The Effect of Intraoperative Margin Assessment During Breast Conserving Surgery for Breast Cancer in a Dutch Cohort.

INTRODUCTION: Intraoperative specimen radiography is a routinely used procedure to ensure adequate resection of non-palpable breast tumors. Intraoperative digital specimen mammography (IDSM) is an alternative to conventional specimen radiography (CSR) which provides immediate specimen evaluation and can potentially decrease operation time. IDSM may also result in lower positive margin and re-excision rates. IDSM was implemented in our hospital in 2018. The objective of this study was to evaluate the effect of using IDSM versus CSR on operation time, margin status and re-excision rates in breast conserving surgery. METHODS: The present study is a single-center retrospective cohort study with 2 patient cohorts: one which underwent CSR (n = 532) and one which underwent IDSM (n = 475). The primary outcome was the operation time. Secondary outcomes were the margin status of the primary surgery, the cavity shaving rate, and the re-excision rate. Differences between cohorts were compared using univariate statistics and multiple regression analyses to adjust for variables that were significantly different between the groups. RESULTS: IDSM use was associated with an 8-minute reduction in surgery time (B = -8.034, 95% CI [-11.6, -4.5]; P < .001). Treatment variables independently associated with the operation time included use of IDSM, type of surgery, and performance of cavity shaving. Cavity shaves were more often performed when IDSM was used (24% for IDSM vs. 14% for CSR, P < .001), while the proportion of negative margin rates (93% for IDSM vs. 96% for CSR, P = .070) was comparable. CONCLUSION: IDSM was associated with a modest reduction in operation time. Surgeons performed more cavity shaves since the introduction of IDSM, but this increase was not reflected by difference in negative margin rates.

Drain versus no drain after hip hemi-arthroplasty for femoral neck fractures; differences in clinical outcomes.

PURPOSE: The routine use of surgical drains in elective hip arthroplasty has been abandoned. Also in acute hip arthroplasty for femoral neck fractures drain use reduces. Question is, whether this is justified in geriatric patients, where the incidence of anticoagulation use is high. Therefore, the aim of this study is to compare the clinical outcomes in patients with and without the use of a wound drain after hip hemiarthroplasty. METHODS: Data were extracted from a prospective hip fracture database and completed by retrospective review of the hospital records at two level II trauma centers between January 1st 2010 and May 16th 2016. Patients with a femoral neck fracture requiring hip hemiarthroplasty were included in the study. RESULTS: This study cohort included 900 patients (68% female), with a median age of 83.5 (IQR 78-88), of which 544 (60%) had a wound drain. Patients with a wound drain needed more days to be ready for discharged (10.0 days (SD ± 43.3), P = < 0.001) compared to patients without a drain (5.3 days (SD ± 4.2). With a drain more hemoglobin loss was found, 2.66 g/dL versus 2.4 g/dL (P = 0.008) and also more packed cells were supplemented, 0.29 versus 0.13 (P = 0.0016). Wound drain placement showed a statistically significant inverse relation with post-operative hematoma; odds ratio (OR 0.61, 95% CI 0.39; 0.94, P = 0.024), but no reduced risk of post-operative deep surgical site infection, (OR 1.09, 95% CI 0.43; 2.72, P = 0.862). CONCLUSION: Surgical drain placement was not associated with a reduced risk of post-operative deep surgical site infections, nor one-year mortality. However, a decreased risk of post-operative wound hematoma was observed. Furthermore, patients with a drain needed more days to be ready for discharge, show more hemoglobin loss and need more packed cell supplementation during admission.

Treatment of early-stage breast cancer with percutaneous thermal ablation, an open-label randomised phase 2 screening trial: rationale and design of the THERMAC trial.

INTRODUCTION: Breast cancer is the most frequently diagnosed malignancy worldwide but almost half of the patients have an excellent prognosis with a 5-year survival rate of 98%-99%. These patients could potentially be treated with thermal ablation to avoid surgical excision, reduce treatment-related morbidity and increase patients' quality of life without jeopardising treatment effectiveness. Previous studies showed highest complete ablation rates for radiofrequency, microwave and cryoablation. However, due to heterogeneity among studies, it is unknown which of these three techniques should be selected for a phase 3 comparative study. METHODS AND ANALYSIS: The aim of this phase 2 screening trial is to determine the efficacy rate of radiofrequency, microwave and cryoablation with the intention to select one treatment for further testing in a phase 3 trial. Additionally, exploratory data are obtained for the phase 3 trial. The design is a multicentre open-label randomised phase 2 screening trial. Patients with unifocal, invasive breast cancer with a maximum diameter of 2 cm without lymph node or distant metastases are included. Triple negative, Bloom-Richardson grade 3 tumours and patients with an indication for neoadjuvant chemotherapy will be excluded. Included patients will be allocated to receive one of the three thermal ablation techniques. Three months later surgical excision will be performed to determine the efficacy of thermal ablation. Treatment efficacy in terms of complete ablation rate will be assessed with CK 8/18 and H&E staining. Secondary outcomes include feasibility of the techniques in an outpatient setting, accuracy of MRI for complete ablation, patient satisfaction, adverse events, side effects, cosmetic outcome, system usability and immune response. ETHICS AND DISSEMINATION: This study protocol was approved by Medical Research Ethics Committee of the Erasmus Medical Center, Rotterdam, the Netherlands. Study results will be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NL9205 (www.trialregister.nl); Pre-results.

Validation of the Nottingham Hip Fracture Score (NHFS) in Patients with Hip Fracture: A Prospective Cohort Study in the Netherlands.

INTRODUCTION: The Nottingham Hip Fracture Score (NHFS) was developed to predict 30-day mortality for patients with hip fracture. This study aimed to validate the NHFS in a cohort with sufficient statistical power. METHODS: Data were extracted from a prospective hip-fracture database (FAMMI). Patients were included between January 1, 2018 and January 11, 2021. All consecutively admitted patients ≥18 years of age with a hip fracture (ie, femoral neck fracture, intertrochanteric fracture, and subtrochanteric fracture) were included. Mann-Whitney's U values were calculated to find potential miscalibration of the NHFS formula. Discrimination evaluation was performed using the concordance statistic as an equivalent to area under the receiver-operating curve. RESULTS: In total, 2,458 patients were included. Mean age was 80±12 years, and 66% were women (n=1,631). Median NHFS was 5 (4-6) and overall 30-day mortality 7.9% (n=195). Overall goodness of fit was tested with Pearson's ?2 (11.8, df 10; P=0.297). No statistically significant signs of miscalibration were found (Mann-Whitney U, P=0.08). Discrimination was tested with area under the receiver- operating curve, which was 72.1% (95% CI 68.7%-75.4%). However, observed 30-day mortality in our population of hip-fracture patients was slightly higher than the NHFS prediction. CONCLUSION: The NHFS seemed to predict 30-day mortality with reasonable accuracy for patients with a hip fracture in a population within the Netherlands.

Antithrombotics in Patients With a Femoral Neck Fracture: Evaluating Daily Practice in an Observational Cohort Study.

INTRODUCTION: Geriatric hip fracture patients are characterized by frailty due to multiple comorbidities, such as cardiovascular disease, in which the use of antithrombotics is frequent. The aim of this study is to assess the effect of antithrombotics on perioperative care and patient outcomes after hip hemiarthroplasty following current guidelines. MATERIALS AND METHODS: This observational cohort study included all consecutively admitted patients with a femoral neck fracture requiring hip hemiarthroplasty between January 1st 2010, and May 16th 2016, in two level II trauma teaching hospitals. Patients with multiple trauma injuries were excluded. RESULTS: In total, n = 907 patients (68% female (n = 615), median age 84 years) were included of which n = 142 used a vitamin K antagonist (VKA) and n = 213 used antiplatelet (AP) therapy. Both were associated with more packed cell supplementation (.4 ± 1.1 units and .3 ± .8 units vs .2 ± .6 units, P < .001 and P = .03, respectively). VKA was associated with more hematomas compared no antithrombotics (23% vs 11%, P = .001). VKA had a longer time to surgery compared to no antithrombotics and AP (24 hours vs 19 and 20 hours, P < .001 and P < .001, respectively) and longer admission duration (9 days vs 7 days P < .001. There were no differences in 30 day mortality nor in 1-year mortality rates. DISCUSSION: All modifiable causes for deep SSI, such as hematomas, should be prevented in acute hip fracture surgery. Since antithrombotics are associated with hematomas, an optimal handling in perioperative setting is necessary. CONCLUSION: VKA was associated with longer time to surgery, more hematomas, and longer admission duration. VKA and AP were associated with more packed cell supplementation.

Randomized controlled trial comparing magnetic marker localization (MaMaLoc) with wire-guided localization in the treatment of early-stage breast cancer.

Wire-guided localization (WGL) is the standard of care in the surgical treatment of nonpalpable breast tumors. In this study, we compare the use of a new magnetic marker localization (MaMaLoc) technique to WGL in the treatment of early-stage breast cancer patients. Open-label, single-center, randomized controlled trial comparing MaMaLoc (intervention) to WGL (control) in women with early-stage breast cancer. Primary outcome was surgical usability measured using the System Usability Scale (SUS, 0-100 score). Secondary outcomes were patient reported, clinical, and pathological outcomes such as retrieval rate, operative time, resected specimen weight, margin status, and reoperation rate. Thirty-two patients were analyzed in the MaMaLoc group and 35 in the WGL group. Patient and tumor characteristics were comparable between groups. No in situ complications occurred. Retrieval rate was 100% in both groups. Surgical usability was higher for MaMaLoc: 70.2 ± 8.9 vs. 58.1 ± 9.1, p < 0.001. Patients reported higher overall satisfaction with MaMaLoc (median score 5/5) versus WGL (score 4/5), p < 0.001. The use of magnetic marker localization (MaMaLoc) for early-stage breast cancer is effective and has higher surgical usability than standard WGL.

Thermal Ablation as an Alternative for Surgical Resection of Small (≤ 2 cm) Breast Cancers: A Meta-Analysis.

Women with early-stage breast cancer have an excellent prognosis with current therapy, but could presumably be treated less invasively, without the need for surgery. The primary goal of this meta-analysis was to examine whether thermal ablation is an effective method to treat early-stage breast cancer. Studies reporting on complete ablation rate after thermal ablation as a treatment of small breast cancers (≤ 2 cm) were included. Methodologic quality of included studies was assessed using MINORS criteria. Complete ablation rates are given as proportions, and meta-regression and subgroup analyses were performed. The overall complete ablation rate in 1266 patients was 86% and was highest after radiofrequency ablation (RFA) (92%). Local recurrence rates varied from 0% to 3%, with a median follow-up of 15 to 61 months. Overall, complication rates were low (5%-18% across techniques) and were highest after high-intensity focused ultrasound ablation and lowest after cryoablation. Cosmetic outcome was good to excellent in at least 85% of patients but was reported infrequently and long-term results of cosmetic outcome after thermal ablation and radiotherapy are still lacking. Thermal ablation techniques treating early-stage breast cancer (≤ 2 cm) are safe and effective based on complete ablation rate and short-term local recurrence rates. Especially, RFA, microwave ablation, and cryoablation are promising techniques as an alternative to surgical resection without jeopardizing current treatment effectiveness or safety. Owing to great heterogeneity in the included studies, a formal recommendation on the best technique is not possible. These findings warrant the design of large randomized controlled trials comparing thermal ablation and breast-conserving surgery in the treatment of T1 breast cancer.

Cost-utility analysis of four common surgical treatment pathways for breast cancer.

BACKGROUND: The aim was to evaluate the cost-utility of four common surgical treatment pathways for breast cancer: mastectomy, breast-conserving therapy (BCT), implant breast reconstruction (BR) and autologous-BR. METHODS: Patient-level healthcare consumption data and results of a large quality of life (QoL) study from five Dutch hospitals were combined. The cost-effectiveness was assessed in terms of incremental costs and quality adjusted life years (QALYs) over a 10-year follow-up period. Costs were assessed from a healthcare provider perspective. RESULTS: BCT resulted in comparable QoL with lower costs compared to implant-BR and autologous-BR and showed better QoL with higher costs than mastectomy (€17,246/QALY). QoL outcomes and costs of especially autologous-BR were affected by the relatively high occurrence of complications. If reconstruction following mastectomy was performed, implant-BR was more cost-effective than autologous-BR. CONCLUSION: The occurrence of complications had a substantial effect on costs and QoL outcomes of different surgical pathways for breast cancer. When this was taken into account, BCT was most the cost-effective treatment. Even with higher costs and a higher risk of complications, implant-BR and autologous-BR remained cost-effective over mastectomy. This pleas for adapting surgical pathways to individual patient preferences in the trade-off between the risks of complications and expected outcomes.

Prospective cohort protocol examining the perioperative indicators for complications and early mortality following hip fracture surgery in the frail patient.

INTRODUCTION: The primary aim is to validate earlier suggested risk factors and to find new associated risk factors for (30-day) mortality after a hip fracture in the frail population. The secondary aim is to determine the factors associated with perioperative complications. At last we want to develop and validate a more specific 30-day mortality prediction tool compared with the Nottingham Hip Fracture Score. The 30-day mortality prediction can help inform surgical risk and guide shared decision-making among patients, family and physicians. METHODS AND ANALYSIS: The study is designed as a prospective multicentre cohort study within the area of Rotterdam, the Netherlands starting from January 2018. All patients over 65 years of age, with an acute proximal hip fracture, are included. Treatment of patients will be by standard practice of care using the latest national and international guidelines. Inclusion will be continued at least until January 2021 and including at least 2500 patients. In this large cohort we hope to have sufficient strength and quality to identify risk factors of 30-day mortality and to compare them to known risk factors in literature. Moreover, we plan to develop and validate a 30-day mortality prediction tool, which identifies patients with a high probability of 30-day mortality. ETHICS AND DISSEMINATION: Ethical approval for this protocol was given by the Ethics Committee of the Maasstad Hospital (TWOR). Patient data are stored anonymously using the Castor data management system. No external funding is used for this study. Results will be published in peer-reviewed publications and at international conferences. TRIAL REGISTRATION NUMBER: NL8313.

Patient reported cosmetic outcome after vacuum assisted excision of benign breast lesions: a cross-sectional study.

OBJECTIVE: Better cosmetic outcome after vacuum assisted excision (VAE) compared to surgical excision of benign breast lesions is suggested in previous studies but has never been evaluated with validated outcome measures. In this study, patient reported cosmetic outcome after VAE was evaluated. METHODS: Patients who underwent VAE between July 2017 and December 2018 were invited to complete the cosmetic subscale of the Dutch Breast Cancer Treatment Outcome Scale, comparing the treated with the untreated breast. Response mode ranged from 1 (no difference) to 4 (large difference) and cosmetic outcome was calculated as the unweighted mean. Clinical outcomes included: tumor size, number of cores, complications, residual lesions and recurrences. RESULTS: Response rate was 73.4% (47 of 64 patients). Median tumor size was 15 mm (range 5-51 mm) and median number of cores 6.5 (range 1-85), complete excision was confirmed in all but two patients. Mean cosmetic outcome was good (mean score ≤1.75) in 74% of patients and no patients reported a poor cosmetic outcome (mean score >3.25). A hematoma occurred in five patients (one needed aspiration) and a skin rash in one patient, no patients developed an infection or seroma. CONCLUSION: In this study VAE is safe and effective for tumors up to 5 cm and patient reported cosmetic outcome was good. Patients with benign lesions could benefit from VAE as an alternative for surgical excision. ADVANCES IN KNOWLEDGE: A formal quantitative measurement of cosmetic outcome after vacuum assisted excision for benign breast lesions was still lacking. This study shows that this cosmetic outcome is overall good in benign lesions up to 5 cm.

Delirium after hip hemiarthroplasty for proximal femoral fractures in elderly patients: risk factors and clinical outcomes.

BACKGROUND: The primary aim of the present study was to verify the potential risk factors for developing a delirium after hip fracture surgery. The secondary aim of this study was to examine the related clinical outcomes after a delirium developed post-hip fracture surgery. PATIENTS AND METHODS: Data were extracted from a prospective hip fracture database and completed by retrospective review of the hospital records. A total of 463 patients undergoing hip fracture (hip hemiarthroplasty) surgery in a level II trauma teaching hospital between January 2011 and May 2016 were included. Delirium was measured using the Delirium Observation Screening Scale, the confusion assessment method, and an observatory judgment by geriatric medicine specialists. RESULTS: The results showed that 26% of the patients (n=121) developed a delirium during hospital stay with a median duration during admission of 5 days (IQR 3-7). The multivariable model showed that the development of delirium was significantly explained by dementia (OR 2.75, P=0.001), age (OR 1.06, P=0.005), and an infection during admission (pneumonia, deep surgical site infection, or urinary tract infection) (OR 1.23, P=0.046). After 1 year of follow-up, patients who developed delirium after hip fracture surgery were significantly more discharged to (semi-independent) nursing homes (P<0.001) and had a significantly higher mortality rate (P<0.001) compared to patients without delirium after hip fracture surgery. CONCLUSIONS: The results showed that 26% of the patients undergoing hip fracture surgery developed a delirium. The risk factors including age, dementia, and infection during admission significantly predicted the development of the delirium. No association was confirmed between delirium and time of admission or time to surgery. The development of delirium after hip fracture surgery was subsequently found to be a significant predictor of admission to a nursing home and mortality after 1 year.

A randomized controlled trial on the effect of a silver carboxymethylcellulose dressing on surgical site infections after breast cancer surgery.

BACKGROUND: The incidence of surgical site infections (SSIs) after breast cancer surgery is relatively high; ranging from 3 to 19%. The role of wound dressings in the prevention of SSI after breast cancer surgery is unclear. This study compares a silver carboxymethylcellulose dressing (AQUACEL Ag Surgical (Aquacel) with standard wound dressing in SSI rate after breast cancer surgery. PATIENTS AND METHODS: A single-centre randomized controlled trial among women ≥18 years, diagnosed with breast cancer, undergoing breast conserving or ablative surgery, was conducted in a combined in and outpatient setting. The intervention was the use of Aquacel, compared with standard gauze dressing. Primary outcome measure was SSI following CDC criteria. RESULTS: A total of 230 patients were analysed: 106 in the Aquacel group and 124 controls. Seven patients (6.6%) developed SSI in the Aquacel group and 16 patients (12.9%) in the control group (RR 0.51 [95% Confidence Interval (CI): 0.22-1.20]; p = 0.112; adjusted OR 0.49 [0.19-1.25] p = 0.135)). Unplanned exploratory subgroup analysis of breast conserving surgery patients showed that SSI rate was 1/56 (1.8%) in the Aquacel group vs. 7/65 (10.8%) in controls; adjusted OR 0.15 [0.02-1.31] p = 0.087. The Aquacel group showed better patient satisfaction (median 8 vs. 7 on a Numerical Rating Scale, p = 0.006), fewer dressing changes within 48 hours(adjusted OR 0.12 [0.05-0.27] p<0.001), fewer re-operations (0% vs. 3.2%, p = 0.062), and lower mean wound-related treatment costs, both in a high (€265.42 (SD = 908) vs. €470.65 (SD = 1223) [p<0.001]) and low (€59.12 (SD = 129) vs. €67.55 (SD = 172) [p<0.001]) attributable costs of SSI model. CONCLUSION: In this randomized controlled trial in women undergoing surgery for breast cancer, the use of AQUACEL Ag Surgical wound dressing did not significantly reduce the occurrence of SSIs compared to standard gauze dressing. The use of Aquacel resulted in significantly improved patient satisfaction, reduced dressing changes and reduced wound-related costs. TRIAL REGISTRATION: www.trialregister.nl: NTR5840.

The minimally invasive anterolateral approach versus the traditional anterolateral approach (Watson-Jones) for hip hemiarthroplasty after a femoral neck fracture: an analysis of clinical outcomes.

PURPOSE: The minimally invasive (MI) anterolateral approach is a relatively new approach for the treatment of femoral neck fractures with a hemiarthroplasty (HA). There is limited research available presenting clinical outcomes after an HA using the MI approach. Therefore the aim of the present study was to compare clinical outcomes of the MI and traditional anterolateral approaches in patients after HA. METHODS: Data were extracted from a prospective hip fracture database and completed by retrospective review of the electronic medical records. Patients undergoing HA in a level II trauma teaching hospital between 1 January 2011 and 1 May 2016 were enrolled. RESULTS: A total of 463 patients (67% female), 223 in the MI group (mean age, 82 ± 7) and 240 (mean age, 81 ± 8) in the traditional anterolateral group were enrolled. No significant difference was found in baseline characteristics. The surgeons experience measured by the operations performed per year was in favour of the MI anterolateral group (26 vs 18, p < 0.001). The median operating time for an MI approach was shorter (53 vs 69 min, p < 0.001). No significant differences were found in mortality rates (p = 0.131) and post-operative complications: haematomas (p = 0.63), dislocations (p = 0.63), deep surgical site infections (p = 0.66) and re-operations. CONCLUSIONS: Our findings show the MI anterolateral approach has a minimally shorter operation time with no difference in post-operative complications and clinical outcomes. We, therefore, conclude that the MI anterolateral approach is a safe alternative for the traditional anterolateral approach with an improved operation time, a smaller incision and less surrounding tissue damage. LEVEL OF EVIDENCE: Prognostic level III retrospective cohort study.

A randomized trial of cryo stripping versus conventional stripping of the great saphenous vein.

OBJECTIVE: This multicenter randomized clinical trial compared cryo stripping of the great saphenous vein (GSV) with conventional stripping. METHODS: The study randomized 494 patients with symptomatic (CEAP) clinical severity class 2 to 4 to cryo stripping (n = 249) or conventional stripping (n = 245). The primary outcome was residual GSV 6 months after surgery measured by venous duplex ultrasound imaging. Secondary outcomes were quality of life, operation time, and postoperative neural damage. Duration of follow-up was 6 months. Quality of life was measured at 6 and 26 weeks postoperatively with the Aberdeen Varicose Vein Questionnaire (AVVQ) and Medical Outcomes Study Short-Form 36 (SF-36) Health Survey. RESULTS: The two groups were well matched at baseline. The percentage of patients with residual GSV at 6 months (primary outcome) was 44% (102 of 230) in the cryo group and 15% (33 of 215) in the conventional group (difference 29%; 95% confidence interval [CI], 21%-37%, P < .001). Median operation time was significantly shorter in the cryo group (30 minutes) compared with the conventional group (39 minutes). Neural damage was 12% in both groups, and thus not significantly different. Scores on the subdomains of the SF-36 showed no significant change between the groups. The AVVQ after conventional stripping was 8.0, which was a better result than the 11.7 result after cryo stripping (difference 2.6 points; 95% CI, 1.0-4.2; P = .001, repeated measurements analysis of variance with adjustment for baseline scores). CONCLUSIONS: Cryo stripping accounts for numerous procedural failures and hence residual GSV in patients. The AVVQ showed small but significantly better results for patients after a conventional stripping. Cryo stripping has no benefits over conventional stripping.