BBI Contributing Editor

LAS VEGAS The late-October annual meeting of the American Society of Anesthesiologists (ASA; Park Ridge, Illinois) was attended by more than 18,500 people and included 300 exhibitors. The conference seemed a bit smaller than in previous years, although the vastness of the Las Vegas Convention Center may have created this impression. There was no lack of important issues. Indeed, there were three with profound implications for patients, anesthesiologists and equipment manufacturers:

1) The growing problem of patient awareness during surgery.
2) The historic problem of anesthesiologists "flying blind," with vital signs alarms turned off during surgery.
3) The emerging problem of misfires of implanted cardioverter defibrillators during surgery.

These are issues that many anesthesiologists have not paid attention to, and have put their heads in the sand and instead focused on complaining that malpractice insurance premiums continue to go up. While tort reform may well be needed, what also is needed are fewer mistakes and adverse outcomes.

Adverse outcome, thwarted discussion

Being awake during surgery is an adverse outcome that generally means poor quality anesthesiology care, yet it happens 40,000 times a year in the U.S. alone, and the ASA has done little to deal with it except oppose public discussion of the issue. In October 2003, evidence was publicized that patient awareness was a growing problem, but the ASA, led by Jeffrey Apfelbaum, MD, of the University of Chicago, took the position that unless there was absolute evidence that brain monitoring reduced awareness, the society would continue to do nothing.

Never mind a plethora of clinical comments, including articles and editorials in The Lancet and Acta Anaesthesiologica Scandinavicia. Or the FDA clearance of Aspect Medical Systems' (Newton, Massachusetts) Bispectral Index (BIS) monitor as a device that tracks the hypnotic component of anesthesia. Or the Joint Commission on Accreditation of Healthcare Organizations (JCAHO; Oakbrook Terrace, Illinois) Sentinel Alert mandating that all providers now track and document any indication of patient awareness during surgery. Or the 1,700 clinical papers on the subject or the 82% reduction in awareness documented in studies where BIS is used. Apparently, that isn't sufficient scientific evidence for the ASA to act, but only for it to form a Task Group to "study" the evidence. And who should be named to lead the task force? The aforementioned Dr. Apfelbaum, who as a spokesperson for the ASA has been bashing consciousness monitoring since the 2003 meeting of the society. The Apfelbaum task force charged to review the depth-of-anesthesia crisis was slated to hold closed-door meetings at the Las Vegas gathering to impartially evaluate the "evidence."

The word on the exhibit floor, from a longtime ASA member, was that the Apfelbaum task force was stacked with anesthesiologists who oppose making depth-of-sedation monitoring a standard of care in anesthesiology. In frustration, that doctor recounted negative comments made by some on the ASA Task Force the day before it was to meet during the ASA meeting. Hearing on the ASA exhibit floor that the impartiality of the task force was suspect, BBI decided to cover the meeting but was told by the ASA that press were not allowed. In an unusual move, the society also changed both the location and time of the meeting from that published in the conference schedule. But in spite of the confusion, more than 150 people found and attended the meeting, making it one of the largest "secret" meetings in ASA history. Even after the meeting was held, the ASA refused to provide any details from it in response to our requests, saying that no one in the organization would comment on the meeting until after the task group made its report, some time in the next calendar year.

After the meeting, BBI interviewed two persons who did attend, who described the gathering as "lively and contentious." At the outset of the meeting it was reported that the task group would have a public presentation and comment at the March 2005 International Anesthesia Research Society (IARS) meeting and would bring a draft guideline to the full House of Delegates at the 2005 ASA meeting next October. Our "insiders," however, told us that when Scott Kelley, medical director of Aspect Medical, made the case for BIS monitoring, there was applause from the 150 attendees. That may have been a signal to Apfelbaum that there was more support for brain monitoring among a broad cross-section of the ASA membership than had previously been thought. The task group reportedly had substantial support for brain monitoring, particularly BIS monitoring, apparently softening from the society's pre-conference position that there "wasn't enough evidence to make brain consciousness monitoring a standard of care."

Our insiders said several anesthesiologists rose to speak in support of consciousness monitoring at the meeting, including Fawzy Estafanous, MD, chief of anesthesiology at the Cleveland Clinic, who recounted the story of how BIS monitoring had become a standard of care at that institution, being used essentially on all patients. This had come about after surgery on the CEO of the clinic, who was able to return to his office and work only two hours after his procedure. When he inquired why his recovery was so fast, and learned it was due to BIS monitoring, he mandated its use on all patients. Estafanous recounted that since that change in policy, not a single episode of "awareness" during surgery has occurred at the clinic, compared to a few such episodes over the same time period in the past, before BIS monitoring was mandated.

Dr. Ira Rampil reportedly commented during the meeting, "The evidence for the benefits of BIS is significant why do we even need this task force?" Such remarks were echoed by an unidentified California anesthesiologist who said, "My partner and I do all our own cases, without CRNA or residents. We have done thousands of cases with and without BIS, and know now that we are not smart enough to do any case without BIS."

At this point, roughly 80% through the meeting, Dr. Orin (Fred) Guidry, president-elect of the ASA, reminded all present that it was in everyone's common interest to advance patient care and safety and advance brain monitoring during surgery. Those remarks reinforced what the two attendees who spoke to BBI about the session termed "a more positive tone" for the balance of the meeting. It is unfortunate that the ASA was so slow to schedule this meeting, occurring as it did after the reports in The Lancet and elsewhere, and the October issuance of the JCAHO Sentinel Event Alert on awareness. The late timing of the meeting gave the appearance of ASA being behind the curve on this important issue. Nonetheless, it is helpful that proposals for final guidelines will be taken up at next year's ASA meetings. We believe it likely that some brain monitoring guideline will be adopted, leaving it open to individual physicians to determine which of the various devices available will be the ones to use. This brings us to the vendor implications of these developments.

It is clear, if ASA makes brain monitoring a new guideline, that a handful of companies are lined up potentially to benefit from this change. These include Aspect Medical, Physiometrix (North Billerica, Massachusetts), Monitor-Technik (Bad Bramstedt, Germany), GE Healthcare (Milwaukee, Wisconsin), with its acquired Datex Entropy Monitoring, and Danmeter A/S (Odense, Denmark). Alaris Medical (San Diego) has abandoned the market already and therefore will have no benefit. However, the remaining potential beneficiaries are not equally well positioned to benefit either.

The only company with an FDA-approved claim on "depth of anesthesia" tracking is Aspect Medical. It also is the company that has far more published research on the effectiveness of its products than the others a total of more than 1,700 papers so far. And it has the most diverse distribution channels, with 10 monitoring companies selling its products, as well as its own direct sales organizations. Apart from the one-time sale of BIS monitors, the ongoing sales of the disposable sensor array will drive company growth. Aspect's competitors are not as well positioned. All of its OEM channel partners will benefit at least from the instrument sales as well, but less so in terms of ongoing sensor sales.

However, two other contenders might see a revival of sorts. Physiometrix, due to its Baxter (Deerfield, Illinois) distribution channels, and Monitor-Technik, with its NarcoTrend device. However, clinical evidence for the effectiveness of either of these devices is less than for Aspect's BIS device, and some recent papers raise questions about the effectiveness of some non-BIS devices.

The other company that could benefit is GE Healthcare, as it is the only vendor able to offer Aspect's BIS monitoring as well as its own Entropy monitor, which uses the same Aspect electrode sensor array. By offering both technologies, GE is positioned to differentiate itself from Philips Medical Systems (Andover, Massachusetts), Spacelabs (Issaquah, Washington), Draeger (Telford, Pennsylvania), Datascope (Mahwah, New Jersey) and the other OEM distributors of BIS, which might bring it modest incremental business. However, in multi-unit sales of patient monitoring, deals turn on issues generally a bit less specific than such product features.

'Flying blind' grows as issue

The second important issue addressed at this year's ASA gathering was the practice by many anesthesiologists of disabling the alarms of other patient vital signs monitoring devices and "flying blind" during anesthesia an issue the society has ignored for more than a decade. But this year, with the issuance of a recommendation by the Anesthesiology Patient Safety Foundation (APSF; Indianapolis) that at least one alarm be left enabled during all general anesthesia, the ASA again found itself pressured by an outside organization to clean up its unsafe practices and utilize the monitoring devices that already exist to make surgery and anesthesiology safer and pain-free. Why do anesthesiologists disable alarms? When we asked several anesthesiologists this question, they cited "frequent false alarms" and the related "noise in the OR environment" as the reason for turning off the alarms on patient monitors. If you compare that rationale to the anesthesiology records that doctors create for patients, one finds few variations in the vital signs charted that could trigger the audible alarm of a vital signs device monitoring these patients, except during induction and late emergence. During maintenance, when an anesthesized patient lying on an operating table is not moving, he or she would not be expected to trigger "frequent false alarms." This raises an important question: Are the anesthesiology records that are manually charted by anesthesiologists accurate reflections of the actual vital signs that patients have? Or are the record's contents being routinely selectively screened to show the patient receiving a more uneventful course of anesthesia then they actually receive? Do anesthesiologists take the question of why they disable the alarms seriously, or are they ignoring the question, just as they did the issue of alertness during surgery? If there are in fact frequent false alarms, then the charting they are doing is fraudulent, or the alarms range is set improperly. If there are no frequent false alarms, then their justification for turning them off is a deception. Either way there is a problem that the ASA has chosen to ignore for more than a decade.

The truth of the statements that there are frequent false alarms will be answered as soon as anesthesiologists adopt automatic anesthesia charting systems, called for by the APSF more than two years ago, to be adopted by 2007. These systems will read the vital signs data directly from all vital signs and anesthetic agent ID monitors and chart them in a manner that the anesthesiologists cannot change after the fact. One reason why many anesthesiologists oppose the implementation of such systems may be that they don't want a system that allows scrutiny of what actually happens during surgery rather than what they represent happened during surgery. Yet these systems are coming, and the best hospitals, concerned about public report cards, are increasingly investing in automated anesthesiology charting systems and other systems to manage the OR practice, materials, staff and billing situation. Companies that are well positioned to benefit from the more widespread adoption of surgical information systems include Eko Systems (Fairfax, Virginia), Picis (Wakefield, Massachusetts), Philips, GE Healthcare, Draeger, Surgical Information Systems (Alpharetta, Georgia) and a few others. All of these companies offer systems that at least provide the automated capture and charting of the anesthesia record during the procedure.

The continued reluctance of the ASA to endorse the use of the technology that already exists sends a poor message to the medical device industry as a whole an industry that has invested hundreds of millions of research dollars on brain monitoring and other devices over the last decade with the expectation that there would be a market for their devices particularly when the incremental cost/procedure is less than $15 and use of such monitoring shortens emergence and recovery time, reduces complications and improves one-year mortality. Fortunately, government and other regulatory organizations (such as JCAHO) have moved in this vacuum of unwillingness to address problems and are beginning to impose regulations on the ASA to protect patients. What is needed are even more aggressive requirements to inform patients about what actually will transpire during surgery. Anesthesiologists need to disclose to patients whether or not they will be using brain monitoring or will routinely be disabling vital sign alarms as part of "informed consent" process so that patients can decide if they wish to receive anesthesia from that provider before they submit to surgery.

So far, as with BIS, calls for the widespread adoption of anesthesiology information management systems have not been taken seriously by the ASA. The society has been encouraged by the APSF to adopt computerized anesthesia charting systems by 2007; but until the vendors of such systems believe the ASA will adopt such a standard, the changes needed to their systems to implement the APSF-endorsed data dictionary of terminology will not be widely implemented, in spite of its adoption as part of the College of American Pathologists' (Northfield, Illinois) SNOMED (systematized nomenclature of medicine) clinical terms. Companies are justifiably reluctant to spend money changing their systems when there is no apparent willingness on the part of the ASA to support their adoption as a standard of practice. The time has come for anesthesia information systems to be mandated as a standard of care in all surgical procedures where a patient is given general anesthesia, so that an accurate, second-by-second, legal record of what actually transpires in the OR is created.

Dealing with ICDs is a growing problem

The Las Vegas meeting revealed additional problems in anesthesiology on the horizon, not the least of which is how to properly manage the increasing number of elderly patients who have implanted cardioverter defibrillators (ICDs) or implanted brain stimulators during surgery. Will the ASA proactively address such problems or wait until there is sufficient data in its closed-claims file to change the practice related to anesthesia for patients with ICDs and/or brain pacers? Patients with ICDs have a greatly increased risk in the OR compared to other patients, and more and more patients up to 400,000 per year are candidates to have ICDs implanted. Patients with ICDs who need surgery will be a ballooning problem as the baby boomers age and receive such devices. The risk is for a misfire of the ICD (which can occur spontaneously or as a result of using monopolar electrosurgical generators or bipolar generators in coagulate rather than cut mode) to suddenly occur creating unexpected patient movement that can lead to irreversible surgical errors. One case mentioned by an instructor at the ASA's "Refresher Course" involved the permanent loss of an eye by a patient whose ICD fired during surgery, an event that typically leads to a multi-million-dollar settlement.

The problem is how to properly disable ICDs, which also provide pacemaker functionality during surgery, so that the surgical procedure can be conducted without the risk of unexpected discharges. The answer is not simple, as ICDs from different manufactures require different programmers to disable them. Some (Medtronic) models can be disabled with "smart magnets," while other models (from Guidant) provide an audible tone that indicates when they are enabled and disabled. Yet even when using magnets, there is no indication whether the device has been properly disabled and therefore cannot fire. The problem of turning off the ICDs before surgery, determining if external pacing is required, then turning them back on and restoring their programs to pre-surgical settings after surgery, is one that only a small percentage of anesthesiologists are familiar with and prepared to address. Indeed, consults from cardiologists or involvement by the ICD device sales or technical support people is required in some cases where the anesthesiologist is not an ICD expert, and such personnel are not always available.

Given the response from the audience observed in the Refresher Course presentations, expertise in this area is not something approaching anything uniform among practicing anesthesiologists. If the ASA is concerned about minimizing malpractice settlements in the future and holding down increases in malpractice insurance, it needs to act now to enact safe procedures and call on the manufacturers of these devices especially Medtronic (Minneapolis), Guidant (Indianapolis), St. Jude (St. Paul, Minnesota) and others to adopt changes that will make this problem more manageable. One solution is a worldwide or at least national standard for the programming interface to implanted ICDs so that a hospital has to invest in only one universal programmer to interrogate and program an ICD from any U.S. manufacturer. The ASA should call on the FDA to mandate this as a precondition for the clearance of any new ICD to be sold in the U.S. and for all replacement ICDs implanted after a particular date. Better indication of what mode the ICD is in also should be mandated. This is already a benefit of the Guidant ICDs, which have an audible intermittent or continuous tone that indicates the mode the ICD is set to (defib-enabled or disabled). This is helpful to the anesthesiologist who needs to be sure that the ICD defib function is disabled during surgery and can't be inadvertently triggered by the surgeon using an electrocautery device. It would be very positive if the ASA and APSF would work with the American College of Cardiology (ACC; Bethesda, Maryland) to push for vendors to adopt a uniform, universal programmer for their various ICDs and other implanted devices. Given the battery life of ICDs, the problem could be solved in less than 10 years if addressed now. The FDA and JCAHO should call together the ICD manufacturers and host the development of such a standard, which could only make surgery safer and reduce future malpractice claims.

On the ASA exhibit floor

This year's ASA conference was a showcase for many technological advances. Draeger was showing its new Apollo gas machine, an upper mid-range product with integrated Draeger vital sign and agent monitors and a revamped and expanded Draeger anesthesia information system (AIM) workstation. The product is pending FDA approval in the U.S., so was shown as a work in progress only. Market clearance was expected to occur in the next few months, so anesthesiologists should be able to purchase the new device early this year. It is an advanced piston-driven, rather than bellows-driven, design better able to deliver gas volumes and support the newest, patient-assisted breathing modes. Draeger also was showing its family of recently introduced patient monitors.

GE Healthcare, which competitors said had been bidding its own patient monitors in recent competitive situations, nonetheless was showing the recently acquired Datex A/S monitors, mounted on their family of Datex gas machines. GE is the clear market leader, but the Draeger Apollo gas machine may cut into that lead in new negotiations.

Datascope was showing its latest Panorama mon- itors along with its own gas machine. It also was showing a new networking and central station, perhaps in a move to dispel the notion, created by its larger competitors, that it was primarily an ambulatory surgical products company. Datascope seems to be repositioning itself to compete in a broader cross-section of the patient monitoring market.

No such uncertainty exists about Nihon Kohden America (NK; Foothill Ranch, California), the hottest and fastest-growing small competitor in the U.S. market. This company has doubled its market share over the last two years in a row and appears to be on the way to doing so again when its fiscal year ends in March. Nihon Kohden offers not as broad a range of products as its larger competitors, but a lower list price, a much longer warranty and technological innovations that set it apart from its larger rivals. One such innovation is the miniaturization that allows the signal conditioning to occur in the sensor cable connectors, rather than in the monitor itself. This allows various different sensors to be plugged into a number of universal connectors on the monitor case. These optional parameters augment the basic parameters built into the monitor, yet are very inexpensive. A typical blood pressure channel adds only $170 to the cost of the basic monitor, much less than other companies charge. Four pressures could be added for less than the cost of one pressure in some other systems. Another thing that impressed us about the Nihon Kohden approach was the robustness of its networking, which supports both wired and WMTS wireless networking. Unlike Draeger, for example, which communicates configuration settings to its monitors when it is attached to its "docking" station, the NK approach is to communicate this via the network itself, eliminating the need for and cost of the docking station as part of the system configuration.

Another innovation is the integration of arrhythmia, ST segment and trend processing in the basic monitor, eliminating the need for attachment to a central station to provide these advanced capabilities. This allows Nihon Kohden's monitors to be used in stand-alone and transport situations while maintaining advanced monitoring features, something that many competitive portable bedside monitors are not able to do. NK's monitors continue to monitor and record all real-time data as well as trends and upload this more complete profile when they are reconnected to a central station through either a cabled or wireless local area network (LAN). Indeed, the transfer of all patient data and demographics across a wireless LAN is an impressive capability of the company's networking approach, one that is not duplicated by many of its larger competitors.

The newest Nihon Kohden monitors include full anesthetic agent ID and tracking and innovative etCO₂ capability that could be initiated with intubated patients but maintained after the endotracheal tube is removed and the patient is breathing spontaneously in either the PACU or ICU setting where ventilation has been discontinued. Nihon Kohden is gaining market share more rapidly than Draeger, Datascope and Welch Allyn (Skaneateles Falls, New York), which didn't exhibit at this ASA meeting). By mid-2005, NK may surpass Draeger and Welch Allyn and further close the gap on Datascope. It is clearly a company positioned as a single-source supplier for the entire hospital, not just the perioperative setting; and a viable one based on the products we saw exhibited at the ASA meeting. If it can gain some group purchasing organization recognition and access, it has a chance of emerging as a major contender in the U.S. market over the next two to three years.

Conmed (Utica, New York), a company best known for its Nellcor (Pleasanton, California)-compatible and other compatible sensors, showed up at ASA with several interesting new monitors, some of which were still works in progress, as they did not yet have FDA market clearance. The most interesting was an endotracheal (ET) tube that had sensors that allowed determination of cardiac output. The sensor array used surrounds the ET tube, and so it does not require a lot of positioning and "fiddling" as the patient position changes. The specially modified ET tubes are perfect doubles for conventional ET tubes, but have the additional sensors required on the balloon to provide this important physiological measurement. The monitor they connect to then displays hemodynamic values continuously, providing important supplemental information to the anesthesiologist for patients with severe cardiopulmonary disease.

Invivo/Intermagnetics General (Orlando, Florida) was showing the newest members of its M-series family, an integration of former Invivo and Medical Data Electronics (MDE; Arleta, California) monitoring technologies. These new products give Invivo a broader range of solutions for the perioperative setting in the hospital or in the ambulatory surgical center, as well as in other inpatient settings, ranging from emergency department, neonatal ICU to telemetry stepdown and moderate acuity ICUs. Coupled with a new marketing direction, and soon to be announced new corporate identity, Invivo is poised to become a bigger player in the patient monitoring market, while maintaining its position as the market leader in the magnetic resonance (MR) monitoring segment.

Two other MR monitoring competitors also were showing devices at ASA. Schiller was showing its current MR monitor, and Medrad (Indianola, Pennsylvania) was showing its unit. Schiller said that GE is now acting as a sales agent for its MR monitors. That would provide additional sales coverage and exposure and have the potential of creating additional market interest in its MR monitor. We expect to see at least one major new MR monitor from one of these three companies by the end of 1Q05. Given pressure from both of its current competitors, Invivo may have its hands full sustaining its dominant market share in this small niche segment.

This was a very important ASA meeting, something the organization almost seemed to go out of its way to suppress. It may be time for the society to rethink its goals, making changes to better serve its members, patients and the public, in achieving what should be a shared goal of making anesthesia safer.