Goyal M.,University of Calgary |
Bonafe A.,Hosital Gui de Chauliac |
Diener H.-C.,University of Duisburg - Essen |
Levy E.I.,State University of New York at Buffalo |
And 18 more authors.
New England Journal of Medicine | Year: 2015
BACKGROUND Among patients with acute ischemic stroke due to occlusions in the proximal anterior intracranial circulation, less than 40% regain functional independence when treated with intravenous tissue plasminogen activator (t-PA) alone. Thrombectomy with the use of a stent retriever, in addition to intravenous t-PA, increases reperfusion rates and may improve long-term functional outcome. METHODS We randomly assigned eligible patients with stroke who were receiving or had received intravenous t-PA to continue with t-PA alone (control group) or to undergo endovascular thrombectomy with the use of a stent retriever within 6 hours after symptom onset (intervention group). Patients had confirmed occlusions in the proximal anterior intracranial circulation and an absence of large ischemic-core lesions. The primary outcome was the severity of global disability at 90 days, as assessed by means of the modified Rankin scale (with scores ranging from 0 [no symptoms] to 6 [death]). RESULTS The study was stopped early because of efficacy. At 39 centers, 196 patients underwent randomization (98 patients in each group). In the intervention group, the median time from qualifying imaging to groin puncture was 57 minutes, and the rate of substantial reperfusion at the end of the procedure was 88%. Thrombectomy with the stent retriever plus intravenous t-PA reduced disability at 90 days over the entire range of scores on the modified Rankin scale (<0.001). The rate of functional independence (modified Rankin scale score, 0 to 2) was higher in the intervention group than in the control group (60% vs. 35%, <0.001). There were no significant between-group differences in 90-day mortality (9% vs. 12%, P = 0.50) or symptomatic intracranial hemorrhage (0% vs. 3%, P = 0.12). CONCLUSIONS In patients receiving intravenous t-PA for acute ischemic stroke due to occlusions in the proximal anterior intracranial circulation, thrombectomy with a stent retriever within 6 hours after onset improved functional outcomes at 90 days. Copyright © 2015 Massachusetts Medical Society. All rights reserved.
News Article | February 22, 2017
SUMMIT, N.J.--(BUSINESS WIRE)--Celgene Corporation (NASDAQ:CELG) today announced that the U.S. Food and Drug Administration (FDA) has expanded the existing indication for REVLIMID (lenalidomide) 10 mg capsules to include use for patients with multiple myeloma as maintenance therapy following autologous hematopoietic stem cell transplant (auto-HSCT). The expanded indication makes REVLIMID the first and only treatment to receive FDA approval for maintenance use following auto-HSCT. “Autologous stem cell transplant after induction therapy is part of the continuum of care for transplant-eligible multiple myeloma patients. However, most patients will still see their disease recur or progress after this treatment,” said Philip McCarthy, M.D., Director, Blood and Marrow Transplant Center, Department of Medicine at Roswell Park Cancer Institute. “Lenalidomide maintenance therapy, which has been shown to increase progression-free survival following autologous stem cell transplant in clinical trials can be considered a standard of care for these patients.” The approval was based on two large studies including more than 1,000 patients comparing REVLIMID maintenance therapy given until disease progression or unacceptable toxicity after auto-HSCT versus no maintenance. In both studies, the primary efficacy endpoint was progression-free survival (PFS) defined from randomization to the date of progression or death, whichever occurred first. In the most current PFS analysis, Study 1 (U.S.-based NCI sponsored cooperative group study CALGB 100104) demonstrated a median PFS of 5.7 years (95% CI: 4.4-not estimable) versus 1.9 years (95% CI: 1.6-2.5) for no maintenance, a difference of 3.8 years (HR 0.38 [95% CI: 0.28-0.50]). Study 2 (European-based study IFM 2005-02) also showed a benefit with a median PFS of 3.9 years (95% CI: 3.3-4.7) versus 2 years (95% CI: 1.8-2.3) for no maintenance, a difference of 1.9 years (HR 0.53 [95% CI: 0.44-0.64]). Individual studies were not powered for an overall survival endpoint. A descriptive analysis showed the median overall survival in Study 1 was 9.3 years (95% CI: 8.5-not estimable) for patients who received REVLIMID versus 7 years (95% CI: 5.9-8.6) for no maintenance (HR 0.59 [95% CI: 0.44-0.78]). In Study 2, median overall survival was 8.8 years (95% CI: 7.4-not estimable) for patients who received REVLIMID versus 7.3 years (95% CI: 6.7-9.0) for no maintenance (HR 0.90 [95% CI: 0.72-1.13]). “In newly-diagnosed multiple myeloma, auto-HSCT remains a viable option for many patients and often provides a strong response against the disease,” said Michael Pehl, President, Global Hematology and Oncology for Celgene. “By expanding the approval for REVLIMID to include post-transplant maintenance, patients have the potential to maintain those responses and, importantly, delay progression of the disease.” As described in the prescribing information, REVLIMID can cause fetal harm and is contraindicated in females who are pregnant. REVLIMID is only available through a restricted distribution program, Revlimid REMS®. Deep vein thrombosis, pulmonary embolism, myocardial infarction and stroke occur in patients with MM treatment with REVLIMID and thromboprophylaxis is recommended. See additional Important Safety Information below. The most frequently reported adverse reactions in ≥20% (REVLIMID arm) across both maintenance studies (Study 1, Study 2 respectively) were neutropenia (79%, 61%), thrombocytopenia (72%, 24%), leukopenia (23%, 32%), anemia (21%, 9%), upper respiratory tract infection (27%, 11%), bronchitis (5%, 47%), nasopharyngitis (2%, 35%), cough (10%, 27%), gastroenteritis (0%, 23%), diarrhea (55%, 39%), rash (32%, 8%), fatigue (23%, 11%), asthenia (0%, 30%), muscle spasm (0%, 33%) and pyrexia (8%, 21%). The most frequently reported Grade 3 or 4 reactions (more than 20% in the REVLIMID arm) included neutropenia, thrombocytopenia, and leukopenia. The frequencies of onset of adverse reactions were generally highest in the first six months of treatment and then the frequencies decreased over time or remained stable throughout treatment. In patients receiving REVLIMID maintenance therapy, hematologic second primary malignancies (SPM) occurred in 7.5% of patients compared to 3.3% in patients receiving placebo. The incidence of hematologic plus solid tumor (excluding squamous cell carcinoma and basal cell carcinoma) SPM was 14.9%, compared to 8.8% in patients receiving placebo with a median follow-up of 91.5 months. Non-melanoma skin cancer SPM, including squamous cell carcinoma and basal cell carcinoma, occurred in 3.9% of patients receiving REVLIMID maintenance, compared to 2.6% in the placebo arm. Patients should be monitored for the development of second primary malignancies. Take into account both the potential benefit of REVLIMID and the risk of second primary malignancies when considering treatment with REVLIMID. REVLIMID in combination with dexamethasone was previously approved in June 2006 for use in patients with multiple myeloma who have received at least one prior therapy, and the indication expanded in February 2015 to include patients newly diagnosed with multiple myeloma. In June 2016, an application was submitted to the European Medicines Agency (EMA) for the review of REVLIMID as maintenance treatment in NDMM patients after receiving an autologous stem cell transplant. In January 2017, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the use of REVLIMID as monotherapy for the maintenance treatment of adult patients with newly diagnosed multiple myeloma (MM) who have undergone autologous stem cell transplantation. CALGB 100104 was a phase III, randomized, controlled, double-blind, multi-center study conducted in 47 centers by the CALGB, which is now part of the Alliance for Clinical Trials in Oncology, a US national oncology cooperative group. 460 newly diagnosed multiple myeloma patients – aged between 18 and 70 years (CLcr ≥ 30 mL/min) – who had undergone induction therapy within 12 months of diagnosis and achieved at least stable disease (SD) or better 90-100 days following autologous stem cell transplant (ASCT), were randomized to receive either REVLIMID maintenance or placebo. The REVLIMID maintenance dose was 10 mg/day (after 3 months increased to 15 mg/day if tolerated) until disease progression, intolerable side effects, patient withdrawal for another reason, or death. The dose was reduced, or treatment was temporarily interrupted or stopped, as needed to manage toxicity. A dose increase to 15 mg once daily occurred in 135 patients (58%). IFM 2005-02 was a phase III, controlled, double-blind, multi-center study conducted by the University Hospital of Toulouse in concert with the IFM, an independent French myeloma cooperative group, at 78 centers in France, Belgium, and Switzerland. 614 newly diagnosed multiple myeloma patients younger than 65 years (CLcr ≥ 30 mL/min) who had undergone induction therapy and did not present with signs of disease progression within 6 months of undergoing ASCT. Patients were then randomized to receive a two-month consolidation regimen of REVLIMID monotherapy 25 mg per day on 21/28 days, followed by either REVLIMID maintenance or placebo. The REVLIMID dose was 10 mg/day (after 3 months increased to15 mg/day if tolerated) until disease progression, intolerable side effects, patient withdrawal for another reason or death. The dose was reduced, or treatment was temporarily interrupted or stopped, as needed to manage toxicity. A dose increase to 15 mg once daily occurred in 185 patients (60%). REVLIMID® (lenalidomide) in combination with dexamethasone (dex) is indicated for the treatment of patients with multiple myeloma (MM) REVLIMID is indicated as maintenance therapy in patients with MM following autologous hematopoietic stem cell transplantation (auto-HSCT) REVLIMID® is indicated for the treatment of patients with transfusion-dependent anemia due to low-or intermediate-1–risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities REVLIMID® is indicated for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials Pregnancy: REVLIMID can cause fetal harm when administered to a pregnant female and is contraindicated in females who are pregnant. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to the fetus Allergic Reactions: REVLIMID is contraindicated in patients who have demonstrated hypersensitivity (e.g., angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis) to lenalidomide REVLIMID REMS® Program: See Boxed WARNINGS: Prescribers and pharmacies must be certified with the REVLIMID REMS program by enrolling and complying with the REMS requirements; pharmacies must only dispense to patients who are authorized to receive REVLIMID. Patients must sign a Patient-Physician Agreement Form and comply with REMS requirements; female patients of reproductive potential who are not pregnant must comply with the pregnancy testing and contraception requirements and males must comply with contraception requirements Hematologic Toxicity: REVLIMID can cause significant neutropenia and thrombocytopenia. Monitor patients with neutropenia for signs of infection. Advise patients to observe for bleeding or bruising, especially with use of concomitant medications that may increase risk of bleeding. MM: Patients taking REVLIMID/dex or REVLIMID maintenance therapy should have their complete blood counts (CBC) assessed every 7 days for the first 2 cycles, on days 1 and 15 of cycle 3, and every 28 days thereafter. MDS: Patients on therapy for del 5q MDS should have their complete blood counts monitored weekly for the first 8 weeks of therapy and at least monthly thereafter. Patients may require dose interruption and/or dose reduction. Please see the Black Box WARNINGS for further information. MCL: Patients taking REVLIMID for MCL should have their CBCs monitored weekly for the first cycle (28 days), every 2 weeks during cycles 2-4, and then monthly thereafter. Patients may require dose interruption and/or dose reduction Venous and Arterial Thromboembolism: See Boxed WARNINGS: Venous thromboembolic events (DVT and PE) and arterial thromboses (MI and CVA) are increased in patients treated with REVLIMID. Patients with known risk factors, including prior thrombosis, may be at greater risk and actions should be taken to try to minimize all modifiable factors (e.g., hyperlipidemia, hypertension, smoking). Thromboprophylaxis is recommended and the regimen should be based on patient’s underlying risks. ESAs and estrogens may further increase the risk of thrombosis and their use should be based on a benefit-risk decision Increased Mortality in Patients with CLL: In a clinical trial in the first-line treatment of patients with CLL, single agent REVLIMID therapy increased the risk of death as compared to single agent chlorambucil. Serious adverse cardiovascular reactions, including atrial fibrillation, myocardial infarction, and cardiac failure, occurred more frequently in the REVLIMID arm. REVLIMID is not indicated and not recommended for use in CLL outside of controlled clinical trials Second Primary Malignancies (SPM): In clinical trials in patients with MM receiving REVLIMID, an increase of hematologic plus solid tumor SPM, notably AML and MDS, have been observed. Monitor patients for the development of SPM. Take into account both the potential benefit of REVLIMID and risk of SPM when considering treatment Hepatotoxicity: Hepatic failure, including fatal cases, has occurred in patients treated with REVLIMID/dex. Pre-existing viral liver disease, elevated baseline liver enzymes, and concomitant medications may be risk factors. Monitor liver enzymes periodically. Stop REVLIMID upon elevation of liver enzymes. After return to baseline values, treatment at a lower dose may be considered Allergic Reactions: Angioedema and serious dermatologic reactions including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported. These events can be fatal. Patients with a prior history of Grade 4 rash associated with thalidomide treatment should not receive REVLIMID. REVLIMID interruption or discontinuation should be considered for Grade 2-3 skin rash. REVLIMID must be discontinued for angioedema, Grade 4 rash, exfoliative or bullous rash, or if SJS or TEN is suspected and should not be resumed following discontinuation for these reactions. REVLIMID capsules contain lactose; risk-benefit of treatment should be evaluated in patients with lactose intolerance Tumor Lysis Syndrome (TLS): Fatal instances of TLS have been reported during treatment with lenalidomide. The patients at risk of TLS are those with high tumor burden prior to treatment. These patients should be monitored closely and appropriate precautions taken Tumor Flare Reaction (TFR): TFR has occurred during investigational use of lenalidomide for CLL and lymphoma. Monitoring and evaluation for TFR is recommended in patients with MCL. Tumor flare may mimic the progression of disease (PD). In patients with Grade 3 or 4 TFR, it is recommended to withhold treatment with REVLIMID until TFR resolves to ≤ Grade 1. REVLIMID may be continued in patients with Grade 1 and 2 TFR without interruption or modification, at the physician’s discretion Impaired Stem Cell Mobilization: A decrease in the number of CD34+ cells collected after treatment (>4 cycles) with REVLIMID has been reported. Consider early referral to transplant center to optimize timing of the stem cell collection Thyroid Disorders: Both hypothyroidism and hyperthyroidism have been reported. Measure thyroid function before start of REVLIMID treatment and during therapy Periodic monitoring of digoxin plasma levels is recommended due to increased C and AUC with concomitant REVLIMID therapy. Patients taking concomitant therapies such as erythropoietin stimulating agents or estrogen containing therapies may have an increased risk of thrombosis. It is not known whether there is an interaction between dex and warfarin. Close monitoring of PT and INR is recommended in patients with MM taking concomitant warfarin Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through next-generation solutions in protein homeostasis, immuno-oncology, epigenetics, immunology and neuro-inflammation. For more information, please visit www.celgene.com. Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn, Facebook and YouTube. This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," “outlook” and similar expressions. Forward-looking statements are based on management’s current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in our Annual Report on Form 10-K and our other reports filed with the Securities and Exchange Commission. All registered trademarks are owned by Celgene Corporation.
Sampaio C.,Edificio Do Hospital Of Santa Maria |
Bronzova J.,Solvay Group |
Hauser R.A.,University of South Florida |
Lang A.E.,University of Toronto |
And 3 more authors.
Movement Disorders | Year: 2011
This report presents the results of 2 randomized trials-Rembrandt and Vermeer-on the efficacy and safety of pardoprunox in patients with early Parkinson's disease. Patients with Parkinson's disease with a Unified Parkinson's Disease Rating Scale-Motor score ≥ 10 and modified Hoehn and Yahr stage ≤ 3 were randomized to pardoprunox (fixed doses of 6 mg/day [n = 115] or 12 mg/day [n = 118] or a flexible-dose range of 12-42 mg/day [n = 116]) or placebo (n = 119) in Rembrandt and pardoprunox 12-42 mg/day (n = 108), pramipexole 1.5-4.5 mg/day (n = 116), or placebo (n = 110) in Vermeer. Pardoprunox showed a significant benefit over placebo in the primary efficacy variable, least-square mean change from baseline in Unified Parkinson's Disease Rating Scale-Motor score: Rembrandt-fixed doses of 6 and 12 mg/day, -6.0 and -4.7 points, respectively; flexible-dose 12-42 mg/day, -5.5 points; placebo, -2.9 points; Vermeer-flexible-dose 12-42 mg/day, -4.9 points; placebo, -2.5 points; pramipexole, -5.7 points. No minimum effective dose was established. Secondary efficacy parameters supported the results of the primary efficacy variable. Pardoprunox tolerability was dose related: flexible-dose 12-42 mg/day showed the highest dropout rate due to treatment-emergent adverse events (Rembrandt, 56.0%; Vermeer, 46.3%) and overall incidence of treatment-emergent adverse events (Rembrandt, 97.4%; Vermeer, 92.6%), primarily due to nausea, somnolence, and dizziness. Because pardoprunox showed similar efficacy across all dose groups, these observations suggest that the 12-42 mg/day dose range was higher than therapeutically required. Furthermore, the early onset of treatment-emergent adverse events and dropouts observed for pardoprunox suggest that titration was too rapid. Pardoprunox significantly improved motor symptoms in patients with early Parkinson's disease, but further investigation into the dose and titration schedule is required to improve tolerability. © 2010 Movement Disorder Society.
News Article | December 2, 2015
A heart-shaped lead urn with an inscription identifying the contents as the heart of Toussaint Perrien, Knight of Brefeillac, found during excavation of the ruins of the medieval Jacobins convent in Rennes, France is shown in this handout photo provided by Rozenn Colleter on December 2, 2015. REUTERS/Rozenn Colleter/Ph.D./INRAP/Handout via Reuters More WASHINGTON (Reuters) - In the ruins of a medieval convent in the French city of Rennes, archaeologists discovered five heart-shaped urns made of lead, each containing an embalmed human heart. Now, roughly four centuries after they were buried, researchers have used modern science to study these old hearts. It turns out three of them bore tell-tale signs of a heart disease very common today. "Every heart was different and revealed its share of surprises," anthropologist Rozenn Colleter of the French National Institute for Preventive Archaeological Research said on Wednesday. "Four of these hearts are very well preserved. It is very rare in archaeology to work on organic materials. The prospects are very exciting." One heart appeared healthy, with no evidence of disease. Three others showed indications of disease, atherosclerosis, with plaque in the coronary arteries. The fifth was poorly preserved. "Only one heart belonged to a women, and was totally degraded, permitting no study," said radiologist Dr. Fatima-Zohra Mokrane of Rangueil Hospital at the University Hospital of Toulouse. One of hearts belonged to a nobleman identified by an inscription on the urn as Toussaint Perrien, Knight of Brefeillac, who died in 1649. His heart had been removed upon his death and was later buried with his wife, Louise de Quengo, Lady of Brefeillac, who died in 1656. Her wonderfully preserved body was found in a coffin at the site, still wearing a cape, wool dress, bonnet and leather shoes with cork soles. The earliest of the urns was dated 1584. The latest was dated 1655. Mokrane said an important aspect of the study was the finding that people hundreds of years ago had atherosclerosis. It is a disease in which plaque made up of fat, cholesterol, calcium and other substances builds up inside the arteries. Plaque hardens over time and narrows the arteries. Atherosclerosis can trigger heart attacks and strokes. "Atherosclerosis is not only a recent pathology, because it was found in different hearts studied," Mokrane said. The researchers cleaned each of the hearts, removed the embalming material and examined them with MRI imaging, CT scans and other methods. Archaeologists excavated the Jacobins convent in Rennes from 2011 to 2013. It was constructed in 1369 and became an important pilgrimage and burial site from the 15th to 17th centuries. About 800 graves were found, Colleter said. The research was presented at a meeting of the Radiological Society of North America in Chicago.
News Article | December 10, 2015
Being happy is nice and all, but don't count on happiness to add years to your life — a new study finds that how happy you are doesn't seem to affect your risk of dying early. The study did find that being unhappy was linked with an increased risk of early death, but it turned out that this was actually because people in poor health also tend to be unhappy. In other words, poor health, and not unhappiness, was the true cause of early death, the researchers said. "Illness makes you unhappy, but unhappiness itself doesn't make you ill," study researcher Bette Liu, of the University of New South Wales in Australia, said in a statement. "We found no direct effect of unhappiness or stress on mortality." [7 Things That Will Make You Happy] For the study, the researchers analyzed information from more than 700,000 U.K. women whose average age was 59. The researchers asked the women to rate their happiness, and then followed up with them for 10 years. The researchers found that 39 percent of the women said they were happy most of the time, 44 percent said they were usually happy and 17 percent said they were usually unhappy. The women who were unhappy were 29 percent more likely to die over the 10-year period, compared with the women who were happy most of the time. However, poor health at the start of the study was strongly associated with unhappiness, and the researchers found that, after they took into account the women's health, the link between unhappiness and early death went away. The study also found that some unhealthy habits, such as smoking, were linked with unhappiness, which also partly explained the link between unhappiness and early death. "Many still believe that stress or unhappiness can directly cause disease, but they are simply confusing cause and effect," Richard Peto, a co-author of the study and a professor ofmedical statistics and epidemiology at the University of Oxford in the United Kingdom, said in a statement. The new study "shows that happiness and unhappiness do not themselves have any direct effect on death rates." Because the study included only women, it's not clear whether the results apply to men as well. In fact, previous studies suggested that men and women may define happiness differently and that it's possible that happiness may be linked more strongly with an early death among men, Philipe de Souto Barreto and Yves Rolland, of the Institute of Ageing at University Hospital of Toulouse in France, wrote in an editorial accompanying the study in the journal. More research is needed in both men and women, as well as in children and older adults, to examine the link between happiness and health, they said. Copyright 2015 LiveScience, a Purch company. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
Bonnevialle N.,University Hospital of Toulouse |
Ibnoulkatib A.,University Hospital of Toulouse |
Mansat P.,University Hospital of Toulouse |
Bonnevialle P.,University Hospital of Toulouse
International Orthopaedics | Year: 2013
Purpose: The Kapandji pinning was initially described for the treatment of surgical neck fractures of the humerus in young patients. The aim of our study was to evaluate functional and radiological outcomes of the Kapandji modified technique in displaced complex three- and four-part fractures. Methods: From 2005 to 2009, 32 patients (23 three-part and nine four-part fractures) were included retrospectively. The mean age was 63 years old (range, 22-86), and the dominant shoulder was involved in 40 % of the cases. Results: At a mean follow up of 25 months (12-72), the mean absolute Constant score achieved 68 points (35-98) and adjusted score 80 % (47-100). Patients had an average forward elevation of the shoulder of 132 (80 -180), an average external rotation of 36 (0 -90), and an average internal rotation to the level of L1 (sacrum to the level of T6). The older the patients were the worst was the active anterior elevation recovery (r = -0.3; p = 0.01). Reduction and fixation of initial varus-displaced fractures was not as reliable as in valgus. In eight cases (25 %), K-wire migrations were observed and were correlated with age over 70 years old (p = 0.001). Two partial osteolysis of the greater tuberosity and two avascular necrosis of the humeral head (one was associated with a non-union) were identified. Moreover, three patients developed adhesive capsulitis. Conclusion: The Kapandji technique with fixation of tuberosities provides satisfactory results for the treatment of complex proximal fractures of the humerus. However, we do not recommend this technique for patients older than 70 years and in cases of varus displaced fractures. © 2013 Springer-Verlag Berlin Heidelberg.
Durand Bechu M.,University Hospital of Toulouse
European Journal of Emergency Medicine | Year: 2015
OBJECTIVE: To compare the perception by naive patients, emergency services clinicians and nurses, of healthcare-induced pain for procedures performed frequently by accident and emergency services. METHODS: A prospective, three-part anonymous survey, given to caregivers and patients at arrival accident and emergency services. The primary endpoint was the a-priori estimated pain score for 10 procedures performed frequently by accident and emergency services. The same estimation was performed with the ‘willingness-to–pay’ method (amount allocated a priori to avoid this pain). RESULTS: Fifty surveys were analyzed in each group, with a significant difference for pain perception between caregivers and patients concerning four procedures: local anesthesia, fracture or dislocation reduction, dressing change and abscess incision. Caregivers always overestimated pain scores compared with patients. No difference was noted for the remaining five procedures: intravenous line insertion and removal, urethral catheterization, wound suture and nasogastric intubation. CONCLUSION: Caregivers should be aware of the most feared procedures by patients to establish pre-emptive analgesia when possible, inform patients and achieve reassurance. Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved.
Jouve P.,University Hospital of Toulouse |
Bazin J.-E.,University Hospital of Toulouse |
Petit A.,University Hospital of Toulouse |
Minville V.,University Hospital of Toulouse |
And 6 more authors.
Anesthesiology | Year: 2013
Background: Effective postoperative analgesia is essential for early rehabilitation after surgery. Continuous wound infiltration (CWI) of local anesthetics has been proposed as an alternative to epidural analgesia (EA) during colorectal surgery. This prospective, double-blind trial compared CWI and EA in patients undergoing elective open colorectal surgery. Methods: Fifty consecutive patients were randomized to receive EA or CWI for 48 h. In both groups, patients were managed according to Enhanced Recovery After Surgery recommendations. The primary outcome was the dynamic pain score measured during mobilization 24 h after surgery (H24) using a 100-mm verbal numerical scale. Secondary outcomes were time to functional recovery, analgesic technique-related side effects, and length of hospital stay. Results: Median postoperative dynamic pain score was lower in the EA than in the CWI group (10 [interquartile range: 1.6-20] vs. 37 [interquartile range: 30-49], P < 0.001) and remained lower until hospital discharge. The median times to return of gut function and tolerance of a normal, complete diet were shorter in the EA than in the CWI group (P < 0.01 each). Sleep quality was also better in the EA group, but there was no difference in urinary retention rate (P = 0.57). The median length of stay was lower in the EA than in the CWI group (4 [interquartile range: 3.4-5.3] days vs. 5.5 [interquartile range: 4.5-7] days; P = 0.006). Conclusion: Within an Enhanced Recovery After Surgery program, EA provided quicker functional recovery than CWI and reduced length of hospital stay after open colorectal surgery. © 2013, the American Society of Anesthesiologists, Inc. Lippincott Williams & Wilkins.
Landi F.,Catholic University of the Sacred Heart |
Calvani R.,Catholic University of the Sacred Heart |
Cesari M.,University Hospital of Toulouse |
Tosato M.,Catholic University of the Sacred Heart |
And 4 more authors.
Clinics in Geriatric Medicine | Year: 2015
Physical function decreases with aging, which may result in adverse outcomes (eg, disability, loss of independence, institutionalization, death). Physical function impairment is a common trait of frailty and sarcopenia. These two conditions, albeit highly common, have not yet received a unique operational definition, which has impeded their implementation in standard practice. Here, we introduce a conceptual model in which sarcopenia is proposed as the biological substrate and the pathway whereby the consequences of physical frailty develop. This conceptualization may open new venues for the design of interventions against physical frailty and promote the translation of findings to the clinical arena. © 2015 Elsevier Inc.
Cognard C.,University Hospital of Toulouse |
Januel A.C.,University Hospital of Toulouse
Neurosurgery | Year: 2015
BACKGROUND: Flow disruption with the WEB technique has been developed to treat large-neck bifurcation aneurysms. OBJECTIVE: To report our anatomic angiographic results at first (3-6 months) and second (18 ± 3 months) angiographic follow-up in a series of 15 patients. METHODS: Fifteen patients (15 aneurysms) were consecutively treated in our center by 2 operators for a large-neck bifurcation aneurysm between March 2012 and February 2014. Results were evaluated by assessing WEB cage position at the aneurysm neck on angiography and high-resolution contrast-enhanced flat-panel detector computed tomography, contrast medium stagnation within the WEB and aneurysm on intraprocedural angiography, and 1-day time-of-flight magnetic resonance angiography. All aneurysms were followed up by angiography. Results at follow-up were graded as complete occlusion, neck remnant, or residual aneurysm. The 2 operators compared postprocedural and follow-up images and classified them as better, same, or worse. Subtracted images were compared in different projections to assess any WEB device compression or shape changes. RESULTS: A worsening was observed between the postprocedural and first follow-up angiography in 10 of 14 (71.5%) and in 4 of 7 (57.2%) between the first and second control angiography. Compression of the WEB cage was observed at first follow-up in 8 of 14 (57.2%) and in an additional 3 of 7 cases (42.8%) at second control. Last angiography showed complete occlusion in 1 of 14 (7.2%), neck remnant in 8 of 14 (57.2%), and residual aneurysm in 5 of 14 (35.7%) cases. CONCLUSION: This article draws attention to the risk of WEB compression and aneurysm recanalization. Future prospective studies should evaluate delayed WEB shape changes with different types of WEB devices (dual layer, single layer, single layer spherical). © 2015 by the Congress of Neurological Surgeons.