Our General Surgery research team is currently attending the Annual Meeting of the Society of American Gastrointestinal and Endoscopic Surgeons in San Antonio, TX, and I wanted to provide some early thoughts on the conference thus far. After attending a full day of scientific sessions and making our rounds across the vendor floor, I've reflected some of the main themes below.
As anticipated, minimally invasive surgery at the forefront, with procedural expansion top of mind:
Between scientific sessions, vendor-sponsored educational sessions, and vendor floor exhibits, it's no surprise that much of the focus this year is around less invasive surgery and the advantages it can bring. And while there have been no shortage of references to the baseline, well-established procedures like the lap cholecystectomy, the clear direction lies in expanding the range and types of procedures in which MIS approaches can be deployed. Much of the physician-led content has placed a great deal of focus on explaining evidence and early experiences with far more aggressive and potentially high-impact uses of laparoscopy, as well as more advanced minimally invasive approaches in procedures of which there has been less widespread adoption. Spanning the uses of laparoscopy in hepatobiliary, pancreatic, colorectal, and bariatric procedures, there is clearly great interest in pushing the bounds of conventional surgical approaches, but rarely the established literature to support truly superior outcomes or benefits from these minimally invasive approaches.There are clearly some procedures, such as the whipple, that will remain heavily dependent upon open procedures and inpatient stays, but there is still an ambitious movement to make surgery less disruptive to the patient while achieving the same resolution of disease.
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Uterine fibroid and uterine arterial embolizations (UFE/UAE) have shown substantial increases in growth in recent years due to shorter recovery time, lower risk of pelvic prolapse, and lower cost compared to hysterectomy. In addition, UFE has gained traction as it is able to spare the uterus (hysterectomy does not) and recent studies show that fertility rates are comparable for UFE and myomectomy, though not guaranteed for either. Growth in UFE/UAE has led to a small drop in hysterectomy volumes as patients prefer the less invasive procedure. Many patients receiving UFE have heretofore foregone treatment and are able to undergo UFE rather than hysterectomy since the fibroids are likely not as severe. This drop in hysterectomy volumes can present a financial challenge for hospitals as per-patient profitability is higher for hysterectomy procedures than UFE. There is still relatively little known about post-procedure health and the type of follow up required by patients presenting a challenge for hospitals as they work to identify future procedure growth.
In a Dutch meta-analysis published by the American Journal of Obstetrics and Gynecology, researchers examined four randomized trials comparing UAE and hysterectomy or myomectomy patients (515 patients in total). Researchers confirm that patients undergoing UAE had less blood loss and a shorter hospital length of stay (60 vs. 86 hours) though note that UAE patients had a higher chance of re-intervention at one, two, and five years. While the authors note that patients receiving both procedures were equally satisfied, the study did not break this down by patients who had to undergo follow-up work.
As gynecology has seen a shift of many procedures to the outpatient setting, it is possible that UFE may soon follow suit. While these are still largely performed as inpatient procedures requiring an overnight stay, advances in technology and physician familiarity may allow them to be performed with less observation. However, considering the higher re-procedure rate of UAE, hospitals should carefully consider if this is the right option given the new imperatives surrounding quality. Providing high quality, low cost care is a top-of-mind issue for many organizations wanting to keep re-procedure rates at a minimum. With UFE gaining ground as patients request the less invasive procedure, hospitals should impose consistent criteria regarding which patients receive UFE, hysterectomy, or myomectomy. Despite the higher re-intervention rate, UFE's positive short-term outcomes and benefit to patients will make it a procedure to watch for the near term.
Kansas City, MO--In a recent study examining over 5,000 PCI patients across four centers in the Saint Luke's Health System, Dr. David M. Safley and colleagues found that, compared to manual compression, vascular closure devices showed reduced rates of major, entry site, and other/unknown bleeding as well as reduced rates of stroke, pseudoaneurysm, and a trend toward lower in-hospital mortality. While major bleeding served as the study's primary endpoint, other endpoints included: myocardial infarction and renal failure as well as GI, retroperitoneal, and genital/urinary bleeding.
The study was designed such that an equal number of PCI patients--1,162--with comparable baseline characteristics were assigned to vascular closure device and manual compression groups, respectively; propensity scoring was then used to match 1,162 pairs of patients who--after receiving either a vascular closure device or medical compression post-PCI--obtained hemostasis. From January 1, 2006 through June 30, 2009, all patients in both groups underwent femoral PCI; among these, 80 percent received single-vessel PCI, and 67.9 percent presented with ACS.
Results indicated that, for patients considered at high-risk for major bleeding by the National Cardiovascular Data Registry (NCDR), vascular closure devices were associated with a 70 percent reduction in bleeding when compared to manual compression--3.1 percent versus 10.3 percent. However, for patients classified as having moderate or low risk for major bleeding, bleeding reductions for the vascular closure device cohort were numerically lower, albeit not statistically significant, when compared to the manual compression one; moderate- and low-risk patients displayed 34 and 61 percent reductions in major bleeding, respectively.
In addition to the primary endpoint of major bleeding, which occurred in 2.4 percent of the vascular closure device group versus 5.2 percent of the manual compression group, entry site bleeding, other/unknown bleeding, stroke, and pseudoaneurysm all showed statistically significant reductions favoring the vascular closure device cohort. While not statistically significant (P=0.07), the vascular closure device group likewise trended toward a shorter length-of-stay than its manual compression counterpart.
|| Manual Compression
|| P Value|
| Major Bleeding
| Entry Site Bleeding
| Other/Unknown Bleeding
Despite outperforming manual compression with regard to reductions in complications across the above categories, the vascular closure device cohort showed equivalent rates of MI, renal failure as well as retroperitoneal, GI, and genital/urinary bleeding -- the study's other endpoints -- when compared to the manual compression group.
On a device-specific level, suture-based and collagen plug-based vascular closure devices both demonstrated reductions in the composite endpoint--major bleeding, vascular occlusion, pseudoaneurysm, significant dissection, or arteriovenous fistula at the access site and peripheral embolization--when compared to manual compression. In fact, suture-based and collagen plug-based devices exhibited complication rates of 1.4 and 3.4 percent, respectively, versus 6.5 percent in each of their respective manual compression groups. Compared against each other, suture-based devices demonstrated more favorable results than their collagen plug-based counterparts in terms of reductions in the composite endpoint--1.4 versus 3.4 percent.
At present, the implications of this study's outcomes remain subject to ongoing debate. From a clinical perspective, some physicians such as Dr. Robert J. Applegate of Wake Forest University School of Medicine argue that the study has value insofar as it suggests that vascular closure devices may reduce the likelihood of major bleeding for those deemed at high risk for this complication; as such, it provides further evidence to support numerous observational studies suggesting an association between vascular closure devices and reduced bleeding. That said, skeptics such as Dr. Sunil V. Rao of Duke University Medical Center contest that randomized data are necessary for the study to have any meaningful implications. Specifically, a meta-analysis of new vascular closure devices is imperative as past meta-analyses have involved only older devices. From a business standpoint, hospitals likewise continue to debate the merits of vascular closure devices given the costs they may add to a given procedure. Although these devices range in price, some may increase costs by several hundred dollars or more for a particular procedure. At the same time, by eliminating the time burden that manual compression puts on nurses and potentially reducing patients' length-of-stay, vascular closure devices may actually promote cost-savings for some institutions. Technology Insights will continue to monitor the vascular closure device pipeline as well as clinical and strategic debates associated with these devices as they continue.
For more information on this topic, please visit: Closure Devices Reduce Major Bleeding Compared with Manual Compression
Recently, the Technology Insights team has fielded several questions about the Hana table, an expensive surgical table that facilitates minimally invasive procedures. Because of its role in facilitating these procedures, the question of the Hana table is completely tied to the question of minimally invasive hip replacement surgery--specifically the anterior approach.
The table is considerably expensive relative to other OR tables (we tend to hear it quoted somewhere around $150,000). To justify such an outlay the technology would have to demonstrate a substantial improvement on current clinical practices, and within minimally invasive joint replacement, that does not appear to be the case at this time. Right now in orthopedics and spine, minimally invasiveness is still a moving target. There are countless approaches being developed and honed by many surgeons, but at this time none have emerged as a true standard. Complicating matters is that in joint replacement and spine what constitutes "minimally-invasive" is subjective. Still, it is an attractive term to patients, and the demand for minimally invasive procedures will grow. There are a few major factors that will determine that rate of growth in hips:
Patient demand--Traditionally a total hip replacement has been an invasive procedure with a long recovery time lasting months. Not surprisingly, any improvement to this extended recovery time would be desirable to patients. Additionally the demographic of patients undergoing hip replacement is changing. Patients are often still employed full-time and express a desire to be back at work as soon as possible. Minimally invasive surgery affords the patient the advantage of a faster, less painful recovery. Cosmetic concerns of a large scar are also reduced with a minimally invasive approach. For all these reasons, consumer demand will be a key factor in the growth of these procedures.
Additional research clarifying clinical benefit--Currently a review of the relevant literature finds few attempts to compare different approaches of minimally invasive surgery to each other. Although the benefits of muscle-sparing procedures have been established, the specific technique for accomplishing this goal is debatable. In addition to the clinical benefits associated with various approaches, a host of other concerns must be considered. The ideal minimally invasive surgical technique would be easily learned, use little if any specialized equipment, and require a short operating time. Many of the proposed approaches claim to fix one of these issues. Additional research and innovation will drive the selection of the optimal technique.
Demonstrated cost benefit to providers--An omnipresent concern for hospitals, cost strongly impacts the growth of new procedures especially those which require expensive supplies or technology. Ideally, total hip replacements would become such low-trauma procedures that they could be performed with minimal perioperative support and a very short length of stay. The evidence that these approaches deliver these advantages is anecdotal, and note demonstrated at a large scale. Minimally invasive surgery could save hospitals much needed supplies and increase throughput. Unfortunately, this shift is unlikely to occur on a large scale in the near future.
All those drivers are noted for minimally invasive hip procedures in general, and since the Hana table is specifically designed for only one approach, a provider runs the risk of betting on a technique that may not win out clinically in the long run, and in fact already has some data suggesting a higher complication rate (see the abstract here). We've also heard that the anterior approach has a substantially longer learning curve than other techniques.
For all these reasons, we've erred on the side of caution in investing in this table and tend to be conservative in recommending its adoption. That being said, there can always be unique circumstances that make the investment more appropriate for certain institutions, and the Technology Insights orthopedics team will happily investigate those circumstances on your behalf.
Study results released this week point to the advantages of implementing screening tools to determine which patients seeing general cardiologists would benefit from a referral to an electrophysiologist and possible therapy using an implantable cardioverter defibrillator (ICD). Screening tools of this nature are not commonly utilized across the country and have the potential to increase the number of patients accessing these life-saving devices.
The study--conducted by Gravelin et al.--looked at patients from two outpatient cardiology offices and their associated medical records. Cardiologists at these offices were given a screening tool, which first asked whether patients' ejection fraction (EF) was 35 percent or lower; if it was, physicians were then asked whether the patient could be referred to an EP physician for an ICD based on other factors such as presence of comorbidities. When appropriate referrals from the screening group were compared to referrals before the implementation of the screening process, researchers found that significantly more eligible patients were referred to an EP during the screening period compared to the time period before the tool at both clinics. One cardiology office demonstrated an 80 percent referral rate compared to its previous 33 percent rate, whereas the other site referred 100 percent of eligible patients compared to 60 percent before the tool. Overall, 41 percent of patients referred for an ICD ended up receiving the therapy.
Currently, studies suggest that the under-implantation of ICDs and cardiac resynchronization therapy defibrillators (CRT-Ds) in eligible patients is a problem across the country: estimates indicate that as few as 27 percent of patients who could benefit from an ICD receive the device. Lack of understanding from some physicians of the appropriate patient population to receive this therapy for primary prevention as well as communication barriers when eligible patients are admitted to the hospital for other reasons (such as complications due to heart failure) can be roadblocks to patients receiving this treatment option. However, other factors must be considered such as patients' willingness to undergo evaluation for an ICD and the complications and risks involved with these devices. The rate of inappropriate, non-life-saving shocks from EP devices can be as high as 5.1 percent, and numerous complications can arise from the implanted ICDs and their leads, some necessitating removal of the implant. As such, patients must be carefully selected once referred for an EP consult based on factors outside of EF.
Despite the debate surrounding appropriate device implantation, screening tools and similar guidelines integrated into clinical practice have the potential to open the door to new treatment options for many patients, particularly if tools are integrated into electronic medical record (EMR) systems. This practice could streamline the referral process for physicians by generating automated alerts when patients could be eligible for device therapy. Technology Insights will continue to follow developments in screening processes for patients receiving ICDs and CRT-Ds.
Medtronic recently announced the approval and launch of the new Activa SC neurostimulator for Deep Brain Stimulation (DBS) throughout the US and Europe. The Activa SC is a single-channel neurostimulator, which complements the Activa PC and Activa RC dual-channel DBS systems. The Activa portfolio of DBS products are approved for treating Parkinson's disease, essential tremor, and dystonia in the US and Europe.
Deep Brain Stimulation is an implanted neurostimulation system that delivers electrical stimulation to targeted brain areas to alleviate the symptoms of Parkinson's disease, essential tremor, and dystonia. While the therapy is completely palliative and not intended to cure movement disorders, it is becoming an increasingly essential option for drug-refractory movement disorder patients to manage their dyskinesias and restore functionality. Medtronic is the only company that provides DBS systems and was first approved in the US in 1997. More than 80,000 people have received DBS therapy worldwide since approval.
Activa SC has allowed Medtronic to advance its portfolio of DBS offerings, by bringing its latest generation of DBS systems--Activa-- a single-channel stimulator. Single channel DBS systems are used for unilateral stimulation, which is performed when physicians identify one side of the brain as causing movement disorders and tremors. Additionally, many patients initiate DBS therapy by having stimulation on only one side, which is often sufficient for managing their condition. Once their symptoms worsen, bilateral stimulation is performed. For patients with more progressed symptoms or whose symptoms originate from both sides of the brain, bilateral stimulation can be done through the Activa PC, Activa RC, or two Activa SC systems.
The Activa SC system runs on a non-rechargeable battery that powers stimulation for years and does not need constant maintenance by the patient. The Activa SC system includes a neurostimulator, a lead that will be targeted at specific brain areas implicated with movement disorders, and an extension wire that connects the neurostimulator to the lead. Additionally, the system comes with a programmer that is used by the physician to set stimulation parameters, as well as another programmer that can be used by the patient to check battery status and modify settings.
A metal shielding disc used by the Axxent Electronic Brachytherapy system has been recalled after dozens of women had small particles of tungsten detected in their breasts during post-surgical follow-up scans. The tungsten had apparently flecked off the shields during intraoperative radiation therapy (IORT) delivered during lumpectomies they received at two hospitals - Hoag Memorial Hospital in Newport Beach, CA and Karmanos-Crittenton Cancer Center in Detroit, MI.
The long-term effects of tungsten on the human body are unknown, though iCAD, Inc. - which recently purchased Xoft, Inc., the developers and former owners of the Axxent system - believes the particles to be non-toxic. Other medical professionals are not so sure, however.
iCAD issued a recall notice last month, and earlier this month two of the affected patients filed suit against Hoag Memorial Hospital and iCAD. The New York Times - which has been reporting repeatedly on safety in radiation therapy over the past year - published an article on the incidents this week.
The shielding device received expedited clearance from the FDA under the 510(k) track. This recall is likely to add fuel to the debates over whether, on the one hand, the FDA is doing a sufficient job of protecting patients from potentially dangerous medical devices while on the other not unduly stifling medical innovation or patient access to potentially live-saving or -enhancing treatments.
Any potential affect on electronic brachytherapy utilization or volumes more broadly remains to be seen, but it should be noted that this recall is restricted to a device used only during intraoperative procedures. It does not extend to the Axxent Electronic Brachytherapy system itself, which delivers low-energy x-rays directly to the tumor bed via a disposable source wire with a micro-miniature x-ray tube attached to its tip. It is a form of high-dose rate brachytherapy (HDR-B) that, unlike isotope-based HDR-B, allows the procedure to be performed in a minimally or even non-shielded environment.
The procedure had been used primarily for breast, endometrial, and skin cancers, with IORT coming to the fore as a more recent application.The patients were all part of a trial to assess the system's potential uses for breast IORT.
The technology has mainly been adopted to date by AMCs and other progressive cancer care providers, and this recall and lawsuit may stymie further efforts to expand the technology into the broader market of community-based cancer care. That said, any concrete effects on adoption and utilization remain to be seen.
iCAD's purchase in late 2010 of Xoft for approximately $13 million adds another wrinkle to this story, as they are now facing a $14.5 million lawsuit. It is not known whether iCAD had knowledge of the potential suit before the purchase or Xoft before the sale, but iCAD has issued a statement saying they may seek "indemnification claims against Xoft as well as insurance coverage" to blunt the potential financial impact of the suit.
Today, the FDA's Neurological Devices Panel is set to review Covidien's Pipeline, an embolization device for the treatment of large/wide-necked intracranial aneurysms in the cavernous and paraclinoid regions of the internal carotid artery. The Pipeline product is designed specifically for cases that are challenging to treat with existing techniques, such as endovascular occlusion coils, due to the large size of the aneurysm neck.
The FDA meeting will examine the company's proposed post-market study for the device that will continue to follow patients from its existing pivotal PUFS trial (Pipeline for Uncoilable or Failed Aneurysms) for a further five years. Clinical study data released prior to this meeting indicated that Pipeline met its primary safety and efficacy targets at 6 months. This pivotal trial included 108 patients with 110 qualifying aneurysms which were treated using Pipeline. The proposed post-market study is centered around the hypothesis that the cumulative incidence of ipsilateral stroke/neurovascular death at five years will be less than 25%. The FDA is investigating whether this primary endpoint will adequately encapsulate the safety concerns associated with the product.
If approved, the Pipeline device has to the potential to be a significant game changer in the cerebral aneurysm space. Cerebral aneurysms affect approximately 27,000 patients a year in the United States. Wide-neck brain aneurysms occur in about 25 percent of these cases and continue to be pose a challenge for both endovascular therapy and open microsurgery techniques. If approved, Wall Street analysts predict potential sales of Pipeline to be upwards of $100 million in the first year alone.