Biopeer

New catheter technique offers heart surgery hope

A study reported in the 30th Annual Scientific Sessions of the Society for Cardiovascular Angiography and Interventions, speaks about the discovery of a catheter technique for patching holes in the heart, in order to avoid possibilities of a surgery. Study claims that the patch closes the ventricular septal defects (VSDs) – ruptures in the wall between the right and left ventricles – facilitating normal blood circulation and restoration of fluid in the lungs. Donald J. Hagler, professor of pediatrics in the Divisions of Pediatric Cardiology and Cardiovascular Diseases, Mayo Clinic, performed implantation of the VSD patch. The patch is pulled into the catheter lengthwise, for threading it through a vein into the right ventricle and across the rupture into the left ventricle. The patch is then pushed partially out of the catheter sheath until the first disc pops open. The catheter is then withdrawn back into the right ventricle, with the first disc positioned against the left ventricular wall and the connecting the shaft filling the hole created by the rupture. From inside the right ventricle, the patch is pushed forward again, releasing the second disc, which covers the rupture on the right side of the heart. Initial trials of patch-implantation were not successful, except for further claims of helping patients regain their strength for a surgery.

Frenchay Hospital in Bristol has reportedly introduced a ‘Fibro Scanner’ that uses sound waves to detect liver diseases non-invasively. The condition of liver is determined by the speed at which the sound waves travel. The faster the sound waves travel, the healthier the liver and vice-versa. “One of the best things is that this procedures takes a matter of minutes and also means that we are able to see many more patients - around 10 to 15 a week as opposed to one or two,” said Robert Przemioslo, consultant in gastroenterology.

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FDA gives thumbs up to two drugs and one device

The United States Food and Drug Administration (FDA) has cleared a drug each for cancer and epilepsy, and a device for the hearing impaired.

Cancer patients can now heave a sigh of relief. The FDA has cleared a new prescription drug Fentora, for treating ‘breakthrough pain’ that comes with cancer. Fentanyl is the main ingredient in Fentora. Fentora will come in tablets that are to be placed between the upper cheek and gum, above a rear molar tooth. The tablets will get dissolved due to saliva, thus increasing the speed with which the medicine will enter the bloodstream Fentora’s manufacturer, Cephalon, hopes the drug will hit the US shelves in the first week of October. However, users of the drug can expect the normal side effects like nausea, vomiting, anemia, constipation and headaches among others that are typical of opioid drugs.

Meanwhile, epilepsy patients suffering from ‘grand-mal’ seizures can now be prescribed Lamictal. On the basis of clinical trial data, FDA approved GlaxoSmithKline’s Lamictal for treating Primary Generalized Tonic-Clonic (PGTC) seizures in children and adults with epilepsy. The company showed that a 66 per cent reduction of PGTC seizures were seen in the trial participants who were given Lamictal compared to 34 per cent in those given a placebo.

The FDA has approved not only drugs but a device too. It cleared Boston Scientific Corporation’s Harmony HiResolution Bionic Ear System (Harmony System), a device that will enable users to hear five-10 times better. Severe-to-profoundly deaf users will not have to adjust any dials to switch between soft and loud sounds. Music appreciation and using the telephone will become easier for the user with this new device.

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FDA approvals for devices and drugs

The US Food and Drug Administration (FDA) has approved the first artificial heart. The FDA granted Abiomed Inc, the developer of the heart, a humanitarian exemption that allows the firm to sell up to 4,000 artificial hearts in a year. The device is fully contained within the chest and does not have any outside wires. The power for the device comes from a battery belt. The company plans to train five hospitals around the country in implanting the hearts. However, its high cost of USD 25,000 and its large size are likely to put it outside the reach of many needy patients.

Meanwhile, the FDA has also cleared a new defibrillator. ZOLL Medical Corporation was granted the 510(k) marketing clearance for its new defibrillator designed for hospital use. The product is expected to be launched in 2007. Per Richard A Packer, President and Chief Executive Officer of ZOLL, like its other devices, the new device too will “help to address the worldwide problem of death from sudden cardiac arrest.”

The FDA has approved not only devices but drugs too. Taro Pharmaceutical Industries Ltd announced that it has received approval for its generic versions of an epilepsy treatment and injectable products. It is now allowed to manufacture 100 mg capsules of phenytoin sodium, the main ingredient in Pfizer Inc’s Dilantin Kapseals. Taro’s Irish unit too has received approvals for manufacturing products bioequivalent to comparable products of Hospira, Inc.

On the other hand, Cardinal Health Inc stated that the FDA has approved its manufacture of Panhematin, the first FDA-approved treatment for acute porphyria. The drug, owned by Ovation Pharmaceuticals Inc, will be the first to be produced at Cardinal’s new sterile plant.

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Heart research advances a few steps

Two independent studies have identified a new gene responsible for cardiomyopathy, a heart disease that causes the heart to enlarge and pump less efficiently. Research groups from McGill University and University of Heidelberg found that the integrin-linked protein kinase (ILK) protein is vital to regulate the heart’s ability to adapt its force of contraction to meet the body's changing needs for oxygenated blood. The loss of ILK in heart cells in animal model systems resulted in cardiomyopathy and heart failure. The findings suggest that ILK and some of its binding partners are crucial components of the cardiac mechanical stretch sensor. The malfunctioning of this sensor causes a significant proportion of human heart failure.

Meanwhile, researchers from the University of Minnesota Medical School have found that insulin resistance in adolescence might be a powerful indicator of diabetes and heart disease in adulthood. In the study, 357 students aged 13 years were tested for their ability to manage insulin using the insulin clamp technique. Lower uptake of glucose into cells was a marker of insulin resistance. The participants were followed and tested again at the ages of 15 and 18. Insulin resistance at age 13 predicted high blood pressure and high levels of blood fats at age 19. On comparing the effectiveness of insulin resistance and body mass index in predicting future risk, they found that insulin resistance was by itself an indicator of increased risk.

Heart device maker St Jude Medical Inc announced that it has received approval from the US Food and Drug Administration for QuickOpt, new programming feature that is designed to replace echocardiography. In less than two minutes, the feature will calculate the timings to which implantable heart defibrillators and cardiac resynchronization therapy defibrillators had to be set.

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Innovations to help paralysis sufferers

Two American studies published in the July 13 issue of the journal Nature promise revolutionary breakthroughs for paralyzed patients.

Scientists from the US firm Cyberkinetics have developed a brain implant BrainGate that allows people to control electronic devices by thought alone. The device was successfully implanted in 25-years old Matthew Nagle, who is paralyzed from the neck down. The device enabled him to play computer games and to open and close the hand on a prosthetic limb just by thinking about them. The BrainGate system uses neuromotor prosthesis, an electronic chip that is inserted into the motor cortex of the brain. The 100 electrodes penetrate into the surface of the brain and pick up the electrical activity of the cells. The resulting signals are interpreted by a computer, which makes it possible to control objects such as artificial limbs, computer cursors or wheelchairs. John Donoghue, director of the brain science program at Brown University, led the study.

Another study was conducted on the same lines by researchers from the Stanford University Schools of Medicine and of Engineering. They have for the first time, made the prosthetic devices fast enough to be practical for paralytic patients. The prosthesis developed is called a brain-computer interface. Krishna Shenoy, PhD, assistant professor of electrical engineering and of neuroscience, and his team worked with rhesus macaque monkeys in the experimental phase. The monkeys were connected to the interface by a tiny silicon chip holding 100 electrodes. The electrodes were implanted in the pre-motor cortex, which is one of the areas responsible for guiding one’s arm. They successfully shortened the process of processing neural impulses by focusing on the end point instead of every step and increased the speed to process signals from the brain by four times.

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Necrotizing Enterocolitis does not discriminate between surgical procedures

A recent study has found that the two emergency surgical interventions performed to correct necrotizing enterocolitis (NEC) in prematurely born infants do not appear to notably improve an infant's survival and later health. The study was published in the May 25 issue of The New England Journal of Medicine.

The two surgical interventions currently used to correct a perforated NEC are primary peritoneal drainage or laparotomy and bowel resection. However, the optimal treatment is uncertain. Scientists from University of Alabama at Birmingham (UAB), Yale University and other scientists designed this multi-center randomized trial to determine if there were any differences in the outcomes of the two operations. They studied 117 preterm infants with perforated NEC in the first clinical trial conducted to compare the results of the two procedures. All study infants were born before 34 weeks gestation and weighed less than 1,500 grams (3.31 pounds). The researchers found that the type of operation performed for perforated NEC does not influence survival or other clinically important outcomes in preterm infants.

There is a significant debate on which procedure is preferable. In the absence of proof supporting the supremacy of one approach over the other, the care of infants requiring surgical intervention depends mostly on the predisposition of the treating institution or the individual surgeon. Reed A. Dimmitt, MD, MSPH, UAB assistant professor of pediatrics and co-author of the study believes that with this study, surgeons will perform the operation they are more at ease with.  The researchers are also hopeful that the study will stimulate a scientific unbiased discussion of alternative operations. With mortality rates approaching 50 per cent in infants who weigh less than 1,500 grams, there is an urgent need to study the mechanisms of the disease and try to prevent NEC.

Blood test results only 80 minutes away

Researchers from the Tokyo University in collaboration with Shimuzu Corporation and Toppan Printing Company have developed a new blood testing device that can analyze a blood sample and produce results within 80 minutes. The device can also state the exact anthithrombotic requirement for the affected person. Antithrombotic agents, also popularly known as anticoagulants are substances that prevent blood coagulation or clots, and are used to treat medical conditions such as dangerous blood clotting in heart and brain.

Recent studies have shown that anti-clotting therapy reduces the severity of a stroke to a great extent. The study has also shown that the therapy resulted in less severe disability and reduced the death ratio after treatment. Regular intake of anticoagulant drugs such as Warfarin sometimes affects an individual inversely causing heavy nosebleeds and brain hemorrhage. This new device is believed to enable millions of people affected by blood clot to tide the danger without facing any adverse side–effects.

For this study, researchers analyzed two important genes that are directly related to blood clotting and metabolism and found that they are directly linked to the dosage of drugs that can be safely administered. Taking this into account, the researchers developed the testing device, which can estimate the exact amount of anticoagulant drug required by the patient. It can also be used in treating and diagnosing diseases such as leukemia, lung cancer, rheumatism and mental illness. Many hospitals in Japan plan to use this product from April this year.