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.
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Radiation therapy has come under a great deal of fire recently, especially for treatment of prostate cancer. Although this is a lengthy entry, we felt it needed to be in order to do justice to the issue. So, please bear with me.
Two days ago, this issue formally went before Medicare, as CMS held its most recent Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) meeting to focus on the use of radiation therapy (RT) for localized prostate cancer. The debate over prostate cancer treatment has been framed by a number of recent events.
In June 2009 the Institute of Medicine released a list of what it deemed to be the top targets for comparative effectiveness research (CER), listing the broad range of treatment options for prostate cancer-- which range from active surveillance to open, laparoscopic, and robotic surgeries, as well as a plethora of RT treatment modalities--as one of its top 25 priorities. The Agency for Healthcare Research and Quality (AHRQ) has also commissioned an updated report on the comparative effectiveness of RT for localized prostate cancer; that report is currently in draft form and will be finalized in the coming months.
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This past week Europace, a journal of the European Heart Rhythm Association, published new data on the under-use of implantable cardioverter defibrillators (ICDs) in patients with heart failure (HF).
The authors of the study analyzed registry data from 3,513 patients. After applying a model based on international guidelines inclusion criteria and epidemiological data, they estimated the number of patients that were indicated for ICD therapy. Their analysis determined that the total population of patients that the guidelines indicate should receive an ICD implant would be 4,261 per million people in the USA (roughly 1.3 million people total--several times larger than the current implanted population).
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At a recent gathering of health economists and industry leaders sponsored by the Institute for Health Technology Studies (InHealth), the impact of the recent reform bill generated a great deal of conversation. While some of the debates drifted towards skepticism and criticism about provisions in the law, the key note address given by Alan Garber, a professor of medicine and economics and Stanford University presented the medical technology industry with a challenge for the future.
In the lecture, entitled "MedTech Innovation in a Reformed Delivery System," Professor Garber argued that the new law does little to address the cost drivers that are leading to the massive unfunded liabilities in the Medicare system. He pointed out that the chief cost drivers was the increasing life expectancy that most developed nations have seen across the second half of the twentieth century. Ultimately, he argued, the fiscal pressure of the Medicare liabilities coupled with the demographic trends would force us to reevaluate how we think about retirement. He proposed that the country could no longer structure retirement and retirement benefits around a specific age, but instead must shift the target age along with shifting life expectancy.
It was within this context that Professor Garber presented an imperative to the medical technology industry: create high quality products that enable people to live (and work) longer and better. Garber went on to explain about how the movement towards bundled payments and accountable care would reward innovation that raises both the extent and the quality of life. Because such innovation would lower acute event rates and improve care, payers and providers would be willing to pay for them. Garber presented an interesting view of the shifting landscape in which health care technology would be evaluated, and therebyhelped frame the subsequent discussions around comparative effectiveness research, which proved to be a vibrant topic throughout the day.
We at TI are looking closely at this area and its potential impact on health care. Look for additional details about this conference and its coverage of comparative effectiveness in this months Inside TI newsletter, where I will highlight some of the main discussions as seen at the InHealth 2010 summit.
At the 12th World Congress of Endoscopic Surgery yesterday evening, an Ethicon Endo-Surgery, Inc.-sponsored session fostered a lively debate over the value and safety of single incision minimally invasive surgery (SIMIS), also known as SPA and SILS, natural orifice translumenal endoscopic surgery (NOTES), and microlaparoscopy. Dr. Keith Zuccala, general surgeon from Connecticut, gave a spirited argument for the superiority of microlaparoscopy, as compared with SIMIS and NOTES. He argued that microlaparoscopy--which is essentially identical to traditional laparoscopy, but with smaller incisions--is the most prudent of these three minimally invasive surgical techniques because it does not alter the clinically proven laparoscopic technique while affording cosmetic benefits similar to those associated with SIMIS and NOTES--one of the main factors driving the adoption of these procedures. According to Dr. Zuccala, SIMIS procedures, while reducing the number of external incisions in the abdomen, increase the internal incisions surgeons need to make as compared to traditional laparoscopy. NOTES procedures, on the other hand, are performed without any external incisions, but may be the riskiest of the three procedures because of the need for surgeons to puncture an internal organ to provide access to the abdominal cavity. In addition to the clinical advantages of the microlaparoscopy approach, Dr. Zuccala also notes that microlaparoscopy does not necessitate any retraining; any surgeon with traditional laparoscopic training can perform microlaparoscopic procedures with the proper instrumentation.
However, microlaparoscopy may not be the silver bullet that its been made out to be. Currently, energy delivery devices and staplers still require standard-sized incisions because micro versions of these instruments are not yet available. Moreover, the safety and clinical efficacy of SIMIS and NOTES is still under investigation, and these techniques may be proven as safe and effective as traditional laparoscopy in the near term. So, while microlaparoscopy may have several practical and clinical advantages over NOTES and SIMIS, the debate over which of these minimally invasive techniques is most prudent will likely continue for some time.
This year, fortunately for us in Technology Insights, the SAGES (Society of American Gastrointestinal and Endoscopic Surgeons) is holding its 12th Annual World Congress of Endoscopic Surgery right here in our backyard, Washington, DC. One of the main topics of interest at today's meeting, not surprisingly, was that of robotic surgery. Going into this session, my initial inclination was that the focus would be on current and advanced uses of modern day robotic platforms--a term effectively synonymous with the da Vinci robot--and the ways in which the robot is advancing techniques such as single port access surgery. However, the topic was even more futuristic, and interesting for that matter.
Much of the focus centered on the idea of innovations in the use of and design of robotic platforms to not only cater to the growing interest in single port access surgeries, but also to cater to the concept of natural orifice translumenal endoscopic surgery. Beyond this, the futuristic concept of intracorporeal robots could involve introduction of a team of miniature externally-controlled robots into a patient's body, which would then team together to perform the litany of functions involved in a given resection or operation. The excitement around these concepts, beyond the ability to further minimize the collateral damage caused by externally controlled surgical instruments, is to enable even greater dexterity and capacity to manipulate the internal anatomy. Although very exciting, these types of innovations are clearly quite a ways away. That said, its interesting to keep tabs on the futuristic innovations currently underway as they will clearly influence minimally invasive (or potentially non-invasive) surgical practice moving forward.