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Clinical and Industry News
Sutter Medical Center Sacramento Develops Its Own RCIS Prep Course
Brenda McCulloch, RN, MSN, CNSToo difficult to study for the registered cardiovascular invasive specialist (RCIS) exam by 
yourself? Can’t afford to go an RCIS prep class? No classes in your area? Those were only some of the challenges our staff faced in preparing for the RCIS Exam. We opted to try an ‘in-house’ approach and in early November seven staff completed the first RCIS Prep Course at Sutter Memorial Hospital in Sacramento, California.
To meet the staff’s request, a series of nine 2-hour classes was developed by the service line clinical nurse specialist. Using the RCIS exam blueprint as a guideline, the focus of the sessions included extensive review of physiology, anatomy review via heart dissection, an in-depth review of hemodynamic monitoring, extensive practice of hemodynamic calculations, the basics of x-ray and radiation safety, and cardiovascular pharmacology. The group met every other week to review and discuss the content, handouts and reference materials. Several of the staff provided mini-lectures to their peers as a way of further developing their expertise. A short test was given each week as a way for the staff to assess their understanding and to hone their test-taking skills. Information taken from actual cases was compiled and used for case study review and hemodynamic calculations. Several of the class participants are applying to take the exam and are feeling much more confident because of their participation in Sutter’s RCIS prep course.
We had a lot of fun with the class. If you have interest in doing this at your own facility, particularly if you are in the Sacramento area, please contact Brenda McCulloch at mccullb@sutterhealth.org.
————————————————————Medtronic Receives FDA Approval of Talent Captiva® System for Endovascular Treatment of Thoracic Aortic Aneurysms
Medtronic, Inc. announced approval by the U.S. Food and Drug Administration (FDA) of the Talent Thoracic Stent Graft with Captivia® Delivery System, which features a tip capture mechanism for controlled deployment and precise placement of the implantable medical device.
Now available for clinical practice in the United States, the Talent Captivia System is used in the endovascular repair of thoracic aortic aneurysms (TAA). While an estimated 60,000 people in the United States have a TAA, only about half are ever diagnosed due to lack of symptoms.
“The Captivia Delivery System’s tip capture mechanism is designed to provide excellent control of the stent graft during deployment to ensure that blood flow isn’t occluded into the nearby arteries,” said Dr. Edward Y. Woo, MD, vice-chief and program director of vascular surgery and endovascular therapy for the University of Pennsylvania Hospital System. “This improvement to the delivery system also increases my confidence in the device’s deployment accuracy.”
Medtronic now offers the Talent Thoracic Stent Graft in longer lengths (up to 215 mm in total length) to accommodate the aortic anatomies of more patients. In addition to tip capture, the Captivia Delivery System features a hydrophilic coating to ease insertion into the femoral artery and navigation through the iliac arteries en route to the aorta.
The Talent Captivia System is indicated specifically for the endovascular repair of fusiform aneurysms and saccular aneurysms/penetrating ulcers of the descending thoracic aorta in patients having appropriate anatomy. More information about Medtronic stent grafts, including the Talent Captivia System, is available online at www.medtronicendovascular.com.
————————————————————Abiomed Receives Conditional FDA Approval for Study with Impella 2.5 in Reducing Heart Muscle Damage in PCI Patients
Abiomed, Inc. announced it has received conditional approval from the U.S. Food and Drug Administration (FDA) to begin MINI-AMI, a prospective, randomized, controlled multi-site trial to assess the potential role of the Impella® 2.5 in reducing infarct size in patients with ST-elevation myocardial infarction (STEMI). The primary objective of this study is to evaluate whether the adjunctive use of the Impella 2.5 for 24 hours following primary percutaneous intervention (PCI) for STEMI has the potential to limit the infarction of at-risk myocardium compared to primary PCI with routine post-PCI care. According to the American Heart Association (AHA), 400,000 patients in the U.S. suffer from STEMI every year.
“This pilot study will determine whether the Impella 2.5 can be the first device to actually shrink infarct size,” said Principal Investigator Jeffrey Moses, MD, New York-Presbyterian Hospital and Columbia University Medical Center. “Today, heart attack survivors can suffer considerable subsequent disability from damaged heart muscle. The intent of this study is to investigate the unique unloading capabilities of Impella 2.5 and its effect in potentially reducing infarct size and improving quality of life for patients.”
“According to the AHA, within five years after surviving your first heart attack, 33% of men and 43% of women will die,” said Michael R. Minogue, Chairman, President and Chief Executive Officer, Abiomed. “This will be the first Impella study to evaluate the potential therapeutic benefits of unloading and reducing the oxygen demand of the heart muscle, as compared to increasing cardiac output in cardiogenic shock patients. We are excited to explore more clinical benefits of Impella with this new, hemodynamically stable patient population.”
The primary endpoint of the study will be a cardiac MRI-assessed ratio of the final infarct area to the total area of myocardium that was at risk. This ratio will be measured at 3 to 5 days after treatment and then again at 90 days. A total of 50 patients at five hospital sites will be randomized to Impella 2.5 support or the institution’s standard of care with no circulatory support post-PCI. The study is based on the hypothesis that Impella’s ability to directly unload the left ventricle will reduce overall infarct area relative to the total area at risk, which has been demonstrated in previous animal studies.1
The MINI-AMI study will enroll patients with acute anterior STEMI or large inferior STEMI, primary PCI performed within five hours of the onset of symptoms, patients undergoing emergent primary PCI of one culprit lesion in one major coronary vessel, and successful revascularization of the native coronary artery at the end of PCI.
A recently published clinical study, “Prognostic Significance of the Occurrence of Acute Heart Failure After Successful Primary Percutaneous Coronary Intervention” by Savic et al,2 published in the Journal of Invasive Cardiology, studied 1,074 consecutive STEMI patients who had no signs of heart failure at admission, were not in cardiogenic shock at admission and were treated with successful PCI. This study serves as a reference for the MINI-AMI patient population and demonstrated the following:
• Acute heart failure (AHF) during hospitalization occurred in 11.1% of patients in this study; • 81.8% of these AHF patients died in the first 30 days; • In some patients, even timely and successful PCI cannot prevent extensive myocardial damage; • Patients who developed AHF had a lower ejection fraction; • There was no significant difference between groups regarding the duration of symptoms or door-to-needle time.The study concluded that even after successful PCI, the occurrence of AHF during hospitalization remains an independent predictor of 30-day and one-year mortality. Additionally, the study noted that further investigation is needed to evaluate whether modification of post-procedural treatment can reduce the incidence of AHF. For additional information please visit: www.abiomed.com.
References
1. Meyns B, Stolinski J, Leunens V, et al. Left ventricular support by catheter-mounted axial flow pump reduces infarct size. J Am Coll Cardiol 2003 Apr 2;41(7):1087-1095. 2. Savic L, Mrdovic I, Perunicic J, et al. Prognostic significance of the occurrence of acute heart failure after successful primary percutaneous coronary intervention. J Invasive Cardiol 2010 Jul;22(7):307-311.————————————————————
Vascular Solutions Launches the VSI StraitSet™ Kit
Vascular Solutions, Inc. announces the immediate availability of the VSI 
StraitSet™ Kit. The VSI StraitSet kit consists of a triaxial introducer comprising a 6 F x 20 cm sheath, inner dilator and metal stiffening cannula. The sheath features an embedded radiopaque marker band at the distal tip and is available with either a hydrophilic coating or a silicone wipe. Included with the introducer in the kit is a 0.018” x 60 cm nitinol mandrel guidewire with a radiopaque platinum coil tip, and a 21G needle in either a 7cm echogenic or a 15 cm Trocar version.
Interventionalists now have a choice of introducer sets: either the new VSI StraitSet or the existing GrebSet® micro-introducer kit, which adds the feature of an angled tip to the introducer for steering the guidewire during placement. The sterile, single-use VSI StraitSet and GrebSet are available in the United States exclusively through Vascular Solutions.
For more information, visit www.vascularsolutions.com.
————————————————————RACE-ER Speeds Up STEMI Care in North Carolina
A program designed to speed up heart attack care has led to significant improvement in the quality of care for heart attack patients after it was extended across North Carolina last year, according to researchers at Duke University Medical Center.
The RACE-ER results mark a notable decrease in hospital death rates, from 7.5 percent in the 2006 RACE study to below 6 percent now.
The program, RACE-ER (Reperfusion of Acute myocardial infarction in Carolina Emergency departments — Emergency Response) builds on the successful RACE project. The initial project involved emergency services personnel, physicians, nurses and administrators working collaboratively. RACE-ER expands the program to all 119 hospitals and all emergency medical services systems throughout North Carolina.
“This program results in many more patients getting life-saving care quickly,” said Christopher Granger, MD, director of the Cardiac Care Unit at the Duke Clinical Research Institute and co-director of RACE.
“Before launching RACE-ER ambulances and community hospitals were not working in integrated regional systems, and patients were suffering with delays in care much longer than recommended in the guidelines. Now, almost all ambulances are obtaining EKGs, patients are being brought directly to the best equipped hospitals, and we are experiencing some of the most rapid treatment in North Carolina that has ever been achieved.”
The RACE-ER study consisted of 6,841 patients with STEMI. Each extension of the RACE program has brought added success and a deeper, more collaborative look at providing the best quality of care.
“We have expanded what we know as door-to-balloon, to really look at the time between the moment the patient accesses the emergency system to when we can offer them treatment,” said Mayme Lou Roettig, RN, MSN, executive director of RACE.
With the RACE and RACE-ER projects, once a patient calls 911 the timer starts. Rather than just improving the speed of care once a patient reaches the hospital, the project takes the task outside of the hospital doors to the emergency vehicle.
The result, Roettig said, is multiple, competing health care systems working together with their EMS agencies to provide the highest quality of care for heart attack patients.
“We developed protocols, that paramedics follow when they have a patient with a STEMI, that empower them to make decisions,” she said. “They know to bypass a smaller emergency department and take the patient directly to a hospital that offers interventional angioplasty. And, they know to call ahead so that the center is prepared when they arrive.”
The results show a substantial change in urban areas with more people calling 911 and more patients going directly to specialty centers. There has also been improvement among smaller hospitals, which transfer patients to specialty centers, in reducing their door-in to door-out times.
“We've seen the impact a program like this can have, simply by getting paramedics, emergency medicine, and hospitals to work in an integrated way. The next steps are to help other states achieve the same success, and to use similar regional systems to improve the care of other cardiac emergencies like cardiac arrest,” Granger said.
The RACE and RACE-ER project leadership also includes James G. Jollis, MD, the co-medical director of RACE and Lisa Monk, RN, the RACE-ER state project leader.
————————————————————Evolutionary Radiation Tracking System Developed at Mayo Clinic
Mayo Clinic is initiating a new imaging exam tracking system that, among other things, enables a comprehensive view of a patient’s radiation exposures over time. Believed to be one of the first of its kind, the new computerized tracking system can replace time-consuming manual tracking processes used in many medical centers.
The DICOM Index Tracker (DIT), designed and architected by Steve G. Langer, PhD at Mayo Rochester, is being developed at Mayo Clinic in Arizona in cooperation with Arizona State University. DIT tracks all the information available in the images contained in a patient’s imaging studies (including dose, scanner utilization and other information) and compiles it into an accessible format.
William Pavlicek, PhD, Chair, Section on Diagnostic Physics at Mayo Clinic in Arizona, said that in the past 20 years there has been a migration to digital imaging for medical tests and as a result patient records contain a fairly accurate history of the radiation dose they've received. Yet, accessing dosage amounts from medical records had to be done manually — he said there has been a struggle to collect all of this information into a central repository. At the same time, the need to track dosages has become greater because of efforts within the medical community to lower radiation doses over time.
The DICOM index tracker centralizes digital images information from tests such as mammography, CT scans, nuclear medicine, cardiac catheterization, etc. The information can then be sorted by patient or procedure to assess the radiation dose and the number of treatments. Equally important, the system has alerting features built in to ensure dosages are within limit guidelines set by the American Academy of Radiologists.
Dr. Pavlicek said the development of DICOM is an evolutionary step for radiology. “For the first time we can monitor all the patient records in a centralized fashion and we can review quality assurance guidelines efficiently and conveniently,” Dr. Pavlicek said. “The benefit for the patient is consistency and continuing to provide an environment that is completely safe which includes the feeling that they are receiving the minimum amount of radiation to achieve a diagnosis.”
Dr. Langer adds: “While the DICOM standard has been around since 1993, every year new supplements are added to the base standard. This makes it challenging to use a fixed database designed to construct patient radiation (or other) queries, because how and where this information is encoded varies from scanner version to version. What makes DIT unique is that it ‘learns’ about new scanner versions as they are encountered, and builds up a knowledge base to enable a standard set of queries.”
The DICOM Index Tracker is being used at both Mayo Clinic in Arizona and Mayo Clinic in Rochester.
————————————————————Endothelial Dysfunction Linked to Heart Disease Also Impacts Alzheimer’s
A dysfunction in the lining of blood vessels that is linked to cardiovascular illness also appears to play a role in the development of Alzheimer’s disease, according to a study published in Circulation Research: Journal of the American Heart Association. As many as 5 million Americans have Alzheimer’s, according to the National Institutes of Health.
Two distinct anomalies in the brain are hallmarks of Alzheimer’s: neurofibrillary tangles, twisted fibers composed primarily of a protein called tau that arise inside nerve cells, or neurons; and amyloid plaques, a buildup between neurons of protein fragments called amyloid beta peptides.
Previous research has found that people with multiple cardiovascular risk factors are also at greater risk for Alzheimer’s. A central feature is nitric oxide deficiency in the endothelium. Nitric oxide is crucial in vasodilation.
“If you look at any risk factor for cardiovascular disease — the standard risk factors like high cholesterol, diabetes, hypertension, smoking, sedentary lifestyle, aging — all of these have been associated with loss of nitric oxide in the endothelium, a condition known as endothelial dysfunction,” said Zvonimir S. Katusic, MD, PhD, senior author of the study and a professor of anesthesiology and pharmacology at the Mayo Clinic in Rochester, Minn.
In the study, the researchers tested whether endothelial dysfunction also plays a role in Alzheimer’s disease. Using endothelial cells from microscopic blood vessels in the human brain, the scientists chemically inhibited eNOS (endothelial nitric oxide synthase), an enzyme involved in nitric oxide production.
Inhibition of eNOS triggered a series of biochemical effects that led to an increase in the production of amyloid precursor protein (APP), the raw material for the amyloid plaques seen in the brains of Alzheimer’s patients.
The quantity and activity of BACE1 also increased. BACE1 is an enzyme that cleaves APP to create the amyloid beta peptides that make up the plaques.
“Once you lose that basal nitric oxide, you see the increases in APP and BACE1, and the increase in amyloid beta generation,” said Susan Austin, PhD, first author of the study and a postdoctoral research fellow at the Mayo Clinic.
The research team also studied tiny blood vessels in the brains of mice that had been genetically engineered to lack the eNOS enzyme. Those mice — which naturally have higher blood pressure and are prone to insulin resistance compared with normal mice — had about a 50 percent reduction in nitrates and nitrites, which indirectly reflect nitric oxide production. The eNOS-deficient mice also showed higher levels of amyloid beta peptide in the brain, along with more APP and BACE1.
The study suggests that preserving a healthy blood vessel wall is important in preventing cognitive impairment and ultimately Alzheimer’s disease, Katusic said. “On the cardiovascular side we’ve known for some time that preservation of healthy endothelium is critical to prevent major cardiovascular events. Now it seems this may have important implications for cognitive impairment.”
The research could help explain, for instance, how exercise benefits cardiovascular health and the aging brain, Katusic said. Previous research has shown that exercise can delay or prevent cognitive impairment.
“There is a lot of literature showing that every time you exercise, you stimulate the endothelium to produce more nitric oxide,” Katusic said. “What we have identified in this paper may help explain the reported (cognitive) benefit of exercise.”
————————————————————Stentys Begins Large-Scale, “Real-Life” Study With Its Self-Apposing Stent for Treatment of AMI
Stentys S.A. has begun the international APPOSITION III study of its self-apposing stent, with 50 patients already enrolled out of a total of 500. The trial primary endpoint is major adverse cardiac events at 12 months post-procedure.
“The cardiologists in our cath lab are extremely excited to be part of the APPOSITION III study, because it allows us to use the Stentys self-apposing stent in a real-life setting for the treatment of acute myocardial infarction (AMI) patients,” said study investigator Prof. Harald Mudra, MD, PhD, Head of the Department of Cardiology, Pulmonology and Internal Intensive Care Medicine of the Neuperlach Hospital in Munich, Germany.
The Stentys stent represents a major breakthrough compared to conventional stents when treating heart attacks: it is self-apposing, i.e. it “fits snugly” into the contour of a blood vessel, and its shape and diameter adapt to the anatomic changes of the coronary arteries during the post-AMI phase. The APPOSITION II randomized trial compared the Stentys Self-Apposing Stent with a conventional, market-leading stent in patients suffering a heart attack. It showed that, three days after an AMI, 28% of patients treated with conventional stents displayed significant malapposition. Malapposition puts AMI patients at significant risk of potential fatal complications such as in-stent thrombosis. In contrast, none of the patients treated with the Stentys stent had stent malapposition.
Based in Princeton, New Jersey, and Paris, Stentys was founded by Jacques Séguin, MD, PhD, (also founder of CoreValve, which was acquired by Medtronic) and Gonzague Issenmann. Stentys received CE-marking for its flagship products in 2010. Its self-apposing stents adapt to the anatomic changes of the arteries in the post-infarction phase and thus prevent the malapposition problem associated with conventional stents. Stentys has commenced marketing activities in several European countries.
