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Purpose: Syndesmotic screw removal following acute syndesmotic injury is a commonly performed procedure. However, recent studies suggest that the removal does not result in improved patient reported outcome, while the procedure has proved not to be without complications. The aim of this study was to present a health-economic evaluation of on-demand removal (ODR) compared to routine removal (RR) of the syndesmotic screw. Methods: Data were collected from the RODEO trial, a randomized controlled non-inferiority trial comparing functional outcome of ODR with RR. Economic evaluation resulted in total costs, costs (in Euro) per quality adjusted life year (QALY) and costs per point improvement on the Olerud Molander Ankle Score (OMAS). This included both direct and indirect costs. Results: Total costs for ODR were significantly lower with a mean difference of 3160 euro compared to RR (p < 0.001). The difference in QALY was not significant. The difference in OMAS at 12 months was 1.79 with an incremental cost-effectiveness ratio (ICER) of €-1763 (p = 0.512). The ICER was well below the willingness to pay. Although unit costs might vary between hospitals and countries, these results provide relevant data of cost-effectiveness. Conclusion: The clinical effectiveness of both ODR and RR can be considered equal. The costs are lower for patients treated with ODR, which leads to the conclusion that ODR is cost-effective. [ABSTRACT FROM AUTHOR]

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Abstract Background Radiographic healing is a common outcome measure in orthopedic trials and adjudication by outcome assessors is often conducted on the basis of plain films alone. The degree to which this process reflects clinical practice, in which both plain films and clinical notes are available, is uncertain. We explored the effect of adding clinical notes to radiographs in the adjudication process of a feasibility trial of tibial shaft fractures. Methods Radiographic and clinical data from a multicenter randomized controlled trial of 51 patients with operatively treated tibial fractures formed the basis of the study data. At the completion of the trial, serial radiographs (anteroposterior and lateral) were independently evaluated for progression of fracture healing, defined as bridging of at least 3 of 4 cortices, by an adjudication committee comprised of 3 blinded orthopaedic trauma surgeons. Immediately after determination of radiographic time to healing, each surgeon was provided with clinical notes associated with each radiographic follow up visit and asked to re-visit their initial impression. Consensus was achieved for both adjudications. We calculated the percentage of time to healing consensus decisions that changed after evaluation of clinical notes. We further examined the contents of clinical notes and their relative influence on the committee's decisions. Results 47 of 51 patients were determined to have healed radiographically during the trial follow-up period, and consideration of clinical notes resulted in a change of 40% (19 of 47) of time to healing consensus decisions; however, revised decisions were equally likely to support an earlier or a later time to healing. Clinical notes that resulted in a change to either a 'healed' or a 'not healed' decision contained significantly more comments of either pain resolution or deterioration, respectively, resumption of or failure to resume weightbearing, or either return or no return to work/pre-injury activities (p < 0.001). Conclusions The addition of clinical notes to the adjudication of radiographic fracture healing changed the outcome decision in a substantial number of cases. Orthopedic trialists should consider the addition of clinical notes to adjudication material in studies of fracture healing in order to enhance the generalizability of their results. Trial Registration The TRUST trial was registered [ID NCT00667849] at http://clinicaltrials.gov/ct2/show/NCT00667849

The city of Amsterdam is going to build a new housing estate: IJburg. About 18,000 houses will be built and finally 45,000 people will live in IJburg. An important objective is to realize a sustainable housing estate: the design is focused on water and energy saving, and theuse of sustainable building materials. An alternative water supply system, in which household water is used besides drinking water, may be an important contribution to this ambition. Household water can be used for toilet flushing, for washing clothes or for both. Amsterdam Water Supply developed five scenarios for such an alternative water supply system. Water saving and supply of two types of water are key elements in these scenarios. Based on a comprehensive selection in which public health aspects, technical feasibility, legislation, acceptance by the public, costs and environmental impact were used as criteria, the optimum scenario was chosen: a dual water system, supplying drinking water from the existing drinking water production plants, andsupplying household water for toilet flushing and washing, produced from a local surface water, the IJ-lake. [ABSTRACT FROM AUTHOR]

Importance: Following clean (class I, not contaminated) surgical procedures, the rate of surgical site infection (SSI) should be less than approximately 2%. However, an infection rate of 12.2% has been reported following removal of orthopedic implants used for treatment of fractures below the knee., Objective: To evaluate the effect of a single dose of preoperative antibiotic prophylaxis on the incidence of SSIs following removal of orthopedic implants used for treatment of fractures below the knee., Design, Setting, and Participants: Multicenter, double-blind, randomized clinical trial including 500 patients aged 18 to 75 years with previous surgical treatment for fractures below the knee who were undergoing removal of orthopedic implants from 19 hospitals (17 teaching and 2 academic) in the Netherlands (November 2014-September 2016), with a follow-up of 6 months (final follow-up, March 28, 2017). Exclusion criteria were an active infection or fistula, antibiotic treatment, reimplantation of osteosynthesis material in the same session, allergy for cephalosporins, known kidney disease, immunosuppressant use, or pregnancy., Interventions: A single preoperative intravenous dose of 1000 mg of cefazolin (cefazolin group, n = 228) or sodium chloride (0.9%; saline group, n = 242)., Main Outcomes and Measures: Primary outcome was SSI within 30 days as measured by the criteria from the US Centers for Disease Control and Prevention. Secondary outcome measures were functional outcome, health-related quality of life, and patient satisfaction., Results: Among 477 randomized patients (mean age, 44 years [SD, 15]; women, 274 [57%]; median time from orthopedic implant placement, 11 months [interquartile range, 7-16]), 470 patients completed the study. Sixty-six patients developed an SSI (14.0%): 30 patients (13.2%) in the cefazolin group vs 36 in the saline group (14.9%) (absolute risk difference, -1.7 [95% CI, -8.0 to 4.6], P = .60)., Conclusions and Relevance: Among patients undergoing surgery for removal of orthopedic implants used for treatment of fractures below the knee, a single preoperative dose of intravenous cefazolin compared with saline did not reduce the risk of surgical site infection within 30 days following implant removal., Trial Registration: clinicaltrials.gov Identifier: NCT02225821.

Background: Differentiating physiological left ventricular hypertrophy (LVH) in athletes from pathological hypertrophic cardiomyopathy (HCM) can be challenging. This study assesses the ability of cardiac MRI (CMR) to distinguish between physiological LVH (so-called athlete's heart) and HCM., Methods: 45 patients with HCM (71% men and 20% athletic) and 734 healthy control participants (60% men and 75% athletic) underwent CMR. Quantitative ventricular parameters were used for multivariate logistic regression with age, gender, sport status and left ventricular (LV) end-diastolic volume (EDV) to ED ventricular wall mass (EDM) ratio as covariates. A second model added the LV EDV : right ventricular (RV) EDV ratio. The performance of the model was subsequently tested., Results: LV EDM was greater in patients with HCM (74 g/m2) compared with healthy athletes/non-athletes (53/41 g/m2), while LV EDV was largest in athletes (114 ml/m2) as compared with non-athletes (94 ml/m2) and patients with HCM (88 ml/m2). The LV EDV : EDM ratio was significantly lower in patients with HCM compared with healthy controls and athletes (1.30/2.39/2.25, p<0.05). The LV EDV : RV EDV ratio was significantly greater in patients with HCM (1.10) than in healthy participants (non-athletes/athletes 0.94/0.93). The regression model resulted in high sensitivity and specificity levels in all and borderline-LVH participants (as defined by septal wall thickness). Corresponding areas under the receiver operator characteristic (ROC) curves were 0.995 (all participants) and 0.992 (borderline-LVH participants only). Adding the LV EDV : RV EDV ratio yielded no additional improvement., Conclusions: A model incorporating the LV EDV : EDM ratio can help distinguish HCM from physiological hypertrophy in athletes. This also applies to cases with borderline LVH, which present the greatest diagnostic challenge in clinical practice., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Background: In the Netherlands about 18,000 procedures with implant removal are performed annually following open or closed reduction and fixation of fractures, of which 30-80% concern the foot, ankle and lower leg region. For clean surgical procedures, the rate of postoperative wound infections (POWI) should be less than ~2%. However, rates of 10-12% following implant removal have been reported, specifically after foot, ankle and lower leg fractures. Currently, surgeons individually decide if antibiotics prophylaxis is given, since no guideline exists. This leads to undesirable practice variation. The aim of the study is to assess the (cost-)effectiveness of a single intravenous gift of Cefazolin prior to implant removal following surgical fixation of foot, ankle and/or lower leg fractures., Methods: This is a double-blind randomized controlled trial in patients scheduled for implant removal following a foot, ankle or lower leg fracture. Primary outcome is a POWI within 30 days after implant removal. Secondary outcomes are quality of life, functional outcome and costs at 30 days and 6 months after implant removal. With 2 x 250 patients a decrease in POWI rate from 10% to 3.3% (expected rate in clean-contaminated elective orthopaedic trauma procedures) can be detected (Power = 80%, 2-sided alpha = 5%, including 15% lost to follow up)., Discussion: If administration of prophylactic antibiotics prior to implant removal reduces the infectious complication rate, this will offer a strong argument to adopt this as standard practice of care. This will consequently lead to less physical and social disabilities and health care use. A preliminary, conservative estimation suggests yearly cost savings in the Netherlands of € 3.5 million per year., Trial Registration: This study is registered at Clinicaltrials.gov ( NCT02225821 ) and the Netherlands Trial Register ( NTR4393 ) and was granted permission by the Medical Ethical Review Committee of the Academic Medical Centre on October 7 2014.

Aims: To investigate whether cardiac resynchronization therapy (CRT) by means of biventricular (BiV) pacing can improve left ventricular (LV) function, remodelling and clinical status in chronically right ventricular (RV) paced patients with mild cardiomyopathy., Methods and Results: Thirty-six chronically (10 +/- 7 years) RV paced patients with left ventricular ejection fraction (LVEF) < 40% or LVEDD > 55 mm, without an established indication for CRT, were subjected to 6 months RV and BiV pacing in a patient-blinded, randomized crossover design. Treatment-effects of BiV pacing were evaluated for LV function, LV remodelling and clinical status. As compared with RV pacing, BiV pacing significantly improved LV function (LVEF 46 +/- 12 vs. 39 +/- 12% and LVFS 24 +/- 7 vs. 21 +/- 7%) and reduced LV end-diastolic and end-systolic diameters and volumes (LVEDD 56 +/- 8 vs. 59 +/- 8 mm, LVESD 43 +/- 8 vs. 47 +/- 9 mm, LVEDV 132 +/- 65 vs.144 +/- 62 mL and LVESV 77 +/- 56 vs. 92 +/- 55 mL, respectively). In 19 patients (53%) response to BiV pacing was clinically relevant, defined as LVESV reduction >15%. BiV pacing also significantly improved NYHA classification., Conclusion: BiV pacing following chronic RV pacing may improve LV function and reverse LV remodelling in patients with relatively mild LV dysfunction or remodelling. Hence, upgrade to BiV pacing might be considered in chronically RV paced patients with mild cardiomyopathy.

A case series is a descriptive study that follows a group of patients who have a similar diagnosis or who are undergoing the same procedure over a certain period of time. As there is no experimental protocol or control for allocation of patients to treatment, surgeons and patients decide on whether or not treatment is given, making the clinical sample representative of a common clinical population. Results of case series can generate hypotheses that are useful in designing further studies, including randomized controlled trials. However, no causal inferences should be made from case series regarding the efficacy of the investigated treatment. This article will provide principles for the design, analysis, and reporting of case series, illustrated by examples from the orthopaedic surgical literature.

Background: In hearts with left bundle branch block (LBBB), both atrioventricular (AV) delay and interventricular (VV) interval determine left ventricular (LV) pump function in cardiac resynchronization therapy (CRT). The optimal combination of AV delay and VV interval currently is determined by extensive hemodynamic testing., Objectives: The purpose of this study was to investigate whether the effective VV interval (VV(eff)) can be used to optimize AV delay and VV interval., Methods: In eight canine hearts with chronic LBBB, LV pacing was performed at various AV delays as well as biventricular pacing at multiple AV delays and VV intervals. LV pump function was assessed from LVdP/dt(max) and stroke volume (conductance catheter). Interventricular asynchrony was calculated from the timing difference between upslope of LV and RV pressure curves. VV(eff) was defined as the time delay between activation of the RV apex and LV lateral wall, irrespective of the source of RV activation (RV pacing or intrinsic conduction). VV(eff) was determined from pacemaker settings and surface ECGs recorded during biventricular pacing at various AV delays (positive values denote LV preexcitation)., Results: For all animals, the relationship between VV(eff) and LVdP/dt(max) as well as LV stroke work was parabolic. Maximal improvement in LVdP/dt(max) was similar during LV pacing, simultaneous biventricular pacing, and sequential biventricular pacing and was obtained at similar values of VV(eff). VV(eff) was strongly correlated with interventricular asynchrony (R = 0.97 +/- 0.03). Optimum LVdP/dt(max) occurred at VV(eff) ranging from -24 to 12 ms (mean -6 +/- 13 ms). For each experiment, the optimal VV(eff) was virtually equal to the value halfway between its minimum (during LV pacing at short AV delay) and maximum (during LBBB) value (R = 0.91)., Conclusion: Use of VV(eff) facilitates determination of the best combination of AV delay and VV interval during biventricular pacing. For each individual heart, VV(eff), resulting in optimum LV pump function, can be estimated using surface ECGs recorded during biventricular pacing.

To investigate ventricular remodeling during long-term right ventricular (RV) pacing after His bundle ablation (HBA) in patients with atrial arrhythmias, a retrospective analysis was performed on echocardiographic data from 45 patients (mean age 57 +/- 11 years) with atrial arrhythmias who underwent HBA and pacemaker implantation (HBA-PI) to control ventricular rate. Echocardiography was performed 1 year before HBA-PI, and up to 7 +/- 2 years of follow-up was conducted. An inverse linear relation was found between the relative increase of left ventricular (LV) end-diastolic diameter (EDD) during long-term RV pacing and LVEDD before HBA-PI (r = -0.61, p<0.001). Patients were divided into 2 groups: those with LVEDDs smaller than the mean LVEDD of 50 mm (group I, 46 +/- 2 mm, n = 28) and those with LVEDDs >50 mm (group II, 56 +/- 4 mm, n = 17). Before HBA-PI, patients in group I had significantly smaller LV weights (167 +/- 44 vs 238 +/- 56 g) and LV end-systolic diameters (30 +/- 2 vs 42 +/- 7 mm) and higher LV ejection fractions (64 +/- 5% vs 49+/- 12%) than those in group II. In group I, long-term RV pacing increased LVEDD, LV end-systolic diameter, LV weight, and left atrial diameter; increased mitral regurgitation; and decreased the LV ejection fraction and LV fractional shortening. No significant changes were observed during long-term RV pacing in group II. In conclusion, long-term RV pacing after HBA adversely affects LV structure and function in patients with initially normal LV dimensions and function.

Today, new pacing algorithms and stimulation methods for the prevention and interruption of atrial tachyarrhythmias can be applied on patients who need bradycardia pacing for conventional reasons. In addition, biventricular pacing as additive treatment for patients with severe congestive heart failure due to ventricular systolic dysfunction and prolonged intraventricular conduction has shown to improve symptoms and reduce hospital admissions. These new pacing technologies and the optimising of the pacing programmes are complex, expensive and time-consuming. Based on many clinical studies the indications for these devices are beginning to emerge. To support the cardiologist's decision-making and to prevent waste of effort and resources, the 'ad hoc committee' has provided preliminary recommendations for implantable devices to treat atrial tachyarrhythmias and to extend the treatment of congestive heart failure respectively.

Background: The 7250 Jewel AF Medtronic model of ICD is the first implantable device in which both therapies for atrial arrhythmias and pacing algorithms for atrial arrhythmia prevention are available. Feasibility of that extensive atrial arrhythmia management requires correct and synergic functioning of different algorithms to control arrhythmias., Methods and Results: The ability of the new pacing algorithms to stabilize the atrial rate following termination of treated atrial arrhythmias was evaluated in the marker channel registration of 600 spontaneously occurring episodes in 15 patients with the Jewel AF. All patients (55+/-15 years) had structural heart disease and documented atrial and ventricular arrhythmias. Dual chamber rate stabilization pacing was present in 245 (41 %) of episodes following arrhythmia termination and was a part of the mode switching operation during which pacing was provided in the dynamic DDI mode. This algorithm could function as the atrial rate stabilization pacing only when there was a slow spontaneous atrial rhythm or in presence of atrial premature beats conducted to the ventricles with a normal AV time. In case of atrial premature beats with delayed or absent conduction to the ventricles and in case of ventricular premature beats, the algorithm stabilized the ventricular rate. The rate stabilization pacing in DDI mode during sinus rhythm following atrial arrhythmia termination was often extended in time due to the device-based definition of arrhythmia termination. This was also the case in patients, in whom the DDD mode with true atrial rate stabilization algorithm was programmed., Conclusions: The rate stabilization algorithms in the Jewel AF applied after atrial arrhythmia termination provide pacing that is not based on the timing of atrial events. Only under certain circumstances the algorithm can function as atrial rate stabilization pacing. Adjustments in availability and functioning of the rate stabilization algorithms might be of benefit for the clinical performance of pacing as part of device therapy for atrial arrhythmias.