Clinical and Industry News

PAD Endovascular Device Market Exceeds $1 Billion A recent analysis published by The Sage Group found that from 2003 to 2005 the dollar value of endovascular devices employed to treat peripheral arterial disease (PAD) increased by almost 50%. This exceptional growth reflects the convergence of several catalysts, stated Mary L. Yost, President of The Sage Group. The 2004 and 2005 introduction of new endovascular technologies enabled more effective and less invasive treatment of femoropopliteal and tibial disease, especially in patients suffering from critical limb ischemia (CLI), she continued. Key endovascular introductions included FoxHollow Technologies’ SilverHawk atherectomy catheter, Spectranetics CLiRpath laser and the PolarCath cryoplasty system (CryoVascular Systems/Boston Scientific), elaborated Yost. In addition, educational efforts by the sponsoring companies raised awareness of PAD therapies among interventionalists as well as key referring physician groups. Over the past three years the interventional community (cardiologists, interventional radiologists and vascular surgeons) has been offered an expanding array of specialized continuing medical education and training courses focusing on PAD. We believe that growing knowledge of the new treatment options has begun to increase the number of patients diagnosed and treated, Yost observed. In addition to higher procedure volumes, the dollar value of the PAD interventional market increased significantly due to a mix-shift to new, higher-priced endovascular therapies. By year end 2005, we estimate that combined sales of the SilverHawk, the CLiRpath laser and the PolarCath system accounted for over 55% of the dollar value of the angioplasty/atherectomy market, she concluded. Although it might seem that this dramatic shift to higher-priced technologies adds to health care inflation, this is not necessarily the case, emphasized Yost. If longer-term data demonstrates improved clinical outcomes, fewer procedural complications, shorter procedure times and/or higher amputation free-survival rates, one or all of these therapies could prove to be cost-effective in treating CLI. According to The Sage Group, approximately 160,000 PAD-related amputations are performed annually in the U.S. For additional information visit www.thesagegroup.us. (Disclosure: Principals of THE SAGE GROUP own shares of Spectranetics Corp.) Public Comment Invited ARRT Proposes Changes to Governing Documents The American Registry of Radiologic Technologists is seeking public comment on proposed changes to three of its governing documents: Rules and Regulations, Standards of Ethics, and Continuing Education Requirements for Renewal of Registration. The comments will be considered by ARRT’s Board of Trustees in advance of the scheduled August 1, 2006, implementation date for the changes. Comments, which must be postmarked by May 31 to be considered, should be mailed to ARRT, Dept. ED, 1255 Northland Dr., St. Paul, MN 55120. The proposed changes, summarized below, are detailed in the documents as they appear in ARRT’s Annual Report to Registered Technologists, which is posted on the www.arrt.org web site. The annual report was mailed earlier this month to technologists and representatives of other concerned communities. Rules and Regulations. ARRT’s Rules and Regulations codify the Registry’s policies and procedures for certification and registration and enforce the Standards of Ethics and Continuing Education Requirements for Renewal of Registration. In addition to the specific changes noted below, proposed changes to the Rules and Regulations are administrative, mostly incorporating R.R.A. (Registered Radiologist Assistants) references where requirements differ from those for RTs. Standards of Ethics. ARRT’s Standards of Ethics are widely recognized as fundamental to its mission of promoting high standards of patient care. At its June 2005 meeting, the ARRT Board of Trustees adopted an interim rule that is now proposed for public comment with final adoption in July 2006. The rule defines failure to immediately report information concerning a patient-care error as an ethics violation. A newly proposed change calls for ARRT to communicate to other certification organizations any adverse decisions against individuals, under the Standards of Ethics, and reasons for sanctions. This information, which is already shared with state licensing agencies, will help to reduce duplicate efforts in ethics investigations. CE Requirements. Ten years ago, RTs weren’t required to report continuing education credits as a pre-requisite for renewing registration every other year. In the decade since, CE has served as the only way that ARRT can quantify RTs’ ongoing professional development efforts. Proposed changes to the CE requirements establish new requirements for reinstatement of registration by examination and clarify Retired status. In addition, several distinctions are noted for RRAs. Technologists who have dropped their registration may, within the allowable time frame of five years, reinstate registration by re-examining. A proposed change would require re-examination in each discipline in which the individual desires reinstatement. Previously, completion of a primary exam was all that was required to reinstate registration of all primary and post-primary categories of certification. CE requirements for RRAs were adopted on an interim basis in June 2005 by the Board of Trustees. They are proposed in a new Section 19 for final adoption. RRA is also added to pertinent sections regarding Retired and Disabled status. In the wake of recent tightening-up of ARRT’s Retired status, a further clarification makes it unethical for an RT recognized by ARRT as Retired to work in any healthcare position that may involve patient contact in an imaging or radiation therapy environment. Headquartered in St. Paul, Minnesota, ARRT evaluates, certifies and annually registers more than 257,000 radiologic technologists across the United States. African-Americans Report Less Trust in Health Care Providers than Whites A national survey suggests that African-Americans may have lower levels of trust in physicians, nurses and other health care providers than whites, especially if they regularly receive care in a facility other than a physician’s office, according to an article in the Archives of Internal Medicine. Physicians and researchers are increasingly recognizing the importance of trust in medical care. Trust has been described as an expectation that medical care providers (physicians, nurses and others) will act in ways that demonstrate the patient’s interests are a priority, the authors write. Many factors contribute to a patient’s trust level, including perceptions of the provider’s medical and interpersonal skills. Patients with low trust in their providers may be less likely to comply with treatment, receive recommended screening exams or develop long-term, quality relationships with their physicians. Chanita Hughes Halbert, PhD, Abramson Cancer Center and University of Pennsylvania, Philadelphia, and colleagues evaluated responses from a national survey of 954 adults, including 432 African-Americans and 522 whites. Researchers conducted telephone interviews between July 7 and Sept. 19, 1999. Participants responded to 46 items that assessed their sociodemographic characteristics, prior health care experiences, where they usually receive care and whether their provider’s racial background matched their own. Trust in health care providers was rated on a scale of one to four, with one indicating that the participant could trust providers to do what is best for patients almost all of the time and four almost none of the time. Low trust was defined as a rating of three or four. Low levels of trust were reported by 44.7 percent of African-Americans and 33.5 percent of whites. Although fewer quality interactions with providers predicted low trust among all participants, other factors that influenced trust appeared different between African-Americans and whites. African-Americans who usually accessed medical care at facilities other than physicians’ offices were most likely to report low trust, while among whites, lack of health insurance, fewer annual health care visits and gender were more likely to predict low trust, with women more likely to have low trust than men. Understanding the factors that influence trust in different patient communities could help physicians take steps to enhance trust and thereby improve medical care, the authors conclude. Training designed to improve provider communication with patients may be needed to improve trust for African-Americans and whites, they write. However, it may be especially important to direct these efforts to health care providers practicing in settings where continuity with patients may be limited to improve trust among African-Americans. In addition, greater access to health care settings (e.g. physicians’ offices) where more effective relationships with providers can be developed may also improve trust in health care providers among African-Americans. Source: Arch Intern Med 2006;166:896-901. End-of-Life Treatment Preferences May Change as Health Declines A study of older adults with advanced chronic illnesses indicates that as a patient’s health declines, that individual may be more likely to accept treatments that would result in mild to severe functional disability, according to an article in the Archives of Internal Medicine. Previous studies have suggested a patient’s current health status may affect how they view treatments that might result in a diminished health state. For instance, patients with diminished states of health rate these health states more highly than does the general public. In addition, cancer patients are more willing to undergo intensive treatment with a small chance of benefit than are members of the general public or physicians. Terri R. Fried, MD, VA Connecticut Healthcare System and Yale University School of Medicine, New Haven, Connecticut, and colleagues conducted in-home interviews of 226 older adults with advanced chronic illnesses. Thirty-five percent had cancer, 36 percent had chronic obstructive pulmonary disease (COPD) and 29 percent had congestive heart failure. The patients were interviewed at least once every four months for a period of up to two years. At each interview, researchers assessed the participants’ health condition and asked the participants whether they would accept treatment for their condition if the treatment resulted in one of four health states: mild physical disability, severe physical disability, cognitive (memory) impairment or pain. Mild physical disability was defined as being unable to leave the house for work, to visit family or for other reasons, and severe physical disability meant the individual would need assistance with everyday tasks. Rating a treatment as acceptable meant that the patients would agree to undergo that treatment, and rating a treatment as unacceptable meant that they would rather die than proceed with treatment. Over the course of the study, patients became significantly more likely to rate mild and severe physical disability as acceptable outcomes of treatment. Patients who had declines in their functional abilities over time also became more likely to rate physical disability as acceptable. At all interviews, cognitive impairment was unacceptable to 75 percent of participants, and the likelihood of rating cognitive impairment as acceptable decreased over time. Pain was unacceptable to 37 percent of patients throughout the study; patients who already had moderate to severe pain were more likely to rate pain as acceptable. The findings suggest that it is difficult for some patients to predict how they will feel about particular treatments in the future. This poses a challenge to advance care planning, in which patients record instructions and preferences for their end-of-life care before they have reached that stage, the authors write. The problems with predicting future hypothetical states of health have led some to conclude that instructional advance directives are a misguided means of care planning, they continue. However, the methods we used to demonstrate the problem of predicting future health states provide a partial solution to the problem. Many patients were still able to think about and express their preferences regarding these states after experiencing a change in their health status. This finding implies that if advance care planning is conducted as a process over time, in which patients are asked to reflect on their preferences after experiencing a change in their health, they will have an opportunity to reflect on how their preferences may be changing. Source: Arch Intern Med 2006;166:890-895. Level of Education Attained Linked With Presence of Coronary Artery Calcium Deposits, an Indicator of Coronary Disease Higher levels of education are associated with a lower prevalence of coronary artery calcium, an indicator of subclinical atherosclerosis among young adults and those in early middle age, according to a study in the Journal of American Medical Association. Many studies have documented that education is inversely associated with a wide array of clinical disease outcomes and death, and this relationship between education and cardiovascular disease and coronary heart disease in particular is among the most consistent and pronounced. But little is known about the relationship between education and subclinical disease (an illness that stays below the surface of clinical detection). Lijing L. Yan, PhD, MPH, of the Feinberg School of Medicine, Northwestern University, Chicago, and Guanghua School of Management, Peking University, Beijing, China, and colleagues analyzed data from the Coronary Artery Risk Development in Young Adults (CARDIA) study, which included 2,913 participants (44.9 percent black; 53.9 percent women). The participants, who were ages 18-30 at baseline in 1985-1986, were recruited from Chicago, Minneapolis, Birmingham, Ala., and Oakland, Calif. There were 128 study participants with less than a high school diploma; 498 were high school graduates; 902 had some college; 764 were college graduates; and 621 had more than a college education. At year 15 of the study, the overall prevalence of coronary artery calcium (CAC) among eligible study participants was 9.3 percent. For the biracial young adult and early middle-aged cohort (ages 33-45 years) with a wide spectrum of educational levels, we found that educational level was inversely associated with prevalence of CAC in a graded dose-response fashion, with particularly higher prevalence for individuals with less than a high school degree, the authors report. The prevalence of CAC was four times higher among study participants with less than a high school degree, compared with those who had more than a college education. These findings are partially explained by risk factors assessed 15 years before the measurement of CAC and by increase in these risk factors over time, the authors write. The risk factors include blood pressure, cholesterol, waist circumference, smoking, and physical activity. The authors suggest that pathways and mechanisms linking education and subclinical disease remain to be further explored. Fundamental changes in preventive measures very early in life are required to address social and economic disparities in health. In addition, integrated prevention and intervention strategies effective for less educated persons are also needed, they conclude. Source: JAMA 2006;295:1793-1800. ACE Inhibitors May Reduce Death, Heart Attack and Stroke in Patients with Coronary Artery Disease Angiotension-converting enzyme (ACE) inhibitors may reduce cardiovascular risk and the risk of death in patients with coronary artery disease, according to a new analysis of previously conducted clinical trials reported in the Archives of Internal Medicine. Researchers continue to examine the effectiveness of several medications in different patient groups. Previous research has shown that ACE inhibitors can help treat patients with coronary artery disease or congestive heart failure. However, studies on the use of ACE inhibitors in patients with coronary artery disease but without heart failure or left ventricle dysfunction have had conflicting results. Nicolas Danchin, MD, FESC, Hopital Europaen Georges Pompidou, Paris, and colleagues analyzed seven previous randomized and controlled trials of ACE inhibitors in patients with coronary artery disease. The studies tested five different ACE inhibitors and included a total of 33,960 patients, who were followed for a minimum of two years and an average of 4.4 years. In each trial, some patients were randomly selected to receive ACE inhibitors and others to receive placebos. When the results of all the trials were analyzed together, treatment with ACE inhibitors significantly reduced the risk of death from any cause, cardiovascular death, myocardial infarction and stroke. The researchers also found that in studies that measured additional outcomes, ACE inhibitors appeared to reduce the risk of onset of diabetes, hospitalization for congestive heart failure and cardiac arrest. In this overview of randomized trials of ACE inhibitors for the long-term secondary prevention of coronary artery disease in patients without left ventricular dysfunction or heart failure, active treatment was associated with a highly significant reduction in all-cause mortality and all major cardiovascular events, the authors conclude. These results, along with those previously reported in patients who have coronary artery disease with left ventricular dysfunction or heart failure, suggest that ACE inhibitor therapy should be systematically used in all patients with documented coronary artery disease. Source: Arch Intern Med 2006;166:787-796. MI Patients Do Better at Hospitals Following Guidelines Duke University Medical Center cardiologists have demonstrated that hospital adherence to national guidelines for treating patients with potential heart attacks saves lives. Specifically, hospitals that were the best at following nine different treatments recommended by the American College of Cardiology (ACC) and the American Heart Association (AHA) had a mortality rate of 4.15%, compared with a 6.31% mortality rate for hospitals that were the worst at following guidelines. Additionally, every 10 percent improvement in guideline adherence led to a 10 percent decline in mortality, the researchers found. The researchers published their findings in the Journal of the American Medical Association. For their study, the researchers consulted a database of 64,775 patients at 350 U.S. hospitals both academic and nonacademic to determine how they adhered to the different quality measures of in-hospital and discharge care. The researchers collect their data through CRUSADE (Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes with Early Implementation of the ACC and AHA Guidelines). Overall, the Duke researchers found the recommended therapies were used only 74% of the time. The team also is looking deeper into the adherence issues by analyzing dosing patterns of guideline-recommended drugs. A recent Duke study involving 387 CRUSADE hospitals found that powerful drugs for preventing clotting in coronary arteries were given at either too high or too low a dose 42% of the time. Study Examines Continued Economic Burden of Acute Coronary Syndrome Despite Standard Medical Interventions Acute coronary syndrome (ACS) is a major contributor to the overall economic burden of cardiovascular disease, estimated at $403.1 billion in 2006. Despite major advances in the treatment of ACS, a new study of 15,508 patients demonstrates that new and recurrent cases remain significant drivers of hospital, medical and pharmacy costs. Total costs for newly diagnosed patients with ACS were $14,274, while costs for patients with recurrent ACS were $12,899, according to a study presented at the 18th annual meeting of the Academy of Managed Care Pharmacy in Seattle. This study illustrates that ACS continues to impose a significant financial burden on the healthcare system, even after an acute event occurs, said one of the study investigators, Patrick McCollam, PharmD, Research Scientist, Eli Lilly and Company. Although patients’ first cardiac events incurred the highest costs, recurrence of events contributed significantly to healthcare utilization. Acute coronary syndrome affects more than 879,000 Americans each year.¹ Despite treatment guidelines, data indicates underutilization of heart medications in ACS patients. When antiplatelet therapy is used, future cardiac events are significantly reduced, but recent studies have shown that up to a third of patients are not responding adequately, or not responding at all, to their current antiplatelet therapy. In the retrospective study, Burden of Illness for Patients with New and Recurrent Acute Coronary Syndrome, 15,508 ACS patients with a primary diagnosis of unstable angina or heart attack were identified at a large U.S. managed care organization. Patient claims were examined the year before, and up to a year after, the first diagnosis, called the index event. Hospitalizations, revascularizations, and overall costs for new (no previous ACS diagnosis) and recurrent (previous evidence of ACS) patients were compared and analyzed. Of the 15,508 identified patients, 82 percent were new ACS patients and 18 percent were recurrent ACS patients. Newly diagnosed patients with ACS were more likely to have a heart attack and be hospitalized for the index event, leading to higher overall index event costs versus the recurrent group ($14,274 versus $12,899). Patients with recurrent events, however, were rehospitalized more frequently during follow-up (0.817 episodes per patient versus 0.57 episodes per patient), stayed in the hospital significantly longer than new onset patients (mean of 7.2 days versus 6.1 days) and were more likely to undergo revascularization procedures during follow up (20.4% versus 16.9%). In addition, recurrent patients had more physician office visits (mean of 22.09 versus 17.86) and ER visits (mean of 2.33 versus 2.14), and higher laboratory utilization during follow up (mean of 7.41 versus 6.40). It is important to note that the recurrent patients were older (average age 59) than new patients, and comorbidities were more prevalent in recurrent patients, thereby increasing the risk of medical complications and corresponding healthcare utilization. References 1. American Heart Association. Heart Disease and Stroke Statistics - Update 2006. 2. Muller I, Besta F, Schulz C, et al. Prevalence of clopidogrel non-responders among patients with stable angina pectoris scheduled for elective coronary stent placement. Thromb Haemost 2003;89:783-787. 3. World Health Organization. The Atlas of Heart Disease and Stroke Types of Cardiovascular Disease 2005. CardiacAssist Receives 510k Market Approval For Transseptal Cannula THTC-EF Cannula for TandemHeart® PTVA® System increases percutaneous VAD blood flow to five liters per minute CardiacAssist, Inc., a Pittsburgh-based medical device company that develops, manufactures and markets cardiac assist devices, has received FDA 510k market approval for its new high-flow cannula. The TandemHeart Transseptal Cannula -Enhanced Flow (THTC-EF) enables the TandemHeart System percutaneous left ventricular assist device to provide blood flow of up to five liters per minute. The THTC-EF is positioned in the left atrium and is part of the TandemHeart Cannula Set, which connects the TandemHeart Pump to the human body. The TandemHeart System is used in critical care cardiology and helps heart failure patients survive heart attacks, high-risk procedures and other cardiac interventions. Garippa said that reaching the five-liter-per-minute mark means that the TandemHeart System can take on even more challenging cardiac cases, giving patients and cardiologists more options and more hope when facing the most difficult heart procedures. The THTC-EF was originally conceived as a product improvement to resolve excess pliability of the currently marketed TandemHeart Transseptal Cannula (THTC). Although such problems are immediately noticed and easily resolved, Garippa said the market desired a more state-of-the-art cannula design. The new cannula has a thinner wall, which allowed CardiacAssist engineers to increase the inside diameter (ID) while keeping the same 21 French (7mm) outside diameter of the currently marketed THTC. The increased ID reduces resistance to flow and therefore the TandemHeart System flow increases from four liters per minute to a maximum of five liters per minute when used in conjunction with a 17 French arterial return. Using a 15 French arterial return, flows increase from 3.5 liters per minute to 4.5 liters per minute, which is equally significant. To date, more than 500 uses of the system in 28 countries at 70 different facilities by 120 different physicians have been performed.

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