Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Capture study shows safety of carotid stenting in 'real-world' setting

18.12.2006
With appropriate training, community physicians achieve gratifying results

The largest-ever study of carotid stenting in high-surgical risk patients has shown that with proper education and training, community physicians are just as successful at using catheter-based techniques to unclog arteries supplying blood to the brain as are those who pioneered the procedure at major university medical centers.

The study was released online today at www.scai.org, and will be published in the January 2007 issue of Catheterization and Cardiovascular Interventions: Journal of the Society for Cardiovascular Angiography and Interventions.

The CAPTURE study (short for Carotid ACCULINK/ACCUNET Post- Approval Trial to Uncover Unanticipated or Rare Events) involved 3,500 patients at increased surgical risk for carotid endarterectomy and 353 physicians at 144 hospitals across the United States. It addressed several questions critical to the evaluation of any new technology, among them: Could carotid stenting safely make the leap to "real-world," everyday use, or would the technique prove beneficial only in the hands of expert physicians"

"The ability to transfer the technology to the community was successful," said Dr. William A. Gray, Director of Endovascular Services and an Associate Professor of Clinical Medicine at Columbia University in New York City. "The study involved multiple physician specialties, multiple experience levels, and multiple sites with very broad geographic representation, and demonstrated that regardless of these differences, outcomes were similar across the board."

In carotid stenting, a physician threads a catheter through a small puncture in a leg artery and into the narrowed artery in the neck, which feeds blood to the brain. A filter is placed through this catheter and expanded above the blockage to protect the brain during the procedure. A flexible and crush-resistant stent is positioned in the blockage and then expanded with a balloon to hold the artery open. Once the procedure is complete, the filter is collapsed and removed.

The Rx Acculink carotid stent and its companion, the Rx Accunet filter, were approved by the Food and Drug Administration (FDA) in 2004 for the treatment of patients who not only have severe plaque build-up in the arteries in the neck—a condition that hikes the risk of stroke—but other medical problems that make it risky to have the plaque removed surgically. The CAPTURE registry was developed to collect FDA-mandated data to assess the ongoing safety of the Rx Acculink and Rx Accunet devices in a large group of patients, as well as the effectiveness of a training program tailored to the experience level of each physician interested in performing carotid stenting.

The study was well designed, with patients undergoing a neurological examination before the procedure, 24 hours afterward, and at 30 days. In addition, the physicians who examined patients for complications were independent of those who performed the stenting procedure. This latter aspect of the study is one of its major strengths, said Dr. Christopher J. White, editor-in-chief of Catheterization and Cardiovascular Interventions. "Because independent observers measured the outcomes of the procedure, we can have confidence that the data are robust, meaningful, and applicable in community practices," Dr. White said.

CAPTURE data revealed no unexpected problems with the carotid stenting devices themselves. In addition, patients fared equally well whether treated by highly experienced physicians or those who were new to carotid stenting but had undergone intensive training and on-site mentoring during their first few procedures. The combined rates of death, heart attack, and stroke were 6.3 percent overall—5.3 percent among the most experienced physicians, 6.0 percent among those with a moderate level of experience, and 7.4 percent among those with little previous experience, differences that were not statistically significant.

Carotid stenting experts hope such data will persuade the Centers for Medicare and Medicaid Services (CMS) to expand coverage for carotid stenting. For now, Medicare coverage is available only for patients who are at high risk for surgery and have symptoms before the procedure, but not those who are symptom-free despite severely narrowed carotid arteries. CMS is now re-evaluating that policy in light of data from CAPTURE and other post-market surveillance studies.

"What we’re really working toward is providing patients with greater access to the technology, where we think it is appropriate," Dr. Gray said.

"The CAPTURE trial is a giant step toward achieving the goal of proving that, in the foreseeable future, nonsurgical carotid stent placement will replace surgery as the treatment of choice for stroke prevention," said Dr. White.

Wayne Powell | EurekAlert!
Further information:
http://www.scai.org

More articles from Studies and Analyses:

nachricht Real-time feedback helps save energy and water
08.02.2017 | Otto-Friedrich-Universität Bamberg

nachricht The Great Unknown: Risk-Taking Behavior in Adolescents
19.01.2017 | Max-Planck-Institut für Bildungsforschung

All articles from Studies and Analyses >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Breakthrough with a chain of gold atoms

In the field of nanoscience, an international team of physicists with participants from Konstanz has achieved a breakthrough in understanding heat transport

In the field of nanoscience, an international team of physicists with participants from Konstanz has achieved a breakthrough in understanding heat transport

Im Focus: DNA repair: a new letter in the cell alphabet

Results reveal how discoveries may be hidden in scientific “blind spots”

Cells need to repair damaged DNA in our genes to prevent the development of cancer and other diseases. Our cells therefore activate and send “repair-proteins”...

Im Focus: Dresdner scientists print tomorrow’s world

The Fraunhofer IWS Dresden and Technische Universität Dresden inaugurated their jointly operated Center for Additive Manufacturing Dresden (AMCD) with a festive ceremony on February 7, 2017. Scientists from various disciplines perform research on materials, additive manufacturing processes and innovative technologies, which build up components in a layer by layer process. This technology opens up new horizons for component design and combinations of functions. For example during fabrication, electrical conductors and sensors are already able to be additively manufactured into components. They provide information about stress conditions of a product during operation.

The 3D-printing technology, or additive manufacturing as it is often called, has long made the step out of scientific research laboratories into industrial...

Im Focus: Mimicking nature's cellular architectures via 3-D printing

Research offers new level of control over the structure of 3-D printed materials

Nature does amazing things with limited design materials. Grass, for example, can support its own weight, resist strong wind loads, and recover after being...

Im Focus: Three Magnetic States for Each Hole

Nanometer-scale magnetic perforated grids could create new possibilities for computing. Together with international colleagues, scientists from the Helmholtz Zentrum Dresden-Rossendorf (HZDR) have shown how a cobalt grid can be reliably programmed at room temperature. In addition they discovered that for every hole ("antidot") three magnetic states can be configured. The results have been published in the journal "Scientific Reports".

Physicist Dr. Rantej Bali from the HZDR, together with scientists from Singapore and Australia, designed a special grid structure in a thin layer of cobalt in...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

Booth and panel discussion – The Lindau Nobel Laureate Meetings at the AAAS 2017 Annual Meeting

13.02.2017 | Event News

Complex Loading versus Hidden Reserves

10.02.2017 | Event News

International Conference on Crystal Growth in Freiburg

09.02.2017 | Event News

 
Latest News

Stingless bees have their nests protected by soldiers

24.02.2017 | Life Sciences

New risk factors for anxiety disorders

24.02.2017 | Life Sciences

MWC 2017: 5G Capital Berlin

24.02.2017 | Trade Fair News

VideoLinks
B2B-VideoLinks
More VideoLinks >>>