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OBJECTIVES: To compare oncological outcomes in patients with early-stage high-intermediate or high-risk endometrial cancer undergoing surgical staging by laparotomy, conventional laparoscopy, or robot-assisted laparoscopy. METHODS: Patients diagnosed between 2015 and 2021 with stage I-II (International Federation of Gynecology and Obstetrics 2009), high-intermediate or high-risk endometrial cancer who underwent staging surgery, were identified in the Netherlands Cancer Registry. Five-year disease-free survival and overall survival were calculated using the Kaplan-Meier method, and differences between groups were evaluated using log-rank testing. Additionally, survival analyses were stratified by histological subtype. The effect of surgical modality on risk of recurrence and all-cause death was assessed by performing Cox regression analysis with inverse probability treatment weighting. RESULTS: In total 941 patients met the inclusion criteria, of whom 399 (42.4%) underwent staging surgery by laparotomy, 273 (29.0%) by laparoscopy, and 269 (28.6%) by robot-assisted laparoscopy. Baseline characteristics were comparable between the three groups. No difference in disease-free survival (75.0% vs 71.2% vs 79.0% p=0.35) or overall survival (72.7% vs 72.3% vs 71.2% p=0.98) was observed between patients after laparotomy, laparoscopy, or robot-assisted laparoscopy, respectively. Subanalyses based on histological subtype showed comparable disease-free survival and overall survival between surgical approaches. After correcting for possible confounders by means of inverse probability treatment weighting, there was no significantly increased risk of recurrence or risk of all-cause death after laparoscopy or robot-assisted laparoscopy. CONCLUSION: Laparoscopic and robot-assisted laparoscopic staging surgery in women with early-stage high-intermediate or high-risk endometrial cancer are safe alternatives to laparotomic staging surgery.
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Monosodium methanearsonate (MSMA), a sodium salt of monomethylarsonic acid (MMA), is a selective contact herbicide used for the control of a broad spectrum of weeds. In water, MSMA dissociates to ions of sodium (Na+) and monomethylarsonate (MMA-) that is stable and does not transform abiotically. In soils characteristic of MSMA use, several simultaneous processes can occur: (1) microbial methylation of MMA to dimethylarsinic acid (DMA), (2) microbial demethylation of MMA to inorganic arsenic (iAs), (3) methylation of iAs to MMA, and (4) sorption and sequestration of MMA and its metabolites to soil minerals. Sequestered residues are residues that cannot be desorbed from soil in environmental conditions. Sequestration is rapid in the initial several days after MSMA application and continues at a progressively slower rate over time. Once sequestered, MMA and its metabolites are inaccessible to soil microorganisms and cannot be transformed. The rate and extent of the sorption and sequestration as well as the mobility of MMA and its metabolites depend on the local edaphic conditions. In typical MSMA use areas, the variability of the edaphic conditions is constrained. The goal of this research was to estimate the amount of iAs potentially added to drinking water as a result of the use of MSMA, with models and scenarios developed by the US Environmental Protection Agency for pesticide risk assessment. In this project, the estimated drinking water concentrations (EDWCs) for iAs were assessed as the average concentration in the reservoir over a 30-year simulation with annual applications of MSMA at maximum label rates. When the total area of suitable land was assumed to be treated, EDWCs ranged from <0.001 to 0.12 µg/L. When high estimates of actually treated acreage are considered, the EDWCs are below 0.06 µg/L across all scenarios. Integr Environ Assess Manag 2024;00:1-12. © 2024 The Author(s). Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC).
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OBJECTIVES: Multiple studies have proven the prognostic value of molecular classification for stage I-III endometrial cancer patients. However, studies on the relevance of molecular classification for stage IV endometrial cancer patients are lacking. Hypothetically, poor prognostic molecular subtypes are more common in higher stages of endometrial cancer. Considering the poor prognosis of stage IV endometrial cancer patients, it is questionable whether molecular classification has additional prognostic value. Therefore, we determined which molecular subclasses are found in stage IV endometrial cancer and if there is a correlation with progression-free and overall survival. METHODS: A retrospective multicenter cohort study was conducted using data from five Dutch hospitals. Patients with stage IV endometrial cancer at diagnosis who were treated with primary cytoreductive surgery or cytoreductive surgery after induction chemotherapy between January 2000 and December 2018 were included. Exclusion criteria were age <18 years or recurrent disease. The molecular classification was performed centrally on all tumor samples according to the World Health Organization 2020 classification (including POLE and estrogen receptor status). The Kaplan-Meier method was used to calculate progression free and overall survival in the molecular subclasses, for the different histological subtypes and for estrogen receptor positive versus estrogen receptor negative tumors. Groups were compared using the log-rank test. RESULTS: 164 stage IV endometrial cancer patients were molecularly classified. Median age of the patients was 67 years (range 33-86). Most patients presented with a non-endometrioid histological subtype (58%). Intra-abdominal complete cytoreductive surgery was achieved in 60.4% of the patients. 101 tumors (61.6%) were classified as p53 abnormal, 35 (21.3%) as no specific molecular profile, 21 (12.8%) as mismatch repair deficient, and 6 (3%) as POLE mutated. Molecular classification had no significant impact on progression free (p=0.056) or overall survival (p=0.12) after cytoreductive surgery. Overall survival was affected by histologic subtype (p<0.0001) and estrogen receptor status (p=0.013). CONCLUSION: The distribution of the molecular subclasses in stage IV endometrial cancer patients differed substantially from the distribution in stage I-III endometrial cancer patients, with the unfavorable subclasses being more frequently present. Although the molecular classification was not prognostic in stage IV endometrial cancer, it could guide adjuvant treatment decisions.
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Endometrial Neoplasms , Neoplasm Staging , Humans , Female , Endometrial Neoplasms/pathology , Endometrial Neoplasms/classification , Endometrial Neoplasms/mortality , Retrospective Studies , Middle Aged , Aged , Prognosis , Cohort Studies , Aged, 80 and over , Cytoreduction Surgical ProceduresABSTRACT
OBJECTIVE: To investigate the efficacy of imiquimod in women with residual or recurrent cervical intraepithelial neoplasia (rrCIN), compared with large loop excision of the transformation zone (LLETZ). DESIGN: Randomised controlled non-inferiority trial. SETTING: One academic and one regional hospital in the Netherlands. POPULATION: Thirty-five women with rrCIN were included in the study between May 2016 and May 2021. METHODS: Women were randomised to receive treatment with 5% imiquimod cream (12.5 mg) intravaginally (three times a week for a duration of 16 weeks) or a LLETZ procedure (standard treatment). MAIN OUTCOME MEASURES: The primary outcome was reduction to normal cytology at 6 months after starting treatment. Secondary outcomes were clearance of high-risk human papilloma virus (hr-HPV) in both groups and reduction to ≤CIN1 in the imiquimod group. Side effects were monitored. RESULTS: Treatment success was 33% (6/18) in the imiquimod group versus 100% (16/16) in the LLETZ group (P < 0.001), whereas HPV clearance was 22% (4/18) in the imiquimod group versus 88% (14/16) in the LLETZ group (P < 0.001). After the randomisation of 35 women, the futility of treatment with imiquimod was proven and the trial was prematurely finished. In the follow-up period, three patients remained without additional treatment, whereas all other patients underwent LLETZ, conisation or hysterectomy. In the LLETZ group none of the patients received additional treatment during 2 years of follow-up. CONCLUSIONS: This is the first randomised controlled trial to show that topical imiquimod has a significantly lower success rate in terms of reduction to normal cytology and hr-HPV clearance, compared with LLETZ, in women with rrCIN. Additionally, imiquimod has numerous side effects and after using imiquimod most women with rrCIN still required additional surgical treatment.
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Background: Endovascular techniques have gained preference over peripheral arterial bypass surgery due to their minimally invasive nature; however, endovascular treatments often show limited efficacy in arterial segments with a high atherosclerotic load. The use of atherectomy devices enables the removal of calcified plaque material and may promote arterial wall remodeling. This study assessed the technical success, safety, and feasibility of the BYCROSS® atherectomy device in femoropopliteal lesions. Methods: This single-center, retrospective cohort study analyzed elective patients undergoing BYCROSS® atherectomy for chronic peripheral arterial disease from March 2022 to May 2023. Patient data, procedural details, and outcomes were retrospectively collected from electronic patient records. The primary performance endpoints of this study were technical success, complications, and patency rates. Primary safety endpoints included 30-day and short-term major adverse limb events (MALEs), major adverse cardiovascular events (MACEs), and mortality rate. Results: The study included 19 patients (median age, 71 years; 63% male) with Fontaine class IIb (26%), III (21%), or IV (53%). The BYCROSS® atherectomy device was used to treat 22 limbs in the femoropopliteal tract, of which 11 lesions (50%) were occlusions and 11 were stenoses, with a median length of 24 cm (interquartile range: 17-38). Technical success was achieved in all cases: 4.5% required atherectomy only, 50% required additional balloon angioplasties, 41% required balloon angioplasties and stenting, and 4.5% required segments only stenting. Additional treatment of below-the-knee arteries was performed in 12 patients. Procedurally related complications (not limited to the use of the BYCROSS® device) occurred in 23% of limbs, including distal embolization and laceration. At 30 days, mortality was 5%, the MACE rate was 11%, and the MALE rate was 0%. The observed mortality rate was not directly related to the procedure. Patency (<50% restenosis at duplex ultrasound) was 83% at 30 days. Conclusions: The use of the BYCROSS® atherectomy device for the treatment of femoropopliteal lesions appears to be safe and feasible, with high technical success and low MALE and MACE rates in a challenging population with long-segment femoropopliteal lesions. Long-term follow-up in larger patient series is needed to confirm these findings and to determine the durability of this technique.
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The initial success and widespread adoption of endovascular aneurysm repair (EVAR) for the treatment of abdominal aortic aneurysms have been tempered by numerous reports of secondary interventions and increased long-term mortality compared with open repair. Over the past decade, several studies on postoperative sac dynamics after EVAR have suggested that the presence of sac regression is a benign feature with a favorable prognosis. Conversely, increasing sacs and even stable sacs can be indicators of more unstable sac behavior with worse outcomes in the long-term. Endoleaks were initially perceived as the main drivers of sac behavior. However, the observation that sac regression can occur in the presence of endoleaks, and vice versa - increasing sacs without evidence of endoleak - on imaging studies, suggests the involvement of other contributing factors. These factors can be divided into anatomical factors, patient characteristics, sac thrombus composition, and device-related factors. The shift of interest away from especially type 2 endoleaks is further supported by promising results with the use of EndoAnchors regarding postoperative sac behavior. This review provides an overview of the existing literature on the implications and known risk factors of post-EVAR sac behavior, describes the accurate measurement of sac behavior, and discusses the use of EndoAnchors to promote sac regression.
Subject(s)
Aortic Aneurysm, Abdominal , Blood Vessel Prosthesis Implantation , Endoleak , Endovascular Procedures , Humans , Aortic Aneurysm, Abdominal/surgery , Aortic Aneurysm, Abdominal/diagnostic imaging , Endovascular Procedures/adverse effects , Endovascular Procedures/instrumentation , Endoleak/etiology , Risk Factors , Treatment Outcome , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Prosthesis DesignABSTRACT
[This corrects the article DOI: 10.3389/fvets.2021.742877.].
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STUDY OBJECTIVES: Pelvic lymph node dissection (PLND) is part of the primary treatment for early-stage cervical cancer and high-intermediate risk or high-risk endometrial cancer. Pelvic lymphocele is a postoperative complication of PLND, and when symptomatic, lymphoceles necessitate treatment. The aim of this study was to investigate the incidence and risk factors of symptomatic lymphocele after robot-assisted laparoscopic PLND in cervical and endometrial cancer. DESIGN: Retrospective cohort study. SETTING: Single-center academic hospital. PATIENTS: Two hundred and fifty-eight patients with cervical cancer and 129 patients with endometrial cancer. INTERVENTIONS: Pelvic lymphadenectomy by robot-assisted laparoscopic surgery. MEASUREMENTS AND MAIN RESULTS: The authors retrospectively included all patients with early-stage cervical cancer and high-intermediate risk or high-risk endometrial cancer who underwent pelvic lymphadenectomy by robot-assisted laparoscopic surgery between 2008 and 2022. Medical records were reviewed for the occurrence of a symptomatic lymphocele. Univariate and multivariate logistic regression analyses were conducted to identify risk factors for developing a symptomatic lymphocele. In total, 387 patients, 258 with cervical cancer and 129 with endometrial cancer, were included in the study. The overall incidence of symptomatic lymphoceles was 9.6% with a median follow-up of 47 months [interquartile range 23-61]. For the entire cohort, smoking was the only significant risk factor for symptomatic lymphoceles identified in univariate (OR 2.47, 95% CI 1.19-5.11) and multivariate analysis (OR 2.42, 95% CI 1.16-5.07). For cervical cancer, body mass index (BMI) (OR 1.09, 95% CI 1.00-1.17) and prior abdominal surgery (OR 2.75, 95% CI 1.22-6.17) were also identified as significant independent risk factors. For endometrial cancer, age was identified as a significant independent risk factor (OR 0.90, 95% CI 0.83-0.97). CONCLUSION: This single-center cohort study demonstrated an incidence of almost 10% of symptomatic lymphoceles after robot-assisted laparoscopic PLND for cervical cancer and endometrial cancer, with a higher risk observed among patients who smoke at the time of diagnosis. Furthermore, risk factors differ between the 2 populations, necessitating further studies to establish risk models.
Subject(s)
Endometrial Neoplasms , Lymphocele , Robotics , Uterine Cervical Neoplasms , Female , Humans , Retrospective Studies , Lymphocele/epidemiology , Lymphocele/etiology , Uterine Cervical Neoplasms/surgery , Uterine Cervical Neoplasms/complications , Cohort Studies , Lymph Node Excision/adverse effects , Endometrial Neoplasms/surgery , Endometrial Neoplasms/complications , Pelvis/surgeryABSTRACT
PURPOSE: Limited research exists on translation of in-vitro glucose measurement interfering compounds to the in-vivo situation. We investigated whether Point-of-Care glucose measurements by Accu Chek Inform II (ACI II) were accurate to monitor glucose concentrations during surgery with general anesthesia by comparing with the reference laboratory hexokinase plasma glucose test. METHOD: Patients undergoing surgery with general anesthesia were included. Anesthesia was maintained with either Sevoflurane or Total intravenous anesthesia (TIVA). Prior to and after induction, blood glucose was measured with ACI II and the hexokinase test. Bland-Altman analysis was performed to assess method agreement. Subgroup analyses on glucose measurement differences per type of maintenance anesthesia were performed. RESULTS: Thirty-nine patients were included, and 78 measurements were performed. All paired measurements had clinically acceptable agreement with a percentage error of 10.0% (95% CI 8.0 to 11.9). The mean difference (95% limits of agreement) between ACI II and hexokinase for all measurements was 0.0 mmol/L (-0.7 to 0.7 mmol/L). Before induction (n = 39), mean difference was -0.1 mmol/L (-0.6 to 0.4 mmol/L), and after induction (n = 39), mean difference was 0.1 mmol/L (-0.8 to 0.9 mmol/L). Further investigation showed the difference varied per test for patients receiving Sevoflurane compared to patients receiving TIVA (-0.2 ± 0.4 mmol/L vs. 0.4 ± 0.3 mmol/L, p < 0.001). Before and after induction, the difference between ACI II and hexokinase measurements increased for patients receiving Sevoflurane compared to patients receiving TIVA (0.4 ± 0.4 mmol/L vs. -0.4 ± 0.3 mmol/L, p < 0.001). CONCLUSION: The agreement between glucose measurements using ACI II and the reference laboratory hexokinase test was clinically acceptable with a percentage error of 10.0% (95% CI 8.0 to 11.9). The use of TIVA may negatively affect the measurement performance of the ACI II.
Subject(s)
Anesthetics, Inhalation , Propofol , Humans , Sevoflurane , Hexokinase , Anesthesia, General , Blood Glucose/analysis , Cohort Studies , Anesthesia, Intravenous , Anesthetics, IntravenousABSTRACT
OBJECTIVE: To evaluate the effect on patient outcomes when introducing a novice robotic surgeon, trained in accordance with a structured learning curriculum, to an experienced robotic surgery team treating cervical cancer patients. METHODS: Patients with early-stage cervical cancer who were treated with primary robot-assisted surgery between 2007 and 2019 were retrospectively included. In addition to the 165 patients included in a former analysis, we included a further 61 consecutively treated patients and divided all 226 patients over three groups: early learning phase of 61 procedures without structured training (group 1), experienced phase of 104 procedures (group 2), and the 61 procedures during introduction of a novice with structured training (group 3). Risk-adjusted cumulative sum (RA-CUSUM) analysis was performed to assess the learning curve effect. Patient outcomes between the groups were compared. RESULTS: Based on RA-CUSUM analysis, no learning curve effect was observed for group 3. Regarding surgical outcomes, mean operation time in group 3 was significantly shorter than group 1 (p < 0.001) and similar to group 2 (p = 0.96). Proportions of intraoperative and postoperative adverse events in group 3 were not significantly different from the experienced group (group 2). Regarding oncological outcomes, the 5-year disease-free survival, disease-specific survival, and overall survival in group 3 were not significantly different from the experienced group. CONCLUSIONS: Introducing a novice robotic surgeon, who was trained in accordance with a structured learning curriculum, resulted in similar patient outcomes as by experienced surgeons suggesting novices can progress through a learning phase without compromising outcomes of cervical cancer patients.
Subject(s)
Laparoscopy , Robotic Surgical Procedures , Surgeons , Uterine Cervical Neoplasms , Female , Humans , Robotic Surgical Procedures/methods , Retrospective Studies , Uterine Cervical Neoplasms/surgery , Uterine Cervical Neoplasms/etiology , Cohort Studies , Learning Curve , Curriculum , Laparoscopy/methodsABSTRACT
This study aimed to establish baseline variables for calves transported by road and ferry from Ireland to the Netherlands and to investigate the effect of journey [two comparable journeys in April (J1) and May (J2) 2022] and source [source farm or mart (SF/MA)] on these variables. A total of 66 calves from the SF/MA were transported from Ireland to commercial veal farms in the Netherlands. Blood samples were collected at the SF/MA, assembly center (Ireland), lairage (France), and on arrival on the veal farm (Netherlands). They were analyzed for indicator variables related to energy balance, hydration/electrolytes, physical/muscular stress, immunity, and inflammation [glucose, beta-hydroxybutyrate (BHB), non-esterified fatty acids (NEFA), potassium, sodium, magnesium, chloride, urea, haematocrit, total protein, creatine kinase, L-lactate, cortisol, white blood cell, neutrophil, lymphocyte and monocyte counts, serum amyloid-A, and haptoglobin]. Health variables eye and nose discharge, skin tent (a measure of dehydration), and navel inflammation were scored by a trained observer, and calves were weighed at every blood-sampling time point. All blood variables and body weight changed significantly (P < 0.05) during transport, most notably between the assembly center and lairage. Reference ranges were available for 18 variables; 11 of these variables exceeded the reference ranges at the lairage, whilst 10 variables exceeded the reference ranges on arrival at the veal farm. However, health variables did not change during transport. A journey-to-journey comparison indicated much variation; 18 out of 25 variables differed significantly on at least one time point. In total, J1 calves experienced a more severe change in BHB, potassium, strong-ion-difference, L-lactate, and eye and nose discharge than J2 calves. The source of calves also affected their physiology; 12 out of 25 variables studied differed significantly, all of which were confined to the first time point. Specifically, MA calves had elevated levels of NEFA, urea, haematocrit, L-lactate, cortisol, white blood cell, neutrophil, and monocyte counts and lower levels of corrected chloride and lymphocyte count. Overall, calves in this study showed a generalized physiological disturbance beyond reference limits during long-distance transport, but no animal died during transport or for 3 weeks post-arrival.
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BACKGROUND: Small-cell carcinoma of the ovary, hypercalcemic type (SCCOHT) is a rare aggressive ovarian malignancy mainly affecting children, adolescents, and young adults. Since the discovery of mutations in the SMARCA4 gene in 2014, SCCOHT has become the subject of extensive investigation. However, international uniform treatment guidelines for SCCOHT are lacking and the outcome remains poor. The aim of this systematic review is to generate an overview of all reported patients with SCCOHT from 1990 onwards, describing the clinical presentation, genetic characteristics, treatment, and outcome. METHODS: A systematic search was performed in the databases Embase, Medline, Web of Science, and Cochrane for studies that focus on SCCOHT. Patient characteristics and treatment data were extracted from the included studies. Survival was estimated using Kaplan-Meier's methodology. To assess the difference between survival, the log-rank test was used. To quantify the effect of the FIGO stage, the Cox proportional hazard regression model was estimated. The chi-squared test was used to study the association between the FIGO stage and the surgical procedures. RESULTS: Sixty-seven studies describing a total of 306 patients were included. The median patient age was 25 years (range 1-60 years). The patients mostly presented with non-specific symptoms such as abdominal pain and sometimes showed hypercalcemia and elevated CA-125. A great diversity in the diagnostic work-up and therapeutic approaches was reported. The chemotherapy regimens were very diverse, all containing a platinum-based (cisplatin or carboplatin) backbone. Survival was strongly associated with the FIGO stage at diagnosis. CONCLUSIONS: SCCOHT is a rare and aggressive ovarian cancer, with a poor prognosis, and information on adequate treatment for this cancer is lacking. The testing of mutations in SMARCA4 is crucial for an accurate diagnosis and may lead to new treatment options. Harmonization and international collaboration to obtain high-quality data on diagnostic investigations, treatment, and outcome are warranted to be able to develop international treatment guidelines to improve the survival chances of young women with SCCOHT.
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OBJECTIVES: To evaluate whether a learning curve affects the bilateral sentinel lymph node (SLN) detection in early-stage cervical cancer. METHODS: All patients with FIGO (2018) stage IA1-IB2 or IIA1 cervical cancer who had undergone robot-assisted SLN mapping performed with a combination of preoperative technetium-99m nanocolloids (including preoperative imaging) and intraoperative blue dye were retrospectively included. Risk-adjusted cumulative sum (RA-CUSUM) analysis was used to determine if a learning curve based on bilateral SLN detection existed in this cohort. RESULTS: A total of 227 cervical cancer patients were included. In 98.2% of patients (223/227) at least one SLN was detected. The bilateral SLN detection rate was 87.2% (198/227). Except for age (OR 1.06 per year, 95%CI 1.02-1.09), no significant risk factors for non-bilateral SLN detection were found (e.g., prior conization, BMI or FIGO stage). The RA-CUSUM analysis showed no clear learning phase during the first procedures and cumulative bilateral detection rate remained at least 80% during the entire inclusion period. CONCLUSIONS: In this single-institution experience, we observed no learning curve affecting robot-assisted SLN mapping using a radiotracer and blue dye in early-stage cervical cancer patients, with stable bilateral detection rates of at least 80% when adhering to a standardized methodology.
Subject(s)
Robotics , Sentinel Lymph Node , Uterine Cervical Neoplasms , Female , Humans , Sentinel Lymph Node/diagnostic imaging , Sentinel Lymph Node/pathology , Sentinel Lymph Node/surgery , Sentinel Lymph Node Biopsy/methods , Uterine Cervical Neoplasms/diagnostic imaging , Uterine Cervical Neoplasms/surgery , Retrospective Studies , Neoplasm Staging , Lymph Nodes/diagnostic imaging , Lymph Nodes/surgery , Lymph Nodes/pathologyABSTRACT
PURPOSE: Endovascular revascularization is the preferred treatment to improve perfusion of the lower extremity in patients with chronic limb-threatening ischemia (CLTI). Patients with CLTI often present with stenotic-occlusive lesions involving the infrapopliteal arteries. Although the frequency of treating infrapopliteal lesions is increasing, the reintervention rates remain high. This study aimed to determine the outcomes and patency of infrapopliteal endovascular reinterventions. METHODS: This retrospective, multicenter cohort study of 3 Dutch hospitals included patients who underwent an endovascular infrapopliteal reintervention in 2015 up to 2021 after a primary infrapopliteal intervention for CLTI. The outcome measures after the reintervention procedures included technical success rate, the mortality rate and complication rate (any deviation from the normal postinterventional course) at 30 days, overall survival, amputation-free survival (AFS), freedom from major amputation, major adverse limb event (MALE), and recurrent reinterventions (a reintervention following the infrapopliteal reintervention). Cox proportional hazard models were used to determine risk factors for AFS and freedom from major amputation or recurrent reintervention. RESULTS: Eighty-one patients with CLTI were included. A total of 87 limbs underwent an infrapopliteal reintervention in which 122 lesions were treated. Technical success was achieved in 99 lesions (81%). The 30-day mortality rate was 1%, and the complication rate was 13%. Overall survival and AFS at 1 year were 69% (95% confidence interval [CI], 55%-79%) and 54% (95% CI, 37%-67%), respectively, and those at 2.5 years were 45% (95% CI, 33%-56%) and 21% (95% CI, 11%-33%), respectively. Freedom from major amputation, MALE, and recurrent reinterventions at 1 year and 2.5 years were 59% (95% CI, 46%-70%) and 41% (95% CI, 25%-56%); 54% (95% CI, 41%-65%) and 36% (95% CI, 21%-51%); and 68% (95% CI, 55%-78%) and 51% (95% CI, 33%-66%), respectively. A Global Limb Anatomic Staging System score of III showed an increased hazard ratio of 2.559 (95% CI, 1.078-6.072; p=0.033) for freedom of major amputation or recurrent reintervention. CONCLUSIONS: The results of this study indicate that endovascular infrapopliteal reinterventions can be performed with acceptable 30-day mortality and complication rates. However, outcomes and patency were moderate to poor, with low AFS, high rates of major amputations, and recurrent reinterventions. CLINICAL IMPACT: This multicenter retrospective study evaluating outcome and patency of endovascular infrapopliteal reinterventions for CLTI, shows that endovascular infrapopliteal reinterventions can be performed with acceptable 30-day mortality and complication rates. However, the short- and mid-term outcomes of the infrapopliteal reinterventions were moderate to poor, with low rates of AFS and a high need for recurrent reinterventions. While the frequency of performing infrapopliteal reinterventions is increasing with additional growing complexity of the disease, alternative treatment options such as venous bypass grafting or deep venous arterialization may be considered and should be studied in randomized controlled trials.
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BACKGROUND: To compare outcomes between different strategies of perioperative cerebral and hemodynamic monitoring during carotid endarterectomy. DATA SOURCES: MEDLINE, EMBASE, CINAHL, and Cochrane CENTRAL databases were searched. METHODS: This review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and prospectively registered in the international prospective register of systematic reviews (CRD42021241891). The Grading of Recommendations, Assessment, Development and Evaluation approach was used to describe the methodological quality of the studies and certainty of the evidence. The primary outcome was 30-day stroke rate. Secondary outcomes measures are 30-day ipsilateral stroke, 30-day mortality, shunt rate, and complication rates. RESULTS: The search identified 3,460 articles. Seventeen randomized controlled trials (RCTs), three prospective observational studies and seven registries were included, reporting on 236,983 patients. The overall pooled 30-day stroke rate is 1.8% (95% CI 1.4-2.2%), ranging from 0 to 12.6%. In RCT's the pooled 30-day stroke rate is 2.7% (95% CI 1.6-3.7%) compared to 1.3% (95% CI 0.8-1.8%) in the registries. The overall stroke risk decreased from 3.7% before the year 2000 to 1.6% after 2000. No significant differences could be identified between different monitoring and shunting strategies, although a trend to higher stroke rates in routine no shunting arms of RCTs was observed. Overall, 30-day mortality, myocardial infarction and nerve injury rates are 0.6% (95% CI 0.4-0.8), 0.8% (95% CI 0.6-1.0) and 1.3% (95% CI 0.4-2.2), respectively. CONCLUSIONS: No significant differences between the compared shunting and monitoring strategies are found. However, routine no shunting is not recommended. The available data are too limited to prefer 1 method of neuromonitoring over another method when selective shunting is applied.
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Endarterectomy, Carotid , Hemodynamic Monitoring , Myocardial Infarction , Stroke , Humans , Hemodynamic Monitoring/adverse effects , Treatment Outcome , Stroke/etiology , Observational Studies as TopicABSTRACT
In addition to the respiratory compromise typical for COVID-19 many papers reported on the thromboembolic complications in these often critically ill patients. In this report, three cases of patients that developed spontaneous major bleeding following treatment with therapeutic anticoagulation for thromboembolic complications of COVID-19 were described. Two cases were treated with coil-embolization and one patient could be treated conservatively. These cases illustrate the presence of a relevant bleeding risk against the background of the well-known thromboembolic complications associated with COVID-19. The increased risks of thromboembolic complications in COVID-19 warrant adequate prophylactic anticoagulation. The optimal dose to obtain a significant risk reduction without a significant increase in the incidence of major bleeding requires further research.
Subject(s)
COVID-19 , Humans , SARS-CoV-2 , Hemorrhage/etiology , Hemorrhage/therapy , Blood Coagulation , Anticoagulants/therapeutic useABSTRACT
BACKGROUND: There is a growing need for genetic testing of women with epithelial ovarian cancer. Mainstream genetic testing provides an alternative care pathway in which non-genetic healthcare professionals offer pre-test counseling themselves. We aimed to explore the impact of mainstream genetic testing on patients' experiences, turnaround times and adherence of non-genetic healthcare professionals to the mainstream genetic testing protocol. METHODS: Patients receiving pre-test counseling at the gynecology departments between April 2018 and April 2020 were eligible to participate in our intervention group. Patients receiving pre-test counseling at the genetics department between January 2017 and April 2020 were eligible to participate in our control group. We evaluated patients' experiences with questionnaires, consisting of questions regarding knowledge, satisfaction and psychosocial outcomes. Patients in the intervention group were sent two questionnaires: one after pre-test counseling and one after receiving their DNA test result. Patients in our control group were sent one questionnaire after receiving their test result. In addition, we collected data regarding turnaround times and adherence of non-genetic healthcare professionals to the mainstream genetic testing protocol. RESULTS: Participation was 79% in our intervention group (105 out of 133 patients) and 60% in our control group (91 out of 152 patients). Knowledge regarding genetics, decisional conflict, depression, anxiety, and distress were comparable in the two groups. In the intervention group, the risk of breast cancer in patients carrying a pathogenic germline variant was discussed less often (49% versus 74% in control group, p ≤ 0.05), and the mean score of regret about the decision to have genetic testing was higher than in the control group (mean 12.9 in the intervention group versus 9.7 in the control group, p ≤ 0.05), although below the clinically relevant threshold of 25. A consent form for the DNA test and a checklist to assess family history were present for ≥ 95% of patients in the intervention group. CONCLUSION: Mainstream genetic testing is an acceptable approach to meet the increase in genetic testing among women with epithelial ovarian cancer.
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INTRODUCTION: Nowadays, two predominant methods for detecting sentinel lymph nodes (SLNs) in cervical cancer are in use. The most conventional method is a combination of a radiotracer, technetium-99m (99mTc) and blue dye. More recently, another method for SLN mapping using indocyanine green (ICG) is becoming widely accepted. ICG is a fluorescent dye, visualised intraoperatively with near-infrared (NIR) fluorescence imaging, providing real-time visual navigation. The presumed advantages of ICG over 99mTc, that is, being cheaper, non-radioactive and logistically more attractive, are only valuable if its detection rate proves to be at least non-inferior. Before omitting the well-functioning and evidence-based combined approach of 99mTc and blue dye, we aim to provide prospective evidence on the non-inferiority of ICG with NIR fluorescence imaging. METHODS AND ANALYSIS: We initiated a prospective non-inferiority study with a paired comparison of both SLN methods in a single sample of 101 patients with International Federation of Gynecology and Obstetrics (FIGO) stage IA-IB2 or IIA1 cervical cancer receiving primary surgical treatment. All patients undergo SLN mapping with ICG and NIR fluorescence imaging in adjunct to mapping with 99mTc (including single photon emission computed tomography with X-ray computed tomography (SPECT/CT)) and blue dye. Surgeons start SLN detection with ICG while being blinded for the preoperative outcome of SPECT/CT to avoid biased detection with ICG. Primary endpoint of this study is bilateral SLN detection rate of both methods (ie, detection of at least one SLN in each hemipelvis). Since we compare strategies for SLN mapping that are already applied in current daily practice for different types of cancer, no additional risks or burdens are expected from these study procedures. ETHICS AND DISSEMINATION: The current study is approved by the Medical Ethics Research Committee Utrecht (reference number 21-014). Findings arising from this study will be disseminated in peer-reviewed journals, academic conferences and through patient organisations. TRIAL REGISTRATION NUMBER: NL9011 and EudraCT 2020-005134-15.
Subject(s)
Lymphadenopathy , Sentinel Lymph Node , Uterine Cervical Neoplasms , Coloring Agents , Female , Humans , Indocyanine Green , Prospective Studies , Sentinel Lymph Node/diagnostic imaging , Sentinel Lymph Node/pathology , Sentinel Lymph Node/surgery , Sentinel Lymph Node Biopsy/methods , Technetium , Uterine Cervical Neoplasms/diagnostic imaging , Uterine Cervical Neoplasms/pathology , Uterine Cervical Neoplasms/surgeryABSTRACT
A longitudinal study was performed to investigate the prevalence of Extended-Spectrum Cephalosporin-Resistant (ESC-R) Escherichia coli colonization in Dutch veal farms. Rectal swabs from 683 calves born in 13 Dutch dairy farms were collected one day prior to transportation to the veal farm at 14 or 28 days of age, and at 5 different time points 8 Dutch veal farms. In addition, characteristics of the calf, cows, and farm management were collected. Rectal swabs were selectively cultured for ESC-R E. coli. In total, 1202 ESC-R E. coli isolates were recovered. Overall, the prevalence of ESC-R E. coli increased from 24.4 % at one day prior to transportation to 57.3 % in week two after arrival of calves at the veal farm. No associations were found between the presence of ESC-R E. coli at the dairy or veal farm and age of transportation, sex and breed. The presence of ESC-R E. coli in week 6, 10, and 18 at the veal farm was positively associated with the presence of ESC-R E. coli in week 10, 18, and 24, respectively (pâ¯<â¯0.05). Individual antibiotic treatments applied before week 2 and 6 upon arrival to the veal farms tended to increase the ESC-R E. coli colonization frequency. Our results indicate that ESC-R E. coli colonization frequency substantially increases after arrival of calves on the veal farm. In addition to individual antibiotic treatments, it is considered likely that frequently applied batch antibiotic treatments are also implicated in the ESC-R E. coli colonization frequency.