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!
Smart Data Transformation – Surfing the Big Wave
02.12.2016 | Fraunhofer-Institut für Angewandte Informationstechnik FIT
Climate change could outpace EPA Lake Champlain protections
18.11.2016 | University of Vermont
In recent years, lasers with ultrashort pulses (USP) down to the femtosecond range have become established on an industrial scale. They could advance some applications with the much-lauded “cold ablation” – if that meant they would then achieve more throughput. A new generation of process engineering that will address this issue in particular will be discussed at the “4th UKP Workshop – Ultrafast Laser Technology” in April 2017.
Even back in the 1990s, scientists were comparing materials processing with nanosecond, picosecond and femtosesecond pulses. The result was surprising:...
Have you ever wondered how you see the world? Vision is about photons of light, which are packets of energy, interacting with the atoms or molecules in what...
A multi-institutional research collaboration has created a novel approach for fabricating three-dimensional micro-optics through the shape-defined formation of porous silicon (PSi), with broad impacts in integrated optoelectronics, imaging, and photovoltaics.
Working with colleagues at Stanford and The Dow Chemical Company, researchers at the University of Illinois at Urbana-Champaign fabricated 3-D birefringent...
In experiments with magnetic atoms conducted at extremely low temperatures, scientists have demonstrated a unique phase of matter: The atoms form a new type of quantum liquid or quantum droplet state. These so called quantum droplets may preserve their form in absence of external confinement because of quantum effects. The joint team of experimental physicists from Innsbruck and theoretical physicists from Hannover report on their findings in the journal Physical Review X.
“Our Quantum droplets are in the gas phase but they still drop like a rock,” explains experimental physicist Francesca Ferlaino when talking about the...
The Max Planck Institute for Physics (MPP) is opening up a new research field. A workshop from November 21 - 22, 2016 will mark the start of activities for an innovative axion experiment. Axions are still only purely hypothetical particles. Their detection could solve two fundamental problems in particle physics: What dark matter consists of and why it has not yet been possible to directly observe a CP violation for the strong interaction.
The “MADMAX” project is the MPP’s commitment to axion research. Axions are so far only a theoretical prediction and are difficult to detect: on the one hand,...
16.11.2016 | Event News
01.11.2016 | Event News
14.10.2016 | Event News
07.12.2016 | Health and Medicine
07.12.2016 | Life Sciences
07.12.2016 | Health and Medicine