July 2005 Clinical and Industry News

Omnicell and Witt Biomedical Announce Inventory Management Partnership to Enhance Cardiology Customers’ Workflow Omnicell, Inc., focusing on supply management technology, and Witt Biomedical Corporation, a cardiology image and information management systems (CIIMS) provider, announced a partnership to provide cardiology departments and cardiac cath labs with integrated productivity and data management systems. Omnicell, Inc., focusing on supply management technology, and Witt Biomedical Corporation, a cardiology image and information management systems (CIIMS) provider, announced a partnership to provide cardiology departments and cardiac cath labs with integrated productivity and data management systems. In the field of cardiology in general and the cath lab specifically, tracking inventory and supplies for each patient for billing and purchasing purposes is critical. By integrating our technologies, only one ADT interface the interface that manages patients' admissions data - is required in the cath lab to take full advantage of our OptiFlex CL systems and Witt's Calysto for Cardiology technology. This results in operational and cost efficiencies for our customers, said Omnicell Chairman, President and CEO Randall A. Lipps. According to Witt Biomedical President Mike Wolfe, the integrated ADT interface is designed with maximum flexibility to accommodate the cath lab staff's workflow preferences for inventory management and charge systems. Wolfe explained, The integration of our technologies eliminates redundancy so customers don't have to enter a patient charge in both companies’ systems in order to maximize revenue at the point of care. Moreover, this alliance offers Witt customers the added option of Omnicell's enterprise-wide inventory solution, which extends beyond cardiology into all facets of hospital supply management. Ultimately, this partnership further integrates both companies’ information systems into the hospital or IDN backbone. Calysto for Cardiology systems encompass physiomonitoring and information technologies, as well as multimodality image acquisition, review and archival with secure, web-enabled access. With this new alliance, Witt customers have the option of Omnicell’s OptiFlex CL technology, which provides a cath lab management system for tracking supplies and procedures to the physician and patient, facilitating cost management and automated charge capture and reordering. The system includes real-time, point-of-use data collection, and inventory tracking software. OptiFlex can be configured with combinations of open tracking systems and closed cabinets, at the discretion of the customer. Joint Commission Announces 2006 National Patient Safety Goals for Laboratories The Joint Commission on Accreditation of Healthcare Organizations has announced the 2006 National Patient Safety Goals and related Requirements that will apply specifically to its accredited laboratories. Major additions to this fourth annual issuance of National Patient Safety Goals, which were approved by the Joint Commission’s Board of Commissioners, include a new Requirement that hands-off of patients between caregivers be standardized, with particular attention to assuring the opportunity for asking and responding to questions. This Requirement is part of the Goal: Improve the effectiveness of communication among caregivers. In addition, a new Goal encourages the active involvement of patients and their families in the patient’s care as a patient safety strategy, and includes a specific Requirement that the laboratory define and communicate the means for patients and their families to report concerns about safety and encourage them to do so. The development and annual updating of the National Patient Safety Goals and Requirements continues to be overseen by a panel that includes widely-recognized patient safety experts, as well as nurses, physicians, pharmacists, risk managers, and other professionals who have hands-on experience in addressing patient safety issues in a wide variety of health care settings. Each year, the Sentinel Event Advisory Group works with the Joint Commission to undertake a systematic review of the literature and available databases to identify candidate new Goals and Requirements. Following a solicitation of input from practitioners, provider organizations, purchasers, consumer groups, and other parties of interest, the Advisory Group determines the highest priority Goals and Requirements and makes its recommendations to the Joint Commission. The Board of Commissioners also affirmed the six existing do not use abbreviations that constitute a single Requirement under the Goal: Improve the effectiveness of communications among caregivers, but acted to delete a related stipulation that each organization also identify an additional three organization-specific do not use abbreviations that have been integral to this Requirement as well. Failure to substantially eliminate the utilization of do not use abbreviations in medication orders remains one of the most frequent non-compliance findings during Joint Commission surveys. The 2006 Laboratory National Patient Safety Goals are: Improve the accuracy of patient identification. Use at least two patient identifiers (neither to be the patient's location) whenever collecting laboratory samples or administering medications or blood products, and use two identifiers to label sample collection containers in the presence of the patient. Processes are established to maintain samples' identity throughout the pre-analytical, analytical and post-analytical processes. Immediately prior to the start of any invasive procedure, conduct a final verification process to confirm the correct patient, procedure, site and availability of appropriate documents. This verification process uses active not passive communication techniques. The patient's identity is re-established if the practitioner leaves the patient's location prior to initiating the procedure. Marking the site is required unless the practitioner is in continuous attendance from the time of the decision to do the procedure and patient consent to the initiation of the procedure (for example, bone marrow collection, or fine needle aspiration). Improve the effectiveness of communication among caregivers. For verbal or telephone orders or for telephonic reporting of critical test results, verify the complete order or test result by having the person receiving the order or test result read-back the complete order or test result. Standardize a list of abbreviations, acronyms and symbols that are not to be used throughout the organization. Measure, assess and, if appropriate, take action to improve the timeliness of reporting, and the timeliness of receipt by the responsible licensed caregiver, of critical test results and values. All values defined as critical by the laboratory are reported directly to a responsible licensed caregiver within time frames established by the laboratory (defined in cooperation with nursing and medical staff). When the patient's responsible licensed caregiver is not available within the time frames, there is a mechanism to report the critical information to an alternative responsible caregiver. Implement a standardized approach to hand off communications, including an opportunity to ask and respond to questions. Reduce the risk of health care-associated infections. Comply with current U.S. Centers for Disease Control and Prevention (CDC) hand hygiene guidelines. Manage as sentinel events all identified cases of unanticipated death or major permanent loss of function associated with health-care associated infection. Encourage the active involvement of patients and their families in the patient's care as a patient safety strategy. Define and communicate the means for patients and their families to report concerns about safety and encourage them to do so. The full text of the 2006 Goals and Requirements is posted on the Joint Commission website, www.jcaho.org. Compliance with the Requirements or alternatives judged to be acceptable is a condition of continuing accreditation for Joint Commission-accredited laboratories. Gene Therapy Improves Heart Stem Cell Treatment Research has shown that stem cell therapy can regrow damaged cardiac tissue in patients after a heart attack. However, that same research found the cutting-edge procedure also raised the risk for dangerous heart arrhythmias. It was a potential case of the cure being worse than the disease, Dr. Eduardo Marban, chief of cardiology at Johns Hopkins School of Medicine and its Heart Institute, said. Now, a new study suggests that gene therapy can help avoid that danger. In laboratory research, at team at the Johns Hopkins University School of Medicine in Baltimore discovered that the source of these arrhythmias were myoblasts, adult stem cells taken from the patients' own healthy skeletal muscle. Reporting in Circulation Research, the researchers say they minimized arrhythmias by using gene therapy to replace a key protein called connexin 43, which was found to be missing in heart muscle fibers that grew after stem cell transplants. Connexin 43 makes up the gap junctions between heart muscle cells, allowing the cells to communicate and to regularly expand and contract. We believe that combining gene therapy with adult stem cell transplantation, we can go a long way to prevent the development of potentially fatal arrhythmias in patients who will have these myoblast transplants, Marban said. UC Davis Researchers Discover Receptor Pathway for C-Reactive Protein and its Effects on Human Aortic Endothelial Cells For the first time, scientists have discovered how C-reactive protein (CRP) is able to access endothelial cells. CRP is a known risk marker for heart disease and, in a study published earlier this year, UC Davis researchers Ishwarlal Jialal and Sridevi Devaraj found that endothelial cells also produce CRP, which is increased 100-fold when cytokines are secreted by human macrophages, a key finding that helps to explain how plaque formation is initiated. Devaraj and Jialal have now discovered how CRP affects endothelial cells and promotes plaque rupture. CRP appears to bind to a family of immunoglobulin-processing receptors known as Fc-gamma receptors. In this study, we convincingly show that CRP binds to two members of the Fc-gamma receptor family, CD64 and CD32, and that by blocking these receptors with specific antibodies, we can reverse the detrimental effects of CRP on endothelial cells, said Jialal, the Robert E. Stowell Chair of Experimental Pathology and director of the Laboratory of Atherosclerosis and Metabolic Research at UC Davis Medical Center. This is the first time that anyone has shown how CRP is able to get into the human aortic endothelial cells. Fc-gamma receptors CD32 and CD64 are the culprits, said Sridevi Devaraj, associate professor of pathology at UC Davis School of Medicine and Medical Center. Work at UC Davis and other institutions has shown that CRP induces endothelial cell dysfunction, thus promoting plaque rupture. CRP causes endothelial cells to produce less nitric oxide and to increase the number of cell adhesion molecules. This, in turn, allows damaging leukocytes to enter the vessels. Devaraj and Jialal also showed, in a previous study, that CRP induces endothelial cells to produce plasminogen activator inhibitor, or PAI-1, which promotes clot formation. In addition, recent studies suggest that plaque tissue also produces CRP. In future studies, we will examine the precise pathways by which these receptors are able to mediate CRP effects so that more specific therapies can be developed to target inflammation, said Jialal. According to the American Heart Association, approximately 1.2 million Americans will have a coronary attack this year. Almost a half million of these people will die. About 7.1 million Americans have survived a heart attack. And another 6.4 million Americans have experienced angina. Reducing the concentration of CRP with drugs, such as statins, has been shown to reduce cardiovascular events. Treating other risk factors such as smoking, obesity, high blood pressure with angiotensin receptor blockers and diabetes with thiazolidinediones and metformin are also shown to reduce the levels of CRP. Terry W. Du Clos, professor of medicine, Department of Veterans Affairs Medical Center and The University of New Mexico School of Medicine, Albuquerque, contributed to this study, which had grant support from the National Institutes of Health. Gore Receives FDA Approval for Gore Viabahn© Endoprosthesis (6, 7, and 8 mm diameters) for use in the Superficial Femoral Artery (SFA). More than 30,000 Gore Viabahn Endoprostheses have been implanted since the product was introduced in 1997. The data provided to the FDA for this approval was based on a randomized multicenter trial comparing one year patency of percutaneous transluminal angioplasty (PTA) to the Gore Viabahn Endoprosthesis. Prior to receiving the SFA indication from the FDA, the device has been marketed in the US for the treatment of tracheo-bronchial strictures. The Gore Viabahn Endoprosthesis is constructed with a reinforced, biocompatible, expanded polytetrafluoroethylene (ePTFE) liner attached to the external nitinol stent structure. The self-expanding ePTFE/nitinol device is designed to allow relining of luminal surfaces in tortuous arterial anatomy. The extreme flexibility of the Gore Viabahn Endoprosthesis enables it to better traverse tortuous areas such as the SFA and conform more closely to the complex anatomy of the artery. The Gore Viabahn Endoprosthesis is also engineered for strength and durability in order to withstand the relentless forces and challenges of the SFA. Radiopaque markers on the Gore Sim-Pull Deployment System enhance visualization to facilitate accurate stent-graft placement. The catheter-based system allows for deployment without device lengthening or shortening. European Heart Guidelines Label Many as Sick, Doctors Say The European guidelines for the prevention of heart disease have blood pressure or cholesterol thresholds that label 76 percent of the adult population as potentially sick, according to an editorial in the British Medical Journal. About half of the Norwegian population would be considered at risk at the age of 24 and about 90 percent by the age of 49, according to research cited in the editorial by general practitioners Steinar Westin and Iona Heath. The guidelines take into account other risk factors and patients are recommended to also change their lifestyles in addition to drug treatment. Still, Heath, of the Caversham Group Practice in London, and Westin, a professor of social medicine at the Norwegian University of Science and Technology in Trondheim, Norway, criticize the disease label that’s attached to the patients. The bottom line is that the doctor is expected to inform the patient that these measurements mean that he or she is at increased cardiovascular risk regardless of the management proposed, Westin and Heath said in their editorial. The European Society of Cardiology recommends treating people with blood pressure of over 140/90 millimeters of mercury and serum cholesterol of 5 millimoles per liter. Some doctors question the benefits, costs, long-term effectiveness, side effects and drug interactions of treating everybody at risk. Seventy-six percent had increased levels of cholesterol and/or blood pressure, according to researchers, who studied 62,000 people between the ages of 20 and 79. They applied the European guidelines, issued in 2003, to the population of Norway. The Norwegian study was published in the Scandinavian Journal of Primary Health Care in 2004. The current life expectancy at birth in Norway is 78.9 years, one of the longest living populations. The figure suggests that even more people would be considered at risk in other countries, Westin and Heath said. Some researchers said everyone over the age of 50 should take aspirin to prevent heart disease as 80 percent of men and 50 percent of women are at risk at that age anyway. Still, Westin and Heath said the potential benefits of a treatment decrease at lower risk levels, while the rates of side effects remain similar, the doctors said. Evidence for the long-term effectiveness of treatment is also lacking, they said, adding that costs would further rise. The huge cost of drug treatment for an ever greater proportion of the population has the potential to destabilize publicly funded health-care systems in even the richest nations, they said. Healthpoint® Launches TheWoundInstitute.com Healthpoint announces the launch of TheWoundInstitute.com, an online source for accredited wound care education designed for physicians and nonphysician clinicians. The site was developed to accommodate the educational preferences and workplace demands of healthcare professionals by allowing clinicians to complete courses at their own pace and register, test, and receive continuing education (CE) or continuing medical education (CME) credits instantly for their course work. The formal launch of the site coincided with the 18th Annual Symposium on Advanced Wound Care and 15th Annual Medical Research Forum on Wound Repair and followed a 3-month beta testing period that included over 2,400 registrants and the issuing of over 1,500 CE and 325 CME certificates. TheWoundInstitute.com (www.thewoundinstitute.com) features comprehensive, research-based courses designed to assist healthcare providers in bridging the gap between knowledge and practice. The site currently features 6 courses that provide basic wound care information to practicing clinicians including: Anatomy and Physiology of Skin and Underlying Tissue Definition and Etiology of Wounds The Wound Healing Process Principles of Wound Healing Wound Assessment and Documentation Treatment Modalities. TheWoundInstitute.com will continue to expand its educational offerings in 2005 with courses designed specifically for physicians and advanced practice clinicians. The next course to be added, The Biology of the Chronic Wound, is expected to be launched later this year and will investigate the pathophysiology and management of chronic wounds, including an exploration of the cellular and biochemical differences between chronic and acute wounds and an examination of prevention and treatment strategies. According to the course author, Robert H. Demling, MD, from Brigham and Women's Hospital in Boston, It is necessary to understand the abnormal microenvironment in chronic, nonhealing wounds, in order to design interventional strategies that both remove barriers to and actively promote healing. Dr. Demling continued, We believe the information in this course will be of significant interest to the clinical community and will provide practical information that can contribute to the successful management of these often devastating wounds. Online continuing education has exploded in popularity within the medical community over the past few years due to the convenience and interactive format afforded by the medium. According to Accreditation Council for Continuing Medical Education (ACCME) statistics, the number of physicians participating in internet-based CME programs increased from 37,879 in 1998 to 329,110 in 2002, while the number of nonphysicians (eg, nurses, pharmacists) participating in online CE programs increased from 24,733 to 323,756 over the same period. TheWoundInstitute.com brings the value and convenience of internet-based continuing education to the wound care community and is the only online, fully accredited educational site listed on the Advancing the PracticeSM website (www.advancingthepractice.org). Advancing the Practice is an interdisciplinary group of healthcare professionals, organizations, and corporations committed to advancing the practice of wound care to improve patient outcomes. TheWoundInstitute.com represents the most recent example of Healthpoint's commitment to continuing education for wound care practitioners. In 2004, over 3,251 clinicians attended Healthpoint's 79 programs, titled Wound Healing: Script for Success, earning over 8,804 continuing educational hours for physicians and RNs. Last year, 4,634 certificates and some 6,396 CE credits were awarded through Healthpoint's representative delivered CE programs. Information about the full range of Healthpoint CE programs can be found under the Education tab at www.healthpoint.com. Vascular Disease Most Common Cause of Male Erectile Dysfunction Dr. Graham Jackson, who established a clinic in England dedicated to providing sexual advice to men with cardiac disease and erectile dysfunction (ED), conducted the largest scientific study of its kind, on 425 men with ED and cardiac disease. In the study, Dr. Jackson wished to see if stable coronary patients with ED could have their oral nitrates discontinued to allow for safe use of a PDE-5 inhibitor, such as Viagra, Levitra or Cialis. More than half of the men on oral nitrates who were clinically stable with good ability to exercise had their nitrates discontinued in the presence of continuing beta-blockade or calcium antagonist therapy and close follow-up. Over 90% of the men no longer taking nitrates were treated with a PDE-5 inhibitor which was effective in restoring sexual function in 85%. Importantly, there have been no adverse cardiac events in the group. This is a huge, groundbreaking advance in our field that shows how multidisciplinary sexual medicine really is, states Irwin Goldstein MD. Coordinating care between the sexual medicine physician and the cardiologist has provided new evidence-based, prospective data to support better clinical care for those men with ED and cardiac disease, who historically have been denied such care. We now know that oral nitrates can be discontinued in the presence of continuing beta blockade and/or calcium antagonist therapy in stable coronary disease patients with ED to allow for the safe use of PDE-5 inhibitors. The Center for Disease Control and Prevention estimates that 1 in 12 (8%) or 22 million adults in the US have heart disease. In the U.S., the prevalence rate for those who have angina pectoris is 17.5 per 1000 people. Nitrate therapy is an absolute contraindication to the use of PDE-5 inhibitors, however, since oral nitrates confer little benefit when added to optimum doses of betablockers and/or calcium antagonists, it followed that stable patients may be able to have their nitrate therapy discontinued or exchanged for a drug that does not react with a PDE-5 inhibitor, such as a calcium antagonist or beta blocker. If you are on nitrates, the best advice is to see your doctor, says Dr. Goldstein. (Source: This study was published in The Journal of Sexual Medicine.) Mortality Risk Higher Month After Heart Attack People are most at risk of dropping dead in the first month after a heart attack, a new study finds, but the most effective treatment to prevent this isn’t done that early on because it, too, is considered riskiest then. The new research should prompt doctors to rethink how patients are treated in those crucial early days. The rate of sudden death was 10 times higher in the first month after a heart attack compared to two years later, researchers report in the New England Journal of Medicine. We need to consider therapies and strategies ... that could protect patients during this early vulnerable period following a heart attack, said Dr. Scott Solomon, a cardiologist at Brigham and Women’s Hospital in Boston, who led the study. Sudden death now accounts for 2 out of 3 heart deaths in the United States, about 450,000 cases each year. Studies have shown that implanted defibrillators can help prevent sudden death by shocking the heart back into a normal rhythm. But those studies were done in patients several years after a heart attack. Last year, a study in the same journal reported that putting the pager-size devices in people just weeks after a heart attack does not improve survival, and guidelines by the American College of Cardiology and American Heart Association recommend that doctors wait one to three months before implanting the device. The new study shows the dilemma that creates. This study shows that patients right after a heart attack perhaps have the highest risk of sudden cardiac death and those patients are deprived of getting a defibrillator. It’s an area that we need to study more closely, said heart association spokesman Dr. Kenneth Ellenbogen, a professor at Medical College of Virginia who was not connected with the study. Researchers studied 14,609 post-heart attack patients enrolled in a drug trial who suffered a muscle-damaging heart attack or heart failure between 1998 and 2001. Seven percent either died suddenly or were revived after cardiac arrest. Researchers found 19 percent of all sudden deaths or cardiac arrests happened within a month of a heart attack. The rate of sudden death or cardiac arrest was highest in the first month after a heart attack 1.4 percent compared to 0.14 after two years. The study was funded by Novartis Pharmaceuticals, which makes several cholesterol and blood pressure-lowering drugs. The solution may be identifying the highest risk patients and employing short-term therapies that are not invasive, said Dr. Alfred Buxton, a cardiologist at Brown Medical School, who had no role in the study. Recent heart attack victims at high risk of sudden death might consider alternatives such as a vest defibrillator or automated external defibrillator similar to those found in airports and other public venues to restart a stopped heart, Buxton wrote in an accompanying editorial. The National Heart, Lung and Blood Institute is currently funding a study that looks at the effectiveness of automated external defibrillators on recent heart attack patients. Determining Prognosis in Patients with Chest Pain Now Easier and More Accurate A new, more precise test is available to improve the accuracy of detecting coronary artery disease and risk of heart attack, and can be done right at the bedside. Physicians in emergency departments are challenged in diagnosing the cause and risk factors of chest pain in their patients. Now, using real-time myocardial contrast echocardiography (RTMCE), a type of ultrasound, physicians are able to rapidly and accurately detect coronary artery disease. A study from the University of Nebraska Medical Center and supported by a local grant (from the Hubbard Foundation), performed dobutamine stress echoes in 158 patients presenting with chest pain and possible acute coronary syndrome using the RTMCE test method. They found that perfusion imaging was better than wall motion analysis during dobutamine stress echo for detecting coronary artery disease and predicting patient outcome. The study suggests that by using this non-invasive method of determining the prognosis for patients with unexplained chest pain, patients can be set on the proper course for long-term survival. (Source: This study was published in the July issue of Echocardiography.) First Patient Receives Targeted Renal Therapy with FlowMedica’s Benephit Delta Infusion System A patient undergoing treatment for clogged coronary arteries has become the first to successfully receive targeted renal therapy (TRT) with the Benephit Delta Infusion System, a new device designed to help prevent kidney dysfunction in certain patients undergoing certain coronary procedures, according to FlowMedica, Inc., the company that developed the system. In addition to chronic kidney disease, the patient suffers from congestive heart failure (CHF). The combination of these conditions greatly increased the patient’s risk of developing kidney failure from the radiocontrast media used during his angiography and stenting procedures. The Benephit Delta system is a novel, catheter-based medical device that enables the administration of physician-specified medications and other therapeutic agents directly to the renal arteries. This system is designed to provide selective infusion to both renal arteries simultaneously, using a single catheter. It received 510(k) clearance from the U.S. Food and Drug Administration (FDA) earlier this year. The Benephit Delta is designed to provide TRT, an alternative to systemic intravenous (IV) infusion of medications to treat kidney dysfunction that is related to a number of conditions, including cardiovascular procedures and diseases, for example, congestive heart failure. Systemic infusion is limited in many instances because it can cause serious side effects such as the lowering of blood pressure. This patient was at high risk for developing kidney failure following the coronary procedure, but we had a positive outcome and the patient was able to avoid a potential burdensome dialysis procedure, said the patient’s interventional cardiologist, Giora Weisz, MD, co-director of clinical services for the Center for Interventional Vascular Therapy (CIVT) at New York-Presbyterian Hospital, and Columbia University Medical Center, New York. TRT with the Benephit Delta system now enables us to treat a substantial segment of patients whose treatment options may have been limited previously due to their increased risk of developing kidney failure. The patient recently had angioplasty to treat two severely blocked coronary arteries. Five stents were placed in his coronary arteries. The Benephit Delta system was used to deliver a medication (fenoldopam) directly into the patient’s kidneys through the renal arteries. Fenoldopam increases blood flow inside the kidneys. The patient did not develop RCN. Cardiologists have estimated that 20 percent of patients undergoing coronary interventions could benefit from TRT for RCN. A number of strategies have been investigated to prevent RCN in at-risk patients, including administering medications and other therapeutic agents through systemic IV infusion. However, systemic infusion of pharmaceuticals often is associated with serious side effects such as hypotension. Researchers believe that the amount of medication that reaches the kidneys often does not attain sufficient levels to be therapeutic and, therefore, the treatment may not be effective. Physicians are assessing the premise that drug benefits to the kidneys will be maximized with TRT because the drug is delivered in a therapeutic dose directly to the kidneys. Furthermore, since medications and other therapeutic agents used for TRT are excreted by the kidneys, side effects are thought to be minimized because the kidneys eliminate most of the drug immediately and, therefore, limit the amount of drug reaching the rest of the body.

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