Clinical and Industry News

Radi Medical Systems Announces 2006 Medicare Hospital Outpatient Payment Rates for Myocardial Fractional Flow Reserve (FFRmyo) Radi Medical Systems, Inc. announced that the Center for Medicare and Medicaid Services (CMS) has approved the proposed 2006 Medicare hospital outpatient payment classifications and rates. The 2006 rates have an increased amount of reimbursement when measuring Myocardial Fractional Flow Reserve (FFRmyo) in multiple coronary vessels. Numerous clinical studies have shown that FFRmyo can be used to accurately assess the functional significance of coronary lesions. Comparative studies have shown that cost savings can be obtained by routinely utilizing FFRmyo to assist in identifying the culprit stenosis via a ˜tailored’ approach in multi-vessel disease. The adjustments to the reimbursement codes for FFRmyo that take effect January 1, 2006 are as follows: APC group 0670, entitled Level II Intravascular and Intracardiac Ultrasound and Flow Reserve’ has a national average payment rate of $1711.22, a decrease of $20.02. APC group 0416, entitled Level I Intravascular and Intracardiac Ultrasound and Flow Reserve’ has a national average payment rate of $978.74, an increase of $704.18. CPT Codes 93571 and 93572 have decreased approximately 4% to $91.89 and $72.00, respectively. APC group 416 and CPT code 93572 are utilized when more then one vessel is interrogated to measure FFRmyo. Commenting on the new CMS ruling, Jim Archetto, COO, Radi Medical Systems Inc, states These revised reimbursement rates mirror the clinical data; specifically, with the advent of drug-eluting stents and aggressive medical therapies, more patients with complex coronary disease are presenting to the cath-lab for diagnosis and treatment. FFRmyo is a quick, clinically validated method for the identification, localization and post intervention assessment of coronary artery disease. The updated reimbursement rates ensure that hospitals can accurately receive payment for this vital procedure. Radi’s physiology platform provides measurement of pressure (FFR), flow (CFR) and intravascular temperature using a single PressureWire®Sensor and one instrument. The new generation of intravascular assessment products includes the PressureWire®5 Sensor coronary guidewire, with significantly improved handling characteristics, and the RadiAnalyzer®Xpress, which provides FFR measurements through a set up sequence. Emergency bypass surgery on angioplasty patients drops 90% Decline seen at Mayo Clinic even as physicians expanded angioplasty to sicker patients When life-threatening problems occur during angioplasty procedures, doctors may perform emergency coronary artery bypass graft surgery, but data from the Mayo Clinic indicates that need to send patients to emergency surgery has dropped sharply, according to a study in the Dec. 6, 2005, issue of the Journal of the American College of Cardiology. "Our review of almost 25 years of data on angioplasty suggests that there has been a dramatic reduction of almost 90 percent in the incidence of coronary artery bypass graft surgery following angioplasty; and this is despite the fact that more recently we are performing angioplasty on very high risk patients," said Mandeep Singh, MD, from the Mayo College of Medicine in Rochester, Minnesota. The researchers, including lead author Eric H. Yang, MD, reviewed a unique registry of every angioplasty performed at the Mayo Clinic. The registry includes more than 23,000 cases and extends back to the first angioplasty procedure in 1979. Data from the Mayo registry were divided into three groups: the "pre-stent" era, 1979 to 1994 (8,905 patients); the "initial stent era," 1995 to 1999 (7,605 patients); and the "current stent era," 2000 to 2003 (6,577 patients). "We knew there had been a reduction, but the magnitude of the reduction was a surprise to us," Dr. Singh said. "The bypass surgery rates, which were close to 3 percent, came down to 0.3 percent in the most recent time period." Dr. Singh said the fact that angioplasty is being offered to sicker patients now makes the reduction even more remarkable. Patients requiring emergency surgery in the most recent study period had a higher prevalence of high blood pressure and heart failure, and they were more likely to have undergone previous procedures, compared to patients in the earlier study periods. Dr. Singh said he believes stents may be responsible for much of the reduction in the rate of life-threatening problems during angioplasty procedures. He also pointed to other improvements in drug therapy and device technology that have made angioplasty safer and more successful. However, among patients who did suffer serious problems during angioplasty and had to be sent into emergency surgery, the researchers did not see an improvement in survival. Death rates were statistically similar in all three study periods, ranging between 10 percent and 14 percent. Dr. Singh pointed out that there were only 41 deaths among patients who underwent emergency bypass surgery, including just two during the 2000 to 2003 study period. He said such small numbers make it difficult to calculate useful statistical comparisons. The study authors pointed out that this analysis is based on a retrospective review of registry data from the Mayo Clinic only, not a prospective trial at multiple institutions, although Dr. Singh noted that the registry is very large. In an editorial in the journal, John A. Bittl, MD, from the Ocala Heart Institute, Munroe Regional Medical Center in Ocala, Florida, said that while the sharp decline in emergency bypass surgery on angioplasty patients is welcome news, he is concerned the results may be used by some providers to argue that back-up surgical facilities are no longer needed. "Almost every hospital wants a share of the lucrative coronary intervention market and every physician hopes that in-laboratory deaths and the need for emergency bypass and will go away completely, but this ideal situation has not been attained," Dr. Bittl said. "The assessment of elective PCI without on-site bypass surgery underway in some states is a step in the right direction. But, choosing the right metrics is challenging. The only meaningful comparison between hospitals with and without on-site surgery is the rate of death or urgent transfer to another facility within a pre-specified period of time after PCI. One proposal that mixes acute events with late endpoints like repeat revascularizations is manipulative and misleading," he added. Dr. Bittl wrote that this study has established an important benchmark and should stimulate exploration of ways to improve angioplasty and make it even safer. Breakthrough in Unraveling Causes of Sudden Cardiac Death in Young People Scientists at the Wales Heart Research Institute, Cardiff University have made a breakthrough in our understanding of the causes of sudden cardiac death (SCD) in young people. (This research has been funded by the British Heart Foundation.) SCD is a major cause of mortality worldwide, and when it occurs in young children and adolescents is particularly devastating. Recent advances have shown that the genetic mutations in the heart's calcium release channels (known as ryanodine receptors) destroy the ability of the channels to work properly following stress or exercise. These channels released too much calcium, possibly explaining how in affected young people, the normal heart signaling is severely disrupted and could lead to tachycardia and arrhythmia. Despite these advances, pinpointing the changes that occur within the mutant channel molecules that cause the increase in calcium release remained elusive. These new insights show that normal channels open and close in a tightly regulated fashion, but that mutations make the activated channels 'jittery' and prevent them from closing properly. Dr. Christopher George, who led the research, explained, "This is crucial new evidence that mutation-linked abnormalities in cardiac calcium release may arise from defects in the channel structure. Although there is a long way to go, this finding gives us vital clues that the precise stabilization of these channels may represent the best way to prevent this catastrophic disease in people containing this faulty gene." Work is already underway to develop a new therapeutic approach which is hoped will eventually restore proper channel closure and may help prevent SCD in susceptible individuals. Source: Circulation, January 6, 2005. Groundbreaking Guidelines Promote Early Detection, Treatment of Arterial Disease Expert panel guides treatment of arterial disease of the legs and feet, kidneys, intestines, and aorta More than 12 million Americans suffer from peripheral arterial disease (PAD), prompting the American College of Cardiology (ACC) and the American Heart Association (AHA) to release the groundbreaking Peripheral Arterial Disease Guidelines to help physicians and all healthcare professionals better treat this alarmingly common condition. The new Guidelines, representing best practices for managing diseases of the aorta and the arteries that supply blood to the legs, feet, kidneys, and intestines, were developed in collaboration with and approved by the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society for Vascular Medicine and Biology, and the ACC/AHA Task Force on Practice Guidelines. These Guidelines provide a concise diagnostic and treatment guidebook for patients suffering from PAD and for physicians, physicians assistants, nurse practitioners, and nurses who are now offering care to treat them, said Alan T. Hirsch, MD, chairman of the writing committee. Our important collaborations with our professional partners in SVMB, SIR, SVS and SCAI make these Guidelines more valuable to all practicing health professionals. We have provided access to the best available evidence that can guide best care. A key source of the power of these recommendations is that they are so broad-based in their origin from every vascular specialty, as they attempt to reach a broad-based audience of clinicians. Everyone can use these Guidelines and a large segment of the public can benefit from them. The PAD Guidelines strongly emphasize the fact that early detection and treatment of peripheral arterial disease can prevent disability and save lives. We’re saying to physicians for the first time, ‘Don’t wait for the patient to complain to you about symptoms that they may not appreciate as hallmark signs of poor health. Ask specific questions to define high-risk groups, and initiate early therapy to maintain functional independence and decrease the risk of heart attack, stroke, and death,’ said Dr. Hirsch, an associate professor of epidemiology, medicine, and radiology at the University of Minnesota and director of Abbott Northwestern’s Vascular Center in Minneapolis. A driving force behind the Guidelines was recognition that a wide range of physicians treat peripheral arterial disease, and each brings a different set of tools and knowledge to the task, depending on background and training. All physicians who treat these conditions need to be aware of the latest information on diagnosis and management, said Dr. Norman R. Hertzer, emeritus chairman of the Department of Vascular Surgery at the Cleveland Clinic Foundation, Cleveland, Ohio. These Guidelines present that information in an objective and dispassionate fashion. Indeed, the guidelines committee took a time-tested approach to analyzing thousands of scientific studies, giving the greatest weight to well-designed randomized clinical trials, but also taking into account smaller studies and expert opinion as needed. We have hammered out, to the best of our abilities, recommendations for clinical practice, but we’ve also been very clear about the relative strengths and weaknesses of each recommendation, said Dr. Ziv J. Haskal, a professor of radiology and surgery, and director of the Division of Vascular and Interventional Radiology at New York-Presbyterian Hospital/Columbia University Medical Center, New York City. These grayer areas mark some of the most important opportunities for future research. Highlights of the guidelines include: Recommended questions and observations that can uncover hidden signs of peripheral arterial disease; Clinical clues that a patient may have renal artery stenosis, a narrowing of the arteries that supply blood to the kidney; Recommendations on when an aneurysm should be treated with surgery or catheter-based therapy, as well as when watchful waiting is the best course; A critical analysis of the strengths and weaknesses of vascular imaging tests and other diagnostic methods; An emphasis on therapeutic choice, including the role of exercise, diet, smoking cessation, and medications, and an objective review of the benefits and drawbacks of surgical and catheter-based therapies; Clinical pathways and treatment algorithms to guide clinical decision-making. The Guidelines have been developed not just for specialists who perform the complex procedures used in the treatment of peripheral arterial disease, but also for primary care physicians, nurse practitioners, and physician assistants, all of whom make the initial diagnosis and initiate therapy. These Guidelines provide the busy practitioner with a series of signposts to mark the pathway to excellent vascular care, Dr. Hirsch said. The PAD Guidelines were also endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; and the Vascular Disease Foundation. The American College of Cardiology, American Heart Association and all other endorsing organizations of the Guidelines are partners in the PAD Coalition, a consortium of 38 health organizations, professional societies and government agencies that have united to raise public and clinician awareness of PAD. The full text of the Guidelines will be published online at www.acc.org and www.heart.org. An executive summary of the Guidelines will be published in the Journal of the American College of Cardiology and in Circulation: Journal of the American Heart Association. Progress Slow In Improving Hospitals’ Patient Safety Systems While there has been some improvement in patient safety systems at hospitals, progress has been slow and the current systems are not close to meeting certain recommendations, according to a study in the December 14 issue of Journal of the American Medical Association. The 1998 Institute of Medicine (IOM) National Roundtable on Health Care Quality and subsequent reports ushered in a period of extensive research about the quality of the U.S. health care system. The IOM report, To Err Is Human, provided in-depth analyses of a wide range of patient safety problems and underscored the need for improvement. Subsequently, the IOM has called for fundamental change ¦ to close the quality gap and save lives, and proposed a national initiative to provide a strategic direction for redesigning the health care system of the 21st century. These documents indicate that successful implementation of change in the nation’s overall health care system requires change in specific patient safety systems at the hospital level. Daniel R. Longo, OblSB, ScD, and colleagues from the University of Missouri-Columbia, conducted a study to assess the status of patient safety systems and examine changes from 2002 to 2004. The study included a survey of all acute care hospitals in Missouri and Utah at 2 points in time, in 2002 and 2004, using a 91-item comprehensive questionnaire (n = 126 for survey 1 and n = 128 for survey 2). The researchers analyzed the responses of the 107 hospitals that responded to both surveys to assess the changes over time. Seven variables were constructed to represent the most important patient safety constructs studied: computerized physician order entry systems, computerized test results, and assessments of adverse events; specific patient safety policies; use of data in patient safety programs; drug storage, administration, and safety procedures; manner of handling adverse event/error reporting; prevention policies; and root cause analysis. For each hospital, the 7 variables were summed to give an overall measure of the patient safety status of the hospital. The researchers found that development and implementation of patient safety systems is at best modest. Self-reported regression in patient safety systems was also found. While 74 percent of hospitals reported full implementation of a written patient safety plan, nearly 9 percent reported no plan. The area of surgery appears to have the greatest level of patient safety systems. Other areas, such as medications, with a long history of efforts in patient safety and error prevention, showed improvements, but the percentage of hospitals with various safety systems was already high at baseline for many systems. Some findings are surprising, given the overall trends; for example, while a substantial percentage of hospitals have medication safety systems, only 3 percent reported full implementation at survey 2 of computerized physician order entry systems for medications, despite the growth of computer technology in general and in hospital billing systems in particular. Response from within the health care system clearly has been slow. In part, this is because of the complexities involved in implementing systems and changing cultures; however, complexity can also be an excuse, the authors write. Based on our findings, we recommend that individual hospitals, including their boards of directors, medical staffs, administration, and staff, review the list of patient safety systems our expert focus groups identified as needed in all hospitals. They can conduct their own survey of where they stand with regard to development and implementation of each of these and report where they stand to the community. While the list may seem long, it is very manageable when viewed by individual hospital departments to which given system characteristics apply. We concur with the larger recommendations of others that nationally there must be a far more aggressive agenda, the researchers write. In an accompanying editorial, Stephen G. Pauker, MD, Ellen M. Zane, BA, MA, and Deeb N. Salem, MD, of the Tufts“New England Medical Center, Boston, comment on the study by Longo et al. To produce sustained change, it is essential to understand root causes of current problems, establish policies to induce and maintain change, create measurements at all levels that shape safer behaviors, and properly measure progress toward the goal of having a safer health care system. Longo et al provide data about the introduction of safety systems, but better measurement systems and better data are also needed about the incidence of adverse events. Rewarding safety will surely help. Some clinicians might consider being paid to perform as being unprofessional, but few could object to creating a safer and higher-quality health care system. Rather than labeling such initiatives as pay-for-performance programs, it may be preferable to think of them as paying for quality and paying for safety. The time has come to take bold action and to embrace change, but first it is time to understand the constraints to accomplishing that change, they write. Source: JAMA.2005; 294:2858-2865, 2906-2908. Drug Compound Restores Youth to Aging Arterial Cells in Elderly Hypertensives Stiff arteries relax like younger blood vessels after taking alagebrium A compound called alagebrium, similar to another used in anti-wrinkle creams, may be useful in reducing the deleterious effects of arterial aging in the majority of elderly Americans with systolic hypertension, a study from researchers at Johns Hopkins shows. This is the first demonstration that this class of drugs, known as collagen-crosslink breakers, can turn back the clock and make old arteries behave like young ones, says senior study investigator and geriatric cardiologist Susan Zieman, MD, an assistant professor at The Johns Hopkins University School of Medicine and its Heart Institute. The Hopkins researchers found that alagebrium, formally known as ALT-711 or 4,5-dimethyl-3-(2-oxo-2-phenylethyl)-thiazolium chloride, reduced stiffening in the vessel wall in the main artery of the neck (carotid artery) by as much as 37 percent. The drug also improved endothelial function, the ability of the vessels’ inner lining to relax and dilate in response to increased stress from blood flow, by 102 percent. Chemically, alagebrium is a so-called crosslink breaker, responsible for destroying the rigid chemical bonds known as advanced glycation endproducts, or AGE for short, that form between body proteins and sugars over time. According to Zieman, both stiffening and reduced capacity of the arteries to expand in response to stress are common effects of aging that occur when the crosslinks form in the body’s key structural proteins, such as collagen, or when AGEs interact directly with enzymes that regulate blood flow. Crosslinking effectively carmelizes the collagen leading to tissue wrinkles, cataracts, as well as stiffening and increased speed and force of blood flow. These processes are accelerated in diabetics. The Hopkins findings, presented at the American Heart Association’s Scientific Sessions 2005, also suggest that the cellular effects of aging caused by AGE are potent targets for new therapies. In the Hopkins study, 13 elderly men and women with systolic hypertension took either daily doses of alagebrium (210 milligrams) for eight weeks or a look-alike pill (placebo), containing no active drug. AGE and collagen levels were monitored through blood tests. Stiffness was measured using a small pressure-sensor device called a tonometer. Ultrasound readings, taken before and after drug therapy, were made as a blood pressure cuff was inflated for five minutes and deflated. This allowed researchers to calculate endothelial function based on how much the blood vessel lining relaxed as a percentage increase of how much the blood vessel could expand. After treatment with alagebrium, neck arteries became less stiff, as shown by tonometer readings and decreased levels of collagen in the blood as AGE crosslinks were broken down. Analysis of additional pressure-wave readings also showed flatter patterns more closely resembling younger arteries than older, stiffer ones, which have wave patterns with higher peaks. While the results did not explain why endothelial function improved, the researchers believe it has to do with the drug’s effects on AGE and cell function. Their theory, Zieman says, is that one chemical reaction, the breakdown of AGE crosslinks, both reduces the structural causes of arterial stiffness in the artery wall and alleviates the detrimental effects of AGE on other enzymes or related proteins, possibly nitric oxide and other chemicals causing vessel inflammation. These results confirm that this drug does have important effects on the aging process in the arteries, but we still have to prove that there’s some benefit to patients in terms of reducing cardiovascular disease, Zieman says. Our next step will be a study, expected to begin in late 2006, of the drug’s potential benefit at preventing or reversing heart failure in the elderly. Alagebrium has been under investigational study since 1999, originally as a treatment for hypertension. While clinical studies have demonstrated the drug’s ability to loosen up stiff arteries, two larger studies in older people with hypertension have not shown significant results in lowering blood pressure. Inflammatory Markers May Help Predict Stroke Risk in Middle-Aged People In addition to traditional risk factors such as diabetes, high blood pressure, age, and race, a particular enzyme and protein found in the blood may help identify middle-aged men and women at increased risk for ischemic stroke, according to a study in the Archives of Internal Medicine. Measurement of inflammatory markers has been reported to identify individuals at increased risk for ischemic stroke. Christie M. Ballantyne, MD, of Baylor College of Medicine and Methodist DeBakey Heart Center, Houston, Texas, and colleagues examined levels of two inflammatory markersC-reactive protein (CRP) and the enzyme lipoprotein-associated phospholipase A2 (Lp-PLA2)to determine if they are associated with increased risk for incident ischemic stroke. The researchers conducted a prospective case-cohort study of 12,762 apparently healthy middle-aged men and women in the Atherosclerosis Risk in Communities (ARIC) study, who were observed for about six years. The final sample size for the analysis was 960, including 194 ischemic stroke cases and 766 non-cases. The authors report that levels of Lp-PLA2 and CRP were higher in middle-aged Americans who subsequently had an ischemic stroke than in those who did not. Mean Lp-PLA2 and CRP levels adjusted for sex, race, and age were higher in the 194 stroke cases than the 766 non-cases, whereas low-density lipoprotein cholesterol (LDL-C) level was not significantly different, the authors write. Individuals with high levels of both CRP and Lp-PLA2 were at the highest risk after adjusting for traditional risk factors compared with individuals with low levels of both, whereas others were at intermediate risk, they continue. In summary, Lp-PLA2 and CRP levels may be complementary to traditional risk factors to identify middle-aged individuals at increased risk for stroke, the authors conclude. Future studies should determine whether selective inhibition of Lp-PLA2 or reduction and/or inhibition of CRP reduces ischemic stroke and whether statins and/or fibrates [two types of cholesterol-lowering drugs] are more effective for stroke prevention in patients with elevated levels of Lp-PLA2. In an accompanying editorial, Archives of Internal Medicine Editor Philip Greenland, MD, and Patrick G. O’Malley, MD, Walter Reed Army Medical Center, write that epidemiologic studies, such as that by Ballantyne and colleagues, are most useful for identifying potential new risk predictors or new potential approaches to treatment requiring further confirmatory observational studies or future clinical trials. From the Ballantyne et al study, it is unclear how useful CRP or Lp-PLA2 level will be for improving risk prediction vs. traditional risk factors alone, they write. Simply showing statistical independence, as recently discussed in an Archives review article, is not adequate for demonstrating clinical utility for risk prediction. Source: Arch Intern Med. 2005;165:2479-2484, 2454-2456. Two Anticoagulant Therapies for Treating Acute Coronary Syndromes Show Similar Outcomes at One Year High-risk patients with acute coronary syndromes (ACS) treated with an early revascularization strategy and enoxaparin or unfractionated heparin at the time of hospitalization for ACS had similar outcomes at one year, including remaining at substantial risk for adverse cardiovascular events, according to a study in the Journal of the American Medical Association. In the Superior Yield of the New Strategy of Enoxaparin, Revascularization, and Glycoprotein IIb/IIIa Inhibitors (SYNERGY) trial, patients at high risk for recurrent ischemic cardiac events were randomly assigned to receive the anticoagulants low-molecular-weight heparin (enoxaparin) or unfractionated heparin. The primary results at 30 days showed that enoxaparin was at least as effective as unfractionated heparin in reducing death or nonfatal myocardial infarction (MI). The current study examines the results at six months and one year. We believe this to be valuable, given the high-risk clinical characteristics of the patient population in SYNERGY and the need to understand the long-term outcomes in patients managed with an early aggressive invasive treatment strategy, the researchers write. Kenneth W. Mahaffey, MD, of Duke Clinical Research Institute, Durham, NC, and colleagues analyzed follow-up data at 6 months and one year from the SYNERGY trial, which included 9,978 patients who were randomized from August 2001 through December 2003 in 487 hospitals in 12 countries. At six months, 541 patients (5.4 percent) had died, and 739 (7.4 percent) had died at one year. The researchers found that death or nonfatal MI at six months occurred in 872 patients receiving enoxaparin (17.6 percent) vs. 884 receiving unfractionated (not separated) heparin (17.8 percent). Rehospitalization within 180 days occurred in 858 patients receiving enoxaparin (17.9 percent) and 911 receiving unfractionated heparin (19.0 percent). One-year all-cause death rates were similar in the two treatment groups. The SYNERGY trial studied a high-risk cohort of patients with NSTE ACS. The 30-day, 6-month, and 1-year data show that this cohort of patients remains at substantial risk for recurrent cardiovascular events and coronary revascularization procedures: nearly 20 percent of patients died or experienced reinfarction by six months. Overall, the rates of death and nonfatal MI were similar at 6 months between treatment groups. The reduction in death or nonfatal MI at 30 days seen in the subgroup of patients treated with consistent therapy during the initial study drug assignment was sustained through 6 months, but mortality at 1 year was similar. Despite aggressive revascularization strategies and high use of evidence-based therapies, patients with high-risk ACS features remain at risk for continued adverse cardiac morbidity and mortality, the authors conclude. Source: JAMA 2005; 294:2594-2600.

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