Multicenter and inter-software evaluation of ablative margins after thermal ablation of colorectal liver metastases.

PURPOSE: To assess the association between minimal ablative margin (MAM) and local tumor progression (LTP) following CT-guided thermal ablation of colorectal liver metastases (CRLM) in a multicenter cohort and across two confirmation software. MATERIALS AND METHODS: This multicenter retrospective study included patients who underwent CT-guided radiofrequency or microwave ablation for CRLM between 2009 and 2021 in three institutions. Three-dimensional (3D) MAM was retrospectively assessed using dedicated ablation confirmation software by automatic non-rigid (Ablation-fit) or semi-automatic rigid co-registration (SAFIR) of intraprocedural pre- and post-ablation contrast-enhanced CT scans by two independent reader teams blinded to patient outcomes. LTP was assessed on a per-tumor basis. Factors associated with LTP-free survival were assessed using multivariable Cox regression analysis. RESULTS: Overall, 113 patients (mean age: 67 ± 10 years; 78 men) who underwent thermal ablation for 189 CRLM (mean diameter: 1.9 ± 1.1 cm) met the inclusion criteria. 173/189 (92%) CRLM could be successfully analyzed using both software. Over a median follow-up of 31 months (IQR: 22-47), 21 of 173 CRLM (12.1%) developed LTP. On multivariable analysis, 3D MAM was independently associated with LTP in both software (Ablation-fit: HR 0.47, 95% CI: 0.36-0.61, p < 0.001; SAFIR: HR 0.42, 95% CI: 0.32-0.55, p < 0.001). No LTP was observed in CRLM ablated with MAM ≥ 4 mm (Ablation-fit) and ≥ 5 mm (SAFIR). The per-tumor median absolute difference in MAM quantification between both software was 2 mm (IQR: 1-3). CONCLUSION: MAM was independently associated with LTP after thermal ablation of CRLM across multicenter data and two confirmation software. Ablations achieving a MAM ≥ 5 mm were associated with local control in both software. CLINICAL RELEVANCE STATEMENT: MAMs from intraprocedural contrast-enhanced CT were independently associated with LTP after thermal ablation of CRLM across multicenter data and two confirmation software, with a margin ≥ 5 mm associated with local control in both software. KEY POINTS: Sufficient ablative margins are critical for local control following thermal ablation of CRLM. Intraprocedural CT-derived MAM was the only independent factor associated with LTP across two confirmation software. No LTP was observed in CRLM ablated with a MAM ≥ 5 mm.

Validation of the Incidence of Reported Periprosthetic Joint Infections in Total Hip and Knee Arthroplasty in the Dutch Arthroplasty Register.

BACKGROUND: Arthroplasty registers underreport the incidence of periprosthetic joint infections (PJIs). We validated the incidence of reported PJIs in total hip arthroplasties (THAs) and total knee arthroplasties (TKAs) in the Dutch Arthroplasty Register (LROI) using data from the Dutch National Nosocomial Surveillance Network (PREZIES). METHODS: All primary THAs and TKAs from the LROI and all primary THAs and TKAs performed in consenting hospitals from PREZIES between 2012 and 2018 were matched on date of birth, date of surgery, sex, hospital, and type of procedure (THA n = 91,208; TKA n = 80,304). Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated for PJIs registered in the LROI, using PREZIES as a reference. RESULTS: The incidence of registered PJIs in THAs was 1.2% in PREZIES and 0.5% in the LROI. For TKAs, this was 0.7 and 0.4%, respectively. The PJIs in THAs in the LROI had a sensitivity of 0.32 (confidence interval [CI]: 0.29 to 0.35), specificity of 1.00 (CI: 1.00 to 1.00), PPV of 0.74 (CI: 0.70 to 0.78), and NPV of 0.99 (CI: 0.99 to 0.99). In TKAs, the sensitivity, specificity, PPV, and NPV were 0.38 (CI: 0.34 to 0.42), 1.00 (CI: 1.00 to 1.00), 0.65 (CI: 0.59 to 0.70), and 1.00 (CI: 1.00 to 1.00), respectively. CONCLUSIONS: The LROI captures approximately one-third of the PJIs as revision within one year for infection or resection arthroplasty. The capture rate of PJIs can be improved by including all reoperations without component exchange and nonsurgical treatments with antibiotics only.

Early Periprosthetic Joint Infections in Total Hip and Knee Arthroplasty: Microorganisms, Mortality, and Implant Survival Using a Combined Dataset From the Dutch Arthroplasty Register and the Dutch National Nosocomial Surveillance Network.

BACKGROUND: Periprosthetic joint infections (PJIs) can lead to higher re-revision rates and even higher mortality rates that may be associated with the responsible microorganism. We evaluated microorganisms that cause early PJIs in primary total hip and knee arthroplasty (THA and TKA) and examined mortality as well as PJI re-revision rates after these PJIs, using a combined dataset from the Dutch Arthroplasty Register and the Dutch National Nosocomial Surveillance Network (PREZIES). Secondly, the most common microorganisms that cause PJIs were described according to patient and implant survival. METHODS: We included all PREZIES-confirmed PJIs (n = 1,648) from the combined dataset in which primary THAs and TKAs (2012 to 2018) from the Dutch Arthroplasty Register and PREZIES were case-level matched. Kaplan-Meier survival analyses were performed to determine mortality and PJI re-revision rates following PJI revision. RESULTS: The most prevalent microorganism in THAs and TKAs was Staphylococcus aureus (THA 34%; TKA 39%), followed by Coagulase-negative staphylococci (THA 20%; TKA 19%), with Staphylococcus epidermidis (THA 12%; TKA 11%) as the most common subtype, and Enterococcus species (THA 8.6%; TKA 5.9%). The 5-year mortality was 15% (95% confidence interval [CI]: 13 to 18) and 18% (CI: 14 to 21) for THA and TKA patients, respectively. The 5-year PJI re-revision rate was 28% (CI: 24 to 34) for THAs and 30% (CI: 24 to 38) for TKAs. In deceased THA patients who had a PJI, Enterococcus species (14%) were more often registered as microorganisms responsible for the PJI than S. epidermidis (8.5%). CONCLUSIONS: Over half of the early PJIs in THAs and TKAs in the Netherlands were caused by Staphylococcus aureus and Coagulase-negative staphylococci including Staphylococcus epidermidis. Both 5-year mortality and PJI re-revision rates following PJI were relatively high.

Stoma-free Survival After Rectal Cancer Resection With Anastomotic Leakage: Development and Validation of a Prediction Model in a Large International Cohort.

OBJECTIVE: To develop and validate a prediction model (STOMA score) for 1-year stoma-free survival in patients with rectal cancer (RC) with anastomotic leakage (AL). BACKGROUND: AL after RC resection often results in a permanent stoma. METHODS: This international retrospective cohort study (TENTACLE-Rectum) encompassed 216 participating centres and included patients who developed AL after RC surgery between 2014 and 2018. Clinically relevant predictors for 1-year stoma-free survival were included in uni and multivariable logistic regression models. The STOMA score was developed and internally validated in a cohort of patients operated between 2014 and 2017, with subsequent temporal validation in a 2018 cohort. The discriminative power and calibration of the models' performance were evaluated. RESULTS: This study included 2499 patients with AL, 1954 in the development cohort and 545 in the validation cohort. Baseline characteristics were comparable. One-year stoma-free survival was 45.0% in the development cohort and 43.7% in the validation cohort. The following predictors were included in the STOMA score: sex, age, American Society of Anestesiologist classification, body mass index, clinical M-disease, neoadjuvant therapy, abdominal and transanal approach, primary defunctioning stoma, multivisceral resection, clinical setting in which AL was diagnosed, postoperative day of AL diagnosis, abdominal contamination, anastomotic defect circumference, bowel wall ischemia, anastomotic fistula, retraction, and reactivation leakage. The STOMA score showed good discrimination and calibration (c-index: 0.71, 95% CI: 0.66-0.76). CONCLUSIONS: The STOMA score consists of 18 clinically relevant factors and estimates the individual risk for 1-year stoma-free survival in patients with AL after RC surgery, which may improve patient counseling and give guidance when analyzing the efficacy of different treatment strategies in future studies.

Learning Curve of Laparoscopic Gastrectomy: A Multicenter Study.

OBJECTIVE: To evaluate the learning curve of laparoscopic gastrectomy (LG) after an implementation program. BACKGROUND: Although LG is increasingly being performed worldwide, little is known about the learning curve. METHODS: Consecutive patients who underwent elective LG for gastric adenocarcinoma with curative intent in each of the 5 highest-volume centers in the Netherlands were enrolled. Generalized additive models and a 2-piece model with a break point were used to determine the learning curve length. Analyses were corrected for casemix and were performed for LG and for the subgroups distal gastrectomy (LDG) and total gastrectomy (LTG). The learning curve effect was assessed for (1) anastomotic leakage; and (2) the occurrence of postoperative complications, conversions to open surgery, and short-term oncological parameters. RESULTS: In total 540 patients were included for analysis, 108 patients from each center; 268 patients underwent LDG and 272 underwent LTG. First, for LG, no learning effect regarding anastomotic leakage could be identified: the rate of anastomotic leakage initially increased, then reached a plateau after 36 cases at 10% anastomotic leakage. Second, the level of overall complications reached a plateau after 20 cases, at 38% overall complications, and at 5% conversions. For both LDG and LTG, each considered separately, fluctuations in secondary outcomes and anastomotic leakage followed fluctuations in casemix. CONCLUSION: On the basis of our study of the first 108 procedures of LG in 5 high-volume centers with well-trained surgeons, no learning curve effect could be identified regarding anastomotic leakage. A learning curve effect was found with respect to overall complications and conversion rate.

The Importance of Awaiting Biopsy Results in Solitary Pathological Proximal Femoral Fractures : Do We Need to Biopsy Solitary Pathological Fractures?

BACKGROUND: The optimal surgical treatment for patients presenting with (impending and complete) pathological proximal femoral fractures is predicated on prognosis. Guidelines recommend a preoperative biopsy to exclude sarcomas, however no evidence confirms a benefit. OBJECTIVE: This study aimed to describe the diagnostic accuracy, morbidity and sarcoma incidence of biopsy results in these patients. MATERIAL AND METHODS: All patients (n = 153) presenting with pathological proximal femoral fractures between 2000 and 2019 were retrospectively evaluated. Patients after inadvertent surgery (n = 25) were excluded. Descriptive statistics were used to evaluate the accuracy and morbidity of diagnostic biopsies. RESULTS: Of 112/128 patients who underwent biopsy, nine (8%) biopsies were unreliable either due to being inconclusive (n = 5) or because the diagnosis changed after resection (n = 4). Of impending fractures, 32% fractured following needle core biopsy. Median time from diagnosis to surgery was 30 days (interquartile range 21-46). The overall biopsy positive predictive value (PPV) to differentiate between sarcoma and non-sarcoma was 1.00 (95% confidence interval [CI] 0.88-1.00). In patients with a previous malignancy (n = 24), biopsy (n = 23) identified the diagnosis in 83% (PPV 0.91, 95% CI 0.71-0.99), of whom five (24%) patients had a new diagnosis. In patients without a history of cancer (n = 61), final diagnosis included carcinomas (n = 24, 39.3%), sarcomas (n = 24, 39.3%), or hematological malignancies (n = 13, 21.3%). Biopsy (n = 58) correctly identified the diagnosis in 66% of patients (PPV 0.80, 95% CI 0.67-0.90). CONCLUSION: This study confirms the importance of a preoperative biopsy in solitary pathological proximal femoral fractures due to the risk of sarcoma in patients with and without a history of cancer. However, biopsy delays the time to definite surgery, results can be inconclusive or false, and it risks completion of impending fractures.

Stoma-free survival after anastomotic leak following rectal cancer resection: worldwide cohort of 2470 patients.

BACKGROUND: The optimal treatment of anastomotic leak after rectal cancer resection is unclear. This worldwide cohort study aimed to provide an overview of four treatment strategies applied. METHODS: Patients from 216 centres and 45 countries with anastomotic leak after rectal cancer resection between 2014 and 2018 were included. Treatment was categorized as salvage surgery, faecal diversion with passive or active (vacuum) drainage, and no primary/secondary faecal diversion. The primary outcome was 1-year stoma-free survival. In addition, passive and active drainage were compared using propensity score matching (2 : 1). RESULTS: Of 2470 evaluable patients, 388 (16.0 per cent) underwent salvage surgery, 1524 (62.0 per cent) passive drainage, 278 (11.0 per cent) active drainage, and 280 (11.0 per cent) had no faecal diversion. One-year stoma-free survival rates were 13.7, 48.3, 48.2, and 65.4 per cent respectively. Propensity score matching resulted in 556 patients with passive and 278 with active drainage. There was no statistically significant difference between these groups in 1-year stoma-free survival (OR 0.95, 95 per cent c.i. 0.66 to 1.33), with a risk difference of -1.1 (95 per cent c.i. -9.0 to 7.0) per cent. After active drainage, more patients required secondary salvage surgery (OR 2.32, 1.49 to 3.59), prolonged hospital admission (an additional 6 (95 per cent c.i. 2 to 10) days), and ICU admission (OR 1.41, 1.02 to 1.94). Mean duration of leak healing did not differ significantly (an additional 12 (-28 to 52) days). CONCLUSION: Primary salvage surgery or omission of faecal diversion likely correspond to the most severe and least severe leaks respectively. In patients with diverted leaks, stoma-free survival did not differ statistically between passive and active drainage, although the increased risk of secondary salvage surgery and ICU admission suggests residual confounding.

Treatment of anastomotic leak after oesophagectomy for oesophageal cancer: large, collaborative, observational TENTACLE cohort study.

BACKGROUND: Anastomotic leak is a severe complication after oesophagectomy. Anastomotic leak has diverse clinical manifestations and the optimal treatment strategy is unknown. The aim of this study was to assess the efficacy of treatment strategies for different manifestations of anastomotic leak after oesophagectomy. METHODS: A retrospective cohort study was performed in 71 centres worldwide and included patients with anastomotic leak after oesophagectomy (2011-2019). Different primary treatment strategies were compared for three different anastomotic leak manifestations: interventional versus supportive-only treatment for local manifestations (that is no intrathoracic collections; well perfused conduit); drainage and defect closure versus drainage only for intrathoracic manifestations; and oesophageal diversion versus continuity-preserving treatment for conduit ischaemia/necrosis. The primary outcome was 90-day mortality. Propensity score matching was performed to adjust for confounders. RESULTS: Of 1508 patients with anastomotic leak, 28.2 per cent (425 patients) had local manifestations, 36.3 per cent (548 patients) had intrathoracic manifestations, 9.6 per cent (145 patients) had conduit ischaemia/necrosis, 17.5 per cent (264 patients) were allocated after multiple imputation, and 8.4 per cent (126 patients) were excluded. After propensity score matching, no statistically significant differences in 90-day mortality were found regarding interventional versus supportive-only treatment for local manifestations (risk difference 3.2 per cent, 95 per cent c.i. -1.8 to 8.2 per cent), drainage and defect closure versus drainage only for intrathoracic manifestations (risk difference 5.8 per cent, 95 per cent c.i. -1.2 to 12.8 per cent), and oesophageal diversion versus continuity-preserving treatment for conduit ischaemia/necrosis (risk difference 0.1 per cent, 95 per cent c.i. -21.4 to 1.6 per cent). In general, less morbidity was found after less extensive primary treatment strategies. CONCLUSION: Less extensive primary treatment of anastomotic leak was associated with less morbidity. A less extensive primary treatment approach may potentially be considered for anastomotic leak. Future studies are needed to confirm current findings and guide optimal treatment of anastomotic leak after oesophagectomy.

Study protocol for a multicenter randomised controlled trial on the (cost)effectiveness of biopsy combined with same-session MR-guided LITT versus biopsy alone in patients with primary irresectable glioblastoma (EMITT trial).

BACKGROUND: Glioblastoma (GBM) is the most common primary, malignant brain tumour with a 5-year survival of 5%. If possible, a glioblastoma is resected and further treated with chemoradiation therapy (CRT), but resection is not feasible in about 30% of cases. Current standard of care in these cases is a biopsy followed by CRT. Magnetic resonance (MR) imaging-guided laser interstitial thermal therapy (LITT) has been suggested as a minimally invasive alternative when surgery is not feasible. However, high-quality evidence directly comparing LITT with standard of care is lacking, precluding any conclusions on (cost-)effectiveness. We therefore propose a multicenter randomized controlled study to assess the (cost-)effectiveness of MR-guided LITT as compared to current standard of care (EMITT trial). METHODS AND ANALYSIS: The EMITT trial will be a multicenter pragmatic randomized controlled trial in the Netherlands. Seven Dutch hospitals will participate in this study. In total 238 patients will be randomized with 1:1 allocation to receive either biopsy combined with same-session MR-guided LITT therapy followed by CRT or the current standard of care being biopsy followed by CRT. The primary outcomes will be health-related quality of life (HR-QoL) (non-inferiority) using EORTC QLQ-C30 + BN20 scores at 5 months after randomization and overall survival (superiority). Secondary outcomes comprise cost-effectiveness (healthcare and societal perspective) and HR-QoL of life over an 18-month time horizon, progression free survival, tumour response, disease specific survival, longitudinal effects, effects on adjuvant treatment, ablation percentage and complication rates. DISCUSSION: The EMITT trial will be the first RCT on the effectiveness of LITT in patients with glioblastoma as compared with current standard of care. Together with the Dutch Brain Tumour Patient association, we hypothesize that LITT may improve overall survival without substantially affecting patients' quality of life. TRIAL REGISTRATION: This trial is registered at ClinicalTrials.gov (NCT05318612).

Care Pathway Analysis to Inform the Earliest Stages of Technology Development: Scoping Oncological Indications in Need of Innovation.

OBJECTIVES: Identifying unmet needs for innovative solutions across disease contexts is challenging but important for directing funding and research efforts and informing early-stage decisions during the innovation process. Our aim was to study the merits of care pathway analysis to scope disease contexts and guide the development of innovative devices. We used oncologic surgery as a case study, for which many intraoperative imaging techniques are under development. METHODS: Care pathway analysis is a mapping process, which produces graphical maps of clinical pathways using important outcomes and subsequent consequences. We performed care pathway analyses for glioblastoma, breast, bladder, prostate, renal, pancreatic, and oral cavity cancer. Differences between a "perfect" care pathway and the current care pathway in terms of percentage of inadequate margins, associated recurrences, quality of life, and 5-year overall survival were calculated to determine unmet needs. Data from The Netherlands Cancer Registry and literature were used. RESULTS: Care pathway analysis showed that highest percentages of inadequate margins were found in oral cavity cancer (72.5%), glioblastoma (48.7%), and pancreatic cancer (43.9%). Inadequate margins showed the strongest increase in recurrences in cancer of oral cavity, and bladder (absolute increases of 43.5% and 41.2%, respectively). Impact on survival was largest for bladder and oral cavity cancer with positive margins. CONCLUSIONS: Care pathway analysis provides overviews of current clinical paths in multiple indications. Disease contexts can be compared via effectiveness gaps that show the potential need for innovative solutions. This information can be used as basis for stakeholder involvement processes to prioritize care pathways in need of innovation.

Performance of a consensus-based algorithm for diagnosing anastomotic leak after minimally invasive esophagectomy for esophageal cancer.

Anastomotic leak (AL) is a common and severe complication after esophagectomy. This study aimed to assess the performance of a consensus-based algorithm for diagnosing AL after minimally invasive esophagectomy. This study used data of the ICAN trial, a multicenter randomized clinical trial comparing cervical and intrathoracic anastomosis, in which a predefined diagnostic algorithm was used to guide diagnosing AL. The algorithm identified patients suspected of AL based on clinical signs, blood C-reactive protein (cut-off value 200 mg/L), and/or drain amylase (cut-off value 200 IU/L). Suspicion of AL prompted evaluation with contrast swallow computed tomography and/or endoscopy to confirm AL. Primary outcome measure was algorithm performance in terms of sensitivity, specificity, and positive and negative predictive values (PPV, NPV), respectively. AL was defined according to the definition of the Esophagectomy Complications Consensus Group. 245 patients were included, and 125 (51%) patients were suspected of AL. The algorithm had a sensitivity of 62% (95% confidence interval [CI]: 46-75), a specificity of 97% (95% CI: 89-100), and a PPV and NPV of 94% (95% CI: 79-99) and 77% (95% CI: 66-86), respectively, on initial assessment. Repeated assessment in 19 patients with persisting suspicion of AL despite negative or inconclusive initial assessment had a sensitivity of 100% (95% CI: 77-100). The algorithm showed poor performance because the low sensitivity indicates the inability of the algorithm to confirm AL on initial assessment. Repeated assessment using the algorithm was needed to confirm remaining leaks.

Predicting mortality in patients with anastomotic leak after esophagectomy: development of a prediction model using data from the TENTACLE-Esophagus study.

Anastomotic leak (AL) is a common but severe complication after esophagectomy, and over 10% of patients with AL suffer mortality. Different prognostic factors in patients with AL are known, but a tool to predict mortality after AL is lacking. This study aimed to develop a prediction model for postoperative mortality in patients with AL after esophagectomy. TENTACLE-Esophagus is an international retrospective cohort study, which included 1509 patients with AL after esophagectomy. The primary outcome was 90-day postoperative mortality. Previously identified prognostic factors for mortality were selected as predictors: patient-related (e.g. comorbidity, performance status) and leak-related predictors (e.g. leucocyte count, overall gastric conduit condition). The prediction model was developed using multivariable logistic regression and validated internally using bootstrapping. Among the 1509 patients with AL, 90-day mortality was 11.7%. Sixteen predictors were included in the prediction model. The model showed good performance after internal validation: the c-index was 0.79 (95% confidence interval 0.75-0.83). Predictions for mortality by the internally validated model aligned well with observed 90-day mortality rates. The prediction model was incorporated in an online tool for individual use and can be found at: https://www.tentaclestudy.com/prediction-model. The developed prediction model combines patient-related and leak-related factors to accurately predict postoperative mortality in patients with AL after esophagectomy. The model is useful for clinicians during counselling of patients and their families and may aid identification of high-risk patients at diagnosis of AL. In the future, the tool may guide clinical decision-making; however, external validation of the tool is warranted.

The value of reducing arthroscopic partial meniscectomy in the treatment of degenerative meniscus tears: a budget impact analysis.

AIMS: Numerous studies have shown that arthroscopic partial meniscectomy (APM) is not (cost-) effective in patients with symptoms attributed to a degenerative meniscus tear. We aimed to assess the budget impact of reducing APM in routine clinical practice in this population. MATERIALS AND METHODS: A patient-level state transition model was developed to simulate patients recently diagnosed with a degenerative meniscus tear. Three strategies were compared: "current guideline" (i.e., postpone surgery to at least 3 months after diagnosis), "APM at any time" (i.e., APM available directly after diagnosis), and "nonsurgical" (i.e., APM no longer performed). Total societal costs over 5 years were calculated to determine the budget impact. Probabilistic and deterministic sensitivity analyses were conducted to address uncertainty. RESULTS: The average cost per patient over 5 years were EUR 5,077, EUR 4,577, and EUR 4,218, for the "APM at any time," "current guideline," and "nonsurgical" strategy, respectively. Removing APM from the treatment mix (i.e., 30,000 patients per year) in the Netherlands, resulted in a reduction in health care expenditures of EUR 54 million (95 percent confidence interval [CI] EUR 38 million-EUR 70 million) compared to the "current guideline strategy" and EUR 129 million (95 percent CI EUR 102 million-EUR 156 million) compared to the "APM at any time" strategy. Sensitivity analyses showed that uncertainty did not alter our conclusions. CONCLUSIONS: Substantial costs can be saved when APM is no longer performed to treat symptoms attributed to degenerative meniscus tears in the Netherlands. It is therefore recommended to further reduce the use of APM to treat degenerative meniscus tears.

Revision risk of salvage compared with acute total hip arthroplasty following femoral neck fracture: an analysis from the Dutch Arthroplasty Register.

BACKGROUND AND PURPOSE: There is no consensus on the treatment of patients with femoral neck fractures between internal fixation (IF) or directly treated with a total hip arthroplasty (fracture-THA) in particular for the age group 60-70 years. Failure of IF is not uncommon, resulting in salvage total hip arthroplasty (salvage-THA). The aim of our study was to compare revision rates of salvage-THA with fracture-THA and osteoarthritis (OA)-THA. PATIENTS AND METHODS: Revision rates and reasons for revision were compared. Data collected in the Dutch Arthroplasty Register (LROI) between 2007 and 2018 was used. The study included 4,310 salvage-THAs, 12,159 fracture-THAs, and 274,147 OA-THAs. We performed Kaplan-Meier survival analyses and Cox regression to evaluate THA survival. RESULTS: No statistically significant difference in revision rates between salvage-THAs and fracture-THAs was found (HR 1.0, 95% CI 0.7-1.3) whereas the revision rate was higher compared with OA-THAs (HR 1.3, CI 1.0-1.5). The 5-year revision rate was 5.0% (CI 4.4-5.8) in salvage-THAs, 4.5% (CI 4.1-5.0) in fracture-THAs, and 3.1% (CI 3.0-3.2) in OA-THAs. A higher revision rate for infection was found in salvage-THAs in comparison with fracture-THAs (HR 1.6, CI 1.0-2.3). CONCLUSION: We found no difference in revision rates for salvage-THAs compared with fracture-THAs. The risk of revision for infection was higher for salvage-THA.

A comparison of uncemented short versus standard stem length in total hip arthroplasty: results from the Dutch Arthroplasty Register.

BACKGROUND AND PURPOSE: We aimed to compare revision rates between uncemented short and standard stems in total hip arthroplasties (THAs) and the corresponding patient-reported outcome measures (PROMs). PATIENTS AND METHODS: We included all short (C.F.P., Fitmore, GTS, Metha, Nanos, Optimys, Pulchra, and Taperloc Microplasty) and standard stems in uncemented THAs registered between 2009 and 2021 in the Dutch Arthroplasty Register. Kaplan-Meier survival and multivariable Cox regression analyses were performed with overall and femoral stem revision as endpoints. RESULTS: Short stems were used in 3,352 and standard stems in 228,917 hips. 10-year overall revision rates (4.8%, 95% confidence interval [CI] 3.7-6.3 vs. 4.5%, CI 4.4-4.6) and femoral stem revision rates (3.0%, CI 2.2-4.2 vs. 2.3%, CI 2.2-2.4) were comparable for short- and standard-stem THAs. Today's predominant short stems (Fitmore and Optimys) showed short-term revision rates similar to that of standard-stem THAs. Other, less frequently used short stems had higher 10-year overall (6.3%, CI 4.7-8.5) and femoral stem (4.5%, CI 3.1-6.3) revision rates. Multivariable Cox regression also showed a higher risk for overall (HR 1.7, CI 1.0-2.9) and femoral stem revision (HR 2.0, CI 1.1-3.5) using the latter short stems compared with standard stems. An exploratory analysis of PROMs showed no difference. CONCLUSION: There was no overall difference in revision rates but a tendency toward increased revision of short stems both for the whole THA and for the stem itself. The less frequently used short stems had increased revision risk. No difference in PROMs was shown.

Arthroscopic partial meniscectomy for the degenerative meniscus tear: a comparison of patients included in RCTs and prospective cohort studies.

BACKGROUND AND PURPOSE: Concerns exist regarding the generalizability of results from randomized controlled trials (RCTs) evaluating arthroscopic partial meniscectomy (APM) to treat degenerative meniscus tears. It has been suggested that study populations are not representative of subjects selected for surgery in daily clinical practice. Therefore, we aimed to compare patients included in trials and prospective cohort studies that received APM for a degenerative meniscus tear. PATIENTS AND METHODS: Individual participant data from 4 RCTs and 2 cohort studies undergoing APM were collected. 1,970 patients were analyzed: 605 patients included in RCTs and 1,365 included in the cohorts. We compared patient and disease characteristics, knee pain, overall knee function, and health-related quality of life at baseline between the RCT and cohort groups using standardized differences, ratios comparing the variance of continuous covariates, and graphical methods such as quantile-quantile plots, side-by-side boxplots, and non-parametric density plots. RESULTS: Differences between RCT and the cohort were observed primarily in age (younger patients in the cohort; standardized difference: 0.32) and disease severity, with the RCT group having more severe symptoms (standardized difference: 0.38). While knee pain, overall knee function, and quality of life generally showed minimal differences between the 2 groups, it is noteworthy that the largest observed difference was in knee pain, where the cohort group scored 7 points worse (95% confidence interval 5-9, standardized difference: 0.29). CONCLUSION: Patients in RCTs were largely representative of those in cohort studies regarding baseline scores, though variations in age and disease severity were observed. Younger patients with less severe osteoarthritis were more common in the cohort; however, trial participants still appear to be broadly representative of the target population.

Short-stem hip arthroplasty in Australia and the Netherlands: a comparison of 12,680 cases between the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) and the Dutch Arthroplasty Register (LROI).

BACKGROUND AND PURPOSE: We compared the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) and the Dutch Arthroplasty Register (LROI) regarding patient, prosthesis, and procedure characteristics as well as revision rates for uncemented short-stem total hip arthroplasties (THAs). PATIENTS AND METHODS: All THAs with an uncemented short-stemmed femoral component performed between 2009 and 2021 were included from the AOANJRR (n = 9,328) and the LROI (n = 3,352). Kaplan-Meier survival analyses and multivariable Schemper's weighted Cox regression analyses with data from 2009-2021 and 2015-2021 were performed with overall revision as endpoint. RESULTS: In Australia, the proportion of male patients (51% vs. 40%), patients with ASA III-IV score (30% vs. 3.7%), BMI ≥ 30.0 (39% vs. 19%), and femoral heads of 36 mm (58% vs. 20%) were higher than in the Netherlands. Short-stem THAs in Australia and the Netherlands had comparable 10-year revision rates (3.4%, 95% confidence interval [CI] 2.9-4.0 vs. 4.8%, CI 3.7-6.3). Multivariable Cox regression analyses with data from 2009-2021 showed a higher risk for revision of short-stem THAs performed in the Netherlands (HR 1.8, CI 1.1-2.8), whereas the risk for revision was comparable (HR 0.9, CI 0.5-1.7) when adjusted for more potential confounders using data from 2015-2021. CONCLUSION: Short-stem THAs in Australia and the Netherlands have similar crude and adjusted revision rates, which are acceptable at 10 years of follow-up.

Learning Curves of Ivor Lewis Totally Minimally Invasive Esophagectomy by Hospital and Surgeon Characteristics: A Retrospective Multinational Cohort Study.

OBJECTIVE: To describe the pooled learning curves of Ivor Lewis totally minimally invasive esophagectomy (TMIE) in hospitals stratified by predefined hospital- and surgeon-related factors. BACKGROUND: Ivor Lewis (TMIE is known to have a long learning curve which is associated with considerable learning associated morbidity. It is unknown whether hospital and surgeon characteristics are associated with more efficient learning. METHODS: A retrospective analysis of prospectively collected data of consecutive Ivor Lewis TMIE patients in 14 European hospitals was performed. Outcome parameters used as proxy for efficient learning were learning curve length, learning associated morbidity, and the plateau level regarding anastomotic leakage and textbook outcome. Pooled incidences were plotted for the factor-based subgroups using generalized additive models and 2-phase models. Casemix predicted outcomes were plotted and compared with observed outcomes. The investigated factors included annual volume, TMIE experience, clinic visits, courses and fellowships followed, and proctor supervision. RESULTS: This study included 2121 patients. The length of the learning curve was shorter for centers with an annual volume >50 compared to centers with an annual volume <50. Analysis with an annual volume cut-off of 30 cases showed similar but less pronounced results. No outcomes suggesting more efficient learning were found for longer experience as consultant, visiting an expert clinic, completing a minimally invasive esophagectomy fellowship or implementation under proctor supervision. CONCLUSIONS: More efficient learning was observed in centers with higher annual volume. Visiting an expert clinic, completing a fellowship, or implementation under a proctor's supervision were not associated with more efficient learning.

Severity of oEsophageal Anastomotic Leak in patients after oesophagectomy: the SEAL score.

BACKGROUND: Anastomotic leak (AL) is a common but severe complication after oesophagectomy. It is unknown how to determine the severity of AL objectively at diagnosis. Determining leak severity may guide treatment decisions and improve future research. This study aimed to identify leak-related prognostic factors for mortality, and to develop a Severity of oEsophageal Anastomotic Leak (SEAL) score. METHODS: This international, retrospective cohort study in 71 centres worldwide included patients with AL after oesophagectomy between 2011 and 2019. The primary endpoint was 90-day mortality. Leak-related prognostic factors were identified after adjusting for confounders and were included in multivariable logistic regression to develop the SEAL score. Four classes of leak severity (mild, moderate, severe, and critical) were defined based on the risk of 90-day mortality, and the score was validated internally. RESULTS: Some 1509 patients with AL were included and the 90-day mortality rate was 11.7 per cent. Twelve leak-related prognostic factors were included in the SEAL score. The score showed good calibration and discrimination (c-index 0.77, 95 per cent c.i. 0.73 to 0.81). Higher classes of leak severity graded by the SEAL score were associated with a significant increase in duration of ICU stay, healing time, Comprehensive Complication Index score, and Esophagectomy Complications Consensus Group classification. CONCLUSION: The SEAL score grades leak severity into four classes by combining 12 leak-related predictors and can be used to the assess severity of AL after oesophagectomy.

Clinical implementation of pre-biopsy magnetic resonance imaging pathways for the diagnosis of prostate cancer.

OBJECTIVE: To assess the outcomes of pre-biopsy magnetic resonance imaging (MRI) pathways, as a tool in biopsy-naïve men with suspicion of prostate cancer, in routine clinical practice. Secondary outcomes included a comparison of transrectal MRI-directed biopsy (TR-MRDB) and transperineal (TP)-MRDB in men with suspicious MRI. PATIENTS AND METHODS: We retrospectively assessed a two-centre cohort of consecutive biopsy-naïve men with suspicion of prostate cancer who underwent a Prostate Imaging-Reporting and Data System version 2 (PI-RADS v2) compliant pre-biopsy MRI in a single, high-volume centre between 2015 and 2019 (Centre 1). Men with suspicious MRI scans underwent TR-MRDB in Centre 1 and TP-MRDB with additional random biopsies (RB) in Centre 2. The MRI and histopathology were assessed in the same institution (Centre 1). Outcomes included: (i) overall detection rates of Grade Group (GG) 1, GG ≥2, and GG ≥3 cancer in men with suspicious MRI; (ii) Biopsy-avoidance due to non-suspicious MRI; and (iii) Cancer detection rates and biopsy-related complications between TR- and TP-MRDB. To reduce confounding bias for MRDB comparisons, inverse probability weighting (IPW) was performed for age, digital rectal examination, prostate-specific antigen (PSA), prostate volume, PSA density, and PI-RADS category. RESULTS: Of the 2597 men included, the overall GG 1, GG ≥2, and GG ≥3 prevalence was 8% (210/2597), 27% (697/2597), and 15% (396/2597), respectively. Biopsy was avoided in 57% (1488/2597) of men. After IPW, the GG 1, GG ≥2 and GG ≥3 detection rates after TR- and TP-MRDB were comparable at 24%, 57%, and 32%; and 18%, 64%, and 38%, respectively; with mean differences of -5.7% (95% confidence interval [CI] -13% to 1.4%), 6.1% (95% CI -2.1% to 14%), and 5.7% (95% CI -1.7% to 13%). Complications were similar in TR-MRDB (0.50%) and TP-MRDB with RB (0.62%; mean difference 0.11%, 95% CI -0.87% to 1.1%). CONCLUSION: This high-volume, two-centre study shows pre-biopsy MRI as a decision tool is implementable in daily clinical practice. Compared to recent trials, a substantially higher biopsy avoidance rate was achieved without compromising GG ≥2/GG ≥3 detection and coinciding with lower over detection rates of GG 1 cancer. Prostate cancer detection and complication rates were comparable for TR- and TP-MRDB.