Clinical and Industry News

Vascular Solutions Launches the Gopher™ Gold Catheter

Vascular Solutions, Inc. announces the availability of the Gopher™ Gold catheter, a support catheter with a twist for treating coronary and peripheral stenoses. A new and improved design of the original Gopher, the Gopher Gold is designed for use when treating coronary and peripheral stenoses over an existing in-place 0.014” guidewire. The Gopher Gold catheter combines a highly torqueable, braided backbone with a 3F, highly radiopaque gold-plated distal tip, resulting in a catheter that can pull itself across a stenoses when rotated by the operator in a clockwise direction. The Gopher Gold catheter also features a 100% PTFE-lined shaft for smooth wire movement, contrast and medication delivery, and guidewire support and exchange. The Gopher Gold catheter is currently available in the United States. For more information, visit www.vascularsolutions.com. _______________

Ohio State Researches Stem Cells for Cardiac Treatment

As the debate over using stem cells for medical research continues at the national level, researchers and clinicians at The Ohio State University Medical Center (Columbus, OH) are studying the effectiveness of using non-embryonic stem cells to regenerate heart muscle to improve outcomes for patients. Earlier this year, Ohio State researchers found that “pretreating” adult stem cells with an anti-angina drug allows them to better adapt to the harsh environment of their transplantation site. Scientists are studying whether transplanted cells eliminate or slow the tissue deterioration that would lead to heart failure. In research published in the Journal of Pharmacology and Experimental Therapeutics, adult stem cells from the bone marrow of rats were pretreated with the drug trimetazidine, or TMZ. The stem cells were then grown under low oxygen conditions to mimic their native and destination environments, and then exposed to stressful conditions that exist in the damaged heart tissue. The pretreated stem cells provided a substantially better therapeutic effect in restoring heart function. “Transplanted stem cells can repair many types of damaged tissue, including heart tissue,” says Dr. Periannan Kuppusamy, associate director of the Ohio State Medical Center’s Dorothy M. Davis Heart and Lung Research Institute. “However, most of the stem cells transplanted in the heart die within a few days due to lack of oxygen and nutrients.” Funding from the National Institutes of Health supported Kuppusamy’s research. In early 2008, OSU Medical Center’s Richard M. Ross Heart Hospital began collaborating with Arteriocyte, a biotechnology company created at Case Western Reserve University (Cleveland, OH) to develop stem-cell therapies for human use. “The biggest challenge is that heart muscle doesn’t typically regenerate,” says Dr. Vincent Pompili, Ohio State’s director of cardiovascular cell-based therapies, who previously served at University Hospitals Case Medical Center. “These studies are allowing us to study individual disease processes and identify ways to accelerate the body’s healing mechanisms.” Two recent Phase I trials offer a glimpse into the potential of stem-cell therapy. The first infused a very low dose of umbilical cord blood stem cells into patients with chronic ischemia. After receiving the stem cells, a significant number of trial participants saw improved blood flow to the heart. According to Pompili, this resulted from the stem cells’ ability to help the body repair itself. The second study examined the effect of human umbilical cord blood stem cells in genetically-engineered mice experiencing a chronic lack of blood flow to one of their limbs. One month after stem cell infusion, researchers noted nearly normal blood flow in the mice limbs. _______________

Study Reveals Mounting Evidence of Fish Oil’s Heart Health Benefits

There is mounting evidence that omega-3 fatty acids from fish or fish oil supplements not only help prevent cardiovascular diseases in healthy individuals, but also reduce the incidence of cardiac events and mortality in patients with existing heart disease. A new study, published in the August 11, 2009, issue of the Journal of the American College of Cardiology, extensively reviews data from a broad range of studies in tens of thousands of patients and sets forth suggested daily targets for omega-3 consumption. “This isn’t just hype; we now have tremendous and compelling evidence from very large studies, some dating back 20 and 30 years, that demonstrate the protective benefits of omega-3 fish oil in multiple aspects of preventive cardiology,” said Carl Lavie, MD, FACC, medical director of Cardiac Rehabilitation and Prevention, Ochsner Medical Center, New Orleans, LA, and lead author of the article. “The strongest evidence of a cardioprotective effect of omega-3s appears in patients with established cardiovascular disease and following a heart attack with up to a 30 percent reduction in CV-related death.” Dietary intake of fish oil can also decrease the risk of atherosclerosis, arrhythmias, heart attack, sudden cardiac death and even health failure. Dr. Lavie adds that although there is a smaller benefit in reducing heart failure death — 9 percent mortality benefit in a major recent randomized controlled trial — this is still very impressive given patients’ grave prognosis. “If we translate this finding, it means that we only need to treat 56 patients for four years to prevent one death,” he said. “And we are talking about a very safe and relatively inexpensive therapy.” Most of the evidence for the cardioprotective benefits supports the use of DHA (docosahexaenoic acid) and EPA (eicosapentaenoic acid), the long-chain fatty acids in the omega-3 family. According to Dr. Lavie, EPA and DHA work by getting into the membranes of cells and, in doing so, may help to improve the heart’s electrical activity, vascular tone, plaque stabilization and blood pressure, among other benefits. Studies show that the reduction in CV events is inversely related to the tissue level EPA and, even more so, DHA. Based on these findings, and because the body does not produce its own essential fatty acids, the authors recommend that healthy individuals should consume 500 mg daily of omega-3 fish oil containing EPA and DHA, and people with known heart disease or heart failure aim for at least 800 to 1,000 mg daily. “There are clear health and heart benefits associated with increasing one’s intake of foods that are rich in Omega-3s, including oily fish like salmon, sardines, trout, herring, and oysters,” said Dr. Lavie. Dr. Lavie and his team came across only a few negative studies, including a recent one that showed no benefit in post-MI patients, but it has raised the possibility that omega-3 fatty acids may not provide as much additional protective benefits in low-risk patients already receiving extensive and rigorous post-MI therapies. “It was a one-year study that enrolled fewer than 4,000 patients and the majority were using aspirin, clopidogrel, statins, beta-blockers and ACE-inhibitors — the best of modern medicine,” he said. “It may be that their risk was so low to start, that a larger study with longer follow-up would be required to better assess the true efficacy of omega-3 in such relatively low-risk patients.” Authors say further studies are needed to investigate and determine optimal dosages, as well as the relative ration of DHA and EPA that provides maximal heart protection in those at risk of cardiovascular disease, and in the treatment of atherosclerosis, arrhythmias and heart attacks. Interestingly, culture has historically played a role; sometimes dubbed the “Eskimo factor,” research shows cultures that have traditionally supported a diet rich in fish oil (Asian and Alaskan American populations) had a lower prevalence of cardiovascular disease and mortality, including a reduced prevalence of atherosclerosis and heart disease, compared to European and United States populations where consumption of fish is lower. Ironically, the introduction of Western dietary practices into Asian and Native American cultures may be diluting the cardioprotective benefits enjoyed by these populations by both reducing the overall intake of fish oils, as well as overwhelming its benefits with other deleterious dietary practices, including high intakes of saturated and trans fats and cholesterol. _______________

Death Rate Decreases Following Hospitalization for Heart Attack

From 1995 to 2006, hospital 30-day death rates decreased significantly for Medicare patients hospitalized for a heart attack, as did the variation in the rate between hospitals, according to a study in the August 19 issue of JAMA. “Over the last 2 decades, health care professional, consumer, and payer organizations have sought to improve outcomes for patients hospitalized with acute myocardial infarction [AMI],” the authors write. However, little has been known about whether hospitals have been achieving better short-term mortality rates for AMI or if there has been a reduction in between-hospital variation in short-term mortality rates. Harlan M. Krumholz, MD, SM, of Yale University School of Medicine, New Haven, Conn., and colleagues examined 30-day risk-standardized mortality rates (RSMRs) for acute care hospitals in the United States in the period between 1995 and 2006 for Medicare patients, 65 years or older (average age, 78 years) who were hospitalized with an AMI. The study included data on 3,195,672 discharges in 2,755,370 patients. The researchers found that the all-cause and in-hospital death rates decreased over the study period. The RSMR, which takes into account the differences in the types of patients across hospitals and is currently being used by the Centers for Medicare and Medicaid Services (CMS) to profile hospital performance, decreased from 18.8 percent in 1995 to 15.8 percent in 2006, and a reduction in between-hospital differences in mortality rates was also observed. “Between 1995 and 2006, the RSMR for patients admitted with AMI showed a marked and significant decrease, as did between-hospital variation. Although the cause of the reduction cannot be determined with certainty, this finding may reflect the success of the many individuals and organizations dedicated to improving care during this period,” the authors conclude. _______________

Angio Procedures Growing at a Steady 4%-5% Clip, with Positive Market Prospects for Angio Systems

According to IMV’s recent census of angio labs in the U.S., an estimated 4.8 million procedures were performed at 1,720 angio lab sites in 2008, including non-coronary vascular angiographic and other procedures performed in the angio labs. From 2004 to 2008, total procedures performed in angio labs grew 20%, from 4.0 million in 2004 to 4.8 million procedures in 2008 for hospitals with 150+ beds, resulting in an average annual growth rate of 4%-5%. “Angio lab procedure volume has grown steadily as the procedure mix has broadened to include a variety of peripheral vascular and other non-coronary angiographic procedures,” observed Lorna Young, Senior Director, Market Research. “From 2004 to 2008, the number of angioplasties, stent placements, IVC filter placements, embolizations and PICC lines/vascular access procedures has contributed to the overall increase of procedures performed in angio labs. We also see that angio labs are accommodating increased numbers of procedures such as vertebroplasties, biopsies and RF tumor ablations.” “Concurrent with this steady procedure growth, the market outlook over the next 2-3 years looks positive, as hospitals seek to retool their older angio labs. While the market for angio labs has experienced a slowdown over the past year, over one-third of the hospitals with 150+ beds are planning to purchase labs from 2009 to 2011+, and ~90% of the planned angio lab purchases will have flat panel image digital detectors.” IMV's 2008/09 Interventional Angiography Lab Market Summary Report describes trends in procedures, angio lab x-ray systems, contrast media utilization, power injectors for angio contrast, capital and contrast media budgets, and site operations characteristics. IMV’s report also includes three market forecast scenarios for 2009-2013, incorporating varying assumptions about the first buyer, replacement and additional unit purchases that are based on market indicators identified in the report. Other report highlights include: • 51% of the angio lab sites had one room, 30% had two rooms, and 19% had three or more rooms. • The average replacement cycle for angio rooms is 11.5 years. • Just under half (49%) of the angiography sites report waiting times for a non-emergency procedure of less than one day, 10% report waiting times of 1 day, 23% report 1+ to 2 days, and 18% report waiting times of 2 days or more. • In addition to interventional radiologists using the angio suite, vascular surgeons are the second most likely physician type to be using angio labs, performing procedures in over half of the sites. IMV’s 2008/09 Interventional Angiography Census Database provides comprehensive profiles of U.S. hospitals with 150+ beds performing interventional angiography procedures, where at least 50% of the total lab volume are non-coronary angiography procedures. For more information, visit www.imvinfo.com. _______________

Abbott Expands XIENCE V® USA Trial to Enroll Patients into Dual Anti-Platelet Therapy (DAPT) Trial

Abbott announced the expansion of the company’s XIENCE V® USA post-approval study designed to evaluate the safety and effectiveness of the Xience V Everolimus Eluting Coronary Stent System in a real-world clinical setting out to five years. The expansion allows for more than 2,000 patients from the XIENCE V USA trial to be eligible to cross over into the landmark Dual Anti-Platelet Therapy (DAPT) Trial, an industry-wide collaboration with medical device and pharmaceutical companies. The first patient was enrolled into the XIENCE V USA expansion by James Hermiller, MD, director, Cardiac Catheterization Labs, The Care Group at St. Vincent Hospital in Indianapolis, Ind. Dr. Hermiller is a principal investigator of the XIENCE V USA trial along with Mitch Krucoff, MD, FACC, FCCP, director, Cardiovascular Devices Unit, Duke Clinical Research Institute in Durham, NC. The XIENCE V USA trial expansion allows for an additional 3,000 patients to be enrolled into Abbott’s study, which was originally designed to study 5,000 patients in the United States. The primary endpoint of XIENCE V USA is a measure of stent thrombosis every year out to five years, as defined by the Dublin/Academic Research Consortium (ARC). The ARC definition of late stent thrombosis was developed to eliminate variability in the definitions across various drug-eluting stent trials. The DAPT Trial is an independent, large-scale study in size (20,000+ patients) and scope intended to determine the appropriate duration for dual anti-platelet therapy as well as the safety and effectiveness of DAPT to protect patients from stent thrombosis and major adverse cardiovascular and cerebrovascular events (MACCE) following the implantation of either a drug-eluting or bare-metal stent. The DAPT concept was developed by a consortium of eight companies (four major stent manufacturers, including Abbott, and four manufacturers of anti-platelet medications) who came together to address a U.S. Food and Drug Administration (FDA) request for this post-market study. The Harvard Clinical Research Institute (www.hcri.harvard.edu) is responsible for the design, conduct and analysis of the overall study. Abbott also supplies a private-label version of XIENCE V to Boston Scientific called the PROMUS® Everolimus-Eluting Coronary Stent System. PROMUS is designed and manufactured by Abbott and supplied to Boston Scientific as part of a distribution agreement between the two companies. Additional information is available at www.xiencev.com _______________

Delays in Defibrillation Not Explained by Traditional Hospital Factors

Traditional hospital factors — such as case volume and academic status — do not appear to predict whether patients with cardiac arrest at that facility are likely to experience delays in receiving defibrillation, according to a report in the July 27 issue of Archives of Internal Medicine, one of the JAMA/Archives journals. The American Heart Association recommends that defibrillation be performed within two minutes of cardiac arrest. Longer delays to defibrillation are associated with lower survival rates following cardiac arrest in the hospital. Previous studies have found that factors associated with individual patients, such as being admitted to the hospital for a non-cardiac diagnosis and experiencing cardiac arrest on evenings and weekends, predicted delayed defibrillation. However, less is known about whether differences between hospitals are associated with these delays. Paul S. Chan, MD, MSc, of the Saint Luke’s Mid-America Hospital Institute, Kansas City, MO, and colleagues analyzed records from 7,479 adult inpatients with cardiac arrest (average age 67 years) at 200 hospitals included in the National Registry of Cardiopulmonary Resuscitation (NRCPR). Hospitals participating in the NRCPR in 2006 were asked to complete a detailed survey, including information about location, hospital teaching status, number of patient beds and the availability of automatic external defibrillators. Rates of delayed defibrillation — defined as longer than the two-minute standard — varied substantially among hospitals and ranged from 2.4 percent to 50.9 percent. Differences between hospitals accounted for a significant amount of the variation between patients; for instance, patients with identical characteristics had 46 percent greater odds of experiencing a defibrillation delay at one randomly selected hospital compared with another. “However, many of the individual hospital characteristics that we explored — such as volume, academic status and hospital-wide mortality rate — were unrelated to hospital performance in defibrillation time,” the authors write. Only the number of beds and the location of the cardiac arrest (for example, in or out of the intensive care unit) were associated with the rate of defibrillation delays, whereas there was no association between delays and geographical location, rate of cardiac arrest per 1,000 patient admissions, existence of an automatic external defibrillator program or most other hospital-related factors assessed. “This lack of correlation between ‘conventional’ hospital-level factors and defibrillation time suggests that other unmeasured characteristics are responsible for certain institutions achieving extremely low rates of delayed defibrillation.” Patients at hospitals with fewer defibrillation delays were less likely to die in the hospital — the odds of survival were 41 percent higher in the one-fourth of hospitals with the fewest defibrillation delays than in the one-fourth of hospitals with the most delays. “Given extensive differences in defibrillation time across institutions and the recognized impact of delayed defibrillation on survival, new approaches to improve hospital performance in defibrillation time could represent a critical area for quality improvement,” the authors conclude. Editorial: Efforts Needed to Close Gap in Care “In the early 1990s, the American Heart Association identified early defibrillation as the single most important predictor of survival in patients who experience cardiac arrest,” write P. Michael Ho, MD, PhD, of the University of Colorado Denver and Denver VA, and Steven M. Bradley, MD, in an accompanying editorial. “Each minute delay between onset of cardiac arrest and defibrillation is associated with a 7 percent to 10 percent lower likelihood of survival.” “In this issue of the Archives, Chan et al extend their prior work by demonstrating wide variation in the frequency of delayed hospital defibrillation among 200 hospitals participating in the National Registry of Cardiopulmonary Resuscitation (NRCPR),” they continue. “Although this article is important in highlighting the gap in care, it is now time to move beyond demonstrating the gap to closing it.” Lessons can be learned from previous efforts to improve heart attack treatment times, Dr. Ho and Dr. Bradley note. “In particular, involving senior leadership, providing prompt data feedback and using a multidisciplinary team-based approach are likely to improve performance. Identification of the practices of NRCPR participant hospitals that have been successful at providing timely defibrillation is also likely to lead to strategies for shortening times to defibrillation. Research testing different approaches to improve timely defibrillation times is needed as well. Once effective strategies have been developed and tested, individual hospitals can implement and adapt those strategies that are feasible within their local environment.” (Source: Arch Intern Med 2009;169[14]: 1260-1261;1265-1273) _______________

Nano-Magnets Guide Stem Cells to Damaged Tissue

Microscopic magnetic particles have been used to bring stem cells to sites of cardiovascular injury in a new method designed to increase the capacity of cells to repair damaged tissue, University College London (UCL) (London, England) scientists announced. The cross-disciplinary research, published in The Journal of the American College of Cardiology: Cardiovascular Interventions, demonstrates a technique where endothelial progenitor cells — a type of stem cell shown to be important in vascular healing processes — have been magnetically tagged with a tiny iron-containing clinical agent, then successfully targeted to a site of arterial injury using a magnet positioned outside the body. Following magnetic targeting, there was a five-fold increase in cell localization at a site of vascular injury in rats. The team also demonstrated a six-fold increase in cell capture in an in vitro flow system (where microscopic particles are suspended in a stream of fluid and examined to see how they behave). Although magnetic fields have been used to guide cellular therapies, this is the first time cells have been targeted using a method directly applicable to clinical practice. The technique uses an FDA (U.S. Food and Drug Administration) approved agent that is already used to monitor cells in humans using MRI (magnetic resonance imaging). Dr. Mark Lythgoe, UCL Centre for Advanced Biomedical Imaging, the senior author of the study, said: “Because the material we used in this method is already FDA-approved, we could see this technology being applied in human clinical trials within 3-5 years. It’s feasible that heart attacks and other vascular injuries could eventually be treated using regular injections of magnetized stem cells. The technology could be adapted to localize cells in other organs and provide a useful tool for the systemic injection of all manner of cell therapies. And it’s not just limited to cells — by focusing tagged antibodies or viruses using this method, cancerous tumors could be much more specifically targeted.” Panagiotis Kyrtatos, also from the UCL Centre for Advanced Biomedical Imaging and lead researcher of the study, added: “This research tackles one of the most critical challenges in the biomedical sciences today: ensuring the effective delivery and retention of cellular therapies to specific targets within the body. “Cell therapies could greatly benefit from nano-magnetic techniques which concentrate cells where they are needed most. The nano-magnets not only assist with the targeting, but with the aid of MRI also allow us to observe how the cells behave once they’re injected.” This work was supported by the UCL Institute of Child Health (Child Health Research Appeal Trust), The British Heart Foundation, the Alexander S. Onassis Public Benefit Foundation and the Biotechnology and Biological Sciences Research Council (BBSRC). _______________

Pronk Technologies Expands Patient Simulator Offerings with the EasySim® Training Simulator

Focus on the training needs of the cath lab Training simulators are often used to keep cath lab staff sharp, optimizing patient outcomes with difficult and infrequent cases and procedures. However, simulators typically used for this purpose are often found to be bulky, complicated devices. Recently, simulator company Pronk Technologies (Sun Valley, CA) released the EasySim® Training Simulator, which focuses on specific training needs for the cath lab and other hospital departments. “We tried to focus on designing a more convenient and complete Training Simulator,” explains Greg Alkire, VP of Sales and Marketing at Pronk Technologies. “Before the EasySim, existing simulators often had to be plugged into the wall or required frequent handling of batteries, rendering them inconvenient. They often did not come complete with cardiac output or 4 invasive pressures, and it was difficult to hook up a12-lead ECG. The EasySim uses patent-pending approaches such as a power management and an internal battery design to provide up to 10 years of use. That’s 10 years without ever plugging into a wall outlet or changing or charging batteries. We also designed a 12-lead banana plug interface into the simulator body for simplifying the connection of ECG leads while reducing noise on the ECG signal.” The EasySim incorporates a remote control with 48 direct access keys, eliminating the need for searching codes or software menus for the physiological parameter/simulation desired. ECG heart rate, ST elevation/deviation, respiration rate, dozens of rhythms/arrhythmias, muscle and baseline noise, four invasive pressures and even cardiac output and temperature are all variable at the touch of a button. The EasySim can also be used for verifying that the monitoring system is working correctly before each shift, prior to critical cases or during a case when a problem develops (defective patient cable or lead wire, for example). For more information, call 800-609-9802 or visit www.MyEasySim.com. _______________

Gender Differences Explain Death Rates Following a Heart Attack

One of the largest studies exploring heart attack-related gender differences found that women are twice as likely to die within 30 days following a heart attack, explained by the distinct risk factors, medical history and heart anatomy of men and women. The study is published in the current issue of the Journal of the American Medical Association and was conducted by researchers at Duke University Medical Center. Women had higher mortality associated with the most severe form of heart attack but, at the other end of the spectrum, a lower risk of unstable angina or acute chest pain without heart attack. The study included data from 11 international, randomized clinical trials of more than 136,000 patients with acute coronary syndromes. Mortality rates at 30 days were nearly 10 percent in women and 5 percent in men. After adjusting for personal characteristics and disease severity, there was not a significant difference between the genders. Women were older with more high blood pressure, high cholesterol, diabetes, and heart failure. Men were more likely to be smokers and have had a history of heart attack or bypass surgery. The factors that appeared to have the largest impact on the higher mortality rates among women included age, smoking, high blood pressure, heart rate, and height. The research team is continuing to study gender disparities in cardiovascular disease, including morality rates one year after a heart attack.

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