Smoking and Activated Clotting Time during coronary angiography and angioplasty: protocol for the ACT-Tobacco trial.

Background: During percutaneous transluminal coronary angioplasty (PTCA), activated clotting time (ACT) measurements are recommended to attest a correct anticoagulation level and, if needed, to administer further unfractionated heparin (UFH) to obtain a therapeutic ACT value. Our clinical routine led us to observe that smokers had lower ACT values after standardized UFH administration during PTCA. Procoagulant status in smokers is well documented. Objectives: To determine whether tobacco negatively affects UFH anticoagulation during PTCA when evaluated by ACT. Methods: The ACT-TOBACCO trial is a single-center, noninterventional, prospective study. The primary end point is the comparison of ACT values after standardized UFH administration between active smokers and nonsmokers (active smoker group vs nonsmoker group) requiring coronary angiography followed by PTCA. The main secondary end points include ACT comparison after the first and second standardized UFH administration according to the patient's smoking status (active, ex-, or nonsmoker) and the clinical presentation of ischemic cardiomyopathy: stable (silent ischemia or stable angina) or unstable (unstable angina or acute coronary syndrome without or with ST-segment elevation). Conclusions: To the best of our knowledge, ACT values during PTCA between smokers and nonsmokers have not previously been compared. As current PTCA procedures increase in complexity and duration, the understanding of procoagulant risk factors such as smoking and the need for reliable anticoagulation monitoring becomes essential to balance hemorrhagic risk against thrombotic risk.

Virtual reality simulator improves the acquisition of basic arthroscopy skills in first-year orthopedic surgery residents.

INTRODUCTION: Arthroscopy training using a virtual reality (VR) simulator is said to improve the training of orthopedic surgery residents, although it has never been evaluated in a large representative population of first-year residents. HYPOTHESIS: We hypothesized that first-year residents who train on a VR simulator would improve their basic arthroscopy skills more than residents who use other training methods. The primary aim was to compare various arthroscopy-learning techniques after 6 months of training. POPULATION AND METHODS: The study population consisted of 107 first-year residents who were tested twice on a VR arthroscopy simulator (December 2017 and June 2018). The residents were divided into three groups: no specific arthroscopy training (A), non-specific and one-off arthroscopy training (B), 6 months of VR arthroscopy simulator training (C). During the testing, they had to perform the Periscoping exercise (orientation of angled scope) and the Catch the Stars Glenohumeral exercise (extraction of loose bodies). The parameters analyzed were time (s), camera alignment relative to horizontal (%), camera path length (cm) and grasper path length (cm). RESULTS: After 6 months, there was a significant difference between groups during the Periscoping exercise in the time (A: 137.8 s; B: 126.7 s; C: 92.2 s) (p<0.0001), camera alignment (A: 93%; B: 98%; C: 97%) (p=0.0028), camera path length (A: 116.9cm; B: 112.5cm; C: 67.3cm) (p<0.0001) and during the Catch the Stars Glenohumeral exercise in the time (A: 112.2 s; B: 103 s; C: 61.4 s) (p<0.0001), camera path length (A: 46.3cm; B: 40.9cm; C: 32.9cm) (p<0.0153) and grasper path length (A: 146.4cm; B: 142.2cm; C: 95.8cm) (p<0.0001). DISCUSSION: The residents who participated in the VR arthroscopy simulator training program for 6 months had better results when performing practical exercises and standard arthroscopy tasks than those who did not receive any training or only received only one-off training. Their final performance indicated technical mastery that the other residents had not achieved. LEVEL OF EVIDENCE: II, Prospective, comparative, non-randomized study.

Cost-effectiveness of four living-donor nephrectomy techniques from a hospital perspective.

BACKGROUND: In Europe, transplantation centres use different nephrectomy techniques: open surgery, and standard, hand-assisted and robot-assisted laparoscopies. Few studies have analysed the disparity in costs and clinical outcomes between techniques. Since donors are healthy patients expecting minimum pain and fast recovery, this study aimed to compare the cost-effectiveness of four nephrectomy techniques focusing on early surgical outcomes, an essential in the donation act. METHODS: A micro-costing approach was used to estimate the cost of implementation from a hospital perspective. Estimates took into account sterilization costs for multiple-use equipment, costs for purchasing single-use equipment, staff and analgesics. The study recruited donors in 20 centres in France. Quality of life by EuroQol-5D was assessed preoperatively, and 4 and 90 days post-operatively. Two effectiveness indicators were built: quality-of-life recovery and post-operative pain days averted (PPDA). The study was registered at ClinicalTrials.gov NCT02830568, on 10 June 2010. RESULTS: A total of 264 donors were included; they underwent open surgery (n = 65), and standard (n = 65), hand-assisted (n = 65) and robot-assisted laparoscopies (n = 69). Use of the nephrectomy techniques differed greatly in cost of implementation and immediate post-operative outcomes but not in clinical outcomes at 90 days. At 4 days, hand-assisted laparoscopy provided the lowest cost per quality-of-life recovery unit of effectiveness (%) and PPDA (days) (€2056/40.1%/2.3 days, respectively). Robot-assisted laparoscopy was associated with the best post-operative outcomes but with the highest cost (€3430/59.1%/2.6 days). CONCLUSION: Hand-assisted, standard and robot-assisted laparoscopies are cost-effective techniques compared with open surgery. Hand-assisted surgery is the most cost-effective procedure. Robot-assisted surgery requires more healthcare resource use but enables the best clinical outcome.

Antibiotic prophylaxis with high-dose cefoxitin in bariatric surgery: an observational prospective single center study.

BACKGROUND: The optimal dose of cefoxitin for antibiotic prophylaxis in obese patients remains uncertain. We evaluated the adequacy of a 4-gram dosing regimen of cefoxitin against the most frequent pathogens that infect patients undergoing bariatric surgery. METHODS: This observational prospective study included obese patients who required bariatric surgery and a 4-gram dose of cefoxitin as an antibiotic prophylaxis. Serum concentrations were measured during surgery (incision, wound closure and in case of reinjection). The pharmacokinetic/pharmacodynamic (PK/PD) target was to obtain free cefoxitin concentrations above 4× MIC, from incision to wound closure (100% ƒT>4xMIC). The targeted MIC was based on the worst-case scenario (the highest ECOFF value of Staphylococcus aureus, Enterobacteriaceae and anaerobic bacteria). The secondary outcomes were the factors related to underdosage. RESULTS: Two hundred patients were included. The mean age of the patients was 46 (±12) years-old, and the mean BMI was 45.8 (±6.9) kg/m2 Bypass surgery was the preferred technique (84%). The percentages of patients who met the PK/PD target (100% fT>4xMIC) of cefoxitin were 37.3%, 1.1% and 0% for S. aureus, Enterobacteriaceae and anaerobic bacteria, respectively. BMIs below 50 kg/m2 (OR 0.29, 95% CI [0.11-0.75], P = 0.0107) and a shorter duration of surgery (OR 0.97, 95% CI [0.95-0.99], P = 0.004) were associated with reaching the target concentrations. CONCLUSIONS: In obese patients undergoing bariatric surgery, a regimen of 4 grams of cefoxitin led to an inadequate coverage for most common pathogens. A longer surgery duration and BMI over 50 kg/m2 increase the risk of underdosage.

Serum albumin or body mass index: Which prognostic factor for survival in patients with acute myeloblastic leukaemia?

Obesity has been associated with an increased risk of developing acute myeloblastic leukaemia (AML). The outcome of AML patients could thus be dependent on their nutritional status that can be evaluated by the simple measurement of serum albumin (SA) and body mass index (BMI). These two parameters could have a value as prognostic factors to guide patients' management. We evaluated the association between SA levels, BMI, and survival, evaluated as overall survival (OS) and event-free survival. Furthermore, we investigated the association between BMI, SA, and other prognostic factors of interest in AML. This retrospective single-center study included 159 patients diagnosed with AML at Nancy Hospital between 2005 and 2013, treated with aracytine and anthracycline. Forty-four percent of patients presented with normal weight while 56% were obese/overweight. Serum albumin levels were <30 g/L for 49 patients, and ≥30 g/L for 110. Thirty-four patients with low SA levels were also obese. Favourable OS was associated with SA levels ≥30 g/L (HR = 0.467; 95% CI 0.230-0.946; P = .034) but was not impacted by the BMI. Serum albumin levels appear to be an independent prognostic factor in AML and a better parameter than BMI for evaluating the nutritional status of patients at diagnosis.

Nephrectomy Complication Is a Risk Factor of Clinically Meaningful Decrease in Health Utility among Living Kidney Donors.

OBJECTIVES: To assess the clinically relevant change in health state utility (HSU) in living kidney donors and whether this change value is constant across measures and clinical conditions and is useful for health economics studies. We aimed to 1) measure the change in the HSU score for living kidney donors from before donation to 3 months after donation and 2) estimate the minimal important decrease (MIDe) in the HSU score for living kidney donors and its associated clinical factors. METHODS: Data from a prospective multicenter observational study measuring quality of life of kidney donors by the three-level EuroQol five-dimensional questionnaire (EQ-5D-3L) and the six-dimensional health state short form (SF-6D) before donation and at 3 months after donation provided HSU scores. Two methods were used to derive the MIDe: the anchor-based method and the distribution-based (standard error of measurement) method. Logistic regression was used to identify clinical factors associated with the MIDe after donation. RESULTS: In total, 228 and 216 donors completed the EQ-5D-3L and the SF-6D, respectively. Mean HSU scores were 0.932 and 0.823 before donation and 0.895 and 0.764 at 3 months after donation. HSU scores were significantly decreased at 3 months, and 18.5% of donors rated their global health as "somewhat worse." By the EQ-5D-3L and the SF-6D, the MIDe was estimated at -0.113 and -0.116 with the anchor-based method and -0.075 and -0.077 with the distribution-based method. Risk of decreased HSU score was significantly associated with clinical complications but only marginally with surgical technique. CONCLUSIONS: A short-term clinically relevant decrease in HSU was significantly associated with clinical complications in kidney donors. Preventing perioperative complications is of prime importance in kidney donation.

Cost-Effectiveness of Thrombectomy in Patients With Acute Ischemic Stroke: The THRACE Randomized Controlled Trial.

BACKGROUND AND PURPOSE: The benefit of mechanical thrombectomy added to intravenous thrombolysis (IVT) in patients with acute ischemic stroke has been largely demonstrated. However, evidence of the economic incentive of this strategy is still limited, especially in the context of a randomized controlled trial. We aimed to analyze whether mechanical thrombectomy combined with IVT (IVMT) is cost-effective when compared with IVT alone. METHODS: Individual-level cost and outcome data were collected in the THRACE randomized controlled trial (Thrombectomie des Artères Cerébrales) including patients with acute ischemic stroke. Patients were assigned to receive IVT or IVMT. The primary outcomes were modified Rankin Scale score of functional independence at 90 days (score 0-2) and the EuroQol-5D quality-of-life score at 1 year. RESULTS: Treating acute ischemic stroke with IVMT (n=200) versus IVT (n=202) increased the rate of functional independence by 10.9% (53.0% versus 42.1%; P=0.028), at an increased cost of $2116 (€1909), with no significant difference in mortality (12% versus 13%; P=0.70) or symptomatic intracranial hemorrhage (2% versus 2%; P=0.71). The cost per one averted case of disability was estimated at $19 379 (€17 480). The incremental cost per one quality-adjusted life year gained was $14 881 (€13 423). On sensitivity analysis, the probability of cost-effectiveness with IVMT was 84.1% in terms of cases of averted disability and 92.2% in terms of quality-adjusted life years. CONCLUSIONS: Based on randomized trial data, this study demonstrates that IVMT used to treat acute ischemic stroke is cost-effective when compared with IVT alone. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01062698.

Target organ damage assessment in French hypertensive patients without established cardiovascular or renal disease: results of the PREVENT-A study.

OBJECTIVES: To evaluate the modalities of subclinical target organ damage (TOD) assessment in France, 2-3 years after publication of the European Society of Hypertension (ESH)/European Society of Cardiology (ESC) 2007 guidelines. METHODS: Two parallel, large, cross-sectional surveys were performed in representative samples of 516 private practice cardiologists, and 943 general practitioners (GPs), in hypertensive patients (952 and 1778, respectively) without established cardiovascular or renal disease. RESULTS: At least one TOD search was performed in 97.6% of cardiologists' patients, performed or ongoing in 96.1% of GPs' patients, with a median number of three TOD searches in both surveys. Only 8.6% of cardiologists' patients and 6.3% of GPs' patients had a full set of TOD analyses [i.e. the five categories investigated: left ventricular hypertrophy (LVH), vascular, renal, retinopathy and cerebrovascular]. When considering the three priority categories of subclinical TOD search recommended by the ESH/ESC guidelines (i.e. LVH, vascular and renal), 63.2% of cardiologists' patients and 49.5% of GPs' patients had this triple assessment completed. The new TOD assessment modalities, namely pulse wave velocity, ankle brachial index and microalbuminuria, were rarely used. Only 3.3% of GPs' patients and 15.4% of cardiologists' patients were reclassified with an upgraded cardiovascular risk. CONCLUSION: Subclinical TOD modalities are commonly assessed in French hypertensive patients without established cardiovascular or renal diseases, although 55% still do not benefit from combined triple LVH, macrovascular and renal assessment. The new modalities of TOD assessment are rarely implemented. Moreover, TOD assessment displayed poor effectiveness in upgrading cardiovascular risk classification.

Impact of co-morbidities on measuring indirect utility by the Medical Outcomes Study Short Form 6D in lower-limb osteoarthritis.

INTRODUCTION: Co-morbidities can influence generic measurement of health indirect utility. We investigated their impact to assess indirect utility with the Medical Outcomes Study Short Form 6D (SF-6D) in patients with osteoarthritis (OA). METHODS: In patients with hip and knee OA from the Knee and Hip Osteo-Arthritis Long-term Assessment (KHOALA) study, co-morbidities were assessed by the Functional Co-morbidity Index. Multivariate linear regressions were used to determine predictors of utility score. RESULTS: For the 878 patients included, the mean (standard deviation (SD)) utility score for 808 patients was 0.66 (11; range 0.32-1.00) and mean number of co-morbidities 2.05 (1.58). Number of co-morbidities (beta = -0.30; p = 0.002), psychiatric disease (beta = -0.043; p < 0.0001) and degenerative disc disease (beta = -0.014; p = 0.018) were predictors of low utility score. The WOMAC functional score had a higher significant effect (beta = -0.003; p < 0.0001) and explained a higher percentage of the model variance. DISCUSSION: Compared to greater negative effect of functional severity of OA, co-morbidities have a negative but relatively marginal impact on indirect utility score. This suggests that, clinically, considering the functional severity of OA remains a first priority.

[Quality of life linked to health in medical economic studies]. / La qualité de vie liée a la santé dans les etudes médico-economiques.

Quality of life plays an established role in public decision making. In the area of health economics, quality of life indicators have become an essential tool in decision analysis.