Novara G.,University of Padua |
Catto J.W.F.,University of Sheffield |
Wilson T.,City of Hope National Cancer Center Duarte |
Annerstedt M.,Herlev University Hospital |
And 8 more authors.
European Urology | Year: 2015
Context Although open radical cystectomy (ORC) is still the standard approach, laparoscopic radical cystectomy (LRC) and robot-assisted radical cystectomy (RARC) have gained popularity. Objective To report a systematic literature review and cumulative analysis of perioperative outcomes and complications of RARC in comparison with ORC and LRC. Evidence acquisition Medline, Scopus, and Web of Science databases were searched using a free-text protocol including the terms robot-assisted radical cystectomy or da Vinci radical cystectomy or robot∗ radical cystectomy. RARC case series and studies comparing RARC with either ORC or LRC were collected. Cumulative analysis was conducted. Evidence synthesis The searches retrieved 105 papers. According to the different diversion type, overall mean operative time ranged from 360 to 420 min. Similarly, mean blood loss ranged from 260 to 480 ml. Mean in-hospital stay was about 9 d for all diversion types, with consistently high readmission rates. In series reporting on RARC with either extracorporeal or intracorporeal conduit diversion, overall 90-d complication rates were 59% (high-grade complication: 15%). In series reporting RARC with intracorporeal continent diversion, the overall 30-d complication rate was 45.7% (high-grade complication: 28%). Reported mortality rates were ≤3% for all diversion types. Comparing RARC and ORC, cumulative analyses demonstrated shorter operative time for ORC, whereas blood loss and in-hospital stay were better with RARC (all p values <0.003). Moreover, 90-d complication rates of any-grade and 90-d grade 3 complication rates were lower for RARC (all p values <0.04), whereas high-grade complication and mortality rates were similar. Conclusions RARC can be performed safely with acceptable perioperative outcome, although complications are common. Cumulative analyses demonstrated that operative time was shorter with ORC, whereas RARC may provide some advantages in terms of blood loss and transfusion rates and, more limitedly, for postoperative complication rates over ORC and LRC. Patient summary Although open radical cystectomy (RC) is still regarded as a standard treatment for muscle-invasive bladder cancer, laparoscopic and robot-assisted RC are becoming more popular. Robotic RC can be safely performed with acceptably low risk of blood loss, transfusion, and intraoperative complications; however, as for open RC, the risk of postoperative complications is high, including a substantial risk of major complication and reoperation. © 2014 European Association of Urology.
De Mulder M.,Medisch Centrum Alkmaar |
De Mulder M.,Erasmus University Rotterdam |
Gitt A.,Herzzentrum Ludwigshafen |
Van Domburg R.,Erasmus University Rotterdam |
And 10 more authors.
European Heart Journal | Year: 2011
AimsThe applicability of currently available risk prediction models for patients undergoing percutaneous coronary interventions (PCIs) is limited. We aimed to develop a model for the prediction of in-hospital mortality after PCI that is based on contemporary and representative data from a European perspective. Methods and resultsOur analyses are based on the Euro Heart Survey of PCIs, which contains information on 46 064 consecutive patients who underwent PCI for different indications in 176 participating European centres during 200508. Patients were randomly divided into a training (n = 23 032) and a validation (n = 23 032) set with similar characteristics. In these sets, 339 (1.5) and 305 (1.3) patients died during hospitalization, respectively. On the basis of the training set, a logistic model was constructed that related 16 independent patient or lesion characteristics with mortality, including PCI indication, advanced age, haemodynamic instability, multivessel disease, and proximal LAD disease. In both the training and validation data sets, the model had a good performance in terms of discrimination (C-index 0.91 and 0.90, respectively) and calibration (HosmerLemeshow P-value 0.39 and 0.18, respectively). Conclusion In-hospital mortality in PCI patients was well predicted by a risk score that contains 16 factors. The score has strong applicability for European practices. © 2011 The Author.
Willems E.,Imelda Hospital |
Smismans A.,Imelda Hospital |
Cartuyvels R.,Jessa Hospital |
Coppens G.,ZOL |
And 3 more authors.
Diagnostic Microbiology and Infectious Disease | Year: 2012
Bloodstream infections remain a major challenge in medicine. Optimal detection of pathogens is only possible if the quality of preanalytical factors is thoroughly controlled. Since the laboratory is responsible for this preanalytical phase, the quality control of critical factors should be integrated in its quality control program. The numerous recommendations regarding blood culture collection contain controversies. Only an unambiguous guideline permits standardization and interlaboratory quality control. We present an evidence-based concise guideline of critical preanalytical determinants for blood culture collection and summarize key performance indicators with their concomitant target values. In an attempt to benchmark, we compared the true-positive rate, contamination rate, and collected blood volume of blood culture bottles in 5 Belgian hospital laboratories. The true-positive blood culture rate fell within previously defined acceptation criteria by Baron et al. (2005) in all 5 hospitals, whereas the contamination rate exceeded the target value in 4 locations. Most unexpected, in each of the 5 laboratories, more than one third of the blood culture bottles were incorrectly filled, irrespective of the manufacturer of the blood culture vials. As a consequence of this shortcoming, one manufacturer recently developed an automatic blood volume monitoring system. In conclusion, clear recommendations for standardized blood culture collection combined with quality control of critical factors of the preanalytical phase are essential for diagnostic blood culture improvement. © 2012 Elsevier Inc.
Vijverman A.-C.,Onze Lieve Vrouw Hospital |
Fox S.H.,University of Toronto
Expert Review of Clinical Pharmacology | Year: 2014
Levodopa remains the most potent drug to treat motor symptoms in Parkinson's disease (PD); however, motor fluctuations and levodopa-induced dyskinesia that occur with long-term use restrict some of its therapeutic value. Despite these limitations, the medical treatment of PD strives for continuous relief of symptoms using different strategies throughout the course of the illness: increasing the half-life of levodopa, using 'levodopa-sparing agents' and adding non-dopaminergic drugs. New options to 'improve' delivery of levodopa are under investigation, including long-acting levodopa, nasal inhalation and continuous subcutaneous or intrajejunal administration of levodopa. Long-acting dopamine agonists were recently developed and are undergoing further comparative studies to investigate potential superiority over the immediate-release formulations. Non-dopaminergic drugs acting on adenosine receptors, cholinergic, adrenergic, serotoninergic and glutamatergic pathways are newly developed and many are being evaluated in Phase II and Phase III trials. This article focuses on promising novel therapeutic approaches for the management of PD motor symptoms and motor complications. We will provide an update since 2011 on new formulations of current drugs, new drugs with promising results in Phase II and Phase III clinical trials, old drugs with new possibilities and some new potential strategies that are currently in Phase I and II of development (study start date may precede 2011 but are included as study is still ongoing or full data have not yet been published). Negative Phase II and Phase III clinical trials published since 2011 will also be briefly mentioned. © Informa UK, Ltd.
Ploumidis A.,Onze Lieve Vrouw Hospital |
Spinoit A.-F.,Onze Lieve Vrouw Hospital |
Spinoit A.-F.,Ghent University |
Naeyer G.D.,Onze Lieve Vrouw Hospital |
And 8 more authors.
European Urology | Year: 2014
Background Pelvic organ prolapse (POP) represents a common female pelvic floor disorder that has a serious impact on quality of life. Several types of procedures with different surgical approaches have been described to correct these defects, but the optimal management is still debated. Objective To describe our surgical technique of robot-assisted sacrocolpopexy (RASC) for POP and to assess its safety and long-term outcomes. Design, setting, and participants A retrospective review of the medical records of 95 consecutive patients who underwent RASC for POP at our centre from April 2006 to December 2011 was performed. Surgical procedure RASC with use of polypropylene meshes was performed in all cases using a standardised technique with the da Vinci Surgical System (Intuitive Surgical, Sunnyvale, CA, USA) in a four-arm configuration. Outcome measurements and statistical analysis Clinical data were collected in a dedicated database. Intraoperative variables, postoperative complications, and outcomes of RASC were assessed. A descriptive statistical analysis was performed. Results and limitations Median operative time was 101 min. No conversion to open surgery was needed. One vaginal and two bladder injuries occurred and were repaired intraoperatively. Only one Clavien grade 3 postoperative complication was observed (bowel obstruction treated laparoscopically). At a median follow-up of 34 mo, persistent POP was observed in four cases (4.2%). One mesh erosion occurred and required robot-assisted removal of the mesh. Ten (10.5%) patients complained de novo urgency after RASC, which resolved in the first few weeks after surgery. No significant de novo bowel or sexual symptoms were reported. Conclusions Our technique of RASC for correction of POP is safe and effective, with limited risk of complications and good long-term results in the treatment of all types of POP. The robotic surgical system facilitates precise and accurate placement of the meshes with short operative time, thereby favouring wider diffusion of minimally invasive treatment of POP. Patient summary We studied the treatment of patients with vaginal prolapse by using a robot-assisted surgical technique to fix the vaginal wall with a synthetic mesh. This technique was found to be safe and effective, with limited risk of complications and good long-term results. © 2013 European Association of Urology. Published by Elsevier B.V. All rights reserved.
Rice T.W.,Vanderbilt University |
Wheeler A.P.,Vanderbilt University |
Bernard G.R.,Vanderbilt University |
Vincent J.-L.,Free University of Colombia |
And 10 more authors.
Critical Care Medicine | Year: 2010
Objective: To evaluate whether TAK-242, a small-molecule inhibitor of Toll-like receptor-4-mediated signaling, suppresses cytokine levels and improves 28-day all-cause mortality rates in patients with severe sepsis. Design: Randomized, double-blind, placebo-controlled trial. Setting: A total of 93 intensive care units worldwide. Patients: A total of 274 patients with severe sepsis and shock or respiratory failure. Interventions: Patients were randomly assigned to receive a 30-min loading dose followed by 96-hr infusions of placebo, TAK-242 1.2 mg/kg/day, or TAK-242 2.4 mg/kg/day. Measurements and Main Results: The primary pharmacodynamic end point was change in serum interleukin-6 levels relative to baseline, with 28-day all-cause mortality rate the primary clinical end point. The trial was terminated because of a lack of effect of TAK-242 in suppressing serum interleukin-6 levels. A total of 274 subjects were randomly assigned and treated. Clinical parameters at baseline were balanced across the three groups. TAK-242 did not suppress interleukin-6 as measured by 0-to 96.5-hr area under the interleukin-6 concentration curve at either dose. Specifically, the area under the effect curve increased by 9% and 26.9% in the TAK-242 1.2 and 2.4 mg/kg/day groups, respectively, which was not statistically different from placebo (p =.63 and.15, respectively). The 28-day mortality rate was 24% in the placebo, 22% in the low-dose, and 17% in the high-dose group (p =.26 for placebo vs. high dose). A nonsignificant reduction in mortality rate was observed in a subset of patients with both shock and respiratory failure (placebo [n = 51], 33%, vs. high dose [n = 52], 19%, p =.10). Transient, dose-related increases in methemoglobin levels were observed with TAK-242 treatment in 30.1% of the patients. Conclusions: TAK-242 failed to suppress cytokine levels in patients with sepsis and shock or respiratory failure. Treatment with TAK-242 resulted in mild increases in serum methemoglobin levels but was otherwise well tolerated. Although observed mortality rates in patients with both shock and respiratory failure were lower with the 2.4 mg/kg/day dose, differences were not significant. © 2010 by the Society of Critical Care Medicine and Lippincott Williams & Wilkins.
Mangiacapra F.,Biomedical University of Rome |
Mangiacapra F.,Onze Lieve Vrouw Hospital |
Barbato E.,Onze Lieve Vrouw Hospital |
Patti G.,Biomedical University of Rome |
And 6 more authors.
JACC: Cardiovascular Interventions | Year: 2010
Objectives: We sought to evaluate the influence of platelet reactivity after clopidogrel, as assessed by the VerifyNow point-of-care assay (Accumetrics, San Diego, California), on myonecrosis in low-to-intermediate risk patients undergoing percutaneous coronary intervention (PCI). Background: Inadequate platelet inhibition at the time of PCI is associated with a higher risk of recurrent ischemic events. Methods: A total of 250 consecutive biomarker-negative patients treated with clopidogrel and undergoing elective PCI were enrolled. Cardiac biomarkers (creatine kinase-myocardial band and troponin I) were measured before and 8 and 24 h after intervention. Platelet reactivity after clopidogrel was assessed immediately before PCI by the VerifyNow P2Y12 point-of-care assay. High platelet reactivity (HPR) after clopidogrel was defined as a platelet reaction unit value ≥240. Results: Patients with HPR (31% of the overall population) showed more frequent myonecrosis, with statistical significance with regard to creatine kinase-myocardial band elevation (35% vs. 20%; p = 0.011), and by trend with regard to troponin-I elevation (47% vs. 35%; p = 0.059). Incidence of periprocedural myocardial infarction was higher in patients with HPR, both by creatine kinase-myocardial band (13% vs. 4%; p = 0.011) and troponin-I definition (32% vs. 19%; p = 0.019). By multivariable analysis, HPR was an independent predictor of periprocedural myocardial infarction. Conclusions: Easily assessed by a point-of-care assay, HPR after clopidogrel is a frequent finding and is associated with increased risk of myonecrosis in low-to-intermediate risk patients undergoing planned PCI. © 2010 American College of Cardiology Foundation.
Volpe A.,Onze Lieve Vrouw Hospital |
Volpe A.,University of Piemonte Orientale |
Ahmed K.,King's College London |
Dasgupta P.,King's College London |
And 6 more authors.
European Urology | Year: 2015
Background The development of structured and validated training curricula is one of the current priorities in robot-assisted urological surgery. Objective To establish the feasibility, acceptability, face validity, and educational impact of a structured training curriculum for robot-assisted radical prostatectomy (RARP), and to assess improvements in performance and ability to perform RARP after completion of the curriculum. Design, setting, and participants A 12-wk training curriculum was developed based on an expert panel discussion and used to train ten fellows from major European teaching institutions. The curriculum included: (1) e-learning, (2) 1 wk of structured simulation-based training (virtual reality synthetic, animal, and cadaveric platforms), and (3) supervised modular training for RARP. Outcome measurements and statistical analysis The feasibility, acceptability, face validity, and educational impact were assessed using quantitative surveys. Improvement in the technical skills of participants over the training period was evaluated using the inbuilt validated assessment metrics on the da Vinci surgical simulator (dVSS). A final RARP performed by fellows on completion of their training was assessed using the Global Evaluative Assessment of Robotic Skills (GEARS) score and generic and procedure-specific scoring criteria. Results and limitations The median baseline experience of participants as console surgeon was 4 mo (interquartile range [IQR] 0-6.5 mo). All participants completed the curriculum and were involved in a median of 18 RARPs (IQR 14-36) during modular training. The overall score for dVSS tasks significantly increased over the training period (p < 0.001-0.005). At the end of the curriculum, eight fellows (80%) were deemed able by their mentors to perform a RARP independently, safely, and effectively. At assessment of the final RARP, the participants achieved an average score ≥4 (scale 1-5) for all domains using the GEARS scale and an average score >10 (scale 4-16) for all procedural steps using a generic dedicated scoring tool. In performance comparison using this scoring tool, the experts significantly outperformed the fellows (mean score for all steps 13.6 vs 11). Conclusions The European robot-assisted urologic training curriculum is acceptable, valid, and effective for training in RARP. Patient summary This study shows that a 12-wk structured training program including simulation-based training and mentored training in the operating room allows surgeons with limited robotic experience to increase their robotic skills and their ability to perform the surgical steps of robot-assisted radical prostatectomy. © 2014 European Association of Urology.
Foubert L.A.,Onze Lieve Vrouw Hospital |
Lecomte P.V.,Onze Lieve Vrouw Hospital |
Nobels F.R.,Onze Lieve Vrouw Hospital |
Gulino A.M.,Edwards Lifesciences |
De Decker K.H.,Onze Lieve Vrouw Hospital
Diabetes Technology and Therapeutics | Year: 2014
Background: A feasibility version of the GlucoClear™ continuous glucose monitoring system (Edwards Lifesciences, Irvine, CA), the intravenous blood glucose (IVBG) system, developed to facilitate glycemic management, was evaluated. Materials and Methods: Two pilot studies were conducted. Ten volunteers with diabetes (1,725 matched pairs) and 10 patients scheduled for intensive care unit (ICU) admission following surgery (1,393 matched pairs) were studied. The patients' blood glucose concentrations were monitored by the IVBG system every 5min for up to 72h. The accuracy of the IVBG system was calculated and compared with the Yellow Springs Instrument (YSI) (Yellows Springs, OH) and Radiometer (Copenhagen, Denmark) measurements to determine the percentage of matched pairs that met 15/20%, 10/15%, 12/12.5%, and 10/10% assessment criteria. Performance was calculated as the percentage of the total measurements that would have been displayed in an unblinded study. Adverse events were monitored. Results: The accuracy of the IVBG system met the International Organization for Standardization ISO 15197 15/20% criterion (99.07% in volunteers, 99.43% in the ICU, and both vs. YSI) and the stricter 10/15% criterion (96.17% in volunteers, 96.77% in the ICU, and both vs. YSI) over the 72-h period and across a broad range of blood glucose concentrations. Performance was 89.97% in the ICU study. The adverse device effects included induration of the peripheral vein, mild bruising, and mild hematoma. In the volunteers, there were patency problems with six catheters. Conclusions: The IVBG system is safe, accurate, and reliable. This minimally invasive system was not affected by potentially interfering medications. Real-time measurements, alarms, and trends provided by the IVBG system might support glycemic control protocols and prevent glycemic events in critically ill patients. © Mary Ann Liebert, Inc. 2014.
Collins J.W.,Karolinska University Hospital |
Verhagen H.,University of Stockholm |
Mottrie A.,Onze Lieve Vrouw Hospital |
Wiklund P.N.,Karolinska University Hospital
European Urology | Year: 2015
Take Home Message Internet-based video-streaming enables us to share surgical knowledge and to study leading surgeons while they operate in their home institutions, and is widely accessible to trainees. Planned developments include enriched learning experiences with improved user friendliness, interactivity, and real-time feedback. © 2015 European Association of Urology.