Patient Information and Understanding Lacking When Faced with Cardiac Device Recalls Although nearly 80 percent of patients prefer to receive cardiac device recall information directly from their cardiologist, more than half primarily receive information about device recalls from the media. This is one of the many findings from two studies released revealing the patient perspective on device recalls, presented at Heart Rhythm 2008. The first of the two patient studies examined the impact of device recalls on patient perception and quality of life. The study, which followed 61 randomly selected patients at the University of Maryland and the VA Baltimore, specifically examined recall information sources, actual patient awareness of recent recalls and psychological effects of the recall. Specific findings revealed: • Recall Information Sources: 24 percent of patients received recall information from their treating physicians and 51 percent received information from media sources. The survey also found that despite extensive information campaigns, eighteen percent of patients were not aware of recent recalls at all. • Recall Information Source Preferences: 79 percent preferred to receive recall information from their cardiologist, while 14 percent cited the manufacturer as their preferred source. Only two percent preferred the media as their primary source. • Psychological Effects: When asked about the effects of recalls on their quality of life, more than half indicated that they would be very worried if their device was recalled and 16 percent felt more nervous and anxious since the recent recalls have occurred. “The latest recalls have put a great deal of focus on technical criteria and appropriate physician actions, however, very little is known about the perspective of those the recalls affect the most — the patients,” said the study’s lead author Timm-Michael Dickfeld, MD, PhD, Director of Electrophysiology at the VA Baltimore and Assistant Professor at the University of Maryland. “These findings show that there are significant discrepancies between patient expectations and their actual education in regards to device performance issues.” While many patients feel they have received enough education about the possibility of a device recall or malfunction, a second patient study conducted by researchers at the University of Oklahoma found that most do not have an adequate understanding of device performance and the likelihood of a recall. Results also showed that language used to describe performance issues can have a direct impact on a patient’s level of concern and overall state-of-mind. The study is the first to explore patient understanding of and reaction to regulatory language used when a device recall occurs. Researchers analyzed patient understanding of current terminology and how their opinions change when the term “device recall” is replaced with “safety advisory.” The study, which surveyed 165 randomly selected patients, showed that changing the language describing a recall could adequately alert patients to device performance issues, but reduce the number of patients who insist on potentially unnecessary device replacement by 50 percent. “Until now there has been a lack of objective data to support changing recall terminology. However, this study shows a direct link between the language used to address device performance and patient actions and perceptions,” said Christina M. Murray, MD, lead author and cardiology fellow-in-training at the University of Oklahoma. “Better strategies for patient information need to be developed and implemented to help correct these inconsistencies and ensure proper education takes place.” Primary Care Physicians Are Not Adhering to Life-Saving Guidelines: Lack of Knowledge Could Put Patients at Greater Risk of Sudden Cardiac Death Implantable cardioverter-defibrillators (ICDs) are the most successful therapy to treat the major causes of sudden cardiac arrest, yet a new study shows that many primary care physicians are not aware of guidelines that determine if an at-risk patient should see a heart rhythm specialist or receive this potentially life-saving device. The study was released at Heart Rhythm 2008. Patients with ischemic cardiomyopathy, a serious disorder that affects approximately 1 out of 100 people, have weakened heart muscles and cannot pump blood efficiently.* Current guidelines recommend ICDs for most patients with this disorder because of their susceptibility to life-threatening cardiac arrhythmias, but the new survey found only a very small minority of family practice and internal medicine physicians have a clear understanding of these guidelines. The first-of-its kind study surveyed more than 300 physicians in northeastern Ohio and tested their knowledge of when a patient should be referred to a heart rhythm specialist. Less than 25 percent of respondents knew when a patient should be referred to a specialist for an ICD after an ischemic cardiomyopathy diagnosis and less than half of respondents knew the correct ejection fraction values that should prompt referral. Of those physicians who do refer patients, 80 percent indicated that patients were reluctant to undergo ICD placement and were therefore, not referred to a specialist. This study demonstrates two possible barriers to ICD implantation. First and foremost, there is incomplete understanding of guidelines. Second, patients may be reluctant to undergo therapy. “If a primary care physician does not have a clear understanding of when a patient should see a heart rhythm specialist, their patients may not receive enough information to understand their condition and the potential treatment options. The study demonstrates the need for increased awareness and education for patients and physicians about sudden cardiac death,” said lead author Kara J. Quan, MD, Section Head and Director of Cardiac Electrophysiology and Associate Professor of Medicine at the MetroHealth Campus of Case Western Reserve University. The Heart and Vascular Center at MetroHealth is recognized for its programs focusing on the prediction and prevention of sudden cardiac death. “These results highlight the importance of ongoing efforts to improve awareness of sudden cardiac death prevention among physicians and patients,” added David S. Rosenbaum, MD, Director of MetroHealth’s Heart & Vascular Center and Professor of Medicine at Case Western Reserve University. “Since sudden cardiac death is a principal cause of death from heart disease, such findings have an important impact on public health.” *MedlinePlus. http://www.nlm.nih.gov/medlineplus/ency/article/000160.htm Cell Phone Technology Helps Treat Heart Attack Victims Wireless communication helps heart attack victims receive potentially life-saving treatment significantly faster than standard practices. Results of a new study released at Heart Rhythm 2008 show that paramedics equipped with pre-hospital ECG devices that wirelessly transmit critical information to emergency rooms while in route to the hospital, can reduce the time it takes to diagnose and treat patients by more than 30 percent. The study is the first to prospectively evaluate hospital time to treatment and outcomes in individuals randomized to receive a pre-hospital ECG versus the usual method of obtaining an ECG after hospital arrival. The earlier a physician receives an ECG reading, the faster a patient can receive proper care or treatment. Beginning in 2003, all paramedic vehicles in Santa Cruz County, California, were equipped with special ECG devices, marking the launch of the Synthesized Twelve-lead ST Monitoring & Real-time Tele-electrocardiography (ST SMART) Study. These modified machines wirelessly transmit an ECG reading to the hospital through mobile phone technology, while continuously monitoring the patient’s status and re-transmitting information to the hospital if changes are detected. The ST SMART study measured two critical windows of time that directly link to survival and long-term well-being of a heart attack patient. Results showed that pre-hospital ECG transmissions shortened both the time to diagnosis, the time it took to receive the first ECG after the patient dialed 9-1-1, and door-to-balloon time. “The earlier you can treat heart attack patients, the lower the risk of permanent heart muscle damage, which is why reducing door-to-balloon time is so important,” stated the study’s lead author Barbara Drew, PhD, from the University of California, San Francisco. “By utilizing mobile phone/ECG technology, physicians are able to diagnose patients faster and mobilize resources in anticipation of a patient’s arrival, rather than reacting once the patient is already in the door.” Patients randomized to the experimental group with pre-hospital ECG cell phone transmission had an initial ECG reading 59 minutes earlier than patients randomized to the control group with their first ECG reading at the hospital. This advanced ECG information from the field allowed physicians to diagnose and understand the severity of the heart attack much earlier, and prepare for treatment before the patient arrived. In addition, patients who received a pre-hospital ECG had an average door-to-balloon time of 79 minutes, 37 minutes faster than those who did not receive a pre-hospital ECG. To date, more than 730 patients have been enrolled in the ST SMART Study. Statin Therapy Associated with Lower Risk of Atrial Fibrillation in Women Statin therapy is associated with a lower prevalence and incidence of atrial fibrillation (AF) in post-menopausal women with coronary disease, according to a new study released at Heart Rhythm 2008. Study findings support the hypothesis that statin drugs may be effective as a non-antiarrhythmic treatment for AF. AF affects over two million people in the United States alone. There are a number of treatments to control AF and reduce the risk that it will cause serious health problems, but none are consistently successful and most have unfavorable side effects, unlike relatively low risk statins. “Women and men are affected by atrial fibrillation differently,” said the study’s lead author Cara Pellegrini, MD, at the University of California, San Francisco. “Since past studies have shown benefits of statin therapy in the male population, we wanted to take a closer look at the effectiveness of statin therapy in women with regard to the risk of developing AF.” The study involved 2,673 post-menopausal women with prior coronary disease in the Heart and Estrogen-Progestin Replacement Study (HERS) to examine the association between statin use and the prevalence and incidence of AF. After an average follow-up of 4.1 years and adjusting for age, race and other risk factors, the prevalence of AF was 65 percent lower and the incidence of AF was 55 percent lower in patients using statin therapy. New Research Finds No Association Between Omega-3 and Vitamin E Intake and Atrial Fibrillation in Women According to new research, there is no evidence of an association between the intake of omega-3 fatty acids or dietary supplements of Vitamin E and the prevalence or incidence of AF in women. Results from two new studies, one on omega-3 fatty acid intake from fish oil, and one on Vitamin E supplements, were released at Heart Rhythm 2008. Focusing on women’s health initiatives, this new research explores the links between common dietary ingredients, including fish oils and vitamins, and whether or not the intake of these ingredients can reduce or increase the development of atrial fibrillation. “Atrial fibrillation affects millions of people, and it is very important for researchers to continue to look for dietary measures or lifestyle behavior to help patients reduce the prevalence and incidence of arrhythmias,” said Bruce D. Lindsay, MD, FHRS, President of the Heart Rhythm Society and Director of Electrophysiology at the Cleveland Clinic Heart and Vascular Institute. “It is important for both patients and doctors to have a clear understanding of the impact, or lack-of impact, common dietary ingredients, like omega-3 and Vitamin E, can have on a patient’s health.” Omega-3 Fatty Acids from Fish Oil: Prior studies have shown conflicting results regarding the association between omega-3 fatty acid intake and the incident of atrial fibrillation. A new study led by Dr. Jarett Berry, MD, and Dr. Donald M. Lloyd-Jones, MD, both at Northwestern University in Chicago, observes the impact of omega-3 fatty acids through dietary fish oil intake. The study included 46,704 participants from the Women’s Health Initiative clinical trials, excluding women in the dietary modification intervention arm and women with AF baseline by ECG or self report. The results show that in both age-adjusted and multivariable adjusted models, there was no association between dietary omega-3 fatty acid intake from fish oil and incidence of AF. Vitamin E Supplementation: A study led by Dr. Bruce Koplan, MD, and Dr. Christine Albert, MD, both at Brigham and Women’s Hospital in Boston, examined the potential risks and benefits of Vitamin E supplementation on the development of AF among 38,933 apparently healthy women over the age of 45 enrolled in the Women’s Health Study. Women in this large, randomized trial were given either Vitamin E or placebo in order to determine whether or not Vitamin E had a distinct effect on the development of cardiovascular disease. Follow-up conducted with the women after 10+ years, showed that Vitamin E supplementation does not reduce or increase the overall development of AF in apparently healthy women. Weight Loss Supplements May Hold Hidden Heart Health Risks A new study reveals that many non-prescription weight loss supplements available online may have hidden heart health dangers. The new study, presented at Heart Rhythm 2008, found that 75 percent of the supplements analyzed contained at least one ingredient associated with life-threatening cardiac complications such as ventricular arrhythmias, cardiac arrest or sudden cardiac death. Two out of three Americans are overweight* and a growing number of weight-loss supplements are easily available for purchase through the Internet. The new study, conducted by a team of researchers from the Center for Cardiac Arrhythmias and Electrophysiology Research at the Texas Heart Institute, is the first to examine the potential heart health risks of weight-loss supplements purchased online. “People are purchasing these diet pills in an effort to become healthier, unaware that they are putting their heart health at serious risk,” said Alireza Nazeri, MD, lead author from the Texas Heart Institute. “The Internet provides easy access to weight-loss supplements, but lacks the necessary information and warnings to protect the public.” The study reviewed the ingredients of 12 different brands of weight-loss supplements available on the Internet. The sample brands were selected by entering the common search terms “diet pills” and “weight-loss supplements” into the Internet search engines Google, MSN and Yahoo and selecting the top four hits from each. A list of ingredients was included on each label, but none included any warning labels on the bottles or shipping packages regarding their potential life-threatening cardiac side effects. The investigators purchased and examined the products. From the ingredients listed on the labels of each brand, researchers identified 11 ingredients with at least one report of life-threatening cardiac complications or death. One ingredient has even been banned by the FDA since 2004. Senior authors of the study included Ali Massumi, MD, FACC, and Director of the Center for Cardiac Arrhythmias and Electrophysiology at St. Luke's Episcopal Hospital-Texas Heart Institute and Mehdi Razavi, MD, Director of Electrophysiology Clinical Research at the Texas Heart Institute. * Centers for Disease Control and Prevention. 2003-2004 National Health and Nutrition Examination Survey (NHANES) http://www.cdc.gov/nchs/products/pubs/pubd/hestats/overweight/overwght_a... ICD Remote Monitoring Helps Maximize Device Clinic Personnel and Resources According to a new study released at Heart Rhythm 2008, wireless technology that allows evaluation of implantable cardiovascular electronic devices from the patient’s home is increasingly being embraced by patients and may significantly improve the number of patients served without requiring additional resources. The study is the first to show how this rapidly evolving technology can increase the number of patient evaluations without directly increasing demands on clinic staff time and resources. The number of follow-up visits for patients with a cardiovascular implantable electronic device (CIED) exceeds 5.8 million visits each year, and will continue to increase as more CIEDs, such as a pacemaker, implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy (CRT) device, are implanted.* As the number of ICD implantations continues to grow, increasing the need for device follow-up visits, study results show that clinics should consider remote monitoring as a supplemental evaluation method for patients in an attempt to maximize clinic resources and provide better patient care. The study, conducted by the Cleveland Clinic, tracked ongoing ICD device follow-up patient visits over a four-year period. Each ICD patient was offered the option of in-person device follow-up or device follow-up supplemented with remote monitoring. The patients who chose remote monitoring were evaluated from home through transmitter use. Between 2003 and 2007, the total number of ICD evaluations increased by 164 percent, allowing for improvements in time management and overall utilization of in-clinic resources. During the study, remote evaluations increased dramatically from 94 to more than 5,000 patients. “We increased our total number of patient evaluations over the past five years, without as much strain as seeing all of the patients in clinic,” said Elizabeth Ching, lead author and RN at the Cleveland Clinic in Cleveland, Ohio. “This growth is a direct result of the clinic’s incorporation of ICD follow-up through remote monitoring evaluations, allowing for better time management and overall improvements in resource allocation.” * The Heart Rhythm Society and the European Heart Rhythm Association, Expert Consensus Statement on the Monitoring of Cardiovascular Implantable Electronic Devices, May 2008.