Healing Connections

Although approved by the U.S. Food and Drug Administration as a palliative treatment for cancer patients who have developed bile duct obstructions, biliary stents are sometimes used “off-label” for the treatment of peripheral vascular disease (PVD). A study in today’s issue of the American Journal of Therapeutics finds that off-label use of biliary stents is increasing, and that the majority of adverse events and device malfunctions associated with the use of these stents occurs during off-label usage.

“Our study found that more than 1 million patients received biliary stents for ‘off-label’ treatments between 2003 and 2006,” explains cardiologist William Maisel, MD, MPH, Director of the Medical Device Safety Institute at Beth Israel Deaconess Medical Center (BIDMC) and senior author of the study. “We also found that more than 80 percent of the reported adverse events and device malfunctions associated with these products have occurred during ‘off-label’ use.”

The most common off-label use for biliary stents is treatment of peripheral arterial disease (PAD), which develops when leg arteries become narrowed by cholesterol plaques. Patients who suffer from PAD can develop pain, skin ulcers, reduced exercise tolerance and even loss of limb. The condition affects millions of patients throughout the U.S. and is a significant cause of morbidity and mortality.

“Clinical management of peripheral artery disease can be challenging,” explains Maisel. Although noninvasive treatment strategies such as exercise training can help some patients, for many others, pain and discomfort persist. In an effort to unblock the vessels, many physicians have turned to stents, flexible tubular devices which can keep the vessels propped open.

Because there is little data supporting the clinical utility and safety of biliary stents for treatment of vascular disorders, Maisel and colleague Jonathan Bridges, MD, of BIDMC’s Cardiovascular Institute decided to take a closer look.

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“We are blessed to have each other to depend on. If you have to go through something bad like cancer, you’re glad to have a friend to go through it with,” said one of two brothers from Savannah, Georgia recovering from robotic prostate cancer surgery. The two siblings flew to The Mount Sinai Medical Center in New York to have lifesaving surgery on the same day this week. Dr. David B. Samadi, M.D., Chief of Robotics and Minimally Invasive Surgery in the Department of Urology at Mount Sinai successfully performed the robotic prostate cancer surgeries on the siblings one after another on Monday, January 14th, 2008.

“The brothers have benefited physically and even emotionally as a result of having their prostatectomy with the da Vinci robotic technology at Mount Sinai together,” said Dr. Samadi. “Each minimally invasive surgery was an hour and twenty minutes which included only a few tiny incisions, limited blood loss (50 CC), no need for blood transfusions, less pain, and a faster recovery which included each of the patients walking the next day and were released from the hospital two days after surgery.”

Also, along with the help of Microvascular and Plastic Surgeon Dr. Jess Ting, M.D. of the Department of Surgery, the doctors were able to preserve each patient’s sexual function after robotic surgery by implanting a nerve graft extracted from each patient’s leg. “I will still be a normal person after robotic surgery, with feeling of all nerves because of the graft,” said one brother.

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The Forsyth Institute has launched a new one-of-a-kind service for the research community. The Forsyth Microbial Identification Microarray Service (MIM) enables the rapid identification of bacterial species in clinical samples. The first service offering, Human Oral Microbe Identification Microarray (HOMIM), will focus on detection of bacterial profiles from the oral cavity. Researchers can use this service to compare bacterial associations in health vs. disease, monitor the effects of therapy on the oral ecology and perform microbial perturbation studies.

The Forsyth research team led by Drs. Bruce Paster and Floyd Dewhirst has used molecular analyses based on 16S rRNA sequencing to identify 550 oral bacterial species. Using this information, they have developed HOMIM, which allows the simultaneous detection of about 300 of the most prevalent oral bacterial species, in a single hybridization. This high throughput technology will allow the evaluation of species that cannot yet be grown in vitro. Information about the service can be found online at www.forsyth.org/mim.

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The Technion- Israel Institute of Technology have developed an innovative device for monitoring respiration, especially in premature babies. The non-invasive technology, which is being clinically tested at the Carmel Medical Center in Haifa, uses sensors to monitor lung activity.

Existing equipment in intensive care units does not monitor for respiratory problems and up to six hours can elapse from when a problem occurs in lung ventilation until medical personnel detect it. Detection therefore generally occurs only when the baby is already exhibiting signs of distress and there is a danger of irreversible damage to the body’s organs.

The unique device developed at the Faculty of Biomedical Engineering can detect respiratory irregularities in newborn babies at an early stage, reducing the risk of long-term damage to vital organs. Early detection of respiratory problems, such as accumulation of air between the lungs and chest cavity walls, partial blockage of the air passages, or breathing from only one lung is prevented, reducing the risk of complications and irreversible brain damage.

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