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Early Intervention Favored for Some Chest Pain Patients Medicine alone may not offer best quality of life for patients with moderate heart attack risk Routine angiography and revascularization procedures, if indicated, appear to offer better quality of life than conservative medical treatment for patients with chest pain and evidence of coronary artery disease, according to a new study. Our bottom line message is that, overall, an early interventional strategy provides small improvements in health-related quality of life without an apparent increase in risk of heart attack or death. Most of these gains appeared to have been due to improvements in angina grade, said Joseph Kim, PhD, at the London School of Hygiene and Tropical Medicine. The controversy was about whether patients with a moderate risk of heart attack do better with an early interventional strategy or a more conservative strategy. Results of previous studies seemed to be inconclusive, while current American Heart Association guidelines recommend either an invasive or a conservative strategy. The RITA-3 trial was designed to assess whether patients on an interventional strategy perform better than those placed on a more conservative strategy with regard to clinical outcomes, as well as health-related quality of life. RITA-3 is the third Randomized Intervention Trial of unstable Angina. Patients were recruited from 45 centers across England and Scotland from Nov. 12, 1997, to Oct. 2, 2001. Patients were eligible for the study if they experienced chest pain at rest and had documented electrocardiographic or previous arteriographic evidence of coronary artery disease. Patients were randomized either to an early intervention (895 patients received maximal medical therapy plus early coronary arteriography with possible myocardial revascularization) or to a more conservative strategy (915 patients were given maximal medical therapy unless symptoms were severe enough to prompt angiography and revascularization). Using four different measures of health status and quality of life, the researchers found that patients who were in the early intervention group generally reported better outcomes after four months. After one year, the intervention group still scored higher, but the differences had narrowed and were not all statistically or clinically significant. Dr. Kim said the decreasing differences between the two groups were probably due to the fact that many patients in the conservative treatment group were ultimately referred to angiography and possible intervention if their symptoms were not adequately managed by drugs alone. Thus, over time, the differences between the groups became blurred. Just over 10 percent of the patients randomized to the conservative therapy group underwent a revascularization procedure during their initial hospitalization. Within one year, revascularizations had been performed in 28 percent of the patients in the conservative therapy group compared to 57 percent of the patients in the early intervention group. What is remarkable is that despite this crossover of patients, we observed statistically significant improvements in health-related quality of life at 4-months follow-up and to a lesser extent at 1-year follow-up, Dr. Kim said. The researchers said that these results appear to strengthen the case for early intervention. The public policy implications of this study are that an early intervention strategy should be recommended to reduce the occurrence of refractory angina and possibly to improve angina-related health related quality of life in patients with non-ST-segment elevation acute coronary syndrome. However, this benefit must be balanced against economic cost and clinical risk of performing an early intervention on all patients, they noted. Dr. Kim noted that the researchers had to make some assumptions about the quality of life of patients at the beginning of the study, because they did not have baseline scores for all the measures. Also, he said there is some uncertainty about what some of the differences in the measured quality of life scores mean in the daily lives of patients. For instance, according to one of the questionnaires used in this study, the Seattle Angina Questionnaire, the differences between the groups after one year were too small to be considered clinically significant, based on the guideline used by the questionnaire’s developer, Dr. John Spertus. If one were to apply Spertus’ guideline strictly, I would have to agree with that interpretation. However, we should keep in mind that an individual’s quality of life is difficult to measure, while quality of life scores in general are difficult to interpret. I would be less inclined to place such a strict interpretation on quality of life scores, Dr. Kim said. Dr. Spertus, at the Mid America Heart Institute in Kansas City, MO, who was not connected with this study, called it a very thorough and well-conducted study that amplifies earlier results on the clinical benefits of early intervention compared to conservative therapy for these patients with chest pain and coronary artery disease. It is particularly important because patients are likely to be at least concerned about their health status - their symptoms, function and quality of life as about the longevity of their survival. Since the original report found no differences in survival or myocardial infarction, these health status data dominate the clinical decision process with respect to optimal therapy; namely that an invasive strategy appears superior, Dr. Spertus said. Dr. Spertus also noted that chest pain was the strongest factor in determining how patients rated their health status. He said the study design and other factors may have delayed referral to angiography for some patients who were suffering chest pain despite drug treatment. He said that choice of early intervention or conservative therapy may depend on what sort of ongoing care and options patients have to manage their chest pain. Thus, I believe that if patients are unlikely to have access to good medical care and close follow-up, then a routine, early invasive strategy is preferable. However, if they will have frequent, careful assessments of their angina control after discharge, then a more conservative strategy is likely to be equally effective in optimizing patients’ outcomes, Dr. Spertus said. German Study Suggests Differences in Drug-eluting Stent Performance for the Treatment of In-Stent Restenosis Results from an independent German study suggest improvements among patients with in-stent restenosis who received the sirolimus-eluting coronary stent versus those who received a paclitaxel-eluting stent or angioplasty. Three hundred patients participated in the ISAR-DESIRE Study, an independent, randomized, controlled trial conducted by Deutsches Herzzentrum Munchen and Rechts der Isar Hospitals. The patients were randomized to treatment with the sirolimus-eluting stent, paclitaxel-eluting stent or angioplasty. Each arm of the study consisted of 100 patients. The results of the study suggest the use of sirolimus-eluting coronary stents (Cypher) may provide better outcomes than the use of paclitaxel-eluting stents (Taxus) and angioplasty in patients with in-stent restenosis, said Professor Adnan Kastrati, MD, a lead trial investigator. The majority of patients, precisely 92% of the study population, received angiographic follow-up. At six months post procedure, 44.6 percent of patients in the balloon angioplasty group experienced restenosis in the affected vessel. In the sirolimus-eluting stent group, 14.3 percent of patients experienced restenosis, while 21.7% of those in the paclitaxel-eluting stent group experienced restenosis. Target vessel revascularization was significantly lower in the sirolimus-eluting stent group 8 percent compared to 19 percent in the paclitaxel-eluting stent group and 33 percent in the angioplasty group. The primary end point was angiographic restenosis at six months, defined as >50% in-segment restenosis. Secondary end points were net lumen gain, defined as the difference between initial minimal lumen diameter (MLD) and MLD at six months, and clinical event rates, including target vessel revascularization (TVR), death, or MI at 9 months. CPR Performance Does Not Follow Guidelines New research indicates that CPR performed outside the hospital and in the hospital often does not meet or adhere to standard guidelines, according to 2 studies. There are indications that the quality of CPR performance influences the outcome. When tested on mannequins, CPR quality performed by lay rescuers and health care professionals tends to deteriorate significantly within a few months after training, but little is known about the quality of actual clinical performance of CPR on patients. CPR guidelines recommend target values for chest compressions, ventilations, and CPR-free intervals allowed for rhythm analysis and defibrillation. There is little information on adherence to these guidelines during advanced cardiac life support during out-of-hospital cardiac arrest. In the first study, Lars Wik, MD, PhD, of Ulleval University Hospital, Oslo, Norway and colleagues examined the performance of paramedics and nurse anesthetists during out-of-hospital advanced cardiac life support (ACLS) by continuously monitoring all chest compressions and ventilations during resuscitation episodes using online defibrillators. The study included 176 adult patients with out-of-hospital cardiac arrest treated by paramedics and nurse anesthetists in Stockholm, Sweden, London, and Akershus, Norway, between March 2002 and October 2003. The defibrillators were modified to measure chest compressions and ventilations, in addition to standard event and electrocardiographic recordings. The primary outcome measure was adherence to international guidelines for CPR. Target values for compression rate were 100 to 120/min; for depth, 38 to 52 mm; and for ventilation rate, 2 ventilations for every 15 compressions before intubation and 10/min to 12/min after intubation. The researchers found that chest compressions were not given 48 percent of the time without spontaneous circulation; this percentage was 38 percent when subtracting the time necessary for electrocardiographic analysis and defibrillation. Combining these data with an average compression rate of 121/min when compressions were given resulted in an average compression rate of 64/min. Average compression depth was 34 mm, 28 percent of the compressions had a depth of 38 mm to 51 mm, and the compression part of the duty cycle was 42 percent. An average of 11 ventilations were given per minute. Sixty-one patients (35 percent) had return of spontaneous circulation, and 5 of 6 patients discharged alive from the hospital had normal neurological outcomes. Whether some of these deficiencies can be improved by specific focus during training needs attention. Through better understanding of the mistakes made in a real-life cardiac arrest situation, training courses might be designed to focus on these aspects. Another approach would be to develop online tools that prompt the rescuer to improved performance. Audiotapes giving instructions on chest compression rate have been reported to improve the compression rate during cardiac arrest in patients, the researchers note in their study, published in the Journal of the American Medical Association. If our study represents how CPR is delivered during resuscitation from out-of-hospital cardiac arrest in other communities, there is a great opportunity to improve CPR quality and, hopefully, patient survival by focusing on delivery of chest compressions of correct depth and rate, with minimal ˜hands-off’ periods, the researchers conclude. In the second report, Benjamin S. Abella, MD, MPhil, of the University of Chicago Hospitals, Chicago, and colleagues conducted a study to determine whether well-trained hospital staff perform CPR compressions and ventilations according to guideline recommendations. According to background information in the article, survival from cardiac arrest remains low despite the introduction of CPR over 50 years ago. The delivery of CPR, with correctly performed chest compressions and ventilations, exerts a significant survival benefit. Conversely, interruptions in CPR or failure to provide compressions during cardiac arrest have been noted to have a negative impact on survival in animal studies. Consensus guidelines clearly define how CPR is to be performed, but the parameters of CPR in actual practice are not routinely measured, nor has the quality been known. Recent studies have challenged the notion that CPR is uniformly performed according to established international guidelines. This study examined in-hospital cardiac arrests at the University of Chicago Hospitals from December 11, 2002 until April 5, 2004. Using a monitor/defibrillator with novel additional sensing capabilities, the researchers recorded parameters of CPR quality including chest compression rate, compression depth, ventilation rate and the fraction of arrest time without chest compressions (no-flow fraction; NFF). Data were collected from 67 in-hospital arrests. The researchers found that analysis of the first 5 minutes of each resuscitation by 30 second segments revealed that chest compression rates were less than 90 compressions per minute in 28.1% of segments. Compression depth was too shallow for 37.4 % of compressions. Ventilation rates were high, with 60.9% of segments containing a rate of more than 20/min. A total of 27 patients (40.3%) achieved return of spontaneous circulation and 7 (10.4%) were discharged from the hospital. There are several potential practical solutions for helping to improve poor CPR quality. The first involves mechanical devices that can provide chest compressions reliably at a set rate and depth. These devices may generate better hemodynamic characteristics than manual chest compressions. Another solution is to improve monitoring and feedback to reduce human error during manual CPR, by using devices such as [a certain type of] CO2 monitors and ‘smart defibrillators’, which can measure CPR characteristics and provide audio feedback to alert rescuers to errors such as incorrect chest compression or ventilation rate, the researchers note. Clopidogrel (Plavix®) Responses Appear Normal in Largest Data Set Smaller studies had raised concerns of resistance to anti-platelet drug Although individual patients respond differently to treatment with the anti-platelet medication clopidogrel (brand name Plavix®), those variations appear normal and may not indicate important differences in the effectiveness of treatment, according to a new study. There is nothing unique about clopidogrel, that’s the whole message, in terms of response variability. As with any agent, there are certain people who respond a lot and certain people who respond not a lot. But when you collect large numbers, you see that most people have a normal response, the vast majority have a very nice anti-platelet response on clopidogrel, said Victor L. Serebruany, MD, PhD, at the HeartDrug Research Laboratories in Towson, Maryland. In order to investigate reports that some patients were not responding to treatment intended to prevent heart attacks or strokes caused by blood clots, Dr. Serebruany and colleagues at the University of Kentucky in Lexington; Duke Clinical Research Institute in Durham, North Carolina; and the Cleveland Clinic in Ohio analyzed data they had collected over more than seven years during a variety of studies of clopidogrel. People started claiming enormously important clinical conclusions, which were based on very vague and very uncertain things, Dr. Serebruany said. The data included the results of blood tests that measured how blood platelets aggregated, or clumped together, following treatment with clopidogrel. The study subjects were 94 healthy volunteers, 405 patients treated after coronary stenting, 25 patients with heart failure, and 20 patients treated after strokes. Out of the 544 subjects, 23 (4.2 percent) had a much higher than normal response, while the blood of 26 (4.8 percent) subjects showed very little change in platelet aggregation despite clopidogrel treatment. An abnormally strong response (hyperresponse) to clopidogrel could raise the risk of bleeding, while a lack of response (hyporesponse) may mean a patient is not adequately protected against dangerous blood clots. However, Dr. Serebruany emphasized that this study did not look at actual health outcomes, and that a low or high response to this laboratory blood test does not necessarily mean a patient is not getting the appropriate benefit from clopidogrel. In addition, he noted that this report was based on combining data from different types of patients and healthy volunteers in studies that were not designed to look at variations in platelet response; so important questions remain to be answered. A trial to prove or disprove that certain platelet characteristics have an association with better or worse clinical outcomes absolutely must be done, he said. Nevertheless, Dr. Serebruany stressed that large trials involving thousands of patients have demonstrated that clopidogrel can prevent heart attacks, strokes and deaths; so it is premature to alter patient treatment based simply on tests of platelet response. There is no reason for people to switch drugs. There have been some anecdotal reports that because of certain platelet measures people were diagnosed with so-called clopidogrel resistance and so then were switched to an earlier drug, Ticlid® (ticlopidine). However, we know that Ticlid is associated with a more toxic side effect profile, he said. Pal Aukrust, MD, PhD, at the National Hospital, University of Oslo, Norway, who was not connected with this study, agreed that it is important to investigate whether platelet responses are related to health outcomes. Future research will have to clarify if hyporesponders and hyperresponders really are at increased risk for thrombotic and bleeding episodes, respectively. Moreover, more suitable and rapid tests for platelet responsiveness, being able to be performed within minutes or hours, will have to be developed. Finally, such different responsiveness to medications most probably also applies to other anti-platelet drugs and other types of drugs. To identify hyperresponders and hyporesponders will be an important task for future research in clinical medicine. Such research can potentially lead to more ‘tailor-made’ medication for each individual, Dr. Aukrust said. Ehtisham Mahmud, MD, at the University of California in San Diego, who also was not connected with this study, called the study an important step toward investigating what has been called clopidogrel resistance. This term has come to be used rather freely without any data supporting it. The current study is a first step in the right direction and based on the results of the study it appears that there is a heterogeneous antiplatelet response to treatment with clopidogrel. And rather than clopidogrel resistant, patients may in fact be clopidogrel hyporesponders. Though the term is arbitrary, it does have a physiological basis, Dr. Mahmud said. Research Studies Link Nanobacteria Infection to Heart Disease Cardiovascular researchers have shown that atherosclerosis might be the lifelong result of various healing mechanisms and inflammatory responses to infection. A long-standing problem has been how to isolate an infectious agent that is present in human tissues that could stimulate the development of atherosclerotic plaques. Until recently, no single infection, viral or bacterial, had been implicated. Three recently published studies conducted by medical researchers have collectively shown that nanobacteria might be the previously unidentified agent involved in the development of atherosclerotic heart disease. A group of researchers at Mayo Clinic, led by Virginia Miller, PhD showed that nanobacteria are present in calcified atherosclerotic coronary arteries and heart valves. In September 2004, cardiovascular researcher Benedict Maniscalco, MD published a study showing that patients with severe coronary artery heart disease tested positive for nanobacterial antigen. The study also indicates that a majority of cardiac patients that received Tetracycline, EDTA (Nanobac Life Sciences, Tampa, FL) and a proprietary blend of nutritional supplements (Nanobac Life Sciences) had a decrease in their coronary artery calcium scores. Finally, at a recent American Heart Association scientific session in New Orleans, Stephen E. Epstein, MD, Director of the Cardiovascular Research Institute at Washington Hospital Medical Center in DC, reported that 94% of people with calcified coronary arteries have nanobacterial infection as measured by Nanobac’s Nanobacterial Antibody Assay, and that antibody results correlated with coronary calcification scoring. The collective weight of the three studies suggests that nanobacteria infection is arguably the previously unknown infectious agent associated with atherosclerotic plaque. Since nanobacteria are physically present in the diseased atherosclerotic tissues and are statistically correlated with heart disease calcification levels, it is also reasonable to assume that long term nanobacteria infection is involved in the development of the calcification in atherosclerotic heart disease. Shortage of Healthcare Workers Drives Changes JCAHO Certification Provides New Standard for Healthcare Staffing Firms Hospitals weighing which staffing firms to use and healthcare professionals who are thinking about going to work for such a firm now have a new factor to consider: Is the staffing company certified by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO)? JCAHO recently certified the first two staffing companies under a new initiative launched in October 2004. JCAHO began its certification for staffing companies in response to the ongoing shortages of nurses, pharmacists and other healthcare professionals that have forced healthcare organizations to increasingly fill positions with temporary workers through contractual arrangements with staffing firms. To become certified, staffing firms must meet standards in several key functional areas such as processes for verifying the credentials and competence of healthcare staff. Certification standards also address topics such as leadership, managing human resources, performance measurement and improvement, and information management. Medical Solutions, Inc., a healthcare staffing firm, is one of just two staffing companies in the country to be certified by JCAHO. Company President and CEO Scott Anderson said that while the certification process demanded significant attention and company resources, it has been well worth the effort. We have benefited greatly by submitting our daily operations to the scrutiny of the JCAHO reviewers, said Anderson, whose Omaha-based staffing company provides nurses and technologists on contract to hospitals nationwide. It puts us on the same playing field with our clients who have gone through a similar process of accreditation and gives them added confidence in the health professionals we are placing in their hospitals and the quality of service we provide. Julie Hogel RN is a former traveling and hospital nurse who now works for Medical Solutions in its Omaha headquarters. She sees JCAHO certification for staffing firms as a positive for the entire healthcare industry because it provides a third party source of information to assist hospitals, as well as prospective employees of staffing firms, in making informed choices. Having been a traveling nurse, I was in the trenches and understand the challenges associated with hospital work, Hogel says. When a staffing company is certified by the same organization that provides accreditation for hospitals, that’s a sure way for the hospitals to get the nurses and technologists that the patients deserve, and it’s a great way for healthcare professionals to evaluate prospective employers. In the end, the patients are the real winners because certification supports all healthcare organizations’ efforts to improve quality of care. The second healthcare staffing firm certified by JCAHO is NovaStaff Healthcare Services, Inc., of Illinois. TM Reduces High Blood Pressure and Cuts Use of Antihypertensive Medication in African Americans A non-drug stress-reduction method reduces both high blood pressure and the use of antihypertensive medication in African Americans. The first-of-its-kind, long-term, clinical trial evaluated 150 men and women, average age 49, with stage I hypertension (average blood pressure 142/95 mm Hg). Subjects were randomly assigned to one of three groups: Transcendental Meditation, progressive muscle relaxation, and conventional health education classes. TM is a form of meditation that originated with an Indian guru, Maharishi Mahesh Yogi, and became very popular in the I970s. Practitioners are given a mantra, usually if not always a polysyllabic word or sound in Sanskrit, that they recite mentally in order to promote relaxation. They are generally told to practice the technique twice a day for about 20 minutes. The results of the one-year study showed that Transcendental Meditation was distinctively effective. Blood pressure in the Transcendental Meditation group reduced by nearly 6 mm diastolic pressure and 3 mm systolic pressure. In contrast, blood pressure in the progressive muscle relaxation group and conventional health education classes reduced by 3 mm diastolic pressure and no change in systolic pressure. Researchers also found a statistically significant reduction in the use of antihypertensive medication in the TM group compared to the other two groups. Nearly two-thirds of the subjects were taking antihypertensive medication at the beginning of the study. At the conclusion of the study, there was a 23% relative reduction of antihypertensive medication use between the TM and two control groups. The results of the study indicate that with many patients with high blood pressure, it may be practical and feasible to lower blood pressure using the TM technique and thereby reduce or eliminate the use of antihypertensive drugs and their side effects, said Frank Staggers, MD, Jr., co-author of the study and senior drug detoxification specialist at Haight Ashbury Free Clinic’s Drug Rehabilitation Program. The prevention of hypertension and the reduction in the use of antihypertensive drugs would be expected to result in major health care cost savings and the prevention of adverse side effects associated with blood pressure drugs. According to prior published research, such reductions in blood pressure over the long term could result in 35% to 45% less stroke and 20% to 25% less coronary heart disease. The study was funded by grants from the National Heart, Lung, and Blood Institute of the National Institutes of Health and the NIH-National Center for Complementary and Alternative Medicine. GE Healthcare Unveils Imaging Technology for Cardiovascular MR Community GE Healthcare unveiled cardiac imaging techniques developed with the world’s first high definition magnetic resonance (HDMR) system. The cardiac applications were launched at the Society for Cardiovascular Magnetic Resonance (SCMR) 8th Annual Scientific Sessions in San Francisco, California. HDMR provides physicians with image clarity of patients who are difficult to image due to movement, including Parkinson’s patients who suffer from uncontrollable patient motion and children who do not respond to sedation. In addition, HDMR is enabling physicians to consistently perform highly targeted studies of diabetic patients with lower blood flow to the lower legs. The cardiovascular imaging techniques introduced at SCMR include: 1.5T Excite HD MR Echo Cardiac Imaging: Real-time imaging of the heart with the resolution of MR at the speed of ultrasound, without the need for breath holding or ECG gating. One in three cardiac patients cannot hold their breath long enough to make an image. Frequently, cardiac patients are too sick to hold their breath and have weak or arrhythmic heartbeats, resulting in special imaging challenges. GE’s MR Echo produces high-definition cardiac images in real time of the sickest of patients, providing clinicians with the contrast detail of MR with the real-time speed and ease of use of echocardiography. Excite HD TRICKS Angiographic Imaging: A new 32-element peripheral 1.5T vascular coil, providing images of the lower leg and foot vessels. More than half of diabetic patients have inadequate characterization of lower-leg vasculature. TRICKS (Time Resolved Imaging of Contrast KineticS), an imaging technique, accelerates the temporal resolution of three-dimensional dynamic imaging. Clinicians can acquire 12 times the amount of data typically collected in a conventional MR angiography exam. ReportCARD: A tool to reduce review, analysis and cardiac MR reporting time. GE’s HDMR, available on GE Signa 1.5T and 3.0T MR systems, enables massively simultaneous imaging in multiple channels in increments of 16. HDMR features balanced acquisition architecture, with individual receive channels connected to dedicated reconstruction engines. JCR Releases Toolkit for Improving Health Care Staff Competence Joint Commission Resources (JCR) announced the release of a new product to assist health care organizations with one of the top compliance issues identified by the Joint Commission on Accreditation of Healthcare Organizations assessing and improving staff competence. (JCR is an affiliate of the Joint Commission.) This CD-ROM toolkit helps ambulatory, behavioral health care, home health, hospital, laboratory, and long term care organizations identify opportunities to enhance their competency assessment processes. Assessing and Improving Staff Competence explains Joint Commission standards and offers tips and strategies for all care settings. It guides health care organizations through: Developing performance standards for all staff positions; Establishing a system for assessing performance expectations; and Defining the frequency and documentation system to ensure competency assessments according to the organization’s performance standards. Many of the resources have been previously published elsewhere in JCR publications, but are now compiled for the first time in a user-friendly toolbox format. This CD-ROM’s interactive format provides links to additional information on specific topics and allows users to perform keyword searches. It requires no new software to buy or download and allows users to print only the pages they want. Assessing and Improving Staff Competence costs $60 using order code AIC-CD01. To order, call JCR Customer Service toll-free at 877-223-6866, 8 a.m. to 8 p.m. CT, weekdays, or visit www.jcrinc.com.

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