Congressmen Charlie Wilson (D-OH), Marion Berry (D-AR) and Mike Ross (D-AR) have introduced the Patient and Pharmacists Protection Act of 2007. This legislation would help counteract a little known provision that was added to the recently passed War Supplemental bill (the U.S. Troop Readiness, Veterans’ Care, Katrina Recovery, and Iraq Accountability Appropriations Act) that could do serious harm to both Medicaid beneficiaries and local pharmacists.

The Problem:

The new law mandates that all Medicaid prescriptions must be written on “tamper resistant” paper in order to be eligible for federal reimbursement beginning October 1, 2007. Currently, most physicians do not use these types of pads, nor are supplies readily available.

Last year, doctors wrote approximately 330 million prescriptions for Medicaid beneficiaries; that’s 11-percent of the nearly 3.1 billion total prescriptions written every year. To implement this requirement in just three short months calls for thousands of new prescriptions and refills to be written on these “tamper-proof” pads.

The tamper proof pad law was designed to prevent Medicaid fraud. However, the timeline for implementation could result in patients being turned away from their pharmacies as of October 1, 2007 if doctors fail to write prescriptions on “tamper resistant” paper.

“My other concern is that some pharmacies may end up forced to close up shop if they’re not getting reimbursed by Medicaid because their clients’ prescriptions aren’t on tamperproof pads,” Wilson said. “The loss of that rural pharmacy could hurt all of my constituents.”

A Solution:

Wilson, Berry and Ross came up with a solution. Their bill, the Patient and Pharmacists Protection Act of 2007, would require that only Class II narcotics be written on tamper resistant paper starting October 1, 2007.

“This will prevent the most dangerous fraud without preventing those in need from receiving their everyday medications,” Wilson said.

“This new bill is a good compromise that will prevent fraud and at the same time alleviate the impact this change will have on local pharmacies and their patients,” said Berry. “So many small-town pharmacies are already struggling to stay in business and this is one way we can help them continue to help others.”

“We have to find a reasonable approach to helping, not hindering, our health care providers deliver quality health care,” Ross said. “I am proud to join with my fellow members of the conservative Democratic Blue Dog Coalition, to introduce this important legislation to ensure that our health care providers continue to have the ability to provide patients with a safe, efficient means of receiving their prescriptions, while easing undue burdens on our local pharmacists and physicians.”

American Pharmacists Association Continue reading →

For the first time, researchers have described hour-by-hour changes in the amount of amyloid beta, a protein that is believed to play a key role in Alzheimer’s disease, in the human brain. A collaborative team of scientists at Washington University School of Medicine in St. Louis and the University of Milan report their results in Science.

“Proving that we can directly measure amyloid beta in the human brain is an important step forward for both clinical and basic research, and that may be true not just in Alzheimer’s disease but also in other serious neurological disorders,” says co-first author David L. Brody, M.D., Ph.D., a Washington University neurologist who treats brain injury and general neurology patients at Barnes-Jewish Hospital.

The results of the study contradicted the expectations of researchers, who were hoping to learn why brain injury is linked to higher risk of Alzheimer’s disease. They had hypothesized that such injuries, caused by motor vehicle accidents, assaults and falls, would lead to an increase in amyloid beta levels. Instead, they found recovery from brain injury, rather than the injury itself, seemed to increase amyloid. The better a patient’s overall neurological status, the higher their amyloid beta levels rose.

“We can’t at this point rule out a very early spike in amyloid right after a brain injury,” notes Brody, assistant professor of neurology. “This study is just the beginning.”

Amyloid beta levels were measured using a technique called microdialysis, which involves placing a small catheter into the brain tissue to sample the fluid in the spaces between cells. The Italian group, headed by Sandra Magnoni, M.D., and Nino Stocchetti, M.D., and located at the Ospedale Maggiore Policlinico, a major trauma center in Milan, brought substantial previous experience with microdialysis to the study.

In the study, 18 patients recovering from traumatic brain injuries or ruptured brain aneurysms had microdialysis catheters placed in their brain tissues to measure amyloid beta while they were in the intensive care unit. Patients’ families in both St. Louis and Milan gave permission in advance, and the catheters were placed when the patients were having other monitoring procedures performed.

“The results have potentially important clinical implications because the measurement of amyloid beta in the human brain may turn out to be a good indicator of how well brain cells are communicating with each other, even in very sick patients,” says senior author David M. Holtzman, M.D., the Andrew B. and Gretchen P. Jones Professor and head of the Department of Neurology at Washington University. “If the results are validated in further studies, this may assist physicians in making important patient management decisions in patients with acute neurological disorders.”

In a study published in 2005, Holtzman and others showed that brain cell communication was directly linked to the levels of amyloid beta in a mouse model of Alzheimer’s disease. When there was increased communication between brain cells, amyloid beta increased. When there was reduced communication, amyloid beta decreased. However, it was not known whether the same relationship between brain cell communication and amyloid beta levels would hold in humans.

“The new data fit well with the previous results in mice, because improved neurological status is likely to go along with increased communication between brain cells,” says Brody. He and his colleagues plan to continue with similar studies that also will include direct measurement of brain electrical activity and the assessment of different forms of amyloid beta.

The results provide scientists important clues about the general origins of Alzheimer’s. Further investigation is needed to answer the specialized question of why brain injury increases risk of Alzheimer’s. This experiment was a test of a model that suggests brain injury accelerates harmful processes that cause Alzheimer’s. Although scientists didn’t find what they expected, this model still cannot be ruled out, according to Brody.

“We haven’t measured how brain injury affects amyloid beta inside cells, nor have we determined whether brain injury affects the ability of amyloid beta to form small aggregates that may be especially harmful,” he explains.

A second explanation for the link between brain injury and Alzheimer’s suggests that injury may reduce the brain’s ability to compensate for Alzheimer’s-related damage, making the symptoms of the disease evident much earlier than they would otherwise appear. Evidence exists for both models, and both could be valid in different settings, according to Brody.

Brody emphasizes the researchers’ gratitude to the families of patients who agreed to participate in the study. While the study did not directly benefit the patients, it provided scientists with an important opportunity to learn about amyloid beta and the connections between Alzheimer’s and brain injury.

“Our ultimate goal is to develop interventions that we can apply after a traumatic brain injury to improve outcomes and reduce the long-term risk of Alzheimer’s,” he says.

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Brody DL, Magnoni S, Schwetye KE, Spinner M, Esparza TJ, Stocchetti N, Zipfel GJ, Holtzman DM. Amyloid-beta dynamics correlate with neurological status in the injured human brain. Science, August 29, 2008.

The National Institutes of Health, the Burroughs Wellcome Career Award in the Biological Sciences, the Cure Alzheimer’s Fund and Eli Lily and Co. supported this research.

Washington University School of Medicine’s 2,100 employed and volunteer faculty physicians also are the medical staff of Barnes-Jewish and St. Louis Children’s hospitals. The School of Medicine is one of the leading medical research, teaching and patient care institutions in the nation, currently ranked third in the nation by U.S. News & World Report. Through its affiliations with Barnes-Jewish and St. Louis Children’s hospitals, the School of Medicine is linked to BJC HealthCare.

Source Michael C. Purdy

Washington University School of Medicine Continue reading →

The National Alliance on Mental Illness (NAMI) declared today that Kansas voters will demonstrate national leadership if they “Vote Yes on 2!” in the referendum on a constitutional amendment on Election Day, Nov 2.

The amendment would eliminate language in the state constitution that singles out people living with mental illness and gives the legislature power to prohibit them from voting. Both houses of the state legislature have already approved the change, which requires voter approval.

The Kansas Mental Health Coalition is leading the campaign for the amendment. NAMI Kansas is a member of the coalition. NAMI’s national organization also is supporting the proposal.

“Two of the four presidents carved on Mount Rushmore-Abraham Lincoln and Teddy Roosevelt-struggled with mental illness,” said NAMI’s national director Mike Fitzpatrick. “No one has ever suggested that they should have been denied the right to vote.”

This year marks the 20th anniversary of the Americans with Disabilities Act (ADA), for which former U.S. Senator Bob Dole of Kansas was a driving force in Congress.

“The ADA was an important step forward as a civil rights law,” Fitzpatrick said. “Through Senator Dole, Kansas played a leading role in its enactment. This year, the state can make history again.”

“The ADA was intended to end discrimination against people living with disabilities, including mental illness,” Fitzpatrick said. “The amendment has the same goal. Through the referendum, Kansas has an opportunity to lead the country by taking another step forward.”

Fitzpatrick outlined reasons to vote for the amendment.

– “This is more than a symbolic issue. Even though the Kansas legislature has not used the constitutional provision to pass a law to prohibit voting by people with mental illness, the authority to do so hangs as a potential threat over the head of any person who lives with a mental illness.”

– “The current provision represents stigma and discrimination. Stigma discourages people from getting help when they need it. People living with mental illness internalize the fact that such a provision is in the state constitution. It increases the stigma already imposed on them and undermines the opportunity for recovery.

– “The trend today is to eliminate language that has no definite or appropriate meaning. Congress for example recently passed legislation to remove “mentally retarded” from federal laws. Kansas can help lead the way to encourage other states to review their own language and provisions.”

“Both nationally and at the state and local level, NAMI respectfully asks Kansas voters to ‘Vote Yes on 2,’” Fitzpatrick said. “It’s the right thing to do.”

Source:

NAMI Continue reading →

For millions of Americans with cancer, the side effects of chemotherapy and other treatment drugs can be devastating. But new drug-delivery research based on nano- and microtechnology from Tel Aviv University might provide much-needed relief, as well as more effective cancer treatment.

New drug delivery technology developed by Prof. Rimona Margalit of Tel Aviv University’s Department of Biochemistry allows drugs to target cancer cells specifically, leaving surrounding healthy cells intact and reducing the painful side effects of chemotherapy. The science utilizes tiny bubbles, visible only through powerful microscopes, that contain payloads of therapeutic drugs.

“This development is on the leading edge of the new frontier of drug delivery and cancer treatment,” says Prof. Margalit. “Bubble technology can also be applied to other medical conditions, including diabetes, osteoarthritis, wounds, and infectious diseases. In twenty years, it could be widespread.”

Target: Cancer

Currently, cancer drugs travel throughout the body delivering powerful medication to all the cells they encounter, both healthy and cancerous. When healthy cells are damaged by unnecessary medication, a patient can experience unpleasant side effects ranging from hair loss to nausea. More worrying are further health risks due to the damage that the medication does to the patient’s immune system.

Called “drug carriers” recent reports of Prof. Margalit’s new technology applied in both cancer and osteoarthritis therapies were published in Nature Nanotechnology and in the Journal of Controlled Release (2008). The technology allows cancer treatment medication to be placed inside tiny bubbles so small that millions fit along a single inch. The surface of the bubbles contains an agent that allows them distinguish cancer cells from healthy ones. When the bubbles “recognize” a cancer cell, they deliver the medication they’re carrying to that cell.

The positive results are twofold: More of the drug gets directly to the cancer cells, enhancing the effectiveness of the treatment, and healthy cells continue to function normally, protected against the painful side-effects of the medication.

Economics, Not Science, Is Researchers’ Next Challenge

Prof. Margalit’s drug carrier technology has already performed well in animal model studies. The next step is to apply the technology to humans. “Economics is the hold-up, not the science,” explains Prof. Margalit, who is in the process of finding a pharmaceutical company to invest in the research.

Although the technology is still a decade or more from clinical trials, this promising discovery offers new hope in oncology.

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Source: George Hunka

American Friends of Tel Aviv University Continue reading →

GE Healthcare, a leading provider of healthcare information technology solutions, announced a vendor-independent educational program, designed specifically for biomedical and technical professionals, to enhance their knowledge of IT concepts for healthcare. GE’s new Healthcare IT curriculum identifies core IT skills critical to servicing and supporting today’s integrated and networked medical devices.

Biomeds today face many challenges as their industry evolves, with device connectivity becoming as important the device itself. The Healthcare IT curriculum is unique in that GE breaks out of the product-training box, offering an educational program that supports the entire biomedical community, regardless of equipment or vendor choice. GE has identified the healthcare-related IT skills that biomeds need to quickly diagnose problems that affect workflow and quality patient care.

“Our vision is to build knowledge and competencies across the healthcare industry, which is why we took the core skills related to healthcare and incorporated them into a comprehensive program suitable for any biomed,” said Michael Reed, manager of GE Healthcare’s Global Education for Clinical Systems Service. “Biomeds know that equipment issues must be resolved quickly because patients’ lives can depend on it. Having the IT knowledge to differentiate an equipment issue from an IT issue, and taking the appropriate action, saves time, and can positively impact patient care.”

The rapid emergence of networked healthcare demands that biomeds acquire new skills in areas in which they typically have not played a part. Biomeds understand the differences between life-critical patient information workflow and mission-critical healthcare enterprise workflow. Among the challenges facing them is where they fit in this cycle of support. Hands-on experience with IT networks and IT concepts gives biomeds the tools they need to work and communicate effectively with their IT departments.

“One advantage of having a company like GE develop this program is that, unlike IT courses taught in a technical environment, the difference between mission-critical and life-critical information is clearly understood,” added Reed. “Additional courses will be added to this program to cover all IT-related topics that impact healthcare and today’s biomed.”

The foundation course in the program, Essentials of Healthcare IT, explores the fundamentals of connectivity. Hands-on labs let students build and troubleshoot flat, switched, routed and wireless networks, using actual equipment, not simulations. Essentials of Healthcare IT is a pre-requisite for the Healthcare IT curriculum.

The newest courses in the program, “Wireless in the Healthcare IT Environment” and “Securing the Healthcare IT Environment,” can be taken in any order after “Essentials of Healthcare IT.”

“Wireless in the Healthcare Environment” addresses the unique challenges of wireless patient monitoring, exploring WiFi and WMTS, as well as RF propagation and frequencies for specific healthcare services.

“Securing the Healthcare IT Environment” covers the handling of sensitive patient information due to HIPAA regulations. It looks closely at the hospital’s infrastructure, as well as the ECRI/ACCE model for risk assessment. Common healthcare network attacks and countermeasures to protect the hospital network are included.

The benefits of the Healthcare IT curriculum include increased IT skills, better-informed decisions, faster repair, and improved communications with the IT department. The hospital benefits from reduced equipment downtime, improved workflow, more accurate diagnosis of problems, all resulting in improved patient care. GE’s website will provide more information on the Healthcare IT program gehealthcare/hcit

About GE Healthcare

GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, performance improvement, drug discovery, and biopharmaceutical manufacturing technologies is helping clinicians around the world re-imagine new ways to predict, diagnose, inform, treat and monitor disease, so patients can live their lives to the fullest.

GE Healthcare’s broad range of products and services enable healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases and other conditions earlier. Our vision for the future is to enable a new “early health” model of care focused on earlier diagnosis, pre-symptomatic disease detection and disease prevention. Headquartered in the United Kingdom, GE Healthcare is a $17 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries.

gehealthcare Continue reading →

October is a significant month in the history of breast cancer. It is of course Breast Cancer Awareness Month, and October 2009 is the 10th anniversary of digital mammography being introduced by GE Healthcare in 1999. October is also the month that Richland Hospital introduces a new GE Healthcare Senographe Essential mammography system as part of the hospital’s medical imaging department. GE Healthcare, a division of General Electric Company (NYSE: GE) made the announcement of the system acquisition.

Senographe Essential is a premium full-field digital mammography system. Digital mammography replaces the film used in traditional mammography with digital files viewed and stored on computers. The Senographe Essential has the largest active field of view available and enables fast and efficient imaging of virtually any size breast. The ergonomic design allows fast and comfortable positioning to promote patient comfort and clinical efficiency. As a digital system, the Senographe provides outstanding image quality with dose efficiency, minimizing re-takes and promoting patient safety.

Replaced analog system

Richland Hospital has been using an analog mammography system since 2001. They upgraded to facilitate second opinions and electronic transfers to breast clinics. According to Marsha Jones, RTRM and Mammography Coordinator, there were a lot of factors in the purchase of the GE Senographe Essential. “It gives us better resolutions for dense breast tissue, preventing retakes,” said Jones. She also noted that the three full-time mammographers appreciated the ease of use and that the ergonomics made the job less taxing physically. “The Essential is more comfortable for the patients. We expect that the shorter exam time will enable us to schedule more patients, increasing throughput, and we hope ultimately, detecting breast cancers sooner.”

“New technology is a game-changer for a hospital, no matter the size or location,” said David Caumartin, General Manager, Mammography at GE Healthcare. “The addition of the Senographe Essential will help Richland Hospital on its own healthymagination journey, as it makes better healthcare more accessible to its service areas.”

Richland Hospital introduced the new mammography system to its employees and the community on October 1 with an open house celebration. Hospital administrators and GE Healthcare executives were on-hand to answer questions and to welcome the new technology to the hospital.

About Richland Hospital

The Richland Hospital is a 25-bed acute care Critical Access hospital serving the health care needs of people in Richland Center and the surrounding area. This hospital was first established in 1924, occupying the Bailey Mansion, which was located where a portion of the current facility now stands. Eight building projects and numerous remodeling and renovation projects have taken place since its beginning. At the present time, over 200 people are employed by the Richland Hospital.

At The Richland Hospital, we provide a comprehensive range of services for all of your health care needs. Led by highly skilled doctors and staff members, our patients can expect the highest level of compassionate care across all of our service lines. For more information, visit our website at: richlandhospital.

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GE Healthcare Continue reading →

Adult patients without health insurance admitted to intensive care units (ICUs) in Pennsylvania hospitals are at a 21 percent increased risk of death compared to similar patients with private insurance, according to researchers from the University of Pennsylvania. The difference in mortality risk was not explained by patient characteristics or differences in care at the hospital level, suggesting that uninsured patients might receive poorer quality care.

The findings will be presented at the ATS 2010 International Conference in New Orleans.

Compared to similar patients with private insurance or Medicaid, uninsured ICU patients were also less likely to receive certain common critical care procedures, including placement of central venous catheters, tracheostomies and acute hemodialysis.

“Previous studies suggested that uninsured critically ill patients may have a higher mortality, and may be less likely to receive certain critical care procedures. But we found that these differences are primarily due to differences in quality within hospitals rather than across hospitals,” said Sarah M. Lyon, M.D., pulmonary and critical care fellow at the Hospital of the University of Pennsylvania. “The higher mortality for uninsured patients does not appear to be caused by uninsured patients tending to go to hospitals with poor overall quality. Instead, we found that even when admitted to the same hospitals, and controlling for other differences between patients, critically ill individuals without insurance are less likely to survive than those with private or Medicaid insurance.”

Dr. Lyon and colleagues analyzed 30-day mortality, and the use of several key ICU procedures, in all adult patients under 65 admitted to Pennsylvania ICUs from 2005 to2006 using state hospital discharge data. They categorized the 166,995 patients as having private health insurance (67.7 percent), Medicaid (28.5 percent), or being uninsured (3.8 percent.) When the researchers analyzed mortality at 30 days, they found that uninsured patients were 21 percent more likely to die than patients with private insurance; those with Medicaid had a 3 percent greater risk of death. Only the mortality difference between private insurance and uninsured patients was statistically significant.

“Our findings suggest that ICU patients without insurance have a higher risk of death and receive less intense treatment in the ICU. Expanding and standardizing health care coverage through health care reform may improve outcomes in critically ill patients,” said Dr. Lyon. “We still do not understand all the reasons for differences in survival between the insured and uninsured. Critically ill patients without insurance may arrive to the hospital in more advanced stages of illness, perhaps in ways we could not control for in our study. Patients without insurance may also have different preferences for intensity of care at the end of life, and may not wish to be kept alive on life support as long as patients with insurance. Another, more concerning explanation is that physicians and hospitals treat patients without insurance differently than those with insurance. More work is needed before we can say with certainty that treatment biases caused these results.”

“The Effect of Health Insurance on Intensive Care Mortality and Procedural Utilization” (Session D14, Wednesday, May 19, 8:15-10:45 a.m., CC-Room 395-396 (Third Level), Morial Convention Center; Abstract 1434)

Source: American Thoracic Society (ATS) Continue reading →

NYU Langone Medical Center completed its first surgery this month using a new near-infrared fluorescence imaging guided system available on the da Vinci Si Surgical System ,the most advanced robotic surgical system in the world. The result is a greatly enhanced visual field, allowing finer assessment and more precise operations. NYU Langone is the first in the world to utilize the enhanced imaging guidance system for selective arterial clamping during kidney sparing surgery for patients with kidney cancer and is among small select group of hospitals in the country and the only one in the northeast to have this technology.

The specially designed camera and endoscopes allow surgeons at NYU Langone’s Robotic Surgery Center to capture images of tissue and surrounding blood vessels by injecting a unique fluorescence dye that is activated by near-infrared light.

“Florescence imaging combined with the new 3-D HD camera scopes gives us clear anatomical landmarks to better map the patient’s vascular anatomy – it’s changing the way we perform surgery,” said Michael Stifelman, MD, associate professor, Department of Urology and director, Robotic Surgery Center at NYU Langone Medical Center. “We can now perform complex kidney surgery in a more sparing manner using a minimally invasive approach. The imagery is so precise we can temporarily stop blood flow to only the part of the kidney needing dissection, allowing the rest of the kidney to remain perfused which prevents potential damage to the healthy tissue.”

The new technique incorporates a redesigned 3-D HD camera that is mounted on one of the four arms of the da Vinci Si surgical robot. In addition to standard real-time images of the surgical field, the camera can switch to view the images of tissue and surrounding blood vessels illuminated by the special dye when exposed to the near-infrared light.

This technique further advances the benefits of robotic surgery for better patient outcomes. Surgeons utilize computerized, highly functional mechanics and miniaturized surgical instruments to replicate every movement of their hands. The flexibility and precise movements of the instruments at the ends of three robotic arms allow both simple and more complex procedures to be done through only a few small, one-quarter-inch long incisions. Because of this, the procedure is less traumatic to the body and results in minimal scarring and faster recovery times for patients.

Source:
Craig Andrews
NYU Langone Medical Center / New York University School of Medicine Continue reading →

While the choices of knee implants are plentiful, the success of total knee replacement surgery still is dependent on the surgeon’s skill, Henry Ford Hospital researchers say.

Researchers found that utilizing a series of common but nuanced surgical techniques is far more important to customizing the fit of a patient’s implant than the implant’s design.

The findings are displayed at the annual meeting of the American Academy of Orthopaedic Surgeons Feb. 15-18 in San Diego.

“Customized knee implants will not replace the need for precise, methodical surgical skill,” says Jason Davis, M.D., a Henry Ford joint replacement surgeon and the study’s lead author. “While improving outcomes will continue to evolve, getting back to the basics of surgery is still paramount to successful knee replacement.”

Since the first knee replacement was performed in 1968, the procedure has greatly improved as have the design of implants. More than 580,000 knee replacements (an estimated two-thirds of patients are female) are performed each year in the United States, according to the AAOS, and more than 150 implant designs are available including ones that are gender- and patient-specific.

Relying on data collected from more than 20 joint replacement surgeons at an orthopaedic specialty hospital, researchers identified several surgical techniques that take into account a patient’s individual knee characteristics and ensure that the implant is properly aligned and balanced with ligaments and soft tissue.

For instance, a gap-balancing technique provides better stability and overall functional performance. Several techniques aim to restore the “soft tissue personality” of the knee beyond just bone replacement. Another technique involves resecting the femur so the implant does not hang over the two sides of the bone. Additionally, researchers offer ways to enable surgeons to safely “downsize” components intraoperatively when needed while improving the balance of the knee.

“Customizing the surgery can be done effectively without the inventory or cost associated with gender- or patient-specific implants,” Dr. Davis says. “By using some of these techniques surgeons can take steps to ensure the proper fitting of an individualized knee replacement.”

The study was not funded.

Source:
David Olejarz
Henry Ford Health System Continue reading →

A mobile compression device is as effective as medication at preventing the formation of blood clots after hip replacement surgery but provides greater patient safety, according to a study in the March issue of the Journal of Bone & Joint Surgery.

“This device is as useful as blood thinners for the reduction of blood clots after hip replacement and it’s superior in safety,” said Douglas E. Padgett, M.D., chief of Adult Reconstruction and Joint Replacement at Hospital for Special Surgery, one of the investigators and final author. “This has the potential to change the paradigm as to how we prevent blood clots after hip replacement. The efficacy is the same, the safety is markedly better and the cost is comparable. This essentially raises the specter of ‘can we use mechanical agents in lieu of the pharmacologic agents to prevent blood clots.’”

Roughly 30 percent to 50 percent of patients undergoing joint replacement surgery, either hip or knee replacement, will develop thromboembolic disease unless they receive preventive care. In people with this condition, blood clots form in veins; if a clot breaks away, it can travel to the lungs causing pulmonary embolism and death. For preventive care, doctors have the choice of using blood thinners or a compression device that wraps around the leg and pumps the leg to maintain normal blood flow.

“The College of Chest Physicians believes the best way to prevent blood clots is to use pharmacologic agents to thin the blood and make it difficult to clot,” Dr. Padgett said. “Orthopedic surgeons on the other hand have to balance the desire to reduce the risk of blood clots with the reality that many of these chemical modalities that thin the blood are in fact associated with bleeding and hemorrhagic complications.”

Until now, the compression devices available were large, could only be used in hospitals and prevented walking. Recently, a company has manufactured a small, battery-operated compression device that people can wear that allows for its use outside of the hospital. The sleeve fits over a patient’s calves in a form fitting manner and is secured with Velcro. The mobile device is smart in that it applies intermittent, sequential pressure to the leg in correlation with the patient’s respiratory cycle, maximizing blood flow to reduce the risk of clot formation. The device is approved by the Food and Drug Administration.

“The other devices that are available are stationary. These are mobile,” said Dr. Padgett. “Back in the day, people used to stay in the hospital for upwards of 10 days, but we are in a whole new day and age now. Patients are leaving the hospital after 48 hours after hip replacement, but it is still the same operation.”

To test the effectiveness and safety of the mobile compression devices, investigators recruited 410 patients who were undergoing hip replacement from a number of hospitals, including Hospital for Special Surgery, Mayo Clinic, Scripps Clinic and the Cleveland Clinic. Patients were randomized to either the compression device, use of which started during surgery and then for 10 days after surgery, or low-molecular-weight heparin, a commonly used blood thinner, for ten days. At ten days, most patients are ambulatory and do not need the device. Of the patients who consented, 392 patients were evaluable in terms of safety and 386 patients were evaluable in terms of efficacy. Doctors could tell whether patients were actually wearing the device by checking the internal timer in the pump unit. The timer detects the amount of time that the device is properly functioning and is actually being worn by the patient.

To look for deep vein blood clots, doctors conducted ultrasounds on patients’ calves and thighs 10 to 12 days after surgery. The investigators found that in patients taking heparin, major bleeding occurred in 6 percent whereas no patients using the mobile device developed major bleeding. Major bleeding events are those that require transfusions or additional surgeries. Blood clots in deep veins below the knee formed in 3 percent of patients in both groups, but blood clots in deep veins above the knee formed in 2 percent of patients receiving heparin compared with 1 percent of patients using the mobile device. Clots that occur above the knee are more dangerous, in that these clots are more likely to break off and travel to the lung where they can result in death.

“This study allows us to take the next step which is to test the device in a larger study with an even larger recruitment of number of centers and number of patients to see if in fact we can quite frankly start to use this device for all elective hip replacements, and eventually knee replacements, and get rid of using chemical prophylaxis,” Dr. Padgett said. Hospital for Special Surgery will be using the device in the Rapid Recovery total hip replacement protocol for patients who are being discharged within 48 hours.

The mobile device, called the Continuous Enhanced Circulation Therapy plus Synchronized Flow Technology compression device, is manufactured by Medical Compression Systems, located in Or Akiva, Israel. Medical Compression Systems provided some funding for the study.

Other authors of the study include Clifford W. Colwell Jr., M.D. at Scripps Clinic, La Jolla, California; Mark Froimson, M.D., at the Cleveland Clinic; Michael Mont, M.D. at Sinai Hospital in Baltimore, Maryland; Merrill Ritter, M.D., at St. Francis Hospital in Mooresville, Indiana; Robert Trousdale, M.D., at Mayo Clinic; Knute Buehler, M.D., at the Orthopedic and Neurological Care and Research Center in Bend, Oregon; Andrew Spitzer, M.D., at Kerlan Jobe Orthopedic Clinic in Los Angeles, and Thomas Donaldson, M.D., at Empire Orthopedic Specialty Clinic in Colton, California.

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Hospital for Special Surgery Continue reading →