Alyssa Pollizzi, Technology Insights
It is no secret that the coordination of medical care could be improved, hence the increase in willingness to consider a new model like the "medical home." Utilizing a team approach to health care delivery allows the physician to improve the quality of care while reigning in health care costs.
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The last two decades have witnessed the rapid ascent and decline of various surgical bariatric procedures. A rapid rise in open gastric bypass characterized the late 1990's and early 2000's. Laparoscopic bypass quickly replaced open approaches, as evidenced by the drastic increase of gastic bypasses performed laproscopically from 18% in 2002 to 72% in 2004.
By late 2008, seven years after receiving FDA approval, laparoscopic adjustable lap banding (LAGB) accounted for 24% of all bariatric procedures in the U.S.
And now we're witnessing the latest shift in bariatric surgery—the rise of laparoscopic sleeve gastrostomy (LSG).
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Matthew Morrill and Christopher Pericak
Our research team reports live from the 2012 meeting of the Radiological Society of North America held in Chicago, Ill. We offer a preview of the major themes expected to emerge from the studies presented at this year's meeting.
The theme at the 2012 RSNA meeting is "Patients First," which seems straightforward at first glance. However, this year's presentations will reveal many surprises about how clinicians are achieving this principle.
Of the 13,162 abstracts submitted for consideration, RSNA coordinators accepted 5,246 for presentations. These studies coalesce into several sub-themes, all of which focus on helping providers appropriately and affordably use imaging to improve patient care.
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Hospital leaders, say goodbye to BSCOE and hello to MBSAQIP.
MBSAQIP (Metabolics and Bariatric Surgery Accreditation Quality Improvement Program) is replacing the COE (Center of Excellence) as well as the BSCN (Bariatric Surgery Center Network) programs, which were operated by ASMBS and ACS, respectively. MBSAQIP is the result of a year-long quality improvement effort and the unification of ASMBS and ACS’s previously separate bariatric accrediting governance bodies. The exact structure of and rules under MSAQIP are still being finalized but are expected to be released by the end of the year, with site visits under the new program slated to begin as early as January 2013.
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GAITHERSBURG, Md.-- On Wednesday, July 20, the FDA's Circulatory System Devices Panel voted 9-0, with one abstention, that the FDA approve Edwards Lifesciences' Sapien valve, a first-in-class device offering inoperable patients with severe aortic stenosis, albeit well enough to benefit from valve replacement, a treatment alternative for the first time. Specific items on which the panel voted included: effectiveness (9-2 in favor), safety (7-3 in favor), and whether the procedure's benefits transcended its associated risks (9-0 in favor). The panel did not, however, have the opportunity to change their questions or re-vote as has been done in past panels. Nonetheless, the majority of the panel concluded that the Sapien heart valve displayed "reasonable assurance" of overall safety and effectiveness in this patient population.
This favorable recommendation for SAPIEN came after more than 10 hours of presentations, discussions, debate, and myriad questions, where a packed house of physicians, clinical experts, industry members, and consumers alike remained on the edge of their seats for the duration of the day. Top-of-mind topics for discussion included persistent concerns around stroke and vascular complications in the PARTNER trial, physician and site training protocols (e.g. the need for a multidisciplinary heart team), the need for a national data repository for all patients (e.g. a nationwide TAVI registry), as well as the importance of post-market surveillance for careful assessment of the device's safety and effectiveness in all patients. Off-label use and patient selection concerns were likewise identified and discussed as critical concerns relating to the device's commercial approval in the United States.
Particular controversy emerged over discussion of a subset of continued access patients who received TAVI following the conclusion of the trial. Questions from the panel focused on clearly defining mortality rates for this small subset population, in which deaths for patients receiving TAVI appeared to be higher than patients administered standard therapy. One panelist, Dr. John Somberg from Rush University Medical Center (Chicago, IL) cited this concern over data as the rationale for his abstention from voting in favor of recommending TAVI for FDA approval.
The debate over patient selection also took center stage in panel discussions, with committee members calling attention to the potential for widespread dissemination of the device in non-surgical patients deemed inappropriate for device implantation. Though lower than the mortality rate for standard therapy patients in the PARTNER trial, the mortality rate for TAVI patients raised the question of not only, "Can you?" implant the device for non-surgical patients, but, "Should you?" Structuring clearly defined patient selection criteria to set not only "the floor" but "the ceiling" for patients unable to receive traditional aortic valve surgery will be critical to successful patient outcomes, as one panelist pointed out.
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A new robot, the Amadeus system, may give Intuitive Surgical a run for its money in the near future. The Amadeus system, which is manufactured by Titan Medical Inc. (Toronto, Canada), would make an interesting addition to the robotics market, which has and continues to be dominated by Intuitive Surgical, the maker of the da Vinci robot.
Titan Medical recently posted on its website the first batch of concept designs for the Amadeus (see below).
Concept Design for the Amadeus surgical robot (Titan Medical Inc., Canada)
According to announcements made by the company at the end of Q1, initial testing of the robot's beta console were recently completed and its makers are happy with the testing's "encouraging results." The company has also disclosed that the Amadeus system will be using arms made by Kuka Robot Group, an international company based in Germany. Among the features of this lightweight arm (pictured below), which will weigh only 14 kg, is that it includes seven degrees of freedom (DOF). This is the same number of DOF as Intuitive's da Vinci.
Lightweight robotic arm (KUKA Robotic Group, Germany)
Despite all this progress, Titan Medical's Amadeus appears to be still several years away from complete development. Still, as far as competition for Intuitive's da Vinci is concerned, the Amadeus seems to be one of the more developed systems out there and may be the closest competitor da Vinci has for now.
It's safe to say that the market for oncology services continues to feel more competitive, driven by continued investment in advanced technologies, the entrance of additional oncology providers, and the growth in freestanding entities offering outpatient cancer treatments.
In contrast to this broader dynamic, however, a recent NEJM study indicates that there has been substantial consolidation in the number of centers performing certain high-risk inpatient cancer surgeries, namely pancreatectomy, esophagectomy, and cystectomy. The study makes note of the various forces at play, including clinical quality, financial upside, patient access, and referral considerations that dictate where patients receive surgery, but the big finding is that the market for these three high-risk cancer surgeries has actually gravitated toward a more condensed model. This finding is quite intuitive when you look at this from a quality of care perspective, as most every surgical discipline is organized around the concept of specialization and procedure volume requirements.
The major focus of the study was to determine the correlation between hospital surgical volume and mortality rates, which I haven't even touched on, but I urge you to read more of this interesting piece.
Leaders in the medical device industry, hospital executives, physicians, and consultants gathered in the Grand Hyatt in Washington DC today at InHealth's 2011 Health Technology Summit. The purpose of the meeting was to discuss the macroeconomic climate in health care and how its pressures will determine the future of clinical technology innovation. Many of discussion points centered on the balance between value and volume. This balance, while rooted in the shifting payment methodologies in the delivery system, also emerged as a dynamic within the medical device industry. Academics, analysts, and industry reps emphasized that the 'new normal' in health care would make the demonstration of value pervasive through all aspects of the delivery system.
Dr. David M. Cutler, the Otto Eckstein Professor of Applied Economics at Harvard University, started of the day with a keynote address that introduced medical technology innovation within the context of the health care system this country has built across the past few decades. He began recalling the story of a heart attack suffered by President Dwight Eisenhower. The President suffered a heart attack while in office in 1955, and after the event was on bed rest for six weeks to recuperate. In the decades following the President Eisenhower's attack, the advances in clinical technology has enabled revascularization (through angioplasty and stenting, as well as coronary artery bypass grafting), such that patients suffering a heart attack recover faster, live longer, and have overall better outcomes. Dr. Cutler emphasized that though the cost of treating a heart attack has climbed dramatically, there is a clear, demonstrable benefit in health and longevity. Today, Dr. Cutler articulated, the advancements made in technology have lead to increasing complexities and, in correlation, the overuse of care. For that reason, the challenge for healthcare is to coordinate that complexity more effectively.
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