High-dose statin treatment around the time of cardiac surgery does not reduce the rate of in-hospital complications after cardiac surgery, according to the results of a new study.
The lack of benefit in the Statin Therapy In Cardiac Surgery (STICS) trial is a bit of a surprise, said lead investigator Barbara Casadei, MD, DPhil, from the John Radcliffe Hospital, University of Oxford, UK.
IBA (Ion Beam Applications SA), the world’s leading provider of proton therapy solutions for the treatment of cancer recently announced that it had received combined clearances from the U.S. Food and Drug Administration (FDA) that will enable IBA to market-launch the proton therapy specific Cone Beam Computed Tomography (CBCT) system. IBA has received clearance from the FDA for its imaging platform adaPT Insight* (FDA 510(k) K132847) and for the Compact Gantry Beam Line (FDA 510(k) K132919). Those combined clearances will enable the CBCT to be marketed in IBA’s two Proton Therapy versions, Proteus®PLUS and Proteus®ONE, in 2014 and 2015 respectively.
As a component of IBA’s Image Guided Proton Therapy (IGPT) system, CBCT provides 3D imaging for increased accuracy in patient treatment. It is fully integrated with IBA’s imaging platform adaPT Insight to offer fast 6D corrections of patient positioning for the Proteus®PLUS and Proteus®ONE proton therapy systems. IBA’s first CBCT is at the validation phase and the first clinical use is expected for the second half of 2014.
Olivier Legrain, Chief Executive Officer of IBA commented: “We are delighted to be the first company to receive marketing authorization from the FDA for the proton therapy specific CBCT technology. The development of imaging capabilities is critical to the expansion of the use of proton therapy in new cancer indications and IBA has developed advanced radiation therapy solutions that improve the overall treatment experience for both clinicians and patients. CBCT is just one example of the latest technological advancements achieved by IBA as we maintain our unrivalled position as the world’s leader in the innovation and delivery of proton therapy.”
On September 11 IBA announced the signing of a global collaboration with Philips Healthcare. The collaboration covers sales, marketing, research and development (R&D) of imaging and therapy solutions in oncology. By merging their respective expertise in therapy and image guidance systems, IBA and Philips will innovate with an integrated vision for more efficient, personalized cancer care. Leveraging high quality imaging and proton therapy offers the potential to increase confidence in the diagnosis and treatment of cancer, reduce short- and long-term side-effects and potentially enhance the quality of life of the patient before, during and after treatment, while reducing the cost of treatment for the healthcare system. The collaboration will also enable both organizations to mutually leverage technologies and solutions: IBA will benefit from Philips diagnostic imaging products offered to oncology care centres, while Philips will leverage IBA proton therapy solutions within its offering for customers in select markets around the world. The commercial collaboration also includes an integrated offering for Molecular Imaging Centres, combining IBA’s expertise in PET radioisotope production centres with Philips’ imaging and diagnostics expertise.
www.iba-worldwide.com
Population Council scientists and their partners have found that their proprietary microbicide gel is safe, stable, and can prevent the transmission of multiple sexually transmitted infections (STIs) in both the vagina and rectum in animals: HIV, herpes simplex virus 2 (HSV-2), and human papillomavirus (HPV). The USAID-funded study also provides the first data that the gel is effective against multiple strains of HIV, and has a window of efficacy in the vagina against all three viruses of at least eight hours prior to exposure. A Phase 1 safety trial of the gel started enrollment in May 2014.
The gel, known as MZC, contains two potent antiviral agents: MIV-150 and zinc acetate. MIV-150 is an enzyme inhibitor that prevents HIV-infected cells from producing new virus, and zinc acetate is an antiviral agent with known activity against HIV and HSV-2. These compounds are mixed in a base of carrageenan, a compound derived from seaweed that has also been shown to have potent activity against HPV. Infection with HSV-2 or HPV is associated with increased risk of HIV infection. Microbicides that target HIV, HSV-2, and HPV may more effectively limit HIV transmission than those that target HIV alone.
In this study, Council scientists and their partners used macaque and mouse models to examine whether MZC gel could prevent the vaginal and rectal transmission of SHIV-RT, HSV-2, and HPV. SHIV-RT is a human/simian immunodeficiency chimeric virus combining the HIV reverse transcriptase (RT) within SIV (the monkey version of HIV). MIV-150 and zinc acetate inhibit HIV-RT via different mechanisms of action. Pre-clinical testing in animals is required by the FDA and is important to ensure the highest level of safety and to build the evidence base for potential efficacy in humans.
Kessler stroke researchers and colleagues have identified an association between over-optimistic estimation of medication self-administration (MSA)ability and memory loss among stroke survivors. Results indicate that assessing patients for their ability to estimate medication skills accurately may predict memory disorder.
Researchers compared 24 stroke survivors with 17 controls, using the Hopkins Medication Schedule to assess MSA, the Geriatric Depression Scale to assess mood, and the Hopkins Verbal Test and Mini-Mental State Examination to assess memory. Results showed that stroke survivors over-estimated their MSA in comparison to controls. Over-estimation of MSA correlated strongly with verbal memory deficit.
Strategies that enhance adherence to medication are a public health priority.
Oncologists at UC San Diego Moores Cancer Center are to meld magnetic resonance imaging (MRI) technology with a traditional ultrasound prostate exam to create a three-dimensional map of the prostate that allows physicians to view growths that were previously undetectable.
An ultrasound machine provides an imperfect view of the prostate, resulting in an under-diagnosis of cancer, said J. Kellogg Parsons, MD, MHS, the UC San Diego Health System urologic oncologist who, along with Christopher Kane, MD, chair of the Department of Urology and Karim Kader, MD, PhD, urologic oncologist, is pioneering the new technology at Moores Cancer Center.
MRI technology was used to identify and locate a probable tumour during a targeted prostate biopsy for a patient who had previously had multiple negative biopsies but had persistently high PSA levels. Resulting biospy confirmed presence of high-grade cancer.
Studies by vascular biologists at The Johns Hopkins Hospital could lead to new treatments for vascular disease.
This work was led by Dan Berkowitz, M.B.B.Ch., and Lewis Romer, M.D., both professors of anesthesiology and critical care medicine at the Johns Hopkins University School of Medicine. The studies focus on the balance between (good) nitric oxide, and (bad) oxidants
Researchers from Penn Medicine have developed a safe and effective technique for inducing sleep in patients with severe obstructive sleep apnea. The new procedure, known as drug-induced sleep endoscopy (DISE), uses progressive doses of anesthesia to pharmacologically induce sleep to the point of the obstruction-causing apnea in a short time frame without a dip in blood oxygen level and with few side effects.
The Penn team recently tested the procedure in 97 patients with severe sleep apnea who were candidates for transoral robotic resection of the tongue, the removal of a section of the tongue where it meets the epiglottis to prevent the tongue from obstructing the airway during sleep, the most common surgical procedure for the treatment of severe sleep apnea.
TransOral Robotic Surgery (TORS) was originally developed by Penn head and neck surgeons for the removal of benign and malignant tumours of the mouth and throat.
The results of a Phase 3 clinical trial involving UCL researchers, called REMoxTB, has found that replacing one of the drugs with the antibiotic moxifloxacin in the standard six-month treatment regimen did not allow the treatment time for tuberculosis (TB) patients to be shortened to four months.
The trial confirmed the safety of daily moxifloxacin over four months of therapy. Researchers concluded that the safety of moxifloxacin, combined with its activity against TB, supports the continued clinical testing of moxifloxacin as a component of other novel regimens.
The American Association for Thoracic Surgery (AATS) has released new evidence-based guidelines for the prevention and treatment of perioperative and postoperative atrial fibrillation (POAF) and flutter for thoracic surgical procedures.
‘These guidelines have the potential to prevent the occurrence of atrial fibrillation in thousands of patients who undergo lung surgery each year. The AATS is committed to its goal of improving the care of patients around the globe who undergo cardiothoracic surgery each year. These guidelines will have a very positive impact on the outcomes of these patients,’ commented David J. Sugarbaker, MD, Director of The Lung Institute and Professor of Surgery, Baylor College of Medicine in Houston, TX, and Past President of the AATS.
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, occurring in one to two percent of the general population. Many studies show an increase in mortality in patients with POAF, although it is not clear to what extent the arrhythmia itself contributes to mortality. POAF is also associated with longer intensive care unit and hospital stays, increased morbidity, including strokes and new central neurologic events, as well as use of more resources. Patients who develop POAF tend to stay two to four days longer in the hospital.
A task force of sixteen experts, including cardiologists, electrophysiology specialists, anaesthesiologists, intensive care specialists, thoracic and cardiac surgeons, and a clinical pharmacist, was invited by the AATS to develop evidence-based guidelines for the prevention and treatment of perioperative/postoperative atrial fibrillation and flutter (POAF) for thoracic surgical procedures.
‘Patients with pre-existing AF represent a high-risk population for stroke, heart failure, and other POAF-related complications,’ says Gyorgy Frendl, MD, PhD, of the Department of Anesthesiology, Perioperative Critical Care and Pain Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA, who co-chaired the task force. ‘Some may present with valvular heart disease. The management of their antiarrhythmic medications and their perioperative anticoagulation may pose a challenge.’
The task force examined evidence and adapted a standard definition for POAF. The task force also developed a set of recommendations for how to:
Define and diagnose POAF
Use physiologic (ECG) monitoring of patients at risk for POAF
Best manage and treat POAF
Use rate control and antiarrhythmic drugs, considering their mechanism of action, side effects, and limitations
Best manage the patient with preexisting AF
Manage anticoagulation for new-onset POAF
Manage (long-term) and how to follow patients with persistent new-onset POAF
Among the task force’s main recommendations are:
Both electrophysiologically-documented AF and clinically diagnosed AF should be included in the clinical documentation and reported in clinical trials/studies.
Patients at risk for POAF should be monitored with continuous ECG telemetry postoperatively for 48 to 72 hours (or less if their hospitalization is shorter) if they are undergoing procedures that pose intermediate or high risk for the development of postoperative AF or have significant additional risk factors for stroke, or if they have a history of preexisting or periodic recurrent AF before their surgery.
In patients without a history of AF, who show clinical signs of possible AF while not monitored with telemetry, ECG recordings to diagnose POAF and ongoing telemetry to monitor the period of AF should be immediately implemented.
Recent evidence suggests that some prevention strategies, such as avoiding beta-blockade withdrawal for those chronically on those medications and correction of serum magnesium when abnormal, may be effective in all patients for reducing the incidence of POAF, but that some of these strategies are underused. The task force recommends that:
Patients taking beta-blockers before thoracic surgery should continue them (even if at reduced doses) during the postoperative period to avoid beta-blockade withdrawal.
Intravenous magnesium supplementation may be considered to prevent postoperative AF when serum magnesium level is low or it is suspected that total body magnesium is depleted.
Digoxin should not be used for prophylaxis against AF.
Catheter or surgical pulmonary vein isolation (at the time of surgery) is not recommended for prevention of POAF for patients who have no previous history of AF.
Complete or partial pulmonary vein isolation at the time of (even bilateral) lung surgery should not be considered for prevention of POAF, as it is unlikely to be effective.
For those patients at increased risk for the development of POAF, preventive administration of medications (diltiazem or amiodarone) may be reasonable. However, these strategies may not be useful for all thoracic surgical patients.
Guidelines for the management of patients with preexisting AF include: criteria for obtaining cardiology consults for preoperative AF; perioperative management of anticoagulation for patients on long-term anticoagulation (warfarin or new oral anticoagulants); postoperative resumption of anticoagulation; and postoperative follow-up. Specifically, catheter or surgical ablation of AF is not recommended for management of patients with postoperative AF after thoracic surgery.
‘These guidelines are best used as a guide for practice and teaching. The applicability of these recommendations to the individual patient should be evaluated on a case-by-case basis, and only applied when clinically appropriate,’ comments Dr. Frendl and the task force. ‘In addition, these guidelines can serve as a tool for uniform practices, to guide preoperative evaluations, and form the basis of large, multicenter cohort studies for the thoracic surgical community.’ EurekAlert
Results of a survey of more than 30,000 nurses across Europe show that nurses who work longer shifts and more overtime are more likely to rate the standard of care delivered on their ward as poor, give a negative rating of their hospitals safety and omit necessary patient care.
Led by researchers at the University of Southampton and the National Nursing Research Unit (NNRU) at King
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