-minimisation analysis performed by using Medicare item numbers and micro-costing analysis. RESULTS: Total number of SLNs identified with ICG-RI and BD-RI was 351 and 315, respectively. Mean number of SLNs identified with ICG-RI and BD-RI was 2.3 (standard deviation [SD] 1.4) and 2.1 (SD 1.1), respectively (p = 0.156). There were no cases of failed mapping with either dual technique. Metastatic SLNs were identified in 38 (25.3%) ICG-RI patients compared with 30 (20%) BD-RI patients (p = 0.641). There were no adverse reactions to ICG, whereas four cases of skin tattooing and anaphylaxis were associated with BD (p = 0.131). ICG-RI cost an additional AU$197.38 per case in addition to the initial cost for the imaging system. CLINICAL TRIAL REGISTRATION:  ACTRN12621001033831. CONCLUSIONS: Novel tracer combination, ICG-RI, provided an effective and safe alternative to "gold standard" dual tracer. The caveat was the significantly greater costs associated with ICG.

ASSESSING THE ACCURACY OF A LARGE OBSERVATIONAL REGISTRY OF NEOVASCULAR AGE-RELATED MACULAR DEGENERATION.

PURPOSE: To evaluate the accuracy of an observational database that tracks real-world treatment outcomes for neovascular age-related macular degeneration. METHODS: We audited 245 randomly sampled eyes from 189 patients with 3,356 visits from 11 doctors in the Fight Retinal Blindness! DATABASE: Sex, birth year, previous treatments received, treatment, and visual acuity were validated against the clinical notes. Error rates, the proportion of missed visits (the number of visits present in the patient record but not entered into Fight Retinal Blindness!), the level of agreement using Cohen's kappa (κ) and intraclass correlation coefficients, and positive and negative predictive values were calculated. A visual acuity error was defined as an absolute difference of ≥5 letters. RESULTS: The overall error rate was 3.5% (95% confidence interval: 3.1-3.9). The error rate for visual acuity was 5.1% (95% confidence interval: 4.2-5.9) and <5% for the remaining fields. The level of agreement for each field ranged from good to excellent (κ or intraclass correlation ≥ 0.75). The positive predictive value and negative predictive value for visits were 99% and 89%, respectively. The proportion of missed visits was 10.2%. CONCLUSION: Accuracy of the Fight Retinal Blindness! database was good (>95%). The rate of missed visits was high, possibly due to the high burden of retrospective data entry or patients switching practitioners during treatment.

Characterization of Poor Visual Outcomes of Neovascular Age-related Macular Degeneration Treated with Anti-Vascular Endothelial Growth Factor Agents.

PURPOSE: To investigate the incidence, characteristics, and baseline predictors of poor visual outcomes in eyes with neovascular age-related macular degeneration (nAMD) receiving intravitreal anti-vascular endothelial growth factor (anti-VEGF) agents in daily clinical practice. DESIGN: Observational study. PARTICIPANTS: Treatment-naive eyes starting anti-VEGF therapy for nAMD between 2007 and 2012 tracked in the Fight Retinal Blindness! registry. Eyes had sustained ≥15 letters of loss from baseline without recovery of visual acuity (VA) at final end point. A subgroup analysis included eyes that sustained ≥30 letters of loss. Controls had not sustained ≥15 letters of loss. METHODS: Kaplan-Meier curves estimated time to first development of loss of ≥15 letters. Cox proportional hazards models evaluated predictors of loss of ≥15 letters. MAIN OUTCOME MEASURES: The proportion of eyes with sustained VA loss within 5 years, the time to development of sustained VA loss, and baseline predictors of sustained VA loss. RESULTS: There were 1760 eyes in total and 856 eyes that completed 5 years follow-up. The proportion of eyes with sustained VA loss of ≥15 letters at 5 years was 22.9% (95% confidence interval [CI], 20.7%-25.1%) and VA loss of ≥30 letters was 10.8% (95% CI, 9.1%-12.5%). Factors independently associated with higher incidence of sustained ≥15-letter loss included age >80 years (odds ratio [OR], 1.33 for patients >80 years vs. ≤80 years; 95% CI, 1.05-1.69; P = 0.02), fewer injections (OR, 0.97 per injection; 95% CI, 0.96-0.98; P = 0.0005), and more visits at which the choroidal neovascularization was graded as active (OR, 1.97 for eyes in upper quartile of active visits vs. eyes in lowest quartile of active visits; 95% CI, 1.39-2.79; P = 0.0001). Baseline VA ≥70 letters was associated with reduced risk of sustained ≥30-letter loss (OR, 0.61; 95% CI, 0.38-0.98; P = 0.04). Baseline angiographic lesion criteria were not significantly associated with sustained VA loss. CONCLUSIONS: Twenty-three percent of eyes with nAMD developed sustained VA loss of ≥15 letters over 5 years of anti-VEGF therapy. Baseline predictors of poor outcomes provide more accurate assessment of the potential benefit from anti-VEGF therapy.

Anti-vascular endothelial growth factor for neovascular age-related macular degeneration: a meta-analysis of randomized controlled trials.

BACKGROUND: To evaluate the relative efficacy and safety of anti-vascular endothelial growth factor (anti-VEGF) agents for the treatment of neovascular age-related macular degeneration (AMD). METHODS: Systematic literature review identifying RCTs comparing anti-VEGF agents to another treatment published before June 2016. Efficacy assessed by mean change in best corrected visual acuity (BCVA) and central macular thickness (CMT) from baseline at up to 2 years followup. Safety assessed by proportions of patients with death, arteriothrombotic and venous thrombotic events, and at least one serious systemic adverse event at up to 2 years of followup. RESULTS: Fifteen RCTs selected for meta-analysis (8320 patients). Two trials compared pegaptanib, and three trials compared ranibizumab versus control. Eight trials compared bevacizumab with ranibizumab. Two trials compared aflibercept with ranibizumab. There were no significant differences between bevacizumab and ranibizumab for BCVA at 1 or 2 years (weighted mean difference = - 0.57, 95% CI - 1.55 to 0.41, P = 0.25 and weighted mean difference = - 0.76, 95% CI - 2.25 to 0.73, P = 0.32, respectively). Ranibizumab was more effective in reducing CMT at 1 year (weighted mean difference = 4.49, 95% CI 1.13 to 7.84, P = 0.009). Risk ratios comparing rates of serious systemic adverse events at 1 and 2 years were slightly out of favour for bevacizumab. Aflibercept compared with ranibizumab demonstrated similar mean change in BCVA, reduction in CMT, and safety at 1 year. CONCLUSIONS: Bevacizumab and ranibizumab had equivalent efficacy for BCVA, while ranibizumab had greater reduction in CMT and less rate of serious systemic adverse events. Aflibercept and ranibizumab had comparable efficacy for BCVA and CMT. This provides information to balance comparable effects on vision and risk of adverse events between anti-VEGF agents.

Simultaneous, same-anaesthetic bilateral total knee arthroplasty has low mortality and complication rates.

PURPOSE: The benefits of simultaneous bilateral total knee arthroplasty (SBTKR) include reduced hospital costs, single anaesthetic exposure and in many cases is also the patient's preference. Despite these potential benefits, risk-adversity with respect to assumed complications and mortality make it difficult for the orthopaedic surgeon and patient to make an informed decision. This study aimed to address the inconsistencies and lack of consensus in previous literature regarding the short-term complications and clinical safety of SBTKR in patients with end-stage knee osteoarthritis (OA). METHODS: A cohort of 950 knees (475 patients) undergoing surgery between 2008 and 2013 was extracted from a prospectively collected clinical database and retrospectively linked to the Australian Joint Replacement Registry and hospital records. Patients underwent sequential SBTKR by their treating surgeon under one anaesthetic. Basic demographic data and outcome data including complications and mortality were collected. All data were analyzed using descriptive statistics only. RESULTS: A total of 413 patients and 826 knees were included. The average age of the cohort was 70 years with range between 46 and 88 years. 50% of patients were female. The overall mortality rate during the study follow-up period was 1.9%, with an average time to death postoperatively of 23.8 months. There were no cases of acute postoperative mortality (< 6 weeks). Medical complication rates were low. CONCLUSIONS: In contrast to the higher mortality and complication rates suggested in previous literature, this study has demonstrated that SBTKR is safe, with low mortality and complication rates under the current surgical protocol. LEVEL OF EVIDENCE: IV.

Medium-Term Outcomes from a Series of 1000 One Anastomosis Gastric Bypass in Australia: A Case Series.

PURPOSE: This study presents the short- (less than 6 months) and medium-term (6 months to 2 years) outcomes for weight loss and type 2 diabetes mellitus (T2DM) for all patients undergoing one anastomosis gastric bypass (OAGB) across multiple institutions between 2015 and 2021. MATERIALS AND METHODS: A retrospective analysis of prospectively collected databases was performed including 1022 participants who underwent OAGB at multiple institutions by multiple surgeons between 2015 and 2021. Primary outcome was percentage total weight loss (TWL) and secondary outcomes were achieving resolution of T2DM; OAGB specific short- and medium-term complications including bile reflux, marginal ulceration and internal herniation. RESULTS: One thousand and twenty-two patients underwent OAGB (81% primary surgery). A percentage of 34.1% (n = 349) had a preoperative diagnosis of type 2 diabetes mellitus (T2DM). Mean TWL was 33.6 ± 9% with a T2DM remission rate of 74% at 1-year post-op. Rates of bile reflux and marginal ulceration was 1.1% (n = 11) and 1.1% (n = 11). There were no cases of internal herniation during the follow-up period. CONCLUSION: OAGB results has echoed previously published work as being efficacious and safe in a short-medium term. The prevalence of complications, especially bile reflux is overall low in our population and no current evidence exists to support an increased risk of metaplasia or malignancy related to bile within the stomach.

Radar localization of breast and axillary lesions with SCOUT: a prospective single institution pilot study.

BACKGROUND: Wire-guided localization has been the mainstay of localization techniques for non-palpable breast and axillary lesions prior to excision. Evidence is still growing for relatively newer localization technologies. This study evaluated the efficacy of the wireless localization technology, SCOUT®, for both breast and axillary surgery. METHODS: Data were extracted from a prospective database (2021-2023) of consecutive patients undergoing wide local excision, excisional biopsy, targeted axillary dissection, or axillary lymph node dissection with SCOUT at a high-volume tertiary centre. Rates of successful reflector placement, intraoperative lesion localization, and reflector retrieval were evaluated. A survey of surgeon-reported ease of lesion localization and reflector retrieval was also evaluated. CLINICAL TRIAL REGISTRATION: ACTRN386751. RESULTS: One-hundred-ninety-five reflectors were deployed in 172 patients. Median interval between deployment and surgery was 3 days (range 1-20) and mean distance from reflector to lesion was 3.2 mm (standard deviation, SD 3.1). Rate of successful localization and reflector retrieval was 100% for both breast and axillary procedures. Mean operating time was 65.8 min (SD 33). None of the reflectors migrated. No reflector deployment or localization-related complications occurred. Ninety-eight percent of surgeons were satisfied with ease of localization for the first half of cases. CONCLUSION: SCOUT is an accurate and reliable method to localize and excise both breast and axillary lesions, and it may overcome some of the limitations of wire-guided localization.

Evolution of Indocyanine Green Fluorescence in Breast and Axilla Surgery: An Australasian Experience.

The evolution of indocyanine green (ICG) fluorescence in breast and axilla surgery from an Australasian perspective is discussed in this narrative review with a focus on breast cancer and reconstruction surgery. The authors have nearly a decade of experience with ICG in a high-volume institution, which has resulted in publications and ongoing future research evaluating its use for predicting mastectomy skin flap perfusion for reconstruction, lymphatic mapping for sentinel lymph node (SLN) biopsy, and axillary reverse mapping (ARM) for prevention of lymphoedema. In the authors' experience, routine use of ICG angiography during breast reconstruction postmastectomy was demonstrated to be cost-effective for the reduction of ischemic complications in the Australian setting. A novel tracer combination, ICG-technetium-99m offered a safe and effective substitute to the "gold standard" dual tracer for SLN biopsy, although greater costs were associated with ICG. An ongoing trial will evaluate ARM node identification using ICG fluorescence during axillary lymph node dissection and potential predictive factors of ARM node involvement. These data add to the growing literature on ICG and allow future research to build on this to improve understanding of the potential benefits of fluorescence-guided surgery in breast cancer and reconstruction surgery.

The evolution of oncovascular pelvic surgery: A historical perspective.

Pelvic exenteration surgery has evolved dramatically in recent decades and now represents the standard of care for many patients with advanced pelvic malignancy. Most recently the use of complex vascular resection and reconstructive techniques have been applied in advanced pelvic oncology surgery at specialist units and these oncovascular techniques are considered one of the frontiers in this field. This article summaries the historical evolution of oncovascular surgery in the pelvis and sets the scene for where this treatment is going. The role of vascular resection and reconstruction in curative treatment of advanced pelvic malignancy is an evolving area that is redefining the boundaries of what was historically thought possible.

Clinical algorithm for the management of advanced pelvic tumours involving the aortoiliac axis.

Pelvic exenteration offers potentially curative treatment for locally advanced and recurrent pelvic tumours. Laterally infiltrating tumours involving the pelvic sidewall have historically been considered unresectable. Highly specialised exenteration units have accumulated experience with en bloc resection of part or all of the iliac vascular system for tumours with major vessel involvement. These approaches involve complex vascular dissection and reconstructive techniques requiring collaboration with the vascular surgery unit. Adding to the complexity is the paucity of evidence on oncovascular techniques in the pelvis given its developing nature. An algorithm for the workup to determine resectability and the vascular reconstruction approach for advanced pelvic tumours involving the aortoiliac axis is suggested based on current literature and personal experience from the authors' unit.

Recurrence in Paraesophageal Hernia: Patient Factors and Composite Surgical Repair in 862 Cases.

BACKGROUND: Repair of giant paraesophageal hernia (PEH) is associated with a considerable hernia recurrence rate by objective measures. This study analyzed a large series of laparoscopic giant PEH repair to determine factors associated with anatomical recurrence. METHOD: Data was extracted from a single-surgeon prospective database of laparoscopic repair of giant PEH from 1991 to 2021. Upper endoscopy was performed within 12 months postoperatively and selectively thereafter. Any supra-diaphragmatic stomach was defined as anatomical recurrence. Patient and hernia characteristics and technical operative factors, including "composite repair" (360° fundoplication with esophagopexy and cardiopexy to right crus), were evaluated with univariate and multivariate analysis. RESULTS: Laparoscopic primary repair was performed in 862 patients. The anatomical recurrence rate was 27.3% with median follow-up of 33 months (IQR 16, 68). Recurrence was symptomatic in 45% of cases and 29% of these underwent a revision operation. Hernia recurrence was associated with younger age, adversely affected quality of life, and were associated with non-composite repair. Multivariate analysis identified age < 70 years, presence of Barrett's esophagus, absence of "composite repair", and hiatus closure under tension as independent factors associated with recurrence (HR 1.27, 95%CI 0.88-1.82, p = 0.01; HR 1.58, 95%CI 1.12-2.23, p = 0.009; HR 1.72, 95%CI 1.2-2.44, p = 0.002; HR 2.05, 95%CI 1.33-3.17, p = 0.001, respectively). CONCLUSION: Repair of giant PEH is associated with substantial anatomical recurrence associated with patient and technique factors. Patient factors included age < 70 years, Barrett's esophagus, and hiatus tension. "Composite repair" was associated with lower recurrence rate.

Trends and variations in post-mastectomy breast reconstruction rates in Australia over 10 years.

BACKGROUND: Offering breast reconstruction (BR) at the time of mastectomy is standard of care in Australia with proven quality-of-life benefits. Previously BR rates in Australia have been low compared to similar countries. Accurate up-to-date information is needed to promote equity in access to BR and inform future planning of services. This study analysed recent trends and variations of BR uptake in Australia. METHOD: Data from the BreastSurgANZ Quality Audit (BQA) were used to identify patients who underwent mastectomy with or without reconstruction for invasive or in situ breast carcinoma from 2010 to 2019. The association between BR uptake and the variables of jurisdiction (state or territory), age, hospital type and remoteness, and remoteness of patients' home addresses were analysed. RESULTS: A total 41 880 women underwent mastectomy between 2010 to 2019. The national BR rate steadily increased from 12.8% in 2010 to 29% in 2019, with a 10-year national average of 21.3%. Statistically significant differences in BR uptake (P < 0.001) were found between states with higher rates in New South Wales and Victoria, with BR more likely in private hospitals and in younger women (P < 0.001), and less likely in remote areas (P < 0.001). CONCLUSION: The Australian BR rate has increased over the 10-year period, but significant variation still exists between states. BR is lower in older women and those living in regional and remote areas. While the steady increase in BR uptake is encouraging, barriers that exist to equitable provision of reconstructive surgical services for all women living with breast cancer still need to be corrected.

Trends in outcomes with adoption of indocyanine green angiography in postmastectomy reconstruction.

BACKGROUND: Indocyanine green angiography (ICGA) aims to reduce ischaemic complications by supplementing intraoperative perfusion assessment of mastectomy flaps. Learning curves for this technology have not been analysed. We evaluated changes in patient outcomes with increasing case volume after ICGA adoption in postmastectomy reconstruction. METHODS: Single-institution retrospective analysis of 320 implant-based reconstructions following mastectomy using ICGA from 2015, when it was introduced, to 2021. Cases chronologically divided into tertiles and complications amongst groups evaluated. Trends in ischaemic complications plotted using weighted moving average. CUSUM analysis determined after how many cases plateau was reached. Number of ischaemic complications prior to plateau calculated with AUC analysis. RESULTS: Ischaemic complications decreased over time (Group 1, 15.1%; Group 2, 11.2%; Group 3, 4.7%, P = 0.034). Cases of delayed reconstruction increased over time (Group 1, 6.6%; Group 2, 28%; Group 3, 22.4%; P < 0.001). Our institution reached plateau of 10% ischaemic complications after 160 cases. Mean incidence of ischaemic complications decreased from 16.9% during the first 160 cases to 3.8% after plateau was reached (P < 0.001). Eleven extra breasts (6.9%) experienced ischaemic complications, that may have been avoided if operated by surgeons after the first 160 cases. CONCLUSIONS: There was increased tendency towards a conservative approach of delaying reconstruction and decreased rates of ischaemic complications with increasing case volume after ICGA implementation. A significant number of cases were needed to reach plateau of minimal ischaemic complications. This data could encourage development of standardized protocols for this technology to shorten learning curves for improved patient outcomes.