Clinical and Industry News

Cardiovascular Credentialing International Maintains Accreditation for Four Credentialing Programs and is Awarded Additional ANSI/ISO/IEC 17024 Accreditations

Cardiovascular Credentialing International (CCI) announces that on December 13th, 2011, the Personnel Certification Accreditation Committee (PCAC) of the American National Standards Institute (ANSI) met and took actions on the results of CCI’s 2011 annual surveillance report. The PCAC supported the assessors’ recommendation to grant CCI continued accreditation for the following four (4) credentialing programs: Registered Cardiovascular Invasive Specialist (RCIS), Registered Cardiac Electrophysiology Specialist (RCES), Registered Cardiac Sonographer (RCS), and the Registered Vascular Specialist (RVS). CCI gained ANSI/ISO/IEC 17024 accreditation for these credentialing programs in 2008.

ANSI’s PCAC also approved the assessors’ recommendation to expand CCI’s accreditation scope to include the following four (4) credentialing programs:

• Certified Cardiographic Technician (CCT)
• Certified Rhythm Analysis Technician (CRAT)
• Registered Congenital Cardiac Sonographer (RCCS)
• Registered Phlebology Sonographer (RPhS)

“To gain and maintain ANSI/ISO/IEC 17024 accreditation is an achievement,” states CCI’s Board President Doug Passey, RCES, RCIS, FSICP, “and 17024 accreditation represents the world’s highest standards as they pertain to personnel credentialing bodies who administer valid credentialing programs.”

About CCI: 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. The CCI Board of Advisors is comprised of representatives nominated by the following organizations to represent their cardiovascular specialty field:

American College of Cardiology (ACC), American College of Phlebology (ACP), American Society of Echocardiography (ASE),

Heart Rhythm Society (HRS), Society for Cardiovascular Angiography and Interventions (SCAI),

Society of Diagnostic Medical Sonography (SDMS),

Society of Invasive Cardiovascular Professionals (SICP),

and the Society for Vascular Ultrasound (SVU).

About ANSI: The American National Standards Institute (ANSI) has served in its capacity as administrator and coordinator of the United States private sector voluntary standardization system for more than 90 years. ANSI was founded in 1918 by five engineering societies and three government agencies. The Institute remains a private, nonprofit membership organization supported by a diverse constituency of private and public sector organizations. ANSI is the official U.S. representative to the International Organization of Standardization (ISO).

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 by email at cjohnson@cci-online.org.

New Culprit in Atherosclerosis: Netrin-1

A new study by New York University (NYU) Langone Medical Center researchers identified a new culprit that leads to atherosclerosis. The research, published online by Nature Immunology on January 8, 2012, explains why cholesterol-laden, coronary artery disease-causing cells called macrophages accumulate in artery plaques.

“We have discovered that macrophages that accumulate in plaques secrete a molecule called netrin-1,” said Kathryn J. Moore, PhD, senior author of the study and associate professor in the Departments of Medicine and Cell Biology at NYU Langone Medical Center. “Our study shows that netrin-1 blocks the normal migration of macrophages out of arteries, causing these immune cells to accumulate and promote the progression of atherosclerosis.”

Artery plaques that break off causing vessel blockages, or potentially fatal heart attacks and strokes are known to have high macrophage cell content. Atherosclerosis is fueled by the presence of these cholesterol-laden macrophages in the artery wall. Typically, the immune system sends macrophages to clean up cholesterol deposits in arteries, but once they fill up with the unhealthy form of cholesterol they get stuck in the arteries, triggering the body’s inflammatory response. The bloated macrophages then become major components of plaque lining artery walls. Until now, the mechanism by which macrophages become trapped has remained unknown.

In this new study, researchers show why macrophages remain in artery plaques leading to atherosclerosis. Netrin-1 promotes atherosclerosis by retaining macrophages in the artery wall. In fact, netrin-1 signals macrophages to stop migrating and as a result, these cells accumulate within the plaque. In addition, study experiments show, genetically deleting netrin-1 can minimize atherosclerosis, reduce the level of macrophages in plaque and promote the migration of macrophages from plaques.

In the study, researchers used a florescent tracking technique to label and monitor the movement of macrophage cells in and out of plaques. This experiment showed how macrophages were immobilized and retained in plaque by netrin-1 expression and also demonstrated macrophage emigration from plaque after the deletion of netrin-1.

“Our study identifies netrin-1 as a novel target for future therapeutic intervention for the treatment of atherosclerosis and cardiovascular disease,” said Janine M. van Gils, PhD, lead author of the study and a post-doctoral researcher in the Marc and Ruti Bell Vascular Biology and Disease Program, Leon H. Charney Division of Cardiology, Department of Medicine at NYU Langone Medical Center. “The development of a new strategy to diminish macrophage accumulation in plaque offers great promise to reducing the occurrence of fatal cardiac events.”

Biomarkers Identify Acute Kidney Injury in Emergency Patients

Acute kidney injury (AKI) has severe consequences, with a 25 to 80 percent risk of in-hospital death. Researchers have found a way to diagnose AKI using a urine test, enabling emergency departments to identify these high-risk patients when they first arrive at the hospital. The study was published online on January 9, 2012, in the Journal of the American College of Cardiology.

Physicians typically measure a patient’s creatinine levels to determine kidney function. But creatinine levels can remain normal for several hours after acute kidney damage, and an accurate assessment requires measurements taken over a period of 1-3 days. This limits their usefulness in an emergency room. Urinary biomarkers, however, require only a half hour or so to obtain a measure of the severity of kidney damage, explains Thomas Nickolas, MD, MS, assistant professor of clinical medicine at Columbia University College of Physicians and Surgeons and a kidney specialist at NewYork-Presbyterian Hospital/The Allen Hospital.

In an international, multi-center study, researchers from Columbia University Medical Center at NewYork-Presbyterian Hospital/The Allen Hospital; Staten Island University Hospital; and Charité-Universitätsmedizin, Max Delbruck Center for Molecular Medicine, and Helios Clinics, Berlin, Germany, took a single measure of five urinary biomarkers from 1,635 emergency room patients upon their admission to the hospital. Although all five biomarkers were elevated in cases of iAKI (intrinsic AKI, the most severe form of AKI), the biomarker called uNGAL was most accurate in the diagnosis of iAKI and best predicted its duration and severity. uNGAL, along with another biomarker, called Kim-1, most accurately predicted death or the need to start dialysis during hospitalization. uNGAL was discovered at NewYork-Presbyterian/Columbia University and at Cincinnati Children’s Hospital; it was measured in this study by Abbott’s ARCHITECT-NGAL assay, which is available commercially outside the US.

“The ability to identify acute kidney damage while the patient is in triage is especially important in busy urban hospitals, where patients cannot wait for repetitive measures of creatinine and are frequently lost to follow-up,” said senior author Jonathan Barasch, MD, PhD, associate professor of medicine and of anatomy and cell biology at Columbia University College of Physicians and Surgeons and a kidney specialist at NewYork-Presbyterian Hospital/The Allen Hospital. “The use of urinary biomarkers could also be of great use to the military, at disaster sites, and in other situations where quick medical decisions must be made.”

“Combining urinary biomarkers such as uNGAL with the current standard marker creatinine will significantly improve the identification of patients at risk of death or dialysis in the hospital,” added Dr. Kai Schmidt-Ott, MD, a kidney specialist at Charité Berlin, research group leader at the Max Delbrück Center for Molecular Medicine, and adjunct assistant professor at Columbia University Medical Center. “Identifying these patients at the earliest possible time in the emergency room may enable us to introduce new treatment options to improve their outcomes.”

Heart Attack Patients in U.S. More Likely to Be Readmitted to the Hospital Than Patients in Other Countries

In an analysis of data from more than 15 countries that included the U.S., Canada, Australia, and many European nations, patients in the U.S. who experienced a ST-segment elevation myocardial infarction (STEMI) were more likely to be readmitted to the hospital at 30 days after the heart attack than patients in other countries, according to a study in the January 4 issue of JAMA.

Heart attack with ST-segment elevation accounts for 29 percent to 38 percent of all heart attacks. “In the present era of primary percutaneous coronary intervention [PCI], survival to hospital discharge has improved dramatically. Subsequently, patients who survive to hospital discharge are at risk for early postdischarge hospital readmission,” according to background information in the article. “Recently, 30-day readmission rates have been proposed as a metric for care of patients with STEMI. However, international rates and predictors of 30-day readmission after STEMI have not been studied.”

Robb D. Kociol, MD, of Duke University Medical Center, Durham, N.C., and colleagues analyzed data from the Assessment of Pexelizumab in Acute Myocardial Infarction study, a large multinational clinical trial, to determine international variation in and predictors of 30-day readmission rates after STEMI and country-level care patterns. The trial enrolled 5,745 patients with STEMI at 296 sites in the United States, Canada, Australia, New Zealand, and 13 European countries from July 2004 to May 2006. Analysis was performed to identify predictors of all-cause and nonelective 30-day postdischarge hospital readmission.

Of the patients enrolled in the trial, there were 5,571 (97.0 percent) included in the analysis who survived to hospital discharge and represented 17 countries; 631 (11.3 percent) were readmitted within 30 days from hospital discharge. The researchers found that factors associated with 30-day readmission were multivessel coronary artery disease, U.S. enrollment (vs. rest of the world), and baseline heart rate. Patients with multivessel disease had almost twice the odds of readmission compared with those without; patients in the United States had a 68 percent increased odds of readmission vs. those outside the United States; and baseline heart rate per 10/min increase was associated with a 9 percent increased odds of readmission.

Thirty-day readmission rates were higher for the United States than other countries (14.5 percent vs. 9.9 percent). Median (midpoint) length of stay was shortest for U.S. patients (3 days) and longest for patients in Germany (8 days).

“Excluding elective readmission for revascularization, U.S. enrollment was still an independent predictor of readmission. After adjustment of the models for country-level median length of stay, U.S. location was no longer an independent predictor of 30-day all-cause or nonelective readmission. Location in the United States was not a predictor of in-hospital death or 30-day postadmission death,” the authors write.

Other predictors of readmission included recurrent ischemia, chronic obstructive pulmonary disease, chronic inflammatory conditions, and a history of hypertension.

The authors write that the finding that STEMI patients in the United States have a higher likelihood of 30-day all-cause hospital readmission may be related to differential rates of early readmission for elective revascularization and shorter median length of stay (LOS) in the United States. “In particular, country-level median LOS attenuates the relationship between the United States and early readmission. Further research is needed to better understand the relationship between LOS and readmission rates and define and optimize overall efficiency of care internationally.”

“Significant attention has been focused on reducing acute myocardial infarction readmission rates in the United States as a means of reducing health care costs, according to the assumption that readmission is (at least in part) preventable. Our analysis shows that readmission may be preventable because rates are nearly one-third lower in other countries, suggesting that the U.S. health care system has features that can be modified to decrease readmission rates. Understanding these international differences may provide important insight into reducing such rates, particularly in the United States.”

Source: Kociol RD, Lopes RD, Clare R, et al. International variation in and factors associated with hospital readmission after myocardial infarction. JAMA: The Journal of the American Medical Association 2012; 307 (1): 66 doi: 10.1001/jama.2011.1926.

Hospitals Invest Heavily in New Heart Attack Care Programs but Fail to Improve Access, Study Suggests

In a new study, researchers have found a 44 percent increase since 2001 in the number of hospitals that offer definitive emergency care to patients with heart attack, but only a 1 percent increase in access to that care. The study, led by Thomas W. Concannon, PhD, Assistant Professor Tufts Medical Center and Tufts University School of Medicine, was published January 1, 2012 in Circulation: Cardiovascular Quality and Outcomes, a journal of the American Heart Association.

Percutaneous coronary intervention (PCI) is available only in about one in three U.S. hospitals. When symptoms of a heart attack begin, those patients who are within a 60-minute drive time of these hospitals have the best chance of PCI enabling them to avoid or reduce the damage of a heart attack.

The number of hospitals with a PCI program grew by 519 during the study period, from 1,176 in 2001 to 1,695 in 2006, an increase of 44 percent. Despite this widespread investment in new programs, the percent of the U.S. population with timely access to PCI only grew from 79.0 to 79.9 percent, an increase of 1 percent. In addition, the increase did not substantially reduce typical drive times for those patients who already had access to the procedure. Median projected drive time to the closest PCI-equipped hospital fell from 11.3 to 10.5 minutes nationally, a drop of only 48 seconds.

The researchers also found substantial regional variation in timely access to PCI. Access was highest in the Northeast (87.8 percent of the population) and lowest in the South (75.7 percent). Better than 90 percent of the population in seven states had timely access to the interventions (California, 90.9 percent Connecticut, 93.6 percent, Delaware, 91.7 percent, Florida, 91.2 percent, Massachusetts, 94.6 percent, New Jersey, 96.5 percent, Rhode Island, 96.1 percent and the District of Columbia, 100 percent). However, less than 50 percent of the population of seven other states lived within a 60-minute drive of a PCI-equipped hospital (North Dakota, 48.9 percent, South Dakota, 40.3 percent, Vermont, 38.3 percent, West Virginia, 45.6 percent, Alaska, 40.0 percent, Montana, 45.3 percent and Wyoming, 30.5 percent).

“New hospital PCI programs after 2001 have largely failed to improve patient access or reduce delays to treatment,” said Concannon. “For regions that wish to boost access to PCI, the focus should be on enhanced ambulance services and on well-positioned PCI programs, rather than on the sheer number of PCI programs. A shift in priorities could make a significant impact and it could save lives.”

The study, “A Percutaneous Coronary Intervention Lab in Every Hospital?” was funded by the Agency for Healthcare Research and Quality and by the Tufts Medical Center Research Fund. The Tufts Medical Center Clinical and Translational Science Institute (CTSI) provided statistical support. Data sources included the 2006 American Hospital Association (AHA) Annual Survey Database of all 50 states and the District of Columbia, the 2006 Health Care Cost and Utilization Project’s (HCUP) State Inpatient Databases from 21 states, and the 2000 US Census. To satisfy inclusion criteria for the study, hospitals were required to perform at least four PCI interventions per calendar year and provide PCI care to U.S. adults aged 18 years or older.

Boston Scientific Epic^™ Stent Demonstrates Positive Clinical Outcomes in ORION Trial

Nine-month data presented at ISET support safety and efficacy of Epic Stent in iliac stenting

Boston Scientific Corporation reports nine-month clinical endpoint data from its ORION trial, demonstrating excellent outcomes for the Company’s Epic^™ Self-Expanding Nitinol Stent System in patients with iliac artery disease.  Results were presented by Daniel Clair, MD, FACS, Principal Investigator of the trial and Chairman of the Department of Vascular Surgery, The Cleveland Clinic Foundation, at the International Symposium on Endovascular Therapy (ISET) in Miami.

The prospective, single-arm ORION trial enrolled 125 patients at 28 sites in the U.S. The trial met its primary endpoint, a composite rate of device- and/or procedure-related major adverse events (MAE) at nine months.  MAE are defined as death within 30 days, myocardial infarction (MI) occurring during hospitalization, target vessel revascularization (TVR) through nine months and amputation of the treated limb through nine months.  The Epic Stent demonstrated a low nine-month MAE rate of 3.4 percent in the intent-to-treat population, which was significantly lower than the pre-specified performance goal of 17 percent (p<0.001) based on historical published outcomes for iliac stenting. All reported major adverse events were related to TVR.  No deaths through 30 days and no amputations through nine months were observed.

Patients experienced significant clinical improvement from baseline to nine months based on feedback from validated questionnaires evaluating walking distance, speed and stair climbing.  An additional measure of effectiveness based on the Rutherford Classification showed improvement in the patient population from 7.2 percent being asymptomatic or having mild claudication (class 0-1) at baseline to 82.3 percent of patients at 30 days and 81.6 percent at nine months.  Duplex ultrasound showed a primary patency of 95.9 percent, primary-assisted patency of 96.7 percent and secondary patency of 98.3 percent, indicating that treated lesions remained open through the nine-month follow-up period.

“We are pleased to report positive outcomes for U.S. patients in the ORION clinical trial. The Epic Stent has been used successfully in Europe for several years and we look forward to offering the device to U.S. physicians upon FDA approval,” said Jeff Mirviss, President of Boston Scientific’s Peripheral Interventions business. 

The Epic Stent is a self-expanding nitinol stent designed to sustain vessel patency, while providing enhanced visibility and accuracy during placement.  It employs an innovative Tandem Architecture™, which is engineered to provide excellent stent flexibility while maintaining predictable radial force characteristics across the entire stent size matrix.  The Epic Stent is compatible with 6F sheaths, and the stent delivery system is compatible with 0.035-inch guidewires.

ORION clinical data is being used to support application for U.S. Food and Drug Administration (FDA) approval of the Epic Stent system, which was submitted to the FDA in September 2011.

The Epic Nitinol Stent System received CE Mark approval and was launched in Europe and other international markets in 2009.  In the U.S, it is an investigational device, limited by applicable law to investigational use only and not available for sale.

JAMA: Cangrelor Helps “Bridge” Stent Patients to Cardiac Surgery

New findings from a research study led by physicians at Scripps Health in San Diego, California, reveal that the investigational drug cangrelor achieves very fast blood thinning effects when needed to protect from heart attacks, but also dissipates rapidly so patients can undergo surgery without the excessive bleeding often associated with blood-thinning medications.

Initial results from the BRIDGE trial were published Jan. 18, 2012, in the Journal of the American Medical Association (JAMA). Launched in January 2009, the BRIDGE trial tests the efficacy of cangrelor, an investigational intravenous antiplatelet that allows patients to be “bridged” from the time that their physicians stop their oral antiplatelet drugs until they undergo cardiac surgery. Study results demonstrated cangrelor maintained target levels of platelet inhibition known to be associated with a low risk of stent thrombosis.

The BRIDGE trial was led by primary investigator Eric Topol, MD, chief academic officer at Scripps Health and director of the Scripps Translational Science Institute (STSI). STSI is an initiative of Scripps Health in collaboration with The Scripps Research Institute.

“This represents an important practical step forward in cardiovascular care,” said Topol. “For the first time, we have validated a way to prevent clotting in patients who have had a recent stent but still require medication as they bridge to another surgery. This represents a fairly common clinical situation — the unplanned operation in a patient with a recent stent.”

The BRIDGE trial was a double-blind, randomized study conducted in 210 patients in the United States and Europe. The trial took place between January 2009 and April 2011. Results showed 99 percent of cangrelor-treated patients maintained target levels of platelet inhibition for all time points measured over the bridging period compared to 19 percent of placebo patients, with no significant excess in surgical bleeding complications.

Attention was brought to this issue in 2004 when former President Clinton presented with a mild heart attack that required urgent bypass surgery. He had received aspirin and clopidogrel, and as a result, had to wait six days before the surgery was performed. According to Topol, these considerations underscore the importance of identifying strategies patients to be safely bridged to their surgical procedure with minimal risk of developing heart attacks or bleeding complications.

According to 2009 data from the Organisation for Economic Co-operation and Development (OECD), more than 2.5 million stent procedures are performed globally per year. Treatment guidelines in the United States and Europe recommend stent patients receive blood-thinning medications for up to 12 months following their stent procedure. It is estimated that up to 25 percent of these patients with stents in place will require a surgical procedure during the first five years after.