Clinical and Industry News

News

Compiled by CathLab Digest

Compiled by CathLab Digest

ACIST Medical Systems Contrast Delivery System Facilitates Diagnosis of 10 Millionth Patient

ACIST Medical Systems, Inc., a Bracco Group company, offering contrast injection system technology for cardiovascular angiography, announced that interventional cardiologists and staff have used the company’s contrast delivery system to help diagnose and treat 10 million patients. The ACIST system is an all-in-one, variable-flow technology that gives physicians control over the full range of injection volumes, from small vessels in the coronaries to large vessels in the ventricles and peripheral vasculature. The system’s widespread adoption in prestigious teaching institutions as well as mainstream community-based hospitals has demonstrated benefits in reducing costs and complexity and in enhancing patient care.

“The ACIST contrast delivery system was developed to help doctors perform angiography more efficiently and, in turn, facilitate timely and appropriate treatment,” said Dr. Robert Wilson, inventor of the ACIST system and Professor of Interventional Cardiology at the University of Minnesota. “The system shortens procedures, decreases the amount of dye injected into patients and reduces radiation exposure for health care professionals and patients.”

The ACIST system features include air column sensors, a hand controller and a monitor that tracks and displays contrast usage. The ACIST system has air column sensors that automatically stop the procedure when air is detected, helping prevent a potentially serious complication for the patient. The hand controller facilitates precise administration of contrast for more consistent imaging with lower contrast amounts, reducing radiation exposure. The hand controller also allows the clinicians to step back from the radiation source during imaging to reduce radiation exposure, as well as deliver contrast without the stress of manually injecting throughout the heart’s vessels — thereby reducing hand fatigue and the potential for carpal tunnel syndrome.

“We are committed to providing best-in-class technology for angiographic imaging. Reaching 10 million procedures with our contrast delivery system is a testament to our product’s effectiveness and efficiency, as well as its ability to reduce radiation exposure for clinicians and patients,” said Thomas Morizio, president and chief operating officer, ACIST Medical Systems. “We are especially proud of the fact that our angiographic system can make a clinical difference while also reducing costs and complexity — essential factors in today’s health care environment. We look forward to continuing to help address the expanding needs of more complex and evolving interventional procedures.”

Headquartered in Eden Prairie, Minn., with regional offices in Europe and Asia, ACIST employs more than 220 people worldwide. To learn more, visit www.acist.com.

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UC San Diego Sulpizio Cardiovascular Center Opens to Public With 4 New Cath Labs

UC San Diego Sulpizio Cardiovascular Center (SCVC) officially opened its doors to the public on August 8 after the California Department of Public Health (CDPH) certified the SCVC for patient care.  The region’s first cardiovascular center is now accessible to the tens of thousands of Californians who are at risk for or suffer from heart disease and stroke. 

The first cardiac inpatients transferred from UC San Diego’s medical centers on July 31. The cardiovascular hybrid operating rooms, catheterization labs and procedural treatment unit (PTU) are in full operation, as well as the ambulatory clinics.

“The SCVC is at the forefront of modern efforts to combat heart and vascular diseases, the most common causes of disability and mortality within our population. As leaders and teachers in this field, we offer advanced diagnostics, novel treatments and access to a number of clinical trials not available anywhere else in the San Diego region,” said Kirk L. Peterson, MD, director, Sulpizio Cardiovascular Center and Professor of Cardiology and Medicine at the UCSD School of Medicine.

According to the American Heart Association, heart disease and stroke are the number one and number three causes of death, and a leading cause of disability, among Californians. Compared to the nation, California has slightly above average rates for coronary heart disease and stroke mortality.

“The opening of the SCVC is a milestone development for UC San Diego Health System,” explained Tom Jackiewicz, CEO of UC San Diego Health System. “In the next five years, we will open Jacobs Medical Center, the Clinical and Translational Research Institute (CTRI), and the Center for the Future of Surgery. Our journey continues today, as we welcome patients, neighbors and supporters to the one place in San Diego where cardiovascular care is fully integrated.”

With the SCVC open, patients now have access to a spectacular facility with 54 new inpatient beds, four new cardiovascular ORs, four new cardiac catheterization laboratories, a new non-invasive cardiovascular laboratory, and outpatient clinics. Nearly 100 new employees have been hired including nurses, telephone operators, technicians, security and a nutritionist. For more information, visit www.heartcenter.ucsd.edu.

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Newest Screen For Newborns Will Indicate Heart Problems

About one in every 120 babies are born with congenital heart disease (CHD), of which about 25 percent are critical, requiring special care early in life. CHD is responsible for more deaths in the first year of life than any other birth defect, but often outcomes can be improved with early detection.

Now a group of physicians and scientists has published an important paper that recommends strategies for national screening for critical CHD, using pulse oximetry. Low oxygen levels would trigger further investigation.

The screening strategy report was published in the journal Pediatrics on August 22.

“Screening for low-blood oxygen saturation can be an effective way to identify otherwise well-appearing babies who have undetected critical CHD,” said one of the report’s authors, Alex Kemper, MD, associate professor of Pediatrics at Duke University Medical Center. “One of the biggest challenges in implementing screening will be the follow up after a positive screen.”

Many of the identified babies will require an evaluation by a pediatric cardiologist or an echocardiogram before they can go home. Because not all hospitals have these services, some babies may need to be transferred to other hospitals.

“Therefore, it is very important to avoid false positive screening results,” Kemper said. “We believe that the strategy we have developed will identify most cases but also have a false positive rate of less than 1 percent.”

The group’s recommendations are based on large studies conducted in the United States and Europe. However, there are still many unanswered questions about how to best screen, including timing and the standards for a positive screen.

For example, the algorithm’s usual cutoff point for oxygen saturation may need to be adjusted for babies in high-altitude nurseries, where blood-oxygen levels may be normally slightly lower.

“We expect that as screening is adopted, these recommendations will be improved, but there is good evidence that this screening can save lives,” Kemper said.

The report was endorsed by the American Academy of Pediatrics, the American College of Cardiology Foundation, and the American Heart Association.

Based on evidence that has already been gathered, the state of New Jersey will initiate CCHD screening on August 31 for all babies before discharge.

“This will be a great opportunity for other states to learn how to begin screening on a wide scale,” Kemper said.

As more information is learned about how to safely and effectively screen newborns, other states are likely to adopt similar rules. In addition, the Secretary of Health and Human Services is now developing a plan to assist states in the identification and treatment of newborns with congenital heart disease.

For screening, testing should ideally occur after the baby is 24 hours old, because there are many changes in the circulatory system very early in life that can cause a false positive screen.

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Coronary Artery Stenting Viable Palliative Option for Infants and Toddlers

Percutaneous coronary intervention (PCI) is not a generally accepted option for infants or toddlers with acute coronary syndrome. However, a new report published in the August issue of Catheterization and Cardiovascular Interventions, a journal of the Society for Cardiovascular Angiography and Interventions (SCAI), found coronary stent implantation to be a feasible and safe palliative option for children fifteen months and younger.

Studies have shown that in adults with acute coronary syndrome (ACS) stent implantation significantly reduces mortality. While ACS is less common in children, there are congenital and acquired heart disease that may compromise coronary circulation in the pediatric population. Due to increased risk of coronary interventions and difficulty of cardiac catheterization techniques in pediatric patients, PCI is not a recommended treatment strategy in this age group.

A research team led by Dr. András Bratincsák from Rady Children’s Hospital in San Diego, California, conducted a retrospective review of seven children who had PCI between June 2006 and June 2010. Of those included in the study all were under 18 years of age and four were 15 months or younger. PCI techniques included balloon coronary angioplasty and coronary stent implantation. Researchers analyzed patient data that included underlying diagnosis, comorbidites, catheterization technique, and outcomes.

In all seven cases, successful stent placement in the proximal portion of the left or right coronary arteries with excellent revascularization was achieved. The average diameter of the heart arteries was 0.65 mm prior to the intervention. Balloon angioplasty did not completely resolve the stenosis and bare metal stents were then implanted to a mean internal diameter of 2.5 mm. The team determined that the average intervention-free period was 434 days after stent implantation. Restenosis and thrombosis did not occur in cases where the implanted stent diameter was greater than 2.5 mm and patients received dual anti-platelet therapy.

“We provide evidence that stent implantation is a relatively safe option for pediatric patients with coronary stenosis, including those under the age of 15 months,” said Dr. Bratincsák. “PCI offers a viable strategy for bridging infants and toddlers with blocked arteries or poor ventricular function to surgical revascularization or transplantation when they are at an older age.”

Source: Bratincsa A, Bratincsa A, El-Said HG. Percutaneous stent implantation into coronary arteries in infants. Catheterization and Cardiovascular Interventions 2011 Aug; (doi: 10.1002/ccd.23173).

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New Data Underscores Importance of Platelet Reactivity Testing to Aid in Risk Assessment

Following Stent Placement, Low Platelet Reactivity at Time of Discharge and After 30 Days Leads to 50% Reduction in Cardiovascular Events

Data announced August 29, 2011 at the European Society of Cardiology (ESC) Congress in Paris and simultaneously published in Circulation  show that stent patients exhibited a 50% reduction in cardiovascular death, heart attack and stent thrombosis over 6 months when they achieved low platelet reactivity, as measured by the Accumetrics’ VerifyNow P2Y12 Test, at discharge and 30 days post-procedure. The VerifyNow P2Y12 Test is used to measure a patient’s platelet reactivity and the antiplatelet effect of medications such as clopidogrel or prasugrel (Plavix and Effient).

“These new findings from GRAVITAS demonstrate that patients who achieve a low level of platelet reactivity do much better after a stent procedure with respect to subsequent cardiovascular events,” said Matthew J. Price, MD, of the Scripps Translational Science Institute and Scripps Clinic in La Jolla, CA. “These results further elucidate how platelet reactivity testing can help us, as physicians, assess the risk profile of our patients and guide us in determining the degree of the effect from the antiplatelet therapy that we prescribe.”

Dr. Price, principal investigator of the GRAVITAS (Gauging Responsiveness with a VerifyNow Assay-Impact on Thrombosis and Safety) trial, presented the results from the new analysis during a State of the Art and Featured Research presentation entitled “Platelet reactivity on clopidogrel therapy and cardiovascular outcomes after percutaneous coronary intervention: a time-dependent pharmacodynamic analysis of the GRAVITAS trial” at the ESC Congress.

With this analysis, GRAVITAS is the largest multicenter randomized trial to demonstrate that reduced levels of platelet reactivity while receiving clopidogrel were independently associated with a lower risk of cardiovascular events, even after elective stent procedures. Further, this marks the second recent published report  highlighting the clinical significance of platelet reactivity measurements not only within the first 24-48 hours of a stent procedure, but also at 30 days after the procedure is completed. This demonstrates the importance of continuing to assess a patient’s platelet reactivity at follow up within the hospital or outpatient settings.

The concept of variability in response to antiplatelet therapy has been well established.  Also being demonstrated with increased frequency is that high residual platelet reactivity is associated with poor patient outcomes. The GRAVITAS study is a multi-center, placebo-controlled study to determine whether high maintenance dose of clopidogrel therapy based on the results of the VerifyNow P2Y12 Test reduces ischemic events post-PCI. The trial was coordinated by Scripps Advanced Clinical Trials.

For more information, visit www.accumetrics.com.

References

  1. Price MJ et al. Circulation 2011;124:1132–1137.
  2. Campo G, et al. J Am Coll Cardiol 2011;57(25):2474–2483.

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European Society of Cardiology: Fat Around the Heart Boosts Heart Attack Risk

Pericardial thickness was significantly correlated with coronary arterial remodeling and non-calcified plaque, related to acute coronary syndrome (ACS), in a Japanese study presented at the ESC Congress 2011 by Dr. Riyo Ogura. Interest in the fat around the heart — so-called pericardial fat — is rapidly growing. Even a thin person can have pericardial fat. Several studies suggest that pericardial fat induces inflammation of the artery wall by secretion of pro-inflammatory proteins and plays a role in the pathogenesis of coronary artery disease. However, there is no information regarding the impact of pericardial fat on coronary arterial remodeling and plaque vulnerability, related to ACS.

One hundred and eight consecutive patients with de novo lesions located in the native coronary artery were studied. The pericardial fat thickness on the right ventricle was measured using transthoracic echocardiography, and arterial remodeling of culprit lesion was assessed by pre-interventional intravascular ultrasound (IVUS). The remodeling index (RI) was calculated as lesion divided by the reference external elastic membrane cross-sectional area. Positive remodeling (PR) was defined as RI >1.05, intermediate remodeling (IR) as between 0.95 and 1.05, and negative remodeling (NR) as <0.95. IVUS findings included plaque eccentricity and morphology-lipid rich, fibrous and calcified.

There was a significant relationship between pericardial fat thickness and RI. Patients with a higher pericardial fat thickness (>10mm, n=55) were significantly associated with high body mass index, high plasma triglyceride level, and high plasma urinary acid level. PR and noncalcified plaque were more common in patients with a higher pericardial thickness.

There was no significant relationship between pericardial fat thickness and plaque eccentricity. Multivariate analysis showed that high pericardial fat thickness was an independent factor affecting coronary positive remodeling.

Ultimately, pericardial fat thickness was significantly correlated with the coronary arterial remodeling and non-calcified plaque in ACS patients.