On Wednesday (April 28th) of this week a new remote catheter navigation (RCN) system was first used for a cardiac ablation procedure. At the the Glenfield Hospital in Leicestershire, UK, 70 year old Kenneth Crocker received an EP ablation for an unspecified atrial arrhythmia. The procedure was carried out with the physician outside of the EP lab, remotely controlling the ablation catheter using a system similar to Stereotaxis' Niobe and Hansen Medical's Sensei.
This relatively new system is manufactured by Catheter Robotics, Inc., a company based out of New Jersey, which introduced their product a couple of years back at the 2008 Boston Atrial Fibrillation Symposium, and has exhibited their machine on the vendor floor at the annual Heart Rhythm Society's (HRS) annual sessions each year since. Their Remote Catheter Manipulation System uses a 3 foot robotic arm that can be fitted with any conventional, commercially-available catheter. A remote control handle manipulates the catheter's insertion, withdrawal, deflection, and rotation, replicating the manual manipulation of a catheter.
Just from a technology perspective, the system offers some key advantages over both Stereotaxis and Hansen. The Catheter Robotics system requires no retrofitting of lab space--it can conveniently be mounted on a typical procedure table--a distinct advantage over Stereotaxis' Niobe which requires a great deal of space and a non-ferrous operating environment. Hansen Medical's Sensei has always been more attractive because of it's mobility and open platform, but the added variable costs of the Artisan catheter are substantial. With the Catheter Robotics system, the catheter enters the vasculature through a standard, commercially-available sheath-introducer in the groin with no part of the robotic system entering the patient's body, thereby adding no additional variable costs to a standard manual ablation procedure. It's capital cost appears to be substantially less than Stereotaxis, and a good deal cheaper than Hansen as well. The Daily Mail quotes the price at £350,000 (roughly $536,000), though that price point could easily change in the American Market.
From a clinical perspective, it's difficult to judge what advances the new technology will bring, though its close approximation of the standard manual motions of catheter control could prove an attractive selling point. Both the Stereotaxis and Hansen systems control catheters through unique interfaces, creating a learning curve for new users. The Catheter Robotics platform could conceivably be picked up with ease by any physician already comfortable with performing manual ablations.
It's eventual entry into the American market is unclear. Last year at HRS I was told by a company representative that they were in the recruitment phase for clinical sites of the human trials. I'll be traveling to Denver for this year's HRS annual sessions and will look for the company to see if any additional updates on that front are available. Be sure to look on the Pipeline for that and any other late breaking news coming from the world of electrophysiology.
In November 2009, the Joint Commission presented its new perinatal core measures. Beginning with discharges on April 1, 2010, administrators can now elect to report on this bundle of measures, which include the following:
- Cesarean section (C-section)
- Elective delivery
- Exclusive breast milk feeding
- Health care-associated bloodstream infections in newborns
- Use of antenatal steroids
The inclusion of exclusive breast milk feeding as a metric has increased attention on recent research findings related to skin-to-skin contact (SSC) immediately following delivery. In a study appearing in the May 1, 2010 issue of the Journal of Human Lactation, researchers at Loma Linda University found that SSC--in which the naked or diapered newborn is placed prone on the mother's bare chest or abdomen and covered with a warm blanket and cap--is directly correlated with increased odds of exclusive breastfeeding during the hospital stay when SSC occurs within three hours of birth. Furthermore, the results indicate a dose-response pattern, wherein increasing SSC duration increases odds of exclusive breastfeeding.
Beyond effects specific to initial breastfeeding success, SSC also mitigates maternal breast engorgement pain, which can affect long-term breastfeeding outcomes, and facilitates maternal attachment behaviors. Moreover, SSC plays a significant role in infant temperature regulation (PDF), as the mother's body warms the infant as effectively as an incubator or warming table. As such, SSC within one hour of delivery can be safe for Cesarean delivered infants, who are believed to suffer mild hypothermia.
Overall, these findings have significant implications for the care of infants and mothers in recovery after delivery. The dose-response relationship between SSC duration and exclusive breastfeeding suggests that some amount of couplet care is ideal. Moreover, increased prevalence of SSC could have downstream effects related to the efficiency of obstetrics care. If breastfeeding begins more quickly and easily for more mothers, fewer patients might require lactation consults later in the maternity stay. In institutions where lactation consults are in high demand and often occur late in the stay, decreasing the need for consults could improve on-time discharge rates and thereby facilitate throughput.
It's no surprise that physicians rely upon many techniques to screen for, diagnose, and treat breast cancer. The imperfect nature of physical exams and imaging studies often requires multiple procedures to be performed on a patient to properly evaluate disease presence, with the objective that better diagnostic performance through a combination of techniques will improved outcomes and reduce unnecessary procedures. Mammography, ultrasound, and MRI are the imaging modalities most commonly used at various points in the breast cancer pathway. The combination of these modalities serves to ensure patients are receiving the most appropriate treatment.
However, even together, these anatomical imaging studies have limitations with respect to both the type and quality of the information obtained. These clinical and operational limitations have and continue to lead to the development of "next-generation" breast imaging modalities, such as 3D tomosynthesis, breast-specific gamma imaging (BSGI), and positron emission mammography (PEM). Despite their limited adoption to date (or no adoption in the U.S. for tomosynthesis as an investigational technology), considerable promise exists for these modalities as they add new anatomical and functional dimensions to standard imaging modalities.
But what happens when you combine these cutting-edge technologies that have, to some extent, demonstrated improvements over much-accepted technologies? Is the end result a "super" modality with synergistic effects, or simply another widget to aid in breast cancer evaluation? Researchers are exploring these very questions, with a hybrid tomosythesis-molecular breast imaging system emerging as a futuristic modality to keep track of in the years to come.
Is Hybrid Tomosynthesis-MBI The Future of Breast Imaging?