Industry News

September Clinical and Industry News

Abbott Enrolls First Patient In New Clinical Trial Of Xience V Drug-Eluting Stent Abbott announced enrollment of the first patient in its SPIRIT IV clinical trial for the continued evaluation of the safety and efficacy of the Xience V Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease in a more complex patient population. Xience V received CE Mark approval earlier this year. The system utilizes the Multi-Link Vision® coronary stent platform. Dr. Ali Rizvi, MD, director of Interventional Cardiology Research at The Heart Center of Indiana in Indianapolis, enrolled the first patient. Preliminary results from clinical studies of the Xience V stent have been promising. SPIRIT IV has been designed to enroll a broader patient group, including patients with multi-vessel coronary artery disease requiring multi-vessel stenting, said Dr. Gregg W. Stone, MD, of Columbia University Medical Center and the Cardiovascular Research Foundation, New York, who is principal investigator for SPIRIT IV. I look forward to the results of this study of patients that will approximate a real-world population. The SPIRIT IV study, which will enroll approximately 1,125 patients at approximately 40 sites in the United States, is a single-blinded, multi-center clinical trial. The study allows for the treatment of up to three de novo native coronary artery lesions, with a maximum of two lesions per vessel, and in some cases, lesions that are located at areas of bifurcation. The Xience V stent system will be randomized 2:1 to Boston Scientific’s Taxus® Express2 Paclitaxel-Eluting Coronary Stent System. The primary endpoint of the trial is ischemia-driven target vessel failure (TVF) at 270 days. Patients will be followed out to five years. Six-month data on the Xience V stent system from the SPIRIT II trial will be presented at the European Society of Cardiology meeting in Barcelona, Spain, on September 5. Abbott’s SPIRIT III pivotal study has completed enrollment of 1,002 patients in the randomized U.S. portion of the trial. Enrollment in the 4.0 mm and the Japan arms of the non-randomized portion of its SPIRIT III clinical trial was temporarily suspended earlier this year, but is expected to resume in the near future. In April 2006, Abbott acquired the vascular intervention and endovascular solutions businesses of Guidant Corporation. The SPIRIT FIRST study of the Xience V System showed positive results at 30 and 180 days for patients with de novo native coronary artery lesions. SPIRIT II and SPIRIT III are large-scale pivotal clinical trials comparing Xience V to the Taxus Express2 Paclitaxel Eluting Coronary Stent System. Appropriateness Criteria Issued for Cardiac Computed Tomography and Cardiac Magnetic Resonance Imaging ACCF and others aim to assist patients, clinicians, and payers in determining reasonable imaging tests The American College of Cardiology Foundation (ACCF), along with key specialty and subspecialty societies, have released Appropriateness Criteria for two relatively new clinical cardiac imaging modalities, cardiac computed tomography (CCT) and cardiac magnetic resonance imaging (CMR). These Criteria were developed in order to address the growth in biomedical imaging to ensure that it is appropriate to patient needs. In response to the need for guidance in ordering and performing advance cardiac imaging procedures, such as CT and CMR, the ACCF has focused a great deal of resources in helping to determine if it is ‘reasonable’ or appropriate to perform a test for a specific indication. We aim to assist patients, clinicians, and payers when determining how best to use cardiac tests and procedures. It is now widely apparent that these imaging studies should be used only when the information provided will have a direct impact on patient care, as medical imaging has undergone tremendous growth in recent years, said Robert Hendel, MD, FACC, chair of the writing group for the Appropriateness Criteria for CCT and CMR. It is also our hope that the criteria will generate discussion between physicians and payers regarding reimbursement, added Dr. Hendel. The CCT and CMR Appropriateness Criteria were developed in collaboration with American College of Radiology, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, American Society of Nuclear Cardiology, North American Society for Cardiac Imaging, Society for Cardiovascular Angiography and Interventions and Society of Interventional Radiology. An appropriate imaging study is defined as one in which the expected incremental information combined with clinical judgment, exceeds the expected negative consequences by a sufficiently wide margin for a specific indication that the procedure is generally considered acceptable care and a reasonable approach for the indication. Negative consequences include the risks of the procedure (i.e., radiation or contrast exposure) and the downstream impact of poor test performance such as the delay in diagnosis (false negatives) or inappropriate diagnosis (false positives). The 39 CCT and 33 CMR indications rated by a technical panel of experts encompassed the majority of clinical scenarios referred for CCT and CMR, respectively. These appropriateness reviews assessed the risks and benefits of the imaging tests for several indications or clinical scenarios and scored them based on a scale of 1-9, where the upper range (7-9) implies that the test is generally acceptable and is a reasonable approach, and the lower range (1-3) implies that the test is generally not acceptable and is not a reasonable approach. The mid range (4-6) indicates an uncertain clinical scenario. The indications for these reviews were drawn from common applications or anticipated uses, as few clinical practice guidelines currently exist for these techniques. These indications were reviewed by an independent group of clinicians and modified by the Working Group, and then panelists rated the indications based on the ACCF Methodology for Evaluating the Appropriateness of Cardiovascular Imaging, which blends a broad range of clinical experience and available evidence-based information. We recommend that cardiovascular professionals use the CCT and CMR Appropriateness Criteria to avoid ordering tests deemed inappropriate in the clinical setting unless there are very unusual circumstances. In addition, clinical scenarios rated uncertain require more research before we understand whether a given test is appropriate or inappropriate for that particular scenario, said Michael Poon, MD, FACC, a member of the writing group for the Appropriateness Criteria for CCT and CMR. The CT and CMR Appropriateness Criteria are the second and third sets of appropriateness criteria to be developed by the ACCF. In October 2005, the ACCF, in collaboration with the American Society of Nuclear Cardiology, issued the Appropriateness Criteria for Single Photon Emission Computed Tomography Myocardial Perfusion Imaging. For the complete Appropriateness Criteria for CCT and CMR, visit www.acc.org. Kimberly-Clark Launches Femoral Angiography Drape for High-Fluid Diagnostic and Interventional Procedures Kimberly-Clark Health Care announced the launch of an Impervious Extra Long (XL) Femoral Angiography Drape to deliver the fluid control required for diagnostic and interventional procedures performed in the catheterization lab and interventional radiology lab, where fluid management is critical for the protection of both patients and staff. The Impervious XL Femoral Angiography Drape features: A film layer that provides impervious protection against strikethrough of blood and other body fluids, as well as dyes, heparin and saline solutions used for irrigation, contrast and cleaning of guide wires. Extended length from top to bottom, as well as improved absorbent fabric reinforcement to minimize the risk of safety hazards from fluid pooling and running off onto staff scrubs, shoes and the floor. Low-lint and abrasion-resistant fabric reinforcement to reduce the risk of lint particles adhering to guide wires, catheters or stents, which can enter the patient’s bloodstream and can cause significant post-procedural complications. In addition to the Impervious XL Femoral Angiography Drape, the Kimberly-Clark cath lab solutions bundle includes Microcool® Breathable Impervious Surgical Gowns and Ultra Non-Reinforced surgical gowns with Secure-Fit® technology, as well as Fluidshield® Face Masks. Immediate Aggressive Treatment Necessary to Fight Hospital-Acquired Infection Incorrect treatment provided to one in three patients with methicillin-resistant staph infections Drug-resistant, hospital-acquired infections often are treated initially with ineffective antibiotics, which increases the risk of death, according to an article in the August issue of Critical Care Medicine, the journal of the Society of Critical Care Medicine. The researchers conducted a three-year retrospective study of 549 Barnes-Jewish Hospital patients with MRSA sterile-site infection to determine the rate of appropriate initial antimicrobial administration and to evaluate the influence of this treatment on outcome. They found that nearly one in three MRSA-infected patients initially received inappropriate treatment for MRSA infection, nearly doubling their risk of death. Physicians should deliver early appropriate antibiotic therapy, says senior author Marin H. Kollef, MD, professor of medicine at Washington University School of Medicine in St. Louis. For methicillin-resistant Staphylococcus aureus (MRSA), that means treating acutely ill hospitalized patients with antibiotics that are active against MRSA instead of less effective antibiotics. The occurrence of MRSA has skyrocketed in the last five to 10 years and is now the most common hospital pathogen. Hospital-acquired MRSA infections have serious consequences, including increases in the risk of death and in healthcare costs. Patients in intensive care units are particularly vulnerable. Hospital mortality associated with MRSA sterile-site infections is reported to be greater than 20 percent. Lead author Garrett E. Schramm, PharmD, says that it is crucial for physicians to aggressively identify and treat patients at risk for sterile-site MRSA infections and for physicians to be aware of local susceptibilities for both hospital and community-acquired MRSA isolates. In our ICUs, we automatically treat for MRSA along with other bacteria when we have a patient with hospital-acquired infection, says Dr. Kollef. Obviously, not everyone will have MRSA infection, but it is so common and the consequences of not treating it upfront are so high that we treat for MRSA before its presence is confirmed. Dr. Kollef says there are no drawbacks to including MRSA treatment in initial therapy, as long as clinicians monitor the patient. If the culture results show no evidence of MRSA infection, then MRSA-related antibiotics can be stopped. In most patients, this is done within 48 hours. Dr. Schramm says that there are a variety of antibiotics that can treat MRSA infections. Many are given intravenously and are appropriate for hospital use, while some, including sulfamethoxazole-trimethoprim (Bactrim: Roche Laboratories Inc., Nutley, NJ), can be administered orally and may be used to treat community-acquired MRSA infections. Dr. Schramm is a clinical pharmacist at Mayo Clinic in Rochester, Minnesota, and a former critical care specialty resident at Barnes-Jewish Hospital in St. Louis. We have the antibiotics, and now we should develop optimal treatment algorithms, concludes Dr. Kollef. This will provide early appropriate therapy, while minimizing emergence of further resistance in MRSA and other bacteria. El Camino Hospital Opens Center Devoted to Heart Disease Prevention for South Asians The first nonprofit center in the world devoted to the prevention of coronary artery disease (CAD) in people of South Asian descent has opened at El Camino Hospital (ECH) in Mountain View, California. The unique South Asian Heart Center (SAHC) is designed to address the epidemic of heart disease among people from India, Bangladesh, Pakistan, Nepal and Sri Lanka, who are four times more likely to suffer a heart attack, and at younger ages, without prior symptoms or warning and without presenting the same risk factors as the general population. More than half of heart attacks among South Asians occur before age 50, compared to an average age of 65.8 for the general male population, and 70.4 for the female population. In California, South Asians have four times the hospitalization rate compared to Caucasians and other Asian populations. The higher rates of heart disease in this group apply across the population, even for lifelong vegetarians who exercise regularly, do not smoke and are not overweight. This global epidemic affects both male and female South Asians living in the United States (including 350,000 who reside in the Bay Area), urban South Asia and elsewhere. Most physicians evaluate South Asian patients the same way they evaluate other patients when assessing for coronary artery disease risk, said Cesar Molina, MD, Medical Director of the SAHC. We now know that applying western standards and traditional guidelines to South Asians leads to underestimating the risk in this population. Additional risk factors beyond high blood pressure, smoking, and obesity may play a causative role, and as a result, they must be screened and treated differently from other ethnic groups. One of our goals is to educate physicians to be aware of and respond to these critical differences. Our comprehensive assessment and risk management program factors in what we call the 4 R’s’, said Ashish Mathur, executive director of SAHC. First we identify all the risk factors including emerging ones that impact South Asians frequently. Then we provide personalized recommendations for prevention, focusing on lifestyle modifications and as necessary, medications. We also provide referrals to wellness resources such as nutritionists knowledgeable in South Asian diets, and fitness, yoga, meditation and stress reduction centers that understand our program and help participants make long term positive lifestyle changes. Finally, we recheck periodically and motivate our participants to real progress. This intense, in-person case management ensures that patients stay and succeed on their heart-health management program and is provided free of charge by the center, funded by community donations. The SAHC has drawn interest and support from some of the world’s leading cardiologists and physicians, such as Dr. Kanu Chatterjee, the Ernest Gallo Distinguished Professor of Medicine at the UCSF Medical Center and Dr. Enas Enas, director of the Coronary Artery Disease Among Asian Indians (CADI) Research Foundation, whose pioneering research initially inspired ECH physicians to develop the program. Both serve on the Center’s Physician Advisory Council. Increased Risk Factors. Dr. Enas’s research showed that traditional risk factors fail to account for the increased rate of cardiovascular disease in South Asians so conventional screening doesn’t adequately identify those at risk. Most standard risk factors high blood pressure, smoking, high LDL cholesterol, low HDL cholesterol, obesity, hypertension, and sedentary lifestyle apply to South Asians as well. But in recent years, researchers have identified additional genetic and metabolic risk factors that play a causative role in premature heart disease among the South Asian population: The dramatic prevalence among South Asians of Metabolic Syndrome/Insulin Resistance (a pre-diabetic condition that can include low HDL cholesterol, high triglycerides, abdominal obesity, high blood pressure and high fasting glucose) and full-blown diabetes. Higher levels among South Asians of Lipoprotein (a) concentrations despite normal cholesterol levels. These are genetically determined and are considered an emerging risk factor in the overall U.S. population. Lower levels of HDL2b, the protective particle within the good cholesterol that is responsible for reverse cholesterol transport, even with normal HDL levels. Significantly higher homocysteine levels, which are associated with higher risk of cardiac death. Girish Shah, a 64-year-old, has had four angioplasties in the past decade despite medication and lifestyle modifications. Although his cholesterol levels were well within standard guidelines, blockages continued to occur. The SAHC heart health assessment and screening identified additional metabolic abnormalities that may have been playing a role in his disease. With the SAHC’s recommendations, and increased awareness of the higher risk, I worked with my physicians to modify my medications, implement lifestyle changes more aggressively, and have since significantly increased my good cholesterol. My last two stress tests have not shown any progression or worsening of my blockages. Mr. Shah is now a donor and the chair of corporate and community outreach for the Center. I want to make sure other South Asians have access to this innovative program, he said. About the South Asian Heart Center at El Camino Hospital. In 2004 El Camino Hospital (ECH) brought a team of more than 80 health professionals together with South Asian community leaders to discuss the abnormally high incidence of heart disease among South Asian populations and explore the idea of a wellness center to address the problem. Today, the Center’s staff members work with more than 40 volunteers to help carry out the Center’s mission. SAHC is a community-funded organization made possible through a growing awareness of the heart health problems of South Asians, and the generosity of the community. Since its inception, ECH has provided significant resources to make SAHC a reality. To schedule a screening, volunteer time, or donate to the center, visit the web site at www.southasianheartcenter.org or call (650) 940-SAHC (7242). CBRPA Announcement The Certification Board for Radiology Practitioner Assistants (CBRPA) would like to announce testing results for 2006. During the 2006 year, the CBRPA certified 81 new RPAs. The CBRPA tested 85 candidates for the examination and four failed. The pass rate is 95-96% and is a similar pass rate to other testing agencies within the Radiologic Technology profession. Currently we have 272 certified Radiology Practitioner Assistants located in 44 states. There are currently 73 students enrolled in the Weber State University RPA program with another 60 students scheduled to start in the 2006 Fall Semester. If further information is needed, please access the organization’s website, www.cbrpa.org or contact Mr. Clements via his e-mail address, rwc@hawaii.rr.com. Roland W. Clements, M.S., M.Ed., FASRT Professor Emeritus, President CBRPA Clements Consulting LLC 757 Kinalau Pl. #601, Honolulu, HI 96813 North Hills Hospital is First in the Nation to Receive Chest Pain Center-Cycle 2 Award Heart attacks don't follow a schedule, and neither should chest pain treatment. At North Hills Hospital, a patient can receive the same level of care on Sunday afternoon that he or she would receive on Tuesday morning. If he needs to go to the cardiovascular lab for intervention, he can go immediately. At most other hospitals, interventional treatment may only be available during business hours. Because of North Hills Hospital’s commitment to providing the most advanced heart attack treatment, the hospital was the first in the nation to be awarded Accredited Chest Pain Center with PCI Designation (also referred to as Cycle 2). This is currently the highest level of accreditation given by the Society for Chest Pain Centers, the same organization that named North Hills Hospital the first in North Texas to receive their original accreditation (Cycle 1). This latest accreditation took a year to complete and was the result of collaboration among hospital employees, administrators, cardiologists, emergency physicians, and local EMS. Community benefits for the hospital’s Cycle 2 award include: Patients can have immediate access to the cardiac cath lab 24 hours a day, seven days a week. EMS continues to fax EKGs from the field to the emergency room, so that when a patient hits the hospital door, the chest pain team can be waiting and available to begin treatment immediately. The hospital has been recognized for its rapid results screening, a lab test that can reveal a heart attack within 18 minutes. Previous lab tests could take more than twice as long. North Hills Hospital, in North Richland Hills, is currently undergoing a $32 million expansion that will add two new floors and a new dedicated heart unit. For information, please contact Bethe Spurlock at (817) 255-1893. Cath Lab Professionals Prove that the Basics are Still Important On August 19th, approximately 300 attendees traveled to New Brunswick, New Jersey, to hear Cath Lab Basics presenters Dr. Morton Kern, Clinical Professor of Medicine and Associate Chief Cardiology at University of California Irvine in Orange, California, and Dr. Michael J. Lim, Director, Interventional Cardiology and Assistant Professor of Medicine at St. Louis Health Sciences Center in St. Louis, Missouri. Presentation topics ranged from hemodynamics to pharmacology to the importance of access, and were well-received by an audience consisting of RNs new to the cath lab as well as nurses and technologists with years of experience. Cath lab staff traveled from as far as California, Florida and South Carolina for the chance to experience a day of high-quality education and an introduction to basic information essential to maximizing patient care in the cath lab. The event offered 4 CE credits. My on-the-job training so far has been like swiss cheese some holes in certain areas, commented one CCU RN who recently crossed over to the cath lab. This course has been excellent. Her comment was echoed by the many enthusiastic attendees who regularly utilize Dr. Kern’s legendary reference guide, The Cardiac Catheterization Handbook, and were pleased to see the author in person. Many felt that the meeting filled an unmet need in the field. One MSN, estimating her experience level in the cath lab as intermediate, said that the course ties together a lot of loose ends. Cath Lab Basics was supported by ACIST Medical Systems, Boston Scientific, Cordis Corporation and GlaxoSmithKline, and sponsored by the North American Center for Continuing Medical Education (www.naccme.com). As a result of these companies’ support, cath lab professionals were able to attend at no charge. Dr. Lim noted, Dr. Kern and I have spent a great deal of time and energy teaching cardiology fellows to perform diagnostic catheterization and coronary interventions. Very early on in this process, we have realized that the nurses and techs in the lab are just as eager to learn the same material. The attendees at this course proved this again and we eagerly look forward to the next Basics course! I am new to the cath lab (started 1 month ago), commented one RN. I find your seminar inspiring, challenging, and exciting. I am looking forward to learning. It’s a very interesting field. Consensus Reached on New Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death First-ever Joint ACC/AHA/ESC Guidelines on VA and SCD Eliminate Inconsistencies The 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death (SCD) were released today by the American College of Cardiology (ACC), American Heart Association (AHA), and the European Society of Cardiology (ESC) in collaboration with the European Heart Rhythm Association (EHRA) and the Heart Rhythm Society (HRS). The purpose of this document is to update and combine the previously published recommendations into one source approved by the major cardiology organizations in the United States and Europe. This document completes the triad of arrhythmia-based guideline topics cosponsored by the ACC, AHA and ESC. In addition to ventricular arrhythmias and sudden cardiac death, management of patients with supraventricular arrhythmias and atrial fibrillation have also been addressed in separate documents. The new ACC/AHA/ESC Guidelines outline recommendations on the evaluation and treatment of patients who have or may be at risk for VA. Evaluation includes noninvasive and invasive techniques such as electrocardiography and electrophysiological testing. Possible therapies include pharmacological, devices, ablation, surgery and revascularization. Acute and chronic therapies are addressed. Prognosis and management are individualized according to symptom burden and severity of underlying heart disease in addition to clinical presentation. In addition to recommendations in patients with specific pathology, cardiomyopathy and heart failure, specific populations are also covered, such as athletes, pregnant women, the elderly and pediatric patients. One of the key updates in the 2006 document is that the implantation of devices now has a range of ejection fractions. Prior to this document, says Douglas P. Zipes, MD, and co-chair of the Guideline Writing Committee, practitioners faced inconsistent recommendations for prophylactic ICD implantation based on ejection fractions, for example. The inconsistencies occurred because clinical investigators chose different ejection fractions for enrollment in trials of therapy, average values of the ejection fraction have been substantially lower than the cut off value for enrollment and subgroup analysis of clinical trial populations based on ejection fraction have not been consistent in their implications. The result was substantial differences among guidelines. The Writing Committee also notes in the 2006 VA Guidelines that differences between the United States and Europe may modulate how recommendations are implemented. Guidelines are composed of recommendations based on the best available medical science; however, implementation of these recommendations will be impacted by the financial, cultural, and societal differences among individual countries. We have consciously attempted to create a streamlined document that would be useful specifically to locate recommendations on the evaluation and treatment of patients who have or may be at risk for ventricular arrhythmias. We are pleased that this consensus document has the support of all the major cardiovascular societies in Europe and the U.S., said A. John Camm, MD, European co-chair of the Guideline Writing Committee. The executive summary was published in the September 5, 2006 issues of the Journal of the American College of Cardiology, and Circulation: Journal of the American Heart Association, and the first September issue of the European Heart Journal (Eur Heart J 2006;27:2099-2140). The full-text guideline is published in Europace and e-published in the same issue of the journals noted above, as well as posted on the ACC (www.acc.org), AHA (www.americanheart.org), and ESC (www.escardio.org) sites.
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