Reacting to the Government decision to drop key amendments to the Criminal Justice and Immigration Bill that would lead to the criminalisation of sex workers Dr Peter Carter, RCN General Secretary & Chief Executive said;

“We welcome the removal of these amendments, which would have further criminalised some of the most vulnerable, stigmatised and marginalised people in our society.

“Criminalisation would have driven underground those in need of properly funded and staffed healthcare support. We now hope this is the end of legislation that seeks to further criminalise sex workers. We now urge the Government to look at improving the healthcare and well-being of these workers and begin to provide pathways out for these men and women.”

Royal College of Nursing (RCN) is the voice of nursing across the UK and is the largest professional union of nursing staff in the world. The RCN promotes the interest of nurses and patients on a wide range of issues and helps shape healthcare policy by working closely with the UK Government and other national and international institutions, trade unions, professional bodies and voluntary organisations.

Royal College of Nursing Continue reading →

Despite hundreds of families being told their children have peanut allergies every year, many of the children may be able to eat peanuts safely, a study by researchers at the University of New South Wales (UNSW) and Sydney Children’s Hospital has found.

Peanut allergies occur in one in 200 infants, according to the Australasian Society of Clinical Immunology and Allergy.

“This is a really important finding,” said Dr Brynn Wainstein, a Sydney Children’s Hospital immunologist and MD candidate at UNSW.

“Because peanut allergies are potentially serious, requiring all sorts of restrictions, families can become very anxious when in fact, some of these families may be worrying unnecessarily,” Dr Wainstein said.

The study, published in the journal Pediatric Allergy and Immunology, involved 84 children with a positive result to a peanut skin-prick-test.

If a child is potentially allergic to peanut, he or she will get a hive as a result of the peanut skin-prick-test. Allergists measure the size of the hive in millimetres.

In this study, a third of the children with a hive of eight millimetres – which has been found elsewhere to be predictive of having peanut allergy – were found not to be allergic to peanuts when they took a peanut challenge. A challenge involves eating peanuts in a hospital environment.

“Diagnostic tests for peanut allergy have poor sensitivity and specificity,” the paper concludes. “Previously described diagnostic cut-off levels do not have general applicability.”

Reasons for this may include variables such as the equipment used and the pressure administered by the practitioner during a skin prick test.

“There is a population of children who have never eaten peanuts – or worse, those that eat them everyday, then have a positive peanut skin test and are told not to eat them,” said Dr Wainstein.

Dr Wainstein said many children who have never eaten peanuts and are found to have a positive peanut skin test are probably NOT allergic to peanut and will need a peanut challenge to determine if they are allergic.

“If the child is able to tolerate normal amounts of peanut every day then the result of any peanut allergy test is irrelevant.”

Allergy practitioners may need to interpret results of allergy tests in the context of their own practices, the researchers found.

“If there is a positive result, people need to ask whether it might be worth a peanut challenge in a hospital environment, especially if their child has never had an allergic reaction to peanut before,” Dr Wainstein said.

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The co-authors of the report are Dr Anthony Yee, Donna Jelley and Mary Ziegler, all from the Sydney Children’s Hospital and Associate Professor John Ziegler, a UNSW conjoint academic in the School of Women’s and Children’s Health, at the Sydney Children’s Hospital.

Contact: Susi Hamilton

University of New South Wales Continue reading →

Medtronic, Inc. (NYSE: MDT) announced its schedule of activities for Cardiostim 2008 – 16th World Congress in Cardiac Electrophysiology and Cardiac Techniques, being held June 18-21, 2008. Media and physician attendees are invited to the following:

- A symposium on REVERSE (Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction), including the first look at 18-month European data, will be held from 2-3:30 p.m. Wednesday, June 18, in Room Athena at the Acropolis Convention Center. REVERSE is the first large-scale, global, randomized, double-blind trial to evaluate cardiac resynchronization therapy (CRT) in asymptomatic or mildly symptomatic heart failure patients (NYHA Class I, II). CRT is investigational in the United States for this patient population.

- ADVANCE CRT-D (ATP Delivery for Painless ICD Therapy) is an international, prospective, randomized, controlled, single-blind trial to compare the safety and efficacy of anti-tachycardia pacing simultaneously delivered from the right and left ventricles (lower chambers of the heart, also known as Bi-ventricular delivery) vs. conventional right ventricular delivery. Data on ADVANCE CRT-D will be presented at 11:20 a.m. Thursday, June 19, in Room Thalie 3.2.

- RELEVANT is a prospective, controlled, parallel, multicenter trial investigating the effectiveness and safety of simplified programming for biventricular defibrillators (CRT-D) in patients with non-ischemic heart failure and a primary prevention ICD indication. Data on RELEVANT will be presented at 11 a.m. Wednesday, June 18, in Room 1.4.

Further, Medtronic announces that enrollments in its Sense-HF (Sensitivity of the InSync Sentry OptiVol Feature for the Prediction of Heart Failure) trial will be completed by the end of June 2008. Sense-HF is a prospective, observational, multicenter, event-driven, international study to evaluate the sensitivity and positive predictive value of Medtronic’s proprietary OptiVol® Fluid Trend data in predicting heart failure-related hospitalizations and health care utilizations associated with the signs and symptoms of worsening heart failure.

Medtronic also is supporting the following Scientific Sessions:

Wednesday, June 18

- Product Performance: Tracking, Transparency and Truth, from 2-3:30 p.m. in Room 1.4, chaired by Dr. M. Santini and Dr. E. Prystowsky
- CareLink: Prime Time for Need-Based Care, from 4-5:30 p.m. in Room Calliope 3.5, chaired by Dr. J. Morgan and Dr. P. Geelen

Thursday, June 19

- The Future of Stimulation Therapy, from 9-10:30 a.m. in Room 1.2, chaired by Dr. A. Proclemer and Dr. L. Mont
- Innovative ICD Solutions for Primary Prevention Patients, from 11 a.m.-12:30 p.m. in Room Thalie 3.2, chaired by Dr. D. Andresen and Dr. P. Mabo
- CRT Therapy: Getting the Best Outcome for Patients Through Optimization, from 4-5:30 p.m. in Room Iris 1.6, by Dr. M. Lunati and Dr. P. Delnoy

Friday, June 20

- Evidence in CRT: Where Are We and Where Are We Going?, from 9-10:30 a.m. in Room Iris 1.6, chaired by Dr. P. Ritter and Dr. A. Buxton

- Implantable Cardiac Monitors: Symptoms Do Not Tell the Full Story, from 11 a.m.-12:30 p.m. in Room Calliope 3.5, chaired by Dr. H. Heidbuchel and Dr. R. Sutton

All presentation times are local to Nice, France.

In addition to attending these data presentations and other educational and scientific sessions, Cardiostim attendees are encouraged to visit the Medtronic exhibit, composed of a Therapy area (B20), a Diagnostics and Monitoring area (A8), CareLink Lounge (B7), and Medtronic Academia Village (Gallieni 29), featuring the company’s newest products, the Vision 3D™ portfolio of implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy-defibrillators (CRT-Ds), which is making its European debut at Cardiostim after having received CE Mark in late spring 2008. The Medtronic Academia Village will offer the opportunity to meet leaders in medical technology education and training. It also includes state-of-the-art simulators for electrophysiology and device applications, as well as informative sessions from 10:30 a.m.-4 p.m. Wednesday-Friday, June 18-20.

About Medtronic

Medtronic, Inc., headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.

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The results of a new scientific study from Oxford Brookes University show that the consumption of caloric beverages has different affects on short-term total energy intake in men and women.

The study, conducted by Viren Ranawana and Professor Jeya Henry of the Functional Food Centre at Oxford Brookes University, is the first of its kind to compare the compensation effect of liquid calories on short-term energy consumption, by gender.

During the research, male and female subjects consumed orange juice from concentrate, semi-skimmed milk, a sugar-sweetened fruit drink, or a calorie-free fruit drink, one hour before their lunchtime meal. Each group was then provided with a self-selection buffet, including a variety of foods in ample quantity, and the amount of energy they then freely consumed was analysed and compared.

The results show that liquid calories are detected by the body and compensated for at the next meal. Both men and women who consumed a drink containing calories in the morning ate less energy for lunch, compared to when they had a calorie-free mid-morning drink. However, while the mean total energy intakes for men following all four beverages were similar, women demonstrated a trend for greater energy intake following the three caloric drinks compared to the control. Thus, using a preload paradigm differing in protocol to previously reported studies, the new research gives evidence of a possible energy compensation dysregulation in women compared to men.

Professor Henry, of Oxford Brookes University, said: “It is important to understand if the growth in caloric beverage consumption is contributing to the increased prevalence of obesity and diabetes. It has been suggested that sugars provided in liquid form encourage ‘passive over-consumption’ of energy from food, but this study shows that the body does compensate in the short term. Further research is now needed to understand the mechanisms involved and whether the body also compensates for liquid calorie consumption in the long term.”

Source:
Mary Harrington

The Sugar Bureau Continue reading →

Lawmakers likely will take action to prevent a 5% reduction in Medicare physician reimbursements scheduled to take effect on Jan. 1, 2007, the AP/Seattle Post-Intelligencer reports (Bridges, AP/Seattle Post-Intelligencer, 7/26). At a hearing of the House Energy and Commerce Health Subcommittee, several House members on Tuesday called for an end to the Sustainable Growth Rate formula used to calculate Medicare physician reimbursements. The SGR formula each year establishes a target for Medicare spending on physician reimbursements, and, in the event spending exceeds the target, “excess spending continues to accumulate until it is recouped by reduced updates” to reimbursements, the Medicare Payment Advisory Commission said in written testimony presented at the hearing. “To work off this excess … the SGR will call for cuts of 5% every year for nine years,” MedPAC said. According to the Congressional Budget Office, replacement of the scheduled 5% reduction in Medicare physician reimbursements with an increase in payments that accounts for higher physician expenses would cost $218 billion over 10 years (Reichard, CQ HealthBeat, 7/25). The last time Congress did not take action to prevent a scheduled reduction in Medicare physician reimbursements was in 2002, when payments decreased by 4.8% (AP/Seattle Post-Intelligencer, 7/26). A Government Accountability Office report released on Friday said reductions in Medicare payments to physicians have not resulted in a decrease in the number of providers accepting Medicare beneficiaries or made it difficult for beneficiaries to find providers (Kaiser Daily Health Policy Report, 7/24).

Burgess Bill
Rep. Michael Burgess (R-Texas) on Monday introduced a bill (HR 5866) that would replace the SGR formula with an annual increase in Medicare physician reimbursements based on the amount of physician expenses as calculated in the Medicare Economic Index. The legislation would reduce the MEI by one percentage point, a move that would result in a 2.7% increase in Medicare physician reimbursements for 2007. In addition, the bill would establish a system for physicians to voluntarily report data on quality of care measures and would implement recommendations from the Institute of Medicine to help improve Medicare Quality Improvement Organizations — private contractors that CMS pays to investigate beneficiary complaints, evaluate quality and work with physicians and hospitals to improve care. Among other provisions, the bill would require QIOs to make information on their efforts to improve care available to all providers, would ensure a minimum funding level for QIOs and would require reviews of funding for QIOs when their responsibilities increase. The legislation also would eliminate the stabilization fund established under the 2003 Medicare law to encourage health insurers to offer prescription drug plans in underserved areas and would end a system in which reimbursements for certain medical education expenses are included in payments to Medicare Advantage plans. Burgess said that he has requested CBO estimates on the cost of the bill (CQ HealthBeat, 7/25).

Comments
Committee Chair Joe Barton (R-Texas) said, “I don’t believe we can continue this Band-Aid approach to fixing this recurring physician payment problem” (AP/Seattle Post-Intelligencer, 7/26). He added, “I want to reiterate: I think it is possible to fix the system, and I think it’s possible to fix it in this Congress, which means, in the next two months.” Subcommittee Chair Nathan Deal (R-Ga.) said that the bill “starts the discussion,” adding, “I certainly support moving forward” on Medicare physician reimbursement issues (CQ HealthBeat, 7/25). Rep. Michael Ferguson (R-N.J.) said the SGR formula is “fatally flawed, and it’s time we start writing its obituary today” (AP/Seattle Post-Intelligencer, 7/26). According to Burgess, the provision in the bill that would establish a system for physicians to voluntarily report data on quality of care measures would allow Medicare beneficiaries to “assess the level of quality their prospective doctors are achieving and decide which doctor they would prefer” (CQ HealthBeat, 7/25).

Hospital Reimbursements
Meanwhile, a lobbying campaign by medical device companies and hospital groups to prompt CMS to change a proposal that would revise changes to Medicare inpatient hospital reimbursements “appears to be paying off,” the Hill reports (Young, The Hill, 7/26). CMS in April announced the proposal, which includes the closure of loopholes used by specialty hospitals and a plan to replace the current charge-based reimbursement system with a cost-based system. Under the proposal, the cost-based reimbursement system would take effect in October, and severity-adjusted reimbursements — which would pay hospitals more for the treatment of sicker patients — would take effect in October 2007. The proposal would affect reimbursements for several inpatient procedures — such as those that involve the implantation of stents, defibrillators and other medical devices (Kaiser Daily Health Policy Report, 7/17). At least 245 lawmakers over the last two months have signed letters sent to CMS Administrator Mark McClellan that raise concerns about the proposal. In addition, Senate Finance Committee Chair Chuck Grassley (R-Iowa) and other lawmakers have requested that CMS delay implementation of the proposal. On Thursday, McClellan sent a response to a letter signed by Sen. Rick Santorum (R-Pa.) and 52 other senators. McClellan writes, “We are acutely aware of the disruptions that could occur if major changes are made too quickly or inappropriately.” CMS might release a final version of the proposal as early as Tuesday, according to the Hill (The Hill, 7/26).

“Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved. Continue reading →

The American Psychiatric Association applauds recent Congressional efforts led by Rep. Danny Davis, D-Ill., to improve treatment for the large number of people with mental illnesses and substance use disorders who are currently incarcerated in U.S. jails and prisons.

The U.S. Senate passed the Second Chance Act (H.R. 1593) this week by unanimous consent. The U.S. House of Representatives passed the legislation last fall. The legislation would provide transitional assistance to ex-offenders in an effort to reduce a return to alcohol abuse. Additionally, the legislation would extend and provide a full continuum of care for treatment of substance use disorders and improve mental health screening and treatment.

“It is a national tragedy that jails and prisons have become the primary mental health care facilities in the United States today,” said APA President Carolyn Robinowitz, M.D. “This bi-partisan action represents significant steps forward in improving access to mental health services and substance abuse treatment programs for those incarcerated within the prison system.”

According to a 2006 report by the U.S. Department of Justice, entitled “Mental Health Problems of Prison and Jail Inmates,” more than half of the population incarcerated in U.S. prisons and jails – including 56 percent of state prisoners, 45 percent of federal prisoners and 64 percent of local jail inmates – were found to have a mental illness. Many of these inmates suffer from treatable disorders such as major depression, bipolar disorder and substance use disorder.

“People with mental illness, left untreated, can develop symptoms and behaviors that lead to their arrest and incarceration,” Robinowitz said. “Treatment can help prevent incarceration. Improving funding and cooperative programs between mental health care professionals and correctional agencies is a step in the right direction.”

About the American Psychiatric Association

The American Psychiatric Association is a national medical specialty society whose more than 38,000 physician members specialize in diagnosis, treatment, prevention and research of mental illnesses including substance use disorders. Visit the APA at psych and HealthyMinds. Continue reading →

Genetics and family history play a large role in a person’s risk for heart disease, but factors in diet, lifestyle and the environment are also thought to influence susceptibility to the disease. A number of studies presented at the American College of Cardiology’s 56th Annual Scientific Session look at how health-related behaviors can influence a person’s risk for cardiovascular disease. ACC.07 is the premier cardiovascular medical meeting, bringing together cardiologists and cardiovascular specialists to further breakthroughs in cardiovascular medicine.

“Because scientific advances are pushing forward at such an incredible pace, our insight into the mechanism and progression of cardiovascular disease is growing exponentially,” said Robert S. Rosenson, M.D., of University of Michigan, Preventive Cardiology, in Ann Arbor, Mich. “The research presented here further demonstrates how researchers are beginning to understand the links between cardiovascular diseases and changes in lifestyle, including quitting smoking, geographic location, diet and weight, and other related factors.”

Effects of Sustained Ingestion of Cocoa on Endothelial Function in Adults with BMI between 25-35 kg/m2: A Randomized, Single Blind, Placebo Controlled Trial (Presentation Number: 1026-34)

Flavonoids, a group of antioxidant compounds found in fruits and vegetables, are not generally labeled as essential nutrients, but play an important role in maintaining one’s health. In fact, studies indicate that there is a strong inverse correlation between the consumption of foods rich in flavonoids – such as wine, green tea, fruits and vegetables – and cardiovascular disease. Cocoa or dark chocolate products are considered one of the most concentrated sources of flavonoids among commonly consumed foods. Since endothelial function has been used extensively to evaluate the effects of foods and nutrients on cardiac risk, researchers at the Yale Prevention Research Center in Connecticut conducted a trial to assess whether the consumption of cocoa would provide any sustained benefits on endothelial function.

Specifically, the team measured the function of the brachial artery to relax and expand to accommodate increased blood flow (also know as flow mediated dilation, or FMD) in adults with a body mass index (BMI) between 25 and 35 kg/m2. In the randomized, single-blind, placebo-controlled crossover study, 45 subjects recruited from the general population of southwestern Connecticut were randomly assigned to one of the three consumption groups: eight ounces of either cocoa without sugar, cocoa with sugar or placebo. For six weeks, all participants underwent endothelial function testing, assessing FMD of the brachial artery using high frequency ultrasound before and after the daily cocoa or placebo consumption.

Cocoa was considered a successful vehicle to improve endothelial function in this trial. Of the 39 subjects who completed the trial, FMD improved significantly in the groups consuming cocoa with no sugar (2.4 %) and cocoa with sugar (1.5 %) from baseline values when compared to placebo (-0.8 %).

“In this sample of healthy adults with BMI between 25 and 35 kg/m2, dark chocolate ingestion over a short period of time was shown to significantly improve endothelial function, leading our team to believe that greater benefit may be seen through a long-term, randomized clinical trial,” said Valentine Yanchou Njike, M.D., of Yale Prevention Research Center, and co-investigator on this study. “While the findings from this study do not suggest that people should start eating more chocolate as part of their daily routine, it does suggest that we pay more attention to how dark chocolate and other flavonoid-rich foods might offer cardiovascular benefits.”

Dr. Njike will present this study on Tuesday, March 27, at 11:00 a.m. in Hall H.

Effects of Diabetes on the Prevalence of Aspirin Resistance During Low Dose Aspirin Therapy (Presentation Number: 1019-179)

Coronary heart disease deaths are often caused by platelets sticking together and forming blood clots (thrombosis) that limit blood flow within heart arteries and result in heart attacks. The use of aspirin has been shown to reduce the risk of heart attack by keeping platelets from sticking together, specifically by blocking an important enzyme, cyclooxygenase-1 (COX-1). However, recent studies suggest that some diabetic patients may be less responsive to these important benefits of aspirin. To date, no prospective analysis of the effects of aspirin dose on platelet inhibition in diabetic versus non-diabetic patients has been conducted.

Researchers from the Sinai Center for Thrombosis Research at Sinai Hospital in Maryland, studied 120 patients (30 patients with diabetes) with stable coronary artery disease, who were randomly assigned to progressively receive 81 mg, 162 mg, or 325 mg of aspirin daily for four weeks each, for a total of 12 weeks. The response to aspirin was measured by methods that directly and indirectly measure inhibition of COX-1, including: adenosine diphosphate (ADP)-induced aggregation and collagen-induced aggregation (important platelet activators playing a role in the development of thrombosis); the VerifyNow aspirin assay test, which determines how well COX-1 is blocked in platelets; and urinary thromboxane, which assesses how well COX-1 is blocked in vivo.

Overall, the prevalence of aspirin resistance was low (less than 5%) during the 81 mg aspirin treatment period using direct measurement of COX-1 inhibition. However, resistance at this dose was markedly higher in diabetic patients as measured by indirect measurements of COX-1 such as the levels of adenosine diphosphate (ADP) (27 vs.14 %), collagen-induced aggregation (27 vs. 4 %), a point-of-care VerifyNow aspirin assay (13 vs. 3 %) and urinary thromboxane levels (37 vs. 17 %).

Despite significant differences at the 81 mg aspirin dose, resistance among diabetics decreased as aspirin dose was increased. At a 325 mg daily dose, collagen-induced platelet aggregation fell significantly, from 54 to 29 percent, as did the prevalence of resistance determined by VerifyNow and urinary thromboxane results. These findings, which are being studied further, suggest that diabetic patients may receive greater benefit from higher aspirin doses.

“Aspirin is a fundamental part of the prevention and treatment of coronary heart disease, but the impact of diabetes and other demographic variables on the responsiveness of platelets to aspirin and accurate dosing remains unclear,” said Paul A. Gurbel, M.D., of Sinai Center for Thrombosis Research and lead author on this study.

“Diabetic patients with coronary artery disease exhibited a higher prevalence of resistance than non-diabetics during therapy with low-dose aspirin, indicating a higher risk of thrombosis. However, at a higher aspirin dose we observed better platelet inhibition in the diabetic patient. Our hope is that this will lead to future studies looking at the best aspirin doses for diabetic patients, moving physicians away from the one-size-fits-all approach to aspirin therapy,” according to Dr. Gurbel.

Dr. Gurbel will present this study on Monday, March 26, at 2:30 p.m. in Hall H.

Nicotine Patches are Safe to Use in Patients with Coronary Artery Disease and Stress-Induced Myocardial Ischemia (Presentation Number: 1013-70)

The most commonly used nicotine replacement products – which help relieve some of the withdrawal symptoms of smoking cessation – are nicotine patches. However, the safety of using these patches for smoking cessation among patients with heart conditions like ischemia (insufficient blood flow to the heart) or coronary artery disease (CAD) is uncertain. Therefore, researchers from the Methodist DeBakey Heart Center in Texas conducted a study to assess the effects of nicotine patches on stress-induced myocardial ischemia using single photon emission computed tomography (SPECT), an imaging technique using gamma rays to show how well blood flows to heart tissue.

In this prospective, multicenter, randomized, placebo-controlled trial, 55 participants – all of whom had greater than nine percent ischemic perfusion defect size (or PDS, a measure of the amount of ischemic heart muscle) according to SPECT scans and who smoked more than 20 cigarettes per day – were randomized to receive either 21 mg nicotine patches or placebo patches while continuing to smoke. After one week, a SPECT scan was repeated and patients were then encouraged to stop smoking and continue to use the patches. Patients underwent a third scan at week four. Nicotine and exhaled carbon monoxide (CO) levels were measured prior to each SPECT and researchers compared the results of active patch-using patients to those given a placebo.

After four weeks, when compared to baseline, nicotine patch users showed a greater rate of CO reduction (22 vs. 12 parts per million, or ppm) versus those administered placebo (23 vs. 19 ppm), which paralleled their decreased cigarette use. However, despite a significant increase in nicotine levels in the active patch group over those four weeks, no significant changes in total or ischemic PDS were observed from baseline, when compared to patients receiving the placebo patches (15 vs. 13 %, compared to 12 vs. 11 %).

“Smoking is a major cause for coronary artery disease, and quitting is the best way to reduce the level of cardiac risk. This is the first prospective study looking at the effects of nicotine patches on changes in blood flow to the heart,” said Monika J. Leja, M.D., of Methodist DeBakey Heart Center, and lead author on this study. “The results from this study show that nicotine patches do not increase stress-induced myocardial ischemia and therefore appear to be a safe method for aiding smoking cessation, even in patients with coronary artery disease and active ischemia.”

Dr. Leja will present this study on Monday, March 26, at 10:00 a.m. in room Hall H.

Evidence Does Not Support Obesity as a Relative Contraindication to Heart Transplantation (Presentation Number: 1016-108)

Recently, guidelines for listing candidates for heart transplant were revised to include obesity (body mass index (BMI) greater than 30 kg/m2) as a potential reason to deny transplantation. However, the evidence supporting this recommendation remains weak. Therefore, using data from the United Network for Organ Sharing (UNOS) Registry, researchers at Columbia University College of Physicians and Surgeons in New York examined the relationship between pre-heart transplant BMI and post-transplant survival.

In this study, investigators looked at 18,622 first-time adult transplant recipients between 1995 and 2005. Using a design developed by the National Heart, Lung, and Blood Institute, recipients were divided into standard BMI categories: underweight (less than 18.5, n=713), normal (18.5-24.99, n=7,539), overweight (25-29.99, n=6,915), obese (30-34.99, n=2,857), severely obese (35-39.99, n=515) and morbidly obese (greater than 40, n=120). Findings from the study demonstrate that while normal weight patients experienced the best survival (10.1 years), survival after transplantation in obese patients (9.6 years) was not statistically different than survival of less severely overweight patients (9.7 years).

“This analysis does not support the latest recommendations, but rather demonstrates that obese patients do not face an increased risk of death after heart transplantation,” said Mark J. Russo, M.D., M.S., of Columbia University’s International Center for Health Outcomes and Innovation Research and lead author on this study.

“This also reveals important information regarding underweight patients who appear to experience the same increased risk of death as patients in the most extreme weight categories (severely and morbidly obese), especially in the first year following transplantation,” according to Dr. Russo.

While the relationship between obesity and cardiac disease receives great attention and the latest recommendations regarding patient selection for heart transplantation focus on the effect of obesity on survival after transplant, it is known that poor nutritional status in patients with end-stage heart failure is a marker for poor prognosis.

“Findings from our current study highlight the risks that malnourished patients face after heart transplantation, which are most comparable to patients with BMIs in most extreme obesity categories,” said Yoshifumi Naka, M.D., Ph.D., of New York-Presbyterian Hospital and Columbia University College of Physicians and Surgeons and senior author on this study. “This emphasizes the need to optimize the nutritional status of patients with heart failure, and it is our hope that future consensus statements from our professional organizations should reflect these findings.”

Dr. Naka goes on to say that even higher risk heart transplant recipients, including both obese and malnourished patients, often have much improved survival after transplantation. In fact, severe end-stage heart failure patients, who without a heart transplant have a life expectancy measured in months, may live 10 or 20 years longer.

Dr. Russo will present this study on Monday, March 26, at 9:00 a.m. in room Hall H.

Adverse Cardiovascular Effects of Air Pollution in Patients With Coronary Heart Disease (Presentation Number: 805-5)

Among the many damaging effects of traffic-derived air pollution, researchers have noted that exposure to air pollution may worsen symptoms of angina (chest pain) or even trigger acute myocardial infarction (heart attack) in people with existing heart conditions. Researchers from the University of Edinburgh in the United Kingdom and Umea University in Sweden conducted a controlled-exposure study of dilute diesel exhaust to determine the direct effects of air pollution on myocardial ischemia in patients with stable coronary heart disease.

In a double-blind, randomized cross-over study, 20 patients with prior myocardial infarction were exposed to dilute diesel exhaust (particle concentration 300 ?µg/m3, similar to levels encountered in urban road traffic) or filtered air during periods of rest and moderate exercise in a controlled-exposure facility. During the exposure, myocardial ischemia was quantified by ST segment analysis using continuous 12-lead electrocardiography.

Overall, exposure to diesel exhaust caused a three-fold increase in maximal ST segment depression (-49 vs. -17 ?µV) among participants. While exercise-induced ST segment depression was present in all patients, there was a marked increase in ischemic burden during exposure to diesel exhaust (-22 vs. -8 ?µV). During periods of exercise, participants experienced a similar increase in heart rate regardless of exposure to either diesel exhaust or filtered air.

“While substantial evidence links exposure to air pollution with cardiovascular disease, these observations are limited by the effect of potential confounding environmental and social factors,” said David Newby, M.D., of the University of Edinburgh and lead investigator on this study. “In a carefully controlled study, we report that brief exposure to diesel exhaust at levels encountered in urban road traffic promotes myocardial ischemia in patients with existing heart conditions. Our findings strengthen the observation that exposure to combustion-derived air pollution is associated with adverse cardiovascular events, including acute myocardial infarction. Environmental health policy interventions targeting reductions in urban air pollution should be considered in order to decrease the risk of adverse cardiovascular events.”

Dr. Nicholas L. Mills will present this study on Monday, March 26, at 7:30 a.m. in Room 265.

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The American College of Cardiology (acc/) represents the majority of board certified cardiovascular physicians in the United States. Its mission is to advocate for quality cardiovascular care through education, research, promotion, development and application of standards and guidelines- and to influence health care policy. ACC.07 and the i2 Summit is the largest cardiovascular meeting, bringing together cardiologists and cardiovascular specialists to share the newest discoveries in treatment and prevention, while helping the ACC achieve its mission to address and improve issues in cardiovascular medicine.

Contact: Leslie Humbel

American College of Cardiology Continue reading →

The U.S. Food and Drug Administration approved Cuvposa (glycopyrrolate) Oral Solution to treat chronic severe drooling caused by neurologic disorders in children ages 3 years to 16 years.

Drooling is normal in infants. But a significant proportion of the developmentally disabled population experiences drooling caused primarily by neuromuscular dysfunction that makes it hard to swallow. Cuvposa reduces drooling by lowering the volume of saliva produced.

Glycopyrrolate was approved decades ago to treat peptic ulcers and reduce salivation in patients under anesthesia. Until now, glycopyrrolate has been used on an off-label basis to treat drooling in the developmentally disabled population, but in a different dosage form than the approved product. A drug is said to be used off-label when a physician prescribes its use in a different way than described in the FDA-approved drug label.

In 2001, the FDA held an advisory committee meeting to discuss how best to develop products for drooling with ethically and scientifically sound trials in children who have neurological disorders. Utilizing the advice provided, the FDA has been able to move forward in addressing the needs of this population.

“Cuvposa provides an important therapy for controlling salivation in patients with neurologic disease,” said John Jenkins, M.D., director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research. “FDA approval not only ensures that the product meets modern standards for safety, effectiveness, quality and labeling; but, also results in a more suitable dose form for this patient population.”

The FDA drug approval process provides a review of product-specific information that is critical to ensuring the safety and efficacy of a finished drug product. For instance, the applicant must demonstrate that its manufacturing processes can reliably produce drug products of expected identity, strength, quality, and purity. FDA’s review of the applicant’s labeling ensures that health care professionals and patients have the information necessary to understand a drug product’s risks and its safe and effective use.

When used off label, oral tablets of glycopyrrolate had to be crushed to treat drooling in children with neurological disorders. Cuvposa is a flavored oral solution that is easier to administer and provides the optimal dose for each patient.

In clinical trials of Cuvposa glycopyrrolate oral solution, 78 percent of the children on the drug reached clinical improvement in drooling compared with 19 percent of those given an inactive substance (placebo).

Common adverse reactions reported with glycopyrrolate are dry mouth, constipation, flushing, and urinary retention.

Cuvposa (glycopyrrolate) Oral Solution is marketed by Shionogi Pharma Inc. of Osaka, Japan.

Source: U.S. Food and Drug Administration

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NOVIAN Health Inc. has developed an Interstitial Laser Therapy (ILT) device. In its initial application, the device, used to treat fibroadenomas (benign tumors) of the breast with tumor sizes up to 20 mm, was granted clearance from the U.S. Food and Drug Administration on May 2, 2007.

“We are extremely pleased to have received FDA clearance, ” said Chip Appelbaum, President and CEO of NOVIAN Health. “This allows us to begin the commercialization phase of establishing and operating treatment sites, which will offer women an alternative to traditional surgery, as well as to expand our clinical development efforts in malignant tumors.” Previously known as Kelsey Inc., the company is now introducing NOVIAN Health as its new name, a reflection of the company’s mission in creating a new path in healthcare.

Lasers have been used successfully to ablate tissue in other areas of medicine, such as prostate cancer. The NOVIAN Health device applies this proven technology to treating non-malignant breast tumors. ILT is a micro-invasive technique that uses needle probes to deliver laser energy into the tumor, causing the tumor to shrink. ILT’s major advantages over the traditional lumpectomy are:

– A micro-invasive surgical process – access via two small needles rather than a scalpel wound
– Local anesthesia rather than general anesthesia or IV sedation
– Minimal post-operative scar tissue
– Reduced risk of surgical complication
– Shorter preparation and quicker recovery time for patients
– Does not preclude any future medical or surgical treatment options

“Thousands of women in the U.S. find breast tumors each year, and about 80 percent of all breast tumors are benign,” said Dr. Kambiz Dowlat, Professor of Surgery at Rush Medical College, Rush University Medical Center and founder of NOVIAN Health. “The traditional treatment for removing these tumors is a lumpectomy. Many women are hesitant to undergo this invasive surgery and, until now, that was really their only option. We believe that breast ILT provides women a better option to treat many tumors.”

NOVIAN Health Inc., located in Chicago, is a small, privately held company with proprietary technology for the treatment of tumors using Interstitial Laser Therapy (ILT). The company has developed, tested, and patented a micro-invasive surgical process that uses ILT (controlled heating) for the ablation of breast tumors as an alternative to the surgically invasive, traditional “lumpectomy.” ILT offers significant advantages over surgical removal including minimal scarring, quicker recovery times, and only requiring local anesthesia. NOVIAN Health recently received its first FDA 510k clearance and expects to offer its technology at centers around the country. Their plan is to launch several centers nationwide that will be associated with existing surgical practices.

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Teenagers who consume a lot of added sugars in soft drinks and foods may have poor cholesterol profiles – which may possibly lead to heart disease in adulthood, according to first-of-its-kind research reported in Circulation: Journal of the American Heart Association.

“Added sugars” are any caloric sweeteners added to foods or beverages by the manufacturer during processing or the consumer.
The National Health and Nutrition Survey (NHANES) of 2,157 teenagers (ages 12 to 18) found the average daily consumption of added sugars was 119 grams (28.3 tsp or 476 calories), accounting for 21.4 percent of their total energy.

The American Heart Association recently recommended a specific upper limit for added sugars intake, based on the number of calories an individual needs throughout the day, according to their energy expenditure, sex and age. For example, an appropriate amount for an individual with an energy requirement of 1,800 calories per day (an average teenage girl ages 14-18 might be in this calorie range) would be no more than 100 calories from added sugars. An individual with a requirement of 2200 calories per day should eat or drink no more than 150 calories from added sugars.

Teens consuming the highest levels of added sugars had lower levels of high density lipoprotein levels (HDL), the good cholesterol, and higher levels of triglycerides and low density lipoproteins (LDL), the bad cholesterol.

“This is the first study to assess the association of added sugars and the indicators of heart disease risk in adolescents,” said Jean Welsh, MPH, PhD, R.N., study author and post-doctoral fellow at Emory University in Atlanta, Ga. “The higher consumers of added sugar have more unfavorable cholesterol levels. The concern is long-term exposure would place them at risk for heart disease later in adulthood.”

Teenagers with the highest levels of added sugar consumption at more than 30 percent of total energy had 49.5 milligrams/deciliter (mg/dL) compared to 54 mg/dL of HDL levels in those with the lowest levels of added sugar consumption – a 9 percent difference.
Previous studies indicate that the largest contributors of added sugars to the diet are sugary beverages such as sodas, fruit drinks, coffees and teas, Welsh said.

“Adolescents are eating 20 percent of their daily calories in sugars that provide few if any other nutrients,” she said. “Sweet things have lost their status as treats.”

The study included dietary recall from one 24-hour period that researchers merged with sugar content data from the U.S. Department of Agriculture My Pyramid Equivalents Databases. Researchers estimated cardiovascular risk by added sugar consumption of less than 10 percent up to more than 30 percent of daily total energy. Two days of dietary data were used among a subsample of 646 adolescents and the key findings remained consistent:

– Those with higher intake of added sugar had higher LDL levels of 94.3 mg/dL compared to 86.7 in those with the lowest levels, a 9 percent difference.

– Triglyceride levels in those with the highest consumption were 79 mg/dL compared to 71.7 mg/dL among the lowest, a 10 percent difference.

– Overweight or obese adolescents with the highest level of added sugar consumption had increased signs of insulin resistance.

“While Americans appear to be working hard to lower their intake of saturated fats, there is not the same awareness when it comes to added sugars,” Welsh said. “The intake of added sugars is positively associated with known cardiovascular risk factors. Added sugars play a significant role in the U.S. diet, contributing substantially to energy intake without contributing important nutrients to the diet.”
Adolescents and adults should “use the labels of the drinks and food they consume to become familiar with the amount of sugar in them,” Welsh said. “Replacing sugar laden drinks with water is one way to substantially reduce sugar and calorie intake.”

Physicians also need to ask adolescents about their sugars intake and guide them to better choices, she said.

Because the researchers used cross-sectional data, they don’t know if added sugars intake caused the differing cholesterol levels, only that they are linked. They also assessed the diet using one 24-hour recall of intake, which may not reflect on a person’s usual intake.
Long-term studies are needed to fully understand the effect that added sugars consumption in adolescence has on cardiovascular disease risk in adulthood, Welsh said.

Co-authors: are Andrea Sharma, Ph.D., M.P.H.; Solveig A.Cunningham, Ph.D.; and Miriam B. Vos, M.D., M.S.P.H. Author disclosures are on the manuscript.

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