BB&T Contributing Writer

ATLANTA – The 2005 annual meeting of the American Society of Anesthesiologists (ASA; Park Ridge, Illinois) was relocated from flooded New Orleans to the Georgia World Congress Center in Atlanta. The late-October conference was blown off course by Hurricane Katrina less than two months before it was to be held. Turnout at the show was very good considering everyone had a relatively short time to reorganize travel plans. Vendors informally polled said that attendance seemed down slightly but that booth traffic was brisk and attendees were purpose-driven.

The ASA was promoting its centennial year as “an educational, research and scientific association of physicians organized to raise and maintain the standards of the medical practice of anesthesiology and improve the care of the patient.” Indeed, advances in patient safety and comfort during the last 100 years have been impressive. Fifty years ago, deaths during surgery attributed to anesthesia were about 1 in 1,500 but today that number has improved more than 10-fold, despite older and sicker patients being treated in operating rooms nationwide. Over the years, anesthesiologists have spearheaded the clinical studies that have led to better monitoring equipment and safer, more predictable anesthetics and they have developed nationally recognized standards of care and emphasized continuing medical education.

Against this backdrop of notable historic achievements, most attendees believed that the hottest topic of this year’s meeting was the issue of patient awareness during general anesthesia and brain monitoring devices currently cleared by the FDA to track depth of anesthesia. Although no one knows the exact number of patients that this condition impacts, 10,000 patients are estimated to experience surgical awareness each year. Prior to the 2004 ASA meeting, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO; Oakbrook Terrace, Illinois) had issued a Sentinel Alert mandating that all providers track and document any indication of patient awareness during surgery. Both events were an embarrassment to ASA leadership as they created an impression that the ASA was a bit “late” in taking up this important issue.

A task force was set up by the ASA (the Task Force on Intraoperative Awareness) to clarify depth of consciousness related to anesthesia, but was unable to reach a consensus position by the 2004 annual meeting in Las Vegas, leaving the society without a clear direction to communicate to practicing members. At the time of the 2004 annual meeting, more than 1,700 clinical papers had been published on the subject of awareness, most of which had been published by ASA’s own members in the association’s journal. Yet the position taken by the task force was that there wasn’t enough data for the ASA to take a position on depth-of-consciousness monitoring.

A year later, the ASA maintains that there has not been a large enough randomized study to end the debate on whether consciousness monitoring (CM) is effective in all surgeries. At this year’s ASA meeting, delegates ratified the Task Force on Intraoperative Awareness’ “Practice Advisory for Intraoperative Awareness and Brain Function Monitoring” and trumpeted the report as “the most thorough document to date to assist anesthesiologists and hospitals in minimizing the risks of awareness under general anesthesia.” While the advisory is not the overwhelming endorsement some had called for, the ASA’s House of Delegates vote approving the final report paved the way for more focused debate and much wider adoption of some form of consciousness monitoring.

This practice advisory will help vendors of consciousness monitors overall, but practice advisories do not have the force of standards because they are, “not supported by scientific literature to the same degree as are standards or guidelines because sufficient numbers of adequately controlled studies are lacking.” Advisories may be adopted, modified, or rejected according to clinical needs and/or restraints perceived by individual practitioners.

With the number of papers and studies published concerning consciousness monitoring now numbering 1,800, the ASA was asked how many more would be needed before it could take a stand on consciousness monitoring. The new ASA president, Orin Guidry, MD, of the Ochsner Clinic Foundation (New Orleans), said that a true evaluation of brain-function monitoring would require a clinical trial of 750,000 patients, given the infrequency of the occurrence of awareness in surgery. He also said that brain function monitors are to be used as an “adjunct” to all the other measuring technologies and protocols available to the anesthesiologist, and that it is not necessary to use the device(s) in all surgeries where there is general anesthesia, but rather decided upon on a case-by-case basis. Patients considered “high risk” for awareness include cardiac, emergency and trauma surgery as well as births by Caesarean section. To the ASA’s credit, it pointed out that although it was not the appropriate group to run a 750,000-person study, it would financially contribute to the effort as an organization.

Respondents to the Practice Advisory survey were divided into two groups: a panel composed of randomly selected active ASA members and a number of consultants who were selected based on their knowledge of intraoperative awareness. The consultants and ASA members disagreed on whether brain function monitors should be used to reduce the risk of intraoperative awareness for all patients, but did agree that these monitors should be used on a case-by-case basis by the individual practitioner for selected patients who exhibit high risk for awareness such as those cases listed above and those who have experienced awareness in past surgeries. Some 62.4% of the ASA members either “disagreed” or “strongly disagreed,” while 52.6% of consultants disagreed or strongly disagreed. When asked whether these devices should be used in high-risk cases, 36.8% of consultants strongly agreed, while only 21.1% of the randomly selected ASA panel strongly agreed.

These responses indicate that there is no industry-wide consensus regarding brain function monitors – a fact that had to be somewhat disappointing to the five companies offering such devices, particularly to Aspect Medical (Newton, Massachusetts), the market leader with its Bispectral Index (BIS) monitor, about which 1,800 studies have been published. BIS also has been used in more than 12 million surgical procedures. However, even a guideline is a victory for all vendors, as it will likely spur wider use of such devices by anesthesiologists “going up the learning curve” of how this technology works and where it is most beneficial to use.

Another question the ASA members and consultants answered was, “Once an episode of intraoperative awareness has been reported and documented, (should) the patient be offered counseling or psychological support?” None of the consultants disagreed or strongly disagreed with this statement, only 5.4% were unsure, and an overwhelming 69.6% said that they strongly agreed with this statement. Interestingly, 2% of the ASA panel members disagreed or strongly disagreed with this statement, and an additional 14.6% were unsure whether this was the right thing to do; only 44.4% of the panel members agreed strongly with the statement. Such insensitivity by ASA members was revealing of their lack of understanding of the serious consequences of such episodes.

Some panel members were clearly concerned about litigation implications, believing they run a higher malpractice risk by referring patients to therapy, as it could be perceived as an admission that the awareness did indeed happen or could have been avoided. By documenting awareness cases (something they have not had to do prior to the JCAHO Sentinel Alert) they believe they may be opening the doors to more litigation. On the other side of these fears is Guidry’s statement that even one case of awareness is too many.

Market implications

Aspect Medical with its Bispectral Index monitor stands to gain additional sensor sales in the market under the new guideline. BIS converts a single channel of frontal EEG into an index of hypnotic (depth of consciousness) level mapping it to a value scale that ranges from 0 to 100. Aspect sells both stand-alone monitors and also has modules available for all major patient monitoring vendors. They also have been the subject of the vast majority of the literature and studies performed to date on the subject of awareness.

Several studies have compared outcomes with BIS-guided anesthetic administration vs. standard clinical practice without BIS. In one study that enrolled 2,500 patients at high risk of intraoperative awareness, explicit recall occurred in 0.17% of patients when BIS monitors were used and in 0.91% of patients managed by routine clinical practice. A small (30 patients) single-blinded study (the anesthesiologists were blinded to the recorded BIS values) compared BIS monitoring with clinical signs during cardiac surgery, and reported one episode of recall in the clinical signs group compared to no episodes in the BIS-monitored group. But decreased awareness isn’t the only benefit of aware- ness monitoring. Non-randomized comparative studies also reported that higher index values (on the BIS scale of 0 to 100) upon arrival in the PACU, related to shorter recovery times and lower anesthetic usage among patients monitored with BIS compared to patients not monitored with BIS.

By incorporating BIS technology into monitoring modules and aggressively pursuing early adopters, Aspect has not had any real competition in the U.S. market. In previous years, Physiometrix (North Billierica, Massachusetts) tried to enter the market but sold very few monitors in spite of its formidable distribution partner, Baxter (Deerfield, Illinois). Nonetheless, Hospira (Lake Forest, Illinois) was willing to spend about $23 million plus repayment of Physiometrix’s bank debt, which totaled another $1 million, to acquire the company. Hospira is a specialty pharmaceutical and medication delivery company that was spun out of Abbott Laboratories (Abbott Park, Illinois).

Hospira noted that while $24 million was a large price to pay, the acquisition provides it with an entry point into the brain-function monitoring market and a technology platform that can be further expanded. It also believes that the Physiometrix technology broadens Hospira’s portfolio for the hospital operating room and intensive care unit, and has an important strategic link to other key Hospira product lines including their medication management systems.

Theoretically, Hospira is well positioned to possibly become a major competitor of Aspect if it can overcome the barrier to entry the latter firm has carefully erected. To date there has not been any other company willing to devote as many resources to the sales and marketing of the Physiometrix product, and Hospira claims to be making investments in both R&D and in the product’s sales force. It has repackaged the device under the SEDLine brain-function monitoring system identity and plans to leverage its established relationships with hospital ICUs and surgical suites, where it already has a significant drug management and delivery business.

The pitch will be that not only does the monitor aid in evaluating the effects of anesthesia and sedation, but can minimize the potential for either over- or under-medicating a patient, speeding a patient’s recovery and expediting hospital discharge. Hospira believes the synergy with its medication management and delivery business will help SEDLine sales in spite of Aspect’s dominant market position. This benefit on consciousness monitoring has already been proven by Aspect.

There are at least four additional companies offering consciousness-monitoring products in the worldwide market and they were in attendance at the ASA conference as well. GE Healthcare (Waukesha, Wisconsin) offers the Entropy brain function monitor, which also tracks depth of anesthesia. The GE monitor is available only in modular form, and not as a stand-alone device. Although that limits the accessibility to only those hospitals that use GE patient monitoring systems, it helps that GE Healthcare is the second-largest supplier of patient monitoring devices in the U.S. hospital market. It also means that GE is the only company that offers two different modules for monitoring level of awareness. Aspect offers a module for all major patient-monitoring systems currently. The algorithm for calculation of Entropy in the EEG signal is in the public domain and detailed descriptions have recently been published. This approach is welcome and an example for others to follow. Other vendors have chosen not to make their algorithms public.

Like Aspect, Hospira and others, GE’s Entropy also utilizes a 0-to-100 index scale to measure the depth of anesthesia. GE Healthcare says that a key differentiator between Entropy and other competitors’ products is that Entropy provides real-time monitoring information. The company claims most anesthesia monitors have a lag time of up to 30 seconds, but Entropy updates facial muscle information every two seconds and EEG every 15 seconds, which gives the anesthesia provider both additional and more timely data.

Danmeter USA (Indianapolis) is another company just entering the consciousness-sedation market with a hand-held portable device that is smaller than some Palm Pilots. It refers to its fuzzy logic-based scale as the Cerebral State Index. Cleared by the FDA in January 2005, Danmeter, like GE, believes that one of the key differentiators in its device is the short two- to six-second reporting delay. Danmeter also believes the ease of portability of its device that enables the caregiver to transport the monitor with the patient through both the operating room and recovery room also sets it apart.

Everest Biomedical Instruments (Chesterfield, Missouri) was a newer company at ASA that was showcasing a depth-of-anesthesia monitor dubbed SNAP II. The company refers to its index as a SNAP index. Although currently installed in investigational sites only (not yet available to the public), Everest Biomedical said its believes that a differential benefit of its technology is its combination of both low- and high-frequency EEG-derived indices. Although slightly larger than the Danmeter CSI monitor, its device is hand-held as well, with a seemingly user-friendly color touch screen.

Lastly, the Narcotrend monitor from MonitorTechnik (Hanover, Germany) also was listed in the ASA Advisory as an available technology for monitoring consciousness sedation, but the company did not have a booth at the ASA. MonitorTechnik classifies its monitor’s results as a letter scale, with “A” representing awake, “B” representing sedated, “C” light anesthesia, “D” general anesthesia, “E” general anesthesia with deep hypnosis, and “F” general anesthesia with increasing burst suppression. In a nod to Aspect’s BIS market grip, however, MonitorTechnik has recently “translated” the alphabet-based Narcotrend scale into a 0 to 100 index, with the stated intention of producing a scale quantitatively similar to the BIS index. This introduces a real problem, however, and a major point of confusion, because the level of consciousness a patient has at 50 on a BIS monitor is not the same as on the other four devices. Without a consistent meaning of “50” on all monitors, the potential for confusion is multiplied. This is an issue that the FDA has not adequately addressed in granting market clearance.

On the oximetry front

There were other types of devices being showcased on the ASA exhibit floor as well. Masimo (Irvine, California) was showcasing its breakthrough non-invasive monitoring technology called Masimo Rainbow SET Pulse CO-Oximetry. Now, in addition to SpO₂, carbon monoxide (and potentially other vital parameters) can be safely and accurately monitored continuously and non-invasively. The Masimo Rainbow SET platform was developed with the intent to deliver accurate monitoring not only of CO non-invasively, but also parameters such as methemoglobin (SpMet) and fractional arterial oxygen saturation (SpaO₂) as well. The Rad-57 is the first step, combining CO and SpO₂ into one device, but we believe derivative devices in the future will be able to handle the other parameters as well.

Many on the exhibit floor were not only talking about Masimo’s new technology, but also the status of its patent infringement battles with Nellcor (Pleasanton, California). All fourth- and fifth-generation Nellcor oximetry products (Oxismart XL, OxiMax, N395, N595, N550 NPB40, MP404, MP506, MP100) were found to infringe upon Masimo patents, whether in a multi-parameter patient monitor or in a stand-alone configuration. Damage was assessed at nearly $165 million in Masimo’s favor.

What does this mean for companies that currently have Nellcor oximeters? What about hospitals that are looking to replace their current Nellcor oximetry with a newer version? These were the questions being floated around the ASA exhibit hall by other vendors who are watching the situation unfold. Several monitoring vendors privately attested that the Masimo issue was much bigger than all the fuss surrounding brain-function monitors.

In other pulse oximetry news, Aspen Medical Products (Irvine, California) was promoting its relationship with Sentec AG (Therwil, Switzerland). Aspen is the U.S. distributor of a device known as the CO-OXSYS monitoring system. This device, available in Europe for more than two years, received 510(k) clearance in the U.S. roughly a year prior to the 2005 ASA meeting and Aspen has been marketing the product for several months. The system has an ear-clip sensor and offers continuous monitoring of SpO₂, PcCO₂, SaO₂ and PR.

Patient monitoring vendors also were busy at the ASA gathering, displaying both new and updated devices. Drager Medical (Telford, Pennsylvania) hailed its receipt of a 2005 Frost & Sullivan (New York) Award for Technology Innovation in the multiparameter patient monitoring market. The award recognizes Drager’s Pick and Go technology, available in its Infinity series of patient monitors. This system eliminates the need for separate transport monitors. The concept behind the Pick and Go technology is that an Infinity multiparameter monitor moves with the patient through various care areas such as from the emergency room to the intensive care unit.

Drager also was showcasing its innovative Apollo anesthesia gas machine platform, which provides an open platform architecture that allows it to integrate with ease into a hospital’s existing workflow. Besides offering breathing sound emulation for times when the anesthesiologist has to turn his or her back to the patient, the machine includes Drager’s third-generation piston ventilator, which the company feels is what really separates it from its competition.

Spacelabs Medical (Issaquah, Washington), an OSI Systems (Hawthorne, California) company, introduced the Blease Frontline Sirius 3000 Anesthesia gas machine to the U.S. market. Blease (Chesham, England), also an OSI Systems company, has been selling the machine in Europe for some time, and has now brought a customized version of the machine to the U.S. under the Spacelabs banner. Although it was informally introducing the machine at the ASA, Spacelabs has yet to begin marketing it in the U.S. even though it recently received 510(k) clearance to do so.

With Spacelabs’ announcement, GE Healthcare, Drager Medical, Datascope (Montvale, California) and Spacelabs all have gas machine entries in the U.S. That means all of the major monitoring vendors, with one notable exception, can consider themselves full-spectrum suppliers. The one exception is Philips Medical Systems (Andover Massachusetts), the overwhelming patient monitoring market share leader with well over 40% of all patient-monitoring installations in the U.S. Look for Philips to respond in some fashion, as it is not likely to allow its competitors to corner the gas machine segment.

Spacelabs also reported that it was entering into a multi-year, worldwide development and licensing agreement with Aspect Medical to incorporate its BISx technology into Spacelabs’ Ultraview SL patient-monitoring systems. Joe Davin, president of Spacelabs global sales & marketing, said, “Spacelabs was the first company to offer BIS technology integrated into patient monitoring systems. We’re pleased to meet our customers’ needs by expanding the collaboration to offer the state-of-the art BIS/x/ system with the Ultraview SL family of patient monitors.”

In other monitoring news, Nihon Kohden (Foothill Ranch, California) said it has received FDA 510(k) clearance on its new NTX non-invasive telemetry transmitter. The NTX transmitter is capable of monitoring ECG, SpO_2, respiration and NIBP. It was designed to give hospitals more flexible monitoring on high-acuity patients. In the past, patients requiring NIBP monitoring have been confined to a hard-wired bedside monitor, limiting their mobility.

Medrad (Indianola, Pennsylvania), a monitoring company that specializes in MRI monitoring, was showcasing its Continuum MR Compatible Infusion System, which features a one-touch automatic bolus, programmable flow rate and bolus limits, as well as an integrated 20 ml to 60 ml syringe holder. This infusion pump system also is compatible with MRI scanners up to and including field strengths of 1.5 Tesla.

Picis (Wakefield, Massachusetts) reported that four more large academic medical centers – University of Kentucky Hospital (Lexington), University Hospitals Health System (Cleveland), University Health System (San Antonio) and Medical University of South Carolina (Charleston) have chosen CareSuite as the information system to help optimize their perioperative services and patient care.

A non-monitoring medical device company, Sienco (Arvada, Colorado), was showing its instrument for measuring coagulation and platelet function in whole blood or plasma, the Sonoclot Coagulation & Platelet Function Analyzer. The Sonoclot Analyzer incorporates Sienco’s whole blood clot detection mechanism and helps clinicians provide more effective clinical management in operating rooms, coagulation labs, STAT labs and intensive care units. This technology would be useful for patients requiring extensive surgeries, for those undergoing major organ surgeries or major orthopedic surgeries or for those prone to developing strokes.

Surgical Information Systems (Alpharetta, Georgia), which also competes in the perioperative software systems market, reported a record third quarter for total revenue and operating income, with a 39% increase in total revenue over the first nine months of 2004. The company experienced a 31% increase in total license revenue to date, compared to the same nine-month period for the prior year, along with a 40% increase in operating income. Revenue growth was attributed to an increase of 125% in new accounts added year to date, as well as momentum from add-on sales with existing customers. During the first nine months of 2005, SIS added numerous key accounts, and said it had recently updated its billing and code-capturing software, adding the belief that such steps help sets it apart based on workflow orientation.

As the ASA celebrates its first 100 years it will be interesting to see what the next century brings. Will the society be at the cutting edge of the adoption of devices that make the surgical experience not only more pleasant for patients, but more importantly, safer? Will the ASA continue to work to ensure that surgical deaths continue to drop and that new technology is encouraged? That will be reality if the ASA places patients at the forefront of its decision-making process and takes steps to make it all happen. These would be impressive achievements in a climate of more acute patient conditions, escalating malpractice costs, shrinkage of reimbursement and increasing deaths from medical errors.