News

Compiled by EPLabDigest

Compiled by EPLabDigest

Cardiovascular Credentialing International to Sunset On-the-Job Training as Qualification Pathway for Invasive Registry Examination  

Effective July 1, 2013, Cardiovascular Credentialing International (CCI) will officially remove the RCIS1 Qualification (also referred to as the On-the-Job Training qualification) that allows applicants who only have two years (full-time or full-time equivalent) working in Invasive Cardiovascular Technology, at the time of application, to qualify for CCI's Invasive Registry examination. The Invasive Registry examination is the required examination for the Registered Cardiovascular Invasive Specialist (RCIS) credential.

The CCI Board of Trustees made this decision to change examination qualifications after consulting with organizations and members of the invasive cardiovascular professional community. CCI recognizes the need for formal education in this field of practice; this is consistent with minimum standards for professional licensure and elevates the overall status of the RCIS credential.

Applicants who wish to apply for the Invasive Registry examination under qualification pathway RCIS1 will have to submit their application by or before June 30, 2013 to be considered. Applications based on the RCIS1 qualification, postmarked after June 30, 2013, will not be processed and will be returned to the applicant instructing him or her to apply under the available qualification pathways.

At this point, there is no foreseen change to the remaining RCIS qualification pathways (RCIS2, RCIS3, RCIS4, and RCIS5). This change in qualification pathways only affects the RCIS credential; no changes to qualifications for any other CCI credential are being made at this time.

The Registered Cardiovascular Invasive Specialist (RCIS) credential is the only internationally recognized credential which demonstrates the obtainment of all the skills and knowledge required to function in the cardiac catheterization laboratory. The RCIS credential is administered and governed by CCI. The RCIS credentialing program is accredited by the American National Standards Institute under the International Standards Organization's ISO/IEC 17024 accreditation guidelines.

CCI is a not-for-profit corporation established for the purpose of administering credentialing examinations as an independent credentialing agency. CCI began credentialing cardiovascular professionals in 1968.

If you would like more information about this topic, please visit www.cci-online.org or contact CCI Director of Communications, Christine Johnson, at 800-326-0268 or email Christine at cjohnson@cci-online.org.

St. Jude Medical Announces Japanese Launch of Smaller, Higher Power ICD and CRT-D Devices  

St. Jude Medical, Inc. announced regulatory approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) and the launch of the Fortify™ ST implantable cardioverter defibrillators (ICD) and Unify™ cardiac resynchronization therapy defibrillator (CRT-D). The reduced footprint of these new devices makes them the smallest available in the industry.

The Unify CRT-D and Fortify ST ICD feature advanced battery technology and circuitry that allow for a smaller device, with more energy capacity and rapid charge times, all while increasing device longevity. The energy capability of a device is particularly important for patients who have an enlarged heart, low ejection fraction, advanced heart failure or previously demonstrated a high defibrillation threshold (the amount of energy required to shock the heart back to a normal rhythm). These devices feature 40J of delivered energy (45J stored), helping to ensure that therapy will be successful for those patients who require a higher energy shock for defibrillation.

Because of the devices’ narrower shape, physicians can implant them using a shorter incision, leading to less time spent closing the incision and a smaller scar for the patient. The company’s DF4 lead connector system further streamlines the procedure by reducing the number of connections between the defibrillation lead and the device, which can improve patient comfort by reducing the bulk of wires in the patient’s chest.

“The Unify and Fortify ST devices were designed to address many of the clinical issues facing our customers, and at the same time reduce the size to make them more comfortable for patients,” said Eric S. Fain, MD, president of the St. Jude Medical Cardiac Rhythm Management Division. “We are happy to offer devices in Japan with the industry’s smallest footprint that will improve disease management of cardiac conditions.”

The Unify CRT-D and Fortify ST ICD also incorporate the new CorVue™ monitoring algorithm. This new feature alerts physicians to variations in thoracic impedance, a measurement that helps physicians better understand a patient’s heart failure status. The algorithm continuously monitors thoracic impedance as a surrogate for fluid retention in multiple vectors, providing information that may be used to index the level of heart failure.

The devices also feature the company’s ShockGuard technology, which is designed to reduce inappropriate and unnecessary shocks for patients. The programming in ShockGuard discriminates between rhythms that require defibrillation therapy and those that do not. Additionally, the advanced sensing technology designed to avoid sensing unwanted signals (T-waves) and offer more anti-tachycardia pacing options, which can convert many fast ventricular arrhythmias painlessly and avoid the need for high voltage shocks. A retrospective analysis of the Advancements in ICD Therapy (ACT) registry, which enrolled more than 5,000 patients and allowed programming at the physician's discretion, demonstrated that at the end of one year, 98.5 percent of patients with the ShockGuard programming would be free of inappropriate shocks.

“The size and shape of the Unify and Fortify ST devices are significantly smaller than that of the current devices, which is truly helpful as patients in Japan tend to be smaller than those in Western countries,” said Dr. Hideo Okamura from the National Cerebral and Cardiovascular Center in Osaka, Japan. “Although smaller, these devices have an extended longevity and a stronger output of energy for shock therapy. Taken together, I believe that these enhanced features will improve patient care.”

The Fortify ST ICD features St. Jude Medical's first-to-market ST segment monitoring diagnostic algorithm, which can add important information to assist in medical decision making and accelerate patient care. The Fortify ST ICD continuously monitors for specific changes in the ST segment of the electrocardiogram that can indicate the onset of serious conditions such as ischemia.

Dr. Takashi Noda from the National Cerebral and Cardiovascular Center added, “It is very important for us as physicians to utilize as many indications and diagnostic data as we can for each heart failure patient therapy and follow up. In addition to the additional data provided with the CorVue, the new devices also have new features and settings that help to reduce inappropriate and unnecessary shock therapy.”

With the device's monitoring diagnostic, small changes in ST segment are continuously and precisely recorded and plotted, and then retrieved for the physician to review during patient follow-up visits. Because many cardiac episodes are transient in nature, continuous ST monitoring is important as it gives physicians more comprehensive ST segment information over time rather than sporadic diagnostic reports when the patient is in the clinic or hospital.

Withings Announces US Availability of its Connected Blood Pressure Monitor for iPad, iPhone and iPod touch

French technology company Withings announced the US availability of its Blood Pressure Monitor (BPM) for iPad®, iPhone® and iPod touch®. This Withings BPM, including blood pressure cuff and companion Withings App, is a modern way to measure and record blood pressure readings in the personal and professional arenas.

With more than 25% of the world’s population* affected by hypertension, Withings has combined advanced technology and sophisticated design to create a medical device that is visually attractive, accurate and easy to use at home, in a professional setting or on the go.

Cédric Hutchings, Withings co-founder says, “Apple has revolutionized the smartphone and tablet market with both its design and functionality. We have strived to extend this revolution into the field of health and fitness by integrating our products to work seamlessly with Apple iOS devices.”

The Withings BPM is truly a plug-and-play solution for blood pressure measurement and tracking. Users simply wrap the blood pressure cuff around their arm and plug it directly into their iPad, iPhone or iPod touch using the incorporated cable. Once connected, the Withings App launches instantly on the iOS device and is ready to begin the measurement. When the reading is complete, the full results (Systole, Diastole and heart rate) are saved directly on the device, eliminating manual tracking.

A user’s stats can be accessed instantly from their iOS device or from their personal Withings webpage. Results are saved denoting dates and time of day for each reading, to help when comparing morning, afternoon and evening readings, and readings over time. Results can easily be shared by emailing results to a doctor and/or using the device’s automatic sharing feature to sync with popular personal health record sites like Google Health™ and Microsoft® HealthVault™ — virtually eliminating the gap between patient and doctor.

When used in conjunction with the Withings WiFi body scale, weight and blood pressure are tracked on the same graph within the app, giving users an at-a-glance health snapshot. Both products bring together in one place two vital pieces of your overall health, which is ideal when tracking trends and early warning signs of health problems.

Withings Blood Pressure Monitor Technical Specifications: (detailed specs)

  • Works with: iPad, iPad 2, iPhone, iPhone 3G, iPhone 3GS, iPhone 4, iPod touch 2nd generation, iPod touch 3rd generation and iPod touch 4th generation
  • Measurement: Oscillometric Method
  • Measurement range: 0 to 285mmHg
  • Pulse: from 40 to 180 beats per minute
  • Cuff circumference: fits arm circumferences from 9” to 17”
  • Pump: automatic inflation with air pump, controlled pressure release
  • FDA: device has received FDA clearance

The Withings Blood Pressure monitor works with iPad, iPhone and iPod touch.

Reference

* Kearney PM, Whelton M, Reynolds K, et al. Global burden of hypertension: analysis of worldwide data. Lancet 2005;365:217-223.

Advanced Cardiac Therapeutics Announces CE Mark Clearance for Innovative Catheter System for the Treatment of Atrial Arrhythmias

Advanced Cardiac Therapeutics, Inc., a developer of innovative temperature-sensing cardiac ablation systems, announced that the company has received CE Mark (Conformité Européenne) clearance for its TEMPASURE™ cardiac ablation catheter. The TEMPASURE system is the world’s first RF cardiac ablation catheter to offer both saline irrigation and temperature-sensing technology.

The TEMPASURE system is designed to result in better outcomes for patients by reducing overall procedure time and increasing therapeutic effectiveness, while avoiding rare but serious adverse events that can occur with current technologies. The system’s novel passive sensing microwave radiometry technology allows the electrophysiologist to measure the temperature of cardiac tissue during the ablation procedure, providing real-time information that enables proper energy delivery and lesion control. This technology is designed to allow, for the first time, safe and effective automatic RF power titration or “Temperature Mode” irrigated ablation.

“We are very pleased that the TEMPASURE temperature-sensing ablation catheter is now cleared for use in countries that recognize CE Mark,” said Peter van der Sluis, the company’s CEO. “We look forward to bringing the TEMPASURE system to patients and physicians in Europe later this year.”

“For more than 20 years, the temperature sensing and energy titration in ‘temperature mode’ in non-irrigated traditional RF catheters have been successful and proven tools to safely guide right-sided ablation procedures and optimize outcomes,” said Vivek Y. Reddy, MD, The Helmsley Trust Professor of Medicine and director, Cardiac Arrhythmia Service at the Mount Sinai Medical Center in New York. “However, the lack of temperature sensing on the proven irrigated RF catheter platform has limited outcomes in left-sided procedures. I am excited to see ACT’s new radiometry technology make available two new features for the first time in left-sided ablation procedures. The company’s technology offers real-time safe temperature control during ablations and in the near term promises automatic titration of RF power to create consistent, deep and wide lesions.”

Heart Rhythm Society Applauds the Introduction of Atrial Fibrillation Resolution in the House of Representatives

The Heart Rhythm Society (HRS) applauds the introduction of House Resolution 295 by Representative Kay Granger (R-TX), Representative Dutch Ruppersberger (D-MD) and Representative Charles Gonzalez (D-TX). The resolution will support efforts by the HRS and other stakeholders to raise public awareness of atrial fibrillation (AF) by enhancing the quality of care and patient safety, advancing research and education, and improving access to appropriate medical treatment for patients suffering from AF.

“The Heart Rhythm Society commends Representative Granger for taking a leadership role in bringing national attention to atrial fibrillation, which impacts about 2.5 million Americans each day,” said Bruce L. Wilkoff, MD, FHRS, president of the Heart Rhythm Society. “We will continue to seek support for this resolution from other members of Congress in the hopes that it is passed into law, which would help to build greater awareness among patients and the public about the disease.”

AF impacts the lives of approximately 2.5 million Americans each day, with another 160,000 Americans diagnosed each year. By 2050, projections show incidence increasing to as high as 12.1 to 15.9 million. While the statistics are staggering, the increased risks for stroke and heart disease associated with AF have enormous implications. The annual cost of AF to the U.S. healthcare system is estimated to be $15.7 billion, and more tragically, the annual cost in American lives is approximately 88,000.

2011 10Q Report Details Important Unanswered Questions for Women with Heart Disease

Cardiovascular disease (CVD) is the number one killer of women in the United States. Although scientists have discovered demonstrable sex differences, treatment options remain the same. In response to this important issue, the Society for Women's Health Research (SWHR) and WomenHeart: The National Coalition for Women with Heart Disease released the long-awaited 2011 10Q Report: Advancing Women's Heart Health through Improved Research, Diagnosis and Treatment on June 21 to a captivated audience on Capitol Hill.

The 2011 10Q Report is an update to the 2006 10Q Report that identified the top 10 unanswered research questions concerning the prevention, diagnosis and treatment of heart disease in women. Because these and other questions still lack answers, SWHR and WomenHeart are issuing an updated 2011 report.

Over 8.6 million women die annually of CVD and more women than men die each year of heart disease. Experts also estimate that one in two women will die of heart disease or stroke per year. There are known sex differences in symptoms and treatment of CVD, yet medical treatment of women has not changed substantially nor has it resulted in appropriate research into these distinct sex differences. The 10Q Report is a call to action to members of Congress, administration officials, researchers, health care providers, and women.

“The 10Q Report shows the major need to focus research funding appropriately for CVD to understand the important sex differences in heart health,” said Phyllis Greenberger, MSW, President and CEO of SWHR. “SWHR and WomenHeart consulted with cardiovascular experts to identify these top 10 unanswered questions to aid researchers in the study of prevention and treatment of this number one killer of women.”

The lack of understanding of sex differences in CVD can be attributed to insufficient recruitment of women and minorities for clinical trials. Improved participation rates would result in more accurate data and understanding of how CVD affects women differently than men. This in turn would produce more appropriate prevention and early detection plans, accurate diagnosis and proper treatment of all women with heart disease.

“The 10Q Report reveals a startling lack of research into how women and men are genetically different in CVD symptoms, diagnosis and treatment,” said Lisa M. Tate, CEO, WomenHeart. “To better care for women, these 10 crucial questions must finally be addressed.”

The Society for Women's Health Research, a national non-profit organization based in Washington D.C., is widely recognized as the thought leader in women's health research, particularly how sex differences influence health. SWHR's mission is to improve the health of all women through advocacy, education and research.  Visit SWHR's website at swhr.org for more information.

WomenHeart: The National Coalition for Women with Heart Disease is a national organization dedicated to promoting women's heart health through advocacy, and patient support. As the leading voice for the 42 million American women living with or at risk of heart disease, WomenHeart advocates for equal access to quality care and champions prevention and early detection, accurate diagnosis and proper treatment of women's heart disease. For more information, visit www.womenheart.org/kit.

Sponsors of the 10Q Report: Advancing Women's Heart Health through Improved Research, Diagnosis and Treatment include Boehringer Ingelheim and Vanguard Charitable Trust of Edwards Lifesciences.

American Heart Association Works with Crowdrise.com to Raise Awareness and Funding for Hands-Only CPR Campaign

Ken Jeong combines his comedic prowess with his medical training in a new Hands-Only CPR video from the American Heart Association that uses the disco hit “Stayin' Alive” to help people remember what to do in a sudden cardiac arrest. The video can be viewed at crowdrise.com/Hands
OnlyCPR.

“I may play insanely crazy and comedic characters on screen, but as an internal medicine physician in real life, I want people to know that sudden cardiac arrest is a serious matter,” said Jeong, star of The Hangover, The Hangover Part 2, and the NBC series Community. “Immediate action can be the difference between life and death. Everyone needs to know it's in their hands to help save a life.”

The American Heart Association is working with Crowdrise.com, a social fundraising website, to raise money to support the association's lifesaving research and educational programs.

Directed by filmmaker Jesse Dylan, the video opens with a group of friends engaged in a lively game of charades. Suddenly one of the guests collapses from cardiac arrest. From the sidelines, Jeong comes to the rescue — clad in a white suit reminiscent of the one worn by John Travolta in the classic film Saturday Night Fever. He dances around and instructs how to perform Hands-Only CPR using the beat of the Bee Gees' “Stayin' Alive” to keep them on track — a song that is the near-perfect rhythm for performing CPR chest compressions.

“Ken Jeong brings relevance, authority as a medical professional, and, of course, excellent comedic timing to our new Hands-Only CPR video,” said Ralph Sacco, MD, president of the American Heart Association. “Even more impressive is his commitment to helping save more lives by volunteering his time for this project, which we know will make an impact by increasing awareness about the importance of learning — and using — Hands-Only CPR.”

For four weeks beginning June 15, visitors to crowdrise.com/HandsOnlyCPR can win prizes for raising money for the American Heart Association.

Members of the Cities of Service coalition — a bipartisan coalition of mayors from across the nation who are working to harness the power of volunteers to solve pressing local challenges — are implementing Volunteer CPR, a high-impact service strategy in which the mayor's office works with local medical professionals and emergency responders to train volunteers in Hands-Only CPR. These volunteers then pledge to teach Hands-Only CPR to at least five others, helping their communities improve their ability to respond to sudden cardiac arrest emergencies. The “Stayin' Alive” video will be available for all cities pursuing similar Volunteer CPR initiatives.

“Stayin' Alive” and chest compressions

Alson Inaba, MD, an American Heart Association CPR instructor and associate professor at the University of Hawaii, is credited with first using “Stayin' Alive” to teach students the correct rate of chest compressions. Studies show that when CPR training uses the song to teach the technique, people are more likely to remember the correct rhythm and feel more confident performing CPR.

About the American Heart Association 

The American Heart Association is devoted to saving people from heart disease and stroke — America's No. 1 and No. 3 killers. They team with millions of volunteers to fund innovative research, fight for stronger public health policies, and provide lifesaving tools and information to prevent and treat these diseases. The Dallas-based association is the nation's oldest and largest voluntary organization dedicated to fighting heart disease and stroke. 

About Crowdrise.com

Crowdrise is a website dedicated to online fundraising, event fundraising, and volunteering. In 2009, Edward Norton, Shauna Robertson and Robert and Jeff Wolfe created Crowdrise after an experiment with what turned out to be a unique and successful campaign to raise money for the Maasai Wilderness Conservation Trust during the New York City Marathon. They raised $1.2 million in less than 8 weeks, much of it from small donors who gave more than once, making it one of the top fundraising success stories of the marathon. Crowdrise takes that experiment to a whole new level: an innovative web platform where millions of individuals use the best tools and technology to raise money for over a million different charities, while competing in fun and quirky challenges with unique incentives and prizes. Thousands of charitable organizations make Crowdrise their home for starting events, team fundraisers, and turning their base of grassroots supporters into a base of grassroots fundraisers.

Initially Healthy Women With New-Onset Atrial Fibrillation May Have Increased Risk of Premature Death

In a follow-up of participants from the Women’s Health Study, seemingly healthy middle-aged women with new-onset atrial fibrillation had an associated increased risk of cardiovascular, noncardiovascular, and all-cause death, with some of the risk potentially explained by nonfatal cardiovascular events, according to a study in JAMA.

“Atrial fibrillation (AF) is the most common cardiac arrhythmia, and its prevalence is markedly increasing over time. Substantial evidence exists that the risk of stroke, congestive heart failure (CHF), and cognitive dysfunction is higher in patients with AF, underscoring the importance of AF as a public health problem. In addition, several studies involving mainly older individuals with and without cardiovascular disease found an increased risk of death in patients with AF,” the authors write. “The risks associated with new-onset AF among middle-aged women and populations with a low comorbidity [co-existing illness] burden are poorly defined.”

David Conen, MD, MPH, of University Hospital, Basel, Switzerland, and colleagues conducted a study with data from the Women’s Health Study to assess the risk of death and cardiovascular events among initially healthy middle-aged women with new-onset AF. Between 1993 and March 2010, 34,722 women participating in the Women's Health Study underwent prospective follow-up. Participants were 95 percent white, older than 45 years (median [midpoint], 53 years), and free of AF and cardiovascular disease at the beginning of the study.

During a median follow-up of 15.4 years, 1,011 women developed AF. Also, there were a total of 1,602 deaths from all causes, including 63 deaths among women in the new onset AF group. The authors’ analysis indicated that the age-adjusted relative risk of all-cause, cardiovascular, and noncardiovascular mortality was significantly higher among women with new-onset AF. “Adjustment for nonfatal cardiovascular events potentially on the causal pathway to death attenuated these relationships, but new-onset AF remained significantly associated with all mortality components,” the authors write. They add that these findings suggest that this increased risk is partly mediated through the occurrence of nonfatal cardiovascular disease, particularly the development of CHF and stroke.

“In this large cohort of initially healthy women at low risk of cardiovascular disease, women with new-onset AF had an increased risk of death and incident cardiovascular events. Because a significant proportion of the excess mortality risk appears attributable to the occurrence of nonfatal cardiovascular events prior to death, there is a potential opportunity to improve the outcome of individuals with new-onset AF through both prevention and optimal management of these associated comorbidities,” the authors conclude.

JAMA. 2011;305[20]2080-2087.

Survey: Physician Alignment Primary Obstacle to ACO Formation

Healthcare facility administrators and physicians report that the most serious obstacle they face in forming Accountable Care Organizations (ACOs) is physician alignment, according to a new survey.

The survey, conducted by AMN Healthcare, the largest healthcare staffing and workforce solutions organization in the United States, asked hospital executives and physicians about their participation in ACOs, and whether or not ACOs will deliver significant cost and quality benefits.

According to AMN Healthcare president and CEO Susan Salka, the survey underscores what is the central issue regarding both ACO formation and the industry-wide effort to enhance quality of care and reduce costs.

“While capital and data are essential to forming ACOs, the success of this emerging model turns on people. Health facility leaders and physicians must align their interests, communicate and cooperate for this model to work,” Salka notes.

Fifty-eight percent of 882 administrators and physicians responding to the survey indicated their facilities are either in the process of forming ACOs or are considering doing so, while 42% said their facilities will not form ACOs in the foreseeable future.

Of those who are moving toward ACOs, 42% said physician alignment is the most serious obstacle to their efforts, followed by lack of capital (38%), lack of integrated IT systems (31%), and lack of evidence-based treatment protocol data (25%).

Of those who are not moving toward ACOs, 40% cited physician alignment as a reason they are not, followed by lack of capital (31%), lack of integrated IT systems (26%), and lack of evidence-based treatment protocol data (23%).

The survey further suggests that the majority of healthcare facility administrators and physicians still hold out hope that ACOs will deliver significant cost and quality benefits over time. Fifty-nine percent of those surveyed either strongly agreed or somewhat agreed that ACOs will deliver benefits and that they are a key to enhancing quality and reducing costs. However, a significant minority (41%) either strongly disagreed or somewhat disagreed with that statement.

Founded in 1985, AMN Healthcare is the nation's largest provider of comprehensive healthcare staffing and workforce solutions. Top brands of AMN Healthcare include American Mobile Healthcare, Merritt Hawkins, Staff Care, O'Grady Payton and NurseFinders.