Clinical and Industry News

New Technology Bodes Well for Pediatric Heart Transplant Patients Children’s Healthcare of Atlanta Study Shows Tissue Doppler Imaging Has Advantages Over Biopsy Doctors at Children’s Healthcare of Atlanta are testing an emerging technology that may change the course of care for children with transplanted hearts. Derek A. Fyfe, MD, PhD, along with fellow researchers at Sibley Heart Center at Children’s, is conducting a study of Tissue Doppler Imaging (TDI) on pediatric heart-transplant patients. TDI is a new ultrasound technology that measures heart function without the invasive and painful elements of cardiac catheterization and biopsy. Children’s Healthcare is one of only four hospitals in the nation that is testing TDI on pediatric transplant patients. Preliminary results of the ongoing study, presented recently at the annual meeting of the International Society for Heart and Lung Transplantation, show that TDI, when used in conjunction with traditional echocardiography, can detect signs of terminal heart failure up to 12 months before the child’s heart actually fails. For the 50 percent of all pediatric heart transplant patients who will need another heart transplant within 12 years due to failure or rejection, early detection is critical because it may give them enough warning to re-list and receive new hearts. Another early result of the study, presented at the American Society of Echocardiography Scientific Sessions in June, is that TDI can effectively measure the deterioration of the right ventricle. Right ventricular deterioration is one of the most common and critical problems for transplanted hearts. Moreover, it typically occurs during the first week after transplant, when invasive biopsies are not usually performed. TDI may also be able to detect signs of rejection, says Dr. Fyfe. If this is proven by our current research, it could offer an alternative to traditional cardiac catheterizations. Children with transplanted hearts typically endure between three and 12 biopsies a year to assess the function of their transplanted hearts and monitor for signs of rejection, procedures that can be both painful and costly. For heart transplant patients and their families, TDI could turn out to be a painless and less expensive option. Money from Lawsuit to Benefit One of the Nation’s Leading Pediatric Cardiac Centers and Emory University More than $1.5 million has been donated to Emory University School of Medicine to endow Kirk R. Kanter, MD, Chief of Cardiothoracic Surgery at Sibley Heart Center at Children’s Healthcare of Atlanta and Director of the Heart and Lung Transplant program at Children’s. Dr. Kanter is also a Professor of Cardiothoracic Surgery at Emory University. The funds for the Kanter Endowment were established from an auto insurance lawsuit involving State Farm Insurance. After many unsuccessful attempts were made to contact eligible recipients for the award stemming from the lawsuit, lawyers from both sides nominated potential beneficiaries to the judge. Attorney Neal Pope, a former patient of Dr. Kanter’s, assisted in the nomination process and recommended establishing the Kanter Endowment. The endowment is one of several other charities receiving money from the lawsuit, which amounted to more than $6 million in unclaimed funds. More than 10 years ago, we performed a heart transplant for Neal, said Dr. Kanter. We are extremely grateful for his efforts and look forward to using the endowment to continue the important work we do for children. We are proud of the level of expertise we can offer patients through our renowned pediatric heart transplant center. The Kanter Endowment will enable greater collaboration between Sibley Heart Center and Emory University. One of the nation’s largest pediatric cardiac programs, Sibley Heart Center surgeons have performed more than 145 pediatric heart transplants since 1988. The endowment will help further research initiatives undertaken by Sibley Heart Center and Emory University and enable the recruitment of additional pediatric cardiothoracic surgeons. LuMend Receives FDA Clearance to Commercially Market the Frontrunner Catheter for CTOs in the Peripheral Vasculature LuMend® Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared an expanded indication of the Frontrunner® CTO Catheter for crossing CTOs in the peripheral vasculature. This includes the superficial femoral artery (SFA), subclavian and iliac arteries. The Frontrunner Catheter is the only FDA-cleared device with a specific indication for crossing chronic total occlusions in both the coronary and peripheral vasculature. The LuMend Frontrunner CTO Catheter is designed to address these clinical challenges by facilitating rapid and reliable placement of conventional guide wires across CTOs. The Frontrunner catheter-based technology features controlled, blunt micro-dissection that gently separates atherosclerotic plaque, creating a passage through the CTO. This enables guide wire access and provides physicians with the opportunity to treat patients using less-invasive coronary procedures. Standard guide wires have proven to be an effective modality for crossing chronic total occlusions in the peripheral vasculature. However the Frontrunner Catheter and its technique of blunt micro-dissection offer a new option for crossing these CTOs in a very safe and efficient manner, notes John Paul Runyon, MD, Interventional Cardiologist at Christ Hospital in Cincinnati, Ohio. He adds, One of the major advantages of the technology we have observed is the catheter’s ability to move through longer peripheral CTOs in a more expeditious manner when compared to standard guide wire technique and technology. The ability to recanalize these longer occlusions with shorter procedure times and successful clinical outcomes is a benefit to both the patient and the hospital system. Guidant Receives U.S. Approval for First Cobalt Chromium Coronary Stent System Guidant Corporation received Food and Drug Administration approval for the MULTI-LINK VISION Coronary Stent System. This marks the introduction of the first in a new class of coronary stents in the United States. The use of the cobalt chromium alloy allows for a thinner strut design and a lower profile, which enables physicians to access challenging coronary blockages. Guidant plans to use its cobalt chromium stent technology in future programs including drug eluting stents and vulnerable plaque therapies. U.S. approval was received for the Multi-Link Vision in 3.0 mm - 4.0 mm diameters and 8 mm to 28 mm lengths. The Multi-Link Vision stent has demonstrated positive clinical results, with a six-month clinically driven target lesion revascularization (TLR) rate of 1.9 percent. TLR is defined as a repeat procedure at the original lesion site any time during the follow-up period. The six-month clinically driven TLR rate for the Multi-Link Vision stent is extremely promising, said Dr. Dean Kereiakes, co-principal investigator for the study; CEO, Ohio Heart Health Center; and medical director of The Lindner Center for Research & Education at The Christ Hospital in Cincinnati. The combination of cobalt chromium and the unique Vision stent design truly expands the treatment options available to interventional cardiologists and their patients. Aventis Receives FDA Approval of Supplemental New Drug Application for Lovenox® Label Change Revises Language on Use in Patients With Mechanical Prosthetic Heart Valves The U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for its Lovenox® (enoxaparin sodium injection) antithrombotic therapy. The product labeling approved by FDA with this sNDA includes revised information regarding the use of Lovenox in patients with mechanical prosthetic heart valves, including pregnant women with mechanical prosthetic heart valves. The sNDA was submitted in October 2002 and was based on a review of the available clinical data, accessible patient registries, and the Aventis safety database for enoxaparin regarding its use in patients with prosthetic heart valves. Introduced in the U.S. in 1993, Lovenox is the most widely studied and used agent in its class and has been prescribed to treat 118 million patients in 96 countries for the prophylaxis and treatment of venous and arterial thrombosis. SCAI Past President to Lead New Cardiovascular Coalition Ten Medical Societies Unite to Achieve Common Goals Joseph D. Babb, MD, FSCAI, was recently named Chair-Elect of the Coalition of Cardiovascular Organizations (CCO), a newly founded entity that unites 10 medical societies focused on optimizing the treatment of heart disease patients. Dr. Babb, who is a recent President of the Society for Cardiovascular Angiography and Interventions (SCAI), is currently Professor of Medicine, Director of the cardiac catheterization laboratories, and Director of the Cardiology Fellowship Training Program at East Carolina University’s Brody School of Medicine. His term as CCO Chair will begin in early 2004. In the meantime, he and the Coalition’s current Chair, Dr. Nathaniel Reichek, are working closely together to give the fledgling organization a good start. Each of the various cardiovascular subspecialty societies has a somewhat different mission, and members tend to identify most strongly with their own subspecialty, but we all share the belief that the needs of our patients will always be our top priority, said Dr. Babb. Working together through the CCO will strengthen the house of cardiology, helping us to speak with a common voice as we work on initiatives that will enable physicians to better serve their patients. The CCO includes representatives from the American College of Cardiology, American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Failure Society of America, NASPE Heart Rhythm Society, Society for Cardiovascular Angiography and Interventions, Society for Cardiovascular Magnetic Resonance, Society of Geriatric Cardiology, Society of Thoracic Surgeons, and the Society for Vascular Medicine and Biology. There was consensus among the member groups that the CCO’s initial efforts should focus on patient education, professional education, advocacy, and the development of practice guidelines. These are important issues for all of the cardiovascular subspecialties, said Dr. Babb. By sharing our resources and pooling our knowledge, we’ll be able to reduce duplicated efforts and improve our overall effectiveness. Dr. Babb is no stranger to forging intersocietal bonds for the good of patient care. During his 2001-02 tenure as President of the SCAI, he brought together representatives of all the international medical societies focused on interventional cardiology. There was a real need for an interventional cardiology round table a place to address the common, overriding concerns that affect interventional cardiologists whether they practice in Taiwan or New York City, said Dr. Babb. There are important parallels between the forum we created for interventional cardiology societies and the cooperative organization we have created for cardiovascular societies through the CCO. Dr. Babb received his medical degree in 1966 from The Johns Hopkins University School of Medicine and then served two years as a commissioned officer in the U.S. Army, earning a Bronze Star. In 1972, he joined The Milton S. Hershey Medical Center as an Assistant Professor of Medicine and was promoted to Associate Professor before moving on to become the Section Chief of Cardiology at Bridgeport Hospital and Clinical Associate Professor at Yale University School of Medicine. He was appointed to his current positions at the Brody School of Medicine in 1995. Headquartered in Bethesda, Md., The Society for Cardiovascular Angiography and Interventions is a 2,600-member professional organization representing invasive and interventional cardiologists. The SCAI’s mission is to promote excellence in invasive and interventional cardiovascular medicine through physician education and representation, and advancement of quality standards to enhance patient care. The SCAI was organized in 1976 under the guidance of Drs. F. Mason Sones and Melvin P. Judkins. The first SCAI Annual Scientific Sessions was held in Chicago in 1978. Joint Commission Announces 2004 National Patient Safety Goals The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) today announced its 2004 National Patient Safety Goals. The Goals, approved by the JCAHO Board of Commissioners last week, continues all of the 2003 Goals and adds a new Goal that will focus on reducing the risk of health care-acquired infections. For each of the National Patient Safety Goals, there are evidence-based Requirements that set forth clear expectations for health care organizations to address specific types of health care errors. The 2003 Requirement to read back verbal and telephone orders in order to confirm their accuracy has been expanded for 2004 to include the read-back of critical test results that are communicated verbally. Beginning January 1, 2004, the nearly 17,000 JCAHO-accredited health care organizations will be evaluated for compliance with all relevant Goals and Requirements. Organizations will still be able to seek prior approval by the Joint Commission of suitable alternatives to the Requirements. The 2004 National Patient Safety Goals and Requirements are: Goal 1: Improve the accuracy of patient identification. Use at least two patient identifiers (neither to be the patient's room number) whenever taking blood samples or administering medications or blood products. Prior to the start of any surgical or invasive procedure, conduct a final verification process, such as a time out, to confirm the correct patient, procedure and site, using active “ not passive “ communication techniques. Goal 2: Improve the effectiveness of communication among caregivers. Requirements: Implement a process for taking verbal or telephone orders or critical test results that requires a verification read-back of the complete order or test result by the person receiving the order or test result. Standardize the abbreviations, acronyms and symbols used throughout the organization, including a list of abbreviations, acronyms and symbols not to use. Goal 3: Improve the safety of using high-alert medications. Requirements: Remove concentrated electrolytes (including, but not limited to, potassium chloride, potassium phosphate, sodium chloride >0.9%) from patient care units. Standardize and limit the number of drug concentrations available in the organization. Goal 4: Eliminate wrong-site, wrong-patient and wrong-procedure surgery. Requirements: Create and use a preoperative verification process, such as a checklist, to confirm that appropriate documents, (e.g., medical records, imaging studies) are available. Implement a process to mark the surgical site, and involve the patient in the marking process. Goal 5: Improve the safety of using infusion pumps. Requirements: Ensure free-flow protection on all general-use and PCA intravenous infusion pumps used in the organization. Goal 6: Improve the effectiveness of clinical alarm systems. Requirements: Implement regular preventive maintenance and testing of alarm systems. Assure that alarms are activated with appropriate settings and are sufficiently audible with respect to distances and competing noise within the unit. Goal 7: Reduce the risk of health care-acquired infections. Requirements: Comply with current CDC hand-hygiene guidelines. Manage as sentinel events all identified cases of unanticipated death or major permanent loss of function associated with a health care-acquired infection. The expert panel which developed these recommendations the Sentinel Event Advisory Group includes well-known patient safety experts, as well as nurses, physicians, risk managers, pharmacists, and other professionals who have hands-on experience addressing patient safety issues in health care settings. Its recommendations were based in part on data drawn from the Joint Commission's Sentinel Event Database and from other established sources. Angioplasty More Effective than Clot Busters in Treating MI A study compared balloon angioplasty with intravenous (thrombolytic) medical therapy for the restoration of coronary artery blood-flow to the heart for patients with acute ST-segment elevation myocardial infarction. A systematic review of 23 clinical trials involving 7,700 patients showed that angioplasty was more effective than drug treatments for both short- and long-term recovery rates in these patients. This study incorporates data from studies using the most up-to-date thrombolytic and angioplasty therapies available, including stents and platelet-blocking medicines, said Dr. Ellen Keeley, assistant professor of internal medicine and the study's lead author. Importantly, long-term data is now available for many of these patients and our results show that angioplasty is not only more effective in the short-term, but its results are durable over time. For patients with ST-segment elevation myocardial infarction, the analysis showed that angioplasty was better than thrombolytic therapy, in the short term (four to six weeks follow-up) at reducing death (7 percent compared with 9 percent for medical therapy); recurrence of nonfatal heart attack (3 percent compared with 7 percent); stroke (1 percent compared with 2 percent); and a combination of all these outcomes (8 percent compared with 14 percent). These differences were sustained for six to 18 months. Other investigators on the study were from William Beaumont Hospital in Royal Oak, Michigan.

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