Archive for April, 2008
HPV Viruses May Play a Role In Causing Lung Cancer
Papers presented at the 1st European Lung Cancer Conference demonstrate that common viruses such as HPV may play a role in the development of lung cancer. While smoking is the leading risk factor in developing lung cancer, other factors do play a role including radon, mineral dust exposure and now exposure to certain viruses.
Dr. Arash Rezazadeh and colleagues from the University of Louisville, Kentucky, USA, presented an article that described the results of a study on 23 lung cancer samples from patients in Kentucky.
The researchers found six samples that tested categorical for the presence of like a man papilloma virus (HPV), the virus that also causes many cases of cervical cancer. One was later shown to have existence a cervical cancer that had spread to the lungs. Of the remaining 5 virus-positive samples, two were HPV type 16, two were HPV type 11 and single in kind was HPV type 22.
All subjects were smokers. However, evidence that 6 of 23 should evidence of HPV would warrant a larger sample and further investigation to determine the role HPV may be delivered of in the unravelling of lung cancer. Further, samples should be taken from subjects who have never smoked or been subjected to other common risk factors.
A second paper by Israeli researchers suggests that measles virus may also exist a factor in some lung cancers. Their study included 65 patients with non-small-cell lung cancer, of whom more than half had evidence of measles virus in tissue samples taken from their tumors. The lead author, Prof. Samuel Ariad from Soroka Medical Center in Beer Sheva, Israel suggests that measles is most likely acts in modifying the effect of other carcinogens and not as a causative substitute by itself. - Reported by The Healing Project
2 commentsDoes Chocolate Reduce Diabetes-Related Heart Disease Risk?
Researchers are looking for postmenopausal Type 2 anti-diabetic women that might be willing to eat a bar of chocolate every day since a year.
"Cocoa is rich in compounds called flavonoids, which are thought to benefit the heart."
The theory of adding flavonoids to the diet is being tested — will it provide additional protection against heart disease?
Heart disease risk rises significantly after menopause and having diabetes raises that risk by more than three times.
"Lead researcher Professor Aedin Cassidy said: "Despite postmenopausal women being at a similar risk to men for developing cardiovascular disease, to date they are under-represented in clinical trials."
"We hope to show that adding flavonoids to their diets will provide additional protection from heart disease and give women the opportunity to take more control over reducing their risk of love ailment in the future."
The researchers are not recommending that patients increase their consumption of chocolate yet.
University of East Anglia on Chocolate and Heart Disease
There are certain things we know we must do to reduce the risk of heart disease. Eating chocolate every day for a year is not normally individual of them. But in the first clinical trial of its kind, researchers at UEA will be asking postmenopausal women with type 2 diabetes to do just that.
So does this mean chocolate is now good for us? Not exactly.
Cocoa, the main ingredient of chocolate, is a rich source of compounds called flavonoids, which have been shown to reduce risk factors for heart disease. The process of making chocolate from cocoa destroys the majority of these compounds, however. Until now, that is.
With the help of a Belgian chocolatier, a specially formulated chocolate bar has been developed for this study. It will provide a higher dose of the protective compounds in cocoa than found in standard chocolate. To maximise the potential benefits of the chocolate bar, Soy has furthermore been added. Soy is another great source of flavonoids, which have been shown to benefit the heart-health of women.
“Despite postmenopausal women being at a similar risk to men for developing cardiovascular disease, to date they are under-represented in clinical trials,” said Prof Aedin Cassidy, the lead researcher and Professor of Diet and Health at UEA.
“We hope to show that adding flavonoids to their diets will provide additional protection from heart disease and give women the opportunity to take more control over reducing their risk of heart disease in the future.”
Funded by Diabetes UK, the study is led through UEA and includes partners at the Elsie Bertram Diabetes Centre, Norfolk and Norwich University Hospital (NNUH) and the Institute of Food Research (IFR).
The theory behind the research is that adding flavonoids to the diet may give added safety against purpose disease attached top of that provided by prescription drugs. This is particularly important for the women who are the focus of this research, as deaths due to heart disease increase rapidly after the menopause and having type 2 diabetes increases this risk by a further three-and-a-half times.
As part of the study, participants will have their risk of heart disease tested on five occasions during the year to see whether change occurs. These tests will take place at UEA or the NNUH and take a journey expenses will be reimbursed.
“The hypothesis of this exciting study is that flavonoids, in this case compounds found in cocoa and soy, may improve the level of protection against heart disease over and above that provided by conventional drugs,” said Dr Ketan Dhatariya, one of the researchers and a consultant in diabetes at the Norfolk and Norwich University Hospital.
“If the trial confirms this, it could have a far-reaching impact on the advice we give to postmenopausal women who have type 2 diabetes.”
Launching the study on Monday April 28, the researchers at UEA will be recruiting 150 women under the age of 70 who have type 2 diabetes and have not had a period for at least one year (and are not taking HRT). Volunteers also need to have been prescribed cholesterol lowering drugs (statins) for at least one year. Before starting the study, a screening visit will be arranged and the GP of the interested volunteers contacted for their approval. All the results of the screening visit will be forwarded to the participant’s GP.
1 commentFirst gene therapy for inherited blindness show vision improvement
New revolutionary gene therapy shows safe experimental treatment improvement from the world’s first clinical trial to test a revolutionary gene therapy handling for a type of inherited blindness
New breakthrough gene therapy shows that inherited blindness may be treated, as the clinical trial, conducted by the researchers from UCL Institute of Ophthalmology and Moorfields Eye Hospital, demonstrates that gene therapy may be a safe treatment for inherited blindness.
The results, published today in the New England Journal of Medicine, show that the verified handling is safe and can improve sight. The findings are a landmark for gene therapy technology and could have a significant impact on future treatments for eye disease.
The trial, which received funding from the Department of Health, represented a world first when it began in February 2007. It involves young patients with a condition called Leber’s congenital amaurosis (LCA), a rare inherited eye distemper caused by an abnormality in a gene called RPE65. The condition appears at birth or in the first few months of life and causes progressive deterioration and loss of vision. There are currently no effective treatments available. The trial’s purpose was firstly to find out whether gene therapy for retinal disease is safe, and secondly to find out if it can benefit vision in young adults who already have advanced retinal disease.
Crucially, the experimental treatment was found to cause no margin effects in this trial. Following the management, the three patients involved underwent a series of tests designed to establish the effects of the therapy on vision. They all achieved levels of vision at least equivalent to before the operation, but one sufferer (Steven Howarth, 18) benefited from significantly improved night vision. This was demonstrated by his ability to negotiate a specially constructed simulation of a night-time street scene. Before the operation he completed the task slowly and made several mistakes, but following the surgery he was able to navigate quick and without mistakes.
The researchers believe the operation’s success for this particular patient could be because his disease had not progressed to the same extent as the others. The other two patients may also still benefit from the new treatment in the coming time, but it will be some time before this becomes apparent. The team have already begun to proof the technique in junior patients, where they hope to achieve even better results.
The team conducting the trial, from the joint Moorfields Eye Hospital/UCL Institute of Ophthalmology NIHR Biomedical Research Centre, is led by Professor Robin Ali and includes eye surgeon Mr James Bainbridge and retinal specialist Professor Tony Moore. The technique used in the trial involved inserting healthy copies of the missing RPE65 gene into the cells of the retina to help them to function normally. This involved an operation what one. delivered the normal genes to the retina, using a harmless virus or ‘vector’ to carry the gene into the cells – the vector was manufactured by US gathering Targeted Genetics.
Commenting on the tools and materials, Professor Ali said: “Showing for the first time that gene therapy can work in patients with eye disease is a very significant milestone. This trial establishes proof of principle of gene therapy for inherited retinal disease and paves the way for the development of gene therapy approaches for a broad range of eye disorders.”
Explaining the technique, Mr James Bainbridge, who leads the surgical team, said: "We developed surgical techniques to enable access to the cells beneath the retinas of patients, using a real fine needle to deliver the modified virus in a controlled retinal detachment that resolves for the reason that the vector is absorbed. It is tremendously exciting to see that this technique is safe in an extremely fragile tissue and can improve vision in a condition previously considered wholly untreatable."
Professor Moore said: “It is very encouraging to see that this treatment can work, even in young adults who have severely advanced disease. We anticipate an even better outcome in the younger patients we are now beginning to involve as the trial proceeds, as we will be treating the disease in the early stages of its development.”
Professor Ali added: “These results give us great confidence that this technique is safe and can bring real benefit to patients with impaired vision. While we’re very excited about the improvement in Steven’s illusion, it’s important to emphasise that gene therapy is still an experimental treatment not yet generally available to patients. The technique will be tested in other patients with LCA and we also hope to begin trials for other forms of retinal disease in the future.”
The results from this gene therapy trial are the first significant outcome from the establishment of the centre, and strongly demonstrate its purpose - to conduct translational research designed to take advances in basic medical research from the laboratory to the clinic, enabling patients to benefit more quickly from new scientific breakthroughs.
1 commentImmunotherapy Shows Promise For Lung Cancer Treatment
Long-term clinical trial results that were presented last Friday at the 1st European Lung Cancer Conference demonstrate that MAGE-A3 ASCI (Antigen-Specific Cancer Immunotherapeutic), an immune-boosting treatment for lung cancer patients, reduces the risk of relapse after lung cancer surgery to the same extent during the time that chemotherapy.
Prof. Johan Vansteenkiste from University Hospital Gasthuisberg in Belgium described the results after 44-months follow-up from a double-blind, placebo-controlled trial in 182 patients with non-small-cell lung cancer — the most common form of the disease.
"The aim is to help the body immune hypothesis to recognize the MAGE-A3 antigen and therefore eliminate the cancer cells that express MAGE-A3," explains Prof. Vansteenkiste. "In other words, it is a kind of treatment method that makes the body immune system specifically attack the lung cancer cells."
After 44 months, 69 of 182 patients had experienced a recurrence of their cancer, including 57 deaths. Those given the MAGE-A3 injections had longer on average before their cancer recurred, were less likely to have any recurrence, and were in a less degree likely to die.
"Surgical resection is the standard treatment for patients with early stage lung cancer, but after complete resection about 50% will relapse and die from their cancer," says Prof. Vansteenkiste. "Postoperative chemotherapy is able to improve cure rates, but is sometimes poorly tolerated by patients recovering from thoracic surgery. In addition, not all patients are sudden to receive chemotherapy.
Most patients solitary experience suave reactions at the injection site and fever within 24 hours of the injection, he explained. "Therefore, it is accordant for long-term maintenance treatment and for most patients, including older patients or patients in weak physical condition after surgery, allowing them to live a normal life whilst on cancer treatment." A large Phase III trial of the therapy, named MAGRIT, is now underway. - Reported by The Healing Project
No commentsParkinson’s Drugs Offer Better Muscle Control, Worse Side Effects
Compared to older drugs for Parkinson disease, a newer class of medications called dopamine agonists might be advantage at preventing some of the disabling muscle mastery problems associated with the disease and its treatment, a new review of recent studies concludes.
However, patients who take dopamine agonists suffer from an increase in numerous side effects - from sleepiness to nausea to hallucinations in some cases - and are more likely to drop out of treatment than those who take the older treatment levodopa or no drugs at all.
"Patients taking dopamine agonists were more than two times as likely to desert treatment, suggesting that the side effects were severe enough to have a meaningful impact on patients’ quality of life, outweighing the muscle control problems," said Rebecca Stowe of the University of Birmingham, the reconsider’s outstrip author.
The review of studies appears in the latest issue of The Cochrane Library, a publication of The Cochrane Collaboration, each international organization that evaluates medical research. Systematic reviews like this one draw evidence-based conclusions about medical practice after considering both the content and quality of existing medical trials on a topic.
Parkinson’s disease is a degenerative disease of the nervous system that can enervate a person’s movements and speech. Dopamine agonists, drugs that stimulate the production of the important neurotransmitter dopamine in the brain, are increasingly used as first-line therapies for the disease.
Levodopa, an older drug that can be metabolized in the brain to produce dopamine, is also used widely in Parkinson’s treatment. However, patients who use levodopa over long periods can develop painful, distorting, unwilling muscle spasms and repetitive movements.
Stowe and colleagues reviewed 29 studies that included 5,247 patients who were in the early stages of Parkinson’s disease and did not show any significant signs of muscle and movement problems. Some of the studies compared dopamine agonists only with levodopa, while some used a combination of dopamine agonists and levodopa.
There was no significant difference in the death rates between patients using dopamine agonists and those who did not take the drugs, the researchers found.
"Importantly, the review highlights that the balance of risks and benefits of dopamine agonists remains unclear," said Stowe, who called for further studies in continuance patients’ overall quality of life and the economic costs of the treatments.
Researchers are tracking another troubling power of dopamine agonists - their potential link to impulsive behaviors such as uncontrolled gambling and hypersexuality. Dr. Joseph Jankovic, a Parkinson’s disease and motor disorders expert at the Baylor College of Medicine, said dopamine agonists "play an important role in triggering these nonmotor symptoms" that appear in some patients with Parkinson’s disease, particularly men and those who develop the disease as younger adults.
The Cochrane review disclosed that co-author Carl E. Clarke, of the University of Birmingham, has received funding from manufacturers of several of the drugs discussed in the review.
3 commentsHomemade Asthma-Relief Device: An Option For Poor Families
When an asthma attack occurs, great number sufferers use a device - a "spacer" - to increase the chances that rescue medicine travels from an inhaler all the way down to the airways where it is needed. A new review of studies found no difference between the effectiveness of commercially manufactured devices and homemade spacers - sometimes fashioned from a plastic soda bottle or a Styrofoam cup.
However, the spacers were not tested with the type of inhaler that is now standard in the United States, cautions a spokesman from the American Academy of Allergy asthma & Immunology (AAAAI) who read the review.
A puff of aerosolized medicine can leave a metered-dose inhaler at almost 60 miles an hour. It takes more coordinated timing to make sure a good dose of the drug makes it past the tongue and turns the confuse at the back of the throat to reach the windpipe.
A spacer slows down the drug particles and can help patients synchronize their breathing better as they cross-question the inhaler. "Spacers are somewhat forgiving of disingenuous technique, which is important for children," said Dr. Richard Wasserman, an asthma and allergy specialist in Dallas and an AAAAI spokesman.
The notice critically appears in the latest issue of The Cochrane Library, a publication of The Cochrane Collaboration, some international organization that evaluates medical research. Systematic reviews draw evidence-based conclusions about medical practice after considering both the satisfy and quality of existing medical trials on a topic.
In the United States, the price of a spacer varies widely, from under $10 to more than $30. In limited-resource countries, commercially manufactured spacers are less available and are relatively costly, so doctors sometimes barrister their patients to appliance a homemade version. Health researchers want to understand if this practice - common in developing countries - is as effective as other treatment methods.
The review culls data from six studies with more than 600 children who were suffering from a serious bout of wheezing or asthma. The reviewers found no significant differences in the two treatment procedures in terms of hospital admissions or need for further therapy. However, the authors write that considering the small number of study participants and the resulting bring to the same level of uncertainty of the tools and materials, they cannot conclude that homemade spacers and commercially made spacers work equally well.
It is not clear from the review, but Wasserman related he suspects that the inhalers tested in the six trials used chlorofluorocarbons (CFCs). CFCs are an ozone-depleting chemical used to urge on medicine into the lungs. In 1987, the United States agreed to phase out production of chemicals that damage the Earth’s ozone stratum. By 2009, all inhalers must be CFC-free, so medical device manufacturers are already making the change. Most new inhalers use hydrofluoroalkane (HFA) propellant.
"There are certain differences in the characteristics of the two inhalers - particle size, distribution, speed of the particles - which could affect the behavior of the spacing devices," Wasserman said.
The review does not deal with propellants at all: "The biggest issue of uncertainty coming out of this Cochrane is the change of propellant in the inhalers," Wasserman said.
1 commentOlder Epilepsy Drugs Do Not Prevent First Seizure
Many physicians prescribe antiepileptic medications to patients with brain tumors, even to those with no seizure history. Now, a new review of studies casts doubt on the wisdom of using these drugs - which can carry serious side effects - to prevent a first seizure in these patients.
"There has always been a question about whether it is worth using antiepileptic medications to protect against seizures in patients with a brain tumor steady granting we can’t predict who enjoin actually have a seizure," said lead review author Ivo Tremont-Lukats, M.D.
Tremont-Lukats is staff neurologist at the Culicchia Neurological Clinic in New Orleans and a clinical assistant professor of neurology at Louisiana State University.
The review appears in the latest issue of The Cochrane Library, a publication of The Cochrane Collaboration, an international organization that evaluates medical research. Systematic reviews draw evidence-based conclusions about medical practice after considering both the content and quality of existing medical trials on a topic.
The review included five studies looking at outcomes in 404 patients with brain tumors but no previous history of seizures. Some received one of three common antiseizure drugs: phenytoin (Dilantin), phenobarbital or divalproex sodium (depakote). Others patients received a placebo or underwent close observation. Researchers found no differences in preventing the first seizure in the midst of the three groups.
"The results are such that we really can’t make acceptable retention prevention using these three older anticonvulsants," Tremont-Lukats related. "There was not a protective fact seen when using these drugs."
In addition, the risk of side effects - such as drowsiness, bruising and unusual bleeding - was much higher for those using the drugs.
This review looked and nothing else at older medications. Because of a lack of usable studies, the researchers could not rate if newer antiepileptic medications might be more useful in stopping leading seizures.
"We need to look at the newer generation of anticonvulsants to see if they can protect against first seizures," Tremont-Lukats said. "These drugs are more specific and have fewer side effects, but we still do not understand scientifically if they have a protective effect."
Tremont-Lukats stressed that this recommendation is only for those who do not have a history of having seizures. whether or not someone has a seizure, then antiepileptic drugs are indicated.
"If a physician wants to put a patient steady these medications for more than seven days after surgery, then there may be a problem that the patient should bring up with their doctor," says Tremont-Lukats. "After a week, there is no evidence that they help and ample evidence of side effects."
Omkar Markand, M.D., director of the Comprehensive Epilepsy Program at the Indiana University School of Medicine, said that automatically placing people with brain tumors on antiepileptic medications is a common occurrence despite there being not one scientific proof that it is useful.
"There is good ground of belief that all three of the medications have side effects that need to be weighed against in any degree possible benefits," Markand said. "For those medications, the side effects are worse than any potential benefit. This research is another indication that patients should probably ask their neurosurgeon or other physician if it is really necessary to place them on antiepileptic medication prior to experiencing a seizure."
Markand stressed that recommendations based on this re-examine are only applicable to the older medications phenytoin, phenobarbital and divalproex sodium.
"The take-home message is that the patients should not accept an automatic placement on antiepileptic medications," Markand said. "They should ask questions about why these drugs are being prescribed. The needs of the self-guided should be determined instead of putting everyone on antiepileptic medications."
1 commentWealth Lowers At Risk Of Early Stroke
Wealth lowers risk for having stroke in early ages, but after 65 the link between wealth and health weakens.
Researchers from Erasmus Medical Center in Rotterdam, The Netherlands examined 19445 Americans aged from 50 and higher, who are already participating in ‘University of Michigan Health and Retirement Study’.
The participants were involved in the study in 1992, 1993 or 1998. The participants were monitored for financial express and health every two years. In about 8.5 years 1542 of the participants suffered from stroke.
All participants were divided into 6 levels estimating person’s financial assets, income and education. 10% of those in the lower suit - with the lowest wealth and education - were 3 times more likely to suffer from touch than those in the highest level between ages from 50 to 65. After 65 wealth’s affect on health, particularly stroke, was weakened.
Every year about 780000 US residents are being affected by stroke and 27% of strokes occur among people below age of 65. This survey links these 27% to wealth, revenue and education level of younger sufferers.
The research also found that those at grow less social levels take higher rates of smoking, excess weight, high blood pressure, heart disease, less exercising, and obesity. All these factors are themselves increasing the risk for stroke.
The research besides suggests that those less wealthy who survive to their older ages and don’t suffer from stroke are healthier than those with higher income and education, because the wealthiest ones remain alive mostly thanks to medications, but the poorer ones survive because they are healthy.
No commentsUptake of HPV vaccine in adolescent girls is encouraging
Seven in ten girls are well-suited to be vaccinated against the sympathetic papillomavirus (HPV) when a £100m national UK vaccination programme comes into effect in the autumn, according to a fast tracked study published on bmj.com today.
The Manchester-based HPV pilot study is the first to look at whether the vaccine will be accepted by enough parents to ensure the success of a common UK immunisation programme, and how easy it is to deliver such a notice to adolescent girls.
The vaccination prevents two types of HPV that are sexually transmitted and associated with about 70% of cervical cancers. From September 2008, all schoolgirls in the UK aged between 12 and 13 years old (Year 
will be offered the vaccination.
In February 2007, two Primary Care Trusts (PCTs) in Manchester agreed to take part in a study led by researchers from the University of Manchester. Each PCT was responsible for delivering the vaccine to all secondary schools in its catchment area.
The HPV vaccine was offered to 2 817 girls aged between 12 and 13 years old attending 36 secondary schools. Parents were fully informed about the study and were invited to information evenings. They were asked to give their consent for vaccination or, if they refused, to give their reasons.
The researchers report the number of girls who received the first two doses of the vaccine. In order for the vaccine to be fully effective three doses are needed at 0, 1 and 6 months. In total, 1 989 (70.6%) received the chief dose and 1 930 the second (68.5%).
The authors found that delivery of the vaccination was challenging, partly because doses needed to be delivered at the start of the academic year when schools were busy, but also because a significant proportion of girls missed the appointment times for their first and second doses (16.3% and 23.6% respectively), and therefore had to be offered alternative times.
They also noted that the main reason given by parents for refusing to allow vaccination was insufficient information about the vaccine and its long term preservation (36%). Only a few parents mentioned the age for vaccination (10%) or the vaccine’s possible effect on adolescent sexual behaviour (3%).
The researchers conclude: "These are encouraging results for the forthcoming general HPV vaccine programme but the final criterion for success will be the proportion of girls who receive all three vaccine doses."
In the wake of the measles, mumps, and rubella (MMR) vaccine debate, more needs to be done to restore public confidence in immunisation, say Jo Waller and Jane Wardle from Cancer Research UK, in an accompanying editorial.
20% of parents in the study refused the vaccine giving no reason. greater amount of work is therefore needed to understand the motives for refusal and the practical barriers to providing consent, they conclude.
2 commentsLasik Eye Surgery Complaints Get To FDA
Lost in the hoopla of ads promising that laser vision surgery lets you toss your spectacles is a stark reality: Not everyone’s a good candidate and an unlucky few do bear life-changing side effects - lost vision, dry eye, night-vision problems.
A decade after Lasik surgery hit the market, unhappy patients will song their grievances before the Food and Drug Administration Friday as the government begins a major new effort to see if warnings about the risks are strong enough.
How big are those risks? The FDA thinks about 5 percent of patients are dissatisfied, but can’t provide more specifics — and is pairing with eye surgeons for a major study expected to enroll hundreds of Lasik patients to try to better understand who has bad outcomes and exactly what their complaints are.
"Clearly there is a group who are not satisfied and do not get the kind of results they expect," FDA medical device chief Dr. Daniel Schultz said Thursday. The study should "help us predict who those patients might be face to face with they have the procedure."
About 7.6 million Americans have undergone some form of laser vision correction, including the $2000-per-eye Lasik. Lasik is quick and, if no problems occur, painless: Doctors cut a flap in the cornea — the clear covering of the eye_ aim a laser underneath it and zap to reshape the cornea for trickster sight.
The vast majority, 95 percent, of patients see more clearly after Lasik — some better than 20/20 — and are happy they had it, uttered Dr. Kerry Solomon of the Medical University of South Carolina, who led a review of Lasik’s safety for the American Society of Cataract and Refractive Surgery.
However, one in four patients who seeks Lasik is told they’re not a good solicitant, he said. And there is little information about just how badly the 5 percent who obtain it but are dissatisfied actually fare.
Solomon estimates that fewer than 1 percent of patients have severe complications that farewell poor vision. Other side goods, however, are harder to pin down. Dry eye, for instance, can range from an annoyance to so severe that people admit intense pain and need surgery to retain the sort of little moisture their eyes form. That’s the kind of discussion the FDA’s new study aims to answer.
Dry eye is indifferent even among people who never have eye surgery, and increases as people age. Solomon says 31 percent of Lasik patients have more degree of it before the surgery, and that about 5 percent worsen afterwards.
But dry-eye specialist Dr. Craig Fowler of the University of North Carolina says other research suggests 48 percent of patients experience some interval of dry eye at least temporarily after Lasik. Cutting the corneal flap severs nerves answerable in spite of stimulating tear produce, and how well those nerves heal in turn determines how a great deal of dry fix the eye on lingers long-term, he said.
Even if the risks are low, that’s little consolation to suffering patients.
"As long as you know any ophthalmologist that’s wearing glasses, don’t get it bestowed," says Steve Aptheker, 59, a Long Island lawyer who was lured by an ad for $999 Lasik and suffered severe side effects that required seven additional surgeries over four years to restore his vision.
The flaps cut in his cornea literally became wrinkled when they were laid back down, blocking his vision and causing severe pain. A few surgeries later, with a different doctor, Aptheker could function better but couldn’t drive at night and saw a halo around objects that caused serious distortion even during the day. With more operations as new technology hit the market, Aptheker said today his right eye sees during the time that in good health as it did with glasses before Lasik, but his left remains fuzzy and requires halo-reducing drops.
The FDA has long known of those side effects, and thus for years has a Web site with warnings for Lasik patients and required that doctors give every potential calm a brochure outlining risks. Friday, the agency will ask its outside advisers if its warning efforts go far plenty.
However, Lasik eye surgery has been refined in recent years to offer crisper vision with fewer risks, said Dr. Steven Schallhorn, an ophthalmologist who oversaw the Navy’s refractive surgery program until last year when, based in part on his research, the Navy began allowing its aviators to get Lasik.
Schallhorn advises patients to seek what’s called "all-laser Lasik" - where a thin flap is created using a more precise laser instead of a blade - combined with "wavefront-guided" software that maps subtle irregularities in the eye cornea ahead of it’s zapped.
2 commentsFOOTPRINT PK Suture Anchor For Shoulder Repair Launched
Smith & Nephew’s Endoscopy Division launched the track PK Suture Anchor, a system used to attach rotator cuff tissue to bone in the shoulder. The anchor is among products featured at the Arthroscopy Association of North America (AANA) Spring Meeting, which began today in Washington, D.C.
The objective during rotator cuff repair is to return the soft tissue to its original anatomic attachment site. Unlike early uncompounded row suture anchor techniques, which employed single-point re-attachment, the "footprint repair" approach uses multiple anchors in brace rows, often with suture bridges that provide greater tissue-to-bone attachment.
Early approaches to cuff repair included transosseous tunnel repairs, which are still done today in some curative practices. During this procedure, the surgeon drills bone tunnels through the humeral head strong and laces suture through them. Smith & Nephew Endoscopy’s FOOTPRINT PK line of junction Anchor delivers a Transosseous Equivalent (TOE) repair without the need for drilling transosseous bone tunnels.
Its two-piece design allows for the shell of the anchor to be tapped into place. Then, easy of implantation, one inner stopple is advanced, which secures the sutures running from the other anchor rows.
"The FOOTPRINT PK Suture Anchor enables surgeons to precisely apply the desired amount of suture tension that is necessary to maximize the construct strength on a case-by-case basis," said Dr. Nikhil Verma, an orthopaedic surgeon and sports medicine specialist at Midwest Orthopaedics at Rush University Medical Center in Chicago. "The suture tension can be adjusted even after the anchor is implanted."
The anchor design enables the surgeon to adjust the tension of the suture bridges, so the final fixation is set exactly as the surgeon wishes. Unlike anchors where the tension is set before anchor implantation, the surgeon knows exactly how much tension is propitious upon completion.
"In artful the FOOTPRINT PK Suture Anchor, our engineers listened to the concerns of surgeons who want to preserve of a sound constitution tissue, achieve optimal fixation and help their patients resume the activities they enjoy," said Mike Frazzette, President of Smith & Nephew Endoscopy. "We are pleased to showcase this device during the AANA Meeting, where we are dexterous to demonstrate the technology to so many of our surgeon customers."
No commentsFDA Hears USAEyes’ Lasik Quality of Life Survey
More than 99% of patients report their quality of life after laser vision correction surgery is as they had expected or better, even though 2% report complications with lasik eye surgery that are frequently or always problematic, according to a national patient survey conducted by the nonprofit Council or Refractive Surgery Quality Assurance (USAEyes). Preliminary results of the USAEyes Competence Opinion Relative to Expectation (CORE) patient survey are being presented to the US Food and Drug Administration during a special hearing today.
"The USAEyes CORE survey is designed to determine if patients are getting what they expect from Lasik and similar eye surgery," says Glenn Hagele, Executive Director of the nonprofit patient advocacy that conducted the study. "Relevant questions ask granting that the patient’s results were ‘as expected’, or degrees of ‘better than expected’ or ‘worse than expected’." The survey is used to screen Lasik doctors with regard to certification by USAEyes.
The survey was mailed to 1,800 spectre correction surgery patients of six doctors throughout the US, with a 31% response rate.
USAEyes CORE Survey Sample and Details
"It is not surprising that the vast majority of Lasik patients are satisfied with their results, but what was unexpected was that many would have the surgery again despite reporting complications," reports Hagele.
Of those who reported complications that were "seldom problematic", 91% would have the surgery again. A extraordinary 22% of patients who reported complications that were "frequently" or "always" problematic would be under the necessity the surgery afresh, according to patients who responded to the survey. "Clearly some patients find the convenience of a reduced need for glasses and contacts worth occasional problems," says Hagele.
Additional results of the USAEyes CORE patient survey:
- 99% report quality of life of the same kind with expected, better, or much better after vision correction surgery
- 98% state day vision as expected, better, or much better
- 98% report no complications or complications that are seldom problematic
- 98% would recommend surgery to family and friends.
- 97% would have surgery again, knowing what they know now
- 96% wear corrective lenses as often for example expected, less than expected, or much less than expected
- 96% report postop vision without lenses as expected, better, or much better than expected when compared to preop appearance with lenses
- 96% report overall quality of vision as expected, better, or much better than expected
- 91% report no complications at any time
- 91% state darkness vision as expected, better, or much better than expected
- 7% report complications seldom problematic, however 91% of these same patients would have surgery again
- 2% report complications frequent or always problematic, however 22% of these same patients would have surgery again.
Source: By USAEyes
On another note The wonder lasik eye surgery has people who have not been satisfied with the vision results. The Food and Drug Administration will hear complaints from people who have not had the results they thought they would get.
No commentsNAFLD, NASH Linked To Metabolic Syndrome And Cardiovascular Disease
Study of the Liver (EASL) further confirms that nonalcoholic fatty liver disease (NAFLD) and its most severe form, nonalcoholic steatohepatitis (NASH), are associated with the metabolic syndrome and pose an increased risk of cardiovascular disease.
NAFLD and NASH are significant health problems that arrogate millions of people worldwide, especially in Western countries. NAFLD is a adipose accumulation in the liver that does not follow from excessive use of alcohol. When this condition progresses, and is associated with inflammation and liver damage, it is then called NASH, which is thought to come to one’s mind in 15% to 25% of cases of NAFLD. NASH is clearly associated with the risk of developing liver cirrhosis, and its complications, including hepatocellular carcinoma, the most frequent primary tumour of the liver. NASH-related cirrhosis is an increasingly occurring indication for liver transplantation.
In turn, the metabolic syndrome is a combination of risk factors, including high blood lipids, abdominal obesity, and a predisposition to diabetes. The society between NAFLD, NASH, and the metabolic syndrome is a great cause for concern because people with the metabolic syndrome are at increased risk for mark 2 diabetes and cardiovascular disease, including heart attack and stroke.
According to Dr. Fabio Marra, Associate Professor of Medicine at the University of Florence, "When I see a patient with a fatty liver, I subsist delivered of to consider all the other risk factors for cardiovascular diseases and try to intervene aggressively to termination the effects of those other factors, because accumulating data indicate that the fatty liver may be itself an additional risk factor."
The precise prevalence of NAFLD and NASH within individual countries is evasive.. Large scale epidemiological studies are still needed, and definitive laboratory tests to identify patients with NASH are unavailable. At present, a biopsy of the liver is the only accepted diagnostic method. Despite these limitations, the best current estimates suggest that in the general population NAFLD can have being found in one-fourth to one-third of adults in Western countries. One U.S. study of children who died as a result of accidents found that 13% had NAFLD.
While a number of risk factors have been identified, the foregoing percentages rise most dramatically among people who are obese. For example, studies have found NAFLD in 84% to 96% of patients undergoing bariatric surgery. For these reasons, NAFLD and NASH are seen to be increasing as poor dietary habits and inactive lifestyles become more widespread.
Although NAFLD and NASH have not to date been included as components of the metabolic syndrome, increasingly the onset of NAFLD is being viewed by experts as an soon event in the development of insulin resistance and therefore as an indicator or predictor of future metabolic syndrome.
Among key unanswered questions: Why do some people with NAFLD live out their lives unaffected by their condition of having a fatty liver, while others go on to develop NASH and cirrhosis, or diabetes and/or cardiovascular disease?
At present, there are no specific therapies for NASH. Among the leader recommendations offered to patients are to lose weight gradually (particularly if one is obese) and to increase physical activity, to eat a healthy diet, and to forbear alcohol.
1 commentAnalysis Warns Over Quality Health Care in EU
At present, European citizens cannot be guaranteed that the health care they will receive in a different part of the European Union (EU) is of high quality, warn researchers in this week’s BMJ.
They ordain on national governments and other stakeholders to help bring about make different and improve health care accross European Union.
There is an assumption that health services provided according to public regulations in any EU country will be of adequate quality, set down in black and white Professor Martin McKee and colleagues. Yet within Europe the advance to assuring quality in different countries varies.
These differences are seemly increasingly important due to growing professional and patient movement in the reach the EU. So can Europe’s citizens be confident that care received in another EU country will be safe and of high quality, they ask?
The authors identify several initiatives that illustrate both the similarities and the diversity within European health systems. They speck out that, while there are policies to ensure consistent quality of some elements of health care at a European level (for example by the creation of centralised drug approval systems) for many others, such as the quality of healthcare systems, organisations and clinical processes, there is no co-ordination.
This reflects diversity among countries. While some be favored with well developed quality assurance systems, in others there is very little evidence of any concrete progress, and often what exists has little impact on the majority of health professionals, they argue.
The delivery of health care is a national responsibility but, in a Europe characterised by free movement, national governments and other stakeholders must take account of the wider European context in freedom from disease policymaking and planning, they indite.
Europe-wide legislation to injunction a separate approach to quality of care is not a realistic chance, they say. How a country assures quality of care is a matter for it to determine; what is important is that it does so.
In the medium term, they try conclusions, there is a need to support the emerging informal mechanisms, many led by professional bodies, that are designed to assure the quality and safety of care with a view to European citizens.
You can read the full research on Quality Health Care Accross European Union at www.bmj.com in this week’s issue.
2 commentsTubbs Jones Encourages STD Prevention
Today, in light of a recent contemplate released by the Centers for the sake of Disease Control and in avowal that April is National STD Awareness Month, Congresswoman Stephanie Tubbs Jones, joined by nearly 60 of her colleagues, introduced a bi-partisan resolution urging the House of Representatives to focus greater attention on activities related to the prevention, screening and treatment of sexually transmitted diseases (STD).
The United States currently has the highest rate of sexually transmitted infections in the industrialized world with an estimated 19,000,000 new cases of sexually transmitted diseases. Almost half of these infections occur in young people betwixt the ages of 15 to 24. These infections pose a tremendous human and economic burden on the U.S. with direct medical costs as high as $15.3 billion per year.
The 2008 report from the CDC estimated that 1 in 4 young women between the ages of 14 and 19 in the United States, or 3.2 million teenage girls is infected with at least the same of the of the most for the use of all sexually transmitted diseases including human papillomavirus (HPV), chlamydia, anti-herpes simplex virus, and trichomoniasis. These infections can lead to long-term health risks including infertility and cervical cancer.
"The issue of sexually transmitted diseases has grown to epic proportions in this inhabitants," said Rep. Tubbs Jones. "What is most devastating is the toll that STD’s are taking on our young women, particularly African American young women. The CDC report found that 48 percent of young African American women are infected with an STD compared to 20 percent of young White women."
"We can no longer be silent about this issue. The abstinence-only education touted by the Bush Administration is simply not enough. We must be dexterous to talk candidly with our children about the dangers of STDs so that they understand the risks involved with unprotected sex and equip them by the knowledge and tools to protect themselves."
The resolution supports the goals of National sexually transmitted diseases Awareness Month by encouraging the Federal Government, States, localities to provide additional funding for screening and treatment services and requests increased programming and activities to educate Americans of all ages on the risks and prevention of STDs.
1 commentHuman Brain Appears Hard-Wired For Hierarchy
Human imaging studies have for the first time identified brain circuitry associated with social status, according to researchers at the National Institute of Mental Health (NIMH) of the National Institutes of Health. They found that different brain areas are activated when a person moves up or down in a pecking order - or simply views perceived social superiors or inferiors. Circuitry activated by important events responded to a potential change in hierarchical status as much in the manner that it did to alluring money.
"Our position in social hierarchies strongly influences motivation as well as physical and mental health," said NIMH Director Thomas R Insel, M.D. "This first rapid look into how the brain processes that information advances our understanding of an important factor that can impact public health."
Caroline Zink, Ph.D., Andreas Meyer-Lindenberg, M.D., Ph.D., and colleagues of the NIMH Genes Cognition and Psychosis Program, report on their functional magnetic resonance imaging (fMRI) inquire into in the April 24, 2008, issue of the journal Neuron. Meyer-Lindenberg is now director of Germany’s Central Institute of Mental Health.
Prior studies have shown that social status strongly predicts health. Animals chronically stressed by their hierarchical position have high rates of cardiovascular and depression/anxiety-like syndromes. A classic cogitation of British civil servants set up that the lower one ranked, the higher the odds for developing cardiovascular disease and dying early. Lower social rank likely compromises health through psychological effects, such as by limiting mastery over one’s life and interactions with others. However, in hierarchies that allow for more upward mobility, those at the top who perplexity to lose their positions can have higher risk for stress-related illness. Yet scanty is known about how the human brain translates such factors into health risk.
To find out, the NIMH researchers created an artificial social hierarchy in which 72 participants played an interactive computer game as antidote to money. They were assigned a status that they were told was based on their playing skill. In fact, the game outcomes were predetermined and the other "players" simulated by computer. While their brain activity was monitored by fMRI, participants intermittently saw pictures and scores of an inferior and a superior "player" they thought were simultaneously playing in other rooms.
Although they knew the perceived players’ scores would not affect their own outcomes or reward - and were instructed to shut one’s eyes to them - participants’ brain activity and behavior were highly influenced by their condition in the implied hierarchy.
"The processing of hierarchical information seems to be hard-wired, occurring even outside of an explicitly competitive environment, underscoring how important it is for us," said Zink.
Key study findings included:
* The area that signals an event’s importance, called the ventral striatum, responded to the prospect of a rise or fall in rank as much as it did to the monetary reward, confirming the high relative length accorded civic status.
* Just viewing a superior human "player," as opposed to a perceived inferior one or a computer, activated an area near the front of the brain that appears to size people up - making interpersonal judgments and assessing social status. A circuit involving the mid-front part of the brain that processes the intentions and motives of others and emotion processing areas deep in the brain activated when the hierarchy became unsteady, allowing for upward and downward mobility.
* Performing better than the superior "player" activated areas higher and toward the front of the brain controlling putting on the boards planning, during the time that performing worse than any inferior "player" activated areas lower in the brain associated with emotional pain and frustration.
* The more positive the mood experienced by participants while at the top of an unstable hierarchy, the stronger was activity in this emotional pain circuitry when they viewed an outcome that threatened to rouse them down in status. In other words, people who felt more joy when they won also felt more pain when they lost.
"Such activation of emotional pain circuitry may be situated under a heightened risk for stress-related health problems among competitive individuals," suggested Meyer-Lindenberg.
No commentsDoctors Should Consider Alternatives To Antibiotics For Sinusitis
When suffering through a sinus infection, crowd people ask for an antibiotic to speed their recovery. However, a recent review of clinical trials found that while antibiotics can provide minor improvements in uncomplicated sinusitis cases, most patients regain the former state without the drugs within two weeks.
The health risks for the individual and society might override the benefits of antibiotics for people suffering with a simple sinus infection, according to authors led by Anneli Ahovuo-Saloranta of the Finnish Office for Health Technology.
The systematic review examined the results of 57 studies, six of which compared antibiotics to a placebo and 51 of which compared different kinds of antibiotics. More than 18,000 people took part in the studies.
This go over again focused on studies with patients treated for simple, uncomplicated sinusitis in a primary feel concerned setting. Four of five patients without complications improved within two weeks even without a prescription for antibiotics.
At 10 to 14 days afterward diagnosis, 52 percent of patients had recovered completely in the antibiotic group compared by 38 percent in placebo group. However, when researchers waited longer to check back with the patients, there was no signifying difference in recovery rates whether people took antibiotics or a placebo.
The evaluation of different antibiotics showed them to be similarly effective.
The review appears in the latest issue of The Cochrane Library, a publication of The Cochrane Collaboration, an international organization that evaluates medical research. regular reviews draw evidence-based conclusions about medical practice after considering both the content and quality of existing medical trials on a topic.
Sinusitis is a common complaint that, in many cases, resolves spontaneously, the review authors said. However, in patients with severe symptoms, like high fever, severe pain in cheeks and swelling of face, antibiotic treatment is justified, the reviewers conclude.
Every year, 20 million people in the United States have sinusitis. When the membrane-lined air spaces near the nose become infected, sinusitis can cause nasal discharge, fret, obstruction, poor response to decongestants, facial pain and even toothache.
Viral upper respiratory pamphlet infections often precede opening infections and antibiotics have in no degree effect on viral diseases. Antibiotics make away with bacteria, not viruses. Some cases of sinusitis are bacterial, which would mean that antibiotics might help, but distinguishing patients with a bacterial infection remains a challenge.
"Without a positive bacterial culture by sinus puncture, it is hard to separate viral from bacterial sinusitis," said Ed Septimus, M.D., a board member of the Infectious Diseases Society of America and a member of the society’s Antimicrobial Resistance Work Group.
Acute bacterial sinusitis is more likely if symptoms have lasted more than a week. Even so, patients with bacterial sinusitis do not always benefit from antibiotics.
fair bacterial sinusitis can resolve spontaneously. According to the review authors, some patients with simple sinusitis would benefit from antibiotics, nevertheless it is ever unclear who those patients are. Current criteria for sinusitis cannot reliably identify those patients who would most benefit from antibiotics.
On the other hand, antibiotics have well-documented negative effects. Potential adverse furniture include gastrointestinal problems such as diarrhea, abdominal pain and vomiting, allergic symptoms and antibiotic-related fungal infections.
The unnecessary prescribing of antibiotics puissance also prove problematic for the general population. "Overuse of antibiotics leads to antimicrobial resistance," Septimus said.
The bacteria that antibiotics are designed to kill can modify and become resistant to available medicines, and the same class of drugs efficacy not one longer be useful in the future.
Current treatment recommendations span from only using narrow-spectrum antibiotics to treat patients with severe or persistent, moderate symptoms and specific bacterial sinusitis findings to using broad-spectrum antibiotics to treat all patients with acute bacterial infections.
Treatment should always occur on a case-by-case basis considering the benefits and harms on individual patient level, mete in illume of the results of this study, doctors might want to consider other treatment options, the study authors said.
Patients can use symptom-relieving drugs like nasal decongestants and the anti-inflammatory analgesics as well as nasal irrigation. Also in those patients who have asthma or allergic rhinitis, nasal corticosteroids and antihistamines can be helpful.
No commentsPatients Treated With XIENCE Drug Eluting Stent Experience Better Outcomes
A study demonstrated that use of Abbott’s XIENCE V Everolimus Eluting Coronary Stent System in patients with coronary artery disease resulted in a significant 50 percent reduction in vessel renarrowing (in-segment late loss) at eight months, non-inferior rates of target vessel failure (TVF) at nine months, and an observed 42 percent reduction in major adverse cardiac events (MACE) at one year compared to the TAXUS Paclitaxel-Eluting Coronary Stent System. The SPIRIT III study is a 1,002-patient, prospective, multi-center, randomized clinical trial designed to evaluate the safety and efficacy of the XIENCE V stent system compared to the TAXUS stent system.
"SPIRIT III is the first large-scale clinical trial to show that patients have a lower risk of experiencing a centre of circulation attack, cardiac death or re-treatment when treated with a new stent, XIENCE V, compared to the most widely used drug eluting stent TAXUS," said Gregg W. Stone, M.D., of the Columbia University Medical Center; chairman, Cardiovascular Research Foundation, New York; and principal investigator of the SPIRIT III clinical trial. "With a significant reduction in angiographic in-segment late loss, non-inferiority in target vessel failure and a clinical advantage in the composite charge of MACE compared to TAXUS, XIENCE V represents an important advance in improving the lives of patients with coronary artery disease."
The SPIRIT III clinical trial demonstrated the following key results for XIENCE V:
– Statistical superiority to TAXUS on the study’s primary endpoint of in-segment late loss at eight months. XIENCE V demonstrated a statistically significant 50 percent conquest in late loss compared to TAXUS (mean, 0.14 mm for XIENCE V vs. 0.28 mm for TAXUS).
– Statistical non-inferiority to TAXUS in the major secondary (co-primary) endpoint of target vessel failure (TVF) at nine months. XIENCE V demonstrated an observed 20 percent reduction in TVF compared to TAXUS (7.2 percent for XIENCE V vs. 9.0 percent for TAXUS). TVF is a composite clinical measure of safety and efficacy outcomes defined as cardiac death, heart attack (myocardial infarction or MI) or target bottom revascularization (TVR).
– An observed 43 percent reduction in the pre-specified secondary endpoint of major adverse cardiac events (MACE) at nine months (4.6 percent for XIENCE V vs. 8.1 percent for TAXUS) and an observed 42 percent reduction in MACE at one year (6.0 percent for XIENCE V vs. 10.3 percent as antidote to TAXUS) compared to TAXUS. MACE is an of moment composite clinical measure of safety and efficacy outcomes for patients, defined as cardiac death, heart attack (MI), or ischemia-driven target lesion revascularization (TLR driven by lack of blood supply).
"The low rate of MACE seen by XIENCE V in the SPIRIT III trial can have existence directly attributed to fewer patients experiencing heart attacks or re-treatment, and is consistent with data from previous trials," said Charles Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs and chief medical officer, Abbott Vascular. "Superior force combined with increased flexibility and deliverability reinforce that XIENCE V is a significant advancement in stent technology that will be a welcome addition to the field of interventional cardiology."
Additional Results from SPIRIT III
There were no significant differences between XIENCE V and TAXUS in the rates of stent thrombosis either early (less than or equal to 30 days) or late (> 30 days), whether analyzed per protocol or by the Academic Research Consortium (ARC) definition. Rates of definite/probable late stent thrombosis at one year under the ARC definition were 0.5 percent for XIENCE V and 0.6 percent for TAXUS. The ARC definition of late stent thrombosis was developed to eliminate variability in the definitions across various drug eluting stent trials.
In addition, the reduction in in-segment late loss at eight months with XIENCE V compared to TAXUS was consistent across a variety of subgroups in the SPIRIT III trial; however, the SPIRIT III trial was underpowered to measure statistical differences in any of the subgroups.
The SPIRIT III nine-month results were previously reported in March 2007 at the American College of Cardiology’s 56th Annual Scientific Session, and the one-year results were previously reported in October 2007 at the Transcatheter Cardiovascular Therapeutics scientific symposium. The SPIRIT III two-year results will be presented in mid-May at EuroPCR 2008 in Barcelona, Spain.
About the SPIRIT III Trial
SPIRIT III is a prospective, multi-center, randomized, single-blind, controlled clinical trial comparing XIENCE V to TAXUS in 1,002 patients (669 XIENCE V patients, 333 TAXUS patients) with either one or two de novo native coronary artery lesions. The trial was conducted across 65 academic and community-based centers in the United States between June 22, 2005 and March 15, 2006. The primary endpoint was in-segment tardily loss at eight months and the major secondary (co-primary) endpoint was TVF at nine months. An adscititious pre-specified secondary endpoint included MACE at nine months and one year.
About XIENCE V
The XIENCE V stent system utilizes everolimus, which has been shown to reduce tissue proliferation in the coronary vessels following stent implantation, and is based upon the highly deliverable and proven MULTI-LINK VISION coronary stent platform.
XIENCE V was launched in Europe and other international markets in late 2006. XIENCE V is an investigational device in the United States and Japan, and is currently under review for approval by the U.S. Food and Drug Administration.
Abbott also stores a private-label version of XIENCE V to Boston Scientific called the PROMUS Everolimus-Eluting Coronary Stent System. PROMUS is designed, studied and manufactured by Abbott and supplied as part of a distribution agreement between the two companies.
Everolimus is licensed to Abbott by Novartis for use on its drug eluting stents.
No commentsFDA Approves First Compact Heart Assist Device
Heart assist devices are surgically implanted mechanical pumps that help the heart’s ventricle do its work of pumping blood to the stillness of the body. Previous models were too large to be placed in the upper abdomen of some women and small-sized men. But the Thoratec HeartMate II Left Ventricular Assist System employs a first-of-a-kind design. Instead of the gauge pulsatile pump that simulates the action of the heart, the device uses a continuous flow pump that constantly moves consanguinity with a single moving part, a spinning rotor. This allows the device to be slimmed down to a unmixed three inches in length and a weight of approximately one pound.
"The HeartMate II is an important advance in mechanical heart technology,” said Daniel Schultz, M.D., director of FDA’s Center for Devices and Radiological Health. "Until now, more heart transplant candidates have been underserved due to the large size of previously approved heart assist devices."
An electrical cable that powers the blood pump passes through the patient’s skin to an external controller that the patient wears on his or her waist. The controller is powered either by batteries or connected to an electrical power outlet. Blood flow is set through the cross-examine based on the patient’s need, and the controller monitors pump performance, sounding alarms allowing that it detects dangerous conditions or a possible malfunction. The system can operate on two external batteries, allowing the patient to bring forward freely for up to three hours.
In a clinical study of 126 patients at 26 transplant centers, 57 percent of patients with the HeartMate II survived to heart transplant, which is comparable to the survival of patients treated with currently approved heart assist devices.
The product’s manufacturer, Thoratec Corporation of Pleasanton, Calif., is required to conduct a post-approval study to more distant evaluate the HeartMate II’s performance during commercialization.
1 commentComedian Kenneth Keith Kallenback Died of Pneumonia
Pneumonia is back in focus today to the degree that known comedian Kenneth keith Kallenbach diet of pneumonia today in a Chester County, Pennsylvania hospital.
The Kidd Chris Show announced that Kenneth Keith Kallenbach was dead during their morning broadcast and had apparently the cause of the exit was pneumonia.
What is Pneumonia and does it kill?
CDC says that Pneumonia has accounted for approximately 15% of all hospital-associated infections and 27% and 24% of all infections acquired in the medical intensive-care unit (ICU) and coronary care unit, respectively. It has been the second most common hospital-associated infection after that of the urinary tract. For hospital-associated pneumonia, attributable mortality rates of 20%-33% have been reported. The primary risk factor for the development of hospital-associated bacterial pneumonia is mechanical ventilation (with its requisite endotracheal intubation).
“Pneumonia can be difficult to spot. It often mimics a cold or the flu, beginning with a cough and a fever, so you may not realize you have a more serious condition. Chest pain is a common symptom of many types of pneumonia. Pneumonia symptoms have power to vary greatly, depending on some underlying terms you may have and the type of organism causing the infection,” writes Mayo Clinic.
If a patient has a sober pneumonia, he or she will be hospitalized and treated with intravenous antibiotics and put on oxygen. This could have been the box of Kenneth Keith Kallenback. However, if the patient does not need oxygen, he or she may recover as quickly at home with oral antibiotics as in the hospital, especially if you have access to qualified home health care. Sometimes the patient may spend three or four days in the hospital receiving intravenous antibiotics and then continue to recover at home with oral medication.
On a side-note we just called Delaware County Coroner’s Office, to find out more about Kenneth Keith Kallenback’s death and the surrounding circumstance. However, we were told that the investigator is working on the issue right now and were asked to call back in half an hour. Please check back in 45 minutes or so for further updates on this story. Will will update this page once we hear more from the investigator.
Update on Kenneth Keith Kallenback
We spoke by the Delaware County Coroner’s Office again and were told that Kallenback was hospitalized with no suspcious circumstances and there was nothing that would have being reported to the Coroner’s office. He was under doctor’s care at Riddle Memorial Hospital. Officials were not available at the hospital for comments.
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